Open Access Journal of Clinical Trials最新文献

{"title":"Cost comparison analysis of laparoscopic versus open aortobifemoral bypass surgery: a randomized controlled trial","authors":"M. Sahba, A. H. Krog, E. M. Pettersen, T. Wisløff, Kg Rogne, J. Sundhagen, Ssh Kazmi","doi":"10.2147/OAJCT.S192552","DOIUrl":"https://doi.org/10.2147/OAJCT.S192552","url":null,"abstract":"1Department of Vascular Surgery, Ostfold Central Hospital, Grålum, Norway; 2Department of Vascular Surgery, Sørlandet Hospital HF, Kristiansand, Norway; 3Department of Infectious Disease Epidemiology and Modelling, Norwegian Institute of Public Health, Oslo, Norway; 4Department of Health Management and Health Economics, University of Oslo, Oslo, Norway; 5Economy Department, Oslo University Hospital, Oslo, Norway; 6Department of Vascular Surgery, Division of Cardiovascular and Pulmonary Diseases, Oslo University Hospital, Oslo, Norway; 7Faculty of Medicine, Oslo University, Oslo, Norway Background: Laparoscopic aortobifemoral bypass (LABFB) surgery has become an established treatment procedure for aortoiliac occlusive disease (AIOD), Trans-Atlantic Inter-Society Consensus II (TASC II), type D lesions. However, studies with an economic evaluation of this procedure are sparse. The main purpose of our study was to compare the costs of LABFB and open aortobifemoral bypass (OABFB) surgery. Patients and methods: This is a substudy of a larger randomized controlled prospective multicenter trial, Norwegian Laparoscopic Aortic Surgery Trial (NLAST). Perioperative data were collected on 70 patients undergoing surgery for AIOD, TASC type D lesions. Thirty-four patients were randomized to LABFB and 36 patients to OABFB. Treatment costs were calculated for the two operative treatments until 30 postoperative days. In addition to fixed and variable costs, direct and indirect costs were also included. Results: The mean total cost of LABFB was 19,798 € and for OABFB 34,016 € until 30 postoperative days. Laparoscopic procedure was 14,218 € less costly than the open procedure. The main factor leading to less cost of LABFB was shorter length of hospital stay (mean 5.3 days, 95% CI 4.1–6.5) as compared to OABFB (mean 10.1 days, 95% CI 7.5–12.6). Ten patients, three in the LABFB and seven in the OABFB group, had complications that resulted in reoperations within the 30 postoperative days. The mean cost of treatment for the complicated patients was 49,349 € and 82,985 €, respectively, for LABFB and OABFB. Conclusion: Laparoscopic aortobifemoral bypass procedure costs less than open aortobifemoral bypass for the treatment of advanced aortoiliac occlusive disease.","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":" ","pages":""},"PeriodicalIF":1.2,"publicationDate":"2019-06-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S192552","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47773913","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":"Effects of pain on cognitive function and mobility","authors":"S. A. Moreira, P. Novak","doi":"10.2147/OAJCT.S182502","DOIUrl":"https://doi.org/10.2147/OAJCT.S182502","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 2019:11 1–10 Open Access Journal of Clinical Trials Dovepress","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":" ","pages":""},"PeriodicalIF":1.2,"publicationDate":"2019-03-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S182502","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45484280","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":"Selective enhancement of focused attention by Alpinia galanga in subjects with moderate caffeine consumption","authors":"S. Srivastava","doi":"10.2147/OAJCT.S164450","DOIUrl":"https://doi.org/10.2147/OAJCT.S164450","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 2018:10 43–49 Open Access Journal of Clinical Trials Dovepress","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":"11 15","pages":""},"PeriodicalIF":1.2,"publicationDate":"2018-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S164450","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41308644","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":"Placebo-only-controlled versus active-controlled trials of new drugs for nine common life-threatening diseases","authors":"Sarah Sorscher, A. AbuDagga, Sammy Almashat, M. Carome, S. Wolfe","doi":"10.2147/OAJCT.S156054","DOIUrl":"https://doi.org/10.2147/OAJCT.S156054","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 2018:10 19–28 Open Access Journal of Clinical Trials Dovepress","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":"10 1","pages":"19-28"},"PeriodicalIF":1.2,"publicationDate":"2018-04-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S156054","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47298153","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":"Open-label Phase II study of everolimus plus endocrine therapy in postmenopausal women with ER-positive and HER2-negative metastatic breast cancer (Chloe