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Sample records for adults trial registration

  1. [A review of international clinical trial registration].

    PubMed

    Yu, He; Liu, Jian-ping

    2007-05-01

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

  2. Legislation for trial registration and data transparency.

    PubMed

    Bian, Zhao-Xiang; Wu, Tai-Xiang

    2010-01-01

    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. PMID:20504337

  3. 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. PMID:24350423

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

    PubMed

    Forshag, Mark S

    2016-08-01

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

  5. Association of trial registration with the results and conclusions of published trials of new oncology drugs

    PubMed Central

    2009-01-01

    Background Registration of clinical trials has been introduced largely to reduce bias toward statistically significant results in the trial literature. Doubts remain about whether advance registration alone is an adequate measure to reduce selective publication, selective outcome reporting, and biased design. One of the first areas of medicine in which registration was widely adopted was oncology, although the bulk of registered oncology trials remain unpublished. The net influence of registration on the literature remains untested. This study compares the prevalence of favorable results and conclusions among published reports of registered and unregistered randomized controlled trials of new oncology drugs. Methods We conducted a cross-sectional study of published original research articles reporting clinical trials evaluating the efficacy of drugs newly approved for antimalignancy indications by the United States Food and Drug Administration (FDA) from 2000 through 2005. Drugs receiving first-time approval for indications in oncology were identified using the FDA web site and Thomson Centerwatch. Relevant trial reports were identified using PubMed and the Cochrane Library. Evidence of advance trial registration was obtained by a search of clinicaltrials.gov, WHO, ISRCTN, NCI-PDQ trial databases and corporate trial registries, as well as articles themselves. Data on blinding, results for primary outcomes, and author conclusions were extracted independently by two coders. Univariate and multivariate logistic regression identified associations between favorable results and conclusions and independent variables including advance registration, study design characteristics, and industry sponsorship. Results Of 137 original research reports from 115 distinct randomized trials assessing 25 newly approved drugs for treating cancer, the 54 publications describing data from trials registered prior to publication were as likely to report statistically significant efficacy

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

    PubMed

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

    2014-01-01

    The European Clinical Trials Directive of 2004 has increased the amount of paper work and reduced the number of initiated clinical trials. Particularly multinational trials have been delayed. To meet this challenge we developed a novel, simplified, fast and easy strategy for on-line toxicity registration for patients treated according to the Nordic/Baltic acute lymphoblastic leukaemia protocol, NOPHO ALL 2008, for children and young adults, including three randomisations. We used a risk-assessment based approach, avoiding reporting of expected adverse events and instead concentrating on 20 well-known serious, but rarer events with focus on changes in therapy introduced in the treatment protocol. This toxicity registration strategy was approved by the relevant regulatory authorities in all seven countries involved, as compliant within the EU directive of 2004. The centre compliance to registration was excellent with 98.9% of all patients being registered within 5weeks from the requested quarterly registration. Currently, four toxicities (thrombosis, fungal infections, pancreatitis and allergic reactions) have been chosen for further detailed exploration due to the cumulative fraction of patients with positive registrations exceeding 5%. This toxicity registration offers real-time toxicity profiles of the total study cohort and provides early warnings of specific toxicities that require further investigation. PMID:24231337

  7. Surgical trials and trial registers: a cross-sectional study of randomized controlled trials published in journals requiring trial registration in the author instructions

    PubMed Central

    2013-01-01

    Background Trial registration and the reporting of trial results are essential to increase transparency in clinical research. Although both have been strongly promoted in recent years, it remains unclear whether they have been successfully implemented in surgery and surgery-related disciplines. In this cross-sectional study, we assessed whether randomized controlled trials (RCTs) published in surgery journals requiring trial registration in their author instructions were indeed registered, and whether the study results of registered RCTs had been submitted to the trial register and were thus publicly available. Methods The ten highest ranked surgery journals requiring trial registration by impact factor (Journal Citation Reports, JCR, 2011) were chosen. We then searched MEDLINE (in PubMed) for RCTs published in the selected journals between 1 June 2012 and 31 December 2012. Any trials recruiting participants before 2004 were excluded because the International Committee of Medical Journal Editors (ICMJE) first proposed trial registration in 2004. We then searched the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) to assess whether the identified RCTs were indeed registered and whether the results of the registered RCTs were available in the register. Results The search retrieved 588 citations. Four hundred and sixty references were excluded in the first screening. A further 25 were excluded after full-text screening. A total of 103 RCTs were finally included. Eighty-five of these RCTs (83%) could be found via the ICTRP. For 7 of 59 (12%) RCTs, which were registered on ClinicalTrials.gov, summary study data had been posted in the results database. Conclusions Although still not fully implemented, trial registration in surgery has gained momentum. In general, however, the submission of summary study data to ClinicalTrials.gov remains poor. PMID:24289719

  8. Comparison of published orthopaedic trauma trials following registration in Clinicaltrials.gov

    PubMed Central

    2011-01-01

    Background After the Food and Drug Administration Modernization Act of 1997, the registration of all clinical trials became mandatory prior to publication. Our primary objective was to determine publication rates for orthopaedic trauma trials registered with ClinicalTrials.gov. We further evaluated methodological consistency between registration and publication. Methods We searched Clinical Trials.gov for all trials related to orthopaedic trauma. We excluded active trials and trials not completed by July 2009, and performed a systematic search for publications resulting from registered closed trials. Information regarding primary and secondary outcomes, intervention, study sponsors, and sample size were extracted from registrations and publications. Results Of 130 closed trials, 37 eligible trials resulted in 16 publications (43.2%). We found no significant differences in publication rates between funding sources for industry sponsored studies and nongovernment/nonindustry sponsored studies (p > 0.05). About half the trials (45%) did not include the NCT ID in the publication. Two (10%) publications had major changes to the primary outcome measure and ten (52.6%) to sample size. Conclusions Registration of orthopaedic trauma trials does not consistently result in publication. When trials are registered, many do not cite NCT ID in the publication. Furthermore, changes that are not reflected in the registry of the trial are frequently made to the final publication. PMID:22151841

  9. 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

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

    PubMed Central

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

    2015-01-01

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

  11. [Clinical trial requests of indigenous diagnostic imaging ultrasound devices in first-time registration application].

    PubMed

    Guo, Zhaojun; Cao, Guofang; Tao, Kan

    2012-11-01

    This article introduces the clinical requests of indigenous diagnostic imaging ultrasound devices in first-time registration application and the clinical trial requests in Technical Review Guidance of Ultrasound Imaging Diagnostic Devices (category III) Registration and puts forward some questions of the guidance's implementation. It is hoped to help concerned people. PMID:23461122

  12. Is Mandatory Prospective Trial Registration Working to Prevent Publication of Unregistered Trials and Selective Outcome Reporting? An Observational Study of Five Psychiatry Journals That Mandate Prospective Clinical Trial Registration

    PubMed Central

    Scott, Amelia; Rucklidge, Julia J.; Mulder, Roger T.

    2015-01-01

    Objective To address the bias occurring in the medical literature associated with selective outcome reporting, in 2005, the International Committee of Medical Journal Editors (ICMJE) introduced mandatory trial registration guidelines and member journals required prospective registration of trials prior to patient enrolment as a condition of publication. No research has examined whether these guidelines are impacting psychiatry publications. Our objectives were to determine the extent to which articles published in psychiatry journals adhering to ICMJE guidelines were correctly prospectively registered, whether there was evidence of selective outcome reporting and changes to participant numbers, and whether there was a relationship between registration status and source of funding. Materials and Methods Any clinical trial (as defined by ICMJE) published between 1 January 2009 and 31 July 2013 in the top five psychiatry journals adhering to ICMJE guidelines (The American Journal of Psychiatry, Archives of General Psychiatry/JAMA Psychiatry, Biological Psychiatry, Journal of the American Academy of Child and Adolescent Psychiatry, and The Journal of Clinical Psychiatry) and conducted after July 2005 (or 2007 for two journals) was included. For each identified trial, where possible we extracted trial registration information, changes to POMs between publication and registry to assess selective outcome reporting, changes to participant numbers, and funding type. Results Out of 3305 articles, 181 studies were identified as clinical trials requiring registration: 21 (11.6%) were deemed unregistered, 61 (33.7%) were retrospectively registered, 37 (20.4%) had unclear POMs either in the article or the registry and 2 (1.1%) were registered in an inaccessible trial registry. Only 60 (33.1%) studies were prospectively registered with clearly defined POMs; 17 of these 60 (28.3%) showed evidence of selective outcome reporting and 16 (26.7%) demonstrated a change in participant

  13. Evaluating adherence to the International Committee of Medical Journal Editors’ policy of mandatory, timely clinical trial registration

    PubMed Central

    Huser, Vojtech; Cimino, James J

    2013-01-01

    Objective To determine whether two specific criteria in Uniform Requirements for Manuscripts (URM) created by the International Committee of Medical Journal Editors (ICMJE)—namely, including the trial ID registration within manuscripts and timely registration of trials, are being followed. Materials and methods Observational study using computerized analysis of publicly available Medline article data and clinical trial registry data. We analyzed a purposive set of five ICMJE founding journals looking at all trial articles published in those journals during 2010–2011, and data from the ClinicalTrials.gov (CTG) trial registry. We measured adherence to trial ID inclusion policy as the percentage of trial journal articles that contained a valid trial ID within the article (journal-based sample). Adherence to timely registration was measured as the percentage of trials that registered the trial before enrolling the first participant within a 60-day grace period. We also examined timely registration rates by year of all phase II and higher interventional trials in CTG (registry-based sample). Results To determine trial ID inclusion, we analyzed 698 clinical trial articles in five journals. A total of 95.8% (661/690) of trial journal articles included the trial ID. In 88.3% the trial-article link is stored within a structured Medline field. To evaluate timely registration, we analyzed trials referenced by 451 articles from the selected five journals. A total of 60% (272/451) of articles were registered in a timely manner with an improving trend for trials initiated in later years (eg, 89% of trials that began in 2008 were registered in a timely manner). In the registry-based sample, the timely registration rates ranged from 56% for trials registered in 2006 to 72% for trials registered in 2011. Discussion Adherence to URM requirements for registration and trial ID inclusion increases the utility of PubMed and links it in an important way to clinical trial repositories

  14. 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. PMID:26515793

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

    PubMed Central

    2013-01-01

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

  16. Trends in global clinical trial registration: an analysis of numbers of registered clinical trials in different parts of the world from 2004 to 2013

    PubMed Central

    Viergever, Roderik F; Li, Keyang

    2015-01-01

    Objectives To analyse developments (and their causes) in the number and proportion of clinical trials that were registered in different parts of the world after the International Committee of Medical Journal Editors (ICMJE) announced in 2004 that it would require registration of clinical trials as a condition for publication. Setting The International Clinical Trials Registry Platform (ICTRP). Design The ICTRP database was searched for all clinical trials that were registered up to 31 December 2013. Results The ICTRP database contained data on 186 523 interventional clinical trials. The annual number of registered clinical trials increased from 3294 in 2004 to 23 384 in 2013. Relative to the number of clinical trial research publications, the global number of registered clinical trials increased fivefold between 2004 and 2013, rising particularly strongly between 2004 and 2005. In certain regions, especially Asia, the annual number of registered trials increased more gradually and continued to increase up to 2013. In India and Japan, two countries with marked but more gradual increases, these increases only happened after several local measures were implemented that encouraged and enforced registration. In most regions, there was a trend toward trials being registered at local registries. Conclusions Clinical trial registration has greatly improved transparency in clinical trial research. However, these improvements have not taken place equally in all parts of the world. Achieving compliance with registration requires a coalescence of global and local measures, and remains a key challenge in many countries. Poor quality of registered trial data and the inaccessibility of trial protocols, results and participant-level data further undermine the potential benefits of clinical trial registration. National and regional registries and the ICTRP have played a leading role in achieving the successes of trial registration to date and should be supported in addressing

  17. Design of the Xylitol for Adult Caries Trial (X-ACT)

    PubMed Central

    2010-01-01

    Background Dental caries incidence in adults is similar to that in children and adolescents, but few caries preventive agents have been evaluated for effectiveness in adults populations. In addition, dentists direct fewer preventive services to their adult patients. Xylitol, an over-the-counter sweetener, has shown some potential as a caries preventive agent, but the evidence for its effectiveness is not yet conclusive and is based largely on studies in child populations. Methods/Design X-ACT is a three-year, multi-center, placebo controlled, double-blind, randomized clinical trial that tests the effects of daily use of xylitol lozenges versus placebo lozenges on the prevention of adult caries. The trial has randomized 691 participants (ages 21-80) to the two arms. The primary outcome is the increment of cavitated lesions. Discussion This trial should help resolve the overall issue of the effectiveness of xylitol in preventing caries by contributing evidence with a low risk of bias. Just as importantly, the trial will provide much-needed information about the effectiveness of a promising caries prevention agent in adults. An effective xylitol-based caries prevention intervention would represent an easily disseminated method to extend caries prevention to individuals not receiving caries preventive treatment in the dental office. Trial Registration ClinicalTrials.Gov NCT00393055 PMID:20920261

  18. 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

  19. 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

  20. 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…

  1. The views of doctors on registration trials in a Japanese rural area: a survey of medical institutions registered to the Tokushima Network for Clinical Trials.

    PubMed

    Yanagawa, H; Irahara, M; Kawashima, S; Kagawa, S

    2008-01-01

    Tokushima University Hospital has established the Tokushima Network for Clinical Trials (TNCT) to promote clinical trials in the area in collaboration with the Tokushima Medical Association. The present study investigated the views of doctors towards registration trials in the TNCT. A questionnaire was provided to 49 clinics/hospitals registered to the TNCT in 2006 and 38 (78%) responded. It revealed that 48% of doctors were aware of registration trials and 87% were favourable towards participating as investigators in them. They considered close contact with developmental drugs, advancement of therapy and the opportunity to learn about state-of-the-art treatment as benefits of participation. The main areas of difficulty included management of adverse reactions and patients' refusal to take part. Many doctors wanted more opportunity to learn about trial-related issues such as regulations. The survey indicates that the TNCT needs to develop the infrastructure and enlighten participants to promote registration trials in this rural regional area. PMID:18831909

  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. Visual scoring of non-cavitated caries lesions and clinical trial efficiency, testing xylitol in caries active adults

    PubMed Central

    Brown, JP; Amaechi, BT; Bader, JD; Gilbert, GH; Makhija, SK; Lozano-Pineda, J; Leo, MC; Chuhe, C; Vollmer, WM

    2013-01-01

    Objectives To better understand the effectiveness of xylitol in caries prevention in adults, and to attempt improved clinical trial efficiency. Methods As part of the Xylitol for Adult Caries Trial (X-ACT), non-cavitated and cavitated caries lesions were assessed in subjects who were experiencing the disease. The trial was a test of the effectiveness of 5 grams/day of xylitol, consumed by dissolving in the mouth five 1 gram lozenges spaced across each day, compared with a sucralose placebo. For this analysis, seeking trial efficiency, 538 subjects aged 21–80, with complete data for four dental examinations were selected from the 691 randomized into the three year trial, conducted at three sites. Acceptable inter and intra examiner reliability before and during the trial was quantified using the kappa statistic. Results The mean annualized non-cavitated plus cavitated lesion transition scores in coronal and root surfaces, from sound to carious favoured xylitol over placebo, during the three cumulative periods of 12, 24, and 33 months, but these clinically and statistically non-significant differences declined in magnitude over time. Restricting the present assessment to those subjects with a higher baseline lifetime caries experience showed possible but inconsistent benefit. Conclusions There was no clear and clinically relevant preventive effect of xylitol on caries in adults with adequate fluoride exposure when non-cavitated plus cavitated lesions were assessed. This conformed to the X-ACT trial result assessing cavitated lesions. Including non-cavitated lesion assessment in this full scale, placebo controlled, multi site, randomized, double blinded clinical trial in adults experiencing dental caries, did not achieve added trial efficiency or demonstrate practical benefit of xylitol. Trial Registration ClinicalTrials.Gov NCT00393055 PMID:24205951

  4. Diabetes Self-Management Smartphone Application for Adults With Type 1 Diabetes: Randomized Controlled Trial

    PubMed Central

    Vandelanotte, Corneel; Fenning, Andrew; Duncan, Mitch J

    2013-01-01

    relation to self-efficacy, self-care activities, and quality of life. Conclusions In adjunct to usual care, the use of a diabetes-related smartphone application combined with weekly text-message support from a health care professional can significantly improve glycemic control in adults with type 1 diabetes. Trial Registration Australian New Zealand Clinical Trials Registry: ACTRN12612000132842; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12612000132842 (Archived by WebCite at http://www.webcitation.org/6Kl4jqn5u). PMID:24225149

  5. Perioperative Intravenous Acetaminophen Attenuates Lipid Peroxidation in Adults Undergoing Cardiopulmonary Bypass: A Randomized Clinical Trial

    PubMed Central

    Billings IV, Frederic T.; Petracek, Michael R.; Roberts II, L. Jackson; Pretorius, Mias

    2015-01-01

    Background Cardiopulmonary bypass (CPB) lyses erythrocytes and induces lipid peroxidation, indicated by increasing plasma concentrations of free hemoglobin, F2-isoprostanes, and isofurans. Acetaminophen attenuates hemeprotein-mediated lipid peroxidation, reduces plasma and urine concentrations of F2-isoprostanes, and preserves kidney function in an animal model of rhabdomyolysis. Acetaminophen also attenuates plasma concentrations of isofurans in children undergoing CPB. The effect of acetaminophen on lipid peroxidation in adults has not been studied. This was a pilot study designed to test the hypothesis that acetaminophen attenuates lipid peroxidation in adults undergoing CPB and to generate data for a clinical trial aimed to reduce acute kidney injury following cardiac surgery. Methods and Results In a prospective double-blind placebo-controlled clinical trial, sixty adult patients were randomized to receive intravenous acetaminophen or placebo starting prior to initiation of CPB and for every 6 hours for 4 doses. Acetaminophen concentrations measured 30 min into CPB and post-CPB were 11.9±0.6 μg/mL (78.9±3.9 μM) and 8.7±0.3 μg/mL (57.6±2.0 μM), respectively. Plasma free hemoglobin increased more than 15-fold during CPB, and haptoglobin decreased 73%, indicating hemolysis. Plasma and urinary markers of lipid peroxidation also increased during CPB but returned to baseline by the first postoperative day. Acetaminophen reduced plasma isofuran concentrations over the duration of the study (P = 0.05), and the intraoperative plasma isofuran concentrations that corresponded to peak hemolysis were attenuated in those subjects randomized to acetaminophen (P = 0.03). Perioperative acetaminophen did not affect plasma concentrations of F2-isoprostanes or urinary markers of lipid peroxidation. Conclusions Intravenous acetaminophen attenuates the increase in intraoperative plasma isofuran concentrations that occurs during CPB, while urinary markers were unaffected

  6. Doses of apixaban and rivaroxaban prescribed in real-world United States cardiology practices compared to registration trials.

    PubMed

    Nguyen, Elaine; White, C Michael; Patel, Manesh R; Fields, Larry E; Peacock, W Frank; Crivera, Concetta; Coleman, Craig I

    2016-07-01

    Using an I.M.S. LifeLink dataset (19 September 2014-11 September 2015), we compared U.S. cardiologist prescribing of the reduced dose of apixaban (2.5 mg) or rivaroxaban (15 mg) to utilization in their corresponding nonvalvular atrial fibrillation registration randomized trials. Of all prescriptions written by cardiologists for these agents, 20.8% of apixaban and 21.7% of rivaroxaban prescriptions were for a reduced dose; corresponding to a 4.4-fold (16.1% absolute) increase in the use of reduced dose apixaban and a 3% relative (0.6% absolute) increase in reduced dose rivaroxaban use vs. their respective registration trials. Further research is needed to better understand appropriate dosing of patients with novel anticoagulants. PMID:27009372

  7. 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. PMID:9554713

  8. Efficacy of chlorhexidine varnish for the prevention of adult caries: a randomized trial.

    PubMed

    Papas, A S; Vollmer, W M; Gullion, C M; Bader, J; Laws, R; Fellows, J; Hollis, J F; Maupomé, G; Singh, M L; Snyder, J; Blanchard, P

    2012-02-01

    The Prevention of Adult Caries Study, an NIDCR-funded multicenter, double-blind, randomized clinical trial, enrolled 983 adults (aged 18-80 yrs) at high risk for developing caries (20 or more intact teeth and 2 or more lesions at screening) to test the efficacy of a chlorhexidine diacetate 10% weight per volume (w/v) dental coating (CHX). We excluded participants for whom the study treatment was contraindicated or whose health might affect outcomes or ability to complete the study. Participants were randomly assigned to receive either the CHX coating (n = 490) or a placebo control (n = 493). Coatings were applied weekly for 4 weeks and a fifth time 6 months later. The primary outcome (total net D(1-2)FS increment) was the sum of weighted counts of changes in tooth surface status over 13 months. We observed no significant difference between the two treatment arms in either the intention-to-treat or per-protocol analyses. Analysis of 3 protocol-specified secondary outcomes produced similar findings. This trial failed to find that 10% (w/v) chlorhexidine diacetate coating was superior to placebo coating for the prevention of new caries (Clinicaltrials.gov registration number NCT00357877). PMID:22156917

  9. 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

  10. “Hardly worth the effort”? Medical journals’ policies and their editors’ and publishers’ views on trial registration and publication bias: quantitative and qualitative study

    PubMed Central

    Williams, Peter

    2013-01-01

    Objectives To determine the proportion of medical journals requiring trial registration and to understand their reasons for adopting (or not adopting) such policies and other measures designed to reduce publication bias. Design Quantitative study of journals’ instructions to authors (in June 2012) and qualitative study of editors’ and publishers’ views on trial registration and publication bias (carried out in Autumn 2012). Setting Random selection of 200 medical journals publishing clinical trials identified from the Cochrane CENTRAL database. Participants Editors (n=13) and publishers (n=3) of journals with different policies on trial registration (and with recently changed policies) identified from the survey of their instructions to authors. Results Only 55/200 journals (28%) required trial registration according to their instructions and a further three (2%) encouraged it. The editors and publishers interviewed explained their journals’ reluctance to require registration in terms of not wanting to lose out to rival journals, not wanting to reject otherwise sound articles or submissions from developing countries, and perceptions that such policies were not relevant to all journals. Some interviewees considered that registration was unnecessary for small or exploratory studies. Conclusions Although many major medical journals state that they will only publish clinical trials that have been prospectively registered, and such policies have been associated with a dramatic increase in the number of trials being registered, most smaller journals have not adopted such policies. Editors and publishers may be reluctant to require registration because they do not understand its benefits or because they fear that adopting such a policy would put their journal at a disadvantage to competitors. PMID:24014339

  11. 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

  12. Permissive underfeeding versus target enteral feeding in adult critically ill patients (PermiT Trial): a study protocol of a multicenter randomized controlled trial

    PubMed Central

    2012-01-01

    Background Nutritional support is an essential part of the management of critically ill patients. However, optimal caloric intake has not been systematically evaluated. We aim to compare two strategies of enteral feeding: permissive underfeeding versus target feeding. Method/Design This is an international multi-center randomized controlled trial in critically ill medical- surgical adult patients. Using a centralized allocation, 862 patients will be randomized to permissive underfeeding or target feeding. Patients in the permissive group receive 50% (acceptable range is 40% to 60%) of the calculated caloric requirement, while those in the targeted group receive 100% (acceptable range 70% to 100%) of the calculated caloric requirement. The primary outcome is 90-day all-cause mortality. Secondary outcomes include ICU and hospital mortality, 28-day, and 180-day mortality as well as health care-associated infections, organ failure, and length of stay in the ICU and hospital. The trial has 80% power to detect an 8% absolute reduction in 90-day mortality assuming a baseline risk of death of 25% at an alpha level of 0.05. Discussion Patient recruitment started in November 2009 and is currently active in five centers. The Data Monitoring Committee advised continuation of the trial after the first interim analysis. The study is expected to finish by November 2013. Trial registration Current Controlled Trials ISRCTN68144998 PMID:23057605

  13. Cognitive-reminiscence therapy and usual care for depression in young adults: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Depression is a common affliction for young adults, and is associated with a range of adverse outcomes. Cognitive-reminiscence therapy is a brief, structured intervention that has been shown to be highly effective for reducing depressive symptoms, yet to date has not been evaluated in young adult populations. Given its basis in theory-guided reminiscence-based therapy, and incorporation of effective therapeutic techniques drawn from cognitive therapy and problem-solving frameworks, it is hypothesized to be effective in treating depression in this age group. Methods and design This article presents the design of a randomized controlled trial implemented in a community-based youth mental health service to compare cognitive-reminiscence therapy with usual care for the treatment of depressive symptoms in young adults. Participants in the cognitive-reminiscence group will receive six sessions of weekly, individual psychotherapy, whilst participants in the usual-care group will receive support from the youth mental health service according to usual procedures. A between-within repeated-measures design will be used to evaluate changes in self-reported outcome measures of depressive symptoms, psychological wellbeing and anxiety across baseline, three weeks into the intervention, post-intervention, one month post-intervention and three months post-intervention. Interviews will also be conducted with participants from the cognitive-reminiscence group to collect information about their experience receiving the intervention, and the process underlying any changes that occur. Discussion This study will determine whether a therapeutic approach to depression that has been shown to be effective in older adult populations is also effective for young adults. The expected outcome of this study is the validation of a brief, evidence-based, manualized treatment for young adults with depressive symptoms. Trial registration Australian New Zealand Clinical Trials Registry ACTRN

  14. 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

  15. 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

  16. A randomized controlled trial examining Iyengar yoga for young adults with rheumatoid arthritis: a study protocol

    PubMed Central

    2011-01-01

    Background Rheumatoid arthritis is a chronic, disabling disease that can compromise mobility, daily functioning, and health-related quality of life, especially in older adolescents and young adults. In this project, we will compare a standardized Iyengar yoga program for young people with rheumatoid arthritis to a standard care wait-list control condition. Methods/Design Seventy rheumatoid arthritis patients aged 16-35 years will be randomized into either the 6-week Iyengar yoga program (12 - 1.5 hour sessions twice weekly) or the 6-week wait-list control condition. A 20% attrition rate is anticipated. The wait-list group will receive the yoga program following completion of the first arm of the study. We will collect data quantitatively, using questionnaires and markers of disease activity, and qualitatively using semi-structured interviews. Assessments include standardized measures of general and arthritis-specific function, pain, mood, and health-related quality of life, as well as qualitative interviews, blood pressure/resting heart rate measurements, a medical exam and the assessment of pro-inflammatory cytokines. Data will be collected three times: before treatment, post-treatment, and two months following the treatment. Discussion Results from this study will provide critical data on non-pharmacologic methods for enhancing function in rheumatoid arthritis patients. In particular, results will shed light on the feasibility and potential efficacy of a novel intervention for rheumatoid arthritis symptoms, paving the way for a larger clinical trial. Trial Registration ClinicalTrials.gov NCT01096823 PMID:21255431

  17. 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

  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. Clinical trials for drug registrations in Asian-Pacific countries: proposal for a new paradigm from a statistical perspective.

    PubMed

    Shih, W J

    2001-08-01

    The world has become more interdependent in the movement of free trade and global markets. The regulations for approval of new drugs in the Asian markets have always been an important issue in the free trade negotiation between the U.S.- and E.U.-based international manufacturers and the Asian-Pacific countries, since pharmaceuticals are of large trade value for them. In 1998 the University of Hong Kong and the Singapore National Medical Research Council jointly hosted the first Asian Clinical Trials Conference. The Society for Clinical Trials was invited as a collaborator for the event, which signified a milestone for interaction between the East and West in the discussion of clinical trials. Many have participated in the discussion of drug approval and registration issues for the Asian region based on the drug development experience in the United States. However, there are many interesting differences between the two regions, which lead to different approval processes for new drugs developed by the U.S.- and E.U.-based international manufacturers. This article highlights some regulatory dilemmas and some key statistical concepts pertinent to these differences. The purpose of this paper is to resolve the regional regulatory and scientific dilemma. A new paradigm of sample size design and data analysis for drug approval for countries in the Asian-Pacific region is proposed. The central premise is that substantial information from multicenter studies has already shown efficacy in the United States or the European Union when a drug manufacturer seeks marketing approval in an Asian country. This leads to the idea of a "consistency trial" using the method of Bayesian most plausible prediction. The method is illustrated with an example. PMID:11514037

  1. A Randomized, Double-Blind Placebo Controlled Trial of Balapiravir, a Polymerase Inhibitor, in Adult Dengue Patients

    PubMed Central

    Nguyen, Nguyet Minh; Tran, Chau Nguyen Bich; Phung, Lam Khanh; Duong, Kien Thi Hue; Huynh, Huy le Anh; Farrar, Jeremy; Nguyen, Quyen Than Ha; Tran, Hien Tinh; Nguyen, Chau Van Vinh; Merson, Laura; Hoang, Long Truong; Hibberd, Martin L.; Aw, Pauline P. K.; Wilm, Andreas; Nagarajan, Niranjan; Nguyen, Dung Thi; Pham, Mai Phuong; Nguyen, Truong Thanh; Javanbakht, Hassan; Klumpp, Klaus; Hammond, Janet; Petric, Rosemary; Wolbers, Marcel; Nguyen, Chinh Tran; Simmons, Cameron P.

    2013-01-01

    Background. Dengue is the most common arboviral infection of humans. There are currently no specific treatments for dengue. Balapiravir is a prodrug of a nucleoside analogue (called R1479) and an inhibitor of hepatitis C virus replication in vivo. Methods. We conducted in vitro experiments to determine the potency of balapiravir against dengue viruses and then an exploratory, dose-escalating, randomized placebo-controlled trial in adult male patients with dengue with <48 hours of fever. Results. The clinical and laboratory adverse event profile in patients receiving balapiravir at doses of 1500 mg (n = 10) or 3000 mg (n = 22) orally for 5 days was similar to that of patients receiving placebo (n = 32), indicating balapiravir was well tolerated. However, twice daily assessment of viremia and daily assessment of NS1 antigenemia indicated balapiravir did not measurably alter the kinetics of these virological markers, nor did it reduce the fever clearance time. The kinetics of plasma cytokine concentrations and the whole blood transcriptional profile were also not attenuated by balapiravir treatment. Conclusions. Although this trial, the first of its kind in dengue, does not support balapiravir as a candidate drug, it does establish a framework for antiviral treatment trials in dengue and provides the field with a clinically evaluated benchmark molecule. Clinical Trials Registration. NCT01096576. PMID:22807519

  2. Self-Management education for adults with poorly controlled epILEpsy (SMILE (UK)): a randomised controlled trial protocol

    PubMed Central

    2014-01-01

    Background Teaching people with epilepsy to identify and manage seizure triggers, implement strategies to remember to take antiepileptic drugs, implement precautions to minimize risks during seizures, tell others what to do during a seizure and learn what to do during recovery may lead to better self-management. No teaching programme exists for adults with epilepsy in the United Kingdom although a number of surveys have shown patients want more information. Methods/Design This is a multicentre, pragmatic, parallel group randomised controlled trial to evaluate the effectiveness and cost-effectiveness of a two-day Self-Management education for epILEpsy (SMILE (UK)), which was originally developed in Germany (MOSES). Four hundred and twenty eight adult patients who attended specialist epilepsy outpatient clinics at 15 NHS participating sites in the previous 12 months, and who fulfil other eligibility criteria will be randomised to receive the intervention (SMILE (UK) course with treatment as usual- TAU) or to have TAU only (control). The primary outcome is the effect on patient reported quality of life (QoL). Secondary outcomes are seizure frequency and psychological distress (anxiety and depression), perceived impact of epilepsy, adherence to medication, management of adverse effects from medication, and improved self-efficacy in management (mastery/control) of epilepsy. Within the trial there will be a nested qualitative study to explore users’ views of the intervention, including barriers to participation and the perceived benefits of the intervention. The cost-effectiveness of the intervention will also be assessed. Discussion This study will provide quantitative and qualitative evidence of the impact of a structured self management programme on quality of life and other aspects of clinical and cost effectiveness in adults with poorly controlled epilepsy. Trial registration Current Controlled Trials: ISRCTN57937389. PMID:24694207

  3. Brain Training Game Boosts Executive Functions, Working Memory and Processing Speed in the Young Adults: A Randomized Controlled Trial

    PubMed Central

    Nouchi, Rui; Taki, Yasuyuki; Takeuchi, Hikaru; Hashizume, Hiroshi; Nozawa, Takayuki; Kambara, Toshimune; Sekiguchi, Atsushi; Miyauchi, Carlos Makoto; Kotozaki, Yuka; Nouchi, Haruka; Kawashima, Ryuta

    2013-01-01

    Background Do brain training games work? The beneficial effects of brain training games are expected to transfer to other cognitive functions. Yet in all honesty, beneficial transfer effects of the commercial brain training games in young adults have little scientific basis. Here we investigated the impact of the brain training game (Brain Age) on a wide range of cognitive functions in young adults. Methods We conducted a double-blind (de facto masking) randomized controlled trial using a popular brain training game (Brain Age) and a popular puzzle game (Tetris). Thirty-two volunteers were recruited through an advertisement in the local newspaper and randomly assigned to either of two game groups (Brain Age, Tetris). Participants in both the Brain Age and the Tetris groups played their game for about 15 minutes per day, at least 5 days per week, for 4 weeks. Measures of the cognitive functions were conducted before and after training. Measures of the cognitive functions fell into eight categories (fluid intelligence, executive function, working memory, short-term memory, attention, processing speed, visual ability, and reading ability). Results and Discussion Our results showed that commercial brain training game improves executive functions, working memory, and processing speed in young adults. Moreover, the popular puzzle game can engender improvement attention and visuo-spatial ability compared to playing the brain training game. The present study showed the scientific evidence which the brain training game had the beneficial effects on cognitive functions (executive functions, working memory and processing speed) in the healthy young adults. Conclusions Our results do not indicate that everyone should play brain training games. However, the commercial brain training game might be a simple and convenient means to improve some cognitive functions. We believe that our findings are highly relevant to applications in educational and clinical fields. Trial

  4. Preoperative single-dose methylprednisolone versus placebo after major liver resection in adults: protocol for a randomised controlled trial

    PubMed Central

    Bressan, Alexsander K; Roberts, Derek J; Bhatti, Sana U; Dixon, Elijah; Sutherland, Francis R; Bathe, Oliver F; Ball, Chad G

    2015-01-01

    Introduction Although randomised controlled trials have demonstrated that preoperative glucocorticoids may improve postoperative surrogate outcomes among patients undergoing major liver resection, evidence supporting improved patient-important outcomes is lacking. This superiority trial aims to evaluate the effect of administration of a bolus of the glucocorticoid methylprednisolone versus placebo during induction of anaesthesia on postoperative morbidity among adults undergoing elective major liver resection. Methods and analysis This will be a randomised, dual-arm, parallel-group, superiority trial. All consecutive adults presenting to a large Canadian tertiary care hospital who consent to undergo major liver resection will be included. Patients aged <18 years and those currently receiving systemic corticosteroid therapy will be excluded. We will randomly allocate participants to a preoperative 500 mg intravenous bolus of methylprednisolone versus placebo. Surgical team members and outcome assessors will be blinded to treatment allocation status. The primary outcome measure will be postoperative complications. Secondary outcome measures will include mortality, the incidence of several specific postoperative complications, and blood levels of select proinflammatory cytokines, acute-phase proteins, and laboratory liver enzymes or function tests on postoperative days 0, 1, 2 and 5. The incidence of postoperative complications and mortality will be compared using Fisher's exact test, while the above laboratory measures will be compared using mixed-effects models with a subject-specific random intercept. Ethics and dissemination This trial will evaluate the protective effect of a single preoperative dose of methylprednisolone on the hazard of postoperative complications. A report releasing study results will be submitted for publication in an appropriate journal, approximately 3 months after finishing the data collection. Trial registration number NCT01997658

  5. 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

  6. [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. PMID:22241267

  7. Disparities in registration and use of an online patient portal among older adults: findings from the LitCog cohort

    PubMed Central

    Smith, Samuel G; O’Conor, Rachel; Aitken, William; Curtis, Laura M; Goel, Mita Sanghavi

    2015-01-01

    Objective To document disparities in registration and use of an online patient portal among older adults. Materials and methods Data from 534 older adults were linked with information from the Northwestern Medicine Electronic Data Warehouse on patient portal registration and use of functions (secure messaging, prescription reauthorizations, checking test results, and monitoring vital statistics). Age, gender, race, education, self-reported chronic conditions, and the Newest Vital Sign health literacy measure were available from cohort data. Results Most patients (93.4%) had a patient portal access code generated for them, and among these 57.5% registered their accounts. In multivariable analyses, White patients (P < .001) and college graduates were more likely to have registered their patient portal (P = .015). Patients with marginal (P = .034) or adequate (P < .001) health literacy were also more likely to have registered their patient portal. Among those registering their accounts, most had messaged their physician (90%), checked a test result (96%), and ordered a reauthorization (55%), but few monitored their vital statistics (11%). Adequate health literacy patients were more likely to have used the messaging function (P = .003) and White patients were more likely to have accessed test results (P = .004). Higher education was consistently associated with prescription reauthorization requests (all P < .05). Discussion Among older American adults, there are stark health literacy, educational, and racial disparities in the registration, and subsequent use of an online patient portal. These population sub-group differences may exacerbate existing health disparities. Conclusions If patient portals are implemented, intervention strategies are needed to monitor and reduce disparities in their use. PMID:25914099

  8. 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…

  9. Preventing Loss of Independence through Exercise (PLIÉ): A Pilot Clinical Trial in Older Adults with Dementia

    PubMed Central

    Barnes, Deborah E.; Mehling, Wolf; Wu, Eveline; Beristianos, Matthew; Yaffe, Kristine; Skultety, Karyn; Chesney, Margaret A.

