WorldWideScience

Sample records for biomedical prevention trials

  1. Advancing community stakeholder engagement in biomedical HIV prevention trials: principles, practices and evidence.

    Science.gov (United States)

    Newman, Peter A; Rubincam, Clara

    2014-12-01

    Community stakeholder engagement is foundational to fair and ethically conducted biomedical HIV prevention trials. Concerns regarding the ethical engagement of community stakeholders in HIV vaccine trials and early terminations of several international pre-exposure prophylaxis trials have fueled the development of international guidelines, such as UNAIDS' good participatory practice (GPP). GPP aims to ensure that stakeholders are effectively involved in all phases of biomedical HIV prevention trials. We provide an overview of the six guiding principles in the GPP and critically examine them in relation to existing social and behavioral science research. In particular, we highlight the challenges involved in operationalizing these principles on the ground in various global contexts, with a focus on low-income country settings. Increasing integration of social science in biomedical HIV prevention trials will provide evidence to advance a science of community stakeholder engagement to support ethical and effective practices informed by local realities and sociocultural differences.

  2. Integrating Behavioral HIV Interventions into Biomedical Prevention Trials with Youth: Lessons from Chicago's Project PrEPare.

    Science.gov (United States)

    Hosek, Sybil G; Green, Keith R; Siberry, George; Lally, Michelle; Balthazar, Christopher; Serrano, Pedro A; Kapogiannis, Bill

    2013-01-01

    On the heels of several trials demonstrating the efficacy of pre-exposure prophylaxis (PrEP) and the recent approval by the FDA of the supplemental indication for Truvada as PrEP, researchers, advocates, and community providers are calling for the investigation of implementation strategies that combine behavioral interventions with biomedical prevention. This paper describes the modification and integration of an evidence-based group-level intervention into a small PrEP pilot trial with young men who have sex with men (YMSM). The behavioral intervention as well as ongoing risk reduction counseling sessions were found to be highly acceptable among a sample of racially diverse YMSM.

  3. Preparing for the unexpected: the pivotal role of social and behavioral sciences in trials of biomedical HIV prevention interventions.

    Science.gov (United States)

    Koblin, Beryl A; Andrasik, Michele; Austin, Judy

    2013-07-01

    A range of efficacies have been reported for biomedical HIV prevention interventions, including antiretroviral treatment, male circumcision, preexposure prophylaxis, microbicides, and preventive vaccines. This range of efficacies probably results from the influence of multiple inputs and processes during trials, including the strength and target of the intervention, host factors, target population characteristics, level of HIV exposure, and intervention dose. Expertise in social and behavioral sciences, in conjunction with basic science, clinical research, epidemiology, biostatistics, and community, is needed to understand the influence of these inputs and processes on intervention efficacy, improve trial design and implementation, and enable interpretation of trial results. In particular, social and behavioral sciences provide the means for investigating and identifying populations suitable for recruitment into and retention in trials and for developing and improving measures of HIV exposure and intervention dose, all within the larger sociocultural context. Integration of social and behavioral sciences early in idea generation and study design is imperative for the successful conduct of biomedical trials and for ensuring optimal data collection approaches necessary for the interpretation of findings, particularly in cases of unexpected results.

  4. Effect of seasonal variation on adult clinical laboratory parameters in Rwanda, Zambia, and Uganda: implications for HIV biomedical prevention trials.

    Directory of Open Access Journals (Sweden)

    Eugene Ruzagira

    Full Text Available To investigate the effect of seasonal variation on adult clinical laboratory parameters in Rwanda, Zambia, and Uganda and determine its implications for HIV prevention and other clinical trials.Volunteers in a cross-sectional study to establish laboratory reference intervals were asked to return for a seasonal visit after the local season had changed from dry to rainy or vice versa. Volunteers had to be clinically healthy, not pregnant and negative for HIV, Hepatitis B and C, and syphilis infection at both visits. At each visit, blood was taken for measurement of hemoglobin, haematocrit, mean corpuscular volume, red blood cells, platelets, total white blood cells (WBC, neutrophils, lymphocytes, monocytes, eosinophils, basophils, CD4/CD8 T cells, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, direct bilirubin, total bilirubin, total immunoglobulin gamma, total protein, creatinine, total amylase, creatine phosphokinase and lactate dehydrogenase (LDH. Consensus dry season reference intervals were applied to rainy season values (and vice versa and the proportion of 'out-of-range' values determined. Percentage differences between dry and rainy season parameter mean values were estimated.In this cohort of 903 volunteers, less than 10.0% of consensus parameter (except LDH values in one season were "out-of-range" in the other. Twenty-two (22 percent of rainy season LDH values fell outside of the consensus dry season interval with the higher values observed in the rainy season. Variability between consensus seasonal means ranged from 0.0% (total WBC, neutrophils, monocytes, basophils, and direct bilirubin to 40.0% (eosinophils. Within sites, the largest seasonal variations were observed for monocytes (Masaka, 11.5%, LDH (Lusaka, 21.7%, and basophils (Kigali, 22.2%.Seasonality had minimal impact on adult clinical laboratory parameter values in Rwanda, Zambia, and Uganda. Seasonal variation may not be an important factor in the

  5. Polyp Prevention Trial

    Science.gov (United States)

    The primary objective of the Polyp Prevention Trial (PPT) is to determine whether a low fat, high fiber, high vegetable and fruit eating plan will decrease the recurrence of adenomatous polyps of the large bowel.

  6. 75 FR 70270 - Submission for OMB Review; Comment Request; Pretesting of NIAID's Biomedical HIV Prevention...

    Science.gov (United States)

    2010-11-17

    ... NIAID's Biomedical HIV Prevention Research Communication Messages SUMMARY: In compliance with the... Collection: Title: Pretesting of NIAID's Biomedical HIV Prevention Research Communication Messages. Type of... biomedical HIV prevention research. The primary objectives of the pretests are to (1) Assess...

  7. 76 FR 6484 - Submission for OMB Review; Comment Request; Pretesting of NIAID's Biomedical HIV Prevention...

    Science.gov (United States)

    2011-02-04

    ... NIAID's Biomedical HIV Prevention Research Communication Messages SUMMARY: Under the provisions of...: Title: Pretesting of NIAID's Biomedical HIV Prevention Research Communication Messages. Type of... biomedical HIV prevention research. The primary objectives of the pretests are to (1) assess...

  8. Clinical Trials | Division of Cancer Prevention

    Science.gov (United States)

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

  9. What is the benefit of the biomedical and behavioral interventions in preventing HIV transmission?

    Directory of Open Access Journals (Sweden)

    Ricardo Kuchenbecker

    2015-09-01

    Full Text Available ABSTRACTIntroduction:Scientific evidence supports the sinergy between biomedical and behavioral interventions aimed at preventing the transmission of HIV as a strategy to eradicate AIDS.Objective:To characterize comparatively the benefits from biomedical and behavioral interventions to prevent HIV transmission.Methods:Narrative review. We performed a comparative analysis of the benefits of studied interventions by means of estimating the number needed to treat (NNT. Evaluated interventions: counseling activities for behavior change to prevent exposure to HIV; antiretroviral pre-exposure prophylaxis (PrEP and antiretroviral post-exposure prophylasis (PEP for HIV and treatment of serodiscordant couples as a strategy for prevention of HIV transmission (TasP.Results:counseling interventions and TasP have smaller NNTs, equal to, respectively, 11 (95%CI 9 - 18 at 12 months and 34 (95%CI 23 - 54 in 42 months comparatively to PrEP interventions, that resulted in 41 (95%CI 28 - 67 individuals receiving antiretrovirals in order to prevent one case of HIV infection at 36 months for men and serodiscordant couples. PEP interventions are associated with protective effects estimated at 81%. Lack of trials evaluating PEP prevents estimate of NNT.Conclusion:The estimate of the NNT can be a helpful parameter in the comparison between the effectiveness of different behavioral and biomedical HIV prevention strategies. Studies evaluating the benefit and safety of combined behavioral and biomedical interventions are needed, especially considering the attributable fraction of each component. Integration of behavioral and biomedical interventions is required to achieve complete suppression of the virus, and thus reducing viral replication, infectivity and the number of cases.

  10. Clinical Trials Management | Division of Cancer Prevention

    Science.gov (United States)

    Information for researchers about developing, reporting, and managing NCI-funded cancer prevention clinical trials. Protocol Information Office The central clearinghouse for clinical trials management within the Division of Cancer Prevention.Read more about the Protocol Information Office. | Information for researchers about developing, reporting, and managing NCI-funded cancer prevention clinical trials.

  11. Trial registration numbers are underreported in biomedical publications.

    Directory of Open Access Journals (Sweden)

    Fleur T van de Wetering

    Full Text Available CONTEXT: Since September 2005, the International Committee of Medical Journal Editors (ICMJE has required that randomised controlled trials (RCTs are prospectively registered in a publicly accessible database. After registration, a trial registration number (TRN is assigned to each RCT, which should make it easier to identify future publications and cross-check published results with associated registry entries, as long as the unique identification number is reported in the article. OBJECTIVE: Our primary objective was to evaluate the reporting of trial registration numbers in biomedical publications. Secondary objectives were to evaluate how many published RCTs had been registered and how many registered RCTs had resulted in a publication, using a sample of trials from the Netherlands Trials Register (NTR. DESIGN, SETTING: TWO DIFFERENT SAMPLES OF RCTS WERE EXAMINED: 1 RCTs published in November 2010 in core clinical journals identified in MEDLINE; 2 RCTs registered in the NTR with a latest expected end date of 31 August 2008. RESULTS: Fifty-five percent (166/302 of the reports of RCTs found in MEDLINE and 60% (186/312 of the published reports of RCTs from the NTR cohort contained a TRN. In both samples, reporting of a TRN was more likely in RCTs published in ICMJE member journals as compared to non-ICMJE member journals (MEDLINE 58% vs. 45%; NTR: 70% vs. 49%. Thirty-nine percent of published RCTs in the MEDLINE sample appear not to have been registered, and 48% of RCTs registered in the NTR seemed not to have been published at least two years after the expected date for study completion. CONCLUSION: Our results show that further promotion and implementation of trial registration and accurate reporting of TRN is still needed. This might be helped by inclusion of the TRN as an item on the CONSORT checklist.

  12. Clinical Trial Design for HIV Prevention Research: Determining Standards of Prevention.

    Science.gov (United States)

    Dawson, Liza; Zwerski, Sheryl

    2015-06-01

    This article seeks to advance ethical dialogue on choosing standards of prevention in clinical trials testing improved biomedical prevention methods for HIV. The stakes in this area of research are high, given the continued high rates of infection in many countries and the budget limitations that have constrained efforts to expand treatment for all who are currently HIV-infected. New prevention methods are still needed; at the same time, some existing prevention and treatment interventions have been proven effective but are not yet widely available in the countries where they most urgently needed. The ethical tensions in this field of clinical research are well known and have been the subject of extensive debate. There is no single clinical trial design that can optimize all the ethically important goals and commitments involved in research. Several recent articles have described the current ethical difficulties in designing HIV prevention trials, especially in resource limited settings; however, there is no consensus on how to handle clinical trial design decisions, and existing international ethical guidelines offer conflicting advice. This article acknowledges these deep ethical dilemmas and moves beyond a simple descriptive approach to advance an organized method for considering what clinical trial designs will be ethically acceptable for HIV prevention trials, balancing the relevant criteria and providing justification for specific design decisions.

  13. The Meaning of Adherence When Behavioral Risk Patterns Vary: Obscured Use- and Method-Effectiveness in HIV-Prevention Trials

    NARCIS (Netherlands)

    Bruin, de M.; Viechtbauer, W.

    2012-01-01

    Background Recently promising trials of innovative biomedical approaches to prevent HIV transmission have been reported. Participants' non-adherence to the prevention methods complicates the analyses and interpretation of trial results. The influence of variable sexual behaviors within and between p

  14. Evaluation of an Intervention among Adolescents to Reduce Preventive Misconception in HIV Vaccine Clinical Trials

    Science.gov (United States)

    Lally, Michelle; Goldsworthy, Richard; Sarr, Moussa; Kahn, Jessica; Brown, Larry; Peralta, Ligia; Zimet, Greg

    2014-01-01

    Purpose Placebo and randomization are important concepts that must be understood before youth can safely participate in HIV vaccine studies or other biomedical trials for HIV prevention. These concepts are central to the phenomenon of preventive misconception which may be associated with an increase in risk behavior among study participants related to mistaken beliefs. Persuasive messaging, traditionally used in the field of marketing, could enhance educational efforts associated with randomized clinical trials. Methods Two educational brochures were designed to increase knowledge about HIV vaccine clinical trials via 1 and 2-sided persuasive messaging. Through the Adolescent Medicine Trials Network, 120 youth were enrolled, administered a mock HIV vaccine trial consent, and then randomized to receive either no supplemental information or one of the two brochures. Results The 2-sided brochure group in which common clinical trial misconceptions were acknowledgedand then refuted had significantly higher scores on knowledge of randomization and interpretation of side effects than the consent-only control group, and willingness to participate in an HIV vaccine trial was not decreased with the use of this brochure. Conclusion Two sided persuasive messaging improves understanding of the concepts of randomization and placebo among youth who would consider participating in an HIV vaccine trial. Further evaluation of this approach should be considered for at-risk youth participating in an actual trial of a biomedical intervention for HIV prevention. PMID:24613097

  15. Stroke Prevention Trials in Sickle Cell Anemia

    Directory of Open Access Journals (Sweden)

    J Gordon Millichap

    2006-06-01

    Full Text Available As part of an International Pediatric Stroke Study launched in 2002, the Stroke Prevention Trial in Sickle Cell Anemia (STOP reports a reduction in the number of overt clinical strokes in children with critically high transcranial Doppler velocities (>200 cm/sec who were regularly transfused.

  16. What is the benefit of the biomedical and behavioral interventions in preventing HIV transmission?

    OpenAIRE

    Ricardo Kuchenbecker

    2015-01-01

    ABSTRACTIntroduction:Scientific evidence supports the sinergy between biomedical and behavioral interventions aimed at preventing the transmission of HIV as a strategy to eradicate AIDS.Objective:To characterize comparatively the benefits from biomedical and behavioral interventions to prevent HIV transmission.Methods:Narrative review. We performed a comparative analysis of the benefits of studied interventions by means of estimating the number needed to treat (NNT). Evaluated interventions: ...

  17. Combination HIV prevention interventions: the potential of integrated behavioral and biomedical approaches.

    Science.gov (United States)

    Brown, Jennifer L; Sales, Jessica M; DiClemente, Ralph J

    2014-12-01

    Combination HIV prevention interventions that integrate efficacious behavioral and biomedical strategies offer the potential to reduce new HIV infections. We overview the efficacy data for three biomedical HIV prevention approaches, namely microbicides, pre-exposure prophylaxis (PrEP), and HIV vaccination; review factors associated with differential acceptability and uptake of these methods; and suggest strategies to optimize the effectiveness and dissemination of combination HIV prevention approaches. A narrative review was conducted highlighting key efficacy data for microbicides, PrEP, and an HIV vaccination and summarizing acceptability data for each of the three biomedical HIV prevention approaches. Recommendations for the integration and dissemination of combined behavioral and biomedical HIV prevention approaches are provided. To date, microbicides and an HIV vaccination have demonstrated limited efficacy for the prevention of HIV. However, PrEP has demonstrated efficacy in reducing HIV incident infections. A diverse array of factors influences both hypothetical willingness and actual usage of each biomedical prevention method. Strategies to effectively integrate and evaluate combination HIV prevention interventions are urgently needed.

  18. Epistemic fault lines in biomedical and social approaches to HIV prevention

    Directory of Open Access Journals (Sweden)

    Adam Barry D

    2011-09-01

    Full Text Available Abstract This paper raises the question of how knowledge creation is organized in the area of HIV prevention and how this concatenation of expertise, resources, at-risk people and viruses shapes the knowledge used to impede the epidemic. It also seeks to trouble the discourses of biomedical pre-eminence in the field of HIV prevention by examining the claim for treatment as prevention, looking at evidence constructed through the biomedical frame and through the lens of the sociology of science. These questions lie within a larger socio-historical context of lagging worldwide attention and funding to prevention in the HIV area and, in particular, neglect of populations at greatest risk. Much contemporary HIV prevention research relies on a population science divided over an epistemic fault line from the communities and individuals who must make sense of the intrusion of a life-threatening disease into their pursuit of pleasure and intimacy. There are, nevertheless, lessons to be learned from prevention success stories among sex workers, injection drug users, and gay and bisexual men. The success stories point to a need for a robust social science agenda that examines: the ways that people are socially organized and networked; the popular strategies and folk wisdoms developed in the face of HIV risk; socio-historical movement of sexual and drug cultures; the dynamics of popular mobilization to advance health; the institutional sources of HIV discourses; and popular understandings of HIV technologies and messages.

  19. Integrating behavioral and biomedical research in HIV interventions: challenges and opportunities.

    Science.gov (United States)

    Rausch, Dianne M; Grossman, Cynthia I; Erbelding, Emily J

    2013-06-01

    Recent clinical trials have demonstrated overwhelming success of biomedical tools to prevent the spread of HIV infection. However, the complex and somewhat disparate results of some of these trials have highlighted the need for effective integration of biomedical and behavioral sciences in the design and implementation of any future intervention trial. Integrating behavioral and biomedical sciences will require appropriate behavioral theories that can be used in the context of biomedical clinical trials and multidisciplinary teams working together from the earliest stages of trial design through to completion. It is also clear that integration of behavioral science will be necessary to implement prevention at the population level and reverse the HIV epidemic.

  20. About the Community Oncology and Prevention Trials Research Group | Division of Cancer Prevention

    Science.gov (United States)

    The Community Oncology and Prevention Trials Research Group supports clinical oncology trials in cancer prevention and control in community settings. The group also supports investigator-initiated research projects in supportive, palliative and end-of-life care, and coordinates clinical oncology research projects with other NCI programs to be done in the community setting. |

  1. Biorepository for Selenium and Vitamin E Cancer Prevention Trial (SELECT) | Division of Cancer Prevention

    Science.gov (United States)

    As the largest prostate cancer prevention trial ever undertaken, the Selenium and Vitamin E Cancer Prevention Trial (SELECT) has assembled a substantial biorepository of specimens. To help make SELECT resources available to a wider research community, NCI and the Southwest Oncology Group are developing a plan for prostate cancer biology and nutritional science and micronutrient studies. |

  2. Prevention Trial in the Cherokee Nation: Design of a Randomized Community Trial

    OpenAIRE

    Komro, Kelli A.; Wagenaar, Alexander C; Boyd, Misty; Boyd, B. J.; Kominsky, Terrence; Pettigrew, Dallas; Tobler, Amy L.; LYNNE-LANDSMAN, SARAH D.; Livingston, Melvin D.; Livingston, Bethany; Molina, Mildred M. Maldonado

    2014-01-01

    Despite advances in prevention science and practice in recent decades, the U.S. continues to struggle with significant alcohol-related risks and consequences among youth, especially among vulnerable rural and Native American youth. The Prevention Trial in the Cherokee Nation is a partnership between prevention scientists and Cherokee Nation Behavioral Health to create, implement, and evaluate a new, integrated community-level intervention designed to prevent underage drinking and associated n...

  3. Clinical Trials Node | Division of Cancer Prevention

    Science.gov (United States)

    The Division of Cancer Prevention (DCP) conducts and supports research to determine a person's risk of cancer and to find ways to reduce the risk. This knowledge is critical to making progress against cancer because risk varies over the lifespan as genetic and epigenetic changes can transform healthy tissue into invasive cancer.

  4. Trial NCT01950403 | Division of Cancer Prevention

    Science.gov (United States)

    The Division of Cancer Prevention (DCP) conducts and supports research to determine a person's risk of cancer and to find ways to reduce the risk. This knowledge is critical to making progress against cancer because risk varies over the lifespan as genetic and epigenetic changes can transform healthy tissue into invasive cancer.

  5. Trial NCT01141231 | Division of Cancer Prevention

    Science.gov (United States)

    The Division of Cancer Prevention (DCP) conducts and supports research to determine a person's risk of cancer and to find ways to reduce the risk. This knowledge is critical to making progress against cancer because risk varies over the lifespan as genetic and epigenetic changes can transform healthy tissue into invasive cancer.

  6. Trial NCT02237183 | Division of Cancer Prevention

    Science.gov (United States)

    The Division of Cancer Prevention (DCP) conducts and supports research to determine a person's risk of cancer and to find ways to reduce the risk. This knowledge is critical to making progress against cancer because risk varies over the lifespan as genetic and epigenetic changes can transform healthy tissue into invasive cancer.

  7. Trial NCT01382082 | Division of Cancer Prevention

    Science.gov (United States)

    The Division of Cancer Prevention (DCP) conducts and supports research to determine a person's risk of cancer and to find ways to reduce the risk. This knowledge is critical to making progress against cancer because risk varies over the lifespan as genetic and epigenetic changes can transform healthy tissue into invasive cancer.

  8. Trial NCT02273362 | Division of Cancer Prevention

    Science.gov (United States)

    The Division of Cancer Prevention (DCP) conducts and supports research to determine a person's risk of cancer and to find ways to reduce the risk. This knowledge is critical to making progress against cancer because risk varies over the lifespan as genetic and epigenetic changes can transform healthy tissue into invasive cancer.

  9. Trial NCT02112188 | Division of Cancer Prevention

    Science.gov (United States)

    The Division of Cancer Prevention (DCP) conducts and supports research to determine a person's risk of cancer and to find ways to reduce the risk. This knowledge is critical to making progress against cancer because risk varies over the lifespan as genetic and epigenetic changes can transform healthy tissue into invasive cancer.

  10. Trial NCT01824836 | Division of Cancer Prevention

    Science.gov (United States)

    The Division of Cancer Prevention (DCP) conducts and supports research to determine a person's risk of cancer and to find ways to reduce the risk. This knowledge is critical to making progress against cancer because risk varies over the lifespan as genetic and epigenetic changes can transform healthy tissue into invasive cancer.

  11. Trial NCT01968798 | Division of Cancer Prevention

    Science.gov (United States)

    The Division of Cancer Prevention (DCP) conducts and supports research to determine a person's risk of cancer and to find ways to reduce the risk. This knowledge is critical to making progress against cancer because risk varies over the lifespan as genetic and epigenetic changes can transform healthy tissue into invasive cancer.

  12. Trial NCT01849250 | Division of Cancer Prevention

    Science.gov (United States)

    The Division of Cancer Prevention (DCP) conducts and supports research to determine a person's risk of cancer and to find ways to reduce the risk. This knowledge is critical to making progress against cancer because risk varies over the lifespan as genetic and epigenetic changes can transform healthy tissue into invasive cancer.

  13. Trial NCT02116530 | Division of Cancer Prevention

    Science.gov (United States)

    The Division of Cancer Prevention (DCP) conducts and supports research to determine a person's risk of cancer and to find ways to reduce the risk. This knowledge is critical to making progress against cancer because risk varies over the lifespan as genetic and epigenetic changes can transform healthy tissue into invasive cancer.

  14. Sex role segregation and mixing among men who have sex with men: implications for biomedical HIV prevention interventions.

    Directory of Open Access Journals (Sweden)

    Benjamin Armbruster

    Full Text Available OBJECTIVE: Men who have sex with men (MSM practice role segregation - insertive or receptive only sex positions instead of a versatile role - in several international settings where candidate biomedical HIV prevention interventions (e.g., circumcision, anal microbicide will be tested. The effects of these position-specific interventions on HIV incidence are modeled. MATERIALS AND METHODS: We developed a deterministic compartmental model to predict HIV incidence among Indian MSM using data from 2003-2010. The model's sex mixing matrix was derived from network data of Indian MSM (n=4604. Our model captures changing distribution of sex roles over time. We modeled microbicide and circumcision efficacy on trials with heterosexuals. RESULTS: Increasing numbers of versatile MSM resulted in little change in HIV incidence over 20 years. Anal microbicides and circumcision would decrease the HIV prevalence at 10 years from 15.6% to 12.9% and 12.7% respectively. Anal microbicides would provide similar protection to circumcision at the population level despite lower modeled efficacy (54% and 60% risk reduction, respectively. Combination of the interventions were additive: in 5 years, the reduction in HIV prevalence of the combination (-3.2% is almost the sum of their individual reductions in HIV prevalence (-1.8% and -1.7%. CONCLUSIONS: MSM sex role segregation and mixing, unlike changes in the sex role distribution, may be important for evaluating HIV prevention interventions in international settings. Synergies between some position-specific prevention interventions such as circumcision and anal microbicides warrant further study.

  15. Community engagement in diverse populations for Alzheimer disease prevention trials.

    Science.gov (United States)

    Romero, Heather R; Welsh-Bohmer, Kathleen A; Gwyther, Lisa P; Edmonds, Henry L; Plassman, Brenda L; Germain, Cassandra M; McCart, Michelle; Hayden, Kathleen M; Pieper, Carl; Roses, Allen D

    2014-01-01

    The recruitment of asymptomatic volunteers has been identified as a critical factor that is delaying the development and validation of preventive therapies for Alzheimer disease (AD). Typical recruitment strategies involve the use of convenience samples or soliciting participation of older adults with a family history of AD from clinics and outreach efforts. However, high-risk groups, such as ethnic/racial minorities, are traditionally less likely to be recruited for AD prevention studies, thus limiting the ability to generalize findings for a significant proportion of the aging population. A community-engagement approach was used to create a registry of 2311 research-ready, healthy adult volunteers who reflect the ethnically diverse local community. Furthermore, the registry's actual commitment to research was examined, through demonstrated participation rates in a clinical study. The approach had varying levels of success in establishing a large, diverse pool of individuals who are interested in participating in pharmacological prevention trials and meet the criteria for primary prevention research trials designed to delay the onset of AD. Our efforts suggest that entry criteria for the clinical trials need to be carefully considered to be inclusive of African Americans, and that sustained effort is needed to engage African Americans in pharmacological prevention approaches.

  16. Selenium and Prostate Cancer Prevention: Insights from the Selenium and Vitamin E Cancer Prevention Trial (SELECT)

    OpenAIRE

    Nicastro, Holly L.; Dunn, Barbara K.

    2013-01-01

    The Selenium and Vitamin E Cancer Prevention Trial (SELECT) was conducted to assess the efficacy of selenium and vitamin E alone, and in combination, on the incidence of prostate cancer. This randomized, double-blind, placebo-controlled, 2 × 2 factorial design clinical trial found that neither selenium nor vitamin E reduced the incidence of prostate cancer after seven years and that vitamin E was associated with a 17% increased risk of prostate cancer compared to placebo. The null result was ...

  17. Probiotics in the prevention of eczema: a randomised controlled trial

    OpenAIRE

    Allen, Stephen J; Jordan, Sue; Storey, Melanie; Catherine A Thornton; Gravenor, Michael B.; Garaiova, Iveta; Plummer, Susan F; Wang, Duolao; Morgan, Gareth

    2014-01-01

    Objective To evaluate a multistrain, high-dose probiotic in the prevention of eczema. Design A randomised, double-blind, placebo-controlled, parallel group trial. Settings Antenatal clinics, research clinic, children at home. Patients Pregnant women and their infants. Interventions Women from 36 weeks gestation and their infants to age 6 months received daily either the probiotic (Lactobacillus salivarius CUL61, Lactobacillus paracasei CUL08, Bifidobacterium animalis subspecies lactis CUL34 a...

  18. Randomized trial on fluorides and sealants for fissure caries prevention

    OpenAIRE

    Lin, HC; Liu, BY; Lo, ECM; Chu, CH

    2012-01-01

    To investigate the effectiveness of topical fluorides in preventing fissure caries, we conducted a randomized controlled trial with parallel groups. In total, 501 children (1,539 molars, 3,078 sites), mean age 9.1 years, who had at least one sound permanent first molar with deep fissures or fissures with signs of early caries were recruited. They were randomly allocated among four groups: (1) resin sealant, single placement; (2) 5% NaF varnish, semi-annual application; (3) 38% silver diamine ...

  19. [Biomedical information on the internet using search engines. A one-year trial].

    Science.gov (United States)

    Corrao, Salvatore; Leone, Francesco; Arnone, Sabrina

    2004-01-01

    The internet is a communication medium and content distributor that provide information in the general sense but it could be of great utility regarding as the search and retrieval of biomedical information. Search engines represent a great deal to rapidly find information on the net. However, we do not know whether general search engines and meta-search ones are reliable in order to find useful and validated biomedical information. The aim of our study was to verify the reproducibility of a search by key-words (pediatric or evidence) using 9 international search engines and 1 meta-search engine at the baseline and after a one year period. We analysed the first 20 citations as output of each searching. We evaluated the formal quality of Web-sites and their domain extensions. Moreover, we compared the output of each search at the start of this study and after a one year period and we considered as a criterion of reliability the number of Web-sites cited again. We found some interesting results that are reported throughout the text. Our findings point out an extreme dynamicity of the information on the Web and, for this reason, we advice a great caution when someone want to use search and meta-search engines as a tool for searching and retrieve reliable biomedical information. On the other hand, some search and meta-search engines could be very useful as a first step searching for defining better a search and, moreover, for finding institutional Web-sites too. This paper allows to know a more conscious approach to the internet biomedical information universe.

  20. Efficacy and effectiveness as aspects of cluster randomized trials with nursing home residents: Methodological insights from a pneumonia prevention trial

    OpenAIRE

    Van Ness, Peter H.; Peduzzi, Peter N.; Quagliarello, Vincent J.

    2012-01-01

    This report discusses how methodological aspects of study efficacy and effectiveness combine in cluster randomized trials in nursing homes. Discussion focuses on the relationships between these study aspects in the Pneumonia Reduction in Institutionalized Disabled Elders (PRIDE) trial, an ongoing cluster randomized clinical trial of pneumonia prevention among nursing home residents launched in October 2009 in Greater New Haven, Connecticut. This clinical trial has enrolled long-term care nurs...

  1. Selenium and prostate cancer prevention: insights from the selenium and vitamin E cancer prevention trial (SELECT).

    Science.gov (United States)

    Nicastro, Holly L; Dunn, Barbara K

    2013-04-03

    The Selenium and Vitamin E Cancer Prevention Trial (SELECT) was conducted to assess the efficacy of selenium and vitamin E alone, and in combination, on the incidence of prostate cancer. This randomized, double-blind, placebo-controlled, 2 × 2 factorial design clinical trial found that neither selenium nor vitamin E reduced the incidence of prostate cancer after seven years and that vitamin E was associated with a 17% increased risk of prostate cancer compared to placebo. The null result was surprising given the strong preclinical and clinical evidence suggesting chemopreventive activity of selenium. Potential explanations for the null findings include the agent formulation and dose, the characteristics of the cohort, and the study design. It is likely that only specific subpopulations may benefit from selenium supplementation; therefore, future studies should consider the baseline selenium status of the participants, age of the cohort, and genotype of specific selenoproteins, among other characteristics, in order to determine the activity of selenium in cancer prevention.

  2. Prevention of hypertension in patients with pre-hypertension: protocol for the PREVER-prevention trial

    Directory of Open Access Journals (Sweden)

    Neto José

    2011-03-01

    Full Text Available Abstract Background Blood pressure (BP within pre-hypertensive levels confers higher cardiovascular risk and is an intermediate stage for full hypertension, which develops in an annual rate of 7 out of 100 individuals with 40 to 50 years of age. Non-drug interventions to prevent hypertension have had low effectiveness. In individuals with previous cardiovascular disease or diabetes, the use of BP-lowering agents reduces the incidence of major cardiovascular events. In the absence of higher baseline risk, the use of BP agents reduces the incidence of hypertension. The PREVER-prevention trial aims to investigate the efficacy, safety and feasibility of a population-based intervention to prevent the incidence of hypertension and the development of target-organ damage. Methods This is a randomized, double-blind, placebo-controlled clinical trial, with participants aged 30 to 70 years, with pre-hypertension. The trial arms will be chlorthalidone 12.5 mg plus amiloride 2.5 mg or identical placebo. The primary outcomes will be the incidence of hypertension, adverse events and development or worsening of microalbuminuria and of left ventricular hypertrophy in the EKG. The secondary outcomes will be fatal or non-fatal cardiovascular events: myocardial infarction, stroke, heart failure, evidence of new sub-clinical atherosclerosis, and sudden death. The study will last 18 months. The sample size was calculated on the basis of an incidence of hypertension of 14% in the control group, a size effect of 40%, power of 85% and P alpha of 5%, resulting in 625 participants per group. The project was approved by the Ethics committee of each participating institution. Discussion The early use of blood pressure-lowering drugs, particularly diuretics, which act on the main mechanism of blood pressure rising with age, may prevent cardiovascular events and the incidence of hypertension in individuals with hypertension. If this intervention shows to be effective and safe

  3. Atrophy rates in asymptomatic amyloidosis: implications for Alzheimer prevention trials.

    Directory of Open Access Journals (Sweden)

    K Abigail Andrews

    Full Text Available There is considerable interest in designing therapeutic studies of individuals at risk of Alzheimer disease (AD to prevent the onset of symptoms. Cortical β-amyloid plaques, the first stage of AD pathology, can be detected in vivo using positron emission tomography (PET, and several studies have shown that ~1/3 of healthy elderly have significant β-amyloid deposition. Here we assessed whether asymptomatic amyloid-PET-positive controls have increased rates of brain atrophy, which could be harnessed as an outcome measure for AD prevention trials. We assessed 66 control subjects (age = 73.5±7.3 yrs; MMSE = 29±1.3 from the Australian Imaging Biomarkers & Lifestyle study who had a baseline Pittsburgh Compound B (PiB PET scan and two 3T MRI scans ~18-months apart. We calculated PET standard uptake value ratios (SUVR, and classified individuals as amyloid-positive/negative. Baseline and 18-month MRI scans were registered, and brain, hippocampal, and ventricular volumes and annualized volume changes calculated. Increasing baseline PiB-PET measures of β-amyloid load correlated with hippocampal atrophy rate independent of age (p = 0.014. Twenty-two (1/3 were PiB-positive (SUVR>1.40, the remaining 44 PiB-negative (SUVR≤1.31. Compared to PiB-negatives, PiB-positive individuals were older (76.8±7.5 vs. 71.7±7.5, p<0.05 and more were APOE4 positive (63.6% vs. 19.2%, p<0.01 but there were no differences in baseline brain, ventricle or hippocampal volumes, either with or without correction for total intracranial volume, once age and gender were accounted for. The PiB-positive group had greater total hippocampal loss (0.06±0.08 vs. 0.02±0.05 ml/yr, p = 0.02, independent of age and gender, with non-significantly higher rates of whole brain (7.1±9.4 vs. 4.7±5.5 ml/yr and ventricular (2.0±3.0 vs. 1.1±1.0 ml/yr change. Based on the observed effect size, recruiting 384 (95%CI 195-1080 amyloid-positive subjects/arm will provide 80% power to detect 25

  4. Probiotics in the prevention of eczema: a randomised controlled trial

    Science.gov (United States)

    Allen, Stephen J; Jordan, Sue; Storey, Melanie; Thornton, Catherine A; Gravenor, Michael B; Garaiova, Iveta; Plummer, Susan F; Wang, Duolao; Morgan, Gareth

    2014-01-01

    Objective To evaluate a multistrain, high-dose probiotic in the prevention of eczema. Design A randomised, double-blind, placebo-controlled, parallel group trial. Settings Antenatal clinics, research clinic, children at home. Patients Pregnant women and their infants. Interventions Women from 36 weeks gestation and their infants to age 6 months received daily either the probiotic (Lactobacillus salivarius CUL61, Lactobacillus paracasei CUL08, Bifidobacterium animalis subspecies lactis CUL34 and Bifidobacterium bifidum CUL20; total of 1010 organisms/day) or matching placebo. Main outcome measure Diagnosed eczema at age 2 years. Infants were followed up by questionnaire. Clinical examination and skin prick tests to common allergens were done at 6 months and 2 years. Results The cumulative frequency of diagnosed eczema at 2 years was similar in the probiotic (73/214, 34.1%) and placebo arms (72/222, 32.4%; OR 1.07, 95% CI 0.72 to 1.6). Among the secondary outcomes, the cumulative frequency of skin prick sensitivity at 2 years was reduced in the probiotic (18/171; 10.5%) compared with the placebo arm (32/173; 18.5%; OR 0.52, 95% CI 0.28 to 0.98). The statistically significant differences between the arms were mainly in sensitisation to cow's milk and hen's egg proteins at 6 months. Atopic eczema occurred in 9/171 (5.3%) children in the probiotic arm and 21/173 (12.1%) in the placebo arm (OR 0.40, 95% CI 0.18 to 0.91). Conclusions The study did not provide evidence that the probiotic either prevented eczema during the study or reduced its severity. However, the probiotic seemed to prevent atopic sensitisation to common food allergens and so reduce the incidence of atopic eczema in early childhood. Trial registration Number ISRCTN26287422. PMID:24947281

  5. Experiences in conducting multiple community-based HIV prevention trials among women in KwaZulu-Natal, South Africa

    Directory of Open Access Journals (Sweden)

    Moodley Jothi

    2010-04-01

    referral for chronic illnesses. Social benefits included training of home-based caregivers and sustainable ongoing HIV prevention education through peer educator programmes. Challenges Several challenges were encountered, including manipulation by participants of their eligibility criteria in order to enroll in the trial. Women attempted to co-enroll in multiple trials to benefit from financial reimbursements and individualised care. The trials became ethically challenging when participants refused to take up referrals for care due to stigma, denial of their HIV status and inadequate health infrastructure. Lack of disclosure of HIV status to partners and family members was particularly challenging. Some of the ethical dilemmas put to the test our responsibility as researchers and our obligation to provide health care to research participants. Conclusion Conducting these five trials in a period of six years provided us with invaluable insights into trial implementation, community participation, recruitment and retention, provision of care and dissemination of trial results. The critical mass of scientists trained as clinical trialists will continue to address the relentless HIV epidemic in our setting and ensure our commitment to finding a biomedical HIV prevention option for women in the future.

  6. Implementing good participatory practice guidelines in the FEM-PrEP Preexposure Prophylaxis Trial for HIV Prevention among African Women: a focus on local stakeholder involvement

    Directory of Open Access Journals (Sweden)

    Mack N

    2013-10-01

    Full Text Available Natasha Mack,1 Stella Kirkendale,1 Paul Omullo,2 Jacob Odhiambo,2 Malebo Ratlhagana,3 Martha Masaki,4 Phumzile Siguntu,5 Kawango Agot,2 Khatija Ahmed,3 Saidi Kapiga,4 Johan Lombaard,5 Lut Van Damme,1 Amy Corneli1 1FHI 360, Durham, NC, USA; 2Impact Research and Development Organization, Bondo, Kenya; 3Setshaba Research Centre, Soshanguve, South Africa; 4Kilimanjaro Christian Medical Center, Moshi, Tanzania; 5Josha Research, Bloemfontein, South Africa Abstract: Biomedical HIV-prevention research is most likely to succeed when researchers actively engage with community stakeholders. To this effect, the Joint United Nations Programme on HIV/AIDS and the AIDS Vaccine Advocacy Coalition developed good participatory practice guidelines for biomedical HIV-prevention trials in 2007 and updated them in 2011. The Preexposure Prophylaxis Trial for HIV Prevention among African Women (FEM-PrEP clinical trial, testing once-daily Truvada as preexposure prophylaxis among women at higher risk of HIV in Kenya, South Africa, and Tanzania, included a community program to engage with local stakeholders. Following the trial, we revisited the community program to situate activities in the context of the 2011 guidelines. In the paper, we describe implementation of the six guidelines relevant to local stakeholder engagement – stakeholder advisory mechanisms, stakeholder engagement plan, stakeholder education plan, communications plan, issues management plan, trial closure, and results dissemination – in light of on-the-ground realities of the trial. We then identify two cross-cutting themes from our considerations: (1 stakeholder education beyond the good participatory practice recommendation to increase research literacy about the specific trial is needed; education efforts should also communicate a base of information on HIV transmission and prevention; and (2 anticipatory preparation is useful in communications planning, issues management, and trial closure and

  7. Why older people refuse to participate in falls prevention trials: A qualitative study

    NARCIS (Netherlands)

    A.B.M. Elskamp (Annemijn); K.A. Hartholt (Klaas); P. Patka (Peter); E.F. van Beeck (Ed); T.J.M. van der Cammen (Tischa)

    2012-01-01

    textabstractBackground/Objectives: Falls are a major public health problem. Older persons are frequently underrepresented in trials, including falls prevention trials. Insight into possible reasons for non-participation could help to improve trial designs and participation rates among this age-group

  8. Selenium and Prostate Cancer Prevention: Insights from the Selenium and Vitamin E Cancer Prevention Trial (SELECT

    Directory of Open Access Journals (Sweden)

    Holly L. Nicastro

    2013-04-01

    Full Text Available The Selenium and Vitamin E Cancer Prevention Trial (SELECT was conducted to assess the efficacy of selenium and vitamin E alone, and in combination, on the incidence of prostate cancer. This randomized, double-blind, placebo-controlled, 2 × 2 factorial design clinical trial found that neither selenium nor vitamin E reduced the incidence of prostate cancer after seven years and that vitamin E was associated with a 17% increased risk of prostate cancer compared to placebo. The null result was surprising given the strong preclinical and clinical evidence suggesting chemopreventive activity of selenium. Potential explanations for the null findings include the agent formulation and dose, the characteristics of the cohort, and the study design. It is likely that only specific subpopulations may benefit from selenium supplementation; therefore, future studies should consider the baseline selenium status of the participants, age of the cohort, and genotype of specific selenoproteins, among other characteristics, in order to determine the activity of selenium in cancer prevention.

  9. Protocol for Northern Ireland Caries Prevention in Practice Trial (NIC-PIP) trial: a randomised controlled trial to measure the effects and costs of a dental caries prevention regime for young children attending primary care dental services

    OpenAIRE

    Noble Solveig; Sutton Matthew; Crealey Grainne; O'Neill Ciaran; Killough Seamus; Donaldson Michael; Milsom Keith M; Tickle Martin; Greer Margaret; Worthington Helen V

    2011-01-01

    Abstract Background Dental caries is a persistent public health problem with little change in the prevalence in young children over the last 20 years. Once a child contracts the disease it has a significant impact on their quality of life. There is good evidence from Cochrane reviews including trials that fluoride varnish and regular use of fluoride toothpaste can prevent caries. The Northern Ireland Caries Prevention in Practice Trial (NIC-PIP) trial will compare the costs and effects of a c...

  10. Primary and Secondary Prevention Trials in Alzheimer Disease: Looking Back, Moving Forward

    Science.gov (United States)

    Hsu, David C.; Marshall, Gad A.

    2015-01-01

    The field of Alzheimer disease (AD) prevention has been a culmination of basic science, clinical, and translational research. In the past three years since the new 2011 AD diagnostic guidelines, large-scale collaborative efforts have embarked on new clinical trials with the hope of someday preventing AD. This review will shed light on the historical and scientific contexts in which these trials were based on, as well as discuss potential challenges these trials may face in the coming years. Primary preventive measures, such as lifestyle, multidomain, medication, and supplemental interventions, will be analyzed. Secondary prevention as represented by disease-modifying interventions, such as anti-amyloid therapy and pioglitazone, will also be reviewed. Finally, hypotheses on future directions for AD prevention trials will be proposed. PMID:27697063

  11. Sexually Transmitted Infections in Women Participating in a Biomedical Intervention Trial in Durban: Prevalence, Coinfections, and Risk Factors.

    Science.gov (United States)

    Abbai, Nathlee Samantha; Wand, Handan; Ramjee, Gita

    2013-01-01

    Background. Sexually transmitted infections (STIs) continue to be a significant public health problem especially among women of reproductive age in Africa. Methods. A total of 2236 women that had enrolled in the MDP301 vaginal microbicide trial were tested for the presence of Chlamydia trachomatis (CT), Neisseria gonorrhea (NG), Treponema pallidum, and Trichomonas vaginalis (TV). Results. CT was identified as the most prevalent STI (11%) followed by TV (10%), NG, and Syphilis (3%). The highest prevalence of coinfection was reported between T. pallidum and TV (19.67%, P = 0.004), followed by CT and TV (13.52%, P ≤ 0.001). Risk factors that were significantly associated with STI acquisition were women of 23 years of age or younger (HR: 1.50, 95% CI 1.17, 1.93), baseline STI with CT (HR: 1.77, 95% CI 1.32, 2.35), TV (HR: 1.58, 95% CI, 1.20, 2.10), and T. pallidum (HR: 5.13, 95% CI 3.65, 7.22), and a low education level (HR: 1.30, 95% CI 1.02, 1.66). Conclusion. Young women with lower education and a history of STIs are at high risk of multiple STIs. Prevention programs should consider target approach to STI prevention among young women. This trial is registered with ISRCTN64716212.

  12. Sexually Transmitted Infections in Women Participating in a Biomedical Intervention Trial in Durban: Prevalence, Coinfections, and Risk Factors

    Directory of Open Access Journals (Sweden)

    Nathlee Samantha Abbai

    2013-01-01

    Full Text Available Background. Sexually transmitted infections (STIs continue to be a significant public health problem especially among women of reproductive age in Africa. Methods. A total of 2236 women that had enrolled in the MDP301 vaginal microbicide trial were tested for the presence of Chlamydia trachomatis (CT, Neisseria gonorrhea (NG, Treponema pallidum, and Trichomonas vaginalis (TV. Results. CT was identified as the most prevalent STI (11% followed by TV (10%, NG, and Syphilis (3%. The highest prevalence of coinfection was reported between T. pallidum and TV (19.67%, P=0.004, followed by CT and TV (13.52%, P≤0.001. Risk factors that were significantly associated with STI acquisition were women of 23 years of age or younger (HR: 1.50, 95% CI 1.17, 1.93, baseline STI with CT (HR: 1.77, 95% CI 1.32, 2.35, TV (HR: 1.58, 95% CI, 1.20, 2.10, and T. pallidum (HR: 5.13, 95% CI 3.65, 7.22, and a low education level (HR: 1.30, 95% CI 1.02, 1.66. Conclusion. Young women with lower education and a history of STIs are at high risk of multiple STIs. Prevention programs should consider target approach to STI prevention among young women. This trial is registered with ISRCTN64716212.

  13. Design of clinical trials in acute kidney injury: a report from an NIDDK workshop--prevention trials.

    Science.gov (United States)

    Okusa, Mark D; Molitoris, Bruce A; Palevsky, Paul M; Chinchilli, Vernon M; Liu, Kathleen D; Cheung, Alfred K; Weisbord, Steven D; Faubel, Sarah; Kellum, John A; Wald, Ron; Chertow, Glenn M; Levin, Adeera; Waikar, Sushrut S; Murray, Patrick T; Parikh, Chirag R; Shaw, Andrew D; Go, Alan S; Chawla, Lakhmir S; Kaufman, James S; Devarajan, Prasad; Toto, Robert M; Hsu, Chi-yuan; Greene, Tom H; Mehta, Ravindra L; Stokes, John B; Thompson, Aliza M; Thompson, B Taylor; Westenfelder, Christof S; Tumlin, James A; Warnock, David G; Shah, Sudhir V; Xie, Yining; Duggan, Emily G; Kimmel, Paul L; Star, Robert A

    2012-05-01

    AKI is an important clinical problem that has become increasingly more common. Mortality rates associated with AKI remain high despite advances in supportive care. Patients surviving AKI have increased long-term mortality and appear to be at increased risk of developing CKD and progressing to ESRD. No proven effective pharmacologic therapies are currently available for the prevention or treatment of AKI. Advances in addressing this unmet need will require the development of novel therapeutic agents based on precise understanding of key pathophysiological events and the implementation of well designed clinical trials. To address this need, the National Institute of Diabetes and Digestive and Kidney Diseases sponsored the "Clinical Trials in Acute Kidney Injury: Current Opportunities and Barriers" workshop in December 2010. The event brought together representatives from academia, industry, the National Institutes of Health, and the US Food and Drug Administration. We report the discussions of workgroups that developed outlines of clinical trials for the prevention of AKI in two patient populations: patients undergoing elective surgery who are at risk for or who develop AKI, and patients who are at risk for contrast-induced AKI. In both of these populations, primary prevention or secondary therapy can be delivered at an optimal time relative to kidney injury. The workgroups detailed primary and secondary endpoints for studies in these groups, and explored the use of adaptive clinical trial designs for trials of novel preventive strategies to improve outcomes of patients with AKI.

  14. Research design considerations for chronic pain prevention clinical trials: IMMPACT recommendations.

    Science.gov (United States)

    Gewandter, Jennifer S; Dworkin, Robert H; Turk, Dennis C; Farrar, John T; Fillingim, Roger B; Gilron, Ian; Markman, John D; Oaklander, Anne Louise; Polydefkis, Michael J; Raja, Srinivasa N; Robinson, James P; Woolf, Clifford J; Ziegler, Dan; Ashburn, Michael A; Burke, Laurie B; Cowan, Penney; George, Steven Z; Goli, Veeraindar; Graff, Ole X; Iyengar, Smriti; Jay, Gary W; Katz, Joel; Kehlet, Henrik; Kitt, Rachel A; Kopecky, Ernest A; Malamut, Richard; McDermott, Michael P; Palmer, Pamela; Rappaport, Bob A; Rauschkolb, Christine; Steigerwald, Ilona; Tobias, Jeffrey; Walco, Gary A

    2015-07-01

    Although certain risk factors can identify individuals who are most likely to develop chronic pain, few interventions to prevent chronic pain have been identified. To facilitate the identification of preventive interventions, an IMMPACT meeting was convened to discuss research design considerations for clinical trials investigating the prevention of chronic pain. We present general design considerations for prevention trials in populations that are at relatively high risk for developing chronic pain. Specific design considerations included subject identification, timing and duration of treatment, outcomes, timing of assessment, and adjusting for risk factors in the analyses. We provide a detailed examination of 4 models of chronic pain prevention (ie, chronic postsurgical pain, postherpetic neuralgia, chronic low back pain, and painful chemotherapy-induced peripheral neuropathy). The issues discussed can, in many instances, be extrapolated to other chronic pain conditions. These examples were selected because they are representative models of primary and secondary prevention, reflect persistent pain resulting from multiple insults (ie, surgery, viral infection, injury, and toxic or noxious element exposure), and are chronically painful conditions that are treated with a range of interventions. Improvements in the design of chronic pain prevention trials could improve assay sensitivity and thus accelerate the identification of efficacious interventions. Such interventions would have the potential to reduce the prevalence of chronic pain in the population. Additionally, standardization of outcomes in prevention clinical trials will facilitate meta-analyses and systematic reviews and improve detection of preventive strategies emerging from clinical trials.

  15. Experiences of a long-term randomized controlled prevention trial in a maiden environment: Estonian Postmenopausal Hormone Therapy trial

    Directory of Open Access Journals (Sweden)

    Rahu Mati

    2008-08-01

    Full Text Available Abstract Background Preventive drugs require long-term trials to show their effectiveness or harms and often a lot of changes occur during post-marketing studies. The purpose of this article is to describe the research process in a long-term randomized controlled trial and discuss the impact and consequences of changes in the research environment. Methods The Estonian Postmenopausal Hormone Therapy trial (EPHT, originally planned to continue for five years, was planned in co-operation with the Women's International Study of Long-Duration Oestrogen after Menopause (WISDOM in the UK. In addition to health outcomes, EPHT was specifically designed to study the impact of postmenopausal hormone therapy (HT on health services utilization. Results After EPHT recruited in 1999–2001 the Women's Health Initiative (WHI in the USA decided to stop the estrogen-progestin trial after a mean of 5.2 years in July 2002 because of increased risk of breast cancer and later in 2004 the estrogen-only trial because HT increased the risk of stroke, decreased the risk of hip fracture, and did not affect coronary heart disease incidence. WISDOM was halted in autumn 2002. These decisions had a major influence on EPHT. Conclusion Changes in Estonian society challenged EPHT to find a balance between the needs of achieving responses to the trial aims with a limited budget and simultaneously maintaining the safety of trial participants. Flexibility was the main key for success. Rapid changes are not limited only to transiting societies but are true also in developed countries and the risk must be included in planning all long-term trials. The role of ethical and data monitoring committees in situations with emerging new data from other studies needs specification. Longer funding for preventive trials and more flexibility in budgeting are mandatory. Who should prove the effectiveness of an (old drug for a new preventive indication? In preventive drug trials companies may

  16. Modernisation of the design of clinical trials for caries preventive agents

    NARCIS (Netherlands)

    Huysmans, M.C.

    2006-01-01

    In January 2002 the International Consensus Workshop on Caries Clinical Trials was organised in Scotland. The meeting was an initiative of both academic and industrial partners, in order to arrive at a consensus about ways to modernise the design of clinical trials for caries preventive agents (Cari

  17. Prevention of Low Back Pain in the Military: A Randomized Clinical Trial

    Science.gov (United States)

    2009-06-01

    physiotherapists, general prac- titioners, chiropractors ) for acute low back pain . At the initial consul- tation clinicians recorded responses to 25...TITLE: Prevention of Low Back Pain in the Military: A Randomized Clinical Trial PRINCIPAL INVESTIGATOR: Steven Z. George PT, Ph.D...Prevention of Low Back Pain in the Military: 5a. CONTRACT NUMBER W81XWH-06-1-0564 A Randomized Clinical Trial 5b. GRANT NUMBER PR054098 5c

  18. Beyond the biomedical and behavioural: towards an integrated approach to HIV prevention in the southern African mining industry.

    Science.gov (United States)

    Campbell, C; Williams, B

    1999-06-01

    While migrant labour is believed to play an important role in the dynamics of HIV-transmission in many of the countries of southern Africa, little has been written about the way in which HIV/AIDS has been dealt with in the industrial settings in which many migrant workers are employed. This paper takes the gold mining industry in the countries of the Southern African Development Community (SADC) as a case study. While many mines made substantial efforts to establish HIV-prevention programmes relatively early on in the epidemic, these appear to have had little impact. The paper analyses the response of key players in the mining industry, in the interests of highlighting the limitations of the way in which both managements and trade unions have responded to HIV. It will be argued that the energy that has been devoted either to biomedical or behavioural prevention programmes or to human rights issues has served to obscure the social and developmental dimensions of HIV-transmission. This argument is supported by means of a case study which seeks to highlight the complexity of the dynamics of disease transmission in this context, a complexity which is not reflected in individualistic responses. An account is given of a new intervention which seeks to develop a more integrated approach to HIV management in an industrial setting.

  19. Knowledge and Perceptions about Clinical Trials and the Use of Biomedical Samples: Findings from a Qualitative Study in Rural Northern Ghana.

    Directory of Open Access Journals (Sweden)

    Samuel Chatio

    Full Text Available Clinical trials conducted in sub-Saharan Africa have helped to address the prevalent health challenges. The knowledge about how communities perceive clinical trials is however only now evolving. This study was conducted among parents whose children participated in past clinical trials in northern Ghana to assess their knowledge and perceptions of clinical trials and the use of biomedical samples.This was a qualitative study based on eighty in-depth interviews with parents. The participants were randomly selected from among parents whose children were enrolled in a clinical trial conducted in the Kassena-Nankana districts between 2000 and 2003. The interviews were transcribed and coded into emergent themes using Nvivo 9 software. The thematic analysis framework was used to analyze the data.Study participants reported that clinical trials were carried out to determine the efficacy of drugs and to make sure that these drugs were suitable for human beings to use. The conduct of clinical trials was perceived to have helped to reduce the occurrence of diseases such as malaria, cerebrospinal meningitis and diarrhea. Quality of care was reported to be better in clinical trials than in the routine care. Parents indicated that participation in clinical trials positively influenced their health-seeking behavior. Apprehensions about blood draw and the use to which samples were put were expressed, with suspicion by a few participants that researchers sold blood samples. The issue of blood draw was most contentious.Parents perception about the conduct of clinical trials in the study districts is generally positive. However, misconceptions made about the use of blood samples in this study must be taken seriously and strategies found to improve transparency and greater community acceptability.

  20. Prevention of contrast-induced AKI: a review of published trials and the design of the prevention of serious adverse events following angiography (PRESERVE) trial.

    Science.gov (United States)

    Weisbord, Steven D; Gallagher, Martin; Kaufman, James; Cass, Alan; Parikh, Chirag R; Chertow, Glenn M; Shunk, Kendrick A; McCullough, Peter A; Fine, Michael J; Mor, Maria K; Lew, Robert A; Huang, Grant D; Conner, Todd A; Brophy, Mary T; Lee, Joanne; Soliva, Susan; Palevsky, Paul M

    2013-09-01

    Contrast-induced AKI (CI-AKI) is a common condition associated with serious, adverse outcomes. CI-AKI may be preventable because its risk factors are well characterized and the timing of renal insult is commonly known in advance. Intravenous (IV) fluids and N-acetylcysteine (NAC) are two of the most widely studied preventive measures for CI-AKI. Despite a multitude of clinical trials and meta-analyses, the most effective type of IV fluid (sodium bicarbonate versus sodium chloride) and the benefit of NAC remain unclear. Careful review of published trials of these interventions reveals design limitations that contributed to their inconclusive findings. Such design limitations include the enrollment of small numbers of patients, increasing the risk for type I and type II statistical errors; the use of surrogate primary endpoints defined by small increments in serum creatinine, which are associated with, but not necessarily causally related to serious, adverse, patient-centered outcomes; and the inclusion of low-risk patients with intact baseline kidney function, yielding low event rates and reduced generalizability to a higher-risk population. The Prevention of Serious Adverse Events following Angiography (PRESERVE) trial is a randomized, double-blind, multicenter trial that will enroll 8680 high-risk patients undergoing coronary or noncoronary angiography to compare the effectiveness of IV isotonic sodium bicarbonate versus IV isotonic sodium chloride and oral NAC versus oral placebo for the prevention of serious, adverse outcomes associated with CI-AKI. This article discusses key methodological issues of past trials investigating IV fluids and NAC and how they informed the design of the PRESERVE trial.

  1. Dissonance and Healthy Weight Eating Disorder Prevention Programs: A Randomized Efficacy Trial

    Science.gov (United States)

    Stice, Eric; Shaw, Heather; Burton, Emily; Wade, Emily

    2006-01-01

    In this trial, adolescent girls with body dissatisfaction (N = 481, M age = 17 years) were randomized to an eating disorder prevention program involving dissonance-inducing activities that reduce thin-ideal internalization, a prevention program promoting healthy weight management, an expressive writing control condition, or an assessment-only…

  2. Selenium and Vitamin E Cancer Prevention Trial (SELECT): Questions and Answers

    Science.gov (United States)

    ... Genetics of Prostate Cancer Prostate Cancer Screening Research Selenium and Vitamin E Cancer Prevention Trial (SELECT): Questions and Answers On This ... E supplement. Should men take vitamin E or selenium supplements for cancer prevention? No. Scientists do not understand how these ...

  3. Testing Mediators of Intervention Effects in Randomized Controlled Trials: An Evaluation of Three Depression Prevention Programs

    Science.gov (United States)

    Stice, Eric; Rohde, Paul; Seeley, John R.; Gau, Jeff M.

    2010-01-01

    Objective: Evaluate a new 5-step method for testing mediators hypothesized to account for the effects of depression prevention programs. Method: In this indicated prevention trial, at-risk teens with elevated depressive symptoms were randomized to a group cognitive-behavioral (CB) intervention, group supportive expressive intervention, CB…

  4. Efficacy and effectiveness as aspects of cluster randomized trials with nursing home residents: methodological insights from a pneumonia prevention trial.

    Science.gov (United States)

    Van Ness, Peter H; Peduzzi, Peter N; Quagliarello, Vincent J

    2012-11-01

    This report discusses how methodological aspects of study efficacy and effectiveness combine in cluster randomized trials in nursing homes. Discussion focuses on the relationships between these study aspects in the Pneumonia Reduction in Institutionalized Disabled Elders (PRIDE) trial, an ongoing cluster randomized clinical trial of pneumonia prevention among nursing home residents launched in October 2009 in Greater New Haven, Connecticut. This clinical trial has enrolled long-term care nursing home residents, over 65years in age, who have either inadequate oral care or swallowing difficulty, previously identified risk factors for pneumonia. It has used a multicomponent intervention consisting of manual tooth/gum brushing, 0.12% chlorhexidine oral rinse administered twice daily by nurses, and upright feeding positioning at meals to reduce rates of radiographically documented pneumonia. Cluster randomization is attractive for nursing home intervention studies because physical proximity and administrative arrangements make it difficult to deliver different interventions to residents of the same nursing home. Implementing an intervention in an entire home requires integration into the daily life of residents and into the administrative procedures of the nursing home. This characteristic of nursing home cluster randomized trials makes them approximate "real-world" research contexts, but implementation can be challenging. The PRIDE trial of pneumonia prevention utilized specific methodological choices that include both efficacy and effectiveness elements. Cluster randomized trials in nursing homes having elements of both efficacy and effectiveness (i.e., hybrid designs) can address some of the methodological challenges of conducting clinical research in nursing homes; they have distinctive advantages and some limitations.

  5. The National Lung Screening Trial (NLST) | Division of Cancer Prevention

    Science.gov (United States)

    The National Lung Screening Trial (NLST) compared two ways of detecting lung cancer: low-dose helical computed tomography (CT) and standard chest X-ray. Both chest X-rays and low-dose helical CT scans have been used to find lung cancer early, but the effects of these screening techniques on lung cancer mortality rates had not been determined. NLST enrolled 53,454 current or former heavy smokers from 33 sites and coordinating centers across the United States. | The National Lung Screening Trial (NLST) compared two ways of detecting lung cancer: participants who received low-dose helical CT scans had a 20% lower risk of dying from lung cancer than participants who received standard chest X-rays.

  6. Prevention of abdominal wound infection (PROUD trial, DRKS00000390: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Heger Ulrike

    2011-11-01

    Full Text Available Abstract Background Wound infection affects a considerable portion of patients after abdominal operations, increasing health care costs and postoperative morbidity and affecting quality of life. Antibacterial coating has been suggested as an effective measure to decrease postoperative wound infections after laparotomies. The INLINE metaanalysis has recently shown the superiority of a slowly absorbable continuous suture for abdominal closure; with PDS plus® such a suture has now been made available with triclosan antibacterial coating. Methods/Design The PROUD trial is designed as a randomised, controlled, observer, surgeon and patient blinded multicenter superiority trial with two parallel groups and a primary endpoint of wound infection during 30 days after surgery. The intervention group will receive triclosan coated polydioxanone sutures, whereas the control group will receive the standard polydioxanone sutures; abdominal closure will otherwise be standardized in both groups. Statistical analysis is based on intention-to-treat population via binary logistic regression analysis, the total sample size of n = 750 is sufficient to ensure alpha = 5% and power = 80%, an interim analysis will be carried out after data of 375 patients are available. Discussion The PROUD trial will yield robust data to determine the effectiveness of antibacterial coating in one of the standard sutures for abdominal closure and potentially lead to amendment of current guidelines. The exploration of clinically objective parameters as well as quality of life holds immediate relevance for clinical management and the pragmatic trial design ensures high external validity. Trial Registration The trial protocol has been registered with the German Clinical Trials Register (DRKS00000390.

  7. Research design considerations for chronic pain prevention clinical trials

    DEFF Research Database (Denmark)

    Gewandter, Jennifer S; Dworkin, Robert H; Turk, Dennis C

    2015-01-01

    , outcomes, timing of assessment, and adjusting for risk factors in the analyses. We provide a detailed examination of 4 models of chronic pain prevention (ie, chronic postsurgical pain, postherpetic neuralgia, chronic low back pain, and painful chemotherapy-induced peripheral neuropathy). The issues...

  8. Nutritional Science Clinical Trials | Division of Cancer Prevention

    Science.gov (United States)

    The Division of Cancer Prevention (DCP) conducts and supports research to determine a person's risk of cancer and to find ways to reduce the risk. This knowledge is critical to making progress against cancer because risk varies over the lifespan as genetic and epigenetic changes can transform healthy tissue into invasive cancer.

  9. Prostate and Urologic Cancer Clinical Trials | Division of Cancer Prevention

    Science.gov (United States)

    The Division of Cancer Prevention (DCP) conducts and supports research to determine a person's risk of cancer and to find ways to reduce the risk. This knowledge is critical to making progress against cancer because risk varies over the lifespan as genetic and epigenetic changes can transform healthy tissue into invasive cancer.

  10. Meaningful prevention of breast cancer metastasis: candidate therapeutics, preclinical validation, and clinical trial concerns.

    Science.gov (United States)

    Zimmer, Alexandra S; Steeg, Patricia S

    2015-01-01

    The development of drugs to treat breast and other cancers proceeds through phase I dose finding, phase II efficacy, and phase III comparative studies in the metastatic setting, only then asking if metastasis can be prevented in adjuvant trials. Compounds without overt cytotoxic activity, such as those developed to inhibit metastatic colonization, will likely fail to shrink established lesions in the metastatic setting and never be tested in a metastasis prevention scenario where they were preclinically validated. We and others have proposed phase II primary and secondary metastasis prevention studies to address this need. Herein, we have asked whether preclinical metastasis prevention data agrees with the positive adjuvant setting trials. The data are limited but complimentary. We also review fundamental pathways involved in metastasis, including Src, integrins, focal adhesion kinase (FAK), and fibrosis, for their clinical progress to date and potential for metastasis prevention. Issues of inadequate preclinical validation and clinical toxicity profiles are discussed.

  11. Pressure sensor-based tongue-placed electrotactile biofeedback for balance improvement - Biomedical application to prevent pressure sores formation and falls

    CERN Document Server

    Vuillerme, Nicolas; Pinsault, Nicolas; Moreau-Gaudry, Alexandre; Fleury, Anthony; Demongeot, Jacques; Payan, Yohan

    2007-01-01

    We introduce the innovative technologies, based on the concept of "sensory substitution", we are developing in the fields of biomedical engineering and human disability. Precisely, our goal is to design, develop and validate practical assistive biomedical and/or technical devices and/or rehabilitating procedures for persons with disabilities, using artificial tongue-placed tactile biofeedback systems. Proposed applications are dealing with: (1) pressure sores prevention in case of spinal cord injuries (persons with paraplegia, or tetraplegia); and (2) balance control improvement to prevent fall in older and/or disabled adults. This paper describes the architecture and the functioning principle of these biofeedback systems and presents preliminary results of two feasibility studies performed on young healthy adults.

  12. Stroke Prevention in Atrial Fibrillation: Latest Clinical Trials and Guidelines

    Directory of Open Access Journals (Sweden)

    Luciana Armaganijan

    2012-04-01

    Full Text Available Atrial Fibrillation (AF is the most common sustained arrhythmia and 1/6 strokes is attributed to AF. The cornerstone of treatment remains maintaining sinus rhythm or appropriate ventricular rate control in addition to prevention of stroke. Oral anticoagulation therapy (OAC with vitamin K antagonists (VKAs has been the gold standard for almost 50 years and a significant reduction in the risk of stroke in patients with AF has been demonstrated. Nonetheless, only 50% of patients with guideline recommendations for OAC treatment actually receive VKAs and half of these will discontinue therapy within 3 to 5 years with only another half achieving therapeutic ranges more than 50% of the time. The aforementioned limitations in addition with frequent blood monitoring have prompted the development of a series of new OAC therapies. The present review focuses on the current pharmacological management for stroke prevention in patients with AF based on current and emerging evidence.

  13. Cost-effectiveness of interventions to prevent HIV and STDs among women: a randomized controlled trial.

    Science.gov (United States)

    Ruger, Jennifer Prah; Abdallah, Arbi Ben; Ng, Nora Y; Luekens, Craig; Cottler, Linda

    2014-10-01

    Injection drug use is a leading transmission route of HIV and STDs, and disease prevention among drug users is an important public health concern. This study assesses cost-effectiveness of behavioral interventions for reducing HIV and STDs infections among injection drug-using women. Cost-effectiveness analysis was conducted from societal and provider perspectives for randomized trial data and Bernoullian model estimates of infections averted for three increasingly intensive interventions: (1) NIDA's standard intervention (SI); (2) SI plus a well woman exam (WWE); and (3) SI, WWE, plus four educational sessions (4ES). Trial results indicate that 4ES was cost-effective relative to WWE, which was dominated by SI, for most diseases. Model estimates, however, suggest that WWE was cost-effective relative to SI and dominated 4ES for all diseases. Trial and model results agree that WWE is cost-effective relative to SI per hepatitis C infection averted ($109 308 for in trial, $6 016 in model) and per gonorrhea infection averted ($9 461 in trial, $14 044 in model). In sensitivity analysis, trial results are sensitive to 5 % change in WWE effectiveness relative to SI for hepatitis C and HIV. In the model, WWE remained cost-effective or cost-saving relative to SI for HIV prevention across a range of assumptions. WWE is cost-effective relative to SI for preventing hepatitis C and gonorrhea. WWE may have similar effects as the costlier 4ES.

  14. [Selenium supplementation trials for cancer prevention and the subsequent risk of type 2 diabetes mellitus: selenium and vitamin E cancer prevention trial and after].

    Science.gov (United States)

    Koyama, Hiroshi; Mutakin; Abdulah, Rizky; Yamazaki, Chiho; Kameo, Satomi

    2013-01-01

    The essential trace element selenium has long been considered to exhibit cancer-preventive, antidiabetic and insulin-mimetic properties. However, recent epidemiological studies have indicated that supranutritional selenium intake and high plasma selenium levels are not necessarily preventive against cancer, and are possible risk factors for developing type 2 diabetes mellitus. The results of the SELECT, Selenium and Vitamin E Cancer Prevention Trial, in which it is hypothesized that the supplementations with selenium and/or vitamin E decrease the prostate cancer incidence among healthy men in the U.S., showed that the supplementation did not prevent the development of prostate cancer and that the incidence of newly diagnosed type 2 diabetes mellitus increased among the selenium-supplemented participants. The Nutritional Prevention of Cancer (NPC) trial showed a decreased risk of prostate cancer among participants taking 200 μg of selenium daily for 7.7 years. However, the results of the NPC trial also showed an increased risk of type 2 diabetes mellitus in the participants with plasma selenium levels in the top tertile at the start of the study. Recently, the association of serum selenium with adipocytokines, such as TNF-α, VCAM-1, leptin, FABP-4, and MCP-1, has been observed. Selenoprotein P has been reported to associated with adiponectin, which suggests new roles of selenoprotein P in cellular energy metabolism, possibly leading to the increased risk of type 2 diabetes mellitus and also the development of cancer. Further studies are required to elucidate the relationship between selenium and adipocytokines and the role of selenoprotein P in the development of type 2 diabetes mellitus and cancer at high levels of selenium.

  15. [Modernisation of the design of clinical trials for caries preventive agents].

    Science.gov (United States)

    Huysmans, M C D N J M

    2006-04-01

    In January 2002 the International Consensus Workshop on Caries Clinical Trials was organised in Scotland. The meeting was an initiative of both academic and industrial partners, in order to arrive at a consensus about ways to modernise the design of clinical trials for caries preventive agents (Caries Clinical Trials or CCTs). All presentations delivered at the workshop and the consensus statements formulated at the end of the workshop were published last year in a special issue of the Journal of Dental Research. In this paper some important aspects are highlighted and the workshop conclusions are presented.

  16. Probiotics’ Preventive Effect on Pediatric Food Allergy:A Meta-analysis of Randomized Controlled Trials

    Institute of Scientific and Technical Information of China (English)

    Xiang-yi Kong; Yi Yang; Jian Guan; Ren-zhi Wang

    2014-01-01

    Objective To investigate the preventive effect of probiotics on pediatric food allergy. Methods From MEDLINE bibliographical database, we searched and reviewed all randomized controlled trials on the preventive effects of probiotics on pediatric food allergies up to September 2013 and excluded the studies that do not meet inclusion criteria and extracted the data. Meta-analysis for the results of homogenous studies was performed using RevMan 5.0 and the co-effect was pooled by using fixed-effects model of relative risk (RR) ratios. Results Ten trials published between 2007 and 2012 including 2701 cases were included. Meta-analysis based on included data showed that the preventive effect of prenatal and postnatal probiotic supplementation on food allergies was not significant with the RR=0.88 (95%CI:0.76-1.03). Conclusion Present evidences cannot show in unequivocal terms that prenatal and postnatal probiotic supplementation will prevent food allergic diseases.

