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Sample records for adults trial registration

  1. Clinical trial registration in oral health journals.

    PubMed

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

    2015-03-01

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

  2. Legislation for trial registration and data transparency.

    PubMed

    Bian, Zhao-Xiang; Wu, Tai-Xiang

    2010-05-26

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

  3. The Quality of Registration of Clinical Trials

    PubMed Central

    Viergever, Roderik F.; Ghersi, Davina

    2011-01-01

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

  4. Trials registration: a new era in Thailand.

    PubMed

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

    2013-10-01

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

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

    PubMed

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

    2012-08-01

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

  6. 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.

  7. 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.

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

    PubMed Central

    2007-01-01

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

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

    PubMed

    Sim, Ida

    2008-01-01

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

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

    PubMed

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

    2007-09-01

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

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

    PubMed

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

    2011-07-01

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

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

    PubMed

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

    2016-04-01

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

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

    PubMed

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

    2006-04-18

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

  15. 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

  16. Family experiences of young adult sex offender registration.

    PubMed

    Comartin, Erin B; Kernsmith, Poco D; Miles, Bart W

    2010-03-01

    Since 1994, policies have been instituted throughout the United States that require sex offenders to register their personal information with law enforcement officials (Jacob Wetterling Crimes against Children and Sexually Violent Offender Registration Program, 1994). With the passage of additional laws, this information is now available to the public via the Internet or a request to a police department. These laws have brought about consequences for both the registrants and for members of their families. A focus group was held with four mothers who have sons listed on the Michigan Sex Offender Registry. Psychological and social consequences of registration were found and policy implications are discussed.

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

    PubMed

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

    2013-01-01

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

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

    PubMed Central

    2013-01-01

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

  19. 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

  20. 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

  1. Family Experiences of Young Adult Sex Offender Registration

    ERIC Educational Resources Information Center

    Comartin, Erin B.; Kernsmith, Poco D.; Miles, Bart W.

    2010-01-01

    Since 1994, policies have been instituted throughout the United States that require sex offenders to register their personal information with law enforcement officials (Jacob Wetterling Crimes against Children and Sexually Violent Offender Registration Program, 1994). With the passage of additional laws, this information is now available to the…

  2. ADULTS: A RANDOMIZED CONTROLLED CLINICAL TRIAL

    PubMed Central

    Shah, Krupa N.; Majeed, Zahraa; Yoruk, Yilmaz B.; Yang, Hongmei; Hilton, Tiffany N.; McMahon, James M.; Hall, William J.; Walck, Donna; Luque, Amneris E.; Ryan, Richard M.

    2016-01-01

    Objective HIV-infected older adults (HOA) are at risk of functional decline. Interventions promoting physical activity that can attenuate functional decline and are easily translated into the HOA community are of high priority. We conducted a randomized, controlled clinical trial to evaluate whether a physical activity counseling intervention based on self-determination theory (SDT) improves physical function, autonomous motivation, depression and the quality of life (QOL) in HOA. Methods A total of 67 community-dwelling HOA with mild-to-moderate functional limitations were randomized to one of two groups: a physical activity counseling group or the usual care control group. We used SDT to guide the development of the experimental intervention. Outcome measures that were collected at baseline and final study visits included a battery of physical function tests, levels of physical activity, autonomous motivation, depression, and QOL. Results The study participants were similar in their demographic and clinical characteristics in both the treatment and control groups. Overall physical performance, gait speed, measures of endurance and strength, and levels of physical activity improved in the treatment group compared to the control group (p<0.05). Measures of autonomous regulation such as identified regulation, and measures of depression and QOL improved significantly in the treatment group compared to the control group (p<0.05). Across the groups, improvement in intrinsic regulation and QOL correlated with an improvement in physical function (p<0.05). Conclusion Our findings suggest that a physical activity counseling program grounded in SDT can improve physical function, autonomous motivation, depression, and QOL in HOA with functional limitations. PMID:26867045

  3. 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

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

    PubMed Central

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

    2016-01-01

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

  5. Competency to stand trial in preadjudicatory juveniles and adults.

    PubMed

    McKee, G R

    1998-01-01

    This study compared the competency to stand trial (CST) of 108 juveniles (ages 7 to 16 years) and 145 adults (17 years or older) undergoing pretrial, court-ordered forensic psychiatric evaluations. Adults were superior on both global and specific competency abilities (p < .001). Clustered by age (<13, 13 and 14, 15 and 16 years old), preteens accused of crimes failed to meet a Dusky v. United States standard, while 13- and 14-year-olds displayed an equal mix of abilities and deficits. Mid-adolescents (ages 15 and 16) were equivalent to adults in CST abilities except in their knowledge about plea bargaining elements. The ramifications of CST in felony juvenile transfer to adult court as well as the needs for ecologically valid, empirically based CST research on adolescents is discussed.

  6. Design of the Prevention of Adult Caries Study (PACS): A randomized clinical trial assessing the effect of a chlorhexidine dental coating for the prevention of adult caries

    PubMed Central

    2010-01-01

    Background Dental caries is one of the primary causes of tooth loss among adults. It is estimated to affect a majority of Americans aged 55 and older, with a disproportionately higher burden in disadvantaged populations. Although a number of treatments are currently in use for caries prevention in adults, evidence for their efficacy and effectiveness is limited. Methods/Design The Prevention of Adult Caries Study (PACS) is a multicenter, placebo-controlled, double-blind, randomized clinical trial of the efficacy of a chlorhexidine (10% w/v) dental coating in preventing adult caries. Participants (n = 983) were recruited from four different dental delivery systems serving four diverse communities, including one American Indian population, and were randomized to receive either chlorhexidine or a placebo treatment. The primary outcome is the net caries increment (including non-cavitated lesions) from baseline to 13 months of follow-up. A cost-effectiveness analysis also will be considered. Discussion This new dental treatment, if efficacious and approved for use by the Food and Drug Administration (FDA), would become a new in-office, anti-microbial agent for the prevention of adult caries in the United States. Trial Registration Number NCT00357877 PMID:20923557

  7. Electronic Cigarette Trial and Use among Young Adults: Reasons for Trial and Cessation of Vaping

    PubMed Central

    Biener, Lois; Song, Eunyoung; Sutfin, Erin L.; Spangler, John; Wolfson, Mark

    2015-01-01

    This paper identifies predictors of trial and current use, and reasons for trying and ceasing use of electronic cigarettes (e-cigarettes) among young adults, with particular attention to former and never smokers. Data are from a mail survey of a population-based sample of adults aged 18 to 35 (N = 4740) in three U.S. metropolitan areas. Survey items assessed trial and use of e-cigarettes, cigarette smoking status, and reasons for trial and for ceasing use of e-cigarettes. Almost 23% reported trial of e-cigarettes, and 8.4% reported using them in the past month. Current smokers were much more likely to have tried e-cigarettes (70.2%) than both former (32.3%) and never smokers (7.6%; p < 0.001) and to have used them in the past month (30.8%, 10.1%, 2.0% respectively; p < 0.001). Smoking status and scores on sensation seeking were significant independent predictors of both trial and current use of e-cigarettes. Never-smokers cite curiosity as the reason for trying e-cigarettes and also that their friends used them. The most frequent reason for ceasing use among never and former smokers was health concerns. For virtually none of them were e-cigarettes their first exposure to nicotine. PMID:26694438

  8. Electronic Cigarette Trial and Use among Young Adults: Reasons for Trial and Cessation of Vaping.

    PubMed

    Biener, Lois; Song, Eunyoung; Sutfin, Erin L; Spangler, John; Wolfson, Mark

    2015-12-17

    This paper identifies predictors of trial and current use, and reasons for trying and ceasing use of electronic cigarettes (e-cigarettes) among young adults, with particular attention to former and never smokers. Data are from a mail survey of a population-based sample of adults aged 18 to 35 (N = 4740) in three U.S. metropolitan areas. Survey items assessed trial and use of e-cigarettes, cigarette smoking status, and reasons for trial and for ceasing use of e-cigarettes. Almost 23% reported trial of e-cigarettes, and 8.4% reported using them in the past month. Current smokers were much more likely to have tried e-cigarettes (70.2%) than both former (32.3%) and never smokers (7.6%; p < 0.001) and to have used them in the past month (30.8%, 10.1%, 2.0% respectively; p < 0.001). Smoking status and scores on sensation seeking were significant independent predictors of both trial and current use of e-cigarettes. Never-smokers cite curiosity as the reason for trying e-cigarettes and also that their friends used them. The most frequent reason for ceasing use among never and former smokers was health concerns. For virtually none of them were e-cigarettes their first exposure to nicotine.

  9. A randomized controlled trial to promote volunteering in older adults.

    PubMed

    Warner, Lisa M; Wolff, Julia K; Ziegelmann, Jochen P; Wurm, Susanne

    2014-12-01

    Volunteering is presumed to confer health benefits, but interventions to encourage older adults to volunteer are sparse. Therefore, a randomized controlled trial with 280 community-dwelling older German adults was conducted to test the effects of a theory-based social-cognitive intervention against a passive waiting-list control group and an active control intervention designed to motivate physical activity. Self-reports of weekly volunteering minutes were assessed at baseline (5 weeks before the intervention) as well as 2 and 6 weeks after the intervention. Participants in the treatment group increased their weekly volunteering minutes to a greater extent than participants in the control groups 6 weeks after the intervention. We conclude that a single, face-to-face group session can increase volunteering among older community-dwelling adults. However, the effects need some time to unfold because changes in volunteering were not apparent 2 weeks after the intervention.

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

    PubMed Central

    Pater, Cornel

    2004-01-01

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

  11. A randomised, controlled trial of a dietary intervention for adults with major depression (the “SMILES” trial): study protocol

    PubMed Central

    2013-01-01

    Background Despite increased investment in its recognition and treatment, depression remains a substantial health and economic burden worldwide. Current treatment strategies generally focus on biological and psychological pathways, largely neglecting the role of lifestyle. There is emerging evidence to suggest that diet and nutrition play an important role in the risk, and the genesis, of depression. However, there are limited data regarding the therapeutic impact of dietary changes on existing mental illness. Using a randomised controlled trial design, we aim to investigate the efficacy and cost-efficacy of a dietary program for the treatment of Major Depressive Episodes (MDE). Methods/Design One hundred and seventy six eligible participants suffering from current MDE are being randomised into a dietary intervention group or a social support group. Depression status is assessed using the Montgomery–Åsberg Depression Rating Scale (MADRS) and Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (Non Patient Edition) (SCID-I/NP). The intervention consists of 7 individual nutrition consulting sessions (of approximately 60 minutes), delivered by an Accredited Practising Dietitian (APD). Sessions commence within one week of baseline assessment. The intervention focuses on advocating a healthy diet based on the Australian Dietary Guidelines and the Dietary Guidelines for Adults in Greece. The control condition comprises a befriending protocol using the same visit schedule and length as the diet intervention. The study is being conducted at two locations in Victoria, Australia (a metropolitan and regional centre). Data collection occurs at baseline (pre-intervention), 3-months (post-intervention) and 6– months. The primary endpoint is MADRS scores at 3 months. A cost consequences analysis will determine the economic value of the intervention. Discussion If efficacious, this program could provide an alternative or adjunct treatment

  12. Risk/MRD adapted GMALL trials in adult ALL.

    PubMed

    Gökbuget, N; Raff, R; Brügge-Mann, M; Flohr, T; Scheuring, U; Pfeifer, H; Bartram, C R; Kneba, M; Hoelzer, D

    2004-01-01

    The German Multicenter Study Group for Adult ALL (GMALL) conducts since 1984 trials with risk adapted study design. The model of conventional prognostic factors comprises now WBC, age, immunophenotype, cytogenetics and molecular genetics. Risk stratification according to these factors allows a highly significant prediction of relapse risk in adult ALL. In the recent GMALL study minimal residual disease (MRD) was added to the risk model. Trials in childhood and adult ALL showed convincingly that MRD is a relevant and independent prognostic factor. It is of particular value in standard risk (SR) patients as defined by conventional factors. In the current GMALL study a risk stratification according to conventional factors is followed by a MRD based stratification in SR patients. Whereas high and very high risk patients receive a stem cell transplantation (SCT) in first CR after induction and first consolidation, SR patients receive cyclic consolidation therapy for one year with MRD monitoring. At the end of the first year a stratification according to course and level of MRD takes place. Treatment is stopped in patients with low risk whereas in high risk patients a SCT is planned. Patients who cannot be allocated to either group are treated as intermediate risk and receive one year of intensified maintenance therapy. Preliminary results show that MRD based risk stratification is feasible and that the treatment recommendations for MRD based risk groups are reasonable. In the future however an earlier identification of high risk patients (after 4 months) will be attempted.

  13. Promoting advance planning for health care and research among older adults: A randomized controlled trial

    PubMed Central

    2012-01-01

    end of the intervention and 6 months later to assess improvement in predictive accuracy and cost savings, if any. Copies of completed guides are made at the time of these assessments. Discussion This study will determine whether the tested intervention guides proxies in making decisions that concur with those of older adults, motivates the latter to record their wishes in writing, and yields savings for the healthcare system. Trial Registration ISRCTN89993391 PMID:22221980

  14. Resist diabetes: A randomized clinical trial for resistance training maintenance in adults with prediabetes

    PubMed Central

    Davy, Brenda M.; Winett, Richard A.; Savla, Jyoti; Marinik, Elaina L.; Baugh, Mary Elizabeth; Flack, Kyle D.; Halliday, Tanya M.; Kelleher, Sarah A.; Winett, Sheila G.; Williams, David M.; Boshra, Soheir

    2017-01-01

    Objective To determine whether a social cognitive theory (SCT)-based intervention improves resistance training (RT) maintenance and strength, and reduces prediabetes prevalence. Research design and methods Sedentary, overweight/obese (BMI: 25–39.9 kg/m2) adults aged 50–69 (N = 170) with prediabetes participated in the 15-month trial. Participants completed a supervised 3-month RT (2×/wk) phase and were randomly assigned (N = 159) to one of two 6-month maintenance conditions: SCT or standard care. Participants continued RT at a self-selected facility. The final 6-month period involved no contact. Assessments occurred at baseline and months 3, 9, and 15. The SCT faded-contact intervention consisted of nine tailored transition (i.e., supervised training to training alone) and nine follow-up sessions. Standard care involved six generic follow-up sessions. Primary outcomes were prevalence of normoglycemia and muscular strength. Results The retention rate was 76%. Four serious adverse events were reported. After 3 months of RT, 34% of participants were no longer prediabetic. This prevalence of normoglycemia was maintained through month 15 (30%), with no group difference. There was an 18% increase in the odds of being normoglycemic for each % increase in fat-free mass. Increases in muscular strength were evident at month 3 and maintained through month 15 (P<0.001), which represented improvements of 21% and 14% for chest and leg press, respectively. Results did not demonstrate a greater reduction in prediabetes prevalence in the SCT condition. Conclusions Resistance training is an effective, maintainable strategy for reducing prediabetes prevalence and increasing muscular strength. Future research which promotes RT initiation and maintenance in clinical and community settings is warranted. Trial Registration ClinicalTrials.gov NCT01112709. PMID:28231265

  15. Group hypnosis vs. relaxation for smoking cessation in adults: a cluster-randomised controlled trial

    PubMed Central

    2013-01-01

    Background Despite the popularity of hypnotherapy for smoking cessation, the efficacy of this method is unclear. We aimed to investigate the efficacy of a single-session of group hypnotherapy for smoking cessation compared to relaxation in Swiss adult smokers. Methods This was a cluster-randomised, parallel-group, controlled trial. A single session of hypnosis or relaxation for smoking cessation was delivered to groups of smokers (median size = 11). Participants were 223 smokers consuming ≥ 5 cigarettes per day, willing to quit and not using cessation aids (47.1% females, M = 37.5 years [SD = 11.8], 86.1% Swiss). Nicotine withdrawal, smoking abstinence self-efficacy, and adverse reactions were assessed at a 2-week follow-up. The main outcome, self-reported 30-day point prevalence of smoking abstinence, was assessed at a 6-month follow up. Abstinence was validated through salivary analysis. Secondary outcomes included number of cigarettes smoked per day, smoking abstinence self-efficacy, and nicotine withdrawal. Results At the 6-month follow up, 14.7% in the hypnosis group and 17.8% in the relaxation group were abstinent. The intervention had no effect on smoking status (p = .73) or on the number of cigarettes smoked per day (p = .56). Smoking abstinence self-efficacy did not differ between the interventions (p = .14) at the 2-week follow-up, but non-smokers in the hypnosis group experienced reduced withdrawal (p = .02). Both interventions produced few adverse reactions (p = .81). Conclusions A single session of group hypnotherapy does not appear to be more effective for smoking cessation than a group relaxation session. Trial registration Current Controlled Trials ISRCTN72839675. PMID:24365274

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

    PubMed

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

    2011-12-01

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

  17. 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…

  18. The EARN-Health Trial: protocol for a randomised controlled trial to identify health effects of a financial savings programme among low-income US adults

    PubMed Central

    Basu, Sanjay; Hamad, Rita; White, Justin S; Modrek, Sepideh; Rehkopf, David H; Cullen, Mark R

    2015-01-01

    Introduction A theory within the social epidemiology field is that financial stress related to having inadequate financial savings may contribute to psychological stress, poor mental health and poor health-related behaviours among low-income US adults. Our objective is to test whether an intervention that encourages financial savings among low-income US adults improves health behaviours and mental health. Methods and analysis A parallel group two-arm controlled superiority trial will be performed in which 700 participants will be randomised to the intervention or a wait list. The intervention arm will be provided an online Individual Development Account (IDA) for 6 months, during which participants receive a $5 incentive (£3.2, €4.5) for every month they save $20 in their account (£12.8, €18), and an additional $5 if they save $20 for two consecutive months. Both groups will be provided links to standard online financial counselling materials. Online surveys in months 0 (prior to randomisation), 6 and 12 (6 months postintervention) will assess self-reported health behaviours and mental health among participants in both arms. The surveys items were tested previously in the US Centers for Disease Control and Prevention national health interviews and related health studies, including self-reported overall health, health-related quality of life, alcohol and tobacco use, depression symptoms, financial stress, optimism and locus of control, and spending and savings behaviours. Trial data will be analysed on an intent-to-treat basis. Ethics and dissemination This protocol was approved by the Institutional Review Board of Stanford University (Protocol ID: 30641). The findings of the trial will be disseminated through peer-reviewed publication. Trial registration number Identifier NCT02185612; Pre-results. PMID:26443663

  19. Plasticity of Attentional Functions in Older Adults after Non-Action Video Game Training: A Randomized Controlled Trial

    PubMed Central

    Mayas, Julia; Parmentier, Fabrice B. R.; Andrés, Pilar; Ballesteros, Soledad

    2014-01-01

    A major goal of recent research in aging has been to examine cognitive plasticity in older adults and its capacity to counteract cognitive decline. The aim of the present study was to investigate whether older adults could benefit from brain training with video games in a cross-modal oddball task designed to assess distraction and alertness. Twenty-seven healthy older adults participated in the study (15 in the experimental group, 12 in the control group. The experimental group received 20 1-hr video game training sessions using a commercially available brain-training package (Lumosity) involving problem solving, mental calculation, working memory and attention tasks. The control group did not practice this package and, instead, attended meetings with the other members of the study several times along the course of the study. Both groups were evaluated before and after the intervention using a cross-modal oddball task measuring alertness and distraction. The results showed a significant reduction of distraction and an increase of alertness in the experimental group and no variation in the control group. These results suggest neurocognitive plasticity in the old human brain as training enhanced cognitive performance on attentional functions. Trial Registration ClinicalTrials.gov NCT02007616 PMID:24647551

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

    PubMed

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

    2017-03-02

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

  1. 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.

  2. Computer Enabled Neuroplasticity Treatment: A Clinical Trial of a Novel Design for Neurofeedback Therapy in Adult ADHD

    PubMed Central

    Cowley, Benjamin; Holmström, Édua; Juurmaa, Kristiina; Kovarskis, Levas; Krause, Christina M.

    2016-01-01

    Background: We report a randomized controlled clinical trial of neurofeedback therapy intervention for ADHD/ADD in adults. We focus on internal mechanics of neurofeedback learning, to elucidate the primary role of cortical self-regulation in neurofeedback. We report initial results; more extensive analysis will follow. Methods: Trial has two phases: intervention and follow-up. The intervention consisted of neurofeedback treatment, including intake and outtake measurements, using a waiting-list control group. Treatment involved ~40 h-long sessions 2–5 times per week. Training involved either theta/beta or sensorimotor-rhythm regimes, adapted by adding a novel “inverse-training” condition to promote self-regulation. Follow-up (ongoing) will consist of self-report and executive function tests. Setting: Intake and outtake measurements were conducted at University of Helsinki. Treatment was administered at partner clinic Mental Capital Care, Helsinki. Randomization: We randomly allocated half the sample then adaptively allocated the remainder to minimize baseline differences in prognostic variables. Blinding: Waiting-list control design meant trial was not blinded. Participants: Fifty-four adult Finnish participants (mean age 36 years; 29 females) were recruited after screening by psychiatric review. Forty-four had ADHD diagnoses, 10 had ADD. Measurements: Symptoms were assessed by computerized attention test (T.O.V.A.) and self-report scales, at intake and outtake. Performance during neurofeedback trials was recorded. Results: Participants were recruited and completed intake measurements during summer 2012, before assignment to treatment and control, September 2012. Outtake measurements ran April-August 2013. After dropouts, 23 treatment and 21 waiting-list participants remained for analysis. Initial analysis showed that, compared to waiting-list control, neurofeedback promoted improvement of self-reported ADHD symptoms, but did not show transfer of learning to T

  3. 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

  4. Randomized Trial of Hypnosis as a Pain and Symptom Management Strategy in Adults with Sickle Cell Disease

    PubMed Central

    Wallen, Gwenyth R; Middleton, Kimberly R; Ames, Nancy; Brooks, Alyssa T; Handel, Daniel

    2014-01-01

    Sickle cell disease (SCD) is the most common genetic disease in African-Americans, characterized by recurrent painful vaso-occlusive crises. Medical therapies for controlling or preventing crises are limited because of efficacy and/or toxicity. This is a randomized, controlled, single-crossover protocol of hypnosis for managing pain in SCD patients. Participants receive hypnosis from a trained hypnosis therapist followed by six weeks of self-hypnosis using digital media. Those in the control arm receive SCD education followed by a six-week waiting period before crossing over to the hypnosis arm of the study. Outcome measures include assessments of pain (frequency, intensity and quality), anxiety, coping strategies, sleep, depression, and health care utilization. To date, there are no published randomized, controlled trials evaluating the efficacy of hypnosis on SCD pain modulation in adults. Self-hypnosis for pain management may be helpful in modulating chronic pain, improving sleep quality, and decreasing use of narcotics in patients with SCD. TRIAL REGISTRATION ClinicalTrials.gov: NCT00393250 PMID:25520557

  5. The debate in favour of using simulation education in pre-registration adult nursing.

    PubMed

    McCallum, Jacqueline

    2007-11-01

    The purpose of this paper is to have a fresh look at the literature on the advantages and disadvantages of simulation education as a teaching, learning and assessment methodology within pre-registration nurse education. It will highlight the reasons why simulation education has been re-introduced into nurse education within many Higher Education Institutions (HEI) in the United Kingdom (UK). This is in an attempt to enable the student nurse to develop competence in the clinical skills required for fitness for award, practice and purpose. This comes at a time when the Nursing and Midwifery Council (NMC) are conducting further research on simulation education and whether it can replace practice hours.

  6. A cognitive-behavioral intervention for emotion regulation in adults with high-functioning autism spectrum disorders: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Adults with high-functioning autism spectrum disorders (ASD) have difficulties in social communication; thus, these individuals have trouble understanding the mental states of others. Recent research also suggests that adults with ASD are unable to understand their own mental states, which could lead to difficulties in emotion-regulation. Some studies have reported the efficacy of cognitive-behavioral therapy (CBT) in improving emotion-regulation among children with ASD. The current study will investigate the efficacy of group-based CBT for adults with ASD. Methods/Design The study is a randomized, waitlist controlled, single-blinded trial. The participants will be 60 adults with ASD; 30 will be assigned to a CBT group and 30 to a waitlist control group. Primary outcome measures are the 20-item Toronto Alexithymia Scale, the Coping Inventory for Stressful Situations, the Motion Picture Mind-Reading task, and an ASD questionnaire. The secondary outcome measures are the Center for Epidemiological Studies Depression Scale, the World Health Organization Quality of Life Scale 26-item version, the Global Assessment of Functioning, State-trait Anxiety Inventory, Social Phobia and Anxiety Inventory, and Liebowitz Social Anxiety Scale. All will be administered during the pre- and post-intervention, and 12 week follow-up periods. The CBT group will receive group therapy over an 8 week period (one session per week) with each session lasting approximately 100 minutes. Group therapy will consist of four or five adults with ASD and two psychologists. We will be using visual materials for this program, mainly the Cognitive Affective Training kit. Discussion This trial will hopefully indicate the efficacy of group-based CBT for adults with high- functioning ASD. Trial registration This trial was registered in The University Hospital Medical Information Network Clinical Trials Registry No. UMIN000006236. PMID:23880333

  7. Protocol for Fit Bodies, Fine Minds: a randomized controlled trial on the affect of exercise and cognitive training on cognitive functioning in older adults

    PubMed Central

    O'Dwyer, Siobhan T; Burton, Nicola W; Pachana, Nancy A; Brown, Wendy J

    2007-01-01

    Background Declines in cognitive functioning are a normal part of aging that can affect daily functioning and quality of life. This study will examine the impact of an exercise training program, and a combined exercise and cognitive training program, on the cognitive and physical functioning of older adults. Methods/Design Fit Bodies, Fine Minds is a randomized, controlled trial. Community-dwelling adults, aged between 65 and 75 years, are randomly allocated to one of three groups for 16 weeks. The exercise-only group do three 60-minute exercise sessions per week. The exercise and cognitive training group do two 60-minute exercise sessions and one 60-minute cognitive training session per week. A no-training control group is contacted every 4 weeks. Measures of cognitive functioning, physical fitness and psychological well-being are taken at baseline (0 weeks), post-test (16 weeks) and 6-month follop (40 weeks). Qualitative responses to the program are taken at post-test. Discussion With an increasingly aged population, interventions to improve the functioning and quality of life of older adults are particularly important. Exercise training, either alone or in combination with cognitive training, may be an effective means of optimizing cognitive functioning in older adults. This study will add to the growing evidence base on the effectiveness of these interventions. Trial Registration Australian Clinical Trials Register: ACTRN012607000151437 PMID:17915035

  8. Clinical Trial of an Oral Live Shigella sonnei Vaccine Candidate, WRSS1, in Thai Adults

    PubMed Central

    Islam, Dilara; Chamnanchanunt, Supat; Ruamsap, Nattaya; Khantapura, Patchariya; Kaewkungwal, Jaranit; Kittitrakul, Chatporn; Luvira, Viravarn; Dhitavat, Jittima; Venkatesan, Malabi M.; Mason, Carl J.; Bodhidatta, Ladaporn

    2016-01-01

    Live attenuated Shigella sonnei vaccine candidate WRSS1, previously tested in U.S. and Israeli volunteers, was evaluated in a population of adult Thai volunteers in which the organism is endemic. In a randomized placebo-controlled, double-blind design, inpatient participants received a single oral dose of 1.6 × 104 CFU of WRSS1. The vaccine was generally well tolerated, with equal numbers of vaccinees and placebo controls showing mild symptoms. Only 3 of 13 vaccinees (23%) had culture-positive stools, while a total of 9 vaccinees were positive by PCR. Lack of vaccine shedding in volunteers correlated with lack of clinical symptoms and immune responses, just as the duration of fecal shedding correlated directly with stronger immune responses. Two months following immunization, 10 vaccinees and 10 newly recruited naive controls received a challenge dose of 1,670 CFU of virulent S. sonnei strain 53G. This dose had previously demonstrated a 75% attack rate for dysentery in Thai volunteers. However, in this study the attack rate for dysentery in naive controls after challenge was 20%. Based on clinical record summaries, 3 vaccinees and 5 naive controls experienced clinically relevant illness (diarrhea/dysentery/fever/shigellosis), and a 40% vaccine efficacy was calculated. When these data are compared to those for the performance of this vaccine candidate in more naive populations, it is clear that a single oral dose of WRSS1 at 104 CFU failed to achieve its full potential in a population in which the organism is endemic. Higher doses and/or repeated immunizations may contribute to improved vaccine shedding and consequent elevation of protective immune responses in a population in which the organism is endemic. (The study has been registered at ClinicalTrials.gov under registration no. NCT01080716.) PMID:27146000

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

    PubMed Central

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

    2016-01-01

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

  10. The Walking Interventions Through Texting (WalkIT) Trial: Rationale, Design, and Protocol for a Factorial Randomized Controlled Trial of Adaptive Interventions for Overweight and Obese, Inactive Adults

    PubMed Central

    Hurley, Jane C; Hollingshead, Kevin E; Todd, Michael; Jarrett, Catherine L; Tucker, Wesley J; Angadi, Siddhartha S

    2015-01-01

    Background Walking is a widely accepted and frequently targeted health promotion approach to increase physical activity (PA). Interventions to increase PA have produced only small improvements. Stronger and more potent behavioral intervention components are needed to increase time spent in PA, improve cardiometabolic risk markers, and optimize health. Objective Our aim is to present the rationale and methods from the WalkIT Trial, a 4-month factorial randomized controlled trial (RCT) in inactive, overweight/obese adults. The main purpose of the study was to evaluate whether intensive adaptive components result in greater improvements to adults’ PA compared to the static intervention components. Methods Participants enrolled in a 2x2 factorial RCT and were assigned to one of four semi-automated, text message–based walking interventions. Experimental components included adaptive versus static steps/day goals, and immediate versus delayed reinforcement. Principles of percentile shaping and behavioral economics were used to operationalize experimental components. A Fitbit Zip measured the main outcome: participants’ daily physical activity (steps and cadence) over the 4-month duration of the study. Secondary outcomes included self-reported PA, psychosocial outcomes, aerobic fitness, and cardiorespiratory risk factors assessed pre/post in a laboratory setting. Participants were recruited through email listservs and websites affiliated with the university campus, community businesses and local government, social groups, and social media advertising. Results This study has completed data collection as of December 2014, but data cleaning and preliminary analyses are still in progress. We expect to complete analysis of the main outcomes in late 2015 to early 2016. Conclusions The Walking Interventions through Texting (WalkIT) Trial will further the understanding of theory-based intervention components to increase the PA of men and women who are healthy, insufficiently

  11. A Text Messaging-Based Smoking Cessation Program for Adult Smokers: Randomized Controlled Trial

    PubMed Central

    Bağcı Bosi, A Tülay; Korchmaros, Josephine; Emri, Salih

    2012-01-01

    Background Despite promising data in Western countries, there is a dearth of research into the efficacy of text messaging-based smoking cessation programs in other settings, including the Middle East, where smoking prevalence rates are higher. Objective This paper reports cessation rates observed in SMS Turkey, a text messaging-based smoking cessation program for adult smokers in Ankara, Turkey. Methods This study was a small-scale, parallel-group randomized controlled trial (RCT) conducted in Ankara, Turkey. Participants were adult daily smokers who were seriously thinking about quitting in the next 15 days and living in Ankara, Turkey. The text messaging intervention, SMS Turkey, provided 6 weeks of daily messages aimed at giving participants skills to help them quit smoking. Messages were sent in an automated fashion, except 2 days and 7 days after the initial quit day. On days 2 and 7, the research assistant manually assigned participants to content “paths” based on whether they were still not smoking or had relapsed. The control arm received a brochure that provided similar information about smoking cessation. The main outcome measure was self-reported 3-month sustained abstinence, verified by carbon monoxide (CO) readings. Neither participants nor researchers were blinded to arm assignment. Results The 151 participants were randomly assigned to 1 of 2 groups: 76 to the SMS Turkey intervention group and 75 to the brochure control group. Using intention to treat, all 151 participants were included in analyses. Three-month cessation trends were not significantly higher in the intervention group: 11% intervention vs 5% control had quit (χ2 1=1.4, P=.24; R2=2.0, 95% CI 0.62-6.3). When the sample was stratified by sex, female intervention participants (14%, n=5) were significantly more likely to have quit at 3 months than female control participants (0%, n=0; χ2 1=3.7, P=.05). Among light smokers (ie, those smoking less than 20 cigarettes per day

  12. Alendronate Once Weekly for the Prevention and Treatment of Bone Loss in Canadian Adult Cystic Fibrosis Patients (CFOS Trial)

    PubMed Central

    Papaioannou, Alexandra; Kennedy, Courtney C.; Freitag, Andreas; Ioannidis, George; O’Neill, John; Webber, Colin; Pui, Margaret; Berthiaume, Yves; Rabin, Harvey R.; Paterson, Nigel; Jeanneret, Alphonse; Matouk, Elias; Villeneuve, Josee; Nixon, Madeline; Adachi, Jonathan D.

    2016-01-01

    Background Patients with cystic fibrosis (CF) are at risk for early bone loss, and demonstrate increased risks for vertebral fractures and kyphosis. A multicenter, randomized, controlled trial was conducted to assess the efficacy, tolerability, and safety of therapy with oral alendronate (FOSAMAX; Merck; Whitehouse Station, NJ) in adults with CF and low bone mass. Methods Participants received placebo or alendronate, 70 mg once weekly, for 12 months. All participants received 800 IV of vitamin D and 1,000 mg of calcium daily. Adults with confirmed CF with a bone mineral density (BMD) T score of < − 1.0 were eligible for inclusion. Participants who had undergone organ transplantation or had other reported contraindications were excluded from the study. The primary outcome measure was the mean (± SD) percentage change in lumbar spine BMD after 12 months. Secondary measures included the percentage change in total hip BMD, the number of new vertebral fractures (grade 1 or 2), and changes in quality of life. Results A total of56 participants were enrolled in the study (mean age, 29.1 ± 8.78 years; 61%male). The absolute percentage changes in lumbar spine and total hip BMDs at follow-up were significantly higher in the alendronate therapy group (5.20 ± 3.67% and 2.14 ± 3.32%, respectively) than those in the control group (− 0.08 ± 3.93% and − 1.3 ± 2.70%, respectively; p < 0.001). At follow-up, two participants (both in the control group) had a new vertebral fracture (not significant), and there were no differences in quality of life or the number of adverse events (including serious and GI-related events). Conclusion Alendronate therapy was well tolerated and produced a significantly greater increase in BMD over 12 months compared with placebo. Trial registration ClinicalTrials.gov Identifier: NCT00157690 PMID:18641106

  13. Economic evaluation of aerobic exercise training in older adults with vascular cognitive impairment: PROMoTE trial

    PubMed Central

    Davis, Jennifer C; Hsiung, Ging-Yuek Robin; Bryan, Stirling; Best, John R; Eng, Janice J; Munkacsy, Michelle; Cheung, Winnie; Chiu, Bryan; Jacova, Claudia; Lee, Philip; Liu-Ambrose, Teresa

    2017-01-01

    Background/objectives Evidence suggests that aerobic exercise may slow the progression of subcortical ischaemic vascular cognitive impairment (SIVCI) by modifying cardiovascular risk factors. Yet the economic consequences relating to aerobic training (AT) remain unknown. Therefore, our primary objective was to estimate the incremental cost per quality-adjusted life years (QALYs) gained of a thrice weekly AT intervention compared with usual care. Design Cost–utility analysis alongside a randomised trial. Setting Vancouver, British Columbia, Canada. Participants 70 adults (mean age of 74 years, 51% women) who meet the diagnostic criteria for mild SIVCI. Intervention A 6-month, thrice weekly, progressive aerobic exercise training programme compared with usual care (CON; comparator) with a follow-up assessment 6 months after formal cessation of aerobic exercise training. Measurements Healthcare resource usage was estimated over the 6-month intervention and 6-month follow-up period. Health status (using the EQ-5D-3L) at baseline and trial completion and 6-month follow-up was used to calculate QALYs. The incremental cost–utility ratio (cost per QALY gained) was calculated. Results QALYs were both modestly greater, indicating a health gain. Total healthcare costs (ie, 1791±1369 {2015 $CAD} at 6 months) were greater, indicating a greater cost for the thrice weekly AT group compared with CON. From the Canadian healthcare system perspective, the incremental cost–utility ratios for thrice weekly AT were cost-effective compared with CON, when using a willingness to pay threshold of $CAD 20 000 per QALY gained or higher. Conclusions AT represents an attractive and potentially cost-effective strategy for older adults with mild SIVCI. Trial registration number NCT01027858. PMID:28360247

  14. The Sonoma Water Evaluation Trial (SWET): A randomized drinking water intervention trial to reduce gastrointestinal illness in older adults

    EPA Science Inventory

    Objectives. We estimate the risk of highly credible gastrointestinal illness (HCGI) among adults 55 and older in a community drinking tap water meeting current U.S. standards. Methods. We conducted a randomized, triple-blinded, crossover trial in 714 households (988 indiv...

  15. Phases I–III Clinical Trials Using Adult Stem Cells

    PubMed Central

    Sanz-Ruiz, Ricardo; Gutiérrez Ibañes, Enrique; Arranz, Adolfo Villa; Fernández Santos, María Eugenia; Fernández, Pedro L. Sánchez; Fernández-Avilés, Francisco

    2010-01-01

    First randomized clinical trials have demonstrated that stem cell therapy can improve cardiac recovery after the acute phase of myocardial ischemia and in patients with chronic ischemic heart disease. Nevertheless, some trials have shown that conflicting results and uncertainties remain in the case of mechanisms of action and possible ways to improve clinical impact of stem cells in cardiac repair. In this paper we will examine the evidence available, analyze the main phase I and II randomized clinical trials and their limitations, discuss the key points in the design of future trials, and depict new directions of research in this fascinating field. PMID:21076533

  16. Internet-based vestibular rehabilitation for adults aged 50 years and over: a protocol for a randomised controlled trial

    PubMed Central

    Geraghty, Adam W A; Kirby, Sarah; Essery, Rosie; Little, Paul; Bronstein, Adolfo; Turner, David; Stuart, Beth; Andersson, Gerhard; Carlbring, Per; Yardley, Lucy

    2014-01-01

    the role of internet interventions in facilitating self-management in older adults. Trial registration number ISRCTN: 86912968. PMID:25052178

  17. 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

  18. Sutureless Adult Voluntary Male Circumcision with Topical Anesthetic: A Randomized Field Trial of Unicirc, a Single-Use Surgical Instrument

    PubMed Central

    2016-01-01

    Introduction The World Health Organization has solicited rapid and minimally invasive techniques to facilitate scale-up of voluntary medical male circumcision (VMMC). Study design Non-blinded randomized controlled field trial with 2:1 allocation ratio. Participants 75 adult male volunteers. Setting Outpatient primary care clinic. Intervention Open surgical circumcision under local anesthetic with suturing vs. Unicirc disposable instrument under topical anesthetic and wound sealing with cyanoacrylate tissue adhesive. Primary Outcome Intraoperative duration. Secondary Outcomes Intraoperative and postoperative pain; adverse events; time to healing; patient satisfaction; cosmetic result. Results The intraoperative time was less with the Unicirc technique (median 12 vs. 25 min, p < 0.001). Wound healing and cosmetic results were superior in the Unicirc group. Adverse events were similar in both groups. Conclusions VMMC with Unicirc under topical anesthetic and wound sealing with cyanoacrylate tissue adhesive is rapid, heals by primary intention with superior cosmetic results, and is potentially safer and more cost-effective than open surgical VMMC. Trial Registration Clinicaltrials.gov NCT02443792 PMID:27299735

  19. Methylphenidate Transdermal System in Adults with Past Stimulant Misuse: An Open-Label Trial

    ERIC Educational Resources Information Center

    McRae-Clark, Aimee L.; Brady, Kathleen T.; Hartwell, Karen J.; White, Kathleen; Carter, Rickey E.

    2011-01-01

    Objective: This 8-week, open-label trial assessed the efficacy of methylphenidate transdermal system (MTS) in 14 adult individuals diagnosed with ADHD and with a history of stimulant misuse, abuse, or dependence. Method: The primary efficacy endpoint was the Wender-Reimherr Adult ADHD Scale (WRAADS), and secondary efficacy endpoints included the…

  20. Designing a Weight Gain Prevention Trial for Young Adults: The CHOICES Study

    ERIC Educational Resources Information Center

    Lytle, Leslie A.; Moe, Stacey G.; Nanney, M. Susie; Laska, Melissa N.; Linde, Jennifer A.; Petrich, Christine A.; Sevcik, Sarah M.

    2014-01-01

    Background: Young adults are at risk for weight gain. Little is known about how to design weight control programs to meet the needs of young adults and few theory-based interventions have been evaluated in a randomized control trial. The Choosing Healthy Options in College Environments and Settings (CHOICES) study was funded to create a…

  1. A Systematic Review of Controlled Trials Evaluating Interventions in Adult Literacy and Numeracy

    ERIC Educational Resources Information Center

    Torgerson, Carole; Porthouse, Jill; Brooks, Greg

    2005-01-01

    This paper reports a systematic review of the quasi-experimental literature in the field of adult literacy and numeracy, published between 1980 and 2002. We included 27 controlled trials (CTs) that evaluated strategies and pedagogies designed to increase adult literacy and numeracy: 18 CTs with no effect sizes (incomplete data) and 9 CTs with full…

  2. 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

  3. Results from an Online Computer-Tailored Weight Management Intervention for Overweight Adults: Randomized Controlled Trial

    PubMed Central

    van Empelen, Pepijn; Boon, Brigitte; Borsboom, Gerard; Visscher, Tommy; Oenema, Anke

    2012-01-01

    Background Prevention of weight gain has been suggested as an important strategy in the prevention of obesity and people who are overweight are a specifically important group to target. Currently there is a lack of weight gain prevention interventions that can reach large numbers of people. Therefore, we developed an Internet-delivered, computer-tailored weight management intervention for overweight adults. The focus of the intervention was on making small (100 kcal per day), but sustained changes in dietary intake (DI) or physical activity (PA) behaviors in order to maintain current weight or achieve modest weight loss. Self-regulation theory was used as the basis of the intervention. Objective This study aims to evaluate the efficacy of the computer-tailored intervention in weight-related anthropometric measures (Body Mass Index, skin folds and waist circumference) and energy balance-related behaviors (physical activity; intake of fat, snacks and sweetened drinks) in a randomized controlled trial. Methods The tailored intervention (TI) was compared to a generic information website (GI). Participants were 539 overweight adults (mean age 47.8 years, mean Body Mass Index (BMI) 28.04, 30.9% male, 10.7% low educated) who where recruited among the general population and among employees from large companies by means of advertisements and flyers. Anthropometric measurements were measured by trained research assistants at baseline and 6-months post-intervention. DI and PA behaviors were assessed at baseline, 1-month and 6-month post-intervention, using self-reported questionnaires. Results Repeated measurement analyses showed that BMI remained stable over time and that there were no statistically significant differences between the study groups (BMI: TI=28.09, GI=27.61, P=.09). Similar results were found for waist circumference and skin fold thickness. Amount of physical activity increased and intake of fat, snacks and sweetened drinks decreased during the course of the

  4. A Randomized Clinical Trial of Cognitive Enhancement Therapy for Adults with Autism Spectrum Disorders

    DTIC Science & Technology

    2015-10-01

    This project is focused on conducting the first randomized-controlled trial of Cognitive Enhancement Therapy (CET) in 54 verbal adults with autism ...of the neuroplastic effects of CET on brain function in support of cognitive enhancement in adult autism . Analyses of treatment effects to date...the need and potential for CET to be a significant treatment advance for verbal adults with autism . Importantly, improvements were found in daily life function and in brain circuitry supporting core abilities.

  5. FDA Approved Registration of Erythromycin for Treatment of Bacterial Kidney Disease (BKD) in Juvenile and Adult Chinook Salmon : Annual Report, Reporting Period March 10, 1989 to March 9, 1990.

    SciTech Connect

    Moffitt, Christine A.

    1991-04-01

    Erythromycin is a therapeutic substance useful against bacterial kidney disease in salmon. In 1989 we began a multi year project to learn more about erythromycin applied to juvenile and adult salmon, with the goal of achieving registration of erythromycin with the US Food and Drug Administration. To begin the study, we studied the pharmacokinetics of erythromycin administered to both adult and juvenile chinook salmon. We monitored blood plasmas time curves from individual adult fish injected with two forms of injectable erythromycin using one of three routes of administration. In addition, we began experiments to evaluate hatchery applications of erythromycin to individually marked adult salmon, and we recovered blood tissues from these fish at the time of spawning. To determine how to use erythromycin in juvenile salmon, we evaluated the adsorption and elimination of erythromycin applied arterially and orally to individual juvenile fish. In feeding trials we determined the palatability to juvenile chinook salmon of feed made with one of two different carriers for erythromycin thiocyanate. 35 refs., 4 figs. , 3 tabs.

  6. Effect of running therapy on depression (EFFORT-D). Design of a randomised controlled trial in adult patients [ISRCTN 1894

    PubMed Central

    2012-01-01

    depression can be used as a standalone or as an add-on intervention. In specialised mental health care, chronic forms of depression, co-morbid anxiety or physical complaints and treatment resistance are common. An add-on strategy therefore seems the best choice. This is the first high quality large trial into the effectiveness of exercise as an add-on treatment for depression in adult patients in specialised mental health care. Trial registration Netherlands Trial Register (NTR): NTR1894 PMID:22260713

  7. Consumption of Sutherlandia frutescens by HIV-Seropositive South African Adults: An Adaptive Double-Blind Randomized Placebo Controlled Trial

    PubMed Central

    Williams, Karen; Gerkovich, Mary M.; Gqaleni, Nceba; Syce, James; Bartman, Patricia; Johnson, Quinton; Folk, William R.

    2015-01-01

    Background Sutherlandia frutescens (L.) R. Br. is widely used as an over the counter complementary medicine and in traditional medications by HIV seropositive adults living in South Africa; however the plant’s safety has not been objectively studied. An adaptive two-stage randomized double-blind placebo controlled study was used to evaluate the safety of consuming dried S. frutescens by HIV seropositive adults with CD4 T-lymphocyte count of >350 cells/μL. Methods In Stage 1 56 participants were randomized to S. frutescens 400, 800 or 1,200 mg twice daily or matching placebo for 24 weeks. In Stage 2 77 additional participants were randomized to either 1,200 mg S. frutescens or placebo. In the final analysis data from Stage 1 and Stage 2 were combined such that 107 participants were analysed (54 in the S. frutescens 1,200 mg arm and 53 in the placebo arm). Results S. frutescens did not change HIV viral load, and CD4 T-lymphocyte count was similar in the two arms at 24 weeks; however, mean and total burden of infection (BOI; defined as days of infection-related events in each participant) was greater in the S. frutescens arm: mean (SD) 5.0 (5.5) vs. 9.0 (12.7) days (p = 0.045), attributed to two tuberculosis cases in subjects taking isoniazid preventive therapy (IPT). Conclusion A possible interaction between S. frutescens and IPT needs further evaluation, and may presage antagonistic interactions with other herbs having similar biochemical (antioxidant) properties. No other safety issues relating to consumption of S. frutescens in this cohort were identified. Trial Registration ClinicalTrials.gov NCT00549523 PMID:26186450

  8. Stepped-care to prevent depression and anxiety in visually impaired older adults – design of a randomised controlled trial

    PubMed Central

    2013-01-01

    Background Subthreshold depression and anxiety are common in the growing population of visually impaired older adults and increase the risk of full-blown depressive or anxiety disorders. Adequate treatment may prevent the development of depression or anxiety in this high risk group. Method/design A stepped-care programme was developed based on other effective interventions and focus groups with professionals and patient representatives of three low vision rehabilitation organisations in the Netherlands and Belgium. The final programme consists of four steps: 1) watchful waiting, 2) guided self-help, 3) problem solving treatment, 4) referral to general practitioner. The (cost-)effectiveness of this programme is evaluated in a randomised controlled trial. Patients (N = 230) are randomly assigned to either a treatment group (stepped-care) or a control group (usual care). The primary outcome is the incidence of depressive and anxiety disorders, measured with the Mini International Neuropsychiatric Interview (MINI). Discussion Preventive interventions for depression and anxiety have received little attention in the field of low vision. A stepped-care programme that focuses on both depression and anxiety has never been investigated in visually impaired older adults before. If the intervention is shown to be effective, this study will result in an evidence based treatment programme to prevent depression or anxiety in patients from low vision rehabilitation organisations. The pragmatic design of the study greatly enhances the generalisability of the results. However, a possible limitation is the difficulty to investigate the contribution of each individual step. Trial registration Identifier: NTR3296 PMID:23937975

  9. Precursors to suicidality and violence on antidepressants: systematic review of trials in adult healthy volunteers

    PubMed Central

    Bielefeldt, Andreas Ø; Danborg, Pia B

    2016-01-01

    Objective To quantify the risk of suicidality and violence when selective serotonin and serotonin-norepinephrine reuptake inhibitors are given to adult healthy volunteers with no signs of a mental disorder. Design Systematic review and meta-analysis. Main outcome measure Harms related to suicidality, hostility, activation events, psychotic events and mood disturbances. Setting Published trials identified by searching PubMed and Embase and clinical study reports obtained from the European and UK drug regulators. Participants Double-blind, placebo-controlled trials in adult healthy volunteers that reported on suicidality or violence or precursor events to suicidality or violence. Results A total of 5787 publications were screened and 130 trials fulfilled our inclusion criteria. The trials were generally uninformative; 97 trials did not report the randomisation method, 75 trials did not report any discontinuations and 63 trials did not report any adverse events or lack thereof. Eleven of the 130 published trials and two of 29 clinical study reports we received from the regulatory agencies presented data for our meta-analysis. Treatment of adult healthy volunteers with antidepressants doubled their risk of harms related to suicidality and violence, odds ratio 1.85 (95% confidence interval 1.11 to 3.08, p = 0.02, I2 = 18%). The number needed to treat to harm one healthy person was 16 (95% confidence interval 8 to 100; Mantel-Haenszel risk difference 0.06). There can be little doubt that we underestimated the harms of antidepressants, as we only had access to the published articles for 11 of our 13 trials. Conclusions Antidepressants double the occurrence of events in adult healthy volunteers that can lead to suicide and violence. PMID:27729596

  10. An Internet-Based Intervention to Promote Mental Fitness for Mildly Depressed Adults: Randomized Controlled Trial

    PubMed Central

    Haverman, Merel; Kramer, Jeannet; Westerhof, Gerben J; Riper, Heleen; Walburg, Jan A; Boon, Brigitte; Bohlmeijer, Ernst

    2013-01-01

    Background Depression is a worldwide problem warranting global solutions to tackle it. Enhancing well-being has benefits in its own right and could be a good strategy for preventing depression. Providing well-being interventions via the Internet may have synergetic effects. Objective Psyfit (“mental fitness online”) is a fully automated self-help intervention to improve well-being based on positive psychology. This study examines the clinical effects of this intervention. Methods We conducted a 2-armed randomized controlled trial that compared the effects of access to Psyfit for 2 months (n=143) to a waiting-list control condition (n=141). Mild to moderately depressed adults in the general population seeking self-help were recruited. Primary outcome was well-being measured by Mental Health Continuum-Short Form (MHC-SF) and WHO Well-being Index (WHO-5); secondary outcomes were depressive symptoms, anxiety, vitality, and general health measured by Center for Epidemiological Studies Depression Scale (CES-D), Hospital Anxiety and Depression Scale Anxiety subscale (HADS-A), and Medical Outcomes Study-Short Form (MOS-SF) vitality and general health subscales, respectively. Online measurements were taken at baseline, 2 months, and 6 months after baseline. Results The dropout rate was 37.8% in the Psyfit group and 22.7% in the control group. At 2-month follow-up, Psyfit tended to be more effective in enhancing well-being (nonsignificantly for MHC-SF: Cohen’s d=0.27, P=.06; significantly for WHO-5: Cohen’s d=0.31, P=.01), compared to the waiting-list control group. For the secondary outcomes, small but significant effects were found for general health (Cohen’s d=0.14, P=.01), vitality (d=0.22, P=.02), anxiety symptoms (Cohen’s d=0.32, P=.001), and depressive symptoms (Cohen’s d=0.36, P=.02). At 6-month follow-up, there were no significant effects on well-being (MHC-SF: Cohen’s d=0.01, P=.90; WHO-5: Cohen’s d=0.26, P=.11), whereas depressive symptoms

  11. Telephone-delivered psychotherapy for rural-dwelling older adults with generalized anxiety disorder: study protocol of a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Generalized Anxiety Disorder (GAD), characterized by excessive and uncontrollable worry, has a negative impact on the health, well-being, and functioning of older adults. Cognitive behavioral therapy has demonstrated efficacy in reducing anxiety and worry in older adults, but the generalizability of these findings to community-dwelling older adults is unknown. The aim of the current study is to examine the efficacy of a cognitive-behavioral intervention delivered by telephone in reducing anxiety and worry in rural community-dwelling older adults with GAD. Methods/Design We propose a randomized controlled trial comparing telephone-delivered cognitive behavioral therapy (CBT-T) with nondirective supportive therapy (NST-T). One hundred seventy six adults 60 years and older diagnosed with GAD will be randomized to one of the two treatment conditions. The primary outcomes are self-report worry and clinician-rated anxiety. Secondary outcomes include depressive symptoms, sleep, quality of life, and functional status. Discussion It is hypothesized that CBT-T will be superior to NST-T in reducing anxiety and worry among older adults with GAD. Further, CBT-T is hypothesized to be superior to NST-T in reducing problems with depressive symptoms, sleep, functional status and quality of life. If this program is successful, it could be implemented as a low-cost program to treat late-life anxiety, especially in rural areas or in circumstances where older adults may not have access to qualified mental health providers. Trial registration clinicaltrials.gov Identifier: NCT01259596 PMID:24506950

  12. Toward onset prevention of cognitive decline in adults with Down syndrome (the TOP-COG study): study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    sample size for a definitive RCT will be estimated under alternative assumptions. Discussion This study is important, as AD is a major problem for Down syndrome adults, for whom there are currently no effective preventions or treatments. It will also delineate the most suitable assessment instruments for this population. Recruitment of intellectually disabled adults is notoriously difficult, and we shall provide valuable information on this, informing future studies. Trial registration Current Controlled Trials ISRCTN Register ID: ISRCTN67338640 (17 November 2011) PMID:24888381

  13. Peer volunteers in an integrative pain management program for frail older adults with chronic pain: study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Chronic pain is common among the older population. A literature review on pain management program showed that exercise, yoga, massage therapy, Tai Chi, and music therapy could significantly reduce pain. In spite of the proven benefits of pain management programs, these intervention programs were effective only in the short term, and older adults would resume their old habits. It has been suggested that interventions comprising some type of social support have great potential to increase the participation of older adults. Therefore, we propose the inclusion of peer volunteers in an integrated pain management program to relieve pain among frail older adults. This study aims to explore the effectiveness of an integrated pain management program supplemented with peer volunteers in improving pain intensity, functional mobility, physical activity, loneliness levels, happiness levels, and the use of non-pharmacological pain-relieving methods among frail older adults with chronic pain. Methods/Design We intend to recruit 30 nursing home residents and 30 peer volunteers from the Institute of Active Ageing in Hong Kong in a group trial for an 8-week group-based integrated pain management program. There will be 16 sessions, with two 1-hour sessions each week. The primary outcome will be pain levels, while secondary outcomes will be assessed according to functional mobility, physical activity, loneliness levels, happiness levels, the use of non-pharmacological pain-relieving methods, and through a questionnaire for volunteers. Discussion In view of the high prevalence of chronic pain among older adults and its adverse impacts, it is important to provide older adults with tools to control their pain. We propose the use of peer volunteers to enhance the effects of an integrated pain management program. It is expected that pain can be reduced and improvements can be achieved among older adults in the areas of physical activity, functional mobility, loneliness levels

  14. A Randomized Clinical Trial of Cognitive Enhancement Therapy for Adults with Autism Spectrum Disorders

    DTIC Science & Technology

    2013-10-01

    Autism Spectrum Disorders PRINCIPAL INVESTIGATOR: Nancy J. Minshew, M.D. CONTRACTING ORGANIZATION: University of Pittsburgh...Enhancement Therapy for Adults with Autism Spectrum Disorders 5a. CONTRACT NUMBER W81XWH-11-1-0665 5b. GRANT NUMBER W81XWH-11-1-0665 5c. PROGRAM...project is focused on conducting the first randomized-controlled trial of Cognitive Enhancement Therapy (CET) in 54 verbal adults with autism spectrum

  15. Open-Label Trial of Immunogenicity and Safety of a 13-Valent Pneumococcal Conjugate Vaccine in Adults ≥50 Years of Age in Mexico

    PubMed Central

    Juergens, Christine; Ruiz Palacios, Guillermo M.; Vazquez-Narvaez, Jorge; Enkerlin-Pauwells, Hermann Leo; Sundaraiyer, Vani; Pathirana, Sudam; Kalinina, Elena; Gruber, William C.; Scott, Daniel A.; Schmoele-Thoma, Beate

    2014-01-01

    This open-label multicenter clinical trial conducted in Mexico assessed the immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine (PCV13) in adults ≥50 years of age not previously vaccinated with the 23-valent pneumococcal polysaccharide vaccine (PPSV23). The PCV13 elicited a robust immune response in this study population, as reflected by the magnitude of fold rises in functional antibody levels measured by serotype-specific opsonophagocytic activity (OPA) assays before and 1 month after vaccination. Although the prevaccination OPA geometric mean titers (GMTs) for the majority of the serotypes were significantly lower in the 50- to 64-year age group than those in the ≥65-year age group, the postvaccination immune responses were generally similar. The overall immune responses were higher for the majority of the serotypes in the Mexican study population than those in similar adult study populations who received the PCV13 in Europe and the United States. PCV13 was well tolerated, and there were no vaccine-related serious adverse events. In conclusion, PCV13 is safe and immunogenic when administered to adults ≥50 years of age in Mexico and has the potential to protect against vaccine-type pneumococcal disease. (This study has been registered at ClinicalTrials.gov under registration no. NCT01432262.) PMID:25499011

  16. Community-deliverable exercise and anxiety in adults with arthritis and other rheumatic diseases: a protocol for a systematic review and meta-analysis of randomised controlled trials

    PubMed Central

    Kelley, George A; Kelley, Kristi S; Callahan, Leigh F

    2017-01-01

    Introduction While anxiety is a major public health problem in adults with arthritis and other rheumatic diseases (AORD), the effects of exercise on anxiety in adults are not well established despite numerous studies on this topic. The purpose of this study is to conduct a systematic review with an aggregate data meta-analysis to determine the effects of community-deliverable exercise interventions (aerobic, strength training or both) on anxiety in adults with AORD. Methods and analysis Randomised controlled exercise intervention trials ≥4 weeks and published in any language up to 31 December 2016 will be included. Studies will be retrieved by searching 8 electronic databases, cross-referencing and expert review. Dual selection and abstraction of data will occur. The primary outcome will be changes in anxiety. Risk of bias will be assessed using the Cochrane risk of bias assessment instrument while confidence in the cumulative evidence will be assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) instrument. Standardised effect sizes for anxiety will be calculated from each study and then pooled using the inverse variance heterogeneity (IVhet) model. Meta-regression based on the IVhet model will be used to examine the relationship between changes in anxiety and selected covariates. Dissemination The results of this study will be presented at a professional conference and published in a peer-reviewed journal. Trial registration number CRD42016048728. PMID:28264834

  17. Impact of Short- and Long-term Tai Chi Mind-Body Exercise Training on Cognitive Function in Healthy Adults: Results From a Hybrid Observational Study and Randomized Trial

    PubMed Central

    Walsh, Jacquelyn N.; Manor, Brad; Hausdorff, Jeffrey; Novak, Vera; Lipsitz, Lewis; Gow, Brian; Macklin, Eric A.; Peng, Chung-Kang

    2015-01-01

    Background: Cognitive decline amongst older adults is a significant public health concern. There is growing interest in behavioral interventions, including exercise, for improving cognition. Studies to date suggest tai chi (TC) may be a safe and potentially effective exercise for preserving cognitive function with aging; however, its short-term and potential long-term impact on physically active, healthy adults is unclear. Objective: To compare differences in cognitive function among long-term TC expert practitioners and age-matched and gender-matched TC-naïve adults and to determine the effects of short-term TC training on measures of cognitive function in healthy, nonsedentary adults. Design: A hybrid design including an observational comparison and a 2-arm randomized clinical trial (RCT) Participants: Healthy, nonsedentary, TC-naive adults (50 y-79 y) and age-matched and gender-matched long-term TC experts Methods: A cross-sectional comparison of cognitive function in healthy TC-naïve (n=60) and TC expert (24.5 y ÷ 12 y experience; n=27) adults: TC-naïve adults then completed a 6-month, 2-arm, wait-list randomized clinical trial of TC training. Six measures of cognitive function were assessed for both cross-sectional and longitudinal comparisons. Results: TC experts exhibited trends towards better scores on all cognitive measures, significantly so for category fluency (P=.01), as well as a composite z score summarizing all 6 cognitive assessments (P=.03). In contrast, random assignment to 6 months of TC training in TC-naïve adults did not significantly improve any measures of cognitive function. Conclusions: In healthy nonsedentary adults, long-term TC training may help preserve cognitive function; however, the effect of short-term TC training in healthy adults remains unclear. Trial Registration: ClinicalTrials.gov NCT01340365 PMID:26331103

  18. Designing Therapeutic Clinical Trials for Older and Frail Adults With Cancer: U13 Conference Recommendations

    PubMed Central

    Hurria, Arti; Dale, William; Mooney, Margaret; Rowland, Julia H.; Ballman, Karla V.; Cohen, Harvey J.; Muss, Hyman B.; Schilsky, Richard L.; Ferrell, Betty; Extermann, Martine; Schmader, Kenneth E.; Mohile, Supriya G.

    2014-01-01

    A majority of cancer diagnoses and deaths occur in patients age ≥ 65 years. With the aging of the US population, the number of older adults with cancer will grow. Although the coming wave of older patients with cancer was anticipated in the early 1980s, when the need for more research on the cancer-aging interface was recognized, many knowledge gaps remain when it comes to treating older and/or frailer patients with cancer. Relatively little is known about the best way to balance the risks and benefits of existing cancer therapies in older patients; however, these patients continue to be underrepresented in clinical trials. Furthermore, the available clinical trials often do not include end points pertinent to the older adult population, such as preservation of function, cognition, and independence. As part of its ongoing effort to advance research in the field of geriatric oncology, the Cancer and Aging Research Group held a conference in November 2012 in collaboration with the National Cancer Institute, the National Institute on Aging, and the Alliance for Clinical Trials in Oncology. The goal was to develop recommendations and establish research guidelines for the design and implementation of therapeutic clinical trials for older and/or frail adults. The conference sought to identify knowledge gaps in cancer clinical trials for older adults and propose clinical trial designs to fill these gaps. The ultimate goal of this conference series is to develop research that will lead to evidence-based care for older and/or frail adults with cancer. PMID:25071116

  19. Effect of a Mobile Phone Intervention on Quitting Smoking in a Young Adult Population of Smokers: Randomized Controlled Trial Study Protocol

    PubMed Central

    Struik, Laura Louise; Hammond, David; Guindon, G Emmanuel; Norman, Cameron D; Whittaker, Robyn; Burns, Catherine M; Grindrod, Kelly A; Brown, K Stephen

    2015-01-01

    , provide a deeper understanding of the factors that drive change in smoking behavior using an app, and improve the design of cessation apps. This trial is among the first to assess the effect of a comprehensive and evidence-informed mHealth smoking cessation app on a large sample of young adult smokers. Strengths of the trial include the high-quality research design and in-depth assessment of the implementation of the intervention. If effective, the trial has the potential to demonstrate that including mHealth technology as a population-based intervention strategy can cost-effectively reach a greater proportion of the population and help young adult smokers to quit. Trial Registration ClinicalTrials.gov NCT01983150; http://clinicaltrials.gov/ct2/show/NCT01983150 (Archived by WebCite at http://www.webcitation.org/6VGyc0W0i). PMID:25599695

  20. Collaborative Care for Older Adults with low back pain by family medicine physicians and doctors of chiropractic (COCOA): study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    analysis of clinical trial notes. Discussion This pragmatic, pilot randomized controlled trial uses a mixed method approach to evaluate the clinical effectiveness, feasibility, and participant and provider perceptions of collaborative care between medical doctors and doctors of chiropractic in the treatment of older adults with low back pain. Trial registration This trial registered in ClinicalTrials.gov on 04 March 2011 with the ID number of NCT01312233. PMID:23324133

  1. A Randomized Controlled Trial of Koru: A Mindfulness Program for College Students and Other Emerging Adults

    ERIC Educational Resources Information Center

    Greeson, Jeffrey M.; Juberg, Michael K.; Maytan, Margaret; James, Kiera; Rogers, Holly

    2014-01-01

    Objective: To evaluate the effectiveness of Koru, a mindfulness training program for college students and other emerging adults. Participants: Ninety students (66% female, 62% white, 71% graduate students) participated between Fall 2012 and Spring 2013. Methods: Randomized controlled trial. It was hypothesized that Koru, compared with a wait-list…

  2. A Randomized Clinical Trial of Cognitive Enhancement Therapy for Adults with Autism Spectrum Disorders

    DTIC Science & Technology

    2014-10-01

    This project is focused on conducting the first randomized-controlled trial of Cognitive Enhancement Therapy (CET) in 54 verbal adults with autism ... spectrum disorders, and assessing the efficacy of this approach in comparison to an active Enriched Supportive Therapy (EST) intervention.

  3. Camperdown Program for Adults Who Stutter: A Student Training Clinic Phase I Trial

    ERIC Educational Resources Information Center

    Cocomazzo, Nadia; Block, Susan; Carey, Brenda; O'Brian, Sue; Onslow, Mark; Packman, Ann; Iverach, Lisa

    2012-01-01

    Objectives: During speech pathology professional preparation there is a need for adequate student instruction with speech-restructuring treatments for adults. An important part of that clinical educational experience is to participate in a clinical setting that produces outcomes equivalent to those attained during clinical trials. A previous…

  4. Open-Label Trial of Atomoxetine Hydrochloride in Adults with ADHD

    ERIC Educational Resources Information Center

    Johnson, Mats; Cederlund, Mats; Rastam, Maria; Areskoug, Bjorn; Gillberg, Christopher

    2010-01-01

    Background: While atomoxetine is an established treatment for attention-deficit/hyperactivity disorder in children, few studies have examined its efficacy for adults. Methods: Open-label trial of atomoxetine in 20 individuals with ADHD, aged 19-47 years, for 10 weeks, and a total of one year for responders. Results: Ten patients met primary…

  5. Rituximab in the Treatment of Refractory Adult and Juvenile Dermatomyositis and Adult Polymyositis: A Randomized, Placebo-phase Trial

    PubMed Central

    Oddis, Chester V.; Reed, Ann M.; Aggarwal, Rohit; Rider, Lisa G.; Ascherman, Dana P.; Levesque, Marc C.; Barohn, Richard J.; Feldman, Brian M.; Harris-Love, Michael O.; Koontz, Diane C.; Fertig, Noreen; Kelley, Stephanie S.; Pryber, Sherrie L.; Miller, Frederick W.; Rockette, Howard E.