    2015-01-01

    Background Current dementia medications have small effect sizes, many adverse effects and do not change the disease course. Therefore, it is critically important to study alternative treatment strategies. The goal of this study was to pilot-test a novel, integrative group exercise program for individuals with mild-to-moderate dementia called Preventing Loss of Independence through Exercise (PLIÉ), which focuses on training procedural memory for basic functional movements (e.g., sit-to-stand) while increasing mindful body awareness and facilitating social connection. Methods We performed a 36-week cross-over pilot clinical trial to compare PLIÉ with usual care (UC) at an adult day program for individuals with dementia in San Francisco, CA. Assessments of physical performance, cognitive function, physical function, dementia-related behaviors, quality of life and caregiver burden were performed by blinded assessors at baseline, 18 weeks (cross-over) and 36 weeks. Our primary outcomes were effect sizes based on between-group comparisons of change from baseline to 18 weeks; secondary outcomes were within-group comparisons of change before and after cross-over. Results Twelve individuals enrolled (7 PLIÉ, 5 UC) and 2 withdrew (1 PLIÉ, 18 weeks; 1 UC, 36 weeks). Participants were 82% women (mean age, 84 ± 4 years); caregivers were 82% daughters (mean age, 56 ± 13 years). Effect sizes were not statistically significant but suggested potentially clinically meaningful (≥0.25 SDs) improvement with PLIÉ versus UC for physical performance (Cohen’s D: 0.34 SDs), cognitive function (0.76 SDs) and quality of life (0.83 SDs) as well as for caregiver measures of participant’s quality of life (0.33 SDs) and caregiver burden (0.49 SDs). Results were similar when within-group comparisons were made before and after cross-over. Conclusions PLIÉ is a novel, integrative exercise program that shows promise for improving physical function, cognitive function, quality of life

  10. Handbook on Tentative Standards and Procedures for the Registration of Secondary Schools. 1979-80 Field Trial Edition.

    ERIC Educational Resources Information Center

    New York State Education Dept., Albany.

    This handbook contains the tentative secondary school registration standards and procedures approved by the New York State Board of Regents for the 1979-80 school year. It explains the program providing for the registration (or accreditation) of New York schools and outlines the steps that will make up the registration procedure. Most of the…

  11. Role of co-trimoxazole prophylaxis in reducing mortality in HIV infected adults being treated for tuberculosis: randomised clinical trial

    PubMed Central

    Mwaba, Peter; Chintu, Chifumbe; Mwinga, Alwyn; Darbyshire, Janet H; Zumla, Alimuddin

    2008-01-01

    Objective To assess the impact of prophylactic oral co-trimoxazole in reducing mortality in HIV positive Zambian adults being treated for pulmonary tuberculosis. Design Double blind placebo controlled randomised clinical trial. Participants Two groups of antiretroviral treatment naive adults with HIV infection: patients newly diagnosed as having tuberculosis and receiving tuberculosis treatment either for the first time or for retreatment after relapse; previously treated patients not receiving treatment. Intervention Oral co-trimoxazole or matching placebo daily. Primary outcome measures Time to death and occurrence of serious adverse events related to study drug. Results 1003 patients were randomised: 835 (416 co-trimoxazole, 419 placebo) were receiving treatment for tuberculosis, 762 (376 co-trimoxazole, 386 placebo) of them newly diagnosed previously untreated patients and 73 (40 co-trimoxazole, 33 placebo) receiving a retreatment regimen; 168 (84 co-trimoxazole, 84 placebo) were not on treatment but had received treatment in the past. Of 835 participants receiving tuberculosis treatment, follow-up information was available for 757, with a total of 1012.6 person years of follow-up. A total of 310 (147 co-trimoxazole, 163 placebo) participants died, corresponding to death rates of 27.3 and 34.4 per 100 person years. In the Cox regression analysis, the hazard ratio for death (co-trimoxazole:placebo) was 0.79 (95% confidence interval 0.63 to 0.99). The effect of co-trimoxazole waned with time, possibly owing to falling adherence levels; in a per protocol analysis based on patients who spent at least 90% of their time at risk supplied with study drug, the hazard ratio was 0.65 (0.45 to 0.93). Conclusions Prophylaxis with co-trimoxazole reduces mortality in HIV infected adults with pulmonary tuberculosis. Co-trimoxazole was generally safe and well tolerated. Trial registration Current Controlled Trials ISRCTN15281875. PMID:18617486

  12. 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

  13. Randomised Controlled Feasibility Trial of an Evidence-Informed Behavioural Intervention for Obese Adults with Additional Risk Factors

    PubMed Central

    Sniehotta, Falko F.; Dombrowski, Stephan U.; Avenell, Alison; Johnston, Marie; McDonald, Suzanne; Murchie, Peter; Ramsay, Craig R.; Robertson, Kim; Araujo-Soares, Vera

    2011-01-01

    Background Interventions for dietary and physical activity changes in obese adults may be less effective for participants with additional obesity-related risk factors and co-morbidities than for otherwise healthy individuals. This study aimed to test the feasibility and acceptability of the recruitment, allocation, measurement, retention and intervention procedures of a randomised controlled trial of an intervention to improve physical activity and dietary practices amongst obese adults with additional obesity related risk factors. Method Pilot single centre open-labelled outcome assessor-blinded randomised controlled trial of obese (Body Mass Index (BMI)≥30 kg/m2) adults (age≥18 y) with obesity related co-morbidities such as type 2 diabetes, impaired glucose tolerance or hypertension. Participants were randomly allocated to a manual-based group intervention or a leaflet control condition in accordance to a 2∶1 allocation ratio. Primary outcome was acceptability and feasibility of trial procedures, secondary outcomes included measures of body composition, physical activity, food intake and psychological process measures. Results Out of 806 potentially eligible individuals identified through list searches in two primary care general medical practices N = 81 participants (63% female; mean-age = 56.56(11.44); mean-BMI = 36.73(6.06)) with 2.35(1.47) co-morbidities were randomised. Scottish Index of Multiple Deprivation (SIMD) was the only significant predictor of providing consent to take part in the study (higher chances of consent for invitees with lower levels of deprivation). Participant flowcharts, qualitative and quantitative feedback suggested good acceptance and feasibility of intervention procedures but 34.6% of randomised participants were lost to follow-up due to overly high measurement burden and sub-optimal retention procedures. Participants in the intervention group showed positive trends for most psychological, behavioural and body

  14. 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

  15. Investigating the efficacy of integrated cognitive behavioral therapy for adult treatment seeking substance use disorder patients with comorbid ADHD: study protocol of a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Attention deficit hyperactivity disorder (ADHD) frequently co-occurs with substance use disorders (SUD). The combination of ADHD and SUD is associated with a negative prognosis of both SUD and ADHD. Pharmacological treatments of comorbid ADHD in adult patients with SUD have not been very successful. Recent studies show positive effects of cognitive behavioral therapy (CBT) in ADHD patients without SUD, but CBT has not been studied in ADHD patients with comorbid SUD. Methods/design This paper presents the protocol of a randomized controlled trial to test the efficacy of an integrated CBT protocol aimed at reducing SUD as well as ADHD symptoms in SUD patients with a comorbid diagnosis of ADHD. The experimental group receives 15 CBT sessions directed at symptom reduction of SUD as well as ADHD. The control group receives treatment as usual, i.e. 10 CBT sessions directed at symptom reduction of SUD only. The primary outcome is the level of self-reported ADHD symptoms. Secondary outcomes include measures of substance use, depression and anxiety, quality of life, health care consumption and neuropsychological functions. Discussion This is the first randomized controlled trial to test the efficacy of an integrated CBT protocol for adult SUD patients with a comorbid diagnosis of ADHD. The rationale for the trial, the design, and the strengths and limitations of the study are discussed. Trial registration This trial is registered in http://www.clinicaltrials.gov as NCT01431235. PMID:23663651

  16. 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

  17. 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

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

    PubMed

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

    2016-07-01

    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 × 10(4) 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 10(4) 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

  19. 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...

  20. 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

  1. Effect of monthly vitamin D3 supplementation in healthy adults on adverse effects of earthquakes: randomised controlled trial

    PubMed Central

    Florkowski, Christopher M; Chambers, Stephen T; Priest, Patricia C; Stewart, Alistair W; Jennings, Lance C; Livesey, John H; Camargo, Carlos A; Scragg, Robert; Murdoch, David R

    2014-01-01

    that participants reported at their usual monthly appointments was significantly higher after the earthquake (χ2 P=0.007) but did not differ between treatment groups. Conclusion In this trial, vitamin D supplementation did not reduce the adverse impact of earthquakes in healthy adults. Trial registration Australian New Zealand Clinical Trials Registry (anzctr.org.au) ACTRN12609000486224 PMID:25516139

  2. 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

  3. 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…

  4. Telehealth Delivery of the Camperdown Program for Adults Who Stutter: A Phase I Trial

    ERIC Educational Resources Information Center

    O'Brian, Sue; Packman, Ann; Onslow, Mark

    2008-01-01

    Purpose: This Phase I trial investigated the viability of telehealth delivery of the Camperdown Program with adults who stutter. This program involves speech restructuring. Method: All treatment was conducted remotely with participant-clinician contact occurring by telephone and e-mail. Results: Ten adults completed the program. The group showed…

  5. A Randomized Trial of a Multifaceted Intervention to Reduce Falls among Community-Dwelling Adults

    ERIC Educational Resources Information Center

    Fox, Patrick J.; Vazquez, Laurie; Tonner, Chris; Stevens, Judy A.; Fineman, Norman; Ross, Leslie K.

    2010-01-01

    Using a randomized controlled trial, we tested the efficacy of a fall prevention intervention to reduce falls among adults in a community-based health promotion program. Adults aged 65 and older within two counties were recruited (control n = 257; intervention n = 286). After 12 months, there was a significant decrease in the number of falls in…

  6. 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…

  7. 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

  8. 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

  9. 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

  10. The PACE Study: A randomised clinical trial of cognitive activity (CA) for older adults with mild cognitive impairment (MCI)

    PubMed Central

    2009-01-01

    Background Research evidence from observational studies suggests that cognitive activity reduces the risk of cognitive impairment in later life as well as the rate of cognitive decline of people with dementia. The Promoting Healthy Ageing with Cognitive Exercise (PACE) study has been designed to determine whether a cognitive activity intervention decreases the rate of cognitive decline amongst older adults with mild cognitive impairment (MCI). Methods/Design The study will recruit 160 community-dwelling men and women aged 65 years of age or over with mild cognitive impairment (MCI). Participants will be randomly allocated to two treatment groups: non-specific education and cognitive activity. The intervention will consist of ten 90-minute sessions delivered twice per week over a period of five weeks. The primary outcome measure of the study is the change from baseline in the total score on the Cambridge Cognitive Score (CAMCOG). Secondary outcomes of interest include changes in memory, attention, executive functions, mood and quality of life. Primary endpoints will be collected 12, 52 and 104 weeks after the baseline assessment. Discussion The proposed project will produce the best available evidence on the merits of increased cognitive activity as a strategy to prevent cognitive decline among older adults with MCI. We anticipate that the results of this study will have implications for the development of evidence-based preventive strategies to reduce the rate of cognitive decline amongst older people at risk of dementia. Trial registration ACTRN12608000556347 PMID:20003398

  11. 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

  12. An Interactive Text Message Intervention to Reduce Binge Drinking in Young Adults: A Randomized Controlled Trial with 9-Month Outcomes

    PubMed Central

    Suffoletto, Brian; Chung, Tammy; Jeong, Kwonho; Fabio, Anthony

    2015-01-01

    analyses. Conclusions An interactive text-message intervention was more effective than self-monitoring or controls in reducing alcohol consumption and alcohol-related injury prevalence up to 6 months after intervention completion. These findings, if replicated, suggest a scalable approach to help achieve sustained reductions in binge drinking and accompanying injuries among young adults. Trial Registration ClinicalTrials.gov NCT01688245 PMID:26580802

  13. Alberta Diabetes and Physical Activity Trial (ADAPT): A randomized theory-based efficacy trial for adults with type 2 diabetes - rationale, design, recruitment, evaluation, and dissemination

    PubMed Central

    2010-01-01

    Background The primary aim of this study was to compare the efficacy of three physical activity (PA) behavioural intervention strategies in a sample of adults with type 2 diabetes. Method/Design Participants (N = 287) were randomly assigned to one of three groups consisting of the following intervention strategies: (1) standard printed PA educational materials provided by the Canadian Diabetes Association [i.e., Group 1/control group)]; (2) standard printed PA educational materials as in Group 1, pedometers, a log book and printed PA information matched to individuals' PA stage of readiness provided every 3 months (i.e., Group 2); and (3) PA telephone counseling protocol matched to PA stage of readiness and tailored to personal characteristics, in addition to the materials provided in Groups 1 and 2 (i.e., Group 3). PA behaviour measured by the Godin Leisure Time Exercise Questionnaire and related social-cognitive measures were assessed at baseline, 3, 6, 9, 12 and 18-months (i.e., 6-month follow-up). Clinical (biomarkers) and health-related quality of life assessments were conducted at baseline, 12-months, and 18-months. Linear Mixed Model (LMM) analyses will be used to examine time-dependent changes from baseline across study time points for Groups 2 and 3 relative to Group 1. Discussion ADAPT will determine whether tailored but low-cost interventions can lead to sustainable increases in PA behaviours. The results may have implications for practitioners in designing and implementing theory-based physical activity promotion programs for this population. Clinical Trials Registration ClinicalTrials.gov identifier: NCT00221234 PMID:20067626

  14. 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

  15. Acupuncture treatment for ischaemic stroke in young adults: protocol for a randomised, sham-controlled clinical trial

    PubMed Central

    Chen, Lifang; Fang, Jianqiao; Jin, Xiaoming; Keeler, Crystal Lynn; Gao, Hong; Fang, Zhen; Chen, Qin

    2016-01-01

    Introduction Stroke in young adults is not uncommon. Although the overall incidence of stroke has been recently declining, the incidence of stroke in young adults is increasing. Traditional vascular risk factors are the main cause of young ischaemic stroke. Acupuncture has been shown to benefit stroke rehabilitation and ameliorate the risk factors for stroke. The aims of this study were to determine whether acupuncture treatment will be effective in improving the activities of daily living (ADL), motor function and quality of life (QOL) in patients of young ischaemic stroke, and in preventing stroke recurrence by controlling blood pressure, lipids and body weight. Methods and analysis In this randomised, sham-controlled, participant-blinded and assessor-blinded clinical trial, 120 patients between 18 and 45 years of age with a recent (within 1 month) ischaemic stroke will be randomised for an 8-week acupuncture or sham acupuncture treatment. The primary outcome will be the Barthel Index for ADL. The secondary outcomes will include the Fugl-Meyer Assessment for motor function; the World Health Organization Quality of Life BREF (WHOQOL-BREF) for QOL; and risk factors that are measured by ambulatory blood pressure, the fasting serum lipid, body mass index and waist circumference. Incidence of adverse events and long-term mortality and recurrence rate during a 10-year and 30-year follow-up will also be investigated. Ethics and dissemination Ethics approval was obtained from the Ethics Committee of The Third Affiliated Hospital of Zhejiang Chinese Medical University. Protocol V.3 was approved in June 2013. The results will be disseminated in a peer-reviewed journal and presented at international congresses. The results will also be disseminated to patients by telephone during follow-up calls enquiring on the patient's post-study health status. Trial registration number ChiCTR-TRC- 13003317; Pre-results. PMID:26739742

  16. Lovastatin for the Treatment of Adult Patients With Dengue: A Randomized, Double-Blind, Placebo-Controlled Trial

    PubMed Central

    Whitehorn, James; Nguyen, Chau Van Vinh; Khanh, Lam Phung; Kien, Duong Thi Hue; Quyen, Nguyen Than Ha; Tran, Nguyen Thi Thanh; Hang, Nguyen Thuy; Truong, Nguyen Thanh; Hue Tai, Luong Thi; Cam Huong, Nguyen Thi; Nhon, Vo Thanh; Van Tram, Ta; Farrar, Jeremy; Wolbers, Marcel; Simmons, Cameron P.; Wills, Bridget

    2016-01-01

    Background. Dengue endangers billions of people in the tropical world, yet no therapeutic is currently available. In part, the severe manifestations of dengue reflect inflammatory processes affecting the vascular endothelium. In addition to lipid lowering, statins have pleiotropic effects that improve endothelial function, and epidemiological studies suggest that outcomes from a range of acute inflammatory syndromes are improved in patients already on statin therapy. Methods. Following satisfactory review of a short pilot phase (40 mg lovastatin vs placebo in 30 cases), we performed a randomized, double-blind, placebo-controlled trial of 5 days of 80 mg lovastatin vs placebo in 300 Vietnamese adults with a positive dengue NS1 rapid test presenting within 72 hours of fever onset. The primary outcome was safety. Secondary outcomes included comparisons of disease progression rates, fever clearance times, and measures of plasma viremia and quality of life between the treatment arms. Results. Adverse events occurred with similar frequency in both groups (97/151 [64%] placebo vs 82/149 [55%] lovastatin; P = .13), and were in keeping with the characteristic clinical and laboratory features of acute dengue. We also observed no difference in serious adverse events or any of the secondary outcome measures. Conclusions. We found lovastatin to be safe and well tolerated in adults with dengue. However, although the study was not powered to address efficacy, we found no evidence of a beneficial effect on any of the clinical manifestations or on dengue viremia. Continuing established statin therapy in patients who develop dengue is safe. Chinese Clinical Trials Registration. ISRCTN03147572. PMID:26565005

  17. 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.

  18. TRialing individualized interventions to prevent functional decline in at-risk older adults (TRIIFL): study protocol for a randomized controlled trial nested in a longitudinal observational study

    PubMed Central

    2013-01-01

    Background Functional decline (FD) is a largely preventable feature of aging, characterized as gradual erosion of functional autonomy. This reduces an older person’s capacity for safe, independent community living. The healthcare needs of an unprecedented aging population places pressure on health systems to develop innovative approaches to ensuring older people live healthy and independent lives for as long as possible. TRIIFL aims to demonstrate that: 1. Incipient FD in older people can be identified using a simple telephone-screening process within four weeks of discharge from an emergency department presentation for a minor health event; and 2. Early engagement into a person-centered individualized intervention arrests or reduces the rate of FD over the next 12 months. Methods/Design A randomized controlled trial (RCT) nested within a 13-month longitudinal cohort study. The RCT (conducted over 12 months) tests the effectiveness of a novel, early, home-based, personalized program (compared with no intervention) in arresting or slowing FD. TRIIFL focuses on older adults living independently in the community, who have not yet had a serious health event, yet are potentially on the cusp of FD. Participants in the longitudinal cohort study will be recruited as they present to one large tertiary hospital Emergency Department, providing they are not subsequently admitted to a ward. Sample size calculations indicate that 570 participants need to be recruited into the longitudinal study, with 100 participants randomized into the trial arms. Measures from all subjects will be taken face-to-face at baseline (recruitment), then subsequently by telephone at one, four, seven and thirteen months later. Measures include functional abilities, quality of life, recent falls, mobility dependence, community supports and health service usage. Specific to the nested RCT, the quality of life tool (SF12) applied at one month, will identify individuals with low mental component quality

  19. Clinical Trials of Adult Stem Cell Therapy in Patients with Ischemic Stroke

    PubMed Central

    2016-01-01

    Stem cell therapy is considered a potential regenerative strategy for patients with neurologic deficits. Studies involving animal models of ischemic stroke have shown that stem cells transplanted into the brain can lead to functional improvement. With current advances in the understanding regarding the effects of introducing stem cells and their mechanisms of action, several clinical trials of stem cell therapy have been conducted in patients with stroke since 2005, including studies using mesenchymal stem cells, bone marrow mononuclear cells, and neural stem/progenitor cells. In addition, several clinical trials of the use of adult stem cells to treat ischemic stroke are ongoing. This review presents the status of our understanding of adult stem cells and results from clinical trials, and introduces ongoing clinical studies of adult stem cell therapy in the field of stroke. PMID:26610894

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

    PubMed Central

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

    2016-01-01

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

  1. Cotrimoxazole Prophylaxis Discontinuation among Antiretroviral-Treated HIV-1-Infected Adults in Kenya: A Randomized Non-inferiority Trial

    PubMed Central

    Polyak, Christina S.; Yuhas, Krista; Singa, Benson; Khaemba, Monica; Walson, Judd; Richardson, Barbra A.; John-Stewart, Grace

    2016-01-01

    Background Cotrimoxazole (CTX) prophylaxis is recommended by the World Health Organization (WHO) for HIV-1-infected individuals in settings with high infectious disease prevalence. The WHO 2006 guidelines were developed prior to the scale-up of antiretroviral therapy (ART). The threshold for CTX discontinuation following ART is undefined in resource-limited settings. Methods and Findings Between 1 February 2012 and 30 September 2013, we conducted an unblinded non-inferiority randomized controlled trial of CTX prophylaxis cessation versus continuation among HIV-1-infected adults on ART for ≥18 mo with CD4 count > 350 cells/mm3 in a malaria-endemic region in Kenya. Participants were randomized and followed up at 3-mo intervals for 12 mo. The primary endpoint was a composite of morbidity (malaria, pneumonia, and diarrhea) and mortality. Incidence rate ratios (IRRs) were estimated using Poisson regression. Among 538 ART-treated adults screened, 500 were enrolled and randomized, 250 per arm. Median age was 40 y, 361 (72%) were women, and 442 (88%) reported insecticide-treated bednet use. Combined morbidity/mortality was significantly higher in the CTX discontinuation arm (IRR = 2.27, 95% CI 1.52–3.38; p < 0.001), driven by malaria morbidity. There were 34 cases of malaria, with 33 in the CTX discontinuation arm (IRR = 33.02, 95% CI 4.52–241.02; p = 0.001). Diarrhea and pneumonia rates did not differ significantly between arms (IRR = 1.36, 95% CI 0.82–2.27, and IRR = 1.43, 95% CI 0.54–3.75, respectively). Study limitations include a lack of placebo and a lower incidence of morbidity events than expected. Conclusions CTX discontinuation among ART-treated, immune-reconstituted adults in a malaria-endemic region resulted in increased incidence of malaria but not pneumonia or diarrhea. Malaria endemicity may be the most relevant factor to consider in the decision to stop CTX after ART-induced immune reconstitution in regions with high infectious disease prevalence

  2. 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

  3. 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

  4. 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

  5. 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

  6. Prevalence of Diabetes Treatment Effect Modifiers: the External Validity of Trials to Older Adults

    PubMed Central

    Weiss, Carlos O.; Boyd, Cynthia M.; Wolff, Jennifer L.; Leff, Bruce

    2012-01-01

    Background and Aims Potential treatment effect modifiers (TEMs) are specific diseases or conditions with a well-described mechanism for treatment effect modification. The prevalence of TEMs in older adults with type 2 diabetes mellitus (DM) is unknown. Objectives were to (1) determine the prevalence of pre-specified potential TEMs; (2) demonstrate the potential impact of TEMs in the older adult population using a simulated trial; (3) identify TEM combinations associated with number of hospitalizations to test construct validity. Methods Data are from the nationally-representative United States National Health and Examination Survey, 1999–2004: 8,646 Civilian, non-institutionalized adults aged 45–64 or 65+ years, including 1,443 with DM. TEMs were anemia, congestive heart failure, liver inflammation, polypharmacy, renal insufficiency, cognitive impairment, dizziness, frequent mental distress, mobility difficulty, and visual impairment. A trial was simulated to examine prevalence of potential TEM impact. The cross-sectional association between TEM patterns and number of hospitalizations was estimated to assess construct validity. Results The prevalence of TEMs was substantial such that 19.0% (95%CI: 14.8–23.2) of middle-aged adults and 38.0% (95% CI: 33.4–42.5) of older adults had any two. A simulated trial with modest levels of interaction suggested the prevalence of TEMs could nullify treatment benefit in 3.9–27.2% of older adults with DM. Compared to having DM alone, hospitalization rate was increased by several combinations of TEMs with substantial prevalence. Conclusions We provide national benchmarks that can be used to evaluate TEM prevalence reported by clinical trials of DM, and correspondingly their external validity to older adults. PMID:23238312

  7. 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

  8. 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

  9. 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…

  10. 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…

  11. 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…

  12. 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

  13. 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

  14. 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

  15. Connecting Health and Technology (CHAT): protocol of a randomized controlled trial to improve nutrition behaviours using mobile devices and tailored text messaging in young adults

    PubMed Central

    2012-01-01

    impact of the intervention on behavioural intention to eat a more healthful diet. This innovative approach if successful may provide a means to deliver a low cost health promotion program that has the potential to reach large groups, particularly young adults. Trial registration Australian and New Zealand Clinical Trials Registry ACTRN12612000250831 PMID:22726532

  16. 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

  17. A randomized controlled trial of analgesia during vaccination in adults.

    PubMed

    Taddio, Anna; Lord, Allison; Hogan, Mary-Ellen; Kikuta, Andrew; Yiu, Ashley; Darra, Erwin; Bruinse, Barbara; Keogh, Tom; Stephens, Derek

    2010-07-19

    Although immunization injections are the most common painful medical procedures, pain-relieving interventions are not routinely used. In this randomized controlled trial, we compared the effectiveness of topical anesthesia using liposomal lidocaine to: (1) vapocoolant spray using a proprietary blend of 1,1,1,3,3-pentafluoropropane and 1,1,1,2-tetrafluoroethane; (2) nurse-administered tactile stimulation; or (3) self-directed distraction by means of reading a magazine. Liposomal lidocaine was more effective (p

  18. 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

  19. 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. PMID:26788520

  20. 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

  1. 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

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

    PubMed Central

    2013-01-01

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

  3. 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

  4. Recruiting young adults into a weight loss trial: report of protocol development and recruitment results.

    PubMed

    Corsino, Leonor; Lin, Pao-Hwa; Batch, Bryan C; Intille, Stephen; Grambow, Steven C; Bosworth, Hayden B; Bennett, Gary G; Tyson, Crystal; Svetkey, Laura P; Voils, Corrine I

    2013-07-01

    Obesity has spread to all segments of the U.S. population. Young adults, aged 18-35 years, are rarely represented in clinical weight loss trials. We conducted a qualitative study to identify factors that may facilitate recruitment of young adults into a weight loss intervention trial. Participants were 33 adults aged 18-35 years with BMI ≥25 kg/m(2). Six group discussions were conducted using the nominal group technique. Health, social image, and "self" factors such as emotions, self-esteem, and confidence were reported as reasons to pursue weight loss. Physical activity, dietary intake, social support, medical intervention, and taking control (e.g. being motivated) were perceived as the best weight loss strategies. Incentives, positive outcomes, education, convenience, and social support were endorsed as reasons young adults would consider participating in a weight loss study. Incentives, advertisement, emphasizing benefits, and convenience were endorsed as ways to recruit young adults. These results informed the Cellphone Intervention for You (CITY) marketing and advertising, including message framing and advertising avenues. Implications for recruitment methods are discussed. PMID:23591327

  5. 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

  6. 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

  7. Impact of rapid antigen detection testing on antibiotic prescription in acute pharyngitis in adults. FARINGOCAT STUDY: a multicentric randomized controlled trial

    PubMed Central

    2010-01-01

    Background Acute pharyngitis is one of the most frequent consultations to the general practitioner and in most of the cases an antibiotic is prescribed in primary care in Spain. Bacterial etiology, mainly by group A beta-hemolytic streptococcus (GABHS), accounts for 10-20% of all these infections in adults. The purpose of this study is to assess the impact of rapid antigen detection testing (RADT) to identify GABHS in acute pharyngitis on the utilization of antibiotics in primary care. Methods/design Multicentric randomized controlled trial in which antibiotic prescription between two groups of patients with acute pharyngitis will be compared. The trial will include two arms, a control and an intervention group in which RADT will be performed. The primary outcome measure will be the proportion of inappropriate antibiotic prescription in each group. Two hundred seventy-six patients are required to detect a reduction in antibiotic prescription from 85% in the control group to 75% in the intervention group with a power of 90% and a level of significance of 5%. Secondary outcome measures will be specific antibiotic treatment, antibiotic resistance rates, secondary effects, days without working, medical visits during the first month and patient satisfaction. Discussion The implementation of RADT would allow a more rational use of antibiotics and would prevent adverse effects of antibiotics, emergence of antibiotic resistance and the growth of inefficient health expenses. Trial registration ISRCTN23587778 PMID:20331895

  8. Effect of hawthorn standardized extract on flow mediated dilation in prehypertensive and mildly hypertensive adults: a randomized, controlled cross-over trial

    PubMed Central

    2012-01-01

    Background Hawthorn extract has been used for cardiovascular diseases for centuries. Recent trials have demonstrated its efficacy for the treatment of heart failure, and the results of several small trials suggest it may lower blood pressure. However, there is little published evidence to guide its dosing. The blood pressure lowering effect of hawthorn has been linked to nitric oxide-mediated vasodilation. The aim of this study was to investigate the relationship between hawthorn extract dose and brachial artery flow mediated dilation (FMD), an indirect measure of nitric oxide release. Methods We used a four-period cross-over design to evaluate brachial artery FMD in response to placebo or hawthorn extract (standardized to 50 mg oligomeric procyanidin per 250 mg extract). Randomly sequenced doses of hawthorn extract (1000 mg, 1500 mg, and 2500 mg) and placebo were assigned to each participant. Doses were taken twice daily for 3 1/2 days followed by FMD and a 4-day washout before proceeding to the next dosing period. Results Twenty-one prehypertensive or mildly hypertensive adults completed the study. There was no evidence of a dose-response effect for our main outcome (FMD percent) or any of our secondary outcomes (absolute change in brachial artery diameter and blood pressure). Most participants indicated that if given evidence that hawthorn could lower their blood pressure, they would be likely to use it either in conjunction with or instead of lifestyle modification or anti-hypertensive medications. Conclusion We found no evidence of a dose-response effect of hawthorn extract on FMD. If hawthorn has a blood pressure lowering effect, it is likely to be mediated via an NO-independent mechanism. Trial Registration This trial has been registered with ClinicalTrials.gov, a service of the U.S. National Institutes of Health: NCT01331486. PMID:22458601

  9. 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

  10. 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

  11. Effective Strategies to Recruit Young Adults Into the TXT2BFiT mHealth Randomized Controlled Trial for Weight Gain Prevention

    PubMed Central

    Balestracci, Kate; Wong, Annette TY; Hebden, Lana; McGeechan, Kevin; Denney-Wilson, Elizabeth; Harris, Mark F; Phongsavan, Philayrath; Bauman, Adrian; Allman-Farinelli, Margaret

    2015-01-01

    (AUD) $139 per person. The least expensive modality was electronic (AUD $37), largely due to a free feature story on one university Web home page, despite Facebook advertising costing AUD $945 per enrolment. The most expensive was print media at AUD $213 and GP letters at AUD $145 per enrolment. Conclusions The research indicated that free electronic media was the most cost-effective strategy, with GP letters the least expensive of the paid strategies in comparison to the other strategies. This study is an important contribution for future research into efficacy, translation, and implementation of cost-effective programs for the prevention of weight gain in young adults. Procedural frameworks for recruitment protocols are required, along with systematic reporting of recruitment strategies to reduce unnecessary expenditure and allow for valuable public health prevention programs to go beyond the research setting. Trial Registration Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12612000924853; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=362872 (Archived by WebCite at http://www.webcitation.org/6YpNfv1gI). PMID:26048581

  12. 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…

  13. 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…

  14. Randomised, double blind, placebo‐controlled trial of selenium supplementation in adult asthma

    PubMed Central

    Shaheen, Seif O; Newson, Roger B; Rayman, Margaret P; Wong, Angela P‐L; Tumilty, Michael K; Phillips, Joanna M; Potts, James F; Kelly, Frank J; White, Patrick T; Burney, Peter G J

    2007-01-01

    Background Epidemiological evidence from observational studies has suggested that blood levels and dietary intake of selenium of adults with asthma are lower than those of controls. The only previous trial of selenium supplementation in adults with asthma found no objective evidence of benefit but involved only 24 participants. Methods A randomised, double blind, placebo‐controlled trial of selenium supplementation was performed in adults with asthma in London, UK, the majority of whom (75%) reported inhaled steroid use at baseline. 197 participants were randomised to receive either a high‐selenium yeast preparation (100 µg daily, n = 99) or placebo (yeast only, n = 98) for 24 weeks. The primary outcome was asthma‐related quality of life (QoL) score. Secondary outcomes included lung function, asthma symptom scores, peak flow and bronchodilator usage. Linear regression was used to analyse the change in outcome between the two treatment arms by “intention to treat”. Results There was a 48% increase in plasma selenium between baseline and end of trial in the active treatment group but no change in the placebo group. While the QoL score improved more in the active treatment group than in the placebo group, the difference in change in score between the two groups was not significant (−0.05 (95% CI −0.19 to 0.09); p = 0.47). Selenium supplementation was not associated with any significant improvement in secondary outcomes compared with placebo. Conclusions Selenium supplementation had no clinical benefit in adults with asthma, the majority of whom were taking inhaled steroids. PMID:17234657

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

    PubMed Central

    2013-01-01

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

  16. Using prophylactic antioxidants to prevent noise-induced hearing damage in young adults: a protocol for a double-blind, randomized controlled trial

    PubMed Central

    2014-01-01

    Background During leisure activities young people are often exposed to excessive noise levels resulting in an increase of noise-induced symptoms such as hearing loss, tinnitus and hyperacusis. Noise-induced tinnitus is often perceived after loud music exposure and provides an important marker for overexposure as a temporary threshold shift that is often not experienced by the individual itself. As oxidative stress plays an important role in the pathogenesis of noise-induced hearing loss, the use of antioxidants to prevent hearing damage has recently become the subject of research. Methods This study proposes a randomized, double-blind, placebo-controlled crossover trial to assess the effects of a prophylactic combination of N-acetylcysteine (600 mg) and magnesium (200 mg) prior to leisure noise exposure in young adults. The primary outcome measure is the tinnitus loudness scored by a visual analogue scale (VAS). Secondary outcome measures are the differences in audiological measurements for the antioxidant treatments compared to placebo intake. Audiological testing comprising of pure tone audiometry including frequencies up to 16 kHz, distortion product otoacoustic emissions, transient-evoked otoacoustic emissions and speech-in-noise testing will be performed prior to and within 7 hours after noise exposure. By use of a mixed effects statistical model, the effects of antioxidants compared to placebo intake will be assessed. Discussion As adolescents and young adults often do not use hearing protection while being exposed to loud music, the use of preventive antioxidant intake may provide a useful and harmless way to prevent noise-induced hearing damage in this population. Furthermore, when exposed to hazardous noise levels the protection provided by hearing protectors might not be sufficient to prevent hearing damage and antioxidants may provide additive otoprotective effects. Previous research mainly focused on occupational noise exposure. The present study

  17. Effects of mental practice embedded in daily therapy compared to therapy as usual in adult stroke patients in Dutch nursing homes: design of a randomised controlled trial

    PubMed Central

    Braun, Susy M; Beurskens, Anna J; van Kroonenburgh, Susanne M; Demarteau, Jeroen; Schols, Jos M; Wade, Derick T

    2007-01-01

    Background Mental practice as an additional cognitive therapy is getting increased attention in stroke rehabilitation. A systematic review shows some evidence that several techniques in which movements are rehearsed mentally might be effective but not enough to be certain. This trial investigates whether mental practice can contribute to a quicker and/or better recovery of stroke in two Dutch nursing homes. The objective is to investigate the therapeutic potential of mental practice embedded in daily therapy to improve individually chosen daily activities of adult stroke patients compared to therapy as usual. In addition, we will investigate prognostic variables and feasibility (process evaluation). Methods A randomised, controlled, observer masked prospective trial will be conducted with adult stroke patients in the (sub)acute phase of stroke recovery. Over a six weeks intervention period the control group will receive multi professional therapy as usual. Patients in the experimental group will be instructed how to perform mental practice, and will receive care as usual in which mental practice is embedded in physical, occupation and speech therapy sessions. Outcome will be assessed at six weeks and six months. The primary outcome measure is the patient-perceived effect on performance of daily activities as assessed by an 11-point Likert Scale. Secondary outcomes are: Motricity Index, Nine Hole Peg Test, Barthel Index, Timed up and Go, 10 metres walking test, Rivermead Mobility Index. A sample size of the patients group and all therapists will be interviewed on their opinion of the experimental program to assess feasibility. All patients are asked to keep a log to determine unguided training intensity. Discussion Advantages and disadvantages of several aspects of the chosen design are discussed. Trial registration ISRCTN27582267 PMID:17937798

  18. 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

  19. 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

  20. 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

  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. A RANDOMIZED CONTROLLED TRIAL OF RESISTANCE EXERCISE TRAINING TO IMPROVE GLYCEMIC CONTROL IN OLDER ADULTS WITH TYPE 2 DIABETES

    Technology Transfer Automated Retrieval System (TEKTRAN)

    OBJECTIVE-To determine the efficacy of high-intensity progressive resistance training (PRT) on glycemic control in older adults with type 2 diabetes. RESEARCH DESIGN AND METHODS-We performed a 16-week randomized controlled trial in 62 Latino older adults (40 women and 22 men; mean +/- SE age 66 +/...

  3. 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…

  4. Home based exercise to improve turning and mobility performance among community dwelling older adults: protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Turning is a common activity for older people, and is one of the activities commonly associated with falls during walking. Falls that occur while walking and turning have also been associated with an increased risk of hip fracture in older people. Despite the importance of stability during turning, there has been little focus on identifying this impairment in at risk older people, or in evaluating interventions aiming to improve this outcome. This study will evaluate the effectiveness of a 16 week tailored home based exercise program in older adults aged (50 years and above) who were identified as having unsteadiness during turning. Methods/Design A single blind randomized controlled trial will be conducted, with assessors blind to group allocation. Study participants will be aged 50 years and above, living in the community and have been identified as having impaired turning ability [outside of age and gender normal limits on the Step Quick Turn (180 degree turn) task on the Neurocom® Balance Master with long plate]. After a comprehensive baseline assessment, those classified as having balance impairment while turning will be randomized to intervention or control group. The intervention group will receive a 16 week individualized balance and strength home exercise program, based on the Otago Exercise Program with additional exercises focused on improving turning ability. Intervention group will attend four visit to the assessment centre over 16 weeks period, for provision, monitoring, modification of the exercise and encourage ongoing participation. Participants in the control group will continue with their usual activities. All participants will be re-assessed on completion of the 16 week program. Primary outcome measures will be the Step Quick Turn Test and Timed-Up and Go test. Secondary outcomes will include other clinical measures of balance, psychological aspects of falls, incidence of falls and falls risk factors. Discussion Results of this study

  5. 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

  6. Improving Motor Control in Walking: A Randomized Clinical Trial in Older Adults with Subclinical Walking Difficulty

    PubMed Central

    Brach, Jennifer S.; Lowry, Kristin; Perera, Subashan; Hornyak, Victoria; Wert, David; Studenski, Stephanie A.; VanSwearingen, Jessie M.