trial)","authors":"T. Shimoi, A. Shimomura, T. Shien, Y. Uemura, H. Kato, M. Kitada, T. Toyama, T. Aihara, H. Mukai","doi":"10.2147/OAJCT.S155706","DOIUrl":"https://doi.org/10.2147/OAJCT.S155706","url":null,"abstract":"Background: This is a randomized, multicenter, open-label, Phase II study designed to evaluate the efficacy of everolimus added to continuous aromatase inhibitor (AI) administration in patients who had maintained stable disease or a better response for at least 5 months. Patients and methods: Patients will be randomized to everolimus and standard therapy groups (1:1 ratio). In the everolimus group, patients will receive everolimus in addition to the AI agent. The standard therapy group will continue AI alone treatment. The primary endpoint is progression-free survival. Target accrual is 130 patients with a two-sided type I error rate of 10% and 80% power to detect 35% risk reduction. Conclusion: The Chloe trial will provide important information about the efficacy and safety of adding everolimus to AI in patients with estrogen receptor-positive and human epidermal growth factor 2-negative metastatic breast cancer.","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":"10 1","pages":"13-18"},"PeriodicalIF":1.2,"publicationDate":"2018-02-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S155706","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46389454","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":"Computerized Cognitive Training to Improve Mood in Senior Living Settings: Design of a Randomized Controlled Trial.","authors":"Marianne Smith,&nbsp;Michael P Jones,&nbsp;Megan M Dotson,&nbsp;Fredric D Wolinsky","doi":"10.2147/OAJCT.S154782","DOIUrl":"https://doi.org/10.2147/OAJCT.S154782","url":null,"abstract":"<p><strong>Purpose: </strong>This two-arm, randomized controlled trial was designed to evaluate a computerized cognitive speed of processing (SOP) training known as <i>Road Tour</i> in the generally older group of adults residing in assisted living (AL) and related senior housing. Study aims focused on depression-related outcomes that were observed in earlier SOP studies using <i>Road Tour</i> with younger, home-dwelling seniors. Study design and baseline outcomes are discussed.</p><p><strong>Participants and methods: </strong>A community-based design engaged AL and related senior living settings as partners in research. Selected staff served as on-site research assistants who were trained to recruit, consent, and train a target of 300 participants from AL and independent living (IL) programs to use the intervention and attention-control computerized training. Ten hours of initial computerized training was followed by two booster sessions at 5 and 11 months. Outcome measures included Useful Field of View (UFOV), 9-item Patient Health Questionnaire (PHQ-9), 12-item Centers for Epidemiological Studies Depression scale (CESD-12), 7-item Generalized Anxiety Disorders GAD-7), Brief Pain Inventory (BPI) and SF-36 Health Survey. Assessments occurred before randomization (pre-training), post-training, 26 and 52 weeks.</p><p><strong>Results: </strong>A total of 351 participants were randomized to the intervention (n=173) and attention-control (n=178) groups. There were no significant differences between groups in demographic characteristics with the exception of education and reported osteoporosis. There were no significant differences in study outcomes between groups at baseline. Participants in AL had significantly lower SOP and self-rated health, and significantly higher depression, anxiety and pain when compared to those in IL programs on the same campus.</p><p><strong>Conclusions: </strong>Compared to earlier SOP training studies using <i>Road Tour</i>, this sample of senior living participants were older, reported more health conditions and poorer overall health, had lower UFOV scores and greater depressive symptoms at baseline. Moreover, participants in AL had greater health challenges than those in IL.</p>","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":"10 ","pages":"29-41"},"PeriodicalIF":1.2,"publicationDate":"2018-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S154782","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"37422026","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":"Life Enhancing Activities for Family Caregivers of people with dementia: protocol for a randomized controlled trial of a positive affect skills intervention.","authors":"Alice Verstaen,&nbsp;Judith T Moskowitz,&nbsp;Karin E Snowberg,&nbsp;Jennifer Merrilees,&nbsp;Glenna A Dowling","doi":"10.2147/oajct.s150597","DOIUrl":"https://doi.org/10.2147/oajct.s150597","url":null,"abstract":"<p><p>Given the increasing number of family caregivers of persons with dementia (PWD) and the associated burden and detriments to both physical and mental health, interventions that aim to improve such outcomes are important. Studies are increasingly demonstrating the unique importance of positive emotions in coping with stress, independent from the impact of negative emotions. However, none have examined the benefits of interventions that target positive emotions