  17. Community readiness to promote Latinas' participation in breast cancer prevention clinical trials.

    Science.gov (United States)

    Lawsin, Catalina R; Borrayo, Evelinn A; Edwards, Ruth; Belloso, Carolina

    2007-07-01

    The high breast cancer (BC) mortality rates that exist among Hispanic women (Latinas) are a health disparity burden that needs to be addressed. Prevention clinical trials are a burgeoning area of cancer prevention efforts and may serve to promote parity. Unfortunately, Latinas, along with other ethnic minority women, continue to be under-represented in this form of research. Previous studies have examined individual barriers to ethnic minorities' participation, but none have assessed community factors contributing to Latinas' under-representation in these studies. The present study addressed these limitations from a community perspective by exploring which factors might inhibit Latinas' participation in clinical trials, specifically BC prevention trials. Using the Community Readiness Model (CRM), 19 key informants were interviewed in four communities, two rural and two urban, in Colorado, USA. The key informant assessment involved a semistructured interview that measured the level of community readiness to encourage participation in BC prevention activities. The results reflected a community climate that did not recognise BC as a health problem that affected Latinas in participating communities. Compared to other healthcare priorities, participation in BC prevention clinical trials was considered a low priority in these communities. Overall, leadership and community resources were not identified or allocated to encourage the participation of Latinas. The results highlight the lack of awareness regarding clinical trials among both community members and leaders. According to the CRM, strategies to enhance awareness at multiple levels in the community are necessary. This study demonstrates how the CRM can be used to better understand a community's perspective on BC, and specifically, the under-representation of Latinas in clinical trials.

  18. Cancer: improving early detection and prevention. A community practice randomised trial.

    OpenAIRE

    Dietrich, A J; O'Connor, G. T.; Keller, A.; Carney, P A; Levy, D; Whaley, F. S.

    1992-01-01

    OBJECTIVE--To test the impact of physician education and facilitator assisted office system interventions on cancer early detection and preventive services. DESIGN--A randomised trial of two interventions alone and in combination. SETTING AND SUBJECTS--Physicians in 98 ambulatory care practices in the United States. INTERVENTIONS--The education intervention consisted of a day long physician meeting directed at improving knowledge, attitudes, and skills relevant to cancer prevention and early ...

  19. An online randomized controlled trial evaluating HIV prevention digital media interventions for men who have sex with men.

    Directory of Open Access Journals (Sweden)

    Sabina Hirshfield

    Full Text Available As HIV infection continues unabated, there is a need for effective interventions targeting at-risk men who have sex with men (MSM. Engaging MSM online where they meet sexual partners is critical for HIV prevention efforts.A randomized controlled trial (RCT conducted online among U.S. MSM recruited from several gay sexual networking websites assessed the impact of 2 HIV prevention videos and an HIV prevention webpage compared to a control condition for the study outcomes HIV testing, serostatus disclosure, and unprotected anal intercourse (UAI at 60-day follow-up. Video conditions were pooled due to reduced power from low retention (53%, n = 1,631. No participant incentives were provided.Follow-up was completed by 1,631 (53% of 3,092 eligible men. In the 60 days after the intervention, men in the pooled video condition were significantly more likely than men in the control to report full serostatus disclosure ('asked and told' with their last sexual partner (OR 1.32, 95% CI 1.01-1.74. Comparing baseline to follow-up, HIV-negative men in the pooled video (OR 0.70, 95% CI 0.54-0.91 and webpage condition (OR 0.43, 95% CI 0.25-0.72 significantly reduced UAI at follow-up. HIV-positive men in the pooled video condition significantly reduced UAI (OR 0.38, 95% CI 0.20-0.67 and serodiscordant UAI (OR 0.53, 95% CI 0.28-0.96 at follow-up.Findings from this online RCT of MSM recruited from sexual networking websites suggest that a low cost, brief digital media intervention designed to engage critical thinking can increase HIV disclosure to sexual partners and decrease sexual risk. Effective, brief HIV prevention interventions featuring digital media that are made widely available may serve as a complementary part of an overall behavioral and biomedical strategy for reducing sexual risk by addressing the specific needs and circumstances of the target population, and by changing individual knowledge, motivations, and community norms.ClinicalTrials.gov NCT

  20. Statistics in biomedical research

    OpenAIRE

    González-Manteiga, Wenceslao; Cadarso-Suárez, Carmen

    2007-01-01

    The discipline of biostatistics is nowadays a fundamental scientific component of biomedical, public health and health services research. Traditional and emerging areas of application include clinical trials research, observational studies, physiology, imaging, and genomics. The present article reviews the current situation of biostatistics, considering the statistical methods traditionally used in biomedical research, as well as the ongoing development of new methods in response to the new p...

  1. Randomized controlled trial of the CGRP receptor antagonist telcagepant for migraine prevention

    DEFF Research Database (Denmark)

    Ho, Tony W; Connor, Kathryn M; Zhang, Ying

    2014-01-01

    OBJECTIVE: To evaluate whether the calcitonin gene-related peptide (CGRP) receptor antagonist telcagepant might be effective for migraine prevention. METHODS: In this randomized, double-blind, placebo-controlled, multicenter trial (ClinicalTrials.gov NCT00797667), patients experiencing 3-14 migra......OBJECTIVE: To evaluate whether the calcitonin gene-related peptide (CGRP) receptor antagonist telcagepant might be effective for migraine prevention. METHODS: In this randomized, double-blind, placebo-controlled, multicenter trial (ClinicalTrials.gov NCT00797667), patients experiencing 3......-14 migraine days during a 4-week baseline were randomized to telcagepant 140 mg, telcagepant 280 mg, or placebo twice daily for 12 weeks. Efficacy was assessed by mean monthly headache days and migraine/probable migraine days (headache plus ≥ 1 associated symptom). RESULTS: The trial was terminated following...... a recommendation from the Safety Monitoring Board due to hepatotoxicity concerns. At termination, the planned 660 patients had been randomized, 656 had been treated with ≥ 1 dose of study medication, and 14 had completed the trial. The mean treatment duration was 48-50 days. Thirteen patients, all...

  2. HIV treatment as prevention: considerations in the design, conduct, and analysis of cluster randomized controlled trials of combination HIV prevention.

    Directory of Open Access Journals (Sweden)

    Marie-Claude Boily

    Full Text Available The rigorous evaluation of the impact of combination HIV prevention packages at the population level will be critical for the future of HIV prevention. In this review, we discuss important considerations for the design and interpretation of cluster randomized controlled trials (C-RCTs of combination prevention interventions. We focus on three large C-RCTs that will start soon and are designed to test the hypothesis that combination prevention packages, including expanded access to antiretroviral therapy, can substantially reduce HIV incidence. Using a general framework to integrate mathematical modelling analysis into the design, conduct, and analysis of C-RCTs will complement traditional statistical analyses and strengthen the evaluation of the interventions. Importantly, even with combination interventions, it may be challenging to substantially reduce HIV incidence over the 2- to 3-y duration of a C-RCT, unless interventions are scaled up rapidly and key populations are reached. Thus, we propose the innovative use of mathematical modelling to conduct interim analyses, when interim HIV incidence data are not available, to allow the ongoing trials to be modified or adapted to reduce the likelihood of inconclusive outcomes. The preplanned, interactive use of mathematical models during C-RCTs will also provide a valuable opportunity to validate and refine model projections.

  3. Effectiveness of Peer-Led Eating Disorders Prevention: A Replication Trial

    Science.gov (United States)

    Becker, Carolyn Black; Bull, Stephanie; Schaumberg, Katherine; Cauble, Adele; Franco, Amanda

    2008-01-01

    The aim of this study was to replicate and extend results of a previous trial that investigated the effectiveness of 2 peer-led eating disorders prevention interventions in reducing eating disorder risk factors in undergraduate women (C. B. Becker, L. M. Smith, & A. C. Ciao, 2006). To extend findings from the previous study by allowing for…

  4. Outcomes from a School-Randomized Controlled Trial of Steps to Respect: A Bullying Prevention Program

    Science.gov (United States)

    Brown, Eric C.; Low, Sabina; Smith, Brian H.; Haggerty, Kevin P.

    2011-01-01

    This study reports the outcomes of a randomized controlled trial of Steps to Respect: A Bullying Prevention Program conducted in 33 California elementary schools. Schools were matched on school demographic characteristics and assigned randomly to intervention or waitlisted control conditions. Outcome measures were obtained from (a) all school…

  5. Randomized Controlled Trial of a Preventive Intervention for Perinatal Depression in High-Risk Latinas

    Science.gov (United States)

    Le, Huynh-Nhu; Perry, Deborah F.; Stuart, Elizabeth A.

    2011-01-01

    Objective: A randomized controlled trial was conducted to evaluate the efficacy of a cognitive-behavioral (CBT) intervention to prevent perinatal depression in high-risk Latinas. Method: A sample of 217 participants, predominantly low-income Central American immigrants who met demographic and depression risk criteria, were randomized into usual…

  6. Exercise program for prevention of groin pain in football players: a cluster-randomized trial

    DEFF Research Database (Denmark)

    Hölmich, P; Larsen, K; Krogsgaard, Kim;

    2010-01-01

    Groin injuries cause major problems in sports and particularly in football. Exercise is effective in treating adductor-related groin pain, but no trials have been published regarding the specific prevention of groin pain or prevention specifically targeting overuse injuries in sport using exercise...... programs. We performed a cluster-randomized trial including 55 football clubs representing 1211 players. The clubs were randomized to an exercise program aimed at preventing groin injuries (n=27) or to a control group training as usual (n=28). The intervention program consisted of six exercises including...... strengthening (concentric and eccentric), coordination, and core stability exercises for the muscles related to the pelvis. Physiotherapists assigned to each club registered all groin injuries. Twenty-two clubs in each group completed the study, represented by 977 players. There was no significant effect...

  7. Protocol for Northern Ireland Caries Prevention in Practice Trial (NIC-PIP trial: a randomised controlled trial to measure the effects and costs of a dental caries prevention regime for young children attending primary care dental services

    Directory of Open Access Journals (Sweden)

    Noble Solveig

    2011-10-01

    Full Text Available Abstract Background Dental caries is a persistent public health problem with little change in the prevalence in young children over the last 20 years. Once a child contracts the disease it has a significant impact on their quality of life. There is good evidence from Cochrane reviews including trials that fluoride varnish and regular use of fluoride toothpaste can prevent caries. The Northern Ireland Caries Prevention in Practice Trial (NIC-PIP trial will compare the costs and effects of a caries preventive package (fluoride varnish, toothpaste, toothbrush and standardised dental health education with dental health education alone in young children. Methods/Design A randomised controlled trial on children initially aged 2 and 3 years old who are regular attenders at the primary dental care services in Northern Ireland. Children will be recruited and randomised in dental practices. Children will be randomised to the prevention package of both fluoride varnish (twice per year for three years, fluoride toothpaste (1,450 ppm F (supplied twice per year, a toothbrush (supplied twice a year or not; both test and control groups receive standardised dental health education delivered by the dentist twice per year. Randomisation will be conducted by the Belfast Trust Clinical Research Support Centre ([CRSC] a Clinical Trials Unit. 1200 participants will be recruited from approximately 40 dental practices. Children will be examined for caries by independent dental examiners at baseline and will be excluded if they have caries. The independent dental examiners will examine the children again at 3 years blinded to study group. The primary end-point is whether the child develops caries (cavitation into dentine or not over the three years. One secondary outcome is the number of carious surfaces in the primary dentition in children who experience caries. Other secondary outcomes are episodes of pain, extraction of primary teeth, other adverse events and costs

  8. Protocol for Northern Ireland Caries Prevention in Practice Trial (NIC-PIP) trial: a randomised controlled trial to measure the effects and costs of a dental caries prevention regime for young children attending primary care dental services

    LENUS (Irish Health Repository)

    Tickle, Martin

    2011-10-10

    Abstract Background Dental caries is a persistent public health problem with little change in the prevalence in young children over the last 20 years. Once a child contracts the disease it has a significant impact on their quality of life. There is good evidence from Cochrane reviews including trials that fluoride varnish and regular use of fluoride toothpaste can prevent caries. The Northern Ireland Caries Prevention in Practice Trial (NIC-PIP) trial will compare the costs and effects of a caries preventive package (fluoride varnish, toothpaste, toothbrush and standardised dental health education) with dental health education alone in young children. Methods\\/Design A randomised controlled trial on children initially aged 2 and 3 years old who are regular attenders at the primary dental care services in Northern Ireland. Children will be recruited and randomised in dental practices. Children will be randomised to the prevention package of both fluoride varnish (twice per year for three years), fluoride toothpaste (1,450 ppm F) (supplied twice per year), a toothbrush (supplied twice a year) or not; both test and control groups receive standardised dental health education delivered by the dentist twice per year. Randomisation will be conducted by the Belfast Trust Clinical Research Support Centre ([CRSC] a Clinical Trials Unit). 1200 participants will be recruited from approximately 40 dental practices. Children will be examined for caries by independent dental examiners at baseline and will be excluded if they have caries. The independent dental examiners will examine the children again at 3 years blinded to study group. The primary end-point is whether the child develops caries (cavitation into dentine) or not over the three years. One secondary outcome is the number of carious surfaces in the primary dentition in children who experience caries. Other secondary outcomes are episodes of pain, extraction of primary teeth, other adverse events and costs which will

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

    Directory of Open Access Journals (Sweden)

    Campbell Karen

    2008-03-01

    Full Text Available Abstract Background Multiple factors combine to support a compelling case for interventions that target the development of obesity-promoting behaviours (poor diet, low physical activity and high sedentary behaviour from their inception. These factors include the rapidly increasing prevalence of fatness throughout childhood, the instigation of obesity-promoting behaviours in infancy, and the tracking of these behaviours from childhood through to adolescence and adulthood. The Infant Feeding Activity and Nutrition Trial (INFANT aims to determine the effectiveness of an early childhood obesity prevention intervention delivered to first-time parents. The intervention, conducted with parents over the infant's first 18 months of life, will use existing social networks (first-time parent's groups and an anticipatory guidance framework focusing on parenting skills which support the development of positive diet and physical activity behaviours, and reduced sedentary behaviours in infancy. Methods/Design This cluster-randomised controlled trial, with first-time parent groups as the unit of randomisation, will be conducted with a sample of 600 first-time parents and their newborn children who attend the first-time parents' group at Maternal and Child Health Centres. Using a two-stage sampling process, local government areas in Victoria, Australia will be randomly selected at the first stage. At the second stage, a proportional sample of first-time parent groups within selected local government areas will be randomly selected and invited to participate. Informed consent will be obtained and groups will then be randomly allocated to the intervention or control group. Discussion The early years hold promise as a time in which obesity prevention may be most effective. To our knowledge this will be the first randomised trial internationally to demonstrate whether an early health promotion program delivered to first-time parents in their existing social groups

  10. A multicentre randomized controlled trial of moderate hypothermia to prevent intracranial hypertension in acute liver failure

    DEFF Research Database (Denmark)

    Bernal, William; Murphy, Nicholas; Brown, Sarah

    2016-01-01

    . In a prospective randomized controlled trial we investigated if maintenance of MH prevented development of ICH in ALF patients at high risk of the complication. METHODS: Patients with ALF, high-grade encephalopathy and intracranial pressure (ICP) monitoring in specialist intensive care units were randomized...... or limit the development of brain swelling, a dangerous complication of the condition. There is limited data on its effects in humans. In a randomized controlled trial in severely ill patients with ALF we compared the effects of different temperatures and found no benefit on improving survival...

  11. A randomised controlled trial for overweight and obese parents to prevent childhood obesity - Early STOPP (STockholm Obesity Prevention Program

    Directory of Open Access Journals (Sweden)

    Cao Yingting

    2011-05-01

    Full Text Available Abstract Background Overweight and obesity have a dramatic negative impact on children's health not only during the childhood but also throughout the adult life. Preventing the development of obesity in children is therefore a world-wide health priority. There is an obvious urge for sustainable and evidenced-based interventions that are suitable for families with young children, especially for families with overweight or obese parents. We have developed a prevention program, Early STOPP, combating multiple obesity-promoting behaviors such unbalanced diet, physical inactivity and disturbed sleeping patterns. We also aim to evaluate the effectiveness of the early childhood obesity prevention in a well-characterized population of overweight or obese parents. This protocol outlines methods for the recruitment phase of the study. Design and methods This randomized controlled trial (RCT targets overweight and/or obese parents with infants, recruited from the Child Health Care Centers (CHCC within the Stockholm area. The intervention starts when infants are one year of age and continues until they are six and is regularly delivered by a trained coach (dietitian, physiotherapist or a nurse. The key aspects of Early STOPP family intervention are based on Swedish recommendations for CHCC, which include advices on healthy food choices and eating patterns, increasing physical activity/reducing sedentary behavior and regulating sleeping patterns. Discussion The Early STOPP trial design addresses weaknesses of previous research by recruiting from a well-characterized population, defining a feasible, theory-based intervention and assessing multiple measurements to validate and interpret the program effectiveness. The early years hold promise as a time in which obesity prevention may be most effective. To our knowledge, this longitudinal RCT is the first attempt to demonstrate whether an early, long-term, targeted health promotion program focusing on healthy

  12. Efficacy of smoking prevention program 'Smoke-free Kids': study protocol of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    van Schayck Onno CP

    2009-12-01

    Full Text Available Abstract Background A strong increase in smoking is noted especially among adolescents. In the Netherlands, about 5% of all 10-year olds, 25% of all 13-year olds and 62% of all 17-year olds report ever smoking. In the U.S., an intervention program called 'Smoke-free Kids' was developed to prevent children from smoking. The present study aims to assess the effects of this home-based smoking prevention program in the Netherlands. Methods/Design A randomized controlled trial is conducted among 9 to 11-year old children of primary schools. Participants are randomly assigned to the intervention and control conditions. The intervention program consists of five printed activity modules designed to improve parenting skills specific to smoking prevention and parent-child communication regarding smoking. These modules will include additional sheets with communication tips. The modules for the control condition will include solely information on smoking and tobacco use. Initiation of cigarette smoking (first instance of puffing on a lighted cigarette, susceptibility to cigarette smoking, smoking-related cognitions, and anti-smoking socialization will be the outcome measures. To collect the data, telephone interviews with mothers as well as with their child will be conducted at baseline. Only the children will be examined at post-intervention follow-ups (6, 12, 24, and 36 months after the baseline. Discussion This study protocol describes the design of a randomized controlled trial that will evaluate the effectiveness of a home-based smoking prevention program. We expect that a significantly lower number of children will start smoking in the intervention condition compared to control condition as a direct result of this intervention. If the program is effective, it is applicable in daily live, which will facilitate implementation of the prevention protocol. Trial registration Netherlands Trial Register NTR1465

  13. Inositol for the prevention of neural tube defects: a pilot randomised controlled trial.

    Science.gov (United States)

    Greene, Nicholas D E; Leung, Kit-Yi; Gay, Victoria; Burren, Katie; Mills, Kevin; Chitty, Lyn S; Copp, Andrew J

    2016-03-28

    Although peri-conceptional folic acid (FA) supplementation can prevent a proportion of neural tube defects (NTD), there is increasing evidence that many NTD are FA non-responsive. The vitamin-like molecule inositol may offer a novel approach to preventing FA-non-responsive NTD. Inositol prevented NTD in a genetic mouse model, and was well tolerated by women in a small study of NTD recurrence. In the present study, we report the Prevention of Neural Tube Defects by Inositol (PONTI) pilot study designed to gain further experience of inositol usage in human pregnancy as a preliminary trial to a future large-scale controlled trial to evaluate efficacy of inositol in NTD prevention. Study subjects were UK women with a previous NTD pregnancy who planned to become pregnant again. Of 117 women who made contact, ninety-nine proved eligible and forty-seven agreed to be randomised (double-blind) to peri-conceptional supplementation with inositol plus FA or placebo plus FA. In total, thirty-three randomised pregnancies produced one NTD recurrence in the placebo plus FA group (n 19) and no recurrences in the inositol plus FA group (n 14). Of fifty-two women who declined randomisation, the peri-conceptional supplementation regimen and outcomes of twenty-two further pregnancies were documented. Two NTD recurred, both in women who took only FA in their next pregnancy. No adverse pregnancy events were associated with inositol supplementation. The findings of the PONTI pilot study encourage a large-scale controlled trial of inositol for NTD prevention, but indicate the need for a careful study design in view of the unwillingness of many high-risk women to be randomised.

  14. HIV-1 transmission linkage in an HIV-1 prevention clinical trial

    Energy Technology Data Exchange (ETDEWEB)

    Leitner, Thomas [Los Alamos National Laboratory; Campbell, Mary S [UNIV OF WASHINGTON; Mullins, James I [UNIV OF WASHINGTON; Hughes, James P [UNIV OF WASHINGTON; Wong, Kim G [UNIV OF WASHINGTON; Raugi, Dana N [UNIV OF WASHINGTON; Scrensen, Stefanie [UNIV OF WASHINGTON

    2009-01-01

    HIV-1 sequencing has been used extensively in epidemiologic and forensic studies to investigate patterns of HIV-1 transmission. However, the criteria for establishing genetic linkage between HIV-1 strains in HIV-1 prevention trials have not been formalized. The Partners in Prevention HSV/HIV Transmission Study (ClinicaITrials.gov NCT00194519) enrolled 3408 HIV-1 serodiscordant heterosexual African couples to determine the efficacy of genital herpes suppression with acyclovir in reducing HIV-1 transmission. The trial analysis required laboratory confirmation of HIV-1 linkage between enrolled partners in couples in which seroconversion occurred. Here we describe the process and results from HIV-1 sequencing studies used to perform transmission linkage determination in this clinical trial. Consensus Sanger sequencing of env (C2-V3-C3) and gag (p17-p24) genes was performed on plasma HIV-1 RNA from both partners within 3 months of seroconversion; env single molecule or pyrosequencing was also performed in some cases. For linkage, we required monophyletic clustering between HIV-1 sequences in the transmitting and seroconverting partners, and developed a Bayesian algorithm using genetic distances to evaluate the posterior probability of linkage of participants sequences. Adjudicators classified transmissions as linked, unlinked, or indeterminate. Among 151 seroconversion events, we found 108 (71.5%) linked, 40 (26.5%) unlinked, and 3 (2.0%) to have indeterminate transmissions. Nine (8.3%) were linked by consensus gag sequencing only and 8 (7.4%) required deep sequencing of env. In this first use of HIV-1 sequencing to establish endpoints in a large clinical trial, more than one-fourth of transmissions were unlinked to the enrolled partner, illustrating the relevance of these methods in the design of future HIV-1 prevention trials in serodiscordant couples. A hierarchy of sequencing techniques, analysis methods, and expert adjudication contributed to the linkage

  15. Trial protocol OPPTIMUM– Does progesterone prophylaxis for the prevention of preterm labour improve outcome?

    Directory of Open Access Journals (Sweden)

    Norman Jane E

    2012-08-01

    Full Text Available Abstract Background Preterm birth is a global problem, with a prevalence of 8 to 12% depending on location. Several large trials and systematic reviews have shown progestogens to be effective in preventing or delaying preterm birth in selected high risk women with a singleton pregnancy (including those with a short cervix or previous preterm birth. Although an improvement in short term neonatal outcomes has been shown in some trials these have not consistently been confirmed in meta-analyses. Additionally data on longer term outcomes is limited to a single trial where no difference in outcomes was demonstrated at four years of age of the child, despite those in the “progesterone” group having a lower incidence of preterm birth. Methods/Design The OPPTIMUM study is a double blind randomized placebo controlled trial to determine whether progesterone prophylaxis to prevent preterm birth has long term neonatal or infant benefit. Specifically it will study whether, in women with singleton pregnancy and at high risk of preterm labour, prophylactic vaginal natural progesterone, 200 mg daily from 22 – 34 weeks gestation, compared to placebo, improves obstetric outcome by lengthening pregnancy thus reducing the incidence of preterm delivery (before 34 weeks, improves neonatal outcome by reducing a composite of death and major morbidity, and leads to improved childhood cognitive and neurosensory outcomes at two years of age. Recruitment began in 2009 and is scheduled to close in Spring 2013. As of May 2012, over 800 women had been randomized in 60 sites. Discussion OPPTIMUM will provide further evidence on the effectiveness of vaginal progesterone for prevention of preterm birth and improvement of neonatal outcomes in selected groups of women with singleton pregnancy at high risk of preterm birth. Additionally it will determine whether any reduction in the incidence of preterm birth is accompanied by improved childhood outcome. Trial

  16. Creating an African HIV clinical research and prevention trials network: HIV prevalence, incidence and transmission.

    Directory of Open Access Journals (Sweden)

    Anatoli Kamali

    Full Text Available HIV epidemiology informs prevention trial design and program planning. Nine clinical research centers (CRC in sub-Saharan Africa conducted HIV observational epidemiology studies in populations at risk for HIV infection as part of an HIV prevention and vaccine trial network. Annual HIV incidence ranged from below 2% to above 10% and varied by CRC and risk group, with rates above 5% observed in Zambian men in an HIV-discordant relationship, Ugandan men from Lake Victoria fishing communities, men who have sex with men, and several cohorts of women. HIV incidence tended to fall after the first three months in the study and over calendar time. Among suspected transmission pairs, 28% of HIV infections were not from the reported partner. Volunteers with high incidence were successfully identified and enrolled into large scale cohort studies. Over a quarter of new cases in couples acquired infection from persons other than the suspected transmitting partner.

  17. Long-term survival of participants in the prostate cancer prevention trial

    Directory of Open Access Journals (Sweden)

    Jonathan L Silberstein

    2014-06-01

    Full Text Available The Prostate Cancer Prevention Trial (PCPT is a seminal study in the field of urology. More than 10 years after its initial publication, updated data from this trial continue to shape our understanding of prostate cancer. Among the major findings from the PCPT has been the demonstration that prostate cancer is common in men with prostate-specific antigen (PSA once thought to be in the normal range, [1] finasteride prevents the development of benign prostatic hypertrophy, [2] it increases the sensitivity of PSA [3] and digital rectal examination. [4] Furthermore the PCPT helped to establish the link between erectile dysfunction and cardiovascular disease, [5] and perhaps most importantly finasteride demonstrated a 25% relative risk reduction in the diagnosis of prostate cancer compared with placebo. [6

  18. The Cool Little Kids randomised controlled trial: Population-level early prevention for anxiety disorders

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    Hiscock Harriet

    2011-01-01

    Full Text Available Abstract Background The World Health Organization predicts that by 2030 internalising problems (e.g. depression and anxiety will be second only to HIV/AIDS in international burden of disease. Internalising problems affect 1 in 7 school aged children, impacting on peer relations, school engagement, and later mental health, relationships and employment. The development of early childhood prevention for internalising problems is in its infancy. The current study follows two successful 'efficacy' trials of a parenting group intervention to reduce internalising disorders in temperamentally inhibited preschool children. Cool Little Kids is a population-level randomised trial to determine the impacts of systematically screening preschoolers for inhibition then offering a parenting group intervention, on child internalising problems and economic costs at school entry. Methods/Design This randomised trial will be conducted within the preschool service system, attended by more than 95% of Australian children in the year before starting school. In early 2011, preschool services in four local government areas in Melbourne, Australia, will distribute the screening tool. The ≈16% (n≈500 with temperamental inhibition will enter the trial. Intervention parents will be offered Cool Little Kids, a 6-session group program in the local community, focusing on ways to develop their child's bravery skills by reducing overprotective parenting interactions. Outcomes one and two years post-baseline will comprise child internalising diagnoses and symptoms, parenting interactions, and parent wellbeing. An economic evaluation (cost-consequences framework will compare incremental differences in costs of the intervention versus control children to incremental differences in outcomes, from a societal perspective. Analyses will use the intention-to-treat principle, using logistic and linear regression models (binary and continuous outcomes respectively to compare outcomes

  19. Effects of selenium supplements on cancer prevention: meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Lee, Eun-Hyun; Myung, Seung-Kwon; Jeon, Young-Jee; Kim, Yeol; Chang, Yoon Jung; Ju, Woong; Seo, Hong Gwan; Huh, Bong Yul

    2011-11-01

    This meta-analysis aimed to investigate the preventive effect of selenium supplements alone on cancer as reported by randomized controlled trials (RCTs). We searched PubMed, EMBASE, and the Cochrane Library in July 2009. Of the 461 articles searched, 8 articles on 9 RCTs, which included 152,538 total participants, 32,110 in antioxidant supplement groups, and 120,428 in placebo groups, were included. In a random-effects meta-analysis of all 9 RCTs, selenium supplementation alone was found to have an overall preventive effect on cancer incidence [relative risk (RR) = 0.76; 95% confidence interval (CI) = 0.58-0.99]. Among subgroup meta-analyses, the preventive effect of selenium supplementation alone on cancer was apparently observed in populations with a low baseline serum selenium level (cancer (RR = 0.68; 95% CI = 0.58 to 0.80; I(2) = 41.5%; n = 8). The meta-analysis of randomized controlled trials indicates that there is possible evidence to support the use of selenium supplements alone for cancer prevention in the low baseline serum selenium level population and in the high-risk population for cancer.

  20. Clinical trials to estimate the efficacy of preventive interventions against malaria in paediatric populations: a methodological review

    Directory of Open Access Journals (Sweden)

    Reed Zarifah

    2009-02-01

    Full Text Available Abstract Background Recent years have seen publication of a considerable number of clinical trials of preventive interventions against clinical malaria in children. There has been variability in the specification of end-points, case definitions, analysis methods and reporting and the relative lack of standardization complicates the ability to make comparative evaluations between trials. Methods To prepare for a WHO consultation on design issues in malaria vaccine trials, controlled trials of preventive interventions against malaria in children in endemic countries were identified in which clinical malaria, or death, had been one of the main end-points. Trials were included that evaluated the impact of vaccines, insecticide-treated bed nets (ITN, intermittent presumptive or preventive therapy in infants (IPTi or, in one instance, vitamin A supplementation. Methods that had been used in these trials were summarized and compared in order to identify issues that were directly relevant to the design of malaria vaccine trials. Results 29 controlled trials of preventive malaria interventions were identified, of which eight were vaccine trials. Vaccine trials that were designed to detect an effect on clinical malaria all reported the incidence rate of first episodes of clinical malaria as their primary endpoint. Only one trial of a preventive intervention (of ITN was identified that was designed to detect an effect on severe malaria. A group of larger trials were designed to detect an effect of impregnated bed nets or curtains on all-cause mortality as the primary end-point. Key methodological and reporting differences between trials are noted in the text. Two issues have been identified that are of some concern. Firstly, the choice of primary endpoint is not stated in the reports of a number of the trials and, secondly, the relationship between pre-specified analysis plans and trial reports is rarely made clear. Conclusion This article reports an

  1. Progesterone for the prevention of preterm birth in women with multiple pregnancies: the AMPHIA trial

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    Scheepers Hubertina CJ

    2007-06-01

    Full Text Available Abstract Background 15% of multiple pregnancies ends in a preterm delivery, which can lead to mortality and severe long term neonatal morbidity. At present, no generally accepted strategy for the prevention of preterm birth in multiple pregnancies exists. Prophylactic administration of 17-alpha hydroxyprogesterone caproate (17OHPC has proven to be effective in the prevention of preterm birth in women with singleton pregnancies with a previous preterm delivery. At present, there are no data on the effectiveness of progesterone in the prevention of preterm birth in multiple pregnancies. Methods/Design We aim to investigate the hypothesis that 17OHPC will reduce the incidence of the composite neonatal morbidity of neonates by reducing the early preterm birth rate in multiple pregnancies. Women with a multiple pregnancy at a gestational age between 15 and 20 weeks of gestation will be entered in a placebo-controlled, double blinded randomised study comparing weekly 250 mg 17OHPC intramuscular injections from 16–20 weeks up to 36 weeks of gestation versus placebo. At study entry, cervical length will be measured. The primary outcome is composite bad neonatal condition (perinatal death or severe morbidity. Secondary outcome measures are time to delivery, preterm birth rate before 32 and 37 weeks, days of admission in neonatal intensive care unit, maternal morbidity, maternal admission days for preterm labour and costs. We need to include 660 women to indicate a reduction in bad neonatal outcome from 15% to 8%. Analysis will be by intention to treat. We will also analyse whether the treatment effect is dependent on cervical length. Discussion This trial will provide evidence as to whether or not 17OHPC-treatment is an effective means of preventing bad neonatal outcome due to preterm birth in multiple pregnancies. Trial registration Current Controlled Trials ISRCTN40512715

  2. Rosuvastatin and the JUPITER trial: critical appraisal of a lifeless planet in the galaxy of primary prevention.

    Science.gov (United States)

    López, Antonio; Wright, James M

    2012-01-01

    In November 2008, the JUPITER trial was published in the New England Journal of Medicine. JUPITER is an acronym for Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin. It was an AstraZeneca sponsored randomized double-blind trial comparing rosuvastatin 20 mg with placebo in 17,802 apparently healthy men and women with LDL cholesterol JUPITER trial have been widely publicized, and based on the trial, the main regulatory agencies have approved rosuvastatin for the indication of primary prevention of vascular events. However, the interpretation and clinical implications of the JUPITER trial have been questioned and remain controversial. The objective of this commentary is to evaluate the relevance, design, results, and conclusions of the JUPITER study.

  3. Sexual scripting of heterosexual penile-anal intercourse amongst participants in an HIV prevention trial in South Africa, Uganda and Zimbabwe.

    Science.gov (United States)

    Duby, Zoe; Hartmann, Miriam; Montgomery, Elizabeth T; Colvin, Christopher J; Mensch, Barbara; van der Straten, Ariane

    2016-01-01

    Sexual risk-taking is influenced by individual, interpersonal and social factors. This paper presents findings from a qualitative follow-up study to a clinical trial evaluating biomedical HIV prevention products among African women, explored participants' perceptions and experiences of heterosexual penile-anal intercourse, as well as the gendered power dynamics and relationship contexts in which this sexual behaviour occurs. In-depth interviews were conducted with 88 women from South Africa, Uganda and Zimbabwe. Findings reveal that despite its social stigmatisation, women engage in penile-anal intercourse for reasons including male pleasure, relationship security, hiding infidelity, menstruation, vaginal infections, money and beliefs that it will prevent HIV transmission. In addition, participants described experiences of non-consensual penile-anal intercourse. We used sexual scripting theory as an analytical framework with which to describe the sociocultural and relationship contexts and gendered power dynamics in which these practices occur. These data on the distinct individual, dyadic and social contexts of heterosexual penile-anal intercourse, and the specific factors that may contribute to women's HIV risk, make a unique contribution to our understanding of heterosexual behaviour in these sub-Saharan countries, thereby helping to inform both current and future HIV prevention efforts for women in the region.

  4. Interim data monitoring to enroll higher-risk participants in HIV prevention trials

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    Umo-Otong John

    2009-06-01

    Full Text Available Abstract Background Lower-than-expected incidence of HIV undermines sample size calculations and compromises the power of a HIV prevention trial. We evaluated the effectiveness of interim monitoring of HIV infection rates and on-going modification of recruitment strategies to enroll women at higher risk of HIV in the Cellulose Sulfate Phase III study in Nigeria. Methods We analyzed prevalence and incidence of HIV and other sexually transmitted infections, demographic and sexual behavior characteristics aggregated over the treatment groups on a quarterly basis. The site investigators were advised on their recruitment strategies based on the findings of the interim analyses. Results A total of 3619 women were screened and 1644 enrolled at the Ikeja and Apapa clinics in Lagos, and at the Central and Peripheral clinics in Port Harcourt. Twelve months after study initiation, the overall incidence of HIV was less than one-third of the pre-study assumption, with rates of HIV that varied substantially between clinics. Due to the low prevalence and incidence rates of HIV, it was decided to close the Ikeja clinic in Lagos and to find new catchment areas in Port Harcourt. This strategy was associated with an almost two-fold increase in observed HIV incidence during the second year of the study. Conclusion Given the difficulties in estimating HIV incidence, a close monitoring of HIV prevalence and incidence rates during a trial is warranted. The on-going modification of recruitment strategies based on the regular analysis of HIV rates appeared to be an efficient method for targeting populations at greatest risk of HIV infection and increasing study power in the Nigeria trial. Trial Registration The trial was registered with the ClinicalTrials.gov registry under #NCT00120770 http://clinicaltrials.gov/ct2/show/NCT00120770

  5. Seasonal intermittent preventive treatment for the prevention of anaemia and malaria in Ghanaian children: a randomized, placebo controlled trial.

    Directory of Open Access Journals (Sweden)

    Margaret Kweku

    Full Text Available BACKGROUND: Malaria and anaemia are the leading causes of morbidity and mortality in children in sub-Saharan Africa. We have investigated the effect of intermittent preventive treatment with sulphadoxine-pyrimethamine or artesunate plus amodiaquine on anaemia and malaria in children in an area of intense, prolonged, seasonal malaria transmission in Ghana. METHODS: 2451 children aged 3-59 months from 30 villages were individually randomised to receive placebo or artesunate plus amodiaquine (AS+AQ monthly or bimonthly, or sulphadoxine-pyrimethamine (SP bimonthly over a period of six months. The primary outcome measures were episodes of anaemia (Hb1 year old when they received IPTc compared to the placebo group. However the incidence of malaria in the post intervention period was higher in children who were <1 year old when they received AS+AQ monthly compared to the placebo group. INTERPRETATION: IPTc is safe and efficacious in reducing the burden of malaria in an area of Ghana with a prolonged, intense malaria transmission season. TRIAL REGISTRATION: ClinicalTrials.gov NCT00119132.

  6. An Effectiveness Trial of a Dissonance-Based Eating Disorder Prevention Program for High-Risk Adolescent Girls

    Science.gov (United States)

    Stice, Eric; Rohde, Paul; Gau, Jeff; Shaw, Heather

    2009-01-01

    Efficacy trials indicate that an eating disorder prevention program involving dissonance-inducing activities that decrease thin-ideal internalization reduces risk for current and future eating pathology, yet it is unclear whether this program produces effects under real-world conditions. The present effectiveness trial tested whether this program…

  7. Healthy eating and obesity prevention for preschoolers: a randomised controlled trial

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    Swinburn Boyd

    2010-04-01

    Full Text Available Abstract Background Developing effective prevention and intervention programs for the formative preschool years is seen as an essential step in combating the obesity epidemic across the lifespan. The overall goal of the current project is to measure the effectiveness of a healthy eating and childhood obesity prevention intervention, the MEND (Mind Exercise Nutrition Do It! program that is delivered to parents of children aged 2-4 years. Methods/Design This randomised controlled trial will be conducted with 200 parents and their 2-4 year old children who attend the MEND 2-4 program in metropolitan and regional Victoria. Parent-child dyads will attend ten 90-minute group workshops. These workshops focus on general nutrition, as well as physical activity and behaviours. They are typically held at community or maternal and child health centres and run by a MEND 2-4 trained program leader. Child eating habits, physical activity levels and parental behaviours and cognitions pertaining to nutrition and physical activity will be assessed at baseline, the end of the intervention, and at 6 and 12 months post the intervention. Informed consent will be obtained from all parents, who will then be randomly allocated to the intervention or wait-list control group. Discussion Our study is the first RCT of a healthy eating and childhood obesity prevention intervention targeted specifically to Australian parents and their preschool children aged 2-4 years. It responds to the call by experts in the area of childhood obesity and child health that prevention of overweight in the formative preschool years should focus on parents, given that parental beliefs, attitudes, perceptions and behaviours appear to impact significantly on the development of early overweight. This is 'solution-oriented' rather than 'problem-oriented' research, with its focus being on prevention rather than intervention. If this is a positive trial, the MEND2-4 program can be implemented as a

  8. Participant selection for preventive Regenerative Medicine trials: ethical challenges of selecting individuals at risk.

    Science.gov (United States)

    Niemansburg, Sophie L; Habets, Michelle G J L; Dhert, Wouter J A; van Delden, Johannes J M; Bredenoord, Annelien L

    2015-11-01

    The innovative field of Regenerative Medicine (RM) is expected to extend the possibilities of prevention or early treatment in healthcare. Increasingly, clinical trials will be developed for people at risk of disease to investigate these RM interventions. These individuals at risk are characterised by their susceptibility for developing clinically manifest disease in future due to the existence of degenerative abnormalities. So far, there has been little debate about the ethical appropriateness of including such individuals at risk in clinical trials. We discuss three main challenges of selecting this participant model for testing RM interventions: the challenge of achieving a proportional risk-benefit balance; complexities in the trial design in terms of follow-up and sample size; and the difficulty of obtaining informed consent due to the many uncertainties. We conclude that selecting the model is not ethically justifiable for first-in-man trials with RM interventions due to the high risks and uncertainties. However, the model can be ethically appropriate for testing the efficacy of RM interventions under the following conditions: interventions should be low risk; the degenerative abnormalities (and other risk factors) should be strongly related with disease within a short time frame; robust preclinical evidence of efficacy needs to be present; and the informed consent procedure should contain extra safeguards with regard to communication on uncertainties.

  9. Preventing hypothermia in elective arthroscopic shoulder surgery patients: a protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Duff Jed

    2012-07-01

    Full Text Available Abstract Background Patients having arthroscopic shoulder surgery frequently experience periods of inadvertent hypothermia. This common perioperative problem has been linked to adverse patient outcomes such as myocardial ischaemia, surgical site infection and coagulopathy. International perioperative guidelines recommend patient warming, using a forced air warming device, and the use of warmed intraoperative irrigation solutions for the prevention of hypothermia in at-risk patient groups. This trial will investigate the effect of these interventions on patients’ temperature, thermal comfort, and total recovery time. Method/Design The trial will employ a randomised 2 x 2 factorial design. Eligible patients will be stratified by anaesthetist and block randomised into one of four groups: Group one will receive preoperative warming with a forced air warming device; group two will receive warmed intraoperative irrigation solutions; group three will receive both preoperative warming and warmed intraoperative irrigation solutions; and group four will receive neither intervention. Participants in all four groups will receive active intraoperative warming with a forced air warming device. The primary outcome measures are postoperative temperature, thermal comfort, and total recovery time. Primary outcomes will undergo a two-way analysis of variance controlling for covariants such as operating room ambient temperature and volume of intraoperative irrigation solution. Discussion This trial is designed to confirm the effectiveness of these interventions at maintaining perioperative normothermia and to evaluate if this translates into improved patient outcomes. Australian New Zealand Clinical Trials Registry number ACTRN12610000591055

  10. Alendronate prevents postmenopausal bone loss in women without osteoporosis. A double-blind, randomized, controlled trial. Alendronate Osteoporosis Prevention Study Group

    DEFF Research Database (Denmark)

    McClung, M; Clemmesen, B; Daifotis, A

    1998-01-01

    BACKGROUND: Preventing bone loss associated with menopause and aging and maintaining the normal micro-architecture of bone provide important opportunities for the prevention of osteoporosis and fractures. OBJECTIVE: To determine the safety and efficacy of alendronate, an aminobisphosphonate......, for preventing postmenopausal bone loss. DESIGN: 3-year double-blind, randomized, placebo-controlled trial. SETTING: 15 osteoporosis centers throughout the world. PARTICIPANTS: 447 women who had recently experienced menopause (6 to 36 months before study entry). INTERVENTION: Participants were randomly assigned...

  11. A conceptual framework and ethics analysis for prevention trials of Alzheimer Disease.

    Science.gov (United States)

    Peters, Kevin R; Lynn Beattie, B; Feldman, Howard H; Illes, Judy

    2013-11-01

    As our understanding of the neurobiology of Alzheimer Disease deepens, it has become evident that early intervention is critical to achieving successful therapeutic impact. The availability of diagnostic criteria for preclinical Alzheimer Disease adds momentum to research directed at this goal and even to prevention. The landscape of therapeutic research is thus poised to undergo a dramatic shift in the next 5-10 years, with clinical trials involving subjects at risk for Alzheimer Disease who have few or no symptoms. These trials will also likely rely heavily on genetics, biomarkers, and or risk factor stratification to identify individuals at risk for Alzheimer Disease. Here, we propose a conceptual framework to guide this next generation of pharmacological and non-pharmacological clinical pursuit, and discuss some of the foreseeable ethical considerations that may accompany them.

  12. Characterization of black raspberry functional food products for cancer prevention human clinical trials.

    Science.gov (United States)

    Gu, Junnan; Ahn-Jarvis, Jennifer H; Riedl, Kenneth M; Schwartz, Steven J; Clinton, Steven K; Vodovotz, Yael

    2014-05-07

    Our team is designing and fully characterizing black raspberry (BRB) food products suitable for long-term cancer prevention studies. The processing, scale-up, and storage effects on the consistency, quality, bioactive stability, and sensory acceptability of two BRB delivery systems of various matrices are presented. BRB dosage, pH, water activity, and texture were consistent in the scale-up production. Confections retained >90% of anthocyanins and ellagitannin after processing. Nectars had >69% of anthocyanins and >66% of ellagitannin retention, which varied with BRB dosage due to the processing difference. Texture remained unchanged during storage. BRB products consumed in a prostate cancer clinical trial were well accepted in sensory tests. Thus, this study demonstrates that two different BRB foods can be formulated to meet quality standards with a consistent bioactive pattern and successfully scaled up for a large human clinical trial focusing on cancer risk and other health outcomes.

  13. The evolution of preclinical Alzheimer’s disease: Implications for prevention trials

    Science.gov (United States)

    Sperling, Reisa; Mormino, Elizabeth; Johnson, Keith

    2014-01-01

    As the field begins to test the concept of preclinical neurodegenerative disease, the hypothetical stage of disease when the pathophysiological process has begun in the brain but clinical symptoms are not yet manifest, a number of intriguing questions have already arisen. In particular, in preclinical Alzheimer’s disease (AD), the temporal relationship of amyloid markers to markers of neurodegeneration and their relative utility in the prediction of cognitive decline among clinically normal older individuals remains to be fully elucidated. Secondary prevention trials in AD have already begun in both genetic-at-risk and amyloid-at-risk cohorts, with several more trials in the planning stages, that should provide critical answers about whether intervention at this very early stage of disease can truly bend the curve of clinical progression. PMID:25442939

  14. Contraceptive use in women enrolled into preventive HIV vaccine trials: experience from a phase I/II trial in East Africa.

    Directory of Open Access Journals (Sweden)

    Hannah Kibuuka

    Full Text Available BACKGROUND: HIV vaccine trials generally require that pregnant women are excluded from participation, and contraceptive methods must be used to prevent pregnancy during the trial. However, access to quality services and misconceptions associated with contraceptive methods may impact on their effective use in developing countries. We describe the pattern of contraceptive use in a multi-site phase I/IIa HIV Vaccine trial in East Africa (Uganda, Kenya and Tanzania and factors that may have influenced their use during the trial. METHODS: Pregnancy prevention counseling was provided to female participants during informed consent process and at each study visit. Participants' methods of contraception used were documented. Methods of contraceptives were provided on site. Pregnancy testing was done at designated visits during the trial. Obstacles to contraceptive use were identified and addressed at each visit. RESULTS: Overall, 103 (31.8% of a total of 324 enrolled volunteers were females. Female participants were generally young with a mean age of 29(+/-7.2, married (49.5% and had less than high school education (62.1%. Hormonal contraceptives were the most common method of contraception (58.3% followed by condom use (22.3%. The distribution of methods of contraception among the three sites was similar except for more condom use and less abstinence in Uganda. The majority of women (85.4% reported to contraceptive use prior to screening. The reasons for not using contraception included access to quality services, insufficient knowledge of certain methods, and misconceptions. CONCLUSION: Although hormonal contraceptives were frequently used by females participating in the vaccine trial, misconceptions and their incorrect use might have led to inconsistent use resulting in undesired pregnancies. The study underscores the need for an integrated approach to pregnancy prevention counseling during HIV vaccine trials. TRIAL REGISTRATION: ClinicalTrials

  15. Viral linkage in HIV-1 seroconverters and their partners in an HIV-1 prevention clinical trial.

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    Mary S Campbell

    Full Text Available BACKGROUND: Characterization of viruses in HIV-1 transmission pairs will help identify biological determinants of infectiousness and evaluate candidate interventions to reduce transmission. Although HIV-1 sequencing is frequently used to substantiate linkage between newly HIV-1 infected individuals and their sexual partners in epidemiologic and forensic studies, viral sequencing is seldom applied in HIV-1 prevention trials. The Partners in Prevention HSV/HIV Transmission Study (ClinicalTrials.gov #NCT00194519 was a prospective randomized placebo-controlled trial that enrolled serodiscordant heterosexual couples to determine the efficacy of genital herpes suppression in reducing HIV-1 transmission; as part of the study analysis, HIV-1 sequences were examined for genetic linkage between seroconverters and their enrolled partners. METHODOLOGY/PRINCIPAL FINDINGS: We obtained partial consensus HIV-1 env and gag sequences from blood plasma for 151 transmission pairs and performed deep sequencing of env in some cases. We analyzed sequences with phylogenetic techniques and developed a Bayesian algorithm to evaluate the probability of linkage. For linkage, we required monophyletic clustering between enrolled partners' sequences and a Bayesian posterior probability of ≥ 50%. Adjudicators classified each seroconversion, finding 108 (71.5% linked, 40 (26.5% unlinked, and 3 (2.0% indeterminate transmissions, with linkage determined by consensus env sequencing in 91 (84%. Male seroconverters had a higher frequency of unlinked transmissions than female seroconverters. The likelihood of transmission from the enrolled partner was related to time on study, with increasing numbers of unlinked transmissions occurring after longer observation periods. Finally, baseline viral load was found to be significantly higher among linked transmitters. CONCLUSIONS/SIGNIFICANCE: In this first use of HIV-1 sequencing to establish endpoints in a large clinical trial, more than

  16. A worksite prevention program for construction workers: design of a randomized controlled trial

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    Proper Karin I

    2010-06-01

    Full Text Available Abstract Background A worksite prevention program was developed to promote the work ability of construction workers and thereby prolong a healthy working life. The objective of this paper is to present the design of a randomized controlled trial evaluating the effectiveness of that intervention program compared with usual care for construction workers. Methods The study is designed as a randomized controlled trial with a follow-up of one year. Employees eligible for this study are construction workers performing actual construction work. The worksite intervention will be compared with usual care. This intervention was developed by using the Intervention Mapping approach and consists of the following components: (1 two individual training sessions of a physical therapist to lower the physical workload, (2 a Rest-Break tool to improve the balance between work and recovery, and (3 two empowerment training sessions to increase the influence of the construction workers at the worksite. Outcome measures are assessed at baseline, 3, 6, and 12 months. The primary outcome measures of this study are work ability and health-related quality of life. Secondary outcome measures include need for recovery, musculoskeletal complaints, work engagement and self efficacy. Cost-effectiveness will be evaluated from the company perspective. Moreover, a process evaluation will be conducted. Discussion The feasibility of the intervention and the study has been enhanced by creating an intervention program that explicitly appeals to construction workers and will not interfere too much with the ongoing construction. The feasibility and effectiveness of this worksite prevention program will be investigated by means of an effect- and a process evaluation. If proven effective, this worksite prevention program can be implemented on a larger scale within the construction industry. Trial Registration NTR1278

  17. The exploitation of "Exploitation" in the tenofovir prep trial in Cameroon: Lessons learned from media coverage of an HIV prevention trial.

    Science.gov (United States)

    Mack, Natasha; Robinson, Elizabeth T; MacQueen, Kathleen M; Moffett, Jill; Johnson, Laura M

    2010-06-01

    media coverage influences how clinical trials are perceived internationally and in communities where trials occur, affecting recruitment, retention, and political support for research. We conducted a discourse analysis of news coverage from 2004-2005 of a trial in Cameroon on oral PrEP for HIV prevention, to identify messages, communication techniques, and sources of messages that were amplified via media. We identified two parallel discourses: one on ethical concerns about the Cameroon trial, and a second, more general "science exploitation" discourse concerned with the potential for trials with vulnerable participant populations to be conducted unethically, benefiting only wealthy populations. Researchers should overtly address exploitation as an integral, ongoing component of research, particularly where historical or cultural conditions set the stage for controversy to emerge.

  18. The PAV trial: Does lactobacillus prevent post-antibiotic vulvovaginal candidiasis? Protocol of a randomised controlled trial [ISRCTN24141277

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    Hurley Susan

    2004-03-01

    Full Text Available Abstract Background Complementary and alternative medicines are used by many consumers, and increasingly are being incorporated into the general practitioner's armamentarium. Despite widespread usage, the evidence base for most complementary therapies is weak or non-existent. Post-antibiotic vulvovaginitis is a common problem in general practice, for which complementary therapies are often used. A recent study in Melbourne, Australia, found that 40% of women with a past history of vulvovaginitis had used probiotic Lactobacillus species to prevent or treat post-antibiotic vulvovaginitis. There is no evidence that this therapy is effective. This study aims to test whether oral or vaginal lactobacillus is effective in the prevention of post-antibiotic vulvovaginitis. Methods/design A randomised placebo-controlled blinded 2 × 2 factorial design is being used. General practitioners or pharmacists approach non-pregnant women, aged 18–50 years, who present with a non-genital infection requiring a short course of oral antibiotics, to participate in the study. Participants are randomised in a four group factorial design either to oral lactobacillus powder or placebo and either vaginal lactobacillus pessaries or placebo. These interventions are taken while on antibiotics and for four days afterwards or until symptoms of vaginitis develop. Women self collect a vaginal swab for culture of Candida species and complete a survey at baseline and again four days after completing their study medications. The sample size (a total of 496 – 124 in each factorial group is calculated to identify a reduction of half in post-antibiotic vulvovaginitis from 23%, while allowing for a 25% drop-out. An independent Data Monitoring Committee is supervising the trial. Analysis will be intention-to-treat, with two pre-specified main comparisons: (i oral lactobacillus versus placebo and (ii vaginal lactobacillus versus placebo.

  19. Clinical Trial Design for Testing the Stem Cell Model for the Prevention and Treatment of Cancer

    Energy Technology Data Exchange (ETDEWEB)

    Reddy, Rishindra M., E-mail: reddyrm@med.umich.edu [Medical Center, University of Michigan, 1500 E. Medical Center Drive, 2120 Taubman Center, Ann Arbor, MI 48109 (United States); Kakarala, Madhuri; Wicha, Max S. [Comprehensive Cancer Center, University of Michigan, 1500 E. Medical Center Drive, Ann Arbor, MI 48109 (United States)

    2011-06-20

    The cancer stem cell model introduces new strategies for the prevention and treatment of cancers. In cancers that appear to follow the stem cell model, pathways such as Wnt, Notch and Hedgehog may be targeted with natural compounds such as curcumin or drugs to reduce the risk of initiation of new tumors. Disease progression of established tumors could also potentially be inhibited by targeting the tumorigenic stem cells alone, rather than aiming to reduce overall tumor size. These new approaches mandate a change in the design of clinical trials and biomarkers chosen for efficacy assessment for preventative, neoadjuvant, adjuvant, and palliative treatments. Cancer treatments could be evaluated by assessing stem cell markers before and after treatment. Targeted stem cell specific treatment of cancers may not result in “complete” or “partial” responses radiologically, as stem cell targeting may not reduce the tumor bulk, but eliminate further tumorigenic potential. These changes are discussed using breast, pancreatic, and lung cancer as examples.

  20. A community intervention trial of multimodal suicide prevention program in Japan: A Novel multimodal Community Intervention program to prevent suicide and suicide attempt in Japan, NOCOMIT-J

    Directory of Open Access Journals (Sweden)

    Suzuki Yuriko

    2008-09-01

    Full Text Available Abstract Background To respond to the rapid surge in the incidence of suicide in Japan, which appears to be an ongoing trend, the Japanese Multimodal Intervention Trials for Suicide Prevention (J-MISP have launched a multimodal community-based suicide prevention program, NOCOMIT-J. The primary aim of this study is to examine whether NOCOMIT-J is effective in reducing suicidal behavior in the community. Methods/DesignThis study is a community intervention trial involving seven intervention regions with accompanying control regions, all with populations of statistically sufficient size. The program focuses on building social support networks in the public health system for suicide prevention and mental health promotion, intending to reinforce human relationships in the community. The intervention program components includes a primary prevention measures of awareness campaign for the public and key personnel, secondary prevention measures for screening of, and assisting, high-risk individuals, after-care for individuals bereaved by suicide, and other measures. The intervention started in July 2006, and will continue for 3.5 years. Participants are Japanese and foreign residents living in the intervention and control regions (a total of population of 2,120,000 individuals. Discussion The present study is designed to evaluate the effectiveness of the community-based suicide prevention program in the seven participating areas. Trial registration UMIN Clinical Trials Registry (UMIN-CTR UMIN000000460.

  1. Biomedical problems of hydrotechnical construction

    Energy Technology Data Exchange (ETDEWEB)

    Avakyan, A.B.; El' piner, L.I.; Delitsyn, V.M.

    1988-04-01

    The effect of hydrotechnical and water-management construction on the living conditions and health of the population was examined. The results were used to develop the scientific bases and methods of biomedical predictions in several stages: evaluating biomedical conditions in territories where a change is expected, and constructing biomedical prediction proper of the effect of hydrotechnical constructions. The development of the indicated predictions make it possible to include measures on intensifying the positive and preventing or abating undesired effects on the biomedical situation when designing hydrotechnical and water-management construction.

  2. Synbiotic for Prevention of Antibiotic-Associated Diarrhea in Children: A Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    SA Jafari

    2014-04-01

    Full Text Available Introduction: Antibiotic- associated diarrhea is a common problem in pediatric population. There is growing interest in probiotics, probiotics and synbiotics for prevention of this complication because of their worldwide availability as dietary supplements. The aim of this study was to assess the efficacy of a synbiotic mixture in prevention of antibiotic- associated diarrhea.   Materials and Methods:  In this randomized controlled  trial,  218 patients ( 111 in the synbiotic and 107 in the placebo group aged 6 months to 14 years with respiratory tract infection and/ or otitis media who needed antibiotic treatment in outpatient setting, were enrolled. They received 1 billion Colony Forming Unit of seven probiotics species plus Fructooligosaccharide in form of powder  or placebo ( matched for size, shape, and volume for 7 days. Amoxicillin, Amoxicillin-clavalanic acid, cefixim and Azithromicin were the most common drugs used by physcicians Mothers recorded stool frequency and consistency daily for 7 days.   Results: We found no significant difference (P>0.05 in occurrence of diarrhea between synbiotic and placebo groups.   Conclusion: This synbiotic mixture did not appear to reduce antibiotic- associated diarrhea in children. Further studies are needed to investigate the potential benefits of Synbiotics in prevention of this disease.    Keywords:  Antibiotic-Associated Diarrhea, Prevention, Synbiotic.

  3. From trials to the public health: pre-exposure prophylaxis for HIV prevention

    Directory of Open Access Journals (Sweden)

    Esper Kallas

    2013-03-01

    Full Text Available Two million two hundred thousand adults were newly HIV-infected in 2011, underscoring the urgent need for new, effective ways to prevent incident infections. Recently, the field of HIV prevention has gathered positive results from different strategies, among different populations, and with varying effect sizes, including the treatment of HIV-positive women and men in discordant couples, male circumcision of HIV-negative men in sub-Saharan Africa, a HIV vaccine evaluated in a community-based trial among HIV-negative men and women in Thailand, the use of vaginal gel formulation of TDF for HIV prevention in women in South Africa, pre-exposure prophylaxis (PrEP with tenofovir disoproxil fumarate (TDF or emtricitabine and TDF (TDF-FTC among HIV-1-serodiscordant heterosexual couples from Kenya and Uganda, and PrEP with TDF-FTC among heterosexual men and women in Africa. Of these interventions, PrEP is an attractive policy because it does not directly interferes with the sexual intercourse, providing people a choice on HIV prevention regardless of cultural, religious, or social harnesses.

  4. Preventing Obesity in the Military Community (POMC: The Development of a Clinical Trials Research Network

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    Elena A. Spieker

    2015-01-01

    Full Text Available Obesity impacts the U.S. military by affecting the health and readiness of active duty service members and their families. Preventing Obesity in Military Communities (POMC is a comprehensive research program within Patient Centered Medical Homes (PCMHs in three Military Training Facilities. This paper describes three pilot randomized controlled trials that target critical high risk periods for unhealthy weight gain from birth to young adulthood: (1 pregnancy and early infancy (POMC-Mother-Baby, (2 adolescence (POMC-Adolescent, and (3 the first tour of duty after boot camp (POMC-Early Career. Each study employs a two-group randomized treatment or prevention program with follow up. POMC offers a unique opportunity to bring together research and clinical expertise in obesity prevention to develop state-of-the-art programs within PCMHs in Military Training Facilities. This research builds on existing infrastructure that is expected to have immediate clinical benefits to DoD and far-reaching potential for ongoing collaborative work. POMC may offer an economical approach for widespread obesity prevention, from conception to young adulthood, in the U.S. military as well as in civilian communities.

  5. Cyproheptadine for prevention of neuropsychiatric adverse effects of efavirenz: a randomized clinical trial.

    Science.gov (United States)

    Dabaghzadeh, Fatemeh; Ghaeli, Padideh; Khalili, Hossein; Alimadadi, Abbas; Jafari, Sirous; Akhondzadeh, Shahin; Khazaeipour, Zahra

    2013-03-01

    Cyproheptadine prevention of the neuropsychiatric adverse effects of an antiretroviral regimen including efavirenz has been evaluated in a randomized clinical trial. Twenty-five patients (16 males and 9 females with mean±SD ages of 36±9 years) in a cyproheptadine group, and 26 patients (17 males and 9 females with mean±SD ages of 34±7 years) in a control group completed the trial. Sexual contact and injection drug use were the main routs of HIV infection in both groups. The patients' neuropsychiatric adverse effects were evaluated based on the Hamilton Depression Rating Scale, Hamilton Anxiety Rating Scale, Positive and Negative Syndrome Scale, Beck Depression Scale, Pittsburgh Sleep Quality Inventory, Positive and Negative Suicide Ideation, and Somatization Subscale of Symptom Checklist 90 at baseline and 4 weeks after treatment. Cyproheptadine significantly decreased the scores of Hamilton Depression Rating Scale, Hamilton Anxiety Rating Scale, Positive and Negative Syndrome Scale, Beck Depression Scale, Pittsburgh Sleep Quality Inventory, Positive and Negative Suicide Ideation of the patients after 4 weeks in comparison with control group. All of the scores increased in control group following antiretroviral therapy. Although short duration of the patients' follow-up was a major limitation of the study, the results of the study showed that cyprohepradine is effective in prevention of depression, anxiety, hallucination, aggressive behaviors, emotional withdrawal, poor rapport, poor impulse control, active social avoidance, suicidal ideation, and improved sleep quality of HIV-positive patients after initiation of antiretroviral therapy including efavirenz.

  6. Whole of Systems Trial of Prevention Strategies for Childhood Obesity: WHO STOPS Childhood Obesity

    Directory of Open Access Journals (Sweden)

    Steven Allender

    2016-11-01

    Full Text Available Background: Community-based initiatives show promise for preventing childhood obesity. They are characterized by community leaders and members working together to address complex local drivers of energy balance. Objectives: To present a protocol for a stepped wedge cluster randomized trial in ten communities in the Great South Coast Region of Victoria, Australia to test whether it is possible to: (1 strengthen community action for childhood obesity prevention, and (2 measure the impact of increased action on risk factors for childhood obesity. Methods: The WHO STOPS intervention involves a facilitated community engagement process that: creates an agreed systems map of childhood obesity causes for a community; identifies intervention opportunities through leveraging the dynamic aspects of the system; and, converts these understandings into community-built, systems-oriented action plans. Ten communities will be randomized (1:1 to intervention or control in year one and all communities will be included by year three. The primary outcome is childhood obesity prevalence among grade two (ages 7–8 y, grade four (9–10 y and grade six (11–12 y students measured using our established community-led monitoring system (69% school and 93% student participation rate in government and independent schools. An additional group of 13 external communities from other regions of Victoria with no specific interventions will provide an external comparison. These communities will also allow us to assess diffusion of the intervention to control communities during the first three years of the trial. Conclusion: This trial will test effectiveness, over a five-year period, of community-owned, -supported and -led strategies designed to address complex and dynamic causes of childhood obesity.

  7. Principles of Biomedical Agriculture Applied to the Plant Family Theaceae To Identify Novel Interventions for Cancer Prevention and Control.

    Science.gov (United States)

    Wang, Yijun; Yang, Yunqiu; Wei, Chaoling; Wan, Xiaochun; Thompson, Henry J

    2016-04-13

    Plant materials from the family Theaceae have been used for over a thousand years as integral components within the food systems of many globally distributed cultures and to treat a variety of human ailments. These markedly different uses remain of considerable interest in the 21st century. This perspective draws heavily from the agricultural and biomedical literature published using plant materials from the genus Camellia. Our objective is to provide a rationale and framework for broadening the scope of investigation of genera and species within Theaceae beyond Camellia sinensis to accelerate the development of a new generation of Theaceae-based pharmaceuticals/nutraceuticals and the more general enhancement of the food supply with Theaceae-containing products that affect the development of chronic diseases such as cancer. This will require a concerted effort to systematically capitalize on the rapidly growing knowledge of germplasm resources within Theaceae using metabolomic profiling in combination with in vivo and in vitro approaches. The successful translation of this research into products that affect human health will be facilitated by recognition of the agronomic factors that are critical in making hot water infusions generically referred to as tea as well as food products containing ground leaf powders.

  8. Climbing for preventing and treating health problems: a systematic review of randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Fechtelpeter, Dennis

    2011-01-01

    Full Text Available Objective: To summarize the best available evidence on effectiveness of therapeutic or sport climbing in preventing or treating health problems. Methods: We searched Medline, Embase, CENTRAL, PsycINFO, PEDro, OTseeker and SportDiscus for randomized controlled trials published up to December 26, 2010. We included all trials assessing patient-relevant outcomes. Two reviewers independently selected relevant studies, assessed their methodological quality and extracted data. Quality of evidence was rated using the GRADE system. Data were entered into RevMan 5 to calculate effect sizes and 95% confidence intervals where appropriate.Results: Eligible for inclusion were four RCTs studying the effectiveness of climbing in (a geriatric patients, (b adults with multiple sclerosis, (c adults with chronic low-back pain and (d children with disabilities and poor motor function. The sample sizes ranged between 20 and 95. All trials had major methodological limitations. We found very low quality evidence that therapeutic climbing may improve activities of daily living in geriatric patients compared to physiotherapy as measured by the Barthel index (difference in mean change score: 2.32 [95%-CI: 0.45 to 4.19]. We found very low quality evidence that therapeutic climbing compared to standard exercise therapy may improve physical functioning (difference in mean change score: 16.15 [95%-CI: 4.45 to 27.85] and general physical health (13.14 [95%-CI: 3.61 to 22.67] as measured by the SF-36 in adults with chronic low back-pain. Conclusions: Evidence for the effectiveness of therapeutic climbing is limited to small trials at high risk of bias. The effects of therapeutic climbing are therefore unclear.

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

    OpenAIRE

    Tompson, AC; Petit-Zeman, S; Goldacre, B.; Heneghan, CJ

    2016-01-01

    Objectives To audit the proportion of clinical trials that had been publically registered and, of the completed trials, the proportion published. Setting 2 major research institutions supported by the National Institute of Health Research (NIHR). Primary and secondary outcome measures The proportion of trials reporting results within 12 months, 24 months and ‘ever’. Factors associated with non-publication were analysed using logistic regression. Inclusion criteria Phases 2–4 clinical trials i...

  10. A randomized controlled trial to prevent glycemic relapse in longitudinal diabetes care: Study protocol (NCT00362193

    Directory of Open Access Journals (Sweden)

    Davis Dianne

    2006-10-01

    Full Text Available Abstract Background Diabetes is a common disease with self-management a key aspect of care. Large prospective trials have shown that maintaining glycated hemoglobin less than 7% greatly reduces complications but translating this level of control into everyday clinical practice can be difficult. Intensive improvement programs are successful in attaining control in patients with type 2 diabetes, however, many patients experience glycemic relapse once returned to routine care. This early relapse is, in part, due to decreased adherence in self-management behaviors. Objective This paper describes the design of the Glycemic Relapse Prevention study. The purpose of this study is to determine the optimal frequency of maintenance intervention needed to prevent glycemic relapse. The primary endpoint is glycemic relapse, which is defined as glycated hemoglobin greater than 8% and an increase of 1% from baseline. Methods The intervention consists of telephonic contact by a nurse practitioner with a referral to a dietitian if indicated. This intervention was designed to provide early identification of self-care problems, understanding the rationale behind the self-care lapse and problem solve to find a negotiated solution. A total of 164 patients were randomized to routine care (least intensive, routine care with phone contact every three months (moderate intensity or routine care with phone contact every month (most intensive. Conclusion The baseline patient characteristics are similar across the treatment arms. Intervention fidelity analysis showed excellent reproducibility. This study will provide insight into the important but poorly understood area of glycemic relapse prevention.

  11. Synbiotic for Prevention of Antibiotic-Associated Diarrhea in Children: A Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Seyed Ali Jafari

    2014-01-01

    Full Text Available Introduction Antibiotic- associated diarrhea is a common problem in pediatric population. There is growing interest in probiotics, probiotics and synbiotics for prevention of this complication because of their worldwide availability as dietary supplements. The aim of this study was to assess the efficacy of a synbiotic mixture in prevention of antibiotic- associated diarrhea.   Materials and Methods:  In this randomized controlled  trial,  218 patients ( 111 in the synbiotic and 107 in the placebo group aged 6 months to 14 years with respiratory tract infection and/ or otitis media who needed antibiotic treatment in outpatient setting, were enrolled. They received 1 billion Colony Forming Unit of seven probiotics species plus Fructooligosaccharide in form of powder  or placebo ( matched for size, shape, and volume for 7 days. Amoxicillin, Amoxicillin-clavalanic acid, cefixim and Azithromicin were the most common drugs used by physcicians Mothers recorded stool frequency and consistency daily for 7 days.   Results: We found no significant difference (P>0.05 in occurrence of diarrhea between synbiotic and placebo groups.   Conclusion: This synbiotic mixture did not appear to reduce antibiotic- associated diarrhea in children. Further studies are needed to investigate the potential benefits of Synbiotics in prevention of this disease.  

  12. Community Trial on Heat Related-Illness Prevention Behaviors and Knowledge for the Elderly

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    Noriko Takahashi

    2015-03-01

    Full Text Available This study aims to explore whether broadcasting heat health warnings (HHWs, to every household and whether the additional home delivery of bottled water labeled with messages will be effective in improving the behaviors and knowledge of elderly people to prevent heat-related illness. A community trial on heat-related-illness-prevention behaviors and knowledge for people aged between 65 and 84 years was conducted in Nagasaki, Japan. Five hundred eight subjects were selected randomly from three groups: heat health warning (HHW, HHW and water delivery (HHW+W, and control groups. Baseline and follow-up questionnaires were conducted in June and September 2012, respectively. Of the 1524 selected subjects, the 1072 that completed both questionnaires were analyzed. The HHW+W group showed improvements in nighttime AC use (p = 0.047, water intake (p = 0.003, cooling body (p = 0.002 and reduced activities in heat (p = 0.047 compared with the control, while the HHW group improved hat or parasol use (p = 0.008. An additional effect of household water delivery was observed in water intake (p = 0.067 and cooling body (p = 0.095 behaviors. HHW and household bottled water delivery improved heat-related-illness-prevention behaviors. The results indicate that home water delivery in addition to a HHW may be needed to raise awareness of the elderly.

  13. Improving the outcome of infants born at <30 weeks' gestation - a randomized controlled trial of preventative care at home

    Directory of Open Access Journals (Sweden)

    Orton Jane

    2009-12-01

    Full Text Available Abstract Background Early developmental interventions to prevent the high rate of neurodevelopmental problems in very preterm children, including cognitive, motor and behavioral impairments, are urgently needed. These interventions should be multi-faceted and include modules for caregivers given their high rates of mental health problems. Methods/Design We have designed a randomized controlled trial to assess the effectiveness of a preventative care program delivered at home over the first 12 months of life for infants born very preterm ( Discussion This paper presents the background, study design and protocol for a randomized controlled trial in very preterm infants utilizing a preventative care program in the first year after discharge home designed to improve cognitive, motor and behavioral outcomes of very preterm children and caregiver mental health at two-years' corrected age. Clinical Trial Registration Number ACTRN12605000492651

  14. The Outcome of Selenium and Vitamin E Cancer Prevention Trial (SELECT) reveals the need for better understanding of selenium biology.