    2016-01-01

    Objective The objective was to test the proposed mechanism of action of a task-specific motor learning intervention by examining its effect on measures of the motor control of gait. Design Single blinded randomized clinical trial. Setting University research laboratory. Participants Forty older adults 65 years of age and older, with gait speed >1.0 m/s and impaired motor skill (Figure of 8 walk time > 8 secs). Interventions The two interventions included a task-oriented motor learning and a standard exercise program. Both interventions lasted 12 weeks, with twice weekly one hour physical therapist supervised sessions. Main Outcome Measures Two measure of the motor control of gait, gait variability and smoothness of walking, were assessed pre and post intervention by assessors masked to treatment arm. Results Of 40 randomized subjects; 38 completed the trial (mean age 77.1±6.0 years). Motor control group improved more than standard group in double support time variability (0.13 vs. 0.05 m/s; adjusted difference, AD=0.006, p=0.03). Smoothness of walking in the anterior/posterior direction improved more in motor control than standard for all conditions (usual: AD=0.53, p=0.05; narrow: AD=0.56, p=0.01; dual task: AD=0.57, p=0.04). Conclusions Among older adults with subclinical walking difficulty, there is initial evidence that task-oriented motor learning exercise results in gains in the motor control of walking, while standard exercise does not. Task-oriented motor learning exercise is a promising intervention for improving timing and coordination deficits related to mobility difficulties in older adults, and needs to be evaluated in a definitive larger trial. PMID:25448244

  7. Accuracy, Validity, and Reliability of an Electronic Visual Analog Scale for Pain on a Touch Screen Tablet in Healthy Older Adults: A Clinical Trial

    PubMed Central

    Bird, Marie-Louise; Callisaya, Michele L; Cannell, John; Gibbons, Timothy; Smith, Stuart T

    2016-01-01

    Background New technology for clinical data collection is rapidly evolving and may be useful for both researchers and clinicians; however, this new technology has not been tested for accuracy, reliability, or validity. Objective This study aims to test the accuracy of visual analog scale (VAS) for pain on a newly designed application on the iPad (iPadVAS) and measure the reliability and validity of iPadVAS compared to a paper copy (paperVAS). Methods Accuracy was determined by physically measuring an iPad scale on screen and comparing it to the results from the program, with a researcher collecting 101 data points. A total of 22 healthy community dwelling older adults were then recruited to test reliability and validity. Each participant completed 8 VAS (4 using each tool) in a randomized order. Reliability was measured using interclass correlation coefficient (ICC) and validity measured using Bland-Altman graphs and correlations. Results Of the measurements for accuracy, 64 results were identical, 2 results were manually measured as being 1 mm higher than the program, and 35 as 1 mm lower. Reliability for the iPadVAS was excellent with individual ICC 0.90 (95% CI 0.82-0.95) and averaged ICC 0.97 (95% CI 0.95-1.0) observed. Linear regression demonstrated a strong relationship with a small negative bias towards the iPad (−2.6, SD 5.0) with limits of agreement from −12.4 to 7.1. Conclusions The iPadVAS provides a convenient, user-friendly, and efficient way of collecting data from participants in measuring their current pain levels. It has potential use in documentation management and may encourage participatory healthcare. Trial Registration Australia New Zealand Clinical Trials Registry (ANZCTR): 367297; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=367297&isReview=true (Archived by Webcite at http://www.webcitation.org/6d9xYoUbD). PMID:26769149

  8. 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

  9. 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. PMID:22964266

  10. 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

  11. A study protocol of a randomised controlled trial to investigate if a community based strength training programme improves work task performance in young adults with Down syndrome

    PubMed Central

    2010-01-01

    resistance training on work task performance and physical activity for adolescents and young adults with Down syndrome. The intervention addresses the impairment of muscle weakness which may improve work task performance and help to increase physical activity levels. Clinical trial registration number Australian New Zealand Clinical Trials Registry ACTRN12609000938202 PMID:20334692

  12. 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

  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. Considerations in Applying the Results of Randomized Controlled Clinical Trials to the Care of Older Adults With Kidney Disease in the Clinical Setting: The SHARP Trial.

    PubMed

    Butler, Catherine R; O'Hare, Ann M

    2016-01-01

    The Study of Heart and Renal Protection (SHARP) found that treatment with ezetemibe and low-dose simvastatin reduced the incidence of major atherosclerotic events in patients with kidney disease. Due to the paucity of evidence-based interventions that lower cardiovascular morbidity in this high-risk population, the SHARP trial will likely have a large impact on clinical practice. However, applying the results of clinical trials conducted in select populations to the care of individual patients in real-world settings can be fraught with difficulty. This is especially true when caring for older adults with complex comorbidity and limited life expectancy. These patients are often excluded from clinical trials, frequently have competing health priorities, and may be less likely to benefit and more likely to be harmed by medications. We discuss key considerations in applying the results of the SHARP trial to the care of older adults with CKD in real-world clinical settings using guiding principles set forth by the American Geriatrics Society's Expert Panel on the Care of Older Adults with Multimorbidity. Using this schema, we emphasize the importance of evaluating trial results in the unique context of each patient's goals, values, priorities, and circumstances. PMID:26709060

  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. PMID:25255784

  16. Efficacy of a text messaging (SMS) based intervention for adults with hypertension: protocol for the StAR (SMS Text-message Adherence suppoRt trial) randomised controlled trial

    PubMed Central

    2014-01-01

    Background Interventions to support people with hypertension in attending clinics and taking their medication have potential to improve outcomes, but delivery on a wide scale and at low cost is challenging. Some trials evaluating clinical interventions using short message service (SMS) text-messaging systems have shown important outcomes, although evidence is limited. We have developed a novel SMS system integrated with clinical care for use by people with hypertension in a low-resource setting. We aim to test the efficacy of the system in improving blood pressure control and treatment adherence compared to usual care. Methods/design The SMS Text-message Adherence suppoRt trial (StAR) is a pragmatic individually randomised three-arm parallel group trial in adults treated for hypertension at a single primary care centre in Cape Town, South Africa. The intervention is a structured programme of clinic appointment, medication pick-up reminders, medication adherence support and hypertension-related education delivered remotely using an automated system with either informational or interactive SMS text-messages. Usual care is supplemented by infrequent non-hypertension related SMS text-messages. Participants are 1:1:1 individually randomised, to usual care or to one of the two active interventions using minimisation to dynamically adjust for gender, age, baseline systolic blood pressure, years with hypertension, and previous clinic attendance. The primary outcome is the change in mean systolic blood pressure at 12-month follow-up from baseline measured with research staff blinded to trial allocation. Secondary outcomes include the proportion of patients with 80% or more of days medication available, proportion of participants achieving a systolic blood pressure less than 140 mmHg and a diastolic blood pressure less than 90 mmHg, hospital admissions, health status, retention in clinical care, satisfaction with treatment and care, and patient related quality of life

  17. 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

  18. 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

  19. 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.). PMID:26391974

  20. 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

  1. Systematic Literature Review of AbobotulinumtoxinA in Clinical Trials for Adult Upper Limb Spasticity

    PubMed Central

    Dashtipour, Khashayar; Chen, Jack J.; Walker, Heather W.; Lee, Michael Y.

    2015-01-01

    ABSTRACT Objective The aim of this study was to elucidate clinical trial efficacy, safety, and dosing practices of abobotulinumtoxinA (ABO) treatment in adult patients with upper limb spasticity (ULS). Methods A systematic literature review was performed to identify randomized controlled trials and other comparative clinical studies of ABO in the treatment of adult ULS published in English between January 1991 and January 2013. Medical literature databases (PubMed, Cochrane Library, and EMBASE) were searched, and a total of 295 records were identified. Of these, 12 primary publications that evaluated ABO for the management of ULS were included in the final data report. Synthesis Total ABO doses ranged between 500 and 1500 U for ULS. Most of the studies in ULS showed statistically significant benefits (reduction in muscle tone based on Ashworth score) of ABO vs. placebo. Statistical significance was reached for most evaluations of spasticity using the Modified Ashworth Scale. Statistically significant effects on active movement and pain were demonstrated, albeit less consistently. ABO was generally well tolerated across the individual studies; most adverse events reported were considered unrelated to treatment. Adverse events considered associated with ABO treatment included fatigue, tiredness, arm pain, skin rashes, flu-like symptoms, worsening of spasm, and weakness. Conclusions On the basis of data extracted from 12 randomized clinical studies, a strong evidence base (9/12 studies) exists for the use of ABO to reduce ULS caused by stroke. PMID:25299523

  2. Reference Intervals in Healthy Adult Ugandan Blood Donors and Their Impact on Conducting International Vaccine Trials

    PubMed Central

    Eller, Leigh Anne; Eller, Michael A.; Ouma, Benson; Kataaha, Peter; Kyabaggu, Denis; Tumusiime, Richard; Wandege, Joseph; Sanya, Ronald; Sateren, Warren B.; Wabwire-Mangen, Fred; Kibuuka, Hannah; Robb, Merlin L.; Michael, Nelson L.; de Souza, Mark S.

    2008-01-01

    Background Clinical trials are increasingly being conducted internationally. In order to ensure enrollment of healthy participants and proper safety evaluation of vaccine candidates, established reference intervals for clinical tests are required in the target population. Methodology/Principal Findings We report a reference range study conducted in Ugandan adult blood bank donors establishing reference intervals for hematology and clinical chemistry parameters. Several differences were observed when compared to previously established values from the United States, most notably in neutrophils and eosinophils. Conclusions/Significance In a recently conducted vaccine trial in Uganda, 31 percent (n = 69) of volunteers screened (n = 223) were excluded due to hematologic abnormalities. If local reference ranges had been employed, 83% of those screened out due to these abnormalities could have been included in the study, drastically reducing workload and cost associated with the screening process. In addition, toxicity tables used in vaccine and drug trial safety evaluations may need adjustment as some clinical reference ranges determined in this study overlap with grade 1 and grade 2 adverse events. PMID:19079547

  3. 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

  4. 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

  5. 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

  6. An investigator-blinded, randomized study to compare the efficacy of combined CBT for alcohol use disorders and social anxiety disorder versus CBT focused on alcohol alone in adults with comorbid disorders: the Combined Alcohol Social Phobia (CASP) trial protocol

    PubMed Central

    2013-01-01

    Background Alcohol use disorders and social anxiety disorder are common and disabling conditions that frequently co-exist. Although there are efficacious treatments for each disorder, only two randomized controlled trials of interventions for these combined problems have been published. We developed a new integrated treatment for comorbid Social Anxiety Disorder and Alcohol Use Disorder based on established Motivational Interviewing (MI) and Cognitive Behaviour Therapy (CBT) interventions for the separate disorders. Compared to established MI/CBT for alcohol use disorders this new intervention is hypothesised to lead to greater reductions in symptoms of social anxiety and alcohol use disorder and to produce greater improvements in quality of life. Higher levels of alcohol dependence will result in relatively poorer outcomes for the new integrated treatment. Methods/design A randomised controlled trial comparing 9 sessions of individual integrated treatment for alcohol and social phobia with 9 sessions of treatment for alcohol use problems alone is proposed. Randomisation will be stratified for stable antidepressant use. Post treatment clinical assessments of alcohol consumption and diagnostic status at 3 and 6 month follow-up will be blind to allocation. Discussion The proposed trial addresses a serious gap in treatment evidence and could potentially define the appropriate treatment for a large proportion of adults affected by these problems. Trial registration Australian New Zealand Clinical Trials Registry: ACTRN12608000228381. PMID:23895258

  7. Internet-based treatment for older adults with depression and co-morbid cardiovascular disease: protocol for a randomised, double-blind, placebo controlled trial

    PubMed Central

    2011-01-01

    Background Depression, cardiovascular disease (CVD) risk factors and cognitive impairment are important causes of disability and poor health outcomes. In combination they lead to an even worse prognosis. Internet or web-based interventions have been shown to deliver efficacious psychological intervention programs for depression on a large scale, yet no published studies have evaluated their impact among patients with co-existing physical conditions. The aims of this randomised controlled trial are to determine the effects of an evidence-based internet intervention program for depression on depressive mood symptoms, cognitive function and treatment adherence in patients at risk of CVD. Methods/Design This study is an internet-based, double-blind, parallel group randomised controlled trial. The trial will compare the effectiveness of online cognitive behavioural therapy with an online attention control placebo. The trial will consist of a 12-week intervention phase with a 40-week follow-up. It will be conducted in urban and rural New South Wales, Australia and will recruit a community-based sample of adults aged 45 to 75 years. Recruitment, intervention, cognitive testing and follow-up data collection will all be internet-based and automated. The primary outcome is a change in severity of depressive symptoms from baseline to three-months. Secondary outcomes are changes in cognitive function and adherence to treatment for CVD from baseline to three, six and 12-months. Discussion Prior studies of depression amongst patients with CVD have targeted those with previous vascular events and major depression. The potential for intervening earlier in these disease states appears to have significant potential and has yet to be tested. Scalable psychological programs using web-based interventions could deliver care to large numbers in a cost effective way if efficacy were proved. This study will determine the effects of a web-based intervention on depressive symptoms and

  8. Text Messaging to Improve Attendance at Post-Operative Clinic Visits after Adult Male Circumcision for HIV Prevention: A Randomized Controlled Trial

    PubMed Central

    Odeny, Thomas A.; Bailey, Robert C.; Bukusi, Elizabeth A.; Simoni, Jane M.; Tapia, Kenneth A.; Yuhas, Krista; Holmes, King K.; McClelland, R. Scott

    2012-01-01

    Background Following male circumcision for HIV prevention, a high proportion of men fail to return for their scheduled seven-day post-operative visit. We evaluated the effect of short message service (SMS) text messages on attendance at this important visit. Methodology We enrolled 1200 participants >18 years old in a two-arm, parallel, randomized controlled trial at 12 sites in Nyanza province, Kenya. Participants received daily SMS text messages for seven days (n = 600) or usual care (n = 600). The primary outcome was attendance at the scheduled seven-day post-operative visit. The primary analysis was by intention-to-treat. Principal Findings Of participants receiving SMS, 387/592 (65.4%) returned, compared to 356/596 (59.7%) in the control group (relative risk [RR] = 1.09, 95% confidence interval [CI] 1.00–1.20; p = 0.04). Men who paid more than US$1.25 to travel to clinic were at higher risk for failure to return compared to those who spent ≤US$1.25 (adjusted relative risk [aRR] 1.35, 95% CI 1.15–1.58; p<0.001). Men with secondary or higher education had a lower risk of failure to return compared to those with primary or less education (aRR 0.87, 95% CI 0.74–1.01; p = 0.07). Conclusions Text messaging resulted in a modest improvement in attendance at the 7-day post-operative clinic visit following adult male circumcision. Factors associated with failure to return were mainly structural, and included transportation costs and low educational level. Trial Registration ClinicalTrials.gov NCT01186575 PMID:22957034

  9. Obesity and physical frailty in older adults: a scoping review of lifestyle intervention trials.

    PubMed

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

    2014-04-01

    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 5-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 (body mass index ≥ 30 kg/m(2)) in older adults (aged >60 years), 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

  10. Portfolio of Clinical Research in Adult Cardiovascular Disease as Reflected in ClinicalTrials.gov

    PubMed Central

    Alexander, Karen P.; Kong, David F.; Starr, Aijing Z.; Kramer, Judith; Chiswell, Karen; Tasneem, Asba; Califf, Robert M.

    2013-01-01

    Background Cardiovascular medicine is widely regarded as a vanguard for evidence‐based drug and technology development. Our goal was to describe the cardiovascular clinical research portfolio from ClinicalTrials.gov. Methods and Results We identified 40 970 clinical research studies registered between 2007 and 2010 in which patients received diagnostic, therapeutic, or other interventions per protocol. By annotating 18 491 descriptors from the National Library of Medicine's Medical Subject Heading thesaurus and 1220 free‐text terms to select those relevant to cardiovascular disease, we identified studies that related to the diagnosis, treatment, or prevention of diseases of the heart and peripheral arteries in adults (n=2325 [66%] included from review of 3503 potential studies). The study intervention involved a drug in 44.6%, a device or procedure in 39.3%, behavioral intervention in 8.1%, and biological or genetic interventions in 3.0% of the trials. More than half of the trials were postmarket approval (phase 4, 25.6%) or not part of drug development (no phase, 34.5%). Nearly half of all studies (46.3%) anticipated enrolling 100 patients or fewer. The majority of studies assessed biomarkers or surrogate outcomes, with just 31.8% reporting a clinical event as a primary outcome. Conclusions Cardiovascular studies registered on ClinicalTrials.gov span a range of study designs. Data have limited verification or standardization and require manual processes to describe and categorize studies. The preponderance of small and late‐phase studies raises questions regarding the strength of evidence likely to be generated by the current portfolio and the potential efficiency to be gained by more research consolidation. PMID:24072529

  11. Comparative trial of five antimicrobial compounds in the treatment of cholera in adults.

    PubMed

    Khan, W A; Begum, M; Salam, M A; Bardhan, P K; Islam, M R; Mahalanabis, D

    1995-01-01

    To compare the efficacy of ciprofloxacin, erythromycin, nalidixic acid and pivmecillinam in the treatment of tetracycline-resistant strains of Vibrio cholerae O1 in adults, a randomized, open, clinical trial was conducted. A tetracycline group was used for comparison. Seventy-five adult men infected with V. cholerae O1 were randomly assigned to receive either 400 mg pivmecillinam or 500 mg of one of each of the other drugs. Ciprofloxacin was given every 12 h and the others every 6 h for 3 d. The mean total stool volume per kg was 155 mL for the ciprofloxacin group, 212 mL for the erythromycin and pivmecillinam groups, 246 mL for nalidixic acid, and 293 mL for tetracycline. The difference between ciprofloxacin and tetracycline was significant (P = 0.045). After 72 h, diarrhoea had stopped in 14 patients (93%) in the ciprofloxacin group and 12 (80%) in the erythromycin group, compared to 5 (42%) of those receiving tetracycline (P = 0.006 and 0.049, respectively). Bacteriological clearance was 100% at 24 h in patients treated with ciprofloxacin compared to 20% and 8.3% (P < 0.001 for both comparisons) in the erythromycin and tetracycline groups. Ciprofloxacin in conjunction with appropriate fluid therapy was the most effective treatment for cholera in adults; erythromycin was the next best. PMID:7747291

  12. A randomized controlled trial of CBT therapy for adults with ADHD with and without medication

    PubMed Central

    2012-01-01

    Background Previous studies of psychological treatment in adults with ADHD have not controlled for medication status and include either medicated participants or mixed samples of medicated and unmedicated participants. The objective of this study is to examine whether use of medication improves outcome of therapy. Method This was a secondary analysis comparing 23 participants randomized to CBT and Dextroamphetamine vs. 25 participants randomized to CBT and placebo. Both patients and investigators were blind to treatment assignment. Two co-primary outcomes were used: ADHD symptoms on the ADHD-RS-Inv completed by the investigator and improvement in functioning as reported by the patient on the Sheehan Disability Scale. Results Both groups showed robust improvement in both symptoms and functioning, but the use of medication did not significantly improve outcome over and above use of CBT and placebo. Conclusion This study replicates previous work demonstrating that CBT is an effective treatment for ADHD in adults. Within the limits of this pilot, secondary analysis we were not able to demonstrate that medication significantly augments the outcome of CBT therapy for adults with ADHD. The study was funded by GlaxoSmithKline, Clinical Trials Registry #GSK707. PMID:22480189

  13. Advance care planning: A systematic review of randomised controlled trials conducted with older adults.

    PubMed

    Weathers, Elizabeth; O'Caoimh, Rónán; Cornally, Nicola; Fitzgerald, Carol; Kearns, Tara; Coffey, Alice; Daly, Edel; O'Sullivan, Ronan; McGlade, Ciara; Molloy, D William

    2016-09-01

    Advance care planning (ACP), involving discussions between patients, families and healthcare professionals on future healthcare decisions, in advance of anticipated impairment in decision-making capacity, improves satisfaction and end-of-life care while respecting patient autonomy. It usually results in the creation of a written advanced care directive (ACD). This systematic review examines the impact of ACP on several outcomes (including symptom management, quality of care and healthcare utilisation) in older adults (>65years) across all healthcare settings. Nine randomised controlled trials (RCTs) were identified by searches of the CINAHL, PubMed and Cochrane databases. A total of 3646 older adults were included (range 72-88 years). Seven studies were conducted with community dwellers and the other two RCTs were conducted in nursing homes. Most studies did not implement a standardised ACD, or measure the impact on quality of end-of-life care or on the death and dying experience. All studies had some risk of bias, with most scoring poorly on the Oxford Quality Scale. While ACP interventions are well received by older adults and generally have positive effects on outcomes, this review highlights the need for well-designed RCTs that examine the economic impact of ACP and its effect on quality of care in nursing homes and other sectors. PMID:27451328

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

    PubMed Central

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

    2015-01-01

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

  15. V-TIME: a treadmill training program augmented by virtual reality to decrease fall risk in older adults: study design of a randomized controlled trial

    PubMed Central

    2013-01-01

    by virtual reality reduces fall risk, improves mobility and enhances cognitive function in a diverse group of older adults. In addition, the comparison to an active control group that undergoes treadmill training without virtual reality will provide evidence as to the added value of addressing motor cognitive interactions as an integrated unit. Trial Registration (NIH)–NCT01732653 PMID:23388087

  16. Glucose-responsive insulin and glucagon delivery (dual-hormone artificial pancreas) in adults with type 1 diabetes: a randomized crossover controlled trial

    PubMed Central

    Haidar, Ahmad; Legault, Laurent; Dallaire, Maryse; Alkhateeb, Ammar; Coriati, Adèle; Messier, Virginie; Cheng, Peiyao; Millette, Maude; Boulet, Benoit; Rabasa-Lhoret, Rémi

    2013-01-01

    hypoglycemia in a group of 15 adults with type 1 diabetes. Trial registration: ClinicalTrials.gov, no. NCT01297946. PMID:23359039

  17. A Randomised Controlled Trial to Reduce Sedentary Time in Young Adults at Risk of Type 2 Diabetes Mellitus: Project STAND (Sedentary Time ANd Diabetes)

    PubMed Central

    Biddle, Stuart J. H.; Edwardson, Charlotte L.; Wilmot, Emma G.; Yates, Thomas; Gorely, Trish; Bodicoat, Danielle H.; Ashra, Nuzhat; Khunti, Kamlesh; Nimmo, Myra A.; Davies, Melanie J.

    2015-01-01

    Aims Type 2 diabetes mellitus (T2DM), a serious and prevalent chronic disease, is traditionally associated with older age. However, due to the rising rates of obesity and sedentary lifestyles, it is increasingly being diagnosed in the younger population. Sedentary (sitting) behaviour has been shown to be associated with greater risk of cardio-metabolic health outcomes, including T2DM. Little is known about effective interventions to reduce sedentary behaviour in younger adults at risk of T2DM. We aimed to investigate, through a randomised controlled trial (RCT) design, whether a group-based structured education workshop focused on sitting reduction, with self-monitoring, reduced sitting time. Methods Adults aged 18–40 years who were either overweight (with an additional risk factor for T2DM) or obese were recruited for the Sedentary Time ANd Diabetes (STAND) RCT. The intervention programme comprised of a 3-hour group-based structured education workshop, use of a self-monitoring tool, and follow-up motivational phone call. Data were collected at three time points: baseline, 3 and 12 months after baseline. The primary outcome measure was accelerometer-assessed sedentary behaviour after 12 months. Secondary outcomes included other objective (activPAL) and self-reported measures of sedentary behaviour and physical activity, and biochemical, anthropometric, and psycho-social variables. Results 187 individuals (69% female; mean age 33 years; mean BMI 35 kg/m2) were randomised to intervention and control groups. 12 month data, when analysed using intention-to-treat analysis (ITT) and per-protocol analyses, showed no significant difference in the primary outcome variable, nor in the majority of the secondary outcome measures. Conclusions A structured education intervention designed to reduce sitting in young adults at risk of T2DM was not successful in changing behaviour at 12 months. Lack of change may be due to the brief nature of such an intervention and lack of focus

  18. 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

  19. Weight gain prevention in young adults: design of the study of novel approaches to weight gain prevention (SNAP) randomized controlled trial

    PubMed Central

    2013-01-01

    Background Weight gain during young adulthood is common and is associated with increased cardiovascular risk. Preventing this weight gain from occurring may be critical to improving long-term health. Few studies have focused on weight gain prevention, and these studies have had limited success. SNAP (Study of Novel Approaches to Weight Gain Prevention) is an NIH-funded randomized clinical trial examining the efficacy of two novel self-regulation approaches to weight gain prevention in young adults compared to a minimal treatment control. The interventions focus on either small, consistent changes in eating and exercise behaviors, or larger, periodic changes to buffer against expected weight gains. Methods/Design SNAP targets recruitment of six hundred young adults (18–35 years) with a body mass index between 21.0-30.0 kg/m2, who will be randomly assigned with equal probability to: (1) minimal intervention control; (2) self-regulation with Small Changes; or (3) self-regulation with Large Changes. Both interventions receive 8 weekly face-to-face group sessions, followed by 2 monthly sessions, with two 4-week refresher courses in each of subsequent years. Participants are instructed to report weight via web at least monthly thereafter, and receive monthly email feedback. Participants in Small Changes are taught to make small daily changes (~100 calorie changes) in how much or what they eat and to accumulate 2000 additional steps per day. Participants in Large Changes are taught to create a weight loss buffer of 5–10 pounds once per year to protect against anticipated weight gains. Both groups are encouraged to self-weigh daily and taught a self-regulation color zone system that specifies action depending on weight gain prevention success. Individualized treatment contact is offered to participants who report weight gains. Participants are assessed at baseline, 4 months, and then annually. The primary outcome is weight gain over an average of 3 years of follow

  20. Arrest of adult hippocampal neurogenesis in mice impairs single- but not multiple-trial contextual fear conditioning

    PubMed Central

    Drew, Michael R.; Denny, Christine A.; Hen, Rene

    2010-01-01

    The role of adult hippocampal neurogenesis in contextual fear conditioning (CFC) is debated. Several studies demonstrated that blocking adult hippocampal neurogenesis in rodents impairs CFC, while several other studies failed to observe an impairment. We sought to determine whether different CFC methods vary in their sensitivity to the arrest of adult neurogenesis. Adult neurogenesis was arrested in mice using low-dose, targeted x-irradiation, and the effects of irradiation were assayed in conditioning procedures that varied in the use of a discrete conditioned stimulus, the number of trials administered, and the final level of conditioning produced. We demonstrate that irradiation impairs CFC in mice when a single-trial CFC procedure is used but not when multiple-trial procedures are used, regardless of the final level of contextual fear produced. In addition, we show that the irradiation-induced deficit in single-trial CFC can be rescued by providing pre-exposure to the conditioning context. These results indicate that adult hippocampal neurogenesis is required for CFC in mice only when brief training is provided. PMID:20695644

  1. 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

  2. Randomised, single-masked non-inferiority trial of femtosecond laser-assisted versus manual phacoemulsification cataract surgery for adults with visually significant cataract: the FACT trial protocol

    PubMed Central

    Day, Alexander C; Burr, Jennifer M; Bunce, Catey; Doré, Caroline J; Sylvestre, Yvonne; Wormald, Richard P L; Round, Jeff; McCudden, Victoria; Rubin, Gary; Wilkins, Mark R

    2015-01-01

    Introduction Cataract is one of the leading causes of low vision in the westernised world, and cataract surgery is one of the most commonly performed operations. Laser platforms for cataract surgery are now available, the anticipated advantages of which are broad and may include better visual outcomes through greater precision and reproducibility, and improved safety. FACT is a randomised single masked non-inferiority trial to establish whether laser-assisted cataract surgery is as good as or better than standard manual phacoemulsification. Methods and analysis 808 patients aged 18 years and over with visually significant cataract will be randomised to manual phacoemulsification cataract surgery (standard care) or laser-assisted cataract surgery (intervention arm). Outcomes will be measured at 3 and 12 months after surgery. The primary clinical outcome is uncorrected distance visual acuity (UDVA, logMAR) at 3 months in the study eye recorded by an observer masked to the trial group. Secondary outcomes include UDVA at 12 months, corrected distance visual acuity at 3 and 12 months, complications, endothelial cell loss, patient-reported outcome measures and a health economic analysis conforming to National Institute for Health and Care Excellence standards. Ethics and dissemination Research Ethics Committee Approval was obtained on 6 February 2015, ref: 14/LO/1937. Current protocol: v2.0 (08/04/2015). Study findings will be published in peer-reviewed journals. Trial registration number ISRCTN: 77602616. PMID:26614627

  3. 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

  4. Mindfulness-based cognitive therapy (MBCT) versus the health-enhancement program (HEP) for adults with treatment-resistant depression: a randomized control trial study protocol

    PubMed Central

    2014-01-01

    Background Major depressive disorder (MDD) is the leading cause of disability in the developed world, yet broadly effective treatments remain elusive. Up to 40% of patients with depression are unresponsive to at least two trials of antidepressant medication and thus have “treatment-resistant depression” (TRD). There is an urgent need for cost-effective, non-pharmacologic, evidence-based treatments for TRD. Mindfulness-Based Cognitive Therapy (MBCT) is an effective treatment for relapse prevention and residual depression in major depression, but has not been previously studied in patients with TRD in a large randomized trial. Methods/Design The purpose of this study was to evaluate whether MBCT is an effective augmentation of antidepressants for adults with MDD who failed to respond to standard pharmacotherapy. MBCT was compared to an active control condition, the Health-Enhancement Program (HEP), which incorporates physical activity, functional movement, music therapy and nutritional advice. HEP was designed as a comparator condition for mindfulness-based interventions to control for non-specific effects. Originally investigated in a non-clinical sample to promote stress reduction, HEP was adapted for a depressed population for this study. Individuals age 18 and older with moderate to severe TRD, who failed to respond to at least two trials of antidepressants in the current episode, were recruited to participate. All participants were taking antidepressants (Treatment as usual; TAU) at the time of enrollment. After signing an informed consent, participants were randomly assigned to either MBCT or HEP condition. Participants were followed for 1 year and assessed at weeks 1–7, 8, 24, 36, and 52. Change in depression severity, rate of treatment response and remission after 8 weeks were the primary outcomes measured by the clinician-rated Hamilton Depression Severity Rating (HAM-D) 17-item scale. The participant-rated Quick Inventory of Depression Symptomology

  5. 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

  6. 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

  7. Treatment of adult asthma: controlled double-blind clinical trial of oxitropium bromide.

    PubMed

    Taytard, A; Auzerie, J; Vergeret, J; Tozon, N; Freour, P

    1984-01-01

    Sixteen young adult sufferers from extrinsic paroxysmal asthma with pollen hypersensitivity took part in a therapeutic trial of the synthetic anticholinergic agent oxitropium bromide administered by a metered dose inhaler. The study comprised three 3-week periods. The first, run-in period was carried out to confirm the ability of the patients to maintain a daily record of symptoms. During the second and third periods, the patient received 3 X 2 inhalations of drug or placebo in a cross-over design. The medical staff was blind to the nature of the aerosol (drug or placebo), which was given in random order. The run-in clinical score was high. Asymptomatic days were relatively infrequent and daily drug consumption was high. Functional studies between the cross-over periods showed flow-rate values close to normal, with an increase in residual volume and functional residual capacity. During treatment either with placebo or oxitropium, there was a statistically significant decrease in clinical scores. Results for oxitropium bromide treatment were significantly better than the run-in values (p less than 0.005) and the placebo period (p less than 0.02). There was no significant change in non-trial drug consumption. Functional values showed no difference in terms of flow rate, although oxitropium did cause a significant improvement in the RV/TLC ratio (p less than 0.05). No adverse reactions were reported. PMID:6376144

  8. 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…

  9. 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,…

  10. 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…

  11. 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…

  12. The Efficacy of Computerized Cognitive Training in Adults With ADHD: A Randomized Controlled Trial.

    PubMed

    Stern, Adi; Malik, Elad; Pollak, Yehuda; Bonne, Omer; Maeir, Adina

    2014-04-22

    Objective: This is a randomized control trial examining the efficiency of computerized cognitive training (CCT) for adults with ADHD, comparing two training conditions with graded levels of executive cognitive demands. Method: Adults with ADHD (n = 60) were randomized into study (n = 34) and control (n = 26) groups. Training was conducted with the computerized AttenFocus program. Control group received a simple, non-hierarchical version with less executive demands. Results: Significant positive changes in symptoms ratings, ecological measures of executive functions, and occupational performance were found in both groups. No significant changes were found in variables of neurocognitive performance battery and quality of life. No significant time by group interaction effects were found. Conclusion: No benefits of the intervention were found relative to the control. Lack of interaction effects may be due to insufficient power, non-specific cognitive training or placebo effects. Results demonstrate some positive findings for general CCT, yet do not support the inclusion of specific higher level executive training. PMID:24756172

  13. Effect of Nicotine Replacement Therapy on Quitting by Young Adults in a Trial Comparing Cessation Services

    PubMed Central

    Buller, David B.; Halperin, Abigail; Severson, Herbert. H; Borland, Ron; Slater, Michael D.; Bettinghaus, Erwin P.; Tinkelman, David; Cutter, Gary R.; Woodall, W. Gill

    2014-01-01

    Context Young adult smokers have the highest smoking prevalence of all US age groups but are least likely to use evidence-based cessation counseling or medication to quit. Objective Use and effectiveness of nicotine patch was explored in a randomized trial evaluating smoking cessation interventions with this population. Participants Smokers aged 18-30 (n=3,094) were recruited through online and off-line methods and from telephone quit lines and analyzed. Design Smokers were enrolled in a pretest-posttest trial, and randomized to one of three cessation services. Setting Trial delivering counseling services by self-help booklet, telephone quit line or online expert system in the 48 continental United States. Intervention Smokers could request a free two-week course of nicotine replacement therapy (NRT) patches from the project. Main Outcome Measure Follow-up surveys at 12-week and 26-weeks assessed smoking abstinence, use of NRT, counseling, and other cessation medications, and smoking-related variables. Results Overall, 69.0% of smokers reported using NRT (M=3.2 weeks) at 12-weeks and 74.8% (M=3.3 weeks) at 26-weeks. More smokers who were sent the free nicotine patches (n=1,695, 54.8%) reported using NRT than those who did not receive them (12-weeks: 84.3% v. 41.9%, p<.001; 26-weeks: 87.6% v. 51.1%, p<.001). NRT use was associated with greater smoking abstinence at 12-weeks (p<.001) and 26-weeks (p<.05), especially if used for more than two weeks (p<.001). Smokers assigned to a self-help booklet or cessation website and heavier smokers were most likely to use NRT (p<.05), while those reporting marijuana use and binge drinking used NRT less (p<.05). Conclusions Many young adults were willing to try NRT and it appeared to help them quit in the context of community-based cessation services. Strategies should be developed to make NRT available to this age group and support them in using it to prevent life-long smoking. PMID:24458316

  14. UK DRAFFT - A randomised controlled trial of percutaneous fixation with kirschner wires versus volar locking-plate fixation in the treatment of adult patients with a dorsally displaced fracture of the distal radius

    PubMed Central

    2011-01-01

    Background Fractures of the distal radius are extremely common injuries in adults. However, the optimal management remains controversial. In general, fractures of the distal radius are treated non-operatively if the bone fragments can be held in anatomical alignment by a plaster cast or orthotic. However, if this is not possible, then operative fixation is required. There are several operative options but the two most common in the UK, are Kirschner-wire fixation (K-wires) and volar plate fixation using fixed-angle screws (locking-plates). The primary aim of this trial is to determine if there is a difference in the Patient-Reported Wrist Evaluation one year following K-wire fixation versus locking-plate fixation for adult patients with a dorsally-displaced fracture of the distal radius. Methods/design All adult patients with an acute, dorsally-displaced fracture of the distal radius, requiring operative fixation are potentially eligible to take part in this study. A total of 390 consenting patients will be randomly allocated to either K-wire fixation or locking-plate fixation. The surgery will be performed in trauma units across the UK using the preferred technique of the treating surgeon. Data regarding wrist function, quality of life, complications and costs will be collected at six weeks and three, six and twelve months following the injury. The primary outcome measure will be wrist function with a parallel economic analysis. Discussion This pragmatic, multi-centre trial is due to deliver results in December 2013. Trial registration Current Controlled Trials ISRCTN31379280 UKCRN portfolio ID 8956 PMID:21914196

  15. 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

  16. 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. PMID:25045624

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

    PubMed Central

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

    2014-01-01

    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. PMID:25045624

  18. 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.

