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Sample records for adults trial registration

  1. Clinical trial registration in oral health journals.

    PubMed

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

    2015-03-01

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

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

    PubMed

    Yu, He; Liu, Jian-ping

    2007-05-01

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

  3. The Quality of Registration of Clinical Trials

    PubMed Central

    Viergever, Roderik F.; Ghersi, Davina

    2011-01-01

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

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

    PubMed

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

    2012-08-01

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

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

    PubMed

    2016-09-21

    This final rule details the requirements for submitting registration and summary results information, including adverse event information, for specified clinical trials of drug products (including biological products) and device products and for pediatric postmarket surveillances of a device product to ClinicalTrials.gov, the clinical trial registry and results data bank operated by the National Library of Medicine (NLM) of the National Institutes of Health (NIH). This rule provides for the expanded registry and results data bank specified in Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA) to help patients find trials for which they might be eligible, enhance the design of clinical trials and prevent duplication of unsuccessful or unsafe trials, improve the evidence base that informs clinical care, increase the efficiency of drug and device development processes, improve clinical research practice, and build public trust in clinical research. The requirements apply to the responsible party (meaning the sponsor or designated principal investigator) for certain clinical trials of drug products (including biological products) and device products that are regulated by the Food and Drug Administration (FDA) and for pediatric postmarket surveillances of a device product that are ordered by FDA. PMID:27658315

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

    PubMed

    Forshag, Mark S

    2016-08-01

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

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

    PubMed

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

    2012-12-01

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

  8. 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

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

    PubMed

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

    2013-06-01

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

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

    PubMed Central

    Stevenson, Graham; Thornton, James G

    2014-01-01

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

  11. Registration and classification of adolescent and young adult cancer cases.

    PubMed

    Pollock, Brad H; Birch, Jillian M

    2008-05-01

    Cancer registries are an important research resource that facilitate the study of etiology, tumor biology, patterns of delayed diagnosis and health planning needs. When outcome data are included, registries can track secular changes in survival related to improvements in early detection or treatment. The surveillance, epidemiology, and end results (SEER) registry has been used to identify major gaps in survival for older adolescent and young adult (AYA) patients compared with younger children and older adults. In order to determine the reasons for this gap, the complete registration and accurate classification of AYA malignancies is necessary. There are inconsistencies in defining the age limits for AYAs although the Adolescent and Young Adult Oncology Progress Review Group proposed a definition of ages 15 through 39 years. The central registration and classification issues for AYAs are case-finding, defining common data elements (CDE) collected across different registries and the diagnostic classification of these malignancies. Goals to achieve by 2010 include extending and validating current diagnostic classification schemes and expanding the CDE to support AYA oncology research, including the collection of tracking information to assess long-term outcomes. These efforts will advance preventive, etiologic, therapeutic, and health services-related research for this understudied age group.

  12. 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

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

    PubMed

    Wade, Derick

    2016-03-01

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

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed Central

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

    2016-01-01

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

  17. 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

  18. 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…

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

    PubMed

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

    2014-01-01

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

  20. 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

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

    PubMed

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

    2015-07-01

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

  2. Adult cancer clinical trials that fail to complete: an epidemic?

    PubMed

    Stensland, Kristian D; McBride, Russell B; Latif, Asma; Wisnivesky, Juan; Hendricks, Ryan; Roper, Nitin; Boffetta, Paolo; Hall, Simon J; Oh, William K; Galsky, Matthew D

    2014-09-01

    The number and diversity of cancer therapeutics in the pipeline has increased over the past decade due to an enhanced understanding of cancer biology and the identification of novel therapeutic targets. At the same time, the cost of bringing new drugs to market and the regulatory burdens associated with clinical drug development have progressively increased. The finite number of eligible patients and limited financial resources available to evaluate promising new therapeutics represent rate-limiting factors in the effort to translate preclinical discoveries into the next generation of standard therapeutic approaches. Optimal use of resources requires understanding and ultimately addressing inefficiencies in the cancer clinical trials system. Prior analyses have demonstrated that a large proportion of trials initiated by the National Cancer Institute (NCI) Cooperative Group system are never completed. While NCI Cooperative Group trials are important, they represent only a small proportion of all cancer clinical trials performed. Herein, we explore the problem of cancer clinical trials that fail to complete within the broader cancer clinical trials enterprise. Among 7776 phase II-III adult cancer clinical trials initiated between 2005-2011, we found a seven-year cumulative incidence of failure to complete of approximately 20% (95% confidence interval = 18% to 22%). Nearly 48000 patients were enrolled in trials that failed to complete. These trials likely contribute little to the scientific knowledge base, divert resources and patients from answering other critical questions, and represent a barrier to progress.

  3. 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).

  4. 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.

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

    PubMed

    McKee, G R

    1998-01-01

    This study compared the competency to stand trial (CST) of 108 juveniles (ages 7 to 16 years) and 145 adults (17 years or older) undergoing pretrial, court-ordered forensic psychiatric evaluations. Adults were superior on both global and specific competency abilities (p < .001). Clustered by age (<13, 13 and 14, 15 and 16 years old), preteens accused of crimes failed to meet a Dusky v. United States standard, while 13- and 14-year-olds displayed an equal mix of abilities and deficits. Mid-adolescents (ages 15 and 16) were equivalent to adults in CST abilities except in their knowledge about plea bargaining elements. The ramifications of CST in felony juvenile transfer to adult court as well as the needs for ecologically valid, empirically based CST research on adolescents is discussed. PMID:9554713

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

    PubMed Central

    2010-01-01

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

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

    PubMed

    Lindeijer, J E

    1987-04-01

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

  8. 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

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

    PubMed

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

    2015-12-01

    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.

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

    PubMed

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

    2015-12-01

    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

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

    PubMed

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

    2014-12-01

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

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

    PubMed Central

    2013-01-01

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

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

    PubMed Central

    2013-01-01

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

  14. 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

  15. [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.

  16. 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…

  17. 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

  18. 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

  19. 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

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

    PubMed

    Shirotani, Mari; Kurokawa, Tatsuo; Chiba, Koji

    2014-07-01

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

  1. 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

  2. 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

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed Central

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

    2014-01-01

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

  5. 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

  6. 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

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

    PubMed

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

    2016-03-01

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

  8. 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

  9. 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...

  10. 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

  11. 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

  12. 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…

  13. 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…

  14. 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…

  15. 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

  16. 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

  17. 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

  18. 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.

  19. 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

  20. 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

  1. 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

  2. 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

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

    PubMed Central

    Bielefeldt, Andreas Ø; Danborg, Pia B

    2016-01-01

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

  4. Cognitive behaviour therapy (CBT) for anxiety and depression in adults with mild intellectual disabilities (ID): a pilot randomised controlled trial

    PubMed Central

    2011-01-01

    Background Several studies have showed that people with intellectual disabilities (ID) have suitable skills to undergo cognitive behavioural therapy (CBT). Case studies have reported successful use of cognitive behavioural therapy techniques (with adaptations) in people with ID. Modified cognitive behavioural therapy may be a feasible and effective approach for the treatment of depression, anxiety, and other mood disorders in ID. To date, two studies have reported group-based manaulised cognitive behavioural treatment programs for depression in people with mild ID. However, there is no individual manualised programme for anxiety or depression in people with intellectual disabilities. The aims of the study are to determine the feasibility of conducting a randomised controlled trial for CBT in people with ID. The data will inform the power calculation and other aspects of carrying out a definitive randomised controlled trial. Methods Thirty participants with mild ID will be allocated randomly to either CBT or treatment as usual (TAU). The CBT group will receive up to 20 hourly individual CBT over a period of 4 months. TAU is the standard treatment which is available to any adult with an intellectual disability who is referred to the intellectual disability service (including care management, community support, medical, nursing or social support). Beck Youth Inventories (Beck Anxiety Inventory & Beck Depression Inventory) will be administered at baseline; end of treatment (4 months) and at six months to evaluate the changes in depression and anxiety. Client satisfaction, quality of life and the health economics will be secondary outcomes. Discussion The broad outcome of the study will be to produce clear guidance for therapists to apply an established psychological intervention and identify how and whether it works with people with intellectual disabilities. Trial registration ISRCTN: ISRCTN38099525 PMID:21492437

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

    PubMed

    Bang, Oh Young

    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.

  6. Disparate Inclusion of Older Adults in Clinical Trials: Priorities and Opportunities for Policy and Practice Change

    PubMed Central

    Snipes, Shedra Amy; King, Denae W.; Torres-Vigil, Isabel; Goldberg, Daniel S.; Weinberg, Armin D.

    2010-01-01

    Older adults are vastly underrepresented in clinical trials in spite of shouldering a disproportionate burden of disease and consumption of prescription drugs and therapies, restricting treatments' generalizability, efficacy, and safety. Eliminating Disparities in Clinical Trials, a national initiative comprising a stakeholder network of researchers, community advocates, policymakers, and federal representatives, undertook a critical analysis of older adults' structural barriers to clinical trial participation. We present practice and policy change recommendations emerging from this process and their rationale, which spanned multiple themes: (1) decision making with cognitively impaired patients; (2) pharmacokinetic differences and physiological age; (3) health literacy, communication, and aging; (4) geriatric training; (5) federal monitoring and accountability; (6) clinical trial costs; and (7) cumulative effects of aging and ethnicity. PMID:20147682

  7. 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

  8. 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

  9. The End of the Wall--Adult Education on Trial.

    ERIC Educational Resources Information Center

    Dohmen, Gunther

    Adult educators need to realize that the decline of socialism in Europe is a matter of spiritual developments and changes of mentalities, attitudes, and patterns of thinking and judging. The occurrence of a general orientation crisis indicates a need for learning as people look for new rules and structures. As a result of the closed system, the…

  10. 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

  11. Designing therapeutic clinical trials for older and frail adults with cancer: U13 conference recommendations.

    PubMed

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

    2014-08-20

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

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

    PubMed Central

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

    2014-01-01

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

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

    PubMed Central

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

    2015-01-01

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

  14. 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

  15. 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

  16. 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…

  17. 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…

  18. 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…

  19. 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

  20. 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

  1. 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

  2. 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

  3. 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

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

    PubMed Central

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

    2013-01-01

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

  5. 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

  6. 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.

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed Central

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

    2016-01-01

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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  1. 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…

  2. 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

  3. 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

  4. 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

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

    PubMed

    Xu, Ying; Chen, Bo; Guo, Yi

    2015-06-01

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

  6. A Randomized Controlled Trial of Cognitive Training Using a Visual Speed of Processing Intervention in Middle Aged and Older Adults

    PubMed Central

    Wolinsky, Fredric D.; Vander Weg, Mark W.; Howren, M. Bryant; Jones, Michael P.; Dotson, Megan M.

    2013-01-01

    Background Age-related cognitive decline is common and may lead to substantial difficulties and disabilities in everyday life. We hypothesized that 10 hours of visual speed of processing training would prevent age-related declines and potentially improve cognitive processing speed. Methods Within two age bands (50–64 and≥65) 681 patients were randomized to (a) three computerized visual speed of processing training arms (10 hours on-site, 14 hours on-site, or 10 hours at-home) or (b) an on-site attention control group using computerized crossword puzzles for 10 hours. The primary outcome was the Useful Field of View (UFOV) test, and the secondary outcomes were the Trail Making (Trails) A and B Tests, Symbol Digit Modalities Test (SDMT), Stroop Color and Word Tests, Controlled Oral Word Association Test (COWAT), and the Digit Vigilance Test (DVT), which were assessed at baseline and at one year. 620 participants (91%) completed the study and were included in the analyses. Linear mixed models were used with Blom rank transformations within age bands. Results All intervention groups had (p<0.05) small to medium standardized effect size improvements on UFOV (Cohen's d = −0.322 to −0.579, depending on intervention arm), Trails A (d = −0.204 to −0.265), Trails B (d = −0.225 to −0.320), SDMT (d = 0.263 to 0.351), and Stroop Word (d = 0.240 to 0.271). Converted to years of protection against age-related cognitive declines, these effects reflect 3.0 to 4.1 years on UFOV, 2.2 to 3.5 years on Trails A, 1.5 to 2.0 years on Trails B, 5.4 to 6.6 years on SDMT, and 2.3 to 2.7 years on Stroop Word. Conclusion Visual speed of processing training delivered on-site or at-home to middle-aged or older adults using standard home computers resulted in stabilization or improvement in several cognitive function tests. Widespread implementation of this intervention is feasible. Trial Registration ClinicalTrials.gov NCT-01165463 PMID:23650501

  7. 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

  8. Chronic pain self-management for older adults: a randomized controlled trial [ISRCTN11899548

    PubMed Central

    Ersek, Mary; Turner, Judith A; Cain, Kevin C; Kemp, Carol A

    2004-01-01

    Background Chronic pain is a common and frequently disabling problem in older adults. Clinical guidelines emphasize the need to use multimodal therapies to manage persistent pain in this population. Pain self-management training is a multimodal therapy that has been found to be effective in young to middle-aged adult samples. This training includes education about pain as well as instruction and practice in several management techniques, including relaxation, physical exercise, modification of negative thoughts, and goal setting. Few studies have examined the effectiveness of this therapy in older adult samples. Methods/Design This is a randomized, controlled trial to assess the effectiveness of a pain self-management training group intervention, as compared with an education-only control condition. Participants are recruited from retirement communities in the Pacific Northwest of the United States and must be 65 years or older and experience persistent, noncancer pain that limits their activities. The primary outcome is physical disability, as measured by the Roland-Morris Disability Questionnaire. Secondary outcomes are depression (Geriatric Depression Scale), pain intensity (Brief Pain Inventory), and pain-related interference with activities (Brief Pain Inventory). Randomization occurs by facility to minimize cross-contamination between groups. The target sample size is 273 enrolled, which assuming a 20% attrition rate at 12 months, will provide us with 84% power to detect a moderate effect size of .50 for the primary outcome. Discussion Few studies have investigated the effects of multimodal pain self-management training among older adults. This randomized controlled trial is designed to assess the efficacy of a pain self-management program that incorporates physical and psychosocial pain coping skills among adults in the mid-old to old-old range. PMID:15285783

  9. 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

  10. 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…

  11. 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…

  12. 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 +/...

  13. 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

  14. 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

  15. 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

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

    PubMed Central

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

    2016-01-01

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

  17. 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

  18. 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

  19. 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.

  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. 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

  2. A Randomized Trial of Tailored Skin Cancer Prevention Messages for Adults: Project SCAPE

    PubMed Central

    Schoenfeld, Elinor R.; Steffen, Alana

    2010-01-01

    Objectives. We evaluated the impact of a mailed, tailored intervention on skin cancer prevention and skin self-examination behaviors of adults at moderate and high risk for skin cancer. Methods. Adults at moderate and high risk for skin cancer were recruited in primary health care settings in Honolulu, HI, and Long Island, NY. After completing a baseline survey, participants were randomized to 2 groups. The treatment group received tailored materials, including personalized risk feedback, and the control group received general educational materials. Multivariate analyses compared sun protection and skin self-examination between groups, controlling for location, risk level, gender, and age. Results. A total of 596 adults completed the trial. The tailored materials had a significant effect on overall sun-protection habits, the use of hats, the use of sunglasses, and the recency of skin self-examination. Some effects were moderated by location and risk level. Conclusions. Tailored communications including personalized risk feedback can improve sun-protection behaviors and skin self-examination among adults at increased risk for skin cancer. These convenient, low-cost interventions can be implemented in a variety of settings and should be tested further to assess their long-term effectiveness. PMID:20167900

  3. A Review of Clinical Trials of Tai Chi and Qigong in Older Adults

    PubMed Central

    Rogers, Carol; Larkey, Linda K.; Keller, Colleen

    2010-01-01

    Initiation and maintenance of physical activity (PA) in older adults is of increasing concern as the benefits of PA have been shown to improve physical functioning, mood, weight and cardiovascular risk factors. Meditative movement forms of PA, such as Tai Chi and Qigong (TC&QG), are holistic in nature and have increased in popularity over the past few decades. Several randomized controlled trials have evaluated TC&QG interventions from multiple perspectives, specifically targeting older adults. The purpose of this report was to synthesize intervention studies targeting TC & QG and identify the physical and psychological health outcomes shown to be associated with TC&QG in community dwelling adults over 55. Based on specific inclusion criteria, 36 research reports with a total of 3,799 participants were included in this review. Five, categories of study outcomes were identified, including falls and balance, physical function, cardiovascular disease, psychological and additional disease specific responses. Significant improvement in clusters of similar outcomes indicated interventions utilizing TC&QG may help older adults improve physical function and reduce blood pressure; fall risk; and depression and anxiety. Missing from the reviewed reports is a discussion of how spiritual exploration with meditative forms of PA, an important component of these movement activities, may contribute to successful aging. PMID:19179544

  4. The Sonoma Water Evaluation Trial: A Randomized Drinking Water Intervention Trial to Reduce Gastrointestinal Illness in Older Adults

    PubMed Central

    Hilton, Joan F.; Wright, Catherine C.; Arnold, Benjamin F.; Saha, Sona; Wade, Timothy J.; Scott, James; Eisenberg, Joseph N.S.

    2009-01-01

    Objectives. We estimated the relative rate of highly credible gastrointestinal illness (HCGI) per year associated with active versus sham household water filtration devices among older adults in a community receiving tap water meeting current US standards. Methods. We conducted a randomized, triple-blinded, crossover trial in 714 households (988 individuals), which used active and sham water filtration devices for 6 months each. We estimated the annual incidence rate ratio of HCGI episodes and the longitudinal prevalence ratio of HCGI days at population and individual levels with a generalized estimating equation (GEE) and generalized linear mixed models (GLMMs), respectively, adjusted for covariates associated with outcome. Results. The incidence rate ratios (active versus sham) were 0.88 (95% confidence interval [CI] = 0.77, 1.00) and 0.85 (95% CI = 0.76, 0.94) HCGI episodes per year estimated by GEE and GLMM models, respectively. The corresponding longitudinal prevalence ratios were 0.88 (95% CI = 0.74, 1.05) and 0.84 (95% CI = 0.78, 0.90) HCGI days per person per year. Conclusions. We observed reductions in population- and individual-level measures of HCGI associated with use of the active filtration device. These findings suggest the need for further research on the impact of drinking water on the health of sensitive subpopulations. PMID:19762663

  5. 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.

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

    PubMed

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

    2014-07-01

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

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed Central

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

    2011-01-01

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

  9. 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

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

    PubMed Central

    2009-01-01

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

  11. 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

  12. 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

  13. 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

  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. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  1. 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,…

  2. 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…

  3. 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…

  4. 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…

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

    PubMed Central

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

    2016-01-01

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

  6. 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

  7. 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.

  8. 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

  9. 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.

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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).

  18. 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

  19. 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

  20. 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

  1. 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

  2. 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

  3. 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

  4. 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.

  5. 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

  6. Changes in the vitamin D endocrine system and bone turnover after oral vitamin D3 supplementation in healthy adults: results of a randomised trial

    PubMed Central

    2012-01-01

    Background There is uncertainty as to which intake of vitamin D is needed to suppress PTH and maintain normal bone metabolism throughout winter at northern latitudes. We aimed to investigate whether four weeks’ daily supplementation with 10 μg vitamin D3 from fish oil produced a greater change in serum vitamin D metabolites, parathyroid hormone, and bone turnover in healthy adults compared with solid multivitamin tablets. Furthermore, it was studied whether age, gender, ethnic background, body mass index, or serum concentrations at baseline predicted the magnitude of change in these parameters. Methods Healthy adults aged 19–48 years living in Oslo, Norway (59°N) were randomised to receive a daily dose of 10 μg vitamin D3 given as fish oil capsules or multivitamin tablets during four weeks in late winter. Serum samples from baseline and after 28 days were analysed for 25-hydroxyvitamin D (s-25(OH)D), 1,25-dihydroxyvitamin D (s-1,25(OH)2D), intact parathyroid hormone (s-iPTH), and osteoclast-specific tartrate-resistant acid phosphatase 5b (s-TRACP). Fifty-five eligible participants completed the intervention (74% of those randomised). Results S-25(OH)D increased by mean 34.1 (SD 13.1) nmol/l, p < 0.001; s-iPTH decreased by mean 1.2 (SD 2.5) pmol/l, p = 0.001; s-1,25(OH)2D increased by mean 13 (SD 48) pmol/l, p = 0.057; and s-TRACP increased by mean 0.38 (SD 0.33) U/l, p < 0.001. For all these parameters, there was no difference between fish oil and multivitamin formulation. Baseline concentrations were the only independent predictors of changes in biochemical parameters. Conclusions Four weeks of daily supplementation with 10 μg vitamin D3 decreased mean s-iPTH and increased s-TRACP concentration, and this did not differ by mode of administration. Our results suggest an increased bone resorption following vitamin D supplementation in young individuals, despite a decrease in parathyroid hormone levels. Trial Registration ClinicalTrials

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

    PubMed Central

    2013-01-01

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

  8. 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

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

    PubMed

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

    2015-10-01

    Adolescent and Young Adult Oncology (AYAO, including patients 15-39 years of age) is an emerging discipline in the field of cancer treatment and research. Poorer survival outcomes for this population and characteristic age-related challenges in care have called attention to the need for increased AYAO research. This chapter outlines pressing questions and reviews recent progress in AYAO research within the current organizational structure of the federal clinical trials enterprise, emphasizing how the United States National Cancer Institute's National Clinical Trials Network (NCTN) has created novel opportunities for collaborative AYAO research among the pediatric and adult NCTN groups. Potential strategies for expanding AYAO research, both within the NCTN and with other partners in the federal and advocacy domains are identified. PMID:26433555

  10. 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

  11. 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

  12. 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.

  13. 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.

  14. 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

  15. 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

  16. Randomized controlled trial of a comprehensive home environment-focused weight loss program for adults

    PubMed Central

    Gorin, Amy A.; Raynor, Hollie A.; Fava, Joseph; Maguire, Kimberly; Robichaud, Erica; Trautvetter, Jennifer; Crane, Melissa; Wing, Rena R.

    2012-01-01

    Objective Behavioral weight loss programs (BWL) provide limited instruction on how to change the environmental context of weight-regulating behaviors, perhaps contributing to regain. Drawing on social ecological models, this trial evaluated a comprehensive weight loss program that targeted both an individual’s behavior and their physical and social home environment. Methods Overweight and obese adults (N=201; 48.9±10.5 years; 78.1% women) were randomized to BWL or to BWL plus home environment changes (BWL+H). Groups met weekly for 6 months and bi-monthly for 12 months. BWL+H participants were given items to facilitate healthy choices in their homes (e.g., exercise equipment, portion plates) and attended treatment with a household partner. Weight loss at 6 and 18 months was the primary outcome. Results BWL+H changed many aspects of the home environment and produced better 6 month weight losses than BWL (p=.017). At 18 months, no weight loss differences were observed (p=.19) and rates of regain were equivalent (p=.30). Treatment response was moderated by gender (6 month p=.01; 18 month p=.006). Women lost more weight in BWL+H than BWL at 6 and 18 months, whereas men in BWL lost more weight than those in BWL+H at 18 months. Partners, regardless of gender, lost more weight in BWL+H than BWL at both time points (ps<.0001). Conclusion The home food and exercise environment is malleable and targeting this microenvironment appears to improve initial weight loss, and in women, 18-month outcomes. Research is needed to understand this gender difference and to develop home-focused strategies with more powerful and sustained weight loss effects. PMID:22309885

  17. 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

  18. 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…

  19. 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

  20. 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

  1. 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

  2. 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

  3. A water-based training program that include perturbation exercises to improve stepping responses in older adults: study protocol for a randomized controlled cross-over trial

    PubMed Central

    Melzer, Itshak; Elbar, Ori; Tsedek, Irit; Oddsson, Lars IE

    2008-01-01

    Background Gait and balance impairments may increase the risk of falls, the leading cause of accidental death in the elderly population. Fall-related injuries constitute a serious public health problem associated with high costs for society as well as human suffering. A rapid step is the most important protective postural strategy, acting to recover equilibrium and prevent a fall from initiating. It can arise from large perturbations, but also frequently as a consequence of volitional movements. We propose to use a novel water-based training program which includes specific perturbation exercises that will target the stepping responses that could potentially have a profound effect in reducing risk of falling. We describe the water-based balance training program and a study protocol to evaluate its efficacy (Trial registration number #NCT00708136). Methods/Design The proposed water-based training program involves use of unpredictable, multi-directional perturbations in a group setting to evoke compensatory and volitional stepping responses. Perturbations are made by pushing slightly the subjects and by water turbulence, in 24 training sessions conducted over 12 weeks. Concurrent cognitive tasks during movement tasks are included. Principles of physical training and exercise including awareness, continuity, motivation, overload, periodicity, progression and specificity were used in the development of this novel program. Specific goals are to increase the speed of stepping responses and improve the postural control mechanism and physical functioning. A prospective, randomized, cross-over trial with concealed allocation, assessor blinding and intention-to-treat analysis will be performed to evaluate the efficacy of the water-based training program. A total of 36 community-dwelling adults (age 65–88) with no recent history of instability or falling will be assigned to either the perturbation-based training or a control group (no training). Voluntary step reaction times

  4. 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…

  5. 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

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

    PubMed Central

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

    2016-01-01

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

  7. 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

  8. Effect of registration on cyclical kinematic data.

    PubMed

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

    2010-08-26

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

  9. 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

  10. 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

  11. 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

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

    PubMed

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

    2013-05-01

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

  13. Double-blind placebo-controlled trial of methylphenidate in the treatment of adult ADHD patients with comorbid cocaine dependence.

    PubMed

    Schubiner, Howard; Saules, Karen K; Arfken, Cynthia L; Johanson, Chris-Ellyn; Schuster, Charles R; Lockhart, Nancy; Edwards, Ann; Donlin, Judy; Pihlgren, Eric

    2002-08-01

    In this 12-week double-blind placebo-controlled trial of methylphenidate (MTP) versus placebo in 48 cocaine-dependent attention-deficit/hyperactivity disorder (ADHD) adults, the authors sought to determine whether MTP would be safe, control ADHD symptoms, and affect cocaine use. Efficacy indexes revealed significantly greater ADHD symptom relief in the MTP group. There were no group differences in self-reported cocaine use, urinalysis results, or cocaine craving. Because of the relatively small sample size, the results are preliminary. However, we found that MTP improved subjective reports of ADHD symptoms and did not worsen cocaine use while participants were in treatment.

  14. 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.

  15. 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

  16. 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…

  17. 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…

  18. 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

  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. Fluoxetine and adult suicidality revisited: an updated meta-analysis using expanded data sources from placebo-controlled trials.