    Science.gov (United States)

    Hatfield, Dolph L; Gladyshev, Vadim N

    2009-02-01

    The recently completed Selenium and Vitamin E Cancer Prevention Trial (SELECT) was one of the largest human cancer prevention trials ever undertaken. Its purpose was to assess the role of selenium and vitamin E in prostate cancer prevention, but SELECT found no decline in prostate cancer. Comparison of this study to other clinical trials involving selenium and to the results of animal studies suggests that the source of the selenium supplement, L-selenomethionine, and the relatively high initial levels of selenium in the enrolled men may have contributed to this outcome. Further analysis of the clinical and animal data highlights the need for mechanistic studies to better understand selenium biology in order to target dietary selenium to appropriate subsets of the human population: those individuals most likely to benefit from this micronutrient.

  15. Prevention of low back pain in female eldercare workers: randomized controlled work site trial

    DEFF Research Database (Denmark)

    Jensen, Lone Donbæk; Gonge, Henrik Gjesing; Jørs, Erik

    2006-01-01

    Study Design. Randomized controlled trial. Objective. To evaluate the effectiveness of an ergonomic and psychosocial intervention in reducing low back pain (LBP) among health care workers. Summary of Background Data. LBP and injuries are reported frequently among health care workers worldwide......, stress management, or reference arm. A total of 163 individuals (79% of the source population) participated in both baseline and follow-up after 2 years. Outcome was intra-individual change in rating of LBP during the past 3 and 12 months. Results. We found no difference in LBP in any of the intervention...... arms over the study period. Conclusion. The study showed no effect of a transfer technique or stress management program targeting LBP. Thus, there is a need for discussing other priorities in the prevention of LBP among health care workers....

  16. Prevention of depression in patients with acute coronary syndrome (DECARD) randomized trial

    DEFF Research Database (Denmark)

    Hjorthøj, Carsten Rygaard; Hansen, Baiba Hedegaard; Hanash, Jamal Abed

    2015-01-01

    AIM: Escitalopram may prevent depression following acute coronary syndrome. We sought to estimate the effects of escitalopram on self-reported health and to identify subgroups with higher efficacy. METHODS: This is a secondary analysis of a 12-month double-blind clinical trial randomizing non......-depressed acute coronary syndrome patients to escitalopram (n = 120) or matching placebo (n = 120). The main outcomes were mean scores on Short Form 36 Health Survey (SF-36) domains, and diagnosis of depression was adjusted for baseline SF-36 scores. RESULTS: Escitalopram did not yield different SF-36...... trajectories on any scale compared with placebo (P > 0.28). Efficacy of escitalopram may have been better among those scoring at least the normative score on general health perceptions (hazard ratio (HR) for depression 0.17 (95% confidence interval 0.02-1.42) ) or social functioning (HR = 0.12 (0...

  17. Initiating and continuing behaviour change within a weight gain prevention trial: a qualitative investigation.

    Directory of Open Access Journals (Sweden)

    Samantha Kozica

    Full Text Available Preventing obesity is an international health priority. In Australia, young women who live in rural communities are at high risk of unhealthy weight gain. Interventions which engage young women and support sustainable behaviour change are needed and comprehensive evaluation of such interventions generates knowledge for population scale-up. This qualitative sub-study aims to identify enablers and barriers to behaviour change initiation and continuation within a community weight gain prevention program.In-depth semi-structured interviews were conducted with program participants 6 months after baseline. All interviews were audio-taped and transcribed verbatim. Transcripts were analysed independently by two investigators via thematic analysis.A total of 28 women with a mean age of 39.9±6.2years and a BMI of 28.6±5.2kg/m2 were purposively recruited from the larger cohort (n = 649 that participated in the prevention trial.Four behaviour change groups emerged were identified from participant interviews: (i no change, (ii relapse, (iii intermittent and (iv continued change. Factors influencing behaviour change initiation and continuation included realistic program expectations and the participant's ability to apply the core program elements including: setting small, achievable behaviour change goals, problem solving and using self-management techniques. Personal knowledge, skills, motivation, self-efficacy, accountability and perceived social and environmental barriers also affected behaviour change. Satisfaction with personal program progress and the perceived amount of program supports required to achieve ongoing behaviour change varied amongst participants. Women who relapsed expressed a desire for more intensive and regular support from health professionals, identified more barriers unrelated to the program, anticipated significant weight loss and had lower satisfaction with their progress.Initiating and continuing behaviour change is a complex

  18. A Randomized trial comparing ticlopidine with aspirin fof the prevention of ischemic cerebral stroke

    Institute of Scientific and Technical Information of China (English)

    Li Yizhao; Li Danian; Wang Lei

    2000-01-01

    OBJECTIVE To assess the effect and cafety of t iclopidine in the prevention of ischemic cerebral stroke and to compare theeffect of low-dose aspirin with t iclopidine. BACKGROUND The effect and safety of ticlopidine irn the prevention of ischemic cerebral stroke in China has not been reported. METHODS 329 patients with TIA or mild ischemic cevebral stroke wasrandonmly assigned to ticlopidine group(165 case) or aspirin group (164 case) in this study.These patrents were randomly allocated to receive either 250mg trclopidine or 50mg aspirin daily and didnd take any other platelet antiaggregating drugs. Time of eacn follow up visit was one to two months. Follow up lasted for 6 to 18 months. RESULTS The event rate for stroke or death from any cause was 8.3% in ticlopidine group arid 14.9% in aspirin group. This repesented a risk reduction of 44.3%(95% cofidence interval, 0.29-0.94) for ticiopidine group as compared with aspirin group. The event raite for ischemic cerebral stroke or myocarction of ticlopidine group(7.0%)was lower than that cf aspirin group(14.8%)(P<0.05).A riskreduction of 52.7%(95% confidence interval,0.24-0.92) for ticlopidine group compared with aspirin group. The rate of adverse effects of ticlopidine group and aspirin group were 6.9% and 11.0% during the trial ,but this was not statistically significant(P<0.05).DISCUSSION and CONCLUSION Therapeutic efficacy for the prevention oi ischemic stroke of ticlopidine was better than that of aspirin, the rate of side effects in ticlopidine group and aspirin group are not statistically significant. So ticiopidine could serve as a first-line drug for the prevention of ischemic stroke.

  19. Surgical mask to prevent influenza transmission in households: a cluster randomized trial.

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    Laetitia Canini

    Full Text Available BACKGROUND: Facemasks and respirators have been stockpiled during pandemic preparedness. However, data on their effectiveness for limiting transmission are scarce. We evaluated the effectiveness of facemask use by index cases for limiting influenza transmission by large droplets produced during coughing in households. METHODOLOGY AND PRINCIPAL FINDINGS: A cluster randomized intervention trial was conducted in France during the 2008-2009 influenza season. Households were recruited during a medical visit of a household member with a positive rapid influenza A test and symptoms lasting less than 48 hours. Households were randomized either to the mask or control group for 7 days. In the intervention arm, the index case had to wear a surgical mask from the medical visit and for a period of 5 days. The trial was initially intended to include 372 households but was prematurely interrupted after the inclusion of 105 households (306 contacts following the advice of an independent steering committee. We used generalized estimating equations to test the association between the intervention and the proportion of household contacts who developed an influenza-like illness during the 7 days following the inclusion. Influenza-like illness was reported in 24/148 (16.2% of the contacts in the intervention arm and in 25/158 (15.8% of the contacts in the control arm and the difference between arms was 0.40% (95%CI: -10% to 11%, P = 1.00. We observed a good adherence to the intervention. In various sensitivity analyses, we did not identify any trend in the results suggesting effectiveness of facemasks. CONCLUSION: This study should be interpreted with caution since the lack of statistical power prevents us to draw formal conclusion regarding effectiveness of facemasks in the context of a seasonal epidemic. TRIAL REGISTRATION: clinicaltrials.gov NCT00774774.

  20. Assessing program sustainability in an eating disorder prevention effectiveness trial delivered by college clinicians.

    Science.gov (United States)

    Rohde, Paul; Shaw, Heather; Butryn, Meghan L; Stice, Eric

    2015-09-01

    Sustainability of the Body Project, a dissonance-based selective eating disorder prevention program supported by efficacy and effectiveness trials, has not previously been examined. This mixed-methods study collected qualitative and quantitative data on training, supervision, and the intervention from 27 mental health clinicians from eight US universities who participated in an effectiveness trial and quantitative data on 2-year sustainability of program delivery. Clinicians, who were primarily masters-level mental health providers, had limited experience delivering manualized interventions. They rated the training and manual favorably, noting that they particularly liked the role-plays of session activities and intervention rationale, but requested more discussion of processes and group management issues. Clinicians were satisfied receiving emailed supervision based on videotape review. They reported enjoying delivering the Body Project but reported some challenges with the manualized format and time constraints. Most clinicians anticipated running more groups after the study ended but only four universities (50%) reported providing additional Body Project groups at the 1-year follow-up assessment and sustained delivery of the groups decreased substantially two years after study completion, with only one university (12%) continuing to deliver groups. The most commonly reported barriers for conducting additional groups were limited time and high staff turnover.

  1. Vaccines licensed and in clinical trials for the prevention of dengue.

    Science.gov (United States)

    Torresi, J; Ebert, G; Pellegrini, M

    2017-02-14

    Dengue has become a major global public health threat with almost half of the world's population living in at-risk areas. Vaccination would likely represent an effective strategy for the management of dengue disease in endemic regions, however to date there is only one licensed preventative vaccine for dengue infection. The development of a vaccine against dengue virus (DENV) has been hampered by an incomplete understanding of protective immune responses against DENV. The most clinically advanced dengue vaccine is the chimeric yellow fever-dengue vaccine (CYD) that employs the yellow fever virus 17D strain as the replication backbone (Chimerivax-DEN; CYD-TDV). This vaccine had an overall pooled protective efficacy of 65.6% but was substantially more effective against severe dengue and dengue hemorrhagic fever. Several other vaccine approaches have been developed including live attenuated chimeric dengue vaccines (DENVax and LAV Delta 30), DEN protein subunit V180 vaccine (DEN1-80E) and DENV DNA vaccines. These vaccines have been shown to be immunogenic in animals and also safe and immunogenic in humans. However, these vaccines are yet to progress to phase III trials to determine their protective efficacy against dengue. This review will summarize the details of vaccines that have progressed to clinical trials in humans.

  2. Evaluating implementation of a fire-prevention injury prevention briefing in children's centres: Cluster randomised controlled trial

    Science.gov (United States)

    Deave, Toity; Hawkins, Adrian; Kumar, Arun; Hayes, Mike; Cooper, Nicola; Watson, Michael; Ablewhite, Joanne; Coupland, Carol; Sutton, Alex; Majsak-Newman, Gosia; McDaid, Lisa; Goodenough, Trudy; Beckett, Kate; McColl, Elaine; Reading, Richard; Kendrick, Denise

    2017-01-01

    Background Many developed countries have high mortality rates for fire-related deaths in children aged 0–14 years with steep social gradients. Evidence-based interventions to promote fire safety practices exist, but the impact of implementing a range of these interventions in children’s services has not been assessed. We developed an Injury Prevention Briefing (IPB), which brought together evidence about effective fire safety interventions and good practice in delivering interventions; plus training and facilitation to support its use and evaluated its implementation. Methods We conducted a cluster randomised controlled trial, with integrated qualitative and cost-effectiveness nested studies, across four study sites in England involving children’s centres in disadvantaged areas; participants were staff and families attending those centres. Centres were stratified by study site and randomised within strata to one of three arms: IPB plus facilitation (IPB+), IPB only, usual care. IPB+ centres received initial training and facilitation at months 1, 3, and 8. Baseline data from children’s centres were collected between August 2011 and January 2012 and follow-up data were collected between June 2012 and June 2013. Parent baseline data were collected between January 2012 and May 2012 and follow-up data between May 2013 and September 2013. Data comprised baseline and 12 month parent- and staff-completed questionnaires, facilitation contact data, activity logs and staff interviews. The primary outcome was whether families had a plan for escaping from a house fire. Treatment arms were compared using multilevel models to account for clustering by children’s centre. Results 1112 parents at 36 children’s centres participated. There was no significant effect of the intervention on families’ possession of plans for escaping from a house fire (adjusted odds ratio (AOR) IPB only vs. usual care: 0.93, 95%CI 0.58, 1.49; AOR IPB+ vs. usual care 1.41, 95%CI 0.91, 2

  3. Biomedical photonics handbook biomedical diagnostics

    CERN Document Server

    Vo-Dinh, Tuan

    2014-01-01

    Shaped by Quantum Theory, Technology, and the Genomics RevolutionThe integration of photonics, electronics, biomaterials, and nanotechnology holds great promise for the future of medicine. This topic has recently experienced an explosive growth due to the noninvasive or minimally invasive nature and the cost-effectiveness of photonic modalities in medical diagnostics and therapy. The second edition of the Biomedical Photonics Handbook presents fundamental developments as well as important applications of biomedical photonics of interest to scientists, engineers, manufacturers, teachers, studen

  4. Simvastatin and Vitamin D for Migraine Prevention: A Randomized Controlled Trial

    Science.gov (United States)

    Buettner, Catherine; Nir, Rony-Reuven; Bertisch, Suzanne M.; Bernstein, Carolyn; Schain, Aaron; Mittleman, Murray A.; Burstein, Rami

    2015-01-01

    Objective To assess efficacy and tolerability of simvastatin plus vitamin D for migraine prevention in adults with episodic migraine. Methods We performed a randomized, double-blind, placebo-controlled trial with a 12-week baseline period and 24-week intervention period in 57 adults with episodic migraine. Participants were randomly assigned to simvastatin 20 mg tablets twice daily plus vitamin D3 1000 international units capsules twice daily or matching placebo tablets and capsules. Results Compared to placebo, participants using simvastatin plus vitamin D3 demonstrated a greater decrease in number of migraine days from the baseline period to intervention weeks 1-12: a change of -8.0 (IQR: -15.0 to -2.0) days in the active treatment group versus +1.0 (IQR: 1.0 to +6.0) days in the placebo group, Pmigraine days at 12 weeks and 9 (29%) at 24 weeks post randomization. In comparison, only 1 patient (3%) in the placebo group (p=0.03) experienced such reduction. Adverse events were similar in both active treatment and placebo groups. Interpretation The results demonstrate that simvastatin plus vitamin D is effective for prevention of headache in adults with episodic migraine. Given statins ability to repair endothelial dysfunction, this economical approach may also reduce the increased risk for vascular diseases among migraineurs. PMID:26418341

  5. Clinical Trial Design for Testing the Stem Cell Model for the Prevention and Treatment of Cancer

    Directory of Open Access Journals (Sweden)

    Max S. Wicha

    2011-06-01

    Full Text Available The cancer stem cell model introduces new strategies for the prevention and treatment of cancers. In cancers that appear to follow the stem cell model, pathways such as Wnt, Notch and Hedgehog may be targeted with natural compounds such as curcumin or drugs to reduce the risk of initiation of new tumors. Disease progression of established tumors could also potentially be inhibited by targeting the tumorigenic stem cells alone, rather than aiming to reduce overall tumor size. These new approaches mandate a change in the design of clinical trials and biomarkers chosen for efficacy assessment for preventative, neoadjuvant, adjuvant, and palliative treatments. Cancer treatments could be evaluated by assessing stem cell markers before and after treatment. Targeted stem cell specific treatment of cancers may not result in “complete” or “partial” responses radiologically, as stem cell targeting may not reduce the tumor bulk, but eliminate further tumorigenic potential. These changes are discussed using breast, pancreatic, and lung cancer as examples.

  6. Acupuncture for Preventing Complications after Radical Hysterectomy: A Randomized Controlled Clinical Trial

    Directory of Open Access Journals (Sweden)

    Wei-min Yi

    2014-01-01

    Full Text Available We aimed to investigate the preventive effects of acupuncture for complications after radical hysterectomy. A single-center randomized controlled single-blinded trial was performed in a western-style hospital in China. One hundred and twenty patients after radical hysterectomy were randomly allocated to two groups and started acupuncture from sixth postoperative day for five consecutive days. Sanyinjiao (SP6, Shuidao (ST28, and Epangxian III (MS4 were selected with electrical stimulation and Zusanli (ST36 without electrical stimulation for thirty minutes in treatment group. Binao (LI14 was selected as sham acupuncture point without any stimulation in control group. The main outcome measures were bladder function and prevalence of postoperative complications. Compared with control group, treatment group reported significantly improved bladder function in terms of maximal cystometric capacity, first voiding desire, maximal flow rate, residual urine, and bladder compliance, and decreased bladder sensory loss, incontinence, and urinary retention on fifteenth and thirtieth postoperative days. Treatment group showed significant advantage in reduction of urinary tract infection on thirtieth postoperative day. But no significant difference between groups was observed for lymphocyst formation. By improving postoperative bladder function, early intervention of acupuncture may provide a valuable alternative method to prevent bladder dysfunctional disorders and urinary tract infection after radical hysterectomy.

  7. Randomized cluster crossover trials for reliable, efficient, comparative effectiveness testing: design of the Prevention of Arrhythmia Device Infection Trial (PADIT).

    Science.gov (United States)

    Connolly, Stuart J; Philippon, Francois; Longtin, Yves; Casanova, Amparo; Birnie, David H; Exner, Derek V; Dorian, Paul; Prakash, Ratika; Alings, Marco; Krahn, Andrew D

    2013-06-01

    Randomized clinical trials are a major advance in clinical research methodology. However, there are myriad important questions about the effectiveness of treatments used in daily practice that are not informed by the results of randomized trials. This is in part because of important limitations inherent in the methodology of randomized efficacy trials which are performed with tight control of inclusion, exclusion, treatment, and follow-up. This approach enhances evaluation of clinical efficacy (performance in controlled situations) but increases complexity and is not well suited to test clinical effectiveness (performance under conditions of actual use). The cluster crossover trial is a new concept for efficient comparative effectiveness testing. Deep tissue infection occurs in 2% of patients after arrhythmia device implantation, usually requires system extraction, and increases mortality. There is variation in antibiotic prophylaxis used to reduce implanted device infections. To efficiently evaluate the comparative effectiveness of antibiotic strategies now in use, we designed a cluster crossover clinical trial, which randomized implanting centres to 1 of 2 prophylactic antibiotic strategies, which became the standard care at the centre for 6 months, followed by crossover to the other strategy, rerandomization, and second crossover. This method greatly reduces trial complexity because it aligns study procedures with usual clinical care and increases generalizability. Pilot studies have tested the feasibility and an 10,800-patient trial, funded by the Canadian Institutes of Health Research, is now under way. The cluster crossover randomized trial design is well suited to efficiently test comparative effectiveness of existing treatments where there is variability of practice, clinical equipoise, and minimal risk.

  8. Rationale, design, and baseline characteristics of a trial of prevention of cardiovascular and renal disease with Fosinopril and Pravastatin in nonhypertensive, nonhypercholesterolemic subjects with microalbuminuria (the Prevention of REnal and Vascular ENdstage Disease Intervention Trial [PREVEND IT])

    NARCIS (Netherlands)

    Diercks, GFH; Janssen, WMT; van Boven, AJ; Bak, AAA; de Jong, PE; Crijns, HJGM; van Gilst, WH

    2000-01-01

    This study describes the rationale, design, and baseline characteristics of a trial to determine whether treatment with fosinopril 20 mg/day and/or pravastatin 40 mg/day will prevent cardiovascular and renal disease in nonhypertensive (RR 10 mg/L once in an early morning spot urine and 15 to 300 mg/

  9. Can improving working memory prevent academic difficulties? a school based randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Anderson Peter

    2011-06-01

    Full Text Available Abstract Background Low academic achievement is common and is associated with adverse outcomes such as grade repetition, behavioural disorders and unemployment. The ability to accurately identify these children and intervene before they experience academic failure would be a major advance over the current 'wait to fail' model. Recent research suggests that a possible modifiable factor for low academic achievement is working memory, the ability to temporarily store and manipulate information in a 'mental workspace'. Children with working memory difficulties are at high risk of academic failure. It has recently been demonstrated that working memory can be improved with adaptive training tasks that encourage improvements in working memory capacity. Our trial will determine whether the intervention is efficacious as a selective prevention strategy for young children at risk of academic difficulties and is cost-effective. Methods/Design This randomised controlled trial aims to recruit 440 children with low working memory after a school-based screening of 2880 children in Grade one. We will approach caregivers of all children from 48 participating primary schools in metropolitan Melbourne for consent. Children with low working memory will be randomised to usual care or the intervention. The intervention will consist of 25 computerised working memory training sessions, which take approximately 35 minutes each to complete. Follow-up of children will be conducted at 6, 12 and 24 months post-randomisation through child face-to-face assessment, parent and teacher surveys and data from government authorities. The primary outcome is academic achievement at 12 and 24 months, and other outcomes include child behaviour, attention, health-related quality of life, working memory, and health and educational service utilisation. Discussion A successful start to formal learning in school sets the stage for future academic, psychological and economic well-being. If

  10. Preventing Weight Gain in Women in Rural Communities: A Cluster Randomised Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Catherine Lombard

    2016-01-01

    Full Text Available Obesity is reaching epidemic proportions in both developed and developing countries. Even modest weight gain increases the risk for chronic illness, yet evidence-based interventions to prevent weight gain are rare. This trial will determine if a simple low-intensity intervention can prevent weight gain in women compared to general health information.We conducted a 1-yr pragmatic, cluster randomised controlled trial in 41 Australian towns (clusters randomised using a computer-generated randomisation list for intervention (n = 21 or control (n = 20. Women aged 18 to 50 yr were recruited from the general population to receive a 1-yr self-management lifestyle intervention (HeLP-her consisting of one group session, monthly SMS text messages, one phone coaching session, and a program manual, or to a control group receiving one general women's health education session. From October 2012 to April 2014 we studied 649 women, mean age 39.6 yr (+/- SD 6.7 and BMI of 28.8 kg/m(2 (+/- SD 6.9 with the primary outcome weight change between groups at 1 yr. The mean change in the control was +0.44 kg (95% CI -0.09 to 0.97 and in the intervention group -0.48 kg (95% CI -0.99 to 0.03 with an unadjusted between group difference of -0.92 kg (95% CI -1.67 to -0.16 or -0.87 kg (95% CI -1.62 to -0.13 adjusted for baseline values and clustering. Secondary outcomes included improved diet quality and greater self-management behaviours. The intervention appeared to be equally efficacious across all age, BMI, income, and education subgroups. Loss to follow-up included 23.8% in the intervention group and 21.8% in the control group and was within the anticipated range. Limitations include lack of sensitive tools to measure the small changes to energy intake and physical activity. Those who gained weight may have been less inclined to return for 1 yr weight measures.A low intensity lifestyle program can prevent the persistent weight gain observed in women. Key features included

  11. Manual hyperinflation partly prevents reductions of functional residual capacity in cardiac surgical patients - a randomized controlled trial

    OpenAIRE

    Paulus, Frederique; Veelo, Denise P; Selma B. de Nijs; Beenen, Ludo FM; Bresser, Paul; de Mol, Bas AJM; Binnekade, Jan M; Schultz, Marcus J

    2011-01-01

    Introduction Cardiac surgery is associated with post-operative reductions of functional residual capacity (FRC). Manual hyperinflation (MH) aims to prevent airway plugging, and as such could prevent the reduction of FRC after surgery. The main purpose of this study was to determine the effect of MH on post-operative FRC of cardiac surgical patients. Methods This was a randomized controlled trial of patients after elective coronary artery bypass graft and/or valve surgery admitted to the inten...

  12. Universal School-Based Depression Prevention 'Op Volle Kracht': a Longitudinal Cluster Randomized Controlled Trial.

    Science.gov (United States)

    Tak, Yuli R; Lichtwarck-Aschoff, Anna; Gillham, Jane E; Van Zundert, Rinka M P; Engels, Rutger C M E

    2016-07-01

    The longitudinal effectiveness of a universal, adolescent school-based depression prevention program Op Volle Kracht (OVK) was evaluated by means of a cluster randomized controlled trial with intervention and control condition (school as usual). OVK was based on the Penn Resiliency Program (PRP) (Gillham et al. Psychological Science, 6, 343-351, 1995). Depressive symptoms were assessed with the Child Depression Inventory (Kovacs 2001). In total, 1341 adolescents participated, Mage = 13.91, SD = 0.55, 47.3 % girls, 83.1 % Dutch ethnicity; intervention group n = 655, four schools; control group n = 735, five schools. Intent-to-treat analyses revealed that OVK did not prevent depressive symptoms, β = -0.01, SE = 0.05, p = .829, Cohen's d = 0.02, and the prevalence of an elevated level of depressive symptoms was not different between groups at 1 year follow-up, OR = 1.00, 95 % CI = 0.60-1.65, p = .992, NNT = 188. Latent Growth Curve Modeling over the 2 year follow-up period showed that OVK did not predict differences in depressive symptoms immediately following intervention, intercept: β = 0.02, p = .642, or changes in depressive symptoms, slope: β = -0.01, p = .919. No moderation by gender or baseline depressive symptoms was found. To conclude, OVK was not effective in preventing depressive symptoms across the 2 year follow-up. The implications of these findings are discussed.

  13. Exploring barriers and facilitators to participation of male-to-female transgender persons in preventive HIV vaccine clinical trials.

    Science.gov (United States)

    Andrasik, Michele Peake; Yoon, Ro; Mooney, Jessica; Broder, Gail; Bolton, Marcus; Votto, Teress; Davis-Vogel, Annet

    2014-06-01

    Observed seroincidence and prevalence rates in male-to-female (MTF) transgender individuals highlight the need for effective targeted HIV prevention strategies for this community. In order to develop an effective vaccine that can be used by transgender women, researchers must understand and address existing structural issues that present barriers to this group's participation in HIV vaccine clinical trials. Overcoming barriers to participation is important for ensuring HIV vaccine acceptability and efficacy for the MTF transgender community. To explore barriers and facilitators to MTF transgender participation in preventive HIV vaccine clinical trials, the HIV Vaccine Trials Network conducted focus groups among transgender women in four urban areas (Atlanta, Boston, Philadelphia, and San Francisco). Barriers and facilitators to engagement of transgender women in preventive HIV vaccine clinical trials led to the following recommendations: (a) transgender cultural competency training, (b) creating trans-friendly environments, (c) true partnerships with local trans-friendly organizations and health care providers, (d) protocols that focus on transgender specific issues, and (e) data collection and tracking of transgender individuals. These results have implications for the conduct of HIV vaccine trials, as well as engagement of transgender women in research programs in general.

  14. Biomedical nanotechnology.

    Science.gov (United States)

    Hurst, Sarah J

    2011-01-01

    This chapter summarizes the roles of nanomaterials in biomedical applications, focusing on those highlighted in this volume. A brief history of nanoscience and technology and a general introduction to the field are presented. Then, the chemical and physical properties of nanostructures that make them ideal for use in biomedical applications are highlighted. Examples of common applications, including sensing, imaging, and therapeutics, are given. Finally, the challenges associated with translating this field from the research laboratory to the clinic setting, in terms of the larger societal implications, are discussed.

  15. Lack of effect of Tai Chi Chuan in preventing falls in elderly people living at home: a randomized clinical trial.

    NARCIS (Netherlands)

    Logghe, I.H.; Zeeuwe, P.E.; Verhagen, A.P.; Wijnen-Sponselee, R.M.; Willemsen, S.P.; Bierma-Zeinstra, S.M.; Rossum, E. van; Faber, M.J.; Faber, B.W.

    2009-01-01

    OBJECTIVES: To evaluate the effectiveness of Tai Chi Chuan in fall prevention in elderly people living at home with a high risk of falling. DESIGN: Randomized controlled trial. SETTING: Two industrial towns in the western part of the Netherlands. PARTICIPANTS: Two hundred sixty-nine elderly people (

  16. Cognitive behaviour therapy to prevent complicated grief among relatives and spouses bereaved by suicide: Csuster andomised controlled trial.

    NARCIS (Netherlands)

    Groot, M.; Keyser, de J.; Neeleman, J.; Kerkhof, A.J.F.M.; Nolen, W.; Burger, H.

    2007-01-01

    Objective To examine the effectiveness of a family based grief counselling programme to prevent complicated grief among first degree relatives and spouses of someone who had committed suicide. Design Cluster randomised controlled trial with follow-up at 13 months after the suicide. Setting General p

  17. Cognitive behaviour therapy to prevent complicated grief among relatives and spouses bereaved by suicide : cluster randomised controlled trial

    NARCIS (Netherlands)

    de Groot, M.; de Keijser, J.; Neeleman, J.; Kerkhof, A.; Nolen, W.; Burger, H.

    2007-01-01

    Objective To examine the effectiveness of a family based grief counselling programme to prevent complicated grief among first degree relatives and spouses of someone who had committed suicide. Design Cluster randomised controlled trial with follow-up at 13 months after the suicide. Setting General p

  18. Verapamil is Less Effective than Triamcinolone for Prevention of Keloid Scar Recurrence After Excision in a Randomized Controlled Trial

    DEFF Research Database (Denmark)

    Danielsen, Patricia L; Rea, Suzanne M; Wood, Fiona M;

    2016-01-01

    A double-blind randomized controlled trial with a paired split-scar design compared verapamil, an L-type Ca2+ channel antagonist, and triamcinolone for prevention of keloid recurrence after excision. Ca2+ channel blocking activity of verapamil in keloid cells was explored. One keloid was excised...

  19. The effectiveness of participatory ergonomics to prevent low-back and neck pain - results of a cluster randomized controlled trial

    NARCIS (Netherlands)

    Driessen, M.T.; Proper, K.I.; Anema, J.R.; Knol, D.L.; Bongers, P.M.; Beek, A.J. van der

    2011-01-01

    Objective The aim of this randomized controlled trial (RCT) was to investigate the effectiveness of the Stay@ Work participatory ergonomics (PE) program to prevent low-back and neck pain. Methods A total of 37 departments were randomly allocated to either the intervention (PE) or control group (no P

  20. The JUPITER and AURORA clinical trials for rosuvastatin in special primary prevention populations: perspectives, outcomes, and consequences

    Directory of Open Access Journals (Sweden)

    Venkata Narla

    2009-11-01

    Full Text Available Venkata Narla, Michael J Blaha, Roger S Blumenthal, Erin D MichosThe Ciccarone Preventive Cardiology Center, Division of Cardiology, Johns Hopkins University School of Medicine, Baltimore, MD, USAAbstract: Statins have emerged at the forefront of preventive cardiology and have significantly reduced cardiovascular events and mortality. Nonetheless, cardiovascular disease remains the leading cause of death in the United States and in other developed countries, as well as the etiology of significant morbidity and health-care expenditure. In an attempt to reduce potentially missed opportunities for instituting preventive therapy, the JUPITER study (Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin and the AURORA study (A Study to Evaluate the Use of Rosuvastatin in Subjects on Regular Hemodialysis: An Assessment of Survival and Cardiovascular Events examined the effect of statins in two specific patient populations who currently do not meet the guidelines for statin treatment, but nonetheless, are at high cardiovascular risk. This review outlines the JUPITER and AURORA trials, interprets the data and significance of the results, analyses the drawbacks and impact of both trials and delineates the potential for further clinical trials.Keywords: JUPITER, AURORA, rosuvastatin, cardiovascular disease

  1. Brief Cognitive-Behavioral Depression Prevention Program for High-Risk Adolescents Outperforms Two Alternative Interventions: A Randomized Efficacy Trial

    Science.gov (United States)

    Stice, Eric; Rohde, Paul; Seeley, John R.; Gau, Jeff M.

    2008-01-01

    In this depression prevention trial, 341 high-risk adolescents (mean age = 15.6 years, SD = 1.2) with elevated depressive symptoms were randomized to a brief group cognitive-behavioral (CB) intervention, group supportive-expressive intervention, bibliotherapy, or assessment-only control condition. CB participants showed significantly greater…

  2. Finasteride concentrations and prostate cancer risk: results from the Prostate Cancer Prevention Trial.

    Directory of Open Access Journals (Sweden)

    Cindy H Chau

    Full Text Available In the Prostate Cancer Prevention Trial (PCPT, finasteride reduced the risk of prostate cancer by 25%, even though high-grade prostate cancer was more common in the finasteride group. However, it remains to be determined whether finasteride concentrations may affect prostate cancer risk. In this study, we examined the association between serum finasteride concentrations and the risk of prostate cancer in the treatment arm of the PCPT and determined factors involved in modifying drug concentrations.Data for this nested case-control study are from the PCPT. Cases were drawn from men with biopsy-proven prostate cancer and matched controls. Finasteride concentrations were measured using a liquid chromatography-mass spectrometry validated assay. The association of serum finasteride concentrations with prostate cancer risk was determined by logistic regression. We also examine whether polymorphisms in the enzyme target and metabolism genes of finasteride are related to drug concentrations using linear regression.Among men with detectable finasteride concentrations, there was no association between finasteride concentrations and prostate cancer risk, low-grade or high-grade, when finasteride concentration was analyzed as a continuous variable or categorized by cutoff points. Since there was no concentration-dependent effect on prostate cancer, any exposure to finasteride intake may reduce prostate cancer risk. Of the twenty-seven SNPs assessed in the enzyme target and metabolism pathway, five SNPs in two genes, CYP3A4 (rs2242480; rs4646437; rs4986910, and CYP3A5 (rs15524; rs776746 were significantly associated with modifying finasteride concentrations. These results suggest that finasteride exposure may reduce prostate cancer risk and finasteride concentrations are affected by genetic variations in genes responsible for altering its metabolism pathway.ClinicalTrials.gov NCT00288106.

  3. Program of rehabilitative exercise and education to avert vascular events after non-disabling stroke or transient ischemic attack (PREVENT Trial: a multi-centred, randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Thompson Kara

    2010-12-01

    Full Text Available Abstract Background Despite lack of outward signs, most individuals after non-disabling stroke (NDS and transient ischemic attack (TIA have significant cardiovascular and cerebrovascular disease and are at high risk of a major stroke, hospitalization for other vascular events, or death. Most have multiple modifiable risk factors (e.g., hypertension, physical inactivity, hyperlipidaemia, diabetes, tobacco consumption, psychological stress. In addition, accelerated rates of depression, cognitive decline, and poor quality of sleep have been reported following TIA, which correlate with poor functional outcomes and reduced quality of life. Thus, NSD and TIA are important warning signs that should not be overlooked. The challenge is not unlike that facing other 'silent' conditions - to identify a model of care that is effective in changing people's current behaviors in order to avert further morbidity. Methods/Design A single blind, randomized controlled trial will be conducted at two sites to compare the effectiveness of a program of rehabilitative exercise and education versus usual care in modifying vascular risk factors in adults after NDS/TIA. 250 adults within 90 days of being diagnosed with NDS/TIA will be randomly allocated to a 12-week program of exercise and education (PREVENT or to an outpatient clinic assessment and discussion of secondary prevention recommendations with return clinic visits as indicated (USUAL CARE. Primary outcome measures will include blood pressure, waist circumference, 12-hour fasting lipid profile, and 12-hour fasting glucose/hemoglobin A1c. Secondary measures will include exercise capacity, walking endurance, physical activity, cognitive function, depression, goal attainment and health-related quality of life. Outcome assessment will be conducted at baseline, post-intervention, and 6- and 12-month follow-ups. Direct health care costs incurred over one year by PREVENT versus USUAL CARE participants will also be

  4. Preventing loss of independence through exercise (PLIE: a pilot clinical trial in older adults with dementia.

    Directory of Open Access Journals (Sweden)

    Deborah E Barnes

    Full Text Available 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.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.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.PLIÉ is a novel, integrative exercise program that shows promise for improving physical function, cognitive function, quality of life and caregiver burden in individuals with

  5. Dezocine for Preventing Postoperative Pain: A Meta-Analysis of Randomized Controlled Trials.

    Directory of Open Access Journals (Sweden)

    Xuelong Zhou

    Full Text Available Dezocine is considered to be an alternative medication for managing postoperative pain. The aim of this study was to assess the efficacy and safety of this drug in this regard.Medline, EMBASE and the Cochrane Central Register of Control Trials (CENTRAL were searched to identify all randomized controlled trials (RCTs that compare dezocine with placebo or dezocine with morphine on postoperative pain. The data were extracted and pooled using Mantel-Haenszel random effects model. Heterogeneity was tested using the I2 statistic with values >50% and Chi2 test with P ≤ 0.05 indicating obvious heterogeneity between the studies.Seven trials evaluating 665 patients were included. The number of patients with at least 50% pain relief was increased (N = 234; RR 3.04, 95% CI 2.27 to 4.08 and physician (N = 465; RR 2.84, 95% CI 1.66 to 4.84 and patient satisfaction (N = 390; RR 2.81, 95% CI 1.85 to 4.26 were improved following the administration of dezocine compared with the placebo. The effects of dezocine were similar to those of morphine in terms of the number of patients reporting at least 50% pain relief within 2-6 h after surgery (N = 235; RR 1.29, 95% CI 1.15 to 1.46 and physician (N = 234; RR 1.18, 95% CI 0.93 to 1.49 and patient (N = 158; RR 1.33, 95% CI 0.93 to 1.92 satisfaction. While, the number of patients with at least 50% pain relief within 0-1 h after surgery increased following dezocine compared with morphine treatment (N = 79; RR 1.45, 95% CI 1.18 to 1.77. There was no difference in the incidence of postoperative nausea and vomiting (PONV following dezocine treatment compared with the placebo (N = 391; RR 1.06, 95% CI 0.42 to 2.68 or morphine treatment (N = 235; RR 0.65, 95% CI 0.14 to 2.93.Dezocine is a promising analgesic for preventing postoperative pain, but further studies are required to evaluate its safety.

  6. [Biomedical activity of biosurfactants].

    Science.gov (United States)

    Krasowska, Anna

    2010-07-23

    Biosurfactants, amphiphilic compounds, synthesized by microorganisms have surface, antimicrobial and antitumor properties. Biosurfactants prevent adhesion and biofilms formation by bacteria and fungi on various surfaces. For many years microbial surfactants are used as antibiotics with board spectrum of activity against microorganisms. Biosurfactants act as antiviral compounds and their antitumor activities are mediated through induction of apoptosis. This work presents the current state of knowledge related to biomedical activity of biosurfactants.

  7. Biomedical Engineering

    CERN Document Server

    Suh, Sang C; Tanik, Murat M

    2011-01-01

    Biomedical Engineering: Health Care Systems, Technology and Techniques is an edited volume with contributions from world experts. It provides readers with unique contributions related to current research and future healthcare systems. Practitioners and researchers focused on computer science, bioinformatics, engineering and medicine will find this book a valuable reference.

  8. Biomedical Libraries

    Science.gov (United States)

    Pizer, Irwin H.

    1978-01-01

    Biomedical libraries are discussed as a distinct and specialized group of special libraries and their unique services and user interactions are described. The move toward professional standards, as evidenced by the Medical Library Association's new certification program, and the current state of development for a new section of IFLA established…

  9. Alternate-day fasting and chronic disease prevention: a review of human and animal trials.

    Science.gov (United States)

    Varady, Krista A; Hellerstein, Marc K

    2007-07-01

    Calorie restriction (CR) and alternate-day fasting (ADF) represent 2 different forms of dietary restriction. Although the effects of CR on chronic disease prevention were reviewed previously, the effects of ADF on chronic disease risk have yet to be summarized. Accordingly, we review here animal and human evidence concerning ADF and the risk of certain chronic diseases, such as type 2 diabetes, cardiovascular disease, and cancer. We also compare the magnitude of risk reduction resulting from ADF with that resulting from CR. In terms of diabetes risk, animal studies of ADF find lower diabetes incidence and lower fasting glucose and insulin concentrations, effects that are comparable to those of CR. Human trials to date have reported greater insulin-mediated glucose uptake but no effect on fasting glucose or insulin concentrations. In terms of cardiovascular disease risk, animal ADF data show lower total cholesterol and triacylglycerol concentrations, a lower heart rate, improved cardiac response to myocardial infarction, and lower blood pressure. The limited human evidence suggests higher HDL-cholesterol concentrations and lower triacylglycerol concentrations but no effect on blood pressure. In terms of cancer risk, there is no human evidence to date, yet animal studies found decreases in lymphoma incidence, longer survival after tumor inoculation, and lower rates of proliferation of several cell types. The findings in animals suggest that ADF may effectively modulate several risk factors, thereby preventing chronic disease, and that ADF may modulate disease risk to an extent similar to that of CR. More research is required to establish definitively the consequences of ADF.

  10. Internet-Based HIV Prevention With At-Home Sexually Transmitted Infection Testing for Young Men Having Sex With Men: Study Protocol of a Randomized Controlled Trial of Keep It Up! 2.0

    Science.gov (United States)

    Madkins, Krystal; Greene, George J; Parsons, Jeffrey T; Johnson, Brent A; Sullivan, Patrick; Bass, Michael; Abel, Rebekah

    2017-01-01

    Background Human immunodeficiency virus (HIV) infections are increasing among young men who have sex with men (YMSM), yet few HIV prevention programs have studied this population. Keep It Up! (KIU!), an online HIV prevention program tailored to diverse YMSM, was developed to fill this gap. The KIU! 2.0 randomized controlled trial (RCT) was launched to establish intervention efficacy. Objective The objective of the KIU! study is to advance scientific knowledge of technology-based behavioral HIV prevention, as well as improve public health by establishing the efficacy of an innovative electronic health (eHealth) prevention program for ethnically and racially diverse YMSM. The intervention is initiated upon receipt of a negative HIV test result, based on the theory that testing negative is a teachable moment for future prevention behaviors. Methods This is a two-group, active-control RCT of the online KIU! intervention. The intervention condition includes modules that use videos, animation, games, and interactive exercises to address HIV knowledge, motivation for safer behaviors, self-efficacy, and behavioral skills. The control condition reflects HIV information that is readily available on many websites, with the aim to understand how the KIU! intervention improves upon information that is currently available online. Follow-up assessments are administered at 3, 6, and 12 months for each arm. Testing for urethral and rectal sexually transmitted infections (STIs) is completed at baseline and at 12-month follow-up for all participants, and at 3- and 6-month follow-ups for participants who test positive at baseline. The primary behavioral outcome is unprotected anal sex at all follow-up points, and the primary biomedical outcome is incident STIs at 12-month follow-up. Results Consistent with study aims, the KIU! technology has been successfully integrated into a widely-used health technology platform. Baseline enrollment for the RCT was completed on December 30, 2015 (N

  11. Effect of probiotic preparation in preventing antibiotic associated diarrhea and colitis: a Clinical trial

    Directory of Open Access Journals (Sweden)

    Nader Zarinfar

    2014-08-01

    Full Text Available Background: Clostridium Difficile is the most common cause of antibiotic- associated diarrhea (AAD and antibiotic associated colitis (AAC in the hospital setting. In this Study, the preventive effect of Lactobacillus coagulance probiotic preparation was investigated on AAD and AAC. Material and Methods: In this double blind randomized clinical trial study, 300 patients under antibiotics treatment according to our inclusion and exclusion criteria were enrolled to the study and randomly divided into two groups, case (tab probiotic, 100mg/day and control group (placebo from initial antibiotic administration till one week after termination of antibiotic consumption. All patients were trained about the signs of diarrhea and colitis. Colitis signs, incidence of diarrhea and its culture findings for the presence of the toxin of Clostridium difficile were recorded and compared between groups. Data were analyzed with appropriate statistical tests and using version 16 of SPSS statistical software. Results: Antibiotic associated diarrhea (AAD was seen in 10 (6.6% and 16 (%10.6 patients of case and control group respectively. There was no significant difference between groups in AAD incidence and positive stool exam regarding the presence of Clostridium difficile toxin. Colitis syndrome were develop in 34 (22.8% and 86 (57% patients of the probiotic and placebo group respectively that was significantly low in case group (p<0.001. Conclusion: There was no statistically significant difference between probiotic group and placebo group in reducing AAD. But, consumption of Lactobacillus coagulance probiotic can reduce the incidence of antibiotic associated colitis.

  12. Aloe vera for prevention of radiation-induced dermatitis: a self-controlled clinical trial.

    Science.gov (United States)

    Haddad, P; Amouzgar-Hashemi, F; Samsami, S; Chinichian, S; Oghabian, M A

    2013-08-01

    To evaluate an Aloe vera lotion for prevention of radiation-induced dermatitis, all patients with a prescription of radiotherapy to a minimum dose of 40 Gy were eligible provided that their treatment area could be divided into two symmetrical halves. Patients were given a lotion of Aloe vera to use on one half of the irradiated area, with no medication to be used on the other half. The grade of dermatitis in each half was recorded weekly until 4 weeks after the end of radiotherapy. The trial enrolled 60 patients (mean age: 52 years; 67% women). Most patients had breast cancer (38%), followed by pelvic (32%), head-and-neck (22%), and other cancers (8%). Field size was 80-320 cm(2) (mean: 177 cm(2)), and the dose of radiotherapy was 40-70 Gy (mean: 54 Gy). Concurrent chemotherapy was administered in 20 patients. From week 4 to week 6 of radiotherapy and then at weeks 2 and 4 after radiotherapy, the mean grade of dermatitis with and without Aloe vera was 0.81 and 1.10 (p Aloe vera reduces the intensity of radiationinduced dermatitis.

  13. Effectiveness and moderators of the preventive intervention kids in divorce situations: A randomized controlled trial.

    Science.gov (United States)

    Pelleboer-Gunnink, Hannah A; Van der Valk, Inge E; Branje, Susan J T; Van Doorn, Muriel D; Deković, Maja

    2015-10-01

    Children of divorced parents have an increased risk of a variety of problems in comparison to children from intact families. Therefore, several intervention programs have been developed directed at children of divorced parents. Yet, empirical data on the effectiveness of these interventions are limited. This study evaluated the school-based, child-directed prevention program Kids In Divorce Situations (KIDS) using a randomized controlled trial. The sample consisted of 156 children randomly assigned at the school level into an experimental (80 children) and control condition (76 children). In addition, 131 mothers and 76 fathers participated in the study. Four assessments took place: a pretest, a posttest, and two follow-up assessments conducted 6 months and 1 year after finishing KIDS. Latent growth analyses demonstrated that the intervention significantly reduced child-reported emotional problems and enhanced child-reported communication with the father and mother-reported communication with the child. The effect sizes ranged from .30-.63. Few moderation effects of gender, time since divorce, or perceived parental conflict on the intervention effects were found. After parental divorce, a limited school-based intervention for children can be efficacious in promoting children's emotional well-being and parent-child communication.

  14. An open trial of videoconference-mediated exposure and ritual prevention for obsessive-compulsive disorder.

    Science.gov (United States)

    Goetter, Elizabeth M; Herbert, James D; Forman, Evan M; Yuen, Erica K; Thomas, J Graham

    2014-06-01

    The gold-standard treatment for OCD is exposure and ritual prevention (ERP), yet despite its well-established efficacy, only a small percentage of OCD patients have access to this treatment. Remote treatments (e.g., videoconferencing) are becoming increasingly popular avenues for treatment delivery and show promise in increasing patient access to evidence-based mental health care. The current pilot study utilized an open trial to examine the feasibility and preliminary efficacy of videoconference-mediated, twice weekly, ERP for adults (n=15) with OCD. Results revealed that ERP was associated with significant improvements in OCD symptoms and large within-group effect sizes. Among the 10 individuals who completed a 3-month follow-up assessment, 30% of participants no longer met DSM-IV-TR criteria for OCD and 80% of participants were rated as very much or much improved on the CGI. This study adds to the growing body of literature suggesting that videoconference-based interventions are viable alternatives to face-to-face treatment.

  15. Randomized controlled trial of a brief dyadic cognitive-behavioral intervention designed to prevent PTSD

    Directory of Open Access Journals (Sweden)

    Alain Brunet

    2013-08-01

    Full Text Available Background : There is a dearth of effective interventions to prevent the development of post-traumatic stress disorder (PTSD. Method : We evaluated the efficacy of a brief dyadic two-session cognitive-behavioral intervention through a controlled trial involving trauma-exposed individuals recruited at the hospital's emergency room. Participants were randomly assigned to either the dyadic intervention group (n=37 or to a waiting list (assessment only group (n=37. Results : In an intent-to-treat analysis, a time-by-group interaction was found, whereby the treated participants had less PTSD symptoms at the post-treatment but not at the pre-treatment compared to controls. Controlling for the improvement observed in the control participants, the intervention yielded a net effect size of d=0.39. Conclusions : A brief, early, and effective intervention can be provided by nurses or social workers in hospital settings, at a fairly low cost to individuals presenting to the emergency room as the result of trauma exposure.

  16. Relation of depression to perceived social support: results from a randomized adolescent depression prevention trial.

    Science.gov (United States)

    Stice, Eric; Rohde, Paul; Gau, Jeff; Ochner, Chris

    2011-05-01

    Theorists posit that certain behaviors exhibited by depressed individuals (e.g., negative self-statements, dependency, reassurance seeking, inappropriate or premature disclosures, passivity, social withdrawal) reduce social support, yet there have been few experimental tests of this hypothesis. Using data from a randomized depression prevention trial (N=253) involving adolescents (M age=15.5, SD=1.2), we tested whether a cognitive behavioral group intervention that significantly reduced depressive symptoms relative to bibliotherapy and educational brochure control conditions through 2-year follow-up produced improvements in perceived parental and friend social support and whether change in depressive symptoms mediated the effect on change in social support. Cognitive behavioral group participants showed significantly greater increases in perceived friend social support through 1-year follow-up relative to bibliotherapy and brochure controls, but there were no significant effects for perceived parental support. Further, change in depressive symptoms appeared to mediate the effects of the intervention on change in perceived friend support. Results provide experimental support for the theory that depressive symptoms are inversely related to perceived social support, but imply that this effect may be specific to friend vs. parental support for adolescents.

  17. Low Vision Depression Prevention Trial in Age-Related Macular Degeneration

    Science.gov (United States)

    Rovner, Barry W.; Casten, Robin J.; Hegel, Mark T.; Massof, Robert W.; Leiby, Benjamin E.; Ho, Allen C.; Tasman, William S.

    2014-01-01

    Purpose To compare the efficacy of behavior activation (BA) + low vision rehabilitation (LVR) with supportive therapy (ST) + LVR to prevent depressive disorders in patients with age-related macular degeneration (AMD). Design Single-masked, attention-controlled, randomized, clinical trial with outcome assessment at 4 months. Participants Patients with AMD and subsyndromal depressive symptoms attending retina practices (n = 188). Interventions Before randomization, all subjects had 2 outpatient LVR visits, and were then randomized to in-home BA+LVR or ST+LVR. Behavior activation is a structured behavioral treatment that aims to increase adaptive behaviors and achieve valued goals. Supportive therapy is a nondirective, psychological treatment that provides emotional support and controls for attention. Main Outcome Measures The Diagnostic and Statistical Manual IV defined depressive disorder based on the Patient Health Questionnaire-9 (primary outcome), Activities Inventory, National Eye Institute Vision Function Questionnaire–25 plus Supplement (NEI-VFQ), and NEI-VFQ quality of life (secondary outcomes). Results At 4 months, 11 BA+LVR subjects (12.6%) and 18 ST+LVR subjects (23.4%) developed a depressive disorder (relative risk [RR], 0.54; 95% CI, 0.27–1.06; P = 0.067). In planned adjusted analyses the RR was 0.51 (95% CI, 0.27–0.98; P = 0.04). A mediational analysis suggested that BA+LVR prevented depression to the extent that it enabled subjects to remain socially engaged. In addition, BA+LVR was associated with greater improvements in functional vision than ST+LVR, although there was no significant between-group difference. There was no significant change or between-group difference in quality of life. Conclusions An integrated mental health and low vision intervention halved the incidence of depressive disorders relative to standard outpatient LVR in patients with AMD. As the population ages, the number of persons with AMD and the adverse effects of comorbid

  18. Evaluating a selective prevention programme for binge drinking among young adolescents: study protocol of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Wiers Reinout

    2011-02-01

    Full Text Available Abstract Background In comparison to other Europe countries, Dutch adolescents are at the top in drinking frequency and binge drinking. A total of 75% of the Dutch 12 to 16 year olds who drink alcohol also engage in binge drinking. A prevention programme called Preventure was developed in Canada to prevent adolescents from binge drinking. This article describes a study that aims to assess the effects of this selective school-based prevention programme in the Netherlands. Methods A randomized controlled trial is being conducted among 13 to 15-year-old adolescents in secondary schools. Schools were randomly assigned to the intervention and control conditions. The intervention condition consisted of two 90 minute group sessions, carried out at the participants' schools and provided by a qualified counsellor and a co-facilitator. The intervention targeted young adolescents who demonstrated personality risk for alcohol abuse. The group sessions were adapted to four personality profiles. The control condition received no further intervention above the standard substance use education sessions provided in the Dutch national curriculum. The primary outcomes will be the percentage reduction in binge drinking, weekly drinking and drinking-related problems after three specified time periods. A screening survey collected data by means of an Internet questionnaire. Students have completed, or will complete, a post-treatment survey after 2, 6, and 12 months, also by means of an online questionnaire. Discussion This study protocol presents the design and current implementation of a randomized controlled trial to evaluate the effectiveness of a selective alcohol prevention programme. We expect that a significantly lower number of adolescents will binge drink, drink weekly, and have drinking-related problems in the intervention condition compared to the control condition, as a result of this intervention. Trial registration This trial is registered in the Dutch

  19. A network meta-analysis on randomized trials focusing on the preventive effect of statins on contrast-induced nephropathy

    DEFF Research Database (Denmark)

    Peruzzi, Mariangela; De Luca, Leonardo; Thomsen, Henrik S;

    2014-01-01

    Contrast-induced nephropathy is a common complication of iodinated contrast administration. Statins may reduce the risk of contrast-induced nephropathy, but data remain inconclusive. We summarized the evidence based on statins for the prevention of contrast-induced nephropathy with a network meta......-analysis. Randomized trials focusing on statins were searched and pooled with random-effect odds ratios. A total of 14 trials (6,160 patients) were included, focusing on atorvastatin (high/low dose), rosuvastatin (high dose), simvastatin (high/low dose), and placebo or no statin therapy before contrast administration...

  20. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... Usually, trial participants must show signs of the disease or condition before they can join this type of trial. Prevention Trials Click for more information In prevention trials, ...

  1. Tuberculosis control in South African gold mines: mathematical modeling of a trial of community-wide isoniazid preventive therapy.

    Science.gov (United States)

    Vynnycky, Emilia; Sumner, Tom; Fielding, Katherine L; Lewis, James J; Cox, Andrew P; Hayes, Richard J; Corbett, Elizabeth L; Churchyard, Gavin J; Grant, Alison D; White, Richard G

    2015-04-15

    A recent major cluster randomized trial of screening, active disease treatment, and mass isoniazid preventive therapy for 9 months during 2006-2011 among South African gold miners showed reduced individual-level tuberculosis incidence but no detectable population-level impact. We fitted a dynamic mathematical model to trial data and explored 1) factors contributing to the lack of population-level impact, 2) the best-achievable impact if all implementation characteristics were increased to the highest level achieved during the trial ("optimized intervention"), and 3) how tuberculosis might be better controlled with additional interventions (improving diagnostics, reducing treatment delay, providing isoniazid preventive therapy continuously to human immunodeficiency virus-positive people, or scaling up antiretroviral treatment coverage) individually and in combination. We found the following: 1) The model suggests that a small proportion of latent infections among human immunodeficiency virus-positive people were cured, which could have been a key factor explaining the lack of detectable population-level impact. 2) The optimized implementation increased impact by only 10%. 3) Implementing additional interventions individually and in combination led to up to 30% and 75% reductions, respectively, in tuberculosis incidence after 10 years. Tuberculosis control requires a combination prevention approach, including health systems strengthening to minimize treatment delay, improving diagnostics, increased antiretroviral treatment coverage, and effective preventive treatment regimens.

  2. Ankles back in randomized controlled trial (ABrCt: braces versus neuromuscular exercises for the secondary prevention of ankle sprains. Design of a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Verhagen Evert ALM

    2011-09-01

    Full Text Available Abstract Background Ankle sprains are the most common sports and physical activity related injury. There is extensive evidence that there is a twofold increased risk for injury recurrence for at least one year post injury. In up to 50% of all cases recurrences result in disability and lead to chronic pain or instability, requiring prolonged medical care. Therefore ankle sprain recurrence prevention in athletes is essential. This RCT evaluates the effect of the combined use of braces and neuromuscular training (e.g. proprioceptive training/sensorimotor training/balance training against the individual use of either braces or neuromuscular training alone on ankle sprain recurrences, when applied to individual athletes after usual care. Methods/Design This study was designed as three way randomized controlled trial with one year follow-up. Healthy individuals between 12 and 70 years of age, who were actively participating in sports and who had sustained a lateral ankle sprain in the two months prior to inclusion, were eligible for inclusion. After subjects had finished ankle sprain treatment by means of usual care, they were randomised to any of the three study groups. Subjects in group 1 received an eight week neuromuscular training program, subjects in group 2 received a sports brace to be worn during all sports activities for the duration of one year, and group 3 received a combination of the neuromuscular training program and a sports brace to be worn during all sports activities for the duration of eight weeks. Outcomes were assessed at baseline and every month for 12 months therafter. The primary outcome measure was incidence of ankle sprain recurrences. Secondary outcome measures included the direct and indirect costs of recurrent injury, the severity of recurrent injury, and the residual complaints during and after the intervention. Discussion The ABrCt is the first randomized controlled trial to directly compare the secondary preventive

  3. Biomedical Materials

    Institute of Scientific and Technical Information of China (English)

    CHANG Jiang; ZHOU Yanling

    2011-01-01

    @@ Biomedical materials, biomaterials for short, is regarded as "any substance or combination of substances, synthetic or natural in origin, which can be used for any period of time, as a whole or as part of a system which treats, augments, or replaces any tissue, organ or function of the body" (Vonrecum & Laberge, 1995).Biomaterials can save lives, relieve suffering and enhance the quality of life for human being.

  4. Metabolic syndrome in Finnish women 7 years after a gestational diabetes prevention trial

    Science.gov (United States)

    Puhkala, Jatta; Raitanen, Jani; Kolu, Päivi; Tuominen, Pipsa; Husu, Pauliina; Luoto, Riitta

    2017-01-01

    Background Risk for developing metabolic syndrome (MeS) after delivery is high among women with gestational diabetes mellitus (GDM), but little is known about development of MeS among women with risk factors for GDM during pregnancy. In the present study, we studied the prevalence of MeS 7 years postpartum among women with GDM risk factors during pregnancy, women with early GDM diagnosis and women without GDM risk factors. We also analysed the early pregnancy risk factors associated with MeS. Methods A Finnish cluster randomised controlled GDM prevention trial was conducted in 2007–2009. The prevalence of MeS according to International Diabetes Federation criteria was determined in the follow-up study 7 years after original trial. Eligible participants (n=289) in 4 study groups (intervention (n=83) and usual care (n=87) with GDM risk factors; early GDM (n=51), and healthy control without GDM risk factors (n=68)) were evaluated for MeS. Binary logistic regression models were used to analyse risk factors associated with MeS. Results 7 years postpartum, the MeS prevalence was 14% (95% CI 8% to 25%) in the intervention group; 15% (CI 8% to 25%) in the usual care group; 50% (CI 35% to 65%) in the early GDM group and 7% (CI 2% to 18%) in the healthy control group. OR for MeS in women with GDM risk factors did not differ from the healthy control group. Body mass index (BMI)-adjusted OR for MeS was 9.18 (CI 1.82 to 46.20) in the early GDM group compared with the healthy control group. Increased prepregnancy BMI was associated with MeS (OR, 1.17, CI 1.08 to 1.28, adjusted for group). Conclusions Increased prepregnancy BMI and early GDM diagnosis were the strongest risk factors for developing MeS 7 years postpartum. Overweight and obese women and especially those with early GDM should be monitored and counselled for cardiometabolic risk factors after delivery. PMID:28298369

  5. A Trial of Calcium and Vitamin D for the Prevention of Colorectal Adenomas

    Science.gov (United States)

    Baron, John A.; Barry, Elizabeth L.; Mott, Leila A.; Rees, Judy R.; Sandler, Robert S.; Snover, Dale C.; Bostick, Roberd M.; Ivanova, Anastasia; Cole, Bernard F.; Ahnen, Dennis J.; Beck, Gerald J.; Bresalier, Robert S.; Burke, Carol A.; Church, Timothy R.; Cruz-Correa, Marcia; Figueiredo, Jane C.; Goodman, Michael; Kim, Adam S.; Robertson, Douglas J.; Rothstein, Richard; Shaukat, Aasma; Seabrook, March E.; Summers, Robert W.

    2015-01-01

    BACKGROUND Epidemiologic and preclinical data suggest that higher intake and serum levels of vitamin D and higher intake of calcium reduce the risk of colorectal neoplasia. To further study the chemopreventive potential of these nutrients, we conducted a randomized, double-blind, placebo-controlled trial of supplementation with vitamin D, calcium, or both for the prevention of colorectal adenomas. METHODS We recruited patients with recently diagnosed adenomas and no known colorectal polyps remaining after complete colonoscopy. We randomly assigned 2259 participants to receive daily vitamin D3 (1000 IU), calcium as carbonate (1200 mg), both, or neither in a partial 2×2 factorial design. Women could elect to receive calcium plus random assignment to vitamin D or placebo. Follow-up colonoscopy was anticipated to be performed 3 or 5 years after the baseline examinations, according to the endoscopist’s recommendation. The primary end point was adenomas diagnosed in the interval from randomization through the anticipated surveillance colonoscopy. RESULTS Participants who were randomly assigned to receive vitamin D had a mean net increase in serum 25-hydroxyvitamin D levels of 7.83 ng per milliliter, relative to participants given placebo. Overall, 43% of participants had one or more adenomas diagnosed during follow-up. The adjusted risk ratios for recurrent adenomas were 0.99 (95% confidence interval [CI], 0.89 to 1.09) with vitamin D versus no vitamin D, 0.95 (95% CI, 0.85 to 1.06) with calcium versus no calcium, and 0.93 (95% CI, 0.80 to 1.08) with both agents versus neither agent. The findings for advanced adenomas were similar. There were few serious adverse events. CONCLUSIONS Daily supplementation with vitamin D3 (1000 IU), calcium (1200 mg), or both after removal of colorectal adenomas did not significantly reduce the risk of recurrent colorectal adenomas over a period of 3 to 5 years. (Funded by the National Cancer Institute; ClinicalTrials.gov number, NCT

  6. A typology of structural approaches to HIV prevention

    OpenAIRE

    Tsai, Alexander C

    2012-01-01

    Renewed enthusiasm for biomedical HIV prevention strategies has followed the recent publication of several high-profile HIV antiretroviral therapy-based HIV prevention trials. In a recent article, Roberts & Matthews (2012) accurately note some of the shortcomings of these individually targeted approaches to HIV prevention and advocate for increased emphasis on structural interventions that have more fundamental effects on the population distribution of HIV. However, they make some implicit as...

  7. Primary HPV screening for cervical cancer prevention: results from European trials

    DEFF Research Database (Denmark)

    Lynge, Elsebeth; Rebolj, Matejka

    2009-01-01

    for each extra detected CIN2+ case; although, in another trial, this number was 49 in women > or =35 years of age. The outcome of HPV testing versus cytological testing depends not only on the relative accuracy of the primary test but also on how radical the different triage procedures are. In two trials......Six European, randomized, controlled trials that will compare human papillomavirus (HPV) testing with cytological testing for cervical screening are under way. We reviewed the results published so far to compare the benefits and costs for participating women. At baseline screening, use of HPV...... testing increased the detection of cervical intraepithelial neoplasia (CIN) grade 2+. Detection of CIN3+ was significantly increased in two trials (relative risks [RRs] 1.70 and 2.26), but not in three other trials (RRs 1.03, 1.09 and 1.31). In three trials, seven extra women had a false-positive test...

  8. A typology of practice narratives during the implementation of a preventive, community intervention trial

    Directory of Open Access Journals (Sweden)

    Hawe Penelope

    2009-12-01

    Full Text Available Abstract Background Traditional methods of process evaluation encompass what components were delivered, but rarely uncover how practitioners position themselves and act relative to an intervention being tested. This could be crucial for expanding our understanding of implementation and its contribution to intervention effectiveness. Methods We undertook a narrative analysis of in-depth, unstructured field diaries kept by nine community development practitioners for two years. The practitioners were responsible for implementing a multi-component, preventive, community-level intervention for mothers of new babies in eight communities, as part of a cluster randomised community intervention trial. We constructed a narrative typology of approaches to practice, drawing on the phenomenology of Alfred Schutz and Max Weber's Ideal Type theory. Results Five types of practice emerged, from a highly 'technology-based' type that was faithful to intervention specifications, through to a 'romantic' type that held relationships to be central to daily operations, with intact relationships being the final arbiter of intervention success. The five types also differed in terms of how others involved in the intervention were characterized, the narrative form (e.g., tragedy, satire and where and how transformative change in communities was best created. This meant that different types traded-off or managed the priorities of the intervention differently, according to the deeply held values of their type. Conclusions The data set constructed for this analysis is unique. It revealed that practitioners not only exercise their agency within interventions, they do so systematically, that is, according to a pattern. The typology is the first of its kind and, if verified through replication, may have value for anticipating intervention dynamics and explaining implementation variation in community interventions.

  9. Prevention of Bone Loss with Risedronate in Breast Cancer Survivors: A Randomized, Controlled Clinical Trial

    Science.gov (United States)

    Greenspan, Susan L.; Vujevich, Karen T.; Brufsky, Adam; Lembersky, Barry C.; van Londen, G.J.; Jankowitz, Rachel C.; Puhalla, Shannon L.; Rastogi, Priya; Perera, Subashan

    2016-01-01

    Purpose Aromatase inhibitors (AIs), adjuvant endocrine therapy for postmenopausal women with hormone receptor positive breast cancer, are associated with bone loss and fractures. Our objectives were to determine if 1) oral bisphosphonate therapy can prevent bone loss in women on an AI and, 2) early changes in bone turnover markers (BTM) can predict later changes in bone mineral density (BMD). Methods We conducted a 2 year double-blind, placebo-controlled, randomized trial in 109 postmenopausal women with low bone mass on an aromatase inhibitor (AI-anastrozole, letrozole, or exemestane) for hormone receptor positive breast cancer. Participants were randomized to once weekly risedronate 35 mg or placebo and all received calcium plus vitamin D. The main outcome measures included BMD, BTM [carboxy-terminal collagen crosslinks (CTX) and N-terminal propeptide of type 1 procollagen (P1NP)] and safety. Results Eighty-seven percent completed 24 months. BMD increased more in the active treatment group compared to placebo with an adjusted difference at 24 months of 3.9 ± 0.7 percentage points at the spine and 3.2 ± 0.5 percentage points at the hip (both p<0.05). The adjusted difference between the active treatment and placebo groups were 0.09 ± 0.04 nmol/LBCE for CTX and 23.3 ± 4.8 µg/mL for P1NP (both p<0.05). Women with greater 12-month decreases in CTX and P1NP in the active treatment group had a greater 24-month increase in spinal BMD (p<0.05). The oral therapy was safe and well tolerated. Conclusion In postmenopausal women with low bone mass and breast cancer on an AI, the oral bisphosphonate risedronate maintained skeletal health. PMID:25792492

  10. Aspirin plus calcium supplementation to prevent superimposed preeclampsia: a randomized trial.

    Science.gov (United States)

    Souza, E V; Torloni, M R; Atallah, A N; Santos, G M S dos; Kulay, L; Sass, N

    2014-05-01

    Preeclampsia is an important cause of maternal and perinatal morbidity and mortality. Previous studies have tested calcium supplementation and aspirin separately to reduce the incidence of preeclampsia but not the effects of combined supplementation. The objective of this study was to investigate the effectiveness of aspirin combined with calcium supplementation to prevent preeclampsia in women with chronic hypertension. A double-blind, placebo-controlled randomized clinical trial was carried out at the antenatal clinic of a large university hospital in São Paulo, SP, Brazil. A total of 49 women with chronic hypertension and abnormal uterine artery Doppler at 20-27 weeks gestation were randomly assigned to receive placebo (N = 26) or 100 mg aspirin plus 2 g calcium (N = 23) daily until delivery. The main outcome of this pilot study was development of superimposed preeclampsia. Secondary outcomes were fetal growth restriction and preterm birth. The rate of superimposed preeclampsia was 28.6% lower among women receiving aspirin plus calcium than in the placebo group (52.2 vs 73.1%, respectively, P=0.112). The rate of fetal growth restriction was reduced by 80.8% in the supplemented group (25 vs 4.8% in the placebo vs supplemented groups, respectively; P=0.073). The rate of preterm birth was 33.3% in both groups. The combined supplementation of aspirin and calcium starting at 20-27 weeks of gestation produced a nonsignificant decrease in the incidence of superimposed preeclampsia and fetal growth restriction in hypertensive women with abnormal uterine artery Doppler.

  11. Vitamin E for prevention of oxaliplatin-induced peripheral neuropathy: a pilot randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Samuel Oliveira de Afonseca

    Full Text Available CONTEXT AND OBJECTIVEOxaliplatin is one of the chemotherapy regimens most used for treating colorectal cancer. One of the main limitations to its use is induction of peripheral neuropathy. Previous studies have shown that vitamin E can reduce the incidence of peripheral neuropathy by 50%. This study aimed to assess the effectiveness of vitamin E for prevention of oxaliplatin-induced peripheral neuropathy.DESIGN AND SETTINGProspective, phase II, randomized pilot study developed at a university hospital in the Greater ABC region.METHODSPatients were randomized five days before starting oxaliplatin treatment, to receive either vitamin E or placebo until the end of the chemotherapy regimen. The outcome was evaluated using the Common Terminology Criteria for Adverse Events (CTCAE, version 3, and specific gradation scales for oxaliplatin-induced peripheral neuropathy. Patients with colorectal and gastric cancer who had been scheduled to receive oxaliplatin-based chemotherapy were included. Both groups received calcium and magnesium supplementation before and after oxaliplatin infusions.RESULTSEighteen patients were randomized to the vitamin E group and 16 to the placebo group. Cumulative incidence of 83% with peripheral neuropathy grades 1/2 was observed in the vitamin E group, versus 68% in the placebo group (P = 0.45. A trend towards more diarrhea was observed among patients who received vitamin E (55.6% vs. 18.8%; P = 0.06. There were no other significant differences in toxicity between the groups.CONCLUSIONSNo significant decrease in the incidence of acute oxaliplatin-induced peripheral neuropathy was demonstrated through vitamin E use.CLINICAL TRIAL REGISTRATIONNCT01523574.