for caregivers of individuals with a chronic and debilitating disease such as dementia. This paper presents the design and methods for a randomized controlled trial (RCT) of a positive affect skills intervention for family caregivers of PWD. The RCT is of a skills-based intervention that seeks to increase the frequency and intensity of positive affect in order to improve outcomes such as well-being, coping, and physical and mental health. The skills are delivered by trained facilitators via five one-to-one Internet video sessions with family caregivers of persons diagnosed with dementia (eg, Alzheimer's disease, vascular dementia, unspecified). The control group is an emotion reporting/waitlist control. Follow-up assessments are conducted post-intervention and at 1, 3, and 6 months post-completion of the intervention. This study promises to be an important and needed step toward improving the lives of caregivers of PWD.</p>","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":"10 ","pages":"1-12"},"PeriodicalIF":1.2,"publicationDate":"2018-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/oajct.s150597","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38976078","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":"Randomized response surface pathway design with odd response outcomes in a Latin Square designed study","authors":"T. Holand, K. Ellingsen, Sagita Dewi, S. Larsen","doi":"10.2147/OAJCT.S139884","DOIUrl":"https://doi.org/10.2147/OAJCT.S139884","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 75–84 Open Access Journal of Clinical Trials Dovepress","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":"9 1","pages":"75-84"},"PeriodicalIF":1.2,"publicationDate":"2017-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S139884","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48396013","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 randomized controlled trial to improve heart failure disparities: the Mālama Puʻuwai (caring for heart) Study","authors":"M. Mau, EunJung Lim, J. Kaholokula, Taylor Loui, Yongjun Cheng, T. Seto","doi":"10.2147/OAJCT.S136066","DOIUrl":"https://doi.org/10.2147/OAJCT.S136066","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 65–74 Open Access Journal of Clinical Trials Dovepress","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":"9 1","pages":"65-74"},"PeriodicalIF":1.2,"publicationDate":"2017-08-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S136066","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43322845","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":"Informing primary care physicians of patients' involvement in clinical trials carried out at a specialist care level","authors":"J. A. Schoenenberger-Arnaiz, Montserrat Solanilla-Puertolas, M. Acer-Puig, J. Gómez-Arbonés","doi":"10.2147/OAJCT.S134555","DOIUrl":"https://doi.org/10.2147/OAJCT.S134555","url":null,"abstract":"Background: Patients enrolled in clinical trials continue to have frequent contacts with primary care physicians because of comorbidities or toxicities. The aim of the present study was to analyze the information provided at different levels, when participants are included in clinical trials organized at a specialized care level. The purpose was to verify if informing the patient's primary care physician is contemplated in the inclusion process. Methods: The authors conducted a cross-sectional study that included the clinical trials approved in the last 2 years by the hospital's Institutional Review Board. In addition, some of the participants in the included clinical trials were interviewed in order to check their knowledge of the type of research taking place. Results: In total, 67 protocols and the accompanying informed consent documents were reviewed. Half of the reviewed protocols (48%) did not provide participants with an identification card. Regarding the role of the primary care physician, 68.6% of clinical trials (46/67) had taken it into account in different ways. In only four trials, the method used to contact the primary care physician was documented. In total, 20 participants were interviewed. Only 3 (15%) knew the title of the study in which they were participating, 14 (70%) were aware of their illness and 6 (30%) did not know how to answer any of these two questions. Almost all participants in the study knew the name of the physician who was the principal investigator in the trial. Conclusion: Information given to health care practitioners, who are not directly involved in clinical trials conducted by specialized medical staff, is still scarce. In our clinical setting, patients participating in clinical trials have a low awareness of such studies. Keywords: informed consent, clinical trials, family physician, wallet card","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":"9 1","pages":"59-64"},"PeriodicalIF":1.2,"publicationDate":"2017-07-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S134555","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48278214","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}