Open Access Journal of Clinical Trials最新文献

{"title":"Efficacy and safety of two fast-absorbing formulations of paracetamol in combination with caffeine for episodic tension-type headache: results from two randomized placebo- and active-controlled trials","authors":"Yong Yue, K. Reed, L. Shneyer, Dongzhou J. Liu","doi":"10.2147/OAJCT.S133629","DOIUrl":"https://doi.org/10.2147/OAJCT.S133629","url":null,"abstract":"php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms (https://www.dovepress.com/terms.php). Open Access Journal of Clinical Trials 2017:9 41–57 Open Access Journal of Clinical Trials Dovepress","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":"9 1","pages":"41-57"},"PeriodicalIF":1.2,"publicationDate":"2017-06-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S133629","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43608563","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":"Phase I dose-escalation trial of intravaginal curcumin in women for cervical dysplasia.","authors":"Leda Gattoc, Paula M Frew, Shontell N Thomas, Kirk A Easley, Laura Ward, H-H Sherry Chow, Chiemi A Ura, Lisa Flowers","doi":"10.2147/OAJCT.S105010","DOIUrl":"10.2147/OAJCT.S105010","url":null,"abstract":"<p><strong>Background: </strong>This is a Phase I trial demonstrating safety and tolerability of intravaginal curcumin for future use in women with cervical neoplasia.</p><p><strong>Objective: </strong>The objective of this study was to assess the safety, tolerability, and pharmacokinetics of intravaginal curcumin in healthy women.</p><p><strong>Study design: </strong>We conducted a 3+3 dose-escalation Phase I trial in a group of women aged 18-45 years. Thirteen subjects were given one of four doses of curcumin powder (500 mg, 1,000 mg, 1,500 mg, and 2,000 mg) packed in gelatin capsules, which was administered intravaginally daily for 14 days. The primary end point for this study was safety based on severe adverse events regarding laboratory toxicity, clinical findings, and colposcopic abnormalities. We administered an acceptability questionnaire to assess product experience and attributes.</p><p><strong>Results: </strong>No dose-limiting toxicities (0/13) were experienced (95% confidence interval: 0.0%-22.8%) in this study. The pharmacokinetics data demonstrated that curcumin and curcumin conjugates were not measurable in the serum and negligible in the urine of the study participants. Although 23 adverse events occurred during the course of the trial, all events were grade I based on the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 and were resolved by the end of the study in an average of 9 days. Fifty-six percent of the adverse events were related to the study drug, which included genital pruritus (23% of subjects), vaginal discharge (100%), vaginal dryness (15%), abnormal prothrombin (23%), and hypokalemia (8%).</p><p><strong>Conclusion: </strong>Intravaginal curcumin was well tolerated by all subjects and safe. In this Phase I trial, there were no severe adverse events observed at any of the administered dose levels. All adverse events were grade I and did not result in early termination of the study. There was no evidence of systemic absorption or significant local absorption of intravaginally administered curcumin.</p>","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":"9 ","pages":"1-10"},"PeriodicalIF":1.2,"publicationDate":"2017-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/53/b8/nihms860884.PMC5459318.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"35070389","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The role of functional, social, and mobility dynamics in facilitating older African Americans participation in clinical research.","authors":"Eve T Shapiro, Jay T Schamel, Kimberly A Parker, Laura A Randall, Paula M Frew","doi":"10.2147/OAJCT.S122422","DOIUrl":"10.2147/OAJCT.S122422","url":null,"abstract":"<p><strong>Purpose: </strong>Older African Americans experience disproportionately higher incidence of morbidity and mortality related to chronic and infectious diseases, yet are significantly underrepresented in clinical research compared to other racial and ethnic groups. This study aimed to understand the extent to which social support, transportation access, and physical impediments function as barriers or facilitators to clinical trial recruitment of older African Americans.</p><p><strong>Methods: </strong>Participants (N=221) were recruited from six African American churches in Atlanta and surveyed on various influences on clinical trial participation.</p><p><strong>Results: </strong>Logistic regression models demonstrated that greater transportation mobility (odds ratio [OR]=2.10; <i>p</i>=0.007) and social ability (OR=1.77; <i>p</i>=0.02) were associated with increased intentions of joining a clinical trial, as was greater basic daily living ability (OR=3.25; <i>p</i>=0.03), though only among single participants. Among adults age ≥65 years, those with lower levels of support during personal crises were more likely to join clinical trials (OR=0.57; <i>p</i>=0.04).</p><p><strong>Conclusion: </strong>To facilitate clinical trial entry, recruitment efforts need to consider the physical limitations of their potential participants, particularly basic physical abilities and disabilities. Crisis support measures may be acting as a proxy for personal health issues among those aged >65 years, who would then be more likely to seek clinical trials for the personal health benefits. Outreach to assisted living homes, hospitals, and other communities is a promising avenue for improved clinical trial recruitment of older African Americans.</p>","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":"9 ","pages":"21-30"},"PeriodicalIF":1.2,"publicationDate":"2017-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/f3/67/nihms861482.PMC5552064.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"35317594","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Quality of clinical trials for selected priority mental and neurological disorders in sub Saharan Africa: A systematic review","authors":"A. Mulugeta, G. Medhin, G. Yimer, Rahimush Jemal, A. Fekadu","doi":"10.2147/OAJCT.S117162","DOIUrl":"https://doi.org/10.2147/OAJCT.S117162","url":null,"abstract":"I medicinal chemistry, purine motifs have attracted a great deal of research interest due to their preponderance in pharmaceutically indispensable compounds. Substituted purine especially 2, 6-disubstituted purine known to be very important medicinal and pharmaceutical intermediate. benzimidazoles are categorized in the important pharmacophores and privileged sub-structures in medicinal chemistry owing to their involvement as a key component for various biological activities. Therefore, introduction of benzimidazole at C-6 position of 2, 6-dichloropurine is supposed to improve its activity and thereby selectivity. Due to individual importance of purine and benzimidazole in living cells, we will present their synthesis as hybrids of benzimidazole at 6-position of purine and evaluated in vitro anticancer activities. Thus, a series of purine/benzimidazole hybrids were prepared by introduction of aromatic, aliphatic and heterocyclic moieties at the 2-position of purine to improve its potency and selectivity. Specifically, these hybrids were substituted with different secondary amines to remarkably increase their activity beyond their normal scope. Synthesized compounds were well characterized by 1H and 13C NMR as well as mass spectroscopy. The newly synthesized compounds were screened for in vitro anticancer activities against 60 tumor cell lines panel assay. These results open up new opportunities for other biological activities.","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":"8 1","pages":"43-52"},"PeriodicalIF":1.2,"publicationDate":"2016-12-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S117162","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68413004","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":"74 1","pages":"13-20"},"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":"8 1","pages":"7-12"},"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":"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":"2015 1","pages":"53-62"},"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":"7 1","pages":"43-51"},"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":"7 1","pages":"35-42"},"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":"Analyzing noninferiority trials: it is time for advantage deficit assessment – an observational study of published noninferiority trials","authors":"B. Gladstone, W. Vach","doi":"10.2147/OAJCT.S74821","DOIUrl":"https://doi.org/10.2147/OAJCT.S74821","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 11–21 Open Access Journal of Clinical Trials Dovepress","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":"7 1","pages":"11-21"},"PeriodicalIF":1.2,"publicationDate":"2015-01-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S74821","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68415569","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}