  12. An interdisciplinary framework for measuring and supporting adherence in HIV prevention trials of ARV-based vaginal rings

    Directory of Open Access Journals (Sweden)

    Kathleen M MacQueen

    2014-09-01

    Full Text Available Introduction: Product adherence and its measurement have emerged as a critical challenge in the evaluation of new HIV prevention technologies. Long-acting ARV-based vaginal rings may simplify use instructions and require less user behaviour, thereby facilitating adherence. One ARV-based ring is in efficacy trials and others, including multipurpose rings, are in the pipeline. Participant motivations, counselling support and measurement challenges during ring trials must still be addressed. In previous HIV prevention trials, this has been done largely using descriptive and post-hoc methods that are highly variable and minimally evaluated. We outline an interdisciplinary framework for systematically investigating promising strategies to support product uptake and adherence, and to measure adherence in the context of randomized, blinded clinical trials. Discussion: The interdisciplinary framework highlights the dual use of adherence measurement (i.e. to provide feedback during trial implementation and to inform interpretation of trial findings and underscores the complex pathways that connect measurement, adherence support and enacted adherence behaviour. Three inter-related approaches are highlighted: 1 adherence support – sequential efforts to define motivators of study product adherence and to develop, test, refine and evaluate adherence support messages; 2 self-reported psychometric measures – creation of valid and generalizable measures based in easily administered scales that capture vaginal ring use with improved predictive ability at screening, baseline and follow-up that better engage participants in reporting adherence; and 3 more objective measurement of adherence – real-time adherence monitoring and cumulative measurement to correlate adherence with overall product effectiveness through innovative designs, models and prototypes using electronic and biometric technologies to detect ring insertion and/or removal or expulsion

  13. Effectiveness of compression stockings to prevent the post-thrombotic syndrome (The SOX Trial and Bio-SOX biomarker substudy: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Rodger Marc A

    2007-07-01

    Full Text Available Abstract Background Post thrombotic syndrome (PTS is a burdensome and costly complication of deep venous thrombosis (DVT that develops in 20–40% of patients within 1–2 years after symptomatic DVT. Affected patients have chronic leg pain and swelling and may develop ulcers. Venous valve disruption from the thrombus itself or thrombus-associated mediators of inflammation is considered to be a key initiating event for the development of venous hypertension that often underlies PTS. As existing treatments for PTS are extremely limited, strategies that focus on preventing the development of PTS in patients with DVT are more likely to be effective and cost-effective in reducing its burden. Elastic compression stockings (ECS could be helpful in preventing PTS; however, data on their effectiveness are scarce and conflicting. Methods/Design The SOX Trial is a randomized, allocation concealed, double-blind multicenter clinical trial. The objective of the study is to evaluate ECS to prevent PTS. A total of 800 patients with proximal DVT will be randomized to one of 2 treatment groups: ECS or placebo (inactive stockings worn on the DVT-affected leg daily for 2 years. The primary outcome is the incidence of PTS during follow-up. Secondary outcomes are severity of PTS, venous thromboembolism (VTE recurrence, death from VTE, quality of life and cost-effectiveness. Outcomes will be evaluated during 6 clinic visits and 2 telephone follow ups. At baseline, 1 and 6 months, blood samples will be obtained to evaluate the role of inflammatory mediators and genetic markers of thrombophilia in the development of PTS (Bio-SOX substudy. Discussion The SOX Trial will be the largest study and the first with a placebo control to evaluate the effectiveness of ECS to prevent PTS. It is designed to provide definitive data on the effects of ECS on the occurrence and severity of PTS, as well as DVT recurrence, cost-effectiveness and quality of life. This study will also

  14. Usage of Calendula officinalis in the prevention and treatment of radiodermatitis: a randomized double-blind controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Franciane Schneider

    2015-04-01

    Full Text Available OBJECTIVE To evaluate the efficacy of Calendula officinalis in relation to Essential Fatty Acids for the prevention and treatment of radiodermatitis. METHOD This is a randomized double-blind controlled clinical trial with 51 patients with head and neck cancer in radiotherapy treatment divided into two groups: control (27 and experimental (24. RESULTS There is statistically significant evidence (p-value = 0.0120 that the proportion of radiodermatitis grade 2 in Essential Fatty Acids group is higher than Calendula group. Through the Kaplan-Meier survival curve we observed that Essential Fatty Acids group has always remained below the Calendula group survival curve, due to the lower risk of developing radiodermatitis grade 1, which makes the usage of Calendula more effective, with statistical significance (p-value = 0.00402. CONCLUSION Calendula showed better therapeutic response than the Essential Fatty Acids in the prevention and treatment of radiodermatitis. Brazilian Registry of Clinical Trials: RBR-237v4b.

  15. Preventing repetition of attempted suicide-III. The Amager Project, 5-year follow-up of a randomized controlled trial

    DEFF Research Database (Denmark)

    Lahoz, Titia; Hvid, Marianne; Wang, August G

    2016-01-01

    BACKGROUND: The Amager Project was initiated as a quasi-experimental study in 2005, based on an active outreach suicide preventive intervention inspired by the Norwegian Baerum Model. A 1-year follow-up study was conducted as a randomized controlled trial showing that this kind of active outreach...... follow-up study. METHOD: One hundred and thirty-three suicide attempters were included at this 5-year follow-up RCT study at Copenhagen University Hospital, Amager, and randomized to a rapid outreach suicide preventive intervention (OPAC) or TAU. RESULTS: Offering OPAC intervention to patients after...

  16. Interventions for the prevention of overweight and obesity in preschool children: a systematic review of randomized controlled trials.

    Science.gov (United States)

    Monasta, L; Batty, G D; Macaluso, A; Ronfani, L; Lutje, V; Bavcar, A; van Lenthe, F J; Brug, J; Cattaneo, A

    2011-05-01

    The objective of this study was to analyse interventions for the prevention of overweight and obesity in children under 5 years of age. We carried out a systematic review focusing exclusively on randomized controlled trials (RCTs). Data sources include Medline, Cochrane Library, EMBASE, CINHAL, PsychInfo and Web of Science. Data were extracted from seventeen articles describing seven RCTs identified through electronic search, screening of references in systematic reviews, own files and contact with authors. RCTs were assessed with the Jadad scale. Four trials were carried out in preschool settings, one with an exclusive educational component, two with an exclusive physical activity component and one with both. Two trials were family-based, with education and counselling for parents and children. The remaining trial was carried out in maternity hospitals, with a training intervention on breastfeeding. None of the interventions had an effect in preventing overweight and obesity. The failure to show an effect may be due to the choice of outcomes, the quality of the RCTs, the suboptimal implementation of the interventions, the lack of focus on social and environmental determinants. More rigorous research is needed on interventions and on social and environmental factors that could impact on lifestyle.

  17. Sodium bicarbonate for the prevention of contrast induced nephropathy: A meta-analysis of published clinical trials

    Energy Technology Data Exchange (ETDEWEB)

    Kunadian, Vijayalakshmi, E-mail: kunadianvijay@aol.com [Cardiothoracic Centre, Freeman Hospital, Newcastle upon Tyne Hospitals, NHS Foundation Trust/Newcastle University, Newcastle upon Tyne (United Kingdom); Zaman, Azfar, E-mail: Azfar.Zaman@nuth.nhs.uk [Cardiothoracic Centre, Freeman Hospital, Newcastle upon Tyne Hospitals, NHS Foundation Trust/Newcastle University, Newcastle upon Tyne (United Kingdom); Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne (United Kingdom); Spyridopoulos, Ioakim [Cardiothoracic Centre, Freeman Hospital, Newcastle upon Tyne Hospitals, NHS Foundation Trust/Newcastle University, Newcastle upon Tyne (United Kingdom); Institute of Human Genetics, Newcastle University, Newcastle upon Tyne (United Kingdom); Qiu, Weiliang [Channing Laboratory, Department of Medicine, Brigham and Women' s Hospital/Harvard Medical School, Boston, MA, United States of America (United States)

    2011-07-15

    Background: Contrast induced nephropathy (CIN) is a serious but rare complication following contrast based procedures. Sodium bicarbonate (NaHCO{sub 3}) has been postulated to prevent CIN by various mechanisms. However, the outcomes following sodium bicarbonate administration to prevent CIN have been inconsistent. Methods: A meta-analysis of published randomized clinical trials to determine if the administration of sodium bicarbonate is superior to sodium chloride among patients with chronic renal failure undergoing catheterization and interventional procedures in preventing CIN was performed. Results: Data were combined across seven published clinical trials consisting of 1734 patients. There were no significant differences in the baseline characteristics between the NaHCO{sub 3} and NaCl groups except patients in the bicarbonate group were heavier (P = 0.04). The odds ratio (OR) for the development of contrast nephropathy for NaHCO{sub 3} versus NaCl was 0.33 (95% confidence interval [CI] 0.16-0.69; P = 0.003). Heterogeneity and publication bias were detectable with P-values 0.01 and 0.0005 respectively. There was no difference between the NaHCO{sub 3} group and the NaCl group in the occurrence of death [OR 0.6; 95% CI (0.26-1.41); P = 0.24], congestive heart failure [OR 0.85; 95% CI (0.32-2.24); P = 0.74] and the requirement for renal replacement therapy [OR 0.56; 95% CI (0.22-1.41); P = 0.22]. Conclusion: This meta-analysis demonstrates that based on currently available randomized trials, the administration of NaHCO{sub 3} is superior to the administration of NaCl alone in the prevention of CIN among patients with moderate to severe chronic kidney disease. However, further controlled clinical trials are needed due to significant study heterogeneity and publication bias.

  18. Behavioral counseling to prevent childhood obesity – study protocol of a pragmatic trial in maternity and child health care

    Directory of Open Access Journals (Sweden)

    Mustila Taina

    2012-07-01

    Full Text Available Abstract Background Prevention is considered effective in combating the obesity epidemic. Prenatal environment may increase offspring's risk for obesity. A child starts to adopt food preferences and other behavioral habits affecting weight gain during preschool years. We report the study protocol of a pragmatic lifestyle intervention aiming at primary prevention of childhood obesity. Methods/Design A non-randomized controlled pragmatic trial in maternity and child health care clinics. The control group was recruited among families who visited the same clinics one year earlier. Eligibility criteria was mother at risk for gestational diabetes: body mass index ≥ 25 kg/m2, macrosomic newborn in any previous pregnancy, immediate family history of diabetes and/or age ≥ 40 years. All maternity clinics in town involved in recruitment. The gestational intervention consisted of individual counseling on diet and physical activity by a public health nurse, and of two group counseling sessions. Intervention continues until offspring’s age of five years. An option to participate a group counseling at child’s age 1 to 2 years was offered. The intervention includes advice on healthy diet, physical activity, sedentary behavior and sleeping pattern. The main outcome measure is offspring BMI z-score and its changes by the age of six years. Discussion Early childhood is a critical time period for prevention of obesity. Pragmatic trials targeting this period are necessary in order to find effective obesity prevention programs feasible in normal health care practice. Trial registration Clinical Trials gov NCT00970710

  19. Open trial of cimetidine in the prevention of upper gastro-intestinal haemorrhage in patients with severe intracranial injury.

    Science.gov (United States)

    Mouawad, E; Deloof, T; Genette, F; Vandesteene, A

    1983-01-01

    The present study evaluates the efficacy of Cimetidine in the prevention of clinically important gastro-intestinal haemorrhage in patients suffering from severe head injury. Fifty patients (39 males and 11 females) were included in the study. We excluded from the trial patients on anticoagulant therapy or concomitant non-steroid anti-inflammatory agents, pregnant and lactating women, and patients with previous histories of peptic ulcer disease.

  20. Improving preventive service delivery at adult complete health check-ups: the Preventive health Evidence-based Recommendation Form (PERFORM cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Moineddin Rahim

    2006-07-01

    Full Text Available Abstract Background To determine the effectiveness of a single checklist reminder form to improve the delivery of preventive health services at adult health check-ups in a family practice setting. Methods A prospective cluster randomized controlled trial was conducted at four urban family practice clinics among 38 primary care physicians affiliated with the University of Toronto. Preventive Care Checklist Forms© were created to be used by family physicians at adult health check-ups over a five-month period. The sex-specific forms incorporate evidence-based recommendations on preventive health services and documentation space for routine procedures such as physical examination. The forms were used in two intervention clinics and two control clinics. Rates and relative risks (RR of the performance of 13 preventive health maneuvers at baseline and post-intervention and the percentage of up-to-date preventive health services delivered per patient were compared between the two groups. Results Randomly-selected charts were reviewed at baseline (n = 509 and post-intervention (n = 608. Baseline rates for provision of preventive health services ranged from 3% (fecal occult blood testing to 93% (blood pressure measurement, similar to other settings. The percentage of up-to-date preventive health services delivered per patient at the end of the intervention was 48.9% in the control group and 71.7% in the intervention group. This is an overall 22.8% absolute increase (p = 0.0001, and 46.6% relative increase in the delivery of preventive health services per patient in the intervention group compared to controls. Eight of thirteen preventive health services showed a statistically significant change (p Conclusion This simple, low cost, clinically relevant intervention improves the delivery of preventive health services by prompting physicians of evidence-based recommendations in a checklist format that incorporates existing practice patterns. Periodic updates

  1. Participating in Clinical Trials

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    Full Text Available ... treatment, screening, diagnostic, prevention, and supportive care trials. Treatment Trials In treatment trials, researchers may gather information about experimental treatments, ...

  2. Randomized controlled trial of pancreatic stenting to prevent pancreatitis after endoscopic retrograde cholangiopancreatography

    Institute of Scientific and Technical Information of China (English)

    Yoshiaki Kawaguchi; Masami Ogawa; Fumio Omata; Hiroyuki Ito; Tooru Shimosegawa; Tetsuya Mine

    2012-01-01

    AIM:To determine the effectiveness of pancreatic duct (PD) stent placement for the prevention of pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP) in high risk patients.METHODS:Authors conducted a single-blind,randomized controlled trial to evaluate the effectiveness of a pancreatic spontaneous dislodgement stent against post-ERCP pancreatitis,including rates of spontaneous dislodgement and complications.Authors defined high risk patients as having any of the following:sphincter of Oddi dysfunction,difficult cannulation,prior history of post-ERCP pancreatitis,pre-cut sphincterotomy,pancreatic ductal biopsy,pancreatic sphincterotomy,intraductal ultrasonography,or a procedure time of more than 30 min.Patients were randomized to a stent group (n =60) or to a non-stent group (n =60).An abdominal radiograph was obtained daily to assess spontaneous stent dislodgement.Post-ERCP pancreatitis was diagnosed according to consensus criteria.RESULTS:The mean age (± standard deviation) was 67.4 ± 13.8 years and the male:female ratio was 68:52.In the stent group,the mean age was 66 ± 13years and the male:female ratio was 33:27,and in the non-stent group,the mean age was 68 ± 14 years and the male:female ratio was 35:25.There were no significant differences between groups with respect to age,gender,final diagnosis,or type of endoscopic intervention.The frequency of post-ERCP pancreatitis in PD stent and non-stent groups was 1.7% (1/60) and 13.3% (8/60),respectively.The severity of pancreatitis was mild in all cases.The frequency of post-ERCP pancreatitis in the stent group was significantly lower than in the non-stent group (P =0.032,Fisher's exact test).The rate of hyperamylasemia were 30% (18/60) and 38.3% (23 of 60) in the stent and non-stent groups,respectively (P =0.05,x2 test).The placement of a PD stent was successful in all 60 patients.The rate of spontaneous dislodgement by the third day was 96.7% (58/60),and the median (range) time to

  3. Comparison of methods for estimating the intraclass correlation coefficient for binary responses in cancer prevention cluster randomized trials.

    Science.gov (United States)

    Wu, Sheng; Crespi, Catherine M; Wong, Weng Kee

    2012-09-01

    The intraclass correlation coefficient (ICC) is a fundamental parameter of interest in cluster randomized trials as it can greatly affect statistical power. We compare common methods of estimating the ICC in cluster randomized trials with binary outcomes, with a specific focus on their application to community-based cancer prevention trials with primary outcome of self-reported cancer screening. Using three real data sets from cancer screening intervention trials with different numbers and types of clusters and cluster sizes, we obtained point estimates and 95% confidence intervals for the ICC using five methods: the analysis of variance estimator, the Fleiss-Cuzick estimator, the Pearson estimator, an estimator based on generalized estimating equations and an estimator from a random intercept logistic regression model. We compared estimates of the ICC for the overall sample and by study condition. Our results show that ICC estimates from different methods can be quite different, although confidence intervals generally overlap. The ICC varied substantially by study condition in two studies, suggesting that the common practice of assuming a common ICC across all clusters in the trial is questionable. A simulation study confirmed pitfalls of erroneously assuming a common ICC. Investigators should consider using sample size and analysis methods that allow the ICC to vary by study condition.

  4. Effects of an Art-Based Curriculum on Clinical Trials Attitudes and Breast Cancer Prevention Knowledge

    Science.gov (United States)

    Herman, Patricia M.; Larkey, Linda K.

    2006-01-01

    Although Latinos now comprise the largest minority in the U.S. population, they continue to be seriously underrepresented in clinical trials. A nonrandomized controlled study of an innovative community-developed clinical trial and breast cancer education program targeting Latinas tested whether use of an art-based curriculum could increase…

  5. Rationale, design, and protocol for the prevention of low back pain in the military (POLM trial (NCT00373009

    Directory of Open Access Journals (Sweden)

    Dugan Jessica L

    2007-09-01

    Full Text Available Abstract Background There are few effective strategies reported for the primary prevention of low back pain (LBP. Core stabilization exercises targeting the deep abdominal and trunk musculature and psychosocial education programs addressing patient beliefs and coping styles represent the current best evidence for secondary prevention of low back pain. However, these programs have not been widely tested to determine if they are effective at preventing the primary onset and/or severity of LBP. The purpose of this cluster randomized clinical trial is to determine if a combined core stabilization exercise and education program is effective in preventing the onset and/or severity of LBP. The effect of the combined program will be compared to three other standard programs. Methods/Design Consecutive Soldiers participating in advanced individual training (AIT will be screened for eligibility requirements and consented to study participation, as appropriate. Companies of Soldiers will be randomly assigned to receive the following standard prevention programs; a core stabilization exercise program (CSEP alone, a CSEP with a psychosocial education (PSEP, a traditional exercise (TEP, or a TEP with a PSEP. Proximal outcome measures will be assessed at the conclusion of AIT (a 12 week training period and include imaging of deep lumbar musculature using real-time ultrasound imaging and beliefs about LBP by self-report questionnaire. We are hypothesizing that Soldiers receiving the CSEP will have improved thickness of selected deep lumbar musculature (transversus abdominus, multifidi, and erector spinae muscles. We are also hypothesizing that Soldiers receiving the PSEP will have improved beliefs about the management of LBP. After AIT, Soldiers will be followed monthly to measure the distal outcomes of LBP occurrence and severity. This information will be collected during the subsequent 2 years following completion of AIT using a web-based data entry system

  6. Early intervention of multiple home visits to prevent childhood obesity in a disadvantaged population: a home-based randomised controlled trial (Healthy Beginnings Trial

    Directory of Open Access Journals (Sweden)

    Alperstein Garth

    2007-05-01

    Full Text Available Abstract Background Studies have shown that a proportion of children as young as two years are already overweight. This indicates that obesity prevention programs that commence as early as possible and are family-focused are needed. This Healthy Beginnings Trial aims to determine the efficacy of a community-based randomized controlled trial (RCT of a home visiting intervention in preventing the early onset of childhood overweight and obesity. The intervention will be conducted over the first two years of life to increase healthy feeding behaviours and physical activity, decrease physical inactivity, enhance parent-child interaction, and hence reduce overweight and obesity among children at 2 and 5 years of age in the most socially and economically disadvantaged areas of Sydney, Australia. Methods/design This RCT will be conducted with a consecutive sample of 782 first time mothers with their newborn children. Pregnant women who are expecting their first child, and who are between weeks 24 and 34 of their pregnancy, will be invited to participate in the trial at the antenatal clinic. Informed consent will be obtained and participants will then be randomly allocated to the intervention or the control group. The allocation will be concealed by sequentially numbered, sealed opaque envelopes containing a computer generated random number. The intervention comprises eight home visits from a specially trained community nurse over two years and pro-active telephone support between the visits. Main outcomes include a duration of breastfeeding measured at 6 and 12 months, b introduction of solids measured at 4 and 6 months, c nutrition, physical activity and television viewing measured at 24 months, and d overweight/obesity status at age 2 and 5 years. Discussion The results of this trial will ascertain whether the home based early intervention is effective in preventing the early onset of childhood overweight and obesity. If proved to be effective, it

  7. A Meta-analysis of alendronate for the prevention and treatment of glucocorticoid-induced osteoporosis

    Institute of Scientific and Technical Information of China (English)

    杨琳

    2013-01-01

    Objective To assess the efficiency and safety of alendronate for the prevention and treatment of glucocorticoidinduced osteoporosis (GIOP) .Methods The electronic databases of PubMed,EMBASE,Cochrane Library,Web of Science,Chinese BioMedical Literature Database (CBM) and Wanfang Data were searched for all randomized controlled trials (RCT) of alendronate vs.placebo.Two reviewers independently selected trials for inclusion,assessed trial quality using Jadad’s scale and extracted

  8. Absence of Fluoride Varnish–Related Adverse Events in Caries Prevention Trials in Young Children, United States

    Science.gov (United States)

    Gregorich, Steven E.; Ramos-Gomez, Francisco; Braun, Patricia A.; Wilson, Anne; Albino, Judith; Tiwari, Tamanna; Harper, Maya; Batliner, Terrence S.; Rasmussen, Margaret; Cheng, Nancy F.; Santo, William; Geltman, Paul L.; Henshaw, Michelle; Gansky, Stuart A.

    2017-01-01

    Introduction Fluoride varnish is an effective prevention intervention for caries in young children. Its routine use in clinical care is supported by meta-analyses and recommended by clinical guidelines, including the US Preventive Services Task Force (B rating). This report is the first prospective systematic assessment of adverse events related to fluoride varnish treatment in young children. Methods We determined the incidence of adverse events related to fluoride varnish treatment in 3 clinical trials on the prevention of early childhood caries, conducted under the auspices of the Early Childhood Caries Collaborating Centers, an initiative sponsored by the National Institute of Dental and Craniofacial Research. Each trial incorporated use of fluoride varnish in its protocol and systematically queried all children’s parents or legal guardians about the occurrence of acute adverse events after each fluoride varnish treatment. Results A total of 2,424 community-dwelling, dentate children aged 0 to 5 years were enrolled and followed for up to 3 years. These children received a cumulative total of 10,249 fluoride varnish treatments. On average, each child received 4.2 fluoride varnish treatments. We found zero fluoride varnish–related adverse events. Conclusion Fluoride varnish was not associated with treatment-related adverse events in young children. Our findings support its safety as an effective prevention intervention for caries in young children. PMID:28207379

  9. Assessing a risk tailored intervention to prevent disabling low back pain - protocol of a cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Marnitz Ulf

    2010-01-01

    Full Text Available Abstract Background Although most patients with low back pain (LBP recover within a few weeks a significant proportion has recurrent episodes or will develop chronic low back pain. Several mainly psychosocial risk factors for developing chronic LBP have been identified. However, effects of preventive interventions aiming at behavioural risk factors and unfavourable cognitions have yielded inconsistent results. Risk tailored interventions may provide a cost efficient and effective means to take systematic account of the individual risk factors but evidence is lacking. Methods/Design This study will be a cluster-randomised controlled trial comparing screening and a subsequent risk tailored intervention for patients with low back pain to prevent chronic low back pain compared to treatment as usual in primary care. A total of 600 patients from 20 practices in each study arm will be recruited in Berlin and Goettingen. The intervention comprises the following elements: Patients will be assigned to one of four risk groups based on a screening questionnaire. Subsequently they receive an educational intervention including information and counselling tailored to the risk group. A telephone/email consulting service for back pain related problems are offered independent of risk group assignment. The primary outcomes will be functional capacity and sick leave. Discussion This trial will evaluate the effectiveness of screening for risk factors for chronic low back pain followed by a risk tailored intervention to prevent chronic low back pain. This trial will contribute new evidence regarding the flexible use of individual physical and psychosocial risk factors in general practice. Trial registration ISRCTN 68205910

  10. Splint: the efficacy of orthotic management in rest to prevent equinus in children with cerebral palsy, a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Maas Josina C

    2012-03-01

    Full Text Available Abstract Background Range of motion deficits of the lower extremity occur in about the half of the children with spastic cerebral palsy (CP. Over time, these impairments can cause joint deformities and deviations in the children's gait pattern, leading to limitations in moblity. Preventing a loss of range of motion is important in order to reduce secondary activity limitations and joint deformities. Sustained muscle stretch, imposed by orthotic management in rest, might be an effective method of preventing a decrease in range of motion. However, no controlled study has been performed. Methods A single blind randomised controlled trial will be performed in 66 children with spastic CP, divided over three groups with each 22 participants. Two groups will be treated for 1 year with orthoses to prevent a decrease in range of motion in the ankle (either with static or dynamic knee-ankle-foot-orthoses and a third group will be included as a control group and will receive usual care (physical therapy, manual stretching. Measurements will be performed at baseline and at 3, 6, 9 and 12 months after treatment allocation. The primary outcome measure will be ankle dorsiflexion at full knee extension, measured with a custom designed hand held dynamometer. Secondary outcome measures will be i ankle and knee flexion during gait and ii gross motor function. Furthermore, to gain more insight in the working mechanism of the orthotic management in rest, morphological parameters like achilles tendon length, muscle belly length, muscle fascicle length, muscle physiological cross sectional area length and fascicle pennation angle will be measured in a subgroup of 18 participants using a 3D imaging technique. Discussion This randomised controlled trial will provide more insight into the efficacy of orthotic management in rest and the working mechanisms behind this treatment. The results of this study could lead to improved treatments. Trial Registration Number

  11. Ibobbly mobile health intervention for suicide prevention in Australian Indigenous youth: a pilot randomised controlled trial

    Science.gov (United States)

    Shand, Fiona; Ridani, Rebecca; Mackinnon, Andrew; De La Mata, Nicole; Christensen, Helen

    2017-01-01

    Objectives Rates of youth suicide in Australian Indigenous communities are 4 times the national youth average and demand innovative interventions. Historical and persistent disadvantage is coupled with multiple barriers to help seeking. Mobile phone applications offer the opportunity to deliver therapeutic interventions directly to individuals in remote communities. The pilot study aimed to evaluate the effectiveness of a self-help mobile app (ibobbly) targeting suicidal ideation, depression, psychological distress and impulsivity among Indigenous youth in remote Australia. Setting Remote and very remote communities in the Kimberley region of North Western Australia. Participants Indigenous Australians aged 18–35 years. Interventions 61 participants were recruited and randomised to receive either an app (ibobbly) which delivered acceptance-based therapy over 6 weeks or were waitlisted for 6 weeks and then received the app for the following 6 weeks. Primary and secondary outcome measures The primary outcome was the Depressive Symptom Inventory—Suicidality Subscale (DSI-SS) to identify the frequency and intensity of suicidal ideation in the previous weeks. Secondary outcomes were the Patient Health Questionnaire 9 (PHQ-9), The Kessler Psychological Distress Scale (K10) and the Barratt Impulsivity Scale (BIS-11). Results Although preintervention and postintervention changes on the (DSI-SS) were significant in the ibobbly arm (t=2.40; df=58.1; p=0.0195), these differences were not significant compared with the waitlist arm (t=1.05; df=57.8; p=0.2962). However, participants in the ibobbly group showed substantial and statistically significant reductions in PHQ-9 and K10 scores compared with waitlist. No differences were observed in impulsivity. Waitlist participants improved after 6 weeks of app use. Conclusions Apps for suicide prevention reduce distress and depression but do not show significant reductions on suicide ideation or impulsivity. A feasible

  12. Role of Lactobacillus in the prevention of Clostridium difficile-associated diarrhea: a meta-analysis of randomized controlled trials

    Institute of Scientific and Technical Information of China (English)

    WU Zhi-juan; DU Xi; ZHENG Jian

    2013-01-01

    Background Clostridium difficile-associated diarrhea (CDAD) is a major public health problem because of significant morbidity and mortality,and many clinicians pay attention to Lactobacillus as a potentially effective treatment.The purpose of this meta-analysis was to evaluate the efficacy of Lactobacillus in the prevention of CDAD.Methods The databases MEDLINE,the Cochrane Central Register of Controlled Trials,metaRegister of Controlled Trials,National Institutes of Health,CNKI,VIP,and Wanfang data were searched to locate all reported randomized controlled trials (RCT) from 1990 to December 2012.Only RCT in English and Chinese using Lactobacillus for the prevention of documented CDAD were considered for study inclusion.The data was analyzed by Review Manager and SPSS software.Results Seven placebo-controlled RCTs that evaluated the prevention of CDAD,which included 1486 subjects,accorded with inclusion and exclusion criteria.The mean age of the subjects ranged from 4.15 to 64.75 years and the proportion of male subjects ranged from 42.0% to 59.1%.The total daily dose of Lactobacillus ranged from 1.2×109-1.2×1012 colonyforming units (CFU).A low risk of bias was attributed to two studies and four studies evaluated a medium-level risk of bias.The combined risk ratio (RR) of developing CDAD was significantly lower in subjects who received Lactobacillus compared with subjects who received placebo (RR 0.38,95% confidence interval (CI) 0.22-0.67).A combination regimen of Lactobacillus acidophilus (L.acidophilus) and Lactobacillus casei (L.casei) (RR 0.05,95% CI 0.01-0.36) showed significant effect sizes for the prevention of CDAD,while single regimens of Lactobacillus plantarum (L.plantarum)and Lactobacillus rhamnosus (L.rhamnosus) did not.Across all trials,positive significant effects of Lactobacillus were observed in the elderly subgroup (RR 0.05,95% Cl 0.01-0.36).Whether the 1×1012-9×1012 CFU/d Lactobacillus could prevent CDAD significantly or not was

  13. Folic acid supplementation in pregnancy to prevent preterm birth: a systematic review and meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Saccone, Gabriele; Berghella, Vincenzo

    2016-04-01

    Folic acid (FA) may have a role in the prevention of pregnancy complications. However, the efficacy of FA supplementation in reducing the risk of preterm birth (PTB) is still unclear. The aim of this systematic review with meta-analysis was to evaluate the efficacy of folic acid supplementation during pregnancy to prevent preterm birth (PTB). The research protocol was designed a priori, defining methods for searching the literature in electronic databases, including and examining articles, and extracting and analyzing data. We included all randomized trials (RCTs) of asymptomatic singleton gestations without prior PTB who were randomized to prophylactic treatment with either FA supplementation or control (placebo or no treatment). The primary outcome was the incidence of PTB pregnancy does not prevent PTB <37 weeks. Daily FA supplementation remains the most important intervention to reduce the risk of neural tube defects.

  14. Prevention of Overweight in Infancy (POI.nz study: a randomised controlled trial of sleep, food and activity interventions for preventing overweight from birth

    Directory of Open Access Journals (Sweden)

    Taylor Barry J

    2011-12-01

    Full Text Available Abstract Background Rapid weight gain during the first three years of life predicts child and adult obesity, and also later cardiovascular and other morbidities. Cross-sectional studies suggest that infant diet, activity and sleep are linked to excessive weight gain. As intervention for overweight children is difficult, the aim of the Prevention of Overweight in Infancy (POI.nz study is to evaluate two primary prevention strategies during late pregnancy and early childhood that could be delivered separately or together as part of normal health care. Methods/Design This four-arm randomised controlled trial is being conducted with 800 families recruited at booking in the only maternity unit in the city of Dunedin, New Zealand. Mothers are randomised during pregnancy to either a usual care group (7 core contacts with a provider of government funded "Well Child" care over 2 years or to one of three intervention groups given education and support in addition to "Well Child" care: the Food, Activity and Breastfeeding group which receives 8 extra parent contacts over the first 2 years of life; the Sleep group which receives at least 3 extra parent contacts over the first 6 months of life with a focus on prevention of sleep problems and then active intervention if there is a sleep problem from 6 months to 2 years; or the Combination group which receives all extra contacts. The main outcome measures are conditional weight velocity (0-6, 6-12, 12-24 months and body mass index z-score at 24 months, with secondary outcomes including sleep and physical activity (parent report, accelerometry, duration of breastfeeding, timing of introduction of solids, diet quality, and measures of family function and wellbeing (parental depression, child mindedness, discipline practices, family quality of life and health care use. This study will contribute to a prospective meta-analysis of early life obesity prevention studies in Australasia. Discussion Infancy is likely to

  15. Partnership for fragility bone fracture care provision and prevention program (P4Bones: study protocol for a secondary fracture prevention pragmatic controlled trial

    Directory of Open Access Journals (Sweden)

    Gaboury Isabelle

    2013-01-01

    Full Text Available Abstract Background Fractures associated with bone fragility in older adults signal the potential for secondary fracture. Fragility fractures often precipitate further decline in health and loss of mobility, with high associated costs for patients, families, society and the healthcare system. Promptly initiating a coordinated, comprehensive pharmacological bone health and falls prevention program post-fracture may improve osteoporosis treatment compliance; and reduce rates of falls and secondary fractures, and associated morbidity, mortality and costs. Methods/design This pragmatic, controlled trial at 11 hospital sites in eight regions in Quebec, Canada, will recruit community-dwelling patients over age 50 who have sustained a fragility fracture to an intervention coordinated program or to standard care, according to the site. Site study coordinators will identify and recruit 1,596 participants for each study arm. Coordinators at intervention sites will facilitate continuity of care for bone health, and arrange fall prevention programs including physical exercise. The intervention teams include medical bone specialists, primary care physicians, pharmacists, nurses, rehabilitation clinicians, and community program organizers. The primary outcome of this study is the incidence of secondary fragility fractures within an 18-month follow-up period. Secondary outcomes include initiation and compliance with bone health medication; time to first fall and number of clinically significant falls; fall-related hospitalization and mortality; physical activity; quality of life; fragility fracture-related costs; admission to a long term care facility; participants’ perceptions of care integration, expectations and satisfaction with the program; and participants’ compliance with the fall prevention program. Finally, professionals at intervention sites will participate in focus groups to identify barriers and facilitating factors for the integrated

  16. Personalised normative feedback for preventing alcohol misuse in university students: Solomon three-group randomised controlled trial.

    Directory of Open Access Journals (Sweden)

    Maria T Moreira

    Full Text Available BACKGROUND: Young people tend to over-estimate peer group drinking levels. Personalised normative feedback (PNF aims to correct this misperception by providing information about personal drinking levels and patterns compared with norms in similar aged peer groups. PNF is intended to raise motivation for behaviour change and has been highlighted for alcohol misuse prevention by the British Government Behavioural Insight Team. The objective of the trial was to assess the effectiveness of PNF with college students for the prevention of alcohol misuse. METHODOLOGY: Solomon three-group randomised controlled trial. 1751 students, from 22 British Universities, allocated to a PNF group, a normal control group, or a delayed measurement control group to allow assessment of any measurement effects. PNF was provided by email. Participants completed online questionnaires at baseline, 6- and 12-months (only 12-months for the delayed measurement controls. Drinking behaviour measures were (i alcohol disorders; (ii frequency; (iii typical quantity, (iv weekly consumption; (v alcohol-related problems; (vi perceived drinking norms; and (vii positive alcohol expectancies. Analyses focused on high-risk drinkers, as well as all students, because of research evidence for the prevention paradox in student drinkers. PRINCIPAL FINDINGS: Follow-up rates were low, with only 50% and 40% responding at 6- and 12-months, respectively, though comparable to similar European studies. We found no evidence for any systematic attrition bias. Overall, statistical analyses with the high risk sub-sample, and for all students, showed no significant effects of the intervention, at either time-point, in a completed case analysis and a multiple imputation analysis. CONCLUSIONS: We found no evidence for the effectiveness of PNF for the prevention of alcohol misuse and alcohol-related problems in a UK student population. REGISTRATION: Controlled-Trials.com ISRCTN30784467.

  17. Clinical Trials Reference Materials and Related Links | Division of Cancer Prevention

    Science.gov (United States)

    Agreements Clinical Trials Agreement Confidential Disclosure Agreements Cooperative Research and Development Agreement (CRADA) - Research Plan Financial and Staffing Contribution of the Parties Exception or Modifications to the CRADA Human Subject Protection/Informed Consent Tutorials (or Education) |

  18. Endoscopic sclerotherapy compared with no specific treatment for the primary prevention of bleeding from esophageal varices. A randomized controlled multicentre trial [ISRCTN03215899].

    NARCIS (Netherlands)

    H.R. van Buuren (Henk); M.C. Rasch (Marijke); P.L. Batenburg (Piet); C.L. Bolwerk (Clemens); J.J. Nicolai (Jan); S.D.J. Werf, van der (Sjoerd); J. Scherpenisse (Joost); J. van Hattum (Jan); E.A. Rauws (Erik); S.W. Schalm (Solko); L.R. Arends (Lidia)

    2003-01-01

    textabstractBACKGROUND: Since esophageal variceal bleeding is associated with a high mortality rate, prevention of bleeding might be expected to result in improved survival. The first trials to evaluate prophylactic sclerotherapy found a marked beneficial effect of prophylactic tre

  19. Efficacy of probiotics in prevention of acute diarrhoea: a meta-analysis of masked, randomised, placebo-controlled trials.

    Science.gov (United States)

    Sazawal, Sunil; Hiremath, Girish; Dhingra, Usha; Malik, Pooja; Deb, Saikat; Black, Robert E

    2006-06-01

    To evaluate the evidence for the use of probiotics in the prevention of acute diarrhoea, we did a meta-analysis of the available data from 34 masked, randomised, placebo-controlled trials. Only one trial was community based and carried out in a developing country. Most of the remaining 33 studies were carried out in a developed country in a health-care setting. Evaluating the evidence by types of acute diarrhoea suggests that probiotics significantly reduced antibiotic-associated diarrhoea by 52% (95% CI 35-65%), reduced the risk of travellers' diarrhoea by 8% (-6 to 21%), and that of acute diarrhoea of diverse causes by 34% (8-53%). Probiotics reduced the associated risk of acute diarrhoea among children by 57% (35-71%), and by 26% (7-49%) among adults. The protective effect did not vary significantly among the probiotic strains Saccharomyces boulardii, Lactobacillus rhamnosus GG, Lactobacillus acidophilus, Lactobacillus bulgaricus, and other strains used alone or in combinations of two or more strains. Although there is some suggestion that probiotics may be efficacious in preventing acute diarrhoea, there is a lack of data from community-based trials and from developing countries evaluating the effect on acute diarrhoea unrelated to antibiotic usage. The effect on acute diarrhoea is dependent on the age of the host and genera of strain used.

  20. Selenium and vitamin E for prostate cancer: post-SELECT (Selenium and Vitamin E Cancer Prevention Trial) status.

    Science.gov (United States)

    Ledesma, Mark C; Jung-Hynes, Brittney; Schmit, Travis L; Kumar, Raj; Mukhtar, Hasan; Ahmad, Nihal

    2011-01-01

    Various formulations of selenium and vitamin E, both essential human dietary components, have been shown to possess a therapeutic and preventive effect against prostate cancer. Fortuitous results of clinical trials also implied a risk-reduction effect of selenium and vitamin E supplements. The Selenium and Vitamin E Cancer Prevention Trial (SELECT), using oral selenium and vitamin E supplementation in disease-free volunteers, was designed to test a prostate cancer chemoprevention hypothesis. SELECT was terminated early because of both safety concerns and negative data for the formulations and doses given. Here, we review and discuss the studies done before and since the inception of SELECT, as well as the parameters of the trial itself. We believe that there is a lack of appropriate in vivo preclinical studies on selenium and vitamin E despite many promising in vitro studies on these agents. It seems that the most effective doses and formulations of these agents for prostate cancer chemoprevention have yet to be tested. Also, improved understanding of selenium and vitamin E biology may facilitate the discovery of these doses and formulations.

  1. Preventing cognitive decline in older African Americans with mild cognitive impairment: design and methods of a randomized clinical trial.

    Science.gov (United States)

    Rovner, Barry W; Casten, Robin J; Hegel, Mark T; Leiby, Benjamin E

    2012-07-01

    Mild Cognitive Impairment (MCI) affects 25% of older African Americans and predicts progression to Alzheimer's disease. An extensive epidemiologic literature suggests that cognitive, physical, and/or social activities may prevent cognitive decline. We describe the methods of a randomized clinical trial to test the efficacy of Behavior Activation to prevent cognitive decline in older African Americans with the amnestic multiple domain subtype of MCI. Community Health Workers deliver 6 initial in-home treatment sessions over 2-3 months and then 6 subsequent in-home booster sessions using language, materials, and concepts that are culturally relevant to older African Americans during this 24 month clinical trial. We are randomizing 200 subjects who are recruited from churches, senior centers, and medical clinics to Behavior Activation or Supportive Therapy, which controls for attention. The primary outcome is episodic memory as measured by the Hopkins Verbal Learning Test-Revised at baseline and at months 3, 12, 18, and 24. The secondary outcomes are general and domain-specific neuropsychological function, activities of daily living, depression, and quality-of-life. The negative results of recent clinical trials of drug treatments for MCI and Alzheimer's disease suggest that behavioral interventions may provide an alternative treatment approach to preserve cognition in an aging society.

  2. Statistics in biomedical research

    Directory of Open Access Journals (Sweden)

    González-Manteiga, Wenceslao

    2007-06-01

    Full Text Available The discipline of biostatistics is nowadays a fundamental scientific component of biomedical, public health and health services research. Traditional and emerging areas of application include clinical trials research, observational studies, physiology, imaging, and genomics. The present article reviews the current situation of biostatistics, considering the statistical methods traditionally used in biomedical research, as well as the ongoing development of new methods in response to the new problems arising in medicine. Clearly, the successful application of statistics in biomedical research requires appropriate training of biostatisticians. This training should aim to give due consideration to emerging new areas of statistics, while at the same time retaining full coverage of the fundamentals of statistical theory and methodology. In addition, it is important that students of biostatistics receive formal training in relevant biomedical disciplines, such as epidemiology, clinical trials, molecular biology, genetics, and neuroscience.La Bioestadística es hoy en día una componente científica fundamental de la investigación en Biomedicina, salud pública y servicios de salud. Las áreas tradicionales y emergentes de aplicación incluyen ensayos clínicos, estudios observacionales, fisología, imágenes, y genómica. Este artículo repasa la situación actual de la Bioestadística, considerando los métodos estadísticos usados tradicionalmente en investigación biomédica, así como los recientes desarrollos de nuevos métodos, para dar respuesta a los nuevos problemas que surgen en Medicina. Obviamente, la aplicación fructífera de la estadística en investigación biomédica exige una formación adecuada de los bioestadísticos, formación que debería tener en cuenta las áreas emergentes en estadística, cubriendo al mismo tiempo los fundamentos de la teoría estadística y su metodología. Es importante, además, que los estudiantes de

  3. Prevention through Activity in Kindergarten Trial (PAKT: A cluster randomised controlled trial to assess the effects of an activity intervention in preschool children

    Directory of Open Access Journals (Sweden)

    Lenz Dorothea

    2010-07-01

    Full Text Available Abstract Background Physical activity and motor skills acquisition are of high importance for health-related prevention and a normal development in childhood. However, few intervention studies exist in preschool children focussing on an increase in physical activity and motor skills. Proof of positive effects is available but not consistent. Methods/Design The design, curriculum, and evaluation strategy of a cluster randomised intervention study in preschool children are described in this manuscript. In the Prevention through Activity in Kindergarten Trial (PAKT, 41 of 131 kindergartens of Wuerzburg and Kitzingen, Germany, were randomised into an intervention and a control group by a random number table stratified for the location of the kindergarten in an urban (more than 20.000 inhabitants or rural area. The aims of the intervention were to increase physical activity and motor skills in the participating children, and to reduce health risk factors as well as media use. The intervention was designed to involve children, parents and teachers, and lasted one academic year. It contained daily 30-min sessions of physical education in kindergarten based on a holistic pedagogic approach termed the "early psychomotor education". The sessions were instructed by kindergarten teachers under regular supervision by the research team. Parents were actively involved by physical activity homework cards. The kindergarten teachers were trained in workshops and during the supervision. Assessments were performed at baseline, 3-5 months into the intervention, at the end of the intervention and 2-4 months after the intervention. The primary outcomes of the study are increases in physical activity (accelerometry and in motor skills performance (composite score of obstacle course, standing long jump, balancing on one foot, jumping sidewise to and fro between baseline and the two assessments during the intervention. Secondary outcomes include decreases in body

  4. Study protocol for a randomized controlled trial comparing mindfulness-based cognitive therapy with maintenance anti-depressant treatment in the prevention of depressive relapse/recurrence: the PREVENT trial

    Directory of Open Access Journals (Sweden)

    Hayes Rachel

    2010-10-01

    Full Text Available Abstract Background Depression is a common and distressing mental health problem that is responsible for significant individual disability and cost to society. Medication and psychological therapies are effective for treating depression and maintenance anti-depressants (m-ADM can prevent relapse. However, individuals with depression often express a wish for psychological help that can help them recover from depression in the long-term. We need to develop psychological therapies that prevent depressive relapse/recurrence. A recently developed treatment, Mindfulness-based Cognitive Therapy (MBCT, see http://www.mbct.co.uk shows potential as a brief group programme for people with recurring depression. In two studies it has been shown to halve the rates of depression recurring compared to usual care. This trial asks the policy research question, is MBCT superior to m-ADM in terms of: a primary outcome of preventing depressive relapse/recurrence over 24 months; and, secondary outcomes of (a depression free days, (b residual depressive symptoms, (c antidepressant (ADM usage, (d psychiatric and medical co-morbidity, (e quality of life, and (f cost effectiveness? An explanatory research question asks is an increase in mindfulness skills the key mechanism of change? Methods/Design The design is a single blind, parallel RCT examining MBCT vs. m-ADM with an embedded process study. To answer the main policy research question the proposed trial compares MBCT plus ADM-tapering with m-ADM for patients with recurrent depression. Four hundred and twenty patients with recurrent major depressive disorder in full or partial remission will be recruited through primary care. Depressive relapse/recurrence over two years is the primary outcome variable. The explanatory question will be addressed in two mutually informative ways: quantitative measurement of potential mediating variables pre/post-treatment and a qualitative study of service users' views and experiences

  5. Optimum dose of vitamin D for disease prevention in older people: BEST-D trial of vitamin D in primary care.

    Science.gov (United States)

    Hin, H; Tomson, J; Newman, C; Kurien, R; Lay, M; Cox, J; Sayer, J; Hill, M; Emberson, J; Armitage, J; Clarke, R

    2017-03-01

    This trial compared the effects of daily treatment with vitamin D or placebo for 1 year on blood tests of vitamin D status. The results demonstrated that daily 4000 IU vitamin D3 is required to achieve blood levels associated with lowest disease risks, and this dose should be tested in future trials for fracture prevention.

  6. An Effectiveness Trial of a Selected Dissonance-Based Eating Disorder Prevention Program for Female High School Students: Long-Term Effects

    Science.gov (United States)

    Stice, Eric; Rohde, Paul; Shaw, Heather; Gau, Jeff

    2011-01-01

    Objective: Efficacy trials found that a dissonance-based eating disorder prevention program in which female high school and college students with body image concerns critique the thin ideal reduced eating disorder risk factors, eating disorder symptoms, and future eating disorder onset. The present effectiveness trial tested whether this program…

  7. The Prevention Program for Externalizing Problem Behavior (PEP) Improves Child Behavior by Reducing Negative Parenting: Analysis of Mediating Processes in a Randomized Controlled Trial

    Science.gov (United States)

    Hanisch, Charlotte; Hautmann, Christopher; Plück, Julia; Eichelberger, Ilka; Döpfner, Manfred

    2014-01-01

    Background: Our indicated Prevention program for preschool children with Externalizing Problem behavior (PEP) demonstrated improved parenting and child problem behavior in a randomized controlled efficacy trial and in a study with an effectiveness design. The aim of the present analysis of data from the randomized controlled trial was to identify…

  8. Preventing mental health problems in children: the Families in Mind population-based cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Hiscock Harriet

    2012-06-01

    Full Text Available Abstract Background Externalising and internalising problems affect one in seven school-aged children and are the single strongest predictor of mental health problems into early adolescence. As the burden of mental health problems persists globally, childhood prevention of mental health problems is paramount. Prevention can be offered to all children (universal or to children at risk of developing mental health problems (targeted. The relative effectiveness and costs of a targeted only versus combined universal and targeted approach are unknown. This study aims to determine the effectiveness, costs and uptake of two approaches to early childhood prevention of mental health problems ie: a Combined universal-targeted approach, versus a Targeted only approach, in comparison to current primary care services (Usual care. Methods/design Three armed, population-level cluster randomised trial (2010–2014 within the universal, well child Maternal Child Health system, attended by more than 80% of families in Victoria, Australia at infant age eight months. Participants were families of eight month old children from nine participating local government areas. Randomised to one of three groups: Combined, Targeted or Usual care. The interventions comprises (a the Combined universal and targeted program where all families are offered the universal Toddlers Without Tears group parenting program followed by the targeted Family Check-Up one-on-one program or (b the Targeted Family Check-Up program. The Family Check-Up program is only offered to children at risk of behavioural problems. Participants will be analysed according to the trial arm to which they were randomised, using logistic and linear regression models to compare primary and secondary outcomes. An economic evaluation (cost consequences analysis will compare incremental costs to all incremental outcomes from a societal perspective. Discussion This trial will inform public health policy by making

  9. A healthier approach to clinical trials evaluating resveratrol for primary prevention of age‐related diseases in healthy populations.

    Science.gov (United States)

    Smoliga, James M; Colombo, E Sage; Campen, Matthew J

    2013-07-01

    In recent years, the wealth of basic science research supporting resveratrol's potential to treat, delay, and even prevent age-related chronic diseases has led to a number of human clinical trials. While such translational research has yielded promising results in clinical populations, recently published conflicting results from studies evaluating resveratrol's potential for primary prevention of chronic disease in healthy / asymptomatic individuals have generated considerable controversy and do not initially appear consistent with findings from animal models. We argue that trials targeting healthy humans are often fundamentally flawed owing to inappropriate use of paradigms only applicable to populations with overt clinical disease and the consequent misleading (typically negative) results can severely retard advancement of drug development. To appropriately perform translational research centered on resveratrol as a primary prevention agent in non-clinical populations, it is critical to utilize study designs which can provide adequate information on clinically relevant outcome measures, avoid paradigms and assumptions from interventions which are specific to clinical populations, and maintain realistic expectations compared to interventions which provide the theoretical maximal response (e.g., caloric restriction and aerobic exercise training).

  10. Social-cognitive theory mediators of behavior change in the National Institute of Mental Health Multisite HIV Prevention Trial.

    Science.gov (United States)

    2001-09-01

    The National Institute of Mental Health Multisite HIV Prevention Trial was a trial of an intervention to reduce sexual HIV risk behaviors among 3,706 low-income at-risk men and women at 7 U.S. research sites. The intervention, based on social-cognitive theory and designed to influence behavior change by improving expected outcomes of condom use and increasing knowledge, skills, and self-efficacy to execute safer sex behaviors, was effective relative to a control condition in reducing sexual risk behavior. At 3 months after completion of the intervention, measures of these potential mediators were higher in the intervention than in the control condition. Although the effect of the intervention on sexual risk behavior was significantly reduced when the variables were controlled statistically, supporting the hypothesis of their mediation of the intervention effect, most of the effect remained unexplained, indicating the influence of unmeasured factors on outcome.

  11. The EARLY ALLIANCE prevention trial: a dual design to test reduction of risk for conduct problems, substance abuse, and school failure in childhood.

    Science.gov (United States)

    Prinz, R J; Dumas, J E; Smith, E P; Laughlin, J E

    2000-06-01

    This paper describes a preventive intervention trial called EARLY ALLIANCE which is aimed at reducing risk for three adverse outcomes in childhood and adolescence: conduct problems, substance abuse, and school failure. The structure of the prevention trial is unique because two linked designs are being implemented concurrently. The primary design focuses on children at elevated risk for adverse outcomes, and compares a targeted, multicontextual preventive intervention with family, classroom, peer relational, and academic components to a universal, schoolwide preventive intervention that emphasizes peaceful conflict management and serves as a "usual care" control condition. The secondary design focuses on children at lower risk for adverse outcomes and compares a universally administered classroom program to the control condition. The paper describes the theoretical foundation for EARLY ALLIANCE, the goals of the prevention trial, the rationale for design choices, and the methods employed.

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

    Science.gov (United States)

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

    2012-09-01

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

  13. Trials

    Directory of Open Access Journals (Sweden)

    Michele Fornaro

    2010-01-01

    Full Text Available Mental Retardation (MR is a developmental disability characterized by impairments in adaptive daily life skills and difficulties in social and interpersonal functioning. Since multiple causes may contribute to MR, associated clinical pictures may vary accordingly. Nevertheless, when psychiatric disorders as Treatment Resistant Depression (TRD and/or alcohol abuse co-exist, their proper detection and management is often troublesome, essentially due to a limited vocabulary MR people could use to describe their symptoms, feelings and concerns, and the lack of reliable screening tools. Furthermore, MR people are among the most medicated subjects, with (over prescription of antidepressants and/or typical antipsychotics being the rule rather than exception. Thus, treatment resistance or even worsening of depression, constitute frequent occurrences. This report describes the case of a person with MR who failed to respond to repetitive trials of antidepressant monotherapies, finally recovering using aripiprazole to fluvoxamine augmentation upon consideration of a putative bipolar diathesis for “agitated” TRD. Although further controlled investigations are needed to assess a putative bipolar diathesis in some cases of MR associated to TRD, prudence is advised in the long-term prescription of antidepressant monotherapies in such conditions.

  14. A randomized trial of an intervention to improve use and adherence to effective coronary heart disease prevention strategies

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    Sheridan Stacey L

    2011-12-01

    Full Text Available Abstract Background Efficacious strategies for the primary prevention of coronary heart disease (CHD are underused, and, when used, have low adherence. Existing efforts to improve use and adherence to these efficacious strategies have been so intensive that they are impractical for clinical practice. Methods We conducted a randomized trial of a CHD prevention intervention (including a computerized decision aid and automated tailored adherence messages at one university general internal medicine practice. After obtaining informed consent and collecting baseline data, we randomized patients (men and women age 40-79 with no prior history of cardiovascular disease to either the intervention or usual care. We then saw them for two additional study visits over 3 months. For intervention participants, we administered the decision aid at the primary study visit (1 week after baseline visit and then mailed 3 tailored adherence reminders at 2, 4, and 6 weeks. We assessed our outcomes (including the predicted likelihood of angina, myocardial infarction, and CHD death over 10 years (CHD risk and self-reported adherence between groups at 3 month follow-up. Data collection occurred from June 2007 through December 2009. All study procedures were IRB approved. Results We randomized 160 eligible patients (81 intervention; 79 control and followed 96% to study conclusion. Mean predicted CHD risk at baseline was 11.3%. The intervention increased self-reported adherence to chosen risk reducing strategies by 25 percentage points (95% CI 8% to 42%, with the biggest effect for aspirin. It also changed predicted CHD risk by -1.1% (95% CI -0.16% to -2%, with a larger effect in a pre-specified subgroup of high risk patients. Conclusion A computerized intervention that involves patients in CHD decision making and supports adherence to effective prevention strategies can improve adherence and reduce predicted CHD risk. Clinical trials registration number ClinicalTrials

  15. Clinical Trials

    Science.gov (United States)

    Clinical trials are research studies that test how well new medical approaches work in people. Each study answers ... prevent, screen for, diagnose, or treat a disease. Clinical trials may also compare a new treatment to a ...

  16. Interpreting trial results following use of different intention-to-treat approaches for preventing attrition bias

    DEFF Research Database (Denmark)

    Dossing, Anna; Tarp, Simon; Furst, Daniel E;

    2014-01-01

    10 biological and targeted drugs based on collections of trials that would correspond to 10 individual meta-analyses. ETHICS AND DISSEMINATION: This study will enhance transparency for evaluating mITT treatment effects described in meta-analyses. The intended audience will include healthcare...... concerns when executing different mITT approaches in meta-analyses. METHODS AND ANALYSIS: Using meta-epidemiology on randomised trials considered less prone to bias (ie, good internal validity) and assessing biological or targeted agents in patients with rheumatoid arthritis, we will meta-analyse data from...

  17. Randomised clinical trial of Levonantradol and Chlorpromazine in the prevention of radiotherapy-induced vomiting

    Energy Technology Data Exchange (ETDEWEB)

    Lucraft, H.H.; Palmer, M.K. (Christie Hospital and Holt Radium Inst., Manchester (UK))

    1982-11-01

    Levonantradol is a cannabis derivative. Cannabinoid anti-emetics are being assessed in cancer chemotherapy but have been little used in radiotherapy to date. A pilot study and randomised trial compared the anti-emetic effect of a standard drug (Chlorpromazine 25 mg) with Levonantradol at two doses (0.5 and 0.75 mg) in patients receiving palliative single fraction radiotherapy to sites likely to cause nausea and vomiting. Most patients were out-patients. Both drugs were well tolerated. The frequency of vomiting was similar in all three groups in both the pilot study and randomised trial.

  18. Lessons learnt from implementing an empirically informed recruitment approach for FEM-PrEP, a large HIV prevention clinical trial

    Directory of Open Access Journals (Sweden)

    Parker C

    2014-12-01

    Full Text Available Caleb Parker,1 Amy Corneli,1 Kawango Agot,2 Jacob Odhiambo,2 Jesse Asewe,2 Khatija Ahmed,3 Joseph Skhosana,3 Malebo Ratlhagana,3 Michele Lanham,1 Christina Wong,1 Jennifer Deese,1 Rachel Manongi,4 Lut Van Damme,1On behalf of the FEM-PrEP recruitment group 1FHI 360, Global Health, Population and Nutrition, Durham, NC, USA; 2Impact Research and Development Organization, Kisumu, Kenya; 3Setshaba Research Centre, Soshanguve, Pretoria, South Africa; 4Kilimanjaro Christian Medical Centre, Moshi, Tanzania Abstract: We implemented an empirically informed, geographically based recruitment approach for FEM-PrEP, a human immunodeficiency virus (HIV prevention clinical trial of daily oral emtricitabine (FTC and tenofovir disoproxil fumarate (TDF for HIV prevention. During the formative research phase, we conducted a modification of the Priorities for Local AIDS Control Efforts (PLACE method and used those data and staff experiences to identify and prioritize for recruitment geographic areas where HIV incidence might be high. During the clinical trial, we implemented a routinely monitored and flexible recruitment plan in the geographical areas identified in the formative research. We describe three lessons learnt from implementing this approach: 1 the PLACE data were critical in identifying places presumed to be high risk; 2 staff experiences, in combination with PLACE data, were needed to inform a practical recruitment strategy; and 3 recruiting in establishments in priority areas identified by the PLACE data led to screening many HIV-positive women at the Bondo site (Kenya, placing additional burden on clinic staff. These lessons learnt highlight the critical importance of having a flexible and monitored recruitment strategy. Although we successfully recruited a study population at higher risk for HIV, FEM-PrEP was unable to determine the effectiveness of FTC/TDF for HIV prevention, due to low adherence to the study product among participants. We must

  19. Feasibility and effects of preventive home visits for at-risk older people: Design of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Catellier Diane

    2009-12-01

    Full Text Available Abstract Background The search for preventive methods to mitigate functional decline and unwanted relocation by older adults living in the community is important. Preventive home visit (PHV models use infrequent but regular visits to older adults by trained practitioners with the goal of maintaining function and quality of life. Evidence about PHV efficacy is mixed but generally supportive. Yet interventions have rarely combined a comprehensive (biopsychosocial occupational therapy intervention protocol with a home visit to older adults. There is a particular need in the USA to create and examine such a protocol. Methods/Design The study is a single-blind randomized controlled pilot trial designed to assess the feasibility, and to obtain preliminary efficacy estimates, of an intervention consisting of preventive home visits to community-dwelling older adults. An occupational therapy-based preventive home visit (PHV intervention was developed and is being implemented and evaluated using a repeated measures design. We recruited a sample of 110 from a population of older adults (75+ who were screened and found to be at-risk for functional decline. Participants are currently living in the community (not in assisted living or a skilled nursing facility in one of three central North Carolina counties. After consent, participants were randomly assigned into experimental and comparison groups. The experimental group receives the intervention 4 times over a 12 month follow-up period while the comparison group receives a minimal intervention of mailed printed materials. Pre- and post-intervention measures are being gathered by questionnaires administered face-to-face by a treatment-blinded research associate. Key outcome measures include functional ability, participation, life satisfaction, self-rated health, and depression. Additional information is collected from participants in the experimental group during the intervention to assess the feasibility of

  20. Preventing Adolescent Social Anxiety and Depression and Reducing Peer Victimization: Intervention Development and Open Trial

    Science.gov (United States)

    La Greca, Annette M.; Ehrenreich-May, Jill; Mufson, Laura; Chan, Sherilynn

    2016-01-01

    Background: Social anxiety disorder (SAD) and depression are common among adolescents, frequently comorbid, and resistant to change. Prevention programs for adolescent SAD are scant, and depression prevention programs do not fully address peer-risk factors. One critical peer-risk factor for SAD and depression is peer victimization. We describe the…

  1. Stepped-care prevention of anxiety and depression in late life. A randomized controlled trial

    NARCIS (Netherlands)

    Veer-Tazelaar, van 't P.J.; Marwijk, van H.W.J.; Oppen, van P.C.; Hout, van H.P.J.; Horst, van der H.E.; Cuijpers, P.; Smit, H.F.E.; Beekman, A.T.F.

    2009-01-01

    ABSTRACT Context Given the public health significance of late-life depression and anxiety, and the limited capacity of treatment, there is an urgent need to develop effective strategies to prevent these disorders. Objective To determine the effectiveness of an indicated stepped-care prevention progr

  2. Does Practice Make Perfect? A Randomized Control Trial of Behavioral Rehearsal on Suicide Prevention Gatekeeper Skills

    Science.gov (United States)

    Cross, Wendi F.; Seaburn, David; Gibbs, Danette; Schmeelk-Cone, Karen; White, Ann Marie; Caine, Eric D.

    2011-01-01

    Suicide is the third leading cause of death among 10-24-year-olds and the target of school-based prevention efforts. Gatekeeper training, a broadly disseminated prevention strategy, has been found to enhance participant knowledge and attitudes about intervening with distressed youth. Although the goal of training is the development of gatekeeper…

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

    Science.gov (United States)

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

    2014-01-01

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

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

    Science.gov (United States)

    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…

  5. Results of Prevention of REStenosis with Tranilast and its Outcomes (PRESTO) trial

    NARCIS (Netherlands)

    D.R. Holmes Jr (David); J.R. Granett (Jeffrey); J.J. Popma (Jeffrey); P.J. Fitzgerald (Peter); D. Fischman (David); J.J. Ferguson (James); A.M. Lincoff (Michael); S. Goldberg (Sheldon); J.A. Brinker; R. Chan; B.R. Davis (Barry); M. Poland; A.M. Zeiher (Andreas); J.T. Willerson (James); S.B. King 3rd (Spencer); L.M. Shapiro; M. Savage (Michael); J.M. Lablanche (Jean Marc); J.E. Tcheng (James); L. Grip (Lars); P.W.J.C. Serruys (Patrick)

    2002-01-01

    textabstractBACKGROUND: Restenosis after percutaneous coronary intervention (PCI) is a major problem affecting 15% to 30% of patients after stent placement. No oral agent has shown a beneficial effect on restenosis or on associated major adverse cardiovascular events. In limited trials, the oral age

  6. Efficacy Trial of a Brief Cognitive-Behavioral Depression Prevention Program for High-Risk Adolescents: Effects at 1- and 2-Year Follow-Up

    Science.gov (United States)

    Stice, Eric; Rohde, Paul; Gau, Jeff M.; Wade, Emily

    2010-01-01

    Objective: To evaluate the effects of a brief group cognitive-behavioral (CB) depression prevention program for high-risk adolescents with elevated depressive symptoms at 1- and 2-year follow-up. Method: In this indicated prevention trial, 341 at-risk youths were randomized to a group CB intervention, group supportive expressive intervention, CB…

  7. Continuous vs episodic prophylactic treatment with amiodarone for the prevention of atrial fibrillation : a randomized trial

    NARCIS (Netherlands)

    Ahmed, Sheba; Rienstra, Michiel; Crijns, Harry J. G. M.; Links, Thera P.; Wiesfeld, Ans C. P.; Hillege, Hans L.; Bosker, Hans A.; Lok, Dirk J. A.; Van Veldhuisen, Dirk J.; Van Gelder, Isabelle C.

    2008-01-01

    Context Amiodarone effectively suppresses atrial fibrillation but causes many adverse events. Objective To compare major events in patients randomized to receive episodic amiodarone treatment with those who received continuous amiodarone treatment while still aiming to prevent atrial fibrillation. D

  8. Dissonance-Based Prevention of Eating Disorder Risk Factors in Middle School Girls: Results from Two Pilot Trials

    Science.gov (United States)

    Rohde, Paul; Auslander, Beth A.; Shaw, Heather; Raineri, Kate M.; Gau, Jeff M.; Stice, Eric

    2014-01-01

    Objective Although several eating disorder prevention programs reduce eating disorder risk factors and symptoms for female high school and college students, few efficacious prevention programs exist for female middle school students, despite the fact that body image and eating disturbances often emerge then. Two pilot trials evaluated a new dissonance-based eating disorder prevention program for middle school girls with body image concerns. Methods Female middle school students with body dissatisfaction from two sites (Study 1: N = 81, M age = 12.1, SD = 0.9; Study 2: N = 52, M age = 12.5, SD = 0.8) were randomized to a dissonance intervention (MS Body Project) or educational brochure control; Study 2 included a 3-month follow-up. Results Intervention participants showed significant posttest reductions in only one of six variables with both Studies 1 and 2 (i.e., pressure to be thin and negative affect, respectively), though posttest effect sizes suggested medium reductions in eating disorder risk factors and symptoms (Study 1 M d = 0.40; Study 2 M d = 0.65); reductions at 3-month follow-up in Study 2 were not evident (M d = 0.19). Conclusions Results suggest that this new middle school version of the Body Project is producing medium magnitude reductions in eating disorder risk factors at posttest but that effects are showing limited persistence. Continued refinement and evaluation of this intervention appears warranted to develop more effective prevention programs for this age group. PMID:24590419

  9. Design and implementation of a dental caries prevention trial in remote Canadian Aboriginal communities

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    Leroux Brian

    2010-05-01

    Full Text Available Abstract Background The goal of this cluster randomized trial is to test the effectiveness of a counseling approach, Motivational Interviewing, to control dental caries in young Aboriginal children. Motivational Interviewing, a client-centred, directive counseling style, has not yet been evaluated as an approach for promotion of behaviour change in indigenous communities in remote settings. Methods/design Aboriginal women were hired from the 9 communities to recruit expectant and new mothers to the trial, administer questionnaires and deliver the counseling to mothers in the test communities. The goal is for mothers to receive the intervention during pregnancy and at their child's immunization visits. Data on children's dental health status and family dental health practices will be collected when children are 30-months of age. The communities were randomly allocated to test or control group by a random "draw" over community radio. Sample size and power were determined based on an anticipated 20% reduction in caries prevalence. Randomization checks were conducted between groups. Discussion In the 5 test and 4 control communities, 272 of the original target sample size of 309 mothers have been recruited over a two-and-a-half year period. A power calculation using the actual attained sample size showed power to be 79% to detect a treatment effect. If an attrition fraction of 4% per year is maintained, power will remain at 80%. Power will still be > 90% to detect a 25% reduction in caries prevalence. The distribution of most baseline variables was similar for the two randomized groups of mothers. However, despite the random assignment of communities to treatment conditions, group differences exist for stage of pregnancy and prior tooth extractions in the family. Because of the group imbalances on certain variables, control of baseline variables will be done in the analyses of treatment effects. This paper explains the challenges of conducting

  10. Progestogens to prevent preterm birth in twin pregnancies: an individual participant data meta-analysis of randomized trials

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    Schuit Ewoud

    2012-03-01

    Full Text Available Abstract Background Preterm birth is the principal factor contributing to adverse outcomes in multiple pregnancies. Randomized controlled trials of progestogens to prevent preterm birth in twin pregnancies have shown no clear benefits. However, individual studies have not had sufficient power to evaluate potential benefits in women at particular high risk of early delivery (for example, women with a previous preterm birth or short cervix or to determine adverse effects for rare outcomes such as intrauterine death. Methods/design We propose an individual participant data meta-analysis of high quality randomized, double-blind, placebo-controlled trials of progestogen treatment in women with a twin pregnancy. The primary outcome will be adverse perinatal outcome (a composite measure of perinatal mortality and significant neonatal morbidity. Missing data will be imputed within each original study, before data of the individual studies are pooled. The effects of 17-hydroxyprogesterone caproate or vaginal progesterone treatment in women with twin pregnancies will be estimated by means of a random effects log-binomial model. Analyses will be adjusted for variables used in stratified randomization as appropriate. Pre-specified subgroup analysis will be performed to explore the effect of progestogen treatment in high-risk groups. Discussion Combining individual patient data from different randomized trials has potential to provide valuable, clinically useful information regarding the benefits and potential harms of progestogens in women with twin pregnancy overall and in relevant subgroups.

  11. Randomized trial of piperaquine with sulfadoxine-pyrimethamine or dihydroartemisinin for malaria intermittent preventive treatment in children.

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    Badara Cisse

    Full Text Available BACKGROUND: The long terminal half life of piperaquine makes it suitable for intermittent preventive treatment for malaria but no studies of its use for prevention have been done in Africa. We did a cluster randomized trial to determine whether piperaquine in combination with either dihydroartemisin (DHA or sulfadoxine-pyrimethamine (SP is as effective, and better tolerated, than SP plus amodiaquine (AQ, when used for intermittent preventive treatment in children delivered by community health workers in a rural area of Senegal. METHODS: Treatments were delivered to children 3-59 months of age in their homes once per month during the transmission season by community health workers. 33 health workers, each covering about 60 children, were randomized to deliver either SP+AQ, DHA+PQ or SP+PQ. Primary endpoints were the incidence of attacks of clinical malaria, and the incidence of adverse events. RESULTS: 1893 children were enrolled. Coverage of monthly rounds and compliance with daily doses was similar in all groups; 90% of children received at least 2 monthly doses. Piperaquine combinations were better tolerated than SP+AQ with a significantly lower risk of common, mild adverse events. 103 episodes of clinical malaria were recorded during the course of the trial. 68 children had malaria with parasitaemia >3000/microL, 29/671 (4.3% in the SP+AQ group, compared with 22/604 (3.6% in the DHA+PQ group (risk difference 0.47%, 95%CI -2.3%,+3.3%, and 17/618 (2.8% in the SP+PQ group (risk difference 1.2%, 95%CI -1.3%,+3.6%. Prevalences of parasitaemia and the proportion of children carrying Pfdhfr and Pfdhps mutations associated with resistance to SP were very low in all groups at the end of the transmission season. CONCLUSIONS: Seasonal IPT with SP+PQ in children is highly effective and well tolerated; the combination of two long-acting drugs is likely to impede the emergence of resistant parasites. TRIAL REGISTRATION: ClinicalTrials.gov NCT00529620.

  12. Treating and preventing influenza in aged care facilities: a cluster randomised controlled trial.

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    Robert Booy

    Full Text Available BACKGROUND: Influenza is an important cause of morbidity and mortality for frail older people. Whilst the antiviral drug oseltamivir (a neuraminidase inhibitor is approved for treatment and prophylaxis of influenza during outbreaks, there have been no trials comparing treatment only (T versus treatment and prophylaxis (T&P in Aged Care Facilities (ACFs. Our objective was to compare a policy of T versus T&P for influenza outbreaks in ACFs. METHODS AND FINDINGS: We performed a cluster randomised controlled trial in 16 ACFs, that followed a policy of either "T"-oseltamivir treatment (75 mg twice a day for 5 days-or "T&P"-treatment and prophylaxis (75 mg once a day for 10 days for influenza outbreaks over three years, in addition to enhanced surveillance. The primary outcome measure was the attack rate of influenza. Secondary outcomes measures were deaths, hospitalisation, pneumonia and adverse events. Laboratory testing was performed to identify the viral cause of influenza-like illness (ILI outbreaks. The study period 30 June 2006 to 23 December 2008 included three southern hemisphere winters. During that time, influenza was confirmed as the cause of nine of the 23 ILI outbreaks that occurred amongst the 16 ACFs. The policy of T&P resulted in a significant reduction in the influenza attack rate amongst residents: 93/255 (36% in residents in T facilities versus 91/397 (23% in T&P facilities (p=0.002. We observed a non-significant reduction in staff: 46/216 (21% in T facilities versus 47/350 (13% in T&P facilities (p=0.5. There was a significant reduction in mean duration of outbreaks (T=24 days, T&P=11 days, p=0.04. Deaths, hospitalisations and pneumonia were non-significantly reduced in the T&P allocated facilities. Drug adverse events were common but tolerated. CONCLUSION: Our trial lacked power but these results provide some support for a policy of "treatment and prophylaxis" with oseltamivir in controlling influenza outbreaks in ACFs. TRIAL

  13. Feasibility of a controlled trial aiming to prevent excessive pregnancy-related weight gain in primary health care

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    Weiderpass Elisabete

    2008-08-01

    Full Text Available Abstract Background Excessive gestational weight gain and postpartum weight retention may predispose women to long-term overweight and other health problems. Intervention studies aiming at preventing excessive pregnancy-related weight gain are needed. The feasibility of implementing such a study protocol in primary health care setting was evaluated in this pilot study. Methods A non-randomized controlled trial was conducted in three intervention and three control maternity and child health clinics in primary health care in Finland. Altogether, 132 pregnant and 92 postpartum women and 23 public health nurses (PHN participated in the study. The intervention consisted of individual counselling on physical activity and diet at five routine visits to a PHN and of an option for supervised group exercise until 37 weeks' gestation or ten months postpartum. The control clinics continued their usual care. The components of the feasibility evaluation were 1 recruitment and participation, 2 completion of data collection, 3 realization of the intervention and 4 the public health nurses' experiences. Results 1 The recruitment rate was slower than expected and the recruitment period had to be prolonged from the initially planned three months to six months. The average participation rate of eligible women at study enrolment was 77% and the drop-out rate 15%. 2 In total, 99% of the data on weight, physical activity and diet and 96% of the blood samples were obtained. 3 In the intervention clinics, 98% of the counselling sessions were realized, their contents and average durations were as intended, 87% of participants regularly completed the weekly records for physical activity and diet, and the average participation percentage in the group exercise sessions was 45%. 4 The PHNs regarded the extra training as a major advantage and the high additional workload as a disadvantage of the study. Conclusion The study protocol was mostly feasible to implement, which

  14. Engagement, Retention, and Progression to Type 2 Diabetes: A Retrospective Analysis of the Cluster-Randomised "Let's Prevent Diabetes" Trial.