    2012-01-01

    Objective To assess the safety and efficacy of rituximab in a randomized, double-blind, placebo-phase, trial of adult and pediatric myositis. Methods Adults with refractory polymyositis and adults and children with refractory dermatomyositis were enrolled. Entry criteria included muscle weakness and ≥2 additional abnormal core set measures (CSM) for adults. JDM patients required ≥ 3 abnormal CSM with or without muscle weakness. Patients were randomized to either ‘rituximab early’ or ‘rituximab late’ and glucocorticoid and immunosuppressive therapy were allowed at entry. The primary endpoint compared the time to achieve the preliminary International Myositis Assessment and Clinical Studies Group definition of improvement (DOI) between the 2 groups. The secondary endpoints were time to achieve ≥20% improvement in muscle strength, and the proportion of early and late rituximab patients achieving DOI at week 8. Results Among 200 randomized patients (76 PM/76 DM/48 JDM), 195 showed no difference in the time to DOI between the rituximab late (n=102) and rituximab early (n=93) groups (p=0.74, log rank) with a median time to DOI of 20.2 weeks and 20.0 weeks respectively. The secondary endpoints also did not significantly differ between the two treatment groups. However, 161 (83%) of randomized patients met the DOI and individual CSM improved in both groups throughout the 44-week trial. Conclusion Although there were no significant differences in the two treatment arms for the primary and secondary endpoints, 83% of refractory adult and juvenile myositis patients met the DOI. The role of B cell depleting therapies in myositis warrants further study with consideration for a different trial design. PMID:23124935

  6. A commercialized dietary supplement alleviates joint pain in community adults: a double-blind, placebo-controlled community trial

    PubMed Central

    2013-01-01

    % versus ↓12%, respectively, interaction effect P = 0.081). Patterns of change in SF-36, systemic inflammation biomarkers, and the 6-minute walk test did not differ significantly between groups during the 8-week study Conclusions Results from this randomized, double blind, placebo-controlled community trial support the use of the Instaflex™ dietary supplement in alleviating joint pain severity in middle-aged and older adults, with mitigation of difficulty performing daily activities most apparent in subjects with knee pain. Trial registration ClinicalTrials.gov Identifier: NCT01956500 PMID:24274358

  7. 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

    Background Increasing physical activity is a viable strategy for improving both the health and quality of life of older adults. Objective The aim of this study was to assess if an Internet-based intervention aimed to increase physical activity was effective in improving quality of life of inactive older adults. In addition, we analyzed the effect of the intervention on quality of life among those participants who successfully reached their individually targeted increase in daily physical activity as indicated by the intervention program, as well as the dose-response effect of increasing physical activity on quality of life. Methods The intervention was tested in a randomized controlled trial and was comprised of an Internet program—DirectLife (Philips)—aimed at increasing physical activity using monitoring and feedback by accelerometry and feedback by digital coaching (n=119). The control group received no intervention (n=116). Participants were inactive 60-70-year-olds and were recruited from the general population. Quality of life and physical activity were measured at baseline and after 3 months using the Research ANd Development 36-item health survey (RAND-36) and wrist-worn triaxial accelerometer, respectively. Results After 3 months, a significant improvement in quality of life was seen in the intervention group compared to the control group for RAND-36 subscales on emotional and mental health (2.52 vs -0.72, respectively; P=.03) and health change (8.99 vs 2.03, respectively; P=.01). A total of 50 of the 119 participants (42.0%) in the intervention group successfully reached their physical activity target and showed a significant improvement in quality of life compared to the control group for subscales on emotional and mental health (4.31 vs -0.72, respectively; P=.009) and health change (11.06 vs 2.03, respectively; P=.004). The dose-response analysis showed that there was a significant association between increase in minutes spent in moderate

  8. Interactive Cognitive-Motor Step Training Improves Cognitive Risk Factors of Falling in Older Adults – A Randomized Controlled Trial

    PubMed Central

    Schoene, Daniel; Valenzuela, Trinidad; Toson, Barbara; Delbaere, Kim; Severino, Connie; Garcia, Jaime; Davies, Thomas A.; Russell, Frances; Smith, Stuart T.; Lord, Stephen R.

    2015-01-01

    Purpose Interactive cognitive-motor training (ICMT) requires individuals to perform both gross motor movements and complex information processing. This study investigated the effectiveness of ICMT on cognitive functions associated with falls in older adults. Methods A single-blinded randomized controlled trial was conducted in community-dwelling older adults (N = 90, mean age 81.5±7) without major cognitive impairment. Participants in the intervention group (IG) played four stepping games that required them to divide attention, inhibit irrelevant stimuli, switch between tasks, rotate objects and make rapid decisions. The recommended minimum dose was three 20-minute sessions per week over a period of 16 weeks unsupervised at home. Participants in the control group (CG) received an evidence-based brochure on fall prevention. Measures of processing speed, attention/executive function (EF), visuo-spatial ability, concerns about falling and depression were assessed before and after the intervention. Results Eighty-one participants (90%) attended re-assessment. There were no improvements with respect to the Stroop Stepping Test (primary outcome) in the intervention group. Compared to the CG, the IG improved significantly in measures of processing speed, visuo-spatial ability and concern about falling. Significant interactions were observed for measures of EF and divided attention, indicating group differences varied for different levels of the covariate with larger improvements in IG participants with poorer baseline performance. The interaction for depression showed no change for the IG but an increase in the CG for those with low depressive symptoms at baseline. Additionally, low and high-adherer groups differed in their baseline performance and responded differently to the intervention. Compared to high adherers, low adherers improved more in processing speed and visual scanning while high-adherers improved more in tasks related to EF. Conclusions This study shows

  9. Problem-solving therapy for adults with diabetic retinopathy and diabetes-specific distress: a pilot randomized controlled trial

    PubMed Central

    Rees, Gwyneth; O'Hare, Fleur; Saeed, Marian; Sudholz, Bronwyn; Sturrock, Bonnie A; Xie, Jing; Speight, Jane; Lamoureux, Ecosse L

    2017-01-01

    Objective To provide preliminary evidence for the impact of problem-solving therapy for diabetes (PST-D) in adults with diabetic retinopathy (DR) and diabetes distress. Research design and methods In a pilot randomized controlled trial, 40 participants with DR and diabetes distress were allocated to the PST-D or control groups. Diabetes distress (DDS), depressive symptoms (PHQ-9), self-care activities (SDSCA), and HbA1c were assessed at baseline, and 3 and 6-month follow-ups. Results At the 6-month follow-up, the PST-D group showed significant improvements relative to the control group, in ‘regimen-related distress’ (PST-D: −1.3±1.4; control: −0.4±1.1), depressive symptoms (PST-D: −4.3±6.1; control: −0.3±4.6), and HbA1c (PST-D: −1.2%±1.01; control: 0.2%±1.2%) (all p<0.05). In multiple regression analysis, adjusting for baseline values and sociodemographic factors, PST-D was associated with significant improvement in ‘regimen-related distress’, depressive symptoms, and HbA1c at the 6-month follow-up (p<0.05). Conclusions PST-D is a promising intervention for improving psychological outcomes and glycemic control. A fully powered study is required to confirm these findings and examine mechanisms of change in HbA1c. Trial registration number ACTRN12616001010482; results. PMID:28243448

  10. Serum Procalcitonin Measurement and Viral Testing to Guide Antibiotic Use for Respiratory Infections in Hospitalized Adults: A Randomized Controlled Trial

    PubMed Central

    Branche, Angela R.; Walsh, Edward E.; Vargas, Roberto; Hulbert, Barbara; Formica, Maria A.; Baran, Andrea; Peterson, Derick R.; Falsey, Ann R.

    2015-01-01

    Background. Viral lower respiratory tract illness (LRTI) frequently causes adult hospitalization and is linked to antibiotic overuse. European studies suggest that the serum procalcitonin (PCT) level may be used to guide antibiotic therapy. We conducted a trial assessing the feasibility of using PCT algorithms with viral testing to guide antibiotic use in a US hospital. Methods. Three hundred patients hospitalized with nonpneumonic LRTI during October 2013–April 2014 were randomly assigned at a ratio of 1:1 to receive standard care or PCT-guided care and viral PCR testing. The primary outcome was antibiotic exposure, and safety was assessed at 1 and 3 months. Results. Among the 151 patients in the intervention group, viruses were identified in 42% (63), and 83% (126) had PCT values of <0.25 µg/mL. There were no significant differences in antibiotic use or adverse events between intervention patients and those in the nonintervention group. Subgroup analyses revealed fewer subjects with positive results of viral testing and low PCT values who were discharged receiving antibiotics (20% vs 45%; P = .002) and shorter antibiotic durations among algorithm-adherent intervention patients versus nonintervention patients (2.0 vs 4.0 days; P = .004). Compared with historical controls (from 2008–2011), antibiotic duration in nonintervention patients decreased by 2 days (6.0 vs 4.0 days; P < .001), suggesting a study effect. Conclusions. Although antibiotic use was similar in the 2 arms, subgroup analyses of intervention patients suggest that physicians responded to viral and biomarker data. These data can inform the design of future US studies. Clinical Trials Registration. NCT01907659. PMID:25910632

  11. A cluster randomised controlled trial of advice, exercise or multifactorial assessment to prevent falls and fractures in community-dwelling older adults: protocol for the prevention of falls injury trial (PreFIT)

    PubMed Central

    Lall, Ranjit; Withers, Emma J; Finnegan, Susanne; Underwood, Martin; Hulme, Claire; Sheridan, Ray; Skelton, Dawn A; Martin, Finbarr; Lamb, Sarah E

    2016-01-01

    Introduction Falls are the leading cause of accident-related mortality in older adults. Injurious falls are associated with functional decline, disability, healthcare utilisation and significant National Health Service (NHS)-related costs. The evidence base for multifactorial or exercise interventions reducing fractures in the general population is weak. This protocol describes a large-scale UK trial investigating the clinical and cost-effectiveness of alternative falls prevention interventions targeted at community dwelling older adults. Methods and analysis A three-arm, pragmatic, cluster randomised controlled trial, conducted within primary care in England, UK. Sixty-three general practices will be randomised to deliver one of three falls prevention interventions: (1) advice only; (2) advice with exercise; or (3) advice with multifactorial falls prevention (MFFP). We aim to recruit over 9000 community-dwelling adults aged 70 and above. Practices randomised to deliver advice will mail out advice booklets. Practices randomised to deliver ‘active’ interventions, either exercise or MFFP, send all trial participants the advice booklet and a screening survey to identify participants with a history of falling or balance problems. Onward referral to ‘active’ intervention will be based on falls risk determined from balance screen. The primary outcome is peripheral fracture; secondary outcomes include number with at least one fracture, falls, mortality, quality of life and health service resource use at 18 months, captured using self-report and routine healthcare activity data. Ethics and dissemination The study protocol has approval from the National Research Ethics Service (REC reference 10/H0401/36; Protocol V.3.1, 21/May/2013). User groups and patient representatives were consulted to inform trial design. Results will be reported at conferences and in peer-reviewed publications. A patient-friendly summary of trial findings will be published on the prevention

  12. Clinical trials: testing of adult chemical heating pad.

    PubMed

    Herman, J; Davis, C; Mackey, M; Fuller, S; Tavakoli, A

    1996-01-01

    Chemical packs are recent innovations in the delivery of dry heat. Because these delivery systems do not have any mechanism for verifying temperature during application, research to determine their safety seems warranted. The purpose of this study was to measure the skin temperature of adults during a 30-minute application of the MediHeat adult heating pad (MH-AHP). Seventy-seven subjects received a 30-minute application of the MH-AHP to their backs while lying in both supine and prone positions. The mean skin temperature in both positions was 101 degrees F. There were significant differences, however, in minimum and maximum skin temperature between positions. Subjects in the prone position had significantly higher maximum skin temperature and significantly lower minimum skin temperature than subjects in the supine position. It is possible that the prone position allows for more air flow over the MH-AHP and that more heat was generated causing the higher maximum temperature. This explanation does not account for the lower minimum temperature. There were no significant differences in perception of heat between the positions at either 5 minutes or 30 minutes. Findings suggest that caution is necessary when applying heating devices that depend on air circulation for heat generation.

  13. Rationale for a randomized controlled trial comparing two prophylaxis regimens in adults with severe hemophilia A: the Hemophilia Adult Prophylaxis Trial.

    PubMed

    Ragni, Margaret V

    2011-10-01

    A major goal of comprehensive hemophilia care is to prevent occurrence of bleeds by prophylaxis or regular preventive factor, one or more times weekly. Although prophylaxis is effective in reducing bleeding and joint damage in children, whether it is necessary to continue into adulthood is not known. The purpose of this article is to describe a Phase III randomized controlled trial to evaluate prophylaxis comparing two dose regimens in adults with severe hemophilia A. I hypothesize that adults with mature cartilage and joints are less susceptible to joint bleeds and joint damage, and that once-weekly recombinant factor VIII prophylaxis, with up to two rescue doses per week, is as effective as thrice-weekly prophylaxis in reducing bleeding frequency, but less costly and more acceptable, with higher quality of life. The ultimate goal of this project is to determine whether once-weekly prophylaxis is any worse than thrice-weekly prophylaxis in reducing joint bleeding frequency, while potentially utilizing less factor, at lower cost, leading to a better quality of life. This is an innovative concept, as it challenges the current paradigm of thrice-weekly prophylaxis in adults, which is based on dosing in children. Furthermore, this trial will assess interdose thrombin generation, a novel tissue factor-based assay of hemostasis, to determine if individualized thrombin generation can predict more individualized prophylaxis dosing, which would be practice changing.

  14. Social Dancing and Incidence of Falls in Older Adults: A Cluster Randomised Controlled Trial

    PubMed Central

    Merom, Dafna; Mathieu, Erin; Cerin, Ester; Morton, Rachael L.; Simpson, Judy M.; Anstey, Kaarin J.; Sherrington, Catherine; Lord, Stephen R.; Cumming, Robert G.

    2016-01-01

    Background The prevention of falls among older people is a major public health challenge. Exercises that challenge balance are recognized as an efficacious fall prevention strategy. Given that small-scale trials have indicated that diverse dance styles can improve balance and gait of older adults, two of the strongest risk factors for falls in older people, this study aimed to determine whether social dance is effective in i) reducing the number of falls and ii) improving physical and cognitive fall-related risk factors. Methods and Findings A parallel two-arm cluster randomized controlled trial was undertaken in 23 self-care retirement villages (clusters) around Sydney, Australia. Eligible villages had to have an appropriate hall for dancing, house at least 60 residents, and not be currently offering dance as a village activity. Retirement villages were randomised using a computer generated randomisation method, constrained using minimisation. Eligible participants had to be a resident of the village, be able to walk at least 50 m, and agree to undergo physical and cognitive testing without cognitive impairment. Residents of intervention villages (12 clusters) were offered twice weekly one-hour social dancing classes (folk or ballroom dancing) over 12 mo (80 h in total). Programs were standardized across villages and were delivered by eight dance teachers. Participants in the control villages (11 clusters) were advised to continue with their regular activities. Main outcomes: falls during the 12 mo trial and Trail Making Tests. Secondary outcomes: The Physiological Performance Assessment (i.e., postural sway, proprioception, reaction time, leg strength) and the Short Physical Performance Battery; health-related physical and mental quality of life from the Short-Form 12 (SF-12) Survey. Data on falls were obtained from 522 of 530 (98%) randomised participants (mean age 78 y, 85% women) and 424 (80%) attended the 12-mo reassessment, which was lower among folk dance

  15. Effects of a Web-Based Tailored Intervention to Reduce Alcohol Consumption in Adults: Randomized Controlled Trial

    PubMed Central

    Candel, Math JJM; Kremers, Stef PJ; Reinwand, Dominique A; Jander, Astrid; de Vries, Hein

    2013-01-01

    .4 drinks per week in the control group, but this did not reach statistical significance (effect size=0.26; beta=−0.12, 95% CI −7.96 to 0.03, P=.05). Intention-to-treat analyses also indicated no statistically significant effect. Separate analyses of the 2 experimental subgroups showed no differences in intervention effects. The dropout rate during the first visit to the intervention website was significantly lower in the alternating condition than in the summative condition (OR 0.23, 95% CI 0.08-0.60, P=.003). Program appreciation was comparable for the 2 experimental groups. Conclusions Complete case analyses revealed that Web-based tailored feedback can be an effective way to reduce alcohol intake among adults. However, this effect was not confirmed when applying multiple imputations. There was no indication that one of the tailoring strategies was more effective in lowering alcohol intake. Nevertheless, the lower attrition rates we found during the first visit suggest that the version of the intervention with alternating questions and advice may be preferred. Trial Registration International Standard Randomized Controlled Trial Number (ISRCTN): 91623132; http://www.controlled-trials.com/ISRCTN91623132 (Archived by WebCite at http://www.webcitation.org/6J4QdhXeG). PMID:24045005

  16. Yoga for Adults with Type 2 Diabetes: A Systematic Review of Controlled Trials.

    PubMed

    Innes, Kim E; Selfe, Terry Kit

    2016-01-01

    A growing body of evidence suggests yogic practices may benefit adults with type 2 diabetes (DM2). In this systematic review, we evaluate available evidence from prospective controlled trials regarding the effects of yoga-based programs on specific health outcomes pertinent to DM2 management. To identify qualifying studies, we searched nine databases and scanned bibliographies of relevant review papers and all identified articles. Controlled trials that did not target adults with diabetes, included only adults with type 1 diabetes, were under two-week duration, or did not include quantitative outcome data were excluded. Study quality was evaluated using the PEDro scale. Thirty-three papers reporting findings from 25 controlled trials (13 nonrandomized, 12 randomized) met our inclusion criteria (N = 2170 participants). Collectively, findings suggest that yogic practices may promote significant improvements in several indices of importance in DM2 management, including glycemic control, lipid levels, and body composition. More limited data suggest that yoga may also lower oxidative stress and blood pressure; enhance pulmonary and autonomic function, mood, sleep, and quality of life; and reduce medication use in adults with DM2. However, given the methodological limitations of existing studies, additional high-quality investigations are required to confirm and further elucidate the potential benefits of yoga programs in populations with DM2.

  17. Yoga for Adults with Type 2 Diabetes: A Systematic Review of Controlled Trials

    PubMed Central

    Innes, Kim E.; Selfe, Terry Kit

    2016-01-01

    A growing body of evidence suggests yogic practices may benefit adults with type 2 diabetes (DM2). In this systematic review, we evaluate available evidence from prospective controlled trials regarding the effects of yoga-based programs on specific health outcomes pertinent to DM2 management. To identify qualifying studies, we searched nine databases and scanned bibliographies of relevant review papers and all identified articles. Controlled trials that did not target adults with diabetes, included only adults with type 1 diabetes, were under two-week duration, or did not include quantitative outcome data were excluded. Study quality was evaluated using the PEDro scale. Thirty-three papers reporting findings from 25 controlled trials (13 nonrandomized, 12 randomized) met our inclusion criteria (N = 2170 participants). Collectively, findings suggest that yogic practices may promote significant improvements in several indices of importance in DM2 management, including glycemic control, lipid levels, and body composition. More limited data suggest that yoga may also lower oxidative stress and blood pressure; enhance pulmonary and autonomic function, mood, sleep, and quality of life; and reduce medication use in adults with DM2. However, given the methodological limitations of existing studies, additional high-quality investigations are required to confirm and further elucidate the potential benefits of yoga programs in populations with DM2. PMID:26788520

  18. 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

  19. Effectiveness of a mHealth Lifestyle Program With Telephone Support (TXT2BFiT) to Prevent Unhealthy Weight Gain in Young Adults: Randomized Controlled Trial

    PubMed Central

    Partridge, Stephanie R; McGeechan, Kevin; Hebden, Lana; Balestracci, Kate; Wong, Annette TY; Denney-Wilson, Elizabeth; Harris, Mark F; Phongsavan, Philayrath; Bauman, Adrian

    2015-01-01

    vegetables (P=.009), fewer sugary soft drinks (P=.002), and fewer energy-dense takeout meals (P=.001) compared to controls. They also increased their total physical activity by 252.5 MET-minutes (95% CI 1.2-503.8, P=.05) and total physical activity by 1.3 days (95% CI 0.5-2.2, P=.003) compared to controls. Conclusions The TXT2BFiT low-intensity intervention was successful in preventing weight gain with modest weight loss and improvement in lifestyle behaviors among overweight young adults. The short-term success of the 12-week intervention period shows potential. Maintenance of the behavior change will be monitored at 9 months. Trial Registration Trial Registration: The Australian New Zealand Clinical Trials Registry ACTRN12612000924853; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12612000924853 (Archived by WebCite at http://www.webcitation.org/6Z6w9LlS9). PMID:26076688

  20. Rationale and study design for a randomised controlled trial to reduce sedentary time in adults at risk of type 2 diabetes mellitus: project stand (Sedentary Time ANd diabetes)

    PubMed Central

    2011-01-01

    Background The rising prevalence of Type 2 Diabetes Mellitus (T2DM) is a major public health problem. There is an urgent need for effective lifestyle interventions to prevent the development of T2DM. Sedentary behaviour (sitting time) has recently been identified as a risk factor for diabetes, often independent of the time spent in moderate-to-vigorous physical activity. Project STAND (Sedentary Time ANd Diabetes) is a study which aims to reduce sedentary behaviour in younger adults at high risk of T2DM. Methods/Design A reduction in sedentary time is targeted using theory driven group structured education. The STAND programme is subject to piloting and process evaluation in line with the MRC framework for complex interventions. Participants are encouraged to self-monitor and self-regulate their behaviour. The intervention is being assessed in a randomised controlled trial with 12 month follow up. Inclusion criteria are a) aged 18-40 years with a BMI in the obese range; b) 18-40 years with a BMI in the overweight range plus an additional risk factor for T2DM. Participants are randomised to the intervention (n = 89) or control (n = 89) arm. The primary outcome is a reduction in sedentary behaviour at 12 months as measured by an accelerometer (count < 100/min). Secondary outcomes include physical activity, sitting/lying time using the ActivPAL posture monitor, fasting and 2 h oral glucose tolerance test, lipids, inflammatory biomarkers, body weight, waist circumference, blood pressure, illness perceptions, and efficacy beliefs for behaviour change. Conclusions This is the first UK trial to address sedentary behaviour change in a population of younger adults at risk of T2DM. The results will provide a platform for the development of a range of future multidisciplinary interventions in this rapidly expanding high-risk population. Trial registration Current controlled trials ISRCTN08434554, MRC project 91409. PMID:22151909

  1. Brief Intervention in the Emergency Department Among Mexican-Origin Young Adults at the US–Mexico Border: Outcomes of a Randomized Controlled Clinical Trial Using Promotores†

    PubMed Central

    Cherpitel, Cheryl J.; Ye, Yu; Bond, Jason; Woolard, Robert; Villalobos, Susana; Bernstein, Judith; Bernstein, Edward; Ramos, Rebeca

    2016-01-01

    Aims A randomized controlled trial of brief intervention (BI), for drinking and related problems, using peer health promotion advocates (promotores), was conducted among at-risk and alcohol-dependent Mexican-origin young adult emergency department (ED) patients, aged 18–30. Methods Six hundred and ninety-eight patients were randomized to: screened only (n = 78), assessed (n = 310) and intervention (n = 310). Primary outcomes were at-risk drinking and Rapid Alcohol Problems Screen (RAPS4) scores. Secondary outcomes were drinking days per week, drinks per drinking day, maximum drinks in a day and negative consequences of drinking. Results At 3- and 12-month follow-up the intervention condition showed significantly lower values or trends on all outcome variables compared to the assessed condition, with the exception of the RAPS4 score; e.g. at-risk drinking days dropped from 2.9 to 1.7 at 3 months for the assessed condition and from 3.2 to 1.2 for the intervention condition. Using random effects modeling controlling for demographics and baseline values, the intervention condition showed significantly greater improvement in all consumption measures at 12 months, but not in the RAPS4 or negative consequences of drinking. Improvements in outcomes were significantly more evident for non-injured patients, those reporting drinking prior to the event, and those lower on risk taking disposition. Conclusions At 12-month follow-up this study demonstrated significantly improved drinking outcomes for Mexican-origin young adults in the ED who received a BI delivered by promotores compared to those who did not. Trial Register ClinicalTrials.gov. Clinical Trial Registration Number NCT02056535. PMID:26243733

  2. Results from the Xylitol for Adult Caries Trial (X-ACT)

    PubMed Central

    Bader, James D.; Vollmer, William M.; Shugars, Daniel A.; Gilbert, Gregg H.; Amaechi, Bennett T.; Brown, John P.; Laws, Reesa L.; Funkhouser, Kimberly A.; Makhija, Sonia K.; Ritter, André V.; Leo, Michael C.

    2013-01-01

    Background Although caries is prevalent in adults, few preventive therapies have been tested in adult populations. This randomized clinical trial evaluated the effectiveness of xylitol lozenges in preventing caries in elevated caries-risk adults. Methods X-ACT was a three-site placebo-controlled randomized trial. Participants (n=691) ages 21–80 consumed five 1.0 g xylitol or placebo lozenges daily for 33 months. Clinical examinations occurred at baseline, 12, 24 and 33 months. Results Xylitol lozenges reduced the caries increment 11%. This reduction, which represented less than one-third of a surface per year, was not statistically significant. There was no indication of a dose-response effect. Conclusions Daily use of xylitol lozenges did not result in a statistically or clinically significant reduction in 33-month caries increment among elevated caries-risk adults. Clinical Implications These results suggest that xylitol used as a supplement in adults does not significantly reduce their caries experience. PMID:23283923

  3. Tai chi qigong as a means to improve night-time sleep quality among older adults with cognitive impairment: a pilot randomized controlled trial

    PubMed Central

    Chan, Aileen WK; Yu, Doris SF; Choi, KC; Lee, Diana TF; Sit, Janet WH; Chan, Helen YL

    2016-01-01

    Purpose Age-related cognitivee decline is a growing public health concern worldwide. More than a quarter of adults with cognitive impairment experience sleep disturbance. The objective of this pilot study was to evaluate the preliminary effects of tai chi qigong (TCQ) on improving the night-time sleep quality of older adults with cognitive impairment. Participants Older adults with cognitive impairment who complain of sleep disturbance. Methods A randomized controlled trial with two groups. Fifty-two subjects were recruited from two district elderly community centers and randomly assigned to either the TCQ group (n=27) or the control group (n=25). The intervention group received TCQ training consisting of two 60-minute sessions each week for 2 months. The control group was advised to maintain their usual activities. Sleep quality was measured by the Chinese Pittsburgh Sleep Quality Index. Quality of life was measured by Short-form 12, cognitive functions measured by mini-mental state examination, and subjective memory deficits measured by the memory inventory for Chinese. Results Data were collected at baseline, 2 months, and 6 months. Significant results were noted at 6 months in the Chinese Pittsburgh Sleep Quality Index global score (P=0.004), sleep duration (P=0.003), habitual sleep efficiency (P=0.002), and the Short-form 12 mental health component (P<0.001). The TCQ participants reported better sleep quality and a better (quality of life) mental health component than the control group. Conclusion TCQ can be considered a useful nonpharmacological approach for improving sleep quality in older adults with cognitive impairment. Clinical trial registration CUHK_CCT00448 (https://www2.ccrb.cuhk.edu.hk/registry/public/287). PMID:27698557

  4. Feasibility randomised controlled trial of Recovery-focused Cognitive Behavioural Therapy for Older Adults with bipolar disorder (RfCBT-OA): study protocol

    PubMed Central

    Tyler, Elizabeth; Lobban, Fiona; Sutton, Chris; Depp, Colin; Johnson, Sheri; Laidlaw, Ken; Jones, Steven H

    2016-01-01

    Introduction Bipolar disorder is a severe and chronic mental health problem that persists into older adulthood. The number of people living with this condition is set to rise as the UK experiences a rapid ageing of its population. To date, there has been very little research or service development with respect to psychological therapies for this group of people. Methods and analysis A parallel two-arm randomised controlled trial comparing a 14-session, 6-month Recovery-focused Cognitive-Behavioural Therapy for Older Adults with bipolar disorder (RfCBT-OA) plus treatment as usual (TAU) versus TAU alone. Participants will be recruited in the North-West of England via primary and secondary mental health services and through self-referral. The primary objective of the study is to evaluate the feasibility and acceptability of RfCBT-OA; therefore, a formal power calculation is not appropriate. It has been estimated that randomising 25 participants per group will be sufficient to be able to reliably determine the primary feasibility outcomes (eg, recruitment and retention rates), in line with recommendations for sample sizes for feasibility/pilot trials. Participants in both arms will complete assessments at baseline and then every 3 months, over the 12-month follow-up period. We will gain an estimate of the likely effect size of RfCBT-OA on a range of clinical outcomes and estimate parameters needed to determine the appropriate sample size for a definitive, larger trial to evaluate the effectiveness and cost-effectiveness of RfCBT-OA. Data analysis is discussed further in the Analysis section in the main paper. Ethics and dissemination This protocol was approved by the UK National Health Service (NHS) Ethics Committee process (REC ref: 15/NW/0330). The findings of the trial will be disseminated through peer-reviewed journals, national and international conference presentations and local, participating NHS trusts. Trial registration number ISRCTN13875321; Pre

  5. Adult and pediatric clinical trials of sublingual immunotherapy in the USA.

    PubMed

    Park, Dai; Daher, Nora; Blaiss, Michael S

    2012-08-01

    Specific allergen immunotherapy has been practiced for allergic rhinoconjunctivitis for over 100 years and is the only treatment option that is disease modifying. In the USA, immunotherapy is usually administered via subcutaneous injection; this is the only route with a US FDA-approved formulation. There is growing interest in developing US-standardized formulations for the sublingual route, but up until recently there have been few US trials. Most of the experience with sublingual immunotherapy (SLIT) comes from Europe, where it is widely used and there is a large body of literature supporting its use. The purpose of this review is to summarize recent adult and pediatric clinical trials of SLIT in the USA. Most of the trials are for inhalant allergies, but there is some early work on SLIT as a novel therapy for food allergies.

  6. A multicentre, pragmatic, parallel group, randomised controlled trial to compare the clinical and cost-effectiveness of three physiotherapy-led exercise interventions for knee osteoarthritis in older adults: the BEEP trial protocol (ISRCTN: 93634563)

    PubMed Central

    2014-01-01

    . Discussion This trial will contribute to the evidence base for management of older adults with knee pain attributable to osteoarthritis in primary care. The findings will have important implications for healthcare commissioners, general practitioners and physiotherapy service providers and it will inform future education of healthcare practitioners. It may also serve to delay or prevent some individuals from becoming surgical candidates. Trial registration ISRCTN: ISRCTN93634563. PMID:25064573

  7. External validity of randomized controlled trials in older adults, a systematic review

    PubMed Central

    van Deudekom, Floor J.; Postmus, Iris; van der Ham, Danielle J.; Pothof, Alexander B.; Broekhuizen, Karen; Blauw, Gerard J.; Mooijaart, Simon P.

    2017-01-01

    Background To critically assess the external validity of randomized controlled trials (RCTs) it is important to know what older adults have been enrolled in the trials. The aim of this systematic review is to study what proportion of trials specifically designed for older patients report on somatic status, physical and mental functioning, social environment and frailty in the patient characteristics. Methods PubMed was searched for articles published in 2012 and only RCTs were included. Articles were further excluded if not conducted with humans or only secondary analyses were reported. A random sample of 10% was drawn. The current review analyzed this random sample and further selected trials when the reported mean age was ≥ 60 years. We extracted geriatric assessments from the population descriptives or the in- and exclusion criteria. Results In total 1396 trials were analyzed and 300 trials included. The median of the reported mean age was 66 (IQR 63–70) and the median percentage of men in the trials was 60 (IQR 45–72). In 34% of the RCTs specifically designed for older patients somatic status, physical and mental functioning, social environment or frailty were reported in the population descriptives or the in- and exclusion criteria. Physical and mental functioning was reported most frequently (22% and 14%). When selecting RCTs on a mean age of 70 or 80 years the report of geriatric assessments in the patient characteristics was 46% and 85% respectively but represent only 5% and 1% of the trials. Conclusion Somatic status, physical and mental functioning, social environment and frailty are underreported even in RCTs specifically designed for older patients published in 2012. Therefore, it is unclear for clinicians to which older patients the results can be applied. We recommend systematic to transparently report these relevant characteristics of older participants included in RCTs. PMID:28346503

  8. Internet-delivered treatment: its potential as a low-intensity community intervention for adults with symptoms of depression: protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    an online delivered treatment for depression in a community sample of Irish adults with symptoms of depression. The study will be a first contribution and depending on the sample recruited the results may be generalizable to people with similar difficulties in Ireland and may therefore give insight into the potential of low-intensity interventions for Irish people with depressive symptoms. Trial registration number Current Controlled Trials ISRCTN03704676. DOI: 10.1186/ISRCTN03704676 PMID:24886179

  9. Discrete-Trial Functional Analysis and Functional Communication Training with Three Adults with Intellectual Disabilities and Problem Behavior

    ERIC Educational Resources Information Center

    Chezan, Laura C.; Drasgow, Erik; Martin, Christian A.

    2014-01-01

    We conducted a sequence of two studies on the use of discrete-trial functional analysis and functional communication training. First, we used discrete-trial functional analysis (DTFA) to identify the function of problem behavior in three adults with intellectual disabilities and problem behavior. Results indicated clear patterns of problem…

  10. An Efficacy Trial of "Steps to Your Health", a Health Promotion Programme for Adults with Intellectual Disability

    ERIC Educational Resources Information Center

    McDermott, Suzanne; Whitner, Wendy; Thomas-Koger, Marlo; Mann, Joshua R.; Clarkson, John; Barnes, Timothy L.; Bao, Haikun; Meriwether, Rebecca A

    2012-01-01

    Objective: Although there are evaluation and effectiveness studies of health promotion interventions for adults with intellectual disabilities (ID), randomized efficacy trials of such interventions are lacking. Design: A randomized active control intervention trial. Setting: The participants attended the health promotion classes in local…

  11. Text Messaging for Exercise Promotion in Older Adults From an Upper-Middle-Income Country: Randomized Controlled Trial

    PubMed Central

    Khoo, Selina; Morris, Tony

    2016-01-01

    the non-SMS texting arm (n=21). Study-unrelated injuries forced 4 participants to discontinue after a few weeks (they were not included in any analyses). Overall retention was 86% (37/43). After 12 weeks, SMS texting arm participants exercised significantly more than non-SMS texting arm participants (mean difference 1.21 times, bias-corrected and accelerated bootstrap [BCa] 95% CI 0.18-2.24). Interview analysis revealed that the SMS text messages positively influenced SMS texting arm participants who experienced exercise barriers. They described the SMS text messages as being encouraging, a push, and a reminder. After 24 weeks, there was no significant difference between the research arms (mean difference 0.74, BCa 95% CI –0.30 to 1.76). There were no significant effects for secondary outcomes. Conclusions This study provides evidence that SMS text messaging is effective in promoting exercise in older adults from an upper-middle-income country. Although the effects were not maintained when SMS text messaging ceased, the results are promising and warrant more research on behavioral mobile health interventions in other regions. Trial Registration Clinicaltrials.gov NCT02123342; http://clinicaltrials.gov/ct2/show/NCT02123342 (Archived by WebCite at http://www.webcitation.org/6eGSsu2EI). PMID:26742999

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

    PubMed Central

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

    2016-01-01

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

  13. Effects of Prophylactic and Therapeutic Paracetamol Treatment during Vaccination on Hepatitis B Antibody Levels in Adults: Two Open-Label, Randomized Controlled Trials

    PubMed Central

    Doedée, Anne M. C. M.; Boland, Greet J.; Pennings, Jeroen L. A.; de Klerk, Arja; Berbers, Guy A. M.; van der Klis, Fiona R. M.; de Melker, Hester E.; van Loveren, Henk; Janssen, Riny

    2014-01-01

    Worldwide, paracetamol is administered as a remedy for complaints that occur after vaccination. Recently published results indicate that paracetamol inhibits the vaccination response in infants when given prior to vaccination. The goal of this study was to establish whether paracetamol exerts similar effects in young adults. In addition, the effect of timing of paracetamol intake was investigated. In two randomized, controlled, open-label studies 496 healthy young adults were randomly assigned to three groups. The study groups received paracetamol for 24 hours starting at the time of (prophylactic use) - or 6 hours after (therapeutic use) the primary (0 month) and first booster (1 month) hepatitis B vaccination. The control group received no paracetamol. None of the participants used paracetamol around the second booster (6 months) vaccination. Anti-HBs levels were measured prior to and one month after the second booster vaccination on ADVIA Centaur XP. One month after the second booster vaccination, the anti-HBs level in the prophylactic paracetamol group was significantly lower (p = 0.048) than the level in the control group (4257 mIU/mL vs. 5768 mIU/mL). The anti-HBs level in the therapeutic paracetamol group (4958 mIU/mL) was not different (p = 0.34) from the level in the control group. Only prophylactic paracetamol treatment, and not therapeutic treatment, during vaccination has a negative influence on the antibody concentration after hepatitis B vaccination in adults. These findings prompt to consider therapeutic instead of prophylactic treatment to ensure maximal vaccination efficacy and retain the possibility to treat pain and fever after vaccination. Trial Registration Controlled-Trials.com ISRCTN03576945 PMID:24897504

  14. Let them eat fruit! The effect of fruit and vegetable consumption on psychological well-being in young adults: A randomized controlled trial

    PubMed Central

    Carr, Anitra C.; Mainvil, Louise A.; Vissers, Margreet C. M.

    2017-01-01

    This study tested the psychological benefits of a 14-day preregistered clinical intervention to increase fruit and vegetable (FV) consumption in 171 low-FV-consuming young adults (67% female, aged 18–25). Participants were randomly assigned into a diet-as-usual control condition, an ecological momentary intervention (EMI) condition involving text message reminders to increase their FV consumption plus a voucher to purchase FV, or a fruit and vegetable intervention (FVI) condition in which participants were given two additional daily servings of fresh FV to consume on top of their normal diet. Self-report outcome measures were depressive symptoms and anxiety measured pre- and post-intervention, and daily negative and positive mood, vitality, flourishing, and flourishing behaviors (curiosity, creativity, motivation) assessed nightly using a smartphone survey. Vitamin C and carotenoids were measured from blood samples pre- and post-intervention, and psychological expectancies about the benefits of FV were measured post-intervention to test as mediators of psychological change. Only participants in the FVI condition showed improvements to their psychological well-being with increases in vitality, flourishing, and motivation across the 14-days relative to the other groups. No changes were found for depressive symptoms, anxiety, or mood. Intervention benefits were not mediated by vitamin C, carotenoids, or psychological expectancies. We conclude that providing young adults with high-quality FV, rather than reminding them to eat more FV (with a voucher to purchase FV), resulted in significant short-term improvements to their psychological well-being. These results provide initial proof-of-concept that giving young adults fresh fruit and vegetables to eat can have psychological benefits even over a brief period of time. Trial registration: Australian New Zealand Clinical Trials Registry ACTRN12615000183583 PMID:28158239

  15. Effect of Baduanjin exercise on cognitive function in older adults with mild cognitive impairment: study protocol for a randomised controlled trial

    PubMed Central

    Zheng, Guohua; Huang, Maomao; Li, Shuzhen; Li, Moyi; Xia, Rui; Zhou, Wenji; Tao, Jing; Chen, Lidian

    2016-01-01

    Introduction Mild cognitive impairment (MCI) is an intermediate stage between the cognitive changes of normal aging and dementia characterised by a reduction in memory and/or other cognitive processes. An increasing number of studies have indicated that regular physical activity/exercise may have beneficial association with cognitive function of older adults with or without cognitive impairment. As a traditional Chinese Qigong exercise, Baduanjin may be even more beneficial in promoting cognitive ability in older adults with MCI, but the evidence is still insufficient. The main purpose of this study is to investigate the effect of Baduanjin exercise on neuropsychological outcomes of community-dwelling older adults with MCI, and to explore its mechanism of action from neuroimaging based on functional MRI (fMRI) and cerebrovascular function. Methods and analysis The design of this study is a randomised, controlled trial with three parallel groups in a 1:1:1 allocation ratio with allocation concealment and assessor blinding. A total of 135 participants will be enrolled and randomised to the 24-week Baduanjin exercise intervention, 24-week brisk walking intervention and 24-week usual physical activity control group. Global cognitive function and the specific domains of cognition (memory, processing speed, executive function, attention and verbal learning and memory) will be assessed at baseline and 9, 17, 25 and 37 weeks after randomisation, while the structure and function of brain regions related to cognitive function and haemodynamic variables of the brain will be measured by fMRI and transcranial Doppler, respectively, at baseline and 25 and 37 weeks after randomisation. Ethics and dissemination Ethics approval was given by the Medical Ethics Committee of the Second People's Hospital of Fujian Province (approval number 2014-KL045-02). The findings will be disseminated through peer-reviewed publications and at scientific conferences. Trial registration number

  16. IQuaD dental trial; improving the quality of dentistry: a multicentre randomised controlled trial comparing oral hygiene advice and periodontal instrumentation for the prevention and management of periodontal disease in dentate adults attending dental primary care

    PubMed Central

    2013-01-01

    gingival margin; oral hygiene self-efficacy and net benefits. Discussion IQuaD will provide evidence for the most clinically-effective and cost-effective approach to managing periodontal disease in dentate adults in Primary Care. This will support general dental practitioners and patients in treatment decision making. Trial registration Protocol ID: ISRCTN56465715 PMID:24160246

  17. The influence of whole grain products and red meat on intestinal microbiota composition in normal weight adults: a randomized crossover intervention trial.

    PubMed

    Foerster, Jana; Maskarinec, Gertraud; Reichardt, Nicole; Tett, Adrian; Narbad, Arjan; Blaut, Michael; Boeing, Heiner

    2014-01-01

    Intestinal microbiota is related to obesity and serum lipid levels, both risk factors for chronic diseases constituting a challenge for public health. We investigated how a diet rich in whole grain (WG) products and red meat (RM) influences microbiota. During a 10-week crossover intervention study, 20 healthy adults consumed two isocaloric diets, one rich in WG products and one high in RM. Repeatedly data on microbiota were assessed by 16S rRNA based denaturing gradient gel electrophoresis (DGGE). A blood sample and anthropometric data were collected. Mixed models and logistic regression were used to investigate effects. Microbiota showed interindividual variability. However, dietary interventions modified microbiota appearance: 8 bands changed in at least 4 participants during the interventions. One of the bands appearing after WG and one increasing after RM remained significant in regression models and were identified as Collinsella aerofaciens and Clostridium sp. The WG intervention lowered obesity parameters, while the RM diet increased serum levels of uric acid and creatinine. The study showed that diet is a component of major relevance regarding its influence on intestinal microbiota and that WG has an important role for health. The results could guide investigations of diet and microbiota in observational prospective cohort studies. Trial registration: ClinicalTrials.gov NCT01449383.

  18. The Influence of Whole Grain Products and Red Meat on Intestinal Microbiota Composition in Normal Weight Adults: A Randomized Crossover Intervention Trial

    PubMed Central

    Foerster, Jana; Maskarinec, Gertraud; Reichardt, Nicole; Tett, Adrian; Narbad, Arjan; Blaut, Michael; Boeing, Heiner

    2014-01-01

    Intestinal microbiota is related to obesity and serum lipid levels, both risk factors for chronic diseases constituting a challenge for public health. We investigated how a diet rich in whole grain (WG) products and red meat (RM) influences microbiota. During a 10-week crossover intervention study, 20 healthy adults consumed two isocaloric diets, one rich in WG products and one high in RM. Repeatedly data on microbiota were assessed by 16S rRNA based denaturing gradient gel electrophoresis (DGGE). A blood sample and anthropometric data were collected. Mixed models and logistic regression were used to investigate effects. Microbiota showed interindividual variability. However, dietary interventions modified microbiota appearance: 8 bands changed in at least 4 participants during the interventions. One of the bands appearing after WG and one increasing after RM remained significant in regression models and were identified as Collinsella aerofaciens and Clostridium sp. The WG intervention lowered obesity parameters, while the RM diet increased serum levels of uric acid and creatinine. The study showed that diet is a component of major relevance regarding its influence on intestinal microbiota and that WG has an important role for health. The results could guide investigations of diet and microbiota in observational prospective cohort studies. Trial registration ClinicalTrials.gov NCT01449383 PMID:25299601

  19. Relaxation Therapy and Anxiety, Self-Esteem, and Emotional Regulation among Adults with Intellectual Disabilities: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Bouvet, Cyrille; Coulet, Aurélie

    2016-01-01

    This pilot study is a randomized controlled trial on the effects of relaxation on anxiety, self-esteem, and emotional regulation in adults with intellectual disabilities (ID) working in a center of supported employment in France. We studied 30 adults with mild or moderate ID who were split at random into a relaxation group (RG, 15 subjects), who…

  20. Group Cognitive Behavioural Therapy and Group Recreational Activity for Adults with Autism Spectrum Disorders: A Preliminary Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Hesselmark, Eva; 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…

  1. A Mixed-Methods Randomized Controlled Trial of Financial Incentives and Peer Networks to Promote Walking among Older Adults

    ERIC Educational Resources Information Center

    Kullgren, Jeffrey T.; Harkins, Kristin A.; Bellamy, Scarlett L.; Gonzales, Amy; Tao, Yuanyuan; Zhu, Jingsan; Volpp, Kevin G.; Asch, David A.; Heisler, Michele; Karlawish, Jason

    2014-01-01

    Background: Financial incentives and peer networks could be delivered through eHealth technologies to encourage older adults to walk more. Methods: We conducted a 24-week randomized trial in which 92 older adults with a computer and Internet access received a pedometer, daily walking goals, and weekly feedback on goal achievement. Participants…

  2. Recommended Patient-Reported Core Set of Symptoms to Measure in Adult Cancer Treatment Trials

    PubMed Central

    Mitchell, Sandra A.; Dueck, Amylou C.; Basch, Ethan; Cella, David; Reilly, Carolyn Miller; Minasian, Lori M.; Denicoff, Andrea M.; O’Mara, Ann M.; Fisch, Michael J.; Chauhan, Cynthia; Aaronson, Neil K.; Coens, Corneel; Bruner, Deborah Watkins

    2014-01-01

    Background The National Cancer Institute’s Symptom Management and Health-Related Quality of Life Steering Committee held a clinical trials planning meeting (September 2011) to identify a core symptom set to be assessed across oncology trials for the purposes of better understanding treatment efficacy and toxicity and to facilitate cross-study comparisons. We report the results of an evidence-synthesis and consensus-building effort that culminated in recommendations for core symptoms to be measured in adult cancer clinical trials that include a patient-reported outcome (PRO). Methods We used a data-driven, consensus-building process. A panel of experts, including patient representatives, conducted a systematic review of the literature (2001–2011) and analyzed six large datasets. Results were reviewed at a multistakeholder meeting, and a final set was derived emphasizing symptom prevalence across diverse cancer populations, impact on health outcomes and quality of life, and attribution to either disease or anticancer treatment. Results We recommend that a core set of 12 symptoms—specifically fatigue, insomnia, pain, anorexia (appetite loss), dyspnea, cognitive problems, anxiety (includes worry), nausea, depression (includes sadness), sensory neuropathy, constipation, and diarrhea—be considered for inclusion in clinical trials where a PRO is measured. Inclusion of symptoms and other patient-reported endpoints should be well justified, hypothesis driven, and meaningful to patients. Conclusions This core set will promote consistent assessment of common and clinically relevant disease- and treatment-related symptoms across cancer trials. As such, it provides a foundation to support data harmonization and continued efforts to enhance measurement of patient-centered outcomes in cancer clinical trials and observational studies. PMID:25006191

  3. 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

    Background The high prevalence of physical inactivity worldwide calls for innovative and more effective ways to promote physical activity (PA). There are limited objective data on the effectiveness of Web-based personalized feedback on increasing PA in adults. Objective It is hypothesized that providing personalized advice based on PA measured objectively alongside diet, phenotype, or genotype information would lead to larger and more sustained changes in PA, compared with nonpersonalized advice. Methods A total of 1607 adults in seven European countries were randomized to either a control group (nonpersonalized advice, Level 0, L0) or to one of three personalized groups receiving personalized advice via the Internet based on current PA plus diet (Level 1, L1), PA plus diet and phenotype (Level 2, L2), or PA plus diet, phenotype, and genotype (Level 3, L3). PA was measured for 6 months using triaxial accelerometers, and self-reported using the Baecke questionnaire. Outcomes were objective and self-reported PA after 3 and 6 months. Results While 1270 participants (85.81% of 1480 actual starters) completed the 6-month trial, 1233 (83.31%) self-reported PA at both baseline and month 6, but only 730 (49.32%) had sufficient objective PA data at both time points. For the total cohort after 6 months, a greater improvement in self-reported total PA (P=.02) and PA during leisure (nonsport) (P=.03) was observed in personalized groups compared with the control group. For individuals advised to increase PA, we also observed greater improvements in those two self-reported indices (P=.006 and P=.008, respectively) with increased personalization of the advice (L2 and L3 vs L1). However, there were no significant differences in accelerometer results between personalized and control groups, and no significant effect of adding phenotypic or genotypic information to the tailored feedback at month 3 or 6. After 6 months, there were small but significant improvements in the objectively

  4. Two-Arm Randomized Pilot Intervention Trial to Decrease Sitting Time and Increase Sit-To-Stand Transitions in Working and Non-Working Older Adults

    PubMed Central

    Kerr, Jacqueline; Takemoto, Michelle; Bolling, Khalisa; Atkin, Andrew; Carlson, Jordan; Rosenberg, Dori; Crist, Katie; Godbole, Suneeta; Lewars, Brittany; Pena, Claudia; Merchant, Gina

    2016-01-01

    Background Excessive sitting has been linked to poor health. It is unknown whether reducing total sitting time or increasing brief sit-to-stand transitions is more beneficial. We conducted a randomized pilot study to assess whether it is feasible for working and non-working older adults to reduce these two different behavioral targets. Methods Thirty adults (15 workers and 15 non-workers) age 50–70 years were randomized to one of two conditions (a 2-hour reduction in daily sitting or accumulating 30 additional brief sit-to-stand transitions per day). Sitting time, standing time, sit-to-stand transitions and stepping were assessed by a thigh worn inclinometer (activPAL). Participants were assessed for 7 days at baseline and followed while the intervention was delivered (2 weeks). Mixed effects regression analyses adjusted for days within participants, device wear time, and employment status. Time by condition interactions were investigated. Results Recruitment, assessments, and intervention delivery were feasible. The ‘reduce sitting’ group reduced their sitting by two hours, the ‘increase sit-to-stand’ group had no change in sitting time (p < .001). The sit-to-stand transition group increased their sit-to-stand transitions, the sitting group did not (p < .001). Conclusions This study was the first to demonstrate the feasibility and preliminary efficacy of specific sedentary behavioral goals. Trial Registration clinicaltrials.gov NCT02544867 PMID:26735919

  5. Mobile Phone Text Messages to Support Treatment Adherence in Adults With High Blood Pressure (StAR): A Single-Blind, Randomized Trial

    PubMed Central

    Bobrow, Kirsten; Farmer, Andrew J; Springer, David; Shanyinde, Milensu; Yu, Ly-Mee; Brennan, Thomas; Rayner, Brian; Namane, Mosedi; Steyn, Krisela; Tarassenko, Lionel; Levitt, Naomi

    2016-01-01

    Background We assessed the effect of automated treatment adherence support delivered via mobile-phone short message system (SMS) text-messages on blood pressure. Methods and Results In this pragmatic single-blind, three-arm randomized trial (StAR), undertaken in South Africa, patients treated for high blood pressure were randomly allocated in a 1:1:1 ratio to information-only or interactive SMS text-messaging, or usual care. The primary outcome was change in systolic blood pressure at 12-months from baseline measured with a validated oscillometric device. All trial staff were masked to treatment allocation. Analyses were intention to treat. Between June 26, 2012 and November 23, 2012, 1372 participants were randomized to receive information-only SMS text-messages (n=457), interactive SMS text-messages (n=458), or usual care (n=457). Primary outcome data were available for 1256 (92%) participants. At 12-months, the mean adjusted change (95% CI) in systolic blood pressure compared to usual care was −2.2 mm Hg (−4.4 to −0.04) with information-only SMS and −1.6 mm Hg (−3.7 to 0.6) with interactive SMS. Odds ratios (95% CI) for the proportion of participants with a blood pressure <140/90mm Hg were for information-only messaging 1.42 (1.03 to 1.95) and for interactive messaging 1.41 (1.02 to 1.95) compared to usual care. Conclusions In this randomized trial of an automated adherence support program delivered by SMS text-message in a general outpatient population of adults with high blood pressure, we found a small, reduction in systolic blood pressure control compared to usual care at 12-months. There was no evidence that an interactive intervention increased this effect. Clinical Trial Registration Information ClinicalTrials.gov. Identifier: South African National Clinical Trials Register number (SANCTR DOH-27-1212-386); Pan Africa Trial Register (PACTR201411000724141). PMID:26769742

  6. Mindfulness-based therapy in adults with an autism spectrum disorder: a randomized controlled trial.

    PubMed

    Spek, Annelies A; van Ham, Nadia C; Nyklíček, Ivan

    2013-01-01

    Research shows that depression and anxiety disorders are the most common psychiatric concern in autism spectrum disorders (ASD). Mindfulness-based therapy (MBT) has been found effective in reducing anxiety and depression symptoms, however research in autism is limited. Therefore, we examined the effects of a modified MBT protocol (MBT-AS) in high-functioning adults with ASD. 42 participants were randomized into a 9-week MBT-AS training or a wait-list control group. Results showed a significant reduction in depression, anxiety and rumination in the intervention group, as opposed to the control group. Furthermore, positive affect increased in the intervention group, but not in the control group. Concluding, the present study is the first controlled trial to demonstrate that adults with ASD can benefit from MBT-AS.

  7. Mitigating Cellular Inflammation in Older Adults: A Randomized Controlled Trial of Tai Chi Chih

    PubMed Central

    Irwin, Michael R.; Olmstead, Richard

    2011-01-01

    OBJECTIVES To evaluate the effects of a behavioral intervention, Tai Chi Chih (TCC) on circulating markers of inflammation in older adults. DESIGN A prospective, randomized, controlled trial with allocation to two arms, TCC and health education (HE), 16 weeks of intervention administration, and 9 weeks follow-up. PARTICIPANTS A total of 83 healthy older adults, aged 59 to 86 years. MEASUREMENTS The primary endpoint was circulating levels of interleukin 6 (IL-6). Secondary outcomes were circulating levels of C-reactive protein (CRP), soluble IL-1 receptor antagonist (sIL-1RA), sIL-6R, soluble intercellular adhesion molecule (sICAM) and IL-18. Severity of depressive symptoms, sleep quality, and physical activity was also assessed over the treatment trial. RESULTS Among those older adults with high levels IL-6 at entry, a trend for a treatment group by time interaction was found (F(1,70)=3.48, P = .07), in which TCC produced a drop of IL-6 levels comparable to those found in TCC and HE subgroups who had low levels of IL-6 at entry (t’s(72)=0.80, 1.63, P’s>0.10), whereas IL-6 in HE remained higher than the TCC- and HE subgroups with low entry IL-6 (t(72)=2.47, P=0.02; t(72)=1.71, P=0.09). Decreases in depressive symptoms in the two treatment groups correlated with decreases of IL-6 (r=.28, P <.05). None of the other cellular markers of inflammation changed in TCC vs. HE. CONCLUSION TCC can be considered a useful behavioral intervention to reduce circulating levels of IL-6 in older adults who show elevated levels of this inflammatory marker and are at risk for inflammation-related morbidity. PMID:21934474

  8. Randomized Trial of Behavior Therapy for Adults with Tourette’s Disorder

    PubMed Central

    Wilhelm, Sabine; Peterson, Alan L.; Piacentini, John; Woods, Douglas W.; Deckersbach, Thilo; Sukhodolsky, Denis G.; Chang, Susanna; Liu, Haibei; Dziura, James; Walkup, John T.; Scahill, Lawrence

    2013-01-01

    Context Tics in Tourette syndrome begin in childhood, peak in early adolescence, and often decline by early adulthood. However, some adult patients continue to have impairing tics. Medications for tics are often effective but can cause adverse effects. Behavior therapy may offer an alternative but has not been examined in a large-scale controlled trial in adults. Objective To test the efficacy of a comprehensive behavioral intervention for tics in adults with Tourette syndrome of at least moderate severity. Design A randomized, controlled trial with posttreatment evaluations at 3 and 6 months for positive responders. Setting Three outpatient research clinics. Subjects Subjects (N = 122; 78 males, age 16 to 69 years) with Tourette syndrome or chronic tic disorder. Interventions Eight sessions of Comprehensive Behavioral Intervention for Tics or 8 sessions of supportive treatment delivered over 10 weeks. Subjects showing a positive response were given 3 monthly booster sessions. Main Outcome Measures Total Tic score of the Yale Global Tic Severity Scale and the Improvement scale of the Clinical Global Impression rated by a clinician blind to treatment assignment. Results Behavior therapy was associated with a significantly greater decrease on the Yale Global Tic Severity Scale (24.0 ± 6.47 to 17.8 ± 7.32) from baseline to endpoint compared to the control treatment (21.8 ± 6.59 to 19.3 ± 7.40) (P < .001; effect size = 0.57). Twenty-four of 63 subjects (38.1%) in CBIT were rated as Much Improved or Very Much Improved on the Clinical Global Impression-Improvement scale compared to 6.8% (4 of 63) in the control group (P < .0001). Attrition was 13.9% with no difference across groups. Subjects in behavior therapy available for assessment at 6 months posttreatment showed continued benefit. Conclusions Comprehensive behavior therapy is a safe and effective intervention for adults with Tourette syndrome. PMID:22868933

  9. Neutropenia as an Adverse Event following Vaccination: Results from Randomized Clinical Trials in Healthy Adults and Systematic Review

    PubMed Central

    Muturi-Kioi, Vincent; Lewis, David; Launay, Odile; Leroux-Roels, Geert; Anemona, Alessandra; Loulergue, Pierre; Bodinham, Caroline L.; Aerssens, Annelies; Groth, Nicola; Saul, Allan; Podda, Audino

    2016-01-01

    Background In the context of early vaccine trials aimed at evaluating the safety profile of novel vaccines, abnormal haematological values, such as neutropenia, are often reported. It is therefore important to evaluate how these trials should be planned not to miss potentially important safety signals, but also to understand the implications and the clinical relevance. Methodology We report and discuss the results from five clinical trials (two with a new Shigella vaccine in the early stage of clinical development and three with licensed vaccines) where the absolute neutrophil counts (ANC) were evaluated before and after vaccination. Additionally, we have performed a systematic review of the literature on cases of neutropenia reported during vaccine trials to discuss our results in a more general context. Principal Findings Both in our clinical trials and in the literature review, several cases of neutropenia have been reported, in the first two weeks after vaccination. However, neutropenia was generally transient and had a benign clinical outcome, after vaccination with either multiple novel candidates or well-known licensed vaccines. Additionally, the vaccine recipients with neutropenia frequently had lower baseline ANC than non-neutropenic vaccinees. In many instances neutropenia occurred in subjects of African descent, known to have lower ANC compared to western populations. Conclusions It is important to include ANC and other haematological tests in early vaccine trials to identify potential safety signals. Post-vaccination neutropenia is not uncommon, generally transient and clinically benign, but many vaccine trials do not have a sampling schedule that allows its detection. Given ethnic variability in the level of circulating neutrophils, normal ranges taking into account ethnicity should be used for determination of trial inclusion/exclusion criteria and classification of neutropenia related adverse events. Trial registration ClinicalTrials.gov NCT02017899

  10. A Serious Game to Increase Healthy Food Consumption in Overweight or Obese Adults: Randomized Controlled Trial

    PubMed Central

    2016-01-01

    Background Obesity is a growing global issue that is linked to cognitive and psychological deficits. Objective This preliminary study investigated the efficacy of training to improve inhibitory control (IC), a process linked to overeating, on consumption and cognitive control factors. Methods This study utilized a multisession mobile phone–based intervention to train IC in an overweight and obese population using a randomized waitlist-control design. A combination of self-assessment questionnaires and psychophysiological measures was used to assess the efficacy of the intervention in terms of improved general IC and modified food consumption after training. Attitudes toward food were also assessed to determine their mediating role in food choices. A total of 58 participants (47 female) completed 2 assessment sessions 3 weeks apart, with 2 weeks of intervention training for the training group during this time. The groups did not differ in baseline demographics including age, body mass index, and inhibitory control. Results Inhibitory control ability improved across the training sessions, with increases in P3 amplitude implying increased cognitive control over responses. Inhibitory control training was associated with increased healthy and reduced unhealthy food consumption in a taste test and in the week following training, as measured by the Healthy Eating Quiz and the food consumption test. Cognitive restraint was enhanced after training for the training but not the waitlist condition in the Three-Factor Eating Questionnaire, implying that attempts to avoid unhealthy foods in the future will be easier for the training group participants. Conclusions Inhibitory control training delivered via a purpose-designed mobile phone app is easy to complete, is convenient, and can increase cognitive restraint and reduce unhealthy food consumption. Trial Registration Australian New Zealand Clinical Trials Registry ACTRN12616000263493; http

  11. Phase 1 Clinical Trials of DAS181, an Inhaled Sialidase, in Healthy Adults

    PubMed Central

    Zenilman, Jonathan M.; Fuchs, Edward J.; Hendrix, Craig W.; Radebaugh, Christine; Jurao, Robert; Nayak, Seema U.; Hamilton, Robert G.; Griffiss, J. McLeod

    2015-01-01

    DAS181, (study drug, Fludase®) was developed for treatment of influenza and parainfluenza infections. Delivered by inhalation, DAS181 cleaves sialic acid receptors from respiratory epithelial cells. Treatment of influenza for three days with DAS181 reduced viral shedding. To increase deposition in the upper airways and decrease systemic absorption, the particle size was increased to 10 microns. We conducted two Phase I trials with three cohorts, randomized 2:1, active drug to placebo. The initial cohort got a single 20 mg dose of DAS181, or placebo; the second, 20 mg DAS181 or placebo for 10 days, and the third got 20 mg of DAS181or placebo for 3 days. Formulations differed slightly in their excipients. Subjects in the 1- and 3-day cohorts completed dosing without serious adverse events. Two subjects in the 10-day cohort stopped at Day 9 after developing respiratory and systemic symptoms, and a third experienced a decrease in FEV1 (Forced Expiratory Volume in 1 second) after the 9th dose and a further decline after the 10th dose. Plasma DAS181, in the 10-day cohort, peaked and began falling before the last dose. Antibodies, predominately IgG with neutralizing activity, were detected in 15/18 subjects by Day 30. The highest IgG concentrations were in the 10-day cohort. The respiratory adverse events occurring after seven days and rapid drug clearance during continued dosing are consistent with the induction of DAS181 antibodies. This could preclude use of this medication for longer than seven days or for repeated courses. (These studies have been registered at ClinicalTrials.gov under registration nos. NCT 00527865 and NCT 01651494.) PMID:26391974

  12. Phase 1 clinical trials of DAS181, an inhaled sialidase, in healthy adults.

    PubMed

    Zenilman, Jonathan M; Fuchs, Edward J; Hendrix, Craig W; Radebaugh, Christine; Jurao, Robert; Nayak, Seema U; Hamilton, Robert G; McLeod Griffiss, J

    2015-11-01

    DAS181, (study drug, Fludase®) was developed for treatment of influenza and parainfluenza infections. Delivered by inhalation, DAS181 cleaves sialic acid receptors from respiratory epithelial cells. Treatment of influenza for three days with DAS181 reduced viral shedding. To increase deposition in the upper airways and decrease systemic absorption, the particle size was increased to 10μm. We conducted two Phase I trials with three cohorts, randomized 2:1, active drug to placebo. The initial cohort got a single 20mg dose of DAS181, or placebo; the second, 20mg DAS181 or placebo for 10days, and the third got 20mg of DAS181 or placebo for 3days. Formulations differed slightly in their excipients. Subjects in the 1- and 3-day cohorts completed dosing without serious adverse events. Two subjects in the 10-day cohort stopped at Day 9 after developing respiratory and systemic symptoms, and a third experienced a decrease in FEV1 (Forced Expiratory Volume in 1s) after the 9th dose and a further decline after the 10th dose. Plasma DAS181, in the 10-day cohort, peaked and began falling before the last dose. Antibodies, predominately IgG with neutralizing activity, were detected in 15/18 subjects by Day 30. The highest IgG concentrations were in the 10-day cohort. The respiratory adverse events occurring after seven days and rapid drug clearance during continued dosing are consistent with the induction of DAS181 antibodies. This could preclude use of this medication for longer than seven days or for repeated courses. (These studies have been registered at ClinicalTrials.gov under registration Nos. NCT 00527865 and NCT 01651494.).

  13. Designing a Weight Gain Prevention Trial for Young Adults: The CHOICES Study

    PubMed Central

    Lytle, Leslie A.; Moe, Stacey G.; Nanney, M. Susie; Laska, Melissa N.; Linde, Jennifer A.

    2014-01-01

    Background Young adults are at risk for weight gain. Little is known about how to design weight control programs to meet the needs of young adults and few theory-based interventions have been evaluated in a randomized control trial. The Choosing Healthy Options in College Environments and Settings (CHOICES) study was funded to create a technology-based program for 2-year community college students to help prevent unhealthy weight gain. The purpose of this paper is to: 1) provide a brief background on weight-related interventions in young adults; 2) describe the study design for the CHOICES study, the conceptual model guiding the research and the CHOICES intervention; and 3) discuss implications of this research for health educators. Translation to Health Education Practice Our experiences from the CHOICES study will be useful in suggesting other theory-based models and intervention strategies that might be helpful in programs attempting to prevent unhealthy weight gain in young adults. In addition, this paper discusses important considerations for working with 2-year colleges on this type of health promotion work. PMID:24910855

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

    PubMed Central

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

    2014-01-01

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

  15. Effects of the immediate recall trial on Delayed Recall performance in the Rey Complex Figure Test in young and older adults.