    PubMed

    Beasley, Charles M; Ball, Susan G; Nilsson, Mary E; Polzer, John; Tauscher-Wisniewski, Sitra; Plewes, John; Acharya, Nayan

    2007-12-01

    Selective serotonin reuptake inhibitor treatments have been suggested by some to induce emergence of suicidality (ideation and behaviors). The objective of this study was to assess suicidality emergence by adverse event and rating scale data in the largest available, adult, major depression, double-blind, placebo-controlled, fluoxetine trial database (18 trials). Adverse event reports and comments for patients (fluoxetine, n = 2200; placebo, n = 1551) were searched for suicide-related events that were then classified into Food and Drug Administration categories. For 16 trials, suicidality was also examined by Hamilton Depression Scale item 3 (suicide) scores, and these data were analyzed along with the combination of event-based data and scale-based data. Comparisons between treatments were made for various estimates of worsening (risk) and improvement (benefit) of suicidality. Fluoxetine treatment did not result in greater worsening but was associated with greater improvement and faster resolution of ideation (P < or = 0.05 vs placebo). Data sources were differentially sensitive in detecting changes in suicidal ideation and behaviors. Fluoxetine treatment led to greater benefit rather than risk for suicidality. PMID:18004137

  1. Vitamin-Mineral Treatment of ADHD in Adults: A 1-Year Naturalistic Follow-Up of a Randomized Controlled Trial.

    PubMed

    Rucklidge, Julia J; Frampton, Chris M; Gorman, Brigette; Boggis, Anna

    2014-05-01

    Objective: Despite widespread use, there is little data investigating the long-term impact of micronutrients on psychiatric disorders. This study investigated the naturalistic outcome 1-year post-baseline of a randomized controlled trials (RCT) that compared micronutrients with placebo in 80 adults with ADHD. Method: All participants were contacted and clinician-rated questionnaires completed. Results: A total of 72 (90%) of the sample participated; although there was significant regression in psychiatric functioning from the end-of-trial on all measures, outcomes remained significantly improved from baseline. Dominant treatment from the end-of-treatment to follow-up was investigated as a mediator of outcome; those staying on the micronutrients performed better than those who switched to medications or discontinued micronutrients. Cost was the most substantial reason why people stopped micronutrient treatment. Conclusion: For the small number of participants who stayed on micronutrients, the benefits conferred through the controlled trial were maintained. The results are limited by small sample, lack of blinding, expectation, and reliance on self-report of symptoms. PMID:24804687

  2. Effect of preventive treatment for tuberculosis in adults infected with HIV: systematic review of randomised placebo controlled trials

    PubMed Central

    Wilkinson, David; Squire, S B; Garner, Paul

    1998-01-01

    Objective: To determine whether preventive treatment for tuberculosis in adults infected with HIV reduces the frequency of tuberculosis and overall mortality. Design: Systematic review and data synthesis of randomised placebo controlled trials. Main outcome measures: Active tuberculosis, mortality, and adverse drug reaction requiring cessation of the study regimen. Outcomes stratified by status of purified protein derivative skin test. Results: Four trials comprising 4055 adults from Haiti, Kenya, the United States, and Uganda were included. All compared isoniazid (6-12 months) with placebo, and one trial also compared multidrug treatment for 3 months with placebo. Mean follow up was 15-33 months. Overall, frequency of tuberculosis (relative risk 0.57, 95% confidence interval 0.41 to 0.79) was reduced in those receiving preventive treatment compared with placebo: mortality was not significantly reduced (0.93, 0.83 to 1.05). In subjects positive for purified protein derivative receiving preventive treatment, the risk of tuberculosis was reduced substantially (0.32, 0.19 to 0.51) and the risk of death was reduced moderately (0.73, 0.57 to 0.95) compared with those taking placebo. In adults negative for purified protein derivative receiving preventive treatment, the risk of tuberculosis (0.82, 0.50 to 1.36) and the risk of death (1.02, 0.89 to 1.17) were not reduced significantly. Adverse drug reactions were more frequent, but not significantly so, in patients receiving drug compared with placebo (1.45, 0.98 to 2.14). Conclusions: Preventive treatment given for 3-12 months protects against tuberculosis in adults infected with HIV, at least in the short to medium term. Protection is greatest in subjects positive for purified protein derivative, in whom death is also less frequent. Long term benefits remain to be shown. Key messages One third of the world’s population is infected with Mycobacterium tuberculosis People infected with HIV are at much increased risk of

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

    PubMed

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

    2008-09-01

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

  4. 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

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

    PubMed Central

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

    2015-01-01

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

  7. 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

  8. 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

  9. 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…

  10. 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

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

    PubMed Central

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

    2016-01-01

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

  12. Switching HIV Treatment in Adults Based on CD4 Count Versus Viral Load Monitoring: A Randomized, Non-Inferiority Trial in Thailand

    PubMed Central

    Jourdain, Gonzague; Le Cœur, Sophie; Ngo-Giang-Huong, Nicole; Traisathit, Patrinee; Cressey, Tim R.; Fregonese, Federica; Leurent, Baptiste; Collins, Intira J.; Techapornroong, Malee; Banchongkit, Sukit; Buranabanjasatean, Sudanee; Halue, Guttiga; Nilmanat, Ampaipith; Luekamlung, Nuananong; Klinbuayaem, Virat; Chutanunta, Apichat; Kantipong, Pacharee; Bowonwatanuwong, Chureeratana; Lertkoonalak, Rittha; Leenasirimakul, Prattana; Tansuphasawasdikul, Somboon; Sang-a-gad, Pensiriwan; Pathipvanich, Panita; Thongbuaban, Srisuda; Wittayapraparat, Pakorn; Eiamsirikit, Naree; Buranawanitchakorn, Yuwadee; Yutthakasemsunt, Naruepon; Winiyakul, Narong; Decker, Luc; Barbier, Sylvaine; Koetsawang, Suporn; Sirirungsi, Wasna; McIntosh, Kenneth; Thanprasertsuk, Sombat; Lallemant, Marc

    2013-01-01

    Background Viral load (VL) is recommended for monitoring the response to highly active antiretroviral therapy (HAART) but is not routinely available in most low- and middle-income countries. The purpose of the study was to determine whether a CD4-based monitoring and switching strategy would provide a similar clinical outcome compared to the standard VL-based strategy in Thailand. Methods and Findings The Programs for HIV Prevention and Treatment (PHPT-3) non-inferiority randomized clinical trial compared a treatment switching strategy based on CD4-only (CD4) monitoring versus viral-load (VL). Consenting participants were antiretroviral-naïve HIV-infected adults (CD4 count 50–250/mm3) initiating non-nucleotide reverse transcriptase inhibitor (NNRTI)-based therapy. Randomization, stratified by site (21 public hospitals), was performed centrally after enrollment. Clinicians were unaware of the VL values of patients randomized to the CD4 arm. Participants switched to second-line combination with confirmed CD4 decline >30% from peak (within 200 cells from baseline) in the CD4 arm, or confirmed VL >400 copies/ml in the VL arm. Primary endpoint was clinical failure at 3 years, defined as death, new AIDS-defining event, or CD4 <50 cells/mm3. The 3-year Kaplan-Meier cumulative risks of clinical failure were compared for non-inferiority with a margin of 7.4%. In the intent to treat analysis, data were censored at the date of death or at last visit. The secondary endpoints were difference in future-drug-option (FDO) score, a measure of resistance profiles, virologic and immunologic responses, and the safety and tolerance of HAART. 716 participants were randomized, 356 to VL monitoring and 360 to CD4 monitoring. At 3 years, 319 participants (90%) in VL and 326 (91%) in CD4 were alive and on follow-up. The cumulative risk of clinical failure was 8.0% (95% CI 5.6–11.4) in VL versus 7.4% (5.1–10.7) in CD4, and the upper-limit of the one-sided 95% CI of the difference was

  13. 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

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

    PubMed

    Hesselmark, Eva; Plenty, Stephanie; Bejerot, Susanne

    2014-08-01

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

  15. Solar UV forecasts: a randomized trial assessing their impact on adults' sun-protection behavior.

    PubMed

    Dixon, Helen G; Hill, David J; Karoly, David J; Jolley, Damien J; Aden, Said M

    2007-06-01

    This study examined the effectiveness of solar UV forecasts and supporting communications in assisting adults to protect themselves from excessive weekend sun exposure. The study was conducted in Australia, where 557 adult participants with workplace e-mail and Internet access were randomly allocated to one of three weather forecast conditions: standard forecast (no UV), standard forecast + UV, standard forecast + UV + sun-protection messages. From late spring through summer and early autumn, they were e-mailed weekend weather forecasts late in the working week. Each Monday they were e-mailed a prompt to complete a Web-based questionnaire to report sun-related behavior and any sunburn experienced during the previous weekend. There were no significant differences between weather forecast conditions in reported hat use, sunscreen use, sun avoidance, or sunburn. Results indicate that provision of solar-UV forecasts in weather forecasts did not promote markedly enhanced personal sun-protection practices among the adults surveyed.

  16. 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.

  17. Undergraduate Cross Registration.

    ERIC Educational Resources Information Center

    Grupe, Fritz H.

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

  18. 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…

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

    PubMed

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

    2013-08-01

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

  20. 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

  1. 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

  2. Donepezil for the Treatment of Language Deficits in Adults With Down Syndrome: A Preliminary 24-Week Open Trial

    PubMed Central

    Heller, James H.; Spiridigliozzi, Gail A.; Sullivan, Jennifer A.; Doraiswamy, P. Murali; Krishnan, Ranga R.; Kishnani, Priya S.

    2009-01-01

    At present, there is no proven pharmacologic treatment for cognitive or language impairments in Down syndrome (DS). Cholinergic deficits have been documented in DS and linked to cognitive deficits. This study is a 24-week open-label clinical trial of donepezil hydrochloride for the treatment of language deficits in adults with DS. To our knowledge, this is the first prospective study to evaluate systematically the effects of donepezil, a cholinesterase inhibitor, on specific language domains in DS. The main finding that emerged was an improvement in expressive language performance following donepezil therapy. Despite the multiple methodological limitations, the results raise important questions regarding the role of the cholinergic system in language function and the specific effect of cholinergic therapy in the treatment of language impairment in DS. The results support the need for large-scale controlled studies of the effects of donepezil treatment on language and on other cognitive domains in DS. PMID:12494428

  3. 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

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

    PubMed

    Allegra, L; Bossi, R

    1988-08-01

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

  5. 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

  6. 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

  7. 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

  8. Integrated smoking cessation and binge drinking intervention for young adults: a pilot efficacy trial.

    PubMed

    Ames, Steven C; Pokorny, Steven B; Schroeder, Darrell R; Tan, Winston; Werch, Chudley E

    2014-05-01

    Alcohol consumption is strongly associated with cigarette smoking in young adults. The primary aim of this investigation was to complete a pilot evaluation of the efficacy of an integrated intervention that targets both cigarette smoking and binge drinking on the cigarette smoking and binge behavior of young adults at 6-month follow-up. Participants were 95 young adult (M=24.3; SD=3.5 years) smokers (≥1 cigarettes per day) who binge drink (≥1 time per month) and who were randomly assigned to standard treatment (n=47) involving six individual treatment visits plus eight weeks of nicotine patch therapy or the identical smoking cessation treatment integrated with a binge drinking intervention (integrated intervention; n=48). Using an intent-to-treat analysis for tobacco abstinence, at both 3 month end of treatment and 6 month follow-up, more participants who received integrated intervention were biochemically confirmed abstinent from tobacco than those who received standard treatment at 3 months (19% vs. 9%, p=0.06) and 6 months (21% vs. 9%, p=0.05). At 6 months, participants who completed the study and who received integrated intervention consumed fewer drinks per month (p<0.05) and number of binge drinking episodes per month (p<0.05) than those who received standard treatment. Preliminary data supports that integrated intervention enhances smoking cessation and reduces binge drinking compared to standard treatment.

  9. Phase II Trial of Talampanel, a Glutamate Receptor Inhibitor, for Adults with Recurrent Malignant Gliomas

    PubMed Central

    Iwamoto, Fabio M.; Kreisl, Teri N.; Kim, Lyndon; Duic, J. Paul; Butman, John A.; Albert, Paul S.; Fine, Howard A.

    2010-01-01

    Background: Glioma cells secrete glutamate and also express AMPA glutamate receptors, which contribute to proliferation, migration and neurotoxicity of malignant gliomas. Talampanel is an oral AMPA receptor inhibitor with excellent CNS penetration and good tolerability in clinical trials for epilepsy and other neurological disorders. Methods: We conducted a phase II trial to evaluate the efficacy of talampanel in patients with recurrent malignant glioma as measured by 6-month progression free survival (PFS6). Results: Thirty patients (22 glioblastomas [GBM], 8 anaplastic gliomas [AG]; 63% men) with median age of 51 years (range, 20 to 67) and median KPS of 80 were included. Patients tolerated treatment well and most adverse events were mild and reversible; the most common toxicities were fatigue (27%), dizziness (23%) and ataxia (17%). There was only one partial response (5%) in the GBM stratum and none among AG patients. With a median follow-up of 13 months, 28 patients (93%) had died. The PFS6 was 4.6% for the initial 22 GBM patients and the study was terminated early due to treatment futility; PFS6 was 0% for 8 AG patients. Median PFS was 5.9 weeks for GBM and 8.9 weeks for AG patients. Median overall survival was 13 weeks for GBM and 14 months for AG patients. Conclusion: Talampanel was well tolerated but had no significant activity as a single agent in unselected recurrent malignant gliomas. PMID:20143438

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. Effects of folic acid supplementation on serum folate and plasma homocysteine concentrations in older adults: a dose-response trial.

    PubMed

    Anderson, Cheryl A M; Jee, Sun Ha; Charleston, Jeanne; Narrett, Matthew; Appel, Lawrence J

    2010-10-15

    The authors' objective in this study was to estimate the changes in serum folate and homocysteine concentration that resulted from 6 weeks of supplementation with folic acid. A randomized, double-blind, placebo-controlled, dose-response trial with a parallel-group design was conducted. A total of 133 participants aged 60-90 years (70% female, 19% nonwhite) were assigned to receive 0, 100, 400, 1,000, or 2,000 μg/day of folic acid for 6 weeks. Data were collected in the United States between June and September 1996. At baseline, median serum folate and plasma homocysteine concentrations were 5.7 ng/mL (interquartile range (25th-75th percentiles), 4.1-7.8) and 8.3 μmol/L (interquartile range, 7.1-10.0), respectively. As the folic acid dose increased, serum folate levels increased (P-trend < 0.001). There was no dose-response relation with homocysteine level among all participants. In analyses restricted to persons with the lowest serum folate concentration (<4.5 ng/mL) at baseline, there was a trend (P = 0.06) toward decreased homocysteine levels with increasing folic acid dose. In healthy, older adults with adequate folate status, folic acid supplementation is not beneficial for homocysteine reduction. However, for older adults with low serum folate levels, supplementation will improve folate status and may be beneficial for lowering homocysteine concentrations.

  16. 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.

  17. 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.

  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. 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…

  20. 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

  1. 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

  2. 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

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

    PubMed Central

    Côté, José

    2016-01-01

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

  4. Osteo-cise: Strong Bones for Life: Protocol for a community-based randomised controlled trial of a multi-modal exercise and osteoporosis education program for older adults at risk of falls and fractures

    PubMed Central

    2012-01-01

    , balance and function (four square step test, functional reach test, timed up-and-go test and 30-second sit-to-stand), falls incidence and health-related quality of life. Cost-effectiveness will also be assessed. Discussion The findings from the Osteo-cise: Strong Bones for Life study will provide new information on the efficacy of a targeted multi-modal community-based exercise program incorporating high velocity resistance training, together with an osteoporosis education and behavioural change program for improving multiple risk factors for falls and fracture in older adults at risk of fragility fracture. Trial registration Australian New Zealand Clinical Trials Registry reference ACTRN12609000100291 PMID:22640372

  5. 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…

  6. 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

  7. 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

  8. 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

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

    PubMed Central

    2011-01-01

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

  10. Immunogenicity, reactogenicity and safety of an inactivated quadrivalent influenza vaccine candidate versus inactivated trivalent influenza vaccine: a phase III, randomized trial in adults aged ≥18 years

    PubMed Central

    2013-01-01

    TIV, without interfering with antibody responses to the three shared antigens. The additional antigen did not appear to alter the safety profile of QIV compared with TIV. This suggests that the candidate QIV is a viable alternative to TIV for use in adults, and could potentially improve protection against influenza B. Trial registration Clinical Trials.gov: NCT01204671/114269 PMID:23883186

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

    PubMed

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

    2011-04-01

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

  12. 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

  13. Computerized scintigraphic technique for the evaluation of adult respiratory distress syndrome: initial clinical trials

    SciTech Connect

    Tatum, J.L.; Burke, T.S.; Sugerman, H.J.; Strash, A.M.; Hirsch, J.I.; Fratkin, M.J.

    1982-04-01

    Eleven patients with suspected adult respiratory distress syndrome (ARDS) and five control patients were studied using a computerized gamma imaging and analysis technique and 99mTc-labeled human serum albumin. The heart and right lung were imaged, lung:heart ratio was plotted vs. time, and a linear regression was fitted to the data points displayed. The slope of this fit was termed the ''slope index.'' An index value of 2 standard deviations greater than the control mean was considered positive. Radiographs from the six positive studies revealed typical diffuse air-space disease. Radiographs from two of the five negative studies demonstrated air-space consolidation. Both of these patients had elevated pulmonary capillary wedge pressure, cardiomegaly, and clinical course consistent with cardiogenic pulmonary edema. These preliminary data demonstrated a good correlation between positive slope index and clinical ARDS.

  14. 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

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed 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

  17. Randomized Controlled Clinical Trial of Zinc Supplementation to Prevent Immunological Failure in HIV-Positive Adults1,2

    PubMed Central

    Baum, Marianna K; Lai, Shenghan; Sales, Sabrina; Page, J. Bryan; Campa, Adriana

    2010-01-01

    Background Adequate zinc is critical for immune function; however, zinc deficiency occurs in >50% of HIV-infected adults. We examined the safety and efficacy of long-term zinc supplementation on HIV disease progression. Methods A prospective randomized controlled clinical trial was conducted with 231 HIV+ adults with low plasma zinc levels (<0.75 μg/ml), randomly assigned into zinc (12 mg of elemental zinc for women and 15 mg for men) or placebo, for 18 months. The primary endpoint was immunological failure. HIV-viral load and CD4+ cell count were determined every 6 months. Questionnaires, pill-counts, plasma zinc and C-reactive protein (hsCRP) were used to monitor adherence with study supplements and ART. Intent-to-treat analysis utilized multiple-event analysis, treating CD4+ cell count <200 cells/mm3 as recurrent immunological failure event. Cox proportional-hazard models and the general-linear model were used to analyze morbidity and mortality data. Results Zinc supplementation for 18 months reduced four-fold the likelihood of immunological failure, controlling for age, gender, lack of food, baseline CD4+ cell count, viral load, and antiretroviral therapy (RR=0.24[95%CI:0.10,0.56],p<0.002). Viral load indicated poor control with ART but was not affected by zinc supplementation. Zinc supplementation also reduced the rate of diarrhea by more than half (OR=0.4[95%CI:0.183-0.981],p=0.019) compared to placebo. There was no significant difference in mortality between the two groups. Conclusion This study demonstrated that long-term (18-month) zinc supplementation at nutritional levels delayed immunological failure and decreased diarrhea over time. This evidence supports the use of zinc supplementation as an adjunct therapy in HIV+ adult cohorts with poor viral control. Summary This study demonstrated that long-term (18-month) zinc supplementation at nutritional levels delayed immunological failure and decreased diarrhea over time. This evidence supports the use of

  18. 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

  19. 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.

  20. 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.

  1. 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

  2. Postcard intervention for depression in community-dwelling older adults: A randomised controlled trial.

    PubMed

    Imai, Hissei; Furukawa, Toshiaki A; Okumiya, Kiyohito; Wada, Taizo; Fukutomi, Eriko; Sakamoto, Ryota; Fujisawa, Michiko; Ishimoto, Yasuko; Kimura, Yumi; Chen, Wen-ling; Tanaka, Mire; Matsubayashi, Kozo

    2015-09-30

    Depression in older adults erodes their health, quality of life and the economy. Existing interventions are not feasible for broad application at the community. Postcard intervention only requires a few resources, and previous studies have shown its effectiveness for patients following drug overdose, self-harm and hospitalisation for major depression. The purpose of the present study is to evaluate the effectiveness of a postcard intervention. Participants were community-dwelling individuals, aged 65 or older, who eat meals alone and with the score of 4 or higher on the 15-item Geriatric Depression Scale (GDS-15). We enrolled 184 eligible participants, with 93 in the intervention and 91 in the control arm. Postcards were sent to participants once a month for eight months. Primary outcome was the GDS-15 score at post-intervention. Secondary outcomes were quality of life and activities of daily living. There was no significant difference in primary and secondary outcomes between completers of the intervention and the control arm. However, most of the participants who received intervention thought the intervention was effective. The postcard intervention for depression in community-dwelling elderly people in Japan is neither feasible nor effective. However, the descriptive results suggest that the intervention may be effective given different parameters.

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

    PubMed Central

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

    2011-01-01

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

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

    PubMed

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

    2011-04-01

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

  5. 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

  6. 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

  7. 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

  8. 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

  9. Family-Focused Treatment for Adolescents and Young Adults at High Risk for Psychosis: Results of a Randomized Trial

    PubMed Central

    Miklowitz, David J.; O’Brien, Mary P.; Schlosser, Danielle A.; Addington, Jean; Candan, Kristin A.; Marshall, Catherine; Domingues, Isabel; Walsh, Barbara C.; Zinberg, Jamie L.; De Silva, Sandra D.; Friedman-Yakoobian, Michelle; Cannon, Tyrone D.

    2014-01-01

    Objective Longitudinal studies have begun to clarify the phenotypic characteristics of adolescents and young adults at clinical high risk for psychosis. This 8-site randomized trial examined whether a 6-month program of family psychoeducation was effective in reducing the severity of attenuated positive and negative psychotic symptoms and enhancing functioning among individuals at high risk. Method Adolescents and young adults (mean 17.4±4.1 years) with attenuated positive psychotic symptoms, brief and intermittent psychosis, or genetic risk with functional deterioration were randomly assigned to 18 sessions of family-focused therapy for individuals at clinical high risk (FFT-CHR) in 6 months or 3 sessions of family psychoeducation (enhanced care, or EC). FFT-CHR included psychoeducation about early signs of psychosis, stress management, communication training, and problem-solving skills training, whereas EC focused on symptom prevention. Independent evaluators assessed participants at baseline and 6 months on positive and negative symptoms and social-role functioning. Results Of 129 participants, 102 (79.1%) were followed at 6 months. Participants in FFT-CHR showed greater improvements in attenuated positive symptoms over 6 months than participants in EC (F[1,97]=5.49, P=.02). Negative symptoms improved independently of psychosocial treatments. Changes in psychosocial functioning depended on age: participants over 19 years showed more role improvement in FFT-CHR, whereas participants between 16 and 19 years showed more role improvement in EC. The results were independent of concurrent pharmacotherapy. Conclusion Interventions that focus on improving family relationships may have prophylactic efficacy in individuals at high risk for psychosis. Future studies should examine the specificity of effects of family intervention compared to individual therapy of the same duration and frequency. PMID:25062592

  10. A Trial of D-Cycloserine to Treat Stereotypies in Older Adolescents and Young Adults With Autism Spectrum Disorder

    PubMed Central

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

    2015-01-01

    Objectives Autism spectrum disorders (ASDs) have core impairments in social communication as well as the presence of repetitive, stereotypic behaviors and restricted interests. Older adolescents and young adults are particularly impacted by these deficits. Preclinical data implicate glutamatergic dysfunction in the pathophysiology of ASDs. D-Cycloserine (DCS), a partial glycineB agonist at the N-methyl-D-aspartic acid receptor site, has been shown to improve sociability in mouse models and a small human study. The sensitivity of the obligatory glycineB co-agonist binding site may change with daily administration of DCS as a result of agonist-induced desensitization. The efficacy of a “pulsed” once-weekly administration versus “daily” administration of DCS was compared. Methods Males and females, ages 14 to 25 years, with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Revision diagnosis of an ASD were enrolled in a double-blind, randomized 10-week trial consisting of 8 weeks of active drug with either weekly or daily administration of 50 mg of DCS followed by a 2-week follow-up visit. Results For the purposes of this study, no statistical or clinical differences existed between the 2 dosage groups on the Aberrant Behavior Checklist subscale 3, which measures stereotypies/repetitive movements. When combining groups, a statistically significant decrease of 37% was found from baseline to week 8 when study drug was completed using a linear mixed effects model (P = 0.003). Conclusions D-Cycloserine was shown to be effective in improving stereotypic symptoms in older adolescents and young adults with ASDs measured by the Aberrant Behavior Checklist subscale 3. In addition, DCS was safe and well tolerated. PMID:24824660

  11. Immunogenicity and safety of Intanza(®)/IDflu(®) intradermal influenza vaccine in South Korean adults: a multicenter, randomized trial.

    PubMed

    Hoon Han, Sang; Hee Woo, Jun; Weber, Francoise; Joo Kim, Woo; Ran Peck, Kyong; Il Kim, Sang; Hwa Choi, Young; Myung Kim, June

    2013-09-01

    Intanza(®)/IDflu(®) (Sanofi Pasteur, Lyon, France) is an intradermal inactivated trivalent influenza vaccine developed as an alternative to intramuscular influenza vaccine. The objective of this study was to confirm the immunogenicity and safety of Intanza/IDflu in South Korean adults. In a phase IV multicenter trial, South Korean adults 18-59 y old (n = 120) and ≥ 60 y old (n = 120) were randomized 1:1 to receive a single dose of Intanza/IDflu (9 µg for 18-59 y, 15 µg for ≥ 60 y) or trivalent intramuscular vaccine (Vaxigrip(®) 15 µg, Sanofi Pasteur, Lyon, France). Blood was collected on pre-vaccination (day 0) and on day 21. Hemagglutination inhibition titers, seroprotection rates and seroconversion rates were determined on day 21. Geometric mean titers, seroprotection and seroconversion rates were similar between the intradermal and intramuscular vaccines in both age groups for all three vaccine strains (A/H1N1, A/H3N2 and B). Both vaccines met Committee for Medicinal Products for Human Use criteria for all three strains. Solicited systemic reactions of the intradermal groups were generally mild, transient, and similar to those of the intramuscular groups. Solicited injection site reactions were more frequent in the intradermal groups but were mostly mild, transient, and consisted mainly of pain, erythema, and pruritus. No treatment-related serious adverse events or other safety concerns were reported. These results confirm that Intanza/IDflu is an effective and well-tolerated alternative to IM influenza vaccination. (Clinicaltrials.gov NCT ID: NCT01215669).

  12. 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

  13. 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.

  14. 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

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed

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

    2015-06-01

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

  17. 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

  18. Phase IV: randomized controlled trial to evaluate lot consistency of trivalent split influenza vaccines in healthy adults.

    PubMed

    Song, Joon Young; Cheong, Hee Jin; Lee, Jacob; Wie, Seong-Heon; Park, Kyung-Hwa; Kee, Sae Yoon; Jeong, Hye Won; Kim, Yeon-Sook; Noh, Ji Yun; Choi, Won Suk; Park, Dae Won; Sohn, Jang Wook; Kim, Woo Joo

    2014-01-01

    Influenza vaccines are the primary method for preventing influenza and its complications. Considering the increasing demand for influenza vaccines, vaccine manufacturers are required to establish large-scale production systems. This phase IV randomized trial was conducted to evaluate the lot consistency of trivalent split influenza vaccines regarding immunogenicity and safety. A total of 1,023 healthy adults aged 18-64 y were enrolled in the study. Subjects were randomly assigned in a 1:1 ratio to receive the GC FLU® Prefilled Syringe or the GC FLU® Injection, and they were further randomized to one of 3 lots of each vaccine in a 1:1:1 ratio. In both GC FLU® Injection and GC FLU® Prefilled Syringe groups, immune responses were equivalent between lots for each of the 3 vaccine strains on day 21. The 2-sided 95% CI of GMT ratios between pairs of lots were between 0.67 and 1.5, meeting the equivalence criteria. After vaccination, all 3 criteria of the European Medicines Agency were met in both GC FLU® Injection and GC FLU® Prefilled Syringe groups. The vaccines showed tolerable safety profiles without serious adverse events. The demonstration of lot consistency, robust immunogenic responses and favorable safety profiles support the reliability of mass-manufacturing systems for the GC FLU® Injection and GC FLU® Prefilled Syringe.

