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":"Evaluation of medication errors with implementation of electronic health record technology in the medical intensive care unit","authors":"Vivian Liao, M. Rabinovich, P. Abraham, S. Perez, Christiana DiPlotti, Jenny E. Han, G. Martin, E. Honig","doi":"10.2147/OAJCT.S131211","DOIUrl":"https://doi.org/10.2147/OAJCT.S131211","url":null,"abstract":"Purpose: Patients in the intensive care unit (ICU) are at an increased risk for medication errors (MEs) and adverse drug events from multifactorial causes. ME rate ranges from 1.2 to 947 per 1,000 patient days in the medical ICU (MICU). Studies with the implementation of electronic health records (EHR) have concluded that it significantly reduced overall prescribing errors and the number of errors that caused patient harm decreased. However, other types of errors, such as wrong dose and omission of required medications increased after EHR implementation. We sought to compare the number of MEs before and after EHR implementation in the MICU, with additional evaluation of error severity. Patients and methods: Prospective, observational, quality improvement study of all patients admitted to a single MICU service at an academic medical center. Patients were evaluated during four periods over 2 years: August–September 2010 (preimplementation; period I), January– February 2011 (2 months postimplementation; period II), August–September 2012 (21 months postimplementation; period III), and January–February 2013 (25 months postimplementation; period IV). All medication orders and administration records were reviewed by an ICU clinical pharmacist and ME was defined as a deviation from established standards for prescribing, dispensing, administering, or documenting medication. The frequency and classification of MEs were compared between groups by chi square; p < 0.05 was considered significant. Results: There was a statistically significant increase in the number of MEs per 1,000 patient days during time periods II (N = 2,592; p < 0.001) and III (N = 2,388; p = 0.0023) compared to baseline (N = 1,972). However, over time there was a significant reduction in medication errors during period IV compared to baseline (N = 1,669; p = 0.0008). Conclusion: In the short-term, EHR did not lead to a reduction in medication errors in the ICU; however, there was a significant decrease in medication errors after 2 years.","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":"9 1","pages":"31-40"},"PeriodicalIF":1.2,"publicationDate":"2017-05-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S131211","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47416481","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 pilot study of a smoking cessation intervention for women living with HIV: study protocol","authors":"S. Kim, Sabreen Darwish, Sang A Lee, R. DeMarco","doi":"10.2147/OAJCT.S126541","DOIUrl":"https://doi.org/10.2147/OAJCT.S126541","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 11–20 Open Access Journal of Clinical Trials Dovepress","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":"9 1","pages":"11-20"},"PeriodicalIF":1.2,"publicationDate":"2017-02-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S126541","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42713176","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":"Development of a randomized two-dimensional response surface pathway design with two interventional and one response variables","authors":"T. Holand, Sagita Dewi, S. Larsen","doi":"10.2147/OAJCT.S115168","DOIUrl":"https://doi.org/10.2147/OAJCT.S115168","url":null,"abstract":"Background: The response surface pathway (RSP) design obtains a random walk pathway, does not need an assumed statistical model, reduces the sample size without reducing accuracy, and covers predefined dose windows. RSP includes one interventional and one result variable without random allocation of doses between design levels. This study aims to present RSP with two interventional and one result variables, combining between- and within-patient models and introduce a randomization procedure in a clinical situation. Methods: To estimate optimal efficacy dose and spreading duration of particulate CaO powder, material consisting of 18 net pens with salmon indicated for lice treatment was required. The study was performed as a randomized “between-patient” RSP designed trial with CaO dose as the interventional variable and percentage lice reduction as the outcome. Each net pen received three treatments with 24-hour intervals of unchanged CaO dose and a starting spreading duration of 2 hours. The change in spreading duration followed a “within-patient” RSP procedure with percentage lice reduction as the outcome. In all participating fish farms, one net pen remained untreated and was used as control. Results: The minimum and the optimal efficacy doses were estimated to be 6.1 g/kg and 8.5 g/kg biomass (bm), respectively. In order to optimize lice reduction, the spreading duration increases with increasing CaO dose. The minimum efficacy combination was predicted to be 6.1 g/kg bm administered in 2:00 (h:mm) and the optimal to be 8.5 g/kg bm in 3:00. Three of the seven net pens allocated to 7.4 g/kg bm erroneously received 8.5 g/kg and due to weather circumstances three other net pens became untreated. Consequently, accuracy of the predictions was slightly reduced. Conclusion: The two-dimensional RSP design combining between- and within-patient RSP detected its power and predicted the two interventional variables to obtain minimum and optimal efficacy with sufficient accuracy.","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":"8 1","pages":"33-42"},"PeriodicalIF":1.2,"publicationDate":"2016-10-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S115168","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68412902","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":"Rain dance: the role of randomization in clinical trials","authors":"J. Diniz, V. Fossaluza, C. Pereira, S. Wechsler","doi":"10.2147/OAJCT.S100446","DOIUrl":"https://doi.org/10.2147/OAJCT.S100446","url":null,"abstract":"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 2016:8 21–32 Open Access Journal of Clinical Trials Dovepress","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":"8 1","pages":"21-32"},"PeriodicalIF":1.2,"publicationDate":"2016-07-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S100446","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68412659","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":"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":"6 1","pages":""},"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":"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}