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    Laura J Gray

    2016-07-01

    Full Text Available Prevention of type 2 diabetes mellitus (T2DM is a global priority. Let's Prevent Diabetes is a group-based diabetes prevention programme; it was evaluated in a cluster-randomised trial, in which the primary analysis showed a reduction in T2DM (hazard ratio [HR] 0.74, 95% CI 0.48-1.14, p = 0.18. We examined the association of engagement and retention with the Let's Prevent Diabetes prevention programme and T2DM incidence.We used data from a completed cluster-randomised controlled trial including 43 general practices randomised to receive either standard care or a 6-h group structured education programme with an annual refresher course for 2 y. The primary outcome was progression to T2DM at 3 y. The characteristics of those who attended the initial education session (engagers versus nonengagers and those who attended all sessions (retainers versus nonretainers were compared. Risk reduction of progression to T2DM by level of attendance was compared to standard care. Eight hundred and eighty participants were recruited, with 447 to the intervention arm, of which 346 (77.4% were engagers and 130 (29.1% were retainers. Retainers and engagers were more likely to be older, leaner, and nonsmokers than nonretainers/nonengagers. Engagers were also more likely to be male and be from less socioeconomically deprived areas than nonengagers. Participants who attended the initial session and at least one refresher session were less likely to develop T2DM compared to those in the control arm (30 people of 248 versus 67 people of 433, HR 0.38 [95% CI 0.24-0.62]. Participants who were retained in the programme were also less likely to develop T2DM compared to those in the control arm (7 people of 130 versus 67 people of 433, HR 0.12 [95% CI 0.05-0.28]. Being retained in the programme was also associated with improvements in glucose, glycated haemoglobin (HbA1c, weight, waist circumference, anxiety, quality of life, and daily step count. Given that the data used are

  15. Multifaceted Intervention to Prevent Venous Thromboembolism in Patients Hospitalized for Acute Medical Illness: A Multicenter Cluster-Randomized Trial.

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    Pierre-Marie Roy

    Full Text Available Misuse of thromboprophylaxis may increase preventable complications for hospitalized medical patients.To assess the net clinical benefit of a multifaceted intervention in emergency wards (educational lectures, posters, pocket cards, computerized clinical decision support systems and, where feasible, electronic reminders for the prevention of venous thromboembolism.Prospective cluster-randomized trial in 27 hospitals. After a pre-intervention period, centers were randomized as either intervention (n = 13 or control (n = 14. All patients over 40 years old, admitted to the emergency room, and hospitalized in a medical ward were included, totaling 1,402 (712 intervention and 690 control and 15,351 (8,359 intervention and 6,992 control in the pre-intervention and intervention periods, respectively.Symptomatic venous thromboembolism or major bleeding (primary outcome occurred at 3 months in 3.1% and 3.2% of patients in the intervention and control groups, respectively (adjusted odds ratio: 1.02 [95% confidence interval: 0.78-1.34]. The rates of thromboembolism (1.9% vs. 1.9%, major bleedings (1.2% vs. 1.3%, and mortality (11.3% vs. 11.1% did not differ between the groups. Between the pre-intervention and intervention periods, the proportion of patients who received prophylactic anticoagulant treatment more steeply increased in the intervention group (from 35.0% to 48.2%: +13.2% than the control (40.7% to 44.1%: +3.4%, while the rate of adequate thromboprophylaxis remained stable in both groups (52.4% to 50.9%: -1.5%; 49.1% to 48.8%: -0.3%.Our intervention neither improved adequate prophylaxis nor reduced the rates of clinical events. New strategies are required to improve thromboembolism prevention for hospitalized medical patients.ClinicalTrials.gov NCT01212393.

  16. Efficacy of Supplementation with B Vitamins for Stroke Prevention: A Network Meta-Analysis of Randomized Controlled Trials.

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    Hongli Dong

    Full Text Available Supplementation with B vitamins for stroke prevention has been evaluated over the years, but which combination of B vitamins is optimal for stroke prevention is unclear. We performed a network meta-analysis to assess the impact of different combinations of B vitamins on risk of stroke.A total of 17 trials (86 393 patients comparing 7 treatment strategies and placebo were included. A network meta-analysis combined all available direct and indirect treatment comparisons to evaluate the efficacy of B vitamin supplementation for all interventions.B vitamin supplementation was associated with reduced risk of stroke and cerebral hemorrhage. The risk of stroke was lower with folic acid plus vitamin B6 as compared with folic acid plus vitamin B12 and was lower with folic acid plus vitamin B6 plus vitamin B12 as compared with placebo or folic acid plus vitamin B12. The treatments ranked in order of efficacy for stroke, from higher to lower, were folic acid plus vitamin B6 > folic acid > folic acid plus vitamin B6 plus vitamin B12 > vitamin B6 plus vitamin B12 > niacin > vitamin B6 > placebo > folic acid plus vitamin B12.B vitamin supplementation was associated with reduced risk of stroke; different B vitamins and their combined treatments had different efficacy on stroke prevention. Folic acid plus vitamin B6 might be the optimal therapy for stroke prevention. Folic acid and vitamin B6 were both valuable for stroke prevention. The efficacy of vitamin B12 remains to be studied.

  17. A Randomized Depression Prevention Trial Comparing Interpersonal Psychotherapy--Adolescent Skills Training to Group Counseling in Schools.

    Science.gov (United States)

    Young, Jami F; Benas, Jessica S; Schueler, Christie M; Gallop, Robert; Gillham, Jane E; Mufson, Laura

    2016-04-01

    Given the rise in depression disorders in adolescence, it is important to develop and study depression prevention programs for this age group. The current study examined the efficacy of Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST), a group prevention program for adolescent depression, in comparison to group programs that are typically delivered in school settings. In this indicated prevention trial, 186 adolescents with elevated depression symptoms were randomized to receive IPT-AST delivered by research staff or group counseling (GC) delivered by school counselors. Hierarchical linear modeling examined differences in rates of change in depressive symptoms and overall functioning from baseline to the 6-month follow-up assessment. Cox regression compared rates of depression diagnoses. Adolescents in IPT-AST showed significantly greater improvements in self-reported depressive symptoms and evaluator-rated overall functioning than GC adolescents from baseline to the 6-month follow-up. However, there were no significant differences between the two conditions in onset of depression diagnoses. Although both intervention conditions demonstrated significant improvements in depressive symptoms and overall functioning, results indicate that IPT-AST has modest benefits over groups run by school counselors which were matched on frequency and duration of sessions. In particular, IPT-AST outperformed GC in reduction of depressive symptoms and improvements in overall functioning. These findings point to the clinical utility of this depression prevention program, at least in the short-term. Additional follow-up is needed to determine the long-term effects of IPT-AST, relative to GC, particularly in preventing depression onset.

  18. Preventive Gabapentin versus Pregabalin to Decrease Postoperative Pain after Lumbar Microdiscectomy: A Randomized Controlled Trial

    Science.gov (United States)

    Qadeer, Mohsin; Waqas, Muhammad; Rashid, Muhammad Jawad; Enam, Syed Ather; Sharif, Salman

    2017-01-01

    Study Design Randomized controlled trial. Purpose The purpose of this study was to compare pregabalin and gabapentin for mean postoperative visual analog score (VAS) for pain in patients undergoing single-level lumbar microdiscectomy for intervertebral disc prolapse at a tertiary care hospital. Overview of Literature Pregabalin has a superior pharmacokinetic profile and analgesic effect at lower doses than gabapentin; however, analgesic efficacy must be established during the perioperative period after lumbar spine surgery. Methods This randomized controlled trial was carried out at our institute from February to October 2011 on 78 patients, with 39 participants in each study group. Patients undergoing lumbar microdiscectomy were randomized to group A (gabapentin) or group B (pregabalin) and started on trial medicines one week before surgery. The VAS for pain was recorded at 24 hours and one week postoperatively. Results Both groups had similar baseline variables, with mean ages of 42 and 39 years in groups A and B, respectively, and a majority of male patients in each group. The mean VAS values for pain at 24 hours for gabapentin vs. pregabalin were comparable (1.97±0.84 vs. 1.6±0.87, respectively; p=0.087) as were the results at one week after surgery (0.27±0.45 vs. 0.3±0.46, respectively; p=0.79). None of the patients required additional analgesia postoperatively. After adjusting for age and sex, the VAS value for group B patients was 0.028 points lower than for group A patients, but this difference was not statistically significant (p=0.817, R2=0.018). Conclusions Pregabalin is equivalent to gabapentin for the relief of postoperative pain at a lower dose in patients undergoing lumbar microdiscectomy. Therefore, other factors, such as dose, frequency, cost, pharmacokinetics, and side effects of these medicines, should be taken into account whenever it is prescribed. PMID:28243376

  19. P3MC: A double blind parallel group randomised placebo controlled trial of Propranolol and Pizotifen in preventing migraine in children

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    Whitham Diane

    2010-06-01

    Full Text Available Abstract Background A recent Cochrane Review demonstrated the remarkable lack of reliable clinical trials of migraine treatments for children, especially for the two most prescribed preventative treatments in the UK, Propranolol and Pizotifen. Migraine trials in both children and adults have high placebo responder rates, e.g. of 23%, but for a trial's results to be generalisable "placebo responders" should not be excluded and for a drug to be worthwhile it should be clearly superior, both clinically and statistically, to placebo. Methods/Design Two multicentre, two arm double blind parallel group randomised controlled trials, with allocation ratio of 2:1 for each comparison, Propranolol versus placebo and Pizotifen versus placebo. The trial is designed to test whether Propranolol is superior to placebo and whether Pizotifen is superior to placebo for the prevention of migraine attacks in children aged 5 - 16 years referred to secondary care out-patient settings with frequent migraine (2-6/4 weeks. The primary outcome measure is the number of migraine attacks during trial weeks 11 to 14. Discussion A strength of this trial is the participation of clinically well defined migraine patients who will also be approached to help with future longer-term follow-up studies. Trial Registration ISRCTN97360154

  20. Results of the Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) trial by stroke subtypes

    DEFF Research Database (Denmark)

    Amarenco, Pierre; Benavente, Oscar; Goldstein, Larry B

    2009-01-01

    BACKGROUND AND PURPOSE: The SPARCL trial showed that atorvastatin 80 mg/d reduces the risk of stroke and other cardiovascular events in patients with recent stroke or transient ischemic attack (TIA). We tested the hypothesis that the benefit of treatment varies according to index event stroke...... subtype. METHODS: Subjects with stroke or TIA without known coronary heart disease were randomized to atorvastatin 80 mg/d or placebo. The SPARCL primary end point was fatal or nonfatal stroke. Secondary end points included major cardiovascular events (MCVE; stroke plus major coronary events). Cox...

  1. Pulsed moxifloxacin for the prevention of exacerbations of chronic obstructive pulmonary disease: a randomized controlled trial

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    Rubinstein Ethan

    2010-01-01

    Full Text Available Abstract Background Acute exacerbations contribute to the morbidity and mortality associated with chronic obstructive pulmonary disease (COPD. This proof-of-concept study evaluates whether intermittent pulsed moxifloxacin treatment could reduce the frequency of these exacerbations. Methods Stable patients with COPD were randomized in a double-blind, placebo-controlled trial to receive moxifloxacin 400 mg PO once daily (N = 573 or placebo (N = 584 once a day for 5 days. Treatment was repeated every 8 weeks for a total of six courses. Patients were repeatedly assessed clinically and microbiologically during the 48-week treatment period, and for a further 24 weeks' follow-up. Results At 48 weeks the odds ratio (OR for suffering an exacerbation favoured moxifloxacin: per-protocol (PP population (N = 738, OR 0.75, 95% confidence interval (CI 0.565-0.994, p = 0.046, intent-to-treat (ITT population (N = 1149, OR 0.81, 95% CI 0.645-1.008, p = 0.059, and a post-hoc analysis of per-protocol (PP patients with purulent/mucopurulent sputum production at baseline (N = 323, OR 0.55, 95% CI 0.36-0.84, p = 0.006. There were no significant differences between moxifloxacin and placebo in any pre-specified efficacy subgroup analyses or in hospitalization rates, mortality rates, lung function or changes in St George's Respiratory Questionnaire (SGRQ total scores. There was, however, a significant difference in favour of moxifloxacin in the SGRQ symptom domain (ITT: -8.2 vs -3.8, p = 0.009; PP: -8.8 vs -4.4, p = 0.006. Moxifloxacin treatment was not associated with consistent changes in moxifloxacin susceptibility. There were more treatment-emergent, drug related adverse events with moxifloxacin vs placebo (p Conclusions Intermittent pulsed therapy with moxifloxacin reduced the odds of exacerbation by 20% in the ITT population, by 25% among the PP population and by 45% in PP patients with purulent/mucopurulent sputum at baseline. There were no unexpected adverse

  2. A Trial of Telephone Support Services to Prevent Further Intimate Partner Violence.

    Science.gov (United States)

    Stevens, Jack; Scribano, Philip V; Marshall, Jessica; Nadkarni, Radha; Hayes, John; Kelleher, Kelly J

    2015-12-01

    We conducted a randomized-controlled trial of telephone support services (TSS) versus enhanced usual care (EUC) for women who had reported intimate partner violence (IPV) within the past year during a visit to a pediatric emergency department. TSS nurse interventionists identified appropriate referrals to community programs, helped participants by problem-solving barriers to obtaining these local services, and provided social support. Three hundred women, ages 18 years and above were recruited. The TSS and EUC groups did not differ on any outcome variable, including IPV victimization, feelings of chronic vulnerability to a perpetrator, depressive symptoms, and posttraumatic stress disorder symptoms.

  3. Aspirin, Calcitriol, and Calcium Do Not Prevent Adenoma Recurrence in a Randomized Controlled Trial

    DEFF Research Database (Denmark)

    Pommergaard, Hans Christian; Burcharth, Jakob; Rosenberg, Jacob

    2016-01-01

    BACKGROUND & AIMS: Chemopreventive strategies might be used to reduce the recurrence of colorectal adenomas and the incidence of colorectal cancer. We performed a randomized, double-blind, placebo-controlled trial to determine whether a combination of acetylsalicylic acid (aspirin), calcitriol......, more than 1 adenoma of any size, or an adenoma of any size and first-degree relatives with colorectal cancer. Subjects were assigned randomly to groups given 0.5 μg calcitriol, 75 mg acetylsalicylic acid, and 1250 mg calcium carbonate (n = 209), or placebo (n = 218), each day for 3 years. The primary...

  4. Depression, Craving, and Substance Use Following a Randomized Trial of Mindfulness-Based Relapse Prevention

    Science.gov (United States)

    Witkiewitz, Katie; Bowen, Sarah

    2010-01-01

    Objective: A strong relation between negative affect and craving has been demonstrated in laboratory and clinical studies, with depressive symptomatology showing particularly strong links to craving and substance abuse relapse. Mindfulness-based relapse prevention (MBRP), shown to be efficacious for reduction of substance use, uses…

  5. Peer-Facilitated Eating Disorder Prevention: A Randomized Effectiveness Trial of Cognitive Dissonance and Media Advocacy

    Science.gov (United States)

    Becker, Carolyn Black; Smith, Lisa M.; Ciao, Anna C.

    2006-01-01

    The authors investigated the effectiveness of 2 interventions in reducing eating disorder risk factors under naturalistic conditions in sororities. On the basis of previous research, the campus sororities chose to implement a semimandatory, 2-session eating disorder prevention program to all new sorority members (N = 90) during sorority…

  6. Lung and Upper Aerodigestive Cancer Clinical Trials | Division of Cancer Prevention

    Science.gov (United States)

    The Division of Cancer Prevention (DCP) conducts and supports research to determine a person's risk of cancer and to find ways to reduce the risk. This knowledge is critical to making progress against cancer because risk varies over the lifespan as genetic and epigenetic changes can transform healthy tissue into invasive cancer.

  7. Randomized controlled trial of the effect of medical audit on AIDS prevention in general practice

    DEFF Research Database (Denmark)

    Sandbæk, Annelli

    1999-01-01

    OBJECTIVE: We aimed to evaluate the effect of a medical audit on AIDS prevention in general practice. METHODS: We conducted a prospective randomized controlled study performed as 'lagged intervention'. At the time of comparison, the intervention group had completed 6 months of audit including a p...

  8. Effectiveness of indometacin to prevent ovulation in modified natural-cycle IVF : A randomized controlled trial

    NARCIS (Netherlands)

    Rijken-Zijlstra, T. M.; Haadsma, M. L.; Hammer, C.; Burgerhof, J. G. M.; Pelinck, M. J.; Simons, A. H. M.; van Echten-Arends, J.; Arts, J. G. E. M.; Land, J. A.; Groen, H.; Hoek, A.

    2013-01-01

    Modified natural-cycle IVF has a lower pregnancy rate per started cycle as compared with IVF with ovarian stimulation due to, for example, premature ovulation. Indometacin administered before ovulation prevents follicle rupture. Therefore, addition of indometacin may improve the effectiveness of mod

  9. Efficacy of smoking prevention program 'Smoke-free Kids': Study protocol of a randomized controlled trial

    NARCIS (Netherlands)

    Hiemstra, M.; Ringlever, L.; Otten, R.; Jackson, C.; Schayck, O.C.P. van; Engels, R.C.M.E.

    2009-01-01

    Background - A strong increase in smoking is noted especially among adolescents. In the Netherlands, about 5% of all 10-year olds, 25% of all 13-year olds and 62% of all 17-year olds report ever smoking. In the U.S., an intervention program called 'Smoke-free Kids' was developed to prevent children

  10. Preventing Perinatal Depression in Low-Income Home Visiting Clients: A Randomized Controlled Trial

    Science.gov (United States)

    Tandon, S. Darius; Perry, Deborah F.; Mendelson, Tamar; Kemp, Karen; Leis, Julie A.

    2011-01-01

    Objective: To assess the efficacy of a 6-week cognitive-behavioral intervention in preventing the onset of perinatal depression and reducing depressive symptoms among low-income women in home visitation programs. Method: Sixty-one women who were pregnant or who had a child less than 6 months of age and who were assessed as at risk for perinatal…

  11. Effectiveness of Earplugs in Preventing Recreational Noise-Induced Hearing Loss : A Randomized Clinical Trial

    NARCIS (Netherlands)

    Ramakers, Geerte G J; Kraaijenga, Véronique J C; Cattani, Guido; van Zanten, Gijsbert A.; Grolman, Wilko

    2016-01-01

    IMPORTANCE: The incidence of hearing loss has risen in past years. Attendance at music festivals and concerts may contribute to this increasing problem. OBJECTIVE: To assess the effectiveness of earplugs in preventing temporary hearing loss immediately following music exposure. DESIGN, SETTING, AND

  12. Supportive and Palliative Care Research Clinical Trials | Division of Cancer Prevention

    Science.gov (United States)

    The Division of Cancer Prevention (DCP) conducts and supports research to determine a person's risk of cancer and to find ways to reduce the risk. This knowledge is critical to making progress against cancer because risk varies over the lifespan as genetic and epigenetic changes can transform healthy tissue into invasive cancer.

  13. Biomedical applications of nisin.

    Science.gov (United States)

    Shin, J M; Gwak, J W; Kamarajan, P; Fenno, J C; Rickard, A H; Kapila, Y L

    2016-06-01

    Nisin is a bacteriocin produced by a group of Gram-positive bacteria that belongs to Lactococcus and Streptococcus species. Nisin is classified as a Type A (I) lantibiotic that is synthesized from mRNA and the translated peptide contains several unusual amino acids due to post-translational modifications. Over the past few decades, nisin has been used widely as a food biopreservative. Since then, many natural and genetically modified variants of nisin have been identified and studied for their unique antimicrobial properties. Nisin is FDA approved and generally regarded as a safe peptide with recognized potential for clinical use. Over the past two decades the application of nisin has been extended to biomedical fields. Studies have reported that nisin can prevent the growth of drug-resistant bacterial strains, such as methicillin-resistant Staphylococcus aureus, Streptococcus pneumoniae, Enterococci and Clostridium difficile. Nisin has now been shown to have antimicrobial activity against both Gram-positive and Gram-negative disease-associated pathogens. Nisin has been reported to have anti-biofilm properties and can work synergistically in combination with conventional therapeutic drugs. In addition, like host-defence peptides, nisin may activate the adaptive immune response and have an immunomodulatory role. Increasing evidence indicates that nisin can influence the growth of tumours and exhibit selective cytotoxicity towards cancer cells. Collectively, the application of nisin has advanced beyond its role as a food biopreservative. Thus, this review will describe and compare studies on nisin and provide insight into its future biomedical applications.

  14. Effects of a multifactorial injury prevention intervention in physical education teachers: A randomized controlled trial.

    Science.gov (United States)

    Vercruysse, Sien; Haerens, Leen; Verhagen, Evert; Goossens, Lennert; De Clercq, Dirk

    2016-10-01

    Physical education (PE) teachers are at a high risk of musculoskeletal sports or work-related injuries because of the physical activity as inherent part of their profession. Such injuries have a negative impact on work and leisure time activities, and effective injury prevention interventions are needed. The present study aimed at testing the effectiveness of an injury prevention intervention that was developed and optimized according to PE teachers' wishes and values. Fifty-five PE teachers were randomly assigned to intervention or control group. Intervention group teachers engaged in two days of training during which they familiarized with eight injury prevention strategies (seven intrinsic and one extrinsic). A special feature of the intervention was that the way of delivery was based on the self-determination theory in order to stimulate participants' motivation to adhere to the proposed strategies. Prospective registrations during one school year were conducted concerning injuries and preventive behaviours. Results showed that the intervention group teachers had a lower number of injuries per 1000 h time of exposure (TOE) than the controls (INT: 0.49, CON: 1.14 injuries/1000 h TOE, OR: 2.32, 95% CI: 1.06-5.07), and applied a broader variety of strategies including dynamic and static stretching, core stability, balance and strength training, when compared to the controls who mainly engaged in warming-up. In conclusion, with the same amount of time, an injury reduction was found in PE teachers through a more balanced use of provided preventive strategies.

  15. Randomized prevention trial for early conduct problems: effects on proactive parenting and links to toddler disruptive behavior.

    Science.gov (United States)

    Gardner, Frances; Shaw, Daniel S; Dishion, Thomas J; Burton, Jennifer; Supplee, Lauren

    2007-09-01

    Despite knowledge of early pathways to conduct problems, few preventive interventions are specifically designed to modify disruptive behavior in toddlerhood. One potential prevention target is proactive and positive parenting, which is associated with reduced risk of conduct problems in preschoolers. This randomized trial with 120 low-income 2-year-old boys examined whether a brief family-centered intervention that reduces disruptive behavior (D. Shaw, T. Dishion, L. Supplee, F. Gardner, & K. Arnds, 2006) also leads to increases in proactive and positive parenting. It also explored whether change in parenting predicts change in disruptive behavior. In the intervention group, proactive and positive parenting skills increased among parents of 3-year-olds. Change in proactive and positive parenting of 2- to 3-year-old toddlers correlated with change in child disruptive behavior, although the mediation effect of positive parenting was of only borderline significance. Findings suggest that even within a brief and multifaceted preventive intervention, change in proactive parenting skills contributes modestly but significantly to change in child problem behavior.

  16. Integrating a Suicide Prevention Program into the Primary Health Care Network: A Field Trial Study in Iran

    Directory of Open Access Journals (Sweden)

    Seyed Kazem Malakouti

    2015-01-01

    Full Text Available Objective. To describe and evaluate the feasibility of integrating a suicide prevention program with Primary Health Care services and evaluate if such system can improve screening and identification of depressive disorder, reduce number of suicide attempters, and lower rate of suicide completion. Methodology. This was a quasi-experimental trial in which one community was exposed to the intervention versus the control community with no such exposure. The study sites were two counties in Western Iran. The intervention protocol called for primary care and suicide prevention collaboration at different levels of care. The outcome variables were the number of suicides committed, the number of documented suicide attempts, and the number of identified depressed cases. Results. We identified a higher prevalence of depressive disorders in the intervention site versus the control site (χ2=14.8, P<0.001. We also found a reduction in the rate of suicide completion in the intervention region compared to the control, but a higher prevalence of suicide attempts in both the intervention and the control sites. Conclusion. Integrating a suicide prevention program with the Primary Health Care network enhanced depression and suicide surveillance capacity and subsequently reduced the number of suicides, especially in rural areas.

  17. Enhanced relapse prevention for bipolar disorder – ERP trial. A cluster randomised controlled trial to assess the feasibility of training care coordinators to offer enhanced relapse prevention for bipolar disorder

    Directory of Open Access Journals (Sweden)

    Peters Sarah

    2007-02-01

    Full Text Available Abstract Background Bipolar Disorder (BD is a common and severe form of mental illness characterised by repeated relapses of mania or depression. Pharmacotherapy is the main treatment currently offered, but this has only limited effectiveness. A recent Cochrane review has reported that adding psycho-social interventions that train people to recognise and manage the early warning signs of their relapses is effective in increasing time to recurrence, improving social functioning and in reducing hospitalisations. However, the review also highlights the difficulties in offering these interventions within standard mental health services due to the need for highly trained therapists and extensive input of time. There is a need to explore the potential for developing Early Warning Sign (EWS interventions in ways that will enhance dissemination. Methods and design This article describes a cluster-randomised trial to assess the feasibility of training care coordinators (CCs in community mental health teams (CMHTs to offer Enhanced Relapse Prevention (ERP to people with Bipolar Disorder. CMHTs in the North West of England are randomised to either receive training in ERP and to offer this to their clients, or to continue to offer treatment as usual (TAU. The main aims of the study are (1 to determine the acceptability of the intervention, training and outcome measures (2 to assess the feasibility of the design as measured by rates of recruitment, retention, attendance and direct feedback from participants (3 to estimate the design effect of clustering for key outcome variables (4 to estimate the effect size of the impact of the intervention on outcome. In this paper we provide a rationale for the study design, briefly outline the ERP intervention, and describe in detail the study protocol. Discussion This information will be useful to researchers attempting to carry out similar feasibility assessments of clinical effectiveness trials and in particular

  18. Novel nonpharmacologic approaches for stroke prevention in atrial fibrillation: results from clinical trials

    Science.gov (United States)

    Proietti, Riccardo; Joza, Jacqueline; Arensi, Andrea; Levi, Michael; Russo, Vincenzo; Tzikas, Apostolos; Danna, Paolo; Sagone, Antonio; Viecca, Maurizio; Essebag, Vidal

    2015-01-01

    Atrial fibrillation (AF), the most common cardiac arrhythmia, confers a 5-fold risk of stroke that increases to 17-fold when associated with mitral stenosis. At this time, the most effective long-term solution to protect patients from stroke and thromboembolism is oral anticoagulation, either with vitamin K antagonists (VKAs) or a novel oral anticoagulant (NOAC). Despite the significant benefits they confer, both VKAs and NOACs are underused because of their increased potential for bleeding, and VKAs are underused because of their narrow therapeutic range, need for regular international normalized ratio checks, and interactions with food or medications. In patients with nonvalvular AF, approximately 90% of strokes originate from the left atrial appendage (LAA); in patients with rheumatic mitral valve disease, many patients (60%) have strokes that originate from the left atrium itself. Surgical LAA amputation or closure, although widely used to reduce stroke risk in association with cardiac surgery, is not currently performed as a stand-alone operation for stroke risk reduction because of its invasiveness. Percutaneous LAA closure, as an alternative to anticoagulation, has been increasingly used during the last decade in an effort to reduce stroke risk in nonvalvular AF. Several devices have been introduced during this time, of which one has demonstrated noninferiority compared with warfarin in a randomized controlled trial. This review describes the available technologies for percutaneous LAA closure, as well as a summary of the published trials concerning their safety and efficacy in reducing stroke risk in AF. PMID:25678828

  19. The NARCONON™ drug education curriculum for high school students: A non-randomized, controlled prevention trial

    Directory of Open Access Journals (Sweden)

    Cecchini Marie A

    2008-03-01

    Full Text Available Abstract Background An estimated 13 million youths aged 12 to 17 become involved with alcohol, tobacco and other drugs annually. The number of 12- to 17-year olds abusing controlled prescription drugs increased an alarming 212 percent between 1992 and 2003. For many youths, substance abuse precedes academic and health problems including lower grades, higher truancy, drop out decisions, delayed or damaged physical, cognitive, and emotional development, or a variety of other costly consequences. For thirty years the Narconon program has worked with schools and community groups providing single educational modules aimed at supplementing existing classroom-based prevention activities. In 2004, Narconon International developed a multi-module, universal prevention curriculum for high school ages based on drug abuse etiology, program quality management data, prevention theory and best practices. We review the curriculum and its rationale and test its ability to change drug use behavior, perceptions of risk/benefits, and general knowledge. Methods After informed parental consent, approximately 1000 Oklahoma and Hawai'i high school students completed a modified Center for Substance Abuse Prevention (CSAP Participant Outcome Measures for Discretionary Programs survey at three testing points: baseline, one month later, and six month follow-up. Schools assigned to experimental conditions scheduled the Narconon curriculum between the baseline and one-month follow-up test; schools in control conditions received drug education after the six-month follow-up. Student responses were analyzed controlling for baseline differences using analysis of covariance. Results At six month follow-up, youths who received the Narconon drug education curriculum showed reduced drug use compared with controls across all drug categories tested. The strongest effects were seen in all tobacco products and cigarette frequency followed by marijuana. There were also significant

  20. Biomedical Plasmonics

    Science.gov (United States)

    Halas, Naomi

    2010-03-01

    The near infrared region of the optical spectrum provides a window into the human body that can be exploited for diagnostics and therapeutics, offering an opportunity to merge these concepts. We have shown that the strong light-absorbing and light-scattering properties of noble metal nanoparticles can be controlled by manipulating their shape: in a core-shell geometry, the metallic shell layer can be easily tuned to this spectral region. This `nanoshell' geometry has proven to be ideal for enhancing both diagnostic and therapeutic modalities for cancer. Nanoshells can serve as light scattering beacons, strong enhancers of fluorescent markers for optical tomography, and impart a highly effective, targeted therapeutic response via their unparalleled light-to-heat conversion properties. This latter effect has been used to induce cell death and tumor remission in animals at greater than 90% efficacy, and is currently in clinical trials. This nanoparticle platform can be combined with MRI contrast agents for the enhancement of dual imaging modalities, and also shows promise as a light-controlled nonviral vector for intracellular gene delivery.

  1. Misreporting of Product Adherence in the MTN-003/VOICE Trial for HIV Prevention in Africa: Participants' Explanations for Dishonesty.

    Science.gov (United States)

    Montgomery, Elizabeth T; Mensch, B; Musara, P; Hartmann, M; Woeber, K; Etima, J; van der Straten, A

    2017-02-01

    Consistent over-reporting of product use limits researchers' ability to accurately measure adherence and estimate product efficacy in HIV prevention trials. While lying is a universal characteristic of the human condition, growing evidence of a stark discrepancy between self-reported product use and biologic or pharmacokinetic evidence demands examination of the reasons research participants frequently misrepresent product use in order to mitigate this challenge in future research. This study (VOICE-D) was an ancillary post-trial study of the vaginal and oral interventions to control the epidemic (VOICE) phase IIb trial (MTN 003). It was conducted in three African countries to elicit candid accounts from former VOICE trial participants about why actual product use was lower than reported. In total 171 participants were enrolled between December 2012 and March 2014 in South Africa (n = 47), Uganda (n = 59) and Zimbabwe (n = 65). Data suggested that participants understood the importance of daily product use and honest reporting, yet acknowledged that research participants typically lie. Participants cited multiple reasons for misreporting adherence, including human nature, self-presentation with study staff, fear of repercussions (study termination resulting in loss of benefits and experience of HIV-related stigma), a permissive environment in which it was easy to get away with misreporting, and avoiding inconvenient additional counseling. Some participants also reported mistrust of the staff and reciprocal dishonesty about the study products. Many suggested real-time blood-monitoring during trials would encourage greater fidelity to product use and honesty in reporting. Participants at all sites understood the importance of daily product use and honesty, while also acknowledging widespread misreporting of product use. Narratives of dishonesty may suggest a wider social context of hiding products from partners and distrust about research, influenced by rumors

  2. Critically engaging: integrating the social and the biomedical in international microbicides research.

    Science.gov (United States)

    Montgomery, Catherine M; Pool, Robert

    2011-09-27

    Randomized controlled trials and critical social theory are known not to be happy bedfellows. Such trials are embedded in a positivist view of the world, seeking definitive answers to testable questions; critical social theory questions the methods by which we deem the world knowable and may consider experiments in the biomedical sciences as social artifacts. Yet both of these epistemologically and methodologically divergent fields offer potentially important advances in HIV research. In this paper, we describe collaboration between social and biomedical researchers on a large, publicly funded programme to develop vaginal microbicides for HIV prevention. In terms of critical engagement, having integrated and qualitative social science components in the protocol meant potentially nesting alternative epistemologies at the heart of the randomized controlled trial. The social science research highlighted the fallibility and fragility of trial data by demonstrating inconsistencies in key behavioural measurements. It also foregrounded the disjuncture between biomedical conceptions of microbicides and the meanings and uses of the study gel in the context of users' everyday lives. These findings were communicated to the clinical and epidemiological members of the team on an ongoing basis via a feedback loop, through which new issues of concern could also be debated and, in theory, data collection adjusted to the changing needs of the programme. Although critical findings were taken on board by the trialists, a hierarchy of evidence nonetheless remained that limited the utility of some social science findings. This was in spite of mutual respect between clinical epidemiologists and social scientists, equal representation in management and coordination bodies, and equity in funding for the different disciplines. We discuss the positive role that social science integrated into an HIV prevention trial can play, but nonetheless highlight tensions that remain where a hierarchy

  3. Biomedical ethics and the biomedical engineer: a review.

    Science.gov (United States)

    Saha, S; Saha, P S

    1997-01-01

    Biomedical engineering is responsible for many of the dramatic advances in modern medicine. This has resulted in improved medical care and better quality of life for patients. However, biomedical technology has also contributed to new ethical dilemmas and has challenged some of our moral values. Bioengineers often lack adequate training in facing these moral and ethical problems. These include conflicts of interest, allocation of scarce resources, research misconduct, animal experimentation, and clinical trials for new medical devices. This paper is a compilation of our previous published papers on these topics, and it summarizes many complex ethical issues that a bioengineer may face during his or her research career or professional practice. The need for ethics training in the education of a bioengineering student is emphasized. We also advocate the adoption of a code of ethics for bioengineers.

  4. Forskolin versus sodium cromoglycate for prevention of asthma attacks: a single-blinded clinical trial.

    Science.gov (United States)

    González-Sánchez, R; Trujillo, X; Trujillo-Hernández, B; Vásquez, C; Huerta, M; Elizalde, A

    2006-01-01

    To determine the efficacy of forskolin in preventing asthma attacks, we performed a single-blinded clinical study in children and adult out-patients at a public hospital in Mexico. Forty patients of either sex with mild persistent or moderate persistent asthma were assigned randomly to 6 months of treatment with forskolin at 10 mg/day orally (capsules) or with two inhalations of sodium cromoglycate every 8 h, i.e. three times a day. The number of patients who had asthma attacks during the treatment period was significantly lower among those receiving forskolin (8/20, 40%) than among those receiving sodium cromoglycate (17/20, 85%). Values of forced expiratory volume in 1 s and forced expiratory flow, mid-phase, A similar in the two groups during the treatment period. We conclude that forskolin is more effective than sod cromoglycate in preventing asthma attacks in patients with mild persistent or moderate persistent asthma.

  5. Association of peripheral differential leukocyte counts with dyslipidemia risk in Chinese patients with hypertension: insight from the China Stroke Primary Prevention Trial[S

    Science.gov (United States)

    Liu, Yanhong; Kong, Xiangyi; Wang, Wen; Fan, Fangfang; Zhang, Yan; Zhao, Min; Wang, Yi; Wang, Yupeng; Wang, Yu; Qin, Xianhui; Tang, Genfu; Wang, Binyan; Xu, Xiping; Hou, Fan Fan; Gao, Wei; Sun, Ningling; Li, Jianping; Venners, Scott A.; Jiang, Shanqun; Huo, Yong

    2017-01-01

    The aim of the present study was to examine the association between peripheral differential leukocyte counts and dyslipidemia in a Chinese hypertensive population. A total of 10,866 patients with hypertension were enrolled for a comprehensive assessment of cardiovascular risk factors using data from the China Stroke Primary Prevention Trial. Plasma lipid levels and total leukocyte, neutrophil, and lymphocyte counts were determined according to standard methods. Peripheral differential leukocyte counts were consistently and positively associated with serum total cholesterol (TC), LDL cholesterol (LDL-C), and TG levels (all P < 0.001 for trend), while inversely associated with HDL cholesterol levels (P < 0.05 for trend). In subsequent analyses where serum lipids were dichotomized (dyslipidemia/normolipidemia), we found that patients in the highest quartile of total leukocyte count (≥7.6 × 109 cells/l) had 1.64 times the risk of high TG [95% confidence interval (CI): 1.46, 1.85], 1.34 times the risk of high TC (95% CI: 1.20, 1.50), and 1.24 times the risk of high LDL-C (95% CI: 1.12, 1.39) compared with their counterparts in the lowest quartile of total leukocyte count. Similar patterns were also observed with neutrophils and lymphocytes. In summary, these findings indicate that elevated differential leukocyte counts are directly associated with serum lipid levels and increased odds of dyslipidemia. PMID:27879312

  6. Primary prevention of cannabis use: a systematic review of randomized controlled trials.

    Directory of Open Access Journals (Sweden)

    Melissa M Norberg

    Full Text Available A systematic review of primary prevention was conducted for cannabis use outcomes in youth and young adults. The aim of the review was to develop a comprehensive understanding of prevention programming by assessing universal, targeted, uni-modal, and multi-modal approaches as well as individual program characteristics. Twenty-eight articles, representing 25 unique studies, identified from eight electronic databases (EMBASE, MEDLINE, CINAHL, ERIC, PsycINFO, DRUG, EBM Reviews, and Project CORK, were eligible for inclusion. Results indicated that primary prevention programs can be effective in reducing cannabis use in youth populations, with statistically significant effect sizes ranging from trivial (0.07 to extremely large (5.26, with the majority of significant effect sizes being trivial to small. Given that the preponderance of significant effect sizes were trivial to small and that percentages of statistically significant and non-statistically significant findings were often equivalent across program type and individual components, the effectiveness of primary prevention for cannabis use should be interpreted with caution. Universal multi-modal programs appeared to outperform other program types (i.e, universal uni-modal, targeted multi-modal, targeted unimodal. Specifically, universal multi-modal programs that targeted early adolescents (10-13 year olds, utilised non-teacher or multiple facilitators, were short in duration (10 sessions or less, and implemented boosters sessions were associated with large median effect sizes. While there were studies in these areas that contradicted these results, the results highlight the importance of assessing the interdependent relationship of program components and program types. Finally, results indicated that the overall quality of included studies was poor, with an average quality rating of 4.64 out of 9. Thus, further quality research and reporting and the development of new innovative programs are

  7. Dysphagia Rehabilitation and Prevention of Aspiration Pneumonia : The trial of Integrative Medicine -

    OpenAIRE

    植田, 耕一郎; Ueda, Koichiro

    2003-01-01

    Dysphagia rehabilitation has made rapid progress for ten years. It has been come into wide use across fields of medical care, health and welfare. Contacting with rehabilitation medicine, it was thought that training was possible for a mouth obstacle. However we have come to the time to reflect about dysphagia rehabilitation. Chronic diseases are increasing in aging society. And integrative medicine is new possibility of dysphagia rehabilitation and prevention of aspiration pneumonia in the si...

  8. Topical Calendula and Betamethasone Valerate in the prevention of acute radiation dermatitis: a randomized prospective trial

    Directory of Open Access Journals (Sweden)

    Fotouhi M

    2007-07-01

    Full Text Available Background: Acute radiation dermatitis is a very common side effect of radiation therapy for many cancers, including breast cancer. Despite the high prevalence of acute radiation dermatitis as well as wet desquamation, only a few trials studying the prophylaxis of this complication using topical treatment have been conducted. In spite of these studies, some controversy still exists about regarding treatments for acute radiation dermatitis, as does some concern about their long-term complications. For this reason, we conducted a clinical trial for a new treatment with the same effectiveness as corticosteroids, but fewer complications. Methods: This trial included 60 patients with pathologic diagnoses of breast cancer for whom radiotherapy had been planned. Patients were 30-73 years old. Patients with radical mastectomy received 5000 cGy over five weeks, and those with conservative surgery received 6000 cGy over six weeks divided in 200 cGy fractions. Patients were divided randomly into two groups: one group received a moderately-potent glucocorticoid steroid, 0.1% betamethasone ointment (30, and the other received the new treatment, 0.1% calendula ointment (30. All patients applied their respective drugs twice daily within the tangential field from the first day of radiation treatment until one month after treatment was completed. Starting one week after radiation therapy commenced, patients were monitored weekly for symptoms of dermatitis and the degree of severity as well as possible adverse drug effects, in addition to such monitoring on the days of their appointments. Four weeks after termination of therapy, patients were again examined, at which time they completed a questionnaire about dermatologic complications. Results: The mean time to develop dermatitis was 3.7 weeks for the betamethasone group and 3.87 weeks for the calendula group. Maximal dermatitis intensity during treatment in the betamethasone group was: 0, 6.7%; I, 73.3%; II, 16

  9. A failed RCT to determine if antibiotics prevent mastitis: Cracked nipples colonized with Staphylococcus aureus: A randomized treatment trial [ISRCTN65289389

    OpenAIRE

    Garland Suzanne M; Lumley Judith; Amir Lisa

    2004-01-01

    Abstract Background A small, non-blinded, RCT (randomised controlled trial) had reported that oral antibiotics reduced the incidence of mastitis in lactating women with Staphylococcus aureus (S. aureus)- colonized cracked nipples. We aimed to replicate the study with a more rigorous design and adequate sample size. Methods Our intention was to conduct a double-blind placebo-controlled trial to determine if an antibiotic (flucloxacillin) could prevent mastitis in lactating women with S. aureus...

  10. Genetic associations with plasma B12, B6, and folate levels in an ischemic stroke population from the Vitamin Intervention for Stroke Prevention (VISP) trial

    OpenAIRE

    Keene, Keith L; Wei-Min eChen; Fang eChen; Stephen Richardson Williams; Elkhatib, Stacey D.; Fang-Chi eHsu; Mychaleckyj, Josyf C; Doheny, Kimberley F.; Pugh, Elizabeth W.; Hua eLing; Cathy C Laurie; Stephanie M Gogarten; Madden, Ebony B.; Worrall, Bradford B.; Sale, Michele M.

    2014-01-01

    B vitamins play an important role in homocysteine metabolism, with vitamin deficiencies resulting in increased levels of homocysteine and increased risk for stroke. We performed a genome-wide association study (GWAS) in 2,100 stroke patients from the Vitamin Intervention for Stroke Prevention (VISP) trial, a clinical trial designed to determine whether the daily intake of high dose folic acid, vitamins B6 and B12 reduce recurrent cerebral infarction. Extensive quality control (QC) measures re...

  11. Genetic Associations with Plasma B12, B6, and Folate Levels in an Ischemic Stroke Population from the Vitamin Intervention for Stroke Prevention (VISP) Trial

    OpenAIRE

    Keene, Keith L; Chen, Wei-Min; Chen, Fang; Stephen R Williams; Elkhatib, Stacey D.; Hsu, Fang-Chi; Mychaleckyj, Josyf C; Doheny, Kimberly F.; Pugh, Elizabeth W.; Ling, Hua; Cathy C Laurie; Stephanie M Gogarten; Madden, Ebony B.; Worrall, Bradford B.; Sale, Michele M.

    2014-01-01

    Background: B vitamins play an important role in homocysteine metabolism, with vitamin deficiencies resulting in increased levels of homocysteine and increased risk for stroke. We performed a genome-wide association study (GWAS) in 2,100 stroke patients from the Vitamin Intervention for Stroke Prevention (VISP) trial, a clinical trial designed to determine whether the daily intake of high-dose folic acid, vitamins B6, and B12 reduce recurrent cerebral infarction. Methods: Extensive quality...

  12. Can orthotic insoles prevent lower limb overuse injuries? A randomized-controlled trial of 228 subjects.

    Science.gov (United States)

    Mattila, V M; Sillanpää, P J; Salo, T; Laine, H-J; Mäenpää, H; Pihlajamäki, H

    2011-12-01

    Lower limb overuse injuries are common among people who are exposed to physical stress. Orthotic shoe insoles are widely used to prevent lower limb overuse injuries. Here, we conducted a randomized-controlled study to examine whether the use of orthotic insoles prevents lower limb overuse injuries. Participants (n=228) were randomly assigned to use (n=73) or not to use (n=147) orthotic insoles. The insoles were molded to the shape of the foot to provide support during physical activity. The main outcome measure in the present study was the physician-diagnosed lower limb overuse injury. Thirty-four (46.6%) subjects in the insole group were diagnosed with a lower limb overuse injury compared with 56 (38.1%) in the control group (P=0.29) during the 6-month study period. When body mass index and the results of a 12-min running test and muscle strength were adjusted in a Cox's regression model, the hazard ratio for lower limb overuse injury in the insole group was 1.3 (95% confidence intervals: 0.8-2.1) compared with the control group. Use of orthotic insoles was not associated with a decrease in lower limb overuse injuries. Our findings suggest that routine use of orthotic insoles does not prevent physical-stress-related lower limb injuries in healthy young male adults.

  13. HIV Prevention for Juvenile Drug Court Offenders: A Randomized Controlled Trial Focusing on Affect Management

    Science.gov (United States)

    Tolou-Shams, Marina; Houck, Christopher D.; Conrad, Selby M.; Tarantino, Nicholas; Stein, L.A.R.; Brown, Larry K.

    2011-01-01

    Background Juvenile drug court offenders have benefited from evidence-based interventions addressing antisocial behavior, mental health and/or substance use; however, interventions addressing HIV risk behavior are lacking. This study presents pilot findings and lessons learned from a group-based HIV prevention intervention delivered to juvenile drug court offenders. Methods Participants were randomized to a 5-session HIV Prevention (n =29) or Health Promotion (n=28) condition and completed measures of sexual risk taking and substance use at baseline and 3 month post-intervention. Results No between-group differences by time emerged on measures of sexual risk-taking or other HIV-related behaviors and attitudes. Both groups improved their rates of HIV testing and decreased their substance use during sex over time. Conclusions Delivering an HIV prevention intervention to drug court offenders is feasible; however, more intensive interventions that incorporate multiple systems and address co-occurring mental health difficulties may be needed to affect sexual behavioral change among these high-risk court-involved youth. PMID:21474529

  14. HIV prevention for juvenile drug court offenders: a randomized controlled trial focusing on affect management.

    Science.gov (United States)

    Tolou-Shams, Marina; Houck, Christopher; Conrad, Selby M; Tarantino, Nicholas; Stein, L A R; Brown, Larry K

    2011-07-01

    Juvenile drug court (JDC) offenders have benefited from evidence-based interventions addressing antisocial behavior, mental health, and substance use; however, interventions addressing HIV risk behavior are lacking. This study presents pilot findings and lessons learned from a group-based HIV prevention intervention delivered to JDC offenders. Participants were randomized to a five-session HIV prevention (n = 29) or health promotion (n = 28) condition and completed measures of sexual risk taking and substance use at baseline and 3 months postintervention. No between-group differences by time emerged on measures of sexual risk taking or other HIV-related behaviors and attitudes. Both groups improved their rates of HIV testing and decreased their substance use during sex over time. Delivering an HIV prevention intervention to drug court offenders is feasible; however, more intensive interventions that incorporate multiple systems and address co-occurring mental health difficulties may be needed to effect sexual behavioral change among these high-risk court-involved youth.

  15. A randomized controlled intervention trial to relieve and prevent neck/shoulder pain

    DEFF Research Database (Denmark)

    Andersen, Lars L; Jørgensen, Marie B; Blangsted, Anne Katrine;

    2008-01-01

    PURPOSE: The objective of this study is to investigate the effect of three different workplace interventions on long-term compliance, muscle strength gains, and neck/shoulder pain in office workers. METHODS: A 1-yr randomized controlled intervention trial was done with three groups: specific...... in maximal muscle strength, and changes in intensity of neck/shoulder pain (scale 0-9) in those with and without pain at baseline. RESULTS: Regular participation was achieved by 54%, 31%, and 16% of those of the participants who answered the questionnaire in SRT (78%), APE (81%), and REF (80%), respectively......, during the first half of the intervention period, and decreased to 35%, 28% and 9%, respectively, during the second half. Shoulder elevation strength increased 9-11% in SRT and APE (P pain at baseline decreased the intensity of neck pain through SRT, from 5.0 +/- 0...

  16. Celecoxib to prevent restenosis--results from the COREA-TAXUS trial.

    Science.gov (United States)

    Doggrell, Sheila A

    2008-02-01

    Celecoxib inhibits Akt, which is stimulated during restenosis. Cell and animal studies showed that celecoxib inhibited Akt stimulation and restenosis. Recently, the COREA-TAXUS (Effect of Celecoxib on Restenosis after Coronary Angioplasty with Taxus stent) trial was performed in subjects with angina or a positive-stress test receiving paclitaxel-eluting stents. The primary end point at 6 months was the in-stent, late luminal loss, which was 0.49 mm in the celecoxib-treated group; less than the 0.75 mm in the group not treated with celecoxib. The rate of revascularisation of the target lesion was lower in celecoxib-treated subjects (5%) than in the untreated subjects (15%). In conclusion, this is an excellent demonstration of translating a mechanism of action of a drug into a clinical use.

  17. Recruitment and retention of participants for an international type 1 diabetes prevention trial

    DEFF Research Database (Denmark)

    Franciscus, Margaret; Nucci, Anita; Bradley, Brenda;

    2014-01-01

    for long-term follow-up assessments. PURPOSE: Our purpose is to summarize the recruitment and retention strategies used to conduct TRIGR from the perspective of the study coordinators. METHODS: TRIGR was designed to test whether weaning to formula containing hydrolyzed versus intact cow's milk protein...... would be efficacious in decreasing risk for development of T1D-associated autoantibodies and T1D among infants identified to be at increased risk for T1D based on their human leukocyte antigen (HLA) profile and family history. Multiple strategies tailored to local issues were required to enroll...... privacy regulations mid-trial. The majority of participants were recruited from primary care antenatal clinics located near the study centers and from a general hospital or pediatric center that was affiliated with a TRIGR Study center. Internet and magazine advertisements were found to be useful...

  18. Functional Outcomes of the Low Vision Depression Prevention Trial in Age-Related Macular Degeneration

    Science.gov (United States)

    Deemer, Ashley D.; Massof, Robert W.; Rovner, Barry W.; Casten, Robin J.; Piersol, Catherine V.

    2017-01-01

    Purpose To compare the efficacy of behavioral activation (BA) plus low vision rehabilitation with an occupational therapist (OT-LVR) with supportive therapy (ST) on visual function in patients with age-related macular degeneration (AMD). Methods Single-masked, attention-controlled, randomized clinical trial with AMD patients with subsyndromal depressive symptoms (n = 188). All subjects had two outpatient low vision rehabilitation optometry visits, then were randomized to in-home BA + OT-LVR or ST. Behavioral activation is a structured behavioral treatment aiming to increase adaptive behaviors and achieve valued goals. Supportive therapy is a nondirective, psychological treatment that provides emotional support and controls for attention. Functional vision was assessed with the activity inventory (AI) in which participants rate the difficulty level of goals and corresponding tasks. Participants were assessed at baseline and 4 months. Results Improvements in functional vision measures were seen in both the BA + OT-LVR and ST groups at the goal level (d = 0.71; d = 0.56 respectively). At the task level, BA + OT-LVR patients showed more improvement in reading, inside-the-home tasks and outside-the-home tasks, when compared to ST patients. The greatest effects were seen in the BA + OT-LVR group in subjects with a visual acuity ≥20/70 (d = 0.360 reading; d = 0.500 inside the home; d = 0.468 outside the home). Conclusions Based on the trends of the AI data, we suggest that BA + OT-LVR services, provided by an OT in the patient's home following conventional low vision optometry services, are more effective than conventional optometric low vision services alone for those with mild visual impairment. (ClinicalTrials.gov number, NCT00769015.) PMID:28273318

  19. Effect of progesterone as maintenance tocolytic therapy on the prevention of recurrent preterm labor: a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Hajieh Borna

    2007-03-01

    Full Text Available Objective: The study evaluated the efficacy and safety of vaginal progesterone on prevention of recurrent preterm labor.Materials and methods: Total number of 70 patients with preterm labor treated with intravenous magnesium sulfate in perinatology department of valiasr hospital entered to a randomized clinical trial. Treatment group after inhibition of preterm labor with magnesium sulfate received progesterone suppository (400 mg daily until delivery and control group received no treatment. Latency until delivery, recurrence of preterm labor and neonatal outcomes were studied. Statistical significance was defined as p< 0.05.Results: Mean latency until delivery (p< 0.05, low birth weight (p< 0.05, birth weight (p< 0.01 were significantly different between the two groups. Recurrence of preterm labor was not significantly different between the groups.Conclusions: The use of vaginal progesterone suppository after successful parenteral tocolysis associated with a longer latency preceding delivery but failed to reduce the incidence of recurrent preterm labor.

  20. Metronidazole (Flagyl) and Arnica Montana in the prevention of post-surgical complications, a comparative placebo controlled clinical trial.

    Science.gov (United States)

    Kaziro, G S

    1984-02-01

    A double blind trial, was designed, in which 118 patients undergoing the removal of impacted wisdom teeth were randomly divided into the following groups; 41 patients received Metronidazole, 39 patients received Arnica Montana, 38 patients received the placebo. Metronidazole was more effective in pain control than Arnica (p less than 0.001) and placebo (p less than 0.01). It prevented swelling better than Arnica (p less than 0.01) and placebo (p less than 0.05) and was more effective in promoting healing than Arnica (p less than 0.01) and placebo (p greater than 0.02). Arnica Montana appeared to give rise to greater pain than placebo (p less than 0.05) and caused more swelling than the placebo (p less than 0.01).

  1. Randomized controlled trials of HIV/AIDS prevention and treatment in Africa: results from the Cochrane HIV/AIDS Specialized Register.

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    Babalwa Zani

    Full Text Available INTRODUCTION: To effectively address HIV/AIDS in Africa, evidence on preventing new infections and providing effective treatment is needed. Ideally, decisions on which interventions are effective should be based on evidence from randomized controlled trials (RCTs. Our previous research described African RCTs of HIV/AIDS reported between 1987 and 2003. This study updates that analysis with RCTs published between 2004 and 2008. OBJECTIVES: To describe RCTs of HIV/AIDS conducted in Africa and reported between 2004 and 2008. METHODS: We searched the Cochrane HIV/AIDS Specialized Register in September 2009. Two researchers independently evaluated studies for inclusion and extracted data using standardized forms. Details included location of trials, interventions, methodological quality, location of principal investigators and funders. RESULTS: Our search identified 834 RCTs, with 68 conducted in Africa. Forty-three assessed prevention-interventions and 25 treatment-interventions. Fifteen of the 43 prevention RCTs focused on preventing mother-to-child HIV transmission. Thirteen of the 25 treatment trials focused on opportunistic infections. Trials were conducted in 16 countries with most in South Africa (20, Zambia (12 and Zimbabwe (9. The median sample size was 628 (range 33-9645. Methods used for the generation of the allocation sequence and allocation concealment were adequate in 38 and 32 trials, respectively, and 58 reports included a CONSORT recommended flow diagram. Twenty-nine principal investigators resided in the United States of America (USA and 18 were from African countries. Trials were co-funded by different agencies with most of the funding obtained from USA governmental and non-governmental agencies. Nineteen pharmaceutical companies provided partial funding to 15 RCTs and African agencies co-funded 17 RCTs. Ethical approval was reported in 65 trials and informed consent in 61 trials. CONCLUSION: Prevention trials dominate the trial

  2. Mortality and morbidity during and after Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial: results by sex.

    Science.gov (United States)

    Oparil, Suzanne; Davis, Barry R; Cushman, William C; Ford, Charles E; Furberg, Curt D; Habib, Gabriel B; Haywood, L Julian; Margolis, Karen; Probstfield, Jeffrey L; Whelton, Paul K; Wright, Jackson T

    2013-05-01

    To determine whether an angiotensin-converting enzyme inhibitor (lisinopril) or calcium channel blocker (amlodipine) is superior to a diuretic (chlorthalidone) in reducing cardiovascular disease incidence in sex subgroups, we carried out a prespecified subgroup analysis of 15 638 women and 17 719 men in the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). Total follow-up (active treatment + passive surveillance using national administrative databases to ascertain deaths and hospitalizations) was 8 to 13 years. The primary outcome was fatal coronary heart disease or nonfatal myocardial infarction. Secondary outcomes included all-cause mortality, stroke, combined cardiovascular disease (coronary heart disease death, nonfatal myocardial infarction, stroke, angina, coronary revascularization, heart failure [HF], or peripheral vascular disease), and end-stage renal disease. In-trial rates of HF, stroke, and combined cardiovascular disease were significantly higher for lisinopril compared with chlorthalidone, and rates of HF were significantly higher for amlodipine compared with chlorthalidone in both men and women. There were no significant treatment sex interactions. These findings did not persist through the extension period with the exception of the HF result for amlodipine versus chlorthalidone, which did not differ significantly by sex. For both women and men, rates were not lower in the amlodipine or lisinopril groups than in the chlorthalidone group for either the primary coronary heart disease outcome or any other cardiovascular disease outcome, and chlorthalidone-based treatment resulted in the lowest risk of HF. Neither lisinopril nor amlodipine is superior to chlorthalidone for initial treatment of hypertension in either women or men. Clinical Trial Registration- clinicaltrials.gov; Identifier: NCT00000542.

  3. Lactobacillus reuteri DSM 17938 in the prevention of antibiotic-associated diarrhoea in children: protocol of a randomised controlled trial

    Science.gov (United States)

    Kołodziej, Maciej; Szajewska, Hania

    2017-01-01

    Introduction Administration of some probiotics appears to reduce the risk of antibiotic-associated diarrhoea (AAD). The effects of probiotics are strain-specific, thus, the efficacy and safety of each probiotic strain should be established separately. We aim to assess the effects of Lactobacillus reuteri DSM 17938 administration for the prevention of diarrhoea and AAD in children. Methods and analysis A total of 250 children younger than 18 years treated with antibiotics will be enrolled in a double-blind, randomised, placebo-controlled trial in which they will additionally receive L. reuteri DSM 17938 at a dose 108 colony-forming units or an identically appearing placebo, orally, twice daily, for the entire duration of antibiotic treatment. The primary outcome measures will be the frequencies of diarrhoea and AAD. Diarrhoea will be defined according to 1 of 3 definitions: (1) ≥3 loose or watery stools per day for a minimum of 48 hours during antibiotic treatment; (2) ≥3 loose or watery stools per day for a minimum of 24 hours during antibiotic treatment; or (3) ≥2 loose or watery stools per day for a minimum of 24 hours during antibiotic treatment. AAD will be diagnosed in cases of diarrhoea, defined clinically as above, caused by Clostridium difficile or for otherwise unexplained diarrhoea (ie, negative laboratory stool tests for infectious agents). Ethics and dissemination The Bioethics Committee approved the study protocol. The findings of this trial will be submitted to a peer-reviewed paediatric journal. Abstracts will be submitted to relevant national and international conferences. Trial registration number NCT02871908. PMID:28057659

  4. Efficacy, safety, and tolerability of three regimens for prevention of malaria: a randomized, placebo-controlled trial in Ugandan schoolchildren.

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    Joaniter Nankabirwa

    Full Text Available BACKGROUND: Intermittent preventive treatment (IPT is a promising malaria control strategy; however, the optimal regimen remains unclear. We conducted a randomized, single-blinded, placebo-controlled trial to evaluate the efficacy, safety, and tolerability of a single course of sulfadoxine-pyrimethamine (SP, amodiaquine + SP (AQ+SP or dihydroartemisinin-piperaquine (DP among schoolchildren to inform IPT. METHODS: Asymptomatic girls aged 8 to 12 years and boys aged 8 to 14 years enrolled in two primary schools in Tororo, Uganda were randomized to receive one of the study regimens or placebo, regardless of presence of parasitemia at enrollment, and followed for 42 days. The primary outcome was risk of parasitemia at 42 days. Survival analysis was used to assess differences between regimens. RESULTS: Of 780 enrolled participants, 769 (98.6% completed follow-up and were assigned a treatment outcome. The risk of parasitemia at 42 days varied significantly between DP (11.7% [95% confidence interval (CI: 7.9, 17.1], AQ+SP (44.3% [37.6, 51.5], and SP (79.7% [95% CI: 73.6, 85.2], p<0.001. The risk of parasitemia in SP-treated children was no different than in those receiving placebo (84.6% [95% CI: 79.1, 89.3], p = 0.22. No serious adverse events occurred, but AQ+SP was associated with increased risk of vomiting compared to placebo (13.0% [95% CI: 9.1, 18.5] vs. 4.7% [95% CI: 2.5, 8.8], respectively, p = 0.003. CONCLUSIONS: DP was the most efficacious and well-tolerated regimen tested, although AQ+SP appears to be a suitable alternative for IPT in schoolchildren. Use of SP for IPT may not be appropriate in areas with high-level SP resistance in Africa. TRIAL REGISTRATION: ClinicalTrials.gov NCT00852371.

  5. Baseline Characteristics of Participants in the Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial (ALLHAT).

    Science.gov (United States)

    Grimm, Richard H.; Margolis, Karen L.; Papademetriou, Vasilios; Cushman, William C.; Ford, Charles E.; Bettencourt, Judy; Alderman, Michael H.; Basile, Jan N.; Black, Henry R.; DeQuattro, Vincent; Eckfeldt, John; Hawkins, C. Morton; Perry, H. Mitchell; Proschan, Michael

    2001-01-01

    -Diuretics and ss-blockers have been shown to reduce the risk of cardiovascular morbidity and mortality in people with hypertension in long-term clinical trials. No study has compared newer more costly antihypertensive agents (calcium antagonists, ACE inhibitors, and alpha-adrenergic blockers) with diuretics for reducing the incidence of cardiovascular disease in an ethnically diverse group of middle-aged and elderly hypertensive patients. The study is a randomized, double-blind, active-controlled clinical trial designed to determine whether the incidence of the primary outcome, fatal coronary heart disease or nonfatal myocardial infarction, differs between treatment initiation with a diuretic versus each of 3 other antihypertensive drugs. Men and women aged >/=55 years with at least 1 other cardiovascular disease risk factor were randomly assigned to chlorthalidone (12.5 to 25 mg/d), amlodipine (2.5 to 10 mg/d), lisinopril (10 to 40 mg/d), or doxazosin (2 to 8 mg/d) for planned follow-up of 4 to 8 years. This report describes the baseline characteristics of the Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) participants. A total of 42 448 participants were randomized from 625 sites in the United States, Canada, Puerto Rico, and the US Virgin Islands. The mean age was 67 years, with 35% aged >/=70 years. Among those randomized, 36% were black, 19% were Hispanic, and 47% were women. The sample includes a high proportion of people with diabetes (36%), patients with existing cardiovascular disease (47%), and smokers (22%). There were no important differences between the randomized treatment groups at baseline. ALLHAT will add greatly to our understanding of the management of hypertension by providing an answer to the following question: are newer antihypertensive agents similar, superior, or inferior to traditional treatment with diuretics?

  6. Adherence to antiretroviral prophylaxis for HIV prevention: a substudy cohort within a clinical trial of serodiscordant couples in East Africa.

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    Jessica E Haberer

    Full Text Available Randomized clinical trials of oral antiretroviral pre-exposure prophylaxis (PrEP for HIV prevention have widely divergent efficacy estimates, ranging from 0% to 75%. These discrepancies are likely due to differences in adherence. To our knowledge, no studies to date have examined the impact of improving adherence through monitoring and/or intervention, which may increase PrEP efficacy, or reported on objective behavioral measures of adherence, which can inform PrEP effectiveness and implementation.Within the Partners PrEP Study (a randomized placebo-controlled trial of oral tenofovir and emtricitabine/tenofovir among HIV-uninfected members of serodiscordant couples in Kenya and Uganda, we collected objective measures of PrEP adherence using unannounced home-based pill counts and electronic pill bottle monitoring. Participants received individual and couples-based adherence counseling at PrEP initiation and throughout the study; counseling was intensified if unannounced pill count adherence fell to 80% adherence. Study limitations include potential shortcomings of the adherence measures and use of a convenience sample within the substudy cohort.The high PrEP adherence achieved in the setting of active adherence monitoring and counseling support was associated with a high degree of protection from HIV acquisition by the HIV-uninfected partner in heterosexual serodiscordant couples. Low PrEP adherence was associated with sexual behavior, alcohol use, younger age, and length of PrEP use. Please see later in the article for the Editors' Summary.

  7. Electrocardiographic measures of left ventricular hypertrophy in the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial.

    Science.gov (United States)

    Ernst, Michael E; Davis, Barry R; Soliman, Elsayed Z; Prineas, Ronald J; Okin, Peter M; Ghosh, Alokananda; Cushman, William C; Einhorn, Paula T; Oparil, Suzanne; Grimm, Richard H

    2016-12-01

    Left ventricular hypertrophy (LVH) predicts cardiovascular risk in hypertensive patients. We analyzed baseline/follow-up electrocardiographies in 26,376 Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial participants randomized to amlodipine (A), lisinopril (L), or chlorthalidone (C). Prevalent/incident LVH was examined using continuous and categorical classifications of Cornell voltage. At 2 and 4 years, prevalence of LVH in the C group (5.57%; 6.14%) was not statistically different from A group (2 years: 5.47%; P = .806, 4 years: 6.54%; P = .857) or L group (2 years: 5.64%; P = .857, 4 years: 6.50%; P = .430). Incident LVH followed similarly, with no difference at 2 years for C (2.99%) compared to A (2.57%; P = .173) or L (3.16%; P = .605) and at 4 years (C = 3.52%, A = 3.29%, L = 3.71%; P = .521 C vs. A, P = .618 C vs. L). Mean Cornell voltage decreased comparably across treatment groups (Δ baseline, 2 years = +3 to -27 μV, analysis of variance P = .8612; 4 years = +10 to -17 μV, analysis of variance P = .9692). We conclude that risk reductions associated with C treatment in secondary end points of the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial cannot be attributed to differential improvements in electrocardiography LVH.

  8. Impact of targeted counseling on reported vaginal hygiene practices and bacterial vaginosis: the HIV Prevention Trials Network 035 study.

    Science.gov (United States)

    Kasaro, Margaret P; Husnik, Marla J; Chi, Benjamin H; Reid, Cheri; Magure, Tsitsi; Makanani, Bonus; Tembo, Tchangani; Ramjee, Gita; Maslankowski, Lisa; Rabe, Lorna; Brad Guffey, M

    2017-04-01

    The objective of this study was to describe the impact of intense counseling to reduce vaginal hygiene practices and its effect on bacterial vaginosis. A secondary data analysis of the HIV Prevention Trials Network 035 study was undertaken, focusing on HIV-negative, nonpregnant women who were at least 18 years old, in seven African sites and one US site. At enrollment and during follow-up quarterly visits, vaginal hygiene practices were determined by face-to-face administration of a behavioral assessment questionnaire. Vaginal hygiene practices were categorized as insertion into the vagina of (1) nothing, (2) water only, and (3) other substances with or without water. Each practice was quantified by frequency and type/combination of inserted substances. At quarterly visits, diagnosis of bacterial vaginosis was made using the Nugent score. Trends for vaginal hygiene practices and bacterial vaginosis were evaluated using generalized estimating equation models. A total of 3087 participants from the HIV Prevention Trials Network 035 study were eligible for this analysis. At enrollment, 1859 (60%) reported recent vaginal hygiene practices. By one year, this figure had decreased to 1019 (33%) with counseling. However, bacterial vaginosis prevalence remained consistent across the study observation period, with 36%-38% of women testing positive for the condition ( p for trend = 0.27). Overall, those who reported douching with water only (AOR = 1.03, 95%CI: 0.94-1.13) and those who reported inserting other substances (AOR= 0.98, 95%CI: 0.88-1.09) in the past quarter were not more likely to have bacterial vaginosis compared to those who reported no insertions. However, in South Africa, an increase in bacterial vaginosis was seen among those who reported inserting other substances (AOR: 1.48, 95%CI: 1.17, 1.88). In conclusion, targeted counseling against vaginal hygiene practices resulted in change in self-reported behavior but did not have an impact on bacterial vaginosis

  9. A Randomized Controlled Trial to Test the Effectiveness of an Immersive 3D Video Game for Anxiety Prevention among Adolescents

    Science.gov (United States)

    Scholten, Hanneke; Malmberg, Monique; Lobel, Adam; Engels, Rutger C. M. E.; Granic, Isabela

    2016-01-01

    Adolescent anxiety is debilitating, the most frequently diagnosed adolescent mental health problem, and leads to substantial long-term problems. A randomized controlled trial (n = 138) was conducted to test the effectiveness of a biofeedback video game (Dojo) for adolescents with elevated levels of anxiety. Adolescents (11–15 years old) were randomly assigned to play Dojo or a control game (Rayman 2: The Great Escape). Initial screening for anxiety was done on 1,347 adolescents in five high schools; only adolescents who scored above the “at-risk” cut-off on the Spence Children Anxiety Survey were eligible. Adolescents’ anxiety levels were assessed at pre-test, post-test, and at three month follow-up to examine the extent to which playing Dojo decreased adolescents’ anxiety. The present study revealed equal improvements in anxiety symptoms in both conditions at follow-up and no differences between Dojo and the closely matched control game condition. Latent growth curve models did reveal a steeper decrease of personalized anxiety symptoms (not of total anxiety symptoms) in the Dojo condition compared to the control condition. Moderation analyses did not show any differences in outcomes between boys and girls nor did age differentiate outcomes. The present results are of importance for prevention science, as this was the first full-scale randomized controlled trial testing indicated prevention effects of a video game aimed at reducing anxiety. Future research should carefully consider the choice of control condition and outcome measurements, address the potentially high impact of participants’ expectations, and take critical design issues into consideration, such as individual- versus group-based intervention and contamination issues. PMID:26816292

  10. The influence of socioeconomic environment on the effectiveness of alcohol prevention among European students: a cluster randomized controlled trial

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    Faggiano Fabrizio

    2011-05-01

    Full Text Available Abstract Background Although social environments may influence alcohol-related behaviours in youth, the relationship between neighbourhood socioeconomic context and effectiveness of school-based prevention against underage drinking has been insufficiently investigated. We study whether the social environment affects the impact of a new school-based prevention programme on alcohol use among European students. Methods During the school year 2004-2005, 7079 students 12-14 years of age from 143 schools in nine European centres participated in this cluster randomised controlled trial. Schools were randomly assigned to either control or a 12-session standardised curriculum based on the comprehensive social influence model. Randomisation was blocked within socioeconomic levels of the school environment. Alcohol use and alcohol-related problem behaviours were investigated through a self-completed anonymous questionnaire at baseline and 18 months thereafter. Data were analysed using multilevel models, separately by socioeconomic level. Results At baseline, adolescents in schools of low socioeconomic level were more likely to report problem drinking than other students. Participation in the programme was associated in this group with a decreased odds of reporting episodes of drunkenness (OR = 0.60, 95% CI = 0.44-0.83, intention to get drunk (OR = 0.60, 95% CI = 0.45-0.79, and marginally alcohol-related problem behaviours (OR = 0.70, 95% CI = 0.46-1.06. No significant programme's effects emerged for students in schools of medium or high socioeconomic level. Effects on frequency of alcohol consumption were also stronger among students in disadvantaged schools, although the estimates did not attain statistical significance in any subgroup. Conclusions It is plausible that comprehensive social influence programmes have a more favourable effect on problematic drinking among students in underprivileged social environments. Trial registration ISRCTN: ISRCTN

  11. A Randomized Controlled Trial to Test the Effectiveness of an Immersive 3D Video Game for Anxiety Prevention among Adolescents.

