Open Access Journal of Clinical Trials最新文献

{"title":"Women in Control: Pioneering Diabetes Self-Management Medical Group Visits in the Virtual World","authors":"S. Mitchell, P. Gardiner, G. Weigel, M. Rosal","doi":"10.4172/2167-0870.1000272","DOIUrl":"https://doi.org/10.4172/2167-0870.1000272","url":null,"abstract":"Background: The current state of diabetes self-management (DSM) education and support for diabetic patients is inadequate, especially for minority women who experience disproportionately high rates of diabetes mellitus (DM) in the US. While DSM education and support enables individuals with diabetes to make positive lifestyle choices and achieve clinical goals, this type of support is difficult to deliver in medical practice settings. Virtual reality can assist DM patients and their clinical teams by providing effective educational tools in an engaging, learner-centered environment that fosters self-efficacy and skill proficiency. Methods: Our prior research demonstrated that virtual worlds are suitable for supporting DSM education. Building upon this success, we are now investigating whether DSM virtual world medical group visits lead to similarly effective health and educational outcomes compared to face-to-face medical group visits. Currently in year one of a five year randomized controlled trial, we aim to compare the effectiveness of a virtual world DSM medical group visit format versus a face-to-face DSM medical group visit format to increase physical activity and improve glucose control (HbA1c) among Black/African American and Hispanic women with uncontrolled DM. We will also conduct a qualitative study of participant engagement with the virtual world platform to characterize learners’ interactions with the technology and assess its correlation with DSM behaviors and diabetes control. Discussion: Novel methods to promote diabetes self-management are critically needed, and the use of virtual world technology to conduct medical group visits offers a unique approach to such issue. If successful, our intervention will increase access to culturally-sensitive diabetes care and improve patient engagement in online DSM learning, leading to higher uptake of DSM behaviors and better diabetes control. Importantly, the program can be easily expanded to other chronic disease areas and scaled for widespread use.","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":1.2,"publicationDate":"2016-06-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.4172/2167-0870.1000272","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"70805909","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"An international, multicenter, observational survey to evaluate diabetes control in subjects using insulin for the treatment of type 1 and type 2 diabetes mellitus in the Czech Republic and Slovak Republic: study protocol for a cross-sectional survey","authors":"J. Brož, D. Žďárská, J. Urbanová, M. Brabec, B. Křivská, V. Donicova, R. Štěpánová, E. Martinka, M. Kvapil","doi":"10.2147/OAJCT.S103459","DOIUrl":"https://doi.org/10.2147/OAJCT.S103459","url":null,"abstract":"Background: Despite the improvements in insulin therapy, a large number of patients fail to achieve their target glycated hemoglobin (HbA1c) levels. Control of diabetes is often unsatisfactory because the patient does not know about the principles of successful insulin therapy (ie, blood glucose self-monitoring, the principles of insulin administration, titration, current dose adjustments, dietary recommendations, and physical activity preventive measures) or because these principles are applied incorrectly or insufficiently. Furthermore, the fear of hypoglycemia may lead to maintaining higher than recommended blood glucose levels. Methods/design: This is a noninterventional, international study focusing on a questionnaire survey of diabetes patients (patient-reported outcome) treated with insulin for at least 1 year. It is designed so that the data obtained reflect real access of patients to insulin treatment. The primary objective is to show the results of glycemic control of diabetes (HbA1c) achieved in diabetes patients treated with at least one dose of insulin. The secondary objective is to monitor the factors potentially affecting these results, which include the frequency and other characteris-tics of hypoglycemia, the frequency of blood glucose self-monitoring, and the effects produced when the results are employed in adjusting the therapy. Furthermore, the study investigates factors related to the principles of insulin administration, dietary regime, and exercise habits. The study will enroll a total of 1,500 patients with type 1 and type 2 diabetes in 150 centers: two-thirds in the Czech Republic and one-third in the Slovak Republic. Discussion: The study is primarily aimed at determining the percentage of insulin-treated diabetes patients reaching the recommended targets for glycemic control (HbA1c). Furthermore, it attempts to identify and describe in detail the factors of failure in achieving the therapeutic goals. An analysis of the data thus obtained may result in recommendations on how to reduce and eliminate all the identified negative factors in the future.","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":1.2,"publicationDate":"2016-06-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S103459","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68412700","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Protocol-writing