    PubMed

    Yamashita, Hikari

    2015-01-01

    This study determines whether the presence or absence of the Immediate Recall trial influences performance among healthy young and older adults on the 30-min Delayed Recall task of the Rey Complex Figure Test. Participants in the 1-test condition (24 young adults and 24 older adults) underwent the Copy trial and 30-min Delayed Recall trial only, while participants in the 2-test condition (24 young adults and 24 older adults) completed the Copy trial, the Immediate Recall trial, and the 30-min Delayed Recall trial. Both older and younger participants in the 2-test condition showed significantly higher scores than those in the 1-test condition on the 30-min Delayed Recall trial. The relevance of these findings to the relationship with testing effects (Roediger & Karpicke, 2006 ) was discussed.

  16. Efficacy of Standard Versus Enhanced Features in a Web-Based Commercial Weight-Loss Program for Obese Adults, Part 2: Randomized Controlled Trial

    PubMed Central

    Morgan, Philip J; Hutchesson, Melinda J; Callister, Robin

    2013-01-01

    Background Commercial Web-based weight-loss programs are becoming more popular and increasingly refined through the addition of enhanced features, yet few randomized controlled trials (RCTs) have independently and rigorously evaluated the efficacy of these commercial programs or additional features. Objective To determine whether overweight and obese adults randomized to an online weight-loss program with additional support features (enhanced) experienced a greater reduction in body mass index (BMI) and increased usage of program features after 12 and 24 weeks compared to those randomized to a standard online version (basic). Methods An assessor-blinded RCT comparing 301 adults (male: n=125, 41.5%; mean age: 41.9 years, SD 10.2; mean BMI: 32.2 kg/m2, SD 3.9) who were recruited and enrolled offline, and randomly allocated to basic or enhanced versions of a commercially available Web-based weight-loss program for 24 weeks. Results Retention at 24 weeks was greater in the enhanced group versus the basic group (basic 68.5%, enhanced 81.0%; P=.01). In the intention-to-treat analysis of covariance with imputation using last observation carried forward, after 24 weeks both intervention groups had reductions in key outcomes with no difference between groups: BMI (basic mean –1.1 kg/m2, SD 1.5; enhanced mean –1.3 kg/m2, SD 2.0; P=.29), weight (basic mean –3.3 kg, SD 4.7; enhanced mean –4.0 kg, SD 6.2; P=.27), waist circumference (basic mean –3.1 cm, SD 4.6; enhanced mean –4.0 cm, SD 6.2; P=.15), and waist-to-height ratio (basic mean –0.02, SD 0.03; enhanced mean –0.02, SD 0.04, P=.21). The enhanced group logged in more often at both 12 and 24 weeks, respectively (enhanced 12-week mean 34.1, SD 28.1 and 24-week mean 43.1, SD 34.0 vs basic 12-week mean 24.6, SD 25.5 and 24-week mean 31.8, SD 33.9; P=.002). Conclusions The addition of personalized e-feedback in the enhanced program provided limited additional benefits compared to a standard commercial Web

  17. Protocol for a multicentre randomiSed controlled TRial of IntraVEnous immunoglobulin versus standard therapy for the treatment of transverse myelitis in adults and children (STRIVE)

    PubMed Central

    Absoud, M; Gadian, J; Hellier, J; Brex, P A; Ciccarelli, O; Giovannoni, G; Kelly, J; McCrone, P; Murphy, C; Palace, J; Pickles, A; Pike, M; Robertson, N; Jacob, A; Lim, M

    2015-01-01

    Introduction Transverse myelitis (TM) is an immune-mediated disorder of the spinal cord which causes motor and sensory disturbance and limited recovery in 50% of patients. Standard treatment is steroids, and patients with more severe disease appear to respond to plasma exchange (PLEX). Intravenous immunoglobulin (IVIG) has also been used as an adjunct to steroids, but evidence is lacking. We propose the first randomised control trial in adults and children, to determine the benefit of additional treatment with IVIG. Methods and analysis 170 adults and children aged over 1 year with acute first episode TM or neuromyelitis optica (with myelitis) will be recruited over a 2.5-year period and followed up for 12 months. Participants randomised to the control arm will receive standard therapy of intravenous methylprednisolone (IVMP). The intervention arm will receive the above standard therapy, plus additional IVIG. Primary outcome will be a 2-point improvement on the American Spinal Injury Association (ASIA) Impairment scale at 6 months postrandomisation by blinded assessors. Additional secondary and tertiary outcome measures will be collected: ASIA motor and sensory scales, Kurtzke expanded disability status scale, International Spinal Cord Injury (SCI) Bladder/Bowel Data Set, Client Services Receipt Index, Pediatric Quality of Life Inventory, EQ-5D, SCI Pain and SCI Quality of Life Data Sets. Biological samples will be biobanked for future studies. After 6-months' follow-up of the first 52 recruited patients futility analysis will be carried out. Health economics analysis will be performed to calculate cost-effectiveness. After 6 months’ recruitment futility analysis will be performed. Ethics and dissemination Research Ethics Committee Approval was obtained: 14/SC/1329. Current protocol: v3.0 (15/01/2015). Study findings will be published in peer-reviewed journals. Trial registration numbers This study is registered with EudraCT (REF: 2014

  18. Efficacy and safety of suanzaoren decoction for chronic insomnia disorder in adults: study protocol for randomised, double-blind, double-dummy, placebo-controlled trial

    PubMed Central

    Zhou, Qi-Hui; Wang, Hui-Lin; Zhou, Xiao-Li; Xu, Meng-Bei; Zhang, Hong-feng; Huang, Li-bo; Lin, Yan

    2017-01-01

    Background Insomnia disorder is defined as a combination of dissatisfaction with sleep quantity or quality and a significant negative impact on daytime functioning. Chronic insomnia disorder refers to clinical symptoms of persistent insomnia at least three nights a week for at least 3 months. Prevalence estimates of insomnia disorder range from 12% to 20% in the adult population, with approximately 50% having a chronic course. The potential side effects of hypnotic medications hinder their clinical application. Thus, traditional Chinese medicine is considered as an alternative option for treating insomnia. Objective To evaluate the efficacy and safety of suanzaoren decoction (SZRD), a classic Chinese herbal prescription, for adult chronic insomnia disorder. Methods/analysis This is a randomised, double-blind, double-dummy, placebo-controlled clinical trial. A total of 150 patients with chronic insomnia disorder are randomised, allocated in a ratio of 1:1:1 to three groups: intervention group, control group and placebo group. The intervention group receives SZRD granule plus zolpidem tartrate (ZT) placebo; the control group receives ZT tablet plus SZRD granule placebo; and the placebo group receives ZT placebo and SZRD granule placebo. The patients receive medicine or placebo for 5 weeks and are followed up at 20 weeks. The primary outcome measures are polysomnography and Pittsburgh Sleep Quality Index. Secondary outcome measures are the Insomnia Severity Index, sleep diary and safety assessment. Outcomes will be assessed at baseline and after treatment. Trial registration number ChiCTR-IOR-16009198. pre-results. PMID:28377394

  19. Effect of beetroot juice on lowering blood pressure in free-living, disease-free adults: a randomized, placebo-controlled trial

    PubMed Central

    2012-01-01

    Background The consumption of beetroot juice on a low nitrate diet may lower blood pressure (BP) and therefore reduce the risk of cardiovascular events. However, it is unknown if its inclusion as part of a normal diet has a similar effect on BP. The aim of the study was to conduct a randomized controlled trial with free-living adults to investigate if consuming beetroot juice in addition to a normal diet produces a measureable reduction in BP. Method Fifteen women and fifteen men participated in a double-blind, randomized, placebo-controlled, crossover study. Volunteers were randomized to receive 500 g of beetroot and apple juice (BJ) or a placebo juice (PL). Volunteers had BP measured at baseline and at least hourly for 24-h following juice consumption using an ambulatory blood pressure monitor (ABPM). Volunteers remained at the clinic for 1-h before resuming normal non-strenuous daily activities. The identical procedure was repeated 2-wk later with the drink (BJ or PL) not consumed on the first visit. Results Overall, there was a trend (P=0.064) to lower systolic blood pressure (SBP) at 6-h after drinking BJ relative to PL. Analysis in men only (n=13) after adjustment for baseline differences demonstrated a significant (P<0.05) reduction in SBP of 4 – 5 mmHg at 6-h after drinking BJ. Conclusions Beetroot juice will lower BP in men when consumed as part of a normal diet in free-living healthy adults. Trial registration anzctr.org.au ACTRN12612000445875 PMID:23231777

  20. Available, accessible, aware, appropriate, and acceptable: a strategy to improve participation of teenagers and young adults in cancer trials.

    PubMed

    Fern, Lorna A; Lewandowski, Jennifer A; Coxon, Katy M; Whelan, Jeremy

    2014-07-01

    Under-representation of teenagers and young adults in clinical trials for cancer is acknowledged internationally and might account for the lower survival gains noted for this group. Little research has focused on strategies to increase participation of teenagers and young adults in clinical trials. We applied a conceptual framework for barriers to recruitment of under-represented populations to data for cancer clinical trials in teenagers and young adults. We did a systematic analysis of data for clinical trial enrolment in Great Britain over 6 years (2005-10), and reviewed the published work for the origins and scientific rationale of age eligibility criteria in clinical trials for cancer. Our Review revealed little scientific evidence for use of age eligibility criteria in cancer clinical trials. Participation in cancer trials fell as age increased. Between 2005 and 2010, participation rates increased for children and young people aged 0-24 years. The highest increase in participation was for teenagers aged 15-19 years, with smaller improvements in rates for 20-24 year olds. Improvements were related to five key criteria, the five As: available, accessible, aware, appropriate, and acceptable. In studies for which age eligibility criteria were appropriate for inclusion of teenagers or young adults or amended during the study period, participation rates for 15-19 year olds were similar to those for 10-14 year olds. We propose a conceptual model for a strategic approach to improve recruitment of teenagers and younger adults to clinical trials for cancer, with use of the five As, which is applicable worldwide for investigators, regulatory authorities, representatives in industry, policy makers, funders, and health-care professionals.

  1. Cell phone Intervention for You (CITY): A randomized, controlled trial of behavioral weight loss intervention for young adults using mobile technology

    PubMed Central

    Svetkey, LP; Batch, BC; Lin, P-H; Intille, SS; Corsino, L; Tyson, CC; Bosworth, HB; Grambow, SC; Voils, C; Loria, C; Gallis, JA; Schwager, J; Bennett, GB

    2015-01-01

    Objectives To determine the effect on weight of two Mobile technology-based (mHealth) behavioral weight loss interventions in young adults. Methods Randomized, controlled comparative effectiveness trial in 18–35 year olds with BMI ≥ 25 kg/m2 (overweight/obese), with participants randomized to 24 months of mHealth intervention delivered by interactive smartphone application on a cell phone (CP); personal coaching enhanced by smartphone self-monitoring (PC); or Control. Results The 365 randomized participants had mean baseline BMI of 35 kg/m2. Final weight was measured in 86% of participants. CP was not superior to Control at any measurement point. PC participants lost significantly more weight than Controls at 6 months (net effect −1.92 kg [CI −3.17, −0.67], p=0.003), but not at 12 and 24 months. Conclusions Despite high intervention engagement and study retention, the inclusion of behavioral principles and tools in both interventions, and weight loss in all treatment groups, CP did not lead to weight loss and PC did not lead to sustained weight loss relative to control. Although mHealth solutions offer broad dissemination and scalability, the CITY results sound a cautionary note concerning intervention delivery by mobile applications. Effective intervention may require the efficiency of mobile technology, the social support and human interaction of personal coaching, and an adaptive approach to intervention design. Trial Registration ClinicalTrials.gov Identifier NCT01092364. https://clinicaltrials.gov/ct2/show/NCT01092364?term=Cell+phone+intervention+for+you&rank=3 PMID:26530929

  2. Promoting smoking cessation in Bangladeshi and Pakistani male adults: design of a pilot cluster randomised controlled trial of trained community smoking cessation workers

    PubMed Central

    2009-01-01

    Background The prevalence of smoking is higher among Pakistani and Bangladeshi males than among the general population. Smokers who receive behavioural support and medication quadruple their chances of stopping smoking, but evidence suggests that these populations do not use National Health Service run stop smoking clinics as frequently as would be expected given their high prevalence of smoking. This study aims to tackle some of the main barriers to use of stop smoking services and adherence to treatment programmes by redesigning service delivery to be more acceptable to these adult male populations. The study compares the effectiveness of trained Pakistani and Bangladeshi smoking cessation workers operating in an outreach capacity ('clinic + outreach') with standard care ('clinic only') to improve access to and success of National Health Service smoking cessation services. Methods/design This is a pilot cluster randomised controlled trial based in Birmingham, UK. Super output areas of Birmingham will be identified in which more than 10% of the population are of Pakistani and/or Bangladeshi origin. From these areas, 'natural geographical communities' will be identified. Sixteen aggregated agglomerations of super output areas will be identified, separating areas from each other using buffer regions in order to reduce potential contamination. These natural communities will be randomised to 'clinic + outreach' (intervention) or 'clinic only' (control) arms. The use of stop smoking services and the numbers of people quitting smoking (defined as prolonged self-reported abstinence at four weeks, three months and six months) will be assessed in each area. In addition, we will assess the impact of the intervention on adherence to smoking cessation treatments and patient satisfaction. Trial registration Current Controlled Trials ISRCTN 82127540. PMID:19682374

  3. Mobilization With Movement for Shoulder Dysfunction in Older Adults: A Pilot Trial

    PubMed Central

    Lirio Romero, Cristina; Torres Lacomba, María; Castilla Montoro, Yurema; Prieto Merino, David; Pacheco da Costa, Soraya; Velasco Marchante, María Jesús; Bodes Pardo, Gema

    2015-01-01

    Objective The purpose of this study was to evaluate the feasibility of the methods proposed to conduct a full randomized clinical trial to assess the effectiveness of mobilization with movement on shoulder functionality in older adults with shoulder dysfunction. Methods A pilot, randomized, single-blinded clinical trial was carried out with 44 older adults (83.9±8.2 years) with shoulder dysfunction in 3 nursing homes in Toledo, Spain. Participants were recruited through information sessions and were randomly allocated into 2 groups. The control group (n = 22) intervention consisted of a physical therapy standard protocol proposed by the Spanish Rheumatology Society. Techniques based on Mulligan’s concepts of mobilization with movement were added to the standard protocol for the experimental group (n = 22) intervention. Interventions took place 3 times a week for 2 consecutive weeks and were performed by 2 experienced therapists. Main outcomes were recruitment rates, participation and adherence to interventions, assessment procedures, and the implementation of mobilization with movement. Clinical outcomes were shoulder functionality, active glenohumeral range of motion, and pain intensity. Data were collected at baseline, after each group intervention, and at 1 and 3 months after finishing interventions. Results All the participants accepted to be randomized. Participation rates were 97.7% for the experimental group and 95.5% for the control group. The analysis of variance did not show any statistically significant difference between treatment groups for any of the variables (all P values for the group effect were greater than .36) or a change of the difference between groups over time (all P values for the time-treatment interactions were greater than .3). Conclusion The research methods tested in this pilot study offer a suitable foundation to conduct a full clinical trial. PMID:26793036

  4. Confronting Challenges in Intervention Research with Ethnically Diverse Older Adults: The USC Well Elderly II Trial

    PubMed Central

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

    2011-01-01

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

  5. Obesity and Physical Frailty in Older Adults: A Scoping Review of Intervention Trials

    PubMed Central

    Porter Starr, Kathryn N.; McDonald, Shelley R.; Bales, Connie W.

    2013-01-01

    Many frail older adults are thin, weak, and undernourished; this component of frailty remains a critical concern in the geriatric field. However, there is also strong evidence that excessive adiposity contributes to frailty by reducing the ability of older adults to perform physical activities and increasing metabolic instability. Our scoping review explores the impact of being obese on physical frailty in older adults by summarizing the state of the science for both clinical markers of physical function and biomarkers for potential underlying causes of obesity-related decline. We used the five-stage methodological framework of Arksey and O’Malley to conduct a scoping review of randomized trials of weight loss and/or exercise interventions for obesity (BMI ≥ 30 kg/m2) in older adults (aged > 60 yrs), examining the outcomes of inflammation, oxidative stress, and lipid accumulation in muscle, as well as direct measures of physical function. Our initial search yielded 212 articles; exclusion of cross-sectional and observational studies, cell culture and animal studies, disease-specific interventions, and articles published before 2001 led to a final result of 21 articles. Findings of these trials included the following major points: The literature consistently confirmed benefits of lifestyle interventions to physical function assessed at the clinical level. Generally speaking, weight loss alone produced a greater effect than exercise alone and the best outcomes were achieved with a combination of weight loss and exercise, especially exercise programs that combined aerobic, resistance, and flexibility training. Weight loss interventions tended to reduce markers of inflammation and/or oxidative damage when more robust weight reduction was achieved and maintained over time, whereas exercise did not change markers of inflammation. However, participation in a chronic exercise program did reduce the oxidative stress induced by an acute bout of exercise. Weight loss

  6. A cognitive-motor intervention using a dance video game to enhance foot placement accuracy and gait under dual task conditions in older adults: a randomized controlled trial

    PubMed Central

    2012-01-01

    Background Computer-based interventions have demonstrated consistent positive effects on various physical abilities in older adults. This study aims to compare two training groups that achieve similar amounts of strength and balance exercise where one group receives an intervention that includes additional dance video gaming. The aim is to investigate the different effects of the training programs on physical and psychological parameters in older adults. Methods Thirty-one participants (mean age ± SD: 86.2 ± 4.6 years), residents of two Swiss hostels for the aged, were randomly assigned to either the dance group (n = 15) or the control group (n = 16). The dance group absolved a twelve-week cognitive-motor exercise program twice weekly that comprised progressive strength and balance training supplemented with additional dance video gaming. The control group performed only the strength and balance exercises during this period. Outcome measures were foot placement accuracy, gait performance under single and dual task conditions, and falls efficacy. Results After the intervention between-group comparison revealed significant differences for gait velocity (U = 26, P = .041, r = .45) and for single support time (U = 24, P = .029, r = .48) during the fast walking dual task condition in favor of the dance group. No significant between-group differences were observed either in the foot placement accuracy test or in falls efficacy. Conclusions There was a significant interaction in favor of the dance video game group for improvements in step time. Significant improved fast walking performance under dual task conditions (velocity, double support time, step length) was observed for the dance video game group only. These findings suggest that in older adults a cognitive-motor intervention may result in more improved gait under dual task conditions in comparison to a traditional strength and balance exercise program. Trial registration

  7. A multicentre comparative trial of sodium valproate and carbamazepine in adult onset epilepsy. Adult EPITEG Collaborative Group.

    PubMed Central

    Richens, A; Davidson, D L; Cartlidge, N E; Easter, D J

    1994-01-01

    The long-term efficacy and safety of sodium valproate and carbamazepine in adult outpatients with newly diagnosed primary generalised or partial and secondarily generalised seizures were compared in a randomised, open, multicentre study at 22 neurology outpatient clinics. Patients were randomised to oral sodium valproate (Epilim EC enteric coated 200 mg tablets twice daily, n = 149) or oral carbamazepine (100 mg twice daily increasing to 200 mg twice daily in week 2, n = 151) and followed up for three years. If clinically necessary, dosages were regularly increased until seizures were controlled or toxicity developed. Sodium valproate and carbamazepine controlled both primary generalised and partial seizures equally effectively overall. Significantly more patients on sodium valproate than carbamazepine (126/140 (90%) v 105/141 (75%), p = 0.001) remained on randomised treatment for at least six months. Skin rashes occurred significantly more often in carbamazepine recipients than in sodium valproate recipients (11.2% v 1.7%, p < 0.05) and carbamazepine was associated with a higher withdrawal rate because of adverse events (15% v 5% on sodium valproate) in the first six months of treatment. There was no difference between the drugs in the rate of withdrawal because of poor seizure control at any stage, regardless of seizure type. At the end of the three year trial period, over 70% of the available patients were still on randomised treatment or had recently stopped treatment after achieving full seizure control. Sodium valproate and carbamazepine were both associated with a high degree of overall seizure control regardless of seizure type and both have good long-term tolerability in adult patients with newly diagnosed epilepsy. Recommendations are made for a higher initial dosage regime for sodium valproate in partial seizures. PMID:8006647

  8. Inclusion of walnut in the diets of adults at risk for type 2 diabetes and their dietary pattern changes: a randomized, controlled, cross-over trial

    PubMed Central

    Njike, Valentine Yanchou; Yarandi, Niloufarsadat; Petraro, Paul; Ayettey, Rockiy G; Treu, Judith A; Katz, David L

    2016-01-01

    Background In our recently published study, including walnuts in the diets of adults with prediabetes led to overall improvement in diet quality. This report adds to those study findings by examining the food groups displaced during walnut inclusion in the diets of those adults with prediabetes. Methods Randomized, controlled, modified Latin square parallel design with 2 treatment arms. The 112 participants (31 men, 81 women) were randomly assigned to a diet with or without dietary counseling to regulate calorie intake in a 1:1 ratio. Within each treatment arm, participants were further randomized to 1 of 2 sequence permutations to receive a walnut-included diet with 56 g (366 kcal) of walnuts per day and a walnut-excluded diet. Participants in the calorie-regulated arm received advice from a dietitian to preserve an isocaloric condition while including walnuts. We analyzed the 12 components of the 2010 Healthy Eating Index to examine dietary pattern changes of study participants. Results Seafood and plant protein foods intake significantly increased with walnut inclusion, compared with their exclusion (2.14±2.06 vs −0.49±2.33; p=0.003). The ingestion of healthful fatty acids also significantly increased with walnut inclusion, compared with their exclusion (1.43±4.53 vs −1.76±4.80; p=0.02). Dairy ingestion increased with walnut inclusion in the calorie-regulated phase, compared with walnut inclusion without calorie regulation (1.06±4.42 vs −2.15±3.64; p=0.02). Conclusions Our data suggest that walnut inclusion in the diets of adults at risk for diabetes led to an increase in intake of other healthful foods. Trial registration number NCT02330848. PMID:27843557

  9. The Cluster-Randomized BRIGHT Trial: Proactive Case Finding for Community-Dwelling Older Adults

    PubMed Central

    Kerse, Ngaire; McLean, Chris; Moyes, Simon A.; Peri, Kathy; Ng, Terence; Wilkinson-Meyers, Laura; Brown, Paul; Latham, Nancy; Connolly, Martin

    2014-01-01

    PURPOSE People are now living longer, but disability may affect the quality of those additional years of life. We undertook a trial to assess whether case finding reduces disability among older primary care patients. METHODS We conducted a cluster-randomized trial of the Brief Risk Identification Geriatric Health Tool (BRIGHT) among 60 primary care practices in New Zealand, assigning them to an intervention or control group. Intervention practices sent a BRIGHT screening tool to older adults every birthday; those with a score of 3 or higher were referred to regional geriatric services for assessment and, if needed, service provision. Control practices provided usual care. Main outcomes, assessed in blinded fashion, were residential care placement and hospitalization, and secondary outcomes were disability, assessed with Nottingham Extended Activities of Daily Living Scale (NEADL), and quality of life, assessed with the World Health Organization Quality of Life scale, abbreviated version (WHOQOL-BREF). RESULTS All 8,308 community-dwelling patients aged 75 years and older were approached; 3,893 (47%) participated, of whom 3,010 (77%) completed the trial. Their mean age was 80.3 (SD 4.5) years, and 55% were women. Overall, 88% of the intervention group returned a BRIGHT tool; 549 patients were referred. After 36 months, patients in the intervention group were more likely than those in the control group to have been placed in residential care: 8.4% vs 6.2% (hazard ratio = 1.32; 95% CI, 1.04–1.68; P = .02). Intervention patients had smaller declines in mean scores for physical health-related quality of life (1.6 vs 2.9 points, P = .007) and psychological health-related quality of life (1.1 vs 2.4 points, P = .005). Hospitalization, disability, and use of services did not differ between groups, however. CONCLUSIONS Our case-finding strategy was effective in increasing identification of older adults with disability, but there was little evidence of improved outcomes

  10. Stepped care for depression and anxiety in visually impaired older adults: multicentre randomised controlled trial

    PubMed Central

    van Rens, Ger H M B; Comijs, Hannie C; Margrain, Tom H; Gallindo-Garre, Francisca; Twisk, Jos W R; van Nispen, Ruth M A

    2015-01-01

    this study adds Stepped care seems to be a promising way to deal with depression and anxiety in visually impaired older adults. This approach could lead to standardised strategies for the screening, monitoring, treatment, and referral of visually impaired older adults with depression and anxiety. Funding, competing interests, data sharing Funded by ZonMw InZicht, the Dutch Organisation for Health Research and Development-InSight Society. There are no competing interests. Full dataset and statistical code are available from the corresponding author. Study registration www.trialregister.nl NTR3296. PMID:26597263

  11. Egg ingestion in adults with type 2 diabetes: effects on glycemic control, anthropometry, and diet quality—a randomized, controlled, crossover trial

    PubMed Central

    Njike, Valentine Y; Ayettey, Rockiy G; Rajebi, Hamid; Treu, Judith A; Katz, David L

    2016-01-01

    Background The inclusion of eggs as part of a healthful diet for adults with diabetes is controversial. We examined the effects of including eggs in the diet of adults with type 2 diabetes on cardiometabolic risk factors. Methods Randomized, controlled, single-blind, crossover trial of 34 adults (mean age 64.5 years; 14 postmenopausal women, 20 men) with type 2 diabetes assigned to one of two possible sequence permutations of two different 12-week treatments (two eggs/day inclusion or egg exclusion), with 6-week washout periods. For the egg inclusion phase, participants received advice from a dietitian on how to preserve an isocaloric condition relative to the egg exclusion phase. The primary outcome was glycemic control as measured by glycated hemoglobin. Secondary measures included anthropometry, blood pressure, and diet quality. Results Compared with the exclusion of eggs in the habitual diet, the inclusion of eggs did not measurably affect glycated hemoglobin (0.01±0.5% vs −0.24±0.7%; p=0.115) and systolic blood pressure (−0.8±13.0 vs −3.0±10.0 mm Hg; p=0.438); and significantly reduced body mass index (0.06±0.8 vs −0.4±0.8 kg/m²; p=0.013) and visceral fat rating (0.2±1.1 vs −0.4±1.0; p=0.016). The inclusion of eggs in the habitual diet of diabetics significantly reduced waist circumference (−0.4±1.2 cm; p=0.004) and percent body fat (−0.7±1.8; p=0.033) from baseline. Conclusions Short-term daily inclusion of eggs in the habitual diet of adults with type 2 diabetes does not improve glycemic control but can improve anthropometric measures. Trial registration number NCT02052037; results. PMID:28074139

  12. A trial of 7-valent Pneumococcal Conjugate Vaccine in HIV-infected Adults

    PubMed Central

    French, Neil; Gordon, Stephen B; Mwalukomo, Thandie; White, Sarah A; Mwafulirwa, Gershom; Longwe, Herbert; Mwaiponya, Martin; Zijlstra, Eduard E; Molyneux, Malcolm E; Gilks, Charles F

    2010-01-01

    Background: Streptococcus pneumoniae is a leading and serious co-infection of HIV-infected adults, particularly in Africa. Prevention of disease by vaccination with the current 23-valent polysaccharide vaccine is sub-optimal. Protein conjugate vaccines offer a further option for protection but no data exist on their clinical efficacy in any adult population. Methods: We conducted a double-blind randomized placebo-controlled clinical efficacy trial of the seven-valent conjugate pneumococcal vaccine in predominantly HIV-infected Malawian adults who had recovered from documented invasive pneumococcal disease (IPD). Vaccine was given as a two dose schedule four weeks apart. The primary end-point was a further episode of IPD caused by a vaccine-serotype or serotype-6A (VST/6A) pneumococcus. Results: Between February 2003 and October 2007, 496 individuals (44% male, 88% HIV seropositive) were followed for 798 person years of observation. There were 67 IPD events in 52 individuals, all in the HIV infected sub-group. There were 24 VST/6A events (19 VST, five 6A) in 24 participants, 5 in vaccine and 19 in the placebo recipients, a vaccine efficacy of 74% (95% CI 30% - 90%). There were 73 deaths in the vaccine arm and 63 in the placebo arm, Hazard Ratio 1.18 (95% confidence intervals 0.84 -1.66). Compared to placebo, serious adverse events were significantly lower (3 vs 17, p = 0.002) and minor adverse events significantly higher (41 vs 13, p = 0.003 ) in vaccine recipients. Conclusions: The seven-valent pneumococcal conjugate vaccine protects HIV infected adults from recurrent IPD of vaccine serotype or serotype 6A. PMID:20200385

  13. Improving outcomes for older adults with heart failure: a randomized trial using a theory-guided nursing intervention.

    PubMed

    Duffy, Joanne R; Hoskins, Lois M; Dudley-Brown, Sharon

    2010-01-01

    Newly discharged older adults with heart failure continue to experience frequent hospital readmissions, lower quality of life, and decreased satisfaction with health services. A theory-guided intervention delivered by home health nurses via the telephone was studied using a randomized controlled trial to assess its feasibility and inform further studies. Findings generated a profile of older adults with heart failure, utilization by patients and nurses, operational issues, and preliminary data on intended outcomes. Implications for further study are presented.

  14. Vancouver At Home: pragmatic randomized trials investigating Housing First for homeless and mentally ill adults

    PubMed Central

    2013-01-01

    and HN groups had high rates of substance dependence, suicidality, and physical illness. Randomization resulted in no meaningful detectable differences between study arms. Trial registration Current Controlled Trials: ISRCTN57595077 (Vancouver at Home study: Housing First plus Assertive Community Treatment versus congregate housing plus supports versus treatment as usual) and ISRCTN66721740 (Vancouver At Home study: Housing First plus Intensive Case Management versus treatment as usual). PMID:24176253

  15. A pilot open label, single dose trial of fenobam in adults with fragile X syndrome

    PubMed Central

    Berry-Kravis, E; Hessl, D; Coffey, S; Hervey, C; Schneider, A; Yuhas, J; Hutchison, J; Snape, M; Tranfaglia, M; Nguyen, D V; Hagerman, R

    2009-01-01

    Objective: A pilot open label, single dose trial of fenobam, an mGluR5 antagonist, was conducted to provide an initial evaluation of safety and pharmacokinetics in adult males and females with fragile X syndrome (FXS). Methods: Twelve subjects, recruited from two fragile X clinics, received a single oral dose of 50–150 mg of fenobam. Blood for pharmacokinetic testing, vital signs and side effect screening was obtained at baseline and numerous time points for 6 h after dosing. Outcome measures included prepulse inhibition (PPI) and a continuous performance test (CPT) obtained before and after dosing to explore the effects of fenobam on core phenotypic measures of sensory gating, attention and inhibition. Results: There were no significant adverse reactions to fenobam administration. Pharmacokinetic analysis showed that fenobam concentrations were dose dependent but variable, with mean (SEM) peak values of 39.7 (18.4) ng/ml at 180 min after the 150 mg dose. PPI met a response criterion of an improvement of at least 20% over baseline in 6 of 12 individuals (4/6 males and 2/6 females). The CPT did not display improvement with treatment due to ceiling effects. Conclusions: Clinically significant adverse effects were not identified in this study of single dose fenobam across the range of dosages utilised. The positive effects seen in animal models of FXS treated with fenobam or other mGluR5 antagonists, the apparent lack of clinically significant adverse effects, and the potential beneficial clinical effects seen in this pilot trial support further study of the compound in adults with FXS. PMID:19126569

  16. Writing for Health: Rationale and Protocol for a Randomized Controlled Trial of Internet-Based Benefit-Finding Writing for Adults With Type 1 or Type 2 Diabetes

    PubMed Central

    Wilhelm, Kay; Robins, Lisa; Proudfoot, Judy

    2017-01-01

    writing exercises. Outcome measures will be administered online at baseline, one-month, and three-month follow-ups. Results This trial is currently underway. The primary outcomes will be diabetes distress and benefit-finding in diabetes. Secondary outcomes will be depression, anxiety, diabetes self-care, perceived health, and health care utilization. We aim to recruit 104 participants. All stages of the study will be conducted online using the Writing for Health program. Group differences will be analyzed on an intention-to-treat basis using mixed models repeated measures. Linguistic analyses of the writing exercise scripts, and examinations of the immediate emotional responses to the writing exercises, will also be undertaken. Conclusions This RCT will be the first study to examine iBFW for adults with type 1 or type 2 diabetes. If iBFW is found to be efficacious in reducing diabetes distress and improving diabetes self-care and other outcomes, iBFW may offer the potential to be a low-cost, easily accessible self-help intervention to improve the wellbeing of adults with diabetes. Trial Registration Australia and New Zealand Clinical Trials Registry (ACTRN12615000241538) PMID:28292741

  17. A 2-year young adult obesity prevention trial in the US: Process evaluation results.

    PubMed

    Laska, Melissa N; Sevcik, Sarah M; Moe, Stacey G; Petrich, Christine A; Nanney, Marilyn S; Linde, Jennifer A; Lytle, Leslie A

    2016-12-01

    Our objective was to conduct a process evaluation of the CHOICES (Choosing Healthy Options in College Environments and Settings) study, a large, randomized, controlled trial designed to prevent unhealthy weight gain in young adults (aged 18-35) attending 2-year community colleges in the USA. The 24-month intervention consisted of participation in an academic course and a social networking and support website. Among intervention participants, completion rates for most course activities were >80%, reflecting a high level of dose received. Course retention and participant satisfaction were also high. Engagement results, however, were mixed with less than half of participants in the online and hybrid sections of the course reporting that they interacted with course materials ≥3 h/week, but 50-75% reporting that they completed required lessons 'all/very thoroughly'. Engagement in the website activities was also mixed with more than half of intervention participants logging onto the website during the first month, but then declining to 25-40% during the following 23 months of the intervention. Intervention engagement is a challenge of online interventions and a challenge of working with the young adult age group in general. Additional research is needed to explore strategies to support engagement among this population, particularly for relatively long intervention durations.

  18. CAPABLE trial: a randomized controlled trial of nurse, occupational therapist and handyman to reduce disability among older adults: rationale and design.

    PubMed Central

    Szanton, Sarah L.; Wolff, J.W.; Leff, B.; Thorpe, R.J.; Tanner, E.K.; Boyd, C.; Xue, Q.; Guralnik, J.; Bishai, D.; Gitlin, L.N.

    2014-01-01

    Background As the population ages, it is increasingly important to test new models of care that improve life quality and decrease health costs. This paper presents the rationale and design for a randomized clinical trial of a novel interdisciplinary program to reduce disability among low income older adults based on a previous pilot trial of the same design showing strong effect. Methods The CAPABLE (Community Aging in Place, Advancing Better Living for Elders) trial is a randomized controlled trial in which low income older adults with self-care disability are assigned to one of two groups: an interdisciplinary team of a nurse, occupational therapist, and handyman to address both personal and environmental risk factors for disability based on participants’ functional goals, or an attention control of sedentary activities of choice. Both groups receive up to 10 home visits over 4 months. Outcomes The primary outcome is decreased disability in self-care (ADL). Secondary outcomes are sustained decrease in self care disability as well as improvement in instrumental ADLS, strength, balance, walking speed, and health care utilization. Careful cost tracking and analysis using intervention data and claims data will enable direct measurement of the cost impact of the CAPABLE approach. CAPABLE has the potential to leverage current health care spending in Medicaid waivers, Accountable Care Organizations and other capitated systems to save the health care system costs as well as improving low income older adults’ ability to age at home with improved life quality. PMID:24685996

  19. Interventions to Improve Medication Adherence among Older Adults: Meta-Analysis of Adherence Outcomes among Randomized Controlled Trials

    ERIC Educational Resources Information Center

    Conn, Vicki S.; Hafdahl, Adam R.; Cooper, Pamela S.; Ruppar, Todd M.; Mehr, David R.; Russell, Cynthia L.

    2009-01-01

    Purpose: This study investigated the effectiveness of interventions to improve medication adherence (MA) in older adults. Design and Methods: Meta-analysis was used to synthesize results of 33 published and unpublished randomized controlled trials. Random-effects models were used to estimate overall mean effect sizes (ESs) for MA, knowledge,…

  20. Cluster Randomized-Controlled Trial of Interventions to Improve Health for Adults with Intellectual Disability Who Live in Private Dwellings

    ERIC Educational Resources Information Center

    Lennox, Nicholas; Bain, Chris; Rey-Conde, Therese; Taylor, Miriam; Boyle, Frances M.; Purdie, David M.; Ware, Robert S.

    2010-01-01

    Background: People with intellectual disability who live in the community often have poor health and healthcare, partly as a consequence of poor communication, recall difficulties and incomplete patient health information. Materials and Methods: A cluster randomized-controlled trial with 2 x 2 factorial design was conducted with adults with…

  1. Outcomes of a Telehealth Intervention for Homebound Older Adults with Heart or Chronic Respiratory Failure: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Gellis, Zvi D.; Kenaley, Bonnie; McGinty, Jean; Bardelli, Ellen; Davitt, Joan; Ten Have, Thomas

    2012-01-01

    Purpose: Telehealth care is emerging as a viable intervention model to treat complex chronic conditions, such as heart failure (HF) and chronic obstructive pulmonary disease (COPD), and to engage older adults in self-care disease management. Design and Methods: We report on a randomized controlled trial examining the impact of a multifaceted…

  2. A Randomized Controlled Trial to Improve Social Skills in Young Adults with Autism Spectrum Disorder: The UCLA PEERS® Program

    ERIC Educational Resources Information Center

    Laugeson, Elizabeth A.; Gantman, Alexander; Kapp, Steven K.; Orenski, Kaely; Ellingsen, Ruth

    2015-01-01

    Research suggests that impaired social skills are often the most significant challenge for those with autism spectrum disorder (ASD), yet few evidence-based social skills interventions exist for adults on the spectrum. This replication trial tested the effectiveness of PEERS, a caregiver-assisted social skills program for high-functioning young…

  3. Efficacy of a text messaging (SMS) based smoking cessation intervention for adolescents and young adults: Study protocol of a cluster randomised controlled trial

    PubMed Central

    2012-01-01

    promote smoking cessation among adolescents and young adults including those with lower educational level and independent of their motivation to quit. Trial registration number ISRCTN: ISRCTN19739792 PMID:22260736

  4. Facebook Recruitment of Young Adult Smokers for a Cessation Trial: Methods, Metrics, and Lessons Learned.

    PubMed

    Ramo, Danielle E; Rodriguez, Theresa M S; Chavez, Kathryn; Sommer, Markus J; Prochaska, Judith J

    2014-04-01

    Further understanding is needed of the functionalities and efficiency of social media for health intervention research recruitment. Facebook was examined as a mechanism to recruit young adults for a smoking cessation intervention. An ad campaign targeting young adult smokers tested specific messaging based on market theory and successful strategies used to recruit smokers in previous clinical trials (i.e. informative, call to action, scarcity, social norms), previously successful ads, and general messaging. Images were selected to target smokers (e.g., lit cigarette), appeal to the target age, vary demographically, and vary graphically (cartoon, photo, logo). Facebook's Ads Manager was used over 7 weeks (6/10/13 - 7/29/13), targeted by age (18-25), location (U.S.), and language (English), and employed multiple ad types (newsfeed, standard, promoted posts, sponsored stories) and keywords. Ads linked to the online screening survey or study Facebook page. The 36 different ads generated 3,198,373 impressions, 5,895 unique clicks, at an overall cost of $2,024 ($0.34/click). Images of smoking and newsfeed ads had the greatest reach and clicks at the lowest cost. Of 5,895 unique clicks, 586 (10%) were study eligible and 230 (39%) consented. Advertising costs averaged $8.80 per eligible, consented participant. The final study sample (n=79) was largely Caucasian (77%) and male (69%), averaging 11 cigarettes/day (SD=8.3) and 2.7 years smoking (SD=0.7). Facebook is a useful, cost-effective recruitment source for young adult smokers. Ads posted via newsfeed posts were particularly successful, likely because they were viewable via mobile phone. Efforts to engage more ethnic minorities, young women, and smokers motivated to quit are needed.

  5. Randomized trial of epidural vs. subcutaneous catheters for managing pain after modified Nuss in adults

    PubMed Central

    Temkit, M’hamed; Ewais, MennatAllah M.; Luckritz, Todd C.; Stearns, Joshua D.; Craner, Ryan C.; Gaitan, Brantley D.; Ramakrishna, Harish; Thunberg, Christopher A.; Weis, Ricardo A.; Myers, Kelly M.; Merritt, Marianne V.; Rosenfeld, David M.

    2016-01-01

    Background Minimally invasive repair of pectus excavatum (MIRPE) is now performed in adults. Managing adult patients’ pain postoperatively has been challenging due to increased chest wall rigidity and the pressure required for supporting the elevated sternum. The optimal pain management regimen has not been determined. We designed this prospective, randomized trial to compare postoperative pain management and outcomes between thoracic epidural analgesia (TEA) and bilateral subcutaneous infusion pump catheters (On-Q). Methods Patients undergoing MIRPE (modified Nuss) underwent random assignment to TEA or On-Q group. Both groups received intravenous, patient-controlled opioid analgesia, with concomitant delivery of local anesthetic. Primary outcomes were length of stay (LOS), opioid use, and pain scores. Results Of 85 randomly assigned patients, 68 completed the study [52 men, 76.5%; mean (range) age, 32.2 (20.0–58.0) years; Haller index, 5.9 (range, 3.0-26.7)]. The groups were equally matched for preoperative variables; however, the On-Q arm had more patients (60.3%). No significant differences were found between groups in mean daily pain scores (P=0.52), morphine-equivalent opioid usage (P=0.28), or hospital stay 3.5 vs. 3.3 days (TEA vs. On-Q; P=0.55). Thirteen patients randomized to TEA refused the epidural and withdrew from the study because they perceived greater benefit of the On-Q system. Conclusions Postoperative pain management in adults after MIRPE can be difficult. Both continuous local anesthetic delivery by TEA and On-Q catheters with concomitant, intravenous, patient-controlled anesthesia maintained acceptable analgesia with a reasonable LOS. In our cohort, there was preference for the On-Q system for pain management. PMID:27621865

  6. Safety and Immunogenicity of a Live Attenuated Tetravalent Dengue Vaccine Candidate in Flavivirus-Naive Adults: A Randomized, Double-Blinded Phase 1 Clinical Trial

    PubMed Central

    George, Sarah L.; Wong, Mimi A.; Dube, Tina J. T.; Boroughs, Karen L.; Stovall, Janae L.; Luy, Betty E.; Haller, Aurelia A.; Osorio, Jorge E.; Eggemeyer, Linda M.; Irby-Moore, Sharon; Frey, Sharon E.; Huang, Claire Y.-H.; Stinchcomb, Dan T.

    2015-01-01

    Background. Dengue viruses (DENVs) infect >300 million people annually, causing 96 million cases of dengue disease and 22 000 deaths [1]. A safe vaccine that protects against DENV disease is a global health priority [2]. Methods. We enrolled 72 flavivirus-naive healthy adults in a phase 1 double-blinded, randomized, placebo-controlled dose-escalation trial (low and high dose) of a live attenuated recombinant tetravalent dengue vaccine candidate (TDV) given in 2 doses 90 days apart. Volunteers were followed for safety, vaccine component viremia, and development of neutralizing antibodies to the 4 DENV serotypes. Results. The majority of adverse events were mild, with no vaccine-related serious adverse events. Vaccinees reported injection site pain (52% vs 17%) and erythema (73% vs 25%) more frequently than placebo recipients. Low levels of TDV-serotype 2 (TDV-2), TDV-3, and TDV-4 viremia were observed after the first but not second administration of vaccine. Overall seroconversion rates and geometric mean neutralization titers after 2 doses were 84.2% and 54.1, respectively, for DENV serotype 1 (DENV-1); 92.1% and 292.8, respectively, for DENV-2; 86.8% and 32.3, respectively, for DENV-3; and 71.1% and 15.0, respectively, for DENV-4. More than 90.0% of high-dose recipients had trivalent or broader responses. Conclusions. TDV was generally well tolerated, induced trivalent or broader neutralizing antibodies to DENV in most flavivirus-naive vaccinees, and is undergoing further development. Clinical Trials Registration. NCT01110551. PMID:25791116

  7. Improving advance care planning for English-speaking and Spanish-speaking older adults: study protocol for the PREPARE randomised controlled trial

    PubMed Central

    Sudore, Rebecca L; Barnes, Deborah E; Le, Gem M; Ramos, Roberto; Osua, Stacy J; Richardson, Sarah A; Boscardin, John; Schillinger, Dean

    2016-01-01

    Introduction Advance care planning (ACP) is a process that allows patients to identify their goals for medical care. Traditionally, ACP has focused on completing advance directives; however, we have expanded the ACP paradigm to also prepare patients to communicate their wishes and make informed decisions. To this end, we created an ACP website called PREPARE (http://www.prepareforyourcare.org) to prepare diverse English-speaking and Spanish-speaking older adults for medical decision-making. Here, we describe the study protocol for a randomised controlled efficacy trial of PREPARE in a safety-net setting. The goal is to determine the efficacy of PREPARE to engage diverse English-speaking and Spanish-speaking older adults in a full spectrum of ACP behaviours. Methods and analysis We include English-speaking and Spanish-speaking adults from an urban public hospital who are ≥55 years old, have ≥2 chronic medical conditions and have seen a primary care physician ≥2 times in the last year. Participants are randomised to the PREPARE intervention (review PREPARE and an easy-to-read advance directive) or the control arm (only the easy-to-read advance directive). The primary outcome is documentation of an advance directive and/or ACP discussion. Secondary outcomes include ACP behaviour change processes measured with validated surveys (eg, self-efficacy, readiness) and a broad range of ACP actions (eg, choosing a surrogate, identifying goals for care, discussing ACP with clinicians and/or surrogates). Using blinded outcome ascertainment, outcomes will be measured at 1 week and at 3, 6 and 12 months, and compared between study arms using mixed-effects logistic regression and mixed-effects linear, Poisson or negative binomial regression. Ethics and dissemination This study has been approved by the appropriate Institutional Review Boards and is guided by input from patient and clinical advisory boards and a data safety monitoring board. The results of this study will

  8. Effectiveness of Housing First with Intensive Case Management in an Ethnically Diverse Sample of Homeless Adults with Mental Illness: A Randomized Controlled Trial

    PubMed Central

    Stergiopoulos, Vicky; Gozdzik, Agnes; Misir, Vachan; Skosireva, Anna; Connelly, Jo; Sarang, Aseefa; Whisler, Adam; Hwang, Stephen W.; O’Campo, Patricia; McKenzie, Kwame

    2015-01-01

    experiencing problems due to alcohol use among foreign-born (vs. Canadian-born) HF participants at 24 months (ratio of rate ratios = 0.19 95% 0.04 to 0.88), relative to baseline. Compared to usual care, HF with ICM can improve housing stability and community functioning and reduce the days of alcohol related problems in an ethnically diverse sample of homeless adults with mental illness within 2-years. Trial Registration Controlled-Trials.com ISRCTN42520374. PMID:26176621

  9. Developmentally adapted cognitive processing therapy for adolescents and young adults with PTSD symptoms after physical and sexual abuse: study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Although childhood sexual and/or physical abuse (CSA/CPA) is known to have severe psychopathological consequences, there is little evidence on psychotherapeutic interventions for adolescents and young adults suffering from post-traumatic stress disorder (PTSD). Equally sparse are data on moderators of treatment response on PTSD-related epigenetic changes, health care costs and loss of productivity, alterations in cognitive processing, and on how successful interventions affect all of these factors. Early treatment may prevent later (co)morbidity. In this paper, we present a study protocol for the evaluation of a newly developed psychotherapeutic manual for PTSD after CSA/CPA in adolescents and young adults – the Developmentally Adapted Cognitive Processing Therapy (D-CPT). Methods/design In a multicenter randomized controlled trial (RCT) D-CPT is compared to treatment as usual (TAU). A sample of 90 adolescent outpatients aged 14 to 21 years will be randomized to one of these conditions. Four assessments will be carried out at baseline, at end of treatment, and 3 and 6 months after end of therapy. Each time, patients will be assessed via clinical interviews and a wide range of questionnaires. In addition to PTSD symptoms and comorbidities, we will evaluate moderators of treatment response, epigenetic profiles, direct and indirect costs of this disorder, and neurophysiological processing of threat cues in PTSD and their respective changes in the course of these two treatments (D-CPT and TAU). Discussion The study will provide new insights in the understudied field of PTSD in adolescents and young adults. A newly developed intervention will be evaluated in this therapeutically underserved population. Results will provide data on treatment efficacy, direct and indirect treatment costs, as well as on associations of treatment outcome and PTSD intensity both to epigenetic profiles and to the neurobiological processing of threat cues. Besides, they will

  10. Online group-based cognitive-behavioural therapy for adolescents and young adults after cancer treatment: A multicenter randomised controlled trial of Recapture Life-AYA

    PubMed Central

    2012-01-01

    modality are highlighted, and the role of both peer and caregiver support in enhancing the effectiveness of this skills-based intervention is also discussed. The innovative videoconferencing delivery method Recapture Life uses has the potential to address the geographic and psychological isolation of adolescents and young adults as they move toward cancer survivorship. It is expected that teaching AYAs coping skills as they resume their normal lives after cancer may have long-term implications for their quality of life. Trial Registration ACTRN12610000717055 PMID:22862906

  11. Immunogenicity and Safety of an AS03-Adjuvanted H7N9 Pandemic Influenza Vaccine in a Randomized Trial in Healthy Adults

    PubMed Central

    Madan, Anuradha; Segall, Nathan; Ferguson, Murdo; Frenette, Louise; Kroll, Robin; Friel, Damien; Soni, Jyoti; Li, Ping; Innis, Bruce L.; Schuind, Anne

    2016-01-01

    Background. Almost 700 cases of human infection with avian influenza A/H7N9 have been reported since 2013. Pandemic preparedness strategies include H7N9 vaccine development. Methods. We evaluated an inactivated H7N9 vaccine in an observer-blind study in healthy adults aged 18–64 years. Participants (420) were randomized to receive 1 of 4 AS03-adjuvanted vaccines (low or medium dose of hemagglutinin with AS03A or AS03B), one nonadjuvanted vaccine, or placebo. The coprimary immunogenicity objective determined whether adjuvanted vaccines elicited an immune response against the vaccine-homologous virus, 21 days after the second vaccine dose per US and European licensure criteria in the per-protocol cohort (n = 389). Results. All adjuvanted vaccines met regulatory acceptance criteria. In groups receiving adjuvanted formulations, seroconversion rates were ≥85.7%, seroprotection rates ≥91.1%, and geometric mean titers ≥92.9% versus 23.2%, 28.6%, and 17.2 for the nonadjuvanted vaccine. The AS03 adjuvant enhanced immune response at antigen-sparing doses. Injection site pain occurred more frequently with adjuvanted vaccines (in ≤98.3% of vaccinees) than with the nonadjuvanted vaccine (40.7%) or placebo (20.0%). None of the 20 serious adverse events reported were related to vaccination. Conclusions. Two doses of AS03-adjuvanted H7N9 vaccine were well tolerated and induced a robust antibody response at antigen-sparing doses in healthy adults. Clinical Trials Registration. NCT01999842. PMID:27609809

  12. Percutaneous fixation with Kirschner wires versus volar locking plate fixation in adults with dorsally displaced fracture of distal radius: randomised controlled trial

    PubMed Central

    Achten, Juul; Parsons, Nick R; Rangan, Amar; Griffin, Damian; Tubeuf, Sandy; Lamb, Sarah E

    2014-01-01

    Objectives To compare the clinical effectiveness of Kirschner wire fixation with locking plate fixation for patients with a dorsally displaced fracture of the distal radius. Design A multicentre two arm parallel group assessor blind randomised controlled trial with 1:1 treatment allocation. Setting 18 trauma centres in the United Kingdom. Participants 461 adults with a dorsally displaced fracture of the distal radius within 3 cm of the radiocarpal joint that required surgical fixation. Patients were excluded if the surgeon thought that the surface of the wrist joint was so badly displaced it required open reduction. Interventions Kirschner wire fixation: wires are passed through the skin over the dorsal aspect of the distal radius and into the bone to hold the fracture in the correct anatomical position. Locking plate fixation: a locking plate is applied through an incision over the volar (palm) aspect of the wrist and secured to the bone with fixed angle locking screws. Main outcome measures Primary outcome measure: validated patient rated wrist evaluation (PRWE). This rates wrist function in two (equally weighted) sections concerning the patient’s experience of pain and disability to give a score out of 100. Secondary outcomes: disabilities of arm, shoulder, and hand (DASH) score, the EuroQol (EQ-5D), and complications related to the surgery. Results The baseline characteristics of the two groups were well balanced, and over 90% of patients completed follow-up. The wrist function of both groups of patients improved by 12 months. There was no clinically relevant difference in the patient rated wrist score at three, six, or 12 months (difference in favour of the plate group was −1.3, 95% confidence interval −4.5 to 1.8; P=0.40). Nor was there a clinically relevant difference in health related quality of life or the number of complications in each group. Conclusions Contrary to the existing literature, and against the rapidly increasing use of locking plate

  13. A Mobile Health Lifestyle Program for Prevention of Weight Gain in Young Adults (TXT2BFiT): Nine-Month Outcomes of a Randomized Controlled Trial

    PubMed Central

    Partridge, Stephanie Ruth; McGeechan, Kevin; Balestracci, Kate; Hebden, Lana; Wong, Annette; Phongsavan, Philayrath; Denney-Wilson, Elizabeth; Harris, Mark F; Bauman, Adrian

    2016-01-01

    (model β=− 4.3, 95% CI − 6.9 to − 1.8). No differences in physical activity were found but all diet behaviors showed that the intervention group, compared with controls at 9 months, had greater odds of meeting recommendations for fruits (OR 3.83, 95% CI 2.10-6.99); for vegetables (OR 2.42, 95% CI 1.32-4.44); for SSB (OR 3.11, 95% CI 1.47-6.59); and for take-out meals (OR 1.88, 95% CI 1.07-3.30). Conclusions Delivery of an mHealth intervention for prevention of weight gain resulted in modest weight loss at 12 weeks with further loss at 9 months in 18- to 35-year-olds. Although there was no evidence of change in physical activity, improvements in dietary behaviors occurred, and were maintained at 9 months. Owing to its scalable potential for widespread adoption, replication trials should be conducted in diverse populations of overweight young adults. Trial Registration Australian and New Zealand Clinical Trials Registry (ANZCTR): ACTRN12612000924853; (Archived by WebCite at http://www.webcitation.org/6i6iRag55) PMID:27335237

  14. Intervention Use and Action Planning in a Web-Based Computer-Tailored Weight Management Program for Overweight Adults: Randomized Controlled Trial

    PubMed Central

    van Empelen, Pepijn; Oenema, Anke

    2014-01-01

    Background There are many online interventions aiming for health behavior change but it is unclear how such interventions and specific planning tools are being used. Objective The aim of this study is to identify which user characteristics were associated with use of an online, computer-tailored self-regulation intervention aimed at prevention of weight gain; and to examine the quality of the goals and action plans that were generated using the online planning tools. Methods Data were obtained with a randomized controlled effect evaluation trial in which the online computer-tailored intervention was compared to a website containing generic information about prevention of weight gain. The tailored intervention included self-regulation techniques such as personalized feedback, goal setting, action planning, monitoring, and other techniques aimed at weight management. Participants included 539 overweight adults (mean age 46.9 years, mean body mass index [BMI] 28.03 kg/m2, 31.2% male, 11% low education level) recruited from the general population. Use of the intervention and its planning tools were derived from server registration data. Physical activity, fat intake, motivational factors, and self-regulation skills were self-reported at baseline. Descriptive analyses and logistic regression analyses were used to analyze the results. Results Use of the tailored intervention decreased sharply after the first modules. Visiting the first tailored intervention module was more likely among participants with low levels of fat intake (OR 0.77, 95% CI 0.62-0.95) or planning for change in PA (OR 0.23, 95% CI 0.05-0.97). Revisiting the intervention was more likely among participants high in restrained eating (OR 2.45, 95% CI 1.12-5.43) or low in proactive coping skills for weight control (OR 0.28, 95% CI 0.10-0.76). The planning tools were used by 5%-55% of the participants, but only 20%-75% of the plans were of good quality. Conclusions This study showed that psychological

  15. STEMS pilot trial: a pilot cluster randomised controlled trial to investigate the addition of patient direct access to physiotherapy to usual GP-led primary care for adults with musculoskeletal pain

    PubMed Central

    Ogollah, Reuben O; Jowett, Sue; Kigozi, Jesse; Tooth, Stephanie; Protheroe, Joanne; Hay, Elaine M; Salisbury, Chris; Foster, Nadine E

    2017-01-01

    Introduction Around 17% of general practitioner (GP) consultations are for musculoskeletal conditions, which will rise as the population ages. Patient direct access to physiotherapy provides one solution, yet adoption in the National Health Service (NHS) has been slow. Setting A pilot, pragmatic, non-inferiority, cluster randomised controlled trial (RCT) in general practice and physiotherapy services in the UK. Objectives Investigate feasibility of a main RCT. Participants Adult patients registered in participating practices and consulting with a musculoskeletal problem. Interventions 4 general practices (clusters) randomised to provide GP-led care as usual or the addition of a patient direct access to physiotherapy pathway. Outcomes Process outcomes and exploratory analyses of clinical and cost outcomes. Data collection Participant-level data were collected via questionnaires at identification, 2, 6 and 12 months and through medical records. Blinding The study statistician and research nurses were blinded to practice allocation. Results Of 2696 patients invited to complete study questionnaires, 978 participated (intervention group n=425, control arm n=553) and were analysed. Participant recruitment was completed in 6 months. Follow-up rates were 78% (6 months) and 71% (12 months). No evidence of selection bias was observed. The direct access pathway was used by 90% of patients in intervention practices needing physiotherapy. Some increase in referrals to physiotherapy occurred from one practice, although waiting times for physiotherapy did not increase (28 days before, 26 days after introduction of direct access). No safety issues were identified. Clinical and cost outcomes were similar in both groups. Exploratory estimates of between group effect (using 36-item Short Form Health Survey (SF-36) Physical Component Summary (PCS)) at 6 months was −0.28 (95% CI −1.35 to 0.79) and at 12 months 0.12 (95% CI −1.27 to 1.51). Conclusions A full RCT is

  16. Assessing the Quality of a Nonrandomized Pragmatic Trial for Primary Prevention of Falls among Older Adults

    PubMed Central

    Albert, Steven M.; Edelstein, Offer; King, Jennifer; Flatt, Jason; Lin, Chyongchiou J.; Boudreau, Robert; Newman, Anne B.

    2014-01-01

    Background Current approaches to falls prevention mostly rely on secondary and tertiary prevention and target individuals at high risk of falls. An alternative is primary prevention, in which all seniors are screened, referred as appropriate, and educated regarding falls risk. Little information is available on research designs that allow investigation of this approach in the setting of aging services delivery, where randomization may not be possible. Methods Healthy Steps for Older Adults, a statewide program of the Pennsylvania (PA) Department of Aging, involves a combination of education about falls and screening for balance problems, with referral to personal physicians and home safety assessments. We developed a nonrandomized statewide trial, Falls Free PA, to assess its effectiveness in reducing falls incidence over 12 months. We recruited 814 seniors who completed the program (503 first time participants, 311 people repeating the program) and 1020 who did not participate in the program, from the same sites. We assessed the quality of this nonrandomized design by examining recruitment, follow-up across study groups, and comparability at baseline. Results Of older adults approached in senior centers, 90.5% (n=2219) signed informed consent, and 1834 (82.4%) completed baseline assessments and were eligible for follow-up. Attrition in the three groups over 12 months was low and non-differential (<10% for withdrawal and <2% for other loss to follow-up). Median follow-up, which involved standardized monthly assessment of falls, was 10 months in all study groups. At baseline the groups did not differ in measures of health or falls risk factors. Conclusions Comparable status at baseline, recruitment from common sites, and similar experience with retention suggest that the nonrandomized design will be effective for assessment of this approach to primary prevention of falls. PMID:24488533

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

    PubMed Central

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

    2017-01-01

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

  18. Adult and adolescent livestock productive asset transfer programmes to improve mental health, economic stability and family and community relationships in rural South Kivu Province, Democratic Republic of Congo: a protocol of a randomised controlled trial

    PubMed Central

    Kohli, Anjalee; Perrin, Nancy A; Remy, Mitima Mpanano; Alfred, Mirindi Bacikenge; Arsene, Kajabika Binkurhorhwa; Nadine, Mwinja Bufole; Heri, Banyewesize Jean; Clovis, Mitima Murhula; Glass, Nancy

    2017-01-01

    Introduction People living in poverty have limited access to traditional financial institutions. Microfinance programmes are designed to meet this gap and show promise in improving income, economic productivity and health. Our Congolese–US community academic research partnership developed two livestock productive asset transfer programmes, Pigs for Peace (PFP) and Rabbits for Resilience (RFR), to address the interlinked health, social and economic well-being of individuals, their families and communities. The community-based randomised controlled trials examine the effectiveness of PFP and RFR to improve health, economic stability, and family and community relationships among male and female adults and adolescents living in 10 rural, postconflict villages of eastern Democratic Republic of Congo. Methods and analysis PFP participants include adult permanent residents of rural villages; adolescent participants in RFR include male and female adolescents 10–15 years old living in the selected rural villages. Participants were randomised to intervention or delayed control group. Participants in PFP completed baseline interview prior to intervention and follow-up interview at 6, 12 and 18 months postintervention. In RFR, participants completed baseline interview prior to intervention and follow-up interview at 6, 12 and 18 months postbaseline. The primary outcome of both trials, the change in baseline mental health distress at 18 months in the intervention group (adults, adolescents) compared to control group, is used to calculate sample size. Ethics and dissemination The Johns Hopkins Medical Institute Internal Review Board approved this protocol. A committee of respected Congolese educators and community members (due to lack of local ethics review board) approved the study. The findings will provide important information on the potential for community-led sustainable development initiatives to build on traditional livelihood (livestock raising, agriculture

  19. Reducing TV watching during adult obesity treatment: two pilot randomized controlled trials.

    PubMed

    Raynor, Hollie A; Steeves, Elizabeth Anderson; Bassett, David R; Thompson, Dixie L; Gorin, Amy A; Bond, Dale S

    2013-12-01

    The more time adults spend being sedentary, the greater the risk of obesity. The effect of reducing television (TV) watching, a prominent sedentary behavior, on weight loss has not been tested in an adult standard behavioral obesity intervention, and the mechanisms by which reducing TV watching influences energy balance behaviors are not well understood. Two, 8-week, pilot, randomized controlled trials were conducted examining the effect of a reduced TV watching prescription on energy balance behaviors and weight loss within an adult standard behavioral obesity intervention. In the first study, participants (n=24) were randomized into one of two conditions: (a) reduce energy intake and increase moderate to vigorous physical activity (MVPA) (INCREASE PA); or (b) reduce energy intake and decrease TV watching (DECREASE TV). As findings from the first pilot study did not show an increase in MVPA in the DECREASE TV group, the second study was designed to examine the effect of adding a reduced TV prescription to a standard intervention to optimize outcomes. In Pilot Study 2, participants (n=28) were randomized to INCREASE PA or to INCREASE PA+DECREASE TV. Outcomes included objectively measured TV watching and MVPA, self-reported light physical activity (LPA-Pilot Study 2 only), self-reported dietary intake while watching TV, and weight. Conditions with TV watching prescriptions significantly reduced TV watching. Both studies showed medium to large effect sizes for conditions with TV watching prescriptions to show greater reductions in dietary intake while watching TV. Pilot Study 1 found a trend for an increase in MVPA in INCREASE PA and Pilot Study 2 found significant increases in MVPA in both conditions. Pilot Study 2 found a significant increase in LPA in the INCREASE PA+DECREASE TV. Results indicate adding a TV watching prescription to a standard obesity intervention did not enhance increases in MVPA, but may assist with reducing dietary intake while TV watching and

  20. Efficacy of Propolis on the Denture Stomatitis Treatment in Older Adults: A Multicentric Randomized Trial

    PubMed Central

    Pina, Gisela de M. S.; Lia, Erica N.; Berretta, Andresa A.; Nascimento, Andresa P.; Torres, Elina C.; Buszinski, Andrei F. M.; de Campos, Tatiana A.; Martins, Vicente de P.

    2017-01-01

    Our hypothesis tested the efficacy and safety of a mucoadhesive oral gel formulation of Brazilian propolis extract compared to miconazole oral gel for the treatment of denture stomatitis due to Candida spp. infection in older adults. Forty patients were randomly allocated in a noninferiority clinical trial into two groups. The control group (MIC) received 20 mg/g miconazole oral gel and the study group (PROP) received mucoadhesive formulation containing standardized extract of 2% (20 mg/g) propolis (EPP-AF®) during 14 days. Patients were examined on days 1, 7, and 14. The Newton's score was used to classify the severity of denture stomatitis. The colony forming unity count (CFU/mL) was quantified and identified (CHROMagar Candida®) before and after the treatment. Baseline characteristics did not differ between groups. Both treatments reduced Newton's score (P < 0.0001), indicating a clinical improvement of the symptoms of candidiasis with a clinical cure rate of 70%. The microbiological cure with significant reduction in fungal burden on T14 was 70% in the miconazole group and 25% in the EPP-AF group. The EPP-AF appears to be noninferior to miconazole considering the clinical cure rate and could be recommended as an alternative treatment in older patients.

  1. Clinical trial perspective for adult and juvenile Huntington's disease using genetically-engineered mesenchymal stem cells.

    PubMed

    Deng, Peter; Torrest, Audrey; Pollock, Kari; Dahlenburg, Heather; Annett, Geralyn; Nolta, Jan A; Fink, Kyle D

    2016-05-01

    Progress to date from our group and others indicate that using genetically-engineered mesenchymal stem cells (MSC) to secrete brain-derived neurotrophic factor (BDNF) supports our plan to submit an Investigational New Drug application to the Food and Drug Administration for the future planned Phase 1 safety and tolerability trial of MSC/BDNF in patients with Huntington's disease (HD). There are also potential applications of this approach beyond HD. Our biological delivery system for BDNF sets the precedent for adult stem cell therapy in the brain and could potentially be modified for other neurodegenerative disorders such as amyotrophic lateral sclerosis (ALS), spinocerebellar ataxia (SCA), Alzheimer's disease, and some forms of Parkinson's disease. The MSC/BDNF product could also be considered for studies of regeneration in traumatic brain injury, spinal cord and peripheral nerve injury. This work also provides a platform for our future gene editing studies, since we will again use MSCs to deliver the needed molecules into the central nervous system.

