Open Access Journal of Clinical Trials最新文献

{"title":"Acti-Tape™ (elastic therapeutic tape) as compared with a knee guard in providing support to the knee joint: an open-label, randomized, crossover study","authors":"Hoong Keong Hui, N. Karne, Navneet Sonawane","doi":"10.2147/OAJCT.S58252","DOIUrl":"https://doi.org/10.2147/OAJCT.S58252","url":null,"abstract":"","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":"6 1","pages":"29-36"},"PeriodicalIF":1.2,"publicationDate":"2014-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S58252","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68415007","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":"ElEVATE: an innovative study design to assess the efficacy, safety, and evolution of cardiovascular parameters in de novo kidney transplant recipients after early conversion from a calcineurin inhibitor to everolimus","authors":"M. Giet, J. Cruzado, J. W. Fijter, H. Holdaas, Z. Wang, A. Speziale, G. Junge","doi":"10.2147/OAJCT.S59549","DOIUrl":"https://doi.org/10.2147/OAJCT.S59549","url":null,"abstract":"Progressive decline in allograft function and cardiovascular mortality after kidney transplantation remain major clinical challenges that can potentially be addressed by the mammalian target of rapamycin (mTOR) inhibitors, everolimus and sirolimus. mTOR inhibitors maintain immunosuppressive efficacy after minimization of calcineurin inhibitor (CNI) therapy and can achieve significant long-term improvements in renal function. Recently, data have accumulated that suggest mTOR inhibitors may offer cardioprotective effects. In animal models, inhibition of mTOR leads to regression of cardiac hypertrophy, and the limited data consistently point to a remodeling benefit following heart transplantation. Experimentally, mTOR inhibitors restrict atherogenesis, confirmed clinically by intravascular ultrasound data demonstrating lower rates of transplant vasculopathy in heart transplant recipients on everolimus. Lastly, mTOR inhibitors appear to ameliorate arterial stiffness, a known risk factor for post-transplant cardio- vascular events, but data remain sparse. The ELEVATE study will examine the renal effect of early conversion from CNI therapy to everolimus after kidney transplantation. Key secondary endpoints include the change in left ventricular mass index, the first time this endpoint has been included in a prospective study of an mTOR inhibitor. The occurrence of cardiovascular events will be rigorously documented and pulse wave velocity is being measured in a subpopulation of patients. Results from this innovative trial are awaited with interest.","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":"6 1","pages":"17-27"},"PeriodicalIF":1.2,"publicationDate":"2014-03-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S59549","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68414591","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":"Improving efficiency in cluster-randomized study design and implementation: Taking advantage of a crossover","authors":"N. Reich, A. Milstone","doi":"10.2147/OAJCT.S56730","DOIUrl":"https://doi.org/10.2147/OAJCT.S56730","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 2014:6 11–15 Open Access Journal of Clinical Trials Dovepress","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":"6 1","pages":"11-15"},"PeriodicalIF":1.2,"publicationDate":"2013-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S56730","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68414685","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":"Growing risk avoidance in Asian oncology site selection: how trends in site selection are limiting growth of the Asia cancer trial landscape","authors":"D. Horsburgh, Yigong Lee, Elvira Zenaida Lansang, Ken J Lee, Malcolm Ogg, K. Wai","doi":"10.2147/OAJCT.S53670","DOIUrl":"https://doi.org/10.2147/OAJCT.S53670","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 2014:6 1–9 Open Access Journal of Clinical Trials","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":"6 1","pages":"1-9"},"PeriodicalIF":1.2,"publicationDate":"2013-12-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S53670","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68414673","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":"Implementing good participatory practice guidelines in the FEM-PrEP Preexposure Prophylaxis Trial for HIV Prevention among African Women: a focus on local stakeholder involvement","authors":"N. Mack, Stella Kirkendale, Paul Omullo, J. Odhiambo, Malebo Ratlhagana, Martha Masaki, Phumzile Siguntu, K. Agot, K. Ahmed, S. Kapiga, Johann Lombaard, L. Damme, A. Corneli","doi":"10.2147/OAJCT.S45717","DOIUrl":"https://doi.org/10.2147/OAJCT.S45717","url":null,"abstract":"Natasha Mack1 Stella Kirkendale1 Paul Omullo2 Jacob Odhiambo2 Malebo Ratlhagana3 Martha Masaki4 Phumzile Siguntu5 Kawango Agot2 Khatija Ahmed3 Saidi Kapiga4 Johan Lombaard5 Lut Van Damme1 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","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":"5 1","pages":"127-135"},"PeriodicalIF":1.2,"publicationDate":"2013-10-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S45717","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68414227","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 0 clinical trials: theoretical