  19. Comparing tailored and narrative worksite interventions at increasing colonoscopy adherence in adults 50-75: a randomized controlled trial.

    PubMed

    Jensen, Jakob D; King, Andy J; Carcioppolo, Nick; Krakow, Melinda; Samadder, N Jewel; Morgan, Susan

    2014-03-01

    Research has identified several communication strategies that could increase adherence to colorectal cancer screening recommendations. Two promising strategies are tailoring and narrative-based approaches. Tailoring is the personalization of information based on individual characteristics. Narrative-based approaches use stories about similar others to counter perceived barriers and cultivate self-efficacy. To compare these two approaches, a randomized controlled trial was carried out at 8 worksites in Indiana. Adults 50-75 (N = 209) received one of four messages about colorectal cancer screening: stock, narrative, tailored, tailored narrative. The primary outcome was whether participants filed a colonoscopy claim in the 18 months following the intervention. Individuals receiving narrative messages were 4 times more likely to screen than those not receiving narrative messages. Tailoring did not increase screening behavior overall. However, individuals with higher cancer information overload were 8 times more likely to screen if they received tailored messages. The results suggest that narrative-based approaches are more effective than tailoring at increasing colorectal cancer screening in worksite interventions. Tailoring may be valuable as a strategy for reaching individuals with high overload, perhaps as a follow-up effort to a larger communication campaign.

  20. 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

  1. Results of a feasibility and acceptability trial of an online smoking cessation program targeting young adult nondaily smokers.

    PubMed

    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.

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. Effects of strength vs aerobic exercise on pain severity in adults with fibromyalgia: a randomized equivalence trial.

    PubMed

    Hooten, W Michael; Qu, Wenchun; Townsend, Cynthia O; Judd, Jeffrey W

    2012-04-01

    Strength training and aerobic exercise have beneficial effects on pain in adults with fibromyalgia. However, the equivalence of strengthening and aerobic exercise has not been reported. The primary aim of this randomized equivalence trial involving patients with fibromyalgia admitted to an interdisciplinary pain treatment program was to test the hypothesis that strengthening (n=36) and aerobic (n=36) exercise have equivalent effects (95% confidence interval within an equivalence margin ± 8) on pain, as measured by the pain severity subscale of the Multidimensional Pain Inventory. Secondary aims included determining the effects of strengthening and aerobic exercise on peak Vo(2) uptake, leg strength, and pressure pain thresholds. In an intent-to-treat analysis, the mean (± standard deviation) pain severity scores for the strength and aerobic groups at study completion were 34.4 ± 11.5 and 37.6 ± 11.9, respectively. The group difference was -3.2 (95% confidence interval, -8.7 to 2.3), which was within the equivalence margin of Δ8. Significant improvements in pain severity (P<.001), peak Vo(2) (P<.001), strength (P<.001), and pain thresholds (P<.001) were observed from baseline to week 3 in the intent-to-treat analysis; however, patients in the aerobic group (mean change 2.0 ± 2.6 mL/kg/min) experienced greater gains (P<.013) in peak Vo(2) compared to the strength group (mean change 0.4 ± 2.6 mL/kg/min). Knowledge of the equivalence and physiological effects of exercise have important clinical implications that could allow practitioners to target exercise recommendations on the basis of comorbid medical conditions or patient preference for a particular type of exercise. This study found that strength and aerobic exercise had equivalent effects on reducing pain severity among patients with fibromyalgia.

  8. Intensive lifestyle intervention improves physical function among obese adults with knee pain: findings from the Look AHEAD trial.

    PubMed

    Foy, Capri G; Lewis, Cora E; Hairston, Kristen G; Miller, Gary D; Lang, Wei; Jakicic, John M; Rejeski, W Jack; Ribisl, Paul M; Walkup, Michael P; Wagenknecht, Lynne E

    2011-01-01

    Lifestyle interventions have resulted in weight loss or improved physical fitness among individuals with obesity, which may lead to improved physical function. This prospective investigation involved participants in the Action for Health in Diabetes (Look AHEAD) trial who reported knee pain at baseline (n = 2,203). The purposes of this investigation were to determine whether an Intensive Lifestyle Intervention (ILI) condition resulted in improvement in self-reported physical function from baseline to 12 months vs. a Diabetes Support and Education (DSE) condition, and whether changes in weight or fitness mediated the effect of the ILI. Outcome measures included the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain, stiffness, and physical function subscales, and WOMAC summary score. ILI participants exhibited greater adjusted mean weight loss (s.e.) vs. DSE participants (-9.02 kg (0.48) vs. -0.78 kg (0.49); P < 0.001)). ILI participants also demonstrated more favorable change in WOMAC summary scores vs. DSE participants (β (s.e.) = -1.81 (0.63); P = 0.004). Multiple regression mediation analyses revealed that weight loss was a mediator of the effect of the ILI intervention on change in WOMAC pain, function, and summary scores (P < 0.001). In separate analyses, increased fitness also mediated the effect of the ILI intervention upon WOMAC summary score (P < 0.001). The ILI condition resulted in significant improvement in physical function among overweight and obese adults with diabetes and knee pain. The ILI condition also resulted in significant weight loss and improved fitness, which are possible mechanisms through which the ILI condition improved physical function.

  9. 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

  10. Phase III, randomized controlled trial to evaluate lot consistency of a trivalent subunit egg-based influenza vaccine in adults.

    PubMed

    Rivera, Luis; Mazara, Sonia; Vargas, Maria; Fragapane, Elena; Casula, Daniela; Groth, Nicola

    2012-07-27

    Vaccination is the most effective preventive strategy to control influenza. The demonstration of lot-to-lot consistency to confirm the reliability of the manufacturing process has become a mandatory step in vaccine development. This phase III, observer-blind, controlled trial assessed lot-to-lot consistency, immunogenicity, and safety of a subunit trivalent influenza vaccine (Agrippal®, Novartis Vaccines and Diagnostics) in healthy adults aged 18-49 years. The immunogenicity and safety profile of Agrippal was compared with a control vaccine (Fluvirin®, Novartis Vaccines and Diagnostics). A total of 1507 subjects were randomized 2:2:2:1 to receive one vaccination of one of the three lots of influenza vaccine or control vaccine. Antibody levels were measured by hemagglutination inhibition assay on days 1 and 22. Adverse reactions were solicited via diary cards for 7 days after vaccination, and unsolicited adverse events were collected throughout the study period. Equivalence of day 22 immune responses to the three lots was shown for each of the three strains. Robust immunogenic responses after one dose were observed for all vaccine groups, and both Center for Biologics Evaluation and Research criteria for licensure of influenza vaccines were met for all three virus strains. Both vaccines exhibited a robust safety profile and were well tolerated, with no differences in local and systemic solicited reactions or in unsolicited adverse events. The demonstration of consistency between manufacturing lots confirms for purposes of clinical development the reliability of the production process. The robust immunogenic responses and favorable safety profiles further support the use of trivalent subunit influenza vaccines Agrippal and Fluvirin for active immunization against influenza. PMID:22659448

  11. 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

  12. 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

  13. How did a Housing First intervention improve health and social outcomes among homeless adults with mental illness in Toronto? Two-year outcomes from a randomised trial

    PubMed Central

    O'Campo, Patricia; Stergiopoulos, Vicky; Nir, Pam; Levy, Matthew; Misir, Vachan; Chum, Antony; Arbach, Bouchra; Nisenbaum, Rosane; To, Matthew J; Hwang, Stephen W

    2016-01-01

    Objectives We studied the impact of a Housing First (HF) intervention on housing, contact with the justice system, healthcare usage and health outcomes among At Home/Chez Soi randomised trial participants in Toronto, a city with an extensive service network for social and health services for individuals who are experiencing homelessness and mental illness. Methods Participants identified as high needs were randomised to receive either the intervention which provided them with housing and supports by an assertive community treatment team (HF+ACT) or treatment as usual (TAU). Participants (N=197) had in-person interviews every 3 months for 2 years. Results The HF+ACT group spent more time stably housed compared to the TAU group with the mean difference between the groups of 45.8% (95% CI 37.1% to 54.4%, p<0.0001). Accounting for baseline differences, HF+ACT group showed significant improvements over TAU group for community functioning, selected quality-of-life subscales and arrests at some time points during follow-up. No differences between HF+ACT and TAU groups over the follow-up were observed for health service usage, community integration and substance use. Conclusions HF for individuals with high levels of need increased housing stability and selected health and justice outcomes over 2 years in a city with many social and health services. Trial registration number ISRCTN42520374. PMID:27619826

  14. 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

  15. 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

  16. 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

  17. 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.

  18. 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...

  19. 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...

  20. 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...

  1. 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...

  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. 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

  4. 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…

  5. Computer-Assisted Registration and Student Statistics Reporting System.

    ERIC Educational Resources Information Center

    Wilson, G. Robert

    This report describes the development and evaluation of a computer-assisted, student-interactive registration program that was designed for a community school in southeastern Florida which offers courses in the curricular areas of adult basic education, GED, adult high school, business and office education, home economics, industrial education,…

  6. Effectiveness and cost-effectiveness of a novel, group self-management course for adults with chronic musculoskeletal pain: study protocol for a multicentre, randomised controlled trial (COPERS)

    PubMed Central

    Carnes, Dawn; Taylor, Stephanie JC; Homer, Kate; Eldridge, Sandra; Bremner, Stephen; Pincus, Tamar; Rahman, Anisur; Underwood, Martin

    2013-01-01

    Introduction Chronic musculoskeletal pain is a common condition that often responds poorly to treatment. Self-management courses have been advocated as a non-drug pain management technique, although evidence for their effectiveness is equivocal. We designed and piloted a self-management course based on evidence for effectiveness for specific course components and characteristics. Methods/analysis COPERS (coping with persistent pain, effectiveness research into self-management) is a pragmatic randomised controlled trial testing the effectiveness and cost-effectiveness of an intensive, group, cognitive behavioural-based, theoretically informed and manualised self-management course for chronic pain patients against a control of best usual care: a pain education booklet and a relaxation CD. The course lasts for 15 h, spread over 3 days, with a –2 h follow-up session 2 weeks later. We aim to recruit 685 participants with chronic musculoskeletal pain from primary, intermediate and secondary care services in two UK regions. The study is powered to show a standardised mean difference of 0.3 in the primary outcome, pain-related disability. Secondary outcomes include generic health-related quality of life, healthcare utilisation, pain self-efficacy, coping, depression, anxiety and social engagement. Outcomes are measured at 6 and 12 months postrandomisation. Pain self-efficacy is measured at 3 months to assess whether change mediates clinical effect. Ethics/dissemination Ethics approval was given by Cambridgeshire Ethics 11/EE/046. This trial will provide robust data on the effectiveness and cost-effectiveness of an evidence-based, group self-management programme for chronic musculoskeletal pain. The published outcomes will help to inform future policy and practice around such self-management courses, both nationally and internationally. Trial registration ISRCTN24426731. PMID:23358564

  7. 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

  8. 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.

  9. 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

  10. 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

  11. 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

  12. 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,...

  13. 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

  14. 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

  15. 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.

  16. 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

  17. Correlates of 1-year incidence of urinary incontinence in older Latino adults enrolled in a community-based physical activity trial.

    PubMed

    Morrisroe, Shelby N; Rodriguez, Larissa V; Wang, Pin-Chieh; Smith, Ariana L; Trejo, Laura; Sarkisian, Catherine A

    2014-04-01

    The prevalence of urinary incontinence (UI) among older urban Latinos is high. Insight into etiologies of and contributing factors to the development of this condition is needed. This longitudinal cohort study identified correlates of 1-year incidence of UI in older community-dwelling Latino adults participating in a senior center-based physical activity trial in Los Angeles, California. Three hundred twenty-eight Latinos aged 60 to 93 participating in Caminemos, a randomized trial to increase walking, were studied. Participants completed an in-person survey and physical performance measures at baseline and 1 year. UI was measured using the International Consultation on Incontinence item: "How often do you leak urine?" Potential correlates of 1-year incidence of UI included sociodemographic, behavioral, medical, physical, and psychosocial characteristics. The overall incidence of UI at 1 year was 17.4%. Incident UI was associated with age, baseline activity of daily living impairment, health-related quality of life (HRQoL), mean steps per day, and depressive symptoms. Multivariate logistic regression models revealed that improvement in physical performance score (odds ratio (OR) = 0.69, 95% confidence interval (CI) = 0.50-0.95) and high baseline physical (OR = 0.60, 95% CI = 0.40-0.89) and mental (OR = 0.62, 95% CI = 0.43-0.91) HRQoL were independently associated with lower rates of 1-year incident UI. An increase in depressive symptoms at 1 year (OR = 4.48, 95% CI = 1.02-19.68) was independently associated with a higher rate of incident UI. One-year UI incidence in this population of older urban Latino adults participating in a walking trial was high but was lower in those who improved their physical performance. Interventions aimed at improving physical performance may help prevent UI in older Latino adults.

  18. 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.

  19. 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

  20. 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

  1. 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

  2. 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

  3. An Inactivated Ross River Virus Vaccine Is Well Tolerated and Immunogenic in an Adult Population in a Randomized Phase 3 Trial

    PubMed Central

    van der Velden, Maikel V. W.; Portsmouth, Daniel; Draxler, Wolfgang; O'Rourke, Maria; Richmond, Peter; Hall, Stephen; McBride, William J. H.; Redfern, Andrew; Aaskov, John; Barrett, P. Noel; Aichinger, Gerald

    2014-01-01

    Ross River virus (RRV) is endemic in Australia and several South Pacific Islands. More than 90,000 cases of RRV disease, which is characterized by debilitating polyarthritis, were reported in Australia in the last 20 years. There is no vaccine available to prevent RRV disease. A phase 3 study was undertaken at 17 sites in Australia to investigate the safety and immunogenicity of an inactivated whole-virus Vero cell culture-derived RRV vaccine in 1,755 healthy younger adults aged 16 to 59 years and 209 healthy older adults aged ≥60 years. Participants received a 2.5-μg dose of Al(OH)3-adjuvanted RRV vaccine, with a second and third dose after 3 weeks and 6 months, respectively. Vaccine-induced RRV-specific neutralizing and total IgG antibody titers were measured after each immunization. Vaccine safety was monitored over the entire study period. The vaccine was safe and well-tolerated after each vaccination. No cases of arthritis resembling RRV disease were reported. The most frequently reported systemic reactions were headache, fatigue, and malaise; the most frequently reported injection site reactions were tenderness and pain. After the third immunization, 91.5% of the younger age group and 76.0% of the older age group achieved neutralizing antibody titers of ≥1:10; 89.1% of the younger age group and 70.9% of the older age group achieved enzyme-linked immunosorbent assay (ELISA) titers of ≥11 PanBio units. A whole-virus Vero cell culture-derived RRV vaccine is well tolerated in an adult population and induces antibody titers associated with protection from RRV disease in the majority of individuals. (This study is registered at www.clinicaltrials.gov under registration no. NCT01242670.) PMID:25540268

  4. Immunogenicity and safety after booster vaccination of diphtheria, tetanus, and acellular pertussis in young adults: an open randomized controlled trial in Japan.

    PubMed

    Hara, Megumi; Okada, Kenji; Yamaguchi, Yuko; Uno, Shingo; Otsuka, Yasuko; Shimanoe, Chisato; Nanri, Hinako; Horita, Mikako; Ozaki, Iwata; Nishida, Yuichiro; Tanaka, Keitaro

    2013-12-01

    The recent increase of pertussis in young adults in Japan is hypothesized to be due in part to waning protection from the acellular pertussis vaccine. While a booster immunization may prevent an epidemic of pertussis among these young adults, little is known about the safety and immunogenicity of such a booster with the diphtheria, tetanus, and acellular pertussis vaccine (DTaP), which is currently available in Japan. One hundred and eleven medical students with a mean age of 19.4 years were randomly divided into 2 groups of 55 and 56 subjects and received, respectively, 0.2 or 0.5 ml of DTaP. Immunogenicity was assessed by performing the immunoassay using serum, and the geometric mean concentration (GMC), GMC ratio (GMCR), seropositive rate, and booster response rate were calculated. Adverse reactions and adverse events were monitored for 7 days after vaccination. After booster vaccination in the two groups, significant increases were found in the antibodies against pertussis toxin, filamentous hemagglutinin, diphtheria toxoid, and tetanus toxoid, and the booster response rates for all subjects reached 100%. The GMCs and GMCRs against all antigens were significantly higher in the 0.5-ml group than in the 0.2-ml group. No serious adverse events were observed. Frequencies of local reactions were similar in the 2 groups, although the frequency of severe local swelling was significantly higher in the 0.5-ml group. These data support the acceptability of booster immunization using both 0.2 and 0.5 ml of DTaP for young adults for controlling pertussis. (This study was registered at UMIN-CTR under registration number UMIN000010672.).

  5. 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

  6. 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

  7. 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…

  8. 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

  9. Changes in sexual behavior of HIV-infected older adults enrolled in a clinical trial of standalone group psychotherapies targeting depression.

    PubMed

    Lovejoy, Travis I; Heckman, Timothy G; Sikkema, Kathleen J; Hansen, Nathan B; Kochman, Arlene

    2015-01-01

    By 2015, one-half of all HIV-positive persons in the U.S. will be 50-plus years of age, and as many as 30 % of older adults living with HIV/AIDS continue to engage in unprotected sexual intercourse. Contemporary positive prevention models often include mental health treatment as a key component of HIV prevention interventions. This secondary data analysis characterized longitudinal patterns of sexual behavior in HIV-positive older adults enrolled in a randomized controlled trial of group mental health interventions and assessed the efficacy of psychosocial treatments that targeted depression to reduce sexual risk behavior. Participants were 295 HIV-positive adults ≥50 years of age experiencing mild to severe depressive symptoms, randomized to one of three study conditions: a 12-session coping improvement group intervention, a 12-session interpersonal support group intervention, or individual therapy upon request. Approximately one-fifth of participants reported one or more occasions of unprotected anal or vaginal intercourse with HIV-negative sexual partners or persons of unknown HIV serostatus over the study period. Changes in sexual behavior did not vary by intervention condition, indicating that standalone treatments that target and reduce depression may be insufficient to reduce sexual risk behavior in depressed HIV-positive older adults.

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

    PubMed

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

    2011-12-01

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

  11. A new combined surface and volume registration

    NASA Astrophysics Data System (ADS)

    Lepore, Natasha; Joshi, Anand A.; Leahy, Richard M.; Brun, Caroline; Chou, Yi-Yu; Pennec, Xavier; Lee, Agatha D.; Barysheva, Marina; De Zubicaray, Greig I.; Wright, Margaret J.; McMahon, Katie L.; Toga, Arthur W.; Thompson, Paul M.

    2010-03-01

    3D registration of brain MRI data is vital for many medical imaging applications. However, purely intensitybased approaches for inter-subject matching of brain structure are generally inaccurate in cortical regions, due to the highly complex network of sulci and gyri, which vary widely across subjects. Here we combine a surfacebased cortical registration with a 3D fluid one for the first time, enabling precise matching of cortical folds, but allowing large deformations in the enclosed brain volume, which guarantee diffeomorphisms. This greatly improves the matching of anatomy in cortical areas. The cortices are segmented and registered with the software Freesurfer. The deformation field is initially extended to the full 3D brain volume using a 3D harmonic mapping that preserves the matching between cortical surfaces. Finally, these deformation fields are used to initialize a 3D Riemannian fluid registration algorithm, that improves the alignment of subcortical brain regions. We validate this method on an MRI dataset from 92 healthy adult twins. Results are compared to those based on volumetric registration without surface constraints; the resulting mean templates resolve consistent anatomical features both subcortically and at the cortex, suggesting that the approach is well-suited for cross-subject integration of functional and anatomic data.

  12. Earth Science Imagery Registration

    NASA Technical Reports Server (NTRS)

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

    2003-01-01

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

  13. Registration Study. Research Note.

    ERIC Educational Resources Information Center

    Baratta, Mary Kathryne

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

  14. CUNY's Voter Registration System.

    ERIC Educational Resources Information Center

    Hershenson, Jay; And Others

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

  15. A multicenter, randomized, double-blind, controlled phase 3 trial of fixed-dose brexpiprazole for the treatment of adults with acute schizophrenia.

    PubMed

    Kane, John M; Skuban, Aleksandar; Ouyang, John; Hobart, Mary; Pfister, Stephanie; McQuade, Robert D; Nyilas, Margaretta; Carson, William H; Sanchez, Raymond; Eriksson, Hans

    2015-05-01

    The objective of this study was to evaluate the efficacy, safety and tolerability of brexpiprazole versus placebo in adults with acute schizophrenia. This was a 6-week, multicenter, placebo-controlled double-blind phase 3 study. Patients with acute schizophrenia were randomized to brexpiprazole 1, 2 or 4 mg, or placebo (2:3:3:3) once daily. The primary endpoint was changed from baseline at week 6 in Positive and Negative Syndrome Scale (PANSS) total score; the key secondary endpoint was Clinical Global Impressions-Severity (CGI-S) at week 6. Brexpiprazole 4 mg showed statistically significant improvement versus placebo (treatment difference: -6.47, p=0.0022) for the primary endpoint. Improvement compared with placebo was also seen for the key secondary endpoint (treatment difference: -0.38, p=0.0015), and on multiple secondary efficacy outcomes. Brexpiprazole 1 and 2mg also showed numerical improvements versus placebo, although p>0.05. The most common treatment-emergent adverse events were headache, insomnia and agitation; incidences of akathisia were lower in the brexpiprazole treatment groups (4.2%-6.5%) versus placebo (7.1%). Brexpiprazole treatment was associated with moderate weight gain at week 6 (1.23-1.89 kg versus 0.35 kg for placebo); there were no clinically relevant changes in laboratory parameters and vital signs. In conclusion, brexpiprazole 4 mg is an efficacious and well-tolerated treatment for acute schizophrenia in adults. Clinical Trials.gov NCT01393613; BEACON trial.

  16. Internet-delivered treatment for older adults with anxiety and depression: implementation of the Wellbeing Plus Course in routine clinical care and comparison with research trial outcomes

    PubMed Central

    Staples, Lauren G.; Fogliati, Vincent J.; Dear, Blake F.; Nielssen, Olav

    2016-01-01

    Background The Wellbeing Plus Course is an internet-delivered psychological intervention for older adults with anxiety or depression. Aims To compare the effectiveness of the Wellbeing Plus Course in a public health setting (clinic group) with its efficacy in a randomised controlled trial (research group). Method Participants (n=949) were Australian adults aged 60 and above. Primary outcome measures were the Patient Health Questionnaire (PHQ-9) and Generalized Anxiety Disorder scale (GAD-7). Results Initial symptom severity was higher in the clinic group and course completion was lower. Both groups showed significant symptom reductions at post-treatment and were satisfied with the treatment. Results were maintained at 3-month follow-up. Within-group symptom changes were comparable between settings; there were no between-group differences on primary outcomes or satisfaction. Conclusions The Wellbeing Plus Course is as effective and acceptable in routine clinical care, as it is in controlled research trials. Declaration of interest N.T. and B.F.D developed the Wellbeing Plus Course but derived no financial benefit from it. Copyright and usage © The Royal College of Psychiatrists 2016. This is an open access article distributed under the terms of the Creative Commons Non-Commercial, No Derivatives (CC BY-NC-ND) license. PMID:27703794

  17. The Community-Acquired Pneumonia immunization Trial in Adults (CAPiTA): what is the future of pneumococcal conjugate vaccination in elderly?

    PubMed

    van Werkhoven, Cornelis H; Bonten, Marc J M

    2015-01-01

    Pneumococcal community-acquired pneumonia (PCAP) and invasive pneumococcal disease (IPD) are important causes of morbidity and mortality in elderly. In the Community-Acquired Pneumonia immunization Trial in Adults (CAPiTA), a randomized double-blind placebo-controlled trial of 84,496 community-dwelling immunocompetent adults over 65 years of age, the 13-valent pneumococcal conjugate vaccine (PCV13) reduced the incidence of first episode of vaccine-type (VT) PCAP with 38 and of VT-IPD with 76% in the modified intention-to-treat population. In The Netherlands, where PCV7 immunization of newborns was introduced in 2007 and replaced by PCV10 in 2011, introduction of PCV13 immunization of elderly--based on 2012 data--would be highly cost effective. However, this is probably different in countries where the VT disease burden has declined more, for instance due to herd effects following child immunization with PCV13. Apart from cost-effectiveness analyses, ethical aspects of PCAP prevention should be taken into account in policy making for pneumococcal vaccination in elderly.

  18. Immunogenicity and Safety of Trivalent Split Influenza Vaccine in Healthy Korean Adults with Low Pre-Existing Antibody Levels: An Open Phase I Trial

    PubMed Central

    Kang, Kyuri; Han, Seunghoon; Hong, Taegon; Jeon, Sangil; Paek, Jeongki; Kang, Jin Han

    2016-01-01

    Purpose A phase I clinical trial was conducted to evaluate the immunogenicity and safety of newly developed egg-cultivated trivalent inactivated split influenza vaccine (TIV) in Korea. Materials and Methods The TIV was administered to 43 healthy male adults. Subjects with high pre-existing titers were excluded in a screening step. Immune response was measured by a hemagglutination inhibition (HI) assay. Results The seroprotection rates against A/California/7/2009 (H1N1), A/Perth/16/2009 (H3N2) and B/Brisbane/60/2009 were 74.42% [95% confidence interval (CI): 61.38–87.46], 72.09% (95% CI: 58.69–85.50), and 86.05% (95% CI: 75.69–96.40), respectively. Calculated seroconversion rates were 74.42% (95% CI: 61.38–87.46), 74.42% (95% CI: 61.38–87.46), and 79.07% (95% CI: 66.91–91.23), respectively. There were 25 episodes of solicited local adverse events in 21 subjects (47.73%), 21 episodes of solicited general adverse events in 16 subjects (36.36%) and 5 episodes of unsolicited adverse events in 5 subjects (11.36%). All adverse events were grade 1 or 2 and disappeared within three days. Conclusion The immunogenicity and safety of TIV established in this phase I trial are sufficient to plan a larger scale clinical trial. PMID:27593862

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-28

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

  20. Comparison of Accelerated and Standard Hepatitis B Vaccination Schedules in High-Risk Healthy Adults: A Meta-Analysis of Randomized Controlled Trials

    PubMed Central

    Zhang, Xuefeng; Wang, Bei; Zhao, Yueyuan; Liu, Pei

    2015-01-01

    Background Selecting the most efficient vaccination schedule is an important issue. Objective To assess the beneficial and harmful effects of accelerated hepatitis B vaccination schedules in high-risk healthy adults. Methods We searched controlled trial registers of The Cochrane Library as well as MEDLINE, EMBASE, VIP Database for Chinese Technical Periodicals, and the Chinese National Knowledge Infrastructure databases for randomized controlled trials published up to December 2013 that compared accelerated hepatitis B vaccine schedules to the standard schedule in adults. The results were presented as relative risk with 95% confidence intervals. Fixed or random effect models were used for analysis. Results We identified 10 randomized trials, all with one or more methodological weaknesses. Compared to the standard schedule, most accelerated schedules resulted in higher proportions of healthy vaccines more rapidly reaching anti-hepatitis B antibody levels >10 IU/L (P<0.05) initially and maintaining similar seroprotection rates after 6 months (P>0.05). Although accelerated schedules produced anti-hepatitis B levels higher than the standard schedule for the first month after the initial vaccine dose, they were significantly lower than the standard schedule after 6 months, except for an accelerated schedule that called for a fourth booster injection 12 months after the initial dose. Subjects administered accelerated vaccine schedules had similar compliance rate as those administered the standard schedule over the first 6 months of vaccination (relative risk = 1.00, 95% confidence interval: 0.84–1.21). Conclusion For rapid seroconversion and almost immediate short-term protection, accelerated vaccination schedules could be useful for at-risk groups. However, additional studies on the long-term protection and effectiveness of the primary doses of accelerated schedules are necessary. PMID:26196903

  1. 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

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

    PubMed Central

    2011-01-01

    flexion test (22 mmHg - 30 mmHg), joint position error test and cervical range of movement. The SF36 scales are scored using norm-based methods with PCS and MCS having a mean score of 50 with a standard deviation of 10. Discussion The perspectives of this study are discussed, in addition to the strengths and weaknesses. Trial registration The study is registered in http://www.ClinicalTrials.gov identifier NCT01431261. PMID:22136113

  3. PROFESSIONAL REGISTRATION OF GOVERNMENT ENGINEERS.

    USGS Publications Warehouse

    Buchanan, Thomas J.

