Open Access Journal of Clinical Trials最新文献

{"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":null,"pages":null},"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":null,"pages":null},"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}

{"title":"Publication bias: what is it? How do we measure it? How do we avoid it?","authors":"F. Song, L. Hooper, Y. Loke","doi":"10.2147/OAJCT.S34419","DOIUrl":"https://doi.org/10.2147/OAJCT.S34419","url":null,"abstract":"Publication bias occurs when results of published studies are systematically different from results of unpublished studies. The term \"dissemination bias\" has also been recommended to describe all forms of biases in the research-dissemination process, including outcome-reporting bias, time-lag bias, gray-literature bias, full-publication bias, language bias, citation bias, and media-attention bias. We can measure publication bias by comparing the results of published and unpublished studies addressing the same question. Following up cohorts of studies from inception and comparing publication levels in studies with statistically significant or \"positive\" results suggested greater odds of formal publication in those with such results, compared to those without. Within reviews, funnel plots and related statistical methods can be used to indicate presence or absence of publication bias, although these can be unreliable in many circumstances. Methods of avoiding publication bias, by identifying and including unpublished outcomes and unpublished studies, are discussed and evaluated. These include searching without limiting by outcome, searching prospective trials registers, searching informal sources, including meeting abstracts and PhD theses, searching regulatory body websites, contacting authors of included studies, and contacting pharmaceutical or medical device companies for further studies. Adding unpublished studies often alters effect sizes, but may not always eliminate publication bias. The compulsory registration of all clinical trials at inception is an important move forward, but it can be difficult for reviewers to access data from unpublished studies located this way. Publication bias may be reduced by journals by publishing high-quality studies regardless of novelty or unexciting results, and by publishing protocols or full-study data sets. No single step can be relied upon to fully overcome the complex actions involved in publication bias, and a multipronged approach is required by researchers, patients, journal editors, peer reviewers, research sponsors, research ethics committees, and regulatory and legislation authorities.","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":1.2,"publicationDate":"2013-07-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S34419","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68413823","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":"Global mental health intervention research and mass trauma","authors":"S. Meffert, S. Ekblad","doi":"10.2147/OAJCT.S37037","DOIUrl":"https://doi.org/10.2147/OAJCT.S37037","url":null,"abstract":"Correspondence: Susan Meffert Department of Psychiatry, University of California, San Francisco, 401 Parnassus Avenue, San Francisco, CA 94143, USA Tel +1 415 476 6100 Fax +1 415 476 7404 Email susan.meffert@ucsf.edu Abstract: The impact of mass trauma on mental health and the treatment of resulting disorders has been a major focus of global mental health work since the inauguration of the field. Descriptive studies in the 1990s provided convincing evidence of the importance of addressing global mental health needs in the aftermath of mass trauma. Nonetheless, despite calls to move ahead with interventional research, few studies have tested the effectiveness of the treatments for survivors of mass trauma. In this study, we use a translational science model to review the status of intervention research for adult survivors of mass trauma with the goal of identifying promising treatments, and presenting a logic model for using available data in a manner that is sensitive to community needs, and integrating with existing systems for capacity building.","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":1.2,"publicationDate":"2013-03-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S37037","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68413841","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 rationale of a randomized controlled trial of melatonin supplementation in men and women with the metabolic syndrome","authors":"P. Terry, Abhinav Goyal, L. Phillips, Hillary M. Superak, M. Kutner","doi":"10.2147/OAJCT.S39551","DOIUrl":"https://doi.org/10.2147/OAJCT.S39551","url":null,"abstract":"Correspondence: Michael H Kutner Department of Biostatistics and Bioinformatics, Emory Rollins School of Public Health, 1518 Clifton Road NE, Atlanta, GA 30322-4201, USA Tel +1 404 712 9708 Fax +1 404 727 1370 Email mkutner@emory.edu Background: The metabolic syndrome is a constellation of interrelated metabolic risk factors that appear to increase the risk of atherosclerotic cardiovascular disease, type 2 diabetes mellitus, and possibly some cancers. Animal studies