  19. Environmental heat exposure and cognitive performance in older adults: a controlled trial.

    PubMed

    Trezza, Beatriz Maria; Apolinario, Daniel; de Oliveira, Rafaela Sanchez; Busse, Alexandre Leopold; Gonçalves, Fábio Luiz Teixeira; Saldiva, Paulo Hilário Nascimento; Jacob-Filho, Wilson

    2015-06-01

    Thermal stress has a negative effect on the cognitive performance of military personnel and industry workers exposed to extreme environments. However, no studies have investigated the effects of environmental thermal stress on the cognitive functions of older adults. We carried out a controlled trial with 68 healthy older adults (mean age 73.3 years, 69 % female), each of whom has been assessed twice on the same day with selected tests from the Cambridge Neuropsychological Test Automated Battery (CANTAB). Repeated sessions were conducted with air temperatures set at 24 °C and 32 °C in a balanced order. Our primary analyses did not show significant differences when comparing the cognitive performance of the total sample under the two experimental temperatures. However, interaction analysis has shown that humidity levels modify the effect of temperature on cognitive outcomes. The subgroup exposed to relative humidity greater than the median value (57.8 %) presented worse cognitive performance in the heat session when compared to the control session. Reported exercising frequency explained individual vulnerability to heat stress. Volunteers with lower levels of physical activity (<4 times per week) were more likely to present worsened cognitive performance under heat stress. In a fully adjusted linear regression model, the performance under heat stress remained associated with relative humidity (β = -0.21; p = 0.007) and frequency of exercising (β = 0.18; p = 0.020). Our results indicate that heat stress may have detrimental effects on the cognitive functioning of some subgroups of older adults and under particular circumstances. Further research is needed for exploring a variety of potentially influential factors. PMID:25916595

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

    PubMed Central

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

    2012-01-01

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

  1. SMA VALIANT TRIAL: A PROSPECTIVE, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF VALPROIC ACID IN AMBULATORY ADULTS WITH SPINAL MUSCULAR ATROPHY

    PubMed Central

    Kissel, John T.; Elsheikh, Bakri; King, Wendy M.; Freimer, Miriam; Scott, Charles B.; Kolb, Stephen J.; Reyna, Sandra P.; Crawford, Thomas O.; Simard, Louise R.; Krosschell, Kristin J.; Acsadi, Gyula; Schroth, Mary K.; D’Anjou, Guy; LaSalle, Bernard; Prior, Thomas W.; Sorenson, Susan; Maczulski, Jo Anne; Swoboda, Kathryn J.

    2013-01-01

    Introduction An open-label trial suggested that valproic acid (VPA) improved strength in adults with spinal muscular atrophy (SMA). We report a 12-month, double-blind, cross-over study of VPA in ambulatory SMA adults. Methods There were 33 subjects, aged 20–55 years, included in this investigation. After baseline assessment, subjects were randomized to receive VPA (10–20 mg/kg/day) or placebo. At 6 months, patients were switched to the other group. Assessments were performed at 3, 6, and 12 months. The primary outcome was the 6-month change in maximum voluntary isometric contraction testing with pulmonary, electrophysiological, and functional secondary outcomes. Results Thirty subjects completed the study. VPA was well tolerated, and compliance was good. There was no change in primary or secondary outcomes at 6 or 12 months. Conclusions VPA did not improve strength or function in SMA adults. The outcomes used are feasible and reliable and can be employed in future trials in SMA adults. PMID:23681940

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. Localized Piezoelectric Alveolar Decortication for Orthodontic Treatment in Adults: A Randomized Controlled Trial.

    PubMed

    Charavet, C; Lecloux, G; Bruwier, A; Rompen, E; Maes, N; Limme, M; Lambert, F

    2016-08-01

    This randomized controlled trial aimed to evaluate the benefits and clinical outcomes of piezocision, which is a minimally invasive approach to corticotomy that is used in orthodontic treatments. Twenty-four adult patients presenting with mild overcrowdings were randomly allocated to either a control group that was treated with conventional orthodontics or a test group that received piezo-assisted orthodontics. The piezocisions were performed 1 wk week after the placement of the orthodontic appliances. Neither grafting material nor sutures were used. All patients were followed every 2 wk, and archwires were changed only when they were no longer active. The periods required for the completion of the overall orthodontic treatments were calculated, and the periodontal parameters were evaluated at baseline and at the end of the orthodontic treatment. Patient-centered outcomes were assessed with a visual analog scale; analgesic use following the procedures was also recorded. The patient characteristics were similar between the 2 groups. The overall treatment time was significantly reduced by 43% in the piezocision group as compared with the control group. In both groups, periodontal parameters (i.e., recession depth, pocket depth, plaque index, and papilla bleeding index) remained unchanged between the baseline and treatment completion time points. No increase in root resorption was observed in either group. Scars were observed in 50% of the patients in the piezocision group. Analgesic consumption was similar following orthodontic appliance placement and piezocision surgery. Patient satisfaction was significantly better in the piezocision group than in the control group. In these conditions, the piezocision technique seemed to be effective in accelerating orthodontic tooth movement. No gingival recessions were observed. The risk of residual scars might limit the indications for piezocision in patients with a high smile line (ClinicalTrials.gov NCT02590835). PMID

  8. A Randomized Trial of an Avatar-Hosted Multiple Behavior Change Intervention for Young Adult Smokers

    PubMed Central

    2013-01-01

    Background Young adulthood is a critical transition period for the development of health behaviors. We present here the results of a randomized controlled trial of an online avatar-hosted personal health makeover program designed for young adult smokers. Methods We conducted a three-group randomized trial comparing delivery of general lifestyle content (Tx1), personally tailored health information (Tx2), and personally tailored health information plus online video–based peer coaching (Tx3) as part of a 6-week online health program. Participants were asked to set weekly goals around eating breakfast, exercise, alcohol use, and cigarette smoking. Eligibility criteria included age (18–30 years) and smoking status (any cigarette use in the previous 30 days). The primary outcome was self-reported 30-day abstinence measured 12 weeks postenrollment. Results Participant (n = 1698) characteristics were balanced across the groups (72% women, mean age 24, 26% nonwhite, 32% high school education or less, and 50% daily smokers). Considering intention to treat, 30-day smoking abstinence rates were statistically significantly higher in the intervention groups (Tx1 = 11%, Tx2 = 23%, Tx3 = 31%, P < .001). Participants in the intervention groups were also more likely to reduce their number of days spent on binge drinking and increase their number of days eating breakfast and exercising. Overall, intervention group participants were much more likely to make positive changes in at least three or four of the target behaviors (Tx1 = 19%, Tx2 = 39%, Tx3 = 41%, P < .001). Conclusions This online avatar-hosted personal health makeover “show” increased smoking abstinence and induced positive changes in multiple related health behaviors. Addition of the online video–based peer coaching further improved behavioral outcomes. PMID:24395994

  9. Randomized Trial of Telephone Outreach to Improve Medication Adherence and Metabolic Control in Adults With Diabetes

    PubMed Central

    Schmittdiel, Julie A.; Pathak, Ram D.; Harris, Ronald I.; Newton, Katherine M.; Ohnsorg, Kris A.; Heisler, Michele; Sterrett, Andrew T.; Xu, Stanley; Dyer, Wendy T.; Raebel, Marsha A.; Thomas, Abraham; Schroeder, Emily B.; Desai, Jay R.; Steiner, John F.

    2014-01-01

    OBJECTIVE Medication nonadherence is a major obstacle to better control of glucose, blood pressure (BP), and LDL cholesterol in adults with diabetes. Inexpensive effective strategies to increase medication adherence are needed. RESEARCH DESIGN AND METHODS In a pragmatic randomized trial, we randomly assigned 2,378 adults with diabetes mellitus who had recently been prescribed a new class of medication for treating elevated levels of glycated hemoglobin (A1C) ≥8% (64 mmol/mol), BP ≥140/90 mmHg, or LDL cholesterol ≥100 mg/dL, to receive 1) one scripted telephone call from a diabetes educator or clinical pharmacist to identify and address nonadherence to the new medication or 2) usual care. Hierarchical linear and logistic regression models were used to assess the impact on 1) the first medication fill within 60 days of the prescription; 2) two or more medication fills within 180 days of the prescription; and 3) clinically significant improvement in levels of A1C, BP, or LDL cholesterol. RESULTS Of the 2,378 subjects, 89.3% in the intervention group and 87.4% in the usual-care group had sufficient data to analyze study outcomes. In intent-to-treat analyses, intervention was not associated with significant improvement in primary adherence, medication persistence, or intermediate outcomes of care. Results were similar across subgroups of patients defined by age, sex, race/ethnicity, and study site, and when limiting the analysis to those who completed the intended intervention. CONCLUSIONS This low-intensity intervention did not significantly improve medication adherence or control of glucose, BP, or LDL cholesterol. Wide use of this strategy does not appear to be warranted; alternative approaches to identify and improve medication adherence and persistence are needed. PMID:25315207

  10. 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

  11. 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

  12. 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. PMID:27462210

  13. 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

  14. 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. PMID:27335539

  15. 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

  16. Culturally-Tailored Smoking Cessation for Adult American Indian Smokers: A Clinical Trial

    PubMed Central

    Smith, Stevens S.; Rouse, Leah M.; Caskey, Mark; Fossum, Jodi; Strickland, Rick; Culhane, J. Kevin; Waukau, Jerry

    2015-01-01

    This collaborative, community-engaged project developed and tested a Culturally-Tailored Treatment (CTT) for American Indian/Alaska Native (AI/AN) smokers in the Menominee tribal community. One hundred three adult AI/AN smokers were randomized to receive either Standard Treatment (n= 53) or CTT (n = 50) for smoking cessation. Both treatment conditions included 12 weeks of varenicline and four individual counseling sessions but differed in terms of cultural tailoring of the counseling. The primary outcome was 7-day biochemically-confirmed point-prevalence abstinence (PPA) at the 6-month end-of-study visit. Both intention-to-treat (ITT) and responder-only analyses were conducted. There were no statistically significant group differences in 7-day PPA. The overall ITT abstinence rate at 6 months was 20%; the responder-only rate was 42%. The current study represents the first randomized smoking cessation clinical trial testing a culturally-tailored smoking cessation intervention designed for a specific AI/AN tribal community that combined FDA-approved cessation medication (varenicline) and innovative cultural intervention components. PMID:26973352

  17. Supervised exercises for adults with acute lateral ankle sprain: a randomised controlled trial

    PubMed Central

    van Rijn, Rogier M; van Os, Anton G; Kleinrensink, Gert-Jan; Bernsen, Roos MD; Verhaar, Jan AN; Koes, Bart W; Bierma-Zeinstra, Sita MA

    2007-01-01

    Background During the recovery period after acute ankle sprain, it is unclear whether conventional treatment should be supported by supervised exercise. Aim To evaluate the short- and long-term effectiveness of conventional treatment combined with supervised exercises compared with conventional treatment alone in patients with an acute ankle sprain. Design Randomised controlled clinical trial. Setting A total of 32 Dutch general practices and the hospital emergency department. Method Adults with an acute lateral ankle sprain consulting general practices or the hospital emergency department were allocated to either conventional treatment combined with supervised exercises or conventional treatment alone. Primary outcomes were subjective recovery (0–10 point scale) and the occurrence of a re-sprain. Measurements were carried out at intake, 4 weeks, 8 weeks, 3 months, and 1 year after injury. Data were analysed using intention-to-treat analyses. Results A total of 102 patients were enrolled and randomised to either conventional treatment alone or conventional treatment combined with supervised exercise. There was no significant difference between treatment groups concerning subjective recovery or occurrence of re-sprains after 3 months and 1-year of follow-up. Conclusion Conventional treatment combined with supervised exercises compared to conventional treatment alone during the first year after an acute lateral ankle sprain does not lead to differences in the occurrence of re-sprains or in subjective recovery. PMID:17925136

  18. “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

  19. 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

  20. A Mobile Telehealth Intervention for Adults With Insulin-Requiring Diabetes: Early Results of a Mixed-Methods Randomized Controlled Trial

    PubMed Central

    Baron, Justine; Hirani, Shashivadan

    2015-01-01

    Background The role of technology in health care delivery has grown rapidly in the last decade. The potential of mobile telehealth (MTH) to support patient self-management is a key area of research. Providing patients with technological tools that allow for the recording and transmission of health parameters to health care professionals (HCPs) may promote behavior changes that result in improved health outcomes. Although for some conditions the evidence of the effectiveness of MTH is clear, to date the findings on the effects of MTH on diabetes management remain inconsistent. Objective This study aims to evaluate an MTH intervention among insulin-requiring adults with diabetes to establish whether supplementing standard care with MTH results in improved health outcomes—glycated hemoglobin (HbA1c), blood pressure (BP), health-related quality of life (HRQoL), diabetes self-management behaviors, diabetes health care utilization, and diabetes self-efficacy and illness beliefs. An additional objective was to explore the acceptability of MTH and patients’ perceptions of, and experience, using it. Methods A mixed-method design consisting of a 9-month, two-arm, parallel randomized controlled trial (RCT) was used in combination with exit qualitative interviews. Quantitative data was collected at baseline, 3 months, and 9 months. Additional intervention fidelity data, such as participants’ MTH transmissions and contacts with the MTH nurse during the study, were also recorded. Results Data collection for both the quantitative and qualitative components of this study has ended and data analysis is ongoing. A total of 86 participants were enrolled into the study. Out of 86 participants, 45 (52%) were randomized to the intervention group and 36 (42%) to the control group. Preliminary data on MTH training sessions and MTH usage by intervention participants are presented in this paper. We expect to publish complete study results in 2015. Conclusions The range of data

  1. Bone Mineral Density Changes among HIV-Uninfected Young Adults in a Randomised Trial of Pre-Exposure Prophylaxis with Tenofovir-Emtricitabine or Placebo in Botswana

    PubMed Central

    Kasonde, Michael; Niska, Richard W.; Rose, Charles; Henderson, Faith L.; Segolodi, Tebogo M.; Turner, Kyle; Smith, Dawn K.; Thigpen, Michael C.; Paxton, Lynn A.

    2014-01-01

    Background Tenofovir-emtricitabine (TDF-FTC) pre-exposure prophylaxis (PrEP) has been found to be effective for prevention of HIV infection in several clinical trials. Two studies of TDF PrEP among men who have sex with men showed slight bone mineral density (BMD) loss. We investigated the effect of TDF and the interaction of TDF and hormonal contraception on BMD among HIV-uninfected African men and women. Method We evaluated the effects on BMD of using daily oral TDF-FTC compared to placebo among heterosexual men and women aged 18–29 years enrolled in the Botswana TDF2 PrEP study. Participants had BMD measurements at baseline and thereafter at 6-month intervals with dual-energy X-ray absorptiometry (DXA) scans at the hip, spine, and forearm. Results A total of 220 participants (108 TDF-FTC, 112 placebo) had baseline DXA BMD measurements at three anatomic sites. Fifteen (6.8%) participants had low baseline BMD (z-score of <−2.0 at any anatomic site), including 3/114 women (2.6%) and 12/106 men (11.3%) (p = 0.02). Low baseline BMD was associated with being underweight (p = 0.02), having high blood urea nitrogen (p = 0.02) or high alkaline phosphatase (p = 0.03), and low creatinine clearance (p = 0.04). BMD losses of >3.0% at any anatomic site at any time after baseline were significantly greater for the TDF-FTC treatment group [34/68 (50.0%) TDF-FTC vs. 26/79 (32.9%) placebo; p = 0.04]. There was a small but significant difference in the mean percent change in BMD from baseline for TDF-FTC versus placebo at all three sites at month 30 [forearm −0.84% (p = 0.01), spine −1.62% (p = 0.0002), hip −1.51% (p = 0.003)]. Conclusion Use of TDF-FTC was associated with a small but statistically significant decrease in BMD at the forearm, hip and lumbar spine. A high percentage (6.8%) of healthy Batswana young adults had abnormal baseline BMD Further evaluation is needed of the longer-term use of TDF in HIV-uninfected persons. Trial

  2. 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

  3. 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

    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/m(2)) adults aged 50-69 (N = 170) with prediabetes (impaired fasting glucose and/or impaired glucose tolerance) completed a supervised 3-month RT (2×/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

  4. 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. PMID:25673817

  5. Brief Report: HIV Drug Resistance in Adults Failing Early Antiretroviral Treatment: Results From the HIV Prevention Trials Network 052 Trial.

    PubMed

    Fogel, Jessica M; Hudelson, Sarah E; Ou, San-San; Hart, Stephen; Wallis, Carole; Morgado, Mariza G; Saravanan, Shanmugam; Tripathy, Srikanth; Hovind, Laura; Piwowar-Manning, Estelle; Sabin, Devin; McCauley, Marybeth; Gamble, Theresa; Zhang, Xinyi C; Eron, Joseph J; Gallant, Joel E; Kumwenda, Johnstone; Makhema, Joseph; Kumarasamy, Nagalingeswaran; Chariyalertsak, Suwat; Hakim, James; Badal-Faesen, Sharlaa; Akelo, Victor; Hosseinipour, Mina C; Santos, Breno R; Godbole, Sheela V; Pilotto, Jose H; Grinsztejn, Beatriz; Panchia, Ravindre; Mayer, Kenneth H; Chen, Ying Q; Cohen, Myron S; Eshleman, Susan H

    2016-07-01

    Early initiation of antiretroviral treatment (ART) reduces HIV transmission and has health benefits. HIV drug resistance can limit treatment options and compromise use of ART for HIV prevention. We evaluated drug resistance in 85 participants in the HIV Prevention Trials Network 052 trial who started ART at CD4 counts of 350-550 cells per cubic millimeter and failed ART by May 2011; 8.2% had baseline resistance and 35.3% had resistance at ART failure. High baseline viral load and less education were associated with emergence of resistance at ART failure. Resistance at ART failure was observed in 7 of 8 (87.5%) participants who started ART at lower CD4 cell counts. PMID:26859828

  6. 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

  7. 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

  8. Effect of vitamin C on inflammation and metabolic markers in hypertensive and/or diabetic obese adults: a randomized controlled trial

    PubMed Central

    Ellulu, Mohammed S; Rahmat, Asmah; Patimah, Ismail; Khaza’ai, Huzwah; Abed, Yehia

    2015-01-01

    Background Obesity is well associated as being an interfering factor in metabolic diseases such as hypertension and diabetes by increasing the secretion of proinflammatory markers from adipose tissue. Having healthy effects, vitamin C could work as an anti-inflammatory agent through its antioxidant capacity. Registration Registration number: FPSK_Mac [13]04. Objective The aim of the study reported here was to identify the effect of vitamin C on reducing the levels of inflammatory markers in hypertensive and/or diabetic obese adults. Subjects and methods Sixty-four obese patients, who were hypertensive and/or diabetic and had high levels of inflammatory markers, from primary health care centers in Gaza City, Palestine, were enrolled into one of two groups in an open-label, parallel, randomized controlled trial. A total of 33 patients were randomized into a control group and 31 patients were randomized into an experimental group. The experimental group was treated with 500 mg vitamin C twice a day. Results In the experimental group, vitamin C significantly reduced the levels of high-sensitivity C-reactive protein (hs-CRP), interleukin 6 (IL-6), fasting blood glucose (FBG), and triglyceride (TG) after 8 weeks of treatment (overall: P<0.001); no changes appeared in total cholesterol (TC). In the control group, there were significant reductions in FBG and TG (P=0.001 and P=0.026, respectively), and no changes in hs-CRP, IL-6, or TC. On comparing the changes in the experimental group with those in the control group at the endpoint, vitamin C was found to have achieved clinical significance in treating effectiveness for reducing hs-CRP, IL-6, and FBG levels (P=0.01, P=0.001, and P<0.001, respectively), but no significant changes in TC or TG were found. Conclusion Vitamin C (500 mg twice daily) has potential effects in alleviating inflammatory status by reducing hs-CRP, IL-6, and FBG in hypertensive and/or diabetic obese patients. PMID:26170625

  9. Plasticity of Brain Networks in a Randomized Intervention Trial of Exercise Training in Older Adults

    PubMed Central

    Voss, Michelle W.; Prakash, Ruchika S.; Erickson, Kirk I.; Basak, Chandramallika; Chaddock, Laura; Kim, Jennifer S.; Alves, Heloisa; Heo, Susie; Szabo, Amanda N.; White, Siobhan M.; Wójcicki, Thomas R.; Mailey, Emily L.; Gothe, Neha; Olson, Erin A.; McAuley, Edward; Kramer, Arthur F.

    2010-01-01

    Research has shown the human brain is organized into separable functional networks during rest and varied states of cognition, and that aging is associated with specific network dysfunctions. The present study used functional magnetic resonance imaging (fMRI) to examine low-frequency (0.008 < f < 0.08 Hz) coherence of cognitively relevant and sensory brain networks in older adults who participated in a 1-year intervention trial, comparing the effects of aerobic and non-aerobic fitness training on brain function and cognition. Results showed that aerobic training improved the aging brain's resting functional efficiency in higher-level cognitive networks. One year of walking increased functional connectivity between aspects of the frontal, posterior, and temporal cortices within the Default Mode Network and a Frontal Executive Network, two brain networks central to brain dysfunction in aging. Length of training was also an important factor. Effects in favor of the walking group were observed only after 12 months of training, compared to non-significant trends after 6 months. A non-aerobic stretching and toning group also showed increased functional connectivity in the DMN after 6 months and in a Frontal Parietal Network after 12 months, possibly reflecting experience-dependent plasticity. Finally, we found that changes in functional connectivity were behaviorally relevant. Increased functional connectivity was associated with greater improvement in executive function. Therefore the study provides the first evidence for exercise-induced functional plasticity in large-scale brain systems in the aging brain, using functional connectivity techniques, and offers new insight into the role of aerobic fitness in attenuating age-related brain dysfunction. PMID:20890449

  10. 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

  11. 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…

  12. Multi-modal intervention to reduce cardiovascular risk among hypertensive older adults: Design of a randomized clinical trial.

    PubMed

    Buford, Thomas W; Anton, Stephen D; Bavry, Anthony A; Carter, Christy S; Daniels, Michael J; Pahor, Marco

    2015-07-01

    Persons aged over 65 years account for over 75% of healthcare expenditures and deaths attributable to cardiovascular disease (CVD). Accordingly, reducing CVD risk among older adults is an important public health priority. Functional status, determined by measures of physical performance, is an important predictor of cardiovascular outcomes in older adults and declines more rapidly in seniors with hypertension. To date, physical exercise is the primary strategy for attenuating declines in functional status. Yet despite the general benefits of training, exercise alone appears to be insufficient for preventing this decline. Thus, alternative or adjuvant strategies are needed to preserve functional status among seniors with hypertension. Prior data suggest that angiotensin converting enzyme inhibitors (ACEi) may be efficacious in enhancing exercise-derived improvements in functional status yet this hypothesis has not been tested in a randomized controlled trial. The objective of this randomized, double-masked pilot trial is to gather preliminary efficacy and safety data necessary for conducting a full-scale trial to test this hypothesis. Sedentary men and women ≥ 65 years of age with functional limitations and hypertension are being recruited into this 24 week intervention study. Participants are randomly assigned to one of three conditions: (1) ACEi plus exercise training, (2) thiazide diuretic plus exercise training, or (3) AT1 receptor antagonist plus exercise training. The primary outcome is change in walking speed and secondary outcomes consist of other indices of CV risk including exercise capacity, body composition, as well as circulating indices of metabolism, inflammation and oxidative stress. PMID:26115878

  13. Multi-modal intervention to reduce cardiovascular risk among hypertensive older adults: Design of a randomized clinical trial

    PubMed Central

    Buford, Thomas W.; Anton, Stephen D.; Bavry, Anthony; Carter, Christy S.; Daniels, Michael J.; Pahor, Marco

    2015-01-01

    Persons aged over 65 years account for over 75% of healthcare expenditures and deaths attributable to cardiovascular disease (CVD). Accordingly, reducing CVD risk among older adults is an important public health priority. Functional status, determined by measures of physical performance, is an important predictor of cardiovascular outcomes in older adults and declines more rapidly in seniors with hypertension. To date, physical exercise is the primary strategy for attenuating declines in functional status. Yet despite the general benefits of training, exercise alone appears to be insufficient for preventing this decline. Thus, alternative or adjuvant strategies are needed to preserve functional status among seniors with hypertension. Prior data suggest that angiotensin converting enzyme inhibitors (ACEi) may be efficacious in enhancing exercise-derived improvements in functional status yet this hypothesis has not been tested in a randomized controlled trial. The objective of this randomized, double-masked pilot trial is to gather preliminary efficacy and safety data necessary for conducting a full-scale trial to test this hypothesis. Sedentary men and women ≥ 65 years of age with functional limitations and hypertension are being recruited into this 24 week intervention study. Participants are randomly assigned to one of three conditions: (1) ACEi plus exercise training, (2) thiazide diuretic plus exercise training, or (3) AT1 receptor antagonist plus exercise training. The primary outcome is change in walking speed and secondary outcomes consist of other indices of CV risk including exercise capacity, body composition, as well as circulating indices of metabolism, inflammation and oxidative stress. PMID:26115878

  14. Improved outcome of adult Burkitt lymphoma/leukemia with rituximab and chemotherapy: report of a large prospective multicenter trial

    PubMed Central

    Walewski, Jan; Döhner, Hartmut; Viardot, Andreas; Hiddemann, Wolfgang; Spiekermann, Karsten; Serve, Hubert; Dührsen, Ulrich; Hüttmann, Andreas; Thiel, Eckhard; Dengler, Jolanta; Kneba, Michael; Schaich, Markus; Schmidt-Wolf, Ingo G. H.; Beck, Joachim; Hertenstein, Bernd; Reichle, Albrecht; Domanska-Czyz, Katarzyna; Fietkau, Rainer; Horst, Heinz-August; Rieder, Harald; Schwartz, Stefan; Burmeister, Thomas; Gökbuget, Nicola

    2014-01-01

    This largest prospective multicenter trial for adult patients with Burkitt lymphoma/leukemia aimed to prove the efficacy and feasibility of short-intensive chemotherapy combined with the anti-CD20 antibody rituximab. From 2002 to 2011, 363 patients 16 to 85 years old were recruited in 98 centers. Treatment consisted of 6 5-day chemotherapy cycles with high-dose methotrexate, high-dose cytosine arabinoside, cyclophosphamide, etoposide, ifosphamide, corticosteroids, and triple intrathecal therapy. Patients >55 years old received a reduced regimen. Rituximab was given before each cycle and twice as maintenance, for a total of 8 doses. The rate of complete remission was 88% (319/363); overall survival (OS) at 5 years, 80%; and progression-free survival, 71%; with significant difference between adolescents, adults, and elderly patients (OS rate of 90%, 84%, and 62%, respectively). Full treatment could be applied in 86% of the patients. The most important prognostic factors were International Prognostic Index (IPI) score (0-2 vs 3-5; P = .0005), age-adjusted IPI score (0-1 vs 2-3; P = .0001), and gender (male vs female; P = .004). The high cure rate in this prospective trial with a substantial number of participating hospitals demonstrates the efficacy and feasibility of chemoimmunotherapy, even in elderly patients. This trial was registered at www.clinicaltrials.gov as #NCT00199082. PMID:25359988

  15. 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…

  16. Internet-based cognitive behavioural therapy for adults with tinnitus in the UK: study protocol for a randomised controlled trial

    PubMed Central

    Beukes, Eldré W; Manchaiah, Vinaya; Allen, Peter M; Baguley, David M; Andersson, Gerhard

    2015-01-01

    Introduction Tinnitus is one of the most distressing hearing-related symptoms. Innovative ways of managing tinnitus distress and the related healthcare burden of treating tinnitus are required. An internet-based cognitive behavioural therapy (iCBT) intervention has been developed in Sweden to improve access to evidence-based tinnitus treatments. This study aims to determine the feasibility and effectiveness of iCBT in reducing the impact associated with tinnitus, in the UK. It, furthermore, aims to establish whether there are subgroups of tinnitus sufferers for whom this iCBT intervention may be more suitable. Methods and analysis A two-armed randomised control trial—with a 1-year follow-up design—will be used to evaluate the effectiveness of iCBT on tinnitus distress. A delayed treatment design using a weekly check-in control group will be used. 70 participants will be randomly assigned to each group by an independent researcher by using a computer-generated randomisation schedule, and after being prestratified for age and tinnitus severity. They will undergo the iCBT e-health intervention online together with audiological therapeutic support. The main outcome measure is the Tinnitus Functional Index. Process evaluation of the intervention will also be conducted. Data analysis will be in accordance with Consolidated Standards of Reporting Trials guidelines. Ethics and dissemination Ethical approval has been granted. If this intervention proves effective, it may be possible that at least some tinnitus sufferers can be managed though an iCBT e-learning treatment programme. This would be cost effective and potentially will free up services for those with more severe problems that need face-to-face treatment. Trial registration number ClinicalTrials.gov; NCT02370810, date 05/03/2015. PMID:26399571

  17. 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

  18. 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

  19. 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

  20. 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

  1. 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

  2. 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

  3. Increasing Access to Clinical Trials and Innovative Therapy for Teenagers and Young Adults with Cancer - A Multiple Stakeholders and Multiple Steps Process.

    PubMed

    Gaspar, Nathalie; Fern, Lorna

    2016-01-01

    The inclusion of teenagers and young adults (TYAs) in cancer clinical trials is focal point for many countries with a specific TYA program. This objective has arisen from data which suggests that lower trial entry may, in part, contribute to lesser survival gains observed in this group when compared to children and some older adult cancers. In this chapter, we discuss obstacles to clinical trials and innovative therapies for TYA. Limited clinical trial availability is discussed in the context of the rarity of TYA cancers and our limited understanding of cancer biology in this group, other obstacles include inappropriate age eligibility criteria, limited accessibility to available trials, a lack of physicians and patients awareness and poor acceptability of trial design. We propose several strategies which could be applied to overcome these obstacles, some ready for implementation and others which require further exploration. Strengthening pediatric and adult oncology collaboration at the individual level and through oncology societies will undoubtedly positively impact accrual to trials for TYA, as will abolishing the use of age as a barrier to drug and trial access. This will allow us to create biologically driven trials and facilitate early new drug access and the creation of biobank collections to drive our understanding of the biology of cancers in this age group. Involving multiple stakeholders in trial design will facilitate acceptable trials to both healthcare professionals and young people themselves. The support of the multidisciplinary TYA team and a culture of research embedded within this are the keys to improving access and participation of TYA in cancer trials. PMID:27595355

  4. 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

  5. Study protocol: a randomised controlled trial of a theory-based online intervention to improve sun safety among Australian adults

    PubMed Central

    2014-01-01

    Background The effects of exposure to ultraviolet radiation are a significant concern in Australia which has one of the highest incidences of skin cancer in the world. Despite most skin cancers being preventable by encouraging consistent adoption of sun-protective behaviours, incidence rates are not decreasing. There is a dearth of research examining the factors involved in engaging in sun-protective behaviours. Further, online multi-behavioural theory-based interventions have yet to be explored fully as a medium for improving sun-protective behaviour in adults. This paper presents the study protocol of a randomised controlled trial of an online intervention based on the Theory of Planned Behaviour (TPB) that aims to improve sun safety among Australian adults. Methods/Design Approximately 420 adults aged 18 and over and predominantly from Queensland, Australia, will be recruited and randomised to the intervention (n = 200), information only (n = 200) or the control group (n = 20). The intervention focuses on encouraging supportive attitudes and beliefs toward sun-protective behaviour, fostering perceptions of normative support for sun protection, and increasing perceptions of control/self-efficacy over sun protection. The intervention will be delivered online over a single session. Data will be collected immediately prior to the intervention (Time 1), immediately following the intervention (Time 1b), and one week (Time 2) and one month (Time 3) post-intervention. Primary outcomes are intentions to sun protect and sun-protective behaviour. Secondary outcomes are the participants’ attitudes toward sun protection, perceptions of normative support for sun protection (i.e. subjective norms, group norms, personal norms and image norms) and perceptions of control/self-efficacy toward sun protection. Discussion The study will contribute to an understanding of the effectiveness of a TPB-based online intervention to improve Australian adults’ sun

  6. LOCAT (low-dose computed tomography for appendicitis trial) comparing clinical outcomes following low- vs standard-dose computed tomography as the first-line imaging test in adolescents and young adults with suspected acute appendicitis: study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Computed tomography is widely used to diagnose acute appendicitis. Many adolescents and young adults are exposed to the associated radiation. A recent single-institution trial has reported promising results for low-dose computed tomography; however, this technique has not yet been widely adopted. LOCAT (low-dose computed tomography for appendicitis trial), a multi-institution randomized controlled non-inferiority trial, aims to compare low-dose computed tomography and standard-dose computed tomography as the first-line imaging tests for adolescents and young adults, and therefore to test the generalizability of the previous single-institution trial results. Methods/Design Participants with suspected appendicitis are randomly assigned to either the low-dose group (with a typical effective dose of 2 mSv) or the standard-dose group (as used in normal practice at each participating site, typically 8 mSv). The primary end point is the negative appendectomy rate (the percentage of the number of uninflamed appendices that were removed among all non-incidental appendectomies), which is a consequence of false-positive diagnoses, with a non-inferiority margin of 4.5 percentage points. The key secondary end point is the appendiceal perforation rate, which is a consequence of delayed (or false-negative) diagnoses. Participant recruitment will be continued until the number of non-incidental appendectomies for each group exceeds 444. The total number of expected participants approximates 3,000, including those not undergoing appendectomy. Discussion In addition to the study protocol, we elaborate on several challenging or potentially debatable components of the study design, including the broad eligibility criteria, choice of the primary end point, potential effect of using advanced imaging techniques on study results, determining and adjusting the radiation doses, ambiguities in reference standards, rationale for the non-inferiority margin, use of the intention

  7. 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

  8. 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…

  9. 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…

  10. 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" UK-based…

  11. 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…

  12. Drug-Resistant Tuberculosis Clinical Trials: Proposed Core Research Definitions in Adults

    PubMed Central

    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, 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.