    1985-01-01

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

  4. Image registration with uncertainty analysis

    DOEpatents

    Simonson, Katherine M.

    2011-03-22

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

  5. Immunogenicity and safety of three 2010-2011 seasonal trivalent influenza vaccines in Chinese toddlers, children and older adults: a double-blind and randomized trial.

    PubMed

    Luo, Feng-Ji; Yang, Li-Qing; Ai, Xing; Bai, Yun-Hua; Wu, Jiang; Li, Shu-Ming; Zhang, Zheng; Lu, Min; Li, Li; Wang, Zhao-Yun; Shi, Nian-Min

    2013-08-01

    The 2009 influenza A(H1N1) pandemic strain was for the first time included in the 2010-2011 seasonal trivalent influenza vaccine (TIV). We conducted a double-blind, randomized trial in Chinese population to assess the immunogenicity and safety of the 2010-2011 TIV manufactured by GlaxoSmithKline and compared it with the counterpart vaccines manufactured by Sanofi Pasteur and Sinovac Biotech. Healthy toddlers (6-36 mo), children (6-12 y) and older adults (≥60 y) with 300 participants in each age group were enrolled to randomly receive two doses (toddlers, 28 d apart) or one dose (children and older adults). The immunogenicity was assessed by hemagglutination-inhibition (HI) assay. The solicited injection-site and systemic adverse events (AEs) were collected within 7 d after vaccination. All the three TIVs were well-tolerated with 15.1% of participants reporting AEs, most of which were mild. No serious AEs and unusual AEs were reported. Fever and pain were the most common systemic and injection-site AEs, respectively. The three TIVs showed good immunogenicity. The seroprotection rates against both H1N1 and H3N2 strains were more than 87% in toddlers after two doses and more than 95% in children and more than 86% in older adults after one dose. The seroprotection rates against B strain were 68-71% in toddlers after two doses, 70-74% in children and 69-72% in older adults after one dose. In conclusion, the three 2010-2011 TIVs had good immunogenicity and safety in Chinese toddlers, children and older adults and were generally comparable in immunogenicity and reactogenicity.

  6. A head-to-head randomized clinical trial of methylphenidate and atomoxetine treatment for executive function in adults with attention-deficit hyperactivity disorder.

    PubMed

    Ni, Hsing-Chang; Shang, Chi-Yung; Gau, Susan Shur-Fen; Lin, Yu-Ju; Huang, Hui-Chun; Yang, Li-Kuang

    2013-10-01

    Results regarding the effects of methylphenidate and atomoxetine on executive functions were inconsistent and no study has directly compared the efficacy of these two medications in improving executive functions in adults with attention-deficit hyperactivity disorder (ADHD). We conducted an 8-10 wk, open-label, head-to-head, randomized clinical trial involving adults with a clinical diagnosis of ADHD confirmed by psychiatric interview. The two treatment arms were immediate-release methylphenidate (IR-methylphenidate) (n = 31) and atomoxetine once daily (n = 32). Executive functions were assessed by the Cambridge Neuropsychological Test Automated Battery (CANTAB), including spatial working memory, spatial span, intra-extra dimensional set shifts, rapid visual information processing and Stockings of Cambridge (SOC). In addition to the symptom assessments at baseline (week 0), visit 2 (week 4-5) and visit 3 (week 8–10), they received CANTAB assessments at baseline and visit 3 (60.4 ± 6.3 d). Compared to baseline, adults treated with atomoxetine showed significant improvement in spatial working memory, spatial short-term memory, sustained attention and spatial planning at visit 3; adults treated with IR-methylphenidate showed significant improvement in spatial working memory at visit 3. Comparing the magnitude of improvement in executive functions between these two medications, the effect was generally similar for the two groups, although atomoxetine might have significantly greater efficacy than IR-methylphenidate in terms of improving spatial planning (SOC). Our results provide evidence to support that both IR-methylphenidate and atomoxetine improved various executive functions in adults with ADHD with greater improvement in atomoxetine than IR-methylphenidate in spatial planning.

  7. The Mediterranean Diet and Cognitive Function among Healthy Older Adults in a 6-Month Randomised Controlled Trial: The MedLey Study

    PubMed Central

    Knight, Alissa; Bryan, Janet; Wilson, Carlene; Hodgson, Jonathan M.; Davis, Courtney R.; Murphy, Karen J.

    2016-01-01

    Evidence from a limited number of randomised controlled intervention trials (RCTs) have shown that a Mediterranean dietary pattern may reduce the risk of cognitive decline and enhance cognitive function among healthy older adults. However, there are currently no data in non-Mediterranean older adult populations. The present study aimed to address this gap by examining the effect of a Mediterranean dietary pattern (MedDiet) for six months on aspects of cognitive function in a randomised controlled intervention trial (the MedLey study) that extended for a duration of 18 months. In the final analysed cohort, a total of 137 men and women (mean age of 72.1 ± 5.0 years) randomly assigned to either a MedDiet or control diet (HabDiet) (i.e., habitual dietary intake), were assessed on a comprehensive neuropsychological test battery, including 11 individual tests. In multivariable-adjusted models, the MedDiet group did not perform significantly better than the HabDiet control group for executive functioning (adjusted mean differences: +2.53, 95% CI −2.59 to 7.65, p = 0.33); speed of processing (adjusted mean differences: +3.24, 95% CI −1.21 to 7.70, p = 0.15); memory (adjusted mean differences: +2.00, 95% CI −3.88 to 7.88, p = 0.50); visual-spatial ability (adjusted mean differences: +0.21, 95% CI −0.38 to 0.81, 0.48); and overall age-related cognitive performance (adjusted mean differences: +7.99, 95% CI −4.00 to 19.9, p = 0.19). In conclusion, this study did not find evidence of a beneficial effect of a MedDiet intervention on cognitive function among healthy older adults. PMID:27657119

  8. A Randomized Controlled Trial on Effects of the Transcendental Meditation Program on Blood Pressure, Psychological Distress, and Coping in Young Adults

    PubMed Central

    Nidich, Sanford I.; Rainforth, Maxwell V.; Haaga, David A.F.; Hagelin, John; Salerno, John W.; Travis, Fred; Tanner, Melissa; Gaylord-King, Carolyn; Grosswald, Sarina; Schneider, Robert H.

    2009-01-01

    Background Psychological distress contributes to the development of hypertension in young adults. This trial assessed the effects of a mind–body intervention on blood pressure (BP), psychological distress, and coping in college students. Methods This was a randomized controlled trial (RCT) of 298 university students randomly allocated to either the Transcendental Meditation (TM) program or wait-list control. At baseline and after 3 months, BP, psychological distress, and coping ability were assessed. A subgroup of 159 subjects at risk for hypertension was analyzed similarly. Results Changes in systolic BP (SBP)/diastolic BP (DBP) for the overall sample were −2.0/−1.2 mm Hg for the TM group compared to +0.4/+0.5 mm Hg for controls (P = 0.15, P = 0.15, respectively). Changes in SBP/DBP for the hypertension risk subgroup were −5.0/−2.8 mm Hg for the TM group compared to +1.3/+1.2 mm Hg for controls (P = 0.014, P = 0.028, respectively). Significant improvements were found in total psychological distress, anxiety, depression, anger/hostility, and coping (P values < 0.05). Changes in psychological distress and coping correlated with changes in SBP (P values < 0.05) and DBP (P values < 0.08). Conclusions This is the first RCT to demonstrate that a selected mind–body intervention, the TM program, decreased BP in association with decreased psychological distress, and increased coping in young adults at risk for hypertension. This mind–body program may reduce the risk for future development of hypertension in young adults. PMID:19798037

  9. 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...

  10. 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…

  11. Randomized Trial of Behavioral Activation, Cognitive Therapy, and Antidepressant Medication in the Acute Treatment of Adults with Major Depression

    ERIC Educational Resources Information Center

    Dimidjian, Sona; Hollon, Steven D.; Dobson, Keith S.; Schmaling, Karen B.; Kohlenberg, Robert J.; Addis, Michael E.; Gallop, Robert; McGlinchey, Joseph B.; Markley, David K.; Gollan, Jackie K.; Atkins, David C.; Dunner, David L.; Jacobson, Neil S.

    2006-01-01

    Antidepressant medication is considered the current standard for severe depression, and cognitive therapy is the most widely investigated psychosocial treatment for depression. However, not all patients want to take medication, and cognitive therapy has not demonstrated consistent efficacy across trials. Moreover, dismantling designs have…

  12. Intensive lifestyle intervention improves physical function among obese adults with knee pain: Findings from the Look AHEAD Trial

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Lifestyle interventions 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...

  13. Quality of Life, Cortisol Blood Levels and Exercise in Older Adults: Results of a Randomized Controlled Trial

    PubMed Central

    Mura, Gioia; Cossu, Giulia; Migliaccio, Gian M; Atzori, Claudio; Nardi, Antonio E; Machado, Sergio; Carta, Mauro G

    2014-01-01

    Introduction: Cortisol plays a central role in the stress response; while high stress can determine physical and psychological impairment, moderate stress, with a mild increase in cortisol level, may have a positive effect on coping and physical performance. This trial attempted to determine whether cortisol levels were associated with Quality of Life (QoL) in a sample of elderly subjects undertaking an exercise program. Methods:42 subjects aged ≥65 years were randomlyassigned in a 1:1 fashion either to a vigorous physical activity (VAG: N=21) or to a postural gimnastic group (PGG: N=21). Differences between the two groups in QoL (on SF-12), and blood cortisol levels were assessed by ANOVA at different times. Results:In both the VAG and PGG, cortisol levels rose at the end of the trial, with statistically significant differences as compared to the baseline. QoL at the end of the trial was higher than in the national normative sample. Cortisol and QoL in both groups decreased slightly 12 weeks after the end of the trial (T2); however, only in the VAG did the difference from the initial level remain statistically significant. At T1 and T2, subjects with higher SF-12 scores were found in subsamples in both groups with cortisol levels moderately increased (between 200 and 300 mg/ml). Conclusion:In a sample of elderly subjects undergoing two different kinds of exercise, a better perception of Quality of Life was associated with a moderate, non-pathological increase in cortisol. The results need to be confirmed by trials on larger samples. PMID:25006344

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

    NASA Astrophysics Data System (ADS)

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

    2005-04-01

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

  15. Task-specific balance training improves self-assessed function in community-dwelling older adults with balance deficits and fear of falling: a randomized controlled trial

    PubMed Central

    Halvarsson, Alexandra; Sahlström, Theres; Ståhle, Agneta

    2014-01-01

    Objective: To evaluate the effects of a 12-week balance training programme on self-assessed function and disability in healthy community-dwelling older adults with self-perceived balance deficits and fear of falling. Design: A prospective, randomized controlled trial. Setting: Stockholm County, Sweden. Participants: A total of 59 community-dwelling older adults (42 women and 17 men) aged 67–93 were randomized to either an intervention group (n = 38) or to serve as controls (n = 21) after baseline testing. Intervention: The intervention was a 12-week, three times per week, progressive, specific and individually adjusted group balance-training programme. Main measures: Self-perceived function and disability measured with Late Life Function and Disability Instrument. Results: The intervention group reported improvement in overall function (p = 0.016), as well as in basic (p = 0.044) and advanced lower extremity function (p = 0.025) compared with the control group. The study showed no improvement in overall disability or upper extremity function. Conclusion: This group balance training programme improves self-assessed function in community-dwelling older adults with balance deficits and fear of falling. PMID:24895381

  16. A randomized controlled trial of brain training with non-action video games in older adults: results of the 3-month follow-up.

    PubMed

    Ballesteros, Soledad; Mayas, Julia; Prieto, Antonio; Toril, Pilar; Pita, Carmen; Laura, Ponce de León; Reales, José M; Waterworth, John A

    2015-01-01

    This randomized controlled study (ClinicalTrials.gov NCT02007616) investigated the maintenance of training effects of 20 1-hr non-action video game training sessions with selected games from a commercial package on several age-declining cognitive functions and subjective wellbeing after a 3-month no-contact period. Two groups of cognitively normal older adults participated in both the post-training (posttest) and the present follow-up study, the experimental group who received training and the control group who attended several meetings with the research team during the study but did not receive training. Groups were similar at baseline on demographics, vocabulary, global cognition, and depression status. Significant improvements in the trained group, and no variation in the control group had been previously found at posttest, in processing speed, attention and visual recognition memory, as well as in two dimensions of subjective wellbeing. In the current study, improvement from baseline to 3 months follow-up was found only in wellbeing (Affection and Assertivity dimensions) in the trained group whereas there was no change in the control group. Previous significant improvements in processing speed, attention and spatial memory become non-significant after the 3-month interval. Training older adults with non-action video games enhanced aspects of cognition just after training but this effect disappeared after a 3-month no-contact follow-up period. Cognitive plasticity can be induced in older adults by training, but to maintain the benefits periodic boosting sessions would be necessary.

  17. 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

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

    PubMed

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

    2014-09-01

    Sleep problems are prevalent among older adults, often persist untreated, and are predictive of health detriments. Given the limitations of conventional treatments, non-pharmacological treatments such as mindfulness-based interventions (MBIs) are gaining popularity for sleep ailments. However, nothing is yet known about the impact of MBIs on sleep in older adults with prodromal sleep disturbances. This article details the design and methodology of a 6-week parallel-group RCT calibrated to test the treatment effect of the Mindful Awareness Practices (MAPs) program versus sleep hygiene education for improving sleep quality, as the main outcome, in older adults with prodromal sleep disturbances. Older adults with current sleep disturbances will be recruited from the urban Los Angeles community. Participants will be randomized into two standardized treatment conditions, MAPs and sleep hygiene education. Each condition will consist of weekly 2-hour group-based classes over the course of the 6-week intervention. The primary objective of this study is to determine if mindfulness meditation practice as engaged through the MAPs program leads to improved sleep quality relative to sleep hygiene education in older adults with prodromal sleep disturbances.

  19. 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

  20. A Primary Care Nurse-Delivered Walking Intervention in Older Adults: PACE (Pedometer Accelerometer Consultation Evaluation)-Lift Cluster Randomised Controlled Trial

    PubMed Central

    Harris, Tess; Kerry, Sally M.; Victor, Christina R.; Ekelund, Ulf; Woodcock, Alison; Iliffe, Steve; Whincup, Peter H.; Beighton, Carole; Ussher, Michael; Limb, Elizabeth S.; David, Lee; Brewin, Debbie; Adams, Fredrika; Rogers, Annabelle; Cook, Derek G.

    2015-01-01

    group: by 1,037 (95% CI 513–1,560) steps/day and 63 (95% CI 40–87) minutes/week, respectively. At 12 months corresponding differences were 609 (95% CI 104–1,115) steps/day and 40 (95% CI 17–63) minutes/week. Counts and counts/minute showed similar effects to steps and MVPA. Adverse events, anthropometry, mood, and pain were similar in the two groups. Participants and practice nurses found the intervention acceptable and enjoyable. Conclusions The PACE-Lift trial increased both step-counts and objectively measured MVPA in ≥10-minute bouts in 60–75 year olds at 3 and 12 months, with no effect on adverse events. To our knowledge, this is the first trial in this age group to demonstrate objective MVPA increases and highlights the value of individualised support incorporating objective PA assessment in a primary care setting. Trial Registration Controlled-Trials.com ISRCTN42122561 PMID:25689364

  1. 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

  2. Bereaved Adults with Intellectual Disabilities: A Combined Randomized Controlled Trial and Qualitative Study of Two Community-Based Interventions

    ERIC Educational Resources Information Center

    Dowling, S.; Hubert, J.; White, S.; Hollins, S.

    2006-01-01

    Background: Bereaved adults with intellectual disabilities are known to experience prolonged and atypical grief which is often unrecognized. The aim of this project was to find an effective way to improve mental health and behavioural outcomes. Methods: Subjects were randomized to two different therapeutic interventions: traditional counselling by…

  3. 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…

  4. Effects of auricular acupressure on weight reduction and abdominal obesity in Asian young adults: a randomized controlled trial.

    PubMed

    Hsieh, Ching Hsiu; Su, Tsann-Jnn; Fang, Yu-Wen; Chou, Pei-Hsuan

    2011-01-01

    The current study was designed to test the efficacy of auricular acupressure on weight reduction and changes of waist circumference and waist-to-hip ratio. This study used a randomized design with one control group and one experimental group consisting of Asian young adults with a waist circumference ≥80 cm in the females and ≥90cm in the males. At completion of eight weeks of auricular therapy, the total sample size was 55 young adults who ranged in age from 18 to 20 years old. Each participant was treated weekly for ear acupressure in ten-minute sessions. Sessions continued for eight weeks wherein the control group received acupressure only while the experimental group received acupressure with the Japanese Magnetic Pearl on the ear acupoints. While both the control and treatment groups showed significant reduction (p ≤ 0.05) to body weight and waist circumference after eight weeks of treatment, only the group treated with Japanese Magnetic Pearls showed decreased waist to hip ratio. Thus, auricular acupressure may be a beneficial addition to weight loss programs for young adults. Auricular acupressure is thus a reasonable option in the treatment of overweight and obesity in young adults. PMID:21598412

  5. 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…

  6. 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

  7. 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…

  8. High phenylalanine levels directly affect mood and sustained attention in adults with phenylketonuria: a randomised, double-blind, placebo-controlled, crossover trial

    PubMed Central

    ten Hoedt, Amber E.; de Sonneville, Leo M. J.; Francois, Baudouin; ter Horst, Nienke M.; Janssen, Mirian C. H.; Rubio-Gozalbo, M. Estela; Wijburg, Frits A.; Hollak, Carla E. M.

    2010-01-01

    The main debate in the treatment of Phenylketonuria (PKU) is whether adult patients need the strict phenylalanine (Phe)-restricted diet. Physicians and patients lack evidence-based guidelines to help them make well-informed choices. We have carried out the first randomised double-blind placebo-controlled trial into the effects of short-term elevation of Phe levels on neuropsychological functions and mood of adults with PKU. Nine continuously treated adults with PKU underwent two 4-week supplementation periods: one with Phe, mimicking normal dietary intake, and one with placebo in randomly allocated order via a randomisation coding list in a double-blind cross-over design. A set of neuropsychological tests (Amsterdam Neuropsychological Tasks) was administered at the end of each study period. In addition, patients and for each patient a friend or relative, completed weekly Profile of Mood States (POMS) questionnaires, evaluating the patients’ mood. Phe levels were measured twice weekly. Mean plasma Phe levels were significantly higher during Phe supplementation compared with placebo (p = 0.008). Neuropsychological tests demonstrated an impairment in sustained attention during Phe supplementation (p = 0.029). Both patients and their friend or relative reported lower scores on the POMS questionnaires during Phe supplementation (p = 0.017 and p = 0.040, respectively). High plasma Phe levels have a direct negative effect on both sustained attention and on mood in adult patients with PKU. A Phe-restricted “diet for life” might be an advisable option for many. PMID:21153445

  9. 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 ...

  10. Effect of a Moderate Fat Diet With and Without Avocados on Lipoprotein Particle Number, Size and Subclasses in Overweight and Obese Adults: A Randomized, Controlled Trial

    PubMed Central

    Wang, Li; Bordi, Peter L.; Fleming, Jennifer A.; Hill, Alison M.; Kris‐Etherton, Penny M.

    2015-01-01

    Background Avocados are a nutrient‐dense source of monounsaturated fatty acids (MUFA) that can be used to replace saturated fatty acids (SFA) in a diet to lower low density lipoprotein cholesterol (LDL‐C). Well‐controlled studies are lacking on the effect of avocado consumption on cardiovascular disease (CVD) risk factors. Methods and Results A randomized, crossover, controlled feeding trial was conducted with 45 overweight or obese participants with baseline LDL‐C in the 25th to 90th percentile. Three cholesterol‐lowering diets (6% to 7% SFA) were fed (5 weeks each): a lower‐fat diet (LF: 24% fat); 2 moderate‐fat diets (34% fat) provided similar foods and were matched for macronutrients and fatty acids: the avocado diet (AV) included one fresh Hass avocado (136 g) per day, and the moderate‐fat diet (MF) mainly used high oleic acid oils to match the fatty acid content of one avocado. Compared with baseline, the reduction in LDL‐C and non‐high‐density lipoprotein (HDL) cholesterol on the AV diet (−13.5 mg/dL, −14.6 mg/dL) was greater (P<0.05) than the MF (−8.3 mg/dL, −8.7 mg/dL) and LF (−7.4 mg/dL, −4.8 mg/dL) diets. Furthermore, only the AV diet significantly decreased LDL particle number (LDL‐P, −80.1 nmol/L, P=0.0001), small dense LDL cholesterol (LDL3+4, −4.1 mg/dL, P=0.04), and the ratio of LDL/HDL (−6.6%, P<0.0001) from baseline. Conclusions Inclusion of one avocado per day as part of a moderate‐fat, cholesterol‐lowering diet has additional LDL‐C, LDL‐P, and non‐HDL‐C lowering effects, especially for small, dense LDL. Our results demonstrate that avocados have beneficial effects on cardio‐metabolic risk factors that extend beyond their heart‐healthy fatty acid profile. Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT01235832. PMID:25567051

  11. Effectiveness of a Web-Based Solution-Focused Brief Chat Treatment for Depressed Adolescents and Young Adults: Randomized Controlled Trial

    PubMed Central

    Conijn, Barbara; Oijevaar, Pien; Riper, Heleen

    2014-01-01

    those younger than 18 year old. Trial Registration Netherlands Trial Register: NTR 1696; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1696 (Archived by WebCite at http://www.webcitation.org/6DspeYWrJ). PMID:24874006

  12. Effect of double dose oseltamivir on clinical and virological outcomes in children and adults admitted to hospital with severe influenza: double blind randomised controlled trial

    PubMed Central

    2013-01-01

    . No important differences in tolerability were found. Conclusions There were no virological or clinical advantages with double dose oseltamivir compared with standard dose in patients with severe influenza admitted to hospital. Registration Clinical Trials NCT00298233 PMID:23723457

  13. Treatment of reducible unstable fractures of the distal radius in adults: a randomised controlled trial of De Palma percutaneous pinning versus bridging external fixation

    PubMed Central

    2010-01-01

    fixator group with regard to the supination movement 6 months after the operation; however, this was not maintained at 24 months. The final results of the radiographic evaluation were similar for the two groups. Overall, five patients developed complications: two with De Palma pinning and three with external fixation. Conclusion There was a small statistically significant difference favouring the De Palma method in early functional at 6 months according to the DASH questionnaire, and for supination movement favouring the fixator group. However, both were not clinical relevant. By 24 months the groups were similar for all outcomes Trial registration Current Controlled Trials ISRCTN04892785 PMID:20587064

  14. 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

  15. Lifestyle weight-loss intervention outcomes in overweight and obese adults with type 2 diabetes: a systematic review and meta-analysis of randomized clinical trials.

    PubMed

    Franz, Marion J; Boucher, Jackie L; Rutten-Ramos, Stephanie; VanWormer, Jeffrey J

    2015-09-01

    The majority of people with type 2 diabetes are overweight or obese, and weight loss is a recommended treatment strategy. A systematic review and meta-analysis was undertaken to answer the following primary question: In overweight or obese adults with type 2 diabetes, what are the outcomes on hemoglobin A1c (HbA1c) from lifestyle weight-loss interventions resulting in weight losses greater than or less than 5% at 12 months? Secondary questions are: What are the lipid (total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and triglycerides) and blood pressure (systolic and diastolic) outcomes from lifestyle weight-loss interventions resulting in weight losses greater than or less than 5% at 12 months? And, what are the weight and metabolic outcomes from differing amounts of macronutrients in weight-loss interventions? Inclusion criteria included randomized clinical trial implementing weight-loss interventions in overweight or obese adults with type 2 diabetes, minimum 12-month study duration, a 70% completion rate, and an HbA1c value reported at 12 months. Eleven trials (eight compared two weight-loss interventions and three compared a weight-loss intervention group with a usual care/control group) with 6,754 participants met study criteria. At 12 months, 17 study groups (8 categories of weight-loss intervention) reported weight loss <5% of initial weight (-3.2 kg [95% CI: -5.9, -0.6]). A meta-analysis of the weight-loss interventions reported nonsignificant beneficial effects on HbA1c, lipids, or blood pressure. Two study groups reported a weight loss of ≥5%: a Mediterranean-style diet implemented in newly diagnosed adults with type 2 diabetes and an intensive lifestyle intervention implemented in the Look AHEAD (Action for Health in Diabetes) trial. Both included regular physical activity and frequent contact with health professionals and reported significant beneficial effects on HbA1c, lipids, and blood pressure. Five

  16. Lifestyle weight-loss intervention outcomes in overweight and obese adults with type 2 diabetes: a systematic review and meta-analysis of randomized clinical trials.