    Science.gov (United States)

    Scholten, Hanneke; Malmberg, Monique; Lobel, Adam; Engels, Rutger C M E; Granic, Isabela

    2016-01-01

    Adolescent anxiety is debilitating, the most frequently diagnosed adolescent mental health problem, and leads to substantial long-term problems. A randomized controlled trial (n = 138) was conducted to test the effectiveness of a biofeedback video game (Dojo) for adolescents with elevated levels of anxiety. Adolescents (11-15 years old) were randomly assigned to play Dojo or a control game (Rayman 2: The Great Escape). Initial screening for anxiety was done on 1,347 adolescents in five high schools; only adolescents who scored above the "at-risk" cut-off on the Spence Children Anxiety Survey were eligible. Adolescents' anxiety levels were assessed at pre-test, post-test, and at three month follow-up to examine the extent to which playing Dojo decreased adolescents' anxiety. The present study revealed equal improvements in anxiety symptoms in both conditions at follow-up and no differences between Dojo and the closely matched control game condition. Latent growth curve models did reveal a steeper decrease of personalized anxiety symptoms (not of total anxiety symptoms) in the Dojo condition compared to the control condition. Moderation analyses did not show any differences in outcomes between boys and girls nor did age differentiate outcomes. The present results are of importance for prevention science, as this was the first full-scale randomized controlled trial testing indicated prevention effects of a video game aimed at reducing anxiety. Future research should carefully consider the choice of control condition and outcome measurements, address the potentially high impact of participants' expectations, and take critical design issues into consideration, such as individual- versus group-based intervention and contamination issues.

  12. A Randomized Controlled Trial to Test the Effectiveness of an Immersive 3D Video Game for Anxiety Prevention among Adolescents.

    Directory of Open Access Journals (Sweden)

    Hanneke Scholten

    Full Text Available Adolescent anxiety is debilitating, the most frequently diagnosed adolescent mental health problem, and leads to substantial long-term problems. A randomized controlled trial (n = 138 was conducted to test the effectiveness of a biofeedback video game (Dojo for adolescents with elevated levels of anxiety. Adolescents (11-15 years old were randomly assigned to play Dojo or a control game (Rayman 2: The Great Escape. Initial screening for anxiety was done on 1,347 adolescents in five high schools; only adolescents who scored above the "at-risk" cut-off on the Spence Children Anxiety Survey were eligible. Adolescents' anxiety levels were assessed at pre-test, post-test, and at three month follow-up to examine the extent to which playing Dojo decreased adolescents' anxiety. The present study revealed equal improvements in anxiety symptoms in both conditions at follow-up and no differences between Dojo and the closely matched control game condition. Latent growth curve models did reveal a steeper decrease of personalized anxiety symptoms (not of total anxiety symptoms in the Dojo condition compared to the control condition. Moderation analyses did not show any differences in outcomes between boys and girls nor did age differentiate outcomes. The present results are of importance for prevention science, as this was the first full-scale randomized controlled trial testing indicated prevention effects of a video game aimed at reducing anxiety. Future research should carefully consider the choice of control condition and outcome measurements, address the potentially high impact of participants' expectations, and take critical design issues into consideration, such as individual- versus group-based intervention and contamination issues.

  13. Electro-acupuncture to prevent prolonged postoperative ileus:A randomized clinical trial

    Institute of Scientific and Technical Information of China (English)

    M; Kay; Garcia; Joseph; S; Chiang; Bob; Thornton; J; Lynn; Palmer; Jennifer; McQuade; Lorenzo; Cohen

    2010-01-01

    AIM:To examine whether acupuncture can prevent prolonged postoperative ileus(PPOI)after intraperitoneal surgery for colon cancer. METHODS:Ninety patients were recruited from the Fudan University Cancer Hospital,Shanghai,China. After surgery,patients were randomized to receive acupuncture(once daily,starting on postoperative day 1, for up to six consecutive days)or usual care.PPOI was defined as an inability to pass flatus or have a bowel movement by 96 h after surgery.The main outcomes were time to first fl...

  14. Biomedical engineering fundamentals

    CERN Document Server

    Bronzino, Joseph D

    2014-01-01

    Known as the bible of biomedical engineering, The Biomedical Engineering Handbook, Fourth Edition, sets the standard against which all other references of this nature are measured. As such, it has served as a major resource for both skilled professionals and novices to biomedical engineering.Biomedical Engineering Fundamentals, the first volume of the handbook, presents material from respected scientists with diverse backgrounds in physiological systems, biomechanics, biomaterials, bioelectric phenomena, and neuroengineering. More than three dozen specific topics are examined, including cardia

  15. Multivitamin and iron supplementation to prevent periconceptional anemia in rural tanzanian women: a randomized, controlled trial.

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    Nilupa S Gunaratna

    Full Text Available Women's nutritional status during conception and early pregnancy can influence maternal and infant outcomes. This study examined the efficacy of pre-pregnancy supplementation with iron and multivitamins to reduce the prevalence of anemia during the periconceptional period among rural Tanzanian women and adolescent girls.A double-blind, randomized controlled trial was conducted in which participants were individually randomized to receive daily oral supplements of folic acid alone, folic acid and iron, or folic acid, iron, and vitamins A, B-complex, C, and E at approximately single recommended dietary allowance (RDA doses for six months.Rural Rufiji District, Tanzania.Non-pregnant women and adolescent girls aged 15-29 years (n = 802.The study arms were comparable in demographic and socioeconomic characteristics, food security, nutritional status, pregnancy history, and compliance with the regimen (p>0.05. In total, 561 participants (70% completed the study and were included in the intention-to-treat analysis. Hemoglobin levels were not different across treatments (median: 11.1 g/dL, Q1-Q3: 10.0-12.4 g/dL, p = 0.65. However, compared with the folic acid arm (28%, there was a significant reduction in the risk of hypochromic microcytic anemia in the folic acid and iron arm (17%, RR: 0.61, 95% CI: 0.42-0.90, p = 0.01 and the folic acid, iron, and multivitamin arm (19%, RR: 0.66, 95% CI: 0.45-0.96, p = 0.03. Inverse probability of treatment weighting (IPTW to adjust for potential selection bias due to loss to follow-up did not materially change these results. The effect of the regimens was not modified by frequency of household meat consumption, baseline underweight status, parity, breastfeeding status, or level of compliance (in all cases, p for interaction>0.2.Daily oral supplementation with iron and folic acid among women and adolescents prior to pregnancy reduces risk of anemia. The potential benefits of supplementation on the risk of

  16. Novel nonpharmacologic approaches for stroke prevention in atrial fibrillation: results from clinical trials

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    Proietti R

    2015-01-01

    Full Text Available Riccardo Proietti,1,2 Jacqueline Joza,1 Andrea Arensi,2 Michael Levi,1 Vincenzo Russo,3 Apostolos Tzikas,4 Paolo Danna,2 Antonio Sagone,2 Maurizio Viecca,2 Vidal Essebag1,5 1McGill University Health Center, Montreal, QC, Canada; 2Cardiology Department, Luigi Sacco Hospital, Milano, Italy; 3Cardiology Department, Second University of Naples, Monaldi Hospital, Naples, Italy; 4Interbalkan European Medical Centre, Thessaloniki, Greece; 5Hôpital Sacré-Coeur de Montréal, Montreal, QC, Canada Abstract: Atrial fibrillation (AF, the most common cardiac arrhythmia, confers a 5-fold risk of stroke that increases to 17-fold when associated with mitral stenosis. At this time, the most effective long-term solution to protect patients from stroke and thromboembolism is oral anticoagulation, either with vitamin K antagonists (VKAs or a novel oral anticoagulant (NOAC. Despite the significant benefits they confer, both VKAs and NOACs are underused because of their increased potential for bleeding, and VKAs are underused because of their narrow therapeutic range, need for regular international normalized ratio checks, and interactions with food or medications. In patients with nonvalvular AF, approximately 90% of strokes originate from the left atrial appendage (LAA; in patients with rheumatic mitral valve disease, many patients (60% have strokes that originate from the left atrium itself. Surgical LAA amputation or closure, although widely used to reduce stroke risk in association with cardiac surgery, is not currently performed as a stand-alone operation for stroke risk reduction because of its invasiveness. Percutaneous LAA closure, as an alternative to anticoagulation, has been increasingly used during the last decade in an effort to reduce stroke risk in nonvalvular AF. Several devices have been introduced during this time, of which one has demonstrated noninferiority compared with warfarin in a randomized controlled trial. This review describes the

  17. Effects of Green Tea Catechins and Theanine on Preventing Influenza Infection among Healthcare Workers: A Randomized Controlled Trial

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    Niino Hitoshi

    2011-02-01

    Full Text Available Abstract Background Experimental studies have revealed that green tea catechins and theanine prevent influenza infection, while the clinical evidence has been inconclusive. This study was conducted to determine whether taking green tea catechins and theanine can clinically prevent influenza infection. Methods Design, Setting, and Participants: A randomized, double-blind, placebo-controlled trial of 200 healthcare workers conducted for 5 months from November 9, 2009 to April 8, 2010 in three healthcare facilities for the elderly in Higashimurayama, Japan. Interventions: The catechin/theanine group received capsules including green tea catechins (378 mg/day and theanine (210 mg/day. The control group received placebo. Main Outcome Measures: The primary outcome was the incidence of clinically defined influenza infection. Secondary outcomes were (1 laboratory-confirmed influenza with viral antigen measured by immunochromatographic assay and (2 the time for which the patient was free from clinically defined influenza infection, i.e., the period between the start of intervention and the first diagnosis of influenza infection, based on clinically defined influenza infection. Results Eligible healthcare workers (n = 197 were enrolled and randomly assigned to an intervention; 98 were allocated to receive catechin/theanine capsules and 99 to placebo. The incidence of clinically defined influenza infection was significantly lower in the catechin/theanine group (4 participants; 4.1% compared with the placebo group (13 participants; 13.1% (adjusted OR, 0.25; 95% CI, 0.07 to 0.76, P = 0.022. The incidence of laboratory-confirmed influenza infection was also lower in the catechin/theanine group (1 participant; 1.0% than in the placebo group (5 participants; 5.1%, but this difference was not significant (adjusted OR, 0.17; 95% CI, 0.01 to 1.10; P = 0.112. The time for which the patient was free from clinically defined influenza infection was significantly

  18. Does a family meetings intervention prevent depression and anxiety in family caregivers of dementia patients? A randomized trial.

    Directory of Open Access Journals (Sweden)

    Karlijn J Joling

    Full Text Available BACKGROUND: Family caregivers of dementia patients are at increased risk of developing depression or anxiety. A multi-component program designed to mobilize support of family networks demonstrated effectiveness in decreasing depressive symptoms in caregivers. However, the impact of an intervention consisting solely of family meetings on depression and anxiety has not yet been evaluated. This study examines the preventive effects of family meetings for primary caregivers of community-dwelling dementia patients. METHODS: A randomized multicenter trial was conducted among 192 primary caregivers of community dwelling dementia patients. Caregivers did not meet the diagnostic criteria for depressive or anxiety disorder at baseline. Participants were randomized to the family meetings intervention (n = 96 or usual care (n = 96 condition. The intervention consisted of two individual sessions and four family meetings which occurred once every 2 to 3 months for a year. Outcome measures after 12 months were the incidence of a clinical depressive or anxiety disorder and change in depressive and anxiety symptoms (primary outcomes, caregiver burden and quality of life (secondary outcomes. Intention-to-treat as well as per protocol analyses were performed. RESULTS: A substantial number of caregivers (72/192 developed a depressive or anxiety disorder within 12 months. The intervention was not superior to usual care either in reducing the risk of disorder onset (adjusted IRR 0.98; 95% CI 0.69 to 1.38 or in reducing depressive (randomization-by-time interaction coefficient = -1.40; 95% CI -3.91 to 1.10 or anxiety symptoms (randomization-by-time interaction coefficient = -0.55; 95% CI -1.59 to 0.49. The intervention did not reduce caregiver burden or their health related quality of life. CONCLUSION: This study did not demonstrate preventive effects of family meetings on the mental health of family caregivers. Further research should determine

  19. Biomedical engineers use electric pulses to destroy cancer cells

    OpenAIRE

    Nystrom, Lynn A.

    2007-01-01

    A team of biomedical engineers at Virginia Tech and the University of California at Berkeley has developed a new minimally invasive method of treating cancer, and they anticipate clinical trials on individuals with prostate cancer will begin soon.

  20. Plasma tocopherols and risk of prostate cancer in the Selenium and Vitamin E Cancer Prevention Trial (SELECT).

    Science.gov (United States)

    Albanes, Demetrius; Till, Cathee; Klein, Eric A; Goodman, Phyllis J; Mondul, Alison M; Weinstein, Stephanie J; Taylor, Philip R; Parnes, Howard L; Gaziano, J Michael; Song, Xiaoling; Fleshner, Neil E; Brown, Powel H; Meyskens, Frank L; Thompson, Ian M

    2014-09-01

    The Selenium and Vitamin E Cancer Prevention Trial (SELECT) showed higher prostate cancer incidence in men supplemented with high-dose α-tocopherol. We, therefore, examined whether presupplementation plasma α-tocopherol or γ-tocopherol was associated with overall or high-grade prostate cancer. A stratified case-cohort sample that included 1,746 incident prostate cancer cases diagnosed through June 2009 and a subcohort of 3,211 men was derived from the SELECT trial of 35,533 men. Plasma was collected at entry from 2001 to 2004, and median follow-up was 5.5 years (range, 0-7.9 years). Incidence of prostate cancer as a function of plasma α-tocopherol, γ-tocopherol, and supplementation with α-tocopherol or selenomethionine was estimated by the hazard ratio (HR). Plasma γ-tocopherol was not associated with prostate cancer. Men with higher α-tocopherol concentrations seemed to have risk similar to that of men with lower concentrations [overall HR for fifth (Q5) vs. first quintile (Q1), 1.21; 95 % confidence interval (CI), 0.88-1.66; P-trend = 0.24; in the trial placebo arm, Q5 HR, 0.85; 95% CI, 0.44-1.62; P-trend = 0.66]. We found a strong positive plasma α-tocopherol association among men receiving the trial selenomethionine supplement [Q5 HR, 2.04; 95% CI, 1.29-3.22; P-trend = 0.005]. A positive plasma α-tocopherol-prostate cancer association also seemed limited to high-grade disease (Gleason grade, 7-10; overall Q5 HR, 1.59; 95% CI, 1.13-2.24; P-trend = 0.001; among men receiving selenomethionine, Q5 HR, 2.12; 95% CI, 1.32-3.40; P-trend = 0.0002). Our findings indicate that higher plasma α-tocopherol concentrations may interact with selenomethionine supplements to increase high-grade prostate cancer risk, suggesting a biologic interaction between α-tocopherol and selenium itself or selenomethionine.

  1. Mortality and morbidity during and after the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial.

    Science.gov (United States)

    Cushman, William C; Davis, Barry R; Pressel, Sara L; Cutler, Jeffrey A; Einhorn, Paula T; Ford, Charles E; Oparil, Suzanne; Probstfield, Jeffrey L; Whelton, Paul K; Wright, Jackson T; Alderman, Michael H; Basile, Jan N; Black, Henry R; Grimm, Richard H; Hamilton, Bruce P; Haywood, L Julian; Ong, Stephen T; Piller, Linda B; Simpson, Lara M; Stanford, Carol; Weiss, Robert J

    2012-01-01

    A randomized, double-blind, active-controlled, multicenter trial assigned 32,804 participants aged 55 years and older with hypertension and ≥ 1 other coronary heart disease risk factors to receive chlorthalidone (n=15,002), amlodipine (n=8898), or lisinopril (n=8904) for 4 to 8 years, when double-blinded therapy was discontinued. Passive surveillance continued for a total follow-up of 8 to 13 years using national administrative databases to ascertain deaths and hospitalizations. During the post-trial period, fatal outcomes and nonfatal outcomes were available for 98% and 65% of participants, respectively, due to lack of access to administrative databases for the remainder. This paper assesses whether mortality and morbidity differences persisted or new differences developed during the extended follow-up. Primary outcome was cardiovascular mortality and secondary outcomes were mortality, stroke, coronary heart disease, heart failure, cardiovascular disease, and end-stage renal disease. For the post-trial period, data are not available on medications or blood pressure levels. No significant differences (P<.05) appeared in cardiovascular mortality for amlodipine (hazard ratio [HR], 1.00; 95% confidence interval [CI], 0.93-1.06) or lisinopril (HR, 0.97; CI, 0.90-1.03), each compared with chlorthalidone. The only significant differences in secondary outcomes were for heart failure, which was higher with amlodipine (HR, 1.12; CI, 1.02-1.22), and stroke mortality, which was higher with lisinopril (HR, 1.20; CI, 1.01-1.41), each compared with chlorthalidone. Similar to the previously reported in-trial result, there was a significant treatment-by-race interaction for cardiovascular disease for lisinopril vs chlorthalidone. Black participants had higher risk than non-black participants taking lisinopril compared with chlorthalidone. After accounting for multiple comparisons, none of these results were significant. These findings suggest that neither calcium channel

  2. Scaling-up from an implementation trial to state-wide coverage: results from the preliminary Melbourne Diabetes Prevention Study

    Directory of Open Access Journals (Sweden)

    Janus Edward D

    2012-08-01

    Full Text Available Abstract Background The successful Greater Green Triangle Diabetes Prevention Program (GGT DPP, a small implementation trial, has been scaled-up to the Victorian state-wide ‘Life!’ programme with over 10,000 individuals enrolled. The Melbourne Diabetes Prevention Study (MDPS is an evaluation of the translation from the GGT DPP to the Life! programme. We report results from the preliminary phase (pMDPS of this evaluation. Methods The pMDPS is a randomised controlled trial with 92 individuals aged 50 to 75 at high risk of developing type 2 diabetes randomised to Life! or usual care. Intervention consisted of six structured 90-minute group sessions: five fortnightly sessions and the final session at 8 months. Participants underwent anthropometric and laboratory tests at baseline and 12 months, and provided self-reported psychosocial, dietary, and physical activity measures. Intervention group participants additionally underwent these tests at 3 months. Paired t tests were used to analyse within-group changes over time. Chi-square tests were used to analyse differences between groups in goals met at 12 months. Differences between groups for changes over time were tested with generalised estimating equations and analysis of covariance. Results Intervention participants significantly improved at 12 months in mean body mass index (−0.98 kg/m2, standard error (SE = 0.26, weight (−2.65 kg, SE = 0.72, waist circumference (−7.45 cm, SE = 1.15, and systolic blood pressure (−3.18 mmHg, SE = 1.26, increased high-density lipoprotein-cholesterol (0.07 mmol/l, SE = 0.03, reduced energy from total (−2.00%, SE = 0.78 and saturated fat (−1.54%, SE = 0.41, and increased fibre intake (1.98 g/1,000 kcal energy, SE = 0.47. In controls, oral glucose at 2 hours deteriorated (0.59 mmol/l, SE = 0.27. Only waist circumference reduced significantly (−4.02 cm, SE = 0.95. Intervention participants significantly

  3. Baseline characteristics of participants in the JUPITER trial, a randomized placebo-controlled primary prevention trial of statin therapy among individuals with low low-density lipoprotein cholesterol and elevated high-sensitivity C-reactive protein.

    Science.gov (United States)

    Ridker, Paul M; Fonseca, Francisco A H; Genest, Jacques; Gotto, Antonio M; Kastelein, John J P; Khurmi, Nardev S; Koenig, Wolfgang; Libby, Peter; Lorenzatti, Alberto J; Nordestgaard, Borge G; Shepherd, James; Willerson, James T; Glynn, Robert J

    2007-12-01

    The Justification for the Use of statins in Primary prevention: an Intervention Trial Evaluating Rosuvastatin (JUPITER) is a randomized, double-blind, placebo-controlled primary prevention trial of statin therapy among persons with average to low levels of low-density lipoprotein (LDL) cholesterol who are at increased cardiovascular risk due to elevated plasma concentrations of the inflammatory biomarker high-sensitivity C-reactive protein (hs-CRP). A total of 17,802 persons with LDL cholesterolor=2 mg/L were recruited from 26 countries and randomly allocated to 20 mg/day rosuvastatin or placebo. In contrast to previous studies of statin therapy in primary prevention, JUPITER is evaluating a group with modest plasma concentrations of LDL cholesterol (median 108 mg/dl, interquartile range 94 to 119). Further, the trial includes 6,801 women (38.2%) and 5,577 participants with metabolic syndrome (32.1%). Thus, in addition to broadening our understanding of statin therapy and inflammation, the JUPITER trial will provide important and clinically relevant information on primary prevention among patients who do not currently qualify for lipid-lowering therapy. In conclusion, as 20 mg of rosuvastatin can reduce LDL cholesterol by up to 50%, JUPITER will also provide crucial safety data for several thousand patients who should achieve LDL cholesterol levels<50 mg/dl on a long-term basis.

  4. A randomized controlled multicenter trial of post-suicide attempt case management for the prevention of further attempts in Japan (ACTION-J

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    Kamijo Yoshito

    2009-09-01

    Full Text Available Abstract Background A previous suicide attempt is a potent risk factor for suicide later on. Crisis intervention, psychiatric and psychosocial evaluation at emergency medical facilities, and follow-up care for suicide attempters are considered important components for suicide prevention. The Japanese Multimodal Intervention Trials for Suicide Prevention (J-MISP includes a randomized, controlled, multicenter trial of post-suicide attempt case management for the prevention of further attempts (ACTION-J to address the continuing increase in suicides in Japan. The primary aim of ACTION-J is to examine the effectiveness of an extensive intervention for suicide attempters in prevention of recurrent suicidal behavior, as compared with standard intervention. This paper describes the rationale and protocol of the ACTION-J trial. Methods/Design In this clinical trial, case management intervention will be provided at 19 emergency medical facilities in Japan. After crisis intervention including psychiatric evaluation, psychosocial assessment, and psychological education, subjects will be randomly assigned to either a group receiving continuous case management or a control group receiving standard care. Suicidal ideation, depressive symptoms, and general health condition will be evaluated as secondary measures. The intervention was initiated in July 2006. By December, 2009, 842 subjects will be randomized. Subject follow-up will continue for 1.5 to 5 years. Discussion Suicide is a complex phenomenon that encompasses multiple factors. Case management by multi-sector collaboration is needed. ACTION-J may provide valuable information on suicide attempters and may develop effective case management to reduce future risk for suicide attempters. Trial registration UMIN Clinical Trials Registry number, UMIN000000444. ClinicalTrials.gov number, NCT00736918.

  5. Problem-solving education to prevent depression among low-income mothers of preterm infants: a randomized controlled pilot trial.

    Science.gov (United States)

    Silverstein, Michael; Feinberg, Emily; Cabral, Howard; Sauder, Sara; Egbert, Lucia; Schainker, Elisabeth; Kamholz, Karen; Hegel, Mark; Beardslee, William

    2011-08-01

    We sought to assess the feasibility and document key study processes of a problem-solving intervention to prevent depression among low-income mothers of preterm infants. A randomized controlled pilot trial (n = 50) of problem-solving education (PSE) was conducted. We assessed intervention provider training and fidelity; recruitment and retention of subjects; intervention acceptability; and investigators' ability to conduct monthly outcome assessments, from which we could obtain empirical estimates of depression symptoms, stress, and functioning over 6 months. Four of four bachelor-level providers were able to deliver PSE appropriately with standardized subjects within 4 weeks of training. Of 12 randomly audited PSE sessions with actual subjects, all met treatment fidelity criteria. Nineteen of 25 PSE subjects (76%) received full four-session courses; no subjects reported negative experiences with PSE. Eighty-eight percent of scheduled follow-up assessments were completed. Forty-four percent of control group mothers experienced an episode of moderately severe depression symptoms over the follow-up period, compared to 24% of PSE mothers. Control mothers experienced an average 1.19 symptomatic episodes over the 6 months of follow-up, compared to 0.52 among PSE mothers. PSE appears feasible and may be a promising strategy to prevent depression among mothers of preterm infants.

  6. E-learning as a complement to presential teaching of blindness prevention: a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Rodrigo Pessoa Cavalcanti Lira

    2013-02-01

    Full Text Available OBJECTIVE: To investigate if E-learning material improves the basal student knowledge level before attending the presential class of blindness prevention (BP and if helps to fix this information one-month after the class. METHODS: Fourth-year medical students were randomly assigned to have a presential class of BP (Traditional group = TG or to have a presential class of BP plus an additional E-learning material (E-learning group = ELG. This material was e-mailed one week before the presential class. The students were submitted to a multiple-choice test (with three options each with seven questions immediately before the presential class, immediately after the class, and one-month later. The three tests had the same questions; however, the answers options were distributed in different sequences. The primary outcome was immediate pretest score. The secondary outcomes were immediate posttest score and one-month posttest score. RESULTS: Among the 120 fourth-year medical students, a random sample of 34 students was assigned to the TG and 34 students was assigned to the ELG. The two groups showed similar immediate posttest score (TG=6.8 and ELG=6.9; P<.754, but the differences at the immediate pretest score (TG=3.6 and ELG=4.7; P<.001, and at the one-month posttest score, were significant (TG=6.1 and ELG=6.8; P<.001. CONCLUSIONS: The pretest and the one-month posttest results suggested that the E-learning material acts as an effective complementary tool of the presential class of blindness prevention.

  7. Effect of multimodality chest physiotherapy in prevention of ventilator-associated pneumonia: A randomized clinical trial

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    Pattanshetty Renu

    2010-01-01

    Full Text Available Background: Despite remarkable progress that has been achieved in the recent years in the diagnosis, prevention, and therapy for ventilator-associated pneumonia (VAP, this disease continues to create complication during the course of treatment in a significant proportion of patients while receiving mechanical ventilation. Objective: This study was designed to evaluate the effect of multimodality chest physiotherapy in intubated and mechanically ventilated patients undergoing treatment in the intensive care units (ICUs for prevention of VAP. Patients and Methods: A total of 101 adult intubated and mechanically ventilated patients were included in this study. Manual hyperinflation (MH and suctioning were administered to patients in the control group (n = 51, and positioning and chest wall vibrations in addition to MH plus suctioning (multimodality chest physiotherapy were administered to patients in the study group (n = 50 till they were extubated. Both the groups were subjected to treatment twice a day. Standard care in the form of routine nursing care, pharmacological therapy, inhalation therapy, as advised by the concerned physician/surgeon was strictly implemented throughout the intervention period. Results: Data were analyzed using SPSS window version 9.0. The Clinical Pulmonary infection Score (CPIS Score showed significant decrease at the end of extubation/successful outcome or discharge in both the groups (P = 0.00. In addition, significant decrease in mortality rate was noted in the study group (24% as compared to the control group (49% (P = 0.007. Conclusions: It was observed in this study that twice-daily multimodality chest physiotherapy was associated with a significant decrease in the CPIS Scores in the study group as compared to the control group suggesting a decrease in the occurrence of VAP. There was also a significant reduction in the mortality rates with the use of multimodality chest physiotherapy in mechanically ventilated

  8. Celecoxib-related gastroduodenal ulcer and cardiovascular events in a randomized trial for gastric cancer prevention

    Institute of Scientific and Technical Information of China (English)

    Guo-Shuang Feng; Harry HX Xia; Ji-You Li; Shiu Kum Lam; Wei-Cheng You; Jun-Ling Ma; Benjamin CY Wong; Lian Zhang; Wei-Dong Liu; Kai-Feng Pan; Lin Shen; Xiao-Dong Zhang; Jie Li

    2008-01-01

    AIM: To evaluate the long-term risk of gastroduodenal ulcer and cardiovascular events induced by celecoxib in a population-based, randomized, double-blind,placebo-controlled study.METHODS: From 2004 to 2006, a total of 1024 Chinese patients (aged 35 to 64 years) with severe chronic atrophic gastritis, intestinal metaplasia or dysplasia were randomly assigned to receive 200 mg of celecoxib twice daily or placebo in Linqu County (Shandong Province, China), a high-risk area of gastric cancer. All gastroduodenal ulcer and cardiovascular events occurred were recorded and the patients were followed up for 1.5 years after treatment. At the end of the trial, a systematic interview survey about other adverse events was conducted.RESULTS: Gastroduodenal ulcer was detected in 19 of 463 (3.72%) patients who Received: celecoxib and 17 of 473 (3.31%) patients who Received placebo,respectively (odds ratio = 1.13, 95% CI = 0.58-2.19).Cardiovascular (CV) events occurred in 4 patients who received celecoxib and in 5 patients who received placebo,respectively.Compared with those who received placebo,patients who received celecoxib had no significant increase in occurrence of Cvevents (hazard ratio = 0.84,95% CI =0.23-3.15).Among the adverse events acquired by interview survey,only the frequency of bloating was significantly higher in patients treated with celecoxib than in those treated with placebo.CONCLUSION:Treatment of gastric cancer with celecoxib is not associated with increased risk of gastroduodenal ulcer and cardiovascular events.

  9. Internet-based prevention of posttraumatic stress symptoms in injured trauma patients: design of a randomized controlled trial

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    Joanne Mouthaan

    2011-11-01

    Full Text Available Background: Injured trauma victims are at risk of developing Posttraumatic Stress Disorder (PTSD and other post-trauma psychopathology. So far, interventions using cognitive behavioral techniques (CBT have proven most efficacious in treating early PTSD in highly symptomatic individuals. No early intervention for the prevention of PTSD for all victims has yet proven effective. In the acute psychosocial care for trauma victims, there is a clear need for easily applicable, accessible, cost-efficient early interventions. Objective: To describe the design of a randomized controlled trial (RCT evaluating the effectiveness of a brief Internet-based early intervention that incorporates CBT techniques with the aim of reducing acute psychological distress and preventing long-term PTSD symptoms in injured trauma victims. Method: In a two armed RCT, 300 injured trauma victims from two Level-1 trauma centers in Amsterdam, the Netherlands, will be assigned to an intervention or a control group. Inclusion criteria are: being 18 years of age or older, having experienced a traumatic event according to the diagnostic criteria of the DSM-IV and understanding the Dutch language. The intervention group will be given access to the intervention's website (www.traumatips.nl, and are specifically requested to login within the first month postinjury. The primary clinical study outcome is PTSD symptom severity. Secondary outcomes include symptoms of depression and anxiety, quality of life, and social support. In addition, a cost-effectiveness analysis of the intervention will be performed. Data are collected at one week post-injury, prior to first login (baseline, and at 1, 3, 6 and 12 months. Analyses will be on an intention-to-treat basis. Discussion: The results will provide more insight into the effects of preventive interventions in general, and Internet-based early interventions specifically, on acute stress reactions and PTSD, in an injured population, during the

  10. Lifestyle change in Kerala, India: needs assessment and planning for a community-based diabetes prevention trial

    Directory of Open Access Journals (Sweden)

    Daivadanam Meena

    2013-02-01

    Full Text Available Abstract Background Type 2 Diabetes Mellitus (T2DM has become a major public health challenge in India. Factors relevant to the development and implementation of diabetes prevention programmes in resource-constrained countries, such as India, have been under-studied. The purpose of this study is to describe the findings from research aimed at informing the development and evaluation of a Diabetes Prevention Programme in Kerala, India (K-DPP. Methods Data were collected from three main sources: (1 a systematic review of key research literature; (2 a review of relevant policy documents; and (3 focus groups conducted among individuals with a high risk of progressing to diabetes. The key findings were then triangulated and synthesised. Results Prevalence of risk factors for diabetes is very high and increasing in Kerala. This situation is largely attributable to rapid changes in the lifestyle of people living in this state of India. The findings from the systematic review and focus groups identified many environmental and personal determinants of these unhealthy lifestyle changes, including: less than ideal accessibility to and availability of health services; cultural values and norms; optimistic bias and other misconceptions related to risk; and low expectations regarding one’s ability to make lifestyle changes in order to influence health and disease outcomes. On the other hand, there are existing intervention trials conducted in India which suggests that risk reduction is possible. These programmes utilize multi-level strategies including mass media, as well as strategies to enhance community and individual empowerment. India’s national programme for the prevention and control of major non-communicable diseases (NCD also provide a supportive environment for further community-based efforts to prevent diabetes. Conclusion These findings provide strong support for undertaking more research into the conduct of community-based diabetes prevention

  11. Regional differences in prevalence of HIV-1 discordance in Africa and enrollment of HIV-1 discordant couples into an HIV-1 prevention trial.

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    Jairam R Lingappa

    Full Text Available BACKGROUND: Most HIV-1 transmission in Africa occurs among HIV-1-discordant couples (one partner HIV-1 infected and one uninfected who are unaware of their discordant HIV-1 serostatus. Given the high HIV-1 incidence among HIV-1 discordant couples and to assess efficacy of interventions for reducing HIV-1 transmission, HIV-1 discordant couples represent a critical target population for HIV-1 prevention interventions and prevention trials. Substantial regional differences exist in HIV-1 prevalence in Africa, but regional differences in HIV-1 discordance among African couples, has not previously been reported. METHODOLOGY/PRINCIPAL FINDINGS: The Partners in Prevention HSV-2/HIV-1 Transmission Trial ("Partners HSV-2 Study", the first large HIV-1 prevention trial in Africa involving HIV-1 discordant couples, completed enrollment in May 2007. Partners HSV-2 Study recruitment data from 12 sites from East and Southern Africa were used to assess HIV-1 discordance among couples accessing couples HIV-1 counseling and testing, and to correlate with enrollment of HIV-1 discordant couples. HIV-1 discordance at Partners HSV-2 Study sites ranged from 8-31% of couples tested from the community. Across all study sites and, among all couples with one HIV-1 infected partner, almost half (49% of couples were HIV-1 discordant. Site-specific monthly enrollment of HIV-1 discordant couples into the clinical trial was not directly associated with prevalence of HIV-1 discordance, but was modestly correlated with national HIV-1 counseling and testing rates and access to palliative care/basic health care (r = 0.74, p = 0.09. CONCLUSIONS/SIGNIFICANCE: HIV-1 discordant couples are a critical target for HIV-1 prevention in Africa. In addition to community prevalence of HIV-1 discordance, national infrastructure for HIV-1 testing and healthcare delivery and effective community outreach strategies impact recruitment of HIV-1 discordant couples into HIV-1 prevention trials.

  12. Respiratory training as strategy to prevent cognitive decline in aging: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Ferreira L

    2015-03-01

    Full Text Available Leandro Ferreira,1 Kátia Tanaka,1 Ruth Ferreira Santos-Galduróz,2,3 José Carlos Fernandes Galduróz1 1Department of Psychobiology, Universidade Federal de São Paulo, São Paulo, SP, Brazil; 2Center of Mathematics, Computation and Cognition, Universidade Federal do ABC, São André, SP, Brazil; 3Institute of Biosciences, Universidade Estadual Paulista Júlio de Mesquita Filho, Rio Claro, SP, Brazil Background: Inadequate oxygenation may cause lesions and brain atrophy during aging. Studies show a positive association between pulmonary function and the cognitive performance of individuals from middle age on. Objective: To investigate the effect of aerobic physical exercises and respiratory training on the blood oxygenation, pulmonary functions, and cognition of the elderly. Design: This was a randomized and controlled trial with three parallel groups. A total of 195 community-dwelling elderly were assessed for eligibility; only n=102 were included and allocated into the three groups, but after 6 months, n=68 were analyzed in the final sample. Participants were randomized into a social interaction group (the control group, an aerobic exercise group (the “walking” group, or a respiratory training group (the “breathing” group. The main outcome measures were the Wechsler Adult Intelligence Scale, Wechsler Memory Scale, Wisconsin Card Sorting Test, respiratory muscular strength, cirtometry (thoracic–abdominal circumference; oxygen saturation in arterial blood (SpO2, and hemogram. Results: No differences were observed for any of the blood parameters. Aerobic exercise and respiratory training were effective in improving the pulmonary parameters. Better cognitive performance was observed for the breathing group as regards abstraction and mental flexibility. The walking group remained stable in the cognitive performance of most of the tests, except attention. The control group presented worst performance in mental manipulation of information

  13. Current Evidence to Justify, and the Methodological Considerations for a Randomised Controlled Trial Testing the Hypothesis that Statins Prevent the Malignant Progression of Barrett's Oesophagus

    Institute of Scientific and Technical Information of China (English)

    David Thurtle; Leo Alexandre; Yoon K Loke; Ed Cheong; Andrew Hart

    2014-01-01

    Barrett's oesophagus is the predominant risk factor for oesophageal adenocarcinoma, a cancer whose incidence is increasing and which has a poor prognosis. This article reviews the latest experimental and epidemiological evidence justifying the development of a randomised controlled trial investigating the hypothesis that statins prevent the malignant progression of Barrett's oesophagus, and explores the methodological considerations for such a trial. The experimental evidence suggests anti-carcinogenic properties of statins on oesophageal cancer cell lines, based on the inhibition of the mevalonate pathway and the production of pro-apoptotic proteins. The epidemiological evidence reports inverse associations between statin use and the incidence of oesophageal carcinoma in both general population and Barrett's oesophagus cohorts. Such a randomised controlled trial would be a large multi-centre trial, probably investigating simvastatin, given the wide clinical experience with this drug, relatively low side-effect profile and low ifnancial cost. As with any clinical trial, high adherence is important, which could be increased with therapy, patient, doctor and system-focussed interventions. We would suggest there is now sufifcient evidence to justify a full clinical trial that attempts to prevent this aggressive cancer in a high-risk population.

  14. Current Evidence to Justify, and the Methodological Considerations for a Randomised Controlled Trial Testing the Hypothesis that Statins Prevent the Malignant Progression of Barrett's Oesophagus

    Directory of Open Access Journals (Sweden)

    David Thurtle

    2014-12-01

    Full Text Available Barrett’s oesophagus is the predominant risk factor for oesophageal adenocarcinoma, a cancer whose incidence is increasing and which has a poor prognosis. This article reviews the latest experimental and epidemiological evidence justifying the development of a randomised controlled trial investigating the hypothesis that statins prevent the malignant progression of Barrett’s oesophagus, and explores the methodological considerations for such a trial. The experimental evidence suggests anti-carcinogenic properties of statins on oesophageal cancer cell lines, based on the inhibition of the mevalonate pathway and the production of pro-apoptotic proteins. The epidemiological evidence reports inverse associations between statin use and the incidence of oesophageal carcinoma in both general population and Barrett’s oesophagus cohorts. Such a randomised controlled trial would be a large multi-centre trial, probably investigating simvastatin, given the wide clinical experience with this drug, relatively low side-effect profile and low financial cost. As with any clinical trial, high adherence is important, which could be increased with therapy, patient, doctor and system-focussed interventions. We would suggest there is now sufficient evidence to justify a full clinical trial that attempts to prevent this aggressive cancer in a high-risk population.

  15. Averting HIV infections in New York City: a modeling approach estimating the future impact of additional behavioral and biomedical HIV prevention strategies.

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    Jason Kessler

    Full Text Available BACKGROUND: New York City (NYC remains an epicenter of the HIV epidemic in the United States. Given the variety of evidence-based HIV prevention strategies available and the significant resources required to implement each of them, comparative studies are needed to identify how to maximize the number of HIV cases prevented most economically. METHODS: A new model of HIV disease transmission was developed integrating information from a previously validated micro-simulation HIV disease progression model. Specification and parameterization of the model and its inputs, including the intervention portfolio, intervention effects and costs were conducted through a collaborative process between the academic modeling team and the NYC Department of Health and Mental Hygiene. The model projects the impact of different prevention strategies, or portfolios of prevention strategies, on the HIV epidemic in NYC. RESULTS: Ten unique interventions were able to provide a prevention benefit at an annual program cost of less than $360,000, the threshold for consideration as a cost-saving intervention (because of offsets by future HIV treatment costs averted. An optimized portfolio of these specific interventions could result in up to a 34% reduction in new HIV infections over the next 20 years. The cost-per-infection averted of the portfolio was estimated to be $106,378; the total cost was in excess of $2 billion (over the 20 year period, or approximately $100 million per year, on average. The cost-savings of prevented infections was estimated at more than $5 billion (or approximately $250 million per year, on average. CONCLUSIONS: Optimal implementation of a portfolio of evidence-based interventions can have a substantial, favorable impact on the ongoing HIV epidemic in NYC and provide future cost-saving despite significant initial costs.

  16. Efficacy of a short multidisciplinary falls prevention program for elderly persons with osteoporosis and a fall history: a randomized controlled trial.

    NARCIS (Netherlands)

    Smulders, E.; Weerdesteijn, V.G.M.; Groen, B.E.; Duysens, J.E.J.; Eijsbouts, A.; Laan, R.F.J.M.; Lankveld, W.G.J.M. van

    2010-01-01

    OBJECTIVE: To evaluate the efficacy of the Nijmegen Falls Prevention Program (NFPP) for persons with osteoporosis and a fall history in a randomized controlled trial. Persons with osteoporosis are at risk for fall-related fractures because of decreased bone strength. A decrease in the number of fall

  17. Effectiveness and cost-effectiveness of an injury prevention programme for adult male amateur soccer players: Design of a cluster-randomised controlled trial

    NARCIS (Netherlands)

    Beijsterveldt, A.M.C. van; Krist, M.R.; Schmikli, S.L.; Stubbe, J.H.; Wit, G.A. de; Inklaar, H.; Port, I.G.L. van de; Backx, F.J.G.

    2011-01-01

    Background and aims Approximately 16% of all sports injuries in the Netherlands are caused by outdoor soccer. A cluster-randomised controlled trial has been designed to investigate the effectiveness and cost-effectiveness of an injury prevention programme ('The11') for male amateur soccer players. T

  18. Prevention of catheter-related bacteremia with a daily ethanol lock in patients with tunnelled catheters: A randomized, placebo-controlled trial

    NARCIS (Netherlands)

    L. Slobbe (Lennert); J.K. Doorduijn (Jeanette); P.J. Lugtenburg (Pieternella); A.E. Barzouhi (Abdelilah); H. Boersma (Eric); W.B. van Leeuwen (Willem); B.J.A. Rijnders (Bart)

    2010-01-01

    textabstractBackground: Catheter-related bloodstream infection (CRBSI) results in significant attributable morbidity and mortality. In this randomized, double-blind, placebo-controlled trial, we studied the efficacy and safety of a daily ethanol lock for the prevention of CRBSI in patients with a tu

  19. The effectiveness of family interventions in preventing adolescent illicit drug use: A systematic review and meta-analysis of randomized controlled trials

    NARCIS (Netherlands)

    Smit, E.; Verdurmen, J.E.E.; Engels, R.C.M.E.

    2015-01-01

    In order to quantify the effectiveness of family interventions in preventing and reducing adolescent illicit drug use, we conducted a systematic review and meta-analysis of randomized controlled trials. We searched the Cochrane Database of Systematic Reviews, Educational Research Information Centre

  20. Evaluation of a School-Based Depression Prevention Program among Adolescents from Low-Income Areas: A Randomized Controlled Effectiveness Trial

    NARCIS (Netherlands)

    Kindt, K.C.M.; Kleinjan, M.; Janssens, J.M.A.M.; Scholte, R.H.J.

    2014-01-01

    A randomized controlled trial was conducted among a potential high-risk group of 1,343 adolescents from low-income areas in The Netherlands to test the effectiveness of the depression prevention program Op Volle Kracht (OVK) as provided by teachers in a school setting. The results showed no main eff

  1. Amphotericin B colloidal dispersion (Amphocil) vs fluconazole for the prevention of fungal infections in neutropenic patients : data of a prematurely stopped clinical trial

    NARCIS (Netherlands)

    Timmers, G J; Zweegman, S; Simoons-Smit, A M; van Loenen, A C; Touw, D; Huijgens, P C

    2000-01-01

    We conducted an open label, randomised clinical trial to compare amphotericin B colloidal dispersion (ABCD, Amphocil) 2 mg/kg/day intravenously with fluconazole 200 mg/day orally, for the prevention of fungal disease in neutropenic patients with haematological malignancies. In the event of unresolve

  2. Programmed Ventricular Stimulation to Risk Stratify for Early Cardioverter-Defibrillator Implantation to Prevent Tachyarrhythmias following Acute Myocardial Infarction (PROTECT-ICD): Trial Protocol, Background and Significance.

    Science.gov (United States)

    Zaman, Sarah; Taylor, Andrew J; Stiles, Martin; Chow, Clara; Kovoor, Pramesh

    2016-11-01

    The 'Programmed Ventricular Stimulation to Risk Stratify for Early Cardioverter-Defibrillator Implantation to Prevent Tachyarrhythmias following Acute Myocardial Infarction' (PROTECT-ICD) trial is an Australian-led multicentre randomised controlled trial targeting prevention of sudden cardiac death in patients who have at least moderately reduced cardiac function following a myocardial infarct (MI). The primary objective of the trial is to assess whether electrophysiological study to guide prophylactic implantation of an implantable cardioverter-defibrillator (ICD) early following MI (first 40 days) will lead to a significant reduction in sudden cardiac death and non-fatal arrhythmia. The secondary objective is to assess the utility of cardiac MRI (CMR) in assessing early myocardial characteristics, and its predictive value for both inducible ventricular tachycardia (VT) at EPS and SCD/ non-fatal arrhythmia at follow-up.

  3. Intermittent preventive treatment of malaria in pregnancy with mefloquine in HIV-negative women: a multicentre randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Raquel González

    2014-09-01

    Full Text Available BACKGROUND: Intermittent preventive treatment in pregnancy (IPTp with sulfadoxine-pyrimethamine (SP is recommended by WHO to prevent malaria in African pregnant women. The spread of SP parasite resistance has raised concerns regarding long-term use for IPT. Mefloquine (MQ is the most promising of available alternatives to SP based on safety profile, long half-life, and high efficacy in Africa. We evaluated the safety and efficacy of MQ for IPTp compared to those of SP in HIV-negative women. METHODS AND FINDINGS: A total of 4,749 pregnant women were enrolled in an open-label randomized clinical trial conducted in Benin, Gabon, Mozambique, and Tanzania comparing two-dose MQ or SP for IPTp and MQ tolerability of two different regimens. The study arms were: (1 SP, (2 single dose MQ (15 mg/kg, and (3 split-dose MQ in the context of long lasting insecticide treated nets. There was no difference on low birth weight prevalence (primary study outcome between groups (360/2,778 [13.0%] for MQ group and 177/1,398 (12.7% for SP group; risk ratio [RR], 1.02 (95% CI 0.86-1.22; p=0.80 in the ITT analysis. Women receiving MQ had reduced risks of parasitemia (63/1,372 [4.6%] in the SP group and 88/2,737 [3.2%] in the MQ group; RR, 0.70 [95% CI 0.51-0.96]; p=0.03 and anemia at delivery (609/1,380 [44.1%] in the SP group and 1,110/2743 [40.5%] in the MQ group; RR, 0.92 [95% CI 0.85-0.99]; p=0.03, and reduced incidence of clinical malaria (96/551.8 malaria episodes person/year [PYAR] in the SP group and 130/1,103.2 episodes PYAR in the MQ group; RR, 0.67 [95% CI 0.52-0.88]; p=0.004 and all-cause outpatient attendances during pregnancy (850/557.8 outpatients visits PYAR in the SP group and 1,480/1,110.1 visits PYAR in the MQ group; RR, 0.86 [0.78-0.95]; p=0.003. There were no differences in the prevalence of placental infection and adverse pregnancy outcomes between groups. Tolerability was poorer in the two MQ groups compared to SP. The most frequently reported

  4. Randomised controlled trial of food elimination diet based on IgG antibodies for the prevention of migraine like headaches

    Directory of Open Access Journals (Sweden)

    Adamson Joy

    2011-08-01

    Full Text Available Abstract Background Research suggests that food intolerance may be a precipitating factor for migraine like headaches. Aim To evaluate the effectiveness of the ELISA (Enzyme Linked Immuno-Sorbent Assay Test and subsequent dietary elimination advice for the prevention of migraine like headaches. Design Randomised controlled trial. Setting Community based volunteers in the UK. Participants Volunteers who met the inclusion criteria for migraine like headaches and had one or more food intolerance were included in the study. Participants received either a true diet (n = 84 or a sham diet (n = 83 sheet. Participants were advised to remove the intolerant foods from their diet for 12 weeks. Main outcome measures Number of headache days over a 12 week period (item A MIDAS questionnaire. Other measures includes the total MIDAS score and total HIT-6 score. Results The results indicated a small decrease in the number of migraine like headaches over 12 weeks, although this difference was not statistically significant (IRR 1.15 95% CI 0.94 to 1.41, p = 0.18. At the 4 week assessment, use of the ELISA test with subsequent diet elimination advice significantly reduced the number of migraine like headaches (IRR 1.23 95%CI 1.01 to 1.50, p = 0.04. The disability and impact on daily life of migraines were not significantly different between the true and sham diet groups. Conclusions Use of the ELISA test with subsequent diet elimination advice did not reduce the disability or impact on daily life of migraine like headaches or the number of migraine like headaches at 12 weeks but it did significantly reduce the number of migraine like headaches at 4 weeks. Trial registration number ISRCTN: ISRTCN89559672

  5. Association between Serum Phospholipid Fatty Acids and Intraprostatic Inflammation in the Placebo Arm of the Prostate Cancer Prevention Trial.

    Science.gov (United States)

    Nash, Sarah H; Schenk, Jeannette M; Kristal, Alan R; Goodman, Phillis J; Lucia, M Scott; Parnes, Howard L; Thompson, Ian M; Lippman, Scott M; Song, Xiaoling; Gurel, Bora; De Marzo, Angelo; Platz, Elizabeth A

    2015-07-01

    Inflammation may play an etiologic role in prostate cancer. Several dietary factors influence inflammation; studies have shown that long-chain n-3 polyunsaturated fatty acids are anti-inflammatory, whereas n-6 and trans fatty acids are proinflammatory. We evaluated whether serum phospholipid n-3, n-6, and trans fatty acids were associated with intraprostatic inflammation, separately in 191 prostate cancer cases and 247 controls from the placebo arm of the Prostate Cancer Prevention Trial (PCPT). Men without a prostate cancer diagnosis underwent prostate biopsy at trial end, and benign prostate tissue inflammation was evaluated in approximately three biopsy cores per man; this was expressed as no, some, or all cores with inflammation. In controls, serum eicosapentaenoic acid [OR of all cores with inflammation versus none (95% CI), 0.35 (0.14-0.89)] and docosahexaenoic acid [OR (95% CI), 0.42 (0.17-1.02)] were inversely associated with, whereas linoleic acid [OR (95% CI), 3.85 (1.41-10.55)] was positively associated with intraprostatic inflammation. Serum trans fatty acids were not associated with intraprostatic inflammation. No significant associations were observed in cases; however, we could not rule out a positive association with linoleic acid and an inverse association with arachidonic acid. Thus, in the PCPT, we found that serum n-3 fatty acids were inversely, n-6 fatty acids were positively, and trans fatty acids were not associated with intraprostatic inflammation in controls. Although, in theory, inflammation could mediate associations of serum fatty acids with prostate cancer risk, our findings cannot explain the epidemiologic associations observed with n-3 and n-6 fatty acids.

  6. Understanding the molecular mechanisms of cancer prevention by dietary phytochemicals:From experimental models to clinical trials

    Institute of Scientific and Technical Information of China (English)

    Girish B Maru; Rasika R Hudlikar; Gaurav Kumar; Khushboo Gandhi; Manoj B Mahimkar

    2016-01-01

    Chemoprevention is one of the cancer prevention approaches wherein natural/synthetic agent(s) are prescribed with the aim to delay or disrupt multiple pathways and processes involved at multiple steps, i.e., initiation, promotion, and progression of cancer. Amongst environmental chemopreventive compounds, diet/beverage-derived components are under evaluation, because of their long history of exposure to humans, high tolerability, low toxicity, and reported biological activities. This compilation briefly covers and compares the available evidence on chemopreventive efficacy and probable mechanism of chemoprevention by selected dietary phytochemicals(capsaicin, curcumin, diallyl sulphide, genistein, green/black tea polyphenols, indoles, lycopene, phenethyl isocyanate, resveratrol, retinoids and tocopherols) in experimental systems and clinical trials. All the dietary phytochemicals covered in this review have demonstrated chemopreventive efficacy against spontaneous or carcinogen-induced experimental tumors and/or associated biomarkers and processes in rodents at several organ sites. The observed anti-initiating, anti-promoting and anti-progression activity of dietary phytochemicals in carcinogen-induced experimental models involve phytochemical-mediated redox changes, modulation of enzymes and signaling kinases resulting to effects on multiple genes and cell signaling pathways. Results from clinical trials using these compounds have not shown them to be chemopreventive. This may be due to our:(1) inability to reproduce the exposure conditions, i.e., levels, complexity, other host and lifestyle factors; and(2) lack of understanding about the mechanisms of action and agent-mediated toxicity in several organs and physiological processes in the host. Current research efforts in addressing the issues of exposure conditions, bioavailability, toxicity and the mode of action of dietary phytochemicals may help address the reason for observed mismatch that may ultimately lead

  7. APOE-related risk of mild cognitive impairment and dementia for prevention trials: An analysis of four cohorts

    Science.gov (United States)

    Ikram, M. Arfan; Karlawish, Jason; Langbaum, Jessica B.; Neuhaus, John M.; Reiman, Eric M.; Roberts, J. Scott; Seshadri, Sudha; Tariot, Pierre N.; Betensky, Rebecca A.

    2017-01-01

    Background With the onset of prevention trials for individuals at high risk for Alzheimer disease, there is increasing need for accurate risk prediction to inform study design and enrollment, but available risk estimates are limited. We developed risk estimates for the incidence of mild cognitive impairment (MCI) or dementia among cognitively unimpaired individuals by APOE-e4 dose for the genetic disclosure process of the Alzheimer’s Prevention Initiative Generation Study, a prevention trial in cognitively unimpaired APOE-e4/e4 homozygote individuals. Methods and findings We included cognitively unimpaired individuals aged 60–75 y, consistent with Generation Study eligibility criteria, from the National Alzheimer’s Coordinating Center (NACC) (n = 5,073, 158 APOE-e4/e4), the Rotterdam Study (n = 6,399, 156 APOE-e4/e4), the Framingham Heart Study (n = 4,078, 67 APOE-e4/e4), and the Sacramento Area Latino Study on Aging (SALSA) (n = 1,294, 11 APOE-e4/e4). We computed stratified cumulative incidence curves by age (60–64, 65–69, 70–75 y) and APOE-e4 dose, adjusting for the competing risk of mortality, and determined risk of MCI and/or dementia by genotype and baseline age. We also used subdistribution hazard regression to model relative hazard based on age, APOE genotype, sex, education, family history of dementia, vascular risk, subjective memory concerns, and baseline cognitive performance. The four cohorts varied considerably in age, education, ethnicity/race, and APOE-e4 allele frequency. Overall, cumulative incidence was uniformly higher in NACC than in the population-based cohorts. Among APOE-e4/e4 individuals, 5-y cumulative incidence was as follows: in the 60–64-y age stratum, it ranged from 0% to 5.88% in the three population-based cohorts versus 23.06% in NACC; in the 65–69-y age stratum, from 9.42% to 10.39% versus 34.62%; and in the 70–75-y age stratum, from 18.64% to 33.33% versus 38.34%. Five-year incidence of dementia was negligible

  8. A trial of intermittent preventive treatment and home-based management of malaria in a rural area of The Gambia

    Directory of Open Access Journals (Sweden)

    Webb Emily L

    2011-01-01

    conclusion can be drawn on the added benefit of IPTc in preventing clinical episodes of malaria among children who had access to HMM in The Gambia. However, the study showed that VHWs can successfully combine provision of HMM with provision of IPTc. Trial Registration ClinicalTrials.gov NCT00944840

  9. Bisphosphonates for the prevention of fractures in osteogenesis imperfecta: meta-analysis of placebo-controlled trials.

    Science.gov (United States)

    Hald, Jannie D; Evangelou, Evangelos; Langdahl, Bente L; Ralston, Stuart H

    2015-05-01

    Bisphosphonates are widely used off-label in the treatment of patients with osteogenesis imperfecta (OI) with the intention of reducing the risk of fracture. Although there is strong evidence that bisphosphonates increase bone mineral density in osteogenesis imperfecta, the effects on fracture occurrence have been inconsistent. The aim of this study was to gain a better insight into the effects of bisphosphonate therapy on fracture risk in patients with osteogenesis imperfecta by conducting a meta-analysis of randomized controlled trials in which fractures were a reported endpoint. We searched Medline, Embase, and the Cochrane Central Register of Controlled Trials in which the effects of bisphosphonates on fracture risk in osteogenesis imperfecta were compared with placebo and conducted a meta-analysis of these studies using standard methods. Heterogeneity was assessed using the I2 statistic. Six eligible studies were identified involving 424 subjects with 751 patient-years of follow-up. The proportion of patients who experienced a fracture was not significantly reduced by bisphosphonate therapy (Relative Risk [RR] = 0.83 [95% confidence interval 0.69-1.01], p = 0.06) with no heterogeneity between studies (I2  = 0). The fracture rate was reduced by bisphosphonate treatment when all studies were considered (RR = 0.71 [0.52-0.96], p = 0.02), but with considerable heterogeneity (I2  = 36%) explained by one study where a small number of patients in the placebo group experienced a large number of fractures. When this study was excluded, the effects of bisphosphonates on fracture rate was not significant (RR = 0.79 [0.61-1.02], p = 0.07, I2  = 0%). We conclude that the effects of bisphosphonates on fracture prevention in osteogenesis imperfecta are inconclusive. Adequately powered trials with a fracture endpoint are needed to further investigate the risks and benefits of bisphosphonates in this condition.

  10. Enhancing implementation of tobacco use prevention and cessation counselling guideline among dental providers: a cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Michie Susan

    2011-02-01

    Full Text Available Abstract Background Tobacco use adversely affects oral health. Tobacco use prevention and cessation (TUPAC counselling guidelines recommend that healthcare providers ask about each patient's tobacco use, assess the patient's readiness and willingness to stop, document tobacco use habits, advise the patient to stop, assist and help in quitting, and arrange monitoring of progress at follow-up appointments. Adherence to such guidelines, especially among dental providers, is poor. To improve guideline implementation, it is essential to understand factors influencing it and find effective ways to influence those factors. The aim of the present study protocol is to introduce a theory-based approach to diagnose implementation difficulties of TUPAC counselling guidelines among dental providers. Methods Theories of behaviour change have been used to identify key theoretical domains relevant to the behaviours of healthcare providers involved in implementing clinical guidelines. These theoretical domains will inform the development of a questionnaire aimed at assessing the implementation of the TUPAC counselling guidelines among Finnish municipal dental providers. Specific items will be drawn from the guidelines and the literature on TUPAC studies. After identifying potential implementation difficulties, we will design two interventions using theories of behaviour change to link them with relevant behaviour change techniques aiming to improve guideline adherence. For assessing the implementation of TUPAC guidelines, the electronic dental record audit and self-reported questionnaires will be used. Discussion To improve guideline adherence, the theoretical-domains approach could provide a comprehensive basis for assessing implementation difficulties, as well as designing and evaluating interventions. After having identified implementation difficulties, we will design and test two interventions to enhance TUPAC guideline adherence. Using the cluster

  11. A randomised trial to compare the safety, tolerability and efficacy of three drug combinations for intermittent preventive treatment in children.

    Directory of Open Access Journals (Sweden)

    Kalifa Bojang

    Full Text Available BACKGROUND: Results from trials of intermittent preventive treatment (IPT in infants and children have shown that IPT provides significant protection against clinical malaria. Sulfadoxine-pyrimethamine (SP given alone or in combination with other drugs has been used for most IPT programmes. However, SP resistance is increasing in many parts of Africa. Thus, we have investigated whether SP plus AQ, SP plus piperaquine (PQ and dihydroartemisinin (DHA plus PQ might be equally safe and effective when used for IPT in children in an area of seasonal transmission. METHODS: During the 2007 malaria transmission season, 1008 Gambian children were individually randomized to receive SP plus amodiaquine (AQ, SP plus piperaquine (PQ or dihydroartemisinin (DHA plus PQ at monthly intervals on three occasions during the peak malaria transmission season. To determine the risk of side effects following drug administration, participants in each treatment group were visited at home three days after the start of each round of drug administration and a side effects questionnaire completed. To help establish whether adverse events were drug related, the same questionnaire was administered to 286 age matched control children recruited from adjacent villages. Morbidity was monitored throughout the malaria transmission season and study children were seen at the end of the malaria transmission season. RESULTS: All three treatment regimens showed good safety profiles. No severe adverse event related to IPT was reported. The most frequent adverse events reported were coughing, diarrhoea, vomiting, abdominal pain and loss of appetite. Cough was present in 15.2%, 15.4% and 18.7% of study subjects who received SP plus AQ, DHA plus PQ or SP plus PQ respectively, compared to 19.2% in a control group. The incidence of malaria in the DHA plus PQ, SP plus AQ and SP plus PQ groups were 0.10 cases per child year (95% CI: 0.05, 0.22, 0.06 (95% CI: 0.022, 0.16 and 0.06 (95% CI: 0.02, 0

  12. Intermittent screening and treatment versus intermittent preventive treatment of malaria in pregnancy: a randomised controlled non-inferiority trial.

    Directory of Open Access Journals (Sweden)

    Harry Tagbor

    Full Text Available BACKGROUND: The effectiveness of intermittent preventive treatment of malaria in pregnancy (IPTp may be compromised by the spread of resistance to sulphadoxine/pyrimethamine (SP across Africa. But little information exists on alternative drugs for IPTp or alternative strategies for the prevention of malaria in pregnancy. Therefore, we have investigated whether screening with a rapid diagnostic test and treatment of those who are positive (IST at routine antenatal clinic attendances is as effective and as safe as SP-IPTp in pregnant women. METHODS AND FINDINGS: During antenatal clinic sessions in six health facilities in Ghana held between March 2007 and September 2007, 3333 pregnant women who satisfied inclusion criteria were randomised into three intervention arms (1 standard SP-IPTp, (2 IST and treatment with SP or (3 IST and treatment with amodiaquine+artesunate (AQ+AS. All women received a long-lasting insecticide treated net. Study women had a maximum of three scheduled follow-up visits following enrollment. Haemoglobin concentration and peripheral parasitaemia were assessed between 36 and 40 weeks of gestation. Birth weight was measured at delivery or within 72 hours for babies delivered at home. Parasite prevalence at enrollment in primigravidae and in multigravidae was 29.6% and 10.2% respectively. At 36-40 weeks of gestation the prevalence of asymptomatic parasitaemia was 12.1% in study women overall and was very similar in all treatment groups. The risk of third trimester severe anaemia or low birth weight did not differ significantly between the three treatment groups regardless of gravidity. IST with AQ+AS or SP was not inferior to SP-IPTp in reducing the risk of low birth weight (RD  =  -1.17[95%CI; -4.39-1.02] for IST-SP vs. SP-IPTp and RD = 0.78[95%CI; -2.11-3.68] for IST-AQAS vs. SP-IPTp; third trimester severe anaemia (RD = 0.29[95%CI; -0.69-1.30] for IST-SP vs. SP-IPTp and RD  =  -0.36[95%CI;-1.12-0.44] for IST-AQAS vs

  13. A single-arm Phase II validation study of preventing oxaliplatin-induced hypersensitivity reactions by dexamethasone: the AVOID trial

    Directory of Open Access Journals (Sweden)

    Yoshida Y

    2015-11-01

    Full Text Available Yoichiro Yoshida,1 Keiji Hirata,2 Hiroshi Matsuoka,3 Shigeyoshi Iwamoto,4 Masahito Kotaka,5 Hideto Fujita,6 Naoya Aisu,1 Seiichiro Hoshino,1 Takeo Kosaka,6 Kotaro Maeda,3 Fumiaki Kiyomi,7 Yuichi Yamashita1 1Department of Gastroenterological Surgery, Fukuoka University Faculty of Medicine, Fukuoka, Japan; 2Department of Surgery, Fukuoka Sanno Hospital, Fukuoka, Japan; 3Department of Surgery, Fujita Health University School of Medicine, Toyoake, Japan; 4Department of Surgery, Kansai Medical University Hirakata Hospital, Osaka, Japan; 5Gastrointestinal Cancer Center, Sano Hospital, Kobe, Japan; 6Department of Surgical Oncology, Kanazawa Medical University, Uchinada, Japan; 7Academia, Industry and Government Collaborative Research Institute of Translational Medicine for Life Innovation, Fukuoka University, Fukuoka, Japan Background: Patients with colorectal cancer treated with oxaliplatin are at risk of hypersensitivity reactions, with the incidence estimated to be 12%–20%. Coinfusion of dexamethasone and oxaliplatin could potentially reduce the incidence of these reactions, but oxaliplatin is reported to be incompatible with alkaline compounds in solution. However, in a previous retrospective study we found that the pH of a solution of dexamethasone and oxaliplatin was less than 7.4, and that hypersensitivity to oxaliplatin could have been prevented by coinfusion of dexamethasone. We aimed to evaluate the effectiveness of coinfusion of dexamethasone and oxaliplatin to prevent oxaliplatin-induced hypersensitivity reactions.Patients and methods: The AVOID trial was a prospective, multicenter, open-label, single-arm Phase II trial conducted from January to September 2013. The study included 73 patients who received capecitabine plus oxaliplatin (XELOX or XELOX plus bevacizumab therapy for colorectal cancer. In all patients, oxaliplatin was administered in combination with dexamethasone. The primary outcome measure was the presence of

  14. Evaluating HIV prevention efforts using semiparametric regression models: results from a large cohort of women participating in an HIV prevention trial from KwaZulu-Natal, South Africa

    Directory of Open Access Journals (Sweden)

    Gita Ramjee

    2013-11-01

    Full Text Available Objective: To describe and quantify the differences in risk behaviours, HIV prevalence and incidence rates by birth cohorts among a group of women in Durban, South Africa. Methods: Cross-sectional and prospective cohort analyses were conducted for women who consented to be screened and enrolled in an HIV prevention trial. Demographic and sexual behaviours were described by five-year birth cohorts. Semiparametric regression models were used to investigate the bivariate associations between these factors and the birth cohorts. HIV seroconversion rates were also estimated by birth cohorts. Results: The prevalence of HIV-1 infection at the screening visit was lowest (20.0% among the oldest (born before 1960 cohorts, while the highest prevalence was observed among those born between 1975 and 79. Level of education increased across the birth cohorts while the median age at first sexual experience declined among those born after 1975 compared to those born before 1975. Only 33.03% of the oldest group reported ever using a condom while engaging in vaginal sex compared to 73.68% in the youngest group; however, HIV and other sexually transmitted infection (STI incidence rates were significantly higher among younger women compared to older women. Conclusions: These findings clearly suggest that demographic and sexual risk behaviours are differentially related to the birth cohorts. Significantly high HIV and STI incidence rates were observed among the younger group. Although the level of education increased, early age at sexual debut was more common among the younger group. The continuing increase in HIV and STI incidence rates among the later cohorts suggests that the future trajectory of the epidemic will be dependent on the infection patterns in younger birth cohorts.

  15. Weight Gain Prevention among Midlife Women: A Randomized Controlled Trial to Address Needs Related to the Physical and Social Environment

    Directory of Open Access Journals (Sweden)

    Courtney D. Perry

    2016-05-01

    Full Text Available Women tend to gain weight at midlife (40–60 years increasing risk of obesity-related chronic diseases. Within specific eating occasions, needs related to the physical and social environment may result in less healthy eating behavior, which can lead to weight gain over time. The purpose of this study was to determine if a dietitian-delivered nutrition counseling intervention tailored to eating occasion needs could improve diet and prevent weight gain among midlife women over two years. A randomized controlled trial was conducted with healthy midlife women (n = 354 in one U.S. metropolitan area. The intervention group (n = 185 received ten hours of individual nutrition counseling from dietitians over six months, while women in a control group (n = 169 received no counseling. Measured height, weight and waist circumference, and dietary intakes were collected at baseline and every six months over two years. Mixed linear models were used to test for intervention effect on change in outcome variables over time. Dietary intakes of fruit, reduced/low-fat dairy foods and refined grains were significantly improved over time in the intervention compared to control group. However, the intervention had no effect on weight over time (p = 0.48. Nutrition counseling tailored to address eating occasion needs improved self-reported diet but did not significantly affect weight change.

  16. Administration of ascorbic acid to prevent bleaching-induced tooth sensitivity: a randomized triple-blind clinical trial.

    Science.gov (United States)

    de Paula, E A; Kossatz, S; Fernandes, D; Loguercio, A D; Reis, A

    2014-01-01

    This study evaluated the effect of ascorbic acid, 500 mg every eight hours, on bleaching-induced tooth sensitivity. A triple-blind, parallel design, and placebo-controlled randomized clinical trial was conducted on 39 adults. The pills (placebo or ascorbic acid) were administered three times per day for 48 hours; the first dose was given one hour prior to each bleaching session. Two bleaching sessions with 35% hydrogen peroxide gel were performed with a one-week interval. Tooth sensitivity was recorded up to 48 hours after bleaching. The color evaluation was performed before and 30 days after bleaching. The absolute risk and intensity of tooth sensitivity were evaluated by Fisher exact and Mann-Whitney U-tests, respectively. Color changes were evaluated by unpaired t-test (α=0.05). There were no significant differences in the absolute risk and intensity of tooth sensitivity and color change between the groups. Both groups showed a similar risk of tooth sensitivity (p>0.05). The perioperative use of an antioxidant, such as ascorbic acid (500 mg, three times daily) perorally, was not able to prevent bleaching-induced tooth sensitivity or reduce its intensity.

  17. Long-term prognosis of women after myocardial infarction. SPRINT Study Group. Secondary Prevention Reinfarction Israeli Nifedipine Trial.

    Science.gov (United States)

    Benderly, M; Behar, S; Reicher-Reiss, H; Boyko, V; Goldbourt, U

    1997-07-15

    Women sustaining myocardial infarction fare worse than men during hospitalization. Reports on long-term survival in women surviving an acute myocardial infarction are controversial. The Secondary Prevention Reinfarction Israeli Nifedipine Trial (SPRINT) registry includes 5,839 consecutive myocardial infarction patients who were hospitalized in 13 coronary care units in Israel between 1981 and 1983. The authors examined sex differences in the long-term survival of 4,808 hospital survivors (1,120 women and 3,688 men). Women exhibited a significantly poorer long-term survival than men. After age adjustment, differences between men and women decreased, leaving a survival probability difference of 11% at the end of 12 years of follow-up. In a subgroup analysis, women exhibited poorer survival than men in a comparison of patients with and without periinfarction congestive heart failure or a history of myocardial infarction preceding the index infarction. The multivariate adjusted hazard ratios associated with female sex in diabetic and nondiabetic patients were 1.46 and 1.13, respectively. In conclusion, a cumulative survival disadvantage for women in comparison with men is still evident after 12 years of follow-up. The mortality difference is diminished but not erased after age adjustment or multivariate adjustment for confounders. The authors' results are compatible with a hypothesis that the main factor underlying the increased long-term mortality in women after myocardial infarction, besides older age, is diabetes mellitus.

  18. Biomedical Engineering Laboratory

    Science.gov (United States)

    2007-11-02

    The Masters of Engineering program with concentration in Biomedical Engineering at Tennessee State University was established in fall 2000. Under... biomedical engineering . The lab is fully equipped with 10 Pentium5-based, 2 Pentium4-based laptops for mobile experiments at remote locations, 8 Biopac...students (prospective graduate students in biomedical engineering ) are regularly using this lab. This summer, 8 new prospective graduate students

  19. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... trial. Prevention Trials Click for more information In prevention trials, researchers study ways to reduce the risk of getting a disease or a specific medical problem. These trials find out if lifestyle changes, such as exercising more, getting more sleep, ...