  2. Distinct Brain and Behavioral Benefits from Cognitive vs. Physical Training: A Randomized Trial in Aging Adults.

    PubMed

    Chapman, Sandra B; Aslan, Sina; Spence, Jeffrey S; Keebler, Molly W; DeFina, Laura F; Didehbani, Nyaz; Perez, Alison M; Lu, Hanzhang; D'Esposito, Mark

    2016-01-01

    Insidious declines in normal aging are well-established. Emerging evidence suggests that non-pharmacological interventions, specifically cognitive and physical training, may counter diminishing age-related cognitive and brain functions. This randomized trial compared effects of two training protocols: cognitive training (CT) vs. physical training (PT) on cognition and brain function in adults 56-75 years. Sedentary participants (N = 36) were randomized to either CT or PT group for 3 h/week over 12 weeks. They were assessed at baseline-, mid-, and post-training using neurocognitive, MRI, and physiological measures. The CT group improved on executive function whereas PT group's memory was enhanced. Uniquely deploying cerebral blood flow (CBF) and cerebral vascular reactivity (CVR) MRI, the CT cohort showed increased CBF within the prefrontal and middle/posterior cingulate cortex (PCC) without change to CVR compared to PT group. Improvements in complex abstraction were positively associated with increased resting CBF in dorsal anterior cingulate cortex (dACC). Exercisers with higher CBF in hippocampi bilaterally showed better immediate memory. The preliminary evidence indicates that increased cognitive and physical activity improves brain health in distinct ways. Reasoning training enhanced frontal networks shown to be integral to top-down cognitive control and brain resilience. Evidence of increased resting CBF without changes to CVR implicates increased neural health rather than improved vascular response. Exercise did not improve cerebrovascular response, although CBF increased in hippocampi of those with memory gains. Distinct benefits incentivize testing effectiveness of combined protocols to strengthen brain health.

  3. A phase I trial of the HIV protease inhibitor nelfinavir in adults with solid tumors

    PubMed Central

    Blumenthal, Gideon M.; Gills, Joell J.; Ballas, Marc S.; Bernstein, Wendy B.; Komiya, Takefumi; Dechowdhury, Roopa; Morrow, Betsy; Root, Hyejeong; Chun, Guinevere; Helsabeck, Cynthia; Steinberg, Seth M.; LoPiccolo, Jaclyn; Kawabata, Shigeru; Gardner, Erin R.; Figg, William D.; Dennis, Phillip A.

    2014-01-01

    Nelfinavir is an HIV protease inhibitor being repurposed as an anti-cancer agent in preclinical models and in small oncology trials, yet the MTD of nelfinavir has not been determined. Therefore, we conducted a Phase Ia study to establish the maximum tolerated dose (MTD) and dose limiting toxicities (DLT) of nelfinavir in subjects with advanced solid tumors. Adults with refractory cancers were given oral nelfinavir twice daily with pharmacokinetic and pharmacodynamic analyses. Twenty-eight subjects were enrolled. Nelfinavir was generally well tolerated. Common adverse events included diarrhea, anemia, and lymphopenia, which were mostly mild. The DLT was rapid-onset neutropenia that was reversible. The MTD was established at 3125 mg twice daily. In an expansion cohort at the MTD, one of 11 (9%) evaluable subjects had a confirmed partial response. This, plus two minor responses, occurred in subjects with neuroendocrine tumors of the midgut or pancreatic origin. Thirty-six percent of subjects had stable disease for more than 6 months. In peripheral blood mononuclear cells, Nelfinavir inhibited AKT and induced markers of ER stress. In summary, nelfinavir is well tolerated in cancer patients at doses 2.5 times the FDA-approved dose for HIV management and showed preliminary activity in tumors of neuroendocrine origin. PMID:25327558

  4. Distinct Brain and Behavioral Benefits from Cognitive vs. Physical Training: A Randomized Trial in Aging Adults

    PubMed Central

    Chapman, Sandra B.; Aslan, Sina; Spence, Jeffrey S.; Keebler, Molly W.; DeFina, Laura F.; Didehbani, Nyaz; Perez, Alison M.; Lu, Hanzhang; D'Esposito, Mark

    2016-01-01

    Insidious declines in normal aging are well-established. Emerging evidence suggests that non-pharmacological interventions, specifically cognitive and physical training, may counter diminishing age-related cognitive and brain functions. This randomized trial compared effects of two training protocols: cognitive training (CT) vs. physical training (PT) on cognition and brain function in adults 56–75 years. Sedentary participants (N = 36) were randomized to either CT or PT group for 3 h/week over 12 weeks. They were assessed at baseline-, mid-, and post-training using neurocognitive, MRI, and physiological measures. The CT group improved on executive function whereas PT group's memory was enhanced. Uniquely deploying cerebral blood flow (CBF) and cerebral vascular reactivity (CVR) MRI, the CT cohort showed increased CBF within the prefrontal and middle/posterior cingulate cortex (PCC) without change to CVR compared to PT group. Improvements in complex abstraction were positively associated with increased resting CBF in dorsal anterior cingulate cortex (dACC). Exercisers with higher CBF in hippocampi bilaterally showed better immediate memory. The preliminary evidence indicates that increased cognitive and physical activity improves brain health in distinct ways. Reasoning training enhanced frontal networks shown to be integral to top-down cognitive control and brain resilience. Evidence of increased resting CBF without changes to CVR implicates increased neural health rather than improved vascular response. Exercise did not improve cerebrovascular response, although CBF increased in hippocampi of those with memory gains. Distinct benefits incentivize testing effectiveness of combined protocols to strengthen brain health. PMID:27462210

  5. Clinical trial perspective for adult and juvenile Huntington's disease using genetically-engineered mesenchymal stem cells

    PubMed Central

    Deng, Peter; Torrest, Audrey; Pollock, Kari; Dahlenburg, Heather; Annett, Geralyn; Nolta, Jan A.; Fink, Kyle D.

    2016-01-01

    Progress to date from our group and others indicate that using genetically-engineered mesenchymal stem cells (MSC) to secrete brain-derived neurotrophic factor (BDNF) supports our plan to submit an Investigational New Drug application to the Food and Drug Administration for the future planned Phase 1 safety and tolerability trial of MSC/BDNF in patients with Huntington's disease (HD). There are also potential applications of this approach beyond HD. Our biological delivery system for BDNF sets the precedent for adult stem cell therapy in the brain and could potentially be modified for other neurodegenerative disorders such as amyotrophic lateral sclerosis (ALS), spinocerebellar ataxia (SCA), Alzheimer's disease, and some forms of Parkinson's disease. The MSC/BDNF product could also be considered for studies of regeneration in traumatic brain injury, spinal cord and peripheral nerve injury. This work also provides a platform for our future gene editing studies, since we will again use MSCs to deliver the needed molecules into the central nervous system. PMID:27335539

  6. “Why Didn’t it Work?” Lessons From a Randomized Controlled Trial of a Web-based Personally Controlled Health Management System for Adults with Asthma

    PubMed Central

    Arguel, Amaël; Dennis, Sarah; Liaw, Siaw-Teng; Coiera, Enrico

    2015-01-01

    Background Personally controlled health management systems (PCHMS), which may include a personal health record (PHR), health management tools, and information resources, have been advocated as a next-generation technology to improve health behaviors and outcomes. There have been successful trials of PCHMS in various health settings. However, there is mixed evidence for whether consumers will use these systems over the long term and whether they ultimately lead to improved health outcomes and behaviors. Objective The aim was to test whether use of a PCHMS by consumers can increase the uptake or updating of a written asthma action plan (AAP) among adults with asthma. Methods A 12-month parallel 2-group randomized controlled trial was conducted. Participants living with asthma were recruited nationally in Australia between April and August 2013, and randomized 1:1 to either the PCHMS group or control group (online static educational content). The primary outcome measure was possession of an up-to-date written AAP poststudy. Secondary measures included (1) utilizing the AAP; (2) planned or unplanned visits to a health care professional for asthma-related concerns; (3) severe asthma exacerbation, inadequately controlled asthma, or worsening of asthma that required a change in treatment; and (4) number of days lost from work or study due to asthma. Ancillary analyses examined reasons for adoption or nonadoption of the intervention. Outcome measures were collected by online questionnaire prestudy, monthly, and poststudy. Results A total of 330 eligible participants were randomized into 1 of 2 arms (intervention: n=154; control: n=176). Access to the PCHMS was not associated with a significant difference in any of the primary or secondary outcomes. Most participants (80.5%, 124/154) did not access the intervention or accessed it only once. Conclusions Despite the intervention being effective in other preventive care settings, system use was negligible and outcome changes

  7. Testing the effectiveness of a self-efficacy based exercise intervention for adults with venous leg ulcers: protocol of a randomised controlled trial

    PubMed Central

    2014-01-01

    improve an individual’s exercise self-efficacy and self-management capacity could have a significant impact in improving the management of people with venous leg ulcers. Information gained from this study will provide much needed information on management of this chronic disease to promote health and independence in this population. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12612000475842. PMID:25277416

  8. Azithromycin vs. Placebo for the Clinical Outcome in Campylobacter concisus Diarrhoea in Adults: A Randomized, Double-Blinded, Placebo-Controlled Clinical Trial

    PubMed Central

    Nielsen, Hans Linde; Kirk, Karina Frahm; Bodilsen, Jacob; Ejlertsen, Tove; Nielsen, Henrik

    2016-01-01

    Campylobacter concisus has been associated with prolonged mild diarrhoea, but investigations regarding the efficacy of antimicrobial treatment have not been reported previously. We initiated a phase 3, single-centre, randomized, double-blinded, placebo-controlled study comparing the efficacy of 500 mg once-daily dose of azithromycin with a 500 mg once-daily dose of placebo for three days, for the treatment of C. concisus diarrhoea in adult patients with a follow-up period of ten days. If symptoms persisted at day ten, the patient was offered cross-over study treatment of three days and another ten-day follow-up period. The primary efficacy endpoint was the clinical response, defined as time to cessation of diarrhoea (<3 stools/day or reversal of accompanying symptoms). Our estimated sample size was 100 patients. We investigated a total of 10,036 diarrheic stool samples from 7,089 adult patients. Five-hundred and eighty-eight C. concisus positive patients were assessed for eligibility, of which 559 were excluded prior to randomization. The three main reasons for exclusion were duration of diarrhoea longer than 21 days (n = 124), previous antibiotic treatment (n = 113), and co-pathogens in stools (n = 87). Therefore, 24 patients completed the trial with either azithromycin (n = 12) or placebo (n = 12). Both groups presented symptoms of mild, prolonged diarrhoea with a mean duration of 18 days (95% CI: 16–19). One person in the azithromycin group and four from the placebo group chose to continue with crossover medication after the initial ten-day period. In the azithromycin group, there was a mean of seven days (95% CI: 5–9) to clinical cure and for the placebo group it was ten days (95% CI: 6–14) (OR—3 (95% CI: -7–1). We observed no differences in all examined outcomes between azithromycin treatment and placebo. However, due to unforeseen recruitment difficulties we did not reach our estimated sample size of 100 patients and statistical power to conclude on

  9. Improving transparency of clinical trials.

    PubMed

    Dal-Ré, Rafael

    2015-06-01

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

  10. A best practice fall prevention exercise program to improve balance, strength / power, and psychosocial health in older adults: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    each training session lasting 30 min. (actual training time). One intervention group will complete an extensive supervised training program, while the other intervention group will complete a short version ('3 times 3’) that is home-based and controlled by weekly phone calls. Post-tests will be conducted right after the intervention period. Additionally, detraining effects will be measured 12 weeks after program cessation. The control group / waiting group will not participate in any specific intervention during the experimental period, but will receive the extensive supervised program after the experimental period. Discussion It is expected that particularly the supervised combination of balance and strength / power training will improve performance in variables of balance, strength / power, body composition, cognitive function, psychosocial well-being, and falls self-efficacy of older adults. In addition, information regarding fall risk assessment, dose–response-relations, detraining effects, and supervision of training will be provided. Further, training-induced health-relevant changes, such as improved performance in activities of daily living, cognitive function, and quality of life, as well as a reduced risk for falls may help to lower costs in the health care system. Finally, practitioners, therapists, and instructors will be provided with a scientifically evaluated feasible, safe, and easy-to-administer exercise program for fall prevention. Trial registration ClinicalTrials.gov Identifier: NCT01906034 PMID:24106864

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

    PubMed Central

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

    2015-01-01

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

  12. A randomised controlled trial to prevent hospital readmissions and loss of functional ability in high risk older adults: a study protocol

    PubMed Central

    2011-01-01

    at baseline within 72 hours of hospital admission, 4 weeks following hospital discharge, 12 weeks following hospital discharge, and 24 weeks following hospital discharge. Outcome assessors are blinded to group allocation. Primary outcomes are emergency hospital readmissions and health service use, functional status, psychosocial well-being and cost effectiveness. Discussion The acute hospital sector comprises the largest component of health care system expenditure in developed countries, and older adults are the most frequent consumers. There are few trials to demonstrate effective models of transitional care to prevent emergency readmissions, loss of functional ability and independence in this population following an acute hospital admission. This study aims to address that gap and provide information for future health service planning which meets client needs and lowers the use of acute care services. Trial Registration No Australian & New Zealand Clinical Trials Registry ACTRN12608000202369 PMID:21861920

  13. A 12-Week Commercial Web-Based Weight-Loss Program for Overweight and Obese Adults: Randomized Controlled Trial Comparing Basic Versus Enhanced Features

    PubMed Central

    Morgan, Philip J; Jones, Penelope; Fletcher, Kate; Martin, Julia; Aguiar, Elroy J; Lucas, Ashlee; Neve, Melinda J; Callister, Robin

    2012-01-01

    Background The development and use of Web-based programs for weight loss is increasing rapidly, yet they have rarely been evaluated using randomized controlled trials (RCTs). Interestingly, most people who attempt weight loss use commercially available programs, yet it is very uncommon for commercial programs to be evaluated independently or rigorously. Objective To compare the efficacy of a standard commercial Web-based weight-loss program (basic) versus an enhanced version of this Web program that provided additional personalized e-feedback and contact from the provider (enhanced) versus a wait-list control group (control) on weight outcomes in overweight and obese adults. Methods This purely Web-based trial using a closed online user group was an assessor-blinded RCT with participants randomly allocated to the basic or enhanced 12-week Web-based program, based on social cognitive theory, or the control, with body mass index (BMI) as the primary outcome. Results We enrolled 309 adults (129/309, 41.8% male, BMI mean 32.3, SD 4 kg/m2) with 84.1% (260/309) retention at 12 weeks. Intention-to-treat analysis showed that both intervention groups reduced their BMI compared with the controls (basic: –0.72, SD 1.1 kg/m2, enhanced: –1.0, SD 1.4, control: 0.15, SD 0.82; P < .001) and lost significant weight (basic: –2.1, SD 3.3 kg, enhanced: –3.0, SD 4.1, control: 0.4, SD 2.3; P < .001) with changes in waist circumference (basic: –2.0, SD 3.5 cm, enhanced: –3.2, SD 4.7, control: 0.5, SD 3.0; P < .001) and waist-to-height ratio (basic: –0.01, SD 0.02, enhanced: –0.02, SD 0.03, control: 0.0, SD 0.02; P < .001), but no differences were observed between the basic and enhanced groups. The addition of personalized e-feedback and contact provided limited additional benefits compared with the basic program. Conclusions A commercial Web-based weight-loss program can be efficacious across a range of weight-related outcomes and lifestyle behaviors and achieve

  14. An educational intervention to reduce the use of potentially inappropriate medications among older adults (EMPOWER study): protocol for a cluster randomized trial

    PubMed Central

    2013-01-01

    Background Currently, far too many older adults consume inappropriate prescriptions, which increase the risk of adverse drug reactions and unnecessary hospitalizations. A health education program directly informing patients of prescription risks may promote inappropriate prescription discontinuation in chronic benzodiazepine users. Methods/Design This is a cluster randomized controlled trial using a two-arm parallel-design. A total of 250 older chronic benzodiazepine users recruited from community pharmacies in the greater Montreal area will be studied with informed consent. A participating pharmacy with recruited participants represents a cluster, the unit of randomization. For every four pharmacies recruited, a simple 2:2 randomization is used to allocate clusters into intervention and control arms. Participants will be followed for 1 year. Within the intervention clusters, participants will receive a novel educational intervention detailing risks and safe alternatives to their current potentially inappropriate medication, while the control group will be wait-listed for the intervention for 6 months and receive usual care during that time period. The primary outcome is the rate of change in benzodiazepine use at 6 months. Secondary outcomes are changes in risk perception, self-efficacy for discontinuing benzodiazepines, and activation of patients initiating discussions with their physician or pharmacist about safer prescribing practices. An intention-to-treat analysis will be followed. The rate of change of benzodiazepine use will be compared between intervention and control groups at the individual level at the 6-month follow-up. Risk differences between the control and experimental groups will be calculated, and the robust variance estimator will be used to estimate the associated 95% confidence interval (CI). As a sensitivity analysis (and/or if any confounders are unbalanced between the groups), we will estimate the risk difference for the intervention via

  15. Phase 1 Trial of the Plasmodium falciparum Blood Stage Vaccine MSP142-C1/Alhydrogel with and without CPG 7909 in Malaria Naïve Adults

    PubMed Central

    Ellis, Ruth D.; Martin, Laura B.; Shaffer, Donna; Long, Carole A.; Miura, Kazutoyo; Fay, Michael P.; Narum, David L.; Zhu, Daming; Mullen, Gregory E. D.; Mahanty, Siddhartha; Miller, Louis H.; Durbin, Anna P.

    2010-01-01

    Background Merozoite surface protein 142 (MSP142) is a leading blood stage malaria vaccine candidate. In order to induce immune responses that cover the major antigenic polymorphisms, FVO and 3D7 recombinant proteins of MSP142 were mixed (MSP142-C1). To improve the level of antibody response, MSP142-C1 was formulated with Alhydrogel plus the novel adjuvant CPG 7909. Methods A Phase 1 clinical trial was conducted in healthy malaria-naïve adults at the Center for Immunization Research in Washington, D.C., to evaluate the safety and immunogenicity of MSP142-C1/Alhydrogel +/− CPG 7909. Sixty volunteers were enrolled in dose escalating cohorts and randomized to receive three vaccinations of either 40 or 160 µg protein adsorbed to Alhydrogel +/− 560 µg CPG 7909 at 0, 1 and 2 months. Results Vaccinations were well tolerated, with only one related adverse event graded as severe (Grade 3 injection site erythema) and all other vaccine related adverse events graded as either mild or moderate. Local adverse events were more frequent and severe in the groups receiving CPG. The addition of CPG enhanced anti-MSP142 antibody responses following vaccination by up to 49-fold two weeks after second immunization and 8-fold two weeks after the third immunization when compared to MSP142-C1/Alhydrogel alone (p<0.0001). After the third immunization, functionality of the antibody was tested by an in vitro growth inhibition assay. Inhibition was a function of antibody titer, with an average of 3% (range −2 to 10%) in the non CPG groups versus 14% (3 to 32%) in the CPG groups. Conclusion/Significance The favorable safety profile and high antibody responses induced with MSP142-C1/Alhydrogel + CPG 7909 are encouraging. MSP142-C1/Alhydrogel is being combined with other blood stage antigens and will be taken forward in a formulation adjuvanted with CPG 7909. Trial Registration ClinicalTrials.gov Identifier: NCT00320658 PMID:20107498

  16. Enhancing Adolescent and Young Adult Oncology Research Within the National Clinical Trials Network: Rationale, Progress, and Emerging Strategies.

    PubMed

    Weiss, Aaron R; Nichols, Craig R; Freyer, David R

    2015-10-01

    Adolescent and Young Adult Oncology (AYAO, including patients 15-39 years of age) is an emerging discipline in the field of cancer treatment and research. Poorer survival outcomes for this population and characteristic age-related challenges in care have called attention to the need for increased AYAO research. This chapter outlines pressing questions and reviews recent progress in AYAO research within the current organizational structure of the federal clinical trials enterprise, emphasizing how the United States National Cancer Institute's National Clinical Trials Network (NCTN) has created novel opportunities for collaborative AYAO research among the pediatric and adult NCTN groups. Potential strategies for expanding AYAO research, both within the NCTN and with other partners in the federal and advocacy domains are identified.

  17. The Resist Diabetes trial: Rationale, design, and methods of a hybrid efficacy/effectiveness intervention trial for resistance training maintenance to improve glucose homeostasis in older prediabetic adults

    PubMed Central

    Marinik, Elaina L.; Kelleher, Sarah; Savla, Jyoti; Winett, Richard A.; Davy, Brenda M.

    2014-01-01

    Advancing age is associated with reduced levels of physical activity, increased body weight and fat, decreased lean body mass, and a high prevalence of type 2 diabetes (T2D). Resistance training (RT) increases muscle strength and lean body mass, and reduces risk of T2D among older adults. The Resist Diabetes trial will determine if a social cognitive theory (SCT)-based intervention improves RT maintenance in older, prediabetic adults, using a hybrid efficacy/effectiveness approach. Sedentary, overweight/obese (BMI 25-39.9 kg/m2) adults aged 50-69 (N=170) with prediabetes (impaired fasting glucose and/or impaired glucose tolerance) completed a supervised 3-month RT (2x/wk) Initiation Phase and were then randomly assigned (n=159; 94% retention) to one of two 6-month maintenance conditions: SCT or Standard care. The SCT intervention consisted of faded contacts compared to Standard care. Participants continue RT at an approved, self-selected community facility during maintenance. A subsequent 6-month period involves no contact for both conditions. Assessments occur at baseline and months 3 (post-initiation), 9 (post-intervention), and 15 (six months after no contact). Primary outcomes are prediabetes indices (i.e., impaired fasting and 2-hour glucose concentration) and strength. Secondary measures include insulin sensitivity, beta-cell responsiveness, and disposition index (oral glucose and C-peptide minimal model); adherence; body composition; and SCT measures. Resist Diabetes is the first trial to examine the effectiveness of a high fidelity SCT-based intervention for maintaining RT in older adults with prediabetes to improve glucose homeostasis. Successful application of SCT constructs for RT maintenance may support translation of our RT program for diabetes prevention into community settings. PMID:24252311

  18. Two Phase II randomized trials on the CRTh2 antagonist AZD1981 in adults with asthma

    PubMed Central

    Kuna, Piotr; Bjermer, Leif; Tornling, Göran

    2016-01-01

    Background Chemoattractant receptor-homologous molecule expressed on T helper type 2 (Th2) cell (CRTh2) receptor antagonists is being investigated for asthma. Objectives The aim of this study was to assess the effects of the CRTh2 receptor antagonist, AZD1981 (with/without inhaled corticosteroids [ICSs]), on lung function and asthma control. Patients and methods Adults aged 18–60 years were enrolled in two randomized, placebo-controlled, parallel-group trials (protocol number: D9830C00003 [study 1, n=209] and protocol number: D9830C00004 [study 2, n=510]). In study 1, patients with stable asthma (forced expiratory volume in 1 second [FEV1]: 65%−110%) were withdrawn from ICS (<400 µg/d) and randomized to AZD1981 1,000 mg twice daily (bid) or placebo. In study 2, patients with uncontrolled asthma (FEV1: 40%−85%) despite ICS therapy (≥500 µg/d) were randomized to 50 mg, 400 mg, or 1,000 mg bid AZD1981 or placebo. The primary efficacy variable for both trials was the change in morning peak expiratory flow after 4 weeks of treatment. Secondary variables included Asthma Control Questionnaire (ACQ-5) scores, FEV1 assessments, safety, and tolerability. In study 2, efficacy was also assessed according to atopic status. Results Following 4 weeks of treatment, there was a nonsignificant increase in morning peak expiratory flow on AZD1981 1,000 mg bid (9.5 L/min vs placebo, P=0.086 [study 1] and 12 L/min vs placebo, P=0.16 [study 2]). In study 2, all doses of AZD1981 provided significant improvements in ACQ-5 scores (0.26–0.3 units vs placebo, P=0.010–0.022); however, there was no dose–response relationship. Improved ACQ-5 scores and FEV1 were observed in the majority of atopic patients treated with AZD1981. AZD1981 was well tolerated across treatment groups. Conclusion Further research may be warranted in atopic patients to fully evaluate the clinical efficacy of AZD1981. PMID:27621597

  19. Mobile phone intervention and weight loss among overweight and obese adults: a meta-analysis of randomized controlled trials.

    PubMed

    Liu, Fangchao; Kong, Xiaomu; Cao, Jie; Chen, Shufeng; Li, Changwei; Huang, Jianfeng; Gu, Dongfeng; Kelly, Tanika N

    2015-03-01

    We conducted a meta-analysis of randomized controlled trials to examine the association of mobile phone intervention with net change in weight-related measures among overweight and obese adults. We searched electronic databases and conducted a bibliography review to identify articles published between the inception date of each database and March 27, 2014. Fourteen trials (including 1,337 participants in total) that met the eligibility criteria were included. Two investigators independently abstracted information on study characteristics and study outcomes. Net change estimates comparing the intervention group with the control group were pooled across trials using random-effects models. Compared with the control group, mobile phone intervention was associated with significant changes in body weight and body mass index (weight (kg)/height (m)(2)) of -1.44 kg (95% confidence interval (CI): -2.12, -0.76) and -0.24 units (95% CI: -0.40, -0.08), respectively. Subgroup analyses revealed that the associations were consistent across study-duration and intervention-type subgroups. For example, net body weight changes were -0.92 kg (95% CI: -1.58, -0.25) and -1.85 kg (95% CI: -2.99, -0.71) in trials of shorter (<6 months) and longer (≥6 months) duration, respectively. These findings provide evidence that mobile phone intervention may be a useful tool for promoting weight loss among overweight and obese adults.

  20. Systematic review of randomised controlled trials of over the counter cough medicines for acute cough in adults

    PubMed Central

    Schroeder, Knut; Fahey, Tom

    2002-01-01

    Objectives To determine whether over the counter cough medicines are effective for acute cough in adults. Design Systematic review of randomised controlled trials. Data sources Search of the Cochrane Acute Respiratory Infections Group specialised register, Cochrane Controlled Trials Register, Medline, Embase, and the UK Department of Health National Research Register in all languages. Included studies All randomised controlled trials that compared oral over the counter cough preparations with placebo in adults with acute cough due to upper respiratory tract infection in ambulatory settings and that had cough symptoms as an outcome. Results 15 trials involving 2166 participants met all the inclusion criteria. Antihistamines seemed to be no better than placebo. There was conflicting evidence on the effectiveness of antitussives, expectorants, antihistamine-decongestant combinations, and other drug combinations compared with placebo. Conclusion Over the counter cough medicines for acute cough cannot be recommended because there is no good evidence for their effectiveness. Even when trials had significant results, the effect sizes were small and of doubtful clinical relevance. Because of the small number of trials in each category, the results have to be interpreted cautiously. What is already know on this topicThe NHS encourages self treatment of acute self limiting illnessesOver the counter cough medicines are commonly used as first line treatment for acute coughWhat this study addsThere is little evidence for or against the effectiveness of over the counter cough medicinesAlthough cough medicines are generally well tolerated, they may be an unnecessary expenseRecommendation of over the counter cough medicines to patients is not justified by current evidence PMID:11834560

  1. Phase 1 trial of dichloroacetate (DCA) in adults with recurrent malignant brain tumors

    PubMed Central

    Dunbar, E. M.; Coats, B. S.; Shroads, A. L.; Langaee, T.; Lew, A.; Forder, J. R.; Shuster, J. J.; Wagner, D. A.

    2015-01-01

    Summary Background Recurrent malignant brain tumors (RMBTs) carry a poor prognosis. Dichloroacetate (DCA) activates mitochondrial oxidative metabolism and has shown activity against several human cancers. Design We conducted an open-label study of oral DCA in 15 adults with recurrent WHO grade III – IV gliomas or metastases from a primary cancer outside the central nervous system. The primary objective was detection of a dose limiting toxicity for RMBTs at 4 weeks of treatment, defined as any grade 4 or 5 toxicity, or grade 3 toxicity directly attributable to DCA, based on the National Cancer Institute’s Common Toxicity Criteria for Adverse Events, version 4.0. Secondary objectives involved safety, tolerability and hypothesis-generating data on disease status. Dosing was based on haplotype variation in glutathione transferase zeta 1/maleylacetoacetate isomerase (GSTZ1/MAAI), which participates in DCA and tyrosine catabolism. Results Eight patients completed at least 1 four week cycle. During this time, no dose-limiting toxicities occurred. No patient withdrew because of lack of tolerance to DCA, although 2 subjects experienced grade 0–1 distal parasthesias that led to elective withdrawal and/or dose-adjustment. All subjects completing at least 1 four week cycle remained clinically stable during this time and remained on DCA for an average of 75.5 days (range 26–312). Conclusions Chronic, oral DCA is feasible and well-tolerated in patients with recurrent malignant gliomas and other tumors metastatic to the brain using the dose range established for metabolic diseases. The importance of genetic-based dosing is confirmed and should be incorporated into future trials of chronic DCA administration. PMID:24297161

  2. Prospective randomized trial of maintenance immunosuppression with rapid discontinuation of prednisone in adult kidney transplantation.

    PubMed

    Suszynski, T M; Gillingham, K J; Rizzari, M D; Dunn, T B; Payne, W D; Chinnakotla, S; Finger, E B; Sutherland, D E R; Najarian, J S; Pruett, T L; Matas, A J; Kandaswamy, R

    2013-04-01

    Rapid discontinuation of prednisone (RDP) has minimized steroid-related complications following kidney transplant (KT). This trial compares long-term (10-year) outcomes with three different maintenance immunosuppressive protocols following RDP in adult KT. Recipients (n=440; 73% living donor) from March 2001 to April 2006 were randomized into one of three arms: cyclosporine (CSA) and mycophenolate mofetil (MMF) (CSA/MMF, n=151); high-level tacrolimus (TAC, 8-12 μg/L) and low-level sirolimus (SIR, 3-7 μg/L) (TACH/SIRL, n=149) or low-level TAC (3-7 μg/L) and high-level SIR (8-12 μg/L) (TACL/SIR(H) , n=140). Median follow-up was ∼7 years. There were no differences between arms in 10-year actuarial patient, graft and death-censored graft survival or in allograft function. There were no differences in the 10-year actuarial rates of biopsy-proven acute rejection (30%, 26% and 20% in CSA/MMF, TACH/SIRL and TACL/SIRH) and chronic rejection (38%, 35% and 31% in CSA/MMF, TACH/SIRL and TACL/SIRH). Rates of new-onset diabetes mellitus were higher with TACH/SIRL (p=0.04), and rates of anemia were higher with TACH/SIRL and TACL/SIRH (p=0.04). No differences were found in the overall rates of 16 other post-KT complications. These data indicate that RDP-based protocol yield acceptable 10-year outcomes, but side effects differ based on the maintenance regimen used and should be considered when optimizing immunosuppression following RDP.

  3. Prospective Randomized Trial of Maintenance Immunosuppression with Rapid Discontinuation of Prednisone in Adult Kidney Transplantation

    PubMed Central

    Suszynski, Thomas M.; Gillingham, Kristen J.; Rizzari, Michael D.; Dunn, Ty B.; Payne, William D.; Chinnakotla, Srinath; Finger, Erik B.; Sutherland, David E.R.; Najarian, John S.; Pruett, Timothy L.; Matas, Arthur J.; Kandaswamy, Raja

    2013-01-01

    Rapid discontinuation of prednisone (RDP) has minimized steroid-related complications following kidney transplant (KT). This trial compares long-term (10-year) outcomes with 3 different maintenance immunosuppressive protocols following RDP in adult KT. Recipients (n=440; 73% living donor) from 3/2001–4/2006 were randomized into 1 of 3 arms: cyclosporine (CSA) and mycophenolate mofetil (MMF) (CSA/MMF, n=151); high-level tacrolimus (TAC, 8–12 μg/L) and low-level sirolimus (SIR, 3–7 μg/L) (TACH/SIRL, n=149); or low-level TAC (3–7 μg/L) and high-level SIR (8–12 μg/L) (TACL/SIRH, n=140). Median follow-up was ~7 years. There were no differences between arms in 10-year actuarial patient (~70%), graft (~60%), death-censored graft (~80%) survival, or in allograft function. There were no differences in the 10-year actuarial rates of biopsy-proven acute rejection (30%, 26%, and 20% in CSA/MMF, TACH/SIRL, and TACL/SIRH) and chronic rejection (38%, 35%, and 31% in CSA/MMF, TACH/SIRL, and TACL/SIRH). Rates of new-onset diabetes mellitus were higher with TACH/SIRL (p=0.04), and rates of anemia were higher with TACH/SIRL and TACL/SIRH (p=0.04). No differences were found in the overall rates of 16 other post-KT complications. These data indicate that RDP-based protocol yield acceptable 10-year outcomes, but side effects differ based on the maintenance regimen used and should be considered when optimizing immunosuppression following RDP. PMID:23432755

  4. The efficacy of atomoxetine in treating adult attention deficit hyperactivity disorder (ADHD): A meta-analysis of controlled trials.

    PubMed

    Ravishankar, Vinutha; Chowdappa, Suresh Vedaveni; Benegal, Vivek; Muralidharan, Kesavan

    2016-12-01

    Atomoxetine, a non-stimulant, is FDA approved drug used in the management of adult ADHD. Since the presentation of adult ADHD is different from the childhood onset condition, there is an urgent need to study the efficacy of atomoxetine on the different symptom domains of adult ADHD. To study the efficacy of atomoxetine in treating adult ADHD compared to placebo, we performed a Medline search for English language publications of Randomized Controlled Trials (RCTs) comparing atomoxetine to placebo for adult ADHD using the keywords "adult ADHD", "atomoxetine" and "placebo". A total of 41 RCTs were returned of which we included 13 relevant RCTs reporting data on 1824 patients with adult ADHD in the analysis. Standardized mean difference between atomoxetine and placebo for the mean baseline-to-endpoint change in total ADHD scores, impulsivity/hyperactivity and inattention scores was calculated, with a 95% confidence limit. Atomoxetine had superior efficacy than placebo on overall adult ADHD scores [-0.45; 95% CI -0.54, -0.35; overall effect p<0.00001]. Atomoxetine was superior to placebo on the domains of both inattention [-0.42; 95% CI -0.49, -0.35; overall effect p<0.00001] and impulsivity/hyperactivity [-0.36; 95% CI -0.44, -0.29; overall effect p<0.00001]. Atomoxetine was significantly more efficacious (p<0.00001) in treating inattention than hyperactivity/impulsivity. Atomoxetine is efficacious in treating adult ADHD compared to placebo, though the efficacy is significantly superior for inattention than hyperactivity/impulsivity.

  5. High-fluoride toothpaste: a multicenter randomized controlled trial in adults

    PubMed Central

    Srinivasan, Murali; Schimmel, Martin; Riesen, Martine; Ilgner, Alexander; Wicht, Michael J; Warncke, Michael; Ellwood, Roger P; Nitschke, Ina; Müller, Frauke; Noack, Michael J

    2014-01-01

    Objective The aim of this single – blind, multicenter, parallel, randomized controlled trial was to evaluate the effectiveness of the application of a high-fluoride toothpaste on root caries in adults. Methods Adult patients (n = 130, ♂ = 74, ♀ = 56; mean age ± SD: 56.9 ± 12.9) from three participating centers, diagnosed with root caries, were randomly allocated into two groups: Test (n = 64, ♂ = 37, ♀ = 27; lesions = 144; mean age: 59.0 ± 12.1; intervention: high-fluoride toothpaste with 5000 ppm F), and Control (n = 66, ♂ = 37, ♀ = 29; lesions = 160; mean age: 54.8 ± 13.5; intervention: regular-fluoride toothpaste with 1350 ppm F) groups. Clinical examinations and surface hardness scoring of the carious lesions were performed for each subject at specified time intervals (T0 – at baseline before intervention, T1 – at 3 months and T2 – at 6 months after intervention). Mean surface hardness scores (HS) were calculated for each patient. Statistical analyses comprised of two-way analysis of variance and post hoc comparisons using the Bonferroni–Dunn correction. Results At T0, there was no statistical difference between the two groups with regard to gender (P = 0.0682, unpaired t-test), or age (P = 0.9786, chi-squared test), and for the overall HS (Test group: HS = 3.4 ± 0.61; Control group: HS = 3.4 ± 0.66; P = 0.8757, unpaired t-test). The anova revealed significantly better HS for the test group than for the control groups (T1: Test group: HS = 2.9 ± 0.67; Control group: HS = 3.1 ± 0.75; T2: Test group: HS = 2.4 ± 0.81; Control group: HS = 2.8 ± 0.79; P < 0.0001). However, the interaction term time-point*group was not significant. Conclusions The application of a high-fluoride containing dentifrice (5000 ppm F) in adults, twice daily, significantly improves the surface hardness of otherwise untreated root caries lesions when compared with the use of regular fluoride

  6. DESIGNING PHARMACEUTICAL TRIALS FOR SARCOPENIA IN FRAIL OLDER ADULTS: EU/US TASK FORCE RECOMMENDATIONS

    PubMed Central

    VELLAS, B.; PAHOR, M.; MANINI, T.; ROOKS, D.; GURALNIK, J.M.; MORLEY, J.; STUDENSKI, S.; EVANS, W.; ASBRAND, C.; FARIELLO, R.; PEREIRA, S.; ROLLAND, Y.; VAN KAN, G. ABELLAN; CESARI, M.; CHUMLEA, WM.C.; FIELDING, R.

    2014-01-01

    An international task force of academic and industry leaders in sarcopenia research met on December 5, 2012 in Orlando, Florida to develop guidelines for designing and executing randomized clinical trials of sarcopenia treatments. The Task Force reviewed results from previous trials in related disease areas to extract lessons relevant to future sarcopenia trials, including practical issues regarding the design and conduct of trials in elderly populations, the definition of appropriate target populations, and the selection of screening tools, outcome measures, and biomarkers. They discussed regulatory issues, the challenges posed by trials of different types of interventions, and the need for standardization and harmonization. The Task Force concluded with recommendations for advancing the field toward better clinical trials. PMID:23933872

  7. Recruiting and retaining young adults in a weight gain prevention trial: Lessons learned from the CHOICES study

    PubMed Central

    Moe, Stacey G; Lytle, Leslie A; Nanney, Marilyn S; Linde, Jennifer A; Laska, Melissa N

    2015-01-01

    Background/Aims Young adults are at risk for weight gain but little is known about designing effective weight control trials for young adults or how to recruit and retain participants in these programs. The Choosing Healthy Options in College Environments and Settings (CHOICES) study evaluated the effectiveness of a weight gain prevention intervention for 2-year college students. We describe the methods used to recruit and retain the colleges and their students, describe the sample and discuss recommendations for future studies. Methods Students were recruited into a 24-month trial of a weight control intervention with assessment periods at baseline, 4-, 12- and 24-months follow-up. Results We successfully recruited 441 students through partnerships with three 2-year colleges through a variety of campus-based methods. Ultimately, 83.4% of the randomized cohort participated in the 24-month assessment period. Those retained more often were white (p=0.03), compared to those who dropped out or were lost to follow-up; no other socio-demographic factor (e.g., gender, ethnicity, education), BMI, body fat, waist circumference or weight status was observed to differ between randomly assigned groups. Conclusions Two-year colleges and their students are interested in participating in weight-related trials and partnering with universities for research. Researchers must work closely with administrators to identify benefits to their institutions and to resolve student-level barriers to recruitment and retention. Our experiences from the CHOICES study should be useful in identifying effective recruitment and retention methods for weight gain prevention trials among young adults. PMID:26378096

  8. Knowledge of Results after Good Trials Enhances Learning in Older Adults

    ERIC Educational Resources Information Center

    Chiviacowsky, Suzete; Wulf, Gabriele; Wally, Raquel; Borges, Thiago

    2009-01-01

    In recent years, some researchers have examined motor learning in older adults. Some of these studies have specifically looked at the effectiveness of different manipulations of extrinsic feedback, or knowledge of results (KR). Given that many motor tasks may already be more challenging for older adults compared to younger adults, making KR more…

  9. A Clinical Trial to Examine Disparities in Quitting between African American and White Adult Smokers: Design, Accrual, and Baseline Characteristics

    PubMed Central

    Nollen, Nicole L.; Cox, Lisa Sanderson; Yu, Qing; Ellerbeck, Edward F.; Scheuermann, Taneisha S.; Benowitz, Neal L.; Tyndale, Rachel F.; Mayo, Matthew S.; Ahluwalia, Jasjit S.

    2016-01-01

    BACKGROUND African Americans smoke fewer cigarettes per day than Whites but experience greater smoking attributable morbidity and mortality. African American-White differences may also exist in cessation but rigorously designed studies have not been conducted to empirically answer this question. METHODS/DESIGN Quit2Live is, to our knowledge, the first head-to-head trial designed with the primary aim of examining African American-White disparities in quitting smoking. Secondary aims are to identify mechanisms that mediate and/or moderate the relationship between race and quitting. The study is ongoing. Study aims are accomplished through a 5-year prospective cohort intervention study designed to recruit equal numbers of African Americans (n=224) and Whites (n=224) stratified on age (< 40, ≥ 40) and gender, key factors known to impact cessation, and all within a restricted income range (≤ 400% federal poverty level). All participants will receive 12 weeks of varenicline in combination smoking cessation counseling. The primary outcome is cotinine-verified 7-day point prevalence abstinence from smoking at week 26. Secondary outcomes are cotinine-verified 7-day point prevalence abstinence from smoking at weeks 4 and 12. DISCUSSION Findings from Quit2Live will not only address if African American-White disparities in quitting smoking exist but, more importantly, will examine mechanisms underlying the difference. Attention to proximal, modifiable mechanisms (e.g., adherence, response to treatment, depression, stress) maximizes Quit2Live’s potential to inform practice. Findings will provide an empirically-derived approach that will guide researchers and clinicians in identifying specific factors to address to improve cessation outcomes and reduce tobacco-related morbidity and mortality in African American and White smokers. TRIAL REGISTRATION NUMBER ClinicalTrials.gov: NCT01836276 PMID:26667382

  10. The effects of a multisite aerobic exercise intervention on asthma morbidity in sedentary adults with asthma: the Ex-asthma study randomised controlled trial protocol

    PubMed Central

    Bacon, Simon L; Lavoie, Kim L; Bourbeau, Jean; Ernst, Pierre; Maghni, Karim; Gautrin, Denyse; Labrecque, Manon; Pepin, Veronique; Pedersen, Bente Klarlund

    2013-01-01

    Objective Aerobic exercise can improve cardiovascular fitness and does not seem to be detrimental to patients with asthma, though its role in changing asthma control and inflammatory profiles is unclear. The main hypothesis of the current randomised controlled trial is that aerobic exercise will be superior to usual care in improving asthma control. Key secondary outcomes are asthma quality of life and inflammatory profiles. Design A total of 104 sedentary adults with physician-diagnosed asthma will be recruited. Eligible participants will undergo a series of baseline assessments including: the asthma control questionnaire; the asthma quality-of-life questionnaire and the inflammatory profile (assessed from both the blood and sputum samples). On completion of the assessments, participants will be randomised (1:1 allocation) to either 12-weeks of usual care or usual care plus aerobic exercise. Aerobic exercise will consist of three supervised training sessions per week. Each session will consist of taking a short-acting bronchodilator, 10 min of warm-up, 40 min of aerobic exercise (50–75% of heart rate reserve for weeks 1–4, then 70–85% for weeks 5–12) and a 10 min cool-down. Within 1 week of completion, participants will be reassessed (same battery as at baseline). Analyses will assess the difference between the two intervention arms on postintervention levels of asthma control, quality of life and inflammation, adjusting for age, baseline inhaled corticosteroid prescription, body weight change and pretreatment dependent variable level. Missing data will be handled using standard multiple imputation techniques. Ethics and dissemination The study has been approved by all relevant research ethics boards. Written consent will be obtained from all participants who will be able to withdraw at any time. Results The result will be disseminated to three groups of stakeholder groups: (1) the scientific and professional community; (2) the research

  11. Six-Month Outcomes from a Randomized Trial Augmenting Serotonin Reuptake Inhibitors with Exposure and Ritual Prevention or Risperidone in Adults with Obsessive-Compulsive Disorder

    PubMed Central

    Foa, Edna B.; Simpson, Helen Blair; Rosenfield, David; Liebowitz, Michael R.; Cahill, Shawn P.; Huppert, Jonathan D.; Bender, James; McLean, Carmen P.; Maher, Michael J.; Campeas, Raphael; Hahn, Chang-Gyu; Imms, Patricia; Pinto, Anthony; Powers, Mark B.; Rodriguez, Carolyn I.; Van Meter, Page E.; Vermes, Donna; Williams, Monnica T.

    2015-01-01

    Objective To compare outcomes after six-month maintenance treatment of adults diagnosed with OCD based on DSM IV criteria who responded to acute treatment with serotonin reuptake inhibitors (SRIs) augmented by exposure therapy (EX/RP) or risperidone. Method A randomized trial was conducted at two academic sites from October 2006 through December 2012. In the Acute Phase, 100 patients on therapeutic SRI dose with at least moderate OCD severity were randomized to 8 weeks of EX/RP, risperidone, or pill placebo. Responders entered the six-month Maintenance Phase, continuing the augmentation strategy they received acutely (30 EX/RP, 8 risperidone). Independent evaluations were conducted every month. The main outcome was the Yale-Brown Obsessive Compulsive Scale (Y-BOCS). Results Intent-to-treat analyses indicated that EX/RP yielded superior OCD outcomes after six-month maintenance treatment than risperidone (Y-BOCS=10.95 versus 18.70;t(40)=2.76,P=.009); more patients randomized to EX/RP met response criteria (Y-BOCS decrease≥25%: 70% versus 22.5%;P<.001) and achieved minimal symptoms (Y-BOCS≤12: 50% versus 5%;P<.001). During maintenance, OCD severity decreased slightly in both conditions (Y-BOCS decrease=2.2 points, P=.020). Lower Y-BOCS at entry to maintenance was associated with more improvement in both conditions (r(38)=.57, P <.001). Conclusion OCD patients on SRIs who responded to acute EX/RP or risperidone maintained their gains over six-month maintenance. Because EX/RP patients improved more during acute treatment than risperidone patients, and both maintained their gains during maintenance, EX/RP yielded superior outcomes six months later. The findings that 50% of patients randomized to EX/RP had minimal symptoms at six-month maintenance, a rate double that of prior studies, suggests that EX/RP maintenance helps maximize long-term outcome. Trial Registration Clinicaltrials.gov identifier: NCT00389493 PMID:25375780

  12. Study protocol of a randomized controlled trial to improve cancer prevention behaviors in adolescents and adults using a web-based intervention supplemented with SMS

    PubMed Central

    2013-01-01

    Background The overall number of cancer cases is increasing and, therefore, strengthening cancer prevention has become a priority. The institutions responsible for its control establish guidelines for primary prevention. These include recommendations, such as: not smoking, following a healthy diet, doing daily physical exercise or avoiding overweight. Adolescence is a period of adoption and/or consolidation of health behaviors, and both school- and family-based interventions have proven effective to improve them. Furthermore, online and mobile phone educational interventions are encouraging. Consequently, the main aim of this study is to assess the efficacy of an intervention in which these requirements (school, family, the Internet and SMS) are combined to prevent behavioral cancer risk. Methods This protocol describes the design and implementation of a complex online program that includes a randomized controlled trial put into practice in two countries: Spain and Mexico. Adolescents and adults of their environment (relatives and teachers) who voluntarily participate will be randomly assigned to the experimental group or to the control group once they have completed the online pre-test. The experimental group members will have free access to a tailor-made and interactive website (http://www.alertagrumete.com). During the academic year, this website will be periodically updated with different school and leisure activities related to the avoidance of risk behaviors. To encourage participation, the program includes a competition that gives rewards to the winners. SMS are also sent to students to stimulate the adoption of healthy behaviors and as a reminder of participation. Finished the intervention, an online post-test is performed in both groups and the impact on the risk behaviors is therefore assessed. Discussion The program is pioneer, since it combines many components which have already proven effective in previous researches. Moreover, it aims to compare

  13. Reducing falls after hospital discharge: a protocol for a randomised controlled trial evaluating an individualised multimodal falls education programme for older adults

    PubMed Central

    Hill, Anne-Marie; Etherton-Beer, Christopher; McPhail, Steven M; Morris, Meg E; Flicker, Leon; Bulsara, Max; Lee, Den-Ching; Francis-Coad, Jacqueline; Waldron, Nicholas; Boudville, Amanda; Haines, Terry

    2017-01-01

    Introduction Older adults frequently fall after discharge from hospital. Older people may have low self-perceived risk of falls and poor knowledge about falls prevention. The primary aim of the study is to evaluate the effect of providing tailored falls prevention education in addition to usual care on falls rates in older people after discharge from hospital compared to providing a social intervention in addition to usual care. Methods and analyses The ‘Back to My Best’ study is a multisite, single blind, parallel-group randomised controlled trial with blinded outcome assessment and intention-to-treat analysis, adhering to CONSORT guidelines. Patients (n=390) (aged 60 years or older; score more than 7/10 on the Abbreviated Mental Test Score; discharged to community settings) from aged care rehabilitation wards in three hospitals will be recruited and randomly assigned to one of two groups. Participants allocated to the control group shall receive usual care plus a social visit. Participants allocated to the experimental group shall receive usual care and a falls prevention programme incorporating a video, workbook and individualised follow-up from an expert health professional to foster capability and motivation to engage in falls prevention strategies. The primary outcome is falls rates in the first 6 months after discharge, analysed using negative binomial regression with adjustment for participant's length of observation in the study. Secondary outcomes are injurious falls rates, the proportion of people who become fallers, functional status and health-related quality of life. Healthcare resource use will be captured from four sources for 6 months after discharge. The study is powered to detect a 30% relative reduction in the rate of falls (negative binomial incidence ratio 0.70) for a control rate of 0.80 falls per person over 6 months. Ethics and dissemination Results will be presented in peer-reviewed journals and at conferences worldwide. This

  14. Plasma Concentrations, Efficacy and Safety of Efavirenz in HIV-Infected Adults Treated for Tuberculosis in Cambodia (ANRS 1295-CIPRA KH001 CAMELIA Trial)

    PubMed Central

    Borand, Laurence; Madec, Yoann; Laureillard, Didier; Chou, Monidarin; Marcy, Olivier; Pheng, Phearavin; Prak, Narom; Kim, Chindamony; Lak, Khemarin Kim; Hak, Chanroeun; Dim, Bunnet; Nerrienet, Eric; Fontanet, Arnaud; Sok, Thim; Goldfeld, Anne E.; Blanc, François-Xavier; Taburet, Anne-Marie

    2014-01-01

    , supporting the 600 mg daily-dose of efavirenz in HIV-tuberculosis co-infected patients. High efavirenz concentrations were related to a higher risk of central nervous system side effects and hepatotoxicity. Trial Registration ClinicalTrials.gov NCT01300481 PMID:24608960

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

    PubMed Central

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

    2010-01-01

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

  16. The effect of methylphenidate intake on brain structure in adults with ADHD in a placebo-controlled randomized trial

    PubMed Central

    van Elst, Ludger Tebartz; Maier, Simon; Klöppel, Stefan; Graf, Erika; Killius, Carola; Rump, Marthe; Sobanski, Esther; Ebert, Dieter; Berger, Mathias; Warnke, Andreas; Matthies, Swantje; Perlov, Evgeniy; Philipsen, Alexandra

    2016-01-01

    Background Based on animal research several authors have warned that the application of methylphenidate, the first-line drug for the treatment of attention-deficit/hyperactivity disorder (ADHD), might have neurotoxic effects potentially harming the brain. We investigated whether methylphenidate application, over a 1-year period, results in cerebral volume decrease. Methods We acquired structural MRIs in a double-blind study comparing methylphenidate to placebo. Global and regional brain volumes were analyzed at baseline, after 3 months and after 12 months using diffeomorphic anatomic registration through exponentiated lie algebra. Results We included 131 adult patients with ADHD into the baseline sample, 98 into the 3-month sample (54 in the methylphenidate cohort and 44 in the placebo cohort) and 76 into the 1-year sample (37 in the methylphenidate cohort and 29 in the placebo cohort). Methylphenidate intake compared with placebo did not lead to any detectable cerebral volume loss; there was a trend toward bilateral cerebellar grey matter increase. Limitations Detecting possible neurotoxic effects of methylphenidate might require a longer observation period. Conclusion There is no evidence of grey matter volume loss after 1 year of methylphenidate treatment in adult patients with ADHD. PMID:27575717

  17. Effect of Micronutrients on Behavior and Mood in Adults with ADHD: Evidence from an 8-Week Open Label Trial with Natural Extension

    ERIC Educational Resources Information Center

    Rucklidge, Julia; Taylor, Mairin; Whitehead, Kathryn

    2011-01-01

    Objective: To investigate the effect of a 36-ingredient micronutrient formula consisting mainly of minerals and vitamins in the treatment of adults with both ADHD and severe mood dysregulation (SMD). Method: 14 medication-free adults (9 men, 5 women; 18-55 years) with ADHD and SMD completed an 8-week open-label trial. Results: A minority reported…

  18. Protein and calorie intakes in adult and pediatric subjects with urea cycle disorders participating in clinical trials of glycerol phenylbutyrate☆

    PubMed Central

    Hook, Debra; Diaz, George A.; Lee, Brendan; Bartley, James; Longo, Nicola; Berquist, William; Le Mons, Cynthia; Rudolph-Angelich, Ingrid; Porter, Marty; Scharschmidt, Bruce F.; Mokhtarani, Masoud

    2016-01-01

    Background Little prospectively collected data are available comparing the dietary intake of urea cycle disorder (UCD) patients to UCD treatment guidelines or to healthy individuals. Objective To examine the protein and calorie intakes of UCD subjects who participated in clinical trials of glycerol phenylbutyrate (GPB) and compare these data to published UCD dietary guidelines and nutritional surveys. Design Dietary data were recorded for 45 adult and 49 pediatric UCD subjects in metabolic control during participation in clinical trials of GPB. Protein and calorie intakes were compared to UCD treatment guidelines, average nutrient intakes of a healthy US population based on the National Health and Nutrition Examination Survey (NHANES) and Recommended Daily Allowances (RDA). Results In adults, mean protein intake was higher than UCD recommendations but lower than RDA and NHANES values, while calorie intake was lower than UCD recommendations, RDA and NHANES. In pediatric subjects, prescribed protein intake was higher than UCD guidelines, similar to RDA, and lower than NHANES data for all age groups, while calorie intake was at the lower end of the recommended UCD range and close to RDA and NHANES data. In pediatric subjects height, weight, and body mass index (BMI) Z-scores were within normal range (− 2 to 2). Conclusions Pediatric patients treated with phenylbutyrate derivatives exhibited normal height and weight. Protein and calorie intakes in adult and pediatric UCD subjects differed from UCD dietary guidelines, suggesting that these guidelines may need to be reconsidered. PMID:27014577

  19. Predictors and impact of non-adherence in adults with attention-deficit/hyperactivity disorder receiving OROS methylphenidate: results from a randomized, placebo-controlled trial

    PubMed Central

    2013-01-01

    , and subjects with high educational degrees may be at increased risk of non-adherence. Clinicians and policymakers should therefore pay special attention to these individuals, as non-adherence is a significant predictor of reduced response to treatment. Trial registration EudraCT #: 2007-002111-82 PMID:23347693

  20. Prevention of Relapse and Recurrence in Adults with Major Depressive Disorder: Systematic Review and Meta-Analyses of Controlled Trials

    PubMed Central

    Lau, Wai Keat; Sim, Jordan; Sum, Min Yi; Baldessarini, Ross J.

    2016-01-01

    Background: Findings of substantial remaining morbidity in treated major depressive disorder (MDD) led us to review controlled trials of treatments aimed at preventing early relapses or later recurrences in adults diagnosed with MDD to summarize available data and to guide further research. Methods: Reports (n = 97) were identified through systematic, computerized literature searching up to February 2015. Treatment versus control outcomes were summarized by random-effects meta-analyses. Results: In 45 reports of 72 trials (n = 14 450 subjects) lasting 33.4 weeks, antidepressants were more effective than placebos in preventing relapses (response rates [RR] = 1.90, confidence interval [CI]: 1.73–2.08; NNT = 4.4; p < 0.0001). In 35 reports of 37 trials (n = 7253) lasting 27.0 months, antidepressants were effective in preventing recurrences (RR = 2.03, CI 1.80–2.28; NNT = 3.8; p < 0.0001), with minor differences among drug types. In 17 reports of 22 trials (n = 1 969) lasting 23.7 months, psychosocial interventions yielded inconsistent or inconclusive results. Conclusions: Despite evidence of the efficacy of drug treatment compared to placebos or other controls, the findings further underscore the substantial, unresolved morbidity in treated MDD patients and strongly encourage further evaluations of specific, improved individual and combination therapies (pharmacological and psychological) conducted over longer times, as well as identifying clinical predictors of positive or unfavorable responses and of intolerability of long-term treatments in MDD. PMID:26152228

  1. The Counseling Older Adults to Control Hypertension (COACH) trial: design and methodology of a group-based lifestyle intervention for hypertensive minority older adults.

    PubMed

    Ogedegbe, Gbenga; Fernandez, Senaida; Fournier, Leanne; Silver, Stephanie A; Kong, Jian; Gallagher, Sara; de la Calle, Franze; Plumhoff, Jordan; Sethi, Sheba; Choudhury, Evelyn; Teresi, Jeanne A

    2013-05-01

    The disproportionately high prevalence of hypertension and its associated mortality and morbidity in minority older adults is a major public health concern in the United States. Despite compelling evidence supporting the beneficial effects of therapeutic lifestyle changes on blood pressure reduction, these approaches remain largely untested among minority elders in community-based settings. The Counseling Older Adults to Control Hypertension trial is a two-arm randomized controlled trial of 250 African-American and Latino seniors, 60 years and older with uncontrolled hypertension, who attend senior centers. The goal of the trial is to evaluate the effect of a therapeutic lifestyle intervention delivered via group classes and individual motivational interviewing sessions versus health education, on blood pressure reduction. The primary outcome is change in systolic and diastolic blood pressure from baseline to 12 months. The secondary outcomes are blood pressure control at 12 months; changes in levels of physical activity; body mass index; and number of daily servings of fruits and vegetables from baseline to 12 months. The intervention group will receive 12 weekly group classes followed by individual motivational interviewing sessions. The health education group will receive an individual counseling session on healthy lifestyle changes and standard hypertension education materials. Findings from this study will provide needed information on the effectiveness of lifestyle interventions delivered in senior centers. Such information is crucial in order to develop implementation strategies for translation of evidence-based lifestyle interventions to senior centers, where many minority elders spend their time, making the centers a salient point of dissemination.

  2. A cognitive training intervention improves modality-specific attention in a randomized controlled trial of healthy older adults

    PubMed Central

    Long, Ashley B.; Morgan, Ashley R.; Rawley-Payne, Melissa; Laurienti, Paul J.

    2009-01-01

    Age-related deficits in cognitive and sensory function can result in increased distraction from background sensory stimuli. This randomized controlled trial investigated the effects of a cognitive training intervention aimed at helping healthy older adults suppress irrelevant auditory and visual stimuli. Sixty-six participants received 8 weeks of either the modality-specific attention training program or an educational lecture control program. Participants who completed the intervention program had larger improvements in modality-specific selective attention following training than controls. These improvements also correlated with reductions in bimodal integration during selective attention. Further, the intervention group showed larger improvements than the control group in non-trained domains such as processing speed and dual-task completion, demonstrating the utility of modality-specific attention training for improving cognitive function in healthy older adults. PMID:19428142

  3. Drug-resistant tuberculosis clinical trials: proposed core research definitions in adults.

    PubMed

    Furin, J; Alirol, E; Allen, E; Fielding, K; Merle, C; Abubakar, I; Andersen, J; Davies, G; Dheda, K; Diacon, A; Dooley, K E; Dravnice, G; Eisenach, K; Everitt, D; Ferstenberg, D; Goolam-Mahomed, A; Grobusch, M P; Gupta, R; Harausz, E; Harrington, M; Horsburgh, C R; Lienhardt, C; McNeeley, D; Mitnick, C D; Nachman, S; Nahid, P; Nunn, A J; Phillips, P; Rodriguez, C; Shah, S; Wells, C; Thomas-Nyang'wa, B; du Cros, P

    2016-03-01

    Drug-resistant tuberculosis (DR-TB) is a growing public health problem, and for the first time in decades, new drugs for the treatment of this disease have been developed. These new drugs have prompted strengthened efforts in DR-TB clinical trials research, and there are now multiple ongoing and planned DR-TB clinical trials. To facilitate comparability and maximise policy impact, a common set of core research definitions is needed, and this paper presents a core set of efficacy and safety definitions as well as other important considerations in DR-TB clinical trials work. To elaborate these definitions, a search of clinical trials registries, published manuscripts and conference proceedings was undertaken to identify groups conducting trials of new regimens for the treatment of DR-TB. Individuals from these groups developed the core set of definitions presented here. Further work is needed to validate and assess the utility of these definitions but they represent an important first step to ensure there is comparability in clinical trials on multidrug-resistant TB.

  4. A Telehealth Intervention Using Nintendo Wii Fit Balance Boards and iPads to Improve Walking in Older Adults With Lower Limb Amputation (Wii.n.Walk): Study Protocol for a Randomized Controlled Trial

    PubMed Central

    Imam, Bita; Finlayson, Heather C; Eng, Janice J; Payne, Michael WC; Jarus, Tal; Goldsmith, Charles H; Mitchell, Ian M

    2014-01-01

    unsupervised phases, and after 1-year follow up. Results Study staff have been hired and trained at both sites and recruitment is currently underway. No participants have been enrolled yet. Conclusions Wii.n.Walk is a promising in-home telehealth intervention that may have useful applications for older adults with LLA who are discharged from rehabilitation or live in remote areas having limited or no access to existing rehabilitation programs. Trial Registration Clinicaltrial.gov NCT01942798; http://clinicaltrials.gov/ct2/show/NCT01942798 (Archived by WebCite at http://www.webcitation.org/6V0w8baKP). PMID:25533902

  5. Effects of an Enhanced Discharge Planning Intervention for Hospitalized Older Adults: A Randomized Trial

    ERIC Educational Resources Information Center

    Altfeld, Susan J.; Shier, Gayle E.; Rooney, Madeleine; Johnson, Tricia J.; Golden, Robyn L.; Karavolos, Kelly; Avery, Elizabeth; Nandi, Vijay; Perry, Anthony J.

    2013-01-01

    Purpose of the Study: To identify needs encountered by older adult patients after hospital discharge and assess the impact of a telephone transitional care intervention on stress, health care utilization, readmissions, and mortality. Design and Methods: Older adult inpatients who met criteria for risk of post-discharge complications were…

  6. Nutrition Education among Low-Income Older Adults: A Randomized Intervention Trial in Congregate Nutrition Sites

    ERIC Educational Resources Information Center

    Mitchell, Roger E.; Ash, Sarah L.; McClelland, Jacquelyn W.

    2006-01-01

    Nutritional well-being among older adults is critical for maintaining health, increasing longevity, and decreasing the impact of chronic illness. However, few well-controlled studies have examined nutritional behavior change among low-income older adults. A prospective, controlled, randomized design examined a five session nutrition education…

  7. Randomised Controlled Trial of Incentives to Improve Attendance at Adult Literacy Classes

    ERIC Educational Resources Information Center

    Brooks, Greg; Burton, Maxine; Cole, Pam; Miles, Jeremy; Torgerson, Carole; Torgerson, David

    2008-01-01

    Background: Incentives have been proposed as a method to improve attendance in adult literacy classes. In the UK, several areas have piloted the use of incentives to promote attendance at adult literacy classes. To date no rigorous evaluation of this policy has been undertaken. This paper describes (as far as we are aware) the "only"…

  8. Interview Skills for Adults with Autism Spectrum Disorder: A Pilot Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Morgan, Lindee; Leatzow, Allison; Clark, Sarah; Siller, Michael

    2014-01-01

    The purpose of this pilot study was to evaluate the efficacy of the interview skills curriculum (ISC), a manualized 12-week group-delivered intervention for young adults with autism spectrum disorder (ASD). This intervention aims to increase social-pragmatic skills essential to a successful job interview. Twenty-eight adults (18-36 years) were…

  9. Housing First Reduces Re-offending among Formerly Homeless Adults with Mental Disorders: Results of a Randomized Controlled Trial

    PubMed Central

    Somers, Julian M.; Rezansoff, Stefanie N.; Moniruzzaman, Akm; Palepu, Anita; Patterson, Michelle

    2013-01-01

    Background Homelessness and mental illness have a strong association with public disorder and criminality. Experimental evidence indicates that Housing First (HF) increases housing stability and perceived choice among those experiencing chronic homelessness and mental disorders. HF is also associated with lower residential costs than common alternative approaches. Few studies have examined the effect of HF on criminal behavior. Methods Individuals meeting criteria for homelessness and a current mental disorder were randomized to one of three conditions treatment as usual (reference); scattered site HF; and congregate HF. Administrative data concerning justice system events were linked in order to study prior histories of offending and to test the relationship between housing status and offending following randomization for up to two years. Results The majority of the sample (67%) was involved with the justice system, with a mean of 8.07 convictions per person in the ten years prior to recruitment. The most common category of crime was “property offences” (mean = 4.09). Following randomization, the scattered site HF condition was associated with significantly lower numbers of sentences than treatment as usual (Adjusted IRR = 0.29; 95% CI 0.12–0.72). Congregate HF was associated with a marginally significant reduction in sentences compared to treatment as usual (Adjusted IRR = 0.55; 95% CI: 0.26–1.14). Conclusions This study is the first randomized controlled trial to demonstrate benefits of HF among a homeless sample with mental illness in the domain of public safety and crime. Our sample was frequently involved with the justice system, with great personal and societal costs. Further implementation of HF is strongly indicated, particularly in the scattered site format. Research examining interdependencies between housing, health, and the justice system is indicated. Trial registration ISRCTN57595077 PMID:24023796

  10. Whole body vibration training improves vibration perception threshold in healthy young adults: A randomized clinical trial pilot study

    PubMed Central

    Hernandez-Mocholi, M.A.; Dominguez-Muñoz, F.J.; Corzo, H.; Silva, S.C.S.; Adsuar, J.C.; Gusi, N.