support conferences for investigator-initiated clinical trials","authors":"Masaya Goto, Y. Muragaki, A. Aruga","doi":"10.2147/OAJCT.S97792","DOIUrl":"https://doi.org/10.2147/OAJCT.S97792","url":null,"abstract":": In investigator-initiated clinical trials, protocols with inappropriate methods might cause bias. However, insufficient data are available to determine which items are important or difficult to discuss in protocol development. We recorded protocol-writing support conferences to determine what items methodologists and investigators discussed. We obtained approval from all applicants to attend our Intelligent Clinical Research and Innovation Center writing support conferences, recorded all the discussions, characterized them, and sorted the items iteratively. In 1 year, we had 18 conferences: nine early protocol conferences and nine rejected protocol conferences. The latter were rejected by the institutional review board, which requested consultation. The most discussed item was outcomes, accounting for ∼ 20% of the total discussion time. In three trials, the main problem was multiple primary outcomes. The second most discussed item was control. Early protocol conferences had more non-preliminary proposal items than rejected ones ( P , 0.001). This study showed important items (especially outcomes and control) for investigators to write protocols. Early protocol-writing conferences helped investigators find questionable items.","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":1.2,"publicationDate":"2016-04-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S97792","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68418773","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Neuropsychiatric symptoms in dementia and the effects of Ginkgo biloba extract EGb 761 ® treatment: additional results from a 24-week randomized, placebo-controlled trial","authors":"Anatol Nacu, R. Hoerr","doi":"10.2147/OAJCT.S93531","DOIUrl":"https://doi.org/10.2147/OAJCT.S93531","url":null,"abstract":"EGb 761 ® on specific neuropsychiatric symptoms. In a 24-week, double-blind, multi-center trial, 410 outpatients with mild to moderate dementia and clinically significant neuropsychiatric symptoms were enrolled and randomized to receive 240 mg/day EGb 761 ® or placebo. The Neuropsychiatric Inventory composite score and the SKT short cognitive performance test were prospectively defined as co-primary outcomes; caregiver distress scores and single item scores were prospectively defined as secondary outcomes. Results: Post-baseline efficacy data were available for 402 patients included in the full analysis set. Neuropsychiatric Inventory composite and caregiver distress scores improved significantly more under EGb 761 ® treatment than under placebo ( P , 0.001). Composite and caregiver distress scores of anxiety, apathy, and disturbances of sleep and nighttime behavior, as well as caregiver distress scores of depression and aberrant motor behavior, were improved most markedly by EGb 761 ® ( P , 0.05 vs placebo). Conclusion: EGb 761 ® at daily doses of 240 mg alleviated neuropsychiatric symptoms of dementia and reduced related caregiver distress.","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":1.2,"publicationDate":"2016-01-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S93531","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68418659","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A televideo exercise and nutrition program for children with acute lymphoblastic leukemia in maintenance therapy: design and methods","authors":"C. Gibson, K. August, J. L. Greene, S. Herrmann, Jaehoon Lee, Susan P Harvey, Kate Lambourne, D. Sullivan","doi":"10.2147/OAJCT.S83292","DOIUrl":"https://doi.org/10.2147/OAJCT.S83292","url":null,"abstract":"License. The full terms of the License are available at http://creativecommons.org/licenses/by-nc/3.0/. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. Permissions beyond the scope of the License are administered by Dove Medical Press Limited. Information on how to request permission may be found at: http://www.dovepress.com/permissions.php Open Access Journal of Clinical Trials 2015:7 77–84 Open Access Journal of Clinical Trials Dovepress","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":1.2,"publicationDate":"2015-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S83292","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68418843","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Deep brain stimulation targeting the fornix for mild Alzheimer dementia: design of the ADvance randomized controlled trial","authors":"K. Holroyd, L. Fosdick, Gwenn S. Smith, Jeannie-Marie S Leoutsakos, C. Munro, E. Oh, Kristen E. Drake, P. Rosenberg, W. Anderson, S. Salloway, J. Pendergrass, A. Burke, D. Wolk, D. Tang‐Wai, F. Ponce, Wael Asaad, M. Sabbagh, M. Okun, G. Baltuch, K. Foote, S. Targum, A. Lozano, C. Lyketsos","doi":"10.2147/OAJCT.S81542","DOIUrl":"https://doi.org/10.2147/OAJCT.S81542","url":null,"abstract":"Recommended Citation Holroyd, Kathryn B.; Fosdick, Lisa; Smith, Gwenn S.; Leoutsakos, Jeannie Marie; Munro, Cynthia A.; Oh, Esther S.; Drake, Kristen E.; Rosenberg, Paul B.; Anderson, William S.; Salloway, Stephen; Pendergrass, J. Cara; Burke, Anna D.; Wolk, David A.; Tang-Wai, David F.; Ponce, Francisco A.; Asaad, Wael F.; Sabbagh, Marwan N.; Okun, Michael S.; Baltuch, Gordon; and al., et, \"Deep Brain Stimulation Targeting the Fornix for Mild Alzheimer Dementia: Design of the ADvance Randomized Controlled Trial\" (2015). Neurology Articles. 