    2016-01-01

    Structured Summary Drug-resistant tuberculosis (DR-TB) is a growing public health problem, and for the first time in decades there are new drugs for treatment of this disease. 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 maximize 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. In order 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 MDR-TB clinical trials. PMID:27046707

  13. 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. PMID:27046707

  14. 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

  15. Update on the transfusion in gastrointestinal bleeding (TRIGGER) trial: statistical analysis plan for a cluster-randomised feasibility trial

    PubMed Central

    2013-01-01

    Background Previous research has suggested an association between more liberal red blood cell (RBC) transfusion and greater risk of further bleeding and mortality following acute upper gastrointestinal bleeding (AUGIB). Methods and design The Transfusion in Gastrointestinal Bleeding (TRIGGER) trial is a pragmatic cluster-randomised feasibility trial which aims to evaluate the feasibility of implementing a restrictive vs. liberal RBC transfusion policy for adult patients admitted to hospital with AUGIB in the UK. This trial will help to inform the design and methodology of a phase III trial. The protocol for TRIGGER has been published in Transfusion Medicine Reviews. Recruitment began in September 2012 and was completed in March 2013. This update presents the statistical analysis plan, detailing how analysis of the TRIGGER trial will be performed. It is hoped that prospective publication of the full statistical analysis plan will increase transparency and give readers a clear overview of how TRIGGER will be analysed. Trial registration ISRCTN85757829 PMID:23837630

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

    PubMed Central

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

    2016-01-01

    Objective To test whether a long term, structured physical activity program compared with a health education program reduces the risk of serious fall injuries among sedentary older people with functional limitations. Design Multicenter, single blinded randomized trial (Lifestyle Interventions and Independence for Elders (LIFE) study). Setting Eight centers across the United States, February 2010 to December 2011. Participants 1635 sedentary adults aged 70-89 years with functional limitations, defined as a short physical performance battery score ≤9, but who were able to walk 400 m. Interventions A permuted block algorithm stratified by field center and sex was used to allocate interventions. Participants were randomized to a structured, moderate intensity physical activity program (n=818) conducted in a center (twice a week) and at home (3-4 times a week) that included aerobic, strength, flexibility, and balance training activities, or to a health education program (n=817) consisting of workshops on topics relevant to older people and upper extremity stretching exercises. Main outcome measures Serious fall injuries, defined as a fall that resulted in a clinical, non-vertebral fracture or that led to a hospital admission for another serious injury, was a prespecified secondary outcome in the LIFE Study. Outcomes were assessed every six months for up to 42 months by staff masked to intervention assignment. All participants were included in the analysis. Results Over a median follow-up of 2.6 years, a serious fall injury was experienced by 75 (9.2%) participants in the physical activity group and 84 (10.3%) in the health education group (hazard ratio 0.90, 95% confidence interval 0.66 to 1.23; P=0.52). These results were consistent across several subgroups, including sex. However, in analyses that were not prespecified, sex specific differences were observed for rates of all serious fall injuries (rate ratio 0.54, 95% confidence interval 0.31 to 0.95 in men

  17. The feasibility of a randomised controlled trial of physiotherapy for adults with joint hypermobility syndrome.

    PubMed Central

    Palmer, Shea; Cramp, Fiona; Clark, Emma; Lewis, Rachel; Brookes, Sara; Hollingworth, William; Welton, Nicky; Thom, Howard; Terry, Rohini; Rimes, Katharine A; Horwood, Jeremy

    2016-01-01

    BACKGROUND Joint hypermobility syndrome (JHS) is a heritable disorder associated with laxity and pain in multiple joints. Physiotherapy is the mainstay of treatment, but there is little research investigating its clinical effectiveness. OBJECTIVES To develop a comprehensive physiotherapy intervention for adults with JHS; to pilot the intervention; and to conduct a pilot randomised controlled trial (RCT) to determine the feasibility of conducting a future definitive RCT. DESIGN Patients' and health professionals' perspectives on physiotherapy for JHS were explored in focus groups (stage 1). A working group of patient research partners, clinicians and researchers used this information to develop the physiotherapy intervention. This was piloted and refined on the basis of patients' and physiotherapists' feedback (stage 2). A parallel two-arm pilot RCT compared 'advice' with 'advice and physiotherapy' (stage 3). Random allocation was via an automated randomisation service, devised specifically for the study. Owing to the nature of the interventions, it was not possible to blind clinicians or patients to treatment allocation. SETTING Stage 1 - focus groups were conducted in four UK locations. Stages 2 and 3 - piloting of the intervention and the pilot RCT were conducted in two UK secondary care NHS trusts. PARTICIPANTS Stage 1 - patient focus group participants (n = 25, three men) were aged > 18 years, had a JHS diagnosis and had received physiotherapy within the preceding 12 months. The health professional focus group participants (n = 16, three men; 14 physiotherapists, two podiatrists) had experience of managing JHS. Stage 2 - patient participants (n = 8) were aged > 18 years, had a JHS diagnosis and no other musculoskeletal conditions causing pain. Stage 3 - patient participants for the pilot RCT (n = 29) were as for stage 2 but the lower age limit was 16 years. INTERVENTION For the pilot RCT (stage 3) the advice intervention was a one

  18. 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

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

    PubMed Central

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

    2016-01-01

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

  20. Understanding the Canadian adult CT head rule trial: use of the theoretical domains framework for process evaluation

    PubMed Central

    2013-01-01

    Background The Canadian CT Head Rule was prospectively derived and validated to assist clinicians with diagnostic decision-making regarding the use of computed tomography (CT) in adult patients with minor head injury. A recent intervention trial failed to demonstrate a decrease in the rate of head CTs following implementation of the rule in Canadian emergency departments. Yet, the same intervention, which included a one-hour educational session and reminders at the point of requisition, was successful in reducing cervical spine imaging rates in the same emergency departments. The reason for the varied effect of the intervention across these two behaviours is unclear. There is an increasing appreciation for the use of theory to conduct process evaluations to better understand how strategies are linked with outcomes in implementation trials. The Theoretical Domains Framework (TDF) has been used to explore health professional behaviour and to design behaviour change interventions but, to date, has not been used to guide a theory-based process evaluation. In this proof of concept study, we explored whether the TDF could be used to guide a retrospective process evaluation to better understand emergency physicians’ responses to the interventions employed in the Canadian CT Head Rule trial. Methods A semi-structured interview guide, based on the 12 domains from the TDF, was used to conduct telephone interviews with project leads and physician participants from the intervention sites in the Canadian CT Head Rule trial. Two reviewers independently coded the anonymised interview transcripts using the TDF as a coding framework. Relevant domains were identified by: the presence of conflicting beliefs within a domain; the frequency of beliefs; and the likely strength of the impact of a belief on the behaviour. Results Eight physicians from four of the intervention sites in the Canadian CT Head Rule trial participated in the interviews. Barriers likely to assist with

  1. A family based tailored counselling to increase non-exercise physical activity in adults with a sedentary job and physical activity in their young children: design and methods of a year-long randomized controlled trial

    PubMed Central

    2011-01-01

    for play and practice fundamental of motor skills. The counselling will be reinforced during the first 6 months followed by a 6-month maintenance period. Discussion If shown to be effective, this unique family based intervention to improve lifestyle behaviours in both adults and children can provide translational model for community use. This study can also provide knowledge whether the lifestyle changes are transformed into relevant biomarkers and self-reported health. Trial registration number ISRCTN: ISRCTN28668090 PMID:22185647

  2. Comparison of the benefits of cochlear implantation versus contra-lateral routing of signal hearing aids in adult patients with single-sided deafness: study protocol for a prospective within-subject longitudinal trial

    PubMed Central

    2014-01-01

    Background Individuals with a unilateral severe-to-profound hearing loss, or single-sided deafness, report difficulty with listening in many everyday situations despite having access to well-preserved acoustic hearing in one ear. The standard of care for single-sided deafness available on the UK National Health Service is a contra-lateral routing of signals hearing aid which transfers sounds from the impaired ear to the non-impaired ear. This hearing aid has been found to improve speech understanding in noise when the signal-to-noise ratio is more favourable at the impaired ear than the non-impaired ear. However, the indiscriminate routing of signals to a single ear can have detrimental effects when interfering sounds are located on the side of the impaired ear. Recent published evidence has suggested that cochlear implantation in individuals with a single-sided deafness can restore access to the binaural cues which underpin the ability to localise sounds and segregate speech from other interfering sounds. Methods/Design The current trial was designed to assess the efficacy of cochlear implantation compared to a contra-lateral routing of signals hearing aid in restoring binaural hearing in adults with acquired single-sided deafness. Patients are assessed at baseline and after receiving a contra-lateral routing of signals hearing aid. A cochlear implant is then provided to those patients who do not receive sufficient benefit from the hearing aid. This within-subject longitudinal design reflects the expected care pathway should cochlear implantation be provided for single-sided deafness on the UK National Health Service. The primary endpoints are measures of binaural hearing at baseline, after provision of a contra-lateral routing of signals hearing aid, and after cochlear implantation. Binaural hearing is assessed in terms of the accuracy with which sounds are localised and speech is perceived in background noise. The trial is also designed to measure the impact of

  3. 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

  4. 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. PMID:27178766

  5. Safety and Immunogenicity of a Live Oral Recombinant Cholera Vaccine VA1.4: A Randomized, Placebo Controlled Trial in Healthy Adults in a Cholera Endemic Area in Kolkata, India

    PubMed Central

    Kanungo, Suman; Sen, Bandana; Ramamurthy, Thandavarayan; Sur, Dipika; Manna, Byomkesh; Pazhani, Gururaja P.; Chowdhury, Goutam; Jhunjhunwala, Puja; Nandy, Ranjan K.; Koley, Hemanta; Bhattacharya, Mihir Kumar; Gupta, Sanjay; Goel, Gaurav; Dey, Bindu; M, Thungapathra; Nair, G. Balakrish; Ghosh, Amit; Mahalanabis, Dilip

    2014-01-01

    Background A live oral cholera vaccine VA 1.4 developed from a non-toxigenic Vibrio cholerae O1 El Tor strain using ctxB gene insertion was further developed into a clinical product following cGMP and was evaluated in a double-blind randomized placebo controlled parallel group two arm trial with allocation ratio of 1∶1 for safety and immunogenicity in men and women aged 18–60 years from Kolkata, India. Method A lyophilized dose of 1.9×109 CFU (n = 44) or a placebo (n = 43) reconstituted with a diluent was administered within 5 minutes of drinking 100 ml of a buffer solution made of sodium bicarbonate and ascorbic acid and a second dose on day 14. Result The vaccine did not elicit any diarrhea related adverse events. Other adverse events were rare, mild and similar in two groups. One subject in the vaccine group excreted the vaccine strain on the second day after first dose. The proportion of participants who seroconverted (i.e. had 4-folds or higher rise in reciprocal titre) in the vaccine group were 65.9% (95% CI: 50.1%–79.5%) at both 7 days (i.e. after 1st dose) and 21 days (i.e. after 2nd dose). None of the placebo recipients seroconverted. Anti-cholera toxin antibody was detected in very few recipients of the vaccine. Conclusion This study demonstrates that VA 1.4 at a single dose of 1.9×109 is safe and immunogenic in adults from a cholera endemic region. No additional benefit after two doses was seen. Trial Registration Clinical Trials Registry-India, National Institute of Medical Statistics (Indian Council of Medical Research) CTRI/2012/04/002582 PMID:24983989

  6. 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

  7. 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…

  8. 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...

  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. Effectiveness of a Web-Based, Computer-Tailored, Pedometer-Based Physical Activity Intervention for Adults: A Cluster Randomized Controlled Trial

    PubMed Central

    Vandelanotte, Corneel; Cardon, Greet; De Bourdeaudhuij, Ilse; De Cocker, Katrien

    2015-01-01

    revealed a significant intervention effect for time spent walking in the at-risk sample (P=.02). Intervention effects were still significant 3 months post baseline for participants’ daily step counts in both the total sample (P=.03) and the at-risk sample (P=.02); however, self-reported PA differences were no longer significant. Conclusions A computer-tailored, pedometer-based PA intervention was effective in increasing both pedometer-based and self-reported PA levels, mainly in the at-risk participants. However, more effort should be devoted to recruit and retain participants in order to improve the public health impact of the intervention. Trial Registration ClinicalTrials.gov: NCT02080585; https://clinicaltrials.gov/ct2/show/NCT02080585 (Archived by WebCite at http://www.webcitation.org/6VvQnRQSy). PMID:25665498

  11. Effect of Registration on Cyclical Kinematic Data

    PubMed Central

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

    2010-01-01

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

  12. 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

  13. 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

  14. ‘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

  15. 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

  16. 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

  17. A Phase 1b Randomized, Controlled, Double-Blinded Dosage-Escalation Trial to Evaluate the Safety, Reactogenicity and Immunogenicity of an Adenovirus Type 35 Based Circumsporozoite Malaria Vaccine in Burkinabe Healthy Adults 18 to 45 Years of Age

    PubMed Central

    Ouédraogo, Alphonse; Tiono, Alfred B.; Kargougou, Désiré; Yaro, Jean Baptiste; Ouédraogo, Esperance; Kaboré, Youssouf; Kangoye, David; Bougouma, Edith C.; Gansane, Adama; Henri, Noelie; Diarra, Amidou; Sanon, Souleymane; Soulama, Issiaka; Konate, Amadou T.; Watson, Nora L.; Brown, Valerie; Hendriks, Jenny; Pau, Maria Grazia; Versteege, Isabella; Wiesken, Edison; Sadoff, Jerald; Nebie, Issa; Sirima, Sodiomon B.

    2013-01-01

    Background Ad35.CS.01 is a pre-erythrocytic malaria candidate vaccine. It is a codon optimized nucleotide sequence representing the P. falciparum circumsporozoite (CS) surface antigen inserted in a replication deficient Adenovirus 35 backbone. A Phase 1a trial has been conducted in the USA in naïve adults and showed that the vaccine was safe. The aim of this study is to assess the safety and immunogenicity of ascending dosages in sub Saharan Africa. Methods A double blind, randomized, controlled, dose escalation, phase Ib trial was conducted in a rural area of Balonghin, the Saponé health district (Burkina Faso). Forty-eight healthy adults aged 18-45 years were randomized into 4 cohorts of 12 to receive three vaccine doses (day 0, 28 and 84) of 109, 1010, 5X1010, 1011 vp of Ad35.CS.01 or normal saline by intra muscular injection. Subjects were monitored carefully during the 14 days following each vaccination for non serious adverse events. Severe and serious adverse events were collected throughout the participant study duration (12 months from the first vaccination). Humoral and cellular immune responses were measured on study days 0, 28, 56, 84, 112 and 140. Results Of the forty-eight subjects enrolled, forty-four (91.7%) received all three scheduled vaccine doses. Local reactions, all of mild severity, occurred in thirteen (27.1%) subjects. Severe (grade 3) laboratory abnormalities occurred in five (10.4%) subjects. One serious adverse event was reported and attributed to infection judged unrelated to vaccine. The vaccine induced both antibody titers and CD8 T cells producing IFNγ and TNFα with specificity to CS while eliciting modest neutralizing antibody responses against Ad35. Conclusion Study vaccine Ad35.CS.01 at four different dose levels was well-tolerated and modestly immunogenic in this population. These results suggest that Ad35.CS.01 should be further investigated for preliminary efficacy in human challenge models and as part of heterologous prime

  18. 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

  19. 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.

  20. Interprofessional attitudes and perceptions: Results from a longitudinal controlled trial of pre-registration health and social care students in Scotland.

    PubMed

    McFadyen, A K; Webster, V S; Maclaren, W M; O'neill, M A

    2010-09-01

    This study made use of a controlled longitudinal design to assess the impact on pre-registration health and social care students of an interprofessional intervention on the attitudes to and perceptions of interprofessional ideals. Evaluation, over four years, of Nursing, Occupational Therapy, Podiatry, Prosthetics and Orthotics, Physiotherapy and Radiography students was performed using the adapted versions of the Readiness for Interprofessional Learning Scale (RIPLS) and the Interdisciplinary Education Perception Scale (IEPS). Baseline samples of the control and experimental groups were 260 and 313 respectively. Support for Interprofessional Education (IPE) appears high but possibly idealistically so initially. Restricted Maximum Likelihood (REML) models were used to assess intervention effects as well as any possible profession or time effects. The intervention was found to have had a significant effect on five of the measured sub-scales and the professions were found to react in a significantly different way on four of the sub-scales. The inclusion of a control group has confirmed previous findings from other studies but also highlights the possible effects of the general learning and teaching methodologies employed within various professions as well as the need for research into the influence of the timing, duration, style and content of clinical placement periods. PMID:20218778

  1. 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…

  2. 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

  3. UK DRAFFT: a randomised controlled trial of percutaneous fixation with Kirschner wires versus volar locking-plate fixation in the treatment of adult patients with a dorsally displaced fracture of the distal radius.

    PubMed Central

    Costa, Matthew L; Achten, Juul; Plant, Caroline; Parsons, Nick R; Rangan, Amar; Tubeuf, Sandy; Yu, Ge; Lamb, Sarah E

    2015-01-01

    BACKGROUND In high-income countries, 6% of all women will have sustained a fracture of the wrist (distal radius) by the age of 80 years and 9% by the age of 90 years. Advances in orthopaedic surgery have improved the outcome for patients: many such fractures can be treated in a plaster cast alone, but others require surgical fixation to hold the bone in place while they heal. The existing evidence suggests that modern locking-plate fixation provides improved functional outcomes, but costs more than traditional wire fixation. METHODS In this multicentre trial, we randomly assigned 461 adult patients having surgery for an acute dorsally displaced fracture of the distal radius to either percutaneous Kirschner-wire fixation or locking-plate fixation. The primary outcome measure was the Patient-Rated Wrist Evaluation© (PRWE) questionnaire at 12 months after the fracture. In this surgical trial, neither the patients nor the surgeons could be blind to the intervention. We also collected information on complications and combined costs and quality-adjusted life-years (QALYs) to assess cost-effectiveness. RESULTS The baseline characteristics of the two groups were well balanced and over 90% of patients completed follow-up. Both groups of patients recovered wrist function by 12 months. There was no clinically relevant difference in the PRWE questionnaire score at 3 months, 6 months or 12 months [difference at 12 months: -1.3; 95% confidence interval (CI) -4.5 to 1.8; p=0.398]. There was no difference in the number of complications in each group and small differences in QALY gains (0.008; 95% CI -0.001 to 0.018); Kirschner-wire fixation represents a cost-saving intervention (-£727; 95% CI -£588 to -£865), particularly in younger patients. CONCLUSIONS Contrary to the existing literature, and against the increasing use of locking-plate fixation, this trial shows that there is no difference between Kirschner wires and volar locking plates for patients with dorsally displaced

  4. 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

  5. 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

  6. 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

  7. Targeted plasma metabolome response to variations in dietary glycemic load in a randomized, controlled, crossover feeding trial in healthy adults

    PubMed Central

    Barton, Sally; Navarro, Sandi L.; Buas, Matthew F.; Y, Schwarz; Gu, Haiwei; Djukovic, Danijel; Raftery, Daniel; Kratz, Mario; Neuhouser, Marian L.; Lampe, Johanna W.

    2015-01-01

    Low versus high glycemic load (GL) diet patterns are inversely associated with obesity and chronic diseases such as cancer and cardiovascular disease. These associations persist beyond the protection afforded by increased fiber alone, representing an important gap in our understanding of the metabolic effects of GL. We conducted a randomized, controlled, crossover feeding trial of two 28-day diet periods of high and low GL. Using LC-MS, targeted metabolomics analysis of 155 metabolites was performed on plasma samples from 19 healthy adults aged 18-45 years. Fourteen metabolites differed significantly between diets (P<0.05), with kynurenate remaining significant after Bonferroni correction (P<4×10-4). Metabolites with the largest difference in abundance were kynurenate and trimethylamine-N-oxide (TMAO), both significantly higher after consumption of the low GL diet. Partial least squares-discriminant analysis showed clear separation between the two diets; however no specific pathway was identified in pathway analyses. We found significant differences in 14 plasma metabolites suggesting a differing metabolic response to low and high GL diets. Kynurenate is associated with reduced inflammation, and may be one mechanism through which protective effects of a low GL diet are manifested and warrants further evaluation. This trial was registered at clinicaltrials.gov as NCT00622661. PMID:26165375

  8. Incidence of Pancreatitis in HIV-1–Infected Individuals Enrolled in 20 Adult AIDS Clinical Trials Group Studies

    PubMed Central

    Reisler, Ronald B.; Murphy, Robert L.; Redfield, Robert R.; Parker, Robert A.

    2005-01-01

    Objective To report on the incidence of clinical- and laboratory-defined pancreatitis in HIV-1–infected individuals treated with antiretrovirals (ARVs). Methods Pancreatitis incidence rates were calculated based on a Poisson distribution for subjects enrolled in 1 or more of 20 Adult AIDS Clinical Trials Group studies from October 1989 through July 1999. Results A total of 8451 subjects were enrolled. The overall pancreatitis rates were 0.61 per 100 person-years (PYs) clinical and 2.23 per 100 PYs clinical/laboratory. Pancreatitis rates for single, dual, and triple nucleoside reverse transcriptase inhibitors (NRTIs) were similar. Rates of pancreatitis in didanosine (ddI) arms seemed to be dose dependent. Pancreatitis rates in ddI/hydroxyurea (HU) arms were not significantly different from the rates for ddI alone. Overall pancreatitis rates for ddI/stavudine (d4T) trials were high at 4.16 per 100 PYs clinical and 6.25 per 100 PYs clinical/laboratory. The highest rates were seen with the combination of indinavir (IDV)/ddI/d4Twith or without HU. Conclusions The combination of NRTIs and definition has an impact on the incidence of pancreatitis. Standardization of definition and more comprehensive evaluations are needed to determine how much of this pancreatitis is directly caused by ARVs and how much is attributable to preexisting comorbidities and other known risk factors. PMID:15905731

  9. Targeted plasma metabolome response to variations in dietary glycemic load in a randomized, controlled, crossover feeding trial in healthy adults.

    PubMed

    Barton, Sally; Navarro, Sandi L; Buas, Matthew F; Schwarz, Yvonne; Gu, Haiwei; Djukovic, Danijel; Raftery, Daniel; Kratz, Mario; Neuhouser, Marian L; Lampe, Johanna W

    2015-09-01

    Low versus high glycemic load (GL) diet patterns are inversely associated with obesity and chronic diseases such as cancer and cardiovascular disease. These associations persist beyond the protection afforded by increased fiber alone, representing an important gap in our understanding of the metabolic effects of GL. We conducted a randomized, controlled, crossover feeding trial of two 28-day diet periods of high and low GL. Using LC-MS, targeted metabolomics analysis of 155 metabolites was performed on plasma samples from 19 healthy adults aged 18-45 years. Fourteen metabolites differed significantly between diets (P < 0.05), with kynurenate remaining significant after Bonferroni correction (P < 4 × 10(-4)). Metabolites with the largest difference in abundance were kynurenate and trimethylamine-N-oxide (TMAO), both significantly higher after consumption of the low GL diet. Partial least squares-discriminant analysis showed clear separation between the two diets; however no specific pathway was identified in pathway analyses. We found significant differences in 14 plasma metabolites suggesting a differing metabolic response to low and high GL diets. Kynurenate is associated with reduced inflammation, and may be one mechanism through which protective effects of a low GL diet are manifested and warrants further evaluation. This trial was registered at clinicaltrials.gov as NCT00622661. PMID:26165375

  10. Feldenkrais Method Balance Classes Improve Balance in Older Adults: A Controlled Trial

    PubMed Central

    Connors, Karol A.; Galea, Mary P.; Said, Catherine M.

    2011-01-01

    The objective of this study was to investigate the effects of Feldenkrais Method balance classes on balance and mobility in older adults. This was a prospective non-randomized controlled study with pre/post measures. The setting for this study was the general community. A convenience sample of 26 community-dwelling older adults (median age 75 years) attending Feldenkrais Method balance classes formed the Intervention group. Thirty-seven volunteers were recruited for the Control group (median age 76.5 years). A series of Feldenkrais Method balance classes (the 33312Getting Grounded Gracefully33313 series), two classes per week for 10 weeks, were conducted. Main outcome measures were Activities-Specific Balance Confidence (ABC) questionnaire, Four Square Step Test (FSST), self-selected gait speed (using GAITRite instrumented gait mat). At re-testing, the Intervention group showed significant improvement on all of the measures (ABC, P = .016, FSST, P = .001, gait speed, P < .001). The Control group improved significantly on one measure (FSST, P < .001). Compared to the Control group, the Intervention group made a significant improvement in their ABC score (P = .005), gait speed (P = .017) and FSST time (P = .022). These findings suggest that Feldenkrais Method balance classes may improve mobility and balance in older adults. PMID:19553385

  11. Feldenkrais method balance classes improve balance in older adults: a controlled trial.

    PubMed

    Connors, Karol A; Galea, Mary P; Said, Catherine M

    2011-01-01

    The objective of this study was to investigate the effects of Feldenkrais Method balance classes on balance and mobility in older adults. This was a prospective non-randomized controlled study with pre/post measures. The setting for this study was the general community. A convenience sample of 26 community-dwelling older adults (median age 75 years) attending Feldenkrais Method balance classes formed the Intervention group. Thirty-seven volunteers were recruited for the Control group (median age 76.5 years). A series of Feldenkrais Method balance classes (the 33312Getting Grounded Gracefully33313 series), two classes per week for 10 weeks, were conducted. Main outcome measures were Activities-Specific Balance Confidence (ABC) questionnaire, Four Square Step Test (FSST), self-selected gait speed (using GAITRite instrumented gait mat). At re-testing, the Intervention group showed significant improvement on all of the measures (ABC, P = .016, FSST, P = .001, gait speed, P < .001). The Control group improved significantly on one measure (FSST, P < .001). Compared to the Control group, the Intervention group made a significant improvement in their ABC score (P = .005), gait speed (P = .017) and FSST time (P = .022). These findings suggest that Feldenkrais Method balance classes may improve mobility and balance in older adults. PMID:19553385

  12. Daytime Sleepiness in Adults With ADHD: A Pilot Trial With a Multiple Sleep Latency Test.

    PubMed

    Sobanski, Esther; Alm, Barbara; Hennig, Oliver; Riemann, Dieter; Feige, Bernd; Schredl, Michael

    2014-04-17

    Objective: To evaluate sleep latency (SL) during the multiple sleep latency test (MSLT) and subjective daytime sleepiness in adult ADHD and controls. Method: Subjective daytime sleepiness was assessed by Epworth Sleepiness Scale (ESS) in 27 unmedicated adults with ADHD and in 182 controls. Thirteen ADHD patients and 26 controls underwent MSLT after one night of polysomnography (PSG). Results: Mean MSLT-SL was 10.6 ± 4.8 min in ADHD and 12.2 ± 4.2 min in controls (n.s.). Mean ESS score was 9.3 ± 4.9 points in ADHD and 6.9 ± 3.4 points in controls (p < .005). MSLT-SL and ESS scores correlated inversely by trend (r = -.45, p < .1) but not with ADHD symptoms or ADHD subtype. Conclusion: Adults with ADHD do not differ from controls in mean MSLT-SL but experience increased subjective daytime sleepiness. Patients with subjective higher daytime tiredness fell asleep faster during MSLT. PMID:24743976

  13. Calcium supplementation trials and bone mass development in children, adolescents, and young adults.

    PubMed

    Vatanparast, Hassanali; Whiting, Susan J

    2006-04-01

    The development of bone mass during childhood through young adulthood is an important determinant of bone health later in life, and calcium is the major building block. Most randomized, double-blind, placebo-controlled trials of calcium supplementation have been done in girls; however, calcium supplementation in boys has been investigated in recent studies. Positive short-term effects on bone measures during growth has been shown in boys and girls, particularly in weight-bearing appendicular bone, although the lifelong effect is not certain. PMID:16673756

  14. 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. PMID:3058135

  15. Discrete-Trial Functional Analysis of Problem Behavior and Functional Communication Training in Three Adults with a Dual Diagnosis of a Significant Intellectual Disability and a Mental Illness

    ERIC Educational Resources Information Center

    Chezan, Laura Claudia

    2012-01-01

    I conducted two studies. First, I examined the applicability of discrete-trial functional analysis (DTFA) for identifying the function of problem behavior in three adults with a dual diagnosis of a significant intellectual disability and a mental illness. Results indicated clear patterns of problem behavior for each participant. Second, I used a…

  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. Supplementary feeding with either ready-to-use fortified spread or corn-soy blend in wasted adults starting antiretroviral therapy in Malawi: Randomised, Investigator Blinded, Controlled Trial

    Technology Transfer Automated Retrieval System (TEKTRAN)

    To investigate the effect of two different food supplements on body mass index (BMI) in wasted Malawian adults with HIV who were starting antiretroviral therapy. A randomised, investigator blinded, controlled trial was used in a large, public clinic associated with a referral hospital in Blantyre, M...

  18. 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…

  19. Mebendazole Compared with Secnidazole in the Treatment of Adult Giardiasis: A Randomised, No-Inferiority, Open Clinical Trial

    PubMed Central

    Almirall, Pedro; Escobedo, Angel A.; Ayala, Idalia; Alfonso, Maydel; Salazar, Yohana; Cañete, Roberto; Cimerman, Sergio; Galloso, Martha; Olivero, Ilmaems; Robaina, Maytee; Tornés, Karen

    2011-01-01

    To compare the efficacy and safety of mebendazole and secnidazole in the treatment of giardiasis in adult patients, a single-centre, parallel group, open-label, randomized non-inferiority trial was carried out. One-hundred and 26 participants who had symptomatic Giardia mono-infection took part in the study. Direct wet mount and/or Ritchie concentration techniques and physical examinations were conducted at the time of enrolment and at the follow-up visit. The primary outcome measure was parasitological cure, performed at 3, 5, 10 days post-treatment. Negative faecal specimens for Giardia were ensured by the same parasitological techniques. At follow up (day 10) the parasitological cure rate for the per protocol populations was 88.7% (55/62) for MBZ and 91.8% (56/61) for SNZ. For the intention to treat populations the cure rate at the end of treatment was 85.9% (55/64) for MBZ and 90.3% (56/62) for SNZ. Both analyzes showed there was not significant statistical difference between MBZ and SNZ treatment efficacy. Both drugs were well tolerated, only mild, transient and self-limited side effects were reported and did not require discontinuation of treatment. A 3-day course of mebendazole seems to be as efficacious and safe for treatment of giardiasis as a single dose of secnidazole in adults. PMID:22174992

  20. Mebendazole compared with secnidazole in the treatment of adult giardiasis: a randomised, no-inferiority, open clinical trial.

    PubMed

    Almirall, Pedro; Escobedo, Angel A; Ayala, Idalia; Alfonso, Maydel; Salazar, Yohana; Cañete, Roberto; Cimerman, Sergio; Galloso, Martha; Olivero, Ilmaems; Robaina, Maytee; Tornés, Karen

    2011-01-01

    To compare the efficacy and safety of mebendazole and secnidazole in the treatment of giardiasis in adult patients, a single-centre, parallel group, open-label, randomized non-inferiority trial was carried out. One-hundred and 26 participants who had symptomatic Giardia mono-infection took part in the study. Direct wet mount and/or Ritchie concentration techniques and physical examinations were conducted at the time of enrolment and at the follow-up visit. The primary outcome measure was parasitological cure, performed at 3, 5, 10 days post-treatment. Negative faecal specimens for Giardia were ensured by the same parasitological techniques. At follow up (day 10) the parasitological cure rate for the per protocol populations was 88.7% (55/62) for MBZ and 91.8% (56/61) for SNZ. For the intention to treat populations the cure rate at the end of treatment was 85.9% (55/64) for MBZ and 90.3% (56/62) for SNZ. Both analyzes showed there was not significant statistical difference between MBZ and SNZ treatment efficacy. Both drugs were well tolerated, only mild, transient and self-limited side effects were reported and did not require discontinuation of treatment. A 3-day course of mebendazole seems to be as efficacious and safe for treatment of giardiasis as a single dose of secnidazole in adults. PMID:22174992

  1. 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. PMID:18308788

  2. 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

  3. Relaxation therapy and anxiety, self-esteem, and emotional regulation among adults with intellectual disabilities: A randomized controlled trial.

    PubMed

    Bouvet, Cyrille; Coulet, Aurélie

    2016-09-01

    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 completed 10 sessions of relaxation therapy, and a control group (CG, 15 subjects), who were on a waiting list. The method used is the pretest and posttest. Variables were assessed by the State-Trait Anxiety Inventory form Y scale, the Rosenberg Self-Esteem scale, and the Emotion Regulation Questionnaire. We found that in the RG, relaxation significantly reduced state anxiety, t(14, 15) = 17.8***, d = -0.72, and improved self-esteem, t(14, 15) = -7.7***, d = 1.03, and cognitive reappraisal, t(14, 15) = -6.3***, d = 1.3, while the CG showed no change for these variables. We conclude that relaxation seems to be an interesting therapeutic option for reducing anxiety in people with ID in a supported employment setting. PMID:26420821

  4. 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. PMID:26678470

  5. Recruitment of Minority Adolescents and Young Adults into Randomised Clinical Trials: Testing the Design of the Technology Enhanced Community Health Nursing (TECH-N) Pelvic Inflammatory Disease Trial

    PubMed Central

    Trent, Maria; Chung, Shang-en; Gaydos, Charlotte; Frick, Kevin D.; Anders, Jennifer; Huettner, Steven; Rothman, Richard; Butz, Arlene

    2016-01-01

    Purpose Pelvic inflammatory disease (PID) disproportionately affects adolescent and young adult (AYA) women and can negatively influence reproductive health trajectories. Few randomized controlled trials (RCTs) have focused on strategies to improve outpatient adherence or to reduce reproductive morbidity in this population. This paper describes the research methods and preliminary effectiveness of recruitment, retention, and intervention strategies employed in a novel RCT designed to test a technology-enhanced community-health nursing (TECH-N) intervention among urban AYA with PID. Methods AYA women aged 13–25 years were recruited during acute PID visits in outpatient clinics and emergency departments (ED) to participate in this IRB-approved trial. Participants completed an audio-computerized self-interview (ACASI), provided vaginal specimens, and were randomized to standard treatment or the intervention. Intervention participants received text-messaging support for 30 days and a community health nurse (CHN) interventionist performed a home visit with clinical assessment within 5 days after enrollment. All patients received a full course of medications and completed research visits at 14-days (adherence), 30 days and 90 days with by an outreach worker. STI testing performed at the 30-and 90-day visits. Exploratory analyses using descriptive statistics were conducted to examine recruitment, retention, and follow-up data to test the overall design of the intervention. Results In the first 48 months, 64% of 463 patients were eligible for the study and 81.2% of 293 eligible patients were recruited for the study (63.3%); 238 (81.2%) of eligible patients were enrolled. Most participants were African American (95.6%) with a mean age of 18.6 (2.3). Ninety-four percent of individuals assigned to the TECH-N intervention completed the nursing visits. All completed visits have been within the 5-day window and over 90% of patients in both arms have been retained over the 3

  6. Development of an exercise intervention to improve cognition in people with mild to moderate dementia: Dementia And Physical Activity (DAPA) Trial, registration ISRCTN32612072.

    PubMed

    Brown, Deborah; Spanjers, Katie; Atherton, Nicky; Lowe, Janet; Stonehewer, Louisa; Bridle, Chris; Sheehan, Bart; Lamb, Sarah E

    2015-06-01

    More than 800000 people in the UK have dementia, and it is a government priority to improve dementia care. Drug treatment options are relatively limited. The Dementia And Physical Activity (DAPA) study is a randomised trial which targets cognition in people with dementia, using an exercise programme. There is evidence to suggest that both aerobic and resistance exercise may be useful in improving cognition. Hence the intervention comprises a supervised part of twice-weekly exercise classes of one hour duration for 4 months, including aerobic exercise at moderate intensity on static bicycles, and resistance (weight training) exercise using weight vests, weight belts and dumbbells. Thereafter participants progress to unsupervised, independent exercise. Aids to behaviour modification have been incorporated into the intervention. The DAPA intervention has been designed to maximise likelihood of effectiveness and cost-effectiveness, and for delivery in the UK National Health Service. PMID:25724322

  7. Increasing the number of inter-arch contacts improves mastication in adults with Down syndrome: a prospective controlled trial.

    PubMed

    Hennequin, Martine; Mazille, Marie-Noëlle; Cousson, Pierre-Yves; Nicolas, Emmanuel

    2015-06-01

    Feeding difficulties due to their condition have been widely described for babies, children and adults with Down syndrome (DS). A previous study demonstrated that, compared with wearing a placebo appliance, wearing an occlusal appliance increased inter-arch dental contacts, improved the oral health status of adults with DS and normalised their mandibular rest position. This longitudinal prospective controlled trial aimed to evaluate whether increasing inter-arch contacts in adults with DS would lead to improved masticatory efficiency. Fourteen subjects with DS (mean age±SD: 28.5±9.3years) and twelve controls without DS (24.6±1.0years) were video recorded while chewing samples of carrot and peanuts with and without an oral appliance that was designed to equalise the number of posterior functional units (PFUs) in both groups. Three parameters were collected during mastication for 15cycles and until swallowing: food refusals, food bolus granulometry (D50) and kinematic parameters of the chewing process (number of cycles, chewing duration and cycle frequency within the chewing sequence). In the DS group, increasing the number of PFUs led to a decrease in bolus particle size, to fewer masticatory cycles needed to produce a bolus ready for swallowing and to a decrease in the occurrence of food refusal, while mean chewing frequency did not vary. In the control group, bolus granulometry and chewing time increased with appliance wear while mean chewing frequency decreased. These changes clearly indicate a functional improvement in subjects with DS. This study also demonstrated a causal relationship between the number of functional pairs of posterior teeth and improved mastication. Any evaluation of feeding behaviour in persons with DS should consider inter-arch dental contacts as an explicative variable for feeding problems and their nutritional and respiratory consequences. PMID:25824190

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

    PubMed Central

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

    2013-01-01

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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. The older people, omega-3, and cognitive health (EPOCH) trial design and methodology: A randomised, double-blind, controlled trial investigating the effect of long-chain omega-3 fatty acids on cognitive ageing and wellbeing in cognitively healthy older adults

    PubMed Central

    2011-01-01

    Background Some studies have suggested an association between omega-3 long-chain polyunsaturated fatty acids (n-3 LC PUFAs) and better cognitive outcomes in older adults. To date, only two randomised, controlled trials have assessed the effect of n-3 LC PUFA supplementation on cognitive function in older cognitively healthy populations. Of these trials only one found a benefit, in the subgroup carrying the ApoE-ε4 allele. The benefits of n-3 LC PUFA supplementation on cognitive function in older normal populations thus still remain unclear. The main objective of the current study was to provide a comprehensive assessment of the potential of n-3 LC PUFAs to slow cognitive decline in normal elderly people, and included ApoE-ε4 allele carriage as a potential moderating factor. The detailed methodology of the trial is reported herein. Methods The study was a parallel, 18-month, randomised, double-blind, placebo-controlled intervention with assessment at baseline and repeated 6-monthly. Participants (N = 391, 53.7% female) aged 65-90 years, English-speaking and with normal cognitive function, were recruited from metropolitan Adelaide, South Australia. Participants in the intervention arm received capsules containing fish-oil at a daily dosage of 1720 mg of docosahexaenoic acid and 600 mg of eicosapentaenoic acid while the placebo arm received the equivalent amount of olive oil in their capsules. The primary outcome is rate of change in cognitive performance, as measured by latent variables for the cognitive constructs (encompassing Reasoning, Working Memory, Short-term Memory, Retrieval Fluency, Inhibition, Simple and Choice-Reaction Time, Perceptual Speed, Odd-man-out Reaction Time, Speed of Memory Scanning, and Psychomotor Speed) and assessed by latent growth curve modeling. Secondary outcomes are change in the Mini-mental State Examination, functional capacity and well-being (including health status, depression, mood, and self-report cognitive functioning), blood

  15. Randomized clinical trial for treatment of chronic nightmares in trauma-exposed adults.

    PubMed

    Davis, Joanne L; Wright, David C

    2007-04-01

    Nightmares and sleep disturbance are fundamental concerns for victims of trauma. This study examined the efficacy of a manualized cognitive-behavioral treatment (CBT) for chronic nightmares in trauma-exposed individuals via a randomized clinical trial. Participants were randomly assigned to a treatment group or wait-list control group, with 27 participants completing the treatment. At the 6-month follow-up assessment, 84% of treated participants reported an absence of nightmares in the previous week. Significant decreases were also reported in symptoms of depression and posttraumatic stress, fear of sleep, and number of sleep problems, while sleep quality and quantity improved. The present study adds to the growing literature indicating this brief CBT as a first-line treatment for trauma-exposed individuals with chronic nightmares. PMID:17427914

  16. 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

  17. Structured skills training for adults with ADHD in an outpatient psychiatric context: an open feasibility trial.

    PubMed

    Morgensterns, E; Alfredsson, J; Hirvikoski, T

    2016-06-01

    The aim of the current study was to evaluate the feasibility, acceptability, and effectiveness of Dialectical Behavioral Therapy-based skills training groups for adults with ADHD in an outpatient psychiatric context. Furthermore, the purpose was to analyze the impact of clinical characteristics on the effect and attrition. Ninety-eight adults (out of 102) with ADHD were allocated to the treatment. Self-rating scales were administered as baseline before the first session (T1), post-treatment (T2), and at 3-month follow-up (T3). Approximately 80 % (74 individuals) attended at least two-thirds of the sessions. Treatment satisfaction was good. ADHD symptoms and ADHD-related functional impairment in every-day life were reduced. Well-being, ability to be mindful, acceptance of emotions and quality of life were increased. The results were stable at 3-month follow-up. None of the predictors, i.e., age, comorbidity, ADHD medication status, IQ-level, treatment credibility, or functional impairment at the beginning of treatment, significantly predicted treatment outcome (change in ADHD symptoms from T1 to T2). Likewise, none of the predictors, i.e., irritability/aggression, comorbidity, and functional impairment, were significantly associated with attrition. Due to the difficulties in predicting treatment outcome, as well as attrition, based on clinical characteristics, broad inclusion criteria should be applied. PMID:26410823

  18. Potential cytochrome P-450 drug–drug interactions in adults with metastatic solid tumors and effect on eligibility for Phase I clinical trials

    PubMed Central

    Wisinski, Kari B.; Cantu, Colby A.; Eickhoff, Jens; Osterby, Kurt; Tevaarwerk, Amye J.; Heideman, Jennifer; Liu, Glenn; Wilding, George; Johnston, Susan; Kolesar, Jill M.