and observational clinical data in humans suggest that supplemental melatonin may ameliorate a number of components of the metabolic syndrome, including elevated glucose, elevated blood pressure, dyslipidemia, and obesity. The primary objective of this clinical trial was to determine the feasibility, efficacy, and safety of melatonin supplementation in men and women with the metabolic syndrome. Methods: Thirty-nine men and women of mixed race/ethnicity were enrolled into a randomized, double-blind, placebo-controlled clinical trial with two arms: placebo for 10 weeks followed by melatonin for 10 weeks, or vice versa, with an interval 6-week washout period, in a crossover trial design. Outcome measures include metabolic syndrome components (blood pressure, glucose, triglycerides, high-density lipoprotein cholesterol, waist circumference), oxidative stress, and inflammation biomarkers. These biomarkers, along with sleep duration and quality and pretreatment endogenous melatonin levels, were measured to explore possible underlying biologic mechanisms. Discussion: This trial will provide knowledge of the effects of melatonin in metabolic syndrome subjects, and lay the groundwork for future clinical trials of melatonin in metabolic syndrome subjects.","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":1.2,"publicationDate":"2013-03-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S39551","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68413868","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":"The Functional Ambulation: Standard Treatment versus Electrical Stimulation Therapy (FASTEST) trial for stroke: study design and protocol","authors":"K. Dunning, P. Kluding, S. Wu, J. Feld, Jivan Ginosian, K. Mcbride","doi":"10.2147/OAJCT.S40057","DOIUrl":"https://doi.org/10.2147/OAJCT.S40057","url":null,"abstract":"1Department of Rehabilitation Sciences, College of Allied Health Sciences, University of Cincinnati, Cincinnati, OH, 2Department of Rehabilitation Medicine, New YorkPresbyterian Hospital/Weill Cornell Medical Center, New York, NY, 3Department of Physical Therapy and Rehabilitation Sciences, University of Kansas Medical Center, Kansas City, KS, 4Department of Biostatistics, University of Florida, Gainesville, FL, 5Department of Community and Family Medicine, Duke University School of Medicine, Durham, NC, 6Bioness Inc, Valencia, CA, USA","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":1.2,"publicationDate":"2013-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S40057","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68414093","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":"Case series of feasibility considerations that impact operational delivery strategy in the highly competitive rheumatoid arthritis space in Asia","authors":"K. Wai, Lisa Marie Saldanha, Elvira Zenaida Lansang, Saumya Nayak, A. Sule, Ken J Lee","doi":"10.2147/OAJCT.S40000","DOIUrl":"https://doi.org/10.2147/OAJCT.S40000","url":null,"abstract":"Correspondence: Karen Wai Quintiles East Asia Pte Ltd, 79 Science Park Drive, 06-08, Cintech IV, Science Park One, Singapore 118264 Tel +65 6602 1561 Fax +65 6872 0430 Email karen.wai@quintiles.com Abstract: The rheumatoid arthritis (RA) clinical trial space is very competitive, and recruiting and retaining subjects is of critical importance. Feasibility studies are a central component of ensuring successful recruitment and retention. A feasibility study is an assessment of the practicality of a proposed study protocol, with the goal of understanding challenges and providing risk mitigation strategies leading to better subject enrolment and study start-up should the assessment be favorable. This paper presents findings from a retrospective case series of RA feasibilities, describing important parameters to consider in the highly competitive RA space in Asia. Key parameters identified and discussed are how decisions on clinical development strategy necessitate changes in the clinical operational delivery strategy, with focus on changes in inclusion and exclusion criteria and patient contribution load; how small the patient population becomes when the clinical trial needs to target the patient population that is refractory to standard therapy; regulatory timelines; and the competitive clinical trial landscape. Feasibility assessments are a snapshot in time exercise. Multiple parameters change over time, and, particularly in a space that has become competitive for subjects, one cannot rely on one static feasibility assessment to predict trial performance accurately. Continuous feasibility assessment will also provide insight into the resourcing needs on the part of the sponsor, contract research organization, and investigative site.","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":1.2,"publicationDate":"2013-02-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S40000","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68414473","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":"Automated patient and medication payment method for clinical trials","authors":"B. Yawn, S. Madison, S. Bertram, W. Pace, Anne Fuhlibrigge, E. Israel, Dawn