    PubMed

    Franz, Marion J; Boucher, Jackie L; Rutten-Ramos, Stephanie; VanWormer, Jeffrey J

    2015-09-01

    The majority of people with type 2 diabetes are overweight or obese, and weight loss is a recommended treatment strategy. A systematic review and meta-analysis was undertaken to answer the following primary question: In overweight or obese adults with type 2 diabetes, what are the outcomes on hemoglobin A1c (HbA1c) from lifestyle weight-loss interventions resulting in weight losses greater than or less than 5% at 12 months? Secondary questions are: What are the lipid (total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and triglycerides) and blood pressure (systolic and diastolic) outcomes from lifestyle weight-loss interventions resulting in weight losses greater than or less than 5% at 12 months? And, what are the weight and metabolic outcomes from differing amounts of macronutrients in weight-loss interventions? Inclusion criteria included randomized clinical trial implementing weight-loss interventions in overweight or obese adults with type 2 diabetes, minimum 12-month study duration, a 70% completion rate, and an HbA1c value reported at 12 months. Eleven trials (eight compared two weight-loss interventions and three compared a weight-loss intervention group with a usual care/control group) with 6,754 participants met study criteria. At 12 months, 17 study groups (8 categories of weight-loss intervention) reported weight loss <5% of initial weight (-3.2 kg [95% CI: -5.9, -0.6]). A meta-analysis of the weight-loss interventions reported nonsignificant beneficial effects on HbA1c, lipids, or blood pressure. Two study groups reported a weight loss of ≥5%: a Mediterranean-style diet implemented in newly diagnosed adults with type 2 diabetes and an intensive lifestyle intervention implemented in the Look AHEAD (Action for Health in Diabetes) trial. Both included regular physical activity and frequent contact with health professionals and reported significant beneficial effects on HbA1c, lipids, and blood pressure. Five

  17. Trial protocol for a randomised controlled trial of red cell washing for the attenuation of transfusion-associated organ injury in cardiac surgery: the REDWASH trial

    PubMed Central

    Murphy, G J; Verheyden, V; Wozniak, M; Sullo, N; Dott, W; Bhudia, S; Bittar, N; Morris, T; Ring, A; Tebbatt, A; Kumar, T

    2016-01-01

    Introduction It has been suggested that removal of proinflammatory substances that accumulate in stored donor red cells by mechanical cell washing may attenuate inflammation and organ injury in transfused cardiac surgery patients. This trial will test the hypotheses that the severity of the postoperative inflammatory response will be less and postoperative recovery faster if patients undergoing cardiac surgery receive washed red cells compared with standard care (unwashed red cells). Methods and analysis Adult (≥16 years) cardiac surgery patients identified at being at increased risk for receiving large volume red cell transfusions at 1 of 3 UK cardiac centres will be randomly allocated in a 1:1 ratio to either red cell washing or standard care. The primary outcome is serum interleukin-8 measured at 5 postsurgery time points up to 96 h. Secondary outcomes will include measures of inflammation, organ injury and volumes of blood transfused and cost-effectiveness. Allocation concealment, internet-based randomisation stratified by operation type and recruiting centre, and blinding of outcome assessors will reduce the risk of bias. The trial will test the superiority of red cell washing versus standard care. A sample size of 170 patients was chosen in order to detect a small-to-moderate target difference, with 80% power and 5% significance (2-tailed). Ethics and dissemination The trial protocol was approved by a UK ethics committee (reference 12/EM/0475). The trial findings will be disseminated in scientific journals and meetings. Trial registration number ISRCTN 27076315. PMID:26977309

  18. 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 Central

    McDonald, Shelley R.; Starr, Kathryn N. Porter; 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 grams 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 enhancement of protein quantity and quality in the Protein arm will result in better outcomes for function and/or lean muscle mass than in the Control arm. Ultimately, we hope our findings will help identify a safe weight loss approach that can delay or prevent late life disability by changing the trajectory of age-associated functional impairment associated with obesity. PMID:25461495

  19. 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 enhancement of protein quantity and quality in the Protein arm will result in better outcomes for function and/or lean muscle mass than in the Control arm. Ultimately, we hope our findings will help identify a safe weight loss approach that can delay or prevent late life disability by changing the trajectory of age-associated functional impairment associated with obesity. PMID:25461495

  20. Molecular Epidemiology of Methicillin-Resistant Staphylococcus aureus (MRSA) among Patients Admitted to Adult Intensive Care Units: the STAR*ICU Trial

    PubMed Central

    Nair, Nisha; Kourbatova, Ekaterina; Poole, Katharine; Huckabee, Charmaine M.; Murray, Patrick; Huskins, W. Charles; Blumberg, Henry M.

    2014-01-01

    Background The multi-center cluster-randomized Strategies to Reduce Transmission of Antimicrobial Resistant Bacteria in Intensive Care Units (STAR*ICU) trial was carried out in 18 U.S. adult intensive care units (ICUs) and evaluated the effectiveness of infection control strategies in reducing transmission of methicillin-resistant Staphylococcus aureus (MRSA) colonization and/or infection. Our study objective was to examine the molecular epidemiology of MRSA and assess the prevalence and risk factors for community acquired (CA)-MRSA genotype nasal carriage at the time of ICU admission. Methods Selected MRSA isolates were subjected to molecular typing using pulsed-field gel electrophoresis. Results Among 5,512 ICU patient-admissions in the STAR*ICU trial during the intervention period, 626 (11%) had a positive nares culture for MRSA. 210/626 (34%) available isolates were selected by weighted random sampling for molecular typing. Of 210 patients, 123 (59%) were male; mean age was 63 years. Molecular typing revealed that 147 isolates (70%) were the USA100 clone; 26 (12%) USA300; 12 (6%) USA500; 8 (4%) USA800; 17 (8%) other. In multivariate analysis, patients with CA-MRSA genotype (USA300, USA400, or USA1000) colonization were less likely to have been hospitalized during the previous 12 months (PR=0.39; 95% C.I. 0.21–0.73) and less likely to have an older age (PR=0.97 per year; 0.95–0.98) compared to patients with a HA-MRSA genotype. Conclusion CA-MRSA genotypes have emerged as a cause of MRSA nares colonization among patients admitted to adult ICUs in the U.S. During the study period (2006), the predominant site of CA-MRSA genotype acquisition appeared to be in the community. PMID:22011531

  1. A Video Game Promoting Cancer Risk Perception and Information Seeking Behavior Among Young-Adult College Students: A Randomized Controlled Trial

    PubMed Central

    Beale, Ivan L; Chen, Minxing; Prokhorov, Alexander V

    2016-01-01

    =.005), maintaining this increase until 20-day follow-up (B=−0.007, SE 0.26, P=.98). Further analyses indicated that perceived threat from virtual cancer cells in the game is related to the increase in perceived severity (B=0.1, SE 0.03, P=.001), and perceived susceptibility is related to changes in ISB at 10-day follow-up (B=0.21, SE 0.08, P=.008). Conclusions The feature of challenge with cancer cells in a virtual environment has the potential to increase cancer risk perception and ISB. The results are promising considering that the Re-Mission intervention was neither designed for cancer risk communication, nor applied among healthy individuals. Further research is needed to understand the theoretical framework underlying the effects of Re-Mission on ISB. The findings call for the development of a Web-based, game-based intervention for cancer risk communication and information seeking among young adults. ClinicalTrial International Standard Randomized Controlled Trial Number (ISRCTN): 15789289; http://www.controlled-trials.com/ISRCTN15789289 (Archived by WebCite at http://www.webcitation.org/6jGYZC3lZ) PMID:27470927

  2. A randomized controlled trial of guided internet-delivered cognitive behaviour therapy for older adults with generalized anxiety.

    PubMed

    Jones, Shannon L; Hadjistavropoulos, Heather D; Soucy, Joelle N

    2016-01-01

    This study aimed to establish the efficacy of guided Internet-delivered cognitive-behaviour therapy (ICBT) for older adults with generalized anxiety disorder (GAD) or subclinical GAD. Participants were randomized to receive seven modules of ICBT (n=24) or to a waiting list condition (WLC; n=22). Faster improvements in symptoms of anxiety and depression were observed for participants in the ICBT condition relative to the WLC, with large between-group effect sizes on the Generalized anxiety disorder-7 (d=.85) and the Patient health questionnaire (d=1.17) obtained at post-treatment. Further reduction in generalized anxiety symptoms was reported over the one-month follow-up. Treatment effects were replicated when control participants subsequently underwent treatment. Higher ratings of treatment credibility, but not expectancy, prior to ICBT predicted improvements over time. The results support the efficacy of ICBT as treatment for older adults with GAD.

  3. An Intervention with Mineral Water Decreases Cardiometabolic Risk Biomarkers. A Crossover, Randomised, Controlled Trial with Two Mineral Waters in Moderately Hypercholesterolaemic Adults.

    PubMed

    Toxqui, Laura; Vaquero, M Pilar

    2016-01-01

    Water intake is essential for health maintenance and disease prevention. The effects of an intervention with two mineral waters, sodium-bicarbonated mineral water (BW) or control mineral water low in mineral content (CW), on cardiometabolic risk biomarkers were studied. In a randomised-controlled crossover-trial, sixty-four moderately hypercholesterolaemic adults were randomly assigned to consume 1 L/day of either BW (sodium, 1 g/L; bicarbonate, 2 g/L) or CW with the main meals for eight weeks, separated by an eight-week washout period. Blood lipids, lipid oxidation, glucose, insulin, aldosterone, urine pH, urinary electrolytes, blood pressure, body weight, fluid intake, energy, and nutrients from total diet and beverages were determined. Total cholesterol, LDL cholesterol, and glucose decreased (p < 0.01), oxidised LDL tended to decrease (p = 0.073), and apolipoprotein B increased during the intervention, without water type effect. Energy and carbohydrates from beverages decreased since soft drinks and fruit juice consumptions decreased throughout the trial. BW increased urinary pH (p = 0.006) and reduced calcium/creatinine excretion (p = 0.011). Urinary potassium/creatinine decreased with both waters. Consumption of 1 L/day of mineral water with the main meals reduces cardiometabolic risk biomarkers, likely to be attributed to a replacement of soft drinks by water. In addition, BW does not affect blood pressure and exerts a moderate alkalizing effect in the body. PMID:27367723

  4. An Intervention with Mineral Water Decreases Cardiometabolic Risk Biomarkers. A Crossover, Randomised, Controlled Trial with Two Mineral Waters in Moderately Hypercholesterolaemic Adults

    PubMed Central

    Toxqui, Laura; Vaquero, M. Pilar

    2016-01-01

    Water intake is essential for health maintenance and disease prevention. The effects of an intervention with two mineral waters, sodium-bicarbonated mineral water (BW) or control mineral water low in mineral content (CW), on cardiometabolic risk biomarkers were studied. In a randomised-controlled crossover-trial, sixty-four moderately hypercholesterolaemic adults were randomly assigned to consume 1 L/day of either BW (sodium, 1 g/L; bicarbonate, 2 g/L) or CW with the main meals for eight weeks, separated by an eight-week washout period. Blood lipids, lipid oxidation, glucose, insulin, aldosterone, urine pH, urinary electrolytes, blood pressure, body weight, fluid intake, energy, and nutrients from total diet and beverages were determined. Total cholesterol, LDL cholesterol, and glucose decreased (p < 0.01), oxidised LDL tended to decrease (p = 0.073), and apolipoprotein B increased during the intervention, without water type effect. Energy and carbohydrates from beverages decreased since soft drinks and fruit juice consumptions decreased throughout the trial. BW increased urinary pH (p = 0.006) and reduced calcium/creatinine excretion (p = 0.011). Urinary potassium/creatinine decreased with both waters. Consumption of 1 L/day of mineral water with the main meals reduces cardiometabolic risk biomarkers, likely to be attributed to a replacement of soft drinks by water. In addition, BW does not affect blood pressure and exerts a moderate alkalizing effect in the body. PMID:27367723

  5. A Phase II, Randomized, Safety and Immunogenicity Trial of a Re-Derived, Live-Attenuated Dengue Virus Vaccine in Healthy Children and Adults Living in Puerto Rico.

    PubMed

    Bauer, Kristen; Esquilin, Ines O; Cornier, Alberto Santiago; Thomas, Stephen J; Quintero Del Rio, Ana I; Bertran-Pasarell, Jorge; Morales Ramirez, Javier O; Diaz, Clemente; Carlo, Simon; Eckels, Kenneth H; Tournay, Elodie; Toussaint, Jean-Francois; De La Barrera, Rafael; Fernandez, Stefan; Lyons, Arthur; Sun, Wellington; Innis, Bruce L

    2015-09-01

    This was a double-blind, randomized, controlled, phase II clinical trial, two dose study of re-derived, live-attenuated, tetravalent dengue virus (TDEN) vaccine (two formulations) or placebo in subjects 1-50 years of age. Among the 636 subjects enrolled, 331 (52%) were primed, that is, baseline seropositive to at least one dengue virus (DENV) type. Baseline seropositivity prevalence increased with age (10% [< 2 years], 26% [2-4 years], 60% [5-20 years], and 93% [21-50 years]). Safety profiles of TDEN vaccines were similar to placebo regardless of priming status. No vaccine-related serious adverse events (SAEs) were reported. Among unprimed subjects, immunogenicity (geometric mean antibody titers [GMT] and seropositivity rates) for each DENV increased substantially in both TDEN vaccine groups with at least 74.6% seropositive for four DENV types. The TDEN vaccine candidate showed an acceptable safety and immunogenicity profile in children and adults ranging from 1 to 50 years of age, regardless of priming status. ClinicalTrials.gov: NCT00468858.

  6. A Phase II, Randomized, Safety and Immunogenicity Trial of a Re-Derived, Live-Attenuated Dengue Virus Vaccine in Healthy Children and Adults Living in Puerto Rico

    PubMed Central

    Bauer, Kristen; Esquilin, Ines O.; Cornier, Alberto Santiago; Thomas, Stephen J.; Quintero del Rio, Ana I.; Bertran-Pasarell, Jorge; Morales Ramirez, Javier O.; Diaz, Clemente; Carlo, Simon; Eckels, Kenneth H.; Tournay, Elodie; Toussaint, Jean-Francois; De La Barrera, Rafael; Fernandez, Stefan; Lyons, Arthur; Sun, Wellington; Innis, Bruce L.

    2015-01-01

    This was a double-blind, randomized, controlled, phase II clinical trial, two dose study of re-derived, live-attenuated, tetravalent dengue virus (TDEN) vaccine (two formulations) or placebo in subjects 1–50 years of age. Among the 636 subjects enrolled, 331 (52%) were primed, that is, baseline seropositive to at least one dengue virus (DENV) type. Baseline seropositivity prevalence increased with age (10% [< 2 years], 26% [2–4 years], 60% [5–20 years], and 93% [21–50 years]). Safety profiles of TDEN vaccines were similar to placebo regardless of priming status. No vaccine-related serious adverse events (SAEs) were reported. Among unprimed subjects, immunogenicity (geometric mean antibody titers [GMT] and seropositivity rates) for each DENV increased substantially in both TDEN vaccine groups with at least 74.6% seropositive for four DENV types. The TDEN vaccine candidate showed an acceptable safety and immunogenicity profile in children and adults ranging from 1 to 50 years of age, regardless of priming status. ClinicalTrials.gov: NCT00468858. PMID:26175027

  7. Treatment of clozapine-associated obesity and diabetes with exenatide (CODEX) in adults with schizophrenia: study protocol for a pilot randomised controlled trial

    PubMed Central

    Mayfield, Karla; Winckel, Karl; Hollingworth, Samantha; Kisely, Steve; Russell, Anthony W.

    2015-01-01

    Background Clozapine causes significant metabolic disturbances including obesity and type 2 diabetes. Recent evidence that reduced glucagon-like-peptide-1 (GLP-1) may contribute to aetiology of clozapine-associated metabolic dysregulation suggests a potential therapeutic role for GLP-1 agonists. Method This open-label, pilot randomised controlled trial evaluates the effect of exenatide in clozapine-treated obese adults who have schizophrenia, with or without poorly controlled diabetes. Sixty out-patients will be randomised to once weekly extended release exenatide or treatment as usual for 24 weeks. Aims To evaluate the feasibility of larger studies regarding methodology, acceptability, tolerability and estimate efficacy for glycaemic control or weight loss. Secondary outcomes are psychosis severity and metabolic parameters. Conclusions This is the first trial investigating GLP-1 agonists for glycaemic control and weight loss in clozapine-treated patients with either diabetes or obesity. Clozapine-associated obesity and diabetes with exenatide (CODEX) will provide proof-of-concept empirical evidence addressing whether this novel treatment is practical and worthy of further investigation. Declaration of interest A.W.R. has received speaker honoraria and travel grants from AstraZeneca, BoehringerIngelheim, Eli Lilly, MSD, Novo Nordisk and Sanofi and has participated on advisory panels for MSD and Novo Nordisk. Copyright and usage © The Royal College of Psychiatrists 2015. This is an open access article distributed under the terms of the Creative Commons Non-Commercial, No Derivatives (CC BY-NC-ND) licence.

  8. A controlled trial of bupropion added to nicotine patch and behavioral therapy for smoking cessation in adults with unipolar depressive disorders.

    PubMed

    Evins, A Eden; Culhane, Melissa A; Alpert, Jonathan E; Pava, Joel; Liese, Bruce S; Farabaugh, Amy; Fava, Maurizio

    2008-12-01

    Although there is a strong relationship between depression and smoking, most nicotine dependence treatment trials exclude depressed smokers. Our objective was to determine whether bupropion improves abstinence rates and abstinence-associated depressive symptoms when added to transdermal nicotine replacement therapy (NRT) and group cognitive behavioral therapy (CBT) in smokers with unipolar depressive disorder (UDD). Adult smokers with current (n = 90) or past (n = 109) UDD were randomly assigned to receive bupropion or placebo added to NRT and CBT for 13 weeks. In the primary analysis, with dropouts considered smokers, 36% (35/97) of those on bupropion and 31% (32/102) on placebo attained biochemically validated 7-day point prevalence abstinence at end of treatment (not significant). Because of a high dropout rate (50%) and a significant difference in abstinence status at dropout by treatment group, a traditional intent-to-treat analysis with last observation carried forward imputation of abstinence status was performed. In this secondary analysis, 56% (54/97) of those on bupropion and 41% (42/102) on placebo met criteria for abstinence at end of trial, chi2 = 4.18, P = 0.04. Nicotine replacement therapy usage and absence of a comorbid anxiety disorder predicted abstinence. Abstinence was associated with increased depressive symptoms, regardless of bupropion treatment. Thus, in the primary analysis, bupropion neither increased the efficacy of intensive group CBT and NRT for smoking cessation in smokers with UDD nor prevented abstinence-associated depressive symptoms. Bupropion seemed to provide an advantage for smoking cessation for those who remained in the trial. The dropout rate was high and was characterized by a higher prevalence of current comorbid anxiety disorder. Given the high abstinence rate achieved with CBT plus NRT, a ceiling effect related to the high level of intervention received by all subjects may have prevented an adequate test of bupropion.

  9. Brain training with non-action video games enhances aspects of cognition in older adults: a randomized controlled trial.

    PubMed

    Ballesteros, Soledad; Prieto, Antonio; Mayas, Julia; Toril, Pilar; Pita, Carmen; Ponce de León, Laura; Reales, José M; Waterworth, John

    2014-01-01

    Age-related cognitive and brain declines can result in functional deterioration in many cognitive domains, dependency, and dementia. A major goal of aging research is to investigate methods that help to maintain brain health, cognition, independent living and wellbeing in older adults. This randomized controlled study investigated the effects of 20 1-h non-action video game training sessions with games selected from a commercially available package (Lumosity) on a series of age-declined cognitive functions and subjective wellbeing. Two groups of healthy older adults participated in the study, the experimental group who received the training and the control group who attended three meetings with the research team along the study. Groups were similar at baseline on demographics, vocabulary, global cognition, and depression status. All participants were assessed individually before and after the intervention, or a similar period of time, using neuropsychological tests and laboratory tasks to investigate possible transfer effects. The results showed significant improvements in the trained group, and no variation in the control group, in processing speed (choice reaction time), attention (reduction of distraction and increase of alertness), immediate and delayed visual recognition memory, as well as a trend to improve in Affection and Assertivity, two dimensions of the Wellbeing Scale. Visuospatial working memory (WM) and executive control (shifting strategy) did not improve. Overall, the current results support the idea that training healthy older adults with non-action video games will enhance some cognitive abilities but not others.

  10. Brain training with non-action video games enhances aspects of cognition in older adults: a randomized controlled trial

    PubMed Central

    Ballesteros, Soledad; Prieto, Antonio; Mayas, Julia; Toril, Pilar; Pita, Carmen; Ponce de León, Laura; Reales, José M.; Waterworth, John

    2014-01-01

    Age-related cognitive and brain declines can result in functional deterioration in many cognitive domains, dependency, and dementia. A major goal of aging research is to investigate methods that help to maintain brain health, cognition, independent living and wellbeing in older adults. This randomized controlled study investigated the effects of 20 1-h non-action video game training sessions with games selected from a commercially available package (Lumosity) on a series of age-declined cognitive functions and subjective wellbeing. Two groups of healthy older adults participated in the study, the experimental group who received the training and the control group who attended three meetings with the research team along the study. Groups were similar at baseline on demographics, vocabulary, global cognition, and depression status. All participants were assessed individually before and after the intervention, or a similar period of time, using neuropsychological tests and laboratory tasks to investigate possible transfer effects. The results showed significant improvements in the trained group, and no variation in the control group, in processing speed (choice reaction time), attention (reduction of distraction and increase of alertness), immediate and delayed visual recognition memory, as well as a trend to improve in Affection and Assertivity, two dimensions of the Wellbeing Scale. Visuospatial working memory (WM) and executive control (shifting strategy) did not improve. Overall, the current results support the idea that training healthy older adults with non-action video games will enhance some cognitive abilities but not others. PMID:25352805

  11. Effects of Pilates on muscle strength, postural balance and quality of life of older adults: a randomized, controlled, clinical trial

    PubMed Central

    Campos de Oliveira, Laís; Gonçalves de Oliveira, Raphael; Pires-Oliveira, Deise Aparecida de Almeida

    2015-01-01

    [Purpose] The aim of the present study was to determine the effects of Pilates on lower leg strength, postural balance and the health-related quality of life (HRQoL) of older adults. [Subjects and Methods] Thirty-two older adults were randomly allocated either to the experimental group (EG, n = 16; mean age, 63.62 ± 1.02 years), which performed two sessions of Pilates per week for 12 weeks, or to the control group (CG, n = 16; mean age, 64.21 ± 0.80), which performed two sessions of static stretching per week for 12 weeks. The following evaluations were performed before and after the interventions: isokinetic torque of knee extensors and flexors at 300°/s, the Timed Up and Go (TUG) test, the Berg Balance Scale, and the Health Survey assessment (SF-36). [Results] In the intra-group analysis, the EG demonstrated significant improvement in all variables. In the inter-group analysis, the EG demonstrated significant improvement in most variables. [Conclusion] Pilates exercises led to significant improvement in isokinetic torque of the knee extensors and flexors, postural balance and aspects of the health-related quality of life of older adults. PMID:25931749

  12. Effects of Pilates on muscle strength, postural balance and quality of life of older adults: a randomized, controlled, clinical trial.

    PubMed

    Campos de Oliveira, Laís; Gonçalves de Oliveira, Raphael; Pires-Oliveira, Deise Aparecida de Almeida

    2015-03-01

    [Purpose] The aim of the present study was to determine the effects of Pilates on lower leg strength, postural balance and the health-related quality of life (HRQoL) of older adults. [Subjects and Methods] Thirty-two older adults were randomly allocated either to the experimental group (EG, n = 16; mean age, 63.62 ± 1.02 years), which performed two sessions of Pilates per week for 12 weeks, or to the control group (CG, n = 16; mean age, 64.21 ± 0.80), which performed two sessions of static stretching per week for 12 weeks. The following evaluations were performed before and after the interventions: isokinetic torque of knee extensors and flexors at 300°/s, the Timed Up and Go (TUG) test, the Berg Balance Scale, and the Health Survey assessment (SF-36). [Results] In the intra-group analysis, the EG demonstrated significant improvement in all variables. In the inter-group analysis, the EG demonstrated significant improvement in most variables. [Conclusion] Pilates exercises led to significant improvement in isokinetic torque of the knee extensors and flexors, postural balance and aspects of the health-related quality of life of older adults. PMID:25931749

  13. 32 CFR 1615.1 - Registration.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... Defense Other Regulations Relating to National Defense SELECTIVE SERVICE SYSTEM ADMINISTRATION OF REGISTRATION § 1615.1 Registration. (a) Registration under selective service law consists of: (1) Completing a registration card or other method of registration prescribed by the Director of Selective Service by a...

  14. 32 CFR 1615.1 - Registration.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Defense Other Regulations Relating to National Defense SELECTIVE SERVICE SYSTEM ADMINISTRATION OF REGISTRATION § 1615.1 Registration. (a) Registration under selective service law consists of: (1) Completing a registration card or other method of registration prescribed by the Director of Selective Service by a...

  15. 32 CFR 1615.1 - Registration.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... Defense Other Regulations Relating to National Defense SELECTIVE SERVICE SYSTEM ADMINISTRATION OF REGISTRATION § 1615.1 Registration. (a) Registration under selective service law consists of: (1) Completing a registration card or other method of registration prescribed by the Director of Selective Service by a...

  16. 32 CFR 1615.1 - Registration.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... Defense Other Regulations Relating to National Defense SELECTIVE SERVICE SYSTEM ADMINISTRATION OF REGISTRATION § 1615.1 Registration. (a) Registration under selective service law consists of: (1) Completing a registration card or other method of registration prescribed by the Director of Selective Service by a...

  17. Efficacy and Safety of MMFS-01, a Synapse Density Enhancer, for Treating Cognitive Impairment in Older Adults: A Randomized, Double-Blind, Placebo-Controlled Trial

    PubMed Central

    Liu, Guosong; Weinger, Jason G.; Lu, Zhong-Lin; Xue, Feng; Sadeghpour, Safa

    2015-01-01

    Background: Cognitive impairment is a major problem in elderly, affecting quality of life. Pre-clinical studies show that MMFS-01, a synapse density enhancer, is effective at reversing cognitive decline in aging rodents. Objective: Since brain atrophy during aging is strongly associated with both cognitive decline and sleep disorder, we evaluated the efficacy of MMFS-01 in its ability to reverse cognitive impairment and improve sleep. Methods: We conducted a randomized, double-blind, placebo-controlled, parallel-designed trial in older adult subjects (age 50–70) with cognitive impairment. Subjects were treated with MMFS-01 (n = 23) or placebo (n = 21) for 12 weeks and cognitive ability, sleep quality, and emotion were evaluated. Overall cognitive ability was determined by a composite score of tests in four major cognitive domains. Results: With MMFS-01 treatment, overall cognitive ability improved significantly relative to placebo (p = 0.003; Cohen’s d = 0.91). Cognitive fluctuation was also reduced. The study population had more severe executive function deficits than age-matched controls from normative data and MMFS-01 treatment nearly restored their impaired executive function, demonstrating that MMFS-01 may be clinically significant. Due to the strong placebo effects on sleep and anxiety, the effects of MMFS-01 on sleep and anxiety could not be determined. Conclusions: The current study demonstrates the potential of MMFS-01 for treating cognitive impairment in older adults. PMID:26519439

  18. The Relieving Effects of BrainPower Advanced, a Dietary Supplement, in Older Adults with Subjective Memory Complaints: A Randomized, Double-Blind, Placebo-Controlled Trial

    PubMed Central

    Zhu, Jingfen; Shi, Rong; Chen, Su; Dai, Lihua; Shen, Tian; Feng, Yi; Gu, Pingping; Shariff, Mina; Nguyen, Tuong; Ye, Yeats; Rao, Jianyu; Xing, Guoqiang

    2016-01-01

    Subjective memory complaints (SMCs) are common in older adults that can often predict further cognitive impairment. No proven effective agents are available for SMCs. The effect of BrainPower Advanced, a dietary supplement consisting of herbal extracts, nutrients, and vitamins, was evaluated in 98 volunteers with SMCs, averaging 67 years of age (47–88), in a randomized, double-blind, placebo-controlled trial. Subjective hypomnesis/memory loss (SML) and attention/concentration deficits (SAD) were evaluated before and after 12-week supplementation of BrainPower Advanced capsules (n = 47) or placebo (n = 51), using a 5-point memory questionnaire (1 = no/slight, 5 = severe). Objective memory function was evaluated using 3 subtests of visual/audio memory, abstraction, and memory recall that gave a combined total score. The BrainPower Advanced group had more cases of severe SML (severity ⩾ 3) (44/47) and severe SAD (43/47) than the placebo group (39/51 and 37/51, < 0.05, < 0.05, resp.) before the treatment. BrainPower Advanced intervention, however, improved a greater proportion of the severe SML (29.5%)(13/44) (P < 0.01) and SAD (34.9%)(15/43)(P < 0.01) than placebo (5.1% (2/39) and 13.5% (5/37), resp.). Thus, 3-month BrainPower Advanced supplementation appears to be beneficial to older adults with SMCs. PMID:27190539

  19. Characteristics of children and young adults with Marfan syndrome and aortic root dilation in a randomized trial comparing atenolol and losartan therapy

    PubMed Central

    Lacro, Ronald V.; Guey, Lin T.; Dietz, Harry C.; Pearson, Gail D.; Yetman, Anji T.; Gelb, Bruce D.; Loeys, Bart L.; Benson, D. Woodrow; Bradley, Timothy J.; De Backer, Julie; Forbus, Geoffrey A.; Klein, Gloria L.; Lai, Wyman W.; Levine, Jami C.; Lewin, Mark B.; Markham, Larry W.; Paridon, Stephen M.; Pierpont, Mary Ella; Radojewski, Elizabeth; Selamet Tierney, Elif Seda; Sharkey, Angela M.; Wechsler, Stephanie Burns; Mahony, Lynn

    2013-01-01

    Background The Pediatric Heart Network designed a clinical trial to compare aortic root growth and other short-term cardiovascular outcomes in children and young adults with Marfan syndrome randomized to receive atenolol or losartan. We report here the characteristics of the screened population and enrolled subjects. Methods and results Between 2007 and 2011, 21 clinical sites randomized 608 subjects, aged 6 months to 25 years who met the original Ghent criteria and had a body surface area–adjusted aortic root diameter z-score >3.0. The mean age at study entry was 11.2 years, 60% were male, and 25% were older teenagers and young adults. The median aortic root diameter z-score was 4.0. Aortic root diameter z-score did not vary with age. Mitral valve prolapse and mitral regurgitation were more common in females. Among those with a positive family history, 56% had a family member with aortic surgery, and 32% had a family member with a history of aortic dissection. Conclusions Baseline demographic, clinical, and anthropometric characteristics of the randomized cohort are representative of patients in this population with moderate to severe aortic root dilation. The high percentage of young subjects with relatives who have had aortic dissection or surgery illustrates the need for more definitive therapy; we expect that the results of the study and the wealth of systematic data collected will make an important contribution to the management of individuals with Marfan syndrome. PMID:23622922

  20. Effects of progressive resistive exercise in adults living with HIV/AIDS: systematic review and meta-analysis of randomized trials.