    2016-01-01

    Objectives: Loss of foot sensitivity is a relevant parameter to assess and prevent in several diseases. It is crucial to determine the vibro-tactile sensitivity threshold response to acute conditions to explore innovative monitor tools and interventions to prevent and treat this challenge. The aims were: 1) to analyze the acute effects of a single whole body vibration session (4min-18Hz-4mm) on vibro-tactile perception threshold in healthy young adults. 2) to analyze the 48 hours effects of 3 whole body vibration sessions on vibro-tactile perception threshold in healthy young adults. Methods: A randomized controlled clinical trial over 3 sessions of whole body vibration intervention or 3 sessions of placebo intervention. Twenty-eight healthy young adults were included: 11 experimental group and 12 placebo group. The experimental group performed 3 sessions of WBV while the placebo group performed 3 sessions of placebo intervention. Results: The vibro-tactile threshold increased right after a single WBV session in comparison with placebo. Nevertheless, after 3 whole body vibration sessions and 48 hours, the threshold decreased to values lower than the initial. Conclusions: The acute response of the vibro-tactile threshold to one whole body vibration session increased, but the 48 hours short-term response of this threshold decreased in healthy young adults. PMID:26944818

  11. Training adults with an autism spectrum disorder to conduct discrete-trial training for young children with autism: a pilot study.

    PubMed

    Lerman, Dorothea C; Hawkins, Lynn; Hoffman, Rachel; Caccavale, Mia

    2013-01-01

    We evaluated a behavioral skills training program for adults with autism spectrum disorder and mild or no intellectual disabilities who were interested in learning the skills used by behavior therapists to work with young children with autism and other developmental disabilities. Four adults, aged 21 to 30 years, participated. We trained each individually using verbal and written instructions, modeling, and role play with feedback to teach 2 basic skills to an adult who played the role of a young child with autism. We evaluated generalization of the discrete-trial training skills by having the participant (a) teach the adult confederate 2 additional targets that we had not included in training and (b) teach a new skill to a young child with autism. Results indicated that 3 of the 4 participants rapidly acquired discrete-trial training skills and that these skills generalized to new targets with the confederate adults and to teaching an actual child with autism.

  12. Hypothermia for severe traumatic brain injury in adults: Recent lessons from randomized controlled trials

    PubMed Central

    Shaefi, Shahzad; Mittel, Aaron M.; Hyam, Jonathan A.; Boone, M. Dustin; Chen, Clark C.; Kasper, Ekkehard M.

    2016-01-01

    Background: Traumatic brain injury (TBI) is a worldwide health concern associated with significant morbidity and mortality. In the United States, severe TBI is managed according to recommendations set forth in 2007 by the Brain Trauma Foundation (BTF), which were based on relatively low quality clinical trials. These guidelines prescribed the use of hypothermia for the management of TBI. Several randomized controlled trials (RCTs) of hypothermia for TBI have since been conducted. Despite this new literature, there is ongoing controversy surrounding the use of hypothermia for the management of severe TBI. Methods: We searched the PubMed database for all RCTs of hypothermia for TBI since 2007 with the intent to review the methodology outcomes of these trials. Furthermore, we aimed to develop evidence-based, expert opinions based on these recent studies. Results: We identified 8 RCTs of therapeutic hypothermia published since 2007 that focused on changes in neurologic outcomes or mortality in patients with severe TBI. The majority of these trials did not identify improvement with the use of hypothermia, though there were subgroups of patients that may have benefited from hypothermia. Differences in methodology prevented direct comparison between studies. Conclusions: A growing body of literature disfavors the use of hypothermia for the management of severe TBI. In general, empiric hypothermia for severe TBI should be avoided. However, based on the results of recent trials, there may be some patients, such as those in Asian centers or with focal neurologic injury, who may benefit from hypothermia. PMID:28168089

  13. Protocol for a randomised controlled trial of standard wound management versus negative pressure wound therapy in the treatment of adult patients with an open fracture of the lower limb: UK Wound management of Open Lower Limb Fractures (UK WOLFF)

    PubMed Central

    Achten, Juul; Parsons, Nick R; Bruce, Julie; Petrou, Stavros; Tutton, Elizabeth; Willett, Keith; Lamb, Sarah E; Costa, Matthew L

    2015-01-01

    Introduction Patients who sustain open lower limb fractures have reported infection risks as high as 27%. The type of dressing applied after initial debridement could potentially affect this risk. In this trial, standard dressings will be compared with a new emerging treatment, negative pressure wound therapy, for patients with open lower limb fractures. Methods and analysis All adult patients presenting with an open lower limb fracture, with a Gustilo and Anderson (G&A) grade 2/3, will be considered for inclusion. 460 consented patients will provide 90% power to detect a difference of eight points in the Disability Rating Index (DRI) score at 12 months, at the 5% level. A randomisation sequence, stratified by trial centre and G&A grade, will be produced and administered by a secure web-based service. A qualitative substudy will assess patients’ experience of giving consent for the trial, and acceptability of trial procedures to patients and staff. Patients will have clinical follow-up in a fracture clinic up to a minimum of 12 months as per standard National Health Service (NHS) practice. Functional and quality of life outcome data will be collected using the DRI, SF12 and EQ-5D questionnaires at 3, 6, 9 and 12 months postoperatively. In addition, information will be requested with regards to resource use and any late complications or surgical interventions related to their injury. The main analysis will investigate differences in the DRI score at 1 year after injury, between the two treatment groups on an intention-to-treat basis. Tests will be two sided and considered to provide evidence for a significant difference if p values are less than 0.05. Ethics and dissemination Ethical approval was given by NRES Committee West Midlands—Coventry & Warwickshire on 6/2/2012 (ref: 12/WM/0001). The results of the trial will be disseminated via peer-reviewed publications and presentations at relevant conferences. Trial registration number ISRCTN33756652. PMID

  14. Guided internet-administered self-help to reduce symptoms of anxiety and depression among adolescents and young adults diagnosed with cancer during adolescence (U-CARE: YoungCan): a study protocol for a feasibility trial

    PubMed Central

    Ander, Malin; Wikman, Anna; Ljótsson, Brjánn; Grönqvist, Helena; Ljungman, Gustaf; Woodford, Joanne; Lindahl Norberg, Annika; von Essen, Louise

    2017-01-01

    Introduction A subgroup of adolescents and young adults diagnosed with cancer during adolescence reports elevated levels of anxiety and depressive symptoms and unmet needs for psychological support. Evidence-based psychological treatments tailored for this population are lacking. This protocol describes a feasibility study of a guided-internet-administered self-help programme (YoungCan) primarily targeting symptoms of anxiety and depression among young persons diagnosed with cancer during adolescence and of the planned study procedures for a future controlled trial. Methods/analysis The study is an uncontrolled feasibility trial with a pre-post and 3-month follow-up design. Potential participants aged 15–25 years, diagnosed with cancer during adolescence, will be identified via the Swedish Childhood Cancer Registry. 30 participants will be included. Participants will receive YoungCan, a 12-week therapist-guided, internet-administered self-help programme consisting primarily of cognitive–behavioural therapy organised into individually assigned modules targeting depressive symptoms, worry and anxiety, body dissatisfaction and post-traumatic stress. Interactive peer support and psychoeducative functions are also available. Feasibility outcomes include: recruitment and eligibility criteria; data collection; attrition; resources needed to complete the study and programme; safety procedures; participants' and therapists' adherence to the programme; and participants' acceptability of the programme and study methodology. Additionally, mechanisms of impact will be explored and data regarding symptoms of anxiety, depression, post-traumatic stress, body dissatisfaction, reactions to social interactions, quality of life, axis I diagnoses according to the Mini International Neuropsychiatric Interview and healthcare service use will be collected. Exploratory analyses of changes in targeted outcomes will be conducted. Ethics/dissemination This feasibility protocol was

  15. Artichoke leaf extract (Cynara scolymus) reduces plasma cholesterol in otherwise healthy hypercholesterolemic adults: a randomized, double blind placebo controlled trial.

    PubMed

    Bundy, Rafe; Walker, Ann F; Middleton, Richard W; Wallis, Carol; Simpson, Hugh C R

    2008-09-01

    Cardiovascular diseases are the chief causes of death in the UK, and are associated with high circulating levels of total cholesterol in the plasma. Artichoke leaf extracts (ALEs) have been reported to reduce plasma lipids levels, including total cholesterol, although high quality data is lacking. The objective of this trial was to assess the effect of ALE on plasma lipid levels and general well-being in otherwise healthy adults with mild to moderate hypercholesterolemia. 131 adults were screened for total plasma cholesterol in the range 6.0-8.0 mmol/l, with 75 suitable volunteers randomised onto the trial. Volunteers consumed 1280 mg of a standardised ALE, or matched placebo, daily for 12 weeks. Plasma total cholesterol decreased in the treatment group by an average of 4.2% (from 7.16 (SD 0.62) mmol/l to 6.86 (SD 0.68) mmol/l) and increased in the control group by an average of 1.9% (6.90 (SD 0.49) mmol/l to 7.03 (0.61) mmol/l), the difference between groups being statistically significant (p=0.025). No significant differences between groups were observed for LDL cholesterol, HDL cholesterol or triglyceride levels. General well-being improved significantly in both the treatment (11%) and control groups (9%) with no significant differences between groups. In conclusion, ALE consumption resulted in a modest but favourable statistically significant difference in total cholesterol after 12 weeks. In comparison with a previous trial, it is suggested that the apparent positive health status of the study population may have contributed to the modesty of the observed response.

  16. Vitamin D₃ Supplementation in Batswana Children and Adults with HIV: A Pilot Double Blind Randomized Controlled Trial

    PubMed Central

    Steenhoff, Andrew P.; Schall, Joan I.; Samuel, Julia; Seme, Boitshepo; Marape, Marape; Ratshaa, Bakgaki; Goercke, Irene; Tolle, Michael; Nnyepi, Maria S.; Mazhani, Loeto; Zemel, Babette S.; Rutstein, Richard M.; Stallings, Virginia A.

    2015-01-01

    Objectives Since vitamin D insufficiency is common worldwide in people with HIV, we explored safety and efficacy of high dose cholecalciferol (D₃) in Botswana, and evaluated potential modifiers of serum 25 hydroxy vitamin D change (Δ25D). Design Prospective randomized double-blind 12-week pilot trial of subjects ages 5.0–50.9 years. Methods Sixty subjects randomized within five age groups to either 4000 or 7000IU per day of D₃ and evaluated for vitamin D, parathyroid hormone, HIV, safety and growth status. Efficacy was defined as serum 25 hydroxy vitamin D (25D) ≥32ng/mL, and safety as no simultaneous elevation of serum calcium and 25D. Also assessed were HIV plasma viral RNA viral load (VL), CD4%, anti-retroviral therapy (ART) regime, and height-adjusted (HAZ), weight-adjusted (WAZ) and Body Mass Index (BMIZ) Z scores. Results Subjects were 50% male, age (mean±SD) 19.5±11.8 years, CD4% 31.8±10.4, with baseline VL log₁₀ range of <1.4 to 3.8 and VL detectable (>1.4) in 22%. From baseline to 12 weeks, 25D increased from 36±9ng/ml to 56±18ng/ml (p<0.0001) and 68% and 90% had 25D ≥32ng/ml, respectively (p = 0.02). Δ25D was similar by dose. No subjects had simultaneously increased serum calcium and 25D. WAZ and BMIZ improved by 12 weeks (p<0.04). HAZ and CD4% increased and VL decreased in the 7000IU/d group (p<0.04). Younger (5–13y) and older (30–50y) subjects had greater Δ25D than those 14–29y (26±17 and 28±12 vs. 11±11ng/ml, respectively, p≤0.001). Δ25D was higher with efavirenz or nevirapine compared to protease inhibitor based treatment (22±12, 27±17, vs. 13±10, respectively, p≤0.03). Conclusions In a pilot study in Botswana, 12-week high dose D₃ supplementation was safe and improved vitamin D, growth and HIV status; age and ART regimen were significant effect modifiers. Trial Registration ClinicalTrials.gov NCT02189902 PMID:25706751

  17. Multicentre, randomised, placebo-controlled trial of extract of Japanese herbal medicine Daikenchuto to prevent bowel dysfunction after adult liver transplantation (DKB 14 Study)

    PubMed Central

    Kaido, Toshimi; Shimamura, Tsuyoshi; Sugawara, Yasuhiko; Sadamori, Hiroshi; Shirabe, Ken; Yamamoto, Michio; Uemoto, Shinji

    2015-01-01

    Introduction This multicentre randomised controlled clinical trial will aim to determine the ability of an extract (TJ-100) of Daikenchuto (traditional Japanese herbal medicine; Kampo) to prevent bowel dysfunction in at least 110 patients after liver transplantation (LT). Methods and analysis The following co-primary end points will be evaluated on postoperative day 7: total oral and enteral caloric intake, abdominal distension and abdominal pain. The secondary end points will comprise sequential changes of total oral and enteral caloric intake after LT, sequential changes in numeric rating scales for abdominal distension and pain, elapsed time to the first postoperative passage of stool, quality of life assessment using the Gastrointestinal Symptom Rating Scale score (Japanese version), postoperative liver function, liver regeneration rate, incidence of bacteraemia and bacterial strain, trough level of immunosuppressants, occurrence of acute cellular rejection, discharge or not within 2 months after LT, sequential changes of portal venous flow to the graft and ascites discharge. The two arms of the study will comprise 55 patients per arm. Ethics and dissemination The study has been conducted according to the CONSORT statement. All participants signed a written consent form, and the study has been approved by the institutional review board of each participating institute and conducted in accordance with the Declaration of Helsinki of 1996. The findings will be disseminated through scientific and professional conferences, and in peer-reviewed journals. Trial registration number The DKB 14 Study was registered in the University Hospital Medical Information Network Clinical Trial Registration (UMIN-CTR), Japan (registration number: UMIN000014326) during 2014. PMID:26419681

  18. MoodHacker Mobile Web App With Email for Adults to Self-Manage Mild-to-Moderate Depression: Randomized Controlled Trial

    PubMed Central

    Gunn, Rebecca; Russell, Jeremy K; Ary, Dennis V

    2016-01-01

    exception of safety-related follow-up calls to subjects reporting current suicidal ideation and/or severe depression symptoms. Results At 6-week follow-up, significant effects were found on depression, behavioral activation, negative thoughts, knowledge, work productivity, work absence, and workplace distress. MoodHacker yielded significant effects on depression symptoms, work productivity, work absence, and workplace distress for those who reported access to an EAP, but no significant effects on these outcome measures for those without EAP access. Participants in the treatment arm used the MoodHacker app an average of 16.0 times (SD 13.3), totaling an average of 1.3 hours (SD 1.3) of use between pretest and 6-week follow-up. Significant effects on work absence in those with EAP access persisted at 10-week follow-up. Conclusions This randomized effectiveness trial found that the MoodHacker app produced significant effects on depression symptoms (partial eta2 = .021) among employed adults at 6-week follow-up when compared to subjects with access to relevant depression Internet sites. The app had stronger effects for individuals with access to an EAP (partial eta2 = .093). For all users, the MoodHacker program also yielded greater improvement on work absence, as well as the mediating factors of behavioral activation, negative thoughts, and knowledge of depression self-care. Significant effects were maintained at 10-week follow-up for work absence. General attenuation of effects at 10-week follow-up underscores the importance of extending program contacts to maintain user engagement. This study suggests that light-touch, CBT-based mobile interventions like MoodHacker may be appropriate for implementation within EAPs and similar environments. In addition, it seems likely that supporting MoodHacker users with guidance from counselors may improve effectiveness for those who seek in-person support. Trial Registration ClinicalTrials.gov NCT02335554; https://clinicaltrials.gov/ct2

  19. Identifying effective and feasible interventions to accelerate functional recovery from hospitalization in older adults: A randomized controlled pilot trial.

    PubMed

    Deer, Rachel R; Dickinson, Jared M; Fisher, Steve R; Ju, Hyunsu; Volpi, Elena

    2016-07-01

    Hospitalization induces functional decline in older adults. Many geriatric patients fail to fully recover physical function after hospitalization, which increases the risk of frailty, disability, dependence, re-hospitalization, and mortality. There is a lack of evidence-based therapies that can be implemented following hospitalization to accelerate functional improvements. The aims of this Phase I clinical trial are to determine 1) the effect size and variability of targeted interventions in accelerating functional recovery from hospitalization and 2) the feasibility of implementing such interventions in community-dwelling older adults. Older patients (≥65years, n=100) will be recruited from a single site during hospitalization for an acute medical condition. Subjects will be randomized to one of five interventions initiated immediately upon discharge: 1. protein supplementation, 2. in-home rehabilitation plus placebo supplementation, 3. in-home rehabilitation plus protein supplementation, 4. single testosterone injection, or 5. isocaloric placebo supplementation. Testing will occur during hospitalization (baseline) and at 1 and 4weeks post-discharge. Each testing session will include measures of muscle strength, physical function/performance, body composition, and psychological function. Physical activity levels will be continuously monitored throughout study participation. Feasibility will be determined through collection of the number of eligible, contacted, and enrolled patients; intervention adherence and compliance; and reasons for declining enrollment and study withdrawal. This research will determine the feasibility of post-hospitalization strategies to improve physical function in older adults. These results will also provide a foundation for performing larger, multi-site clinical trials to improve physical function and reduce readmissions in geriatric patents.

  20. Analyzing Milestones in Smoking Cessation: Illustration in a Nicotine Patch Trial in Adult Smokers

    ERIC Educational Resources Information Center

    Shiffman, Saul; Scharf, Deborah M.; Shadel, William G.; Gwaltney, Chad J.; Dang, Qianyu; Paton, Stephanie M.; Clark, Duncan B.

    2006-01-01

    Tests of addiction treatments seldom reveal where treatment exercises its effect (i.e., promoting initial abstinence, preventing lapses, and/or impeding progression from lapse to relapse). The authors illustrate analyses distinguishing effects on these milestones in a randomized trial of high-dose nicotine patch (35 mg; n = 188) versus placebo (n…

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

    Technology Transfer Automated Retrieval System (TEKTRAN)

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

  2. Pesticide Registration Information System

    EPA Pesticide Factsheets

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

  3. Low Enrollment of Adolescents and Young Adults Onto Cancer Trials: Insights From the Community Clinical Oncology Program

    PubMed Central

    Roth, Michael E.; O’Mara, Ann M.; Seibel, Nita L.; Dickens, David S.; Langevin, Anne-Marie; Pollock, Brad H.

    2016-01-01

    Purpose: Stagnant outcomes for adolescents and young adults (AYAs; 15 to 39 years old) with cancer are partly attributed to poor enrollment onto clinical trials. The National Cancer Institute (NCI) Community Clinical Oncology Program (CCOP) was developed to improve clinical trial participation in the community setting, where AYAs are most often treated. Further, many CCOP sites had pediatric and medical oncologists with collaborative potential for AYA recruitment and care. For these reasons, we hypothesized that CCOP sites enrolled proportionately more AYAs than non-CCOP sites onto Children’s Oncology Group (COG) trials. Methods: For the 10-year period 2004 through 2013, the NCI Division of Cancer Prevention database was queried to evaluate enrollments into relevant COG studies. The proportional enrollment of AYAs at CCOP and non-CCOP sites was compared and the change in AYA enrollment patterns assessed. All sites were COG member institutions. Results: Although CCOP sites enrolled a higher proportion of patients in cancer control studies than non-CCOP sites (3.5% v 1.8%; P < .001), they enrolled a lower proportion of AYAs (24.1% v 28.2%, respectively; P < .001). Proportional AYA enrollment at CCOP sites decreased during the intervals 2004 through 2008 and 2009 through 2013 (26.7% v 21.7%; P < .001). Conclusion: Despite oncology practice settings that might be expected to achieve otherwise, CCOP sites did not enroll a larger proportion of AYAs in clinical trials than traditional COG institutions. Our findings suggest that the CCOP (now the NCI Community Oncology Research Program) can be leveraged for developing targeted interventions for overcoming AYA enrollment barriers. PMID:27026648

  4. 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

  5. Comparison of Two Theory-Based, Fully Automated Telephone Interventions Designed to Maintain Dietary Change in Healthy Adults: Study Protocol of a Three-Arm Randomized Controlled Trial

    PubMed Central

    Quintiliani, Lisa M; Turner-McGrievy, Gabrielle M; Migneault, Jeffrey P; Heeren, Timothy; Friedman, Robert H

    2014-01-01

    Background Health behavior change interventions have focused on obtaining short-term intervention effects; few studies have evaluated mid-term and long-term outcomes, and even fewer have evaluated interventions that are designed to maintain and enhance initial intervention effects. Moreover, behavior theory has not been developed for maintenance or applied to maintenance intervention design to the degree that it has for behavior change initiation. Objective The objective of this paper is to describe a study that compared two theory-based interventions (social cognitive theory [SCT] vs goal systems theory [GST]) designed to maintain previously achieved improvements in fruit and vegetable (F&V) consumption. Methods The interventions used tailored, interactive conversations delivered by a fully automated telephony system (Telephone-Linked Care [TLC]) over a 6-month period. TLC maintenance intervention based on SCT used a skills-based approach to build self-efficacy. It assessed confidence in and barriers to eating F&V, provided feedback on how to overcome barriers, plan ahead, and set goals. The TLC maintenance intervention based on GST used a cognitive-based approach. Conversations trained participants in goal management to help them integrate their newly acquired dietary behavior into their hierarchical system of goals. Content included goal facilitation, conflict, shielding, and redundancy, and reflection on personal goals and priorities. To evaluate and compare the two approaches, a sample of adults whose F&V consumption was below public health goal levels were recruited from a large urban area to participate in a fully automated telephony intervention (TLC-EAT) for 3-6 months. Participants who increase their daily intake of F&V by ≥1 serving/day will be eligible for the three-arm randomized controlled trial. A sample of 405 participants will be randomized to one of three arms: (1) an assessment-only control, (2) TLC-SCT, and (3) TLC-GST. The maintenance

  6. ‘TXT2BFiT’ a mobile phone-based healthy lifestyle program for preventing unhealthy weight gain in young adults: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Despite international efforts to arrest increasing rates of overweight and obesity, many population strategies have neglected young adults as a target group. Young adults are at high risk for unhealthy weight gain which tends to persist throughout adulthood with associated chronic disease health risks. Methods/design TXT2BFiT is a nine month two-arm parallel-group randomized controlled trial aimed at improving weight management and weight-related dietary and physical activity behaviors among young adults. Participants are recruited via general practice (primary medical care) clinics in Sydney, New South Wales, Australia. All participants receive a mailed resource outlining national physical activity and dietary guidelines and access to the study website. Additional resources accessible to the intervention arm via the study website include Smartphone mobile applications, printable handouts, an interactive healthy weight tracker chart, and a community blog. The study consists of two phases: (1) Intensive phase (weeks 1 to 12): the control arm receives four short message service (SMS) text messages; the intervention arm receives eight SMS messages/week tailored to their baseline stage-of-change, one Email/week, and personalized coaching calls during weeks 0, 2, 5, 8, and 11; and (2) Maintenance phase (weeks 14 to 36): the intervention arm receives one SMS message/month, one Email/month and booster coaching calls during months 5 and 8. A sample of N = 354 (177 per arm) is required to detect differences in primary outcomes: body weight (kg) and body mass index (kg/m2), and secondary outcomes: physical activity, sitting time, intake of specific foods, beverages and nutrients, stage-of-change, self-efficacy and participant well-being, at three and nine months. Program reach, costs, implementation and participant engagement will also be assessed. Discussion This mobile phone based program addresses an important gap in obesity prevention efforts to date. The

  7. Effects of Combined Calcium and Vitamin D Supplementation on Insulin Secretion, Insulin Sensitivity and β-Cell Function in Multi-Ethnic Vitamin D-Deficient Adults at Risk for Type 2 Diabetes: A Pilot Randomized, Placebo-Controlled Trial

    PubMed Central

    Gagnon, Claudia; Daly, Robin M.; Carpentier, André; Lu, Zhong X.; Shore-Lorenti, Catherine; Sikaris, Ken; Jean, Sonia; Ebeling, Peter R.

    2014-01-01

    -cell function in multi-ethnic adults with low vitamin D status at risk of type 2 diabetes. However, in participants with prediabetes, supplementation with vitamin D and calcium may improve insulin sensitivity. Trial Registration Australian New Zealand Clinical Trials Registry ACTRN12609000043235 PMID:25299668

  8. 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.

  9. 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

  10. Protocol for a double-blind randomised controlled trial of low dose intradermal grass pollen immunotherapy versus a histamine control on symptoms and medication use in adults with seasonal allergic rhinitis (PollenLITE)

    PubMed Central

    2013-01-01

    Background Subcutaneous immunotherapy with high dose grass pollen (typically microgram quantities) was first described over 100 years ago. This treatment suppresses allergen-induced cutaneous late responses, with lesser effects on early responses. We previously reported that repeated 2-weekly intradermal injections of grass pollen - containing approximately 7 ng of major allergen Phl p 5 – led to a progressive suppression of the allergen-induced cutaneous response, and that by the sixth injection, this was inhibited by over 90%. The purpose of this trial is to investigate the clinical efficacy of intradermal desensitisation with low doses (i.e. nanogram quantities) of grass pollen allergen for seasonal allergic rhinitis. Methods/design The Pollen Low dose Intradermal therapy Evaluation (PollenLITE) is a single centre double-blind randomised parallel group controlled trial of the efficacy and safety of intradermal grass pollen injections plus standard treatment, versus histamine injections plus standard treatment, in adults with moderate-severe grass pollen-induced allergic rhinitis (‘summer hay fever’). A minimum of ninety adults with a history of moderate-severe persistent allergic rhinitis during the UK grass pollen season will be randomised into two equal groups to receive 7 or 8 intradermal injections of grass pollen extract (containing approximately 7 ng of major allergen Phl p 5) or histamine, before the grass pollen season. In the summer, participants will score their symptoms, medication requirements, visual analogue scores, and complete EuroQOL (EQ-5D-5 L) and mini Rhinoconjunctivitis Quality of Life Questionnaires. Global assessments will also be recorded at the end of the pollen season. Blood samples will be collected from all participants for mechanistic immune assays. Skin punch biopsies will also be collected in 40 participants selected at random from intradermal injection sites after the grass pollen season for mechanistic assays. Finally

  11. Interview skills for adults with autism spectrum disorder: a pilot randomized controlled trial.

    PubMed

    Morgan, Lindee; Leatzow, Allison; Clark, Sarah; Siller, Michael

    2014-09-01

    The purpose of this pilot study was to evaluate the efficacy of the interview skills curriculum (ISC), a manualized 12-week group-delivered intervention for young adults with autism spectrum disorder (ASD). This intervention aims to increase social-pragmatic skills essential to a successful job interview. Twenty-eight adults (18-36 years) were randomly assigned to one of two groups: ISC or waitlist control. Results revealed that the experimental group showed larger gains in social-pragmatic skills observed during a mock job interview than the control group. Treatment effects on distal outcomes, including social adaptive behaviors and depressive symptoms were not significant, although the respective effect sizes were medium/large. Results indicate that a brief, low-intensity treatment can improve the job-interview performance of young adults with ASD.

  12. Clove oil as an anaesthetic for adult sockeye salmon: Field trials

    USGS Publications Warehouse

    Woody, C.A.; Nelson, Jack L.; Ramstad, K.

    2002-01-01

    Wild migrating sockeye salmon Oncorhynchus nerka exposed to 20, 50 and 80 mg 1-1 of clove oil could be handled within 3 min, recovered within 10 min, and survived 15 min exposure trials. Fish tested at 110 mg 1-1 did not recover from 15 min exposure trials. Response curves developed for induction and recovery time considered the following predictors: clove oil concentration, sex, fish length and depth. A significant positive dependence was observed between induction time and fish length for 20, 50 and 80 mg 1-1 test concentrations; no dependence was observed between induction time and length at 110 and 140 mg 1-1. Recovery time differed as a function of clove oil concentration, but not fish size. A concentration of 50 mg 1-1 is recommended for anaesthetizing sockeye salmon ranging in length from 400 to 550 mm at water temperatures averaging 9-10??C.

  13. 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…

  14. Effects of Weight Loss on Foot Structure and Function in Obese Adults: A Pilot Randomized Controlled Trial

    PubMed Central

    Song, Jinsup; Kane, Reagan; Tango, Dana N.; Vander Veur, Stephanie S.; Furmato, James; Komaroff, Eugene; Foster, Gary D.

    2015-01-01

    Objective To investigate the effects of weight reduction on foot structure, gait, and dynamic plantar loading in obese adults. Design In a 3-month randomized-controlled trial, participants were randomized to receive either a weight loss intervention based on portion-controlled meals or a delayed-treatment control. Participants 41 adults (32 F, 9 M) with a mean + SD age of 56.2 + 4.7 years and a BMI of 35.9 + 4.2 kg/m2. Measurements Arch Height Index (AHI), Malleolar Valgus Index (MVI), spatial and temporal gait parameters, plantar peak pressure (PP) and weight were measured at baseline, 3, and 6 months. Results The intervention group experienced significantly greater weight loss than did the control group (5.9 ± 4.0 kg versus 1.9 ± 3.2 kg, p = 0.001) after 3 months. There were no differences between the groups in anatomical foot structure or gait. However, the treatment group showed a significantly reduced PP than the control group beneath the lateral arch and the metatarsals 4 (all P values < .05) at 3 months. The change in PP correlated significantly with the change in weight at the metatarsal 2 (r=0.57, p=0.0219), metatarsal 3 (r=0.56, p=0.0064) and the medial arch (r=0.26, p<0.0001) at 6 months. Conclusion This was the first RCT designed to assess the effects of weight loss on foot structure, gait, and plantar loading in obese adults. Even a modest weight loss significantly reduced the dynamic plantar loading in obese adults. However, weight loss appeared to have no effects on foot structure and gait. PMID:25245307

  15. Effects of 12-week proprioception training program on postural stability, gait, and balance in older adults: a controlled clinical trial.

    PubMed

    Martínez-Amat, Antonio; Hita-Contreras, Fidel; Lomas-Vega, Rafael; Caballero-Martínez, Isabel; Alvarez, Pablo J; Martínez-López, Emilio

    2013-08-01

    The purpose of this study was to evaluate the effect of a 12-week-specific proprioceptive training program on postural stability, gait, balance, and fall prevention in adults older than 65 years. The present study was a controlled clinical trial. Forty-four community dwelling elderly subjects (61-90 years; mean age, 78.07 ± 5.7 years) divided into experimental (n = 20) and control (n = 24) groups. The participants performed the Berg balance test before and after the training program, and we assessed participants' gait, balance, and the risk of falling, using the Tinetti scale. Medial-lateral plane and anterior-posterior plane displacements of the center of pressure, Sway area, length and speed, and the Romberg quotient about surface, speed, and distance were calculated in static posturography analysis (EPS pressure platform) under 2 conditions: eyes open and eyes closed. After a first clinical evaluation, patients were submitted to 12 weeks proprioception training program, 2 sessions of 50 minutes every week. This program includes 6 exercises with the BOSU and Swiss ball as unstable training tools that were designed to program proprioceptive training. The training program improved postural balance of older adults in mediolateral plane with eyes open (p < 0.05) and anterior-posterior plane with eyes closed (p < 0.01). Significant improvements were observed in Romberg quotient about surface (p < 0.05) and speed (p < 0.01) but not about distance (p > 0.05). After proprioception training, gait (Tinetti), and balance (Berg) test scores improved 14.66% and 11.47% respectively. These results show that 12 weeks proprioception training program in older adults is effective in postural stability, static, and dynamic balance and could lead to an improvement in gait and balance capacity, and to a decrease in the risk of falling in adults aged 65 years and older.

  16. UK Fixation of Distal Tibia Fractures (UK FixDT): protocol for a randomised controlled trial of ‘locking’ plate fixation versus intramedullary nail fixation in the treatment of adult patients with a displaced fracture of the distal tibia

    PubMed Central

    Achten, Juul; Parsons, Nicholas R; McGuinness, Katie R; Petrou, Stavros; Lamb, Sarah E; Costa, Matthew L

    2015-01-01

    Introduction The treatment of displaced, extra-articular fractures of the distal tibia remains controversial. These injuries are difficult to manage due to limited soft tissue cover, poor vascularity of the area and proximity to the ankle joint. Surgical treatment options are expanding and include locked intramedullary nails, plate and screw fixation and external fixator systems. The nail and plate options are most commonly used in the UK, but controversy exists over which treatment is most clinically and cost-effective. In this multicentre randomised controlled trial we aim to assess ratings of disability 6 months postinjury in patients who have sustained a distal tibia fracture treated with either an intramedullary nail or plate and locking screw fixation. Methods and analysis Adult patients presenting at trial centres with an acute fracture of the distal tibia will be considered for inclusion. A total of 320 patients will provide 90% power to detect a difference of 8 points in Disability Rating Index (DRI) score at 6 months at the 5% level. The randomisation sequence is stratified by trial centre and age, and administered via web-based service with 1:1 treatment allocation. Baseline demographic and pre-injury functional data and radiographs will be collected using the DRI, Olerud and Molander, and EuroQol EQ-5D questionnaire. Clinical assessment, early complications and radiographs will be recorded at 6–8 weeks. Functional outcome, health-related quality of life and resource use will be collected at 3, 6 and 12 months postoperatively. The main analysis will investigate differences in DRI 6 months postsurgery, between the two treatment groups, on an intention-to-treat basis. Tests will be two-sided and considered to provide evidence for a significant difference if p values are <0.05. Ethics and dissemination NRES Committee West-Midlands, 6/11/2012 (ref:12/WM/0340). The results of the trial will be disseminated via peer-reviewed publications and

  17. Effects of a very high saturated fat diet on LDL particles in adults with atherogenic dyslipidemia: A randomized controlled trial

    PubMed Central

    Chiu, Sally; Williams, Paul T.

    2017-01-01

    that very high saturated fat intake may increase cardiovascular disease risk in phenotype B individuals. This trial was registered at clinicaltrials.gov (NCT00895141). Trial registration Clinicaltrials.gov NCT00895141. PMID:28166253

  18. Effectiveness of a Group Support Lifestyle Modification (GSLiM) Programme among Obese Adults in Workplace: A Randomised Controlled Trial

    PubMed Central

    Azmi Mohamed, Mohd Nahar; Mukhtar, Firdaus

    2016-01-01

    targeted weight loss, improving weight self-efficacy, friend social support, and quality of life compared to dietary counseling. Trial Registration Iranian Registry of Clinical Trials IRCT201104056127N1 PMID:27537687

  19. The Effect of Azithromycin in Adults with Stable Neutrophilic COPD: A Double Blind Randomised, Placebo Controlled Trial

    PubMed Central

    Simpson, Jodie L.; Powell, Heather; Baines, Katherine J.; Milne, David; Coxson, Harvey O.; Hansbro, Philip M.; Gibson, Peter G.

    2014-01-01

    scans, no alterations were observed. Conclusions In stable COPD with neutrophilic bronchitis, add-on azithromycin therapy showed a trend to reduced severe exacerbations sputum neutrophils, CXCL8 levels and bacterial load. Future studies with a larger sample size are warranted. Trial Registration Australian New Zealand Clinical Trials Registry ACTRN12609000259246 PMID:25148049

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

    PubMed Central

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

    2012-01-01

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

  1. Behavioural weight management programmes for adults assessed by trials conducted in everyday contexts: systematic review and meta-analysis.

    PubMed

    Hartmann-Boyce, J; Johns, D J; Jebb, S A; Summerbell, C; Aveyard, P

    2014-11-01

    This systematic review and meta-analysis of effectiveness trials comparing multicomponent behavioural weight management programmes with controls in overweight and obese adults set out to determine the effectiveness of these interventions implemented in routine practice. To be included, interventions must have been multicomponent, delivered by the therapists who would deliver the intervention in routine practice and in that same context, and must be widely available or feasible to implement with little additional infrastructure or staffing. Searches of electronic databases were conducted, and augmented by screening reference lists and contacting experts (November 2012). Data were extracted by two reviewers, with mean difference between intervention and control for 12-month change in weight, blood pressure, lipids and glucose calculated using baseline observation carried forward. Data were also extracted on adverse events, quality of life and mood measures. Although there were many published efficacy trials, only eight effectiveness trials met the inclusion criteria. Pooled results from five study arms providing access to commercial weight management programmes detected significant weight loss at 12 months (mean difference -2.22 kg, 95% confidence interval [CI] -2.90 to -1.54). Results from two arms of a study testing a commercial programme providing meal replacements also detected significant weight loss (mean difference -6.83 kg, 95% CI -8.39 to -5.26). In contrast, pooled results from five interventions delivered by primary care teams showed no evidence of an effect on weight (mean difference -0.45 kg, 95% CI -1.34 to 0.43). One study testing an interactive web-based intervention detected a significant effect in favour of the intervention at 12 months, but the study was judged to be at high risk of bias and the effect did not persist at 18 months. Few studies reported other outcomes, limiting comparisons between interventions. Few trials have examined the

  2. Design and Implementation of a Randomized Controlled Social and Mobile Weight Loss Trial for Young Adults (project SMART)

    PubMed Central

    Patrick, K; Marshall, SJ; Davila, EP; Kolodziejczyk, JK; Fowler, J; Calfas, KJ; Huang, J; Rock, CL; Griswold, W; Gupta, A; Merchant, G; Norman, GJ; Raab, F; Donohue, M; Fogg, BJ; Robinson, TN

    2014-01-01

    Purpose To describe the theoretical rationale, intervention design, and clinical trial of a two-year weight control intervention for young adults deployed via social and mobile media. Methods A total of 404 overweight or obese college students from three Southern California universities (Mage = 22(±4) years; MBMI=29(±2.8); 70% female) were randomized to participate in the intervention or to receive an informational web-based weight loss program. The intervention is based on behavioral theory and integrates intervention elements across multiple touch points, including Facebook, SMS, smartphone applications, blogs, and e-mail. Participants are encouraged to seek social support among their friends, self-monitor their weight weekly, post their health behaviors on Facebook, and e-mail their weight loss questions/concerns to a health coach. The intervention is adaptive because new theory-driven and iteratively tailored intervention elements are developed and released over the course of the two-year intervention in response to patterns of use and user feedback. Measures of body mass index, waist circumference, physical activity (PA), sedentary behavior (SED), diet, weight management practices, smoking, alcohol, sleep, body image, self-esteem, and depression occur at 6, 12, 18, and 24 months. Currently, all participants have been recruited, and all are in the final year of the trial. Conclusion Theory-driven, evidence-based strategies for PA, SED, and dietary intake can be embedded in an intervention using social and mobile technologies to promote healthy weight-related behaviors in young adults. PMID:24215774

  3. Motor Learning Versus StandardWalking Exercise in Older Adults with Subclinical Gait Dysfunction: A Randomized Clinical Trial

    PubMed Central

    Brach, Jennifer S.; Van Swearingen, Jessie M.; Perera, Subashan; Wert, David M.; Studenski, Stephanie

    2013-01-01

    Background Current exercise recommendationsfocus on endurance and strength, but rarely incorporate principles of motor learning. Motor learning exerciseis designed to address neurological aspects of movement. Motor learning exercise has not been evaluated in older adults with subclinical gait dysfunction. Objectives Tocompare motor learning versus standard exercise on measures of mobility and perceived function and disability. Design Single-blind randomized trial. Setting University research center. Participants Olderadults (n=40), mean age 77.1±6.0 years), who had normal walking speed (≥1.0 m/s) and impaired motor skill (Figure of 8 walk time > 8 s). Interventions The motor learning program (ML) incorporated goal-oriented stepping and walking to promote timing and coordination within the phases of the gait cycle. The standard program (S) employed endurance training by treadmill walking.Both included strength training and were offered twice weekly for one hour for 12 weeks. Measurements Primary outcomes included mobility performance (gait efficiency, motor skill in walking, gait speed, and walking endurance)and secondary outcomes included perceived function and disability (Late Life Function and Disability Instrument). Results 38 of 40 participants completed the trial (ML, n=18; S, n=20). ML improved more than Sin gait speed (0.13 vs. 0.05 m/s, p=0.008) and motor skill (−2.2 vs. −0.89 s, p<0.0001). Both groups improved in walking endurance (28.3 and 22.9m, but did not differ significantly p=0.14). Changes in gait efficiency and perceived function and disability were not different between the groups (p>0.10). Conclusion In older adults with subclinical gait dysfunction, motor learning exercise improved some parameters of mobility performance more than standard exercise. PMID:24219189

  4. Clinical trials with the new antitussive levodropropizine in adult bronchitic patients.

    PubMed

    Allegra, L; Bossi, R

    1988-08-01

    The results of 6 clinical trials involving a total of 174 patients are reported. Levodropropizine (S(-)-3-(4-phenyl-piperazin-1-yl)-propane-1,2-diol, DF 526) was compared in double-blind manner with placebo, morclofone and cloperastine. The antitussive activity and therapeutic efficacy of the drug were shown to be greater than those of placebo and morclofone and similar to those of cloperastine. Levodropropizine was effective in about 80% of patients; in responders, cough frequency was reduced by an average of 33-51%. Levodropropizine was generally well tolerated and mild side-effects were reported for only 3% of patients.

  5. An efficacy trial of ‘Steps to Your Health’, a health promotion programme for adults with intellectual disability

    PubMed Central

    McDermott, Suzanne; Whitner, Wendy; Thomas-Koger, Marlo; Mann, Joshua R; Clarkson, John; Barnes, Timothy L; Bao, Haikun; Meriwether, Rebecca A

    2015-01-01

    Objective Although there are evaluation and effectiveness studies of health promotion interventions for adults with intellectual disabilities (ID), randomized efficacy trials of such interventions are lacking. Design A randomized active control intervention trial. Setting The participants attended the health promotion classes in local disability agency service facilities. Method: We enrolled 443 individuals and randomly assigned them to one of two eight-week participatory classes. The ‘Steps to Your Health’ (STYH) classes emphasized moderate to vigorous physical activity (MVPA), healthy eating and body mass index (BMI) reduction. The control intervention focused on hygiene and safety. Results We did not find a statistically significant difference in mean MVPA or BMI change between completers of the STYH group compared to the control group one year after the intervention was completed. We did find that participation in STYH classes had a non-significant association with odds of reduction in BMI (odds ratio [OR] 2.87, 95% confidence interval [CI] 0.91–9.11) and completers who lived in group homes were more likely than their counterparts who lived with families or in apartments to decrease their BMI (OR 4.61; 95% CI 1.14–18.64). Conclusions This trial did not demonstrate a significant effect of STYH participation on change in mean minutes of MVPA or mean BMI 12 months after classes ended, although there was a non-significant association with odds of reduction of BMI (p = 0.07). This study has implications for design of intervention studies in people with intellectual disability (ID). PMID:26633904

  6. Efficacy Outcome Measures for Procedural Sedation Clinical Trials in Adults: An ACTTION Systematic Review.

    PubMed

    Williams, Mark R; McKeown, Andrew; Dexter, Franklin; Miner, James R; Sessler, Daniel I; Vargo, John; Turk, Dennis C; Dworkin, Robert H

    2016-01-01

    Successful procedural sedation represents a spectrum of patient- and clinician-related goals. The absence of a gold-standard measure of the efficacy of procedural sedation has led to a variety of outcomes being used in clinical trials, with the consequent lack of consistency among measures, making comparisons among trials and meta-analyses challenging. We evaluated which existing measures have undergone psychometric analysis in a procedural sedation setting and whether the validity of any of these measures support their use across the range of procedures for which sedation is indicated. Numerous measures were found to have been used in clinical research on procedural sedation across a wide range of procedures. However, reliability and validity have been evaluated for only a limited number of sedation scales, observer-rated pain/discomfort scales, and satisfaction measures in only a few categories of procedures. Typically, studies only examined 1 or 2 aspects of scale validity. The results are likely unique to the specific clinical settings they were tested in. Certain scales, for example, those requiring motor stimulation, are unsuitable to evaluate sedation for procedures where movement is prohibited (e.g., magnetic resonance imaging scans). Further work is required to evaluate existing measures for procedures for which they were not developed. Depending on the outcomes of these efforts, it might ultimately be necessary to consider measures of sedation efficacy to be procedure specific.

  7. A Commentary on the Michigan Sex Offender Registration Article

    ERIC Educational Resources Information Center

    Rasmussen, Lucinda A.

    2010-01-01

    This paper presents the author's comments on the Michigan sex offender registration article "Family Experiences of Young Adult Sex Offender Registration" (Comartin, Kernsmith, & Miles, 2010). The article is an important piece of research that addresses a much neglected and almost invisible population in the annals of research: the…

  8. Supportive-expressive and coping group teletherapies for HIV-infected older adults: a randomized clinical trial.

    PubMed

    Heckman, Timothy G; Heckman, Bernadette D; Anderson, Timothy; Lovejoy, Travis I; Mohr, David; Sutton, Mark; Bianco, Joseph A; Gau, Jen-Tzer

    2013-11-01

    This clinical trial tested whether telephone-administered supportive-expressive group therapy or coping effectiveness training reduce depressive symptoms in HIV-infected older adults. Participants from 24 states (N = 361) completed the Geriatric Depression Scale at pre-intervention, post-intervention, and 4- and 8-month follow-up and were randomized to one of three study arms: (1) 12 weekly sessions of telephone-administered, supportive-expressive group therapy (tele-SEGT; n = 122); (2) 12 weekly sessions of telephone-administered, coping effectiveness training (tele-CET; n = 118); or (3) a standard of care (SOC) control group (n = 121). Tele-SEGT participants reported fewer depressive symptoms than SOC controls at post-intervention (MSEGT = 11.9, MSOC = 14.3) and 4- (MSEGT = 12.5, MSOC = 14.4) and 8-month follow-up (MSEGT = 12.7, MSOC = 14.5) and fewer depressive symptoms than tele-CET participants at post-intervention (MSEGT = 12.4, MCET = 13.6) and 8-month follow-up (MSEGT = 12.7, MCET = 14.1). Tele-CET participants reported no statistically significant differences from SOC controls in GDS values at any assessment period. Tele-SEGT constitutes an efficacious treatment to reduce depressive symptoms in HIV-infected older adults.

  9. Methylphenidate significantly improves driving performance of adults with attention-deficit hyperactivity disorder: a randomized crossover trial.

    PubMed

    Verster, Joris C; Bekker, Evelijne M; de Roos, Marlise; Minova, Anita; Eijken, Erik J E; Kooij, J J Sandra; Buitelaar, Jan K; Kenemans, J Leon; Verbaten, Marinus N; Olivier, Berend; Volkerts, Edmund R

    2008-05-01

    Although patients with attention-deficit hyperactivity disorder (ADHD) have reported improved driving performance on methylphenidate, limited evidence exists to support an effect of treatment on driving performance and some regions prohibit driving on methylphenidate. A randomized, crossover trial examining the effects of methylphenidate versus placebo on highway driving in 18 adults with ADHD was carried out. After three days of no treatment, patients received either their usual methylphenidate dose (mean: 14.7 mg; range: 10-30 mg) or placebo and then the opposite treatment after a six to seven days washout period. Patients performed a 100 km driving test during normal traffic, 1.5 h after treatment administration. Standard deviation of lateral position (SDLP), the weaving of the car, was the primary outcome measure. Secondary outcome measurements included the standard deviation of speed and patient reports of driving performance. Driving performance was significantly better in the methylphenidate than in the placebo condition, as reflected by the SDLP difference (2.3 cm, 95% CI = 0.8-3.8, P = 0.004). Variation in speed was similar on treatment and on placebo (-0.05 km/h, 95% CI = -0.4 to 0.2, P = 0.70). Among adults with ADHD, with a history of a positive clinical response to methylphenidate, methylphenidate significantly improves driving performance.

  10. Community-Based Accompaniment with Supervised Antiretrovirals for HIV-Positive Adults in Peru: A Cluster-Randomized Trial.

    PubMed

    McLaughlin, Megan M; Franke, Molly F; Muñoz, Maribel; Nelson, Adrianne K; Saldaña, Olga; Cruz, Janeth Santa; Wong, Milagros; Zhang, Zibiao; Lecca, Leonid; Ticona, Eduardo; Arevalo, Jorge; Sanchez, Eduardo; Sebastián, Jose Luis; Shin, Sonya

    2017-01-10

    We conducted a cluster-randomized trial to estimate effects of directly observed combination antiretroviral therapy (DOT-cART) on retention with viral suppression among HIV-positive adults in Peru. We randomly allocated facilities to receive the 12-month intervention plus the standard of care, including adherence support provided through accompaniment. In the intervention arm, health workers supervised doses, twice daily, and accompanied patients to appointments. Among 356 patients, intention-to-treat analyses showed no statistically significant benefit of DOT, relative to no-DOT, at 12 or 24 months (adjusted probability of primary outcome: 0.81 vs. 0.73 and 0.76 vs. 0.68, respectively). A statistically significant benefit of DOT was found in per-protocol and as-treated analyses at 12 months (0.83 for DOT vs. 0.73 for no DOT, p value: 0.02 per-protocol, 0.01 as-treated), but not 24 months. Rates of retention with viral suppression were high in both arms. Among adults receiving robust adherence support, the added effect of time-limited DOT, if any, is small-to-moderate.

  11. Physical Exercise with Multicomponent Cognitive Intervention for Older Adults with Alzheimer's Disease: A 6-Month Randomized Controlled Trial

    PubMed Central

    Kim, Min-Ji; Han, Chang-Wan; Min, Kyoung-Youn; Cho, Chae-Yoon; Lee, Chae-Won; Ogawa, Yoshiko; Mori, Etsuro; Kohzuki, Masahiro

    2016-01-01

    Aims This study aimed to investigate the effect of 6-month physical exercise with a multicomponent cognitive program (MCP) on the cognitive function of older adults with moderate to severe Alzheimer's disease (AD). Methods We included 33 participants with AD in a 6-month randomized controlled trial. The intervention group participated in physical exercise and received a MCP. The control group received only the MCP. Before and after the intervention, cognitive outcomes were assessed using the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog), Mini-Mental State Examination, and the Clock Drawing Test. Physical performance was evaluated by exercise time, the number of pedal rotation, total load, grip strength, and the Berg Balance Scale (BBS). Results In all cognitive measures, there were no significant improvements between the two groups after 6 months in the baseline value-adjusted primary analysis. However, the ADAS-cog score was significantly lower between the two groups in secondary analysis adjusted for baseline value, age, sex, and education years. All physical outcomes were significantly higher in the intervention group except for total load compared with baseline measurements. Conclusion This study indicates that it is possible to improve cognitive function in older adults with moderate to severe AD through 6-month physical exercise with a multicomponent cognitive intervention. PMID:27403134

  12. A trial of d-cycloserine to treat the social deficit in older adolescents and young adults with autism spectrum disorders.

    PubMed

    Urbano, Maria; Okwara, Leonore; Manser, Paul; Hartmann, Kathrin; Deutsch, Stephen I

    2015-01-01

    Autism spectrum disorders are difficult for older adolescents and young adults as impaired social communication affects the transition to adult life. d-Cycloserine, a partial glycine agonist at the N-methyl-d-aspartic acid receptor, was tested in a double-blind randomized trial in 20 older adolescents and young adults with autism spectrum disorders using two dosing strategies (50 mg daily versus 50 mg weekly) for 8 weeks with a 2-week follow-up after discontinuation. d-Cycloserine caused statistically and clinically significant improvement with no differentiation between dosing strategies on the Social Responsiveness Scale and the Aberrant Behavior Checklist before and after d-cycloserine administration.

  13. Adaptation of a previously validated vaccination report card for use in adult vaccine clinical trials to align with the 2007 FDA Toxicity Grading Scale Guidance.

    PubMed

    Norquist, Josephine M; Khawaja, Shazia S; Kurian, Cizely; Mast, T Christopher; Liaw, Kai-Li; Robertson, Michael N; Evans, Barbara; Gutsch, David; Saddier, Patricia

    2012-09-01

    The Adult/Adolescent Vaccination Report Card (VRC) was developed and validated by Merck in 1998 for use in vaccine clinical trials to collect information from trial subjects on complaints for both local and systemic events after vaccination. This short report describes the revision to the original validated VRC in order to align with the guidelines outlined in the 2007 FDA Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Since the VRC elicits trial subjects' self-reports of any adverse experiences (AE) occurring post vaccination, it was important that subsequent modifications of the VRC retained the original user-friendly characteristics while gathering the appropriate information to align with the FDA Guidance. A convenience sample of 15 participants (71% females, 87% white and mean (SD) age 45 (13) years was recruited to obtain feedback in order to revise the Adult/Adolescent VRC. Based on the feedback received, the following were slightly revised: ruler for the measurements of local systemic reactions, severity ratings, and general instructions. The revised VRC is currently being used in Merck vaccine clinical trials.

  14. 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

  15. Overcoming Clinical Inertia: A Randomized Clinical Trial of a Telehealth Remote Monitoring Intervention Using Paired Glucose Testing in Adults With Type 2 Diabetes

    PubMed Central

    Blozis, Shelley A; Young, Heather M; Nesbitt, Thomas S; Quinn, Charlene C

    2015-01-01

    Background Type 2 diabetes mellitus is a worldwide challenge. Practice guidelines promote structured self-monitoring of blood glucose (SMBG) for informing health care providers about glycemic control and providing patient feedback to increase knowledge, self-efficacy, and behavior change. Paired glucose testing—pairs of glucose results obtained before and after a meal or physical activity—is a method of structured SMBG. However, frequent access to glucose data to interpret values and recommend actions is challenging. A complete feedback loop—data collection and interpretation combined with feedback to modify treatment—has been associated with improved outcomes, yet there remains limited integration of SMBG feedback in diabetes management. Incorporating telehealth remote monitoring and asynchronous electronic health record (EHR) feedback from certified diabetes educators (CDEs)—specialists in glucose pattern management—employ the complete feedback loop to improve outcomes. Objective The purpose of this study was to evaluate a telehealth remote monitoring intervention using paired glucose testing and asynchronous data analysis in adults with type 2 diabetes. The primary aim was change in glycated hemoglobin (A1c)—a measure of overall glucose management—between groups after 6 months. The secondary aims were change in self-reported Summary of Diabetes Self-Care Activities (SDSCA), Diabetes Empowerment Scale, and Diabetes Knowledge Test. Methods A 2-group randomized clinical trial was conducted comparing usual care to telehealth remote monitoring with paired glucose testing and asynchronous virtual visits. Participants were aged 30-70 years, not using insulin with A1c levels between 7.5% and 10.9% (58-96 mmol/mol). The telehealth remote monitoring tablet computer transmitted glucose data and facilitated a complete feedback loop to educate participants, analyze actionable glucose data, and provide feedback. Data from paired glucose testing were analyzed

  16. An Innovative Multiphased Strategy to Recruit Underserved Adults into a Randomized Trial of a Community-Based Diabetes Risk Reduction Program

    ERIC Educational Resources Information Center

    Santoyo-Olsson, Jasmine; Cabrera, Julissa; Freyre, Rachel; Grossman, Melanie; Alvarez, Natalie; Mathur, Deepika; Guerrero, Maria; Delgadillo, Adriana T.; Kanaya, Alka M.; Stewart, Anita L.

    2011-01-01

    Purpose: To conduct and evaluate a two-phased community-based approach to recruit lower socioeconomic status, minority, or Spanish-speaking adults at risk of developing diabetes to a randomized trial of a lifestyle intervention program delivered by a public health department. Design: Within geographic areas comprising our target population, 4…

  17. Comparison of Computer Based Instruction to Behavior Skills Training for Teaching Staff Implementation of Discrete-Trial Instruction with an Adult with Autism

    ERIC Educational Resources Information Center

    Nosik, Melissa R.; Williams, W. Larry; Garrido, Natalia; Lee, Sarah

    2013-01-01

    In the current study, behavior skills training (BST) is compared to a computer based training package for teaching discrete trial instruction to staff, teaching an adult with autism. The computer based training package consisted of instructions, video modeling and feedback. BST consisted of instructions, modeling, rehearsal and feedback. Following…

  18. The Efficacy of Internet-Based Mindfulness Training and Cognitive-Behavioral Training With Telephone Support in the Enhancement of Mental Health Among College Students and Young Working Adults: Randomized Controlled Trial

    PubMed Central

    Chio, Floria HN; Chan, Amy TY; Lui, Wacy WS; Wu, Ellery KY

    2017-01-01

    Background College students and working adults are particularly vulnerable to stress and other mental health problems, and mental health promotion and prevention are needed to promote their mental health. In recent decades, mindfulness-based training has demonstrated to be efficacious in treating physical and psychological conditions. Objective The aim of our study was to examine the efficacy of an Internet-based mindfulness training program (iMIND) in comparison with the well-established Internet-based cognitive-behavioral training program (iCBT) in promoting mental health among college students and young working adults. Methods This study was a 2-arm, unblinded, randomized controlled trial comparing iMIND with iCBT. Participants were recruited online and offline via mass emails, advertisements in newspapers and magazines, announcement and leaflets in primary care clinics, and social networking sites. Eligible participants were randomized into either the iMIND (n=604) or the iCBT (n=651) condition. Participants received 8 Web-based sessions with information and exercises related to mindfulness or cognitive-behavioral principles. Telephone or email support was provided by trained first tier supporters who were supervised by the study’s research team. Primary outcomes included mental and physical health-related measures, which were self-assessed online at preprogram, postprogram, and 3-month follow-up. Results Among the 1255 study participants, 213 and 127 completed the post- and 3-month follow-up assessment, respectively. Missing data were treated using restricted maximum likelihood estimation. Both iMIND (n=604) and iCBT (n=651) were efficacious in improving mental health, psychological distress, life satisfaction, sleep disturbance, and energy level. Conclusions Both Internet-based mental health programs showed potential in improving the mental health from pre- to postassessment, and such improvement was sustained at the 3-month follow-up. The high attrition

  19. Effect of dietary prebiotic supplementation on advanced glycation, insulin resistance and inflammatory biomarkers in adults with pre-diabetes: a study protocol for a double-blind placebo-controlled randomised crossover clinical trial

    PubMed Central

    2014-01-01

    Background Advanced glycation endproducts (AGEs) contribute to the development of vascular complications of diabetes and have been recently implicated in the pathogenesis of diabetes. Since AGEs are generated within foodstuffs upon food processing, it is increasingly recognised that the modern diet is replete with AGEs. AGEs are thought to stimulate chronic low-grade inflammation and promote oxidative stress and have been linked to the development of insulin resistance. Simple therapeutic strategies targeted at attenuating the progression of chronic low-grade inflammation and insulin resistance are urgently required to prevent or slow the development of type 2 diabetes in susceptible individuals. Dietary modulation of the human colonic microbiota has been shown to confer a number of health benefits to the host, but its effect on advanced glycation is unknown. The aim of this article is to describe the methodology of a double-blind placebo-controlled randomised crossover trial designed to determine the effect of 12 week consumption of a prebiotic dietary supplement on the advanced glycation pathway, insulin sensitivity and chronic low-grade inflammation in adults with pre-diabetes. Methods/Design Thirty adults with pre-diabetes (Impaired Glucose Tolerance or Impaired Fasting Glucose) aged between 40–60 years will be randomly assigned to receive either 10 grams of prebiotic (inulin/oligofructose) daily or 10 grams placebo (maltodextrin) daily for 12 weeks. After a 2-week washout period, study subjects will crossover to receive the alternative dietary treatment for 12 weeks. The primary outcome is the difference in markers of the advanced glycation pathway carboxymethyllysine (CML) and methylglyoxal (MG) between experimental and control treatments. Secondary outcomes include HbA1c, insulin sensitivity, lipid levels, blood pressure, serum glutathione, adiponectin, IL-6, E-selectin, myeloperoxidase, C-reactive protein, Toll-like Receptor 4 (TLR4), soluble receptor

  20. A randomized controlled trial to evaluate the effect of incorporating peanuts into an American Diabetes Association meal plan on the nutrient profile of the total diet and cardiometabolic parameters of adults with type 2 diabetes

    PubMed Central

    2014-01-01

    Background According to the American Diabetes Association (ADA), the nutritional goals for patients with type 2 diabetes (T2D) are to achieve an optimal nutrient intake to achieve normoglycemia and a cardioprotective lipid profile. Peanuts are nutrient dense foods that contain high levels of monounsaturated fat (MUFA) and are a natural source of arginine, fiber, phytosterols, resveritrol, niacin, folate, vitamin E and magnesium, which have the potential for improving blood lipids and glycemic control. This study sought to evaluate the effect of a peanut enriched ADA meal plan on the nutrient profile of the total diet and cardiometabolic parameters in adults with T2D. Methods This was a randomized, prospective 24-week parallel-group clinical trial with 60 adults with T2D [age range 34–84 years; body mass index (BMI) range 17.2-48.7 kg/m2]. Subjects consumed an ADA meal plan containing ~20% of energy from peanuts (peanut group) or a peanut-free ADA meal plan (control group). Weight, BMI, waist circumference (WC) and nutrient intake from 24-hour recalls were measured every 4 weeks and fasting blood glucose (FBG), HbA1c and blood lipids were measured every 12 weeks. A mixed-model repeated-measures analysis of covariance was performed to assess the significance of changes in the cardiometabolic parameters. Results A higher polyunsaturated fat (PUFA) to saturated fat diet ratio and higher intake of MUFA, PUFA, α-tocopherol, niacin and magnesium was observed in the peanut group as compared to the control group (P < 0.01-P = 0.04). Both groups experienced mild reductions in weight, BMI, and WC during the study (P = 0.01-P = 0.03), however there were no differences between the two groups in these measurements or in FBG, HbA1c or blood lipids. For each kilogram of weight loss in the entire cohort there were associations for reductions in WC of 0.48 cm (P < 0.01), FBG of 0.11 mmol/l (P = 0.01) and HbA1c of 0.07% (P < 0.01). Conclusions Daily

  1. Effect of day-case unilateral cochlear implantation in adults on general and disease-specific quality of life, postoperative complications and hearing results, tinnitus, vertigo and cost-effectiveness: protocol for a randomised controlled trial

    PubMed Central

    Derks, Laura S M; Wegner, Inge; Smit, Adriana L; Thomeer, Hans G X M; Topsakal, Vedat; Grolman, Wilko

    2016-01-01

    Introduction Cochlear implantation is an increasingly common procedure in the treatment of severe to profound sensorineural hearing loss (SNHL) in children and adults. It is often performed as a day-case procedure. The major drive towards day-case surgery has been from a logistical, economical and societal perspective, but we also speculate that the patient's quality of life (QoL) is at least equal to inpatient surgery if not increased as a result of rapid discharge and rehabilitation. Even though cochlear implantation seems well suited to a day-case approach and this even seems to be common practice in some countries, evidence is scarce and of low quality to guide us towards the preferred treatment option. Methods and analysis A single-centre, non-blinded, randomised, controlled trial was designed to (primarily) investigate the effect on general QoL of day-case cochlear implantation compared to inpatient cochlear implantation and (secondarily) the effect of both methods on (subjective) hearing improvement, disease-specific QoL, tinnitus, vertigo and cost-effectiveness. 30 adult patients with severe to profound bilateral postlingual SNHL who are eligible for unilateral cochlear implantation will be randomly assigned to either the day-case or inpatient treatment group. The outcome measures will be assessed using auditory evaluations, questionnaires (preoperatively, at 1-week, 3-week, 3-month and 1-year follow-up) and costs diaries (weekly during the first month postoperatively, after which once in a month until 1-year follow-up). Preoperative and postoperative outcomes will be compared. The difference in costs and benefit will be represented using the incremental cost utility/effectiveness ratio. The analyses will be carried out on an intention-to-treat basis. Ethics and dissemination This research protocol was approved by the Institutional Review Board of the UMC Utrecht (NL45590.041.13; V.5, November 2015). The trial results will be disseminated through peer

  2. Effect of type and amount of dietary carbohydrate on biomarkers of glucose homeostasis and C reactive protein in overweight or obese adults: results from the OmniCarb trial

    PubMed Central

    Juraschek, Stephen P; Miller, Edgar R; Selvin, Elizabeth; Carey, Vincent J; Appel, Lawrence J; Christenson, Robert H; Sacks, Frank M

    2016-01-01

    Objective The glycemic index (GI) of dietary carbohydrate is thought to affect glucose homeostasis. Recently, the Effect of Amount and Type of Dietary Carbohydrates on Risk for Cardiovascular Heart Disease and Diabetes Study (OmniCarb) trial reported that a low-GI diet did not improve insulin sensitivity. We conducted this ancillary study of the OmniCarb trial to determine the effects of GI and carbohydrate content on glucose homeostasis and inflammation. Research design and methods OmniCarb was a randomized cross-over feeding study conducted in overweight or obese adults without diabetes (N=163). Participants were fed each of 4 diets for 5 weeks with 2-week washout periods. Weight was held constant. Diets were: high GI (GI≥65) with high carbohydrate (58% kcal), low GI (GI≤45) with low carbohydrate (40% kcal), low GI with high carbohydrate, and high GI with low carbohydrate. We measured glycated albumin (GA), fructosamine, and high sensitivity C reactive protein (CRP) at baseline and following each dietary period. These biomarkers were compared within-person between diets. Results The study population was 52% female and 50% black. Mean age was 53 (SD, 11) years; mean body mass index was 32 (SD 6) kg/m2. Reducing GI had no effect on GA or fructosamine, but increased fasting glucose in the setting of a high-carbohydrate diet (+2.2 mg/dL; p=0.02). Reducing carbohydrate content decreased GA in the setting of a high-GI diet (−0.2%; p=0.03) and decreased fructosamine in the setting of a low-GI diet (−4 µmol/L; p=0.003). Reducing carbohydrate while simultaneously increasing GI significantly reduced both GA (−0.2%; p=0.04) and fructosamine (−4 µmol/L; p=0.009). Neither reducing GI nor amount of carbohydrate affected insulin or CRP. Conclusions Reducing carbohydrate, regardless of high or low GI, decreased GA and fructosamine. This suggests that reducing carbohydrate content, rather than GI, is a better strategy for lowering glycemia in adults at risk

  3. 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

  4. Widespread sucralose exposure in a randomized clinical trial in healthy young adults.

    PubMed

    Sylvetsky, Allison C; Walter, Peter J; Garraffo, H Martin; Robien, Kim; Rother, Kristina I

    2017-04-01

    Background: Low-calorie sweeteners (LCSs) are found in many foods and beverages, but consumers may not realize their presence, and their role in appetite, weight, and health is controversial. Although consumption limits based on toxicologic safety are well established, the threshold required to exert clinically relevant metabolic effects is unknown.Objectives: This study aimed to determine whether individuals who do not report consumption of LCSs can be correctly characterized as "unexposed" and to investigate whether instructions to avoid LCSs are effective in minimizing exposure.Design: Eighteen healthy 18- to 35-y-old "nonconsumers" (<1 food or beverage with LCSs/mo) enrolled in a 2-wk trial designed to evaluate the effects of LCSs on the gut microbiota. The trial consisted of 3 visits. At baseline, participants were counseled extensively about avoiding LCSs. After the run-in, participants were randomly assigned to consume diet soda containing sucralose or carbonated water (control) 3 times/d for 1 wk. Food diaries were maintained throughout the study, and a spot urine sample was collected at each visit.Results: At baseline, 8 participants had sucralose in their urine (29.9-239.0 ng/mL; mean ± SD: 111.4 ± 91.5 ng/mL). After the run-in, sucralose was found in 8 individuals (2 of whom did not have detectable sucralose at baseline) and ranged from 25.0 to 1062.0 ng/mL (mean ± SD: 191.7 ± 354.2 ng/mL). Only 1 participant reported consumption of an LCS-containing food before her visit. After the intervention, sucralose was detected in 3 individuals randomly assigned to receive carbonated water (26-121 ng/mL; mean ± SD: 60.7 ± 52.4 ng/mL).Conclusions: Despite the selection of healthy volunteers with minimal reported LCS consumption, more than one-third were exposed to sucralose at baseline and/or before randomization, and nearly half were exposed after assignment to the control. This shows that instructions to avoid LCSs are not effective and that nondietary

  5. FAST CP: protocol of a randomised controlled trial of the efficacy of a 12-week combined Functional Anaerobic and Strength Training programme on muscle properties and mechanical gait deficiencies in adolescents and young adults with spastic-type cerebral palsy

    PubMed Central

    Gillett, Jarred G; Lichtwark, Glen A; Boyd, Roslyn N; Barber, Lee A

    2015-01-01

    Introduction Individuals with cerebral palsy (CP) have muscles that are smaller, weaker and more resistant to stretch compared to typically developing people. Progressive resistance training leads to increases in muscle size and strength. In CP, the benefits of resistance training alone may not transfer to improve other activities such as walking; however, the transfer of strength improvements to improved mobility may be enhanced by performing training that involves specific functional tasks or motor skills. This study aims to determine the efficacy of combined functional anaerobic and strength training in (1) influencing muscle strength, structure and function and (2) to determine if any changes in muscle strength and structure following training impact on walking ability and gross motor functional capacity and performance in the short (following 3 months of training) and medium terms (a further 3 months post-training). Methods and analysis 40 adolescents and young adults with CP will be recruited to undertake a 12-week training programme. The training programme will consist of 3×75 min sessions per week, made up of 5 lower limb resistance exercises and 2–3 functional anaerobic exercises per session. The calf muscles will be specifically targeted, as they are the most commonly impacted muscles in CP and are a key muscle group involved in walking. If, as we believe, muscle properties change following combined strength and functional training, there may be long-term benefits of this type of training in slowing the deterioration of muscle function in people with spastic-type CP. Ethics and dissemination Ethical approval has been obtained from the ethics committees at The University of Queensland (2014000066) and Children's Health Queensland (HREC/15/QRCH/30). The findings will be disseminated by publications in peer-reviewed journals, conferences and local research organisations’ media. Trial registration number Australian and New Zealand Clinical Trials

  6. Guided and unguided internet-based vestibular rehabilitation versus usual care for dizzy adults of 50 years and older: a protocol for a three-armed randomised trial

    PubMed Central

    van der Wouden, Johannes C; Bosmans, Judith E; Smalbrugge, Martin; van Diest, Willianne; Essery, Rosie; Yardley, Lucy; van der Horst, Henriëtte E; Maarsingh, Otto R

    2017-01-01

    Introduction Dizziness is a common symptom in general practice with a high prevalence among older adults. The most common cause of dizziness in general practice is peripheral vestibular disease. Vestibular rehabilitation (VR) is a safe and effective treatment for peripheral vestibular disease that entails specific exercises to maximise the central nervous system compensation for the effects of vestibular pathology. An internet-based VR intervention has recently been shown to be safe and effective. Online interventions are low cost and easily accessible, but prone to attrition and non-adherence. A combination of online and face-to-face therapy, known as blended care, may balance these advantages and disadvantages. Methods and analysis A single-blind, three-arm, randomised controlled trial among patients aged 50 years and over presenting with dizziness of vestibular origin in general practice will be performed. In this study, we will compare the clinical and cost-effectiveness of stand-alone internet-based VR and internet-based VR with physiotherapeutic support (‘blended care’) with usual care during 6 months of follow-up. We will use a translated Dutch version of a British online VR intervention. Randomisation will be stratified by dizziness severity. The primary outcome measure is the Vertigo Symptoms Scale—Short Form. Intention-to-treat analysis will be performed, adjusting for confounders. The economic evaluation will be conducted from a societal perspective. We will perform an additional analysis on the data to identify predictors of successful treatment in the same population to develop a clinical decision rule for general practitioners. Ethics and dissemination The ethical committee of the VU University Medical Center approved ethics and dissemination of the study protocol. The insights and results of this study will be widely disseminated through international peer-reviewed journals and conference presentations. Trial registration number Pre

  7. Pedometer-Based Internet-Mediated Intervention For Adults With Chronic Low Back Pain: Randomized Controlled Trial

    PubMed Central

    Kadri, Reema; Hughes, Maria; Kerr, Eve A; Piette, John D; Holleman, Rob; Kim, Hyungjin Myra; Richardson, Caroline R

    2013-01-01

    .6 (95% CI 0.3-2.8, P=.02) for the complete case analysis and 1.2 (95% CI -0.09 to 2.5, P=.07) for the all case analysis. A post hoc analysis of patients with baseline RDQ scores ≥4 revealed even larger adjusted differences between groups at 6 months but at 12 months the differences were no longer statistically significant. Conclusions Intervention participants, compared with those receiving usual care, reported a greater decrease in back pain-related disability in the 6 months following study enrollment. Between-group differences were especially prominent for patients reporting greater baseline levels of disability but did not persist over 12 months. Primarily, automated interventions may be an efficient way to assist patients with managing chronic back pain; additional support may be needed to ensure continuing improvements. Trial Registration ClinicalTrials.gov NCT00694018; http://clinicaltrials.gov/ct2/show/NCT00694018 (Archived by WebCite at http://www.webcitation.org/6IsG4Y90E). PMID:23969029

  8. Tiotropium in the add-on treatment of asthma in adults: clinical trial evidence and experience.

    PubMed

    Vogelberg, Christian

    2016-12-01

    Asthma is a chronic inflammatory airway disease, and its treatment is frequently challenging despite detailed national and international guidelines. While basic anti-inflammatory therapy usually consists of inhaled corticosteroids in doses adapted to the asthma severity, add-on treatment with bronchodilators is essential in more severe asthma. Only recently, the long-acting anticholinergic tiotropium was introduced into the GINA guidelines. This review reports on the studies that have been performed with tiotropium in adult asthmatic patients. Following early proof-of-concept studies, several studies with tiotropium as an add-on therapy to inhaled corticosteroids (ICS), with or without a long-acting beta agonist (LABA), demonstrated convincing clinical benefit for patients. Important lung function parameters and quality of life scores significantly improved shortly after onset of the add-on therapy with tiotropium, and some studies even demonstrated non-inferiority against salmeterol. All studies reported an excellent safety profile of tiotropium. The still growing body of tiotropium studies, both in adults and children, will help to identify the position of tiotropium in future asthma guidelines and might also indicate which patients benefit most from an add-on therapy with tiotropium.