Littlefield, M. Kurland, M. Wechsler","doi":"10.2147/OAJCT.S38489","DOIUrl":"https://doi.org/10.2147/OAJCT.S38489","url":null,"abstract":"Barbara P Yawn1 Suzanne Madison1 Susan Bertram1 Wilson D Pace2 Anne Fuhlbrigge3 Elliot Israel3 Dawn Littlefield1 Margary Kurland1 Michael E Wechsler4 1Olmsted Medical Center, Department of Research, Rochester, MN, 2UCDHSC, Department of Family Medicine, University of Colorado Health Science Centre, Aurora, CO, 3Brigham and Women’s Hospital, Pulmonary and Critical Care Division, Boston, MA, 4National Jewish Medical Center, Division of Pulmonology, Denver, CO, USA","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":1.2,"publicationDate":"2013-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S38489","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68413619","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":"The role of technology in avoiding bias in the design and execution of clinical trials","authors":"H. Goodale, D. Mcentegart","doi":"10.2147/OAJCT.S40760","DOIUrl":"https://doi.org/10.2147/OAJCT.S40760","url":null,"abstract":"Correspondence: Hazel Goodale Perceptive Informatics Inc, Lady Bay House, Meadow Grove, Nottingham, NG2 3HF, United Kingdom Tel +44 115 844 3962 Fax +44 115 955 7555 Email hazel.goodale@perceptive.com Abstract: There are many documented instances in which bias has had an adverse effect on the results of clinical trials. This has led to a number of design techniques being developed that can be implemented in clinical trials in order to reduce bias. Sources of bias referring to published case studies are reviewed and discussed. The potential uses of technology to alleviate bias are outlined, particularly the use of centralized interactive response systems to randomize patients and manage medication in such a way as to limit the risk of bias caused by knowledge of either a patient’s current treatment or future treatment assignments. Potential sources of bias include selection bias, accidental bias, assessment bias, observer bias, and operational bias. These can arise through inadequate randomization and concealment methods during the trial. The blind may be broken by individual code breaks or through deduction in studies with frequent dose adjustments; there is scope for deduction in adaptive trials that might also introduce bias. Technology can reduce or eliminate the potential for bias in a variety of manners including central randomization and secure methods to protect the blinding and trial integrity. However, if the separation of randomization and dispensing, made possible by the use of technology, is not applied correctly then new unblinding scenarios can be introduced.","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":1.2,"publicationDate":"2013-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S40760","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68414181","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":"Biology and natural history of human papillomavirus infection","authors":"J. V. Fernandes, J. Araújo, T. A. A. Fernandes","doi":"10.2147/OAJCT.S37741","DOIUrl":"https://doi.org/10.2147/OAJCT.S37741","url":null,"abstract":"Human papillomavirus (HPV) is one of the most common causes of sexually trans- mitted diseases worldwide. It has been proposed that the great majority of women and men have been infected with HPV at least once during their lifetime. HPV infection is associated with a variety of clinical conditions, ranging from benign lesions to cervical cancer. In most cases, the infection is transient, where most of the individuals are healing, eliminating the virus without the presence of any clinical manifestation. Actually, more than 120 HPV types have been cataloged, of which approximately 40 can infect the mucosa of the anogenital tract and are collectively known as mucosal HPV, which are classified based on their oncogenic potential as either low- or high-risk HPV types. The low-risk HPV type causes benign hyperproliferative lesions or genital warts, with a very limited tendency for malignant progression, while the high-risk HPV type is strongly associated with premalignant and malignant cervical lesions. The HPV cycle initiates when the virus gains access to undifferentiated cells of the basement membrane of the squamous columnar junction epithelium of the ectocervix, after these regions are exposed to mechanical or chemical trauma. The basal cells in the transformation zone retain the ability to differentiate, a property required for virion production. Cervical infection with high-risk HPV typically lasts from 12 to 18 months and in most cases is cleared spontaneously. However, in some women the immune response is insufficient to eliminate the virus, resulting in a persistent, long-term infection that may progress to a malignant lesion. In this review, we discuss the biology and natural history of HPV infection and its association with cervical cancer.","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":1.2,"publicationDate":"2013-01-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S37741","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68414039","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}