  20. Biomedical engineering principles

    CERN Document Server

    Ritter, Arthur B; Valdevit, Antonio; Ascione, Alfred N

    2011-01-01

    Introduction: Modeling of Physiological ProcessesCell Physiology and TransportPrinciples and Biomedical Applications of HemodynamicsA Systems Approach to PhysiologyThe Cardiovascular SystemBiomedical Signal ProcessingSignal Acquisition and ProcessingTechniques for Physiological Signal ProcessingExamples of Physiological Signal ProcessingPrinciples of BiomechanicsPractical Applications of BiomechanicsBiomaterialsPrinciples of Biomedical Capstone DesignUnmet Clinical NeedsEntrepreneurship: Reasons why Most Good Designs Never Get to MarketAn Engineering Solution in Search of a Biomedical Problem

  1. Fundamental of biomedical engineering

    CERN Document Server

    Sawhney, GS

    2007-01-01

    About the Book: A well set out textbook explains the fundamentals of biomedical engineering in the areas of biomechanics, biofluid flow, biomaterials, bioinstrumentation and use of computing in biomedical engineering. All these subjects form a basic part of an engineer''s education. The text is admirably suited to meet the needs of the students of mechanical engineering, opting for the elective of Biomedical Engineering. Coverage of bioinstrumentation, biomaterials and computing for biomedical engineers can meet the needs of the students of Electronic & Communication, Electronic & Instrumenta

  2. A randomised controlled trial of preventive spinal manipulation with and without a home exercise program for patients with chronic neck pain

    Directory of Open Access Journals (Sweden)

    Descarreaux Martin

    2011-02-01

    Full Text Available Abstract Background Evidence indicates that supervised home exercises, combined or not with manual therapy, can be beneficial for patients with non-specific chronic neck pain (NCNP. The objective of the study is to investigate the efficacy of preventive spinal manipulative therapy (SMT compared to a no treatment group in NCNP patients. Another objective is to assess the efficacy of SMT with and without a home exercise program. Methods Ninety-eight patients underwent a short symptomatic phase of treatment before being randomly allocated to either an attention-group (n = 29, a SMT group (n = 36 or a SMT + exercise group (n = 33. The preventive phase of treatment, which lasted for 10 months, consisted of meeting with a chiropractor every two months to evaluate and discuss symptoms (attention-control group, 1 monthly SMT session (SMT group or 1 monthly SMT session combined with a home exercise program (SMT + exercise group. The primary and secondary outcome measures were represented by scores on a 10-cm visual analog scale (VAS, active cervical ranges of motion (cROM, the neck disability index (NDI and the Bournemouth questionnaire (BQ. Exploratory outcome measures were scored on the Fear-avoidance Behaviour Questionnaire (FABQ and the SF-12 Questionnaire. Results Our results show that, in the preventive phase of the trial, all 3 groups showed primary and secondary outcomes scores similar to those obtain following the non-randomised, symptomatic phase. No group difference was observed for the primary, secondary and exploratory variables. Significant improvements in FABQ scores were noted in all groups during the preventive phase of the trial. However, no significant change in health related quality of life (HRQL was associated with the preventive phase. Conclusions This study hypothesised that participants in the combined intervention group would have less pain and disability and better function than participants from the 2 other groups during the

  3. Atorvastatin reduces the risk of cardiovascular events in patients with carotid atherosclerosis: a secondary analysis of the Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) trial

    DEFF Research Database (Denmark)

    Sillesen, H.; Amarenco, P.; Hennerici, M.G.

    2008-01-01

    BACKGROUND AND PURPOSE: The Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) trial found that treatment with atorvastatin 80 mg per day reduced the risk of stroke and cardiovascular events in patients with a recent transient ischemic attack (TIA) or stroke. We hypothesized...... this benefit would be greatest in the subgroup of patients with carotid stenosis. METHODS: The SPARCL trial randomized patients with TIA or stroke within 1 to 6 months without known coronary heart disease (CHD) and low-density lipoprotein cholesterol 100 to 190 mg/dL to treatment with atorvastatin 80 mg per...

  4. Rationale and Baseline Characteristics of PREVENT: A Second-Generation Intervention Trial in Subjects At-Risk (Prodromal) of Developing First-Episode Psychosis Evaluating Cognitive Behavior Therapy, Aripiprazole, and Placebo for the Prevention of Psychosis

    Science.gov (United States)

    Bechdolf, Andreas; Müller, Hendrik; Stützer, Hartmut; Wagner, Michael; Maier, Wolfgang; Lautenschlager, Marion; Heinz, Andreas; de Millas, Walter; Janssen, Birgit; Gaebel, Wolfgang; Michel, Tanja Maria; Schneider, Frank; Lambert, Martin; Naber, Dieter; Brüne, Martin; Krüger-Özgürdal, Seza; Wobrock, Thomas; Riedel, Michael; Klosterkötter, Joachim

    2011-01-01

    Antipsychotics, cognitive behavioral therapy (CBT), and omega-3-fatty acids have been found superior to control conditions as regards prevention of psychosis in people at-risk of first-episode psychosis. However, no large-scale trial evaluating the differential efficacy of CBT and antipsychotics has been performed yet. In PREVENT, we evaluate CBT, aripiprazole, and clinical management (CM) as well as placebo and CM for the prevention of psychosis in a randomized, double-blind, placebo-controlled trial with regard to the antipsychotic intervention and a randomized controlled trial with regard to the CBT intervention with blinded ratings. The hypotheses are first that CBT and aripiprazole and CM are superior to placebo and CM and second that CBT is not inferior to aripiprazole and CM combined. The primary outcome is transition to psychosis. By November 2010, 156 patients were recruited into the trial. The subjects were substantially functionally compromised (Social and Occupational Functioning Assessment Scale mean score 52.5) and 78.3% presented with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition axis I comorbid diagnosis. Prior to randomization, 51.5% of the participants preferred to be randomized into the CBT arm, whereas only 12.9% preferred pharmacological treatment. First, assessments of audiotaped treatment sessions confirmed the application of CBT-specific skills in the CBT condition and the absence of those in CM. The overall quality rating of the CBT techniques applied in the CBT condition was good. When the final results of the trial are available, PREVENT will substantially expand the current limited evidence base for best clinical practice in people at-risk (prodromal) of first-episode psychosis. PMID:21860040

  5. HPTN 071 (PopART: a cluster-randomized trial of the population impact of an HIV combination prevention intervention including universal testing and treatment: mathematical model.

    Directory of Open Access Journals (Sweden)

    Anne Cori

    Full Text Available BACKGROUND: The HPTN 052 trial confirmed that antiretroviral therapy (ART can nearly eliminate HIV transmission from successfully treated HIV-infected individuals within couples. Here, we present the mathematical modeling used to inform the design and monitoring of a new trial aiming to test whether widespread provision of ART is feasible and can substantially reduce population-level HIV incidence. METHODS AND FINDINGS: The HPTN 071 (PopART trial is a three-arm cluster-randomized trial of 21 large population clusters in Zambia and South Africa, starting in 2013. A combination prevention package including home-based voluntary testing and counseling, and ART for HIV positive individuals, will be delivered in arms A and B, with ART offered universally in arm A and according to national guidelines in arm B. Arm C will be the control arm. The primary endpoint is the cumulative three-year HIV incidence. We developed a mathematical model of heterosexual HIV transmission, informed by recent data on HIV-1 natural history. We focused on realistically modeling the intervention package. Parameters were calibrated to data previously collected in these communities and national surveillance data. We predict that, if targets are reached, HIV incidence over three years will drop by >60% in arm A and >25% in arm B, relative to arm C. The considerable uncertainty in the predicted reduction in incidence justifies the need for a trial. The main drivers of this uncertainty are possible community-level behavioral changes associated with the intervention, uptake of testing and treatment, as well as ART retention and adherence. CONCLUSIONS: The HPTN 071 (PopART trial intervention could reduce HIV population-level incidence by >60% over three years. This intervention could serve as a paradigm for national or supra-national implementation. Our analysis highlights the role mathematical modeling can play in trial development and monitoring, and more widely in evaluating the

  6. Effect of angiotensin receptor blockers in the prevention of type 2 diabetes and cardiovascular events: a meta-analysis of randomized trials

    Institute of Scientific and Technical Information of China (English)

    SONG Hui-fen; WANG Su; LI Hong-wei

    2012-01-01

    Background As the incidence of type 2 diabetes is rapidly increasing,prevention of the disease should be considered as a crucial objective in the near future.Several studies have shown angiotensin receptor blockers (ARBs) may contribute to the prevention of new-onset type 2 diabetes.This study was conducted to determine if ARBs as monotherapy or combination therapy may experience a decreased incidence of new-onset type 2 diabetes and prevent cardiovascular events.Methods Relevant experimental and clinical studies were identified by searching MEDLINE (1969 to May 30,2011) to extract a consensus of trial data involving the effect of ARBs on prevention of new-onset type 2 diabetes and cardiovascular events.Studies were included if they were randomized controlled trials versus placebo/routine therapy.A random-effects model was utilized.Subgroup and sensitivity analyses were conducted.Results Eleven trials were identified,including 82738 patients.ARBs prevented new-onset type 2 diabetes (odds ratio 0.8 (95% CI 0.76,0.85)).Regardless of indication for use,essential hypertension (seven trials),impaired glucose tolerance (one trial),cardiocerebrovascular disease (two trials) or heart failure (one trial),reductions in new-onset type 2 diabetes were maintained (0.75 (0.69,0.82),0.85 (0.78,0.92),0.80 (0.76,0.85) and 0.80 (0.64,0.99),respectively).No statistical heterogeneity was observed for any evaluation.However,ARBs did not significantly reduce the odds of all-cause mortality,myocardial infarction and heart failure versus control therapy among all of these studies.But ARBs did reduce the odds of cardiac death and heart failure among the heart failure study versus control therapy.Conclusion ARBs have significant ability to reduce risk of developing new-onset type 2 diabetes but does not improve cardiovascular outcomes over the study follow-up periods among all of included studies.

  7. The rationale, design, and baseline characteristics of PREVENT-DM: A community-based comparative effectiveness trial of lifestyle intervention and metformin among Latinas with prediabetes.

    Science.gov (United States)

    Perez, Alberly; Alos, Victor A; Scanlan, Adam; Maia, Catarina M; Davey, Adam; Whitaker, Robert C; Foster, Gary D; Ackermann, Ronald T; O'Brien, Matthew J

    2015-11-01

    Promotora Effectiveness Versus Metformin Trial (PREVENT-DM) is a randomized comparative effectiveness trial of a lifestyle intervention based on the Diabetes Prevention Program delivered by community health workers (or promotoras), metformin, and standard care. Eligibility criteria are Hispanic ethnicity, female sex, age ≥ 20 years, fluent Spanish-speaking status, BMI ≥ 23 kg/m(2), and prediabetes. We enrolled 92 participants and randomized them to one of the following three groups: standard care, DPP-based lifestyle intervention, or metformin. The primary outcome of the trial is the 12-month difference in weight between groups. Secondary outcomes include the following cardiometabolic markers: BMI, waist circumference, blood pressure, and fasting plasma glucose, hemoglobin A1C (HbA1c), total cholesterol, triglycerides, LDL cholesterol, HDL cholesterol, and insulin. PREVENT-DM participants are socioeconomically disadvantaged Latinas with a mean annual household income of $15,527 ± 9922 and educational attainment of 9.7 ± 3.6 years. Eighty-six percent of participants are foreign born, 20% have a prior history of gestational diabetes, and 71% have a first-degree relative with diagnosed diabetes. At baseline, PREVENT-DM participants had a mean age of 45.1 ± 12.5 years, weight of 178.8 ± 39.3 lbs, BMI of 33.3 ± 6.5 kg/m(2), HbA1c of 5.9 ± 0.2%, and waist circumference of 97.4 ± 11.1cm. Mean baseline levels of other cardiometabolic markers were normal. The PREVENT-DM study successfully recruited and randomized an understudied population of Latinas with prediabetes. This trial will be the first U.S. study to test the comparative effectiveness of metformin and lifestyle intervention versus standard care among prediabetic adults in a "real-world" setting.

  8. A failed RCT to determine if antibiotics prevent mastitis: Cracked nipples colonized with Staphylococcus aureus: A randomized treatment trial [ISRCTN65289389

    Directory of Open Access Journals (Sweden)

    Garland Suzanne M

    2004-09-01

    Full Text Available Abstract Background A small, non-blinded, RCT (randomised controlled trial had reported that oral antibiotics reduced the incidence of mastitis in lactating women with Staphylococcus aureus (S. aureus- colonized cracked nipples. We aimed to replicate the study with a more rigorous design and adequate sample size. Methods Our intention was to conduct a double-blind placebo-controlled trial to determine if an antibiotic (flucloxacillin could prevent mastitis in lactating women with S. aureus-colonized cracked nipples. We planned to recruit two groups of 133 women with S. aureus-colonized cracked nipples. Results We spent over twelve months submitting applications to five hospital ethics committees and seven funding bodies, before commencing the trial. Recruitment to the trial was very slow and only ten women were randomized to the trial after twelve months, and therefore the trial was stopped early. Conclusions In retrospect we should have conducted a feasibility study, which would have revealed the low number of women in these Melbourne hospitals (maternity wards and breastfeeding clinics with damaged nipples. The appropriate use of antibiotics for breastfeeding women with cracked nipples still needs to be tested.

  9. Effectiveness of the Strengthening Families Programme 10–14 in Poland for the prevention of alcohol and drug misuse: protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Okulicz-Kozaryn Katarzyna

    2012-06-01

    Full Text Available Abstract Background Alcohol and other drug use and misuse is a significant problem amongst Polish youth. The SFP10-14 is a family-based prevention intervention that has positive results in US trials, but questions remain about the generalizability of these results to other countries and settings. Methods/Design A cluster randomized controlled trial in community settings across Poland. Communities will be randomized to a SFP10-14 trial arm or to a control arm. Recruitment and consent of families, and delivery of the SFP10-14, will be undertaken by community workers. The primary outcomes are alcohol and other drug use and misuse. Secondary (or intermediate outcomes include parenting practices, parent–child relations, and child problem behaviour. Interview-based questionnaires will be administered at baseline, 12 and 24 months. Discussion The trial will provide information about the effectiveness of the SFP10-14 in Poland. Trial registration International Standard Randomised Controlled Trial Number: ISRCTN89673828

  10. Pregnancy incidence and risk factors among women participating in vaginal microbicide trials for HIV prevention: systematic review and meta-analysis.

    Directory of Open Access Journals (Sweden)

    Alfred Musekiwa

    Full Text Available INTRODUCTION: Pregnancy is contraindicated in vaginal microbicide trials for the prevention of HIV infection in women due to the unknown maternal and fetal safety of the microbicides. Women who become pregnant are taken off the microbicide during pregnancy period but this result in reduction of the power of the trials. Strategies to reduce the pregnancy rates require an understanding of the incidence and associated risk factors of pregnancy in microbicide trials. This systematic review estimates the overall incidence rate of pregnancy in microbicide trials and describes the associated risk factors. METHODS: A comprehensive literature search was carried out to identify eligible studies from electronic databases and other sources. Two review authors independently selected studies and extracted relevant data from included studies. Meta-analysis of incidence rates of pregnancy was carried out and risk factors of pregnancy were reported narratively. RESULTS: Fifteen studies reporting data from 10 microbicide trials (N=27,384 participants were included. A total of 4,107 participants (15.0% fell pregnant and a meta-analysis of incidence rates of pregnancy from 8 microbicide trials (N=25,551 yielded an overall incidence rate of 23.37 (95%CI: 17.78 to 28.96 pregnancies per 100 woman-years. However, significant heterogeneity was detected. Hormonal injectable, intra-uterine device (IUD or implants or sterilization, older age, more years of education and condom use were associated with lower pregnancy. On the other hand, living with a man, history of pregnancy, self and partner desire for future baby, oral contraceptive use, increased number of unprotected sexual acts and inconsistent use of condoms were associated with higher pregnancy. CONCLUSIONS: The incidence rate of pregnancy in microbicide trials is high and strategies for its reduction are urgently required in order to improve the sample size and power of these trials.

  11. Effectiveness of a school-based physical activity-related injury prevention program on risk behavior and neuromotor fitness a cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Bakker Ingrid

    2010-01-01

    Full Text Available Abstract Background To investigate the effects of a school-based physical activity-related injury prevention program, called 'iPlay', on risk behavior and neuromotor fitness. Methods In this cluster randomized controlled trial 40 primary schools throughout the Netherlands were randomly assigned in an intervention (n = 20 or control group (n = 20. The study includes 2,210 children aged 10-12 years. The iPlay-intervention takes one school year and consists of a teacher manual, informative newsletters and posters, a website, and simple exercises to be carried out during physical education classes. Outcomes measures were self-reported injury preventing behavior, self-reported behavioral determinants (knowledge, attitude, social-influence, self-efficacy, and intention, and neuromotor fitness. Results The iPlay-program was not able to significantly improve injury-preventing behavior. The program did significantly improve knowledge and attitude, two determinants of behavior. The effect of the intervention-program on behavior appeared to be significantly mediated by knowledge and attitude. Improved scores on attitude, social norm, self-efficacy and intention were significantly related to changes in injury preventing behavior. Furthermore, iPlay resulted in small non-significant improvements in neuromotor fitness in favor of the intervention group. Conclusion This cluster randomized controlled trial showed that the iPlay-program did significantly improved behavioral determinants. However, this effect on knowledge and attitude was not strong enough to improve injury preventing behavior. Furthermore, the results confirm the hypothetical model that injury preventing behavior is determined by intention, attitude, social norm and self-efficacy. Trial number ISRCTN78846684

  12. Effect of candesartan on prevention (DIRECT-Prevent 1) and progression (DIRECT-Protect 1) of retinopathy in type 1 diabetes: randomised, placebo-controlled trials

    DEFF Research Database (Denmark)

    Chaturvedi, N.; Porta, M.; Klein, R.;

    2008-01-01

    BACKGROUND: Results of previous studies suggest that renin-angiotensin system blockers might reduce the burden of diabetic retinopathy. We therefore designed the DIabetic REtinopathy Candesartan Trials (DIRECT) Programme to assess whether candesartan could reduce the incidence and progression of ...

  13. Improving adolescent social competence and behavior: a randomized trial of an 11-week equine facilitated learning prevention program.

    Science.gov (United States)

    Pendry, Patricia; Carr, Alexa M; Smith, Annelise N; Roeter, Stephanie M

    2014-08-01

    There is growing evidence that promoting social competence in youth is an effective strategy to prevent mental, emotional, and behavioral disorders in adulthood. Research suggests that programs delivered in collaboration with schools are particularly effective when they target social and emotional skill building, utilize an interactive instructional style, provide opportunities for youth participation and self-direction, and include explicit attempts to enhance youth social competence. A relatively new but popular approach that incorporates these characteristics is human animal interaction, which can be implemented in educational settings. We report the results from a randomized clinical trial examining the effects of an 11-week equine facilitated learning (EFL) program on the social competence and behavior of 5th-8th grade children. Children (N = 131) were recruited through referral by school counselors and school-based recruitment and then screened for low social competence. Researchers randomly assigned children to an experimental (n = 53) or waitlisted control group (n = 60). Children in the experimental group participated in an 11-week EFL program consisting of once-weekly, 90-min sessions of individual and team-focused activities, whereas children in the control group served as a wait-listed control and participated 16 weeks later. Parents of children in both groups rated child social competence at pretest and posttest. Three independent raters observed and reported children's positive and negative behavior using a validated checklist during each weekly session. Results indicated that program participation had a moderate treatment effect (d = .55) on social competence (p = .02) that was independent of pretest levels, age, gender, and referral status. Results showed that higher levels of program attendance predicted children's trajectories of observed positive (β = .500; p = .003) and negative behavior (β = -.062; p < .001) over the 11-week program.

  14. Effects of preventive online mindfulness interventions on stress and mindfulness: A meta-analysis of randomized controlled trials

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    Wasantha P. Jayawardene, MD, PhD

    2017-03-01

    Full Text Available Empirical evidence suggested that mind-body interventions can be effectively delivered online. This study aimed to examine whether preventive online mindfulness interventions (POMI for non-clinical populations improve short- and long-term outcomes for perceived-stress (primary and mindfulness (secondary. Systematic search of four electronic databases, manuscript reference lists, and journal content lists was conducted in 2016, using 21 search-terms. Eight randomized controlled trials (RCTs evaluating effects of POMI in non-clinical populations with adequately reported perceived-stress and mindfulness measures pre- and post-intervention were included. Random-effects models utilized for all effect-size estimations with meta-regression performed for mean age and %females. Participants were volunteers (adults; predominantly female from academic, workplace, or community settings. Most interventions utilized simplified Mindfulness-Based Stress Reduction protocols over 2–12 week periods. Post-intervention, significant medium effect found for perceived-stress (g = 0.432, with moderate heterogeneity and significant, but small, effect size for mindfulness (g = 0.275 with low heterogeneity; highest effects were for middle-aged individuals. At follow-up, significant large effect found for perceived-stress (g = 0.699 with low heterogeneity and significant medium effect (g = 0.466 for mindfulness with high heterogeneity. No publication bias was found for perceived-stress; publication bias found for mindfulness outcomes led to underestimation of effects, not overestimation. Number of eligible RCTs was low with inadequate data reporting in some studies. POMI had substantial stress reduction effects and some mindfulness improvement effects. POMI can be a more convenient and cost-effective strategy, compared to traditional face-to-face interventions, especially in the context of busy, hard-to-reach, but digitally-accessible populations.

  15. The relationship between parental stress and postpartum depression among adolescent mothers enrolled in a randomized controlled prevention trial.

    Science.gov (United States)

    Venkatesh, Kartik K; Phipps, Maureen G; Triche, Elizabeth W; Zlotnick, Caron

    2014-08-01

    Given the high co-occurrence of depression and parental stress among adolescent mothers, we evaluated the relationship between parental stress and postpartum depression among primiparous adolescent mothers. We conducted an observational analysis among a cohort of 106 adolescent mothers at 289 postpartum visits who were enrolled in a randomized controlled trial to prevent postpartum depression. Parental stress was measured using the Parenting Stress Index, short form. The Structured Clinical Interview for DSM-IV Childhood Diagnoses was administered to assess for postpartum depression; subthreshold depression was assessed using the Children's Depression Rating Scale, revised version. Generalized estimating equations were utilized to assess the relationship of parental stress on postpartum depression during the first 6 months postpartum. We present adjusted odds ratios (AOR) controlling for study arm, age, born in the United States, prior history of depression, and number of study visits. The median age was 16 years, 53% were Latina, and 16% reported a past history of depression. Nineteen adolescents (19%) were diagnosed with postpartum depression and 25% experienced high levels of parental stress through 6 months postpartum. Adolescent mothers who reported higher levels of parental stress were at significantly increased risk for postpartum depression [AOR 1.06 (95% CI 1.04-1.09); p stress predicted subsequent postpartum depression when assessing parental stress at visits prior to a depression diagnosis to determine whether we could establish a temporal association [AOR 1.06 (95% CI 1.02-1.09); p stress was also a risk factor for subthreshold depression [AOR 1.04 (95% CI 1.01-1.07); p stress was a significant risk factor for developing both postpartum depression as well as subthreshold depression among adolescent mothers. Interventions that target a reduction in parental stress may lead to less depression severity among primiparous adolescent mothers.

  16. Use of probiotic Lactobacillus preparation to prevent diarrhoea associated with antibiotics: randomised double blind placebo controlled trial

    Science.gov (United States)

    D'Souza, Aloysius L; Muthu, Nirmala; Rogers, Thomas R; Want, Susan; Rajkumar, Chakravarthi; Bulpitt, Christopher J

    2007-01-01

    Objective To determine the efficacy of a probiotic drink containing Lactobacillus for the prevention of any diarrhoea associated with antibiotic use and that caused by Clostridium difficile. Design Randomised double blind placebo controlled study. Participants 135 hospital patients (mean age 74) taking antibiotics. Exclusions included diarrhoea on admission, bowel pathology that could result in diarrhoea, antibiotic use in the previous four weeks, severe illness, immunosuppression, bowel surgery, artificial heart valves, and history of rheumatic heart disease or infective endocarditis. Intervention Consumption of a 100 g (97 ml) drink containing Lactobacillus casei, L bulgaricus, and Streptococcus thermophilus twice a day during a course of antibiotics and for one week after the course finished. The placebo group received a longlife sterile milkshake. Main outcome measures Primary outcome: occurrence of antibiotic associated diarrhoea. Secondary outcome: presence of C difficile toxin and diarrhoea. Results 7/57 (12%) of the probiotic group developed diarrhoea associated with antibiotic use compared with 19/56 (34%) in the placebo group (P=0.007). Logistic regression to control for other factors gave an odds ratio 0.25 (95% confidence interval 0.07 to 0.85) for use of the probiotic, with low albumin and sodium also increasing the risk of diarrhoea. The absolute risk reduction was 21.6% (6.6% to 36.6%), and the number needed to treat was 5 (3 to 15). No one in the probiotic group and 9/53 (17%) in the placebo group had diarrhoea caused by C difficile (P=0.001). The absolute risk reduction was 17% (7% to 27%), and the number needed to treat was 6 (4 to 14). Conclusion Consumption of a probiotic drink containing L casei, L bulgaricus, and S thermophilus can reduce the incidence of antibiotic associated diarrhoea and C difficile associated diarrhoea. This has the potential to decrease morbidity, healthcare costs, and mortality if used routinely in patients aged over 50

  17. Assessing Odor Level when Using PrePex for HIV Prevention: A Prospective, Randomized, Open Label, Blinded Assessor Trial to Improve Uptake of Male Circumcision.

    Science.gov (United States)

    Mutabazi, Vincent; Bitega, Jean Paul; Ngeruka, Leon Muyenzi; Karema, Corine; Binagwaho, Agnes

    2015-01-01

    The PrePex is a WHO--prequalified medical device for adult male circumcision for HIV prevention. The Government of Rwanda was the first country to implement the PrePex device and acts as the leading center of excellence providing training and formal guidelines. As part of the Government's efforts to improve PrePex implementation, it made efforts to improve the psychological acceptability of device by men, thus increasing uptake with VMMC in sub-Saharan Africa. Some men who underwent the PrePex procedure complained of foreskin odor while wearing the PrePex 3-7 days after it was placed. This complaint was identified as potential risk for uptake of the device. Researchers from Rwanda assumed there is a possible relation between the level of foreskin odor and patient foreskin hygiene technique. The Government of Rwanda decided to investigate those assumptions in a scientific way and conduct a trial to test different hygiene-cleaning methods in order to increase the acceptability of PrePex and mitigate the odor concern. The main objective of the trial was to compare odor levels between three arms, having identical personal hygiene but different foreskin hygiene techniques using either clear water with soap during a daily shower, soapy water using a syringe, or chlorhexidine using a syringe. One hundred and one subjects were enrolled to the trial and randomly allocated into three trial arms. Using chlorhexidine solution daily almost completely eliminated odor, and was statistically significant more effective that the other two arms. The trial results suggest that odor from the foreskin, while wearing the PrePex device, could be related to the growth of anaerobic bacteria, which can be prevented by a chlorhexidine cleaning method. This finding can be used to increase acceptability by men when considering PrePex as one of the leading methods for HIV prevention in VMMC programs.

  18. Assessing Odor Level when Using PrePex for HIV Prevention: A Prospective, Randomized, Open Label, Blinded Assessor Trial to Improve Uptake of Male Circumcision.

    Directory of Open Access Journals (Sweden)

    Vincent Mutabazi

    Full Text Available The PrePex is a WHO--prequalified medical device for adult male circumcision for HIV prevention. The Government of Rwanda was the first country to implement the PrePex device and acts as the leading center of excellence providing training and formal guidelines. As part of the Government's efforts to improve PrePex implementation, it made efforts to improve the psychological acceptability of device by men, thus increasing uptake with VMMC in sub-Saharan Africa. Some men who underwent the PrePex procedure complained of foreskin odor while wearing the PrePex 3-7 days after it was placed. This complaint was identified as potential risk for uptake of the device. Researchers from Rwanda assumed there is a possible relation between the level of foreskin odor and patient foreskin hygiene technique. The Government of Rwanda decided to investigate those assumptions in a scientific way and conduct a trial to test different hygiene-cleaning methods in order to increase the acceptability of PrePex and mitigate the odor concern. The main objective of the trial was to compare odor levels between three arms, having identical personal hygiene but different foreskin hygiene techniques using either clear water with soap during a daily shower, soapy water using a syringe, or chlorhexidine using a syringe. One hundred and one subjects were enrolled to the trial and randomly allocated into three trial arms. Using chlorhexidine solution daily almost completely eliminated odor, and was statistically significant more effective that the other two arms. The trial results suggest that odor from the foreskin, while wearing the PrePex device, could be related to the growth of anaerobic bacteria, which can be prevented by a chlorhexidine cleaning method. This finding can be used to increase acceptability by men when considering PrePex as one of the leading methods for HIV prevention in VMMC programs.

  19. The EARLY ALLIANCE prevention trial: an integrated set of interventions to promote competence and reduce risk for conduct disorder, substance abuse, and school failure.

    Science.gov (United States)

    Dumas, J E; Prinz, R J; Smith, E P; Laughlin, J

    1999-03-01

    Describes the EARLY ALLIANCE interventions, an integrated set of four programs designed to promote competence and reduce risk for early-onset conduct disorder, substance abuse, and school failure. These interventions are evaluated as part of a prevention trial that begins at school entry and targets child functioning and socializing practices across multiple contexts (school, peer group, family) and multiple domains (affective, social, and achievement coping-competence). The paper presents the conceptual foundation of the four interventions, including a synopsis of the risk and protective factors associated with conduct disorder and related outcomes, and of the coping-competence model driving EARLY ALLIANCE. The developmental rationale, intended impact, and procedures are described for each intervention: a universally administered classroom program and indicated, peer, reading-mentoring, and family programs. Interventions are currently being tested in a prevention trial, which is briefly summarized.

  20. How has the economic downturn affected communities and implementation of science-based prevention in the randomized trial of communities that care?

    Science.gov (United States)

    Kuklinski, Margaret R; Hawkins, J David; Plotnick, Robert D; Abbott, Robert D; Reid, Carolina K

    2013-06-01

    This study examined implications of the economic downturn that began in December 2007 for the Community Youth Development Study (CYDS), a longitudinal randomized controlled trial of the Communities That Care (CTC) prevention system. The downturn had the potential to affect the internal validity of the CYDS research design and implementation of science-based prevention in study communities. We used archival economic indicators and community key leader reports of economic conditions to assess the extent of the economic downturn in CYDS communities and potential internal validity threats. We also examined whether stronger economic downturn effects were associated with a decline in science-based prevention implementation. Economic indicators suggested the downturn affected CYDS communities to different degrees. We found no evidence of systematic differences in downturn effects in CTC compared to control communities that would threaten internal validity of the randomized trial. The Community Economic Problems scale was a reliable measure of community economic conditions, and it showed criterion validity in relation to several objective economic indicators. CTC coalitions continued to implement science-based prevention to a significantly greater degree than control coalitions 2 years after the downturn began. However, CTC implementation levels declined to some extent as unemployment, the percentage of students qualifying for free lunch, and community economic problems worsened. Control coalition implementation levels were not related to economic conditions before or after the downturn, but mean implementation levels of science-based prevention were also relatively low in both periods.

  1. William Hunter Harridge Lecture. Carotid endarterectomy versus stenting for stroke prevention: what we have and will learn from Carotid Revascularization Endarterectomy versus Stenting Trial.

    Science.gov (United States)

    Weaver, Fred A

    2014-07-01

    The Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) has major implications for the future of carotid revascularization and stroke prevention. The purpose of The William Hinter Harridge Lecture was to discuss the history of carotid revascularization before CREST, to delineate the emergence of carotid artery stenting as an alternative to carotid endarterectomy, analyze the key findings in CREST, and describe the next phase of investigation, CREST-2.

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

    OpenAIRE

    1984-01-01

    The clinical anticonvulsant efficacy of single dose rectal and oral administration of diazepam 20 mg was examined in two double-blind placebo-controlled trials in adult epileptic patients. All subjects suffered from drug resistant epilepsy and frequently experienced serial seizures. Diazepam was administered rectally as a new experimental suppository formulation immediately after a seizure and was highly effective in preventing recurrent fits within a 24 h observation period (p less than 0.00...

  3. Rapid Antiretroviral Therapy Initiation for Women in an HIV-1 Prevention Clinical Trial Experiencing Primary HIV-1 Infection during Pregnancy or Breastfeeding.

    Directory of Open Access Journals (Sweden)

    Susan Morrison

    Full Text Available During an HIV-1 prevention clinical trial in East Africa, we observed 16 cases of primary HIV-1 infection in women coincident with pregnancy or breastfeeding. Nine of eleven pregnant women initiated rapid combination antiretroviral therapy (ART, despite having CD4 counts exceeding national criteria for ART initiation; breastfeeding women initiated ART or replacement feeding. Rapid ART initiation during primary HIV-1 infection during pregnancy and breastfeeding is feasible in this setting.

  4. Engagement, Recruitment, and Retention in a Trans-Community, Randomized Controlled Trial for the Prevention of Obesity in Rural American Indian and Hispanic Children

    OpenAIRE

    Cruz, Theresa H.; Davis, Sally M; FitzGerald, Courtney A.; Canaca, Glenda F.; Keane, Patricia C.

    2014-01-01

    Engagement, recruitment and retention of participants are critical to the success of research studies but specific strategies are rarely elucidated in the literature. The purpose of this paper is to describe the engagement, recruitment and retention process and outcomes in the Child Health Initiative for Lifelong Eating and Exercise (CHILE) study, and to describe lessons learned in the process. CHILE is a multi-level, group randomized controlled trial of a childhood obesity prevention interve...

  5. A multicentre randomised controlled trial evaluating lactobacilli and bifidobacteria in the prevention of antibiotic-associated diarrhoea in older people admitted to hospital: the PLACIDE study protocol

    Directory of Open Access Journals (Sweden)

    Allen Stephen J

    2012-05-01

    Full Text Available Abstract Background Antibiotic associated diarrhoea complicates 5–39% of courses of antibiotic treatment. Major risk factors are increased age and admission to hospital. Of particular importance is C. difficile associated diarrhoea which occurs in about 4% of antibiotic courses and may result in severe illness, death and high healthcare costs. The emergence of the more virulent 027 strain of C. difficile has further heightened concerns. Probiotics may prevent antibiotic associated diarrhoea by several mechanisms including colonization resistance through maintaining a healthy gut flora. Methods This study aims to test the hypothesis that administration of a probiotic comprising two strains of lactobacilli and two strains of bifidobacteria alongside antibiotic treatment prevents antibiotic associated diarrhoea. We have designed a prospective, parallel group trial where people aged 65 years or more admitted to hospital and receiving one or more antibiotics are randomly allocated to receive either one capsule of the probiotic or a matching placebo daily for 21 days. The primary outcomes are the frequency of antibiotic associated and C. difficile diarrhoea during 8–12 weeks follow-up. To directly inform routine clinical practice, we will recruit a sufficient number of patients to demonstrate a 50% reduction in the frequency of C. difficile diarrhoea with a power of 80%. To maximize the generalizability of our findings and in view of the well-established safety record of probiotics, we will recruit a broad range of medical and surgical in-patients from two different health regions within the UK. Discussion Antibiotic associated diarrhoea constitutes a significant health burden. In particular, current measures to prevent and control C. difficile diarrhoea are expensive and disrupt clinical care. This trial may have considerable significance for the prevention of antibiotic associated diarrhoea in hospitals. Trial registration International

  6. The VITamin D and OmegA-3 TriaL (VITAL): rationale and design of a large randomized controlled trial of vitamin D and marine omega-3 fatty acid supplements for the primary prevention of cancer and cardiovascular disease.

    Science.gov (United States)

    Manson, Joann E; Bassuk, Shari S; Lee, I-Min; Cook, Nancy R; Albert, Michelle A; Gordon, David; Zaharris, Elaine; Macfadyen, Jean G; Danielson, Eleanor; Lin, Jennifer; Zhang, Shumin M; Buring, Julie E

    2012-01-01

    Data from laboratory studies, observational research, and/or secondary prevention trials suggest that vitamin D and marine omega-3 fatty acids may reduce risk for cancer or cardiovascular disease (CVD), but primary prevention trials with adequate dosing in general populations (i.e., unselected for disease risk) are lacking. The ongoing VITamin D and OmegA-3 TriaL (VITAL) is a large randomized, double-blind, placebo-controlled, 2 x 2 factorial trial of vitamin D (in the form of vitamin D(3) [cholecalciferol], 2000 IU/day) and marine omega-3 fatty acid (Omacor fish oil, eicosapentaenoic acid [EPA]+docosahexaenoic acid [DHA], 1g/day) supplements in the primary prevention of cancer and CVD among a multi-ethnic population of 20,000 U.S. men aged ≥ 50 and women aged ≥ 55. The mean treatment period will be 5 years. Baseline blood samples will be collected in at least 16,000 participants, with follow-up blood collection in about 6000 participants. Yearly follow-up questionnaires will assess treatment compliance (plasma biomarker measures will also assess compliance in a random sample of participants), use of non-study drugs or supplements, occurrence of endpoints, and cancer and vascular risk factors. Self-reported endpoints will be confirmed by medical record review by physicians blinded to treatment assignment, and deaths will be ascertained through national registries and other sources. Ancillary studies will investigate whether these agents affect risk for diabetes and glucose intolerance; hypertension; cognitive decline; depression; osteoporosis and fracture; physical disability and falls; asthma and other respiratory diseases; infections; and rheumatoid arthritis, systemic lupus erythematosus, thyroid diseases, and other autoimmune disorders.

  7. Safety and efficacy of device closure for patent foramen ovale for secondary prevention of neurological events: Comprehensive systematic review and meta-analysis of randomized controlled trials

    Energy Technology Data Exchange (ETDEWEB)

    Hakeem, Abdul [University of Arkansas for Medical Sciences, Little Rock, AR (United States); Marmagkiolis, Konstantinos [Citizens Memorial Hospital Heart and Vascular Institute, Bolivar, MO (United States); Hacioglu, Yalcin; Uretsky, Barry F.; Gundogdu, Betul [University of Arkansas for Medical Sciences, Little Rock, AR (United States); Leesar, Massoud [University of Alabama at Birmingham, Birmingham, AL (United States); Bailey, Steven R. [University of Texas Health Sciences Center at San Antonio, San Antonio, TX (United States); Cilingiroglu, Mehmet, E-mail: mcilingiroglu@yahoo.com [Arkansas Heart Hospital, Little Rock, AR (United States)

    2013-11-15

    Background: Controversy persists regarding the management of patients with cryptogenic stroke and patent foramen ovale (PFO). We performed a meta-analysis of randomized controlled trials comparing PFO closure with medical therapy. Methods and Results: A prospective protocol was developed and registered using the following data sources: PubMed, Cochrane Register of Controlled Trials, conference proceedings, and Internet-based resources of clinical trials. Primary analyses were performed using the intention-to-treat method. Three randomized trials comparing percutaneous PFO closure vs. medical therapy for secondary prevention of embolic neurological events formed the data set. Baseline characteristics were similar. During long-term follow-up, the pooled incidence of the primary endpoint (composite of stroke, death, or fatal stroke) was 3.4% in the PFO closure arm and 4.8% in the medical therapy group [risk-reduction (RR) 0.7 (0.48–1.06); p = 0.09]. The incidence of recurrent neurological events (secondary endpoint) was 1.7% for PFO closure and 2.7% for medical therapy [RR 0.66 (0.35–1.24), p = 0.19]. There was no difference in terms of death or adverse events between the two groups. Conclusions: While this meta-analysis of randomized clinical trials demonstrated no statistical significance in comparison to medical therapy, there was a trend towards overall improvement in outcomes in the PFO closure group.

  8. Prevention of Bleeding in Orthognathic Surgery--A Systematic Review and Meta-Analysis of Randomized Controlled Trials

    DEFF Research Database (Denmark)

    Olsen, Jesper J; Skov, Jane; Ingerslev, Janne

    2016-01-01

    and operating time. This review is registered at PROSPERO (CRD42014014840). RESULTS: Eleven trials were included for review. The individual trials demonstrated the effects on IOB from hypotensive anesthetic regimens, the use of aprotinin, and the herbal medicine Yunnan Baiyao. Six studies of tranexamic acid...

  9. An interdisciplinary intervention to prevent falls in community-dwelling elderly persons: protocol of a cluster-randomized trial [PreFalls

    Directory of Open Access Journals (Sweden)

    Schuster Tibor

    2011-02-01

    Full Text Available Abstract Background Prevention of falls in the elderly is a public health target in many countries around the world. While a large number of trials have investigated the effectiveness of fall prevention programs, few focussed on interventions embedded in the general practice setting and its related network. In the Prevent Falls (PreFalls trial we aim to investigate the effectiveness of a pre-tested multi-modal intervention compared to usual care in this setting. Methods/Design PreFalls is a controlled multicenter prospective study with cluster-randomized allocation of about 40 general practices to an experimental or a control group. We aim to include 382 community dwelling persons aged 65 and older with an increased risk of falling. All participating general practitioners are trained to systematically assess the risk of falls using a set of validated tests. Patients from intervention practices are invited to participate in a 16-weeks exercise program with focus on fall prevention delivered by specifically trained local physiotherapists. Patients from practices allocated to the control group receive usual care. Main outcome measure is the number of falls per individual in the first 12 months (analysis by negative binomial regression. Secondary outcomes include falls in the second year, the proportion of participants falling in the first and the second year, falls associated with injury, risk of falls, fear of falling, physical activity and quality of life. Discussion Reducing falls in the elderly remains a major challenge. We believe that with its strong focus on a both systematic and realistic fall prevention strategy adapted to primary care setting PreFalls will be a valuable addition to the scientific literature in the field. Trial registration NCT01032252

  10. Role of vitamin K2 in preventing the recurrence of hepatocellular carcinoma after curative treatment: A meta-analysis of randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Riaz Irbaz Bin

    2012-11-01

    Full Text Available Abstract Background Hepatocellular cancer is notorious for recurrence even after curative therapy. High recurrence determines the long term prognosis of the patients. Vitamin K2 has been tested in trials for its effect on prevention of recurrence and improving survival. The results are inconclusive from individual trials and in our knowledge no systematic review which entirely focuses on Vitamin K2 as a chemo preventive agent is available to date. This review is an attempt to pool all the existing trials together and update the existing knowledge on the topic. Methods Medline, Embase and Cochrane Register of Controlled trials were searched for randomized controlled trials where vitamin K2 or its analogues, in any dosage were compared to placebo or No vitamin K2, for participants of any age or sex. Reference lists and abstracts of conference proceedings were searched by hand. Additional papers were identified by a manual search of the references from the key articles. Attempt was made to contact the authors of primary studies for missing data and with the experts in the field. Trials were assessed for inclusion by two independent reviewers. Primary outcomes were recurrence rates and survival rates. There were no secondary outcomes. Data was synthesized using a random effects model and results presented as relative risk with 95% Confidence Intervals. Result For recurrence of hepatocellular cancer after hepatic resection or local ablative therapy, compared with controls, participants receiving Vitamin K2, pooled relative risks for hepatocellular cancer were 0.60; 95% CI: 0.28–1.28, p = 0.64 at 1 yr 0.66; 95% CI: 0.47–0.91, p = 0.01 at 2 yr; 0.71; 95% CI: 0.58–0.85, p = 0.004 at 3 yr respectively. The results were combined using the random analysis model. Conclusion Five RCTs evaluated the preventive efficacy of menatetrenone on HCC recurrence after hepatic resection or local ablative therapy. The meta-analysis of all five studies

  11. Protocol for “Seal or Varnish?” (SoV trial: a randomised controlled trial to measure the relative cost and effectiveness of pit and fissure sealants and fluoride varnish in preventing dental decay

    Directory of Open Access Journals (Sweden)

    Chestnutt Ivor Gordon

    2012-11-01

    Full Text Available Abstract Background Dental caries remains a significant public health problem, prevalence being linked to social and economic deprivation. Occlusal surfaces of first permanent molars are the most susceptible site in the developing permanent dentition. Cochrane reviews have shown pit and fissure sealants (PFS and fluoride varnish (FV to be effective over no intervention in preventing caries. However, the comparative cost and effectiveness of these treatments is uncertain. The primary aim of the trial described in this protocol is to compare the clinical effectiveness of PFS and FV in preventing dental caries in first permanent molars in 6-7 year-olds. Secondary aims include: establishing the costs and the relative cost-effectiveness of PFS and FV delivered in a community/school setting; examining the impact of PFS and FV on children and their parents/carers in terms of quality of life/treatment acceptability measures; and examining the implementation of treatment in a community setting. Methods/design The trial design comprises a randomised, assessor-blinded, two-arm, parallel group trial in 6–7 year old schoolchildren. Clinical procedures and assessments will be performed at 66 primary schools, in deprived areas in South Wales. Treatments will be delivered via a mobile dental clinic. In total, 920 children will be recruited (460 per trial arm. At baseline and annually for 36 months dental caries will be recorded using the International Caries Detection and Assessment System (ICDAS by trained and calibrated dentists. PFS and FV will be applied by trained dental hygienists. The FV will be applied at baseline, 6, 12, 18, 24 and 30 months. The PFS will be applied at baseline and re-examined at 6, 12, 18, 24, and 30 months, and will be re-applied if the existing sealant has become detached/is insufficient. The economic analysis will estimate the costs of providing the PFS versus FV. The process evaluation will assess implementation and

  12. Powering biomedical devices

    CERN Document Server

    Romero, Edwar

    2013-01-01

    From exoskeletons to neural implants, biomedical devices are no less than life-changing. Compact and constant power sources are necessary to keep these devices running efficiently. Edwar Romero's Powering Biomedical Devices reviews the background, current technologies, and possible future developments of these power sources, examining not only the types of biomedical power sources available (macro, mini, MEMS, and nano), but also what they power (such as prostheses, insulin pumps, and muscular and neural stimulators), and how they work (covering batteries, biofluids, kinetic and ther

  13. Biomedical applications of polymers

    CERN Document Server

    Gebelein, C G

    1991-01-01

    The biomedical applications of polymers span an extremely wide spectrum of uses, including artificial organs, skin and soft tissue replacements, orthopaedic applications, dental applications, and controlled release of medications. No single, short review can possibly cover all these items in detail, and dozens of books andhundreds of reviews exist on biomedical polymers. Only a few relatively recent examples will be cited here;additional reviews are listed under most of the major topics in this book. We will consider each of the majorclassifications of biomedical polymers to some extent, inclu

  14. Biomedical engineering fundamentals

    CERN Document Server

    Bronzino, Joseph D; Bronzino, Joseph D

    2006-01-01

    Over the last century,medicine has come out of the "black bag" and emerged as one of the most dynamic and advanced fields of development in science and technology. Today, biomedical engineering plays a critical role in patient diagnosis, care, and rehabilitation. As such, the field encompasses a wide range of disciplines, from biology and physiology to informatics and signal processing. Reflecting the enormous growth and change in biomedical engineering during the infancy of the 21st century, The Biomedical Engineering Handbook enters its third edition as a set of three carefully focused and

  15. Biomedical Engineering Desk Reference

    CERN Document Server

    Ratner, Buddy D; Schoen, Frederick J; Lemons, Jack E; Dyro, Joseph; Martinsen, Orjan G; Kyle, Richard; Preim, Bernhard; Bartz, Dirk; Grimnes, Sverre; Vallero, Daniel; Semmlow, John; Murray, W Bosseau; Perez, Reinaldo; Bankman, Isaac; Dunn, Stanley; Ikada, Yoshito; Moghe, Prabhas V; Constantinides, Alkis

    2009-01-01

    A one-stop Desk Reference, for Biomedical Engineers involved in the ever expanding and very fast moving area; this is a book that will not gather dust on the shelf. It brings together the essential professional reference content from leading international contributors in the biomedical engineering field. Material covers a broad range of topics including: Biomechanics and Biomaterials; Tissue Engineering; and Biosignal Processing* A hard-working desk reference providing all the essential material needed by biomedical and clinical engineers on a day-to-day basis * Fundamentals, key techniques,

  16. Handbook of biomedical optics

    CERN Document Server

    Boas, David A

    2011-01-01

    Biomedical optics holds tremendous promise to deliver effective, safe, non- or minimally invasive diagnostics and targeted, customizable therapeutics. Handbook of Biomedical Optics provides an in-depth treatment of the field, including coverage of applications for biomedical research, diagnosis, and therapy. It introduces the theory and fundamentals of each subject, ensuring accessibility to a wide multidisciplinary readership. It also offers a view of the state of the art and discusses advantages and disadvantages of various techniques.Organized into six sections, this handbook: Contains intr

  17. Japan Diabetes Outcome Intervention Trial-1(J-DOIT1, a nationwide cluster randomized trial of type 2 diabetes prevention by telephone-delivered lifestyle support for high-risk subjects detected at health checkups: rationale, design, and recruitment

    Directory of Open Access Journals (Sweden)

    Sakane Naoki

    2013-01-01

    Full Text Available Abstract Background Lifestyle modifications are considered the most effective means of delaying or preventing the development of type 2 diabetes (T2DM. To contain the growing population of T2DM, it is critical to clarify effective and efficient settings for intervention and modalities for intervention delivery with a wide population reach. The Japan Diabetes Outcome Intervention Trial-1 (J-DOIT1 is a cluster randomized controlled trial to test whether goal-focused lifestyle coaching delivered by telephone can prevent the development of T2DM in high-risk individuals in a real-world setting. This paper describes the study design and recruitment of the study subjects. Methods For the recruitment of study subjects and their follow-up annually over 3 years, we employed health checkups conducted annually at communities and worksites. Health care divisions recruited from communities and companies across Japan formed groups as a cluster randomization unit. Candidates for the study, aged 20-65 years with fasting plasma glucose (FPG of 5.6-6.9 mmol/l, were recruited from each group using health checkups results in 2006. Goal-focused lifestyle support is delivered by healthcare providers via telephone over a one-year period. Study subjects will be followed-up for three years by annual health checkups. Primary outcome is the development of diabetes defined as FPG≥7.0 mmol/l on annual health checkup or based on self-report, which is confirmed by referring to medical cards. Results Forty-three groups (clusters, formed from 17 health care divisions, were randomly assigned to an intervention arm (22 groups or control arm (21 clusters between March 2007 and February 2008. A total of 2840 participants, 1336 from the intervention and 1504 from the control arm, were recruited. Consent rate was about 20%, with no difference between the intervention and control arms. There were no differences in cluster size and characteristics of cluster between the groups. There

  18. Mothers after Gestational Diabetes in Australia (MAGDA): A Randomised Controlled Trial of a Postnatal Diabetes Prevention Program

    Science.gov (United States)

    O’Reilly, Sharleen L.; Versace, Vincent; Best, James D.; Carter, Rob; Oats, Jeremy J. N.; Ackland, Michael; Ebeling, Peter R.; Shih, Sophy T. F.; Hagger, Virginia; Coates, Michael; Wildey, Carol

    2016-01-01

    Background Gestational diabetes mellitus (GDM) is an increasingly prevalent risk factor for type 2 diabetes. We evaluated the effectiveness of a group-based lifestyle modification program in mothers with prior GDM within their first postnatal year. Methods and Findings In this study, 573 women were randomised to either the intervention (n = 284) or usual care (n = 289). At baseline, 10% had impaired glucose tolerance and 2% impaired fasting glucose. The diabetes prevention intervention comprised one individual session, five group sessions, and two telephone sessions. Primary outcomes were changes in diabetes risk factors (weight, waist circumference, and fasting blood glucose), and secondary outcomes included achievement of lifestyle modification goals and changes in depression score and cardiovascular disease risk factors. The mean changes (intention-to-treat [ITT] analysis) over 12 mo were as follows: −0.23 kg body weight in intervention group (95% CI −0.89, 0.43) compared with +0.72 kg in usual care group (95% CI 0.09, 1.35) (change difference −0.95 kg, 95% CI −1.87, −0.04; group by treatment interaction p = 0.04); −2.24 cm waist measurement in intervention group (95% CI −3.01, −1.42) compared with −1.74 cm in usual care group (95% CI −2.52, −0.96) (change difference −0.50 cm, 95% CI −1.63, 0.63; group by treatment interaction p = 0.389); and +0.18 mmol/l fasting blood glucose in intervention group (95% CI 0.11, 0.24) compared with +0.22 mmol/l in usual care group (95% CI 0.16, 0.29) (change difference −0.05 mmol/l, 95% CI −0.14, 0.05; group by treatment interaction p = 0.331). Only 10% of women attended all sessions, 53% attended one individual and at least one group session, and 34% attended no sessions. Loss to follow-up was 27% and 21% for the intervention and control groups, respectively, primarily due to subsequent pregnancies. Study limitations include low exposure to the full intervention and glucose metabolism profiles

  19. Bispectral index monitoring prevent awareness during total intravenous anesthesia: a prospective, randomized,double-blinded, multi-center controlled trial

    Institute of Scientific and Technical Information of China (English)

    ZHANG Chen; GUO Jian-rong; JIN Yao-jun; WU Gang; YUAN Wei; YUAN Zhi-guo; YUE Yun; XU Liang; MA Ya-qun; SUN Yan-xia; LI Yan-hong; ZHANG Liang; FENG Chun-sheng; LUO Bing; ZHAO Zhen-long

    2011-01-01

    Background Awareness is a serious complication of general anesthesia.In China,the incidence of intraoperative awareness was 1% in patients undergoing total intravenous anesthesia (TIVA).In this study,we compared the incidence of awareness between Bispectral index (BIS)-guided and routine TIVA protocol and evaluated the effect of BIS on preventing awareness.Methods A prospective,randomized,double-blinded,multicenter controlled trial was performed.Patients (≥18 years of age) undergoing TIVA were randomly divided into BIS-guided group (Group A,BIS was monitored and recommended to maintain between 40-60) and control group (Group B,BIS was monitored but the screen was covered).The intraoperative BIS values were downloaded and the BIS trends of confirmed awareness cases were analyzed to determine whether light anesthesia existed.Results Of the total 5228 patients,2919 patients were assigned to Group A and 2309 to Group B.Four cases of confirmed awareness (0.14%) were reported in the BIS-guided group and 15 (0.65%) in the control group (P=0.002,OR=0.21,95% confidence intervals:0.07-0.63).The incidence of possible awareness (0.14% vs.0.26%,P=0.485) and dreaming (3.1% vs.3.1%,P=0.986) was comparable between BIS-guided group and the control group.Among the 19 confirmed awareness cases,intraoperative BIS trends of six cases were downloaded and identified.Five of them showed signs of light anesthesia as BIS >60 and lasted 19-106 minutes,whereas one case had a stable BIS trend and the values were within 60 during the operation.Another five awareness cases were reviewed for anesthesia procedures,of which improper light anesthesia were confirmed.Conclusions BIS-guided TIVA (BIS was recommended to maintain between 40-60) decreased the risk of awareness compared with routine TIVA.The main reason for awareness was light anesthesia.

  20. Efficacy and safety of N-acetylcysteine in prevention of noise induced hearing loss: a randomized clinical trial.

    Science.gov (United States)

    Kopke, Richard; Slade, Martin D; Jackson, Ronald; Hammill, Tanisha; Fausti, Stephen; Lonsbury-Martin, Brenda; Sanderson, Alicia; Dreisbach, Laura; Rabinowitz, Peter; Torre, Peter; Balough, Ben

    2015-05-01

    Despite a robust hearing conservation program, military personnel continue to be at high risk for noise induced hearing loss (NIHL). For more than a decade, a number of laboratories have investigated the use of antioxidants as a safe and effective adjunct to hearing conservation programs. Of the antioxidants that have been investigated, N-acetylcysteine (NAC) has consistently reduced permanent NIHL in the laboratory, but its clinical efficacy is still controversial. This study provides a prospective, randomized, double-blinded, placebo-controlled clinical trial investigating the safety profile and the efficacy of NAC to prevent hearing loss in a military population after weapons training. Of the 566 total study subjects, 277 received NAC while 289 were given placebo. The null hypothesis for the rate of STS was not rejected based on the measured results. While no significant differences were found for the primary outcome, rate of threshold shifts, the right ear threshold shift rate difference did approach significance (p = 0.0562). No significant difference was found in the second primary outcome, percentage of subjects experiencing an adverse event between placebo and NAC groups (26.7% and 27.4%, respectively, p = 0.4465). Results for the secondary outcome, STS rate in the trigger hand ear, did show a significant difference (34.98% for placebo-treated, 27.14% for NAC-treated, p-value = 0.0288). Additionally, post-hoc analysis showed significant differences in threshold shift rates when handedness was taken into account. While the secondary outcomes and post-hoc analysis suggest that NAC treatment is superior to the placebo, the present study design failed to confirm this. The lack of significant differences in overall hearing loss between the treatment and placebo groups may be due to a number of factors, including suboptimal dosing, premature post-exposure audiograms, or differences in risk between ears or subjects. Based on secondary outcomes and post hoc

  1. ENLIGHT and LEIR biomedical facility.

    Science.gov (United States)

    Dosanjh, M; Cirilli, M; Navin, S

    2014-07-01

    Particle therapy (including protons and carbon ions) allows a highly conformal treatment of deep-seated tumours with good accuracy and minimal dose to surrounding tissues, compared to conventional radiotherapy using X-rays. Following impressive results from early phase trials, over the last decades particle therapy in Europe has made considerable progress in terms of new institutes dedicated to charged particle therapy in several countries. Particle therapy is a multidisciplinary subject that involves physicists, biologists, radio-oncologists, engineers and computer scientists. The European Network for Light Ion Hadron Therapy (ENLIGHT) was created in response to the growing needs of the European community to coordinate such efforts. A number of treatment centres are already operational and treating patients across Europe, including two dual ion (protons and carbon ions) centres in Heidelberg (the pioneer in Europe) and Pavia. However, much more research needs to be carried out and beamtime is limited. Hence there is a strong interest from the biomedical research community to have a facility with greater access to relevant beamtime. Such a facility would facilitate research in radiobiology and the development of more accurate techniques of dosimetry and imaging. The Low Energy Ion Ring (LEIR) accelerator at CERN presents such an opportunity, and relies partly on CERN's existing infrastructure. The ENLIGHT network, European Commission projects under the ENLIGHT umbrella and the future biomedical facility are discussed.

  2. Prevention of recurrent sickness absence in workers with common mental disorders : Results of a cluster-randomised controlled trial

    NARCIS (Netherlands)

    Arends, I; Klink, van der J.J.L.; Rhenen, van W.; Boer, de M.R.; Bültmann, U.

    2013-01-01

    Workers with common mental disorders (CMDs) frequently experience recurrent sickness absence but interventions to prevent this are lacking. The goal of this study was to evaluate the effectiveness of the Stimulating Healthy participation And Relapse Prevention at work intervention in preventing recu

  3. Sensors for biomedical applications

    NARCIS (Netherlands)

    Bergveld, Piet

    1986-01-01

    This paper considers the impact during the last decade of modern IC technology, microelectronics, thin- and thick-film technology, fibre optic technology, etc. on the development of sensors for biomedical applications.

  4. Biomedical signal processing

    CERN Document Server

    Akay, Metin

    1994-01-01

    Sophisticated techniques for signal processing are now available to the biomedical specialist! Written in an easy-to-read, straightforward style, Biomedical Signal Processing presents techniques to eliminate background noise, enhance signal detection, and analyze computer data, making results easy to comprehend and apply. In addition to examining techniques for electrical signal analysis, filtering, and transforms, the author supplies an extensive appendix with several computer programs that demonstrate techniques presented in the text.

  5. Biomedical signal analysis

    CERN Document Server

    Rangayyan, Rangaraj M

    2015-01-01

    The book will help assist a reader in the development of techniques for analysis of biomedical signals and computer aided diagnoses with a pedagogical examination of basic and advanced topics accompanied by over 350 figures and illustrations. Wide range of filtering techniques presented to address various applications. 800 mathematical expressions and equations. Practical questions, problems and laboratory exercises. Includes fractals and chaos theory with biomedical applications.

  6. Glyceryl trinitrate for prevention of post-ERCP pancreatitis and improve the rate of cannulation: a meta-analysis of prospective, randomized, controlled trials.

    Directory of Open Access Journals (Sweden)

    Jiexia Ding

    Full Text Available BACKGROUND: Acute pancreatitis is the most common complication of diagnostic and therapeutic endoscopic retrograde cholangiopancreatography (ERCP. Several clinical trials used glyceryl trinitrate (GTN to prevent the incidence of post-ERCP pancreatitis (PEP. However, the results were still controversial. OBJECTIVE: To conduct a meta-analysis of published, full-length, randomized controlled trials evaluating the effect of prophylactic GTN on the prevention of PEP, improve the rate of cannulation and the prevention of hyperamylasemia. METHODS: Literature searches were conducted using PubMed, EMBASE, The Cochrane Library and Web of Knowledge databases, using keywords "post-ERCP" and "pancreatitis" and limited in randomized controlled trials. RESULTS: Twelve RCTs involving 2649 patients were included. Eleven RCTs compared GTN with placebo for PEP prevention. Meta-analysis showed the overall incidence of PEP was significantly reduced by GTN treatment (RR 0.67; 95% CI, 0.52-0.87. Nevertheless, GTN administration did not decrease the incidence of moderate to severe PEP (RR 0.70; 95% CI, 0.42-1.15. Subgroup analyses revealed that GTN administered by sublingual was more effective than transdermal and topical in reducing the incidence of PEP. Besides, the prophylactic effect of GTN was far more obvious in the group of high PEP incidence than in the group of low PEP incidence. Additionally, the incidence of hyperamylasemia was significantly reduced by GTN treatment (RR 0.69; 95% CI, 0.54-0.90. No differences of the successful cannulation rate of bile ducts (RR 1.03; 95% CI, 0.99-1.06 attributable to GTN were observed. CONCLUSION: Prophylactic use of GTN reduced the overall incidence of PEP and hyperamylasemia. However, GTN was not helpful for the severity of PEP and the rate of cannulation.

  7. PRALIMAP: study protocol for a high school-based, factorial cluster randomised interventional trial of three overweight and obesity prevention strategies

    Directory of Open Access Journals (Sweden)

    Agrinier Nelly

    2010-12-01

    Full Text Available Abstract Background Given the increase in overweight and obesity prevalence in adolescents in the last decade, effective prevention strategies for these conditions in adolescents are urgently needed. The PRALIMAP (Promotion de l'ALImentation et de l'Activité Physique trial aims to evaluate the effectiveness for these conditions of 3 health promotion strategies -- educational, screening and environmental -- applied singly or in combination in high schools over a 2-year intervention period. Methods PRALIMAP is a stratified 2 × 2 × 2 factorial cluster randomised controlled trial including 24 state high schools in Lorraine, northeastern France, in 2 waves: 8 schools in 2006 (wave 1 and 16 in 2007 (wave 2. Students entering the selected high schools in the 4 academic years from 2006 to 2009 are eligible for data collection. Interventional strategies are organized over 2 academic years. The follow-up consists of 3 visits: at the entry of grade 10 (T0, grade 11 (T1 and grade 12 (T2. At T0, 5,458 (85.7% adolescents participated. The educational strategy consists of nutritional lessons, working groups and a final party. The screening strategy consists in detecting overweight/obesity and eating disorders in adolescents and proposing, if necessary, an adapted care management program of 7 group educational sessions. The environmental strategy consists in improving dietary and physical activity offerings in high schools and facilities, especially catering. The main outcomes are body size evolution over time, nutritional behaviour and knowledge, health and quality of life. An evaluation process documents how each intervention strategy is implemented in the schools and estimates the dose of the intervention, allowing for a per protocol analysis after the main intention-to-treat analysis. Discussion PRALIMAP aims at improving the prevention and management of overweight and obesity in adolescents by translating current evidence into public health practice

  8. Risk Behavior among Women enrolled in a Randomized Controlled Efficacy Trial of an Adenoviral Vector Vaccine to Prevent HIV Acquisition: the Step Study

    Science.gov (United States)

    Novak, Richard M.; Metch, Barbara; Buchbinder, Susan; Cabello, Robinson; Donastorg, Yeycy; Figoroa, John-Peter; Adbul-Jauwad, Hend; Joseph, Patrice; Koenig, Ellen; Metzger, David; Sobieszycz, Magda; Tyndall, Mark; Zorilla, Carmen

    2013-01-01

    Objectives Report of risk behavior, HIV incidence, and pregnancy rates among women participating in the Step Study, a phase IIB trial of MRKAd5 HIV-1 gag/pol/nef vaccine in HIV-negative individuals who were at high risk of HIV-1. Design Prospective multicenter, double-blinded, placebo-controlled trial Methods Women were from North American (NA) and Caribbean and South America (CSA) sites. Risk behavior was collected at screening and 6-month intervals. Differences in characteristics between groups were tested with Chi-square, two-sided Fisher’s exact tests, and Wilcoxon rank sum tests. Generalized estimating equation models were used to assess behavioral change. Results Among 1134 enrolled women, the median number of male partners was 18; 73.8% reported unprotected vaginal sex, 15.9% unprotected anal sex and 10.8% evidence of a sexually transmitted infection in the 6 months prior to baseline. With 3344 person-years (p–y) of follow up, there were 15 incident HIV infections: incidence rate was 0.45 per 100/p-y (95% CI 0.25, 0.74). Crack cocaine use in both regions (relative risk [RR]=2.4 [1.7,3.3]) and in CSA, unprotected anal sex (RR=6.4 [3.8. 10.7]) and drug use (RR=4.1 [2.1, 8.0]) were baseline risk behaviors associated with HIV acquisition. There was a marked reduction in risk behaviors after study enrollment with some recurrence in unprotected vaginal sex. Of 963 non-sterilized women, 304 (31.6%) became pregnant. Conclusions Crack cocaine use and unprotected anal sex are important risk criteria to identify high-risk women for HIV efficacy trials. Pregnancy during the trial was a common occurrence and needs to be considered in trial planning for prevention trials in women. PMID:23807272

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

    Directory of Open Access Journals (Sweden)

    Carlbring Per

    2013-02-01

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

  10. Supporting Treatment decision making to Optimise the Prevention of STROKE in Atrial Fibrillation: The STOP STROKE in AF study. Protocol for a cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Gattellari Melina

    2012-07-01

    Full Text Available Abstract Background Suboptimal uptake of anticoagulation for stroke prevention in atrial fibrillation has persisted for over 20 years, despite high-level evidence demonstrating its effectiveness in reducing the risk of fatal and disabling stroke. Methods The STOP STROKE in AF study is a national, cluster randomised controlled trial designed to improve the uptake of anticoagulation in primary care. General practitioners from around Australia enrolling in this ‘distance education’ program are mailed written educational materials, followed by an academic detailing session delivered via telephone by a medical peer, during which participants discuss patient de-identified cases. General practitioners are then randomised to receive written specialist feedback about the patient de-identified cases either before or after completing a three-month posttest audit. Specialist feedback is designed to provide participants with support and confidence to prescribe anticoagulation. The primary outcome is the proportion of patients with atrial fibrillation receiving oral anticoagulation at the time of the posttest audit. Discussion The STOP STROKE in AF study aims to evaluate a feasible intervention via distance education to prevent avoidable stroke due to atrial fibrillation. It provides a systematic test of augmenting academic detailing with expert feedback about patient management. Trial registration Australian Clinical Trials Registry Registration Number: ACTRN12611000076976.

  11. The APPLe study: a randomized, community-based, placebo-controlled trial of azithromycin for the prevention of preterm birth, with meta-analysis.

    Directory of Open Access Journals (Sweden)

    Nynke R van den Broek

    2009-12-01

    Full Text Available BACKGROUND: Premature birth is the major cause of perinatal mortality and morbidity in both high- and low-income countries. The causes of preterm labour are multiple but infection is important. We have previously described an unusually high incidence of preterm birth (20% in an ultrasound-dated, rural, pregnant population in Southern Malawi with high burdens of infective morbidity. We have now studied the impact of routine prophylaxis with azithromycin as directly observed, single-dose therapy at two gestational windows to try to decrease the incidence of preterm birth. METHODS AND FINDINGS: We randomized 2,297 pregnant women attending three rural and one peri-urban health centres in Southern Malawi to a placebo-controlled trial of oral azithromycin (1 g given at 16-24 and 28-32 wk gestation. Gestational age was determined by ultrasound before 24 wk. Women and their infants were followed up until 6 wk post delivery. The primary outcome was incidence of preterm delivery, defined as 6,200 pregnancies shows no effect on preterm birth (relative risk 1.02, 95% confidence interval 0.86-1.22. CONCLUSIONS: This study provides no support for the use of antibiotics as routine prophylaxis to prevent preterm birth in high risk populations; prevention of preterm birth requires alternative strategies. TRIAL REGISTRATION: Current Controlled Trials ISRCTN84023116

  12. Tailored education for older patients to facilitate engagement in falls prevention strategies after hospital discharge--a pilot randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Anne-Marie Hill

    Full Text Available BACKGROUND: The aims of the study were to evaluate the effect of providing tailored falls prevention education in hospital on: i engagement in targeted falls prevention behaviors in the month after discharge: ii patients' self-perceived risk and knowledge about falls and falls prevention strategies after receiving the education. METHODS: A pilot randomized controlled trial (n = 50: baseline and outcome assessments conducted by blinded researchers. PARTICIPANTS: hospital inpatients 60 years or older, discharged to the community. Participants were randomized into two groups. The intervention was a tailored education package consisting of multimedia falls prevention information with trained health professional follow-up, delivered in addition to usual care. Outcome measures were engagement in falls prevention behaviors in the month after discharge measured at one month after discharge with a structured survey, and participants' knowledge, confidence and motivation levels before and after receiving the education. The feasibility of providing the intervention was examined and falls outcomes (falls, fall-related injuries were also collected. RESULTS: Forty-eight patients (98% provided follow-up data. The complete package was provided to 21 (84% intervention group participants. Participants in the intervention group were significantly more likely to plan how to safely restart functional activities [Adjusted odds ratio 3.80, 95% CI (1.07, 13.52, p = 0.04] and more likely to complete other targeted behaviors such as completing their own home exercise program [Adjusted odds ratio 2.76, 95% CI (0.72, 10.50, p = 0.14] than the control group. The intervention group was significantly more knowledgeable, confident and motivated to engage in falls prevention strategies after receiving the education than the control group. There were 23 falls (n = 5 intervention; n = 18 control and falls rates were 5.4/1000 patient days (intervention; 18.7/1000 patient days

  13. Rosuvastatin for Primary Prevention in Older Persons With Elevated C-Reactive Protein and Low to Average Low-Density Lipoprotein Cholesterol Levels: Exploratory Analysis of a Randomized Trial

    DEFF Research Database (Denmark)

    Glynn, R.J.; Koenig, W.; Nordestgaard, B.G.;

    2010-01-01

    or older. Design: Secondary analysis of JUPITER ( Justification for the Use of statins in Prevention: an Intervention Trial Evaluating Rosuvastatin), a randomized, double-blind, placebo-controlled trial. Setting: 1315 sites in 26 countries randomly assigned participants in JUPITER. Participants: Among...

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

    Directory of Open Access Journals (Sweden)

    Amelia Scott

    Full Text Available To address the bias occurring in the medical literature associated with selective outcome reporting, in 2005, the International Committee of Medical Journal Editors (ICMJE introduced mandatory trial registration guidelines and member journals required prospective registration of trials prior to patient enrolment as a condition of publication. No research has examined whether these guidelines are impacting psychiatry publications. Our objectives were to determine the extent to which articles published in psychiatry journals adhering to ICMJE guidelines were correctly prospectively registered, whether there was evidence of selective outcome reporting and changes to participant numbers, and whether there was a relationship between registration status and source of funding.Any clinical trial (as defined by ICMJE published between 1 January 2009 and 31 July 2013 in the top five psychiatry journals adhering to ICMJE guidelines (The American Journal of Psychiatry, Archives of General Psychiatry/JAMA Psychiatry, Biological Psychiatry, Journal of the American Academy of Child and Adolescent Psychiatry, and The Journal of Clinical Psychiatry and conducted after July 2005 (or 2007 for two journals was included. For each identified trial, where possible we extracted trial registration information, changes to POMs between publication and registry to assess selective outcome reporting, changes to participant numbers, and funding type.Out of 3305 articles, 181 studies were identified as clinical trials requiring registration: 21 (11.6% were deemed unregistered, 61 (33.7% were retrospectively registered, 37 (20.4% had unclear POMs either in the article or the registry and 2 (1.1% were registered in an inaccessible trial registry. Only 60 (33.1% studies were prospectively registered with clearly defined POMs; 17 of these 60 (28.3% showed evidence of selective outcome reporting and 16 (26.7% demonstrated a change in participant numbers of 20% or more; only 26 (14

  15. Barriers and enablers to the implementation of the 6-PACK falls prevention program: A pre-implementation study in hospitals participating in a cluster randomised controlled trial

    Science.gov (United States)

    Brand, Caroline A.; Landgren, Fiona S.; Melhem, Mayer M.; Bian, Evelyn; Brauer, Sandra G.; Hill, Keith D.; Livingston, Patricia M.