    2015-01-01

    Purpose Potential cytochrome P-450 (CYP) drug–drug interactions in adults with metastatic solid tumors and their effect on eligibility for Phase I clinical trials were characterized. Methods This study included adult patients with metastatic solid tumors seen by a medical oncologist from January 2008 through July 2011. The medications used by these patients were identified. Each medication's potential for interacting with CYP isozymes was also characterized. Medication changes required to meet Phase I trial eligibility criteria were also reviewed. Results Data from 1773 patients were analyzed: 1489 were not enrolled in a Phase I trial and 284 were enrolled in a Phase I trial. Polypharmacy was significantly more prevalent in the group enrolled in a Phase I trial compared with those not enrolled (95% versus 80%, p < 0.001). The majority of patients not enrolled in a Phase I trial were taking at least one CYP isozyme inhibitor (87%) and at least one CYP isozyme inducer (45%). In a separate analysis, four Phase I trials were evaluated. Of 295 screened patients, 3.2% could not enroll due to concurrent medications. Charts from 74 enrolled patients revealed 655 concurrent medications—93 medications required further review for eligibility involving 51 (69%) of patients. Of the 93 medications, 38 (41%) were stopped and 41 (44%) were changed for the study. Conclusion Polypharmacy and the use of medications that interact with CYP isoyzmes were common in adult patients with metastatic solid tumors. Patients enrolling in Phase I studies often require medication changes to meet eligibility requirements. PMID:25987691

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

    PubMed Central

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

    2015-01-01

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

  20. 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

  1. Safety and Tolerability of Conserved Region Vaccines Vectored by Plasmid DNA, Simian Adenovirus and Modified Vaccinia Virus Ankara Administered to Human Immunodeficiency Virus Type 1-Uninfected Adults in a Randomized, Single-Blind Phase I Trial

    PubMed Central

    Hayton, Emma-Jo; Rose, Annie; Ibrahimsa, Umar; Del Sorbo, Mariarosaria; Capone, Stefania; Crook, Alison; Black, Antony P.; Dorrell, Lucy; Hanke, Tomáš

    2014-01-01

    Trial Design HIV-1 vaccine development has advanced slowly due to viral antigenic diversity, poor immunogenicity and recently, safety concerns associated with human adenovirus serotype-5 vectors. To tackle HIV-1 variation, we designed a unique T-cell immunogen HIVconsv from functionally conserved regions of the HIV-1 proteome, which were presented to the immune system using a heterologous prime-boost combination of plasmid DNA, a non-replicating simian (chimpanzee) adenovirus ChAdV-63 and a non-replicating poxvirus, modified vaccinia virus Ankara. A block-randomized, single-blind, placebo-controlled phase I trial HIV-CORE 002 administered for the first time candidate HIV-1- vaccines or placebo to 32 healthy HIV-1/2-uninfected adults in Oxford, UK and elicited high frequencies of HIV-1-specific T cells capable of inhibiting HIV-1 replication in vitro. Here, detail safety and tolerability of these vaccines are reported. Methods Local and systemic reactogenicity data were collected using structured interviews and study-specific diary cards. Data on all other adverse events were collected using open questions. Serum neutralizing antibody titres to ChAdV-63 were determined before and after vaccination. Results Two volunteers withdrew for vaccine-unrelated reasons. No vaccine-related serious adverse events or reactions occurred during 190 person-months of follow-up. Local and systemic events after vaccination occurred in 27/32 individuals and most were mild (severity grade 1) and predominantly transient (<48 hours). Myalgia and flu-like symptoms were more strongly associated with MVA than ChAdV63 or DNA vectors and more common in vaccine recipients than in placebo. There were no intercurrent HIV-1 infections during follow-up. 2/24 volunteers had low ChAdV-63-neutralizing titres at baseline and 7 increased their titres to over 200 with a median (range) of 633 (231-1533) post-vaccination, which is of no safety concern. Conclusions These data demonstrate safety and good

  2. 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

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

    PubMed Central

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

    2016-01-01

    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. PMID:27580688

  4. 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

    2016-01-01

    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. PMID:27580688

  5. Clinical trials of an intravenous oxygenator in patients with adult respiratory distress syndrome.

    PubMed

    High, K M; Snider, M T; Richard, R; Russell, G B; Stene, J K; Campbell, D B; Aufiero, T X; Thieme, G A

    1992-11-01

    In patients with severe adult respiratory distress syndrome, mechanical ventilation may not be able to ensure gas exchange sufficient to sustain life. We report the use of an intravenous oxygenator (IVOX) in five patients who were suffering from severe adult respiratory distress syndrome as a result of aspiration, fat embolism, or pneumonia. IVOX was used in an attempt to provide supplemental transfer of CO2 and O2 and thereby reduce O2 toxicity and barotrauma. All patients were tracheally intubated, sedated, and chemically paralyzed and had a PaO2 < 60 mmHg when the lungs were ventilated with an FIO2 = 1.0 and a positive end expiratory pressure of > or = 5 cmH2O. The right common femoral vein was located surgically, and the patient was systemically anticoagulated with heparin. A hollow introducer tube was inserted into the right common femoral vein, and the furled IVOX was passed into the inferior vena cava and advanced until the tip was in the lower portion of the superior vena cava. IVOX use ranged from 2 h to 4 days. In this group of patients, IVOX gas exchange ranged from 21 to 87 ml x min-1 of CO2 and from 28 to 85 ml x min-1 of O2. One of the five patients survived and was discharged from the hospital. The IVOX transferred up to 28% of metabolic gas-exchange requirements. One patient with a small vena cava showed signs of caval obstruction. Three other patients demonstrated signs of a septic syndrome after the device was inserted.(ABSTRACT TRUNCATED AT 250 WORDS) PMID:1443737

  6. Phase II Trial of Oral Aminopterin for Adults and Children with Refractory Acute Leukemia

    PubMed Central

    Cole, Peter D.; Drachtman, Richard A.; Smith, Angela K.; Cate, Sarah; Larson, Richard A.; Hawkins, Douglas S.; Holcenberg, John; Kelly, Kara; Kamen, Barton A.

    2010-01-01

    Purpose To determine the antileukemic activity of weekly oral aminopterin in patients with refractory acute leukemia; to describe the pharmacodynamic properties of aminopterin; and to contrast the intracellular metabolism of aminopterin and methotrexate by patients’ blasts in vitro. Experimental Design Forty-six patients were enrolled in three strata: children with acute lymphoblastic leukemia (ALL), adults with ALL, and patients with acute myeloid leukemia (AML).Aminopterin was given weekly, in two doses of 2mg/m2, 12 hours apart. Limited sampling pharmacokinetic analysis was done during the first week of therapy. Accumulation of [3H]aminopterin and [3H]methotrexate by leukemic blasts was studied in vitro. Results Six of 22 children with ALL (27%; 95% confidence interval, 8–47%) had clinically significant responses. None of those with AML and only two of 11 adults with ALL had responses meeting protocol definitions, although peripheral blast counts tended to decrease with therapy in all groups. Mucosal toxicity was minimal, even with limited use of leucovorin rescue. Complete bioavailability of aminopterin was confirmed, with a mean area under the curve of 0.52 ± 0.03 µmol hour/L after oral dosing. No relationship between aminopterin pharmacokinetics and response was seen. In vitro, aminopterin showed more consistent metabolism by leukemic blasts to polyglutamates than methotrexate. Lineage-specific differences in the pattern of intracellular antifolylpolyglutamates were observed. Conclusions Weekly oral aminopterin has significant activity among children with refractory ALL. With greater cellular accumulation and metabolism, more reliable bioavailability than methotrexate, and tolerable toxicity at this dose and schedule, aminopterin deserves further study as a potent alternative to methotrexate. PMID:16299240

  7. Intensified Adjuvant IFADIC Chemotherapy for Adult Soft Tissue Sarcoma: A Prospective Randomized Feasibility Trial

    PubMed Central

    Brodowicz, Thomas; Schwameis, Eva; Widder, Joachim; Amann, Gabriele; Wiltschke, Christoph; Dominkus, Martin; Windhager, Reinhard; Ritschl, Peter; Pötter, Richard; Kotz, Rainer

    2000-01-01

    Purpose. The present prospective randomized adjuvant trial was carried out to compare the toxicity, feasibility and efficacy of augmented chemotherapy added to hyperfractionated accelerated radiotherapy after wide or marginal resection of grade 2 and grade 3 soft tissue sarcoma (STS). Patients and methods. Fifty-nine patients underwent primary surgery by wide or marginal excision and were subsequently randomized to receive radiotherapy alone or under the addition of six courses of ifosfamide (1500 mg/m2 , days 1–4), dacarbazine (DTIC) (200 mg/m2 , days 1–4) and doxorubicin (25 mg/m2 , days 1–2) administered in 14-day-intervals supported by granulocyte-colony stimulating factor (30 × 106 IU/day, s.c.) on days 5–13. According to the randomization protocol, 28 patients received radiotherapy only, whereas 31 patients were treated with additional chemotherapy. Results. The relative ifosfamide–doxorubicin–DTIC (IFADIC) dose intensity achieved was 93%. After a mean observation period of 41±19.7 months (range, 8.1–84 months), 16 patients (57%) in the control group versus 24 patients (77%) in the chemotherapy group were free of disease (p>0.05).Within the control group, tumor relapses occurred in 12 patients (43%;six patients with distant metastases, two with local relapse, four with both) versus seven patients (23%; five patients with distant metastases, one with local recurrence, one with both) from the chemotherapy group. Relapse-free survival (RFS) (p=0.1), time to local failure (TLF) (p=0.09), time to distant failure (TDF) (p=0.17) as well as overall survival (OS) (p=0.4) did not differ significantly between the two treatment groups. Treatment-related toxicity was generally mild in both treatment arms. Conclusion. We conclude that the safety profile of intensified IFADIC added to radiotherapy was manageable and tolerable in the current setting. Inclusion of intensified IFADIC was not translated into a significant benefit concerning OS, RFS, TLF and

  8. Psychoeducation with problem-solving (PEPS) therapy for adults with personality disorder: a pragmatic randomised controlled trial to determine the clinical effectiveness and cost-effectiveness of a manualised intervention to improve social functioning.

    PubMed Central

    McMurran, Mary; Crawford, Mike J; Reilly, Joe; Delport, Juan; McCrone, Paul; Whitham, Diane; Tan, Wei; Duggan, Conor; Montgomery, Alan A; Williams, Hywel C; Adams, Clive E; Jin, Huajie; Lewis, Matthew; Day, Florence

    2016-01-01

    -to-treat analyses compared individuals as randomised, regardless of treatment received or availability of 72-week follow-up SFQ data. Median attendance at psychoeducation sessions was approximately 90% and for problem-solving sessions was approximately 50%. PEPS therapy plus usual treatment was no more effective than usual treatment alone for the primary outcome [adjusted difference in means for SFQ -0.73 points, 95% confidence interval (CI) -1.83 to 0.38 points; p = 0.19], any of the secondary outcomes or social problem-solving. Over the follow-up, PEPS costs were, on average, £182 less than for usual treatment. It also resulted in 0.0148 more quality-adjusted life-years. Neither difference was statistically significant. At the National Institute for Health and Care Excellence thresholds, the intervention had a 64% likelihood of being the more cost-effective option. More adverse events, mainly incidents of self-harm, occurred in the PEPS arm, but the difference was not significant (adjusted incidence rate ratio 1.24, 95% CI 0.93 to 1.64). LIMITATIONS There was possible bias in adverse event recording because of dependence on self-disclosure or reporting by the clinical team. Non-completion of problem-solving sessions and non-standardisation of usual treatment were limitations. CONCLUSIONS We found no evidence to support the use of PEPS therapy alongside standard care for improving social functioning of adults with personality disorder living in the community. FUTURE WORK We aim to investigate adverse events by accessing centrally held NHS data on deaths and hospitalisation for all PEPS trial participants. TRIAL REGISTRATION Current Controlled Trials ISRCTN70660936. FUNDING This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 52. See the NIHR Journals Library website for further project information. PMID:27431341

  9. Implant-supported mandibular overdentures in very old adults: a randomized controlled trial.

    PubMed

    Müller, F; Duvernay, E; Loup, A; Vazquez, L; Herrmann, F R; Schimmel, M

    2013-12-01

    The purpose of this study was (1) to investigate denture satisfaction following the conversion of existing mandibular complete dentures to implant overdentures (IOD) in very old edentulous patients who depend on help for activities of daily living and (2) to evaluate secondary end points, such as functional, structural, nutritional, and patient-centered aspects. For this randomized clinical trial, 2 interforaminal short implants were placed in the intervention group (n = 16, 85.0 ± 6.19 yrs) to retain mandibular IODs; the control group (n = 18, 84.1 ± 5.55 yrs) received conventional relines. During the first year, no implant was lost; however, 2 patients died. IODs proved more stable, and participants in the intervention group demonstrated significantly higher denture satisfaction as well as an increased oral health-related quality of life compared to the control group. Maximum voluntary bite force improved significantly with IODs, yet the chewing efficiency was not different between groups. Masseter muscle thickness increased with IODs, mainly on the preferred chewing side. Body mass index decreased in both groups, but the decline tended to be smaller in the intervention group; blood markers and the Mini Nutritional Assessment did not confirm this tendency. These results indicate that edentulous patients who depend on help for activities of daily living may benefit from IODs even late in life. PMID:24158342

  10. A phase I randomized, multicenter trial of CPX in adult subjects with mild cystic fibrosis.

    PubMed

    McCarty, Nael A; Standaert, Thomas A; Teresi, Mary; Tuthill, Cynthia; Launspach, Janice; Kelley, Thomas J; Milgram, Laura J H; Hilliard, Kathleen A; Regelmann, Warren E; Weatherly, Mark R; Aitken, Moira L; Konstan, Michael W; Ahrens, Richard C

    2002-02-01

    CPX (8-cyclopentyl-1,3-dipropylxanthine) is a novel compound currently under development as a potential treatment for cystic fibrosis (CF). The drug has been shown to increase chloride efflux and CFTR trafficking in vitro in CF airway cells. This phase I multicenter, single-dose, placebo-controlled trial was performed at four institutions. Thirty-seven subjects homozygous for the Delta F(508) allele were studied in an escalating dose protocol of seven single-dose cohorts (1, 3, 10, 30, 100, 300, and 1,000 mg) to evaluate the safety, pharmacokinetics, and efficacy of CPX. Efficacy was determined using nasal transepithelial potential difference and sweat chloride measurements prior to dosing and at 1, 2, and 4 hr postdose. The incidence of adverse events in the treatment group was similar to that with placebo, indicating safety of the single doses studied. One serious adverse event (an acute pulmonary exacerbation) occurred 13 days after dosing, and was not considered related to the study drug. The maximal plasma CPX concentration and total amount of CPX absorbed appeared to be linearly related to dose, but was highly variable throughout the dose range studied, suggesting inconsistent absorption. There was no apparent effect of single-dose administration on either nasal transepithelial potential difference or sweat chloride measurements. The positive safety and pharmacokinetic findings of this study support continued development of CPX as a potential therapeutic for CF. PMID:11802244

  11. Effect of Fruit Juice on Cholesterol and Blood Pressure in Adults: A Meta-Analysis of 19 Randomized Controlled Trials

    PubMed Central

    Liu, Kai; Xing, Anhui; Chen, Ka; Wang, Bin; Zhou, Rui; Chen, Shihui; Xu, Hongxia; Mi, Mantian

    2013-01-01

    Background The effect of fruit juice on serum cholesterol and blood pressure in humans has generated inconsistent results. We aimed to quantitatively evaluate the effect of fruit juice on serum cholesterol and blood pressure in adults. Methods We performed a strategic literature search of PubMed, EMBASE, and the Cochrane Library (updated to October, 2012) for randomized controlled trials that evaluated the effects of fruit juice on serum cholesterol and blood pressure. Study quality was assessed by using the Jadad scale. Weighted mean differences were calculated for net changes in cholesterol and blood pressure by using fixed-effects model. Prespecified subgroup and sensitivity analyses were conducted to explore the potential heterogeneity. Results Nineteen trials comprising a total of 618 subjects were included in this meta-analysis. Fruit juice consumption borderlinely reduced the diastolic blood pressure (DBP) by 2.07 mm Hg (95% CI: −3.75, −0.39 mm Hg; p = 0.02), but did not show significant effects on total cholesterol (TC), high-density lipoprotein-cholesterol (HDL-C), low-density lipoprotein-cholesterol (LDL-C) concentrations or systolic blood pressure (SBP) values. A significant reduction of TC concentration was observed in low-median intake of total polyphenols group. Subgroup analyses for HDL-C and LDL-C concentrations did not show statistically significant results. No significant heterogeneity was detected for all the measures. Conclusion This meta-analysis suggested that fruit juice had a borderline significant effect on reducing DBP, but had no effect on TC, HDL-C, LDL-C concentrations or SBP. PMID:23637831

  12. 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. PMID:25424512

  13. Outcome measures in intervention trials for adults with autism spectrum disorders; a systematic review of assessments of core autism features and associated emotional and behavioural problems.

    PubMed

    Brugha, Traolach S; Doos, Lucy; Tempier, Althea; Einfeld, Stewart; Howlin, Patricia

    2015-06-01

    A systematic review was conducted of outcome measures used in treatment trials for older adolescents and adults with autism spectrum disorders (ASDs). Of 818 titles only 30 articles (19 of which involved pharmacological treatments) were identified that met inclusion criteria (sample size > 5; mean age of group > 15 years; mean IQ > 30; ASD diagnosis confirmed; use of objective ASD outcome measures; focus on symptoms core to or typically associated with ASDs). Selected studies included randomized and placebo-controlled trials, retrospective assessment studies, case series and open label or case-control trials. Use of outcome measures varied with frequent use of non-standardized assessments, very little use of measures designed specifically for individuals with ASD or of instruments focusing on core ASD deficits, such as communication or social functioning. Most commonly used were the Clinical Global Impression (CGI) rating scale and the Yale-Brown Obsessive Compulsive Scale (Y-BOCS). The strengths or deficiencies of the outcome measures used were not systematically evaluated. Although there are now many well controlled treatment trials for children with ASDs, adult intervention research is very limited. The lack of valid and reliable outcome measures for adults with ASDs compromises attempts at treatment evaluation. PMID:26077193

  14. Evaluation of Mail Registration.

    ERIC Educational Resources Information Center

    San Diego Community Coll. District, CA. Research and Planning.

    The San Diego Community College District (SDCCD) implemented mail registration for all continuing students in spring 1986. In fall 1986, a comprehensive evaluation of the registration system was conducted to assess the impact of mail registration on student enrollment, to determine the impact of mailing class schedules to students' homes, to…

  15. 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. PMID:22804106

  16. 37 CFR 2.133 - Amendment of application or registration during proceedings.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... the Trademark Trial and Appeal Board only in the context of a concurrent use registration proceeding... registration during proceedings. 2.133 Section 2.133 Patents, Trademarks, and Copyrights UNITED STATES PATENT... Partes Proceedings § 2.133 Amendment of application or registration during proceedings. (a)...

  17. 37 CFR 2.133 - Amendment of application or registration during proceedings.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... the Trademark Trial and Appeal Board only in the context of a concurrent use registration proceeding... registration during proceedings. 2.133 Section 2.133 Patents, Trademarks, and Copyrights UNITED STATES PATENT... Partes Proceedings § 2.133 Amendment of application or registration during proceedings. (a)...

  18. 37 CFR 2.133 - Amendment of application or registration during proceedings.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... the Trademark Trial and Appeal Board only in the context of a concurrent use registration proceeding... registration during proceedings. 2.133 Section 2.133 Patents, Trademarks, and Copyrights UNITED STATES PATENT... Partes Proceedings § 2.133 Amendment of application or registration during proceedings. (a)...

  19. 37 CFR 2.133 - Amendment of application or registration during proceedings.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... the Trademark Trial and Appeal Board only in the context of a concurrent use registration proceeding... registration during proceedings. 2.133 Section 2.133 Patents, Trademarks, and Copyrights UNITED STATES PATENT... Partes Proceedings § 2.133 Amendment of application or registration during proceedings. (a)...

  20. 37 CFR 2.133 - Amendment of application or registration during proceedings.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... the Trademark Trial and Appeal Board only in the context of a concurrent use registration proceeding... registration during proceedings. 2.133 Section 2.133 Patents, Trademarks, and Copyrights UNITED STATES PATENT... Partes Proceedings § 2.133 Amendment of application or registration during proceedings. (a)...

  1. Long-Term Treatment Outcome in Adult Male Prisoners With Attention-Deficit/Hyperactivity Disorder: Three-Year Naturalistic Follow-Up of a 52-Week Methylphenidate Trial.

    PubMed

    Ginsberg, Ylva; Långström, Niklas; Larsson, Henrik; Lindefors, Nils

    2015-10-01

    Despite high rates of attention-deficit/hyperactivity disorder (ADHD) among adult lawbreakers, particularly the long-term effects of ADHD pharmacotherapy remain unclear, not the least because of ethical challenges with preventing control subjects in randomized controlled trials from receiving medication over prolonged time. We followed up adult male prisoners with ADHD who completed a 5-week randomized, double-blind, placebo-controlled trial followed by a 47-week open-label extension of osmotic-release oral system methylphenidate in a Swedish high-security prison from 2007 to 2010 (ClinicalTrials.gov: NCT00482313). Twenty-five trial completers were prospectively followed up clinically 1 year (24/25, 96% participated fully or in part) and 3 years (20/25, 80% participation) after trial regarding ADHD symptoms (observer and self-reports), psychosocial functioning, substance misuse, and criminal reoffending. Methylphenidate-related improvements in ADHD symptoms and psychosocial functioning obtained during the 52-week trial were maintained at 1- and 3-year follow-ups. Specifically, after 3 years, 75% (15/20) of the respondents had been released from prison, and 67% of these (10/15) had employment, usually full time. In contrast, nonmedicated respondents at the 3-year follow-up (5/20) reported more ADHD symptoms, functional impairment, and substance misuse compared with currently medicated respondents (15/20). Further, 40% of the respondents self-reported reoffending, indicating a substantially lower relapse rate than expected (70%-80%).In summary, although these observations need validation from new and larger samples, positive effects were maintained after 4 years of methylphenidate treatment. Most study completers were employed and had no relapse in substance misuse or criminality. These results suggest that motivational support and continued medication are important for improved outcome in adult criminal offenders with ADHD. PMID:26284932

  2. Effect of phosphorus supplementation on weight gain and waist circumference of overweight/obese adults: a randomized clinical trial

    PubMed Central

    Ayoub, J J; Samra, M J A; Hlais, S A; Bassil, M S; Obeid, O A

    2015-01-01

    Background: Phosphorus status is inversely correlated with body weight; however, the effect of phosphorus supplementation on body weight in a controlled design has not been studied. Methods: This is a double-blind, randomized, placebo-controlled trial of 63 adults aged 18–45 years with a body mass index (BMI) of ⩾25 kg m−2 and normal kidney function at the American University of Beirut. Participants were randomly assigned to the placebo or phosphorus group where daily placebo or phosphorus supplements were ingested with three main meals (breakfast, lunch and dinner) for a period of 12 weeks. Primary outcomes were changes in anthropometric measures, blood metabolites (including lipid profile, glucose and insulin) and subjective appetite scores. The trial is registered with Clinical Trial.gov, NCT02329990. Results: Body weight was significantly lower in the phosphorus group when compared with the placebo group (−0.65 kg (95% confidence interval (CI) −1.69 to 0.40) vs 1.13 kg (95% CI 0.19 to 2.06), P=0.01). Similarly, BMI and waist circumference were significantly lower in the phosphorus group when compared with the placebo group (−0.24 kg m−2 (95% CI −0.59 to 0.12) vs 0.42 kg m−2 (95% CI 0.05 to 0.78), P=0.01; −3.62 cm (95% CI−4.90 to −2.33) vs 0.38 cm ( 95% CI−0.44 to 1.20), P<0.001; respectively). Several parameters of subjective appetite scores were decreased in the phosphorus-supplemented group. Conclusions: Phosphorus supplementation for 12 weeks significantly decreases body weight, BMI, waist circumference and subjective appetite scores. These findings support a promising role of the mineral phosphorus in the prevention and management of obesity, especially abdominal adiposity. The exact mechanisms of action and longer-term effects still need to be elucidated. PMID:26690287

  3. The causal role of breakfast in energy balance and health: a randomized controlled trial in lean adults1234

    PubMed Central

    Betts, James A; Richardson, Judith D; Chowdhury, Enhad A; Holman, Geoffrey D; Tsintzas, Kostas; Thompson, Dylan

    2014-01-01

    Background: Popular beliefs that breakfast is the most important meal of the day are grounded in cross-sectional observations that link breakfast to health, the causal nature of which remains to be explored under real-life conditions. Objective: The aim was to conduct a randomized controlled trial examining causal links between breakfast habits and all components of energy balance in free-living humans. Design: The Bath Breakfast Project is a randomized controlled trial with repeated-measures at baseline and follow-up in a cohort in southwest England aged 21–60 y with dual-energy X-ray absorptiometry–derived fat mass indexes ≤11 kg/m2 in women (n = 21) and ≤7.5 kg/m2 in men (n = 12). Components of energy balance (resting metabolic rate, physical activity thermogenesis, energy intake) and 24-h glycemic responses were measured under free-living conditions with random allocation to daily breakfast (≥700 kcal before 1100) or extended fasting (0 kcal until 1200) for 6 wk, with baseline and follow-up measures of health markers (eg, hematology/biopsies). Results: Contrary to popular belief, there was no metabolic adaptation to breakfast (eg, resting metabolic rate stable within 11 kcal/d), with limited subsequent suppression of appetite (energy intake remained 539 kcal/d greater than after fasting; 95% CI: 157, 920 kcal/d). Rather, physical activity thermogenesis was markedly higher with breakfast than with fasting (442 kcal/d; 95% CI: 34, 851 kcal/d). Body mass and adiposity did not differ between treatments at baseline or follow-up and neither did adipose tissue glucose uptake or systemic indexes of cardiovascular health. Continuously measured glycemia was more variable during the afternoon and evening with fasting than with breakfast by the final week of the intervention (CV: 3.9%; 95% CI: 0.1%, 7.8%). Conclusions: Daily breakfast is causally linked to higher physical activity thermogenesis in lean adults, with greater overall dietary energy intake but no

  4. The causal role of breakfast in energy balance and health: a randomized controlled trial in obese adults12

    PubMed Central

    Chowdhury, Enhad A; Richardson, Judith D; Holman, Geoffrey D; Tsintzas, Kostas; Thompson, Dylan; Betts, James A

    2016-01-01

    Background: The causal nature of associations between breakfast and health remain unclear in obese individuals. Objective: We sought to conduct a randomized controlled trial to examine causal links between breakfast habits and components of energy balance in free-living obese humans. Design: The Bath Breakfast Project is a randomized controlled trial with repeated measures at baseline and follow-up among a cohort in South West England aged 21–60 y with dual-energy X-ray absorptiometry–derived fat mass indexes of ≥13 kg/m2 for women (n = 15) and ≥9 kg/m2 for men (n = 8). Components of energy balance (resting metabolic rate, physical activity thermogenesis, diet-induced thermogenesis, and energy intake) were measured under free-living conditions with random allocation to daily breakfast (≥700 kcal before 1100) or extended fasting (0 kcal until 1200) for 6 wk, with baseline and follow-up measures of health markers (e.g., hematology/adipose biopsies). Results: Breakfast resulted in greater physical activity thermogenesis during the morning than when fasting during that period (difference: 188 kcal/d; 95% CI: 40, 335) but without any consistent effect on 24-h physical activity thermogenesis (difference: 272 kcal/d; 95% CI: −254, 798). Energy intake was not significantly greater with breakfast than fasting (difference: 338 kcal/d; 95% CI: −313, 988). Body mass increased across both groups over time but with no treatment effects on body composition or any change in resting metabolic rate (stable within 8 kcal/d). Metabolic/cardiovascular health also did not respond to treatments, except for a reduced insulinemic response to an oral-glucose-tolerance test over time with daily breakfast relative to an increase with daily fasting (P = 0.05). Conclusions: In obese adults, daily breakfast leads to greater physical activity during the morning, whereas morning fasting results in partial dietary compensation (i.e., greater energy intake) later in the day. There were

  5. 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

  6. Choroidal thickness profiles in myopic eyes of young adults in the Correction of Myopia Evaluation Trial cohort

    PubMed Central

    Harb, Elise; Hyman, Leslie; Gwiazda, Jane; Marsh-Tootle, Wendy; Zhang, Qinghua; Hou, Wei; Norton, Thomas T; Weise, Katherine; Dirkes, Keri; Zangwill, Linda M

    2015-01-01

    Purpose To examine the relationship of choroidal thickness with axial length (AL) and myopia in young adult eyes in the ethnically diverse Correction of Myopia Evaluation Trial (COMET) cohort. Design Cross-sectional, multi-center, study Methods In addition to measures of myopia by cycloplegic autorefraction and AL by A-scan ultrasonography, participants underwent optical coherence tomography imaging of the choroid (RTVue) in both eyes at their last visit (14 years after baseline). Using digital calipers, two independent readers measured choroidal thickness in the right eye (left eye if poor quality; n=37) at seven locations: fovea and 750, 1500, 2250μm nasal (N) and temporal (T) to the fovea. Results Choroidal thickness measurements were available from 294/346 (85%) of imaged participants (mean age: 24.3±1.4 years; 44.9% male) with mean myopia of -5.3±2.0D and mean AL of 25.5±1.0mm. Overall, choroidal thickness varied by location (p<0.0001) and was thickest at the fovea (273.8±70.9 μm) and thinnest nasally (N2250,191.5±69.3 μm). Multivariable analyses showed significantly thinner choroids in eyes with more myopia and longer AL at all locations except T2250 (p≤0.001) and presence of peri-papillary crescent at all locations except T1500 and T2250 (p≤0.0001). Choroidal thickness varied by ethnicity at N2250 (p<0.0001), with Asians having the thinnest and African Americans the thickest choroids. Conclusion Choroids are thinner in longer, more myopic young adult eyes. The thinning was most prominent nasally and in eyes with a crescent. In the furthest nasal location, ethnicity was associated with choroidal thickness. The findings suggest that choroidal thickness should be evaluated, especially in the nasal regions where myopic degenerations are most commonly seen clinically. PMID:25896460

  7. Randomized sham controlled double-blind trial of repetitive transcranial magnetic stimulation for adults with severe Tourette syndrome

    PubMed Central

    Landeros-Weisenberger, Angeli; Mantovani, Antonio; Motlagh, Maria; de Alvarenga, Pedro Gomes; Katsovich, Liliya; Leckman, James F.; Lisanby, Sarah H.

    2014-01-01

    Background A small proportion of individuals with Tourette syndrome (TS) have a lifelong course of illness that fails to respond to conventional treatments. Open label studies have suggested that low frequency (1-Hz) repetitive transcranial magnetic stimulation (rTMS) targeting the supplementary motor area (SMA) may be effective in reducing tic severity. Objective/Hypothesis To examine the efficacy of rTMS over the SMA for TS in a randomized double-blind sham-controlled trial (RCT). Methods We conducted a two-site RCT-rTMS with 20 adults with severe TS for 3 weeks. Treatment consisted of 15 sessions (1-Hz; 30 min; 1,800 pulses per day) of active or sham rTMS at 110% of the motor threshold over the SMA. A subsequent 3 week course of active rTMS treatment was offered. Results Of the 20 patients (16 males; mean age of 33.7 ± 12.2 years), 9 received active and 11 received sham rTMS. After 3 weeks, patients receiving active rTMS showed on average a 17.3% reduction in the YGTSS total tic score compared to a 13.2% reduction in those receiving sham rTMS, resulting in no statistically significant reduction in tic severity (p=0.27). An additional 3 week open label active treatment for those patients (n = 7) initially randomized to active rTMS resulted in a significant overall 29.7% reduction in tic severity compared to baseline (p=0.04). Conclusion This RCT did not demonstrate efficacy of 3-week SMA-targeted low frequency rTMS in the treatment of severe adult TS. Further studies using longer or alternative stimulation protocols are warranted. PMID:25912296

  8. Effects of Walnuts on Endothelial Function in Overweight Adults with Visceral Obesity: A Randomized, Controlled, Crossover Trial

    PubMed Central

    Katz, David L.; Davidhi, Anna; Ma, Yingying; Kavak, Yasemin; Bifulco, Lauren; Njike, Valentine Yanchou

    2013-01-01

    Objectives Metabolic syndrome is a precursor of diabetes and cardiovascular disease (CVD). Walnut ingestion has been shown to reduce CVD risk indices in diabetes. This randomized controlled crossover trial was performed to investigate the effects of daily walnut consumption on endothelial function and other biomarkers of cardiac risk in a population of overweight individuals with visceral adiposity. Methods Forty-six overweight adults (average age, 57.4 years; 28 women, 18 men) with elevated waist circumference and 1 or more additional signs of metabolic syndrome were randomly assigned to two 8-week sequences of walnut-enriched ad libitum diet and ad libitum diet without walnuts, which were separated by a 4-week washout period. The primary outcome measure was the change in flow-mediated vasodilation (FMD) of the brachial artery. Secondary measures included serum lipid panel, fasting glucose and insulin, Homeostasis Model Assessment–Insulin Resistance values, blood pressure, and anthropometric measures. Results FMD improved significantly from baseline when subjects consumed a walnut-enriched diet as compared with the control diet (1.4% ± 2.4% versus 0.3% ± 1.5%; p = 0.019). Beneficial trends in systolic blood pressure reduction were seen, and maintenance of the baseline anthropometric values was also observed. Other measures were unaltered. Conclusion Daily ingestion of 56 g of walnuts improves endothelial function in overweight adults with visceral adiposity. The addition of walnuts to the diet does not lead to weight gain. Further study of the potential role of walnut intake in diabetes and CVD prevention is warranted. PMID:23756586

  9. 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

  10. Phase 2 trial of erlotinib plus sirolimus in adults with recurrent glioblastoma

    PubMed Central

    Reardon, David A.; Desjardins, Annick; Vredenburgh, James J.; Gururangan, Sridharan; Friedman, Allan H.; Herndon, James E.; Marcello, Jennifer; Norfleet, Julie A.; McLendon, Roger E.; Sampson, John H.; Friedman, Henry S.

    2010-01-01

    We evaluated the anti-tumor activity and safety of erlotinib, a receptor tyrosine kinase inhibitor of the epidermal growth factor receptor, plus sirolimus, an inhibitor of the mammalian target of rapamycin, among patients with recurrent glioblastoma (GBM) in a phase 2, open-label, single-arm trial. Thirty-two patients received daily erlotinib and sirolimus. The doses of erlotinib and sirolimus were 150 mg and 5 mg for patients not on concurrent CYP3A-inducing anti-epileptics (EIAEDS), and 450 mg and 10 mg for patients on EIAEDS. Evaluations were performed every two months. The primary endpoint was 6-month progression-free survival and secondary endpoints included safety and overall survival. Archival tumor samples were assessed for EGFR, EGFRvIII, PTEN, pAKT and pS6. Enrolled patients were heavily pre-treated including 53% who had received three or more prior chemotherapy agents and 28% who had received prior bevacizumab therapy. The most common grade ≥2 adverse events were rash (59%), mucositis (34%) and diarrhea (31%). Grade 3 or higher events were rare. Best radiographic response included stable disease in 15 patients (47%); no patients achieved either a CR or PR. The estimated 6-month progression-free survival was 3.1% for all patients. Progression-free survival was better for patients not on EIAEDs (P = 0.03). Tumor markers failed to show an association with PFS except for increased pAKT expression which achieved borderline significance (P = 0.045). Although neither rash nor diarrhea had an association with outcome, hyperlipidemia was associated with longer PFS (P = 0.029). Erlotinib plus sirolimus was well tolerated but had negligible activity among unselected recurrent GBM patients. PMID:19562254

  11. Clinical trial of focal segmental glomerulosclerosis in children and young adults.

    PubMed

    Gipson, Debbie S; Trachtman, Howard; Kaskel, Frederick J; Greene, Tom H; Radeva, Milena K; Gassman, Jennifer J; Moxey-Mims, Marva M; Hogg, Ronald J; Watkins, Sandra L; Fine, Richard N; Hogan, Susan L; Middleton, John P; Vehaskari, V Matti; Flynn, Patti A; Powell, Leslie M; Vento, Suzanne M; McMahan, June L; Siegel, Norman; D'Agati, Vivette D; Friedman, Aaron L

    2011-10-01

    This NIH-funded multicenter randomized study of focal segmental glomerulosclerosis (FSGS) treatment compared the efficacy of a 12-month course of cyclosporine to a combination of oral pulse dexamethasone and mycophenolate mofetil in children and adults with steroid-resistant primary FSGS. Of the 192 patients enrolled, 138 were randomized to cyclosporine (72) or to mycophenolate/dexamethasone (66). The primary analysis compared the levels of an ordinal variable measuring remission during the first year. The odds ratio (0.59) for achieving at least a partial remission with mycophenolate/dexamethasone compared to cyclosporine was not significant. Partial or complete remission was achieved in 22 mycophenolate/dexamethasone- and 33 cyclosporine-treated patients at 12 months. The main secondary outcome, preservation of remission for 26 weeks following cessation of treatment, was not significantly different between these two therapies. During the entire 78 weeks of study, 8 patients treated with cyclosporine and 7 with mycophenolate/dexamethasone died or developed kidney failure. Thus, our study did not find a difference in rates of proteinuria remission following 12 months of cyclosporine compared to mycophenolate/dexamethasone in patients with steroid-resistant FSGS. However, the small sample size might have prevented detection of a moderate treatment effect. PMID:21734640

  12. Clinical trial of focal segmental glomerulosclerosis in children and young adults

    PubMed Central

    Gipson, Debbie S.; Trachtman, Howard; Kaskel, Frederick J.; Greene, Tom H.; Radeva, Milena K.; Gassman, Jennifer J.; Moxey-Mims, Marva M.; Hogg, Ronald J.; Watkins, Sandra L.; Fine, Richard N.; Hogan, Susan L.; Middleton, John P.; Vehaskari, V. Matti; Flynn, Patti A.; Powell, Leslie M.; Vento, Suzanne M.; McMahan, June L.; Siegel, Norman; D’Agati, Vivette D.; Friedman, Aaron L.