  9. 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

  10. Effectiveness of regular reporting of spirometric results combined with a smoking cessation advice by a primary care physician on smoking quit rate in adult smokers: a randomized controlled trial. ESPIROTAB study

    PubMed Central

    2011-01-01

    of other preventive actions to minimise patient risk. Comparing adult smokers in the intervention group with those in the control group, a minimum improvement expected with respect to the rates of smoking cessation would represent a large number of avoided morbimortality. Trial Registration ClinicalTrials.gov: NCT01296295 PMID:21708047

  11. Effect of exercise on cognitive performance in community-dwelling older adults: review of intervention trials and recommendations for public health practice and research.

    PubMed

    Snowden, Mark; Steinman, Lesley; Mochan, Kara; Grodstein, Francine; Prohaska, Thomas R; Thurman, David J; Brown, David R; Laditka, James N; Soares, Jesus; Zweiback, Damita J; Little, Deborah; Anderson, Lynda A

    2011-04-01

    There is evidence from observational studies that increasing physical activity may reduce the risk of cognitive decline in older adults. Exercise intervention trials have found conflicting results. A systematic review of physical activity and exercise intervention trials on cognition in older adults was conducted. Six scientific databases and reference lists of previous reviews were searched. Thirty studies were eligible for inclusion. Articles were grouped into intervention-outcome pairings. Interventions were grouped as cardiorespiratory, strength, and multicomponent exercises. Cognitive outcomes were general cognition, executive function, memory, reaction time, attention, cognitive processing, visuospatial, and language. An eight-member multidisciplinary panel rated the quality and effectiveness of each pairing. Although there were some positive studies, the panel did not find sufficient evidence that physical activity or exercise improved cognition in older adults. Future research should report exercise adherence, use longer study durations, and determine the clinical relevance of measures used.

  12. Transition of adolescents with HIV to adult care: characteristics and current practices of the adolescent trials network for HIV/AIDS interventions.

    PubMed

    Gilliam, Patricia P; Ellen, Jonathan M; Leonard, Lori; Kinsman, Sara; Jevitt, Cecilia M; Straub, Diane M

    2011-01-01

    The transition process from pediatric to adult health care for adolescents with chronic diseases is always challenging and can be even more so for adolescents with HIV disease. The purpose of this study was to describe characteristics and current practices surrounding the transition of adolescents from the clinics of the Adolescent Trials Network for HIV/AIDS Interventions to adult medical care. This report focuses on the processes of transition, perceived barriers and facilitators, and anecdotal reports of successes and failures. Practice models used to assist adolescents during transition to adult medical care are described. Interviews were conducted with 19 key informants from 14 Adolescent Trials Network clinics. Findings revealed no consistent definition of "successful" transition, little consensus among the sites regarding specific elements of a transition program, and a lack of mechanisms to assess outcomes. Sites that viewed transition as a process rather than an event consistently described more structured program elements.

  13. 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.

  14. Physical activity and resting pulse rate in older adults: findings from a randomized controlled trial

    PubMed Central

    ó Hartaigh, Bríain; Pahor, Marco; Buford, Thomas W.; Dodson, John A.; Forman, Daniel E.; Gill, Thomas M.

    2014-01-01

    Background Elevated resting pulse rate (RPR) is a well-recognized risk factor for adverse outcomes. Epidemiological evidence supports the beneficial effects of regular exercise for lowering RPR, but studies are mainly confined to persons younger than 65 years. We set out to evaluate the utility of a physical activity (PA) intervention for slowing RPR among older adults. Methods A total of 424 seniors (ages 70-89 years) were randomized to a moderate intensity PA intervention or an education-based “successful aging” (SA) health program. RPR was assessed at baseline, 6 months and 12 months. Longitudinal differences in RPR were evaluated between treatment groups using generalized estimating equation (GEE) models, reporting unstandardized beta coefficients (β) with robust standard errors (SE). Results Increased frequency and duration of aerobic training was observed for the PA group at 6 and 12 months as compared with the SA group (P <0.001). In both groups, RPR remained unchanged over the course of the 12-month study period (P =0.67). No significant improvement was observed (β [SE] = 0.58 [0.88], P =0.51) for RPR when treatment groups were compared using the GEE method. Comparable results were found after omitting participants with a pacemaker, cardiac arrhythmia, or who were receiving beta-blockers. Conclusions Twelve months of moderate intensity aerobic training did not improve RPR among older adults. Additional studies are needed to determine whether physical activity of longer duration and/or greater intensity can slow RPR in older persons. PMID:25262271

  15. Developmental contributions to macronutrient selection: a randomized controlled trial in adult survivors of malnutrition

    PubMed Central

    Campbell, Claudia P.; Raubenheimer, David; Badaloo, Asha V.; Gluckman, Peter D.; Martinez, Claudia; Gosby, Alison; Simpson, Stephen J.; Osmond, Clive; Boyne, Michael S.; Forrester, Terrence E.

    2016-01-01

    Background and objectives: Birthweight differences between kwashiorkor and marasmus suggest that intrauterine factors influence the development of these syndromes of malnutrition and may modulate risk of obesity through dietary intake. We tested the hypotheses that the target protein intake in adulthood is associated with birthweight, and that protein leveraging to maintain this target protein intake would influence energy intake (EI) and body weight in adult survivors of malnutrition. Methodology: Sixty-three adult survivors of marasmus and kwashiorkor could freely compose a diet from foods containing 10, 15 and 25 percentage energy from protein (percentage of energy derived from protein (PEP); Phase 1) for 3 days. Participants were then randomized in Phase 2 (5 days) to diets with PEP fixed at 10%, 15% or 25%. Results: Self-selected PEP was similar in both groups. In the groups combined, selected PEP was 14.7, which differed significantly (P < 0.0001) from the null expectation (16.7%) of no selection. Self-selected PEP was inversely related to birthweight, the effect disappearing after adjusting for sex and current body weight. In Phase 2, PEP correlated inversely with EI (P = 0.002) and weight change from Phase 1 to 2 (P = 0.002). Protein intake increased with increasing PEP, but to a lesser extent than energy increased with decreasing PEP. Conclusions and implications: Macronutrient intakes were not independently related to birthweight or diagnosis. In a free-choice situation (Phase 1), subjects selected a dietary PEP significantly lower than random. Lower PEP diets induce increased energy and decreased protein intake, and are associated with weight gain. PMID:26817484

  16. Immunological efficacy of pneumococcal vaccine strategies in HIV-infected adults: a randomized clinical trial.

    PubMed

    Sadlier, C; O'Dea, S; Bennett, K; Dunne, J; Conlon, N; Bergin, C

    2016-09-01

    The aim of this study was to compare the immunologic response to a prime-boost immunization strategy combining the 13-valent conjugate pneumococcal vaccine (PCV13) with the 23-valent polysaccharide pneumococcal vaccine (PPSV23) versus the PPSV23 alone in HIV-infected adults. HIV-infected adults were randomized to receive PCV13 at week 0 followed by PPSV23 at week 4 (n = 31, prime-boost group) or PPSV23 alone at week 4 (n = 33, PPSV23-alone group). Serotype specific IgG geometric mean concentration (GMC) and functional oposonophagocytic (OPA) geometric mean titer (GMT) were compared for 12 pneumococcal serotypes shared by both vaccines at week 8 and week 28. The prime-boost vaccine group were more likely to achieve a ≥2-fold increase in IgG GMC and a GMC >1 ug/ml at week 8 (odds ratio (OR) 2.00, 95% confidence interval (CI) 1.46-2.74, p < 0.01) and week 28 (OR 1.95, 95% CI 1.40-2.70, p < 0.01). Similarly, the prime-boost vaccine group were more likely to achieve a ≥4-fold increase in GMT at week 8 (OR 1.71, 95% CI 1.22-2.39, p < 0.01) and week 28 (OR 1.6, 95% CI 1.15-2.3, p < 0.01). This study adds to evidence supporting current pneumococcal vaccination recommendations combining the conjugate and polysaccharide pneumococcal vaccines in the United States and Europe for HIV-infected individuals.

  17. Pesticide poisoning in Zhejiang, China: a retrospective analysis of adult cases registration by occupational disease surveillance and reporting systems from 2006 to 2010

    PubMed Central

    Zhang, Meibian; Fang, Xinglin; Zhou, Lifang; Su, Liling; Zheng, Jiajia; Jin, Minjuan; Zou, Hua; Chen, Guangdi

    2013-01-01

    Objective Despite the rapid industrialisation and urbanisation over the past 30 years, agriculture is one of the largest economic sectors in China and the unregulated use of pesticides result in extensive pesticide poisoning. The objective of this study was to analyse pesticide poisoning cases registration received by Zhejiang Provincial Center for Disease Control and Prevention, China. Design Register-based study. Setting Cases registered regarding pesticide poisoning. Data were obtained from the Occupational Disease Surveillance and Reporting Systems in Zhejiang province from 2006 to 2010, which contains anonymous records representing general population of Zhejiang province, China. Participants All cases registered as pesticide poisoning were identified. Primary outcome Monthly and age-group pesticide poisoning death rates were calculated. Results A total of 20 097 pesticide poisoning cases with 1413 deaths were recorded during the study period. There were 10 513 male pesticide poisoning cases with 782 deaths, and 9584 females with 631 deaths. Pesticide poisoning occurred mostly in non-occupational exposure (79.86%), in which the majority (85.77%) of the cases was of intentional pesticide poisoning. The occupational exposure was most common in men during the farming season. The death rate increased stepwise with age, and the pesticide suicide rate was higher in the older age group. Conclusions Pesticide poisoning remains a major health problem in China, and further recommendations to reduce the pesticide poisoning are required. PMID:24270833

  18. Stress management and sexual health of young adults: a pilot randomised controlled trial.

    PubMed

    Dimou, P A; Bacopoulou, F; Darviri, C; Chrousos, G P

    2014-01-01

    Young people often experience excessive stress that definitely undermines their sexual life and leads them to adopt risky sexual behaviours. As such, the design and application of a stress management programme in this particular age group is, undoubtedly, a crucial matter. In this parallel randomised controlled trial, 60 psychology students of the Panteion University of Athens, aged 18–20, were randomly assigned to undergo either an 8-week stress management programme (n = 30; diaphragmatic breathing–progressive muscle relaxation and guided imagery, twice a day) or not (n = 30). Self-reported validated measures were used to evaluate stress, stressful life events, health locus of control, general health status, sexual behaviours, sexual desire, satisfaction from sexual life and interpersonal relationships. Between-group analyses revealed statistically significant differences in internal health locus of control and general health evaluation. Within the intervention group analyses showed reductions in BMI, stress, the ‘chance’ subscale of multidimensional health locus of control (MHLC) and greater satisfaction from sexual life. No other significant change was reported. We deem that our results should encourage relevant future studies.

  19. Calorie restriction in overweight seniors: response of older adults to a dieting study: the CROSSROADS randomized controlled clinical trial.

    PubMed

    Haas, Marilyn C; Bodner, Eric V; Brown, Cynthia J; Bryan, David; Buys, David R; Keita, Akilah Dulin; Flagg, Lee Anne; Goss, Amy; Gower, Barbara; Hovater, Martha; Hunter, Gary; Ritchie, Christine S; Roth, David L; Wingo, Brooks C; Ard, Jamy; Locher, Julie L

    2014-01-01

    We conducted a study designed to evaluate whether the benefits of intentional weight loss exceed the potential risks in a group of community-dwelling obese older adults who were at increased risk for cardiometabolic disease. The CROSSROADS trial used a prospective randomized controlled design to compare the effects of changes in diet composition alone or combined with weight loss with an exercise only control intervention on body composition and adipose tissue deposition (Specific Aim #1: To compare the effects of changes in diet composition alone or combined with weight loss with an exercise only control intervention on body composition, namely visceral adipose tissue), cardiometabolic disease risk (Specific Aim #2: To compare the effects of a change in diet composition alone or combined with weight loss with an exercise only control intervention on cardiometabolic disease risk), and functional status and quality of life (Specific Aim #3: To compare the effects of a change in diet composition alone or combined with weight loss with an exercise only control intervention on functional status and quality of life). Participants were randomly assigned to one of three groups: Exercise Only (Control) Intervention, Exercise + Diet Quality + Weight Maintenance Intervention, or Exercise + Diet Quality + Weight Loss Intervention. CROSSROADS utilized a lifestyle intervention approach consisting of exercise, dietary, and behavioral components. The development and implementation of the CROSSROADS protocol, including a description of the methodology, detailing specific elements of the lifestyle intervention, assurances of treatment fidelity, and participant retention; outcome measures and adverse event monitoring; as well as unique data management features of the trial results, are presented in this article.

  20. Consuming foods with added oligofructose improves stool frequency: a randomised trial in healthy young adults.

    PubMed

    Dahl, Wendy J; Wright, Arnelle R; Specht, Gretchen J; Christman, Mary; Mathews, Anne; Meyer, Diederick; Boileau, Thomas; Willis, Holly J; Langkamp-Henken, Bobbi

    2014-01-01

    The impact of oligofructose (OF) intake on stool frequency has not been clearly substantiated, while significant gastrointestinal (GI) symptoms have been reported in some individuals. The aim of the present study was to determine the effects of OF on stool frequency and GI symptoms in healthy adults. In an 8-week, randomised, double-blind, parallel-arm study, ninety-eight participants were provided with 16 g OF in yogurt and snack bars (twenty male and thirty female) or matching control foods (seventeen male and thirty-one female), to incorporate, by replacement, into their usual diets. Participants completed a daily online questionnaire recording stool frequency and rating four symptoms: bloating, flatulence, abdominal cramping and noise, each on a Likert scale from '0' for none (no symptoms) to '6' for very severe, with a maximum symptom intensity score of 24 (sum of severities from all four symptoms). Online 24 h dietary recalls were completed during pre-baseline and weeks 4, 6 and 8 to determine fibre intake. When provided with OF foods, fibre intake increased to 24·3 (sem 0·5) g/d from pre-baseline (12·1 (sem 0·5) g/d; P < 0·001). Stool frequency increased with OF from 1·3 (sem 0·2) to 1·8 (sem 0·2) stools per d in males and 1·0 (sem 0·1) to 1·4 (sem 0·1) stools per d in females during intervention weeks compared with pre-baseline (P < 0·05),but did not change for control participants (males: 1·6 (sem 0·2) to 1·8 (sem 0·2); females: 1·3 (sem 0·1) to 1·4 (sem 0·1)). Flatulence was the most commonly reported symptom. Mean GI symptom intensity score was higher for the OF group (3·2 (sem 0·3)) v. control (1·7 (sem 0·1)) (P < 0·01), with few participants reporting above moderate symptoms. No change in symptom intensity occurred over time. Consuming yogurt and snack bars with 16 g OF improves regularity in young healthy adults. However, GI symptoms, resulting from an increase in oligofructose intake, may not diminish with time.

  1. Centrifugal pump and roller pump in adult cardiac surgery: a meta-analysis of randomized controlled trials.

    PubMed

    Saczkowski, Richard; Maklin, Michelle; Mesana, Thierry; Boodhwani, Munir; Ruel, Marc

    2012-08-01

    Centrifugal pump (CP) and roller pump (RP) designs are the dominant main arterial pumps used in cardiopulmonary bypass (CPB). Trials reporting clinical outcome measures comparing CP and RP are controversial. Therefore, a meta-analysis was undertaken to evaluate clinical variables from randomized controlled trials (RCTs). Keyword searches were performed on Medline (1966-2011), EmBase (1980-2011), and CINAHL (1981-2011) for studies comparing RP and CP as the main arterial pump in adult CPB. Pooled fixed-effects estimates for dichotomous and continuous data were calculated as an odds ratio and weighted-mean difference, respectively. The P value was utilized to assess statistical significance (P < 0.05) between CP and RP groups. Eighteen RCTs met inclusion criteria, which represented 1868 patients (CP = 961, RP = 907). The prevailing operation was isolated coronary artery bypass graft surgery (CP = 88%, RP = 87%). Fixed-effects pooled estimates were performed for end-of-CPB (ECP) and postoperative day one (PDO) for platelet count (ECP: P = 0.51, PDO: P = 0.16), plasma free hemoglobin (ECP: P = 0.36, PDO: P = 0.24), white blood cell count (ECP: P = 0.21, PDO: P = 0.66), and hematocrit (ECP: P = 0.06, PDO: P = 0.51). No difference was demonstrated for postoperative blood loss (P = 0.65) or red blood cell transfusion (P = 0.71). Intensive care unit length of stay (P = 0.30), hospital length of stay (P = 0.33), and mortality (P = 0.91) were similar between the CP and RP groups. Neurologic outcomes were not amenable to pooled analysis; nevertheless, the results were inconclusive. There was no reported pump-related malfunction or mishap. The meta-analysis of RCTs comparing CP and RP in adult cardiac surgery suggests no significant difference for hematological variables, postoperative blood loss, transfusions, neurological outcomes, or mortality.

  2. COMPARISON OF VOLUMETRIC REGISTRATION ALGORITHMS FOR TENSOR-BASED MORPHOMETRY

    PubMed Central

    Villalon, Julio; Joshi, Anand A.; Toga, Arthur W.; Thompson, Paul M.

    2015-01-01

    Nonlinear registration of brain MRI scans is often used to quantify morphological differences associated with disease or genetic factors. Recently, surface-guided fully 3D volumetric registrations have been developed that combine intensity-guided volume registrations with cortical surface constraints. In this paper, we compare one such algorithm to two popular high-dimensional volumetric registration methods: large-deformation viscous fluid registration, formulated in a Riemannian framework, and the diffeomorphic “Demons” algorithm. We performed an objective morphometric comparison, by using a large MRI dataset from 340 young adult twin subjects to examine 3D patterns of correlations in anatomical volumes. Surface-constrained volume registration gave greater effect sizes for detecting morphometric associations near the cortex, while the other two approaches gave greater effects sizes subcortically. These findings suggest novel ways to combine the advantages of multiple methods in the future. PMID:26925198

  3. Controlled-release phentermine/topiramate in severely obese adults: a randomized controlled trial (EQUIP).

    PubMed

    Allison, David B; Gadde, Kishore M; Garvey, William Timothy; Peterson, Craig A; Schwiers, Michael L; Najarian, Thomas; Tam, Peter Y; Troupin, Barbara; Day, Wesley W

    2012-02-01

    A 56-week randomized controlled trial was conducted to evaluate safety and efficacy of a controlled-release combination of phentermine and topiramate (PHEN/TPM CR) for weight loss (WL) and metabolic improvements. Men and women with class II and III obesity (BMI ≥ 35 kg/m(2)) were randomized to placebo, PHEN/TPM CR 3.75/23 mg, or PHEN/TPM CR 15/92 mg, added to a reduced-energy diet. Primary end points were percent WL and proportions of patients achieving 5% WL. Secondary end points included waist circumference (WC), systolic and diastolic blood pressure (BP), fasting glucose, and lipid measures. In the primary analysis (randomized patients with at least one postbaseline weight measurement who took at least one dose of assigned drug or placebo), patients in the placebo, 3.75/23, and 15/92 groups lost 1.6%, 5.1%, and 10.9% of baseline body weight (BW), respectively, at 56 weeks (P < 0.0001). In categorical analysis, 17.3% of placebo patients, 44.9% of 3.75/23 patients, and 66.7% of 15/92 patients, lost at least 5% of baseline BW at 56 weeks (P < 0.0001). The 15/92 group had significantly greater changes relative to placebo for WC, systolic and diastolic BP, fasting glucose, triglycerides, total cholesterol, low-density lipoprotein (LDL), and high-density lipoprotein (HDL). The most common adverse events were paresthesia, dry mouth, constipation, dysgeusia, and insomnia. Dropout rate from the study was 47.1% for placebo patients, 39.0% for 3.75/23 patients, and 33.6% of 15/92 patients. PHEN/TPM CR demonstrated dose-dependent effects on weight and metabolic variables in the direction expected to be beneficial with no evidence of serious adverse events induced by treatment.

  4. Zonisamide for Weight Reduction in Obese Adults A 1-Year Randomized Controlled Trial

    PubMed Central

    Gadde, Kishore M.; Kopping, Mariko F.; Wagner, H. Ryan; Yonish, Gretchen M.; Allison, David B.; Bray, George A.

    2013-01-01

    SUMMARY Background Obese individuals who have failed to achieve adequate weight loss with lifestyle changes have limited non-surgical therapeutic options. We evaluated the efficacy and tolerability of zonisamide, an antiepileptic drug, for enhancing weight loss in obese patients receiving diet and lifestyle guidance. Methods This was a 1-year randomized, double-blind, placebo-controlled trial conducted between January 2006 and September 2011 at Duke University Medical Center. Patients were 225 obese (mean [SD] body mass index 37.6 [4.9]) women (134 [59.6%]) and men (91 [40.4%]) without diabetes. Interventions were daily dosing with placebo (n=74), zonisamide 200 mg (n=76), orzonisamide 400 mg (n=75), in addition to diet and lifestyle counseling by a dietitian for 1 year. Primary outcome was change in body weight at 1-year. Results Of the 225 randomized patients, 218 (97%) provided 1-year follow-up assessments. Change(least-squares mean) in body weight was -4.0 kg (−3.7%; 95% CI, −5.8 kg to −2.3 kg) for placebo, −4.4 kg (−3.9%; −6.1 to −2.6, P=.79vs placebo) for zonisamide 200 mg, and −7.3 kg (−6.8%; −9.0 to −5.6, P=.009vs placebo) for zonisamide 400 mg. In the categorical analysis,23 (31%) on placebo, 26 (34%; P=.71) on zonisamide 200 mg, and 41 (55%; P=.007) onzonisamide 400 mg achieved ≥5% weight loss; for ≥10% weight loss, the corresponding numbers were 6 (8%), 17 (22%; P=.022), and 24 (32%; P=.001). Gastrointestinal, nervous system and psychiatric adverse events occurred at a higher incidence with zonisamide than with placebo. Conclusion Zonisamide 400 mg/d moderately enhanced weight loss achieved with diet and lifestyle counseling, but had a high incidence of adverse events. PMID:23147455

  5. Open Clinical Trial on Using Nifuroxazide Compared to Probiotics in Treating Acute Diarrhoeas in Adults

    PubMed Central

    Begovic, Begler; Ahmedtagic, Sead; Calkic, Lejla; Vehabović, Midhat; Kovacevic, Sanela Bakić; Catic, Tarik; Mehic, Meliha

    2016-01-01

    Background: Nifuroxazide is well known and often used anti-diarrhoeal medicine which has been pushed back from routine practice in recent years and often replaced with probiotics. Even probiotics are accepted and placed in some therapeutic guidelines for diarrhoea treatment, there are no enough evidence for its effectiveness and no comparative efficacy data with nifuroxazide in treatment of acute diarrhea. Patients and Methods: In open, prospective observational study, the efficacy and safety of nifuroxazide were compared with a probiotic containing lactic acid bacteria in the treatment of acute diarrhoea. A total number of 169 adult patients were included in this study, who administered nifuroxazide in the dose of 200 mg/4 times a day, while they took preparation containing lactic acid bacteria (1,2 x 107 live lyophilised lactic-acid bacteria) three times a day for three days. Results: Mean time to last unformed stool (TLUS) in a group which was treated with nifuroxazide was two days, while it took five days for the stool normalisation in the group using probiotic (p=0.0001). Conclusions: Orally administered nifuroxazide has demonstrated better efficiency as compared to probiotic in treating acute diarrhoea, and both medicines have shown the same safety and tolerance in this study. PMID:28144199

  6. A randomized clinical trial of a coping improvement group intervention for HIV-infected older adults

    PubMed Central

    Sikkema, Kathleen J.; Hansen, Nathan; Kochman, Arlene; Heh, Victor; Neufeld, Sharon

    2011-01-01

    This research tested if a 12-session coping improvement group intervention (n = 104) reduced depressive symptoms in HIV-infected older adults compared to an interpersonal support group intervention (n = 105) and an individual therapy upon request (ITUR) control condition (n = 86). Participants were 295 HIV-infected men and women 50-plus years of age living in New York City, Cincinnati, OH, and Columbus, OH. Using A-CASI assessment methodology, participants provided data on their depressive symptoms using the Geriatric Depression Screening Scale (GDS) at pre-intervention, post-intervention, and 4- and 8-month follow-up. Whether conducted with all participants (N = 295) or only a subset of participants diagnosed with mild, moderate, or severe depressive symptoms (N = 171), mixed models analyses of repeated measures found that both coping improvement and interpersonal support group intervention participants reported fewer depressive symptoms than ITUR controls at post-intervention, 4-month follow-up, and 8-month follow-up. The effect sizes of the differences between the two active interventions and the control group were greater when outcome analyses were limited to those participants with mild, moderate, or severe depressive symptoms. At no assessment period did coping improvement and interpersonal support group intervention participants differ in depressive symptoms. PMID:20857188

  7. A randomized clinical trial of a coping improvement group intervention for HIV-infected older adults.

    PubMed

    Heckman, Timothy G; Sikkema, Kathleen J; Hansen, Nathan; Kochman, Arlene; Heh, Victor; Neufeld, Sharon

    2011-04-01

    This research tested if a 12-session coping improvement group intervention (n = 104) reduced depressive symptoms in HIV-infected older adults compared to an interpersonal support group intervention (n = 105) and an individual therapy upon request (ITUR) control condition (n = 86). Participants were 295 HIV-infected men and women 50-plus years of age living in New York City, Cincinnati, OH, and Columbus, OH. Using A-CASI assessment methodology, participants provided data on their depressive symptoms using the Geriatric Depression Screening Scale (GDS) at pre-intervention, post-intervention, and 4- and 8-month follow-up. Whether conducted with all participants (N = 295) or only a subset of participants diagnosed with mild, moderate, or severe depressive symptoms (N = 171), mixed models analyses of repeated measures found that both coping improvement and interpersonal support group intervention participants reported fewer depressive symptoms than ITUR controls at post-intervention, 4-month follow-up, and 8-month follow-up. The effect sizes of the differences between the two active interventions and the control group were greater when outcome analyses were limited to those participants with mild, moderate, or severe depressive symptoms. At no assessment period did coping improvement and interpersonal support group intervention participants differ in depressive symptoms.

  8. Is Surgery for Displaced, Midshaft Clavicle Fractures in Adults Cost-Effective? Results Based on a Multicenter Randomized Controlled Trial

    PubMed Central

    2010-01-01

    Objectives To determine the cost-effectiveness of open reduction internal fixation (ORIF) of displaced, midshaft clavicle fractures in adults. Design Formal cost-effectiveness analysis based on a prospective, randomized controlled trial. Setting Eight hospitals in Canada (seven university affiliated and one community hospital) Patients/Participants 132 adults with acute, completely displaced, midshaft clavicle fractures Intervention Clavicle ORIF versus nonoperative treatment Main Outcome Measurements Utilities derived from SF-6D Results The base-case cost per quality adjusted life year (QALY) gained for ORIF was $65,000. Cost-effectiveness improved to $28,150/QALY gained when the functional benefit from ORIF was assumed to be permanent, with cost per QALY gained falling below $50,000 when the functional advantage persisted for 9.3 years or more. In other sensitivity analyses, the cost per QALY gained for ORIF fell below $50,000 when ORIF cost less than $10,465 (base case cost $13,668) or the long-term utility difference between nonoperative treatment and ORIF was greater than 0.034 (base-case difference 0.014). Short-term disutility associated with fracture healing also affected cost-effectiveness, with the cost per QALY gained for ORIF falling below $50,000 when the utility of a fracture treated nonoperatively prior to union was less than 0.617 (base-case utility 0.706) or when nonoperative treatment increased the time to union by 20 weeks (base-case difference 12 weeks). Conclusions The cost-effectiveness of ORIF after acute clavicle fracture depended on the durability of functional advantage for ORIF compared to nonoperative treatment. When functional benefits persisted for more than 9 years, ORIF had favorable value compared with many accepted health interventions. PMID:20577073

  9. Impact of Adding a Decision Aid to Patient Education in Adults with Asthma: A Randomized Clinical Trial

    PubMed Central

    Légaré, France; Moisan, Jocelyne; Boulet, Louis-Philippe

    2017-01-01

    Background Not providing adequate patient education interventions to asthma patients remains a major care gap. To help asthma patients and caregivers discuss inhaled controller medication use, our team has previously developed a decision aid (DA). We sought to assess whether adding this DA to education interventions improved knowledge, decisional conflict, and asthma control among adults with asthma. Methods A parallel clinical trial (NCT02516449). We recruited adults with asthma, aged 18 to 65 years, prescribed inhaled controller medication to optimize asthma control. Educators randomly allocated participants either to the education + DA or to the education group. At baseline and two-month follow-up, we measured asthma knowledge (primary outcome) with a validated self-administered questionnaire (score –37 to +37). Secondary outcomes included decisional conflict and asthma control. Blinded assessors collected data. Between the two time points, the within- and between-group changes were estimated by generalized linear mixed models. Results Fifty-one participants (response rate: 53%; age: 44 ± 13 years; women: n = 32) were randomized either to the education + DA group (n = 26) or to the education group (n = 25), and included in statistical analyses. Between baseline and follow-up, mean [95% CI] knowledge scores increased from 21.5 [19.9–23.2] to 25.1 [23.1–27.0] in the education + DA group (P = 0.0002) and from 24.0 [22.3–25.7] to 26.0 [24.0–28.0] in the education group (P = 0.0298). In both of the groups, decisional conflict and asthma control improved. There were no differences between groups. Conclusions Education improved knowledge, decisional conflict, and asthma control whether the DA was added or not. PMID:28107540

  10. Kaatsu training to enhance physical function of older adults with knee osteoarthritis: Design of a randomized controlled trial

    PubMed Central

    Buford, Thomas W.; Fillingim, Roger B.; Manini, Todd M.; Sibille, Kimberly T.; Vincent, Kevin R.; Wu, Samuel S.

    2015-01-01

    As the U.S. population ages, efficacious interventions are needed to manage pain and maintain physical function among older adults with osteoarthritis (OA). Skeletal muscle weakness is a primary contributory factor to pain and functional decline among persons with OA, thus interventions are needed that improve muscle strength. High-load resistance exercise is the best-known method of improving muscle strength; however high-compressive loads commonly induce significant joint pain among persons with OA. Thus interventions with low-compressive loads are needed which improve muscle strength while limiting joint stress. This study is investigating the potential of an innovative training paradigm, known as Kaatsu, for this purpose. Kaatsu involves performing low-load exercise while externally-applied compression partially restricts blood flow to the active skeletal muscle. The objective of this randomized, single-masked pilot trial is to evaluate the efficacy and feasibility of chronic Kaatsu training for improving skeletal muscle strength and physical function among older adults. Participants aged ≥ 60 years with physical limitations and symptomatic knee OA will be randomly assigned to engage in a 3-month intervention of either (1) center-based, moderate-load resistance training, or (2) Kaatsu training matched for overall workload. Study dependent outcomes include the change in 1) knee extensor strength, 2) objective measures of physical function, and 3) subjective measures of physical function and pain. This study will provide novel information regarding the therapeutic potential of Kaatsu training while also informing about the long-term clinical viability of the paradigm by evaluating participant safety, discomfort, and willingness to continually engage in the intervention. PMID:26111922

  11. A phase 2 trial of long-acting TransCon growth hormone in adult GH deficiency.

    PubMed

    Höybye, Charlotte; Pfeiffer, Andreas F H; Ferone, Diego; Christiansen, Jens Sandahl; Gilfoyle, David; Christoffersen, Eva Dam; Mortensen, Eva; Leff, Jonathan A; Beckert, Michael

    2017-04-01

    TransCon growth hormone is a sustained-release human growth hormone prodrug under development in which unmodified growth hormone is transiently linked to a carrier molecule. It is intended as an alternative to daily growth hormone in the treatment of growth hormone deficiency. This was a multi-center, randomized, open-label, active-controlled trial designed to compare the safety (including tolerability and immunogenicity), pharmacokinetics and pharmacodynamics of three doses of weekly TransCon GH to daily growth hormone (Omnitrope). Thirty-seven adult males and females diagnosed with adult growth hormone deficiency and stable on growth hormone replacement therapy for at least 3 months were, following a wash-out period, randomized (regardless of their pre-study dose) to one of three TransCon GH doses (0.02, 0.04 and 0.08 mg GH/kg/week) or Omnitrope 0.04 mg GH/kg/week (divided into 7 equal daily doses) for 4 weeks. Main outcomes evaluated were adverse events, immunogenicity and growth hormone and insulin-like growth factor 1 levels. TransCon GH was well tolerated; fatigue and headache were the most frequent drug-related adverse events and reported in all groups. No lipoatrophy or nodule formation was reported. No anti-growth hormone-binding antibodies were detected. TransCon GH demonstrated a linear, dose-dependent increase in growth hormone exposure without accumulation. Growth hormone maximum serum concentration and insulin-like growth factor 1 exposure were similar after TransCon GH or Omnitrope administered at comparable doses. The results suggest that long-acting TransCon GH has a profile similar to daily growth hormone but with a more convenient dosing regimen. These findings support further TransCon GH development.

  12. A Community-based Fitness and Mobility Exercise (FAME) Program for Older Adults with Chronic Stroke: a Randomized Controlled Trial

    PubMed Central

    Pang, Marco Y.C.; Eng, Janice J.; Dawson, Andrew S.; McKay, Heather A.; Harris, Jocelyn E.

    2011-01-01

    OBJECTIVES To examine the effects of a community-based group exercise program for older individuals with chronic stroke. DESIGN Prospective, single-blind, randomized controlled intervention trial. SETTING Intervention was community-based. Data collection was performed in a research laboratory located in a rehabilitation hospital. PARTICIPANTS Sixty-three older individuals (≥50 years) with a chronic stroke (post-stroke duration ≥ 1 year) who were living in the community. INTERVENTION Participants were randomized into intervention group (n=32) or control group (n=31). The intervention group underwent a Fitness and Mobility Exercise (FAME) program designed to improve cardiorespiratory fitness, mobility, leg muscle strength, balance and hip bone mineral density (BMD) (1-hour sessions, 3 sessions/week, for 19 weeks). The control group underwent a seated upper extremity program. MEASUREMENTS (1) cardiorespiratory fitness (maximal oxygen consumption), (2) mobility (Six Minute Walk Test), (3) leg muscle strength (isometric knee extension), (4) balance (Berg Balance Scale), (5) activity and participation (Physical Activity Scale for Individuals with Physical Disabilities) and (6) femoral neck BMD (Dual-energy X-ray absorptiometry). RESULTS The intervention group had significantly more gains in cardiorespiratory fitness, mobility, and paretic leg muscle strength than controls. Femoral neck BMD of the paretic leg was maintained in the intervention group whereas a significant decline of the same occurred in controls. There was no significant time × group interaction for balance, activity and participation, non-paretic leg muscle strength and non-paretic femoral neck BMD. CONCLUSION The FAME program is feasible and beneficial for improving some of the secondary complications resulting from physical inactivity in older adults living with stroke. It may serve as a good model of community-based fitness program for preventing secondary diseases in older adults living with

  13. Polymyositis - adult

    MedlinePlus

    ... rash is a sign of a similar condition, dermatomyositis . Common symptoms include: Muscle weakness in the shoulders ... in the treatment of refractory adult and juvenile dermatomyositis and adult polymyositis: a randomized, placebo-phase trial. ...

  14. Adult male circumcision with a circular stapler versus conventional circumcision: A prospective randomized clinical trial.

    PubMed

    Jin, X D; Lu, J J; Liu, W H; Zhou, J; Yu, R K; Yu, B; Zhang, X J; Shen, B H

    2015-06-01

    Male circumcision is the most frequently performed procedure by urologists. Safety and efficacy of the circumcision procedure requires continual improvement. In the present study, we investigated the safety and efficacy of a new male circumcision technique involving the use of a circular stapler. In total, 879 consecutive adult male patients were randomly divided into 2 groups: 441 underwent stapler circumcision, and 438 underwent conventional circumcision. The operative time, pain score, blood loss volume, healing time, treatment costs, and postoperative complications were compared between the two groups. The operative time and blood loss volume were significantly lower in the stapler group than in the conventional group (6.8 ± 3.1 vs 24.2 ± 3.2 min and 1.8 ± 1.8 vs 9.4 ± 1.5 mL, respectively; P<0.01 for both). The intraoperative and postoperative pain scores were significantly lower in the stapler group than in the conventional group (0.8 ± 0.5 vs 2.4 ± 0.8 and 4.0 ±0.9 vs 5.8 ± 1.0, respectively; P<0.01 for both). Additionally, the stapler group had significantly fewer complications than the conventional group (2.7% vs 7.8%, respectively; P<0.01). However, the treatment costs in the stapler group were much higher than those in the conventional group (US$356.60 ± 8.20 vs US$126.50 ± 7.00, respectively; P<0.01). Most patients (388/441, 88.0%) who underwent stapler circumcision required removal of residual staple nails. Overall, the present study has shown that stapler circumcision is a time-efficient and safe male circumcision technique, although it requires further improvement.

  15. 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

  16. A randomized single blind crossover trial comparing leather and commercial wrist splints for treating chronic wrist pain in adults

    PubMed Central

    Thiele, Jill; Nimmo, Rachel; Rowell, Wendy; Quinn, Stephen; Jones, Graeme

    2009-01-01

    Background To compare the effectiveness of a custom-made leather wrist splint (LS) with a commercially available fabric splint (FS) in adults with chronic wrist pain. Methods Participants (N = 25, mean age = 54) were randomly assigned to treatment order in a 2-phase crossover trial. Splints were worn for 2 weeks, separated by a one-week washout period. Outcomes were assessed at baseline and after each splint phase using the Australian/Canadian Osteoarthritis Hand Index (AUSCAN), the Canadian Occupational Performance Measure (COPM) and Jamar dynamometer by an observer blinded to treatment allocation. Results Both styles of wrist splint significantly reduced pain (effect size LS 0.79, FS 0.43), improved hand function and increased grip strength compared to baseline (all p < 0.05) with no increase in wrist stiffness. There was a consistent trend for the LS to be superior to the FS but this was statistically significant only for patient perceived occupational performance (p = 0.008) and satisfaction (p = 0.015). Lastly, 72% of patients preferred the custom-made leather splint compared to the commercially available splint. Conclusion Leather wrist splints were superior to a commercially available fabric splint for the short-term relief of pain and dysfunction. PMID:19843345

  17. Dietary Patterns and Blood Pressure in Adults: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

    PubMed

    Ndanuko, Rhoda N; Tapsell, Linda C; Charlton, Karen E; Neale, Elizabeth P; Batterham, Marijka J

    2016-01-01

    Hypertension is a major risk factor for developing cardiovascular disease, stroke, and kidney disease. To lower blood pressure (BP), several lifestyle changes are recommended such as weight loss, exercise, and following a healthy diet. Investigating the effect of single nutrients may have positive results, but food is consumed as part of a whole diet, resulting in nutrient interactions. The aim of this systematic review and meta-analysis was to assess the effect of dietary patterns on BP in adults. Studies that were published between January 1999 and June 2014 were retrieved using Scopus, Web of Science, and the MEDLINE database. Seventeen randomized controlled trials were included in the meta-analysis. The results suggest that healthy dietary patterns such as the Dietary Approaches to Stop Hypertension diet, Nordic diet, and Mediterranean diet significantly lowered systolic BP and diastolic BP by 4.26 mm Hg and 2.38 mm Hg, respectively. These diets are rich in fruit, vegetables, whole grains, legumes, seeds, nuts, fish, and dairy and low in meat, sweets, and alcohol. Lifestyle factors such as exercise and weight loss in combination with dietary changes may also reduce BP. Further research is needed to establish the effect of dietary patterns on BP in different cultures other than those identified in this review. The review was registered on PROSPERO (International prospective register of systematic reviews) as CRD42015016272.

  18. Effect of Bifidobacterium animalis ssp. lactis GCL2505 on visceral fat accumulation in healthy Japanese adults: a randomized controlled trial

    PubMed Central

    TAKAHASHI, Shota; ANZAWA, Daisuke; TAKAMI, Kazuyo; ISHIZUKA, Akihiro; MAWATARI, Takashi; KAMIKADO, Kohei; SUGIMURA, Haruhi; NISHIJIMA, Tomohiko

    2016-01-01

    Bifidobacterium animalis ssp. lactis GCL2505 (B. lactis GCL2505) is able to survive passage through the intestine and then proliferate, leading to an increase in the amount of gut bifidobacteria. In the present study, we evaluated the impact of B. lactis GCL2505 on abdominal visceral fat storage in overweight and mildly obese Japanese adults. This clinical study was a double-blind, randomized, placebo-controlled, parallel-group comparative trial performed for 12 weeks. Healthy Japanese subjects (N=137) with body mass indices ranging from 23 to 30 kg/m2 consumed either fermented milk containing B. lactis GCL2505 or a placebo every day, and then visceral and subcutaneous abdominal fat areas were measured by computed tomography as the primary endpoints. The number of fecal bifidobacteria was also measured. Visceral fat area, but not subcutaneous fat area, was significantly reduced from baseline at 8 and 12 weeks in the GCL2505 group, compared with the placebo group. The total number of fecal bifidobacteria was significantly increased in the GCL2505 group. These results indicate that B. lactis GCL2505 reduces abdominal visceral fat, a key factor associated with metabolic disorders. This finding suggests that this probiotic strain can potentially serve as a specific functional food to achieve visceral fat reduction in overweight or mildly obese individuals. PMID:27867803

  19. A new method of infrared thermography for quantification of brown adipose tissue activation in healthy adults (TACTICAL): a randomized trial.

    PubMed

    Ang, Qi Yan; Goh, Hui Jen; Cao, Yanpeng; Li, Yiqun; Chan, Siew-Pang; Swain, Judith L; Henry, Christiani Jeyakumar; Leow, Melvin Khee-Shing

    2017-05-01

    The ability to alter the amount and activity of brown adipose tissue (BAT) in human adults is a potential strategy to manage obesity and related metabolic disorders associated with food, drug, and environmental stimuli with BAT activating/recruiting capacity. Infrared thermography (IRT) provides a non-invasive and inexpensive alternative to the current methods (e.g. (18)F-FDG PET) used to assess BAT. We have quantified BAT activation in the cervical-supraclavicular (C-SCV) region using IRT video imaging and a novel image computational algorithm by studying C-SCV heat production in healthy young men after cold stimulation and the ingestion of capsinoids in a prospective double-blind placebo-controlled randomized trial. Subjects were divided into low-BAT and high-BAT groups based on changes in IR emissions in the C-SCV region induced by cold. The high-BAT group showed significant increases in energy expenditure, fat oxidation, and heat output in the C-SCV region post-capsinoid ingestion compared to post-placebo ingestion, but the low-BAT group did not. Based on these results, we conclude that IRT is a promising tool for quantifying BAT activity.

  20. Dietary Patterns and Blood Pressure in Adults: A Systematic Review and Meta-Analysis of Randomized Controlled Trials12

    PubMed Central

    Tapsell, Linda C; Batterham, Marijka J

    2016-01-01

    Hypertension is a major risk factor for developing cardiovascular disease, stroke, and kidney disease. To lower blood pressure (BP), several lifestyle changes are recommended such as weight loss, exercise, and following a healthy diet. Investigating the effect of single nutrients may have positive results, but food is consumed as part of a whole diet, resulting in nutrient interactions. The aim of this systematic review and meta-analysis was to assess the effect of dietary patterns on BP in adults. Studies that were published between January 1999 and June 2014 were retrieved using Scopus, Web of Science, and the MEDLINE database. Seventeen randomized controlled trials were included in the meta-analysis. The results suggest that healthy dietary patterns such as the Dietary Approaches to Stop Hypertension diet, Nordic diet, and Mediterranean diet significantly lowered systolic BP and diastolic BP by 4.26 mm Hg and 2.38 mm Hg, respectively. These diets are rich in fruit, vegetables, whole grains, legumes, seeds, nuts, fish, and dairy and low in meat, sweets, and alcohol. Lifestyle factors such as exercise and weight loss in combination with dietary changes may also reduce BP. Further research is needed to establish the effect of dietary patterns on BP in different cultures other than those identified in this review. The review was registered on PROSPERO (International prospective register of systematic reviews) as CRD42015016272. PMID:26773016

  1. Predictors of Retention Among African American and Hispanic Older Adult Research Participants in the Well Elderly 2 Randomized Controlled Trial

    PubMed Central

    Carlson, Mike; Jackson, Jeanne; Mandel, Deborah; Blanchard, Jeanine; Holguin, Jess; Lai, Mei-Ying; Marterella, Abbey; Vigen, Cheryl; Gleason, Sarah; Lam, Claudia; Azen, Stan; Clark, Florence

    2017-01-01

    The purpose of this study was to document predictors of long-term retention among minority participants in the Well Elderly 2 Study, a randomized controlled trial of a lifestyle intervention for community-dwelling older adults. The primary sample included 149 African American and 92 Hispanic men and women aged 60–95 years, recruited at senior activity centers and senior residences. Chi-square and logistic regression procedures were undertaken to examine study-based, psychosocial, and health-related predictors of retention at 18 months following study entry. For both African Americans and Hispanics, intervention adherence was the strongest predictor. Retention was also related to high active coping and average (vs. high or low) levels of activity participation among African Americans and high social network strength among Hispanics. The results suggest that improved knowledge of the predictors of retention among minority elders can spawn new retention strategies that can be applied at individual, subgroup, and sample-wide levels. PMID:24652865

  2. Comparing tailored and narrative worksite interventions at increasing colonoscopy adherence in adults 50-75: a randomized controlled trial.

    PubMed

    Jensen, Jakob D; King, Andy J; Carcioppolo, Nick; Krakow, Melinda; Samadder, N Jewel; Morgan, Susan

    2014-03-01

    Research has identified several communication strategies that could increase adherence to colorectal cancer screening recommendations. Two promising strategies are tailoring and narrative-based approaches. Tailoring is the personalization of information based on individual characteristics. Narrative-based approaches use stories about similar others to counter perceived barriers and cultivate self-efficacy. To compare these two approaches, a randomized controlled trial was carried out at 8 worksites in Indiana. Adults 50-75 (N = 209) received one of four messages about colorectal cancer screening: stock, narrative, tailored, tailored narrative. The primary outcome was whether participants filed a colonoscopy claim in the 18 months following the intervention. Individuals receiving narrative messages were 4 times more likely to screen than those not receiving narrative messages. Tailoring did not increase screening behavior overall. However, individuals with higher cancer information overload were 8 times more likely to screen if they received tailored messages. The results suggest that narrative-based approaches are more effective than tailoring at increasing colorectal cancer screening in worksite interventions. Tailoring may be valuable as a strategy for reaching individuals with high overload, perhaps as a follow-up effort to a larger communication campaign.

  3. Phase IV: randomized controlled trial to evaluate lot consistency of trivalent split influenza vaccines in healthy adults.

    PubMed

    Song, Joon Young; Cheong, Hee Jin; Lee, Jacob; Wie, Seong-Heon; Park, Kyung-Hwa; Kee, Sae Yoon; Jeong, Hye Won; Kim, Yeon-Sook; Noh, Ji Yun; Choi, Won Suk; Park, Dae Won; Sohn, Jang Wook; Kim, Woo Joo

    2014-01-01

    Influenza vaccines are the primary method for preventing influenza and its complications. Considering the increasing demand for influenza vaccines, vaccine manufacturers are required to establish large-scale production systems. This phase IV randomized trial was conducted to evaluate the lot consistency of trivalent split influenza vaccines regarding immunogenicity and safety. A total of 1,023 healthy adults aged 18-64 y were enrolled in the study. Subjects were randomly assigned in a 1:1 ratio to receive the GC FLU® Prefilled Syringe or the GC FLU® Injection, and they were further randomized to one of 3 lots of each vaccine in a 1:1:1 ratio. In both GC FLU® Injection and GC FLU® Prefilled Syringe groups, immune responses were equivalent between lots for each of the 3 vaccine strains on day 21. The 2-sided 95% CI of GMT ratios between pairs of lots were between 0.67 and 1.5, meeting the equivalence criteria. After vaccination, all 3 criteria of the European Medicines Agency were met in both GC FLU® Injection and GC FLU® Prefilled Syringe groups. The vaccines showed tolerable safety profiles without serious adverse events. The demonstration of lot consistency, robust immunogenic responses and favorable safety profiles support the reliability of mass-manufacturing systems for the GC FLU® Injection and GC FLU® Prefilled Syringe.

  4. Prospective clinical trial of hepatitis B vaccination in adults with and without type-2 diabetes mellitus

    PubMed Central

    Van Der Meeren, Olivier; Peterson, James T.; Dionne, Marc; Beasley, Richard; Ebeling, Peter R.; Ferguson, Murdo; Nissen, Michael D.; Rheault, Paul; Simpson, Richard W.; De Ridder, Marc; Crasta, Priya D.; Miller, Jacqueline M.; Trofa, Andrew F.

    2016-01-01

    ABSTRACT  Objective: Patients with diabetes mellitus are at increased risk for hepatitis B virus (HBV) infection and its complications. HBV vaccination is recommended for adults with diabetes in the United States and other countries. However, few studies have assessed safety and immunogenicity of hepatitis B vaccine in such patients. We assessed the safety and immunogenicity of recombinant hepatitis B vaccine in subjects with and without diabetes mellitus. Methods: Prospective, multi-country controlled study in 21 centers (www.clinicaltrials.gov NCT01627340). Four hundred and sixteen participants with Type-2 diabetes and 258 controls matched for age and body mass index (BMI) (2:1 ratio) received 3-doses of HBV vaccine (Engerix-B™, GSK Vaccines, Belgium) according to a 0, 1, 6 months schedule. Antibodies were measured against HBV surface antigen and expressed as seroprotection rates (anti-HBs ≥10mIU/mL) and geometric mean concentration (GMC). Results: The median age and BMI in patients with diabetes and controls (according-to-protocol cohort) were 54 y and 32.1 kg/m2, and 53 y and 30.8 kg/m2, respectively. Seroprotection rates (GMCs) one month post-dose-3 were 75.4% (147.6 mIU/mL) and 82.0% (384.2 mIU/mL) in patients with diabetes and controls, respectively. Age-stratified seroprotection rates for patients with diabetes were 88.5% (20–39 years), 81.2% (40–49 years), 83.2% (50–59 years), and 58.2% (≥60 years). The overall safety profile of hepatitis B vaccine was similar between groups. Conclusions: Hepatitis B vaccine is immunogenic in patients with diabetes and has a similar safety profile to vaccination in healthy controls. Because increasing age was generally associated with a reduction in seroprotection rates, hepatitis B vaccine should be administered as soon as possible after the diagnosis of diabetes. PMID:27123743

  5. Effect of the Web-Based Intervention MyPlan 1.0 on Self-Reported Fruit and Vegetable Intake in Adults Who Visit General Practice: A Quasi-Experimental Trial

    PubMed Central

    Crombez, Geert; Van der Mispel, Celien; Verloigne, Maite; Van Stappen, Vicky; De Bourdeaudhuij, Ilse

    2016-01-01

    conducted in MLwiN. Results A total of 426 adults initially agreed to participate (control group: n=149; GPs’ intervention group: n=41; researchers’ intervention group: n=236). A high attrition rate was observed in both intervention groups (71.8%, 199/277) and in the control group (59.1%, 88/149). In comparison to no change in the control group, both the GPs’ intervention group (fruit: χ2 1=10.9, P=.004; vegetable: χ2 1=5.3, P=.02) and the researchers’ intervention group (fruit: χ2 1=18.0, P=.001; vegetable: χ2 1=12.8, P<.001) increased their intake of fruit and vegetables. Conclusions A greater increase in fruit and vegetable intake was found when the Web-based intervention MyPlan 1.0 was used compared to usual care of health promotion in general practice (ie, flyers with general information). However, further investigation on which (or combinations of which) behavior change techniques are effective, how to increase response rates, and the influence of delivery mode in routine practice is required. Trial Registration ClinicalTrials.gov NCT02211040; https://clinicaltrials.gov/ct2/show/NCT02211040 (Archived by WebCite® at http://www.webcitation.org/6f8yxTRii) PMID:26929095

  6. A Prospective Open-Label Trial of Memantine Hydrochloride for the Treatment of Social Deficits in Intellectually Capable Adults With Autism Spectrum Disorder.

    PubMed

    Joshi, Gagan; Wozniak, Janet; Faraone, Stephen V; Fried, Ronna; Chan, James; Furtak, Stephannie; Grimsley, Emily; Conroy, Kristina; Kilcullen, J Ryan; Woodworth, K Yvonne; Biederman, Joseph

    2016-06-01

    This prospective 12-week open-label trial evaluates the tolerability and efficacy of memantine hydrochloride for the treatment of core social and cognitive deficits in adults with high-functioning autism spectrum disorder (ASD). Measures for assessment of therapeutic response included the Social Responsiveness Scale-Adult Research Version (SRS-A), disorder-specific Clinical Global Impression scales, Behavior Rating Inventory of Executive Functioning-Adult Self-Report, Diagnostic Analysis of Nonverbal Accuracy Scale, and Cambridge Neuropsychological Test Automated Battery. Eighteen adults (mean age, 28 ± 9.5 years) with high-functioning ASD (SRS-A raw score, 99 ± 17) were treated with memantine (mean dose, 19.7 ± 1.2 mg/d; range, 15-20 mg), and 17 (94%) completed the trial. Treatment with memantine was associated with significant reduction on informant-rated (SRS-A, -28 ± 25; P < 0.001) and clinician-rated (Clinical Global Impression-Improvement subscale ≤2, 83%) measures of autism severity. In addition, memantine treatment was associated with significant improvement in ADHD and anxiety symptom severity. Significant improvement was noted in nonverbal communication on the Diagnostic Analysis of Nonverbal Accuracy Scale test and in executive function per self-report (Behavior Rating Inventory of Executive Functioning-Adult Self-Report Global Executive Composite, -6 ± 8.8; P < 0.015) and neuropsychological assessments (Cambridge Neuropsychological Test Automated Battery). Memantine treatment was generally well tolerated and was not associated with any serious adverse events. Treatment with memantine appears to be beneficial for the treatment of ASD and associated psychopathology and cognitive dysfunction in intellectually capable adults. Future placebo-controlled trials are warranted.

  7. Efficacy and cost-effectiveness of a web-based intervention with mobile phone support to treat depressive symptoms in adults with diabetes mellitus type 1 and type 2: design of a randomised controlled trial

    PubMed Central

    2013-01-01

    Background A diagnosis of diabetes mellitus types 1 or 2 doubles the odds of a comorbid depressive disorder. The combined diseases have a wide range of adverse outcomes, such as a lower quality of life, poorer diabetes outcomes and increased healthcare utilisation. Diabetes patients with depression can be treated effectively with psychotherapy, but access to psychological care is limited. In this study we will examine the efficacy and cost-effectiveness of a newly developed web-based intervention (GET.ON Mood Enhancer Diabetes) for people with diabetes and comorbid depressive symptoms. Methods/Design A two-arm randomised controlled trial will be conducted. Adults with diabetes (type 1 or type 2) with increased depression scores (> 22 on the German version of the Center for Epidemiological Studies Depression Scale (CES-D)) will be included. Eligible participants will be recruited through advertisement in diabetes patient journals and via a large-scale German health insurance company. The participants will be randomly assigned to either a 6-week minimally guided web-based self-help program or an online psychoeducation program on depression. The study will include 260 participants, which will enable us to detect a statistically significant difference with a group effect size of d = 0.35 at a power of 80% and a significance level of p = 0.05. The primary outcome measure will be the level of depression as assessed by the CES-D. The secondary outcome measures will be: diabetes-specific emotional distress, glycaemic control, self-management behaviour and the participants’ satisfaction with the intervention. Online self-assessments will be collected at baseline and after a 2 months period, with additional follow-up measurements 6 and 12 months after randomisation. The data will be analysed on an intention-to-treat basis and per protocol. In addition, we will conduct an economic evaluation from a societal perspective. Discussion If this intervention is shown to be

  8. Efficacy of high doses of oral penicillin versus amoxicillin in the treatment of adults with non-severe pneumonia attended in the community: study protocol for a randomised controlled trial

    PubMed Central

    2013-01-01

    Background Streptococcus pneumoniae is the bacterial agent which most frequently causes pneumonia. In some Scandinavian countries, this infection is treated with penicillin V since the resistances of pneumococci to this antibiotic are low. Four reasons justify the undertaking of this study; firstly, the cut-off points which determine whether a pneumococcus is susceptible or resistant to penicillin have changed in 2008 and according to some studies published recently the pneumococcal resistances to penicillin in Spain have fallen drastically, with only 0.9% of the strains being resistant to oral penicillin (minimum inhibitory concentration>2 μg/ml); secondly, there is no correlation between pneumococcal infection by a strain resistant to penicillin and therapeutic failure in pneumonia; thirdly, the use of narrow-spectrum antibiotics is urgently needed because of the dearth of new antimicrobials and the link observed between consumption of broad-spectrum antibiotics and emergence and spread of antibacterial resistance; and fourthly, no clinical study comparing amoxicillin and penicillin V in pneumonia in adults has been published. Our aim is to determine whether high-dose penicillin V is as effective as high-dose amoxicillin for the treatment of uncomplicated community-acquired pneumonia. Methods We will perform a parallel group, randomised, double-blind, trial in primary healthcare centres in Spain. Patients aged 18 to 65 without significant associated comorbidity attending the physician with signs and symptoms of lower respiratory tract infection and radiological confirmation of the diagnosis of pneumonia will be randomly assigned to either penicillin V 1.6 million units thrice-daily during 10 days or amoxicillin 1,000 mg thrice-daily during 10 days. The main outcome will be clinical cure at 14 days, defined as absence of fever, resolution or improvement of cough, improvement of general wellbeing and resolution or reduction of crackles indicating that no

  9. A multicenter randomized controlled trial for bright light therapy in adults with intellectual disabilities and depression: Study protocol and obstacle management.

    PubMed

    Hamers, Pauline C M; Evenhuis, Heleen M; Hermans, Heidi

    2017-01-01

    Due to the limited cognitive and communicative abilities of adults with intellectual disabilities (ID), current treatment options for depression are often limited to lifestyle changes and pharmacological treatment. Bright light therapy (BLT) is an effective intervention for both seasonal and non-seasonal depression in the general population. BLT is an inexpensive, easy to carry out intervention with minimal side effects. However, knowledge on its anti-depressant effect in adults with ID is lacking. Obstacles in realizing a controlled intervention study in this particular study population may have contributed to this lack. To study the effect of BLT on depression in this population, it is necessary to successfully execute a multicenter randomized controlled trial (RCT). Therefore, the study protocol and the management of anticipated obstacles regarding this trial are presented.

  10. Safety and tolerability of atomoxetine in treatment of attention deficit hyperactivity disorder in adult patients: an integrated analysis of 15 clinical trials.

    PubMed

    Camporeale, Angelo; Porsdal, Vibeke; De Bruyckere, Katrien; Tanaka, Yoko; Upadhyaya, Himanshu; Deix, Claudia; Deberdt, Walter

    2015-01-01

    The safety profile of atomoxetine in the treatment of attention deficit hyperactivity disorder has been studied in many clinical trials. We performed an integrated safety analysis of 15 clinical trials in adults with attention deficit hyperactivity disorder. The analysis pooled patient data into three groups: acute placebo-controlled trials; long-term placebo-controlled trials; all trials. In total, 4829 adults (18-77 years, median: 36 years) were exposed to atomoxetine. Statistically significantly more atomoxetine-treated than placebo-treated patients experienced treatment-emergent adverse events (81.3% vs. 68.3% acute; 90.6% vs. 76.8% long term) and discontinued due to adverse events (8.9% vs. 4.0% acute; 17.9% vs. 6.3% long term). No statistically significant differences were observed in the proportion of patients experiencing serious adverse events. No previously unknown adverse events were identified. The most common adverse events included nausea, dry mouth, decreased appetite, insomnia and erectile dysfunction. Mean increases in heart rate (+5.2 beats per min) and blood pressure (systolic +2 mmHg, diastolic +1.9 mmHg) were modest. The proportion of patients experiencing clinically significant increases in blood pressure and heart rate at any time was statistically significantly higher with atomoxetine (systolic blood pressure 13-17%, diastolic blood pressure 37-40%, heart rate 42-43%) compared to placebo (systolic blood pressure 8-13%, diastolic blood pressure 29-34%, heart rate 21-26%). There was no increased risk of suicidal ideation or behaviour. Our findings confirm atomoxetine's known safety profile. From a safety perspective, atomoxetine is a useful treatment option for adults with attention deficit hyperactivity disorder.