and practical implications in oncologic drug development","authors":"P. Coloma","doi":"10.2147/OAJCT.S32978","DOIUrl":"https://doi.org/10.2147/OAJCT.S32978","url":null,"abstract":"textabstractDrug discovery and development has become a risky, expensive, and protracted process, with the cost of introducing a new drug to the market going as high as US$2 billion and the entire process taking at least 10-15 years. Great advances in biomedical research in recent years have not resulted in translation into medical product development, and there has been substantial decline in both new drug applications and biological license applications. To address this so-called \"pipeline problem,\" both the US Food and Drug Administration and its European counterpart, the European Agency for the Evaluation of Medicinal Products (now European Medicines Agency) endorsed the concept of Phase 0 studies (also known as exploratory investigational new drug studies), aimed towards identifying, early in the process of drug development, viable candidates and eliminating those lacking promise. Primary study endpoints of trials conducted under an exploratory investigational new drug can include evaluation of analogs for lead selection, modulation of a molecular target in vivo, whole-body imaging for tissue distribution/target binding affinity, and agent pharmacokinetics. Phase 0 trials bridge the gap between traditional preclinical testing and clinical studies and are intended to provide a better understanding of a new compound's pharmacokinetics, pharmacodynamics, and target localization before initiation of Phase I trials. When such information can be obtained earlier, decisions regarding drug development can also be made at an earlier point in time, potentially reducing costs of initial preclinical studies and time-to-first-in-human testing. This review provides an overview of the various conditions that have to be met in order for a Phase 0 trial to be successful, citing examples of two candidate drugs that have been further developed after Phase 0 trials in oncology. Challenges and opportunities with Phase 0 trials are discussed, including ethical issues associated with trials that have no therapeutic or diagnostic intent.","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":"5 1","pages":"119-126"},"PeriodicalIF":1.2,"publicationDate":"2013-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S32978","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68413701","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":"Subjective endpoints in clinical trials: the case for blinded independent central review","authors":"R. Walovitch, Bin Yao, Patrick Chokron, H. Le, G. Bubley","doi":"10.2147/OAJCT.S50283","DOIUrl":"https://doi.org/10.2147/OAJCT.S50283","url":null,"abstract":"Primary efficacy and safety endpoints in clinical trials are often subjective assessments made by site personnel. For international confirmatory trials conducted over broad geographic regions and different clinical practice settings, variability in these subjective assessments can be substantial. Centralized endpoint assessment committees (EACs) offer a mechanism through which to reduce assessment bias and potentially increase assessment precision and accuracy, particularly in open-label trials. An overview of regulatory agencies' rationales for an EAC is reviewed. In addition, the two main types of EACs, the blinded independent central review, and the consensus panel are compared. Selection of endpoints for EAC evaluation and design of EAC process to maximize EAC value proposition are also discussed.","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":"5 1","pages":"111-117"},"PeriodicalIF":1.2,"publicationDate":"2013-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S50283","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68414664","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":"Clinical trials update: recent and ongoing studies in anticoagulation for atrial fibrillation","authors":"James W. Wisler","doi":"10.2147/OAJCT.S49106","DOIUrl":"https://doi.org/10.2147/OAJCT.S49106","url":null,"abstract":": Atrial fibrillation is the most common sustained cardiac arrhythmia in the adult population, with a marked increased risk associated with age. Perhaps the most devastating complications of atrial fibrillation include acute ischemic stroke or systemic embolization. Vitamin K antagonists such as warfarin have served as the primary pharmacologic agent for the prevention of these thrombotic complications. Despite the widespread use of vitamin K antagonists, their effectiveness is hindered by several factors, including delayed onset of action, multiple food and drug interactions, onerous monitoring and dosing regimens","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":"5 1","pages":"101-110"},"PeriodicalIF":1.2,"publicationDate":"2013-08-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S49106","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68414437","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 of a prospective, multinational registry to evaluate patients hospitalized with hyponatremia: the HN Registry","authors":"P. Hauptman, A. Greenberg, J. Verbalis, A. Amin, S. Sigal, J. Chiong, S. Chase, J. Dasta","doi":"10.2147/OAJCT.S49421","DOIUrl":"https://doi.org/10.2147/OAJCT.S49421","url":null,"abstract":"Background: Hyponatremia is a prevalent condition in patients hospitalized across a broad range of conditions, including heart failure, cirrhosis, and the syndrome of inappropriate antidiuretic hormone (SIADH) secretion. Whether present on admission or developing during hospitalization, hyponatremia has been associated with increased mortality, longer hospital stays, and higher costs. Little is known, however, about its management and outcomes outside of clinical trial settings. Methods: The Hyponatremia Registry (HN Registry) is a prospective, observational, multicenter, multinational study of patients hospitalized with either hypervolemic hyponatremia (cirrhosis and heart failure) in the United States or euvolemic hyponatremia (SIADH) in both the United States and Europe. Study enrollment began in September 2010 at community, tertiary, and academic medical centers. Overall, the HN Registry is expected to enroll . 5,000 patients with hyponatremia, at . 280 sites. Data will be used to characterize demographic and clinical characteristics of patients hospitalized with hyponatremia, evaluate the comparative effectiveness of available treatment modalities, and document and compare length of hospital stay as a reflection of resource use associated with hospital management. Discussion: Despite better understanding of the clinical consequences, economic impact, and prognostic significance of euvolemic and hypervolemic hyponatremia, there remains a need to evaluate current “real-world” management. The HN Registry is designed to provide contemporary data on in-hospital evaluation, management, and length of stay in a large cohort of adult patients with hyponatremia. The HN Registry generated several design and analytical challenges that required unique approaches to facilitate collection of the most clinically relevant data.","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":"5 1","pages":"93-100"},"PeriodicalIF":1.2,"publicationDate":"2013-08-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S49421","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68414624","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":"Can fish oil supplementation improve endothelial function in asymptomatic offspring of patients with peripheral arterial disease","authors":"J. Spark, C. Delaney, R. Allan, M. H. Ho, Michelle D. Miller","doi":"10.2147/OAJCT.S46642","DOIUrl":"https://doi.org/10.2147/OAJCT.S46642","url":null,"abstract":"Correspondence: J Ian Spark Department of Vascular Surgery, Flinders Medical Centre, Flinders Drive, Bedford Park, Adelaide, SA 5042, Australia Tel +618 8204 5445 Fax +618 8204 7106 Email ian.spark@health.sa.gov.au Background: Peripheral arterial disease affects 10%–25% of adults aged .55 years, and while a multitude of risk factors exist, one key influence is genetics. Rather than awaiting the onset of debilitating symptoms, interventions that target high-risk individuals and prevent or delay the onset of symptoms would have widespread impact. The aim of this study is to implement a 12-week fish oil intervention (10 mL/day containing approximately 1.5 g of eicosapentaenoic acid and 1 g of docosahexaenoic acid), with the intention of improving endothelial function, inflammation, and lipid status in a high-risk population, ie, those with impaired endothelial function and a parent with symptomatic peripheral arterial disease. Methods: This is a parallel-group, double-blind, randomized controlled trial involving administration of fish oil containing either about 1.5 g of docosahexaenoic acid and 1 g of docosahexaenoic acid (intervention) or about 0.15 g of eicosapentaenoic acid and about 0.1 g of docosahexaenoic acid for 12 consecutive weeks (control). The participants are 100 offspring of adults with diagnosed peripheral arterial disease who themselves have an ankle-brachial pressure index $0.9 but impaired endothelial function according to peripheral arterial tonometry. Measures performed at baseline and at 6 and 12 weeks include flow-mediated dilatation, Creactive protein, absolute neutrophil and lymphocyte counts, tumor necrosis factor-α, interleukin-1β, and interleukin-6 levels, thromboxane and prostacyclin, lipid status, and homocysteine, nitrite, and nitrate levels. Participants will be phoned fortnightly to monitor adherence and side effects, while participants will maintain a diary of fish oil consumption on a daily basis, and fish oil returned will be measured to confirm adherence. Participants will complete validated surveys to determine background diet and physical activity levels. Discussion: This study will examine the effectiveness of a moderate-dose fish oil intervention in reversing endothelial dysfunction in asymptomatic offspring of patients with peripheral arterial disease. It provides the opportunity to delay the progression of peripheral arterial disease using a cheap and readily available dietary supplement that has minimal side effects compared with synthetic vasoactive pharmacological medications.","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":"20 1","pages":"83-91"},"PeriodicalIF":1.2,"publicationDate":"2013-07-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S46642","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68414288","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}