    PubMed

    O'Brien, K; Tynan, A-M; Nixon, S; Glazier, R H

    2008-07-01

    This systematic review examined the effectiveness and safety of progressive resistive exercise (PRE) interventions on immunological/virological, cardiopulmonary, weight, and body composition, strength and psychological outcomes in adults living with HIV. Using Cochrane Collaboration protocol, we included randomized controlled trials from 1980-2006 comparing PRE interventions with no PRE or another intervention. Ten studies met inclusion criteria. Seventeen meta-analyses were performed. Results indicated that PRE or a combination of PRE and aerobic exercise may lead to statistically significant increases in weight (WMD: 2.68 kg; 95%CI: 0.40, 4.97) and arm and thigh girth (WMD: 7.91 cm; 95%CI: 2.18, 13.65) among exercisers versus non-exercisers. Trends toward improvement in submaximum heart rate and exercise time also were found. Individual studies suggested that PRE contributed to improved strength and psychological status. Findings are limited to participants who continued to exercise. Progressive resistive exercise appears to be safe and may be beneficial for medically-stable adults living with HIV.

  1. Meta-analysis of randomized controlled trials comparing outcomes for stapled hemorrhoidopexy versus LigaSure hemorrhoidectomy for symptomatic hemorrhoids in adults.

    PubMed

    Lee, Ko-Chao; Chen, Hong-Hwa; Chung, Kuan-Chih; Hu, Wan-Hsiang; Chang, Chia-Lo; Lin, Shung-Eing; Tsai, Kai-Lung; Lu, Chien-Chang

    2013-01-01

    This purpose of the meta-analysis was to compare treatment outcomes for adult patients with symptomatic hemorrhoids treated by stapled hemorrhoidopexy or LigaSure hemorrhoidectomy. A search of public medical databases was made to identify randomized controlled trials (RCTs) comparing stapled hemorrhoidopexy (SH) with LigaSure hemorrhoidectomy (LH) for the treatment of adult patients with symptomatic grade 3 and grade 4 hemorrhoids. Postoperative pain as measured using a visual analog scale was the primary outcome, and rate of recurrent prolapse and postoperative bleeding were secondary outcome measures. Four RCTs were identified that met the inclusion criteria. Data for the pooled outcomes were analyzed using odds ratio (OR) analysis. None of the studies in the analysis indicated a significant difference between SH and LH for the outcomes VAS pain score, recurrence rate, or postoperative bleeding. Pooled analysis revealed a significant OR in favor of the SH method for recurrent prolapse (OR = 5.529, P = 0.016) for up to 2 years after surgery. No significant differences between the two methods were identified for VAS pain scores (OR = -1.060, P = 0.149) or postoperative bleeding OR = 1.188, P = 0.871). Pooled analysis of RCT results comparing SH to LH for symptomatic hemorrhoids revealed a significantly greater incidence of recurrent prolapse for SH. The two techniques were associated with similar levels of postoperative pain and postoperative bleeding.

  2. Safety and Immunogenicity of a Rederived, Live-Attenuated Dengue Virus Vaccine in Healthy Adults Living in Thailand: A Randomized Trial

    PubMed Central

    Watanaveeradej, Veerachai; Gibbons, Robert V.; Simasathien, Sriluck; Nisalak, Ananda; Jarman, Richard G.; Kerdpanich, Angkool; Tournay, Elodie; De La Barrerra, Rafael; Dessy, Francis; Toussaint, Jean-François; Eckels, Kenneth H.; Thomas, Stephen J.; Innis, Bruce L.

    2014-01-01

    Safety and immunogenicity of two formulations of a live-attenuated tetravalent dengue virus (TDEN) vaccine produced using rederived master seeds from a precursor vaccine were tested against a placebo control in a phase II, randomized, double blind trial (NCT00370682). Two doses were administered 6 months apart to 120 healthy, predominantly flavivirus-primed adults (87.5% and 97.5% in the two vaccine groups and 92.5% in the placebo group). Symptoms and signs reported after vaccination were mild to moderate and transient. There were no vaccine-related serious adverse events or dengue cases reported. Asymptomatic, low-level viremia (dengue virus type 2 [DENV-2], DENV-3, or DENV-4) was detected in 5 of 80 vaccine recipients. One placebo recipient developed a subclinical natural DENV-1 infection. All flavivirus-unprimed subjects and at least 97.1% of flavivirus-primed subjects were seropositive to antibodies against all four DENV types 1 and 3 months post-TDEN dose 2. The TDEN vaccine was immunogenic with an acceptable safety profile in flavivirus-primed adults. PMID:24865677

  3. Safety and immunogenicity of a rederived, live-attenuated dengue virus vaccine in healthy adults living in Thailand: a randomized trial.

    PubMed

    Watanaveeradej, Veerachai; Gibbons, Robert V; Simasathien, Sriluck; Nisalak, Ananda; Jarman, Richard G; Kerdpanich, Angkool; Tournay, Elodie; De La Barrerra, Rafael; Dessy, Francis; Toussaint, Jean-François; Eckels, Kenneth H; Thomas, Stephen J; Innis, Bruce L

    2014-07-01

    Safety and immunogenicity of two formulations of a live-attenuated tetravalent dengue virus (TDEN) vaccine produced using rederived master seeds from a precursor vaccine were tested against a placebo control in a phase II, randomized, double blind trial (NCT00370682). Two doses were administered 6 months apart to 120 healthy, predominantly flavivirus-primed adults (87.5% and 97.5% in the two vaccine groups and 92.5% in the placebo group). Symptoms and signs reported after vaccination were mild to moderate and transient. There were no vaccine-related serious adverse events or dengue cases reported. Asymptomatic, low-level viremia (dengue virus type 2 [DENV-2], DENV-3, or DENV-4) was detected in 5 of 80 vaccine recipients. One placebo recipient developed a subclinical natural DENV-1 infection. All flavivirus-unprimed subjects and at least 97.1% of flavivirus-primed subjects were seropositive to antibodies against all four DENV types 1 and 3 months post-TDEN dose 2. The TDEN vaccine was immunogenic with an acceptable safety profile in flavivirus-primed adults.

  4. A water-based training program that includes perturbation exercises improves speed of voluntary stepping in older adults: a randomized controlled cross-over trial.

    PubMed

    Elbar, Ori; Tzedek, Irit; Vered, Elisha; Shvarth, Gali; Friger, Michael; Melzer, Itshak

    2013-01-01

    This study evaluated the effects of a water exercise training program that includes perturbation exercises (WEP) to improve the speed of voluntary stepping reaction in older adults. Speed of voluntary stepping considered as an important skill to prevent a fall when balance is lost. In a single-blinded randomized controlled trial with a crossover design thirty-six independent old adults (64-88 years old) were divided into two groups. Group A received WEP for the first 12 weeks, followed by no intervention for the second 12 weeks. Group B did not receive intervention for the first 12 weeks and received WEP for the second 12 weeks. Voluntary Step Execution Test and postural stability in upright standing (eyes open and closed conditions) were measured at baseline, 12 weeks, and 24 weeks. A significant interaction effect between group and time was found for the step execution, due to improvement in initiation phase and swing phase durations in the WEP group. Also significant improvement in postural stability parameters in eyes open and closed conditions is noted. The present results indicate that the primary benefit of WEP that include perturbations to induce stepping, was a reduction in voluntary stepping times. The WEP generalized to a better control of balance in up-right standing. PMID:22951028

  5. Effectiveness of Nurse-Practitioner-Delivered Brief Motivational Intervention for Young Adult Alcohol and Drug Use in Primary Care in South Africa: A Randomized Clinical Trial

    PubMed Central

    Mertens, Jennifer R.; Ward, Catherine L.; Bresick, Graham F.; Broder, Tina; Weisner, Constance M.

    2014-01-01

    Aims: To assess the effectiveness of brief motivational intervention for alcohol and drug use in young adult primary care patients in a low-income population and country. Methods: A randomized controlled trial in a public-sector clinic in Delft, a township in the Western Cape, South Africa recruited 403 patients who were randomized to either single-session, nurse practitioner-delivered Brief Motivational Intervention plus referral list or usual care plus referral list, and followed up at 3 months. Results: Although rates of at-risk alcohol use and drug use did not differ by treatment arm at follow-up, patients assigned to the Brief Motivational Intervention had significantly reduced scores on ASSIST (Alcohol, Smoking and Substance Involvement Screening Test) for alcohol—the most prevalent substance. Conclusion: Brief Motivational Intervention may be effective at reducing at-risk alcohol use in the short term among low-income young adult primary care patients; additional research is needed to examine long-term outcomes. PMID:24899076

  6. A water-based training program that includes perturbation exercises improves speed of voluntary stepping in older adults: a randomized controlled cross-over trial.

    PubMed

    Elbar, Ori; Tzedek, Irit; Vered, Elisha; Shvarth, Gali; Friger, Michael; Melzer, Itshak

    2013-01-01

    This study evaluated the effects of a water exercise training program that includes perturbation exercises (WEP) to improve the speed of voluntary stepping reaction in older adults. Speed of voluntary stepping considered as an important skill to prevent a fall when balance is lost. In a single-blinded randomized controlled trial with a crossover design thirty-six independent old adults (64-88 years old) were divided into two groups. Group A received WEP for the first 12 weeks, followed by no intervention for the second 12 weeks. Group B did not receive intervention for the first 12 weeks and received WEP for the second 12 weeks. Voluntary Step Execution Test and postural stability in upright standing (eyes open and closed conditions) were measured at baseline, 12 weeks, and 24 weeks. A significant interaction effect between group and time was found for the step execution, due to improvement in initiation phase and swing phase durations in the WEP group. Also significant improvement in postural stability parameters in eyes open and closed conditions is noted. The present results indicate that the primary benefit of WEP that include perturbations to induce stepping, was a reduction in voluntary stepping times. The WEP generalized to a better control of balance in up-right standing.

  7. The Relieving Effects of BrainPower Advanced, a Dietary Supplement, in Older Adults with Subjective Memory Complaints: A Randomized, Double-Blind, Placebo-Controlled Trial.

    PubMed

    Zhu, Jingfen; Shi, Rong; Chen, Su; Dai, Lihua; Shen, Tian; Feng, Yi; Gu, Pingping; Shariff, Mina; Nguyen, Tuong; Ye, Yeats; Rao, Jianyu; Xing, Guoqiang

    2016-01-01

    Subjective memory complaints (SMCs) are common in older adults that can often predict further cognitive impairment. No proven effective agents are available for SMCs. The effect of BrainPower Advanced, a dietary supplement consisting of herbal extracts, nutrients, and vitamins, was evaluated in 98 volunteers with SMCs, averaging 67 years of age (47-88), in a randomized, double-blind, placebo-controlled trial. Subjective hypomnesis/memory loss (SML) and attention/concentration deficits (SAD) were evaluated before and after 12-week supplementation of BrainPower Advanced capsules (n = 47) or placebo (n = 51), using a 5-point memory questionnaire (1 = no/slight, 5 = severe). Objective memory function was evaluated using 3 subtests of visual/audio memory, abstraction, and memory recall that gave a combined total score. The BrainPower Advanced group had more cases of severe SML (severity ⩾ 3) (44/47) and severe SAD (43/47) than the placebo group (39/51 and 37/51, < 0.05, < 0.05, resp.) before the treatment. BrainPower Advanced intervention, however, improved a greater proportion of the severe SML (29.5%)(13/44) (P < 0.01) and SAD (34.9%)(15/43)(P < 0.01) than placebo (5.1% (2/39) and 13.5% (5/37), resp.). Thus, 3-month BrainPower Advanced supplementation appears to be beneficial to older adults with SMCs. PMID:27190539

  8. Effects of supplementation with the fat-soluble vitamins E and D on fasting flow-mediated vasodilation in adults: a meta-analysis of randomized controlled trials.

    PubMed

    Joris, Peter J; Mensink, Ronald P

    2015-03-10

    The effects of fat-soluble vitamin supplementation on cardiovascular disease (CVD) risk are not clear. Therefore, we performed a meta-analysis to quantify effects of fat-soluble vitamin supplements on fasting flow-mediated vasodilation (FMD) of the brachial artery, a validated marker to assess CVD risk. Randomized placebo-controlled trials (RCTs) were identified by a systematic search till July 2014. Seven RCTs studying the effects of vitamin E supplements (range: 300 to 1800 IU per day) and nine RCTs examining the effects of vitamin D supplements, that involved, respectively, 303 and 658 adults, were included. No studies with carotenoid or vitamin K supplements were found. Vitamin E supplementation increased FMD vs. control by 2.42% (95% CI: 0.46% to 4.37%; p = 0.015). No effects of vitamin D supplementation were found (0.15%; 95% CI: -0.21% to 0.51%; p = 0.41). These effects did not depend on subject characteristics, treatment characteristics or technical aspects of the FMD measurement. However, no dose-response relationship was evident for vitamin E, statistical significance depended on one study, while the levels of supplement were far above recommended intakes. The current meta-analysis, therefore, does not provide unambiguous evidence to support the use of fat-soluble vitamin supplements to improve fasting FMD in adults.

  9. The effect of genetic counseling for adult offspring of patients with type 2 diabetes on attitudes toward diabetes and its heredity: a randomized controlled trial.

    PubMed

    Nishigaki, M; Tokunaga-Nakawatase, Y; Nishida, J; Kazuma, K

    2014-10-01

    The aim of this study is to investigate the effect of diabetes genetic counseling on attitudes toward diabetes and its heredity in relatives of type 2 diabetes patients. This study was an unmasked, randomized controlled trial at a medical check-up center in Japan. Subjects in this study are healthy adults between 30 and 60 years of age who have a family history of type 2 diabetes in their first degree relatives. Participants in the intervention group received a brief genetic counseling session for approximately 10 min. Genetic counseling was structured based on the Health Belief Model. Both intervention and control groups received a booklet for general diabetes prevention. Risk perception and recognition of diabetes, and attitude towards its prevention were measured at baseline, 1 week and 1 year after genetic counseling. Participants who received genetic counseling showed significantly higher recognition about their sense of control over diabetes onset than control group both at 1 week and 1 year after the session. On the other hand, anxiety about diabetes did not change significantly. The findings show that genetic counseling for diabetes at a medical check center helped adults with diabetes family history understand they are able to exert control over the onset of their disease through lifestyle modification.

  10. Long term maintenance of weight loss with non-surgical interventions in obese adults: systematic review and meta-analyses of randomised controlled trials

    PubMed Central

    Dombrowski, S U; Knittle, K; Avenell, A; Araújo-Soares, V

    2014-01-01

    Objective To systematically review and describe currently available approaches to supporting maintenance of weight loss in obese adults and to assess the evidence for the effectiveness of these interventions. Design Systematic review with meta-analysis. Data sources Medline, PsycINFO, Embase, and the Cochrane Central Register of Controlled Trials. Study selection Studies were identified through to January 2014. Randomised trials of interventions to maintain weight loss provided to initially obese adults (aged ≥18) after weight loss of ≥5% body weight with long term (≥12 months) follow-up of weight change (main outcome) were included. Study appraisal and synthesis Potential studies were screened independently and in duplicate; study characteristics and outcomes were extracted. Meta-analyses were conducted to estimate the effects of interventions on weight loss maintenance with the inverse variance method and a random effects model. Results are presented as mean differences in weight change, with 95% confidence intervals. Results 45 trials involving 7788 individuals were included. Behavioural interventions focusing on both food intake and physical activity resulted in an average difference of −1.56 kg (95% confidence interval −2.27 to −0.86 kg; 25 comparisons, 2949 participants) in weight regain compared with controls at 12 months. Orlistat combined with behavioural interventions resulted in a −1.80 kg (−2.54 to −1.06; eight comparisons, 1738 participants) difference compared with placebo at 12 months. All orlistat studies reported higher frequencies of adverse gastrointestinal events in the experimental compared with placebo control groups. A dose-response relation for orlistat treatment was found, with 120 mg doses three times a day leading to greater weight loss maintenance (−2.34 kg, −3.03 to −1.65) compared with 60 mg and 30 mg three times a day (−0.70 kg, 95% confidence interval −1.92 to 0.52), P=0.02. Conclusions Behavioural

  11. Evaluation of Bacillus subtilis R0179 on gastrointestinal viability and general wellness: a randomised, double-blind, placebo-controlled trial in healthy adults.

    PubMed

    Hanifi, A; Culpepper, T; Mai, V; Anand, A; Ford, A L; Ukhanova, M; Christman, M; Tompkins, T A; Dahl, W J

    2015-03-01

    A probiotic formulation of Enterococcus faecium R0026 and Bacillus subtilis R0179 has been evaluated in previous clinical trials. However, B. subtilis R0179 has not been evaluated as a single probiotic strain or in combination with other strains at doses higher than 0.1×109 cfu. To establish oral dose-response tolerance and gastrointestinal (GI) viability of B. subtilis R0179, a randomised, double-blind, placebo-controlled trial in healthy adults (n=81; 18-50 years old) was conducted. Participants received B. subtilis R0179 at 0.1, 1.0 or 10×109 cfu/capsule/day or placebo for four weeks. General wellness was assessed using a daily questionnaire evaluating GI, cephalic, ear-nose-throat, behavioural, emetic, and epidermal symptoms. GI symptoms were further evaluated using a weekly gastrointestinal symptom rating scale (GSRS). GI transit viability of B. subtilis R0179 was assessed by plating and microbiota analysis by 16S rRNA at baseline, week 4 of the intervention and washout. General wellness and GI function were not affected by oral consumption of B. subtilis R0179 at any dose. Daily questionnaire syndrome scores were not different from baseline and did not exceed a clinically significant score of 1. GSRS syndrome scores were not different from baseline and ranged from 1.1±0.1 to 1.9±0.2. Faecal viable counts of B. subtilis R0179 demonstrated a dose response: the placebo group (1.1±0.1 log10 cfu/g) differed from 0.1×109 (4.6±0.1 log10 cfu/g), 1×109 (5.6±0.1 log10 cfu/g) and 10×109 (6.4±0.1 log10 cfu/g) (P<0.0001). No significant changes in phyla were observed, but sequence reads binned to multiple operational taxonomic units matching closest to Ruminococci increased during probiotic supplementation. B. subtilis R0179 survives passage through the human GI tract and is well tolerated by healthy adults at intakes from 0.1 to 10×109 cfu/day. The trial has been registered at www.clinicaltrials.gov under NCT01802151. PMID:25062611

  12. Effects of resistance training with and without caloric restriction on physical function and mobility in overweight and obese older adults: a randomized controlled trial1234

    PubMed Central

    Nicklas, Barbara J; Chmelo, Elizabeth; Delbono, Osvaldo; Carr, J Jeffrey; Lyles, Mary F; Marsh, Anthony P

    2015-01-01

    Background: Resistance training (RT) improves muscle strength and overall physical function in older adults. RT may be particularly important in the obese elderly who have compromised muscle function. Whether caloric restriction (CR) acts synergistically with RT to enhance function is unknown. Objective: As the primary goal of the Improving Muscle for Functional Independence Trial (I’M FIT), we determined the effects of adding CR for weight loss on muscle and physical function responses to RT in older overweight and obese adults. Design: I’M FIT was a 5-mo trial in 126 older (65–79 y) overweight and obese men and women who were randomly assigned to a progressive, 3-d/wk, moderate-intensity RT intervention with a weight-loss intervention (RT+CR) or without a weight-loss intervention (RT). The primary outcome was maximal knee extensor strength; secondary outcomes were muscle power and quality, overall physical function, and total body and thigh compositions. Results: Body mass decreased in the RT+CR group but not in the RT group. Fat mass, percentage of fat, and all thigh fat volumes decreased in both groups, but only the RT+CR group lost lean mass. Adjusted postintervention body- and thigh-composition measures were all lower with RT+CR except intermuscular adipose tissue (IMAT). Knee strength, power, and quality and the 4-m gait speed increased similarly in both groups. Adjusted postintervention means for a 400-m walk time and self-reported disability were better with RT+CR with no group differences in other functional measures, including knee strength. Participants with a lower percentage of fat and IMAT at baseline exhibited a greater improvement in the 400-m walk and knee strength and power. Conclusions: RT improved body composition (including reducing IMAT) and muscle strength and physical function in obese elderly, but those with higher initial adiposity experienced less improvement. The addition of CR during RT improves mobility and does not compromise

  13. A Multicenter, Open-Label Trial to Evaluate the Quality of Life in Adults with ADHD Treated with Long-Acting Methylphenidate (OROS MPH): Concerta Quality of Life (CONQoL) Study

    ERIC Educational Resources Information Center

    Mattos, Paulo; Rodrigues Louza, Mario; Fernandes Palmini, Andre Luis; de Oliveira, Irismar Reis; Lopes Rocha, Fabio

    2013-01-01

    The available literature provides few studies on the effectiveness of methylphenidate in improving quality of life in individuals with ADHD. Objective: To assess the effectiveness of Methyphenidate OROS formulation (OROS MPH) through QoL in adults with ADHD. Method: A 12-week, multicenter, open-label trial involving 60 patients was used. The…

  14. Effect of a Web-Based Behavior Change Program on Weight Loss and Cardiovascular Risk Factors in Overweight and Obese Adults at High Risk of Developing Cardiovascular Disease: Randomized Controlled Trial

    PubMed Central

    Watson, Sinead; Woodside, Jayne V; Ware, Lisa J; Hunter, Steven J; McGrath, Alanna; Cardwell, Christopher R; Appleton, Katherine M; Young, Ian S

    2015-01-01

    weight at 3 months (34%, 11/32 vs 3%, 1/33, P<.001) and 6 months (41%, 13/32 vs 18%, 6/33, P=.047), but not at 12 months (22%, 7/32 vs 21%, 7/33, P=.95) versus control group. The intervention group showed improvements in total cholesterol, triglycerides, and adopted more positive dietary and physical activity behaviors for up to 3 months verus control; however, these improvements were not sustained. Conclusions Although the intervention group had high attrition levels, this study provides evidence that this Web-based program can be used to initiate clinically relevant weight loss and lower CVD risk up to 3-6 months based on the proportion of intervention group participants losing ≥5% of their body weight versus control group. It also highlights a need for augmenting Web-based programs with further interventions, such as in-person support to enhance engagement and maintain these changes. Trial Registration ClinicalTrials.gov NCT01472276; http://clinicaltrials.gov/ct2/show/study/NCT01472276 (Archived by Webcite at http://www.webcitation.org/6Z9lfj8nD). PMID:26183659

  15. Hot topics in parenteral nutrition. Rationale for using new lipid emulsions in parenteral nutrition and a review of the trials performed in adults.

    PubMed

    Calder, Philip C

    2009-08-01

    Lipids traditionally used in parenteral nutrition are based on n-6 fatty acid-rich vegetable oils such as soyabean oil. This practice may not be optimal because it may present an excessive supply of linoleic acid. Alternatives to the use of soyabean oil include its partial replacement by so-called medium-chain TAG (MCT), olive oil or fish oil, either alone or in combination. Lipid emulsions containing MCT are well established, but those containing olive oil and fish oil, although commercially available, are still undergoing trials in different patient groups. Emulsions containing olive oil or fish oil are well tolerated and without adverse effects in a wide range of adult patients. An olive oil-soyabean oil emulsion has been used in quite small studies in critically-ill patients and in patients with trauma or burns with little real evidence of advantage over soyabean oil or MCT-soyabean oil. Fish oil-containing lipid emulsions have been used in adult patients post surgery (mainly gastrointestinal). This approach has been associated with alterations in patterns of inflammatory mediators and in immune function and, in some studies, a reduction in the length of stay in the intensive care unit and in hospital. One study indicates that peri-operative administration of fish oil may be superior to post-operative administration. Fish oil has been used in critically-ill adults. Here, the influence on inflammatory processes, immune function and clinical end points is not clear, since there are too few studies and those that are available report contradictory findings. One important factor is the dose of fish oil required to influence clinical outcomes. Further studies that are properly designed and adequately powered are required in order to strengthen the evidence base relating to the use of lipid emulsions that include olive oil and fish oil in critically-ill patients and in patients post surgery.