  11. Antimalarial efficacy of a quantified extract of Nauclea pobeguinii stem bark in human adult volunteers with diagnosed uncomplicated falciparum malaria. Part 1: a clinical phase IIA trial.

    PubMed

    Mesia, Kahunu; Tona, Lutete; Mampunza, Ma Miezi; Ntamabyaliro, Nsengi; Muanda, Tsobo; Muyembe, Tamfum; Cimanga, Kanyanga; Totté, Jozef; Mets, Tony; Pieters, Luc; Vlietinck, Arnold J

    2012-02-01

    The aim of this phase IIA clinical trial was to assess the efficacy of an 80 % ethanolic quantified extract (containing 5.6 % strictosamide as the putative active constituent) from Nauclea pobeguinii stem bark denoted as PR 259 CT1 in a small group of adult patients diagnosed with uncomplicated falciparum malaria. Results obtained from a phase I clinical trial on healthy male volunteers indicated that the oral administration during meals of two 500 mg capsules three times daily (each eight hours) during seven days was well tolerated and showed only mild and self-resolving adverse effects. This PR 259 CT1 drug regimen was obtained by mathematical conversion of animal doses obtained in several in vivo studies in mice to human equivalent doses as in falciparum malaria patients. The phase IIA study was an open cohort study in eleven appraisable adult patients suffering from proven Plasmodium falciparum malaria. The study was specifically designed to assess the efficacy of PR 259 CT1 administered with a dose regimen of two 500 mg capsules three times daily for three days, followed by outpatient treatment of one 500 mg capsule three times daily for the next four days, in order to prove that this therapeutic dose, which was calculated from animal doses, was effective to treat adult malaria patients and consequently useful for a future Phase IIB clinical trial. This study would then substitute a dose-escalating trial, which in general is used to find the appropriate dose for clinical studies. The phase IIA clinical trial was carried out according to the WHO 2003 14-day test, and the results revealed that all eleven patients were completely cleared of parasitemia and fever on days 3, 7, and 14 except for one patient, who experienced a recurrence of parasitemia at days 7 until 14. Besides this adequate clinical and parasitological response (ACPR), this trial also demonstrated that PR 259 CT1 was well tolerated with only mild and self-resolving adverse effects

  12. Collaborative Depression Treatment in Older and Younger Adults with Physical Illness: Pooled Comparative Analysis of Three Randomized Clinical Trials

    PubMed Central

    Ell, Kathleen; Aranda, María P.; Xie, Bin; Lee, Pey-Jiuan; Chou, Chih-Ping

    2010-01-01

    Objective There have been few comparisons of the effectiveness of collaborative depression care between older versus younger adults with co-morbid illness, particularly among low-income populations. Design Intent-to-treat analyses are conducted on pooled data from three randomized controlled trials that tested collaborative care aimed at improving depression, quality of life and treatment receipt. Settings Trials were conducted in oncology and primary care safety net clinics and diverse home health care programs. Participants 1,081 patients with major depressive symptoms and cancer, diabetes or other co-morbid illness. Intervention Similar intervention protocols included patient, provider, socio-cultural and organizational adaptations. Measurements The PHQ-9 depression, SF-12/20 quality-of-life, self-reported hospitalization, ER, ICU utilization, and antidepressant, psychotherapy treatment receipt are assessed at baseline, 6, 12 months. Results There are no significant differences in reducing depression symptoms (P ranged 0.18-0.58), improving quality-of-life (t=1.86, df=669, P=0.07 for physical functioning at 12 months; and P ranged 0.23-0.99 for all others) between patients ≥60 versus 18-59. Both age group intervention patients have significantly higher rates of a 50% PHQ-9 reduction (older: Wald χ2[df=1]=4.82, p=0.03; younger: Wald χ2[df=1]=6.47, p=0.02), greater reduction in major depression rates (older: Wald χ2[df=1]=7.72, p=0.01; younger: Wald χ2[df=1]=4.0, p=0.05) than enhanced-usual-care patients at 6 months, and are no significant age group differences in treatment type or intensity. Conclusion Collaborative depression care in individuals with co-morbid illness is as effective in reducing depression in older patients as younger patients, including among low-income, minority patients. Patient, provider, and organizational adaptations of depression care management models may contribute to positive outcomes. PMID:20220588

  13. Attitudes Toward Cancer Clinical Trial Participation in Young Adults with a History of Cancer and a Healthy College Student Sample: A Preliminary Investigation.

    PubMed

    Grigsby, Timothy J; Kent, Erin E; Montoya, Michael J; Sender, Leonard S; Morris, Rebecca A; Ziogas, Argyrios; Anton-Culver, Hoda

    2014-03-01

    Purpose: Adolescents and young adults (AYAs) aged 15-39 at diagnosis have very low cancer clinical trial accrual rates. To date, no studies have examined attitudes toward clinical trial participation in this age range to determine if certain individuals are less likely to enroll if offered participation. The current study assessed attitudes toward participation using the Cancer Treatment Subscale of the Attitudes toward Cancer Trials Scales. Methods: Data were collected from a sample of leukemia and lymphoma survivors (n=99) and a healthy college student sample (n=397). Following a principal components analysis, two subscales-Personal Barriers/Safety and Personal Benefits-were retained for analysis. Results: In the cancer survivor group, only 14 (13.3%) reported being offered participation in a cancer clinical trial, and only 8 of those 14 (7.6% of survivors) participated. Responses from leukemia and lymphoma survivors revealed no significant relationships between age, gender, race/ethnicity, clinical trial participation, insurance status, or social class with Personal Benefits or Personal Barriers/Safety. Healthy college females had more negative Personal Barriers/Safety attitudes compared to males after adjusting for race/ethnicity and social class (p=0.01), but no associations were present when examining Personal Benefits as an outcome. Conclusion: This preliminary investigation suggests that drivers of attitudes toward clinical trial participation in AYAs are not well understood and may impact cancer trial participation. Future work should focus on defining attitudes toward cancer clinical trials in the AYA population and developing interventions to increase awareness, knowledge, and positive attitudes toward participating in cancer research.

  14. Effects of an Oral Ghrelin Mimetic on Body Composition and Clinical Outcomes in Healthy Older Adults: A Randomized, Controlled Trial

    PubMed Central

    Nass, Ralf; Pezzoli, Suzan S.; Oliveri, Mary Clancy; Patrie, James T.; Harrell, Frank E.; Clasey, Jody L.; Heymsfield, Steven B.; Bach, Mark A.; Lee Vance, Mary; Thorner, Michael O.

    2009-01-01

    Background Growth hormone (GH) secretion and muscle mass decline from mid-puberty throughout life culminating in sarcopenia, frailty, decreased function and loss of independence. Objective Determine if an oral ghrelin mimetic (MK-677) would enhance GH secretion into the young adult range without serious adverse effects, prevent the decline of fat-free mass (FFM), and decrease abdominal visceral fat (AVF) in healthy older adults. Design Two-year, double-blind, randomized, placebo-controlled, modified-crossover clinical trial. Setting General Clinical Research Center study performed at a University Hospital. Participants Sixty-five healthy men and women (on or off hormone replacement therapy) ages 60-81. Intervention Oral administration of MK-677 (25 mg) or placebo once daily. Measurements Growth hormone and insulin-like growth factor-I (IGF-I); FFM and AVF were the primary endpoints after one year of treatment. Other endpoints: weight, fat mass, insulin sensitivity, lipid and cortisol levels, bone mineral density, limb lean and fat mass, isokinetic strength, function and quality of life; all endpoints were assessed at baseline and every 6 months. Limitations Study design (duration and subject number) not sufficient to evaluate functional endpoints in healthy elderly Results Daily MK-677 significantly increased GH and IGF-I levels to those of healthy young adults without serious adverse effects. With placebo, mean (95% Cl) FFM decreased -0.5 (-1.1 to 0.2) kg, however, FFM increased 1.1 (0.7 to 1.5) kg with MK-677 (P<0.001, MK-677 vs. placebo); body cell mass as reflected by intracellular water decreased -1.0 (-2.1 to 0.2) kg with placebo, but increased 0.8 (-0.1 to 1.6) kg with MK-677 (P=0.021). There were no significant differences in AVF or total fat mass. However, the average increase in limb fat in the MK-677 group (1.1 kg) was greater than with placebo (0.24 kg); P=0.001. Body weight increased 0.8 (-0.3 to 1.8) kg with placebo and 2.7 (2.0 to 3.5) kg with MK-677

  15. Associations among environmental supports, physical activity, and blood pressure in African-American adults in the PATH trial.

    PubMed

    Coulon, Sandra M; Wilson, Dawn K; Egan, Brent M

    2013-06-01

    High blood pressure disproportionately affects African-American adults and is a leading cause of stroke and heart attack. Engaging in recommended levels of physical activity reduces blood pressure, and social and physical environmental supports for physical activity may increase engagement in physical activity. Based on social cognitive theory within a bioecological framework, the present study tested hypotheses that perceived peer social support for physical activity and neighborhood walkability would be positively associated with physical activity, and that physical activity would mediate their relation with blood pressure. Baseline data were collected with 434 African-American adults in underserved communities (low income, high crime) participating in the Positive Action for Today's Health (PATH) trial. Perceived peer social support for physical activity and neighborhood walkability were measured with validated surveys. Physical activity was assessed with 7-day accelerometry (moderate-to-vigorous physical activity, min/day) and with a 4-week recall of walking. Three blood pressure assessments were taken by trained staff using standard protocols, with values from the second and third assessments averaged. The sample was predominantly female (63%), overweight (mean body mass index = 30.9, SD = 8.4), and had slightly elevated blood pressures with a mean systolic blood pressure of 132.4 (SD = 17.9) and a mean diastolic blood pressure of 81.4 (SD = 11.0). Results demonstrated that peer social support for physical activity (B = 2.43, p = .02) and neighborhood walkability (B = 2.40, p = .046) were significantly related to average daily moderate-to-vigorous physical activity. Neighborhood walkability was also significantly associated with self-reported average daily walking (B = 8.86, p = .02). Physical activity did not mediate their relation with blood pressure and no significant direct effects of these variables on blood pressure were found. The positive influence of

  16. CSPP CDX Registration Guide

    EPA Pesticide Factsheets

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

  17. Lesson 6: Registration

    EPA Pesticide Factsheets

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

  18. Registration of Enlist Duo

    EPA Pesticide Factsheets

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

  19. 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...

  20. 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...

  1. 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...

  2. 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...

  3. 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...

  4. Determinants of Weight Gain Prevention in Young Adult and Midlife Women: Study Design and Protocol of a Randomized Controlled Trial

    PubMed Central

    2015-01-01

    Background Treatment of overweight and obesity through body weight reduction has been monumentally ineffective as few individuals are able to sustain weight loss. Rather than treating weight gain once it has become problematic, prevention of weight gain over time may be more effective. Objective The aim of this research is to preclude the burden of adult obesity in women by identifying the determinants of weight gain prevention. The objective of this randomized controlled trial (RCT) is to compare a weight gain prevention intervention delivered by the registered dietitian versus counselor. Methods This is a 12-month parallel-arm weight gain prevention RCT designed to increase self-efficacy, self-regulation, outcome expectations and family and social support through the use of a nutrition education intervention in women, aged 18-45 years, from the Urbana-Champaign (Illinois, USA) area. Women have been randomized to registered dietitian, counselor or wait-list control groups (August 2014) and are undergoing weekly nutrition education sessions for four months, followed by monthly sessions for eight months (through August 2015). Outcome measures, including: (1) dietary intake, (2) physical activity, (3) anthropometric and blood pressure measurements, (4) biochemical markers of health, (5) eating behaviors and health perceptions, and (6) mediators of behavior change, were collected before the intervention began (baseline) and will be collected at 3, 6, 9, and 12 months of the study. Results In total, 87 women have been randomized to intervention groups, and 81 women have completed first week of the study. Results are expected in early 2016. Conclusions This RCT is one of the first to examine weight gain prevention in women across normal, overweight, and obese body mass index categories. Results of this research are expected to have application to evidence-based practice in weight gain prevention for women and possibly have implication for policy regarding decreasing the

  5. Effective Treatment of Depressive Disorders in Medical Clinics for Adolescents and Young Adults living with HIV: A controlled trial

    PubMed Central

    Brown, Larry K.; Kennard, Betsy D.; Emslie, Graham J.; Mayes, Taryn L.; Whiteley, Laura B.; Bethel, James; Xu, Jiahong; Thornton, Sarah; Tanney, Mary R.; Hawkins, Linda A.; Garvie, Patricia A.; Subramaniam, Geetha A.; Worrell, Carol J.; Stoff, Laura W.

    2015-01-01

    Objective Preliminary test of a manualized, measurement-guided treatment for depression for adolescents and young adults in care at four sites of the Adolescent Trials Network for HIV/AIDS Interventions (ATN). Design The U.S. sites were randomly assigned to either a 24-week, combination cognitive behavioral therapy and medication management algorithm (COMB) tailored for youth living with HIV (YLWH) or to treatment as usual (TAU). Methods Youth at TAU sites had access to therapists and medication management as needed. COMB site clinicians were trained in the manualized intervention and participated in supervision calls to monitor intervention fidelity. Results Over the course of the study with 44 participants, those in COMB, compared to those in TAU, reported fewer depressive symptoms, p<0.01 (as measured by the Quick Inventory for Depression Symptomatology) and were more likely to be in remission, p<0.001, (65% vs.10% at week 24 end of treatment, and 71% vs. 7% at week 48 final follow-up). A greater proportion of COMB participants received psychotherapy (95% vs. 45%, p<0.001) and attended more sessions (12.6 vs. 5, p<0.001) than those in TAU. Viral load decreased in both groups and was associated (p<0.05) with reduction in depressive symptoms. Conclusions A 24-week manualized, measurement-guided psychotherapy and medication management algorithm tailored for YLWH was more effective in achieving and sustaining remission from depression than treatment as usual at HIV care clinic sites. Given observed treatment efficacy, this structured combination treatment could be disseminated to medical clinics in order to successfully treat YLWH, who are at particular risk for depression. PMID:26761270

  6. Lisdexamfetamine Dimesylate for Adults with Moderate to Severe Binge Eating Disorder: Results of Two Pivotal Phase 3 Randomized Controlled Trials

    PubMed Central

    McElroy, Susan L; Hudson, James; Ferreira-Cornwell, M Celeste; Radewonuk, Jana; Whitaker, Timothy; Gasior, Maria

    2016-01-01

    The efficacy and safety of lisdexamfetamine dimesylate (LDX) vs placebo in binge eating disorder (BED) was evaluated in two multicenter, double-blind, placebo-controlled trials. Adults (study 1, n=383; study 2, n=390) meeting DSM-IV-TR BED criteria were randomized (1:1) to placebo or LDX (50 or 70 mg/day) dose titration; optimized doses were maintained to the end of double-blind treatment (week 12/early termination). Change from baseline in binge eating days/week at weeks 11−12 (primary efficacy endpoint) was assessed with mixed-effects models for repeated measures. Secondary endpoints related to binge eating and medical parameters, safety, and treatment compliance were also assessed. Least squares mean (95% CI) treatment differences for change from baseline binge eating days/week at weeks 11–12 significantly favored LDX (study 1: –1.35 [–1.70, –1.01] study 2: –1.66 [–2.04, –1.28] both P<0.001). In both studies, treatment-emergent adverse events (TEAEs) reported by ⩾10% of LDX participants were dry mouth, insomnia, and headache. Serious TEAEs occurred in two (1.1%) placebo participants in each study and in three (1.6%) and one (0.6%) LDX participants in study 1 and study 2, respectively. Across studies, mean increases from baseline at week 12/early termination with LDX for pulse and systolic and diastolic blood pressure ranged from 4.41–6.31 b.p.m. and 0.2–1.45 and 1.06–1.83 mm Hg, respectively. LDX (50 and 70 mg/day) was superior to placebo in decreasing binge eating days/week from baseline and improving binge eating–related key secondary endpoints. Safety results appear consistent with the known safety profile of LDX. PMID:26346638

  7. Effectiveness of dietary interventions among adults of retirement age: a systematic review and meta-analysis of randomized controlled trials

    PubMed Central

    2014-01-01

    Background Retirement from work involves significant lifestyle changes and may represent an opportunity to promote healthier eating patterns in later life. However, the effectiveness of dietary interventions during this period has not been evaluated. Methods We undertook a systematic review of dietary interventions among adults of retirement transition age (54 to 70 years). Twelve electronic databases were searched for randomized controlled trials evaluating the promotion of a healthy dietary pattern, or its constituent food groups, with three or more months of follow-up and reporting intake of specific food groups. Random-effects models were used to determine the pooled effect sizes. Subgroup analysis and meta-regression were used to assess sources of heterogeneity. Results Out of 9,048 publications identified, 68 publications reporting 24 studies fulfilled inclusion criteria. Twenty-two studies, characterized by predominantly overweight and obese participants, were included in the meta-analysis. Overall, interventions increased fruit and vegetable (F&V) intake by 87.5 g/day (P <0.00001), with similar results in the short-to-medium (that is, 4 to 12 months; 85.6 g/day) and long-term (that is, 13 to 58 months; 87.0 g/day) and for body mass index (BMI) stratification. Interventions produced slightly higher intakes of fruit (mean 54.0 g/day) than of vegetables (mean 44.6 g/day), and significant increases in fish (7 g/day, P = 0.03) and decreases in meat intake (9 g/day, P <0.00001). Conclusions Increases in F&V intakes were positively associated with the number of participant intervention contacts. Dietary interventions delivered during the retirement transition are therefore effective, sustainable in the longer term and likely to be of public health significance. PMID:24712557

  8. Intensive lifestyle intervention improves physical function among obese adults with knee pain: findings from the Look AHEAD trial.

    PubMed

    Foy, Capri G; Lewis, Cora E; Hairston, Kristen G; Miller, Gary D; Lang, Wei; Jakicic, John M; Rejeski, W Jack; Ribisl, Paul M; Walkup, Michael P; Wagenknecht, Lynne E

    2011-01-01

    Lifestyle interventions have resulted in weight loss or improved physical fitness among individuals with obesity, which may lead to improved physical function. This prospective investigation involved participants in the Action for Health in Diabetes (Look AHEAD) trial who reported knee pain at baseline (n = 2,203). The purposes of this investigation were to determine whether an Intensive Lifestyle Intervention (ILI) condition resulted in improvement in self-reported physical function from baseline to 12 months vs. a Diabetes Support and Education (DSE) condition, and whether changes in weight or fitness mediated the effect of the ILI. Outcome measures included the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain, stiffness, and physical function subscales, and WOMAC summary score. ILI participants exhibited greater adjusted mean weight loss (s.e.) vs. DSE participants (-9.02 kg (0.48) vs. -0.78 kg (0.49); P < 0.001)). ILI participants also demonstrated more favorable change in WOMAC summary scores vs. DSE participants (β (s.e.) = -1.81 (0.63); P = 0.004). Multiple regression mediation analyses revealed that weight loss was a mediator of the effect of the ILI intervention on change in WOMAC pain, function, and summary scores (P < 0.001). In separate analyses, increased fitness also mediated the effect of the ILI intervention upon WOMAC summary score (P < 0.001). The ILI condition resulted in significant improvement in physical function among overweight and obese adults with diabetes and knee pain. The ILI condition also resulted in significant weight loss and improved fitness, which are possible mechanisms through which the ILI condition improved physical function.

  9. Intensive Lifestyle Intervention Improves Physical Function Among Obese Adults With Knee Pain: Findings From the Look AHEAD Trial

    PubMed Central

    Foy, Capri G.; Lewis, Cora E.; Hairston, Kristen G.; Miller, Gary D.; Lang, Wei; Jakicic, John M.; Rejeski, W. Jack; Ribisl, Paul M.; Walkup, Michael P.; Wagenknecht, Lynne E.

    2011-01-01

    Lifestyle interventions have resulted in weight loss or improved physical fitness among individuals with obesity, which may lead to improved physical function. This prospective investigation involved participants in the Action for Health in Diabetes (Look AHEAD) trial who reported knee pain at baseline (n = 2,203). The purposes of this investigation were to determine whether an Intensive Lifestyle Intervention (ILI) condition resulted in improvement in self-reported physical function from baseline to 12 months vs. a Diabetes Support and Education (DSE) condition, and whether changes in weight or fitness mediated the effect of the ILI. Outcome measures included the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain, stiffness, and physical function subscales, and WOMAC summary score. ILI participants exhibited greater adjusted mean weight loss (s.e.) vs. DSE participants (−9.02 kg (0.48) vs. −0.78 kg (0.49); P < 0.001)). ILI participants also demonstrated more favorable change in WOMAC summary scores vs. DSE participants (β (s.e.) = −1.81 (0.63); P = 0.004). Multiple regression mediation analyses revealed that weight loss was a mediator of the effect of the ILI intervention on change in WOMAC pain, function, and summary scores (P < 0.001). In separate analyses, increased fitness also mediated the effect of the ILI intervention upon WOMAC summary score (P < 0.001). The ILI condition resulted in significant improvement in physical function among overweight and obese adults with diabetes and knee pain. The ILI condition also resulted in significant weight loss and improved fitness, which are possible mechanisms through which the ILI condition improved physical function. PMID:20559303

  10. Effects of strength vs aerobic exercise on pain severity in adults with fibromyalgia: a randomized equivalence trial.

    PubMed

    Hooten, W Michael; Qu, Wenchun; Townsend, Cynthia O; Judd, Jeffrey W

    2012-04-01

    Strength training and aerobic exercise have beneficial effects on pain in adults with fibromyalgia. However, the equivalence of strengthening and aerobic exercise has not been reported. The primary aim of this randomized equivalence trial involving patients with fibromyalgia admitted to an interdisciplinary pain treatment program was to test the hypothesis that strengthening (n=36) and aerobic (n=36) exercise have equivalent effects (95% confidence interval within an equivalence margin ± 8) on pain, as measured by the pain severity subscale of the Multidimensional Pain Inventory. Secondary aims included determining the effects of strengthening and aerobic exercise on peak Vo(2) uptake, leg strength, and pressure pain thresholds. In an intent-to-treat analysis, the mean (± standard deviation) pain severity scores for the strength and aerobic groups at study completion were 34.4 ± 11.5 and 37.6 ± 11.9, respectively. The group difference was -3.2 (95% confidence interval, -8.7 to 2.3), which was within the equivalence margin of Δ8. Significant improvements in pain severity (P<.001), peak Vo(2) (P<.001), strength (P<.001), and pain thresholds (P<.001) were observed from baseline to week 3 in the intent-to-treat analysis; however, patients in the aerobic group (mean change 2.0 ± 2.6 mL/kg/min) experienced greater gains (P<.013) in peak Vo(2) compared to the strength group (mean change 0.4 ± 2.6 mL/kg/min). Knowledge of the equivalence and physiological effects of exercise have important clinical implications that could allow practitioners to target exercise recommendations on the basis of comorbid medical conditions or patient preference for a particular type of exercise. This study found that strength and aerobic exercise had equivalent effects on reducing pain severity among patients with fibromyalgia.

  11. Weight loss intervention for young adults using mobile technology: design and rationale of a randomized controlled trial – Cell phone Intervention for You (CITY)

    PubMed Central

    Batch, Bryan C.; Tyson, Crystal; Bagwell, Jacqueline; Corsino, Leonor; Intille, Stephen; Lin, Pao-Hwa; Lazenka, Tony; Bennett, Gary; Bosworth, Hayden B.; Voils, Corrine; Grambow, Steven; Sutton, Aziza; Bordogna, Rachel; Pangborn, Matthew; Schwager, Jenifer; Pilewski, Kate; Caccia, Carla; Burroughs, Jasmine; Svetkey, Laura P.

    2014-01-01

    Background The obesity epidemic has spread to young adults, leading to significant public health implications later in adulthood. Intervention in early adulthood may be an effective public health strategy for reducing the long-term health impact of the epidemic. Few weight loss trials have been conducted in young adults. It is unclear what weight loss strategies are beneficial in this population. Purpose To describe the design and rationale of the NHLBI-sponsored Cell Phone Intervention for You (CITY) study, which is a single center, randomized three-arm trial that compares the impact on weight loss of 1) a behavioral intervention that is delivered almost entirely via cell phone technology (Cell Phone group); and 2) a behavioral intervention delivered mainly through monthly personal coaching calls enhanced by self-monitoring via cell phone (Personal Coaching group), each compared to; 3) a usual care, advice-only control condition. Methods A total of 365 community-dwelling overweight/obese adults aged 18–35 years were randomized to receive one of these three interventions for 24 months in parallel group design. Study personnel assessing outcomes were blinded to group assignment. The primary outcome is weight change at 12 months. We hypothesize that each active intervention will cause more weight loss than the usual care condition. Study completion is anticipated in 2014. Conclusions If effective, implementation of the CITY interventions could mitigate the alarming rates of obesity in young adults through promotion of weight loss. PMID:24462568

  12. A randomized, open-label, multicenter trial for the safety and efficacy of adult mesenchymal stem cells after acute myocardial infarction.

    PubMed

    Lee, Jun-Won; Lee, Seung-Hwan; Youn, Young-Jin; Ahn, Min-Soo; Kim, Jang-Young; Yoo, Byung-Su; Yoon, Junghan; Kwon, Woocheol; Hong, In-Soo; Lee, Kyounghoon; Kwan, Jun; Park, Keum Soo; Choi, Donghoon; Jang, Yang Soo; Hong, Mun K

    2014-01-01

    Recent studies suggest that the intracoronary administration of bone marrow (BM)-derived mesenchymal stem cells (MSCs) may improve left ventricular function in patients with acute myocardial infarction (AMI). However, there is still argumentative for the safety and efficacy of MSCs in the AMI setting. We thus performed a randomized pilot study to investigate the safety and efficacy of MSCs in patients with AMI. Eighty patients with AMI after successful reperfusion therapy were randomly assigned and received an intracoronary administration of autologous BM-derived MSCs into the infarct related artery at 1 month. During follow-up period, 58 patients completed the trial. The primary endpoint was changes in left ventricular ejection fraction (LVEF) by single-photon emission computed tomography (SPECT) at 6 month. We also evaluated treatment-related adverse events. The absolute improvement in the LVEF by SPECT at 6 month was greater in the BM-derived MSCs group than in the control group (5.9% ± 8.5% vs 1.6% ± 7.0%; P=0.037). There was no treatment-related toxicity during intracoronary administration of MSCs. No significant adverse cardiovascular events occurred during follow-up. In conclusion, the intracoronary infusion of human BM-derived MSCs at 1 month is tolerable and safe with modest improvement in LVEF at 6-month follow-up by SPECT. (ClinicalTrials.gov registration number: NCT01392105).

  13. How did a Housing First intervention improve health and social outcomes among homeless adults with mental illness in Toronto? Two-year outcomes from a randomised trial

    PubMed Central

    O'Campo, Patricia; Stergiopoulos, Vicky; Nir, Pam; Levy, Matthew; Misir, Vachan; Chum, Antony; Arbach, Bouchra; Nisenbaum, Rosane; To, Matthew J; Hwang, Stephen W

    2016-01-01

    Objectives We studied the impact of a Housing First (HF) intervention on housing, contact with the justice system, healthcare usage and health outcomes among At Home/Chez Soi randomised trial participants in Toronto, a city with an extensive service network for social and health services for individuals who are experiencing homelessness and mental illness. Methods Participants identified as high needs were randomised to receive either the intervention which provided them with housing and supports by an assertive community treatment team (HF+ACT) or treatment as usual (TAU). Participants (N=197) had in-person interviews every 3 months for 2 years. Results The HF+ACT group spent more time stably housed compared to the TAU group with the mean difference between the groups of 45.8% (95% CI 37.1% to 54.4%, p<0.0001). Accounting for baseline differences, HF+ACT group showed significant improvements over TAU group for community functioning, selected quality-of-life subscales and arrests at some time points during follow-up. No differences between HF+ACT and TAU groups over the follow-up were observed for health service usage, community integration and substance use. Conclusions HF for individuals with high levels of need increased housing stability and selected health and justice outcomes over 2 years in a city with many social and health services. Trial registration number ISRCTN42520374. PMID:27619826

  14. Beneficial effects of citrus juice fermented with Lactobacillus plantarum YIT 0132 on atopic dermatitis: results of daily intake by adult patients in two open trials

    PubMed Central

    HARIMA-MIZUSAWA, Naomi; KAMACHI, Keiko; KANO, Mitsuyoshi; NOZAKI, Daisuke; UETAKE, Tatsuo; YOKOMIZO, Yuji; NAGINO, Takayuki; TANAKA, Akira; MIYAZAKI, Kouji; NAKAMURA, Shinichiro

    2015-01-01

    This study aimed to examine whether daily intake of citrus juice containing heat-killed Lactobacillus plantarum YIT 0132 (LP0132-fermented juice) alleviates symptoms of atopic dermatitis. This was a natural extension of our previous study in which LP0132 was shown to enhance IL-10 production in vitro and LP0132-fermented juice was found to alleviate symptoms and enhance quality of life (QOL) in patients with Japanese cedar pollinosis. In two open trials, Trial 1 and Trial 2, 32 and 18 adult patients with mild to moderate atopic dermatitis consumed LP0132-fermented juice for 8 weeks. Skin conditions and QOL were subjectively evaluated using Skindex-16 before intake of the juice (Pre-treatment), 8 weeks after starting intake (Treatment) and 8 weeks after termination of intake (Post-treatment). Blood parameters were also analyzed. Comparison of the Treatment and Post-treatment time points with the Pre-treatment time point revealed significant reductions in the Skindex-16 overall score and the 3 domain subscores (symptoms, emotions, and functioning domains) in both trials. Moreover, blood levels of eosinophil cationic protein (ECP), total immunoglobulin E (IgE) and specific IgEs for Japanese cedar and cypress pollen were significantly attenuated in Trial 2. The findings suggest that daily intake of citrus fermented juice containing heat-killed LP0132 has beneficial effects on symptoms and QOL in patients with mild to moderate atopic dermatitis due to an immunomodulatory effect via attenuation of IgE and ECP. PMID:26858928

  15. The acute and sub-chronic effects of cocoa flavanols on mood, cognitive and cardiovascular health in young healthy adults: a randomized, controlled trial

    PubMed Central

    Massee, Laura A.; Ried, Karin; Pase, Matthew; Travica, Nikolaj; Yoganathan, Jaesshanth; Scholey, Andrew; Macpherson, Helen; Kennedy, Greg; Sali, Avni; Pipingas, Andrew

    2015-01-01

    Cocoa supplementation has been associated with benefits to cardiovascular health. However, cocoa's effects on cognition are less clear. A randomized, placebo-controlled, double-blind clinical trial (n = 40, age M = 24.13 years, SD = 4.47 years) was conducted to investigate the effects of both acute (same-day) and sub-chronic (daily for four-weeks) 250 mg cocoa supplementation on mood and mental fatigue, cognitive performance and cardiovascular functioning in young, healthy adults. Assessment involved repeated 10-min cycles of the Cognitive Demand Battery (CDB) encompassing two serial subtraction tasks (Serial Threes and Sevens), a Rapid Visual Information Processing task, and a mental fatigue scale over the course of half an hour. The Swinburne University Computerized Cognitive Assessment Battery (SUCCAB) was also completed to evaluate cognition. Cardiovascular function included measuring both peripheral and central blood pressure and cerebral blood flow. At the acute time point, consumption of cocoa significantly improved self-reported mental fatigue and performance on the Serial Sevens task in cycle one of the CDB. No other significant effects were found. This trial was registered with the Australian and New Zealand Clinical Trial Registry (Trial ID: ACTRN12613000626763). Accessible via http://www.anzctr.org.au/TrialSearch.aspx?searchTxt=ACTRN12613000626763&ddlSearch=Registered. PMID:26042037

  16. Safety and immunogenicity of novel respiratory syncytial virus (RSV) vaccines based on the RSV viral proteins F, N and M2-1 encoded by simian adenovirus (PanAd3-RSV) and MVA (MVA-RSV); protocol for an open-label, dose-escalation, single-centre, phase 1 clinical trial in healthy adults

    PubMed Central

    Green, C A; Scarselli, E; Voysey, M; Capone, S; Vitelli, A; Nicosia, A; Cortese, R; Thompson, A J; Sande, C S; de Lara, Catherine; Klenerman, P; Pollard, A J

    2015-01-01

    Introduction Respiratory syncytial virus (RSV) infection causes respiratory disease throughout life, with infants and the elderly at risk of severe disease and death. RSV001 is a phase 1 (first-in-man), open-label, dose-escalation, clinical trial of novel genetic viral-vectored vaccine candidates PanAd3-RSV and modified vaccinia virus Ankara (MVA)-RSV. The objective of RSV001 is to characterise the (primary objective) safety and (secondary objective) immunogenicity of these vaccines in healthy younger and older adults. Methods and analysis Heterologous and homologous ‘prime’/boost combinations of PanAd3-RSV and single-dose MVA-RSV are evaluated in healthy adults. 40 healthy adults aged 18–50 years test one of four combinations of intramuscular (IM) or intranasal (IN) PanAd3-RSV prime and IM PanAd3 or IM MVA-RSV boost vaccination, starting at a low dose for safety. The following year an additional 30 healthy adults aged 60–75 years test either a single dose of IM MVA-RSV, one of three combinations of IN or IM PanAd3-RSV prime and PanAd3-RSV or MVA-RSV boost vaccination used in younger volunteers, and a non-vaccinated control group. Study participants are self-selected volunteers who satisfy the eligibility criteria and are assigned to study groups by sequential allocation. Safety assessment includes the daily recording of solicited and unsolicited adverse events for 1 week after vaccination, as well as visit (nursing) observations and safety bloods obtained at all scheduled attendances. Laboratory measures of RSV-specific humoral and cellular immune responses after vaccination will address the secondary end points. All study procedures are performed at the Centre for Clinical Vaccinology and Tropical Medicine (CCVTM), Oxford, UK. Ethics and dissemination RSV001 has clinical trial authorisation from the Medicines and Healthcare Products Regulatory Agency (MHRA) and ethics approval from NRES Berkshire (reference 13/SC/0023). All study procedures adhere

  17. Design of a Randomized Controlled Trial of a Web-Based Intervention to Reduce Cardiovascular Disease Risk Factors among Remote Reservation-Dwelling American Indian Adults with Type 2 Diabetes

    ERIC Educational Resources Information Center

    Henderson, Jeffrey A.; Chubak, Jessica; O'Connell, Joan; Ramos, Maria C.; Jensen, Julie; Jobe, Jared B.

    2012-01-01

    We describe a randomized controlled trial, the Lakota Oyate Wicozani Pi Kte (LOWPK) trial, which was designed to determine whether a Web-based diabetes and nutritional intervention can improve risk factors related to cardiovascular disease (CVD) among a group of remote reservation-dwelling adult American Indian men and women with type 2 diabetes…

  18. The effects of vitamin D and calcium supplementation on pancreatic beta cell function, insulin sensitivity and glycemia in adults at high risk for diabetes. The CaDDM Randomized Controlled Trial

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Suboptimal vitamin D and calcium status has been associated with higher risk of type 2 diabetes in observational studies but evidence from trials is lacking. The objective of this trial was to determine whether vitamin D supplementation, with or without calcium, improves glucose homeostasis in adult...

  19. Effectiveness of Senior Dance on risk factors for falls in older adults (DanSE): a study protocol for a randomised controlled trial

    PubMed Central

    Franco, Marcia R; Sherrington, Catherine; Tiedemann, Anne; Pereira, Leani S; Perracini, Monica R; Faria, Claudia R S; Pinto, Rafael Z; Pastre, Carlos M

    2016-01-01

    disseminated through publication in peer-reviewed journals and presentations at conferences. Trial registration number NCT02603523, Pre-results. PMID:28039296

  20. 14 CFR 47.15 - Registration number.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

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

  1. 14 CFR 47.15 - Registration number.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

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

  2. 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,...

  3. The MOSAIC study - comparison of the Maudsley Model of Treatment for Adults with Anorexia Nervosa (MANTRA) with Specialist Supportive Clinical Management (SSCM) in outpatients with anorexia nervosa or eating disorder not otherwise specified, anorexia nervosa type: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    -up period. However, the study has to contend with difficulties directly related to running a large multi-center randomized controlled trial and the psychopathology of AN. These issues are discussed. Trial Registration Current Controlled Trials ISRCTN67720902 - A Maudsley outpatient study of treatments for anorexia nervosa and related conditions. PMID:23721562

  4. Tavistock Adult Depression Study (TADS): a randomised controlled trial of psychoanalytic psychotherapy for treatment-resistant/treatment-refractory forms of depression

    PubMed Central

    2012-01-01

    -up for the proper evaluation of treatment outcome. This pushes at the limits of the design of randomised therapeutic trials. We discuss some of the consequent problems and suggest how they may be mitigated. Trial registration Current Controlled Trials ISRCTN40586372 PMID:22686185

  5. Can social dancing prevent falls in older adults? a protocol of the Dance, Aging, Cognition, Economics (DAnCE) fall prevention randomised controlled trial

    PubMed Central

    2013-01-01

    diversity in exercise programs targeting seniors recognises the heterogeneity of multicultural populations and may further increase the number of taking part in exercise. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12612000889853 The trial is now in progress with 12 villages already have been randomised. PMID:23675705

  6. Multi-institutional phase 2 clinical and pharmacogenomic trial of tipifarnib plus etoposide for elderly adults with newly diagnosed acute myelogenous leukemia

    PubMed Central

    Vener, Tatiana I.; Raponi, Mitch; Ritchie, Ellen K.; Smith, B. Douglas; Gore, Steven D.; Morris, Lawrence E.; Feldman, Eric J.; Greer, Jacqueline M.; Malek, Sami; Carraway, Hetty E.; Ironside, Valerie; Galkin, Steven; Levis, Mark J.; McDevitt, Michael A.; Roboz, Gail R.; Gocke, Christopher D.; Derecho, Carlo; Palma, John; Wang, Yixin; Kaufmann, Scott H.; Wright, John J.; Garret-Mayer, Elizabeth

    2012-01-01

    Tipifarnib (T) exhibits modest activity in elderly adults with newly diagnosed acute myelogenous leukemia (AML). Based on preclinical synergy, a phase 1 trial of T plus etoposide (E) yielded 25% complete remission (CR). We selected 2 comparable dose levels for a randomized phase 2 trial in 84 adults (age range, 70-90 years; median, 76 years) who were not candidates for conventional chemotherapy. Arm A (T 600 mg twice a day × 14 days, E 100 mg days 1-3 and 8-10) and arm B (T 400 mg twice a day × 14 days, E 200 mg days 1-3 and 8-10) yielded similar CR, but arm B had greater toxicity. Total CR was 25%, day 30 death rate 7%. A 2-gene signature of high RASGRP1 and low aprataxin (APTX) expression previously predicted for T response. Assays using blasts from a subset of 40 patients treated with T plus E on this study showed that AMLs with a RASGRP1/APTX ratio of more than 5.2 had a 78% CR rate and negative predictive value 87%. This ratio did not correlate with outcome in 41 patients treated with conventional chemotherapies. The next T-based clinical trials will test the ability of the 2-gene signature to enrich for T responders prospectively. This study is registered at www.clinicaltrials.gov as #NCT00602771. PMID:22001391

  7. Multi-institutional phase 2 clinical and pharmacogenomic trial of tipifarnib plus etoposide for elderly adults with newly diagnosed acute myelogenous leukemia.

    PubMed

    Karp, Judith E; Vener, Tatiana I; Raponi, Mitch; Ritchie, Ellen K; Smith, B Douglas; Gore, Steven D; Morris, Lawrence E; Feldman, Eric J; Greer, Jacqueline M; Malek, Sami; Carraway, Hetty E; Ironside, Valerie; Galkin, Steven; Levis, Mark J; McDevitt, Michael A; Roboz, Gail R; Gocke, Christopher D; Derecho, Carlo; Palma, John; Wang, Yixin; Kaufmann, Scott H; Wright, John J; Garret-Mayer, Elizabeth

    2012-01-05

    Tipifarnib (T) exhibits modest activity in elderly adults with newly diagnosed acute myelogenous leukemia (AML). Based on preclinical synergy, a phase 1 trial of T plus etoposide (E) yielded 25% complete remission (CR). We selected 2 comparable dose levels for a randomized phase 2 trial in 84 adults (age range, 70-90 years; median, 76 years) who were not candidates for conventional chemotherapy. Arm A (T 600 mg twice a day × 14 days, E 100 mg days 1-3 and 8-10) and arm B (T 400 mg twice a day × 14 days, E 200 mg days 1-3 and 8-10) yielded similar CR, but arm B had greater toxicity. Total CR was 25%, day 30 death rate 7%. A 2-gene signature of high RASGRP1 and low aprataxin (APTX) expression previously predicted for T response. Assays using blasts from a subset of 40 patients treated with T plus E on this study showed that AMLs with a RASGRP1/APTX ratio of more than 5.2 had a 78% CR rate and negative predictive value 87%. This ratio did not correlate with outcome in 41 patients treated with conventional chemotherapies. The next T-based clinical trials will test the ability of the 2-gene signature to enrich for T responders prospectively. This study is registered at www.clinicaltrials.gov as #NCT00602771.

  8. Therapist adherence in the strong without anorexia nervosa (SWAN) study: A randomized controlled trial of three treatments for adults with anorexia nervosa

    PubMed Central

    Andony, Louise J; Tay, Elaine; Allen, Karina L; Wade, Tracey D; Hay, Phillipa; Touyz, Stephen; McIntosh, Virginia VW; Treasure, Janet; Schmidt, Ulrike H; Fairburn, Christopher G; Erceg-Hurn, David M; Fursland, Anthea; Crosby, Ross D; Byrne, Susan M

    2015-01-01

    Objective To develop a psychotherapy rating scale to measure therapist adherence in the Strong Without Anorexia Nervosa (SWAN) study, a multi-center randomized controlled trial comparing three different psychological treatments for adults with anorexia nervosa. The three treatments under investigation were Enhanced Cognitive Behavioural Therapy (CBT-E), the Maudsley Anorexia Nervosa Treatment for Adults (MANTRA), and Specialist Supportive Clinical Management (SSCM). Method The SWAN Psychotherapy Rating Scale (SWAN-PRS) was developed, after consultation with the developers of the treatments, and refined. Using the SWAN-PRS, two independent raters initially rated 48 audiotapes of treatment sessions to yield inter-rater reliability data. One rater proceeded to rate a total of 98 audiotapes from 64 trial participants. Results The SWAN-PRS demonstrated sound psychometric properties, and was considered a reliable measure of therapist adherence. The three treatments were highly distinguishable by independent raters, with therapists demonstrating significantly more behaviors consistent with the actual allocated treatment compared to the other two treatment modalities. There were no significant site differences in therapist adherence observed. Discussion The findings provide support for the internal validity of the SWAN study. The SWAN-PRS was deemed suitable for use in other trials involving CBT-E, MANTRA, or SSCM. © 2015 The Authors. International Journal of Eating Disorders Published by Wiley Periodicals, Inc. (Int J Eat Disord 2015; 48:1170–1175) PMID:26769445

  9. Comparison of community health worker-led diabetes medication decision-making support for low-income Latino and African American adults with diabetes using e-Health tools versus print materials: A randomized controlled trial

    PubMed Central

    Heisler, Michele; Choi, Hwajung; Palmisano, Gloria; Mase, Rebecca; Richardson, Caroline; Fagerlin, Angela; Montori, Victor M.; Spencer, Michael; An, Laurence C.

    2015-01-01

    Background Health care centers serving low-income communities have scarce resources to support medication decision-making among patients with poorly controlled diabetes. Objective We compared outcomes between community health worker (CHW) use of a tailored, interactive web-based tablet-delivered tool (iDecide) versus use of print educational materials. Design A randomized two-arm trial from 2011-2013. Trial Registration NCT01427660. Setting Community health center in Detroit serving a Latino and African American low-income population. Participants 188 adults with a hemoglobinA1c >7.5% (55%) or who reported questions, concerns, or difficulty taking diabetes medications Primary Funding Sources Agency for Health Care Quality and Research (1R18HS019256-01) and P30DK092926 (MCDTR) Measurements Primary outcomes were changes in knowledge about anti-hyperglycemic medications, patient-reported medication decisional conflict, and satisfaction with anti-hyperglycemic medication information. We also examined changes in diabetes distress, self-efficacy, medication adherence, and A1c. Intervention Participants were randomized to receive a 1-2 hour session with a CHW using either iDecide or printed educational materials and two follow-up calls. Results 94% of participants completed three-month follow-up. Both groups improved across most measures. iDecide participants reported greater improvements in satisfaction with medication information (helpfulness, p=.007; clarity, p=.03) and in diabetes distress compared to the print materials group (p<0.001). There were no differences between groups in other outcomes. Limitations The study was conducted at one health center over a short period, and the CHWs were experienced in behavioral counseling, thus possibly mitigating the need for additional support tools. Conclusions Most outcomes were similarly improved among participants receiving both types of diabetes medication decision-making support. Longer-term evaluations are necessary to

  10. Multicenter, double-blind, randomized, phase II trial to assess the safety and efficacy of ceftolozane-tazobactam plus metronidazole compared with meropenem in adult patients with complicated intra-abdominal infections.

    PubMed

    Lucasti, Christopher; Hershberger, Ellie; Miller, Benjamin; Yankelev, Sara; Steenbergen, Judith; Friedland, Ian; Solomkin, Joseph

    2014-09-01

    Ceftolozane-tazobactam (TOL-TAZ) is a novel antibacterial with activity against Pseudomonas aeruginosa and other common Gram-negative pathogens, including extended-spectrum β-lactamase (ESBL)-producing Enterobacteriaceae, that are associated with complicated intra-abdominal infections (cIAIs). This prospective, double-blind, randomized, multicenter, phase II trial assessed patient clinical and microbiological responses to and the safety of TOL-TAZ plus metronidazole compared with those of meropenem. Hospitalized adults with cIAIs that required surgical intervention were randomized (2:1) to receive intravenous (i.v.) TOL-TAZ (1.5 g [containing 1,000 mg TOL and 500 mg TAZ] every 8 h [q8h]) with or without i.v. metronidazole (500 mg q8h) or i.v. meropenem (1 g q8h) for 4 to 7 days. The primary endpoint was the clinical response at the test-of-cure visit in the microbiologically modified intent-to-treat (mMITT) and microbiologically evaluable (ME) populations. Secondary measures included the patients' microbiological response and safety. In total, 82 patients received TOL-TAZ (90.2% with metronidazole), and 39 received meropenem. For the mMITT population, clinical cure was seen in 83.6% of the patients (51/61; 95% confidence interval [CI], 71.9 to 91.8) who received TOL-TAZ and 96.0% of the patients (24/25; 95% CI, 79.6 to 99.9) who received meropenem (difference, -12.4%; 95% CI, -34.9% to 11.1%); in the ME population, clinical cure was seen in 88.7% and 95.8% of the patients (difference, -7.1%; 95% CI, -30.7% to 16.9%) who received TOL-TAZ and meropenem, respectively. TOL-TAZ demonstrated microbiological success against Escherichia coli (89.5%), Klebsiella pneumoniae (100%), and P. aeruginosa (100%). The adverse event rates were similar in the groups (50.0% with TOL-TAZ and 48.8% with meropenem). TOL-TAZ in combination with metronidazole was well tolerated and resulted in clinical and microbiological success rates supportive of further clinical development in

  11. 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.

  12. Design and Recruitment for a Randomized Controlled Trial of Problem Solving Therapy to Prevent Depression among Older Adults with Need for Supportive Services

    PubMed Central

    Albert, Steven M.; King, Jennifer; Dew, Mary Amanda; Begley, Amy; Anderson, Stewart; Karp, Jordan; Gildengers, Ari; Butters, Meryl; Reynolds, Charles F.

    2015-01-01

    Background Addressing subthreshold depression (indicated prevention) as well as vulnerabilities that increase the risk of major depression or anxiety disorders (selective prevention) is important for protecting mental health in old age. The Depression-Agency Based Collaborative is a prevention trial involving older adults recruited from aging services sites (home care agencies, senior housing senior centers) who meet criteria for subthreshold depression and disability. Objective To examine (i) the effectiveness of partnerships with aging services sites for recruiting at-risk older adults, (ii) the quality of recruitment and acceptability of the Dep-ABC assessment and intervention, and (iii) the baseline status of participants. Methods Dep-ABC is a single-blind randomized controlled prevention trial set in aging services settings but with centralized screening, randomization, in-home assessments, and follow-up. Its intervention arm involves 6–8 sessions of problem-solving therapy, in which older adults aged 60+ learn to break down problems that affect wellbeing and develop strategies to address them. We examined participation rates to assess quality of recruitment across sites and level of disability according to service use. Results Dep-ABC randomized 104 participants, 68.4% of eligible older adults. Screening using self-reported disability successfully netted a sample in which 74% received home care agency services, with remaining participants similarly impaired in structured self-reports of impairment and on observed performance tests. Conclusions Direct outreach to aging services providers is an effective way to identify older adults with service needs at high risk of major depression. Problem solving therapy is acceptable to this population and can be added to current services. PMID:26706911

  13. Trials in adult critical care that show increased mortality of the new intervention: Inevitable or preventable mishaps?

    PubMed

    Russell, James A; Williams, Mark D

    2016-12-01

    Several promising therapies assessed in the adult critically ill in large, multicenter randomized controlled trials (RCTs) were associated with significantly increased mortality in the intervention arms. Our hypothesis was that there would be wide ranges in sponsorship (industry or not), type(s) of intervention(s), use of DSMBs, presence of interim analyses and early stopping rules, absolute risk increase (ARI), and whether or not adequate prior proof-of-principle Phase II studies were done of RCTs that found increased mortality rates of the intervention compared to control groups. We reviewed RCTs that showed a statistically significant increased mortality rate in the intervention compared to control group(s). We recorded source of sponsorship, sample sizes, types of interventions, mortality rates, ARI (as well as odds ratios, relative risks and number needed to harm), whether there were pre-specified interim analyses and early stopping rules, and whether or not there were prior proof-of-principle (also known as Phase II) RCTs. Ten RCTs (four industry sponsored) of many interventions (high oxygen delivery, diaspirin cross-linked hemoglobin, growth hormone, methylprednisolone, hetastarch, high-frequency oscillation ventilation, intensive insulin, NOS inhibition, and beta-2 adrenergic agonist, TNF-α receptor) included 19,126 patients and were associated with wide ranges of intervention versus control group mortality rates (25.7-59 %, mean 29.9 vs 17-49 %, mean 25 %, respectively) yielding ARIs of 2.6-29 % (mean 5 %). All but two RCTs had pre-specified interim analyses, and seven RCTs were stopped early. All RCTs were preceded by published proof-of-principle RCT(s), two by the same group. Seven interventions (except diaspirin cross-linked hemoglobin and the NOS inhibitor) were available for use clinically at the time of the pivotal RCT. Common, clinically available interventions used in the critically ill were associated with increased mortality in large

  14. Effect of a Stepped-Care Intervention Approach on Weight Loss in Adults: The Step-Up Study Randomized Trial

    PubMed Central

    Jakicic, John M.; Tate, Deborah F.; Lang, Wei; Davis, Kelli K.; Polzien, Kristen; Rickman, Amy D.; Erickson, Karen; Neiberg, Rebecca H.; Finkelstein, Eric A.

    2014-01-01

    Context Given the obesity epidemic, effective but resource efficient weight loss treatments are needed. Stepped treatment approaches customize interventions based on milestone completion and can be more effective while costing less to administer than conventional treatment paradigms. Objective We hypothesized that compared to a standard behavioral weight loss intervention (SBWI), a stepped-care weight loss intervention (STEP) would result in greater weight loss. Design Randomized trial with participants enrolled between May 2008 and February 2010. Data collection was completed by September 2011. Setting 2 universities affiliated with academic medical centers. Participants Participants were 363 overweight and obese adults (BMI: 25 to <40 kg/m2; age: 18–55 years; 33% non-white, 83% female) who were randomized to SBWI or STEP interventions. Interventions All participants were placed on a low calorie diet, prescribed increases in physical activity and had group counseling sessions ranging from weekly to monthly during an 18-month time period. SBWI participants were assigned to a fixed program. Among STEP participants, counseling frequency, type, and weight loss strategies could be modified every 3 months in response to observed weight loss as it related to weight loss goals. Main Outcome Measure Mean change in weight over 18 months. Additional outcomes include resting heart rate and blood pressure, waist girth, body composition, fitness, physical activity, dietary intake, and costs. Results Of the 363 participants randomized, 260 participants (71.6%) provided a measure of mean change in weight over 18 months. The 18 month intervention resulted in weight decreasing from 93.1 kg (95% CI: 91.0, 95.2) to 85.6 kg (95% CI: 83.4, 88.0) (p<0.01) in SBWI and from 92.7 kg (95% CI: 90.8, 94.6) to 86.4 kg (95% CI: 84.5, 88.4) in STEP (p<0.01). Percent weight change from baseline to 18 months was −8.1% (95% CI: −9.4, −6.9) in SBWI (p<0.01) and −6.9% (95% CI: −8.0, −5

  15. Methods of data collection and analysis for the economic evaluation alongside a national, multi-centre trial in the UK: Conventional ventilation or ECMO for Severe Adult Respiratory Failure (CESAR)

    PubMed Central

    Thalanany, Mariamma M; Mugford, Miranda; Hibbert, Clare; Cooper, Nicola J; Truesdale, Ann; Robinson, Steven; Tiruvoipati, Ravindranath; Elbourne, Diana R; Peek, Giles J; Clemens, Felicity; Hardy, Polly; Wilson, Andrew

    2008-01-01

    Registrations The CESAR trial registration number is ISRCTN47279827. PMID:18447931

  16. Clinical Trial Participation and Time to Treatment Among Adolescents and Young Adults With Cancer: Does Age at Diagnosis or Insurance Make a Difference?

    PubMed Central

    Parsons, Helen M.; Harlan, Linda C.; Seibel, Nita L.; Stevens, Jennifer L.; Keegan, Theresa H.M.

    2011-01-01

    Purpose Because adolescent and young adult (AYA) patients with cancer have experienced variable improvement in survival over the past two decades, enhancing the quality and timeliness of cancer care in this population has emerged as a priority area. To identify current trends in AYA care, we examined patterns of clinical trial participation, time to treatment, and provider characteristics in a population-based sample of AYA patients with cancer. Methods Using the National Cancer Institute Patterns of Care Study, we used multivariate logistic regression to evaluate demographic and provider characteristics associated with clinical trial enrollment and time to treatment among 1,358 AYA patients with cancer (age 15 to 39 years) identified through the Surveillance, Epidemiology, and End Results Program. Results In our study, 14% of patients age 15 to 39 years had enrolled onto a clinical trial; participation varied by type of cancer, with the highest participation in those diagnosed with acute lymphoblastic leukemia (37%) and sarcoma (32%). Multivariate analyses demonstrated that uninsured, older patients and those treated by nonpediatric oncologists were less likely to enroll onto clinical trials. Median time from pathologic confirmation to first treatment was 3 days, but this varied by race/ethnicity and cancer site. In multivariate analyses, advanced cancer stage and outpatient treatment alone were associated with longer time from pathologic confirmation to treatment. Conclusion Our study identified factors associated with low clinical trial participation in AYA patients with cancer. These findings support the continued need to improve access to clinical trials and innovative treatments for this population, which may ultimately translate into improved survival. PMID:21931022

  17. Immunogenicity and safety of Fluzone(®) intradermal and high-dose influenza vaccines in older adults ≥65 years of age: a randomized, controlled, phase II trial.

    PubMed

    Tsang, Peter; Gorse, Geoffrey J; Strout, Cynthia B; Sperling, Malcolm; Greenberg, David P; Ozol-Godfrey, Ayca; DiazGranados, Carlos; Landolfi, Victoria

    2014-05-01

    We conducted a randomized, controlled, multicenter, phase II study to evaluate the immunogenicity and safety of an investigational intradermal (ID) trivalent influenza vaccine (TIV) and a high-dose (HD) intramuscular (IM) TIV in older adults (≥65 years of age). Older adult subjects were immunized with ID vaccine containing either 15μg hemagglutinin (HA)/strain (n=636) or 21μg HA/strain (n=634), with HD IM vaccine containing 60μg HA/strain (n=320), or with standard-dose (SD) IM vaccine (Fluzone(®); 15μg HA/strain; n=319). For comparison, younger adults (18-49 years of age) were immunized with SD IM vaccine. In older adults, post-vaccination geometric mean titers induced by the ID vaccines were superior to those induced by the SD IM vaccine for the A/H1N1 and A/H3N2 strains and non-inferior for the B strain. Seroconversion rates induced by the ID vaccines were superior to those induced by the SD IM vaccine in older adults for the A/H1N1 and B strains and non-inferior for the A/H3N2 strain. Results did not differ significantly for the two ID vaccine dosages. Post-vaccination geometric mean titers, seroconversion rates, and most seroprotection rates were significantly higher in HD vaccine recipients than in older adult recipients of the SD IM or ID vaccines and, for most measures, were comparable to those of younger adult SD IM vaccine recipients. Injection-site reactions, but not systemic reactions or unsolicited adverse events, were more common with the ID vaccines than with the IM vaccines. No treatment-related serious adverse events were reported. This study demonstrated that: (1) the ID and HD vaccines were well-tolerated and more immunogenic than the SD IM vaccine in older adults; (2) the HD vaccine was more immunogenic than the ID vaccines in older adults; and (3) the HD vaccine in older adults and the SD IM vaccine in younger adults elicited comparable antibody responses (ClinicalTrials.gov identifier no.: NCT00551031).

  18. Image registration by parts

    NASA Technical Reports Server (NTRS)

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

    1997-01-01

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

  19. Analysis of subpixel registration

    NASA Technical Reports Server (NTRS)

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

    1984-01-01

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

  20. Towards operational multisensor registration

    NASA Technical Reports Server (NTRS)

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

    1991-01-01

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

  1. The effect of (L-)carnitine on weight loss in adults: a systematic review and meta-analysis of randomized controlled trials.

    PubMed

    Pooyandjoo, M; Nouhi, M; Shab-Bidar, S; Djafarian, K; Olyaeemanesh, A

    2016-10-01

    This study provides a systematic review and meta-analysis of randomized controlled trials, which have examined the effect of the carnitine on adult weight loss. Relevant studies were identified by systematic search of PubMed, Embase, Cochrane Central Register of Controlled Trials and reference lists of relevant marker studies. Nine studies (total n = 911) of adequate methodological quality were included in the review. Trials with mean difference (MD) of 95% confidence interval (CI) were pooled using random effect model. Results from meta-analysis of eligible trials revealed that subjects who received carnitine lost significantly more weight (MD: -1.33 kg; 95% CI: -2.09 to -0.57) and showed a decrease in body mass index (MD: -0.47 kg m(-2) ; 95% CI: -0.88 to -0.05) compared with the control group. The results of meta-regression analysis of duration of consumption revealed that the magnitude of weight loss resulted by carnitine supplementation significantly decreased over time (p = 0.002). We conclude that receiving the carnitine resulted in weight loss. Using multiple-treatments meta-analysis of the drugs and non-pharmacotherapy options seem to be insightful areas for research. © 2016 World Obesity.

  2. Comparison of computer based instruction to behavior skills training for teaching staff implementation of discrete-trial instruction with an adult with autism.

    PubMed

    Nosik, Melissa R; Williams, W Larry; Garrido, Natalia; Lee, Sarah

    2013-01-01

    In the current study, behavior skills training (BST) is compared to a computer based training package for teaching discrete trial instruction to staff, teaching an adult with autism. The computer based training package consisted of instructions, video modeling and feedback. BST consisted of instructions, modeling, rehearsal and feedback. Following training, participants were evaluated in terms of their accuracy on completing critical skills for running a discrete trial program. Six participants completed training; three received behavior skills training and three received the computer based training. Participants in the BST group performed better overall after training and during six week probes than those in the computer based training group. There were differences across both groups between research assistant and natural environment competency levels.

  3. Results of a 2-year randomized, controlled obesity prevention trial: Effects on diet, activity and sleep behaviors in an at-risk young adult population.

    PubMed

    Laska, Melissa N; Lytle, Leslie A; Nanney, Marilyn S; Moe, Stacey G; Linde, Jennifer A; Hannan, Peter J

    2016-08-01

    Excess weight gain tends to occur in young adulthood. However, research examining effective weight-related interventions for this age group has been limited. As one of seven trials in the EARLY Trials consortium (Early Adult Reduction of weight through LifestYle intervention), the CHOICES Study (Choosing Healthy Options in College Environments and Settings) tested effects of a technology-integrated, young adult weight gain prevention intervention. It was a randomized controlled trial with assessments at baseline (2011) and 4-, 12- and 24-months post-intervention initiation and included 441 participants (ages 18-35) who were students at three Minnesota community colleges. The 24-month intervention included a 1-credit academic course and social networking and support online intervention. This analysis examined effects on 12 secondary behavioral outcomes across three domains: diet (fast food, sugary beverages, breakfast, at-home meal preparation), physical activity/screen time (minutes and energy expenditure in leisure time physical activity, television viewing, leisure time computer use) and sleep (hours of sleep, time required to fall asleep, days not getting enough rest, difficulty staying awake). The intervention resulted in significant reductions in fast food (p=0.007) but increases in difficulty staying awake (p=0.015). There was limited evidence of other behavior changes at 4months (0.05adults, particularly when addressing multiple weight-related outcomes.

  4. Correlates of 1-year incidence of urinary incontinence in older Latino adults enrolled in a community-based physical activity trial.

    PubMed

    Morrisroe, Shelby N; Rodriguez, Larissa V; Wang, Pin-Chieh; Smith, Ariana L; Trejo, Laura; Sarkisian, Catherine A

    2014-04-01

    The prevalence of urinary incontinence (UI) among older urban Latinos is high. Insight into etiologies of and contributing factors to the development of this condition is needed. This longitudinal cohort study identified correlates of 1-year incidence of UI in older community-dwelling Latino adults participating in a senior center-based physical activity trial in Los Angeles, California. Three hundred twenty-eight Latinos aged 60 to 93 participating in Caminemos, a randomized trial to increase walking, were studied. Participants completed an in-person survey and physical performance measures at baseline and 1 year. UI was measured using the International Consultation on Incontinence item: "How often do you leak urine?" Potential correlates of 1-year incidence of UI included sociodemographic, behavioral, medical, physical, and psychosocial characteristics. The overall incidence of UI at 1 year was 17.4%. Incident UI was associated with age, baseline activity of daily living impairment, health-related quality of life (HRQoL), mean steps per day, and depressive symptoms. Multivariate logistic regression models revealed that improvement in physical performance score (odds ratio (OR) = 0.69, 95% confidence interval (CI) = 0.50-0.95) and high baseline physical (OR = 0.60, 95% CI = 0.40-0.89) and mental (OR = 0.62, 95% CI = 0.43-0.91) HRQoL were independently associated with lower rates of 1-year incident UI. An increase in depressive symptoms at 1 year (OR = 4.48, 95% CI = 1.02-19.68) was independently associated with a higher rate of incident UI. One-year UI incidence in this population of older urban Latino adults participating in a walking trial was high but was lower in those who improved their physical performance. Interventions aimed at improving physical performance may help prevent UI in older Latino adults.

  5. Talking Health, A pragmatic randomized-controlled health literacy trial targeting sugar-sweetened beverage consumption among adults: Rationale, design & methods

    PubMed Central

    Zoellner, Jamie; Chen, Yvonnes; Davy, Brenda; You, Wen; Hedrick, Valisa; Corsi, Terri; Estabrooks, Paul

    2014-01-01

    High consumption of sugar-sweetened beverages (SSB) contributes to a wide range of poor health outcomes. Further, few US adults drink less than the recommended ≤8 ounces per day; and individuals with low socioeconomic, low health literacy status, and in rural areas are even less likely to meet recommendations. Unfortunately, few SSB behavioral interventions exist targeting adults, and none focus on low health literacy in rural areas. Talking Health, a type 1 effectiveness-implementation hybrid trial targeting adults in rural southwest Virginia, was developed using the RE-AIM planning and evaluation framework (reach, effectiveness, adoption, implementation, maintenance). The primary aim of this pragmatic randomized-controlled trial was to determine the effectiveness of a scalable 6-month intervention aimed at decreasing SSB consumption (SIPsmartER) when compared to a matched contact physical activity promotion control group (MoveMore). SIPsmartER was developed based upon the Theory of Planned Behavior and uses health literacy strategies to improve comprehension of the intervention content among participants. MoveMore is based on a research-tested intervention that was adapted to address all theory of planned behavior constructs and health literacy principles. Secondary aims include additional health outcomes (e.g., physical activity, weight) and reach, adoption, implementation, and maintenance indicators. This paper highlights the opportunities and considerations for developing health behavior trials that aim to determine intervention effectiveness, provide all study participants an opportunity to benefit from research participation, and collect key information on reach and the potential for organizational adoption, implementation, and maintenance with the longer-term goal of speeding translation into practice settings. PMID:24246819

  6. Weight loss referrals for adults in primary care (WRAP): protocol for a multi-centre randomised controlled trial comparing the clinical and cost-effectiveness of primary care referral to a commercial weight loss provider for 12 weeks, referral for 52 weeks, and a brief self-help intervention [ISRCTN82857232

    PubMed Central

    2014-01-01

    Background Recent trials demonstrate the acceptability and short term efficacy of primary care referral to a commercial weight loss provider for weight management. Commissioners now need information on the optimal duration of intervention and the longer term outcomes and cost effectiveness of such treatment to give best value for money. Methods/Design This multicentre, randomised controlled trial with a parallel design will recruit 1200 overweight adults (BMI ≥28 kg/m2) through their primary care provider. They will be randomised in a 2:5:5 allocation to: Brief Intervention, Commercial Programme for 12 weeks, or Commercial Programme for 52 weeks. Participants will be followed up for two years, with assessments at 0, 3, 12 and 24 months. The sequential primary research questions are whether the CP interventions achieve significantly greater weight loss from baseline to 12 months than BI, and whether CP52 achieves significantly greater weight loss from baseline to 12 months than CP12. The primary outcomes will be an intention to treat analysis of between treatment differences in body weight at 12 months. Clinical effectiveness will be also be assessed by measures of weight, fat mass, and blood pressure at each time point and biochemical risk factors at 12 months. Self-report questionnaires will collect data on psychosocial factors associated with adherence, weight-loss and weight-loss maintenance. A within-trial and long-term cost-effectiveness analysis will be conducted from an NHS perspective. Qualitative methods will be used to examine the participant experience. Discussion The current trial compares the clinical and cost effectiveness of referral to a commercial provider with a brief intervention. This trial will specifically examine whether providing longer weight-loss treatment without altering content or intensity (12 months commercial referral vs. 12 weeks) leads to greater weight loss at one year and is sustained at 2 years. It will also

  7. Effect of Vitamin D3 Supplementation on Inflammatory Markers and Glycemic Measures among Overweight or Obese Adults: A Systematic Review of Randomized Controlled Trials

    PubMed Central

    Zuk, Aleksandra; Fitzpatrick, Tiffany; Rosella, Laura C.