    2012-01-01

    This NIH-funded multicenter randomized study of focal segmental glomerulosclerosis (FSGS) treatment compared the efficacy of a 12-month course of cyclosporine to a combination of oral pulse dexamethasone and mycophenolate mofetil in children and adults with steroid-resistant primary FSGS. Of the 192 patients enrolled, 138 were randomized to cyclosporine (72) or to mycophenolate/dexamethasone (66). The primary analysis compared the levels of an ordinal variable measuring remission during the first year. The odds ratio (0.59) for achieving at least a partial remission with mycophenolate/dexamethasone compared to cyclosporine was not significant. Partial or complete remission was achieved in 22 mycophenolate/dexamethasone- and 33 cyclosporine-treated patients at 12 months. The main secondary outcome, preservation of remission for 26 weeks following cessation of treatment, was not significantly different between these two therapies. During the entire 78 weeks of study, 8 patients treated with cyclosporine and 7 with mycophenolate/dexamethasone died or developed kidney failure. Thus, our study did not find a difference in rates of proteinuria remission following 12 months of cyclosporine compared to mycophenolate/dexamethasone in patients with steroid-resistant FSGS. However, the small sample size might have prevented detection of a moderate treatment effect. PMID:21734640

  13. Exercise volume and aerobic fitness in young adults: the Midwest Exercise Trial-2.

    PubMed

    Schubert, Matthew M; Washburn, Richard A; Honas, Jeffery J; Lee, Jaehoon; Donnelly, Joseph E

    2016-01-01

    To examine the effect of exercise volume at a fixed intensity on changes in aerobic fitness. Ninety-two overweight/obese individuals (BMI 25-40 kg m(2)), age 18-30 years, 50 % women, completed a 10 mo, 5 d wk(-1) supervised exercise intervention at 2 levels of exercise energy expenditure (400 or 600 kcal session(-1)) at 70-80 % heart rate (HR) max. Exercise consisted primarily of walking/jogging on motor-driven treadmills. The duration and intensity of all exercise sessions were verified by a downloadable HR monitor set to collect HR in 1-min epochs. All participants were instructed to continue their typical patterns of non-exercise physical activity and dietary intake over the duration of the 10 mo intervention. Maximal aerobic capacity (indirect calorimetry) was assessed on a motor-driven treadmill using a modified Balke protocol at baseline, mid-point (5 mo), and following completion of the 10 mo intervention. VO2 max (L min(-1)) increased significantly in both the 400 (11.3 %) and 600 kcal session(-1) groups (14 %) compared to control (-2.0 %; p < 0.001); however, the differences between exercise groups were not significant. Similar results were noted for change in relative VO2 max (mL kg(-1) min(-1)); however, the magnitude of change was greater than for absolute VO2 max (L min(-1)) (400 group = 18.3 %; 600 group = 20.2 %) due to loss of body weight over the 10-mo intervention in both exercise groups. Our results indicate that exercise volume was not associated with change in aerobic fitness in a sample of previously sedentary, overweight and obese young adults. PMID:27026879

  14. YOGA IN SEDENTARY ADULTS WITH ARTHRITIS: EFFECTS OF A RANDOMIZED CONTROLLED PRAGMATIC TRIAL

    PubMed Central

    Moonaz, Steffany; Bingham, Clifton O.; Wissow, Lawrence; Bartlett, Susan J.

    2015-01-01

    Objective To evaluate the impact of Integral-based hatha yoga in sedentary people with arthritis. Methods 75 sedentary adults aged 18+ with rheumatoid arthritis (RA) or knee osteoarthritis (OA) were randomly assigned to 8 weeks of yoga (2 60 min classes and 1 home practice/wk) or waitlist. Poses were modified for individual needs. The primary endpoint was physical health (SF36 Physical Component Summary [PCS]) adjusted for baseline; exploratory adjusted outcomes included fitness, mood, stress, self-efficacy, SF36 health-related quality of life (HRQL) and RA disease activity. In everyone completing yoga, we explored long-term effects at 9 months. Results Participants were mostly female (96%), white (55%), and college-educated (51%), with a mean (SD) age of 52 (12). Average disease duration was 9 (9) yrs. and 49% had RA. At 8 weeks, yoga was associated with significantly higher PCS (6.5; 95% CI: 2.0,10.7), walking capacity (125 m; 95% CI:15,235), positive affect (5.2; 95% CI:1.4,8.9) and lower CES-D (−3.0; 95% CI: −4.8,−1.3). Significant (p<.05) improvements were evident in SF36 Role Physical, Pain, General Health, Vitality and Mental Health scales. Balance, grip strength, and flexibility were similar between groups. 22/28 on waitlist completed yoga. Among all yoga participants, significant (p<.05) improvements were observed in mean PCS, flexibility, 6-min walk, all psychological and most HRQL domains at 8 weeks with most still evident 9 months later. Of seven adverse events, none were associated with yoga. Conclusions Preliminary evidence suggests yoga classes may help sedentary individuals with arthritis safely increase physical activity and improve physical and psychological health, and HRQL. PMID:25834206

  15. Physiotherapy informed by Acceptance and Commitment Therapy (PACT): protocol for a randomised controlled trial of PACT versus usual physiotherapy care for adults with chronic low back pain

    PubMed Central

    Godfrey, Emma; Galea Holmes, Melissa; Wileman, Vari; McCracken, Lance; Moss-Morris, Rona; Pallet, John; Sanders, Duncan; Barcellona, Massimo; Critchley, Duncan

    2016-01-01

    Introduction Chronic low back pain (CLBP) is a common condition and source of significant suffering, disability and healthcare costs. Current physiotherapy treatment is moderately effective. Combining theory-based psychological methods with physiotherapy could improve outcomes for people with CLBP. The primary aim of this randomised controlled trial (RCT) is to evaluate the efficacy of Physiotherapy informed by Acceptance and Commitment Therapy (PACT) on functioning in patients with CLBP. Methods and analysis The PACT trial is a two-armed, parallel-group, multicentre RCT to assess the efficacy of PACT in comparison with usual physiotherapy care (UC). 240 patients referred to physiotherapy with CLBP will be recruited from three National Health Service (NHS) hospitals trusts. Inclusion criteria are: age ≥18 years, CLBP ≥12-week duration, scoring ≥3 points on the Roland-Morris Disability Questionnaire (RMDQ) and adequate understanding of spoken and written English to participate. Patients will be randomised to PACT or UC (120 per arm stratified by centre) by an independent randomisation service and followed up at 3 and 12 months post randomisation. The sample size of 240 will provide adequate power to detect a standardised mean difference of 0.40 in the primary outcome (RMDQ; 5% significance, 80% power) assuming attrition of 20%. Analysis will be by intention to treat conducted by the trial statistician, blind to treatment group, following a prespecified analysis plan. Estimates of treatment effect at the follow-up assessments will use an intention-to-treat framework, implemented using a linear mixed-effects model. Ethics and dissemination This trial has full ethical approval (14/SC/0277). It will be disseminated via peer-reviewed publications and conference presentations. The results will enable clinicians, patients and health service managers to make informed decisions regarding the efficacy of PACT for patients with CLBP. Trial registration number ISRCTN

  16. Persistently Elevated Serum Interleukin-6 Predicts Mortality Among Adults Receiving Combination Antiretroviral Therapy in Botswana: Results from a Clinical Trial

    PubMed Central

    McDonald, Bethan; Moyo, Sikhulile; Gabaitiri, Lesego; Gaseitsiwe, Simani; Bussmann, Hermann; Koethe, John R.; Musonda, Rosemary; Makhema, Joseph; Novitsky, Vladimir; Marlink, Richard G.; Wester, C. William

    2013-01-01

    Abstract Elevated serum levels of inflammatory biomarkers have been associated with increased mortality and morbidity among HIV-infected individuals receiving combination antiretroviral therapy (cART) in European and U.S. cohorts. Few similar data are available from sub-Saharan Africa, where most cART-treated adults reside and the prevalence of advanced immunosuppression and opportunistic infections (OIs) at cART initiation is higher. This was a retrospective nested case-control analysis of clinical trial data from the completed Adult Antiretroviral Treatment and Drug Resistance (“Tshepo”) study, 2002–2007, Gaborone, Botswana. We measured pretreatment serum levels of interleukin-6 (IL-6), high sensitivity C-reactive protein, and D-dimer in stored plasma samples from 32 deceased participants (cases) and 64 survivors (controls), matched for age, sex, baseline CD4+ cell count, and plasma HIV-1 RNA. Multivariate conditional logistic regression analyses were used to compare inflammatory biomarker levels, adjusting for pretreatment body mass index (BMI) and the presence of OIs. A total of 37 (5.7%) of 650 patients died on study, for a crude mortality rate of 20.6/1,000 person-years. Of 37 (86%) study participants who died on study 32 were included in this analysis. Causes of death (n=32) included non-AIDS-defining events (31.3%), HIV-related OIs (28.1%), cART/toxicity-related (21.9%), other infectious etiologies (15.6%), and unknown (3.1%). Median time to death was 31 weeks [interquartile range (IQR) 14–64]. Median baseline levels of all three biomarkers were higher in cases compared to matched controls. After adjusting for BMI and the presence of OIs, only baseline and most recent (near time of event) levels of IL-6 remained as significant predictors of all-cause mortality [adjusted OR (aOR)=1.25, 95% CI (1.05–1.48); p=0.012; and aOR=1.48 (1.05–2.09); p=0.027, respectively]. Serum IL-6 levels are important predictors of all-cause mortality in this adult

  17. Phase 1 Clinical Trial of Intratumoral Reovirus Infusion for the Treatment of Recurrent Malignant Gliomas in Adults

    PubMed Central

    Kicielinski, Kimberly P; Chiocca, E Antonio; Yu, John S; Gill, George M; Coffey, Matt; Markert, James M

    2014-01-01

    Reovirus, an oncolytic RNA virus exhibiting antiglioma activity, was shown in a previous single institution phase 1 study found that the inoculation of the virus to be well tolerated in patients with recurrent malignant glioma (MG). The goals of multicenter study reported herein were to determine the dose-limiting toxicity, maximum tolerated dose, and target lesion response rate when reovirus was administered in a novel fashion via intratumoral infusion for 72 hours in patients with recurrent malignant glioma. Fifteen adult patients were treated in a dose escalation study ranging from 1 × 108 to 1 × 1010 tissue culture infectious dose 50, tentimes the dose achieved in the previous trial. Neurological, functional examinations, and imaging studies were completed pre- and postinfusion. There was one grade 3 adverse event (convulsions) felt to be possibly related to treatment, but no grade 4 adverse events considered probably or definitely related to treatment. Dose-limiting toxicity were not identified and a maximum tolerated dose was not reached. Evidence of antiglioma activity was seen in some patients. This first report of intratumoral infusion of reovirus in patients with recurrent malignant glioma demonstrated the approach to be safe and well tolerated, warranting further studies. PMID:24553100

  18. 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. PMID:26773016

  19. Coffee consumption and cystatin-C-based estimated glomerular filtration rates in healthy young adults: results of a clinical trial.

    PubMed

    Saito, Masafumi; Nemoto, Tohru; Tobimatsu, Satoshi; Ebata, Midori; Le, Yulan; Nakajima, Kei

    2011-01-01

    Recently it has been reported that the estimated glomerular filtration rate (eGFR) is higher in habitual coffee consumers than in noncoffee consumers. However, the causality remains unclear. Therefore, we conducted a clinical trial to investigate the effects of coffee consumption on kidney function. Nineteen asymptomatic nonsmokers aged 21-27 years old participated in this study. They consumed coffee (18 g coffee beans/450 mL per day) or green tea as a comparator for 2 weeks in a crossover design. Although creatinine-based eGFR was not affected after consuming either beverage, all cystatin-C-based eGFRs determined using five different equations were significantly increased after coffee consumption (means: 5.0-7.7%), but not after green tea consumption (means: 0.1-1.6%). Serum adiponectin and magnesium levels increased significantly after coffee consumption (means: 13.6% and 4.3%, resp.), but not after green tea consumption. These findings suggest that even a short period of coffee consumption may increase cystatin-C-based eGFR, along with favorable changes in serum adiponectin, in healthy young adults. PMID:21773013

  20. Effects of a Prekindergarten Educational Intervention on Adult Health: 37-Year Follow-Up Results of a Randomized Controlled Trial

    PubMed Central

    Schweinhart, Lawrence; Montie, Jeanne; Neidell, Matthew

    2009-01-01

    Objectives. We used 37 years of follow-up data from a randomized controlled trial to explore the linkage between an early educational intervention and adult health. Methods. We analyzed data from the High/Scope Perry Preschool Program (PPP), an early school-based intervention in which 123 children were randomized to a prekindergarten education group or a control group. In addition to exploring the effects of the program on health behavioral risk factors and health outcomes, we examined the extent to which educational attainment, income, family environment, and health insurance access mediated the relationship between randomization to PPP and behavioral and health outcomes. Results. The PPP led to improvements in educational attainment, health insurance, income, and family environment Improvements in these domains, in turn, lead to improvements in an array of behavioral risk factors and health (P = .01). However, despite these reductions in behavioral risk factors, participants did not exhibit any overall improvement in physical health outcomes by the age of 40 years. Conclusions. Early education reduces health behavioral risk factors by enhancing educational attainment, health insurance coverage, income, and family environments. Further follow-up will be needed to determine the long-term health effects of PPP. PMID:19542034

  1. Results of a Feasibility and Acceptability Trial of an Online Smoking Cessation Program Targeting Young Adult Nondaily Smokers

    PubMed Central

    Berg, Carla J.; Schauer, Gillian L.

    2012-01-01

    Despite increases in nondaily smoking among young adults, no prior research has aimed to develop and test an intervention targeting this group. Thus, we aimed to develop and test the feasibility, acceptability, and potential effectiveness of an online intervention targeting college student nondaily smokers. We conducted a one-arm feasibility and acceptability trial of a four-week online intervention with weekly contacts among 31 college student nondaily smokers. We conducted assessments at baseline (B), end of treatment (EOT), and six-week followup (FU). We maintained a 100% retention rate over the 10-week period. Google Analytics data indicated positive utilization results, and 71.0% were satisfied with the program. There were increases (P < .001) in the number of people refraining from smoking for the past 30 days and reducing their smoking from B to EOT and to FU, with additional individuals reporting being quit despite recent smoking. Participants also increased in their perceptions of how bothersome secondhand smoke is to others (P < .05); however, no other attitudinal variables were altered. Thus, this intervention demonstrated feasibility, acceptability, and potential effectiveness among college-aged nondaily smokers. Additional research is needed to understand how nondaily smokers define cessation, improve measures for cessation, and examine theoretical constructs related to smoking among this population. PMID:22570666

  2. 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. PMID:27043118

  3. 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 families of…

  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. 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

  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. A randomised controlled trial and cost-effectiveness analysis of high-frequency oscillatory ventilation against conventional artificial ventilation for adults with acute respiratory distress syndrome. The OSCAR (OSCillation in ARDS) study.

    PubMed Central

    Lall, Ranjit; Hamilton, Patrick; Young, Duncan; Hulme, Claire; Hall, Peter; Shah, Sanjoy; MacKenzie, Iain; Tunnicliffe, William; Rowan, Kathy; Cuthbertson, Brian; McCabe, Chris; Lamb, Sallie

    2015-01-01

    society per QALY of £88,790 and an ICER for the cost to the NHS per QALY of £ 78,260. CONCLUSIONS The use of HFOV had no effect on 30-day mortality in adult patients undergoing mechanical ventilation for ARDS and no economic advantage. We suggest that further research into avoiding ventilator-induced lung injury should concentrate on ventilatory strategies other than HFOV. TRIAL REGISTRATION Current Controlled Trials ISRCTN10416500. PMID:25800686

  9. A Qualitative Study of Phase III Cancer Clinical Trial Enrollment Decision-Making: Perspectives from Adolescents, Young Adults, Caregivers, and Providers

    PubMed Central

    Schwartz, Lisa A.; Reilly, Anne; Deatrick, Janet A.; Balis, Frank

    2014-01-01

    Purpose: The mortality reduction rate for adolescents and young adults (AYAs) with cancer has not demonstrated the same rate of improvement as for children, due partly to insufficient phase III cancer clinical trial enrollment. This study describes three key components of phase III cancer clinical trial enrollment—family decision-making patterns, factors that influence AYAs' involvement, and attitudes (perceived barriers and benefits) toward trial participation—and evaluated a measure of attitudes. Methods: Participants were AYAs (15–23 years old at study) diagnosed with cancer and offered a phase III cancer clinical trial within the past 3–21 months, their primary caregivers, and their healthcare providers. Interviews assessed: (a) phase III clinical trial decision-making experiences and (b) relevance of the Pediatric Research Participation Questionnaire (PRPQ) in the assessment of AYAs' attitudes toward enrollment on phase III cancer clinical trials. Results: Thirteen AYAs, 16 caregivers, and 11 providers were interviewed. Four decision-making patterns were identified, with AYA abdicates to caregiver and caregiver-based and AYA-endorsed the most commonly described, but with variation across respondents. Distress and reduced health-related quality of life limited AYAs' involvement in the enrollment decision, while developmental and emotional maturity facilitated involvement. Perceived barriers and benefits to enrollment were reported, and the PRPQ was deemed relevant with minor modifications. Conclusions: Findings suggest that AYAs may not be fully involved in phase III cancer clinical trial enrollment decision-making, and caregivers and providers are challenged to overcome factors that limit their involvement. The PRPQ shows promise as a tool for systematically evaluating clinical trial attitudes. PMID:24669354

  10. A Qualitative Study of Phase III Cancer Clinical Trial Enrollment Decision-Making: Perspectives from Adolescents, Young Adults, Caregivers, and Providers.

    PubMed

    Barakat, Lamia P; Schwartz, Lisa A; Reilly, Anne; Deatrick, Janet A; Balis, Frank

    2014-03-01

    Purpose: The mortality reduction rate for adolescents and young adults (AYAs) with cancer has not demonstrated the same rate of improvement as for children, due partly to insufficient phase III cancer clinical trial enrollment. This study describes three key components of phase III cancer clinical trial enrollment-family decision-making patterns, factors that influence AYAs' involvement, and attitudes (perceived barriers and benefits) toward trial participation-and evaluated a measure of attitudes. Methods: Participants were AYAs (15-23 years old at study) diagnosed with cancer and offered a phase III cancer clinical trial within the past 3-21 months, their primary caregivers, and their healthcare providers. Interviews assessed: (a) phase III clinical trial decision-making experiences and (b) relevance of the Pediatric Research Participation Questionnaire (PRPQ) in the assessment of AYAs' attitudes toward enrollment on phase III cancer clinical trials. Results: Thirteen AYAs, 16 caregivers, and 11 providers were interviewed. Four decision-making patterns were identified, with AYA abdicates to caregiver and caregiver-based and AYA-endorsed the most commonly described, but with variation across respondents. Distress and reduced health-related quality of life limited AYAs' involvement in the enrollment decision, while developmental and emotional maturity facilitated involvement. Perceived barriers and benefits to enrollment were reported, and the PRPQ was deemed relevant with minor modifications. Conclusions: Findings suggest that AYAs may not be fully involved in phase III cancer clinical trial enrollment decision-making, and caregivers and providers are challenged to overcome factors that limit their involvement. The PRPQ shows promise as a tool for systematically evaluating clinical trial attitudes. PMID:24669354

  11. 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

  12. Factors that influence the willingness of young adults in Dar es Salaam, Tanzania, to participate in phase I/II HIV vaccine trials

    PubMed Central

    Mbunda, Theodora; Bakari, Muhammad; Tarimo, Edith A. M.; Sandstrom, Eric; Kulane, Asli

    2014-01-01

    Background HIV/AIDS continues to destroy the lives of young people especially in low-income countries. The inclusion of youths in HIV vaccine trials is of utmost importance in obtaining an effective vaccine that is acceptable to them. Objective To characterize the willingness of young adults in Tanzania to participate in an HIV vaccine trial and the factors that influence this willingness. Design Four hundred and fifty young adults who visited a youth-friendly Infectious Diseases Clinic (IDC) from February 2012 to September 2012 completed a self-administered questionnaire concerning sociodemographic information, their knowledge about and perception of HIV vaccine studies, and the availability of social support. Results Of our participants, 50.6% expressed willingness to participate in HIV vaccine trials, and this willingness was positively correlated with having some knowledge about HIV vaccine studies (AOR, 2.2; 95% CI: 1.4–3.4), a positive perception toward such studies (AOR, 2.3; 95% CI: 1.5–3.6), having a relationship with someone who could help them make a decision (AOR, 2.5; 95% CI: 1.3–4.9), and age at the time of sexual debut (AOR, 2.6; 95% CI 1.0–6.7) for 15- to 19-year-olds and (AOR, 2.7; 95% CI 1.0–7.1) for older participants. Conclusions The participants exhibited a moderate willingness to participate in HIV vaccine trials, which was associated with a positive perception of and some knowledge about such trials, having a relationship with someone who might influence their decision as well as age at time of sexual debut. More efforts should be made to inform the youths about specific HIV vaccine trials and related matters, as well as to engage significant others in the decision-making process. PMID:24572007

  13. 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

  14. 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

  15. Randomized, Controlled Trial of a 13-Valent Pneumococcal Conjugate Vaccine Administered Concomitantly with an Influenza Vaccine in Healthy Adults

    PubMed Central

    Gurtman, Alejandra; Rubino, John; Smith, William; van Cleeff, Martin; Jayawardene, Deepthi; Giardina, Peter C.; Emini, Emilio A.; Gruber, William C.; Scott, Daniel A.; Schmöle-Thoma, Beate

    2012-01-01

    A randomized, double-blind, phase 3 trial evaluated the immunogenicity, safety, and tolerability of a 13-valent pneumococcal conjugate vaccine (PCV13) coadministered with trivalent inactivated influenza vaccine (TIV) in pneumococcal vaccine-naive adults. Participants ages 50 to 59 years (n = 1,116) received TIV with PCV13 (group 1) or placebo (group 2) (1:1 randomization); 1 month later, group 1 received placebo and group 2 received PCV13. A hemagglutination inhibition (HAI) assay for TIV and a standardized enzyme-linked immunosorbent assay for pneumococcal serotype-specific immunoglobulin G (IgG) were performed and opsonophagocytic activity (OPA) titers (assessed post hoc) were measured at baseline and 1 and 2 months postvaccination. The rises in HAI assay geometric mean titer (GMT) and percentage of participants in groups 1 and 2 with ≥4-fold increases in HAI responses (A/H1N1, 84.0% and 81.2%, respectively; A/H3N2, 71.1% and 69.5%, respectively; and B, 60.6% and 60.3%, respectively) were similar. In group 1, all serotypes met the predefined IgG geometric mean concentration (GMC) ratio noninferiority criterion relative to group 2, but GMCs were lower in group 1 than group 2. When comparing group 1 with group 2, 5 serotypes did not meet the OPA GMT ratio noninferiority criterion, and OPA GMTs were significantly lower for 10 serotypes. PCV13 injection site reactions were similar and mostly mild in both groups. Systemic events were more frequent in group 1 (86.2%) than group 2 (76.7%; P < 0.001); no vaccine-related serious adverse events occurred. Coadministration of PCV13 and TIV was well tolerated but associated with lower PCV13 antibody responses and is of unknown clinical significance. Given the positive immunologic attributes of PCV13, concomitant administration with TIV should be dictated by clinical circumstances. PMID:22739693

  16. 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

  17. 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

  18. 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

  19. Lisdexamfetamine Dimesylate for Adults with Moderate to Severe Binge Eating Disorder: Results of Two Pivotal Phase 3 Randomized Controlled Trials.

    PubMed

    McElroy, Susan L; Hudson, James; Ferreira-Cornwell, M Celeste; Radewonuk, Jana; Whitaker, Timothy; Gasior, Maria

    2016-04-01

    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

  20. 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

  1. Genetic analysis of adult plant, quantitative resistance to stripe rust in wheat cultivar 'Stephens' in multi-environment trials.

    PubMed

    Dolores Vazquez, M; James Peterson, C; Riera-Lizarazu, Oscar; Chen, Xianming; Heesacker, Adam; Ammar, Karim; Crossa, Jose; Mundt, Christopher C

    2012-01-01

    The wheat (Triticum aestivum L.) cultivar 'Stephens' has been grown commercially in the USA Pacific Northwest for 30 years. The durable resistance of 'Stephens' to stripe rust (Puccinia striiformis f. sp. tritici) was believed to be due to a combination of seedling and adult plant resistance genes. Multilocation field trials, diversity array technology (DArT), and simple sequence repeat (SSR) markers were used to identify quantitative trait loci (QTL) for resistance. Recombinant inbred lines were assessed for stripe rust response in eight locations/years, five in 2008 and three in 2009. The data from Mt. Vernon, WA, differed from all other environments, and composite interval mapping (CIM) identified three QTL, QYrst.orr-1AL, QYrst.orr-4BS, and QYrpl.orr-6AL, which accounted for 12, 11, and 6% of the phenotypic variance, respectively. CIM across the remaining six environments identified four main QTL. Two QTL, QYrst.orr-2BS.2 and QYrst.orr-7AS, were detected in five of six environments and explained 11 and 15% of the phenotypic variance, respectively. Two other QTL, QYrst.orr-2AS and QYrpl.orr-4BL, were detected across four and three of six environments, and explained 19 and 9% of the phenotypic variance, respectively. The susceptible parent 'Platte' contributed QYrpl.orr-4BL and QYrpl.orr-6AL, with the remaining QTL originating from 'Stephens'. For each environment, additional minor QTL were detected, each accounting for 6-10% of the phenotypic variance. Different QTL with moderate effects were identified in both 'Stephens' and 'Platte'. Significant QTL × environment interactions were evident, suggesting that specificity to plant stage, pathogen genotype, and/or temperature was important. PMID:21912857

  2. 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. PMID:25923852

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

    PubMed

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

    2015-12-01

    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 adults with ASD. Using a randomized controlled design, 22 young adults 18-24 years of age were randomly assigned to a treatment (n = 12) or delayed treatment control (n = 10) group. Results revealed that the treatment group improved significantly in overall social skills, frequency of social engagement, and social skills knowledge, and significantly reduced ASD symptoms related to social responsiveness following PEERS. Most treatment gains were maintained at a 16-week follow-up assessment with new improvements observed. PMID:26109247

  4. Demographic and Clinical Characteristics of Middle-Aged versus Younger Adults Enrolled in a Clinical Trial of a Web-Delivered Psychosocial Treatment for Substance Use Disorders

    PubMed Central

    Kalapatapu, Raj K.; Campbell, Aimee; Aharonovich, Efrat; Hu, Mei-Chen; Levin, Frances R.; Nunes, Edward V.

    2012-01-01

    Objective Evidence suggests that substance abuse is becoming more prevalent in middle-aged adults. The objective of this secondary analysis was to add to the growing empirical literature on the unique features of middle-aged substance abuse populations. Methods We descriptively compared baseline demographic and clinical characteristics of middle-aged (age 45–62, n = 111) and younger (age 18–44, n = 395) substance abusers entering a web-based psychosocial treatment study as part of the National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN). Results A significantly greater percentage of middle-aged adults were non-Caucasian and had a marital status other than single/never married. There was a significant association between frequency of Internet use and the age group. Forty-six percent of middle-aged adults versus 21% of younger adults reported no Internet use in the prior 90 days. A significantly greater percentage of middle-aged adults used cocaine, and a significantly greater percentage of younger adults used marijuana and opioids. Clinically significant cognitive impairment (z less than −1.0) was found for the average participant in both groups on logical association of familiar concepts. Conclusions This secondary analysis of a NIDA CTN study provides additional information on the unique features of middle-aged substance abusers. Increasing knowledge of similarities and differences between younger and middle-aged substance abusers can help with potential age-specific substance abuse treatment planning. PMID:23340711

  5. 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.

  6. 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

  7. 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

  8. 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

    Harima-Mizusawa, Naomi; Kamachi, Keiko; Kano, Mitsuyoshi; Nozaki, Daisuke; Uetake, Tatsuo; Yokomizo, Yuji; Nagino, Takayuki; Tanaka, Akira; Miyazaki, Kouji; Nakamura, Shinichiro

    2016-01-01

    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

  9. A trial assessing N-3 as treatment for injury-induced cachexia (ATLANTIC trial): does a moderate dose fish oil intervention improve outcomes in older adults recovering from hip fracture?

    PubMed Central

    2010-01-01

    effective and alternative treatment methods post proximal femoral fracture surgery which may ultimately result in a reduction in systemic inflammation, loss of weight and lean muscle and improvements in nutritional status, mobility, independence and quality of life among elderly patients. Trial Registration ACTRN12609000241235 PMID:20964865

  10. 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…

  11. 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...

  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). PMID:24431901

  13. A Randomized, Open-Label, Multicenter Trial for the Safety and Efficacy of Adult Mesenchymal Stem Cells after Acute Myocardial Infarction

    PubMed Central

    Lee, Jun-Won; 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) PMID:24431901

  14. 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

  15. Voter Registration and Canvassing.

    ERIC Educational Resources Information Center

    Institute for Political/Legal Education, Sewell, NJ.

    Detailed procedures for community voter registration surveys to be conducted by high school students are presented. Methods for organizational structure, selection of canvassing districts, conducting the survey, processing the data, and initiating a registration drive are outlined. Student personnel include a general coordinator, a field staff to…

  16. 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

  17. 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

  18. 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

    2012-01-01

    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

  19. 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

  20. Use of ChAd3-EBO-Z Ebola virus vaccine in Malian and US adults, and boosting of Malian adults with MVA-BN-Filo: a phase 1, single-blind, randomised trial, a phase 1b, open-label and double-blind, dose-escalation trial, and a nested, randomised, double-blind, placebo-controlled trial

    PubMed Central

    Tapia, Milagritos D; Sow, Samba O; Lyke, Kirsten E; Haidara, Fadima Cheick; Diallo, Fatoumata; Doumbia, Moussa; Traore, Awa; Coulibaly, Flanon; Kodio, Mamoudou; Onwuchekwa, Uma; Sztein, Marcelo B; Wahid, Rezwanul; Campbell, James D; Kieny, Marie-Paule; Moorthy, Vasee; Imoukhuede, Egeruan B; Rampling, Tommy; Roman, Francois; De Ryck, Iris; Bellamy, Abbie R; Dally, Len; Mbaya, Olivier Tshiani; Ploquin, Aurélie; Zhou, Yan; Stanley, Daphne A; Bailer, Robert; Koup, Richard A; Roederer, Mario; Ledgerwood, Julie; Hill, Adrian V S; Ballou, W Ripley; Sullivan, Nancy; Graham, Barney; Levine, Myron M

    2016-01-01

    Summary Background The 2014 west African Zaire Ebola virus epidemic prompted worldwide partners to accelerate clinical development of replication-defective chimpanzee adenovirus 3 vector vaccine expressing Zaire Ebola virus glycoprotein (ChAd3-EBO-Z). We aimed to investigate the safety, tolerability, and immunogenicity of ChAd3-EBO-Z in Malian and US adults, and assess the effect of boosting of Malians with modified vaccinia Ankara expressing Zaire Ebola virus glycoprotein and other filovirus antigens (MVA-BN-Filo). Methods In the phase 1, single-blind, randomised trial of ChAd3-EBO-Z in the USA, we recruited adults aged 18–65 years from the University of Maryland medical community and the Baltimore community. In the phase 1b, open-label and double-blind, dose-escalation trial of ChAd3-EBO-Z in Mali, we recruited adults 18–50 years of age from six hospitals and health centres in Bamako (Mali), some of whom were also eligible for a nested, randomised, double-blind, placebo-controlled trial of MVA-BN-Filo. For randomised segments of the Malian trial and for the US trial, we randomly allocated participants (1:1; block size of six [Malian] or four [US]; ARB produced computer-generated randomisation lists; clinical staff did randomisation) to different single doses of intramuscular immunisation with ChAd3-EBO-Z: Malians received 1 × 1010 viral particle units (pu), 2·5 × 1010 pu, 5 × 1010 pu, or 1 × 1011 pu; US participants received 1 × 1010 pu or 1 × 1011 pu. We randomly allocated Malians in the nested trial (1:1) to receive a single dose of 2 × 108 plaque-forming units of MVA-BN-Filo or saline placebo. In the double-blind segments of the Malian trial, investigators, clinical staff, participants, and immunology laboratory staff were masked, but the study pharmacist (MK), vaccine administrator, and study statistician (ARB) were unmasked. In the US trial, investigators were not masked, but participants were. Analyses were per

  1. Drug evaluation and registration in Hungary.

    PubMed

    Paál, T L; Káldor, A; Fäller, K

    1988-02-01

    In Hungary, the actual drug evaluation and registration system reflects international standards and national traditions. The compulsory drug registration system that was established in 1933 was among the first in Europe. Laboratory control (since 1927), clinical trials (since 1951) and human clinical pharmaceutical experiments (since 1967) are prerequisites for new-drug approval. Applications should be sent to the National Institute of Pharmacy, which has the overall responsibility for the registration of pharmaceutical products. Applications are assessed on the basis of the drug's quality, safety, and efficacy. The procedure follows several steps: evaluation of chemical and pharmaceutical data by the staff of the National Institute of Pharmacy; evaluation of toxicologic and pharmacologic documentation with the help of the Committee on Drug Administration; after consultation with the Committee on Medical Research Ethics (mandatory in cases of original new drugs), authorized clinical pharmacologic investigations are conducted in the units of the Clinical Pharmacological Network, which are supervised by the National Center for Clinical Pharmacology; clinical trials; application for registration (scientific evaluation); and finally, application to the Ministry of Health for a marketing authorization. The process may be facilitated appreciably for preparations already registered in another country. Moreover, Hungary is an active member in the World Health Organization (WHO), Pharmaceutical Inspection Convention of the European Free Trade Association (EFTA PIC), the Council of Mutual Economic Assistance (COMECON), and other international pharmaceutical and clinical pharmaceutical collaborations. PMID:3360964

  2. 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

  3. 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

  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. 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

  7. Talking health, a pragmatic randomized-controlled health literacy trial targeting sugar-sweetened beverage consumption among adults: rationale, design & methods.

    PubMed

    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 oz 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

  8. 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. PMID:27283096

  9. 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

  10. 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

  11. The Effect of Early Goal-Directed Therapy on Outcome in Adult Severe Sepsis and Septic Shock Patients: A Meta-Analysis of Randomized Clinical Trials

    PubMed Central

    Xu, Jing-Yuan; Chen, Qi-Hong; Liu, Song-Qiao; Pan, Chun; Xu, Xiu-Ping; Han, Ji-Bin; Xie, Jian-Feng; Huang, Ying-Zi; Guo, Feng-Mei; Yang, Yi

    2016-01-01

    BACKGROUND: Whether early goal-directed therapy (EGDT) improves outcome in severe sepsis and septic shock remains unclear. We performed a meta-analysis of existing clinical trials to examine whether EGDT improved outcome in the resuscitation of adult sepsis patients compared with control care. METHODS: We searched for eligible studies using MEDLINE, Elsevier, Cochrane Central Register of Controlled Trials, and Web of Science databases. Studies were eligible if they compared the effects of EGDT versus control care on mortality in adult patients with severe sepsis and septic shock. Two reviewers extracted data independently. Data including mortality, sample size of the patients with severe sepsis and septic shock, and resuscitation end points were extracted. Data were analyzed using methods recommended by the Cochrane Collaboration Review Manager 4.2 software. Random errors were evaluated by trial sequential analysis (TSA). RESULTS: Nine studies compared EGDT with control care, and 5202 severe sepsis and septic shock patients were included. A nonsignificant trend toward reduction in the longest all-cause mortality was observed in the EGDT group compared with control care (relative risk, 0.89; 99% confidence interval, 0.74–1.07; P = 0.10). However, EGDT significantly reduced intensive care unit mortality in severe sepsis and septic shock patients (relative risk, 0.72; 99% confidence interval, 0.57–0.90; P = 0.0002). TSA indicated lack of firm evidence for a beneficial effect. CONCLUSIONS: In this meta-analysis, a nonsignificant trend toward reduction in the longest all-cause mortality in patients resuscitated with EGDT was noted. However, EGDT significantly reduced intensive care unit mortality in severe sepsis and septic shock patients. TSA indicated a lack of firm evidence for the results. More powered, randomized controlled trials are needed to determine the effects. PMID:27049857

  12. 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

  13. 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. PMID:25704503

  14. Smartphone app speeds registration.

    PubMed

    2011-03-01

    Two Denver area EDs have entered the digital world with the use of a mobile application that allows patients to pre-register before coming to the ED. Patients can use their smart phones to determine if they need to go to the ED and which one is closest. The ED registration desk receives the pre-registration form, which provides basic information, via fax. Once the information is received, registration notifies the charge nurse so the ED can prepare to receive the patient. PMID:21449510

  15. 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

  16. A Randomized Trial to Measure the Impact of a Community-Based Cognitive Training Intervention on Balance and Gait in Cognitively Intact Black Older Adults

    PubMed Central

    Smith-Ray, Renae L.; Makowski-Woidan, Beth; Hughes, Susan L.