  16. Improvements in well-being and vagal tone following a yogic breathing-based life skills workshop in young adults: Two open-trial pilot studies

    PubMed Central

    Goldstein, Michael R; Lewis, Gregory F; Newman, Ronnie; Brown, Janice M; Bobashev, Georgiy; Kilpatrick, Lisa; Seppälä, Emma M; Fishbein, Diana H; Meleth, Sreelatha

    2016-01-01

    Background: While efficacy of Sudarshan Kriya Yoga (SKY) has been demonstrated in a number of prior studies, little is known about the effects of SKY taught as part of the Your Enlightened Side (YES+) workshop designed for college students and other young adults. Aims: This study aimed to assess the effects of YES+, a yogic breathing-based life skills workshop, on multiple measures of well-being and physiological stress response. Materials and Methods: Two nonrandomized open-trial pilot studies were conducted with a total of 74 young adults (age 25.4 ± 6.6 years; 55% female). Study 1 collected a variety of self-report questionnaires at baseline, postworkshop, and 1-month follow-up. Study 2 collected self-report questionnaires in addition to electrocardiography with a stationary cycling challenge at baseline and 1-month follow-up. Results: Study 1: Improvements in self-reported depression (P's ≤ 0.010), perceived stress (P's ≤ 0.002), life satisfaction (P's ≤ 0.002), social connectedness (P's ≤ 0.004), and gratitude (P's ≤ 0.090) were observed at postworkshop and 1-month after workshop relative to baseline. Study 2: Improvements in self-reported emotion regulation were observed at 1-month follow-up relative to baseline (P = 0.019). Positive and Negative Affect Schedule-Expanded Form positive affect increased (P = 0.021), while fatigue and sadness decreased (P's ≤ 0.005). During the stationary cycling challenge, rate to recovery of electrocardiography inter-beat interval also increased from baseline to 1-month follow-up (P = 0.077). Conclusions: These findings suggest that a life skills workshop integrating yogic breathing techniques may provide self-empowering tools for enhancing well-being in young adults. Future research is indicated to further explore these effects, particularly in regards to vagal tone and other aspects of stress physiology. PMID:26865767

  17. A randomized controlled trial of brain training with non-action video games in older adults: results of the 3-month follow-up.

    PubMed

    Ballesteros, Soledad; Mayas, Julia; Prieto, Antonio; Toril, Pilar; Pita, Carmen; Laura, Ponce de León; Reales, José M; Waterworth, John A

    2015-01-01

    This randomized controlled study (ClinicalTrials.gov NCT02007616) investigated the maintenance of training effects of 20 1-hr non-action video game training sessions with selected games from a commercial package on several age-declining cognitive functions and subjective wellbeing after a 3-month no-contact period. Two groups of cognitively normal older adults participated in both the post-training (posttest) and the present follow-up study, the experimental group who received training and the control group who attended several meetings with the research team during the study but did not receive training. Groups were similar at baseline on demographics, vocabulary, global cognition, and depression status. Significant improvements in the trained group, and no variation in the control group had been previously found at posttest, in processing speed, attention and visual recognition memory, as well as in two dimensions of subjective wellbeing. In the current study, improvement from baseline to 3 months follow-up was found only in wellbeing (Affection and Assertivity dimensions) in the trained group whereas there was no change in the control group. Previous significant improvements in processing speed, attention and spatial memory become non-significant after the 3-month interval. Training older adults with non-action video games enhanced aspects of cognition just after training but this effect disappeared after a 3-month no-contact follow-up period. Cognitive plasticity can be induced in older adults by training, but to maintain the benefits periodic boosting sessions would be necessary. PMID:25926790

  18. Effect of Reiki Therapy on Pain and Anxiety in Adults: An In-Depth Literature Review of Randomized Trials with Effect Size Calculations

    PubMed Central

    Thrane, Susan; Cohen, Susan M.

    2013-01-01

    Objective To calculate the effect of Reiki therapy for pain and anxiety in randomized clinical trials. Data Sources A systematic search of PubMed, ProQuest, Cochrane, PsychInfo, CINAHL, Web of Science, Global Health, and Medline databases was conducted using the search terms pain, anxiety, and Reiki. The Center for Reiki Research was also examined for articles. Study Selection Studies that used randomization and a control or usual care group, used Reiki therapy in one arm of the study, published in 2000 or later in peer-reviewed journals in English, and measured pain or anxiety were included. Results After removing duplicates, 49 articles were examined and 12 articles received full review. Seven studies met the inclusion criteria: four articles studied cancer patients; one examined post-surgical patients; and two analyzed community dwelling older adults. Effect sizes were calculated for all studies using Cohen’s d statistic. Effect sizes for within group differences ranged from d=0.24 for decrease in anxiety in women undergoing breast biopsy to d=2.08 for decreased pain in community dwelling adults. The between group differences ranged from d=0.32 for decrease of pain in a Reiki versus rest intervention for cancer patients to d=4.5 for decrease in pain in community dwelling adults. Conclusions While the number of studies is limited, based on the size Cohen’s d statistics calculated in this review, there is evidence to suggest that Reiki therapy may be effective for pain and anxiety. Continued research using Reiki therapy with larger sample sizes, consistently randomized groups, and standardized treatment protocols is recommended. PMID:24582620

  19. A randomized controlled trial of brain training with non-action video games in older adults: results of the 3-month follow-up

    PubMed Central

    Ballesteros, Soledad; Mayas, Julia; Prieto, Antonio; Toril, Pilar; Pita, Carmen; Laura, Ponce de León; Reales, José M.; Waterworth, John A.

    2015-01-01

    This randomized controlled study (ClinicalTrials.gov NCT02007616) investigated the maintenance of training effects of 20 1-hr non-action video game training sessions with selected games from a commercial package on several age-declining cognitive functions and subjective wellbeing after a 3-month no-contact period. Two groups of cognitively normal older adults participated in both the post-training (posttest) and the present follow-up study, the experimental group who received training and the control group who attended several meetings with the research team during the study but did not receive training. Groups were similar at baseline on demographics, vocabulary, global cognition, and depression status. Significant improvements in the trained group, and no variation in the control group had been previously found at posttest, in processing speed, attention and visual recognition memory, as well as in two dimensions of subjective wellbeing. In the current study, improvement from baseline to 3 months follow-up was found only in wellbeing (Affection and Assertivity dimensions) in the trained group whereas there was no change in the control group. Previous significant improvements in processing speed, attention and spatial memory become non-significant after the 3-month interval. Training older adults with non-action video games enhanced aspects of cognition just after training but this effect disappeared after a 3-month no-contact follow-up period. Cognitive plasticity can be induced in older adults by training, but to maintain the benefits periodic boosting sessions would be necessary. PMID:25926790

  20. Effect of Reiki therapy on pain and anxiety in adults: an in-depth literature review of randomized trials with effect size calculations.

    PubMed

    Thrane, Susan; Cohen, Susan M

    2014-12-01

    The objective of this study was to calculate the effect of Reiki therapy for pain and anxiety in randomized clinical trials. A systematic search of PubMed, ProQuest, Cochrane, PsychInfo, CINAHL, Web of Science, Global Health, and Medline databases was conducted using the search terms pain, anxiety, and Reiki. The Center for Reiki Research also was examined for articles. Studies that used randomization and a control or usual care group, used Reiki therapy in one arm of the study, were published in 2000 or later in peer-reviewed journals in English, and measured pain or anxiety were included. After removing duplicates, 49 articles were examined and 12 articles received full review. Seven studies met the inclusion criteria: four articles studied cancer patients, one examined post-surgical patients, and two analyzed community dwelling older adults. Effect sizes were calculated for all studies using Cohen's d statistic. Effect sizes for within group differences ranged from d = 0.24 for decrease in anxiety in women undergoing breast biopsy to d = 2.08 for decreased pain in community dwelling adults. The between group differences ranged from d = 0.32 for decrease of pain in a Reiki versus rest intervention for cancer patients to d = 4.5 for decrease in pain in community dwelling adults. Although the number of studies is limited, based on the size Cohen's d statistics calculated in this review, there is evidence to suggest that Reiki therapy may be effective for pain and anxiety. Continued research using Reiki therapy with larger sample sizes, consistently randomized groups, and standardized treatment protocols is recommended. PMID:24582620

  1. High intake of fatty fish, but not of lean fish, affects serum concentrations of TAG and HDL-cholesterol in healthy, normal-weight adults: a randomised trial.

    PubMed

    Hagen, Ingrid V; Helland, Anita; Bratlie, Marianne; Brokstad, Karl A; Rosenlund, Grethe; Sveier, Harald; Mellgren, Gunnar; Gudbrandsen, Oddrun A

    2016-08-01

    The aim of the present study was to examine whether high intake of lean or fatty fish (cod and farmed salmon, respectively) by healthy, normal-weight adults would affect risk factors of type 2 diabetes and CVD when compared with lean meat (chicken). More knowledge is needed concerning the potential health effects of high fish intake (>300 g/week) in normal-weight adults. In this randomised clinical trial, thirty-eight young, healthy, normal-weight participants consumed 750 g/week of lean or fatty fish or lean meat (as control) for 4 weeks at dinner according to provided recipes to ensure similar ways of preparations and choices of side dishes between the groups. Energy and macronutrient intakes at baseline and end point were similar in all groups, and there were no changes in energy and macronutrient intakes within any of the groups during the course of the study. High intake of fatty fish, but not lean fish, significantly reduced TAG and increased HDL-cholesterol concentrations in fasting serum when compared with lean meat intake. When compared with lean fish intake, fatty fish intake increased serum HDL-cholesterol. No differences were observed between lean fish, fatty fish and lean meat groups regarding fasting and postprandial glucose regulation. These findings suggest that high intake of fatty fish, but not of lean fish, could beneficially affect serum concentrations of TAG and HDL-cholesterol, which are CVD risk factors, in healthy, normal-weight adults, when compared with high intake of lean meat. PMID:27363518

  2. Effect of Exercise and Cognitive Activity on Self-Reported Sleep Quality in Community-Dwelling Older Adults with Cognitive Complaints: A Randomized Controlled Trial

    PubMed Central

    Pa, Judy; Goodson, William; Bloch, Andrew; King, Abby C.; Yaffe, Kristine; Barnes, Deborah E.

    2015-01-01

    Objectives To compare the effects of different types of physical and mental activity on self-reported sleep quality over 12 weeks in older adults with cognitive and sleep complaints. Design Randomized controlled trial. Setting General community. Participants Seventy-two inactive community-dwelling older adults with self-reported sleep and cognitive problems (mean age 73.3±6.1; 60% women). Intervention Random allocation to four arms using a two-by-two factorial design: aerobic+cognitive training, aerobic+educational DVD, stretching+cognitive training, and stretching+educational DVD arms (60 min/d, 3 d/wk for physical and mental activity for 12 weeks). Measurements Change in sleep quality using seven questions from the Sleep Disorders Questionnaire on the 2005–06 National Health and Nutrition Examination Survey (range 0–28, with higher scores reflecting worse sleep quality). Analyses used intention-to-treat methods. Results Sleep quality scores did not differ at baseline, but there was a significant difference between the study arms in change in sleep quality over time (p<.005). Mean sleep quality scores improved significantly more in the stretching+educational DVD arm (5.1 points) than in the stretching+cognitive training (1.2 points), aerobic+educational DVD (1.1 points), or aerobic+cognitive training (0.25 points) arm (all p<.05, corrected for multiple comparisons). Differences between arms were strongest for waking at night (p=.02) and taking sleep medications (p=.004). Conclusion Self-reported sleep quality improved significantly more with low-intensity physical and mental activities than with moderate- or high-intensity activities in older adults with self-reported cognitive and sleep difficulties. Future longer-term studies with objective sleep measures are needed to corroborate these results. PMID:25516028

  3. The effect of a single, large bolus of vitamin D in healthy adults over the winter and following year: a randomized, double-blind, placebo-controlled trial

    PubMed Central

    Kearns, MD; Binongo, JNG; Watson, D; Alvarez, JA; Lodin, D; Ziegler, TR; Tangpricha, V

    2014-01-01

    BACKGROUND/OBJECTIVES Although single, high doses of vitamin D effectively maintain vitamin D sufficiency in several populations, no studies have evaluated healthy adults over winter, during which vitamin D status declines. This study investigated whether high-dose vitamin D3 given once to healthy adults before winter will (1) prevent the wintertime decline in vitamin D status, (2) promote vitamin D sufficiency 1 year following the dose and (3) prevent the rise of parathyroid hormone (PTH) concentrations. SUBJECTS/METHODS In this double-blind, placebo-controlled trial, we assessed plasma 25(OH)D and PTH concentrations at baseline, 5, 90 and 365 days after drug administration in 28 healthy adults. In all, >80% of subjects returned at each time point. RESULTS At baseline, the young, healthy participants had a mean plasma 25(OH)D concentration of 17.5 ± 6.1 ng/ml. Only two subjects exhibited plasma 25(OH)D concentrations >30 ng/ml. At 5 days, subjects randomized to vitamin D3 had a higher mean plasma 25(OH)D concentration compared with the placebo group (39.1 vs 19.1 ng/ml, P<0.001). Plasma 25(OH)D concentrations returned to baseline at 90 and 365 days in the vitamin D3 group and remained unchanged in the placebo group. PTH and calcium concentrations were unrelated to changes in 25(OH)D levels and similar between groups over time. CONCLUSIONS A dose of 250 000 IU of vitamin D3 given once in November resulted in a robust increase in plasma 25(OH)D after 5 days, but it was unable to sustain this increase after 90 days. A larger or more frequent dosing regimen may be needed for long-term vitamin D sufficiency. PMID:25271011

  4. A randomized trial to assess the utility of preintubation adult fiberoptic bronchoscope assessment in patients for thoracic surgery requiring one-lung ventilation

    PubMed Central

    Amin, Nayana; Tarwade, Pritee; Shetmahajan, Madhavi; Pramesh, C. S.; Jiwnani, Sabita; Mahajan, Abhishek; Purandare, Nilendu

    2016-01-01

    Background: Confirmation of placement of Double lumen endobronchial tubes (DLETT) and bronchial blockers (BBs) with the pediatric fiberoptic bronchoscope (FOB) is the most preferred practice worldwide. Most centers possess standard adult FOBs, some, particularly in developing countries might not have access to the pediatric-sized devices. We have evaluated the role of preintubation airway assessment using the former, measuring the distance from the incisors to the carina and from carina to the left and right upper lobe bronchus in deciding the depth of insertion of the lung isolation device. Methods: The study was a randomized, controlled, double-blind trial consisting of 84 patients (all >18 years) undergoing thoracic surgery over a 12-month period. In the study group (n = 38), measurements obtained during FOB with the adult bronchoscope decided the depth of insertion of the lung isolation device. In the control group (n = 46), DLETTs and BBs were placed blindly followed by clinical confirmation by auscultation. Selection of the type and size of the lung isolation device was at the discretion of the anesthesiologist conducting the case. In all cases, pediatric FOB was used to confirm accurate placement of devices. Results: Of 84 patients (DLETT used in 76 patients; BB used in 8 patients), preintubation airway measurements significantly improved the success rate of optimal placement of lung isolation device from 25% (11/44) to 50% (18/36) (P = 0.04). Our incidence of failed device placement at initial insertion was 4.7% (4/84). Incidence of malposition was 10% (8/80) with 4 cases in each group. The incidence of suboptimal placement was lower in the study group at 38.9% (14/36) versus 65.9% (29/44). Conclusions: Preintubation airway measurements with the adult FOB reduces airway manipulations and improves the success rate of optimal placement of DLETT and BB. PMID:27052065

  5. High intake of fatty fish, but not of lean fish, affects serum concentrations of TAG and HDL-cholesterol in healthy, normal-weight adults: a randomised trial.

    PubMed

    Hagen, Ingrid V; Helland, Anita; Bratlie, Marianne; Brokstad, Karl A; Rosenlund, Grethe; Sveier, Harald; Mellgren, Gunnar; Gudbrandsen, Oddrun A

    2016-08-01

    The aim of the present study was to examine whether high intake of lean or fatty fish (cod and farmed salmon, respectively) by healthy, normal-weight adults would affect risk factors of type 2 diabetes and CVD when compared with lean meat (chicken). More knowledge is needed concerning the potential health effects of high fish intake (>300 g/week) in normal-weight adults. In this randomised clinical trial, thirty-eight young, healthy, normal-weight participants consumed 750 g/week of lean or fatty fish or lean meat (as control) for 4 weeks at dinner according to provided recipes to ensure similar ways of preparations and choices of side dishes between the groups. Energy and macronutrient intakes at baseline and end point were similar in all groups, and there were no changes in energy and macronutrient intakes within any of the groups during the course of the study. High intake of fatty fish, but not lean fish, significantly reduced TAG and increased HDL-cholesterol concentrations in fasting serum when compared with lean meat intake. When compared with lean fish intake, fatty fish intake increased serum HDL-cholesterol. No differences were observed between lean fish, fatty fish and lean meat groups regarding fasting and postprandial glucose regulation. These findings suggest that high intake of fatty fish, but not of lean fish, could beneficially affect serum concentrations of TAG and HDL-cholesterol, which are CVD risk factors, in healthy, normal-weight adults, when compared with high intake of lean meat.

  6. Randomized controlled trial of oatmeal consumption versus noodle consumption on blood lipids of urban Chinese adults with hypercholesterolemia

    PubMed Central

    2012-01-01

    Background Cardiovascular disease (CVD) is the leading cause of death in China and worldwide. Whole grain oats can reduce risk of CVD by reducing total and LDL-cholesterol, major risk factors for CVD. While this association has been established in many populations, data from Asian populations is limited. Thus, this study investigated the impact of oat consumption on cholesterol levels in Chinese adults. Male and female data from this work were previously published separately in mandarin in two Chinese journals. The combined male and female data were reanalyzed and are presented here. Methods A randomized, controlled, parallel-arm study was conducted at Beijing Hospital, Beijing china. Subjects were adults (men and women) with mild to moderate hypercholesterolemia. The oat group (n=85) consumed 100grams of instant oat cereal versus the control group (n=81) who consumed 100grams of wheat flour-based noodles daily for 6weeks. Laboratory and anthropometric measurements were conducted at baseline and at the end of the 6-week intervention. Results Dietary fiber intake increased significantly in the oat group compared to the control group at the end of the 6-week intervention. Total-, LDL-cholesterol and waist circumference decreased significantly in the oat group compared to the control. HDL-cholesterol decreased significantly in the control group versus the oat group. There were no significant changes in blood pressure, other anthropometric or laboratory measures between the two groups at the end of the intervention. Conclusions Instant oatmeal consumed daily for 6 weeks significantly increased fiber intake and decreased major risk factors for CVD in Chinese adults with hypercholesterolemia. Increased consumption of whole grains, including oats, should continue to be encouraged. PMID:22866937

  7. Effectiveness of conventional versus virtual reality based vestibular rehabilitation in the treatment of dizziness, gait and balance impairment in adults with unilateral peripheral vestibular loss: a randomised controlled trial

    PubMed Central

    2012-01-01

    Background Unilateral peripheral vestibular loss results in gait and balance impairment, dizziness and oscillopsia. Vestibular rehabilitation benefits patients but optimal treatment remains unkown. Virtual reality is an emerging tool in rehabilitation and provides opportunities to improve both outcomes and patient satisfaction with treatment. The Nintendo Wii Fit Plus® (NWFP) is a low cost virtual reality system that challenges balance and provides visual and auditory feedback. It may augment the motor learning that is required to improve balance and gait, but no trials to date have investigated efficacy. Methods/Design In a single (assessor) blind, two centre randomised controlled superiority trial, 80 patients with unilateral peripheral vestibular loss will be randomised to either conventional or virtual reality based (NWFP) vestibular rehabilitation for 6 weeks. The primary outcome measure is gait speed (measured with three dimensional gait analysis). Secondary outcomes include computerised posturography, dynamic visual acuity, and validated questionnaires on dizziness, confidence and anxiety/depression. Outcome will be assessed post treatment (8 weeks) and at 6 months. Discussion Advances in the gaming industry have allowed mass production of highly sophisticated low cost virtual reality systems that incorporate technology previously not accessible to most therapists and patients. Importantly, they are not confined to rehabilitation departments, can be used at home and provide an accurate record of adherence to exercise. The benefits of providing augmented feedback, increasing intensity of exercise and accurately measuring adherence may improve conventional vestibular rehabilitation but efficacy must first be demonstrated. Trial registration Clinical trials.gov identifier: NCT01442623 PMID:22449224

  8. Outcome of Adult Brain Tumor Consortium (ABTC) prospective dose-finding trials of I-125 balloon brachytherapy in high-grade gliomas: challenges in clinical trial design and technology development when MRI treatment effect and recurrence appear similar

    PubMed Central

    Stieber, V.; Mikkelsen, T.; Judy, K.; Weingart, J.; Barnett, G.; Olson, J.; Desideri, S.; Ye, X.; Grossman, S.

    2016-01-01

    Objectives The aim of this study is to define the maximal safe radiation dose to guide further study of the GliaSite balloon brachytherapy (GSBT) system in untreated newly diagnosed glioblastoma (NEW-GBM) and recurrent high-grade glioma (REC-HGG). GBST is a balloon placed in the resection cavity and later filled through a subcutaneous port with liquid I-125 Iotrex, providing radiation doses that diminish uniformly with distance from the balloon surface. Methods The Adult Brain Tumor Consortium initiated prospective dose-finding studies to determine maximum tolerated dose in NEW-GBM treated before standard RT or after surgery for REC-HGG. Patients were inevaluable if there was progression before the 90-day posttreatment toxicity evaluation point. Results Ten NEW-GBM patients had the balloon placed, and 2/10 reached the 90 day timepoint. Five REC-HGG enrolled and two were assessable at the 90-day evaluation endpoint. Imaging progression occurred before 90-day evaluation in 7/12 treated patients. The trials were closed as too few patients were assessable to allow dose escalation, although no dose-limiting toxicities (DLTs) were observed. Median survival from treatment was 15.3 months (95 % CI 7.1–23.6) for NEW-GBM and 12.8 months (95 % CI 4.2–20.9) for REC-HGG. Conclusion These trials failed to determine a maximum tolerated dose (MTD) for further testing as early imaging changes, presumed to be progression, were common and interfered with the assessment of treatment-related toxicity. The survival outcomes in these and other related studies, although based on small populations, suggest that GSBT may be worthy of further study using clinical and survival endpoints, rather than standard imaging results. The implications for local therapy development are discussed.

  9. Exploring the effect of companion robots on emotional expression in older adults with dementia: a pilot randomized controlled trial.

    PubMed

    Moyle, Wendy; Cooke, Marie; Beattie, Elizabeth; Jones, Cindy; Klein, Barbara; Cook, Glenda; Gray, Chrystal

    2013-05-01

    This pilot study aimed to compare the effect of companion robots (PARO) to participation in an interactive reading group on emotions in people living with moderate to severe dementia in a residential care setting. A randomized crossover design, with PARO and reading control groups, was used. Eighteen residents with mid- to late-stage dementia from one aged care facility in Queensland, Australia, were recruited. Participants were assessed three times using the Quality of Life in Alzheimer's Disease, Rating Anxiety in Dementia, Apathy Evaluation, Geriatric Depression, and Revised Algase Wandering Scales. PARO had a moderate to large positive influence on participants' quality of life compared to the reading group. The PARO intervention group had higher pleasure scores when compared to the reading group. Findings suggest PARO may be useful as a treatment option for people with dementia; however, the need for a larger trial was identified. PMID:23506125

  10. Three-dimensional precise orientation of bilateral auricular trial prosthesis using a facebow for a young adult with Crouzon syndrome

    PubMed Central

    Rathee, Manu; Tamrakar, Amit Kumar; Kundu, Renu; Yunus, Nadeem

    2014-01-01

    Facial deformity can be debilitating, especially in the psychological and cosmetic aspects. Although surgical correction or replacement of deformed or missing parts is the ideal treatment, prosthetic replacement serves the purpose in case of surgical limitations. Prosthetic rehabilitation of a missing auricle is an acceptable option as it provides better control over the tortuous anatomical shape and shade of the missing portion. Improper spatial orientation of the prosthetic ear on the face can damage the results of even the most aesthetic prosthesis. This case report describes a simple and innovative method for precise spatial orientation of auricular trial prosthesis using a facebow and custom-made adjustable mechanical retention design using stainless steel wire. PMID:25096652

  11. Three-dimensional precise orientation of bilateral auricular trial prosthesis using a facebow for a young adult with Crouzon syndrome.

    PubMed

    Rathee, Manu; Tamrakar, Amit Kumar; Kundu, Renu; Yunus, Nadeem

    2014-01-01

    Facial deformity can be debilitating, especially in the psychological and cosmetic aspects. Although surgical correction or replacement of deformed or missing parts is the ideal treatment, prosthetic replacement serves the purpose in case of surgical limitations. Prosthetic rehabilitation of a missing auricle is an acceptable option as it provides better control over the tortuous anatomical shape and shade of the missing portion. Improper spatial orientation of the prosthetic ear on the face can damage the results of even the most aesthetic prosthesis. This case report describes a simple and innovative method for precise spatial orientation of auricular trial prosthesis using a facebow and custom-made adjustable mechanical retention design using stainless steel wire. PMID:25096652

  12. Differences in Reach and Attrition Between Web-Based and Print-Delivered Tailored Interventions Among Adults over 50 Years of Age: Clustered Randomized Trial

    PubMed Central

    Bolman, Catherine; Golsteijn, Rianne Henrica Johanna; De Vries, Hein; Mudde, Aart Nicolaas; van Stralen, Maartje Marieke; Lechner, Lilian

    2012-01-01

    participants of the printed intervention. The dropout rate was significantly higher in the Web-based intervention group (53%) compared to the print-delivered intervention (39%, P<.001). A low intention to be physically active was a strong predictor for dropout within both delivery modes (P<.001). The difference in dropout rate between the Web-based and the printed intervention was not explained by user characteristics. Conclusions The reach of the same tailored physical activity (PA) intervention in a printed or Web-based delivery mode differed between sociodemographic subgroups of participants over 50 years of age. Although the reach of the Web-based intervention is lower, Web-based interventions can be a good channel to reach high-risk populations (lower PA intention and higher BMI). While the dropout rate was significantly higher in the Web-based intervention group, no specific user characteristics explained the difference in dropout rates between the delivery modes. More research is needed to determine what caused the high rate of dropout in the Web-based intervention. Trial Registration Dutch Trial Register (NTR): 2297: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2297 (Archived by WebCite at http://www.webcitation.org/65TkwoESp). PMID:23246790

  13. Updates from guardian™: a comprehensive registration programme.

    PubMed

    Ozelo, Margareth C

    2015-12-01

    Turoctocog alfa is an approved B-domain truncated recombinant factor VIII concentrate for adults and children with haemophilia A. Clinical data for turoctocog alfa have been reported from the guardian(™) 1, guardian(™) 2 and guardian(™) 3 phase III trials. guardian(™) 1 and guardian(™) 3 phase III trials enrolled 150 adolescents/adults (≥ 12 yr), and 63 children (<12 yr), respectively, with previously treated severe haemophilia A and no history of inhibitors; 188 of these patients continued into the ongoing guardian(™) 2 extension trial. In the three trials, patients have received prophylaxis with turoctocog alfa three times weekly or every second day, with breakthrough bleeds resolved to an expected postinjection level of ≥ 0.50 IU/mL. No safety concerns have arisen, and no patients have developed confirmed inhibitors (primary endpoint). Indeed, no confirmed inhibitors have been detected in >200 patients treated for a cumulative total of >54,000 exposure days in the phase III trials. Pooled efficacy data show a favourable long-term effect of turoctocog alfa on annualised bleeding rate and a success rate for haemostatic response of 86%; 90% of bleeds were resolved with 1-2 doses. This article reviews the clinical development of turoctocog alfa with reference to the guardian(™) clinical programme, describing results obtained to date and ongoing trials.

  14. Effect of a tart cherry juice supplement on arterial stiffness and inflammation in healthy adults: a randomised controlled trial.