    2017-01-01

    Evidence for effective falls prevention interventions in acute wards is limited. One reason for this may be suboptimal program implementation. This study aimed to identify perceived barriers and enablers of the implementation of the 6-PACK falls prevention program to inform the implementation in a randomised controlled trial. Strategies to optimise successful implementation of 6-PACK were also sought. A mixed-methods approach was applied in 24 acute wards from 6 Australian hospitals. Participants were nurses working on participating wards and senior hospital staff including Nurse Unit Managers; senior physicians; Directors of Nursing; and senior personnel involved in quality and safety or falls prevention. Information on barriers and enablers of 6-PACK implementation was obtained through surveys, focus groups and interviews. Questions reflected the COM-B framework that includes three behaviour change constructs of: capability, opportunity and motivation. Focus group and interview data were analysed thematically, and survey data descriptively. The survey response rate was 60% (420/702), and 12 focus groups (n = 96 nurses) and 24 interviews with senior staff were conducted. Capability barriers included beliefs that falls could not be prevented; and limited knowledge on falls prevention in patients with complex care needs (e.g. cognitive impairment). Capability enablers included education and training, particularly face to face case study based approaches. Lack of resources was identified as an opportunity barrier. Leadership, champions and using data to drive practice change were recognised as opportunity enablers. Motivation barriers included complacency and lack of ownership in falls prevention efforts. Motivation enablers included senior staff articulating clear goals and a commitment to falls prevention; and use of reminders, audits and feedback. The information gained from this study suggests that regular practical face-to-face education and training for nurses

  16. Process evaluation of the Enabling Mothers toPrevent Pediatric Obesity Through Web-Based Learning and Reciprocal Determinism (EMPOWER) randomized control trial.

    Science.gov (United States)

    Knowlden, Adam P; Sharma, Manoj

    2014-09-01

    Family-and-home-based interventions are an important vehicle for preventing childhood obesity. Systematic process evaluations have not been routinely conducted in assessment of these interventions. The purpose of this study was to plan and conduct a process evaluation of the Enabling Mothers to Prevent Pediatric Obesity Through Web-Based Learning and Reciprocal Determinism (EMPOWER) randomized control trial. The trial was composed of two web-based, mother-centered interventions for prevention of obesity in children between 4 and 6 years of age. Process evaluation used the components of program fidelity, dose delivered, dose received, context, reach, and recruitment. Categorical process evaluation data (program fidelity, dose delivered, dose exposure, and context) were assessed using Program Implementation Index (PII) values. Continuous process evaluation variables (dose satisfaction and recruitment) were assessed using ANOVA tests to evaluate mean differences between groups (experimental and control) and sessions (sessions 1 through 5). Process evaluation results found that both groups (experimental and control) were equivalent, and interventions were administered as planned. Analysis of web-based intervention process objectives requires tailoring of process evaluation models for online delivery. Dissemination of process evaluation results can advance best practices for implementing effective online health promotion programs.

  17. Efficacy of Sucralfate Mouth Wash in Prevention of 5-fluorouracil Induced Oral Mucositis: A Prospective, Randomized, Double-Blind, Controlled Trial.

    Science.gov (United States)

    Ala, Shahram; Saeedi, Majid; Janbabai, Ghasem; Ganji, Reza; Azhdari, Elham; Shiva, Afshin

    2016-01-01

    Sucralfate has been used for the prevention and treatment of radiotherapy- and chemotherapy-induced stomatitis and mucositis in a number of studies, but the results are contradictory. To answer such discrepancies, the present study was designed to evaluate the efficacy of sucralfate mouthwash in prevention of 5-fluorouracil (5-FU)-induced oral mucositis in patients with gastrointestinal malignancies. Patients with gastrointestinal cancers receiving 5-FU-based chemotherapy regimens were included in this randomized, blinded, controlled trial and were randomly allocated to either sucralfate mouthwash (every 6 h) or placebo. The patients were visited at fifth and tenth day of trial; the presence and severity of oral mucositis and the intensity of pain were assessed. The patients receiving sucralfate experienced lower frequency and severity of mucositis (76% vs. 38.5%, P = 0.005 and 84 vs. 38.5%, P oral mucositis in patients with gastrointestinal malignancies compared with placebo, indicating its efficacy in the prevention of chemotherapy-induced mucositis.

  18. Biomedical engineering for health research and development.

    Science.gov (United States)

    Zhang, X-Y

    2015-01-01

    Biomedical engineering is a new area of research in medicine and biology, providing new concepts and designs for the diagnosis, treatment and prevention of various diseases. There are several types of biomedical engineering, such as tissue, genetic, neural and stem cells, as well as chemical and clinical engineering for health care. Many electronic and magnetic methods and equipments are used for the biomedical engineering such as Computed Tomography (CT) scans, Magnetic Resonance Imaging (MRI) scans, Electroencephalography (EEG), Ultrasound and regenerative medicine and stem cell cultures, preparations of artificial cells and organs, such as pancreas, urinary bladders, liver cells, and fibroblasts cells of foreskin and others. The principle of tissue engineering is described with various types of cells used for tissue engineering purposes. The use of several medical devices and bionics are mentioned with scaffold, cells and tissue cultures and various materials are used for biomedical engineering. The use of biomedical engineering methods is very important for the human health, and research and development of diseases. The bioreactors and preparations of artificial cells or tissues and organs are described here.

  19. Stay@Work: Participatory Ergonomics to prevent low back and neck pain among workers: design of a randomised controlled trial to evaluate the (cost-effectiveness

    Directory of Open Access Journals (Sweden)

    Proper Karin I

    2008-10-01

    Full Text Available Abstract Background Low back pain (LBP and neck pain (NP are a major public health problem with considerable costs for individuals, companies and society. Therefore, prevention is imperative. The Stay@Work study investigates the (cost-effectiveness of Participatory Ergonomics (PE to prevent LBP and NP among workers. Methods In a randomised controlled trial (RCT, a total of 5,759 workers working at 36 departments of four companies is expected to participate in the study at baseline. The departments consisting of about 150 workers are pre-stratified and randomised. The control departments receive usual practice and the intervention departments receive PE. Within each intervention department a working group is formed including eight workers, a representative of the management, and an occupational health and safety coordinator. During a one day meeting, the working group follows the steps of PE in which the most important risk factors for LBP and NP, and the most adequate ergonomic measures are identified on the basis of group consensus. The implementation of ergonomic measures at the department is performed by the working group. To improve the implementation process, so-called 'ergocoaches' are trained. The primary outcome measure is an episode of LBP and NP. Secondary outcome measures are actual use of ergonomic measures, physical workload, psychosocial workload, intensity of pain, general health status, sick leave, and work productivity. The cost-effectiveness analysis is performed from the societal and company perspective. Outcome measures are assessed using questionnaires at baseline and after 6 and 12 months. Data on the primary outcome as well as on intensity of pain, sick leave, work productivity, and health care costs are collected every 3 months. Discussion Prevention of LBP and NP is beneficial for workers, employers, and society. If the intervention is proven (cost-effective, the intervention can have a major impact on LBP and NP

  20. Evaluation of ‘I-Preventive’: a digital preventive tool for musculoskeletal disorders in computer workers—a pilot cluster randomised trial

    Science.gov (United States)

    Lanhers, C; Pereira, B; Garde, G; Maublant, C; Coudeyre, E

    2016-01-01

    Objectives I-Preventive is a digital preventive tool for musculoskeletal disorders (MSDs) in computer workers. We sought to determine its impact on pain in computer workers with upper limb MSDs and visual discomfort. Methods We conducted a pilot cluster randomised trial in 2 different sites of a tyre factory in France. We randomised 200 employees to either an intervention group (I-Preventive) or control group, each comprising symptomatic and asymptomatic employees. The workers were followed up for 5 months. The main outcome was overall recovery from symptoms following 1 month's intervention based on Nordic-style and eyestrain questionnaires. Results We included 185/200 workers: 96 in the intervention group (mean age 41.8±1.4 years; 88.5% males) and 79 in the control group (mean age 42.9±12.0 years; 94.5% males). The most painful areas (numerical scale ≥2) were the neck (40.0%), upper back (18.8%) and shoulders (15.7%). For the most painful anatomical area, the Nordic score significantly decreased after 1 month in the intervention group (p=0.038); no change was observed in the control group (p=0.59). After 1 month's use, the intervention group reported less pain in the painful area and less visual discomfort symptoms (p=0.02). Adherence to the I-Preventive program was 60%. Conclusions I-Preventive is effective in the short term on musculoskeletal symptoms and visual discomfort by promoting active breaks and eyestrain treatment. This easy-to-use digital tool allows each worker to focus on areas of their choice via personalised, easy exercises that can be performed in the workplace. Trial registration number NCT02350244; Pre-results. PMID:27660316

  1. The LIPPSMAck POP (Lung Infection Prevention Post Surgery - Major Abdominal - with Pre-Operative Physiotherapy) trial: study protocol for a multi-centre randomised controlled trial

    OpenAIRE

    Boden, Ianthe; Browning, Laura; Elizabeth H Skinner; Reeve, Julie; El-Ansary, Doa; Robertson, Iain K.; Denehy, Linda

    2015-01-01

    Background Post-operative pulmonary complications are a significant problem following open upper abdominal surgery. Preliminary evidence suggests that a single pre-operative physiotherapy education and preparatory lung expansion training session alone may prevent respiratory complications more effectively than supervised post-operative breathing and coughing exercises. However, the evidence is inconclusive due to methodological limitations. No well-designed, adequately powered, randomised con...

  2. Insecticide-treated nets for the prevention of malaria in pregnancy: a systematic review of randomised controlled trials.

    Directory of Open Access Journals (Sweden)

    Carol Gamble

    2007-03-01

    Full Text Available BACKGROUND: Protection from malaria with insecticide-treated bednets (ITNs during pregnancy is widely advocated, but evidence of benefit has been inconsistent. We undertook a systematic review of randomised trials. METHODS AND FINDINGS: Three cluster-randomised and two individually randomised trials met the inclusion criteria; four from Africa (n = 6,418 and one from Thailand (n = 223. In Africa, ITNs compared to no nets increased mean birth weight by 55 g (95% confidence interval [CI] 21-88, reduced low birth weight by 23% (relative risk [RR] 0.77, 95% CI 0.61-0.98, and reduced miscarriages/stillbirths by 33% (RR 0.67, 0.47-0.97 in the first few pregnancies. Placental parasitaemia was reduced by 23% in all gravidae (RR 0.77, 0.66-0.90. The effects were apparent in the cluster-randomised trials and the one individually randomised trial in Africa. The trial in Thailand, which randomised individuals to ITNs or untreated nets, showed reductions in anaemia and fetal loss in all gravidae, but not reductions in clinical malaria or low birth weight. CONCLUSIONS: ITNs used throughout pregnancy or from mid-pregnancy onwards have a beneficial impact on pregnancy outcome in malaria-endemic Africa in the first few pregnancies. The potential impact of ITNs in pregnant women and their newborns in malaria regions outside Africa requires further research.

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

    OpenAIRE

    Amelia Scott; Julia J Rucklidge; Roger T Mulder

    2015-01-01

    Objective To address the bias occurring in the medical literature associated with selective outcome reporting, in 2005, the International Committee of Medical Journal Editors (ICMJE) introduced mandatory trial registration guidelines and member journals required prospective registration of trials prior to patient enrolment as a condition of publication. No research has examined whether these guidelines are impacting psychiatry publications. Our objectives were to determine the extent to which...

  4. Phase III trial of selenium to prevent prostate cancer in men with high-grade prostatic intraepithelial neoplasia: SWOG S9917.

    Science.gov (United States)

    Marshall, James R; Tangen, Catherine M; Sakr, Wael A; Wood, David P; Berry, Donna L; Klein, Eric A; Lippman, Scott M; Parnes, Howard L; Alberts, David S; Jarrard, David F; Lee, W Robert; Gaziano, J Michael; Crawford, E David; Ely, Benjamin; Ray, Michael; Davis, Warren; Minasian, Lori M; Thompson, Ian M

    2011-11-01

    The threat of prostate cancer and the significant and often negative impact of its treatment underscore the importance of prevention. High-grade prostatic intraepithelial neoplasia (HGPIN) has been identified as a potential premalignant lesion marking an increased risk of prostate cancer and substantial evidence suggests that men with HGPIN are in need of prostate cancer prevention. In vitro, in vivo, epidemiologic, and clinical trial evidence that selenium supplementation protects against prostate cancer motivated the study we report here: a double-blind, randomized, placebo-controlled trial of selenium 200 (μg/d) as selenomethionine in men with HGPIN. The primary endpoint was progression of HGPIN to prostate cancer over a 3-year period. This National Cancer Institute Intergroup trial was coordinated by the Southwest Oncology Group (SWOG). Of 619 enrolled patients, 423 randomized men with HGPIN (212 selenium and 211 placebo) were eligible (by central pathology review) and included in the primary analysis. Three-year cancer rates were 36.6% (placebo) versus 35.6% (selenium; P = 0.73, adjusted). The majority of patients who developed cancer on trial (70.8%, selenium and 75.5%, placebo) had a Gleason score of 6 or less than 6; there were no differences in Gleason scores between the two arms. Subset analyses included the finding of a nonsignificantly reduced prostate cancer risk (relative risk = 0.82; 95% CI: 0.40-1.69) in selenium versus placebo patients in the lowest quartile of baseline plasma selenium level (selenium levels, selenium supplementation had no effect on prostate cancer risk. The 36% prostate cancer rate in men with HGPIN indicates the association of this lesion with an elevated prostate cancer risk. Future study in this setting should focus on selenium-deficient populations and selenium pharmacogenetics.

  5. Probiotics for Prevention of Atopy and Food Hypersensitivity in Early Childhood: A PRISMA-Compliant Systematic Review and Meta-Analysis of Randomized Controlled Trials.

    Science.gov (United States)

    Zhang, Guo-Qiang; Hu, Hua-Jian; Liu, Chuan-Yang; Zhang, Qiao; Shakya, Shristi; Li, Zhong-Yue

    2016-02-01

    Most studies investigated probiotics on food hypersensitivity, not on oral food challenge confirmed food allergy in children. The authors systematically reviewed the literature to investigate whether probiotic supplementation prenatally and/or postnatally could reduce the risk of atopy and food hypersensitivity in young children.PubMed, Embase, the Cochrane Central Register of Controlled Trials, and 4 main Chinese literature databases (Wan Fang, VIP, China National Knowledge Infrastructure, and SinoMed) were searched for randomized controlled trials regarding the effect of probiotics on the prevention of allergy in children. The last search was conducted on July 11, 2015.Seventeen trials involving 2947 infants were included. The first follow-up studies were analyzed. Pooled analysis indicated that probiotics administered prenatally and postnatally could reduce the risk of atopy (relative risk [RR] 0.78; 95% confidence interval [CI] 0.66-0.92; I = 0%), especially when administered prenatally to pregnant mother and postnatally to child (RR 0.71; 95% CI 0.57-0.89; I = 0%), and the risk of food hypersensitivity (RR 0.77; 95% CI 0.61-0.98; I = 0%). When probiotics were administered either only prenatally or only postnatally, no effects of probiotics on atopy and food hypersensitivity were observed.Probiotics administered prenatally and postnatally appears to be a feasible way to prevent atopy and food hypersensitivity in young children. The long-term effects of probiotics, however, remain to be defined in the follow-up of existing trials. Still, studies on probiotics and confirmed food allergy, rather than surrogate measure of food hypersensitivity, are warranted.

  6. The effectiveness of an intervention in increasing community health clinician provision of preventive care: a study protocol of a non-randomised, multiple-baseline trial

    Directory of Open Access Journals (Sweden)

    McElwaine Kathleen M

    2011-12-01

    prior to and following the intervention with randomly selected samples of clinicians from each facility group to assess the reported provision of preventive care, and the acceptability of the practice change intervention and implementation. Discussion The study will provide novel evidence regarding the ability to increase clinician's routine provision of preventive care across a network of community health facilities. Trial registration Australian Clinical Trials Registry ACTRN12611001284954 Universal Trial Number (UTN U1111-1126-3465

  7. Efficacy of a multifaceted podiatry intervention to improve balance and prevent falls in older people: study protocol for a randomised trial

    Directory of Open Access Journals (Sweden)

    Menz Hylton B

    2008-11-01

    Full Text Available Abstract Background Falls in older people are a major public health problem, with at least one in three people aged over 65 years falling each year. There is increasing evidence that foot problems and inappropriate footwear increase the risk of falls, however no studies have been undertaken to determine whether modifying these risk factors decreases the risk of falling. This article describes the design of a randomised trial to evaluate the efficacy of a multifaceted podiatry intervention to reduce foot pain, improve balance, and reduce falls in older people. Methods Three hundred community-dwelling men and women aged 65 years and over with current foot pain and an increased risk of falling will be randomly allocated to a control or intervention group. The "usual cae" control group will receive routine podiatry (i.e. nail care and callus debridement. The intervention group will receive usual care plus a multifaceted podiatry intervention consisting of: (i prefabricated insoles customised to accommodate plantar lesions; (ii footwear advice and assistance with the purchase of new footwear if current footwear is inappropriate; (iii a home-based exercise program to strengthen foot and ankle muscles; and (iv a falls prevention education booklet. Primary outcome measures will be the number of fallers, number of multiple fallers and the falls rate recorded by a falls diary over a 12 month period. Secondary outcome measures assessed six months after baseline will include the Medical Outcomes Study Short Form 12 (SF-12, the Manchester Foot Pain and Disability Index, the Falls Efficacy Scale International, and a series of balance and functional tests. Data will be analysed using the intention to treat principle. Discussion This study is the first randomised trial to evaluate the efficacy of podiatry in improving balance and preventing falls. The trial has been pragmatically designed to ensure that the findings can be generalised to clinical practice. If

  8. ICT-based system to predict and prevent falls (iStoppFalls): study protocol for an international multicenter randomized controlled trial

    Science.gov (United States)

    2014-01-01

    Background Falls are very common, especially in adults aged 65 years and older. Within the current international European Commission’s Seventh Framework Program (FP7) project ‘iStoppFalls’ an Information and Communication Technology (ICT) based system has been developed to regularly assess a person’s risk of falling in their own home and to deliver an individual and tailored home-based exercise and education program for fall prevention. The primary aims of iStoppFalls are to assess the feasibility and acceptability of the intervention program, and its effectiveness to improve balance, muscle strength and quality of life in older people. Methods/Design This international, multicenter study is designed as a single-blinded, two-group randomized controlled trial. A total of 160 community-dwelling older people aged 65 years and older will be recruited in Germany (n = 60), Spain (n = 40), and Australia (n = 60) between November 2013 and May 2014. Participants in the intervention group will conduct a 16-week exercise program using the iStoppFalls system through their television set at home. Participants are encouraged to exercise for a total duration of 180 minutes per week. The training program consists of a variety of balance and strength exercises in the form of video games using exergame technology. Educational material about a healthy lifestyle will be provided to each participant. Final reassessments will be conducted after 16 weeks. The assessments include physical and cognitive tests as well as questionnaires assessing health, fear of falling, quality of life and psychosocial determinants. Falls will be followed up for six months by monthly falls calendars. Discussion We hypothesize that the regular use of this newly developed ICT-based system for fall prevention at home is feasible for older people. By using the iStoppFalls sensor-based exercise program, older people are expected to improve in balance and strength outcomes. In addition, the exercise

  9. Comparison of tai chi vs. strength training for fall prevention among female cancer survivors: study protocol for the GET FIT trial

    Directory of Open Access Journals (Sweden)

    Winters-Stone Kerri M

    2012-12-01

    Full Text Available Abstract Background Women with cancer are significantly more likely to fall than women without cancer placing them at higher risk of fall-related fractures, other injuries and disability. Currently, no evidence-based fall prevention strategies exist that specifically target female cancer survivors. The purpose of the GET FIT (Group Exercise Training for Functional Improvement after Treatment trial is to compare the efficacy of two distinct types of exercise, tai chi versus strength training, to prevent falls in women who have completed treatment for cancer. The specific aims of this study are to: 1 Determine and compare the efficacy of both tai chi training and strength training to reduce falls in older female cancer survivors, 2 Determine the mechanism(s by which tai chi and strength training each reduces falls and, 3 Determine whether or not the benefits of each intervention last after structured training stops. Methods/Design We will conduct a three-group, single-blind, parallel design, randomized controlled trial in women, aged 50–75 years old, who have completed chemotherapy for cancer comparing 1 tai chi 2 strength training and 3 a placebo control group of seated stretching exercise. Women will participate in supervised study programs twice per week for six months and will be followed for an additional six months after formal training stops. The primary outcome in this study is falls, which will be prospectively tracked by monthly self-report. Secondary outcomes are maximal leg strength measured by isokinetic dynamometry, postural stability measured by computerized dynamic posturography and physical function measured by the Physical Performance Battery, all measured at baseline, 3, 6 and 12 months. The sample for this trial (N=429, assuming 25% attrition will provide adequate statistical power to detect at least a 47% reduction in the fall rate over 1 year by being in either of the 2 exercise groups versus the control group. Discussion

  10. Novel Method for Recruiting Representative At-Risk Individuals into Cancer Prevention Trials: Online Health Risk Assessment in Employee Wellness Programs.

    Science.gov (United States)

    Hui, Siu-Kuen Azor; Miller, Suzanne M; Hazuda, Leah; Engelman, Kimberly; Ellerbeck, Edward F

    2016-09-01

    Participation in cancer prevention trials (CPT) is lower than 3 % among high-risk healthy individuals, and racial/ethnic minorities are the most under-represented. Novel recruitment strategies are therefore needed. Online health risk assessment (HRA) serves as a gateway component of nearly all employee wellness programs (EWPs) and may be a missed opportunity. This study aimed to explore employees' interest, willingness, motivators, and barriers of releasing their HRA responses to an external secure research database for recruitment purpose. We used qualitative research methods (focus group and individual interviews) to examine employees' interest and willingness in releasing their online HRA responses to an external, secure database to register as potential CPT participants. Fifteen structured interviews (40 % of study participants were of racial/ethnic minority) were conducted, and responses reached saturation after four interviews. All employees showed interest and willingness to release their online HRA responses to register as a potential CPT participant. Content analyses revealed that 91 % of participants were motivated to do so, and the major motivators were to (1) obtain help in finding personally relevant prevention trials, (2) help people they know who are affected by cancer, and/or (3) increase knowledge about CPT. A subset of participants (45 %) expressed barriers of releasing their HRA responses due to concerns about credibility and security of the external database. Online HRA may be a feasible but underutilized recruitment method for cancer prevention trials. EWP-sponsored HRA shows promise for the development of a large, centralized registry of racially/ethnically representative CPT potential participants.

  11. A Medical Student–Delivered Smoking Prevention Program, Education Against Tobacco, for Secondary Schools in Brazil: Study Protocol for a Randomized Trial

    Science.gov (United States)

    Xavier, Luiz Eduardo De Freitas; Bernardes-Souza, Breno; Lisboa, Oscar Campos; Seeger, Werner; Groneberg, David Alexander; Tran, Thien-An; Fries, Fabian Norbert; Corrêa, Paulo César Rodrigues Pinto

    2017-01-01

    Background Smoking is the largest preventable cause of morbidity and mortality in Brazil. Education Against Tobacco (EAT) is a large network of medical students in 13 countries who volunteer for school-based prevention in the classroom setting. A recent quasi-experimental EAT study conducted in Germany showed significant short-term smoking cessation effects on 11- to 15-year-old adolescents. Objective The aim of this study is both to describe and to provide the first randomized long-term evaluation of the EAT intervention involving a photoaging app for its effectiveness to reduce the smoking prevalence among 12- to 17-year-old pupils in Brazilian public schools. Methods A randomized controlled trial will be conducted among approximately 1500 adolescents aged 12 to 17 years in grades 7-11 of public secondary schools in Brazil. The prospective experimental study design includes measurements at baseline and at 6 and 12 months postintervention. The study groups will consist of randomized classes receiving the standardized EAT intervention (90 minutes of mentoring in a classroom setting) and control classes within the same schools (no intervention). The questionnaire measures smoking status, gender, social, and cultural aspects as well as predictors of smoking. Biochemical validation of smoking status is conducted via random carbon monoxide measurements. The primary end point is the difference of the change in smoking prevalence in the intervention group versus the difference in the control group at 12 months of follow-up. The differences in smoking behavior (smoking onset, quitting) between the 2 groups as well as effects on the different genders will be studied as secondary outcomes. Results The recruitment of schools, participating adolescents, and medical students was conducted from August 2016 until January 2017. The planned period of data collection is February 2017 until June 2018. Data analysis will follow in July 2018 and data presentation/publication will

  12. Evaluating a selective prevention programme for binge drinking among young adolescents: study protocol of a randomized controlled trial

    NARCIS (Netherlands)

    Lammers, J.; Goossens, F.; Lokman, S.; Monshouwer, K.; Lemmers, L.; Conrod, P.; Wiers, R.; Engels, R.; Kleinjan, M.

    2011-01-01

    Background In comparison to other Europe countries, Dutch adolescents are at the top in drinking frequency and binge drinking. A total of 75% of the Dutch 12 to 16 year olds who drink alcohol also engage in binge drinking. A prevention programme called Preventure was developed in Canada to prevent a

  13. Evaluating a selective prevention programme for binge drinking among young adolescents: Study protocol of a randomized controlled trial

    NARCIS (Netherlands)

    Lammers, J.; Goossens, F.; Lokman, S.; Monshouwer, K.; Lemmers, A.C.J.; Conrod, P.; Wiers, R.W.H.J.; Engels, R.C.M.E.; Kleinjan, M.

    2011-01-01

    Background In comparison to other Europe countries, Dutch adolescents are at the top in drinking frequency and binge drinking. A total of 75% of the Dutch 12 to 16 year olds who drink alcohol also engage in binge drinking. A prevention programme called Preventure was developed in Canada to prevent a

  14. Efficacy Trial of a Selective Prevention Program Targeting Both Eating Disorder Symptoms and Unhealthy Weight Gain among Female College Students

    Science.gov (United States)

    Stice, Eric; Rohde, Paul; Shaw, Heather; Marti, C. Nathan

    2012-01-01

    Objective: Evaluate a selective prevention program targeting both eating disorder symptoms and unhealthy weight gain in young women. Method: Female college students at high-risk for these outcomes by virtue of body image concerns (N = 398; M age = 18.4 years, SD = 0.6) were randomized to the Healthy Weight group-based 4-hr prevention program,…

  15. Computeen: A Randomized Trial of a Preventive Computer and Psychosocial Skills Curriculum for At-Risk Adolescents

    Science.gov (United States)

    Lang, Jason M.; Waterman, Jill; Baker, Bruce L.

    2009-01-01

    Computeen, a preventive technology and psychosocial skills development program for at-risk adolescents, was designed to improve computer skills, self-esteem, and school attitudes, and reduce behavior problems, by combining elements of community-based and empirically supported prevention programs. Fifty-five mostly Latino adolescents from 12 to 16…

  16. Study protocol for a group randomized controlled trial of a classroom-based intervention aimed at preventing early risk factors for drug abuse: integrating effectiveness and implementation research

    Directory of Open Access Journals (Sweden)

    Keegan Natalie

    2009-09-01

    Full Text Available Abstract Background While a number of preventive interventions delivered within schools have shown both short-term and long-term impact in epidemiologically based randomized field trials, programs are not often sustained with high-quality implementation over time. This study was designed to support two purposes. The first purpose was to test the effectiveness of a universal classroom-based intervention, the Whole Day First Grade Program (WD, aimed at two early antecedents to drug abuse and other problem behaviors, namely, aggressive, disruptive behavior and poor academic achievement. The second purpose--the focus of this paper--was to examine the utility of a multilevel structure to support high levels of implementation during the effectiveness trial, to sustain WD practices across additional years, and to train additional teachers in WD practices. Methods The WD intervention integrated three components, each previously tested separately: classroom behavior management; instruction, specifically reading; and family-classroom partnerships around behavior and learning. Teachers and students in 12 schools were randomly assigned to receive either the WD intervention or the standard first-grade program of the school system (SC. Three consecutive cohorts of first graders were randomized within schools to WD or SC classrooms and followed through the end of third grade to test the effectiveness of the WD intervention. Teacher practices were assessed over three years to examine the utility of the multilevel structure to support sustainability and scaling-up. Discussion The design employed in this trial appears to have considerable utility to provide data on WD effectiveness and to inform the field with regard to structures required to move evidence-based programs into practice. Trial Registration Clinical Trials Registration Number: NCT00257088

  17. A Review of HIV Prevention Studies that Use Social Networking Sites: Implications for Recruitment, Health Promotion Campaigns, and Efficacy Trials.

    Science.gov (United States)

    Jones, Jamal; Salazar, Laura F

    2016-11-01

    This review describes the use of social networking sites (SNS) in the context of primary prevention of HIV. A review was conducted to assess the published literature for HIV interventions using SNS. Sixteen articles describing twelve interventions were included. SNS were instrumental in recruiting hard-to-reach populations within a short amount of time; were able to reach wide audiences beyond the targeted population for HIV prevention campaigns; and helped to significantly reduce sexual risk behaviors and increase HIV testing. SNS are a viable option to recruit hidden populations, engage the target audience, and disseminate HIV prevention messages. Researchers should use SNS to generate sampling frames that can be used to select participants. Practitioners should use SNS to post images of preventive behavior within health promotion campaigns. Researchers should use multiple SNS platforms to engage participants. As more studies are published using SNS for HIV prevention, meta-analyses will be needed.

  18. Study protocol for a randomized controlled trial comparing mindfulness-based cognitive therapy with maintenance anti-depressant treatment in the prevention of depressive relapse/recurrence: the PREVENT trial

    OpenAIRE

    2010-01-01

    Background Depression is a common and distressing mental health problem that is responsible for significant individual disability and cost to society. Medication and psychological therapies are effective for treating depression and maintenance anti-depressants (m-ADM) can prevent relapse. However, individuals with depression often express a wish for psychological help that can help them recover from depression in the long-term. We need to develop psychological therapies that prevent depressiv...

  19. Value for money: economic evaluation of two different caries prevention programmes compared with standard care in a randomized controlled trial

    NARCIS (Netherlands)

    J.H. Vermaire; C. van Loveren; W.B.F. Brouwer; M. Krol

    2014-01-01

    A cost-effectiveness analysis was conducted during a 3-year randomized controlled clinical trial in a general dental practice in the Netherlands in which 230 6-year-old children (± 3 months) were assigned to either regular dental care, an increased professional fluoride application (IPFA) programme

  20. Value for Money: Economic Evaluation of Two Different Caries Prevention Programmes Compared with standard Care in a Randomized Controlled Trial

    NARCIS (Netherlands)

    Vermaire, J.H.; Loveren, C. van; Brouwer, W.B.F.; Krol, M.

    2014-01-01

    A cost-effectiveness analysis was conducted during a 3-year randomized controlled clinical trial in a general dental practice in the Netherlands in which 230 6-year-old children (± 3 months) were assigned to either regular dental care, an increased professional fluoride application (IPFA) programme

  1. Effectiveness of the 'Healthy School and Drugs' prevention programme on adolescents' substance use: a randomized clustered trial

    NARCIS (Netherlands)

    Malmberg, M.; Kleinjan, M.; Overbeek, G.J.; Vermulst, A.A.; Monshouwer, K.; Lammers, J.; Vollebergh, W.A.M.; Engels, R.C.M.E.

    2014-01-01

    Aim To evaluate the effectiveness of the Healthy School and Drugs programme on alcohol, tobacco and marijuana use among Dutch early adolescents. Design Randomized clustered trial with two intervention conditions (i.e. e-learning and integral). Setting General population of 11-15-year-old adolescents

  2. Alcohol Prevention and School Students: Findings from an Australian 2-Year Trial of Integrated Harm Minimization School Drug Education

    Science.gov (United States)

    Midford, Richard; Ramsden, Robyn; Lester, Leanne; Cahill, Helen; Mitchell, Johanna; Foxcroft, David R.; Venning, Lynne

    2014-01-01

    The Drug Education in Victorian Schools program provided integrated education about licit and illicit drugs, employed a harm minimization approach that incorporated participatory, critical thinking and skill-based teaching methods, and engaged parental influence through home activities. A cluster-randomized, controlled trial of the program was…

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

    Science.gov (United States)

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

    2008-01-01

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

  4. Risk moderation of a parent and student preventive alcohol intervention by adolescent and family factors : A cluster randomized trial

    NARCIS (Netherlands)

    Verdurmen, Jacqueline E E; Koning, Ina M.; Vollebergh, Wilma A M; van den Eijnden, Regina J J M; Engels, Rutger C M E

    2014-01-01

    Objective: To examine risk moderation of an alcohol intervention targeting parents and adolescents. Design: A cluster randomized trial including 2937 Dutch early adolescents (m=12.68. years, SD=0.51) and their parents randomized over four conditions: parent intervention, student intervention, combin

  5. Effectiveness of the 'Healthy School and Drugs' prevention programme on adolescents' substance use: a randomized clustered trial

    NARCIS (Netherlands)

    Malmberg, M.; Kleinjan, M.; Overbeek, G.; Vermulst, A.; Monshouwer, K.; Lammers, J.; Vollebergh, W.A.M.; Engels, R.C.M.E.

    2014-01-01

    Aim: To evaluate the effectiveness of the Healthy School and Drugs programme on alcohol, tobacco and marijuana use among Dutch early adolescents. Design: Randomized clustered trial with two intervention conditions (i.e. e-learning and integral). Setting: General population of 11-15-year-old adolesce

  6. Effectiveness of the 'Healthy School and Drugs' prevention programme on adolescents' substance use : A randomized clustered trial

    NARCIS (Netherlands)

    Malmberg, Monique; Kleinjan, Marloes; Overbeek, Geertjan; Vermulst, Ad; Monshouwer, Karin; Lammers, Jeroen; Vollebergh, Wilma A M; Engels, Rutger C M E

    2014-01-01

    Aim: To evaluate the effectiveness of the Healthy School and Drugs programme on alcohol, tobacco and marijuana use among Dutch early adolescents. Design: Randomized clustered trial with two intervention conditions (i.e. e-learning and integral). Setting: General population of 11-15-year-old adolesce

  7. Biomedical enhancements as justice.

    Science.gov (United States)

    Nam, Jeesoo

    2015-02-01

    Biomedical enhancements, the applications of medical technology to make better those who are neither ill nor deficient, have made great strides in the past few decades. Using Amartya Sen's capability approach as my framework, I argue in this article that far from being simply permissible, we have a prima facie moral obligation to use these new developments for the end goal of promoting social justice. In terms of both range and magnitude, the use of biomedical enhancements will mark a radical advance in how we compensate the most disadvantaged members of society.

  8. Advances in biomedical engineering

    CERN Document Server

    Brown, J H U

    1976-01-01

    Advances in Biomedical Engineering, Volume 6, is a collection of papers that discusses the role of integrated electronics in medical systems and the usage of biological mathematical models in biological systems. Other papers deal with the health care systems, the problems and methods of approach toward rehabilitation, as well as the future of biomedical engineering. One paper discusses the use of system identification as it applies to biological systems to estimate the values of a number of parameters (for example, resistance, diffusion coefficients) by indirect means. More particularly, the i

  9. Advances in biomedical engineering

    CERN Document Server

    Brown, J H U

    1976-01-01

    Advances in Biomedical Engineering, Volume 5, is a collection of papers that deals with application of the principles and practices of engineering to basic and applied biomedical research, development, and the delivery of health care. The papers also describe breakthroughs in health improvements, as well as basic research that have been accomplished through clinical applications. One paper examines engineering principles and practices that can be applied in developing therapeutic systems by a controlled delivery system in drug dosage. Another paper examines the physiological and materials vari

  10. Biomedical implantable microelectronics.

    Science.gov (United States)

    Meindl, J D

    1980-10-17

    Innovative applications of microelectronics in new biomedical implantable instruments offer a singular opportunity for advances in medical research and practice because of two salient factors: (i) beyond all other types of biomedical instruments, implants exploit fully the inherent technical advantages--complex functional capability, high reliability, lower power drain, small size and weight-of microelectronics, and (ii) implants bring microelectronics into intimate association with biological systems. The combination of these two factors enables otherwise impossible new experiments to be conducted and new paostheses developed that will improve the quality of human life.

  11. Ethics in biomedical engineering.

    Science.gov (United States)

    Morsy, Ahmed; Flexman, Jennifer

    2008-01-01

    This session focuses on a number of aspects of the subject of Ethics in Biomedical Engineering. The session starts by providing a case study of a company that manufactures artificial heart valves where the valves were failing at an unexpected rate. The case study focuses on Biomedical Engineers working at the company and how their education and training did not prepare them to deal properly with such situation. The second part of the session highlights the need to learn about various ethics rules and policies regulating research involving human or animal subjects.

  12. A randomised controlled trial of Heparin versus EthAnol Lock THerapY for the prevention of Catheter Associated infecTion in Haemodialysis patients – the HEALTHY-CATH trial

    Directory of Open Access Journals (Sweden)

    Broom Jennifer K

    2012-11-01

    Full Text Available Abstract Background Tunnelled central venous dialysis catheter use is significantly limited by the occurrence of catheter-related infections. This randomised controlled trial assessed the efficacy of a 48 hour 70% ethanol lock vs heparin locks in prolonging the time to the first episode of catheter related blood stream infection (CRBSI. Methods Patients undergoing haemodialysis (HD via a tunnelled catheter were randomised 1:1 to once per week ethanol locks (with two heparin locks between other dialysis sessions vs thrice per week heparin locks. Results Observed catheter days in the heparin (n=24 and ethanol (n=25 groups were 1814 and 3614 respectively. CRBSI occurred at a rate of 0.85 vs. 0.28 per 1000 catheter days in the heparin vs ethanol group by intention to treat analysis (incident rate ratio (IRR for ethanol vs. heparin 0.17; 95%CI 0.02-1.63; p=0.12. Flow issues requiring catheter removal occurred at a rate of 1.6 vs 1.4 per 1000 catheter days in the heparin and ethanol groups respectively (IRR 0.85; 95% CI 0.20-3.5 p =0.82 (for ethanol vs heparin. Conclusions Catheter survival and catheter-related blood stream infection were not significantly different but there was a trend towards a reduced rate of infection in the ethanol group. This study establishes proof of concept and will inform an adequately powered multicentre trial to definitively examine the efficacy and safety of ethanol locks as an alternative to current therapies used in the prevention of catheter-associated blood stream infections in patients dialysing with tunnelled catheters. Trial Registration Australian New Zealand Clinical Trials Registry ACTRN12609000493246

  13. The biomedical disciplines and the structure of biomedical and clinical knowledge.

    Science.gov (United States)

    Nederbragt, H

    2000-11-01

    The relation between biomedical knowledge and clinical knowledge is discussed by comparing their respective structures. The knowledge of a disease as a biological phenomenon is constructed by the interaction of facts and theories from the main biomedical disciplines: epidemiology, diagnostics, clinical trial, therapy development and pathogenesis. Although these facts and theories are based on probabilities and extrapolations, the interaction provides a reliable and coherent structure, comparable to a Kuhnian paradigma. In the structure of clinical knowledge, i.e. knowledge of the patient with the disease, not only biomedical knowledge contributes to the structure but also economic and social relations, ethics and personal experience. However, the interaction between each of the participating "knowledges" in clinical knowledge is not based on mutual dependency and accumulation of different arguments from each, as in biomedical knowledge, but on competition and partial exclusion. Therefore, the structure of biomedical knowledge is different from that of clinical knowledge. This difference is used as the basis for a discussion in which the place of technology, evidence-based medicine and the gap between scientific and clinical knowledge are evaluated.

  14. Cost-effectiveness of a pragmatic structured education intervention for the prevention of type 2 diabetes: economic evaluation of data from the Let's Prevent Diabetes cluster-randomised controlled trial

    Science.gov (United States)

    Ahrabian, D; Davies, M J; Khunti, K; Yates, T; Gray, A M

    2017-01-01

    Objectives Prevention of type 2 diabetes mellitus (TD2M) is a priority for healthcare systems. We estimated the cost-effectiveness compared with standard care of a structured education programme (Let's Prevent) targeting lifestyle and behaviour change to prevent progression to T2DM in people with prediabetes. Design Cost-effectiveness analysis alongside randomised controlled trial. Setting 44 general practices in Leicestershire, England. Participants 880 participants with prediabetes randomised to receive either standard care or a 6-hour group structured education programme with follow-up sessions in a primary care setting. Main outcome measure Incremental cost utility from the UK National Health Service (NHS) perspective. Quality of life and resource use measured from baseline and during the 36 months follow-up using the EuroQoL EQ-5D and 15D instruments and an economic questionnaire. Outcomes measured using quality-adjusted life years (QALYs) and healthcare costs calculated in 2012–2013 prices. Results After accounting for clustering and missing data, the intervention group was found to have a net gain of 0.046 (95% CI −0.0171 to 0.109) QALYs over 3 years, adjusted for baseline utility, at an additional cost of £168 (95% CI −395 to 732) per patient compared with the standard care group. The incremental cost-effectiveness ratio is £3643/QALY with an 86% probability of being cost-effective at a willingness to pay threshold of £20 000/QALY. Conclusions The education programme had higher costs and higher quality of life compared with the standard care group. The Let's Prevent programme is very likely to be cost-effective at a willingness to pay threshold of £20 000/QALY gained. Trial registration number ISRCTN80605705. PMID:28069625

  15. Prevention of restenosis after coronary balloon angioplasty: rationale and design of the Fluvavastatin Angioplasty Restenosis (FLARE) Trial

    NARCIS (Netherlands)

    J.J.R.M. Bonnier (Hans); G. Jackson (Graham); C.M. Miguel (Carlos); J. Shepherd; M.C. Vrolix (Mathias); P.W.J.C. Serruys (Patrick); D.P. Foley (David)

    1994-01-01

    textabstractPrevention of restenosis after successful percutaneous transluminal coronary balloon angioplasty (PTCA) continues to present the greatest therapeutic challenge in interventional cardiology. Experimental and pathological studies describe restenosis as no more than the biologic healing res

  16. Building Successful Relationships in the PLCO Cancer Screening Trial.

    Science.gov (United States)

    Marcus, Pamela M; Broski, Karen G; Buys, Saundra S; Childs, Jeffery; Church, Timothy R; Gohagan, John K; Gren, Lisa H; Higgins, Darlene; Jaggi, Rachel; Jenkins, Victoria; Johnson, Christine C; Lappe, Karen; O'Brien, Barbara; Ogden, Sheryl L; Prorok, Philip C; Reding, Douglas; Shambaugh, Vicki; Yokochi, Lance A; Yurgalevitch, Susan

    2015-01-01

    Biomedical research cannot succeed without funding, knowledgeable staff, and appropriate infrastructure. There are however equally important but intangible factors that are rarely considered in planning large multidisciplinary endeavors or evaluating their success. The Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial required extensive collaborations between individuals from many fields, including clinicians, clinical trialists, and administrators; it also addressed questions across the spectrum of cancer prevention and control. In this manuscript, we examine the experiences and opinions of trial staff regarding the building of successful relationships in PLCO. We summarize, in narrative form, data collected using open-ended questionnaires that were administered to the National Cancer Institute project officers, coordinating center staff, screening center principal investigators, and screening center coordinators in 2015, about 3 years after publication of the final primary trial manuscript. Trust, respect, listening to others, and in-person interaction were frequently mentioned as crucial to building successful relationships.

  17. A randomised control trial of low glycaemic index carbohydrate diet versus no dietary intervention in the prevention of recurrence of fetal macrosomia.

    LENUS (Irish Health Repository)

    Walsh, Jennifer

    2010-04-23

    Abstract Background Maternal weight and maternal weight gain during pregnancy exert a significant influence on infant birth weight and the incidence of macrosomia. Fetal macrosomia is associated with an increase in both adverse obstetric and neonatal outcome, and also confers a future risk of childhood obesity. Studies have shown that a low glycaemic diet is associated with lower birth weights, however these studies have been small and not randomised 1 2 . Fetal macrosomia recurs in a second pregnancy in one third of women, and maternal weight influences this recurrence risk 3 . Methods\\/Design We propose a randomised control trial of low glycaemic index carbohydrate diet vs. no dietary intervention in the prevention of recurrence of fetal macrosomia. Secundigravid women whose first baby was macrosomic, defined as a birth weight greater than 4000 g will be recruited at their first antenatal visit. Patients will be randomised into two arms, a control arm which will receive no dietary intervention and a diet arm which will be commenced on a low glycaemic index diet. The primary outcome measure will be the mean birth weight centiles and ponderal indices in each group. Discussion Altering the source of maternal dietary carbohydrate may prove to be valuable in the management of pregnancies where there has been a history of fetal macrosomia. Fetal macrosomia recurs in a second pregnancy in one third of women. This randomised control trial will investigate whether or not a low glycaemic index diet can affect this recurrence risk. Current Controlled Trials Registration Number ISRCTN54392969

  18. The effectiveness of a trauma-focused psycho-educational secondary prevention program for children exposed to interparental violence: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Overbeek Mathilde M

    2012-02-01

    Full Text Available Abstract Background Children who witness interparental violence are at a heightened risk for developing psychosocial, behavioral and cognitive problems, as well as posttraumatic stress symptoms. For these children the psycho-educational secondary prevention program 'En nu ik...!' ('It's my turn now!' has been developed. This program includes specific therapeutic factors focused on emotion awareness and expression, increasing feelings of emotional security, teaching specific coping strategies, developing a trauma narrative, improving parent-child interaction and psycho-education. The main study aim is to evaluate the effectiveness of the specific therapeutic factors in the program. A secondary objective is to study mediating and moderating factors. Methods/design This study is a prospective multicenter randomized controlled trial across cities in the Netherlands. Participants (N = 140 are referred to the secondary preventive intervention program by police, social work, women shelters and youth (mental health care. Children, aged 6-12 years, and their parents, who experienced interparental violence are randomly assigned to either the intervention program or the control program. The control program is comparable on nonspecific factors by offering positive attention, positive expectations, recreation, distraction, warmth and empathy of the therapist, and social support among group participants, in ways that are similar to the intervention program. Primary outcome measures are posttraumatic stress symptoms and emotional and behavioral problems of the child. Mediators tested are the ability to differentiate and express emotions, emotional security, coping strategies, feelings of guilt and parent-child interaction. Mental health of the parent, parenting stress, disturbances in parent-child attachment, duration and severity of the domestic violence and demographics are examined for their moderating effect. Data are collected one week before the program

  19. Increasing efficacy of primary care-based counseling for diabetes prevention: Rationale and design of the ADAPT (Avoiding Diabetes Thru Action Plan Targeting trial

    Directory of Open Access Journals (Sweden)

    Mann Devin M

    2012-01-01

    Full Text Available Abstract Background Studies have shown that lifestyle behavior changes are most effective to prevent onset of diabetes in high-risk patients. Primary care providers are charged with encouraging behavior change among their patients at risk for diabetes, yet the practice environment and training in primary care often do not support effective provider counseling. The goal of this study is to develop an electronic health record-embedded tool to facilitate shared patient-provider goal setting to promote behavioral change and prevent diabetes. Methods The ADAPT (Avoiding Diabetes Thru Action Plan Targeting trial leverages an innovative system that integrates evidence-based interventions for behavioral change with already-existing technology to enhance primary care providers' effectiveness to counsel about lifestyle behavior changes. Using principles of behavior change theory, the multidisciplinary design team utilized in-depth interviews and in vivo usability testing to produce a prototype diabetes prevention counseling system embedded in the electronic health record. Results The core element of the tool is a streamlined, shared goal-setting module within the electronic health record system. The team then conducted a series of innovative, "near-live" usability testing simulations to refine the tool and enhance workflow integration. The system also incorporates a pre-encounter survey to elicit patients' behavior-change goals to help tailor patient-provider goal setting during the clinical encounter and to encourage shared decision making. Lastly, the patients interact with a website that collects their longitudinal behavior data and allows them to visualize their progress over time and compare their progress with other study members. The finalized ADAPT system is now being piloted in a small randomized control trial of providers using the system with prediabetes patients over a six-month period. Conclusions The ADAPT system combines the influential

  20. A Non-Inferiority, Individually Randomized Trial of Intermittent Screening and Treatment versus Intermittent Preventive Treatment in the Control of Malaria in Pregnancy.

    Directory of Open Access Journals (Sweden)

    Harry Tagbor

    Full Text Available The efficacy of intermittent preventive treatment for malaria with sulfadoxine-pyrimethamine (IPTp-SP in pregnancy is threatened in parts of Africa by the emergence and spread of resistance to SP. Intermittent screening with a rapid diagnostic test (RDT and treatment of positive women (ISTp is an alternative approach.An open, individually randomized, non-inferiority trial of IPTp-SP versus ISTp was conducted in 5,354 primi- or secundigravidae in four West African countries with a low prevalence of resistance to SP (The Gambia, Mali, Burkina Faso and Ghana. Women in the IPTp-SP group received SP on two or three occasions whilst women in the ISTp group were screened two or three times with a RDT and treated if positive for malaria with artemether-lumefantrine (AL. ISTp-AL was non-inferior to IPTp-SP in preventing low birth weight (LBW, anemia and placental malaria, the primary trial endpoints. The prevalence of LBW was 15.1% and 15.6% in the IPTp-SP and ISTp-AL groups respectively (OR = 1.03 [95% CI: 0.88, 1.22]. The mean hemoglobin concentration at the last clinic attendance before delivery was 10.97g/dL and 10.94g/dL in the IPTp-SP and ISTp-AL groups respectively (mean difference: -0.03 g/dL [95% CI: -0.13, +0.06]. Active malaria infection of the placenta was found in 24.5% and in 24.2% of women in the IPTp-SP and ISTp-AL groups respectively (OR = 0.95 [95% CI 0.81, 1.12]. More women in the ISTp-AL than in the IPTp-SP group presented with malaria parasitemia between routine antenatal clinics (310 vs 182 episodes, rate difference: 49.4 per 1,000 pregnancies [95% CI 30.5, 68.3], but the number of hospital admissions for malaria was similar in the two groups.Despite low levels of resistance to SP in the study areas, ISTp-AL performed as well as IPTp-SP. In the absence of an effective alternative medication to SP for IPTp, ISTp-AL is a potential alternative to IPTp in areas where SP resistance is high. It may also have a role in areas where malaria

  1. Phase III trial of casopitant, a novel neurokinin-1 receptor antagonist, for the prevention of nausea and vomiting in patients receiving moderately emetogenic chemotherapy

    DEFF Research Database (Denmark)

    Herrstedt, Jørn; Apornwirat, Wichit; Shaharyar, Ahmed;

    2009-01-01

    PURPOSE: The purpose of this phase III trial was to evaluate the efficacy and safety of regimens containing casopitant, a novel neurokinin-1 receptor antagonist, for the prevention of chemotherapy-induced nausea and vomiting during the first cycle in patients receiving moderately emetogenic chemo...... proportion of patients with nausea or significant nausea in those receiving casopitant. Adverse events were balanced among study arms. CONCLUSION: All casopitant regimens studied were more effective than the control regimen. Casopitant was generally well tolerated.......PURPOSE: The purpose of this phase III trial was to evaluate the efficacy and safety of regimens containing casopitant, a novel neurokinin-1 receptor antagonist, for the prevention of chemotherapy-induced nausea and vomiting during the first cycle in patients receiving moderately emetogenic...... chemotherapy (MEC). PATIENTS AND METHODS: Predominantly female patients (98%) diagnosed with breast cancer (96%) who were chemotherapy-naïve and scheduled to receive an anthracycline and cyclophosphamide (AC) -based regimen were enrolled onto this multinational, randomized, double-blind, parallel...

  2. Protocol for a randomised controlled trial of a school based cognitive behaviour therapy (CBT intervention to prevent depression in high risk adolescents (PROMISE

    Directory of Open Access Journals (Sweden)

    Sayal Kapil

    2010-11-01

    Full Text Available Abstract Background Depression in adolescents is a significant problem that impairs everyday functioning and increases the risk of severe mental health disorders in adulthood. Relatively few adolescents with depression are identified and referred for treatment indicating the need to investigate alternative preventive approaches. Study Design A pragmatic cluster randomised controlled trial evaluating the effectiveness of a school based prevention programme on symptoms of depression in "high risk" adolescents (aged 12-16. The unit of allocation is year groups (n = 28 which are assigned to one of three conditions: an active intervention based upon cognitive behaviour therapy, attention control or treatment as usual. Assessments will be undertaken at screening, baseline, 6 months and 12 months. The primary outcome measure is change on the Short Mood and Feeling Questionnaire at 12 months. Secondary outcome measures will assess changes in negative thoughts, self esteem, anxiety, school connectedness, peer attachment, alcohol and substance misuse, bullying and self harm. Discussion As of August 2010, all 28 year groups (n = 5023 had been recruited and the assigned interventions delivered. Final 12 month assessments are scheduled to be completed by March 2011. Trial Registration ISRCTN19083628

  3. Biomedical Engineering in Modern Society

    Science.gov (United States)

    Attinger, E. O.

    1971-01-01

    Considers definition of biomedical engineering (BME) and how biomedical engineers should be trained. State of the art descriptions of BME and BME education are followed by a brief look at the future of BME. (TS)

  4. Quality control in colorectal cancer screening: Systematic microbiological investigation of endoscopes used in the NORCCAP (Norwegian Colorectal Cancer Prevention) trial

    OpenAIRE

    Kristiansen Bjørn; Jørgensen Anita; Bretthauer Michael; Hofstad Bjørn; Hoff Geir

    2003-01-01

    Abstract Background Endoscopic colorectal cancer (CRC) screening is currently implemented in many countries. Since endoscopes cannot be sterilised, the transmission of infectious agents through endoscopes has been a matter of concern. We report on a continuous quality control programme in a large-scale randomised controlled trial on flexible sigmoidoscopy screening of an average-risk population. Continuously, throughout a two-year screening period, series of microbiological samples were taken...

  5. Preliminary findings of a randomized trial of non-pharmaceutical interventions to prevent influenza transmission in households.

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    Benjamin J Cowling

    Full Text Available BACKGROUND: There are sparse data on whether non-pharmaceutical interventions can reduce the spread of influenza. We implemented a study of the feasibility and efficacy of face masks and hand hygiene to reduce influenza transmission among Hong Kong household members. METHODOLOGY/PRINCIPAL FINDINGS: We conducted a cluster randomized controlled trial of households (composed of at least 3 members where an index subject presented with influenza-like-illness of <48 hours duration. After influenza was confirmed in an index case by the QuickVue Influenza A+B rapid test, the household of the index subject was randomized to 1 control or 2 surgical face masks or 3 hand hygiene. Households were visited within 36 hours, and 3, 6 and 9 days later. Nose and throat swabs were collected from index subjects and all household contacts at each home visit and tested by viral culture. The primary outcome measure was laboratory culture confirmed influenza in a household contact; the secondary outcome was clinically diagnosed influenza (by self-reported symptoms. We randomized 198 households and completed follow up home visits in 128; the index cases in 122 of those households had laboratory-confirmed influenza. There were 21 household contacts with laboratory confirmed influenza corresponding to a secondary attack ratio of 6%. Clinical secondary attack ratios varied from 5% to 18% depending on case definitions. The laboratory-based or clinical secondary attack ratios did not significantly differ across the intervention arms. Adherence to interventions was variable. CONCLUSIONS/SIGNIFICANCE: The secondary attack ratios were lower than anticipated, and lower than reported in other countries, perhaps due to differing patterns of susceptibility, lack of significant antigenic drift in circulating influenza virus strains recently, and/or issues related to the symptomatic recruitment design. Lessons learnt from this pilot have informed changes for the main study in 2008

  6. Randomized, Placebo-Controlled Phase 2 Trial of a Lactobacillus crispatus Probiotic Given Intravaginally for Prevention of Recurrent Urinary Tract Infection

    Science.gov (United States)

    Au-Yeung, Melissa; Hooton, Thomas M.; Fredricks, David N.; Roberts, Pacita L.; Czaja, Christopher A.; Yarova-Yarovaya, Yuliya; Fiedler, Tina; Cox, Marsha; Stamm, Walter E.

    2011-01-01

    Background. Urinary tract infections (UTIs) are common among women and frequently recur. Depletion of vaginal lactobacilli is associated with UTI risk, which suggests that repletion may be beneficial. We conducted a double-blind placebo-controlled trial of a Lactobacillus crispatus intravaginal suppository probiotic (Lactin-V; Osel) for prevention of recurrent UTI in premenopausal women. Methods. One hundred young women with a history of recurrent UTI received antimicrobials for acute UTI and then were randomized to receive either Lactin-V or placebo daily for 5 d, then once weekly for 10 weeks. Participants were followed up at 1 week and 10 weeks after intervention and for UTIs; urine samples for culture and vaginal swabs for real-time quantitative 16S ribosomal RNA gene polymerase chain reaction for L. crispatus were collected. Results. Recurrent UTI occurred in 7/48 15% of women receiving Lactin-V compared with 13/48 27% of women receiving placebo (relative risk [RR], .5; 95% confidence interval, .2–1.2). High-level vaginal colonization with L. crispatus (≥106 16S RNA gene copies per swab) throughout follow-up was associated with a significant reduction in recurrent UTI only for Lactin-V (RR for Lactin-V, .07; RR for placebo, 1.1; P < .01). Conclusions. Lactin-V after treatment for cystitis is associated with a reduction in recurrent UTI. Larger efficacy trials of this novel preventive method for recurrent UTI are warranted. Clinical Trials Registration. NCT00305227. PMID:21498386

  7. Results of a 2-year randomized, controlled obesity prevention trial: Effects on diet, activity and sleep behaviors in an at-risk young adult population.

    Science.gov (United States)

    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 (0.05prevention among young adults, particularly when addressing multiple weight-related outcomes.

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

    Directory of Open Access Journals (Sweden)

    Scheltens Philip

    2010-02-01

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

  9. Anatomy for Biomedical Engineers

    Science.gov (United States)

    Carmichael, Stephen W.; Robb, Richard A.

    2008-01-01

    There is a perceived need for anatomy instruction for graduate students enrolled in a biomedical engineering program. This appeared especially important for students interested in and using medical images. These students typically did not have a strong background in biology. The authors arranged for students to dissect regions of the body that…

  10. Holography In Biomedical Sciences

    Science.gov (United States)

    von Bally, G.

    1988-01-01

    Today not only physicists and engineers but also biological and medical scientists are exploring the potentials of holographic methods in their special field of work. Most of the underlying physical principles such as coherence, interference, diffraction and polarization as well as general features of holography e.g. storage and retrieval of amplitude and phase of a wavefront, 3-d-imaging, large field of depth, redundant storage of information, spatial filtering, high-resolving, non-contactive, 3-d form and motion analysis are explained in detail in other contributions to this book. Therefore, this article is confined to the applications of holography in biomedical sciences. Because of the great number of contributions and the variety of applications [1,2,3,4,5,6,7,8] in this review the investigations can only be mentioned briefly and the survey has to be confined to some examples. As in all fields of optics and laser metrology, a review of biomedical applications of holography would be incomplete if military developments and their utilization are not mentioned. As will be demonstrated by selected examples the increasing interlacing of science with the military does not stop at domains that traditionally are regarded as exclusively oriented to human welfare like biomedical research [9]. This fact is actually characterized and stressed by the expression "Star Wars Medicine", which becomes increasingly common as popular description for laser applications (including holography) in medicine [10]. Thus, the consequence - even in such highly specialized fields like biomedical applications of holography - have to be discussed.

  11. What is biomedical informatics?

    Science.gov (United States)

    Bernstam, Elmer V; Smith, Jack W; Johnson, Todd R

    2010-02-01

    Biomedical informatics lacks a clear and theoretically-grounded definition. Many proposed definitions focus on data, information, and knowledge, but do not provide an adequate definition of these terms. Leveraging insights from the philosophy of information, we define informatics as the science of information, where information is data plus meaning. Biomedical informatics is the science of information as applied to or studied in the context of biomedicine. Defining the object of study of informatics as data plus meaning clearly distinguishes the field from related fields, such as computer science, statistics and biomedicine, which have different objects of study. The emphasis on data plus meaning also suggests that biomedical informatics problems tend to be difficult when they deal with concepts that are hard to capture using formal, computational definitions. In other words, problems where meaning must be considered are more difficult than problems where manipulating data without regard for meaning is sufficient. Furthermore, the definition implies that informatics research, teaching, and service should focus on biomedical information as data plus meaning rather than only computer applications in biomedicine.

  12. Biomedical Applications of Nanodiamonds: An Overview.

    Science.gov (United States)

    Passeri, D; Rinaldi, F; Ingallina, C; Carafa, M; Rossi, M; Terranova, M L; Marianecci, C

    2015-02-01

    Nanodiamonds are a novel class of nanomaterials which have raised much attention for application in biomedical field, as they combine the possibility of being produced on large scale using relatively inexpensive synthetic processes, of being fluorescent as a consequence of the presence of nitrogen vacancies, of having their surfaces functionalized, and of having good biocompatibility. Among other applications, we mainly focus on drug delivery, including cell interaction, targeting, cancer therapy, gene and protein delivery. In addition, nanodiamonds for bone and dental implants and for antibacterial use is discussed. Techniques for detection and imaging of nanodiamonds in biological tissues are also reviewed, including electron microscopy, fluorescence microscopy, Raman mapping, atomic force microscopy, thermal imaging, magnetic resonance imaging, and positron emission tomography, either in vitro, in vivo, or ex vivo. Toxicological aspects related to the use of nanodiamonds are also discussed. Finally, patents, preclinical and clinical trials based on the use of nanodiamonds for biomedical applications are reviewed.

  13. Harnessing supramolecular peptide nanotechnology in biomedical applications

    Science.gov (United States)

    Chan, Kiat Hwa; Lee, Wei Hao; Zhuo, Shuangmu; Ni, Ming

    2017-01-01

    The harnessing of peptides in biomedical applications is a recent hot topic. This arises mainly from the general biocompatibility of peptides, as well as from the ease of tunability of peptide structure to engineer desired properties. The ease of progression from laboratory testing to clinical trials is evident from the plethora of examples available. In this review, we compare and contrast how three distinct self-assembled peptide nanostructures possess different functions. We have 1) nanofibrils in biomaterials that can interact with cells, 2) nanoparticles that can traverse the bloodstream to deliver its payload and also be bioimaged, and 3) nanotubes that can serve as cross-membrane conduits and as a template for nanowire formation. Through this review, we aim to illustrate how various peptides, in their various self-assembled nanostructures, possess great promise in a wide range of biomedical applications and what more can be expected. PMID:28223805

  14. Prevalence of HIV-1 drug resistance among women screening for HIV prevention trials in KwaZulu-Natal, South Africa (MTN-009.

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    Urvi M Parikh

    Full Text Available BACKGROUND: A major concern with using antiretroviral (ARV-based products for HIV prevention is the potential spread of drug resistance, particularly from individuals who are HIV-infected but unaware of their status. Limited data exist on the prevalence of HIV infection or drug resistance among potential users of ARV-based prevention products. METHODS: A cross-sectional study of reproductive-aged women who presented to screen for an HIV prevention trial was conducted at 7 clinical sites in Durban, South Africa. CD4+T cell counts, HIV-1 RNA levels and population sequencing of the protease and reverse transcriptase genes were performed for all women with 2 positive HIV rapid tests. Resistance mutations were identified using the Stanford Calibrated Population Resistance Tool. RESULTS: Of the 1073 evaluable women, 400(37% were confirmed as HIV-infected. Of those, plasma HIV-1 RNA was detectable in 365/400(91% and undetectable(200 copies/ml analyzed for drug resistance, 26(7.4% had nucleoside reverse transcriptase inhibitor (NRTI, non-nucleoside reverse transcriptase inhibitor (NNRTI or protease inhibitor (PI drug resistance mutations. Among those with resistance, 18/26 participants(62% had single-class NNRTI resistance and 5/26(19% had dual-class NRTI/NNRTI. Major mutations in reverse transcriptase included K65R(n = 1, L74I(n = 1, K103N(n = 19, V106M(n = 4, Y181C(n = 2, M184V(n = 4, and K219E/R(n = 2. Major PI-resistance mutations were rare: M46L(n = 1 and I85V(n = 1. All participants were infected with subtype C virus, except one infected with subtype A. CONCLUSIONS: In women from Durban, South Africa screening for an HIV prevention trial, the HIV prevalence was high (37% and HIV drug resistance prevalence was above 5%. This study highlights the potential challenges faced when implementing an ARV-based prevention product that overlaps with first-line antiretroviral therapy. Effective screening to exclude HIV

  15. 'Be active, eat right', evaluation of an overweight prevention protocol among 5-year-old children: design of a cluster randomised controlled trial

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    Veldhuis Lydian

    2009-06-01

    Full Text Available Abstract Background The prevalence of overweight and obesity in children has at least doubled in the past 25 years with a major impact on health. In 2005 a prevention protocol was developed applicable within Youth Health Care. This study aims to assess the effects of this protocol on prevalence of overweight and health behaviour among children. Methods and design A cluster randomised controlled trial is conducted among 5-year-old children included by 44 Youth Health Care teams randomised within 9 Municipal Health Services. The teams are randomly allocated to the intervention or control group. The teams measure the weight and height of all children. When a child in the intervention group is detected with overweight according to the international age and gender specific cut-off points of BMI, the prevention protocol is applied. According to this protocol parents of overweight children are invited for up to three counselling sessions during which they receive personal advice about a healthy lifestyle, and are motivated for and assisted in behavioural change. The primary outcome measures are Body Mass Index and waist circumference of the children. Parents will complete questionnaires to assess secondary outcome measures: levels of overweight inducing/reducing behaviours (i.e. being physically active, having breakfast, drinking sweet beverages and watching television/playing computer games, parenting styles, parenting practices, and attitudes of parents regarding these behaviours, health-related quality of life of the children, and possible negative side effects of the prevention protocol. Data will be collected at baseline (when the children are aged 5 years, and after 12 and 24 months of follow-up. Additionally, a process and a cost-effectiveness evaluation will be conducted. Discussion In this study called 'Be active, eat right' we evaluate an overweight prevention protocol for use in the setting of Youth Health Care. It is hypothesized that the

  16. Aspirin for primary prevention of cardiovascular events: meta-analysis of randomized controlled trials and subgroup analysis by sex and diabetes status.

    Directory of Open Access Journals (Sweden)

    Manling Xie

    Full Text Available To evaluate the benefits and harms of aspirin for the primary prevention of CVD and determine whether the effects vary by sex and diabetes status.We searched Medline, Embase, and Cochrane databases for randomized controlled trials comparing the effects of aspirin with placebo or control in people with no pre-existing CVD. Two investigators independently extracted data and assessed the study quality. Analyses were performed using Stata version 12.Fourteen trials (107,686 participants were eligible. Aspirin was associated with reductions in major cardiovascular events (risk ratio, 0.90; 95% confidence interval, 0.85-0.95, myocardial infarction (0.86; 0.75-0.93, ischemic stroke (0.86; 0.75-0.98 and all-cause mortality (0.94; 0.89-0.99. There were also increases in hemorrhagic stroke (1.34; 1.01-1.79 and major bleeding (1.55; 1.35-1.78 with aspirin. The number needed to treat to prevent 1 major cardiovascular event over a mean follow-up of 6.8 years was 284. By comparison, the numbers needed to harm to cause 1 major bleeding is 299. In subgroup analyses, pooled results demonstrated a reduction in myocardial infarction among men (0.71; 0.59-0.85 and ischemic stroke among women (0.77; 0.63-0.93. Aspirin use was associated with a reduction (0.65; 0.51-0.82 in myocardial infarction among diabetic men. In meta-regression analyses, the results suggested that aspirin therapy might be associated with a decrease in stroke among diabetic women and a decrease in MI among diabetic men and risk reductions achieved with low doses (75 mg/day were as large as those obtained with higher doses (650 mg/day.The use of low-dose aspirin was beneficial for primary prevention of CVD and the decision regarding an aspirin regimen should be made on an individual patient basis. The effects of aspirin therapy varied by sex and diabetes status. A clear benefit of aspirin in the primary prevention of CVD in people with diabetes needs more trials.

  17. Predictors of web-based follow-up response in the Prevention of Low Back Pain in the Military Trial (POLM

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    Robinson Michael E

    2011-06-01

    Full Text Available Abstract Background Achieving adequate follow-up in clinical trials is essential to establish the validity of the findings. Achieving adequate response rates reduces bias and increases probability that the findings can be generalized to the population of interest. Therefore, the purpose of this study was to determine the influence of attention, demographic, psychological, and health status factors on web-based response rates in the ongoing Prevention of Low Back Pain in the Military (POLM trial. Methods Twenty companies of Soldiers (n = 4,325 were cluster randomized to complete a traditional exercise program including sit-ups (TEP with or without a psychosocial educational program (PSEP or a core stabilization exercise program (CSEP with or without PSEP. A subgroup of Soldiers (n = 371 was randomized to receive an additional physical and ultrasound imaging (USI examination of key trunk musculature. As part of the surveillance program, all Soldiers were encouraged to complete monthly surveys via email during the first year. Descriptive statistics of the predictor variables were obtained and compared between responders and non-responders using two sample t-tests or chi-square test, as appropriate. Generalized linear mixed models were subsequently fitted for the dichotomous outcomes to estimate the effects of the predictor variables. The significance level was set at .05 a priori. Results The overall response rate was 18.9% (811 subjects for the first year. Responders were more likely to be older, Caucasian, have higher levels of education and income, reservist military status, non smoker, lower BMI, and have received individualized attention via the physical/USI examination (p Conclusion The overall web based response rate during the first year of the POLM trial was consistent with studies that used similar methodology, but lower when compared to rates expected for standard clinical trials. One year response rate was significantly associated with

  18. Terahertz Imaging for Biomedical Applications Pattern Recognition and Tomographic Reconstruction

    CERN Document Server

    Yin, Xiaoxia; Abbott, Derek

    2012-01-01

    Terahertz Imaging for Biomedical Applications: Pattern Recognition and Tomographic Reconstruction presents the necessary algorithms needed to assist screening, diagnosis, and treatment, and these algorithms will play a critical role in the accurate detection of abnormalities present in biomedical imaging. Terahertz biomedical imaging has become an area of interest due to its ability to simultaneously acquire both image and spectral information. Terahertz imaging systems are being commercialized with an increasing number of trials performed in a biomedical setting. Terahertz tomographic imaging and detection technology contributes to the ability to identify opaque objects with clear boundaries,and would be useful to both in vivo and ex vivo environments. This book also: Introduces terahertz radiation techniques and provides a number of topical examples of signal and image processing, as well as machine learning Presents the most recent developments in an emerging field, terahertz radiation Utilizes new methods...

  19. Computeen: a randomized trial of a preventive computer and psychosocial skills curriculum for at-risk adolescents.

    Science.gov (United States)

    Lang, Jason M; Waterman, Jill; Baker, Bruce L

    2009-09-01

    Computeen, a preventive technology and psychosocial skills development program for at-risk adolescents, was designed to improve computer skills, self-esteem, and school attitudes, and reduce behavior problems, by combining elements of community-based and empirically supported prevention programs. Fifty-five mostly Latino adolescents from 12 to 16 years old who were living in affordable housing communities participated in this randomized wait-list control study. Results showed considerable improvements in computer self-efficacy, decreases in internalizing behavior problems, and excellent attendance and consumer satisfaction. Self-esteem and school motivation results were mixed. Computer self-efficacy mediated the relationship between improved computer skills and self-esteem. Younger adolescents showed greater improvement than did older adolescents. EDITORS' STRATEGIC IMPLICATIONS: Although there are limitations to this study's sample size and scope, Computeen appears promising as a developmentally appropriate, strengths-based prevention program.

  20. Rivaroxaban in the Prevention of Stroke and Systemic Embolism in Patients with Non-Valvular Atrial Fibrillation: Clinical Implications of the ROCKET AF Trial and Its Subanalyses.

    Science.gov (United States)

    Spencer, Ryan J; Amerena, John V

    2015-12-01

    Atrial fibrillation (AF) is an increasingly common cause of stroke and systemic embolism. While warfarin has been the mainstay of stroke prevention in patients with AF, newer novel oral anticoagulant medications are now available. Rivaroxaban, a direct factor