    2016-01-01

    Background Obesity induced low-grade chronic inflammation disrupts proper immune and metabolic function. Vitamin D deficiency increases inflammation, which is associated with cardiometabolic risk. This systematic review examines the association between oral vitamin D (VD) supplementation and circulating inflammatory biomarkers and glycemic outcomes from randomized controlled trials (RCTs) of overweight and/or obese adults. Methods MEDLINE OVID, EMBASE and the Cochrane Central Register of Controlled Trials were searched according to a predefined protocol. Eligible RCTs included adults randomized to receive either oral VD or placebo. Two reviewers independently assessed RCTs for inclusion. Bias was assessed using the Cochrane Collaboration risk of bias tool. Mean differences were calculated comparing end-of-study sample means between the independent VD and placebo groups. Results Eleven unique RCTs met inclusion criteria from a total of 3,383 identified citations, including 79 screened articles and 14 full text data extractions. Inflammatory and glycemic measures were reported in 7 and 10 RCTs, respectively. Most trial findings were non-significant with considerable heterogeneity in design, participants and outcomes. All but one trial was rated as either high or unclear risk of bias. Two RCTs reported significant changes in inflammatory biomarkers; however, the mean difference between groups was not statistically significant: C-reactive protein 0.19 mg/L (p = 0.88); Tumor Necrosis Factor -0.54 pg/ml (p = 0.20). Two other trials found significant mean differences in fasting plasma glucose -0.32 mmol/L (p = 0.03), Hemoglobin A1c -0.13% (p = 0.04), and Homeostatic Model Assessment -0.86 (p = 0.02) following VD supplementation. Conclusions Overall, there is no clear established benefit of VD supplementation on inflammatory biomarkers among overweight/obese adults. Baseline serum VD possibly influences the effect of VD repletion on inflammatory markers. Risk of bias was

  8. An Inactivated Ross River Virus Vaccine Is Well Tolerated and Immunogenic in an Adult Population in a Randomized Phase 3 Trial

    PubMed Central

    van der Velden, Maikel V. W.; Portsmouth, Daniel; Draxler, Wolfgang; O'Rourke, Maria; Richmond, Peter; Hall, Stephen; McBride, William J. H.; Redfern, Andrew; Aaskov, John; Barrett, P. Noel; Aichinger, Gerald

    2014-01-01

    Ross River virus (RRV) is endemic in Australia and several South Pacific Islands. More than 90,000 cases of RRV disease, which is characterized by debilitating polyarthritis, were reported in Australia in the last 20 years. There is no vaccine available to prevent RRV disease. A phase 3 study was undertaken at 17 sites in Australia to investigate the safety and immunogenicity of an inactivated whole-virus Vero cell culture-derived RRV vaccine in 1,755 healthy younger adults aged 16 to 59 years and 209 healthy older adults aged ≥60 years. Participants received a 2.5-μg dose of Al(OH)3-adjuvanted RRV vaccine, with a second and third dose after 3 weeks and 6 months, respectively. Vaccine-induced RRV-specific neutralizing and total IgG antibody titers were measured after each immunization. Vaccine safety was monitored over the entire study period. The vaccine was safe and well-tolerated after each vaccination. No cases of arthritis resembling RRV disease were reported. The most frequently reported systemic reactions were headache, fatigue, and malaise; the most frequently reported injection site reactions were tenderness and pain. After the third immunization, 91.5% of the younger age group and 76.0% of the older age group achieved neutralizing antibody titers of ≥1:10; 89.1% of the younger age group and 70.9% of the older age group achieved enzyme-linked immunosorbent assay (ELISA) titers of ≥11 PanBio units. A whole-virus Vero cell culture-derived RRV vaccine is well tolerated in an adult population and induces antibody titers associated with protection from RRV disease in the majority of individuals. (This study is registered at www.clinicaltrials.gov under registration no. NCT01242670.) PMID:25540268

  9. Preventing Depression in Adults With Subthreshold Depression: Health-Economic Evaluation Alongside a Pragmatic Randomized Controlled Trial of a Web-Based Intervention

    PubMed Central

    Berking, Matthias; Smit, Filip; Lehr, Dirk; Nobis, Stephanie; Riper, Heleen; Cuijpers, Pim; Ebert, David

    2017-01-01

    supports guidelines recommending Web-based treatment for sD and adds that this not only restores health in people with sD, but additionally reduces the risk of developing a MDD. Offering the intervention has an acceptable likelihood of being more cost-effective than enhanced usual care and could therefore reach community members on a wider scale. Trial registration German Clinical Trials Register: DRKS00004709; http://www.drks.de/DRKS00004709 (Archived by WebCite at http://www.webcitation.org/6kAZVUxy9) PMID:28052841

  10. Safety evaluation of the consumption of high dose milk fat globule membrane in healthy adults: a double-blind, randomized controlled trial with parallel group design.

    PubMed

    Hari, Sayaka; Ochiai, Ryuji; Shioya, Yasushi; Katsuragi, Yoshihisa

    2015-01-01

    Consumption of milk fat globule membrane (MFGM) in combination with habitual exercise suppresses age-associated muscle loss. The effects of high dose MFGM, however, are not known. A double-blind, randomized controlled trial with parallel group design was conducted to evaluate the safety of consuming high dose MFGM tablets. The subjects were 32 healthy adult men and women. Subjects were given 5 times the recommended daily intake of the tablets containing 6.5 g of MFGM or whole milk powder for 4 weeks. Stomach discomfort and diarrhea were observed; however, these symptoms were transitory and slight and were not related to consumption of the test tablets. In addition, there were no clinically significant changes in anthropometric measurements or blood tests. Total degree of safety assessed by the physicians of all subjects was "safe." These findings suggest that consumption of the tablets containing 6.5 g MFGM for 4 weeks is safe for healthy adults.

  11. Suspension of Registrations under FIFRA

    EPA Pesticide Factsheets

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

  12. Registration Documents for Enlist Duo Herbicide (2014)

    EPA Pesticide Factsheets

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

  13. Systematic Literature Review of Randomized Control Trials Assessing the Effectiveness of Nutrition Interventions in Community-Dwelling Older Adults

    ERIC Educational Resources Information Center

    Bandayrel, Kristofer; Wong, Sharon

    2011-01-01

    Objective: Nutrition interventions may play an important role in maintaining the health and quality of life in community-dwelling older adults. To the authors' knowledge, no systematic literature review has been conducted on the effectiveness of nutrition interventions in the community-dwelling older adult population. Design: Systematic literature…

  14. Distributed Continuous Registration.

    ERIC Educational Resources Information Center

    Myers, Donald L.

    1981-01-01

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

  15. Registration Priorities: A Report.

    ERIC Educational Resources Information Center

    Walters, Judy E.

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

  16. 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.

  17. 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…

  18. 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…

  19. Efficacy of two injection-site localisation techniques for botulinum toxin injections: a single-blind, crossover, randomised trial protocol among adults with hemiplegia due to stroke

    PubMed Central

    Morel, Claire; Hauret, Isabelle; Andant, Nicolas; Bonnin, Armand; Pereira, Bruno; Coudeyre, Emmanuel

    2016-01-01

    Introduction Botulinum toxin injections are an effective treatment for limb spasticity following stroke. Different tracking techniques are used for this purpose: palpation, electrostimulation, electromyography and ultrasound. Yet very few studies have compared these different techniques, and none has successfully proved the superior efficacy of ultrasound-guided injections compared to another tracking method. The primary objective of our study was therefore to compare the efficacy of botulinum toxin injections depending on the tracking technique used: ultrasound versus electrostimulation. Methods and analysis This is a clinical, single-centre, prospective, interventional, single-blind, crossover, randomised trial. In total, 30 patients aged between 18 and 80 years presenting with triceps surae spasticity (evaluated >1 on the modified Ashworth scale) associated with hemiplegia sequelae due to stroke will be included. The patients will be selected among those who attend for consultation the Physical Medicine and Rehabilitation Department of the Clermont-Ferrand University Hospital. One group will receive the abobotulinumtoxinA (BoNT-A) injection guided by electrostimulation then ultrasound, and the second group's botulinum toxin injections will be guided by ultrasound then electrostimulation. For each patient, the duration of study participation is 5 months. The primary end point is variation in passive ankle dorsiflexion range of motion at slow and high speeds (Tardieu scale) with the knee straight. Ethics and dissemination This study received ethics approval form the CPP of Rhônes-Alpes region. Results will be published in a peer-reviewed journal. Trial registration number NCT01935544; pre-results. PMID:27852706

  20. Effects of standard training in the use of closed-circuit televisions in visually impaired adults: design of a training protocol and a randomized controlled trial

    PubMed Central

    2010-01-01

    Background Reading problems are frequently reported by visually impaired persons. A closed-circuit television (CCTV) can be helpful to maintain reading ability, however, it is difficult to learn how to use this device. In the Netherlands, an evidence-based rehabilitation program in the use of CCTVs was lacking. Therefore, a standard training protocol needed to be developed and tested in a randomized controlled trial (RCT) to provide an evidence-based training program in the use of this device. Methods/Design To develop a standard training program, information was collected by studying literature, observing training in the use of CCTVs, discussing the content of the training program with professionals and organizing focus and discussion groups. The effectiveness of the program was evaluated in an RCT, to obtain an evidence-based training program. Dutch patients (n = 122) were randomized into a treatment group: normal instructions from the supplier combined with training in the use of CCTVs, or into a control group: instructions from the supplier only. The effect of the training program was evaluated in terms of: change in reading ability (reading speed and reading comprehension), patients' skills to operate the CCTV, perceived (vision-related) quality of life and tasks performed in daily living. Discussion The development of the CCTV training protocol and the design of the RCT in the present study may serve as an example to obtain an evidence-based training program. The training program was adjusted to the needs and learning abilities of individual patients, however, for scientific reasons it might have been preferable to standardize the protocol further, in order to gain more comparable results. Trial registration http://www.trialregister.nl, identifier: NTR1031 PMID:20219120

  1. 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.

  2. Changes in sexual behavior of HIV-infected older adults enrolled in a clinical trial of standalone group psychotherapies targeting depression

    PubMed Central

    Lovejoy, Travis I.; Heckman, Timothy G.; Sikkema, Kathleen J.; Hansen, Nathan B.; Kochman, Arlene

    2014-01-01

    By 2015, one-half of all HIV-positive persons in the U.S. will be 50-plus years of age, and as many as 30% of older adults living with HIV/AIDS continue to engage in unprotected sexual intercourse. Contemporary positive prevention models often include mental health treatment as a key component of HIV prevention interventions. This secondary data analysis characterized longitudinal patterns of sexual behavior in HIV-positive older adults enrolled in a randomized controlled trial of group mental health interventions and assessed the efficacy of psychosocial treatments that targeted depression to reduce sexual risk behavior. Participants were 295 HIV-positive adults ≥ 50 years of age experiencing mild to severe depressive symptoms, randomized to one of three study conditions: a 12-session coping improvement group intervention, a 12-session interpersonal support group intervention, or individual therapy upon request. Approximately one-fifth of participants reported one or more occasions of unprotected anal or vaginal intercourse with HIV-negative sexual partners or persons of unknown HIV serostatus over the study period. Changes in sexual behavior did not vary by intervention condition, indicating that standalone treatments that target and reduce depression may be insufficient to reduce sexual risk behavior in depressed HIV-positive older adults. PMID:24668254

  3. Changes in sexual behavior of HIV-infected older adults enrolled in a clinical trial of standalone group psychotherapies targeting depression.

    PubMed

    Lovejoy, Travis I; Heckman, Timothy G; Sikkema, Kathleen J; Hansen, Nathan B; Kochman, Arlene

    2015-01-01

    By 2015, one-half of all HIV-positive persons in the U.S. will be 50-plus years of age, and as many as 30 % of older adults living with HIV/AIDS continue to engage in unprotected sexual intercourse. Contemporary positive prevention models often include mental health treatment as a key component of HIV prevention interventions. This secondary data analysis characterized longitudinal patterns of sexual behavior in HIV-positive older adults enrolled in a randomized controlled trial of group mental health interventions and assessed the efficacy of psychosocial treatments that targeted depression to reduce sexual risk behavior. Participants were 295 HIV-positive adults ≥50 years of age experiencing mild to severe depressive symptoms, randomized to one of three study conditions: a 12-session coping improvement group intervention, a 12-session interpersonal support group intervention, or individual therapy upon request. Approximately one-fifth of participants reported one or more occasions of unprotected anal or vaginal intercourse with HIV-negative sexual partners or persons of unknown HIV serostatus over the study period. Changes in sexual behavior did not vary by intervention condition, indicating that standalone treatments that target and reduce depression may be insufficient to reduce sexual risk behavior in depressed HIV-positive older adults.

  4. The hidden KPI registration accuracy.

    PubMed

    Shorrosh, Paul

    2011-09-01

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

  5. 77 FR 75670 - Importer of Controlled Substances; Notice of Registration; Fisher Clinical Services,Inc.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-21

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

  6. 14 CFR 47.43 - Invalid registration.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

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

  7. 32 CFR 1615.1 - Registration.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

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

  8. 32 CFR 1615.1 - Registration.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

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

  9. 32 CFR 1615.1 - Registration.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

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

  10. 14 CFR 47.43 - Invalid registration.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

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

  11. 14 CFR 47.43 - Invalid registration.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

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

  12. 32 CFR 1615.1 - Registration.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

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

  13. 32 CFR 1615.1 - Registration.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

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

  14. Internet-delivered treatment for older adults with anxiety and depression: implementation of the Wellbeing Plus Course in routine clinical care and comparison with research trial outcomes

    PubMed Central

    Staples, Lauren G.; Fogliati, Vincent J.; Dear, Blake F.; Nielssen, Olav

    2016-01-01

    Background The Wellbeing Plus Course is an internet-delivered psychological intervention for older adults with anxiety or depression. Aims To compare the effectiveness of the Wellbeing Plus Course in a public health setting (clinic group) with its efficacy in a randomised controlled trial (research group). Method Participants (n=949) were Australian adults aged 60 and above. Primary outcome measures were the Patient Health Questionnaire (PHQ-9) and Generalized Anxiety Disorder scale (GAD-7). Results Initial symptom severity was higher in the clinic group and course completion was lower. Both groups showed significant symptom reductions at post-treatment and were satisfied with the treatment. Results were maintained at 3-month follow-up. Within-group symptom changes were comparable between settings; there were no between-group differences on primary outcomes or satisfaction. Conclusions The Wellbeing Plus Course is as effective and acceptable in routine clinical care, as it is in controlled research trials. Declaration of interest N.T. and B.F.D developed the Wellbeing Plus Course but derived no financial benefit from it. Copyright and usage © The Royal College of Psychiatrists 2016. This is an open access article distributed under the terms of the Creative Commons Non-Commercial, No Derivatives (CC BY-NC-ND) license. PMID:27703794

  15. Managing stress and anxiety through qigong exercise in healthy adults: a systematic review and meta-analysis of randomized controlled trials

    PubMed Central

    2014-01-01

    Background An increasing number of studies have documented the effectiveness of qigong exercise in helping people reduce psychological stress and anxiety, but there is a scarcity of systematic reviews evaluating evidence from randomized controlled trials (RCTs) conducted among healthy subjects. Methods Thirteen databases were searched for RCTs from their inception through June 2013. Effects of qigong exercise were pooled across trials. Standardized mean differences (SMDs) were calculated for the pooled effects. Heterogeneity was assessed using the I 2 test. The risk of bias was assessed using the Cochrane criteria. Results Seven RCTs met the inclusion criteria. Two RCTs suggested that qigong exercise immediately relieved anxiety among healthy adults, compared to lecture attendance and structured movements only. Four RCTs suggested qigong exercise relieved anxiety (pooled SMD = -0.75; 95% CI, -1.11 to -0.40), and three RCTs suggested that qigong exercise reduced stress (pooled SMD = -0.88; 95% CI, -1.22 to -0.55) among healthy subjects following one to three months of qigong practice, compared to wait-list controls. Conclusions The available evidence suggests that qigong exercise reduces stress and anxiety in healthy adults. However, given the limited number of RCTs and their methodological flaws, further rigorously designed RCTs are needed. PMID:24400778

  16. Evaluation of the preliminary effectiveness of hand massage therapy on postoperative pain of adults in the intensive care unit after cardiac surgery: a pilot randomized controlled trial.

    PubMed

    Boitor, Mădălina; Martorella, Géraldine; Arbour, Caroline; Michaud, Cécile; Gélinas, Céline

    2015-06-01

    Although many intensive care unit patients experience significant pain, very few studies explored massage to maximize their pain relief. This study aimed to evaluate the preliminary effects of hand massage on pain after cardiac surgery in the adult intensive care unit. A pilot randomized controlled trial was used for this study. The study was conducted in a Canadian medical-surgical intensive care unit. Forty adults who were admitted to the intensive care unit after undergoing elective cardiac surgery in the previous 24 hours participated in the study. They were randomly assigned to the experimental (n = 21) or control (n = 19) group. The experimental group received a 15-minute hand massage, and the control group received a 15-minute hand-holding without massage. In both groups the intervention was followed by a 30-minute rest period. The interventions were offered on 2-3 occasions within 24 hours after surgery. Pain, muscle tension, and vital signs were assessed. Pain intensity and behavioral scores were decreased for the experimental group. Although hand massage decreased muscle tension, fluctuations in vital signs were not significant. This study supports potential benefits of hand massage for intensive care unit postoperative pain management. Although larger randomized controlled trials are necessary, this low-cost nonpharmacologic intervention can be safely administered.

  17. 75 FR 10312 - Importer of Controlled Substances; Notice of Registration

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-05

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

  18. A Multi-Site Randomized Clinical Trial to Reduce Suicidal Ideation in Suicidal Adult Outpatients with Major Depressive Disorder: Development of a Methodology to Enhance Safety

    PubMed Central

    McCall, W. Vaughn; Benca, Ruth; Rosenquist, Peter B; Riley, Mary Anne; Hodges, Chelsea; Gubosh, Brittany; McCloud, Laryssa; Newman, Jill C; Case, Doug; Rumble, Meredith; Mayo, Mark; White, Kaitlin Hanley; Phillips, Marjorie; Krystal, Andy

    2015-01-01

    Background/Aims Suicide is a major public health concern, yet there are very few randomized clinical trials that have been conducted to reduce suicidal ideation in patients at risk for suicide. We describe the rationale and refinements of such a trial that is designed to assess the effect of a hypnotic medication on suicidal ideation in adult outpatients currently experiencing suicidal ideation. Methods “Reducing Suicidal Ideation Through Insomnia Treatment (REST-IT)” is a multi-site randomized clinical trial that includes 3 recruiting sites and one data management site. This 4-year study is in its second year of recruitment. The purpose of the study is to compare hypnotic medication versus placebo as an add-on treatment to a selective serotonin reuptake inhibitor as a means of reducing suicidal ideation in depressed adult outpatients with insomnia and suicidal ideation. The safety features of the study follow the 2001 NIH guidelines for studies that include patients at risk of suicide. Results Five hundred and eighty-four potential participants have undergone telephone screening; 67% of these failed the phone screen, most often due to an absence of expressed suicidal ideation (26% of the telephone screen fails). One hundred and twelve persons appeared for a face-to-face baseline assessment, and 40 of these had completed a taper of their ineffective psychotropic medications before the baseline assessments. Sixty-four% of those who completed baseline assessments failed to proceed to randomization, most commonly because of no clinically significant suicidal ideation (51% of those excluded at baseline). One participant was offered and accepted voluntary psychiatric hospitalization in lieu of study participation. Thus far, 40 participants have been randomized into the study, 88.7% of scheduled visits have been attended, with 93.8% adherence for the SSRI and 91.6% adherence for the randomized hypnotic versus placebo. None of the randomized participants have required

  19. 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.

  20. Image registration with uncertainty analysis

    DOEpatents

    Simonson, Katherine M [Cedar Crest, NM

    2011-03-22

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

  1. Immunogenicity and Safety of Trivalent Split Influenza Vaccine in Healthy Korean Adults with Low Pre-Existing Antibody Levels: An Open Phase I Trial

    PubMed Central

    Kang, Kyuri; Han, Seunghoon; Hong, Taegon; Jeon, Sangil; Paek, Jeongki; Kang, Jin Han

    2016-01-01

    Purpose A phase I clinical trial was conducted to evaluate the immunogenicity and safety of newly developed egg-cultivated trivalent inactivated split influenza vaccine (TIV) in Korea. Materials and Methods The TIV was administered to 43 healthy male adults. Subjects with high pre-existing titers were excluded in a screening step. Immune response was measured by a hemagglutination inhibition (HI) assay. Results The seroprotection rates against A/California/7/2009 (H1N1), A/Perth/16/2009 (H3N2) and B/Brisbane/60/2009 were 74.42% [95% confidence interval (CI): 61.38–87.46], 72.09% (95% CI: 58.69–85.50), and 86.05% (95% CI: 75.69–96.40), respectively. Calculated seroconversion rates were 74.42% (95% CI: 61.38–87.46), 74.42% (95% CI: 61.38–87.46), and 79.07% (95% CI: 66.91–91.23), respectively. There were 25 episodes of solicited local adverse events in 21 subjects (47.73%), 21 episodes of solicited general adverse events in 16 subjects (36.36%) and 5 episodes of unsolicited adverse events in 5 subjects (11.36%). All adverse events were grade 1 or 2 and disappeared within three days. Conclusion The immunogenicity and safety of TIV established in this phase I trial are sufficient to plan a larger scale clinical trial. PMID:27593862

  2. Co-occurring amphetamine use and associated medical and psychiatric comorbidity among opioid-dependent adults: results from the clinical Trials Network

    PubMed Central

    Pilowsky, Daniel J; Wu, Li-Tzy; Burchett, Bruce; Blazer, Dan G; Woody, George E; Ling, Walter

    2011-01-01

    Background In response to the rising rate of treatment admissions related to illicit use of amphetamines (eg, methamphetamine), we examined the prevalence of amphetamine use among treatment-seeking, opioid-dependent adults, explored whether amphetamine users were as likely as nonamphetamine users to enroll in opioid-dependence treatment trials, and determined whether amphetamine users manifested greater levels of medical and psychiatric comorbidity than nonusers. Methods The sample included 1257 opioid-dependent adults screened for participation in three-multisite studies of the National Drug Abuse Treatment Clinical Trials Network (CTN001-003), which studied the effectiveness of buprenorphine for opioid detoxification under varying treatment conditions. Patients were recruited from 23 addiction treatment programs across the US. Medical and psychiatric comorbidity were examined by past-month amphetamine use (current vs former) and route of administration. Five mutually exclusive groups were examined, ie, nonusers, current amphetamine injectors, current amphetamine noninjectors, former amphetamine injectors, and former amphetamine noninjectors. Results Of the sample (n = 1257), 22.3% had a history of regular amphetamine use. Of the 280 amphetamine users, 30.3% reported injection as their primary route. Amphetamine users were more likely than nonusers to be white and use more substances. Amphetamine users were as likely as nonusers to enroll in treatment trials. Bivariate analyses indicated elevated rates of psychiatric problems (depression, anxiety, hallucinations, cognitive impairment, violence, suicidal thoughts/attempts) and medical illnesses (dermatological, hepatic, cardiovascular, respiratory, neurological, seizure, allergy conditions) among amphetamine users. After adjusting for demographic variables and lifetime use of other substances: current amphetamine users and former injectors showed an increased likelihood of having medical illnesses and

  3. 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

  4. Can primary care team-based transition to insulin improve outcomes in adults with type 2 diabetes: the stepping up to insulin cluster randomized controlled trial protocol

    PubMed Central

    2014-01-01

    study with important potential implications for people with T2D, healthcare professionals and funders of healthcare though making better use of scarce healthcare resources, improving timely access to therapy that can improve disease outcomes. Trial registration Australian and New Zealand Clinical Trials Registry ACTRN12612001028897 PMID:24528528

  5. Cognitive behavior therapy-based psychoeducational groups for adults with ADHD and their significant others (PEGASUS): an open clinical feasibility trial.

    PubMed

    Hirvikoski, T; Waaler, E; Lindström, T; Bölte, S; Jokinen, J

    2015-03-01

    The aim of this pilot study was to investigate the feasibility and effectiveness of a new psychoeducative intervention program (PEGASUS) for adults with ADHD and their significant others in a psychiatric outpatient context. At three outpatient psychiatric clinics, adults with ADHD and their significant others took part in PEGASUS, a psychoeducational program based on theories from cognitive behavioral therapy, neuropsychology, and cross-disciplinary evidence regarding ADHD. In total, 108 adults were allocated to treatment (51 with ADHD and their 57 significant others). Feasibility was evaluated regarding suitability of the intervention at a psychiatric outpatient clinic and treatment completion. Preliminary efficacy was evaluated per protocol from baseline to post-intervention (n = 41 adults with ADHD and 40 significant others). In a feasibility analysis, the intervention was judged to be a suitable treatment option for 94.5 % of all individuals with a primary diagnosis of ADHD at an outpatient psychiatric clinic. In total, 43 out of 51 allocated individuals with ADHD (84.3 %) completed the intervention. The corresponding figures for their significant others were 42 out of 57 (73.7 %). Knowledge about ADHD increased, and both the quality of relationships and psychological well-being improved from baseline to post-intervention in all participants. The significant others reported a reduction in the subjective burden of care, such as worry and guilt. The objective burden of care (such as financial problems) did not change. The findings support the potential value of psychoeducation for adults with ADHD and their significant others. An ongoing randomized controlled trial will generate further evidence concerning the PEGASUS program.

  6. Immunogenicity and safety of three 2010-2011 seasonal trivalent influenza vaccines in Chinese toddlers, children and older adults: a double-blind and randomized trial.

    PubMed

    Luo, Feng-Ji; Yang, Li-Qing; Ai, Xing; Bai, Yun-Hua; Wu, Jiang; Li, Shu-Ming; Zhang, Zheng; Lu, Min; Li, Li; Wang, Zhao-Yun; Shi, Nian-Min

    2013-08-01

    The 2009 influenza A(H1N1) pandemic strain was for the first time included in the 2010-2011 seasonal trivalent influenza vaccine (TIV). We conducted a double-blind, randomized trial in Chinese population to assess the immunogenicity and safety of the 2010-2011 TIV manufactured by GlaxoSmithKline and compared it with the counterpart vaccines manufactured by Sanofi Pasteur and Sinovac Biotech. Healthy toddlers (6-36 mo), children (6-12 y) and older adults (≥60 y) with 300 participants in each age group were enrolled to randomly receive two doses (toddlers, 28 d apart) or one dose (children and older adults). The immunogenicity was assessed by hemagglutination-inhibition (HI) assay. The solicited injection-site and systemic adverse events (AEs) were collected within 7 d after vaccination. All the three TIVs were well-tolerated with 15.1% of participants reporting AEs, most of which were mild. No serious AEs and unusual AEs were reported. Fever and pain were the most common systemic and injection-site AEs, respectively. The three TIVs showed good immunogenicity. The seroprotection rates against both H1N1 and H3N2 strains were more than 87% in toddlers after two doses and more than 95% in children and more than 86% in older adults after one dose. The seroprotection rates against B strain were 68-71% in toddlers after two doses, 70-74% in children and 69-72% in older adults after one dose. In conclusion, the three 2010-2011 TIVs had good immunogenicity and safety in Chinese toddlers, children and older adults and were generally comparable in immunogenicity and reactogenicity.

  7. A Randomized Controlled Trial on Effects of the Transcendental Meditation Program on Blood Pressure, Psychological Distress, and Coping in Young Adults

    PubMed Central

    Nidich, Sanford I.; Rainforth, Maxwell V.; Haaga, David A.F.; Hagelin, John; Salerno, John W.; Travis, Fred; Tanner, Melissa; Gaylord-King, Carolyn; Grosswald, Sarina; Schneider, Robert H.

    2009-01-01

    Background Psychological distress contributes to the development of hypertension in young adults. This trial assessed the effects of a mind–body intervention on blood pressure (BP), psychological distress, and coping in college students. Methods This was a randomized controlled trial (RCT) of 298 university students randomly allocated to either the Transcendental Meditation (TM) program or wait-list control. At baseline and after 3 months, BP, psychological distress, and coping ability were assessed. A subgroup of 159 subjects at risk for hypertension was analyzed similarly. Results Changes in systolic BP (SBP)/diastolic BP (DBP) for the overall sample were −2.0/−1.2 mm Hg for the TM group compared to +0.4/+0.5 mm Hg for controls (P = 0.15, P = 0.15, respectively). Changes in SBP/DBP for the hypertension risk subgroup were −5.0/−2.8 mm Hg for the TM group compared to +1.3/+1.2 mm Hg for controls (P = 0.014, P = 0.028, respectively). Significant improvements were found in total psychological distress, anxiety, depression, anger/hostility, and coping (P values < 0.05). Changes in psychological distress and coping correlated with changes in SBP (P values < 0.05) and DBP (P values < 0.08). Conclusions This is the first RCT to demonstrate that a selected mind–body intervention, the TM program, decreased BP in association with decreased psychological distress, and increased coping in young adults at risk for hypertension. This mind–body program may reduce the risk for future development of hypertension in young adults. PMID:19798037

  8. Dietary omega-3 fatty acid supplementation increases the rate of muscle protein synthesis in older adults: a randomized controlled trial123

    PubMed Central

    Smith, Gordon I; Atherton, Philip; Reeds, Dominic N; Mohammed, B Selma; Rankin, Debbie; Rennie, Michael J; Mittendorfer, Bettina

    2011-01-01

    Background: Loss of muscle mass with aging is a major public health concern. Omega-3 (n–3) fatty acids stimulate protein anabolism in animals and might therefore be useful for the treatment of sarcopenia. However, the effect of omega-3 fatty acids on human protein metabolism is unknown. Objective: The objective of this study was to evaluate the effect of omega-3 fatty acid supplementation on the rate of muscle protein synthesis in older adults. Design: Sixteen healthy, older adults were randomly assigned to receive either omega-3 fatty acids or corn oil for 8 wk. The rate of muscle protein synthesis and the phosphorylation of key elements of the anabolic signaling pathway were evaluated before and after supplementation during basal, postabsorptive conditions and during a hyperaminoacidemic-hyperinsulinemic clamp. Results: Corn oil supplementation had no effect on the muscle protein synthesis rate and the extent of anabolic signaling element phosphorylation in muscle. Omega-3 fatty acid supplementation had no effect on the basal rate of muscle protein synthesis (mean ± SEM: 0.051 ± 0.005%/h compared with 0.053 ± 0.008%/h before and after supplementation, respectively; P = 0.80) but augmented the hyperaminoacidemia-hyperinsulinemia–induced increase in the rate of muscle protein synthesis (from 0.009 ± 0.005%/h above basal values to 0.031 ± 0.003%/h above basal values; P < 0.01), which was accompanied by greater increases in muscle mTORSer2448 (P = 0.08) and p70s6kThr389 (P < 0.01) phosphorylation. Conclusion: Omega-3 fatty acids stimulate muscle protein synthesis in older adults and may be useful for the prevention and treatment of sarcopenia. This trial was registered at clinical trials.gov as NCT00794079. PMID:21159787

  9. The Mediterranean Diet and Cognitive Function among Healthy Older Adults in a 6-Month Randomised Controlled Trial: The MedLey Study

    PubMed Central

    Knight, Alissa; Bryan, Janet; Wilson, Carlene; Hodgson, Jonathan M.; Davis, Courtney R.; Murphy, Karen J.

    2016-01-01

    Evidence from a limited number of randomised controlled intervention trials (RCTs) have shown that a Mediterranean dietary pattern may reduce the risk of cognitive decline and enhance cognitive function among healthy older adults. However, there are currently no data in non-Mediterranean older adult populations. The present study aimed to address this gap by examining the effect of a Mediterranean dietary pattern (MedDiet) for six months on aspects of cognitive function in a randomised controlled intervention trial (the MedLey study) that extended for a duration of 18 months. In the final analysed cohort, a total of 137 men and women (mean age of 72.1 ± 5.0 years) randomly assigned to either a MedDiet or control diet (HabDiet) (i.e., habitual dietary intake), were assessed on a comprehensive neuropsychological test battery, including 11 individual tests. In multivariable-adjusted models, the MedDiet group did not perform significantly better than the HabDiet control group for executive functioning (adjusted mean differences: +2.53, 95% CI −2.59 to 7.65, p = 0.33); speed of processing (adjusted mean differences: +3.24, 95% CI −1.21 to 7.70, p = 0.15); memory (adjusted mean differences: +2.00, 95% CI −3.88 to 7.88, p = 0.50); visual-spatial ability (adjusted mean differences: +0.21, 95% CI −0.38 to 0.81, 0.48); and overall age-related cognitive performance (adjusted mean differences: +7.99, 95% CI −4.00 to 19.9, p = 0.19). In conclusion, this study did not find evidence of a beneficial effect of a MedDiet intervention on cognitive function among healthy older adults. PMID:27657119

  10. Overcoming the Barriers Experienced in Conducting a Medication Trial in Adults with Aggressive Challenging Behaviour and Intellectual Disabilities

    ERIC Educational Resources Information Center

    Oliver-Africano, P.; Dickens, S.; Ahmed, Z.; Bouras, N.; Cooray, S.; Deb, S.; Knapp, M.; Hare, M.; Meade, M.; Reece, B.; Bhaumik, S.; Harley, D.; Piachaud, J.; Regan, A.; Ade Thomas, D.; Karatela, S.; Rao, B.; Dzendrowskyj, T.; Lenotre, L.; Watson, J.; Tyrer, P.

    2010-01-01

    Background: Aggressive challenging behaviour in people with intellectual disability (ID) is frequently treated with antipsychotic drugs, despite a limited evidence base. Method: A multi-centre randomised controlled trial was undertaken to investigate the efficacy, adverse effects and costs of two commonly prescribed antipsychotic drugs…

  11. Randomized Trial of Behavioral Activation, Cognitive Therapy, and Antidepressant Medication in the Acute Treatment of Adults with Major Depression

    ERIC Educational Resources Information Center

    Dimidjian, Sona; Hollon, Steven D.; Dobson, Keith S.; Schmaling, Karen B.; Kohlenberg, Robert J.; Addis, Michael E.; Gallop, Robert; McGlinchey, Joseph B.; Markley, David K.; Gollan, Jackie K.; Atkins, David C.; Dunner, David L.; Jacobson, Neil S.

    2006-01-01

    Antidepressant medication is considered the current standard for severe depression, and cognitive therapy is the most widely investigated psychosocial treatment for depression. However, not all patients want to take medication, and cognitive therapy has not demonstrated consistent efficacy across trials. Moreover, dismantling designs have…

  12. Intensive lifestyle intervention improves physical function among obese adults with knee pain: Findings from the Look AHEAD trial

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Lifestyle interventions causing weight loss or improved physical fitness in obese individuals may lead to improved physical function. This study involved participants in the Action for Health in Diabetes (Look AHEAD) trial who reported knee pain at baseline (n = 2,203). The purposes of this study we...

  13. Intensive lifestyle intervention improves physical function among obese adults with knee pain: Findings from the Look AHEAD Trial

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Lifestyle interventions have resulted in weight loss or improved physical fitness among individuals with obesity, which may lead to improved physical function. This prospective investigation involved participants in the Action for Health in Diabetes (Look AHEAD) trial who reported knee pain at basel...

  14. Randomized Trial of Cognitive-Behavioral Therapy for Chronic Posttraumatic Stress Disorder in Adult Female Survivors of Childhood Sexual Abuse

    ERIC Educational Resources Information Center

    McDonagh, Annmarie; Friedman, Matthew; McHugo, Gregory; Ford, Julian; Sengupta, Anjana; Mueser, Kim; Demment, Christine Carney; Fournier, Debra; Schnurr, Paula P.

    2005-01-01

    The authors conducted a randomized clinical trial of individual psychotherapy for women with posttraumatic stress disorder (PTSD) related to childhood sexual abuse (n = 74), comparing cognitive-behavioral therapy (CBT) with a problem-solving therapy (present-centered therapy; PCT) and to a wait-list (WL). The authors hypothesized that CBT would be…

  15. Spacecraft camera image registration

    NASA Technical Reports Server (NTRS)

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

    1987-01-01

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

  16. Quality of Life, Cortisol Blood Levels and Exercise in Older Adults: Results of a Randomized Controlled Trial

    PubMed Central

    Mura, Gioia; Cossu, Giulia; Migliaccio, Gian M; Atzori, Claudio; Nardi, Antonio E; Machado, Sergio; Carta, Mauro G

    2014-01-01

    Introduction: Cortisol plays a central role in the stress response; while high stress can determine physical and psychological impairment, moderate stress, with a mild increase in cortisol level, may have a positive effect on coping and physical performance. This trial attempted to determine whether cortisol levels were associated with Quality of Life (QoL) in a sample of elderly subjects undertaking an exercise program. Methods:42 subjects aged ≥65 years were randomlyassigned in a 1:1 fashion either to a vigorous physical activity (VAG: N=21) or to a postural gimnastic group (PGG: N=21). Differences between the two groups in QoL (on SF-12), and blood cortisol levels were assessed by ANOVA at different times. Results:In both the VAG and PGG, cortisol levels rose at the end of the trial, with statistically significant differences as compared to the baseline. QoL at the end of the trial was higher than in the national normative sample. Cortisol and QoL in both groups decreased slightly 12 weeks after the end of the trial (T2); however, only in the VAG did the difference from the initial level remain statistically significant. At T1 and T2, subjects with higher SF-12 scores were found in subsamples in both groups with cortisol levels moderately increased (between 200 and 300 mg/ml). Conclusion:In a sample of elderly subjects undergoing two different kinds of exercise, a better perception of Quality of Life was associated with a moderate, non-pathological increase in cortisol. The results need to be confirmed by trials on larger samples. PMID:25006344

  17. A Reduced-Dose Seasonal Trivalent Influenza Vaccine Is Safe and Immunogenic in Adult and Elderly Patients in a Randomized Controlled Trial

    PubMed Central

    Tamas, Ferenc; Jankovics, Istvan

    2012-01-01

    With the recent pandemic of influenza A (H1N1) and vaccine shortages, there has been considerable interest in developing influenza vaccines with reduced doses, allowing for increased production capacity. Here we report a prospective, randomized, double-blind, single-center clinical trial of a reduced-dose whole-virion inactivated, adjuvanted influenza vaccine in adult and elderly volunteers. A total of 234 subjects, including 120 adults (18 to 60 years of age) and 114 elderly subjects (>60 years of age) were enrolled to receive either 6 μg or the conventional 15-μg dose of seasonal trivalent influenza vaccines. The subjects were followed for safety analysis, and serum samples were obtained to assess immunogenicity by hemagglutination inhibition testing. The subjects developed antibody responses against the seasonal influenza A virus H1N1 and H3N2 strains, as well as the seasonal influenza B virus included in the vaccines. Single doses of 6 μg fulfilled licensing criteria for seasonal influenza vaccines. No significant differences in rates of seroconversion or seroprotection or in geometric mean titers were found between the two dosage levels. All adverse events were rare, mild, and transient. We found that the present reduced-dose vaccine is safe and immunogenic in healthy adult and elderly subjects and triggers immune responses that comply with licensing criteria. PMID:22219315

  18. A randomized controlled trial of brain training with non-action video games in older adults: results of the 3-month follow-up.

    PubMed

    Ballesteros, Soledad; Mayas, Julia; Prieto, Antonio; Toril, Pilar; Pita, Carmen; Laura, Ponce de León; Reales, José M; Waterworth, John A

    2015-01-01

    This randomized controlled study (ClinicalTrials.gov NCT02007616) investigated the maintenance of training effects of 20 1-hr non-action video game training sessions with selected games from a commercial package on several age-declining cognitive functions and subjective wellbeing after a 3-month no-contact period. Two groups of cognitively normal older adults participated in both the post-training (posttest) and the present follow-up study, the experimental group who received training and the control group who attended several meetings with the research team during the study but did not receive training. Groups were similar at baseline on demographics, vocabulary, global cognition, and depression status. Significant improvements in the trained group, and no variation in the control group had been previously found at posttest, in processing speed, attention and visual recognition memory, as well as in two dimensions of subjective wellbeing. In the current study, improvement from baseline to 3 months follow-up was found only in wellbeing (Affection and Assertivity dimensions) in the trained group whereas there was no change in the control group. Previous significant improvements in processing speed, attention and spatial memory become non-significant after the 3-month interval. Training older adults with non-action video games enhanced aspects of cognition just after training but this effect disappeared after a 3-month no-contact follow-up period. Cognitive plasticity can be induced in older adults by training, but to maintain the benefits periodic boosting sessions would be necessary.

  19. The Safety and Efficacy of an Enzyme Combination in Managing Knee Osteoarthritis Pain in Adults: A Randomized, Double-Blind, Placebo-Controlled Trial

    PubMed Central

    Bolten, Wolfgang W.; Glade, Michael J.; Raum, Sonja; Ritz, Barry W.

    2015-01-01

    This randomized, double-blind, placebo-controlled, and comparator-controlled trial evaluated the safety and efficacy of an enzyme combination, as Wobenzym, in adults with moderate-to-severe osteoarthritis (OA) of the knee. Adults (n = 150) received Wobenzym, diclofenac (a nonsteroidal anti-inflammatory drug, NSAID), or placebo for 12 weeks. Improvement in pain scores (Lequesne Functional Index) did not differ between subjects treated with Wobenzym or diclofenac, and both treatment groups improved compared to placebo (P < 0.05). Reduction in total WOMAC scores (secondary outcome measure) did not differ between Wobenzym and diclofenac, although only diclofenac emerged as different from placebo (P < 0.05). The median number of rescue medication (paracetamol) tablets consumed was less in the Wobenzym group compared to placebo (P < 0.05), while there was no difference between diclofenac and placebo. Adverse events were similar in frequency in Wobenzym and placebo groups (7.2% and 9.1% of subjects, resp.) and higher in diclofenac group (15.6%). Wobenzym is comparable to the NSAID diclofenac in relieving pain and increasing function in adults with moderate-to-severe painful knee OA and reduces reliance on analgesic medication. Wobenzym is associated with fewer adverse events and, therefore, may be appropriate for long-term use. PMID:25802756

  20. Mindfulness-based intervention for prodromal sleep disturbances in older adults: design and methodology of a randomized controlled trial.

    PubMed

    Black, David S; O'Reilly, Gillian A; Olmstead, Richard; Breen, Elizabeth C; Irwin, Michael R

    2014-09-01

    Sleep problems are prevalent among older adults, often persist untreated, and are predictive of health detriments. Given the limitations of conventional treatments, non-pharmacological treatments such as mindfulness-based interventions (MBIs) are gaining popularity for sleep ailments. However, nothing is yet known about the impact of MBIs on sleep in older adults with prodromal sleep disturbances. This article details the design and methodology of a 6-week parallel-group RCT calibrated to test the treatment effect of the Mindful Awareness Practices (MAPs) program versus sleep hygiene education for improving sleep quality, as the main outcome, in older adults with prodromal sleep disturbances. Older adults with current sleep disturbances will be recruited from the urban Los Angeles community. Participants will be randomized into two standardized treatment conditions, MAPs and sleep hygiene education. Each condition will consist of weekly 2-hour group-based classes over the course of the 6-week intervention. The primary objective of this study is to determine if mindfulness meditation practice as engaged through the MAPs program leads to improved sleep quality relative to sleep hygiene education in older adults with prodromal sleep disturbances.

  1. An open‐label phase I trial of a live attenuated H2N2 influenza virus vaccine in healthy adults

    PubMed Central

    Talaat, Kawsar R.; Karron, Ruth A.; Liang, Philana H.; McMahon, Bridget A.; Luke, Catherine J.; Thumar, Bhagvanji; Chen, Grace L.; Min, Ji‐Young; Lamirande, Elaine W.; Jin, Hong; Coelingh, Kathy L.; Kemble, George W.; Subbarao, Kanta

    2012-01-01

    Please cite this paper as: Talaat et al. (2012) An open‐label phase I trial of a live attenuated H2N2 influenza virus vaccine in healthy adults. Influenza and Other Respiratory Viruses DOI: 10.1111/j.1750‐2659.2012.00350.x. Background  Live attenuated influenza vaccines (LAIV) against a variety of strains of pandemic potential are being developed and tested. We describe the results of an open‐label phase I trial of a live attenuated H2N2 virus vaccine. Objectives  To evaluate the safety, infectivity, and immunogenicity of a live attenuated H2N2 influenza virus vaccine. Participants/methods  The A/Ann Arbor/6/60 (H2N2) virus used in this study is the attenuated, cold‐adapted, temperature‐sensitive strain that provides the genetic backbone of seasonal LAIV (MedImmune). We evaluated the safety, infectivity, and immunogenicity of two doses of 107 TCID50 of this vaccine administered by nasal spray 4 weeks apart to normal healthy seronegative adults. Results  Twenty‐one participants received a first dose of the vaccine; 18 participants received a second dose. No serious adverse events occurred during the trial. The most common adverse events after vaccination were headache and musculoskeletal pain. The vaccine was restricted in replication: 24% and 17% had virus detectable by culture or rRT‐PCR after the first and second dose, respectively. Antibody responses to the vaccine were also restricted: 24% of participants developed an antibody response as measured by either hemagglutination‐inhibition assay (10%), or ELISA for H2 HA‐specific serum IgG (24%) or IgA (16%) after either one or two doses. None of the participants had a neutralizing antibody response. Vaccine‐specific IgG‐secreting cells as measured by enzyme‐linked immunospot increased from a mean of 0·5 to 2·0/106 peripheral blood mononuclear cells (PBMCs); vaccine‐specific IgA‐secreting cells increased from 0·1 to 0·5/106 PBMCs. Conclusions  The live attenuated H2N2

  2. Serum Parathyroid Hormone Responses to Vitamin D Supplementation in Overweight/Obese Adults: A Systematic Review and Meta-Analysis of Randomized Clinical Trials.

    PubMed

    Lotito, Ashley; Teramoto, Masaru; Cheung, May; Becker, Kendra; Sukumar, Deeptha

    2017-03-06

    Obesity is often associated with vitamin D deficiency and secondary hyperparathyroidism. Vitamin D supplementation typically leads to the reductions in serum parathyroid hormone (PTH) levels, as shown in normal weight individuals. Meanwhile, the dose of vitamin D supplementation for the suppression of PTH may differ in overweight and obese adults. We conducted a systematic review and meta-analysis of randomized controlled trials to determine the dose of vitamin D supplementation required to suppress PTH levels in overweight/obese individuals. We identified 18 studies that examined overweight or obese healthy adults who were supplemented with varying doses of vitamin D3. The primary outcomes examined were changes in PTH and serum 25-hydroxyvitamin D (25OHD) levels from baseline to post-treatment. The results of the meta-analysis showed that there was a significant treatment effect of vitamin D supplementation on PTH, total standardized mean difference (SMD) (random effects) = -0.38 (95% CI = -0.56 to -0.20), t = -4.08, p < 0.001. A significant treatment effect of vitamin D supplementation was also found on 25OHD, total SMD (random effects) = 2.27 (95% CI = 1.48 to 3.06) t = 5.62, p < 0.001. Data from available clinical trials that supplemented adults with D3 ranging from 400 IU to 5714 IU, showed that 1000 IU of vitamin D supplementation best suppressed serum PTH levels, total SMD = -0.58, while vitamin D supplementation with 4000 IU showed the greatest increase in serum 25OH levels. Vitamin D and calcium supplementation of 700 IU and 500 mg, respectively, also showed a significant treatment effect on the suppression of PTH with a total SMD = -5.30 (95% CI = -9.72 to -0.88). In conclusion, the meta analysis of available clinical trials indicates that 1000 IU vitamin D supplementation can suppress serum PTH levels, while 4000 IU of vitamin D was associated with the largest increase in serum 25OHD levels in the overweight and obese population.

  3. Serum Parathyroid Hormone Responses to Vitamin D Supplementation in Overweight/Obese Adults: A Systematic Review and Meta-Analysis of Randomized Clinical Trials

    PubMed Central

    Lotito, Ashley; Teramoto, Masaru; Cheung, May; Becker, Kendra; Sukumar, Deeptha

    2017-01-01

    Obesity is often associated with vitamin D deficiency and secondary hyperparathyroidism. Vitamin D supplementation typically leads to the reductions in serum parathyroid hormone (PTH) levels, as shown in normal weight individuals. Meanwhile, the dose of vitamin D supplementation for the suppression of PTH may differ in overweight and obese adults. We conducted a systematic review and meta-analysis of randomized controlled trials to determine the dose of vitamin D supplementation required to suppress PTH levels in overweight/obese individuals. We identified 18 studies that examined overweight or obese healthy adults who were supplemented with varying doses of vitamin D3. The primary outcomes examined were changes in PTH and serum 25-hydroxyvitamin D (25OHD) levels from baseline to post-treatment. The results of the meta-analysis showed that there was a significant treatment effect of vitamin D supplementation on PTH, total standardized mean difference (SMD) (random effects) = −0.38 (95% CI = −0.56 to −0.20), t = −4.08, p < 0.001. A significant treatment effect of vitamin D supplementation was also found on 25OHD, total SMD (random effects) = 2.27 (95% CI = 1.48 to 3.06) t = 5.62, p < 0.001. Data from available clinical trials that supplemented adults with D3 ranging from 400 IU to 5714 IU, showed that 1000 IU of vitamin D supplementation best suppressed serum PTH levels, total SMD = −0.58, while vitamin D supplementation with 4000 IU showed the greatest increase in serum 25OH levels. Vitamin D and calcium supplementation of 700 IU and 500 mg, respectively, also showed a significant treatment effect on the suppression of PTH with a total SMD = −5.30 (95% CI = −9.72 to −0.88). In conclusion, the meta analysis of available clinical trials indicates that 1000 IU vitamin D supplementation can suppress serum PTH levels, while 4000 IU of vitamin D was associated with the largest increase in serum 25OHD levels in the overweight and obese population. PMID

  4. Reduction of Alcohol Drinking in Young Adults by Naltrexone: A Double-Blind, Placebo-Controlled, Randomized Clinical Trial of Efficacy and Safety

    PubMed Central

    O’Malley, Stephanie S.; Corbin, William R.; Leeman, Robert F.; DeMartini, Kelly S.; Fucito, Lisa M.; Ikomi, Jolomi; Romano, Denise M.; Wu, Ran; Toll, Benjamin A.; Sher, Kenneth J.; Gueorguieva, Ralitza; Kranzler, Henry R.

    2015-01-01

    Objective Naltrexone, an opioid antagonist, may facilitate reduction in drinking among young adults. We compared the efficacy and safety of naltrexone administered daily plus targeted dosing with placebo to reduce drinking in heavy drinking young adults. Methods Randomized, double-blind, placebo-controlled study, outpatient research center, March 2008-January 2012. Participants were ages 18-25, reporting ≥ 4 heavy drinking days in the prior 4 weeks. Interventions included naltrexone 25 mg daily plus 25 mg targeted (at most daily) in anticipation of drinking (n = 61) or daily/targeted placebo (n = 67). All received a personalized feedback session and brief counseling every other week. Primary outcomes were percent days heavy drinking (PHDD) and percent days abstinent (PDA) over the 8-week treatment period. Secondary outcomes included drinks/drinking day and percent days with estimated blood alcohol levels ≥0.08 g/dL. Results Of 140 randomized, 128 began treatment, comprising the evaluable sample. During treatment, PHDD (Naltrexone M=21.60, SD=16.05; Placebo M=22.90, SD=13.20) (p=0.58) and PDA (Naltrexone M=56.60, SD=22.52; Placebo M=62.50, SD=15.75) (p=0.39) did not differ by group. Naltrexone significantly reduced drinks per drinking day (Naltrexone M=4.90, SD=2.28; Placebo M=5.90, SD=2.51) (p=0.009) and percentage of drinking days with estimated BAC ≥0.08 g/dL (Naltrexone M=35.36, SD=28.40; Placebo M=45.74, SD=26.80) (p=0.042). There were no serious adverse events. Sleepiness was more common with naltrexone. Conclusions Naltrexone did not reduce frequency of drinking or heavy drinking days, but reduced secondary measures of drinking intensity. While effects were modest, the risk-benefit ratio favors offering naltrexone to help young adult heavy drinkers reduce their drinking. Registration clinicaltrials.gov NCT00568958 PMID:25742208

  5. Study Protocol: Screening and Treatment of Alcohol-Related Trauma (START) – a randomised controlled trial

    PubMed Central

    2012-01-01

    Background The incidence of mandibular fractures in the Northern Territory of Australia is very high, especially among Indigenous people. Alcohol intoxication is implicated in the majority of facial injuries, and substance use is therefore an important target for secondary prevention. The current study tests the efficacy of a brief therapy, Motivational Care Planning, in improving wellbeing and substance misuse in youth and adults hospitalised with alcohol-related facial trauma. Methods and design The study is a randomised controlled trial with 6 months of follow-up, to examine the effectiveness of a brief and culturally adapted intervention in improving outcomes for trauma patients with at-risk drinking admitted to the Royal Darwin Hospital maxillofacial surgery unit. Potential participants are identified using AUDIT-C questionnaire. Eligible participants are randomised to either Motivational Care Planning (MCP) or Treatment as Usual (TAU). The outcome measures will include quantity and frequency of alcohol and other substance use by Timeline Followback. The recruitment target is 154 participants, which with 20% dropout, is hoped to provide 124 people receiving treatment and follow-up. Discussion This project introduces screening and brief interventions for high-risk drinkers admitted to the hospital with facial trauma. It introduces a practical approach to integrating brief interventions in the hospital setting, and has potential to demonstrate significant benefits for at-risk drinkers with facial trauma. Trial Registration The trial has been registered in Australian New Zealand Clinical Trials Registry (ANZCTR) and Trial Registration: ACTRN12611000135910. PMID:23106916

  6. Bereaved Adults with Intellectual Disabilities: A Combined Randomized Controlled Trial and Qualitative Study of Two Community-Based Interventions

    ERIC Educational Resources Information Center

    Dowling, S.; Hubert, J.; White, S.; Hollins, S.

    2006-01-01

    Background: Bereaved adults with intellectual disabilities are known to experience prolonged and atypical grief which is often unrecognized. The aim of this project was to find an effective way to improve mental health and behavioural outcomes. Methods: Subjects were randomized to two different therapeutic interventions: traditional counselling by…

  7. An Evaluation of the Implementation of Hand Held Health Records with Adults with Learning Disabilities: A Cluster Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Turk, Vicky; Burchell, Sarah; Burrha, Sukhjinder; Corney, Roslyn; Elliott, Sandra; Kerry, Sally; Molloy, Catherine; Painter, Kerry

    2010-01-01

    Background: Personal health records were implemented with adults with learning disabilities (AWLD) to try to improve their health-care. Materials and Method: Forty GP practices were randomized to the Personal Health Profile (PHP) implementation or control group. Two hundred and one AWLD were interviewed at baseline and 163 followed up after 12…

  8. A Randomized Trial about Glycemic Index and Glycemic Load Improves Outcomes among Adults with Type 2 Diabetes

    ERIC Educational Resources Information Center

    Miller, Carla K.; Gutschall, Melissa

    2009-01-01

    Glycemic index (GI) represents the postprandial glucose response of carbohydrate foods, and glycemic load (GL) represents the quantity and quality of carbohydrate consumed. A diet lower in GI and GL may improve diabetes management. A 9-week intervention regarding GI and GL was evaluated among adults in the age range of 40-70 years who had had type…

  9. Efficacy of atomoxetine in adults with attention deficit hyperactivity disorder: An integrated analysis of the complete database of multicenter placebo-controlled trials

    PubMed Central

    Asherson, Philip; Bushe, Chris; Saylor, Keith; Tanaka, Yoko; Deberdt, Walter; Upadhyaya, Himanshu

    2014-01-01

    Persistence of attention deficit hyperactivity disorder (ADHD) into adulthood can be disabling or lead to substantial impairment. Several clinical trials of atomoxetine (ATX) in adults with ADHD have been reported following the National Institute for Health and Clinical Excellence (NICE) guidelines issued in 2008. We performed an integrated analysis of all Eli Lilly-sponsored, randomized, double-blind, placebo-controlled studies of ATX in adults with ADHD completed as of May 2012. Individual patient data were pooled from six short-term (10–16 week) studies (1961 patients) and three longer-term (six-month) studies (1413 patients). In the short-term analysis, ATX patients achieved a significantly greater mean reduction in ADHD symptoms than placebo patients (−12.2 vs −8.1; Conners’ Adult ADHD Rating Scale–Investigator-Rated: Screening Version (CAARS-Inv: SV); p<0.001). In the longer-term analysis, respective improvements after six months were −13.2 vs −9.7 (p<0.001). Response rates at study endpoints for ATX vs placebo, based on CAARS-Inv: SV improvement ≥30% and Clinical Global Impressions of ADHD-Severity (CGI-ADHD-S) ≤3 were 34.8% vs 22.3% in the short-term and 43.4% vs 28.0% after six months, and CAARS-Inv: SV improvements ≥40% were 41.3% vs 25.3% in the short-term and 44.0% vs 31.4% after six months (all p<0.001). Overall, ATX had a clinically significant effect in adults with ADHD, with reductions in core symptoms and clinically meaningful responder rates. PMID:25035246

  10. Outcome after relapse of acute lymphoblastic leukemia in adult patients included in four consecutive risk-adapted trials by the PETHEMA Study Group

    PubMed Central

    Oriol, Albert; Vives, Susana; Hernández-Rivas, Jesús-María; Tormo, Mar; Heras, Inmaculada; Rivas, Concepción; Bethencourt, Concepción; Moscardó, Federico; Bueno, Javier; Grande, Carlos; del Potro, Eloy; Guardia, Ramon; Brunet, Salut; Bergua, Juan; Bernal, Teresa; Moreno, Maria-José; Calvo, Carlota; Bastida, Pilar; Feliu, Evarist; Ribera, Josep-Maria

    2010-01-01

    Background About one half of adults with acute lymphoblastic leukemia are not cured of the disease and ultimately die. The objective of this study was to explore the factors influencing the outcome of adult patients with relapsed acute lymphoblastic leukemia. Design and Methods We analyzed the characteristics, the outcome and the prognostic factors for survival after first relapse in a series of 263 adult patients with acute lymphoblastic leukemia (excluding those with mature B-cell acute lymphoblastic leukemia) prospectively enrolled in four consecutive risk-adapted PETHEMA trials. Results The median overall survival after relapse was 4.5 months (95% CI, 4–5 months) with a 5-year overall survival of 10% (95% CI, 8%–12%); 45% of patients receiving intensive second-line treatment achieved a second complete remission and 22% (95% CI, 14%–30%) of them remained disease free at 5 years. Factors predicting a good outcome after rescue therapy were age less than 30 years (2-year overall survival of 21% versus 10% for those over 30 years old; P<0.022) and a first remission lasting more than 2 years (2-year overall survival of 36% versus 17% among those with a shorter first remission; P<0.001). Patients under 30 years old whose first complete remission lasted longer than 2 years had a 5-year overall survival of 38% (95% CI, 23%–53%) and a 5-year disease-free survival of 53% (95% CI, 34%–72%). Conclusions The prognosis of adult patients with acute lymphoblastic leukemia who relapse is poor. Those aged less than 30 years with a first complete remission lasting longer than 2 years have reasonable possibilities of becoming long-term survivors while patients over this age or those who relapse early cannot be successfully rescued using the therapies currently available. PMID:20145276

  11. Immunoprotective effects of oral intake of heat-killed Lactobacillus pentosus strain b240 in elderly adults: a randomised, double-blind, placebo-controlled trial.

    PubMed

    Shinkai, Shoji; Toba, Masamichi; Saito, Takao; Sato, Ikutaro; Tsubouchi, Mina; Taira, Kiyoto; Kakumoto, Keiji; Inamatsu, Takashi; Yoshida, Hiroto; Fujiwara, Yoshinori; Fukaya, Taro; Matsumoto, Tetsuya; Tateda, Kazuhiro; Yamaguchi, Keizo; Kohda, Noriyuki; Kohno, Shigeru

    2013-05-28

    Oral intake of Lactobacillus pentosus strain b240 (b240) has been shown to enhance the secretion of salivary secretory IgA in elderly adults. However, its clinical benefits remain to be determined. We tested the hypothesis that b240 exerts a protective effect against the common cold in elderly adults. The design of the present study was a randomised, double-blind, placebo-controlled trial (RCT) with parallel three-group comparison. For this purpose, 300 eligible elderly adults were randomly allocated to one of three groups, namely a placebo, low-dose or high-dose b240 group. Participants in the low-dose and high-dose b240 groups were given tablets containing 2 × 10(9) or 2 × 10(10) cells, respectively, of heat-killed b240, while those in the placebo group were given tablets without b240. Each group consumed their respective tablets once daily for 20 weeks. The common cold was assessed on the basis of a diary. Change in quality of life was evaluated using the SF-36. Of the total participants, 280 completed the 20-week RCT. The accumulated incidence rate of the common cold was 47·3, 34·8 and 29·0 % for the placebo, low-dose b240 and high-dose b240 groups, respectively (P for trend = 0·012). Lower incidence rates were consistently observed throughout the experimental period in the b240 groups (log-rank test, P= 0·034). General health perception, as determined by the SF-36, dose-dependently increased in the b240 groups (P for trend = 0·016). In conclusion, oral intake of b240 significantly reduced the incidence rate of the common cold in elderly adults, indicating that b240 might be useful in improving resistance against infection through mucosal immunity.

  12. Results of a Randomized Controlled Trial to Examine the Efficacy of a Chronic Pain Self-Management Group for Older Adults [ISRCTN11899548

    PubMed Central

    Ersek, Mary; Turner, Judith A.; Cain, Kevin C.; Kemp, Carol A.

    2008-01-01

    Chronic pain is a common, disabling problem in older adults. Pain self-management training is a multimodal therapy that has been found to be effective in young to middle-aged adult samples; however, few studies have examined the effectiveness of this therapy in older adults. In this randomized, controlled trial, we evaluated a pain self-management training group (SMG) intervention as compared with an education-only (BOOK) control condition. Participants, 65 years of age or older who experienced persistent, noncancer pain that limited their activities, were recruited from 43 retirement communities in the Pacific Northwest of the United States. The primary outcome was physical disability, as measured by the Roland-Morris Disability Questionnaire. Secondary outcomes were depression (Geriatric Depression Scale), pain intensity (Brief Pain Inventory), and pain-related interference with activities (Brief Pain Inventory). Randomization occurred by facility to minimize cross-contamination between groups. Two-hundred and fifty-six individuals, mean age=81.8 (SD: 6.5), enrolled and 218 completed the study. No significant differences in outcomes were found between groups at post-intervention, 6-month follow-up, or 12-month follow-up. The SMG group showed a significantly greater increase over time, relative to the BOOK group, in two process measures, as measured by the Chronic Pain Coping Inventory: use of relaxation and use of exercise/stretching. In both cases, the increase was greatest from baseline to the post-intervention assessment. Study findings indicate that additional research is needed to determine the most effective content and delivery methods for self-management therapies targeted at older adults with chronic pain. PMID:18086516

  13. Survival analysis of banding and bonding molar tubes in adult patients over a 12-month period: a split-mouth randomized clinical trial.

    PubMed

    Oeiras, Valéria Jacques; Silva, Valéria Assis Almeida E; Azevedo, Leidiana Aguiar; Lobato, Vanessa Soares; Normando, David

    2016-12-22

    This split-mouth randomized clinical trial aimed to compare the survival rate of bonding and banding molar tubes in adult orthodontic patients. Eligibility criteria included adults (aged >18 years), no active caries, restorations, or fractures in the upper and lower molars. The main outcome was any type of first-time failure in molar tubes. A computer-generated randomization scheme was used in a 1:1 ratio. The survival rate was estimated for 32 adult patients, in whom a tube was bonded to a molar tooth using composite resin on one side and a band was cemented with glass ionomer onto the same tooth in the contralateral arch. A total of 59 banded and 59 bonded molars were followed up for 12 months. Blinding was not applicable. Survival analysis including Cox regression was used at p < 0.05. The survival rate of bonded molars was not statistically different from that of banded molars (log-rank test, p = 0.97). Hazard ratio (HR) was 0.72 (95%CI, 0.38-1.31). Bonded upper molars yielded a survival rate of 81.25% (26 out of 32) compared to 71.87% (23 out of 32) for banded upper molars. The survival rate was 66.66% (18 out of 27) for banded lower molars and 59.25% for bonded lower molars (16 out of 27). The HR for lower vs. upper arch was 2.16 (95%CI, 1.18-3.98). No serious problem was observed other than gingivitis associated with plaque accumulation. In contrast to previous studies in young patients, in adults, bonding orthodontic tubes to molars is similar to molar banding. However, both procedures had a high failure rate in the lower arch.

  14. Treatment of reducible unstable fractures of the distal radius in adults: a randomised controlled trial of De Palma percutaneous pinning versus bridging external fixation

    PubMed Central

    2010-01-01

    fixator group with regard to the supination movement 6 months after the operation; however, this was not maintained at 24 months. The final results of the radiographic evaluation were similar for the two groups. Overall, five patients developed complications: two with De Palma pinning and three with external fixation. Conclusion There was a small statistically significant difference favouring the De Palma method in early functional at 6 months according to the DASH questionnaire, and for supination movement favouring the fixator group. However, both were not clinical relevant. By 24 months the groups were similar for all outcomes Trial registration Current Controlled Trials ISRCTN04892785 PMID:20587064

  15. Effect of double dose oseltamivir on clinical and virological outcomes in children and adults admitted to hospital with severe influenza: double blind randomised controlled trial

    PubMed Central

    2013-01-01

    . No important differences in tolerability were fou