30. https://scholar.barrowneuro.org/neurology/30","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":1.2,"publicationDate":"2015-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S81542","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68418076","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Design, and participant enrollment, of a randomized controlled trial evaluating effectiveness and cost-effectiveness of a community-based case management intervention, for patients suffering from COPD","authors":"S. S. Sørensen, K. M. Pedersen, U. Weinreich, L. Ehlers","doi":"10.2147/OAJCT.S82533","DOIUrl":"https://doi.org/10.2147/OAJCT.S82533","url":null,"abstract":"License. The full terms of the License are available at http://creativecommons.org/licenses/by-nc/3.0/. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. Permissions beyond the scope of the License are administered by Dove Medical Press Limited. Information on how to request permission may be found at: http://www.dovepress.com/permissions.php Open Access Journal of Clinical Trials 2015:7 53–62 Open Access Journal of Clinical Trials Dovepress","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":1.2,"publicationDate":"2015-06-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S82533","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68418455","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"On controversial statistical issues in clinical research","authors":"S. Chow, Fuyu Song","doi":"10.2147/OAJCT.S63266","DOIUrl":"https://doi.org/10.2147/OAJCT.S63266","url":null,"abstract":"In clinical development of a test treatment under investigation, clinical trials are often conducted for evaluation of safety and efficacy of the test treatment. To provide an accurate and reliable assessment, adequate and well-controlled clinical trials using valid study designs are necessarily conducted for obtaining substantial evidence of safety and efficacy of the test treat - ment under investigation. In practice, however, some debatable issues are commonly encountered regardless compliance with good statistics practice and good clinical practice. These issues include, but are not limited to: 1) appropriateness of statistical hypotheses for clinical investiga- tion; 2) correctness of power analysis assumptions; 3) integrity of randomization and blinding; 4) post hoc endpoint selection; 5) impact of protocol amendments on the characteristics of the trial population; 6) multiplicity in clinical trials; 7) missing data imputation; 8) adaptive design methods; and 9) independence of a data monitoring committee. In this article, these issues are briefly described. The impact of these issues on the evaluation of the safety and efficacy of the test treatment under investigation are discussed with examples whenever applicable. Some recommendations regarding possible resolutions of these issues are also provided.","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":1.2,"publicationDate":"2015-05-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S63266","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68414965","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effect of GenF20 Plus on serum IGF-1 levels in healthy adults: a randomized controlled study","authors":"Navneet Sonawane, V. Kale, S. Erande, J. Chaudhary","doi":"10.2147/OAJCT.S75969","DOIUrl":"https://doi.org/10.2147/OAJCT.S75969","url":null,"abstract":"License. The full terms of the License are available at http://creativecommons.org/licenses/by-nc/3.0/. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. Permissions beyond the scope of the License are administered by Dove Medical Press Limited. Information on how to request permission may be found at: http://www.dovepress.com/permissions.php Open Access Journal of Clinical Trials 2015:7 35–42 Open Access Journal of Clinical Trials Dovepress","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":1.2,"publicationDate":"2015-03-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S75969","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68415678","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Conducting clinical trials in emerging markets of sub-Saharan Africa: review of guidelines and resources for foreign sponsors","authors":"Gaurav Puppalwar, M. Mourya, G. Kadhe, A. Mane","doi":"10.2147/OAJCT.S77316","DOIUrl":"https://doi.org/10.2147/OAJCT.S77316","url":null,"abstract":"License. The full terms of the License are available at http://creativecommons.org/licenses/by-nc/3.0/. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. Permissions beyond the scope of the License are administered by Dove Medical Press Limited. Information on how to request permission may be found at: http://www.dovepress.com/permissions.php Open Access Journal of Clinical Trials 2015:7 23–34 Open Access Journal of Clinical Trials Dovepress","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":1.2,"publicationDate":"2015-03-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S77316","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68415900","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}