    2015-01-01

    Introduction Fall prevention is important for maintaining mobility and independence into old age. Approaches for reducing falls include exercise, tai chi, and home modifications; however, causes of falling are multifactorial and include not just physical but cognitive factors. Cognitive decline occurs with age, but older adults with the greatest declines in executive function experience more falls. The purpose of this study was twofold: to demonstrate the feasibility of a community-based cognitive training program for cognitively intact Black older adults and to analyze its impact on gait and balance in this population. Method This pilot study used a pretest/posttest randomized trial design with assignment to an intervention or control group. Participants assigned to the intervention completed a computer-based cognitive training class that met 2 days a week for 60 min over 10 weeks. Classes were held at senior/community centers. Primary outcomes included balance as measured by the Berg Balance Scale (BBS), 10-meter gait speed, and 10-meter gait speed under visuospatial dual-task condition. All measures were assessed at baseline and immediately post-intervention. Results Participants were community-dwelling Black adults with a mean age of 72.5 and history of falls (N = 45). Compared to controls, intervention participants experienced statistically significant improvements in BBS and gait speed. Mean performance on distracted gait speed also improved more for intervention participants compared to controls. Conclusion Findings from this pilot randomized trial demonstrate the feasibility of a community-based cognitive training intervention. They provide initial evidence that cognitive training may be an efficacious approach toward improving balance and gait in older adults known to have a history of falls. PMID:25274713

  17. A double blind, randomised controlled trial of glycerol adjuvant therapy in adult bacterial meningitis in a high HIV seroprevalence setting in Malawi

    PubMed Central

    Ajdukiewicz, Katherine M.B.; Cartwright, Katharine E.; Scarborough, Matthew; Mwambene, James B.; Goodson, Patrick; Molyneux, Malcolm E.; Zijlstra, Eduard E.; French, Neil; Whitty, Christopher J.M.; Lalloo, David G.

    2014-01-01

    Summary Background Southern Africa has a high incidence of bacterial meningitis in adults, often associated with HIV co-infection. Even with appropriate antibiotic therapy, mortality exceeds 50% and is not improved with corticosteroids. Glycerol adjuvant therapy reduced mortality and long-term morbidity (deafness) in bacterial meningitis in children and is being promoted. If similarly effective in adults, glycerol would provide a cheap, available adjuvant therapy in Africa. Methods Following a dose-finding study, we conducted a randomised double-blind placebo-controlled trial of oral glycerol in adults with bacterial meningitis. Patients with clinical and CSF findings suggestive of bacterial meningitis were randomised either to glycerol or an equivalent volume of sugar solution. The primary outcome was mortality at 40 days with secondary outcomes including disability and mortality restricted to pneumococcal disease. Findings 75ml glycerol QDS was best tolerated and was used for the main study. 265 patients were randomised to receive glycerol or placebo. The trial was stopped early on the advice of the Data and Safety Monitoring Board (DSMB) following a planned interim analysis. Mortality by day 40 was 61/125 (49%) in the placebo and 86/136 (69%) in the glycerol arms, Adjusted Odds Ratio 2·4 (95% CI 1·3-4·2 p0·003). There was no benefit from glycerol for death and disability by day 40 by intention to treat or in predefined subgroups. Two serious adverse events occurred possibly due to study drug. Interpretation Oral glycerol therapy did not improve mortality in adults with bacterial meningitis and cannot be recommended as a suitable adjuvant therapy in resource-poor settings with a high HIV prevalence. PMID:21334262

  18. An inactivated Ross River virus vaccine is well tolerated and immunogenic in an adult population in a randomized phase 3 trial.

    PubMed

    Wressnigg, Nina; 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

    2015-03-01

    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

  19. 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…

  20. 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...

  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, 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...

  3. 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...

  4. 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...

  5. An Internet Intervention to Improve Asthma Management: Rationale and Protocol of a Randomized Controlled Trial

    PubMed Central

    Lau, Annie YS; Dennis, Sarah; Liaw, Siaw-Teng; Coiera, Enrico

    2013-01-01

    Background Many studies have shown the effectiveness of self-management for patients with asthma. In particular, possession and use of a written asthma action plan provided by a doctor has shown to significantly improve patients’ asthma control. Yet, uptake of a written asthma action plan and preventative asthma management is low in the community, especially amongst adults. Objective A Web-based personally controlled health management system (PCHMS) called Healthy.me will be evaluated in a 2010 CONSORT-compliant 2-group (static websites verse PCHMS) parallel randomized controlled trial (RCT) (allocation ratio 1:1). Methods The PCHMS integrates an untethered personal health record with consumer care pathways and social forums. After eligibility assessment, a sample of 300 adult patients with moderate persistent asthma will be randomly assigned to one of these arms. After 12 months of using either Healthy.me or information websites (usual care arm), a post-study assessment will be conducted. Results The primary outcome measure is possession of or revision of an asthma action plan during the study. Secondary outcome measures include: (1) adherence to the asthma action plan, (2) rate of planned and unplanned visits to healthcare providers for asthma issues, (3) usage patterns of Healthy.me and attrition rates, (4) asthma control and asthma exacerbation scores, and (5) impact of asthma on life and competing demands, and days lost from work. Conclusions This RCT will provide insights into whether access to an online PCHMS will improve uptake of a written asthma action plan and preventative asthma actions. Trial Registration Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12612000716864; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=362714 (Archived by WebCite at http://www.webcitation.org/6IYBJGRnW). PMID:23942523

  6. SULFUR PESTICIDE REGISTRATION STANDARD

    EPA Science Inventory

    The document contains information regarding reregistration of pesticide products containing the subject active ingredient. The document includes how to register under a registration standard, regulatory position and rationale, and summaries of data requirements and data gaps. Als...

  7. 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

  8. Improved motor and cognitive performance with sodium nitrite supplementation is related to small metabolite signatures: a pilot trial in middle-aged and older adults

    PubMed Central

    DeVan, Allison E.; Cruickshank-Quinn, Charmion; Reisdorph, Nichole; Bassett, Candace J.; Evans, Trent D.; Brooks, Forrest A.; Bryan, Nathan S.; Chonchol, Michel B.; Giordano, Tony; McQueen, Matthew B.; Seals, Douglas R.

    2015-01-01

    Advancing age is associated with reductions in nitric oxide bioavailability and changes in metabolic activity, which are implicated in declines in motor and cognitive function. In preclinical models, sodium nitrite supplementation (SN) increases plasma nitrite and improves motor function, whereas other nitric oxide-boosting agents improve cognitive function. This pilot study was designed to translate these findings to middle-aged and older (MA/O) humans to provide proof-of-concept support for larger trials. SN (10 weeks, 80 or 160 mg/day capsules, TheraVasc, Inc.) acutely and chronically increased plasma nitrite and improved performance on measures of motor and cognitive outcomes (all p<0.05 or better) in healthy MA/O adults (62 ± 7 years). Untargeted metabolomics analysis revealed that SN significantly altered 33 (160 mg/day) to 45 (80 mg/day) different metabolites, 13 of which were related to changes in functional outcomes; baseline concentrations of 99 different metabolites predicted functional improvements with SN. This pilot study provides the first evidence that SN improves aspects of motor and cognitive function in healthy MA/O adults, and that these improvements are associated with, and predicted by, the plasma metabolome. Our findings provide the necessary support for larger clinical trials on this promising pharmacological strategy for preserving physiological function with aging. PMID:26626856

  9. Improved motor and cognitive performance with sodium nitrite supplementation is related to small metabolite signatures: a pilot trial in middle-aged and older adults.

    PubMed

    Justice, Jamie N; Johnson, Lawrence C; DeVan, Allison E; Cruickshank-Quinn, Charmion; Reisdorph, Nichole; Bassett, Candace J; Evans, Trent D; Brooks, Forrest A; Bryan, Nathan S; Chonchol, Michel B; Giordano, Tony; McQueen, Matthew B; Seals, Douglas R

    2015-11-01

    Advancing age is associated with reductions in nitric oxide bioavailability and changes in metabolic activity, which are implicated in declines in motor and cognitive function. In preclinical models, sodium nitrite supplementation (SN) increases plasma nitrite and improves motor function, whereas other nitric oxide-boosting agents improve cognitive function. This pilot study was designed to translate these findings to middle-aged and older (MA/O) humans to provide proof-of-concept support for larger trials. SN (10 weeks, 80 to 160 mg/day capsules, TheraVasc, Inc.) acutely and chronically increased plasma nitrite and improved performance on measures of motor and cognitive outcomes (all p<0.05 or better) in healthy MA/O adults (62 ± 7 years). Untargeted metabolomics analysis revealed that SN significantly altered 33 (160 mg/day) to 45 (80 mg/day) different metabolites, 13 of which were related to changes in functional outcomes; baseline concentrations of 99 different metabolites predicted functional improvements with SN. This pilot study provides the first evidence that SN improves aspects of motor and cognitive function in healthy MA/O adults, and that these improvements are associated with, and predicted by, the plasma metabolome. Our findings provide the necessary support for larger clinical trials on this promising pharmacological strategy for preserving physiological function with aging. PMID:26626856

  10. A Randomized Controlled Trial of Personalized Text Message Reminders to Promote Medication Adherence Among HIV-Positive Adolescents and Young Adults.

    PubMed

    Garofalo, Robert; Kuhns, Lisa M; Hotton, Anna; Johnson, Amy; Muldoon, Abigail; Rice, Dion

    2016-05-01

    HIV-positive adolescents and young adults often experience suboptimal medication adherence, yet few interventions to improve adherence in this group have shown evidence of efficacy. We conducted a randomized trial of a two-way, personalized daily text messaging intervention to improve adherence to antiretroviral therapy (ART) among N = 105 poorly adherent HIV-positive adolescents and young adults, ages 16-29. Adherence to ART was assessed via self-reported visual analogue scale (VAS; 0-100 %) at 3 and 6-months for mean adherence level and proportion ≥90 % adherent. The average effect estimate over the 6-month intervention period was significant for ≥90 % adherence (OR = 2.12, 95 % CI 1.01-4.45, p < .05) and maintained at 12-months (6 months post-intervention). Satisfaction scores for the intervention were very high. These results suggest both feasibility and initial efficacy of this approach. Given study limitations, additional testing of this intervention as part of a larger clinical trial with objective and/or clinical outcome measures of adherence is warranted. PMID:26362167

  11. 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

  12. The effects of n-3 long-chain polyunsaturated fatty acid supplementation on biomarkers of kidney injury in adults with diabetes: results of the GO-FISH trial.

    PubMed

    Miller, Edgar R; Juraschek, Stephen P; Anderson, Cheryl A; Guallar, Eliseo; Henoch-Ryugo, Karen; Charleston, Jeanne; Turban, Sharon; Bennett, Michael R; Appel, Lawrence J

    2013-06-01

    OBJECTIVE Long-chain n-3 polyunsaturated fatty acid (n-3 PUFA) supplements may have renoprotective effects in patients with diabetes, but previous trials have been inconsistent. We performed a randomized controlled trial of n-3 PUFA supplementation on urine albumin excretion and markers of kidney injury in adults with type 2 diabetes. RESEARCH DESIGN AND METHODS We conducted a randomized, placebo-controlled, two-period crossover trial to test the effects of 4 g/day of n-3 PUFA supplementation on markers of glomerular filtration and kidney injury in adults with adult-onset diabetes and greater than or equal to trace amounts of proteinuria. Each period lasted 6 weeks and was separated by a 2-week washout. The main outcome was urine albumin excretion and, secondarily, markers of kidney injury (kidney injury molecule-1, N-acetyl β-d-glucosaminidase [NAG], neutrophil gelatinase-associated lipocalin [NGAL], and liver fatty acid-binding protein [LFABP]), serum markers of kidney function (cystatin C, β2-microglobulin, and creatinine), and estimated glomerular filtration rate (eGFR). RESULTS Of the 31 participants, 29 finished both periods. A total of 55% were male, and 61% were African American; mean age was 67 years. At baseline, mean BMI was 31.6 kg/m(2), median eGFR was 76.9 mL/min/1.73 m(2), and median 24-h urine albumin excretion was 161 mg/day. Compared with placebo, n-3 PUFA had nonsignificant effects on urine albumin excretion (-7.2%; 95% CI -20.6 to 8.5; P = 0.35) and significant effects on urine NGAL excretion (-16% [-29.1 to -0.5%]; P = 0.04). There was no effect on serum markers of kidney function or eGFR. In subgroup analyses, there were significant decreases in 24-h urinary excretion of albumin, NGAL, LFABP, and NAG among participants taking medications that block the renin-angiotensin-aldosterone system (RAAS). CONCLUSIONS These results suggest a potential effect of n-3 PUFA supplementation on markers of kidney injury in patients with diabetes and early

  13. 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

  14. Automatic parameter selection for multimodal image registration.

    PubMed

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

    2010-05-01

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

  15. The Addition of Gemtuzumab Ozogamicin to Induction Chemotherapy in Acute Myeloid Leukaemia : An IndividualPatient Data Meta-analysis of Randomised Trials in Adults

    PubMed Central

    Hills, Robert K; Castaigne, Sylvie; Appelbaum, Frederick R; Delaunay, Jacques; Petersdorf, Stephen; Othus, Megan; MD, Elihu H Estey; Dombret, Hervé; Chevret, Sylvie; Ifrah, Norbert; Cahn, Jean-Yves; Récher, Christian; Chilton, Lucy; Moorman, Anthony V; Burnett, Alan K

    2014-01-01

    Summary Background Gemtuzumab Ozogamicin (GO) was the first example of antibody directed chemotherapy in cancer and developed for Acute Myeloid Leukaemia. Its role has been unclear. Five randomised trials where it was combined with standard induction chemotherapy in adults have produced different results. In an effort to clarify the level of benefit, if any, and in which patients outcomes might be improved, an individual patient data meta-analysis of these 5 trials has been undertaken. Methods All randomised trials of GO in adults (age >15), given in conjunction with the first course of intensive induction chemotherapy for AML (excluding APL) were identified. In a collaboration between the groups involved, source data concerning demographics, treatment was requested in May 2013 and collected in 3325 randomised patients (median age 58). All trials were centrally randomised and open-label, with survival as primary endpoint. Analyses are presented by standard techniques, and within standardised risk groups Results Remission rates were not increased, but by significantly reducing the risk of relapse overall survival at 5 years was improved irrespective of patient age (30.7% vs 34.6%; HR 0.90 (95% CI 0.82-0.98), p=0.01). The survival benefit was particularly clear in those with favourable cytogenetics (55.2% vs 76.3%; HR0.47 (0.31-0.73), p=0.0005), but also observed in intermediate risk patients (34.1% vs 39.4%; HR 0.84 (0.75-0.95), p=0.007) Patients with adverse karyotype did not benefit overall or within any trial. Dose levels of 3mg/m2 were associated with less toxicity and equal efficacy. Interpretation GO can be safely added to conventional induction therapy. For patients who do not have adverse cytogenetics there is a significant survival benefit. These data suggest that the use of GO should be re-evaluated and the license status of GO may need to be reviewed. Role of funding source There was no funder for this meta-analysis. PMID:25008258

  16. 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. PMID:24863143

  17. 14 CFR 47.15 - Registration number.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

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

  18. 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,...

  19. 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,...

  20. Immunogenicity and safety results from a randomized multicenter trial comparing a Tdap-IPV vaccine (REPEVAX®) and a tetanus monovalent vaccine in healthy adults

    PubMed Central

    Laurichesse, Henri; Zimmermann, Ulrich; Galtier, Florence; Launay, Odile; Duval, Xavier; Richard, Patrick; Sadorge, Christine; Soubeyrand, Benoit

    2012-01-01

    In adults with a tetanus-prone injury, combined vaccines such as Tdap-IPV (REPEVAX®) can boost immunity against several diseases simultaneously. This Phase IIIb, parallel-group, open-label trial compared antibody responses to Tdap-IPV and tetanus monovalent vaccine (TMV; Vaccin Tétanique Pasteur® or Tetavax®) against tetanus toxoid 10 and 28 d post-vaccination. Between July and December 2009, four centers in France and five in Germany recruited healthy adults who had received a tetanus-containing vaccine 5−10 y previously. Participants were randomized 1:1 to receive at the first visit a single dose (0.5 mL) of Tdap-IPV or TMV, with follow-up visits at Day 10 and Day 28. Outcomes: per protocol (PP) population immunogenicity at Day 10 (primary) and at Day 28 (secondary); safety throughout the study. Of 456 adults randomized, 223 received Tdap-IPV and 233 received TMV (PP population: 183 and 199 participants, respectively). All participants receiving Tdap-IPV and 99.0% receiving TMV had an anti-tetanus antibody concentration ≥ 0.1 IU/mL, confirming non-inferiority of Tdap-IPV to TMV (95% confidence interval of the difference: –1.2, 3.6). Number of adverse events reported was comparable in each group. Injection-site reactions were reported by 76.6% participants receiving Tdap-IPV and 74.6% receiving TMV. Systemic events (e.g., malaise, myalgia and headache) were reported in 47.7% and 39.7% of the Tdap-IPV and the TMV groups, respectively. Tdap-IPV is effective and well-tolerated for use in the management of tetanus-prone injuries in emergency settings in persons for whom a booster against diphtheria, pertussis and poliomyelitis is also needed. ClinicalTrials.gov identifier: NCT00928785. Research sponsored by Sanofi Pasteur MSD. PMID:23032160

  1. 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

  2. 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

  3. A randomised controlled trial and cost-effectiveness evaluation of "booster" interventions to sustain increases in physical activity in middle-aged adults in deprived urban neighbourhoods

    PubMed Central

    2010-01-01

    whether the effectiveness of the intervention is modified by access to community facilities. A one-year integrated feasibility study will confirm that recruitment targets are achievable based on a 10% sample. Discussion The choice of study population, study interventions, brief intervention preceding the study, and outcome measure are discussed. Trial Registration Current Controlled Trials: ISRCTN56495859; ClinicalTrials.gov: NCT00836459. PMID:20047672

  4. 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…

  5. 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...

  6. 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…

  7. 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…

  8. 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...

  9. 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

  10. Efficacy and tolerability of borage oil in adults and children with atopic eczema: randomised, double blind, placebo controlled, parallel group trial

    PubMed Central

    Takwale, A; Tan, E; Agarwal, S; Barclay, G; Ahmed, I; Hotchkiss, K; Thompson, J R; Chapman, T; Berth-Jones, J

    2003-01-01

    Objective To study the efficacy and tolerability of borage oil, which contains a high concentration of γ linolenic acid, in children and adults with atopic eczema. Design Single centre, randomised, double blind, placebo controlled, parallel group trial. Setting Acute district general hospital in Nuneaton, England. Participants 151 patients, of whom 11 failed to return for assessment, leaving an evaluable population of 140 (including 69 children). Intervention Adults received four capsules of borage oil twice daily (920 mg γ linolenic acid), and children received two capsules twice daily, for 12 weeks. Main outcome measures Change in total sign score at 12 weeks measured with the six area, six sign, atopic dermatitis (SASSAD) score (primary endpoint); symptom scores, assessed on visual analogue scales; topical corticosteroid requirement, assessed on a five point scale; global assessment of response by participants; adverse events and tolerability. Results The mean SASSAD score fell from 30 to 27 in the borage oil group and from 28 to 23 in the placebo group. The difference between the mean improvements in the two groups was 1.4 (95% confidence interval -2.2 to 5.0) points in favour of placebo (P = 0.45). No significant differences occurred between treatment groups in the other assessments. Subset analysis of adults and children did not indicate any difference in response. The treatments were well tolerated. Conclusion γ linolenic acid is not beneficial in atopic dermatitis. PMID:14670885

  11. Impact of Oral Sildenafil on Exercise Performance in Children and Young Adults After Fontan Operation: A Randomized, Double-Blind, Placebo-Controlled, Crossover Trial

    PubMed Central

    Goldberg, David J.; French, Benjamin; McBride, Michael G.; Marino, Bradley S.; Mirarchi, Nicole; Hanna, Brian D.; Wernovsky, Gil; Paridon, Stephen M.; Rychik, Jack

    2011-01-01

    Background Children and young adults with single ventricle physiology have abnormal exercise capacity after Fontan operation. A medication capable of decreasing pulmonary vascular resistance should allow for improved cardiac filling and improved exercise capacity. Methods and Results This study was a double-blind, placebo-controlled, crossover trial conducted in children and young adults after Fontan. Subjects were randomized to receive placebo or sildenafil (20 mg tid) for 6 weeks. After a 6-week washout, subjects crossed over for an additional 6 weeks. Each subject underwent an exercise stress test at the start and finish of each phase. Following sildenafil subjects had a significantly decreased respiratory rate and decreased minute ventilation at peak exercise. At the anaerobic threshold subjects had significantly decreased ventilatory equivalents of carbon dioxide. There was no change in oxygen consumption during peak exercise although there was a suggestion of improved oxygen consumption at the anaerobic threshold. Improvement at the anaerobic threshold was limited to the subgroup with single left or mixed ventricular morphology and to the subgroup with baseline serum brain natriuretic peptide levels ≥ 100 pg/ml. Conclusion In this cohort, sildenafil significantly improved ventilatory efficiency during peak and sub-maximal exercise. There was also a suggestion of improved oxygen consumption at the anaerobic threshold in two subgroups. These findings suggest that sildenafil may be an important agent to improve exercise performance in children and young adults with single ventricle physiology following Fontan operation. PMID:21382896

  12. 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.

  13. Mindfulness-based intervention for prodromal sleep disturbances in older adults: Design and methodology of a randomized controlled trial

    PubMed Central

    Black, David S.; O’Reilly, Gillian A.; Olmstead, Richard; Breen, Elizabeth C.; Irwin, Michael R.

    2014-01-01

    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. PMID:24993561

  14. General Information about Adult Hodgkin Lymphoma

    MedlinePlus

    ... Adult Hodgkin Lymphoma Treatment (PDQ®)–Patient Version General Information About Adult Hodgkin Lymphoma Go to Health Professional ... the PDQ Adult Treatment Editorial Board . Clinical Trial Information A clinical trial is a study to answer ...

  15. β-Blockers in sepsis: protocol for a systematic review and meta-analysis of randomised control trials

    PubMed Central

    Duan, Erick H; Oczkowski, Simon J W; Belley-Cote, Emilie; Whitlock, Richard; Lamontagne, Francois; Devereaux, Phillip J; Cook, Deborah J

    2016-01-01

    Introduction Sepsis is a common and deadly complication of infection. As part of the host response, sympathetic stimulation can result in septic myocardial depression, and metabolic, haematological and immunological dysfunction. Administration of β-blockers may attenuate this pathophysiological response to infection, but the effects on clinical outcomes are unknown. The objective of this systematic review is to determine the efficacy and safety of β-blockers in adults with sepsis using data from randomised control trials. Methods and analysis We will identify randomised control trials comparing treatment with β-blockers, versus placebo or standard care in adults with sepsis. Data sources will include MEDLINE, EMBASE, CENTRAL, clinical trial registries and conference proceedings. Two reviewers will independently determine trial eligibility. For each included trial, we will conduct duplicate independent data extraction, risk of bias assessment and evaluation of the quality of the evidence using the GRADE approach. Ethics and dissemination Our systematic review will evaluate the effects of β-blockers in adults with sepsis, comprehensively summarising and appraising the available evidence from randomised control trials. The results of this systematic review will help clinicians treating patients with sepsis to understand the potential role of β-blockade, and inform future research on this topic. Our findings will be disseminated through conference presentation and publication in a peer-reviewed journal. Trial registration number CRD42016036933. PMID:27338886

  16. 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.

  17. 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.

  18. The efficacy of vigorous-intensity exercise as an aid to smoking cessation in adults with elevated anxiety sensitivity: study protocol for a randomized controlled trial

    PubMed Central

    2012-01-01

    Background Although cigarette smoking is a leading cause of death and disability in the United States (US), over 40 million adults in the US currently smoke. Quitting smoking is particularly difficult for smokers with certain types of psychological vulnerability. Researchers have frequently called attention to the relation between smoking and anxiety-related states and disorders, and evidence suggests that panic and related anxiety vulnerability factors, specifically anxiety sensitivity (AS or fear of somatic arousal), negatively impact cessation. Accordingly, there is merit to targeting AS among smokers to improve cessation outcome. Aerobic exercise has emerged as a promising aid for smoking cessation for this high-risk (for relapse) group because exercise can effectively reduce AS and other factors predicting smoking relapse (for example, withdrawal, depressed mood, anxiety), and it has shown initial efficacy for smoking cessation. The current manuscript presents the rationale, study design and procedures, and design considerations of the Smoking Termination Enhancement Project (STEP). Methods STEP is a randomized clinical trial that compares a vigorous-intensity exercise intervention to a health and wellness education intervention as an aid for smoking cessation in adults with elevated AS. One hundred and fifty eligible participants will receive standard treatment (ST) for smoking cessation that includes cognitive behavioral therapy (CBT) and nicotine replacement therapy (NRT). In addition, participants will be randomly assigned to either an exercise intervention (ST+EX) or a health and wellness education intervention (ST+CTRL). Participants in both arms will meet 3 times a week for 15 weeks, receiving CBT once a week for the first 7 weeks, and 3 supervised exercise or health and wellness education sessions (depending on randomization) per week for the full 15-week intervention. Participants will be asked to set a quit date for 6 weeks after the baseline visit

  19. A Web-Based Psychoeducational Intervention Program for Depression and Anxiety in an Adult Community in Selangor, Malaysia: Protocol of a Randomized Controlled Trial

    PubMed Central

    Mukhtar, Firdaus; Ibrahim, Normala; Phang, Cheng-Kar; Tan, Kit-Aun; Ahmad, Rozali

    2016-01-01

    , this study will be the first randomized controlled trial of a Web-based psychoeducational intervention program for depression and anxiety in an adult community in Malaysia. The results from this study will determine the effectiveness of a psychoeducational intervention program in the management of depression and anxiety among adults in the community. If proven to be effective, the intervention can serve as a new modality to manage and reduce the burden of these disorders in the community. ClinicalTrial International Standard Randomized Controlled Trial Number (ISRCTN): 39656144; http://www.isrctn.com/ISRCTN39656144 (Archived by WebCite at http://www.webcitation.org/6hSVhV71K) PMID:27329333

  20. An Internet-Based Counseling Intervention With Email Reminders that Promotes Self-Care in Adults With Chronic Heart Failure: Randomized Controlled Trial Protocol

    PubMed Central

    Payne, Ada YM; Ross, Heather; White, Michel; D'Antono, Bianca; Chan, Sammy; Barr, Susan I; Gwadry-Sridhar, Femida; Nigam, Anil; Perreault, Sylvie; Farkouh, Michael; McDonald, Michael; Goodman, Jack; Thomas, Scott; Zieroth, Shelley; Isaac, Debra; Oh, Paul; Rajda, Miroslaw; Chen, Maggie; Eysenbach, Gunther; Liu, Sam; Zbib, Ahmad

    2014-01-01

    generalized estimation equations with repeated measures on an intention-to-treat basis. Secondary outcomes will be analyzed using repeated-measures linear mixed models with a random effects intercept. All significant main effects or interactions in the statistical models will be followed up with post hoc contrasts using a Bonferroni correction with a 2-sided statistical significance criterion of P<.05. Results This 3.5-year, proof-of-principle trial will establish the e-infrastructure for a pan-Canadian e-platform for CHF that is comprised of a standardized, evidence-based protocol of e-Counseling. Conclusions CHF-CePPORT is designed to improve long-term adherence to self-care behaviors and quality of life among patients with CHF. It will demonstrate a distinct Canadian initiative to build capacity for preventive eHealth services for patients with CHF. Trial Registration ClinicalTrials.gov NCT01864369; http://clinicaltrials.gov/ct2/show/NCT01864369 (Archived by WebCite at http://www.webcitation.org/6Iiv6so7E). PMID:24480783

  1. A randomized controlled trial of a new behavioral home-based nutrition education program, "Eat Well with CF," in adults with cystic fibrosis.

    PubMed

    Watson, Helen; Bilton, Diana; Truby, Helen

    2008-05-01

    Cystic fibrosis (CF) remains the most common genetically inherited disease in the white population and its prognosis is affected by nutritional status. Adults with the disease are now surviving longer and new strategies are required to ensure that they maintain optimal nutrition. This article reports preliminary data from a randomized controlled trial of a 10-week home-based behavioral nutrition intervention, "Eat Well with CF." Outcome measures of weight change over 6 and 12 months and changes in CF-specific nutrition knowledge score, self-efficacy score, reported dietary fat intake and health-related quality-of-life score were compared between the intervention group (n=34) and a standard care control group (n=34). The hypotheses to be tested were that adults with CF completing "Eat Well with CF" would have an improved nutritional status, improvement in specific nutrition knowledge, and an improvement in self-efficacy regarding their ability to cope with a special diet, compared to those receiving standard care. There were substantial improvements in the intervention group's specific CF nutrition knowledge score, self-efficacy score, and reported fat intake compared to control, but no substantial change in body mass index or health-related quality of life over time. Home-based nutrition education incorporating behavioral strategies can be an effective way to support adults with CF, enabling improvement in self-management skills in relation to diet and pancreatic enzyme replacement therapy. This study revealed gaps in basic nutrition knowledge and skills, inadequate knowledge of diet-disease links and pancreatic enzyme replacement therapy. These need to be identified when subjects progress from pediatric to adult care, and programs such as "Eat Well with CF" are a useful adjunct for registered dietitians trying to manage this diverse but growing population. PMID:18442509

  2. 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

  3. 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

  4. Evaluation of buspirone for relapse-prevention in adults with cocaine dependence: an efficacy trial conducted in the real world.

    PubMed

    Winhusen, Theresa; Brady, Kathleen T; Stitzer, Maxine; Woody, George; Lindblad, Robert; Kropp, Frankie; Brigham, Gregory; Liu, David; Sparenborg, Steven; Sharma, Gaurav; Vanveldhuisen, Paul; Adinoff, Bryon; Somoza, Eugene

    2012-09-01

    Cocaine dependence is a significant public health problem for which there are currently no FDA-approved medications. Hence, identifying candidate compounds and employing an efficient evaluation process is crucial. This paper describes key design decisions made for a National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) study that uses a novel two-stage process to evaluate buspirone (60 mg/day) for cocaine-relapse prevention. The study includes pilot (N=60) and full-scale (estimated N=264) trials. Both trials will be randomized, double-blind, and placebo-controlled and both will enroll treatment-seeking cocaine-dependent participants engaged in inpatient/residential treatment and scheduled for outpatient treatment post-discharge. All participants will receive contingency management in which incentives are given for medication adherence as evaluated by the Medication Events Monitoring System (MEMS). The primary outcome measure is maximum days of continuous cocaine abstinence, as assessed by twice-weekly urine drug screens (UDS) and self-report, during the 15-week outpatient treatment phase. Drug-abuse outcomes include cocaine use as assessed by UDS and self-report of cocaine use, other substance use as assessed by UDS and self-report of substance use (i.e., alcohol and/or illicit drugs), cocaine bingeing, HIV risk behavior, quality of life, functioning, and substance abuse treatment attendance. Unique aspects of the study include conducting an efficacy trial in community treatment programs, a two-stage process to efficiently evaluate buspirone, and an evaluation of mediators by which buspirone might exert a beneficial effect on relapse prevention. PMID:22613054

  5. 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…

  6. 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…

  7. The Effects of Acupressure Training on Sleep Quality and Cognitive Function of Older Adults: A 1-Year Randomized Controlled Trial.

    PubMed

    Zeng, Hui; Liu, Mengjiao; Wang, Ping; Kang, Jiaxun; Lu, Fenghua; Pan, Lu

    2016-10-01

    We explored the effects of acupressure training on older adults' sleep quality and cognitive function. Ninety older adults with impaired sleep quality were selected from screened volunteers and randomly divided into equal control and experimental groups; 82 completed the 1-year follow-up. Participants in the control group were given instructions on sleep health, while those in the experimental group received sleep health instructions plus individual and small group acupressure training sessions and support to practice the intervention on their own each day. All participants were assessed by trained assistants blind to study group allocation using Chinese versions of the Pittsburgh Sleep Quality Index, the Epworth Sleepiness Scale, the Mini-Mental State Examination, and four subscales from the revised Chinese version of the Wechsler Memory Scale, at baseline and at 3, 6, and 12 months. Repeated measures analysis of variance showed that acupressure training improved older adults' sleep quality and cognitive function, but the mediating effect of sleep on the relationship between acupressure training and cognitive function was not supported. Given the ease, simplicity, and safety of acupressure training observed with community-dwelling older adults in China, attempts should be made to replicate these preliminary positive findings with larger samples. © 2016 Wiley Periodicals, Inc. PMID:27327537

  8. Mindfulness Training Increases Momentary Positive Emotions and Reward Experience in Adults Vulnerable to Depression: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Geschwind, Nicole; Peeters, Frenk; Drukker, Marjan; van Os, Jim; Wichers, Marieke

    2011-01-01

    Objective: To examine whether mindfulness-based cognitive therapy (MBCT) increases momentary positive emotions and the ability to make use of natural rewards in daily life. Method: Adults with a life-time history of depression and current residual depressive symptoms (mean age = 43.9 years, SD = 9.6; 75% female; all Caucasian) were randomized to…

  9. 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

  10. Effect of a Family-Oriented Communication Skills Training Program on Depression, Anxiety, and Stress in Older Adults: A Randomized Clinical Trial

    PubMed Central

    Ghazavi, Zahra; Feshangchi, Simin; Alavi, Mousa; Keshvari, Mahrokh

    2016-01-01

    Background Older adults face several physical and psychological problems such as hearing loss, vision loss, and memory loss, which diminish the quality of their communication. Poor communication in turn affects their psychological wellbeing and induces substantial depression, anxiety, and stress. The family has an important role in the mental health of older adults. Objectives This study aimed to investigate the effect of a family-oriented communication skills training program on depression, anxiety, and stress in older adults. Patients and Methods For this randomized controlled clinical trial, we enrolled 64 older adults from two healthcare centers affiliated to the Isfahan University of Medical Sciences. The subjects were randomly allocated to an experimental group (n = 32) and a control group (n = 32). In the experimental group, older adults along with their primary caregiver participated in six sessions of communication skill education. The control group participated in two training sessions on nutrition and exercise. All participants answered the DASS21 questionnaire three times—at the start of the study, at the end of the sixth week, and a month after the last educational session of the experimental group. Data were analyzed using chi-square, Fisher’s exact and t tests and by repeated measures analysis of variance (ANOVA). Results In the experimental group, the mean depression score significantly reduced from 10.56 ± 3.34 before intervention to 7.46 ± 2.80 and 6.30 ± 2.75 after intervention and at follow-up, respectively; the mean anxiety score significantly reduced from 8.46 ± 1.88 before intervention to 5.83 ± 1.93 and 5.80 ± 2.12 after intervention and at follow-up, respectively; and the mean stress score significantly decreased from 11.40 ± 4.53 before intervention to 8.90 ± 3.81 and 8.43 ± 3.31 after intervention and at follow-up, respectively (P < 0.05 for all three domains). In contrast, the control group did not show any significant

  11. A Randomized Clinical Trial Comparison Between Pivotal Response Treatment (PRT) and Adult-Driven Applied Behavior Analysis (ABA) Intervention on Disruptive Behaviors in Public School Children with Autism.

    PubMed

    Mohammadzaheri, Fereshteh; Koegel, Lynn Kern; Rezaei, Mohammad; Bakhshi, Enayatolah

    2015-09-01

    Children with autism often demonstrate disruptive behaviors during demanding teaching tasks. Language intervention can be particularly difficult as it involves social and communicative areas, which are challenging for this population. The purpose of this study was to compare two intervention conditions, a naturalistic approach, Pivotal Response Treatment (PRT) with an adult-directed ABA approach on disruptive behavior during language intervention in the public schools. A randomized clinical trial design was used with two groups of children, matched according to age, sex and mean length of utterance. The data showed that the children demonstrated significantly lower levels of disruptive behavior during the PRT condition. The results are discussed with respect to antecedent manipulations that may be helpful in reducing disruptive behavior. PMID:25953148

  12. A clinical trial of single dose rectal and oral administration of diazepam for the prevention of serial seizures in adult epileptic patients.

    PubMed Central

    Milligan, N M; Dhillon, S; Griffiths, A; Oxley, J; Richens, A

    1984-01-01

    The clinical anticonvulsant efficacy of single dose rectal and oral administration of diazepam 20 mg was examined in two double-blind placebo-controlled trials in adult epileptic patients. All subjects suffered from drug resistant epilepsy and frequently experienced serial seizures. Diazepam was administered rectally as a new experimental suppository formulation immediately after a seizure and was highly effective in preventing recurrent fits within a 24 h observation period (p less than 0.001). Pharmacokinetic studies revealed a wide range of serum diazepam concentrations 60 min after administration of the suppository (mean serum diazepam level 190 +/- 73 (SD ng/ml). In a similar study oral administration of diazepam 20 mg significantly reduced the incidence of serial seizures compared with a placebo (p less than 0.01) and the mean 60 min serum diazepam level was 273 +/- 190 (SD) ng/ml. PMID:6368753

  13. Meal-based enhancement of protein quality and quantity during weight loss in obese older adults with mobility limitations: rationale and design for the MEASUR-UP trial.

    PubMed

    McDonald, Shelley R; Porter Starr, Kathryn N; Mauceri, Luisa; Orenduff, Melissa; Granville, Esther; Ocampo, Christine; Payne, Martha E; Pieper, Carl F; Bales, Connie W

    2015-01-01

    Obese older adults with even modest functional limitations are at a disadvantage for maintaining their independence into late life. However, there is no established intervention for obesity in older individuals. The Measuring Eating, Activity, and Strength: Understanding the Response - Using Protein (MEASUR-UP) trial is a randomized controlled pilot study of obese women and men aged ≥60 years with mild to moderate functional impairments. Changes in body composition (lean and fat mass) and function (Short Physical Performance Battery) in an enhanced protein weight reduction (Protein) arm will be compared to those in a traditional weight loss (Control) arm. The Protein intervention is based on evidence that older adults achieve optimal rates of muscle protein synthesis when consuming about 25-30 g of high quality protein per meal; these participants will consume ~30 g of animal protein at each meal via a combination of provided protein (beef) servings and diet counseling. This trial will provide information on the feasibility and efficacy of enhancing protein quantity and quality in the context of a weight reduction regimen and determine the impact of this intervention on body weight, functional status, and lean muscle mass. We hypothesize that the enhancem