    PubMed

    Lynn, Anthony; Mathew, Shilpa; Moore, Chris T; Russell, Jean; Robinson, Emma; Soumpasi, Vithleem; Barker, Margo E

    2014-06-01

    Tart cherries are a particularly rich source of anthocyanins. Evidence indicates that dietary intake of anthocyanins is inversely associated with arterial stiffness. We conducted an open-label randomised placebo controlled study to determine whether a tart cherry juice concentrate (Cherry Active) reduced arterial stiffness, inflammation and risk markers for cardiovascular disease in 47 healthy adults (30-50 years). Participants consumed 30 ml of cherry concentrate diluted to a volume of 250 ml with water or the same volume of an energy matched control drink daily for six weeks. Measurements were taken at baseline and at the end of the intervention. There was no effect of the intervention on arterial stiffness (P = 0.218), c-reactive protein (P = 0.220), systolic blood pressure (P = 0.163), diastolic blood pressure (P = 0.121), total cholesterol (P = 0.342) and high density lipoprotein cholesterol (P = 0.127). At the end of the intervention, plasma antioxidant capacity (measured as the ferric reducing ability of plasma (FRAP)) was significantly higher in the intervention group than the control group (P = 0.012). We conclude that a tart cherry juice concentrate rich in anthocyanins has no effect on arterial stiffness, c-reactive protein and risk markers for cardiovascular disease, but evokes a minor increase in antioxidant status in healthy adults. PMID:24570273

  15. 22 CFR 122.3 - Registration fees.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  16. 22 CFR 122.3 - Registration fees.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  17. Computer Assisted Operations: Registration Records, Schedules

    ERIC Educational Resources Information Center

    College and University, 1977

    1977-01-01

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

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

    PubMed

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

    2008-10-20

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

  19. Design and baseline characteristics of the PODOSA (Prevention of Diabetes & Obesity in South Asians) trial: a cluster, randomised lifestyle intervention in Indian and Pakistani adults with impaired glycaemia at high risk of developing type 2 diabetes

    PubMed Central

    Douglas, Anne; Bhopal, Raj S; Bhopal, Ruby; Forbes, John F; Gill, Jason M R; McKnight, John; Murray, Gordon; Sattar, Naveed; Sharma, Anu; Wallia, Sunita; Wild, Sarah; Sheikh, Aziz

    2013-01-01

    be submitted for publication during 2013. Trial registration Current controlled trials ISRCTN25729565 (http://www.controlled-trials.com/isrctn/). PMID:23435795

  20. A Phase I, Open-Label Trial, Evaluating the Safety and Immunogenicity of Candidate Tuberculosis Vaccines AERAS-402 and MVA85A, Administered by Prime-Boost Regime in BCG-Vaccinated Healthy Adults

    PubMed Central

    Satti, Iman; Hokey, David A.; Dheenadhayalan, Veerabadran; Stockdale, Lisa; Manjaly Thomas, Zita-Rose; Minhinnick, Alice; Wilkie, Morven; Vermaak, Samantha; Meyer, Joel; O’Shea, Matthew K.; Pau, Maria Grazia; Versteege, Isabella; Douoguih, Macaya; Hendriks, Jenny; Sadoff, Jerald; Landry, Bernard; Moss, Paul; McShane, Helen

    2015-01-01

    Background MVA85A and AERAS-402 are two clinically advanced viral vectored TB vaccine candidates expressing Mycobacterium tuberculosis antigens designed to boost BCG-induced immunity. Clinical trials with candidate malaria vaccines have demonstrated that adenoviral vector based priming immunisation, followed by MVA vector boost, induced high levels of immunity. We present the safety and immunogenicity results of the first clinical trial to evaluate this immunisation strategy in TB. Methods In this phase 1, open-label trial, 40 healthy previously BCG-vaccinated participants were enrolled into three treatment groups and vaccinated with 1 or 2 doses of AERAS-402 followed by MVA85A; or 3 doses of AERAS-402. Results Most related adverse events (AEs) were mild and there were no vaccine related serious AEs. Boosting AERAS-402 with MVA85A significantly increased Ag85A-specific T-cell responses from day of vaccination. Two priming doses of AERAS-402 followed by MVA85A boost, resulted in a significantly higher AUC post-peak Ag85A response compared to three doses of AERAS-402 and historical data with MVA85A vaccination alone. The frequency of CD8+ T-cells producing IFN-γ, TNF-α and IL-2 was highest in the group receiving two priming doses of AERAS-402 followed by MVA85A. Conclusions Vaccination with AERAS-402 followed by MVA85A was safe and increased the durability of antigen specific T-cell responses and the frequency and polyfunctionality of CD8+ T-cells, which may be important in protection against TB. Further clinical trials with adenoviral prime-MVA85A boost regimens are merited to optimise vaccination intervals, dose and route of immunisation and to evaluate this strategy in the target population in TB high burden countries. Trial Registration ClinicalTrials.gov NCT01683773. PMID:26529238

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

    PubMed Central

    2014-01-01

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

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

    NASA Astrophysics Data System (ADS)

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

    2016-03-01

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

  3. 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

    PubMed Central

    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 who are at high risk for CVD. Enrollment on a rolling basis of 180 planned participants began during 2009; an average 18-month follow-up was completed by June 2011. The primary outcome variable is change in glycosylated hemoglobin level after an average 18-month follow-up period. Secondary outcome variables include changes in low-density lipoprotein cholesterol, systolic blood pressure, body mass index, and smoking status, as well as an evaluation of intervention cost-effectiveness. If effective, the LOWPK trial may serve as a guide for future chronic disease intervention trials in remote, technologically challenged settings. PMID:23001642

  4. Randomised controlled trial of montelukast plus inhaled budesonide versus double dose inhaled budesonide in adult patients with asthma

    PubMed Central

    Price, D; Hernandez, D; Magyar, P; Fiterman, J; Beeh, K; James, I; Konstantopoulos, S; Rojas, R; van Noord, J A; Pons, M; Gilles, L; Leff, J

    2003-01-01

    Background: Inhaled corticosteroids (ICS) affect many inflammatory pathways in asthma but have little impact on cysteinyl leukotrienes. This may partly explain persistent airway inflammation during chronic ICS treatment and failure to achieve adequate asthma control in some patients. This double blind, randomised, parallel group, non-inferiority, multicentre 16 week study compared the clinical benefits of adding montelukast to budesonide with doubling the budesonide dose in adults with asthma. Methods: After a 1 month single blind run in period, patients inadequately controlled on inhaled budesonide (800 µg/day) were randomised to receive montelukast 10 mg + inhaled budesonide 800 µg/day (n=448) or budesonide 1600 µg/day (n=441) for 12 weeks. Results: Both groups showed progressive improvement in several measures of asthma control compared with baseline. Mean morning peak expiratory flow (AM PEF) improved similarly in the last 10 weeks of treatment compared with baseline in both the montelukast + budesonide group and in the double dose budesonide group (33.5 v 30.1 l/min). During days 1–3 after start of treatment, the change in AM PEF from baseline was significantly greater in the montelukast + budesonide group than in the double dose budesonide group (20.1 v 9.6 l/min, p<0.001), indicating faster onset of action in the montelukast group. Both groups showed similar improvements with respect to "as needed" ß agonist use, mean daytime symptom score, nocturnal awakenings, exacerbations, asthma free days, peripheral eosinophil counts, and asthma specific quality of life. Both montelukast + budesonide and double dose budesonide were generally well tolerated. Conclusion: The addition of montelukast to inhaled budesonide is an effective and well tolerated alternative to doubling the dose of inhaled budesonide in adult asthma patients experiencing symptoms and inadequate control on budesonide alone. PMID:12612295

  5. Normal Laboratory Reference Intervals among Healthy Adults Screened for a HIV Pre-Exposure Prophylaxis Clinical Trial in Botswana

    PubMed Central

    Segolodi, Tebogo M.; Henderson, Faith L.; Rose, Charles E.; Turner, Kyle T.; Zeh, Clement; Fonjungo, Peter N.; Niska, Richard; Hart, Clyde; Paxton, Lynn A.

    2014-01-01

    Introduction Accurate clinical laboratory reference values derived from a local or regional population base are required to correctly interpret laboratory results. In Botswana, most reference intervals used to date are not standardized across clinical laboratories and are based on values derived from populations in the United States or Western Europe. Methods We measured 14 hematologic and biochemical parameters of healthy young adults screened for participation in the Botswana HIV Pre-exposure Prophylaxis Study using tenofovir disoproxil fumarate and emtricitabine (TDF/FTC) (TDF2 Study). Reference intervals were calculated using standard methods, stratified by gender, and compared with the site-derived reference values used for the TDF2 study (BOTUSA ranges), the Division of AIDS (DAIDS) Grading Table for Adverse Events, the Botswana public health laboratories, and other regional references. Results Out of 2533 screened participants, 1786 met eligibility criteria for participation in study and were included in the analysis. Our reference values were comparable to those of the Botswana public health system except for amylase, blood urea nitrogen (BUN), phosphate, total and direct bilirubin. Compared to our reference values, BOTUSA reference ranges would have classified participants as out of range for some analytes, with amylase (50.8%) and creatinine (32.0%) producing the highest out of range values. Applying the DAIDS toxicity grading system to the values would have resulted in 45 and 18 participants as having severe or life threatening values for amylase and hemoglobin, respectively. Conclusion Our reference values illustrate the differences in hematological and biochemical analyte ranges between African and Western populations. Thus, the use of western-derived reference laboratory values to screen a group of Batswana adults resulted in many healthy people being classified as having out-of-range blood analytes. The need to establish accurate local or regional

  6. A Randomized, Controlled Safety, and Immunogenicity Trial of the M72/AS01 Candidate Tuberculosis Vaccine in HIV-Positive Indian Adults

    PubMed Central

    Kumarasamy, Nagalingeswaran; Poongulali, Selvamuthu; Bollaerts, Anne; Moris, Philippe; Beulah, Faith Esther; Ayuk, Leo Njock; Demoitié, Marie-Ange; Jongert, Erik; Ofori-Anyinam, Opokua

    2016-01-01

    Abstract Human immunodeficiency virus (HIV)-associated tuberculosis is a major public health threat. We evaluated the safety and immunogenicity of the candidate tuberculosis vaccine M72/AS01 in HIV-positive and HIV-negative Indian adults. Randomized, controlled observer-blind trial (NCT01262976). We assigned 240 adults (1:1:1) to antiretroviral therapy (ART)-stable, ART-naive, or HIV-negative cohorts. Cohorts were randomized 1:1 to receive M72/AS01 or placebo following a 0, 1-month schedule and followed for 12 months (time-point M13). HIV-specific and laboratory safety parameters, adverse events (AEs), and M72-specific T-cell-mediated and humoral responses were evaluated. Subjects were predominantly QuantiFERON-negative (60%) and Bacille Calmette–Guérin-vaccinated (73%). Seventy ART-stable, 73 ART-naive, and 60 HIV-negative subjects completed year 1. No vaccine-related serious AEs or ART-regimen adjustments, or clinically relevant effects on laboratory parameters, HIV-1 viral loads or CD4 counts were recorded. Two ART-naive vaccinees died of vaccine-unrelated diseases. M72/AS01 induced polyfunctional M72-specific CD4+ T-cell responses (median [interquartile range] at 7 days postdose 2: ART-stable, 0.9% [0.7–1.5]; ART-naive, 0.5% [0.2–1.0]; and HIV-negative, 0.6% [0.4–1.1]), persisting at M13 (0.4% [0.2–0.5], 0.09% [0.04–0.2], and 0.1% [0.09–0.2], respectively). Median responses were higher in the ART-stable cohort versus ART-naive cohort from day 30 onwards (P ≤ 0.015). Among HIV-positive subjects (irrespective of ART-status), median responses were higher in QuantiFERON-positive versus QuantiFERON-negative subjects up to day 30 (P ≤ 0.040), but comparable thereafter. Cytokine-expression profiles were comparable between cohorts after dose 2. At M13, M72-specific IgG responses were higher in ART-stable and HIV-negative vaccinees versus ART-naive vaccinees (P ≤ 0.001). M72/AS01 was well-tolerated and immunogenic in this population of

  7. Reproductive Health CHOICES for Young Adults with Sickle Cell Disease or Trait: Randomized Controlled Trial Outcomes over Two Years.

    PubMed

    Gallo, Agatha M; Wilkie, Diana J; Yao, Yingwei; Molokie, Robert E; Stahl, Christiane; Hershberger, Patricia E; Zhao, Zhongsheng; Suarez, Marie L; Johnson, Bonnye; Angulo, Rigoberto; Carrasco, Jesus; Angulo, Veronica; Thompson, Alexis A

    2016-04-01

    Interventions to assist reproductive health decision-making in populations affected by sickle cell disease (SCD) or trait (SCT) lack proven efficacy over time. Our aim was to compare effects of CHOICES, a Web-based multimedia education program on implementing informed reproductive plans, and usual care education (e-Book) on reproductive knowledge, intention, and behavior over 24 months. We randomized 234 participants with SCD (n = 138) or SCT (n = 96) (age 18-35 years, 35 % male, 94 % African American) to CHOICES and e-Book groups. Participants completed a sickle cell-specific reproductive measure before and four times after the intervention (6, 12, 18 and 24 months). Compared to the e-Book group the CHOICES group had significantly more improvement in knowledge over time (p = .004) but not intention (p = .18) or behavior (p = .69). At baseline, 114 (48.7 %) participants reported having partners who would not put the couple at risk for their children inheriting SCD. Of the 116 (49.6 %) at-risk participants, a higher poroportion of those who were in the CHOICES group chose partners that reduced their risk by the last visit than the e-Book group (p = .04). Study findings provide important insights for designing a national trial of the CHOICES intervention focusing on subjects whose partner status puts them at risk for having a child with SCD.

  8. Prognostic features in the third MRC myelomatosis trial. Medical Research Council's Working Party on Leukaemia in Adults.

    PubMed Central

    1980-01-01

    This paper reports the prognostic significance of clinical and laboratory features recorded at presentation in 485 patients entered into the Medical Research Council's 3rd therapeutic trial in myelomatosis between July 1975 and August 1978. The data were complete up to 1 January 1980, with a median follow-up time of 36 months. The 3 major determinants of prognosis were the blood urea concentration (BUC), the haemoglobin concentration ([Hb]), and the clinical performance status. Three prognostic groups based on these determinants were specified. The groups contained 22%, 56% and 22% of the patients and gave 2-year survival probabilities of 76%, 50% and 9% respectively. Patients in the good-prognosis group had a BUC less than or equal to 8 mM. [Hb] greater than or equal to 100 g/l, and no or minimal symptoms. Those in the poor-prognosis group had either [Hb] less than or equal to 75 g/l or a BUC greater than 10 mM and restricted clinical activity. Patients who had combinations of the 3 determinant features which excluded them from these 2 groups were classified into an intermediate prognosis group. PMID:7459218

  9. Falls and risk factors for falls in community-dwelling adults with dementia (NutriAlz trial).

    PubMed

    Salvà, Antoni; Roqué, Marta; Rojano, Xavier; Inzitari, Marco; Andrieu, Sandrine; Schiffrin, Eduardo J; Guigoz, Yves; Vellas, Bruno

    2012-01-01

    To estimate the number of fallers and risk factors for falls in a cohort with dementia, we did a secondary analysis of a cluster-randomized controlled trial (NutriAlz) in 11 outpatient and day care centers in Catalonia (Spain) including 626 community-dwelling patients with dementia, followed for 12 months. Participants' characteristics were assessed at baseline, at 6 and 12 months [fall in the earlier 6 mo, anthropometric data, comorbidities, Mini-Mental State Examination, Clinical Dementia Rating, Basic Activities of Daily Living (BADL), Instrumental Activities of Daily Living, Neuropsychiatric Inventory Questionnaire, Zarit Caregiver Burden Interview and Mini-Nutritional Assessment]. Multivariate logistic regression models and generalized linear models were used to explore risk factors for falls and changes in health and function. Two hundred twenty-three participants fell during the 12 months follow-up (35.62%). Risk factors identified for falls were age (odds ratio (OR)=1.03, 95% confidence interval (CI), 1.00-1.05), BADL (OR=1.18, 95% CI, 1.05-1.32), and earlier fall (OR=2.30, 95% CI, 1.57-3.35). Fallers had worse health than nonfallers, and their dependence increased significantly more in BADL during the study, compared with nonfallers. Dependence in BADL is a risk factor and a consequence of falls; interventions aimed at preventing falls in dementia patients could promote autonomy in BADL and slow its decline.

  10. Effect of a 6-month vegan low-carbohydrate (‘Eco-Atkins’) diet on cardiovascular risk factors and body weight in hyperlipidaemic adults: a randomised controlled trial

    PubMed Central

    Jenkins, David J A; Wong, Julia M W; Kendall, Cyril W C; Esfahani, Amin; Ng, Vivian W Y; Leong, Tracy C K; Faulkner, Dorothea A; Vidgen, Ed; Paul, Gregory; Mukherjea, Ratna; Krul, Elaine S; Singer, William

    2014-01-01

    diet, thus improving heart disease risk factors. Trial Registration clinicaltrials.gov (http://www.clinicaltrials.gov/), #NCT00256516. PMID:24500611

  11. Effects of Daily Almond Consumption on Cardiometabolic Risk and Abdominal Adiposity in Healthy Adults With Elevated LDL‐Cholesterol: A Randomized Controlled Trial

    PubMed Central

    Berryman, Claire E.; West, Sheila G.; Fleming, Jennifer A.; Bordi, Peter L.; Kris‐Etherton, Penny M.

    2015-01-01

    Background Evidence consistently shows that almond consumption beneficially affects lipids and lipoproteins. Almonds, however, have not been evaluated in a controlled‐feeding setting using a diet design with only a single, calorie‐matched food substitution to assess their specific effects on cardiometabolic risk factors. Methods and Results In a randomized, 2‐period (6 week/period), crossover, controlled‐feeding study of 48 individuals with elevated LDL‐C (149±3 mg/dL), a cholesterol‐lowering diet with almonds (1.5 oz. of almonds/day) was compared to an identical diet with an isocaloric muffin substitution (no almonds/day). Differences in the nutrient profiles of the control (58% CHO, 15% PRO, 26% total fat) and almond (51% CHO, 16% PRO, 32% total fat) diets were due to nutrients inherent to each snack; diets did not differ in saturated fat or cholesterol. The almond diet, compared with the control diet, decreased non‐HDL‐C (−6.9±2.4 mg/dL; P=0.01) and LDL‐C (−5.3±1.9 mg/dL; P=0.01); furthermore, the control diet decreased HDL‐C (−1.7±0.6 mg/dL; P<0.01). Almond consumption also reduced abdominal fat (−0.07±0.03 kg; P=0.02) and leg fat (−0.12±0.05 kg; P=0.02), despite no differences in total body weight. Conclusions Almonds reduced non‐HDL‐C, LDL‐C, and central adiposity, important risk factors for cardiometabolic dysfunction, while maintaining HDL‐C concentrations. Therefore, daily consumption of almonds (1.5 oz.), substituted for a high‐carbohydrate snack, may be a simple dietary strategy to prevent the onset of cardiometabolic diseases in healthy individuals. Clinical Trial Registration URL: www.clinicaltrials.gov; Unique Identifier: NCT01101230. PMID:25559009

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

    PubMed Central

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

    2016-01-01

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

  13. Oxytocin efficacy is modulated by dosage and oxytocin receptor genotype in young adults with high-functioning autism: a 24-week randomized clinical trial

    PubMed Central

    Kosaka, H; Okamoto, Y; Munesue, T; Yamasue, H; Inohara, K; Fujioka, T; Anme, T; Orisaka, M; Ishitobi, M; Jung, M; Fujisawa, T X; Tanaka, S; Arai, S; Asano, M; Saito, D N; Sadato, N; Tomoda, A; Omori, M; Sato, M; Okazawa, H; Higashida, H; Wada, Y

    2016-01-01

    Recent studies have suggested that long-term oxytocin administration can alleviate the symptoms of autism spectrum disorder (ASD); however, factors influencing its efficacy are still unclear. We conducted a single-center phase 2, pilot, randomized, double-blind, placebo-controlled, parallel-group, clinical trial in young adults with high-functioning ASD, to determine whether oxytocin dosage and genetic background of the oxytocin receptor affects oxytocin efficacy. This trial consisted of double-blind (12 weeks), open-label (12 weeks) and follow-up phases (8 weeks). To examine dose dependency, 60 participants were randomly assigned to high-dose (32 IU per day) or low-dose intranasal oxytocin (16 IU per day), or placebo groups during the double-blind phase. Next, we measured single-nucleotide polymorphisms (SNPs) in the oxytocin receptor gene (OXTR). In the intention-to-treat population, no outcomes were improved after oxytocin administration. However, in male participants, Clinical Global Impression-Improvement (CGI-I) scores in the high-dose group, but not the low-dose group, were significantly higher than in the placebo group. Furthermore, we examined whether oxytocin efficacy, reflected in the CGI-I scores, is influenced by estimated daily dosage and OXTR polymorphisms in male participants. We found that >21 IU per day oxytocin was more effective than ⩽21 IU per day, and that a SNP in OXTR (rs6791619) predicted CGI-I scores for ⩽21 IU per day oxytocin treatment. No severe adverse events occurred. These results suggest that efficacy of long-term oxytocin administration in young men with high-functioning ASD depends on the oxytocin dosage and genetic background of the oxytocin receptor, which contributes to the effectiveness of oxytocin treatment of ASD. PMID:27552585

  14. Calorie Restriction in Overweight SeniorS: Response of Older Adults to a Dieting Study: The CROSSROADS Randomized Controlled Clinical Trial

    PubMed Central

    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 (VAT)), 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), 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

  15. Cost-Effectiveness analysis of Recovery Management Checkups (RMC) for adults with chronic substance use disorders: evidence from a four-year randomized trial

    PubMed Central

    McCollister, Kathryn E.; French, Michael T.; Freitas, Derek M.; Dennis, Michael L.; Scott, Christy K.; Funk, Rodney R.

    2013-01-01

    Aims This study performs the first cost-effectiveness analysis (CEA) of Recovery Management Checkups (RMC) for adults with chronic substance use disorders. Design Cost-effectiveness analysis of a randomized clinical trial of RMC. Participants were randomly assigned to a control condition of outcome monitoring (OM-only) or the experimental condition OM-plus-RMC, with quarterly follow-up for four years. Setting Participants were recruited from the largest central intake unit for substance abuse treatment in Chicago, Illinois, USA. Participants 446 participants who were 38 years old on average, 54 percent male, and predominantly African American (85%). Measurements Data on the quarterly cost per participant come from a previous study of OM and RMC intervention costs. Effectiveness is measured as the number of days of abstinence and number of substance-use-related problems. Findings Over the four-year trial, OM-plus-RMC cost on average $2,184 more than OM-only (p<0.01). Participants in OM-plus-RMC averaged 1,026 days abstinent and had 89 substance-use-related problems. OM-only averaged 932 days abstinent and reported 126 substance-use-related problems. Mean differences for both effectiveness measures were statistically significant (p<0.01). The incremental cost-effectiveness ratio for OM-plus-RMC was $23.38 per day abstinent and $59.51 per reduced substance-related problem. When additional costs to society were factored into the analysis, OM-plus-RMC was less costly and more effective than OM-only. Conclusions Recovery Management Checkups are a cost-effective and potentially cost-saving strategy for promoting abstinence and reducing substance-use-related problems among chronic substance users. PMID:23961833

  16. Oxytocin efficacy is modulated by dosage and oxytocin receptor genotype in young adults with high-functioning autism: a 24-week randomized clinical trial.

    PubMed

    Kosaka, H; Okamoto, Y; Munesue, T; Yamasue, H; Inohara, K; Fujioka, T; Anme, T; Orisaka, M; Ishitobi, M; Jung, M; Fujisawa, T X; Tanaka, S; Arai, S; Asano, M; Saito, D N; Sadato, N; Tomoda, A; Omori, M; Sato, M; Okazawa, H; Higashida, H; Wada, Y

    2016-01-01

    Recent studies have suggested that long-term oxytocin administration can alleviate the symptoms of autism spectrum disorder (ASD); however, factors influencing its efficacy are still unclear. We conducted a single-center phase 2, pilot, randomized, double-blind, placebo-controlled, parallel-group, clinical trial in young adults with high-functioning ASD, to determine whether oxytocin dosage and genetic background of the oxytocin receptor affects oxytocin efficacy. This trial consisted of double-blind (12 weeks), open-label (12 weeks) and follow-up phases (8 weeks). To examine dose dependency, 60 participants were randomly assigned to high-dose (32 IU per day) or low-dose intranasal oxytocin (16 IU per day), or placebo groups during the double-blind phase. Next, we measured single-nucleotide polymorphisms (SNPs) in the oxytocin receptor gene (OXTR). In the intention-to-treat population, no outcomes were improved after oxytocin administration. However, in male participants, Clinical Global Impression-Improvement (CGI-I) scores in the high-dose group, but not the low-dose group, were significantly higher than in the placebo group. Furthermore, we examined whether oxytocin efficacy, reflected in the CGI-I scores, is influenced by estimated daily dosage and OXTR polymorphisms in male participants. We found that >21 IU per day oxytocin was more effective than ⩽21 IU per day, and that a SNP in OXTR (rs6791619) predicted CGI-I scores for ⩽21 IU per day oxytocin treatment. No severe adverse events occurred. These results suggest that efficacy of long-term oxytocin administration in young men with high-functioning ASD depends on the oxytocin dosage and genetic background of the oxytocin receptor, which contributes to the effectiveness of oxytocin treatment of ASD. PMID:27552585

  17. Effects of a Low Dose of Fish Oil on Inflammatory Markers of Brazilian HIV-Infected Adults on Antiretroviral Therapy: A Randomized, Parallel, Placebo-Controlled Trial

    PubMed Central

    Oliveira, Julicristie M.; Rondó, Patrícia H. C.; Lima, Lourdes R. A. V.; Fortuna, Elizabeth S.; Yudkin, John S.

    2015-01-01

    Background: The benefits of antiretroviral therapy for HIV-infected subjects have been limited by an increased risk of metabolic and cardiovascular diseases. The objective of this study was to assess the effects of a low dose of marine omega-3 fatty acids on inflammatory marker concentrations in HIV-infected subjects under antiretroviral therapy (ART). Methods: This was a randomized, parallel, placebo-controlled trial that investigated the effects of 3 g fish oil/day (540 mg of eicosapentaenoic acid—EPA plus 360 mg of docosahexaenoic acid—DHA) or 3 g soy oil/day (placebo) for 24 weeks in 83 male and non-pregnant female HIV-infected adults on ART. Results: There were no differences between groups for the measures at baseline. Multilevel analyses revealed no statistically significant relationship between the longitudinal changes in high sensitivity-C reactive protein (hs-CRP) (Wald Chi2 = 0.17, p = 0.918), fibrinogen (Wald Chi2 = 3.82, p = 0.148), and factor VIII (Wald Chi2 = 5.25, p = 0.073) with fish oil. No significant changes in interleukin-6 (IL6), interleukin-1 beta (IL1-beta) and tumor necrosis factor-alpha (TNF-alpha) serum concentrations were observed with fish oil supplements for 12 weeks. Conclusions: Compared to placebo, a low dose of 900 mg omega-3 fatty acids (EPA plus DHA) in fish oil capsules did not change hs-CRP, fibrinogen, factor VIII, IL6, IL1-beta and TNF-alpha serum concentrations in HIV-infected subjects on ART. Further invest