MedWorm.com provides a medical RSS filtering service. Over 6000 RSS medical sources are combined and output via different filters. This feed contains the latest items from the 'Contemporary Clinical Trials' source. Thu, 09 Feb 2012 03:37:29 +0100 http://www.medworm.com/index.php?rid=5640142&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714412000067%2Fabstract%3Frss%3Dyes (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5640142 Mon, 30 Jan 2012 09:32:34 +0100 5640142 http://www.medworm.com/index.php?rid=5640143&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411003260%2Fabstract%3Frss%3Dyes We welcome the study report by Lipton et al. on comprehension and retention of study-related concepts by research subjects. It is very important that participants understand the information of a study and have knowledge of the relevance, risks and consequences before they agree to participate. We would like to raise some discussion points. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5640143 Mon, 16 Jan 2012 05:00:00 +0100 5640143 http://www.medworm.com/index.php?rid=5563320&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS155171441100317X%2Fabstract%3Frss%3Dyes (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5563320 Sun, 01 Jan 2012 05:00:00 +0100 5563320 http://www.medworm.com/index.php?rid=5563319&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411002953%2Fabstract%3Frss%3Dyes (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5563319 Sun, 01 Jan 2012 05:00:00 +0100 5563319 http://www.medworm.com/index.php?rid=5640149&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411003144%2Fabstract%3Frss%3Dyes Conclusion: We identified multiple barriers to patient accrual including short duration of enrollment period, protocol design, complex dosing schedule, requirement for staff availability during week-end and after hours, multiple departments' involvement, protocol acceptance, eligibility criteria, competing protocols, and limited staff. Each of these areas should be targeted for intervention in order to plan and conduct successful future clinical trials. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5640149 Mon, 26 Dec 2011 05:00:00 +0100 5640149 http://www.medworm.com/index.php?rid=5640158&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411002783%2Fabstract%3Frss%3Dyes Abstract: Objectives: Community Health Workers (CHWs) have been recommended to reduce diabetes disparities, but few robust trials of this approach have been conducted. Limitations of prior studies include: unspecified a priori outcomes; lack of blinded outcome assessments; high participant attrition rates; and lack of attention to intervention fidelity. These limitations reflect challenges in balancing methodologic rigor with the needs of vulnerable populations. The Mexican-American Trial of Community Health workers (MATCH) was a blinded randomized controlled trial testing CHW efficacy in improving physiologic outcomes and self-management behaviors among Mexican-Americans with type 2 diabetes. This paper describes methods used to overcome limitations of prior studies.Research design and me... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5640158 Fri, 23 Dec 2011 05:00:00 +0100 5640158 http://www.medworm.com/index.php?rid=5640153&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411002758%2Fabstract%3Frss%3Dyes Abstract: Glioblastoma multiforme (GBM) is the commonest primary malignant brain tumour in adults. Standard treatment comprises surgery, radiotherapy and chemotherapy; however this condition remains incurable as these tumours are highly invasive and involve critical areas of the brain making it impossible to remove them surgically or cure them with radiotherapy. In the majority of cases the tumour recurs within 2 to 3cm of the original site of tumour resection. Furthermore, the blood–brain barrier profoundly limits the access of many systemically administered chemotherapeutics to the tumour. Convection-enhanced delivery (CED) is a promising technique of direct intracranial drug delivery involving the implantation of microcatheters into the brain. Carboplatin represents an ideal chemother... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5640153 Fri, 23 Dec 2011 05:00:00 +0100 5640153 http://www.medworm.com/index.php?rid=5640168&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411003156%2Fabstract%3Frss%3Dyes This study is a randomized trial in older, obese men and women designed to test the hypothesis that adding a self-regulatory intervention (SRI), focused around self-monitoring of SPA, to a weight loss intervention will result in less weight and fat mass regain following weight loss than a comparable intervention that lacks this self-regulatory behavioral strategy. Participants (n=72) are randomized to a 5-month weight loss intervention with or without the addition of a behavioral component that includes an innovative approach to promoting increased SPA. Both groups then transition to self-selected diet and exercise behavior for a 5-month follow-up. Throughout the 10-month period, the SRI group is provided with an intervention designed to promote a SPA level that is equal to or greater than... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5640168 Mon, 19 Dec 2011 05:00:00 +0100 5640168 http://www.medworm.com/index.php?rid=5640151&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411002898%2Fabstract%3Frss%3Dyes Conclusions: Strengths of the Registry include large sample sizes, stringent review of clinical and molecular data, annually updated information, and regular interactions between patients and investigators. Registry data provide new insights into the burdens of DM and FSHD, such as, psychological problems and reduced employment. Opportunities abound for investigators to utilize Registry resources to assess the impact of these and other burdens on health care costs, progression of symptoms, and quality of life. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5640151 Mon, 19 Dec 2011 05:00:00 +0100 5640151 http://www.medworm.com/index.php?rid=5640150&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411002904%2Fabstract%3Frss%3Dyes Abstract: The purpose of this report is to identify factors associated with attrition and adherence of young women to a 16-week randomized aerobic exercise intervention on biomarkers associated with breast cancer risk. The exercise group was prescribed a progressive weight-bearing aerobic exercise program consisting of 30 minute workouts, 5 times/wk for 16weeks. Adherence was calculated as the average minutes of exercise per week during participation in the study. Of the total of 212 women randomized into the exercise intervention 46 dropped out, of which 82.5% dropped out during the earlier stages of exercise suggesting that reasons for withdrawal may have been related to difficulties with initiating physical activity. Time commitment or lack of time was the primary reason for withdrawal.... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5640150 Fri, 16 Dec 2011 05:00:00 +0100 5640150 http://www.medworm.com/index.php?rid=5640167&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411002874%2Fabstract%3Frss%3Dyes Abstract: For any particular psychological instrument, published normative distributions have been derived in one to at most a few specific “reference” populations. Here a method is provided for estimating a normative distribution pertinent to the specific population being evaluated in a randomized clinical trial. Normative quantiles are obtained using quantile regression, a method chosen for its flexibility in that no assumptions are made about the parametric form (e.g., Gaussian) of the normative distribution to be estimated. Outcome is regressed on disease severity for the τth quantile using that sample of consented participants who were not randomized because they fell below the trial's disease severity entry criterion. The τth quantile of the normative distribution is then estim... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5640167 Mon, 12 Dec 2011 05:00:00 +0100 5640167 http://www.medworm.com/index.php?rid=5640165&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411002710%2Fabstract%3Frss%3Dyes Abstract: Colorectal cancer (CRC) is a significant cause of mortality and morbidity in the United States, much of which could be prevented through adequate screening. Consensus guidelines recommend that high-risk groups initiate screening earlier with colonoscopy and more frequently than average risk persons. However, a large proportion of high risk individuals do not receive regular colonoscopic screening. The Family Health Promotion Project (FHPP) is a randomized-controlled trial to test the effectiveness of a telephone-based counseling intervention to increase adherence to risk-appropriate colonoscopy screening in high risk individuals. Unaffected members of CRC families from two national cancer family registries were enrolled (n=632) and randomized to receive either a single session te... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5640165 Thu, 08 Dec 2011 05:00:00 +0100 5640165 http://www.medworm.com/index.php?rid=5640162&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411002734%2Fabstract%3Frss%3Dyes Abstract: Although medical service delivery via home-based telehealth technology (HBT) is gaining wider acceptance in managing chronic illnesses such as diabetes or chronic obstructive pulmonary disease, few studies have tested HBT applications of psychotherapy. Clinicians, administrators, and researchers question whether delivering psychotherapeutic services to patients in their homes via video-conferencing technology compromises patient safety, potency of treatment, or data security. Despite these concerns, HBT service delivery may increase access to evidence-based psychotherapies for veterans with posttraumatic stress disorder (PTSD), who may be less willing or less able to receive weekly treatment at a VA medical center or outpatient clinic due to symptom severity or other similar barr... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5640162 Thu, 08 Dec 2011 05:00:00 +0100 5640162 http://www.medworm.com/index.php?rid=5640144&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411002722%2Fabstract%3Frss%3Dyes Abstract: Methylene blue-MMX® tablets are proposed as colonic diagnostic staining. Methylene blue taken prior to colonoscopy is expected to provide an effective staining of colonic and rectal mucosa leaving unstained the dysplastic or polypoid areas.The present single dose, open-label study investigated the safety of methylene blue after single oral doses of 200 and 400mg in healthy volunteers. The absolute bioavailability was also investigated after the intake of 2L of bowel cleansing preparation in 2h and by comparing the dose of 200mg with a single iv dose of 100mg in the same subjects.Only non-serious adverse events occurred. Related events occurred to 8/22 subjects. Most of the events were mild and transient. Abnormal transaminases, gastrointestinal disorders and dysuria frequency we... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5640144 Thu, 08 Dec 2011 05:00:00 +0100 5640144 http://www.medworm.com/index.php?rid=5640159&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411002825%2Fabstract%3Frss%3Dyes Abstract: Dropout is common in longitudinal clinical trials and when the probability of dropout depends on unobserved outcomes even after conditioning on available data, it is considered missing not at random and therefore nonignorable. To address this problem, mixture models can be used to account for the relationship between a longitudinal outcome and dropout. We propose a Natural Spline Varying-coefficient mixture model (NSV), which is a straightforward extension of the parametric Conditional Linear Model (CLM). We assume that the outcome follows a varying-coefficient model conditional on a continuous dropout distribution. Natural cubic B-splines are used to allow the regression coefficients to semiparametrically depend on dropout and inference is therefore more robust. Additionally, th... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5640159 Mon, 05 Dec 2011 05:00:00 +0100 5640159 http://www.medworm.com/index.php?rid=5640154&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411002655%2Fabstract%3Frss%3Dyes We present exact two-stage Mann–Whitney designs in the context of two-arm randomized clinical trials. In addition to describing the designs, we present tables of decision rules under a variety of assumed realities for use in trial planning. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5640154 Mon, 05 Dec 2011 05:00:00 +0100 5640154 http://www.medworm.com/index.php?rid=5640164&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411002850%2Fabstract%3Frss%3Dyes We present the methodology of a randomized, controlled clinical trial of 300 individuals with CLBP aged 65years or older. The specific aims are, 1) to determine the effectiveness of a mindfulness meditation program in increasing function and reducing pain among older adults with CLBP, and 2) to evaluate the impact of mindfulness meditation on neuropsychological performance in older adults with CLBP. The intervention program is modeled on the Mindfulness-Based Stress Reduction Program (MBSR) and the control is adapted from the 10 Keys™ to Healthy Aging. We will measure self-reported and objectively measured physical function and include a variety of measures to assess pain intensity and pain interference and psychological function. Our primary hypothesis is that the MBSR program will be m... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5640164 Fri, 02 Dec 2011 05:00:00 +0100 5640164 http://www.medworm.com/index.php?rid=5640163&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411002849%2Fabstract%3Frss%3Dyes Conclusion: This large prospective, randomised, open label trial will establish the effect of HMG-coA-reductase inhibitors (Atorvastatin) on cardiovascular risk in adult patients after successful coarctation repair. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5640163 Fri, 02 Dec 2011 05:00:00 +0100 5640163 http://www.medworm.com/index.php?rid=5640161&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411002746%2Fabstract%3Frss%3Dyes In this study the intervention and control groups will be compared for children's outcomes at ages 3½ and 5years. Primary outcome measures will be 1) BMI, 2) selected dietary measures using a validated survey tool, and 3) physical activity and screen time using a new generation of tri-axial accelerometers. Intention to treat principles will be used in the analysis. Multiple imputation will be used to impute outcomes for subjects lost to follow-up. A cost-effectiveness analysis (CEA) and cost-utility analysis for both HBT Phase 1 and 2 will also be conducted.Discussion: This is the first time that a home-based early intervention strategy has been implemented to prevent the development of childhood obesity and obesity-conducive behaviours. The results of this trial will ascertain whether ea... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5640161 Fri, 02 Dec 2011 05:00:00 +0100 5640161 http://www.medworm.com/index.php?rid=5640152&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411002813%2Fabstract%3Frss%3Dyes Discussion: The CoBalT trial will provide evidence on the clinical and cost effectiveness of CBT as an adjunct to antidepressant medication in the treatment of depression that has not responded to pharmacotherapy. Given the move to widen access to ‘talking therapies’, the results of this study will be timely. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5640152 Fri, 02 Dec 2011 05:00:00 +0100 5640152 http://www.medworm.com/index.php?rid=5640147&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411002709%2Fabstract%3Frss%3Dyes Conclusion: A contemporary approach to subject recruitment and frequent evaluation is needed to assure responsiveness to emerging challenges to accrual and the evolving scientific literature. A focus on investing on improving systems for physician recruitment may be key to meeting recruitment target in chemoprevention trials. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5640147 Fri, 02 Dec 2011 05:00:00 +0100 5640147 http://www.medworm.com/index.php?rid=5640146&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411002837%2Fabstract%3Frss%3Dyes Conclusion: Methods and materials increasing understanding and more accurately informing participants of what is involved in participation may increase enrollment in a prospective observational study. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5640146 Wed, 30 Nov 2011 05:00:00 +0100 5640146 http://www.medworm.com/index.php?rid=5563321&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411002862%2Fabstract%3Frss%3Dyes With this issue, I begin my tenure as Editor-in-Chief of Contemporary Clinical Trials. I am delighted and honored to have the opportunity to lead the Journal and to put my efforts to work for its continued success. On behalf of all involved with Contemporary Clinical Trials, I thank Dr. Kathleen Drennan and Dr. Suzanne Hambright for their enormous contributions as former Editor-in-Chief and Managing Editor, respectively, which have left an enduring mark on the journal. I am deeply grateful for everything they have done for the Journal. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5563321 Wed, 30 Nov 2011 05:00:00 +0100 5563321 http://www.medworm.com/index.php?rid=5640169&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411002667%2Fabstract%3Frss%3Dyes Abstract: This note addresses the questions of whether one should safeguard against a potential loss of power due to random variations of the accrual time, how this “insurance” can be formulated, and how much the sample size needs to be increased to obtain it. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5640169 Mon, 28 Nov 2011 05:00:00 +0100 5640169 http://www.medworm.com/index.php?rid=5640166&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411002680%2Fabstract%3Frss%3Dyes Abstract: Background: HIV-infected prisoners experience poor HIV treatment outcomes post-release. Directly administered antiretroviral therapy (DAART) is a CDC-designated, evidence-based adherence intervention for drug users, yet untested among released prisoners.Methods: Sentenced HIV-infected prisoners on antiretroviral therapy (ART) and returning to New Haven or Hartford, Connecticut were recruited and randomized 2:1 to a prospective controlled trial (RCT) of 6months of DAART versus self-administered therapy (SAT); all subjects received case management services. Subjects meeting DSM-IV criteria for opioid dependence were offered immediate medication-assisted treatment. Trained outreach workers provided DAART once-daily, seven days per week, including behavioral skills training during th... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5640166 Mon, 28 Nov 2011 05:00:00 +0100 5640166 http://www.medworm.com/index.php?rid=5640160&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411002679%2Fabstract%3Frss%3Dyes Abstract: Computer-assisted interventions hold the promise of minimizing two problems that are ubiquitous in substance abuse treatment: the lack of ready access to treatment and the challenges to providing empirically-supported treatments. Reviews of research on computer-assisted treatments for mental health and substance abuse report promising findings, but study quality and methodological limitations remain an issue. In addition, relatively few computer-assisted treatments have been tested among illicit substance users. This manuscript describes the methodological considerations of a multi-site effectiveness trial conducted within the National Institute on Drug Abuse's (NIDA's) National Drug Abuse Treatment Clinical Trials Network (CTN). The study is evaluating a web-based version of the... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5640160 Mon, 28 Nov 2011 05:00:00 +0100 5640160 http://www.medworm.com/index.php?rid=5640156&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411002795%2Fabstract%3Frss%3Dyes This study will provide evidence regarding the effectiveness of a multi-component behaviorally based intervention for promoting exercise adoption among people with mobility impairments that necessitate wheelchair use. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5640156 Mon, 28 Nov 2011 05:00:00 +0100 5640156 http://www.medworm.com/index.php?rid=5640155&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411002801%2Fabstract%3Frss%3Dyes This study is the first to examine the feasibility of this exercise format in both the chronically ill patient and spouse and explore benefits at the individual and couple level. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5640155 Mon, 28 Nov 2011 05:00:00 +0100 5640155 http://www.medworm.com/index.php?rid=5640148&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411002692%2Fabstract%3Frss%3Dyes Conclusion: Trial introduction meetings involving researcher led presentation of information, followed by group discussion, can help enhance the information provided in the patient information leaflet in a useful and non coercive manner. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5640148 Mon, 28 Nov 2011 05:00:00 +0100 5640148 http://www.medworm.com/index.php?rid=5640145&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS155171441100276X%2Fabstract%3Frss%3Dyes Conclusions: Loss to follow-up was minimized by contacting potential participants through Facebook. Social networking websites are a promising method to recruit adolescents. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5640145 Mon, 28 Nov 2011 05:00:00 +0100 5640145 http://www.medworm.com/index.php?rid=5640157&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411002771%2Fabstract%3Frss%3Dyes We report here on the use of interactive telephone technology for collecting longitudinal data in a large randomized non-blinded parallel trial.Data were primarily collected via an automated interactive telephone system which enabled data to be downloaded by researchers periodically via a secure website. Alternative methods were used by some participants to provide data; here we analyze the demographic profiles of groups by preferred data provision, and consider the cost-effectiveness and efficiency of such a system.The automated telephone system was used to provide the majority of data obtained (75.7%), however the group preferring to use this system to provide the majority of their data was on the whole older, more likely to be married, university educated, higher income and white compar... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5640157 Thu, 24 Nov 2011 05:00:00 +0100 5640157 http://www.medworm.com/index.php?rid=5563354&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411002643%2Fabstract%3Frss%3Dyes Discussion: The double-blind design eliminates behavioral factors that affect body weight. If children gain less body fat when drinking sugar-free than when drinking sugar-sweetened beverages that would show that liquid sugar indeed bypasses biological satiation mechanisms. It would also suggest that a reduction in liquid sugars could decrease body fat more effectively than reduction of other calorie sources. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5563354 Fri, 18 Nov 2011 05:00:00 +0100 5563354 http://www.medworm.com/index.php?rid=5563324&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411002618%2Fabstract%3Frss%3Dyes As plans are moving ahead to establish the Global Rare Disease Patient Registry and Data Repository (GRDR), ,contributing registries are in need of guidance on the informed consent process for patients whose information will be included in a registry. One of the GRDR goals is to aggregate de-identified patient medical information linked to their biospecimens, using voluntary patient identifiers. The aim of the GRDR is to provide a resource for research that will improve the quality of life of those with rare diseases, develop therapeutic interventions and, ultimately, find cures. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5563324 Thu, 17 Nov 2011 05:00:00 +0100 5563324 http://www.medworm.com/index.php?rid=5563353&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411002588%2Fabstract%3Frss%3Dyes We describe a unique study design intended to evaluate an IBI with a disaster-affected population-based sample. Description and rationale are provided for sampling selection and procedures, selection of assessment measures and methods, design of the intervention, and statistical evaluation of critical outcomes. Unique features of this intervention include the use of a population-based sample, telephone and internet-based assessments, and development of a highly individualized web-based intervention. Challenges related to the development and large-scale evaluation of IBIs targeting post-disaster mental health problems, as well as implications for future research and practice are discussed. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5563353 Wed, 16 Nov 2011 05:00:00 +0100 5563353 http://www.medworm.com/index.php?rid=5563352&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS155171441100259X%2Fabstract%3Frss%3Dyes Abstract: The Flexibility, Toning, and Balance (FlexToBa™) Trial is a two-armed randomized controlled trial which will contrast the effects of a DVD-delivered, home-based, physical activity intervention and a Healthy Aging attention control condition on physical activity, functional performance, functional limitations, and quality of life in low active, older adults. This innovative trial will recruit 300 participants across central Illinois who will be randomized into the intervention arm or control arm of the study. The intervention will last 6months with a 6month follow-up. Assessments at baseline, post intervention and follow-up will include physical activity (self-report and accelerometry), a battery of functional performance measures, functional limitations, quality of life, and an... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5563352 Mon, 14 Nov 2011 05:00:00 +0100 5563352 http://www.medworm.com/index.php?rid=5563331&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411002631%2Fabstract%3Frss%3Dyes Abstract: The Data and Safety Monitoring Board (DSMB) for the Breastfeeding, Antiretrovirals, and Nutrition study, a clinical trial aimed to prevent postnatal HIV transmission, recommended halting randomization to the enhanced standard-of-care (control) arm. The 67 mother–infant pairs on the control arm and less than 21weeks postpartum at the time of the DSMB recommendation were read a script informing them of the DSMB decision and offering them the maternal or infant antiretroviral interventions for the remainder of the 28-week breastfeeding period. This paper describes the BAN study response to the DSMB decision and what the women on the control arm chose, when given a choice to start the maternal or infant antiretroviral interventions. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5563331 Mon, 14 Nov 2011 05:00:00 +0100 5563331 http://www.medworm.com/index.php?rid=5563322&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411002606%2Fabstract%3Frss%3Dyes We are pleased to publish the outcome of the second in a series of meetings held by the Office of Rare Diseases Research, National Institutes of Health, Bethesda, MD, on the development of a comprehensive registry for patients with rare diseases. The editorial and meeting discussion in this issue focus on the complexity and challenges of obtaining informed consent in a registry of this magnitude. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5563322 Fri, 11 Nov 2011 05:00:00 +0100 5563322 http://www.medworm.com/index.php?rid=5563342&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411002448%2Fabstract%3Frss%3Dyes This study has the potential to provide a new effective computer tailored smoking relapse prevention program as well as insight into effective smoking relapse prevention strategies. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5563342 Thu, 10 Nov 2011 05:00:00 +0100 5563342 http://www.medworm.com/index.php?rid=5563323&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS155171441100262X%2Fabstract%3Frss%3Dyes Informed consent is a fundamental ethical requirement in most clinical research. Much has been written about the benefits and barriers of research-related informed consent from patients prior to participating in medical research studies. Consent templates and examples exist and are widely available for use by organizations or individual investigators. Appropriately designed templates provide the required elements as mandated by federal regulations and international standards. Nonetheless, research consent forms are often long and complex and not always useful to participant understanding. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5563323 Thu, 10 Nov 2011 05:00:00 +0100 5563323 http://www.medworm.com/index.php?rid=5563335&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411002527%2Fabstract%3Frss%3Dyes Conclusions: The results can provide information on potential directions for future family recruitment. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5563335 Wed, 09 Nov 2011 05:00:00 +0100 5563335 http://www.medworm.com/index.php?rid=5563346&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411002552%2Fabstract%3Frss%3Dyes We present the rationale and design of a randomized-controlled trial, Anticholinergic versus Botulinum Toxin, Comparison Trial for the Treatment of Bothersome Urge Urinary Incontinence: ABC trial, conducted by the NICHD-funded Pelvic Floor Disorders Network. We discuss the innovative nature of this trial and the challenges related to choice of patient population, maintaining masking, cost effectiveness, ethical considerations, measuring adherence, and placebo development and testing. Enrollment began in April, 2010. 242 participants will be randomized and primary outcome data analysis is anticipated to begin in mid 2012. Several challenges in the trial design are discussed. Randomization to placebo intra-detrusor injections may limit recruitment, potentially impacting generalizability. Oth... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5563346 Mon, 07 Nov 2011 05:00:00 +0100 5563346 http://www.medworm.com/index.php?rid=5563345&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411002461%2Fabstract%3Frss%3Dyes Abstract: Analysis of preclinical studies using human tumors xenografted into rodents is commonly performed with Tumor Growth Index (TGI) and Tumor Growth Delay index (TGDi). To circumvent the limitations of these parameters, two new parameters, Time To Relapse (TTR) and Tumor Growth Speed (TGS), were developed using a mathematical modeling approach based on an exponential tumor growth. TTR is similar to progression free survival used in human clinical trials and TGS characterizes the pattern of tumor cell proliferation. Parameters were estimated for each rodent by the maximum likelihood method and statistical analyses were performed using ANOVA. These criteria can be used when tumor growths are assessed by repeated measures of their volume. As an example, we used data from a previously pu... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5563345 Mon, 07 Nov 2011 05:00:00 +0100 5563345 http://www.medworm.com/index.php?rid=5563327&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411002515%2Fabstract%3Frss%3Dyes Abstract: The patient's perspective of treatment outcomes is increasingly important to consumers and providers of healthcare. Recent studies have shown that traditional clinical endpoints may not accurately reflect the patient experience with treatment. Often patients' experience of their disease and associated treatment differs from the perspective of their physicians. When implemented with a clear and effective assessment strategy, patient-reported outcome (PRO) measures can be used to collect data directly from patients in the clinical setting. These data can be applied to a range of outcomes, such as treatment efficacy, safety, and patient satisfaction. Such information is valuable at various stages of drug development and can be used to understand the patient's perspective of the trea... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5563327 Thu, 03 Nov 2011 04:00:00 +0100 5563327 http://www.medworm.com/index.php?rid=5563349&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411002576%2Fabstract%3Frss%3Dyes Abstract: Poorer postcodes within 5 regions in England have a lower response to bowel-cancer screening invitations than do richer postcodes. An extension of the sample-size formula for two proportions is used to determine that needed to detect an increase in response rate that varies by deprivation quintile. The proportions plugged into the formula are weighted averages based on the relationship between response and deprivation; the response rate is adjusted to be constant across deprivation quintiles. From a baseline period between October 2006 and January 2009, detection of an absolute or relative increase of at least 1,2,3,4 and 5% in response rate is required for the richest to poorest quintiles respectively because the interventions were chosen as those most likely to have an effect i... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5563349 Fri, 28 Oct 2011 04:00:00 +0100 5563349 http://www.medworm.com/index.php?rid=5563348&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411002564%2Fabstract%3Frss%3Dyes Conclusions: Home health care provides a venue where patients and physicians can be informed by nurses about osteoporosis and fracture risks and, consequently, initiate appropriate therapy. This multi-modal intervention is easily transportable to other home health agencies and adaptable to other medical conditions and settings. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5563348 Fri, 28 Oct 2011 04:00:00 +0100 5563348 http://www.medworm.com/index.php?rid=5563347&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411002540%2Fabstract%3Frss%3Dyes Abstract: Cigarette smoking is prevalent in cocaine/methamphetamine-dependent patients and associated with significant morbidity and mortality, yet, the provision of smoking cessation treatment in conjunction with substance use disorder (SUD) treatment is not standard practice. This is due, in part, to clinician concern that combining smoking cessation treatment with SUD treatment could lead to poorer SUD outcomes. The NIDA Clinical Trials Network is conducting a 10-week, two-group, randomized trial to evaluate the impact of providing smoking cessation treatment (SCT) with SUD treatment as usual (TAU), compared to TAU alone, in smokers who are in outpatient treatment for cocaine or methamphetamine dependence. Approximately 528 participants, recruited from 12 community treatment programs, w... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5563347 Fri, 28 Oct 2011 04:00:00 +0100 5563347 http://www.medworm.com/index.php?rid=5563343&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS155171441100245X%2Fabstract%3Frss%3Dyes Abstract: Data from laboratory studies, observational research, and/or secondary prevention trials suggest that vitamin D and marine omega-3 fatty acids may reduce risk for cancer or cardiovascular disease (CVD), but primary prevention trials with adequate dosing in general populations (i.e., unselected for disease risk) are lacking. The ongoing VITamin D and OmegA-3 TriaL (VITAL) is a large randomized, double-blind, placebo-controlled, 2x2 factorial trial of vitamin D (in the form of vitamin D3 [cholecalciferol], 2000IU/day) and marine omega-3 fatty acid (Omacor® fish oil, eicosapentaenoic acid [EPA]+docosahexaenoic acid [DHA], 1g/day) supplements in the primary prevention of cancer and CVD among a multi-ethnic population of 20,000 U.S. men aged ≥50 and women aged ≥55. The mean treat... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5563343 Fri, 28 Oct 2011 04:00:00 +0100 5563343 http://www.medworm.com/index.php?rid=5563351&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411002539%2Fabstract%3Frss%3Dyes Conclusions: Adaptive designs are more efficient from the statistical point of view but they are not yet widely used because of complex and computationally intensive methods needed, substantial effort for planning the trials and lack of regulatory guidance. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5563351 Wed, 26 Oct 2011 04:00:00 +0100 5563351 http://www.medworm.com/index.php?rid=5563350&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411002497%2Fabstract%3Frss%3Dyes Abstract: Amyotrophic lateral sclerosis (ALS) clinical trials suffer a large proportion of drop-outs. Ignoring missing data can lead not only to underpowered tests, but also to selection bias. Current strategies for handling not at random missing data have several limitations. To determine the most effective approach, we compared the standard procedures with the pattern mixture model, using the data from a randomized dose-finding trial on lithium for the treatment of ALS, which reported a high rate of drop-outs (68.4%). We evaluated the ALS Functional Rating Scale-Revised (ALSFRS-R) profile using mixed effect models on different reference populations (1. Intention-to-treat, 2. “Completers”, 3. Last observation carried forward, 4. “0-imputation”). All four strategies have limitation... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5563350 Mon, 24 Oct 2011 04:00:00 +0100 5563350 http://www.medworm.com/index.php?rid=5563344&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411002473%2Fabstract%3Frss%3Dyes Abstract: It is widely recognized that traditional randomized controlled trials (RCTs) have limited generalizability due to the numerous ways in which conditions of RCTs differ from those experienced each day by patients and physicians. As a result, there has been a recent push towards pragmatic trials that better mimic real-world conditions. One way in which RCTs differ from normal everyday experience is that all patients in the trial have uncertainty about what treatment they were assigned. Outside of the RCT setting, if a patient is prescribed a drug then there is no reason for them to wonder if it is a placebo. Uncertainty about treatment assignment could affect both treatment and placebo response. We use a potential outcomes approach to define relevant causal effects based on combinat... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5563344 Mon, 24 Oct 2011 04:00:00 +0100 5563344 http://www.medworm.com/index.php?rid=5563341&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411002424%2Fabstract%3Frss%3Dyes Abstract: A fundamental linchpin for obtaining rigorous findings in quantitative research involves the selection of survey instruments. Psychometric recommendations are available for the processes for scale development and testing and guidance for selection of established scales. These processes are necessary to address the validity link between the phenomena under investigation, the empirical measures and, ultimately, the theoretical ties between these and the world views of the participants. Detailed information is most often provided about study design and protocols, but far less frequently is a detailed theoretical explanation provided for why specific instruments are chosen. Guidance to inform choices is often difficult to find when scales are needed for specific cultural, ethnic, or ... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5563341 Mon, 24 Oct 2011 04:00:00 +0100 5563341 http://www.medworm.com/index.php?rid=5563340&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411002369%2Fabstract%3Frss%3Dyes Abstract: Having the potential to stop a clinical trial early for futility during an interim analysis is an important feature of sequential clinical trials. Conditional power and predictive power methods are widely used to analyze interim data in determining whether a trial is likely to eventually demonstrate both statistically significant and clinically meaningful results. Herein we introduce a new approach to early stopping in clinical trial designs, which can be viewed as a hybridization of the conditional and predictive power methods and has both methods as its special cases. The proposed hybridization, along with a novel resampling method, can be used together to assess futility in sequential trials with time-to-event outcomes. The proposed approach to futility assessment applies to s... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5563340 Mon, 24 Oct 2011 04:00:00 +0100 5563340 http://www.medworm.com/index.php?rid=5563339&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411002370%2Fabstract%3Frss%3Dyes Abstract: Most breast cancer survivors do not engage in regular physical activity. Our physical activity behavior change intervention for breast cancer survivors significantly improved physical activity and health outcomes post-intervention during a pilot, feasibility study. Testing in additional sites with a larger sample and longer follow-up is warranted to confirm program effectiveness short and longer term. Importantly, the pilot intervention resulted in changes in physical activity and social cognitive theory constructs, enhancing our potential for testing mechanisms mediating physical activity behavior change. Here, we report the rationale, design, and methods for a two-site, randomized controlled trial comparing the effects of the BEAT Cancer physical activity behavior change interv... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5563339 Mon, 24 Oct 2011 04:00:00 +0100 5563339 http://www.medworm.com/index.php?rid=5563334&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411002382%2Fabstract%3Frss%3Dyes Conclusions: NPs are willing to recommend clinical trials but need more education about the benefits and burdens of clinical trials, the associated ethical concerns, and evidence regarding the translatability of research to clinical practice to increase their knowledge and comfort level with discussing clinical trials. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5563334 Mon, 24 Oct 2011 04:00:00 +0100 5563334 http://www.medworm.com/index.php?rid=5563332&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411002485%2Fabstract%3Frss%3Dyes Conclusion: Utilizing the social triad concept led to success in planning and carrying out the recruitment of predominantly minority school children with high participation rates. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5563332 Mon, 24 Oct 2011 04:00:00 +0100 5563332 http://www.medworm.com/index.php?rid=5563330&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411002436%2Fabstract%3Frss%3Dyes Conclusions: Findings suggest a shift in the relevance of the clinical environment since the 1990s, as well as changes in CCOP structure associated with accrual performance. Rather than a limited number of physicians being responsible for the preponderance of trial accrual, there is a trend toward accrual among a larger number of physicians each accruing relatively fewer patients to trial. Understanding this dynamic in the context of CCOP efficiency may inform and strengthen CCOP organization and physician practice. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5563330 Mon, 24 Oct 2011 04:00:00 +0100 5563330 http://www.medworm.com/index.php?rid=5563326&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411002357%2Fabstract%3Frss%3Dyes Abstract: Reference percentile curves represent the covariate-dependent distribution of a quantitative measurement and are often used to summarize and monitor dynamic processes such as human growth. We propose a new nonparametric method based on a radial smoothing (RS) technique to estimate age-specific reference percentile curves assuming the underlying distribution is relatively close to normal. We compared the RS method with both the LMS and the generalized additive models for location, scale and shape (GAMLSS) methods using simulated data and found that our method has smaller estimation error than the two existing methods. We also applied the new method to analyze height growth data from children being followed in a clinical observational study of growth hormone treatment, and compared... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5563326 Mon, 24 Oct 2011 04:00:00 +0100 5563326 http://www.medworm.com/index.php?rid=5563325&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411002503%2Fabstract%3Frss%3Dyes To the Editor: When I was a young statistician just starting my career, I ran the analyses called for in one particular protocol, and the result was that our treatment did not work. As far as I was concerned, that was the end of the story. The director of my group had other ideas, and told me that “we need to challenge these results” . The fact that this episode occurred in the private sector in no way excuses it. But at least we can understand the motivation. What would we say if instead it were the regulatory authority that urged the sponsor to keep twisting the analyses until we came up with something that showed the result we want? This is a question I asked myself all these years later, as a “not so young” statistician, reading the recent article by Chen et al. . (Source: Con... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5563325 Mon, 24 Oct 2011 04:00:00 +0100 5563325 http://www.medworm.com/index.php?rid=5563333&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411002345%2Fabstract%3Frss%3Dyes Abstract: Obsessive–compulsive disorder (OCD) is a leading cause of disability worldwide, however for reasons that are poorly understood ethnic minority groups are not well represented in clinical research studies. Thus, although African Americans experience equivalent rates of OCD according to epidemiological surveys, the generalizability of findings from clinical trials remains unknown. Research designed to improve identification, assessment and treatment of OCD is an important public health priority. The purpose of this study is to report outreach methods used to recruit African American adults for participation in an OCD research study. A variety of methods were employed, including radio advertisements, public transportation advertising, community outreach, and online advertising. A ... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5563333 Thu, 20 Oct 2011 04:00:00 +0100 5563333 http://www.medworm.com/index.php?rid=5563328&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411002333%2Fabstract%3Frss%3Dyes This report provides a rationale for selecting sites by identifying both a set of basic site selection criteria important to most trials as well as criteria specific to the features of a particular study's design. In this two-tier system, although all these criteria must be met, some criteria are firm and viewed as essential for a site to conduct the trial. Other criteria, such as those that support study recruitment or participant retention, are flexible. These flexible criteria may be addressed through several alternative solutions that meet the original intent of the criterion.We illustrate how the study specific features and requirements of Stimulant Reduction Intervention using Dosed Exercise (STRIDE), a multisite clinical trial evaluating the efficacy of exercise or health education,... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5563328 Wed, 05 Oct 2011 04:00:00 +0100 5563328 http://www.medworm.com/index.php?rid=5563337&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411002096%2Fabstract%3Frss%3Dyes This study compares methods for analyzing correlated survival data from physician-randomized trials of health care quality improvement interventions. Several proposed methods adjust for correlated survival data; however the most suitable method is unknown. Applying the characteristics of our study example, we performed three simulation studies to compare conditional, marginal, and non-parametric methods for analyzing clustered survival data. We simulated 1000 datasets using a shared frailty model with (1) fixed cluster size, (2) variable cluster size, and (3) non-lognormal random effects. Methods of analyses included: the nonlinear mixed model (conditional), the marginal proportional hazards model with robust standard errors, the clustered logrank test, and the clustered permutation test (... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5563337 Tue, 04 Oct 2011 04:00:00 +0100 5563337 http://www.medworm.com/index.php?rid=5277304&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411002163%2Fabstract%3Frss%3Dyes (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5277304 Mon, 03 Oct 2011 19:47:36 +0100 5277304 http://www.medworm.com/index.php?rid=5563336&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411002102%2Fabstract%3Frss%3Dyes Abstract: Obesity is common among low-income mid-life women, yet most published weight loss studies have not focused on this population and have been highly resourced efficacy trials. Thus, practical type 2 translational studies are needed to evaluate weight loss interventions for low-income women. In this paper, we present the rationale, study design, and baseline characteristics of a type 2 translational study that evaluates both the processes and outcomes of a weight loss intervention for low-income women given at 6 county health departments in North Carolina. Key features of this study include random selection of study sites, intervention delivery by current staff at study sites, efforts to integrate the intervention with local community resources, a focus on evaluating the processes o... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5563336 Mon, 03 Oct 2011 04:00:00 +0100 5563336 http://www.medworm.com/index.php?rid=5563329&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411002114%2Fabstract%3Frss%3Dyes Conclusion: Multiple recruitment strategies and flexible, responsive approaches to recruitment and retention guided by the socio-ecologic model facilitated optimal implementation of an intervention for preadolescent girls. Through the application of the socio-ecologic model researchers and program leaders will be able to identify strategies to enhance the probability of successful outcomes. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5563329 Mon, 03 Oct 2011 04:00:00 +0100 5563329 http://www.medworm.com/index.php?rid=5563338&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411002084%2Fabstract%3Frss%3Dyes Abstract: Military personnel who engaged in the conflicts in Afghanistan and Iraq frequently present for mental health care because of the stresses of service and readjustment. Although excellent treatments are available to treat the typical presenting problems, there is a need for additional empirically supported treatment approaches for this population. Because these veterans have high levels of comorbidity, transdiagnostic treatment – treatment that applies to more than one diagnosis – may be an efficient approach for this group. Acceptance and Commitment Therapy (ACT) is one such approach that is well-known and has high face validity for veterans, but it has not been rigorously evaluated as a treatment for trauma-related mental health problems. Described herein is an ongoing multi-... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5563338 Mon, 26 Sep 2011 04:00:00 +0100 5563338 http://www.medworm.com/index.php?rid=5277328&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411002059%2Fabstract%3Frss%3Dyes Abstract: Permuted block design is the most popular randomization method used in clinical trials, especially for trials with more than two treatments and unbalanced allocation, because of its consistent imbalance control and simplicity in implementation. However, the risk of selection biases caused by high proportion of deterministic assignments is a cause of concern. Efron's biased coin design and Wei's urn design provide better allocation randomness without deterministic assignments, but they do not consistently control treatment imbalances. Alternative randomization designs with improved performances have been proposed over the past few decades, including Soares and Wu's big stick design, which has high allocation randomness, but is limited to two-treatment balanced allocation scenarios... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5277328 Thu, 15 Sep 2011 04:00:00 +0100 5277328 http://www.medworm.com/index.php?rid=5277327&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411002023%2Fabstract%3Frss%3Dyes We describe an ongoing trial examining the effectiveness of a particular CDSMS approach called the Flinders Program. The Flinders Program is a clinician-led generic self-management intervention that provides a set of tools and a structured process that enables health workers and patients to collaboratively assess self-management behaviours, identify problems, set goals, and develop individual care plans covering key self-care, medical, psychosocial and carer issues. A sample of 252 older Australians that have two or more chronic conditions will be randomly assigned to receive either CDSMS or an attention control intervention (health information only) for 6months. Outcomes will be assessed using self-reported health measures taken at baseline and post-intervention. This project will be the ... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5277327 Wed, 14 Sep 2011 04:00:00 +0100 5277327 http://www.medworm.com/index.php?rid=5277329&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411002072%2Fabstract%3Frss%3Dyes Abstract: Modified Zelen's approach is a randomization technique useful in multi-center trials where balance in treatment assignments within a center is desired. It has great balancing properties in a study with equal allocation to several treatment arms. This technique can also be used in studies with unequal allocation, where it would provide an allocation ratio close to the targeted one within centers as well as across centers. However, the implementation of the modified Zelen's approach for unequal allocation involves more than just imposing a constraint on within-center imbalance in treatment assignments, as is the case with equal allocation. Failure to account for this might provide a potential for accidental bias and (even in a double-blind study) selection and evaluation bias. The ... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5277329 Mon, 12 Sep 2011 04:00:00 +0100 5277329 http://www.medworm.com/index.php?rid=5277326&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411002047%2Fabstract%3Frss%3Dyes Abstract: Background: Lower socioeconomic status at both the individual and neighborhood level is associated with increased health risks. Weight loss can reduce this risk, but few high quality weight-loss studies target this population.Objectives: STARS tests a culturally appropriate, group-based behavioral and social support intervention on body weight and waist circumference in women from financially disadvantaged neighborhoods.Design: A stratified (by BMI) randomized trial. Randomization to group was generated by a random numbers table with allocation concealment by opaque envelopes.Methods: Participants 25–50years who had a BMI≥25kg/m2 and a waist circumference≥88cm were recruited from 18 census tracts in Columbia, SC with high rates of poverty between November 2008 and November ... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5277326 Mon, 05 Sep 2011 04:00:00 +0100 5277326 http://www.medworm.com/index.php?rid=5277310&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411002060%2Fabstract%3Frss%3Dyes Abstract: It's estimated that around 200million people are annually infected with Giardia lamblia, making the disease a major cause of morbidity worldwide. The current treatment of giardiasis includes the use of several drugs, among them, herbal medicines formulated with Mentha crispa. Thus, the purpose of this study was to evaluate the therapeutic efficacy of M. crispa in the treatment of giardiasis. The research consisted initially of a cross-sectional study for the selection of subjects with giardiasis. After that, there was a randomized, open, in parallel with active control study, in order to verify the therapeutic efficacy of M. crispa in the treatment of giardiasis. Coprology samples were collected from 1622 patients between May 2005 and May 2007 for a series of parasitological exam... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5277310 Mon, 05 Sep 2011 04:00:00 +0100 5277310 http://www.medworm.com/index.php?rid=5277306&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411002035%2Fabstract%3Frss%3Dyes Editor: Su is correct that the proposed randomization method represents improvement over existing methods for forcing balance, in that it better handles the case in which different covariates can be ranked in terms of importance. Hence, the article represents progress. However, the new method shares the same problem that standard minimization does, in that it cannot simultaneously force adequate balance and remain unpredictable . Like minimization, it can do one, or the other, and emphasizing this gives the appearance that it can do both at the same time . But if one chooses extreme biasing probabilities, so as to always minimize the imbalance function, then the procedure is predictable, and there is no allocation concealment, and selection bias is a concern . Note that even covariates not... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5277306 Thu, 01 Sep 2011 04:00:00 +0100 5277306 http://www.medworm.com/index.php?rid=5277325&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411001844%2Fabstract%3Frss%3Dyes Abstract: Despite several advances in the care of critically ill patients, sepsis and septic shock continue to carry the largest burden of mortality and morbidity. Trials comparing vasopressors in shock have been disappointing and several key issues in methodology may need to be explored. There has been substantial progress in evolving adaptive trial methodology, however these have seldom been translated to clinical trials. This paper discusses some of the issues relevant to critical illness. To illustrate the potential contribution of adaptive trials we discuss fixed sample size design including event and time to event studies. We then explore group sequential and adaptive trial design, enrichment strategies and sample size re-estimation. An attractive feature of responsive adaptive desig... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5277325 Fri, 12 Aug 2011 04:00:00 +0100 5277325 http://www.medworm.com/index.php?rid=5277311&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411001388%2Fabstract%3Frss%3Dyes Abstract: Informed consent is a process that involves providing all pertinent study information to the potential study participant. The information imparted in the form gives all such information as would enable a potential participant to come to a decision regarding his/her participation in the study. Various study related aspects are outlined in the participant information leaflet including the background of the study, the benefits and risks, treatment alternatives; the methodology of the study, follow up schedules, confidentiality of the data, compensations and remunerations and right to not participate or withdraw from the study. We have continued a similar exercise for a phase I, first-in-human study, conducted by our center. Here, the volunteers were asked certain questions pertainin... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5277311 Fri, 12 Aug 2011 04:00:00 +0100 5277311 http://www.medworm.com/index.php?rid=5277305&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411001856%2Fabstract%3Frss%3Dyes Pediatric trauma is a major health problem worldwide causing almost 40% of pediatric mortality . Curiosity, limited physical ability, and lack of experience make children more exposed to injury. Priorities in the management and prevention for pediatric trauma must be identified, and a strategic planning for pediatric trauma research should be implemented. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5277305 Fri, 12 Aug 2011 04:00:00 +0100 5277305 http://www.medworm.com/index.php?rid=5277321&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411001819%2Fabstract%3Frss%3Dyes Abstract: Randomised controlled trials (RCTs) which involve cost-effectiveness evaluations rarely use health economic input when undertaking sample size calculations for the trial design; however, in studies undertaken with cost-effectiveness as the primary outcome, sample size calculations should be directly related to the cost-effectiveness result rather than to the effectiveness outcome alone. This paper reports on a case in which a clinical trial design sample size and power calculations were determined with regard to cost-effectiveness using the net monetary benefit (NMB) approach to demonstrate the feasibility of sample size calculation for cost-effectiveness in a real life setting.The proposed RCT of fetal fibronectin screening (fFN) for women with threatened pre-term labour is disc... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5277321 Mon, 08 Aug 2011 04:00:00 +0100 5277321 http://www.medworm.com/index.php?rid=5277320&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411001789%2Fabstract%3Frss%3Dyes Abstract: Child obesity has become an important public health concern, especially in rural areas. Primary care providers are well positioned to intervene with children and their parents, but encounter many barriers to addressing child overweight and obesity. This paper describes the design and methods of a cluster-randomized controlled trial to evaluate a parent-mediated approach utilizing physician's brief motivational interviewing and parent group sessions to treat child (ages 5–11years) overweight and obesity in the primary care setting in Southern Appalachia. Specific aims of this pilot project will be 1) to establish a primary care based and parent-mediated childhood overweight intervention program in the primary care setting, 2) to explore the efficacy of this intervention in promo... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5277320 Mon, 08 Aug 2011 04:00:00 +0100 5277320 http://www.medworm.com/index.php?rid=5277315&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411001753%2Fabstract%3Frss%3Dyes Abstract: Due to the changing population in patients with myocardial infarction, recruiting patients in clinical trials continues to challenge clinical investigators. The Cardiovascular Cell Therapy Research Network (CCTRN) chose to expand the reach and power of its recruitment effort by incorporating both referral and treatment satellite centers. Eight treatment satellites were successfully identified and they screened patients over a two year period. The result of this effort was an increase in recruitment, with these treatment satellites contributing 30% of the patients to two of the three Network studies. The hurdles that these satellite treatment centers faced and how they surmounted them provide instruction to clinical research groups eager to expand to satellite systems and to healt... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5277315 Fri, 05 Aug 2011 04:00:00 +0100 5277315 http://www.medworm.com/index.php?rid=5277322&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411001832%2Fabstract%3Frss%3Dyes Abstract: Infertility afflicts 15% of couples who wish to conceive. Despite intensive evaluation of both male and female partners, the etiology may remain unknown leading to a diagnosis of unexplained infertility. For such couples, treatment often entails ovulation induction (OI) with fertility medications coupled with intrauterine insemination. Complications of this therapy include ovarian hyperstimulation syndrome and creation of multiple gestation pregnancies, which can be complicated by preterm labor and delivery, and the associated neonatal morbidity and expense of care for preterm infants. The Assessment of Multiple Intrauterine Gestations from Ovarian Stimulation (AMIGOS) study is designed to assess whether OI in couples with unexplained infertility with an aromatase inhibitor produ... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5277322 Thu, 04 Aug 2011 04:00:00 +0100 5277322 http://www.medworm.com/index.php?rid=5277324&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411001820%2Fabstract%3Frss%3Dyes Conclusions: Neighborhood contextual and environmental measures are described to test ecologic factors that may contribute to behavioral maintenance. Theoretically guided interventions that account for multiple levels of influence in behavior initiation and maintenance stand to improve health outcomes in vulnerable populations. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5277324 Wed, 03 Aug 2011 04:00:00 +0100 5277324 http://www.medworm.com/index.php?rid=5277314&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411001777%2Fabstract%3Frss%3Dyes Conclusions: NLST's EVP is designed to produce a highly accurate count of lung cancer deaths. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5277314 Wed, 03 Aug 2011 04:00:00 +0100 5277314 http://www.medworm.com/index.php?rid=5277317&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411001509%2Fabstract%3Frss%3Dyes Abstract: Over the past decade many signaling pathways have been identified and implicated in cancer development. This has lead to rational drug development of many new molecules that target specific nodes on one or more signaling pathways. It is now believed that targeting key parallel or compensatory pathways may require combining two or more new molecular entities (2NMEs). This approach to drug development differs from the classic case where a single component of a new combination regimen has yet to receive FDA approval. The approach presents numerous challenges to both regulatory authorities and industry sponsors. Of course, the key challenge is the usual demonstration of both safety and efficacy of the proposed combination. In addition, however, superiority of the 2NME-based regimen o... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5277317 Tue, 02 Aug 2011 04:00:00 +0100 5277317 http://www.medworm.com/index.php?rid=5082611&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411001583%2Fabstract%3Frss%3Dyes (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5082611 Mon, 01 Aug 2011 22:42:37 +0100 5082611 http://www.medworm.com/index.php?rid=5277319&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411001765%2Fabstract%3Frss%3Dyes This study is a multi-center, randomized controlled trial examining the effects of 2years of CR on biomarkers of longevity among non-obese (BMI≥22kg/m2 and (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5277319 Mon, 01 Aug 2011 04:00:00 +0100 5277319 http://www.medworm.com/index.php?rid=5277313&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411001790%2Fabstract%3Frss%3Dyes Abstract: Patients with malignant disease enrolled in trials of thrombotic disorders may experience competing events such as death. The occurrence of a competing event may prevent the thrombotic event from being observed. Standard survival analysis techniques ignore competing risks, resulting in possible bias and distorted inferences. To assess the impact of competing events on the results of a previously reported trial comparing low molecular weight heparin (LMWH) with oral anticoagulant (OAC) therapy for the prevention of recurrent venous thromboembolism (VTE) in patients with advanced cancer, we compare the results from standard survival analysis with those from competing risk techniques which are based on the cumulative incidence function (CIF) and Gray's test. The Kaplan–Meier metho... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5277313 Mon, 01 Aug 2011 04:00:00 +0100 5277313 http://www.medworm.com/index.php?rid=5277308&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411001480%2Fabstract%3Frss%3Dyes Conclusions: This study contributes important information regarding the safety of balneotherapy in hypertensive and obese diabetics by showing no alterations of antioxidant, inflammatory, or metabolic indices. The findings of this study confirm that balneotherapy is not contraindicated for hypertensive or obese patients. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5277308 Fri, 29 Jul 2011 04:00:00 +0100 5277308 http://www.medworm.com/index.php?rid=5277307&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411001534%2Fabstract%3Frss%3Dyes Abstract: Erythropoiesis stimulating agents (ESA) are widely used for hemoglobin correction in patients suffering from renal anemia. However, their beneficial non-hematopoietic effects on renal deterioration have not been adequately assessed. The Primavera study is the first prospective, controlled trial to assess whether ESA treatment could ameliorate progression of chronic kidney disease (CKD) in non-anemic patients. Primavera is a single-blind, 24-month trial in which patients are randomized to placebo or to C.E.R.A., a continuous erythropoietin receptor activator. Patients with type 2 diabetes or who have undergone kidney transplantation are eligible to enter the study if they have CKD stage III (estimated GFR [eGFR] 30–59mL/min/1.73m2), urinary albumin to creatinine ratio (UACR) ≥... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5277307 Fri, 29 Jul 2011 04:00:00 +0100 5277307 http://www.medworm.com/index.php?rid=5277323&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411001807%2Fabstract%3Frss%3Dyes Abstract: Background: Cardiovascular disease (CVD) is the leading cause of death, and principal reason for the large difference in life expectancy between indigenous Māori and the non-indigenous population in New Zealand. CVD guidelines recommend that people who are at high risk or who have had previous CVD should be offered aspirin, blood pressure lowering and lipid lowering therapies. However, prescribing and adherence rates are low and CVD events remain high.Aim: To assess whether a medication strategy using a fixed dose combination pill (‘polypill’) could improve prescribing and adherence to recommended medications, lower blood pressure and improve lipids compared with current care over 12months.Methods: IMProving Adherence using Combination Therapy (IMPACT) is an open-label rando... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5277323 Thu, 28 Jul 2011 04:00:00 +0100 5277323 http://www.medworm.com/index.php?rid=5277318&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411001510%2Fabstract%3Frss%3Dyes Conclusions: Randomization resulted in comparable study arms. Recently, several critical reviews raised major concerns on the reliability of open health intervention trials, because of uncertain sustainability and non-blinding bias. In this regard, the presented trial featuring objective outcome measures, a simultaneous intervention in the control communities and a 12-month follow up period will provide valuable evidence. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5277318 Tue, 26 Jul 2011 04:00:00 +0100 5277318 http://www.medworm.com/index.php?rid=5277312&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411001492%2Fabstract%3Frss%3Dyes Conclusions: Patients with COPD represent a heterogeneous population in terms of their reporting of symptoms and response to treatment. GMM analyses are able to identify sub-groups of responders and non-responders. Application of this methodology could be of value on other endpoints in COPD and in other disease areas. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5277312 Mon, 25 Jul 2011 04:00:00 +0100 5277312 http://www.medworm.com/index.php?rid=5277309&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411001522%2Fabstract%3Frss%3Dyes Conclusion: Tulsi has stood the test and is as effective as Chlorhexidine and Listerine in reducing the salivary S. mutans levels. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5277309 Mon, 25 Jul 2011 04:00:00 +0100 5277309 http://www.medworm.com/index.php?rid=5277316&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411001479%2Fabstract%3Frss%3Dyes In this study we evaluate the use of the power prior distribution, illustrated with data from a large randomized clinical trial on the effect of ST-wave analysis in intrapartum fetal monitoring. We advocate the use of a power prior distribution with pre-specified fixed study weights based on differences in study characteristics. We propose obtaining a ranking of the historical studies via expert elicitation, based on relevance for the current study, and specify study weights accordingly. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5277316 Fri, 22 Jul 2011 04:00:00 +0100 5277316 http://www.medworm.com/index.php?rid=5082634&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411001467%2Fabstract%3Frss%3Dyes Conclusion: This study is designed to examine clinically relevant effects of a novel, non-invasive and potentially low cost approach to reduce the incidence of allergic disease and facilitate neurodevelopment during early childhood. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5082634 Sun, 03 Jul 2011 23:00:00 +0100 5082634 http://www.medworm.com/index.php?rid=5082633&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411001455%2Fabstract%3Frss%3Dyes We describe a novel protocol to develop a prediction model that identifies patients with nerve-related neck and arm pain who are likely to benefit from the early introduction of neural tissue management (NTM). Prediction models for musculoskeletal treatments have usually been developed by analyzing single group study data with standard logistic regression. However, this approach has important limitations and our two step process for model development will address these limitations. Eligible patients will be aged 18 to 60years with a minimum four week episode of non-traumatic neck and unilateral arm pain that is reproduced by a mechanical provocation test for the cervical nerve roots and median nerve. The outcome being predicted by the model is patient-reported improvement four weeks after ... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5082633 Sun, 03 Jul 2011 23:00:00 +0100 5082633 http://www.medworm.com/index.php?rid=5082630&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411001339%2Fabstract%3Frss%3Dyes Discussion: Post Marketing Observational Studies (PMOS) are essential for the assessment of real-life effectiveness and population based benefit–risk ratios. The effect of access to care, compliance, adherence to guidelines, patient comorbidity and concomitant medication use could only be assessed with observational studies. IVORY will provide information about true life effectiveness, benefit–risk ratios, cost-effectiveness and barriers to the process–outcome optimization. The results will have implications for decision makers and health care stakeholders regarding the management of osteoporosis in Canada. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5082630 Sun, 03 Jul 2011 23:00:00 +0100 5082630 http://www.medworm.com/index.php?rid=5082616&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411001431%2Fabstract%3Frss%3Dyes Conclusions: The GoodNEWS trial successfully recruited and evaluated CVD-related risk among African-American participants using a CBPR approach. Several logistical challenges resulted in extending the recruitment, preliminary training, and measurement periods. The challenges were overcome with the assistance of a local community consultant and a professional event planner. Our experience supports the need for incorporating non-traditional community-based staff into the design and operational plan of CBPR trials. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5082616 Sun, 03 Jul 2011 23:00:00 +0100 5082616 http://www.medworm.com/index.php?rid=5082635&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411001443%2Fabstract%3Frss%3Dyes Discussion: DVT remains prevalent despite the use of conventional prophylactic measures, in part because certain patients (particularly the elderly) are unable to receive preventive treatment because of a high risk of bleeding complications and co-morbidity. Statins have been shown to have beneficial effects in arterial atherothrombosis and are frequently administered to elderly patients to treat coronary artery. We hypothesize that peri-operative statin treatment may be beneficial in those patients restricted from the conventional prophylaxis for DVT.Research highlights: ► Current preventive measures for DVT has limitations. ► Venous and arterial thrombosis share common pathophysiology. ► Statin has potential for prevention of venous thrombosis. ► We are performing prospective ran... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5082635 Wed, 22 Jun 2011 23:00:00 +0100 5082635 http://www.medworm.com/index.php?rid=5082631&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411001406%2Fabstract%3Frss%3Dyes Conclusions: Considering the high prevalence of distress and sleep disturbances in the cancer population, should MBSR produce sleep effects comparable to CBT-I, it may be more comprehensive — making it the treatment of choice for addressing cancer-related psychological sequelae.Research highlights: ► Distress and sleep problems are prevalent problems in individuals with cancer. ► A randomized non-inferiority trial will compare two psychological treatments. ► Cognitive Behavior Therapy (CBT-I) has demonstrated efficacy for treating insomnia. ► Mindfulness-Based Stress Reduction (MBSR) may improve insomnia as well as distress. ► If comparable to CBT-I, MBSR more a comprehensive treatment for common cancer symptoms. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5082631 Thu, 16 Jun 2011 23:00:00 +0100 5082631 http://www.medworm.com/index.php?rid=5082620&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS155171441100142X%2Fabstract%3Frss%3Dyes Conclusions: The increased compliance with the good clinical practice guideline and improvement in the mean cumulative scores in 2008–09 was probably the outcome of greater awareness amongst the clinical researchers within the institute. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5082620 Wed, 15 Jun 2011 23:00:00 +0100 5082620 http://www.medworm.com/index.php?rid=5082615&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411001418%2Fabstract%3Frss%3Dyes Conclusions: Multisite randomized clinical trial designs can offer the field of CAM research a more standardized and efficient approach to examine the effectiveness of novel therapies and treatments. Special attention must be given to intervention fidelity, consistent data collection and ensuring data quality. Assessment and reporting of quantitative indicators of data quality should be required.Highlights: ► We describe coordination of a multisite complementary and alternative medicine trial. ► We describe management and data monitoring, as well as quality assurance procedures. ► We share experience from a study of reflexology for women with advanced breast cancer. ► We show an efficient approach to examine the effectiveness of reflexology therapy. ► Assessment and reporting of ... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5082615 Wed, 15 Jun 2011 23:00:00 +0100 5082615 http://www.medworm.com/index.php?rid=5082632&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS155171441100139X%2Fabstract%3Frss%3Dyes Abstract: In many clinical trials with time-to-event outcomes there are interim analyses planned at pre-specified event counts. It is of great value to predict when the pre-specified event milestones can be reached based on the available data as the timeline for a study is essential to the study sponsors and data monitoring committees for logistic planning purposes. Both parametric and non-parametric approaches exist in the literature for estimating the underlining survival function, based on which the predictions of future event times can be determined. The parametric approaches assume that the survival function is smooth, which is often not the case as the survival function usually has one or multiple change points and the hazard functions can differ significantly before and after a chan... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5082632 Sun, 12 Jun 2011 23:00:00 +0100 5082632 http://www.medworm.com/index.php?rid=5082627&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411001091%2Fabstract%3Frss%3Dyes Abstract: People with advanced pulmonary disease (APD), such as those with chronic obstructive pulmonary disease, have markedly impaired quality of life. Home Oxygen Therapy (HOT) itself is burdensome, although it often improves survival duration and quality of life in these patients. The exact burdens on informal caregivers of these patients are unknown. The central purpose of the pragmatic randomized controlled study described in this protocol is to determine the effectiveness of improving the skills and knowledge of carers of patients with APD who use HOT. Specifically we aimed to estimate the incremental impact of this carer intervention above usual care on health, economic, psychological and social domains for patient and carer dyads relative to the level of current burden. Eligible p... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5082627 Tue, 07 Jun 2011 23:00:00 +0100 5082627 http://www.medworm.com/index.php?rid=5082628&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411001108%2Fabstract%3Frss%3Dyes Conclusions: FLAX-PAD will generate data on the safety, tolerability, cardiovascular efficacy and genomic response to a diet rich in flaxseed. It will determine the effects on primary and secondary events (stroke, myocardial infarctions, angina pectoris, cardiac arrhythmias) as well as in secondary endpoints (exercise performance, blood pressure and circulating lipid levels) in patients with PAD. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5082628 Sun, 05 Jun 2011 23:00:00 +0100 5082628 http://www.medworm.com/index.php?rid=5082626&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411001017%2Fabstract%3Frss%3Dyes Abstract: Background and rationale: To date, few studies have investigated the effects of combined renin-angiotensin system blockade/calcium channel blockade on central aortic blood pressure. The Conduit Artery Function Evaluation (CAFE) sub-study of the Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT) investigated the effects of amlodipine/perindopril and atenolol/bendroflumethiazide on central aortic blood pressure (CABP). Similar brachial blood pressure levels were achieved; however, there was a significant difference, in favor of the amlodipine/perindopril combination, on the effects of CABP. No study has investigated the effects of a combination of an angiotensin receptor blocker/calcium channel blocker compared to those of a calcium channel blocker/angiotensin-converting enzyme inhi... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5082626 Wed, 01 Jun 2011 23:00:00 +0100 5082626 http://www.medworm.com/index.php?rid=5082619&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411001078%2Fabstract%3Frss%3Dyes Abstract: Caregivers for a family member with dementia experience chronic long-term stress that may benefit from new complementary therapies such as mindfulness-based stress reduction. Little is known however, about the challenges of recruiting and retaining family caregivers to research on mind–body based complementary therapies. Our pilot study is the first of its kind to successfully recruit caregivers for a family member with dementia to a randomized controlled pilot study of mindfulness-based stress reduction. The study used an array of recruitment strategies and techniques that were tailored to fit the unique features of our recruitment sources and employed retention strategies that placed high value on establishing early and ongoing communication with potential participants. Innov... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5082619 Wed, 01 Jun 2011 23:00:00 +0100 5082619 http://www.medworm.com/index.php?rid=5082614&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS155171441100108X%2Fabstract%3Frss%3Dyes This article describes the Network's challenges as it initiated three protocols in a polarized cultural atmosphere at a time when oversight bodies were positioning themselves for the tightest vigilance of promising new therapies. Effective strategies involving ongoing education, open communication, and relationship building with the oversight community are discussed. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5082614 Wed, 01 Jun 2011 23:00:00 +0100 5082614 http://www.medworm.com/index.php?rid=5082613&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411001042%2Fabstract%3Frss%3Dyes Abstract: Background: Comprehension and retention of study-related concepts by research subjects are understudied, particularly in certain areas of women's health such as menopausal hormone therapy (MHT).Methods: In a multi-center trial of MHT, a 9-item participant comprehension questionnaire (PCQ) tested knowledge of key concerns relating to MHT at two study sites. The PCQ was administered at baseline. At study site1, PCQ was re-administered to assess information retention months later. Multivariable analyses assessed predictors of participant comprehension after adjusting for age, race, education, annual family income (AFI), menopausal symptoms and study site.Results: 151 participants (n=89 at site I, n=62 at site II) completed the PCQ at baseline; 71 participants from site I completed t... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5082613 Wed, 01 Jun 2011 23:00:00 +0100 5082613 http://www.medworm.com/index.php?rid=5082629&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS155171441100111X%2Fabstract%3Frss%3Dyes Abstract: Clinicians often face difficult decisions despite the lack of evidence from randomized trials. Thus, clinical evidence is often shaped by non-randomized studies exploiting multivariable approaches to limit the extent of confounding. Since their introduction, propensity scores have been used more and more frequently to estimate relevant clinical effects adjusting for established confounders, especially in small datasets. However, debate persists on their real usefulness in comparison to standard multivariable approaches such as logistic regression and Cox proportional hazard analysis. This holds even truer in light of key quantitative developments such as bootstrap and Bayesian methods. This qualitative review aims to provide a concise and practical guide to choose between propens... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5082629 Tue, 31 May 2011 23:00:00 +0100 5082629 http://www.medworm.com/index.php?rid=4880054&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411001169%2Fabstract%3Frss%3Dyes (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=4880054 Tue, 31 May 2011 17:45:27 +0100 4880054 http://www.medworm.com/index.php?rid=5082625&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411001029%2Fabstract%3Frss%3Dyes This study will investigate the effect of exercise in combination with vitamin D and calcium on prevention of drug-induced osteoporosis in postmenopausal women prescribed AIs for the treatment of breast cancer. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5082625 Thu, 26 May 2011 23:00:00 +0100 5082625 http://www.medworm.com/index.php?rid=5082623&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411000978%2Fabstract%3Frss%3Dyes Abstract: Randomized, placebo-controlled trials often use time-to-event as the primary endpoint, even when a continuous measure of disease severity is available. We compare the power to detect a treatment effect using either rate of change, as estimated by linear models of longitudinal continuous data, or time-to-event estimated by Cox proportional hazards models. We propose an analytic inflation factor for comparing the two types of analyses assuming that the time-to-event can be expressed as a time-to-threshold of the continuous measure. We conduct simulations based on a publicly available Alzheimer's disease data set in which the time-to-event is algorithmically defined based on a battery of assessments. A Cox proportional hazards model of the time-to-event endpoint is compared to a lin... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5082623 Thu, 26 May 2011 23:00:00 +0100 5082623 http://www.medworm.com/index.php?rid=5082612&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411001066%2Fabstract%3Frss%3Dyes Abstract: The recent unearthing of a US-funded study wherein unknowing Guatemalans were exposed to syphilis, gonorrhea, or chancroid sent shock waves throughout the scientific community. Prompted by this revelation, the Presidential Commission for the Study of Bioethical Issues has been convened to determine if current “standards adequately guard the health and well-being of participants in scientific studies supported by the Federal Government.” This communication revisits the statutory and regulatory framework undergirding federally sponsored human subject research and explores its continued relevance in a rapidly globalizing enterprise. The emerging patterns are daunting and disconcerting. Over half of all clinical trials registered with ClinicalTrials.gov (http://clinicaltrials.gov... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5082612 Thu, 26 May 2011 23:00:00 +0100 5082612 http://www.medworm.com/index.php?rid=5082624&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411000991%2Fabstract%3Frss%3Dyes Abstract: The recently proposed Rolling 6 Phase I study design is an alternative to the standard 3+3 patient cohort design. It was proposed as a way to reduce the time necessary to complete a trial by reducing the downtime during which Phase I trials are suspended for evaluation of dose-limiting toxicity (DLT). We performed a paired comparison of the Rolling 6 and 3+3 designs via a large simulation study over a wide spectrum of conditions defined by inter-patient arrival time, number of doses, DLT dose response slope, DLT dose response shape, and starting dose. Our results in general confirm that, on average, trials will be completed more quickly with the Rolling 6, with negligible penalty in terms of patient safety during the trial or as a result of the selected MTD, although the Rolling ... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5082624 Tue, 24 May 2011 23:00:00 +0100 5082624 http://www.medworm.com/index.php?rid=5082621&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411001005%2Fabstract%3Frss%3Dyes We present study design and methods for MI Values as well as data on feasibility of recruitment methods and treatment integrity. At study completion, findings will contribute to the emerging literature examining the efficacy of MI in the treatment of pediatric obesity. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5082621 Tue, 24 May 2011 23:00:00 +0100 5082621 http://www.medworm.com/index.php?rid=5082617&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411001030%2Fabstract%3Frss%3Dyes Discussion: Key differences with successful prevalence recruitment strategies highlight four main issues to consider when recruiting participants from primary care into iCBT studies — lack of equipoise, a need for an assertive approach, coding of depression in GP databases and help seeking behaviour in depression which can all act as potential contributors to failure to recruit. However other non-primary care recruitment methods, such as the use of media channels, which are already shown to be effective in non-primary care settings should be considered if these methods more accurately target the population who would be willing to adopt iCBT more generally. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5082617 Wed, 18 May 2011 23:00:00 +0100 5082617 http://www.medworm.com/index.php?rid=5082618&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411001054%2Fabstract%3Frss%3Dyes This study aimed to assess the attitudes of oncology physicians and nurses toward phase I, II, and III cancer clinical trials.Methods: A questionnaire was administered to 358 oncology physicians and nurses.Results: The effective response rate was 79.3%. Of the respondents, 67.6%, 95.1%, and 98.6% reported that cancer patients would benefit from phase I, II, and III trials, respectively. Respondents would also recommend that their patients participate in phase I (64.4%), II (88.4%), and III trials (95.1%). When asked to assume the role of cancer patients, the respondents themselves were willing to participate in phase I (48.2%), II (72.9%), and III trials (89.8%). Respondents who admitted having little or no understanding of cancer clinical trials were not willing to recommend participation... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5082618 Tue, 17 May 2011 23:00:00 +0100 5082618 http://www.medworm.com/index.php?rid=5082622&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS155171441100098X%2Fabstract%3Frss%3Dyes Abstract: Given the controversy about the comparative efficacy of first- compared with second-generation antipsychotics in the treatment of schizophrenia, more large-scale evidence is needed to guide clinicians in their prescriptions. Most randomized controlled trials (RCTs) were conducted in centers of excellence on highly selected samples, poorly representative of real-world patients, and often suffered conflicts of interest as they were sponsored by drug companies.The primary aim of the present study is to compare the effectiveness of haloperidol, olanzapine and aripiprazole in a representative sample of schizophrenia patients. The GiSAS trial is an open-label, independent, pragmatic RCT in Italian community-based public psychiatric services. At least 260 patients meeting the DSM-IV cri... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=5082622 Sun, 15 May 2011 23:00:00 +0100 5082622 http://www.medworm.com/index.php?rid=4880074&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411000966%2Fabstract%3Frss%3Dyes Abstract: Dealing with high placebo response remains a big challenge to conventional clinical trials for psychiatric disorders. A widely-used design strategy is to implement a placebo lead-in phase prior to randomization. The sequentially parallel design (SPD) proposed by Fava et al., which contains two consecutive double-blind treatment stages, has recently been promoted to reduce both the high placebo response and the required sample size in clinical trials for psychiatric disorders. Our work aims to study these two design strategies and evaluate the relevant statistical approaches for continuous measures under SPD in the presence of missing data.Based on the FDA archived database, we found that a longer placebo lead-in period seemed to help in identifying more placebo responders and thu... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=4880074 Thu, 12 May 2011 23:00:00 +0100 4880074 http://www.medworm.com/index.php?rid=4880065&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411000954%2Fabstract%3Frss%3Dyes Abstract: Randomised clinical trials are commonly undertaken in medical and dental research. However, few authors discuss the difficulties associated with such studies, including costs, ethical issues and recruitment of an adequate number of patients. There is little information available on the number of studies which are terminated early as a result of these issues, but it seems likely that at least 10% of clinical studies never reach completion.This paper reviews two nationally funded clinical studies which were terminated early. It highlights the problems associated with patient recruitment and also some issues which may benefit researchers undertaking similar studies in the future. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=4880065 Mon, 09 May 2011 23:00:00 +0100 4880065 http://www.medworm.com/index.php?rid=4880064&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411000942%2Fabstract%3Frss%3Dyes Conclusions: The manner in which cord blood is stored needs to be considered so that participation in future studies does not risk depletion of the cord blood supply. In addition, it appears that the process of storing umbilical cord blood leads to restricted demographic characteristics of eligible participants, which may impact recruitment in clinical trials. These results are relevant to designing future cord blood studies in T1D and other non-malignant diseases. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=4880064 Mon, 09 May 2011 23:00:00 +0100 4880064 http://www.medworm.com/index.php?rid=4880073&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411000917%2Fabstract%3Frss%3Dyes Conclusion: We hypothesize that treatment with bosentan, an endothelin-1 receptor antagonist, improves maximum exercise capacity and functional capacity in adult Fontan patients. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=4880073 Sun, 08 May 2011 23:00:00 +0100 4880073 http://www.medworm.com/index.php?rid=4880058&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411000930%2Fabstract%3Frss%3Dyes This study demonstrates the profoundly positive economic impact on the healthcare system in Taiwan by sponsored clinical trials. To understand the trend of economic benefits of the trials on pharmaceutical expenditure, it would be important to analyze the cost avoidance of trials regularly in an institution. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=4880058 Sun, 08 May 2011 23:00:00 +0100 4880058 http://www.medworm.com/index.php?rid=4880056&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411000929%2Fabstract%3Frss%3Dyes Editor, I read the recent publication on MRI trial with a great interest. Parker et al. concluded that brain MRI may not be an appropriate screening tool to evaluate potential neurotoxicity in subjects during routine clinical studies without a baseline examination .” Indeed, I am questionable about the rationale of this work. Since the neurotoxicity is extremely rare to present as structural defect that can be viewed by MRI test, it is suspected whether the implementation of MRI for usage in this trial is appropriate or not. If it is considered useless at first, it should not be done although the ethical committee approved the proposal. Indeed, any unnecessary thing should not be allowed although it is safety or has very few side effects (such as MRI). (Source: Contemporary Clinical Tria... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=4880056 Thu, 05 May 2011 23:00:00 +0100 4880056 http://www.medworm.com/index.php?rid=4880071&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411000875%2Fabstract%3Frss%3Dyes Abstract: Substantial evidence clearly demonstrates the deleterious effects of industrially-produced trans fatty acids (TFA); however, data are lacking from large, well controlled human feeding studies that directly compare the effects of industrially-produced and naturally-occurring TFA. The purpose of the current study is to determine whether consumption of TFA derived from different sources differentially affect risk factors of cardiovascular disease (CVD). The study was a randomized, crossover design, controlled-feeding intervention designed to compare the effects of the following diet treatments on risk factors of CVD: low TFA diet (base diet, 34% energy from fat; 0.1% energy from TFA), base diet with vaccenic acid (3.0% energy), base diet with mixed isomers of TFA from partially hydr... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=4880071 Mon, 02 May 2011 23:00:00 +0100 4880071 http://www.medworm.com/index.php?rid=4880057&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411000474%2Fabstract%3Frss%3Dyes Abstract: The design and analysis of cluster randomized trials can require more sophistication than individually randomized trials. However, the need for statistical methods that account for the clustered design has not always been appreciated, and past reviews have found widespread deficiencies in methodology and reporting. We reviewed cluster randomized trials of cancer screening interventions published in 1995–2010 to determine whether the use of appropriate statistical methods had increased over time. Literature searches yielded 50 articles reporting outcome analyses of cluster randomized trials of breast, cervix and colorectal cancer screening interventions. Of studies published in 1995–1999, 2000–2002, 2003–2006 and 2007–2010, 55% (6/11), 82% (9/11), 92% (12/13) and 60% (9/... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=4880057 Thu, 21 Apr 2011 23:00:00 +0100 4880057 http://www.medworm.com/index.php?rid=4880055&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411000887%2Fabstract%3Frss%3Dyes After publication of our recent trial of scarcity messages to boost recruitment to the txt2stop smoking cessation trial, we received correspondence asking whether those who joined the trial in response to these messages would have higher attrition rates versus those who joined without the scarcity messages. We have performed additional analysis to answer this question. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=4880055 Thu, 21 Apr 2011 23:00:00 +0100 4880055 http://www.medworm.com/index.php?rid=4880072&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411000905%2Fabstract%3Frss%3Dyes Discussion: Participation in both intervention arms during and following treatment for breast cancer was feasible and acceptable to women. Future work, designed to inform translation into practice, will evaluate the quality of life, clinical, psychosocial and behavioural outcomes associated with each mode of delivery. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=4880072 Sun, 17 Apr 2011 23:00:00 +0100 4880072 http://www.medworm.com/index.php?rid=4880070&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411000851%2Fabstract%3Frss%3Dyes Conclusions: Results indicate that trialists ought to consider Bayesian methods in addition to traditional approaches for analysis of clinical trials. Though findings from this small sample did not demonstrate either method to consistently outperform the other, they did suggest the need to replicate these comparisons using data from varied clinical trials in order to determine the conditions under which the different methods would be most efficient. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=4880070 Sun, 17 Apr 2011 23:00:00 +0100 4880070 http://www.medworm.com/index.php?rid=4880069&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411000863%2Fabstract%3Frss%3Dyes Abstract: Long-term weight-loss maintenance is notoriously difficult to achieve and promote. As the novelty of weight loss treatment fades, enthusiasm for diet and exercise tends to wane in the maintenance phase. Given the recognition of obesity as a chronic disorder requiring continued engagement in weight-control behaviors, there is a need to identify cost-effective and supportive therapies that can sustain motivation. In this paper, we describe the study design and baseline characteristics of participants enrolled in a trial to evaluate a program (Keep It Off) developed specifically for weight-loss maintenance using therapeutic phone contact with recent weight losers throughout the period in which they are at highest risk for weight regain. In the Keep It Off randomized clinical trial w... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=4880069 Thu, 14 Apr 2011 23:00:00 +0100 4880069 http://www.medworm.com/index.php?rid=4880063&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411000553%2Fabstract%3Frss%3Dyes Conclusions: Findings highlight the importance of country specific estimates for enrollment targets in longitudinal pediatric studies and suggest that enrollment estimates should be lowered when the study involves the general population, painful procedures, or makes multiple demands on families. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=4880063 Wed, 06 Apr 2011 23:00:00 +0100 4880063 http://www.medworm.com/index.php?rid=4880066&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411000486%2Fabstract%3Frss%3Dyes Abstract: A previous randomized clinical trial based on self-determination theory (SDT) and consistent with the Public Health Service (PHS) Guideline for Treating Tobacco Use and Dependence demonstrated that an intensive intervention could change autonomous self-regulation and perceived competence, which in part facilitated long-term tobacco abstinence. The current article describes a pragmatic comparative effectiveness trial of three SDT-based intensive tobacco-dependence interventions. Eligible participants are randomized to one of the three treatment conditions designed to facilitate long-term maintenance of tobacco abstinence, namely, Community Care (CC), which includes the 6month SDT-based intervention previously shown to promote autonomous self-regulation, perceived competence, medic... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=4880066 Sun, 03 Apr 2011 23:00:00 +0100 4880066 http://www.medworm.com/index.php?rid=4655677&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411000607%2Fabstract%3Frss%3Dyes (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=4655677 Wed, 30 Mar 2011 22:35:30 +0100 4655677 http://www.medworm.com/index.php?rid=4880068&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411000504%2Fabstract%3Frss%3Dyes Abstract: It is of vital importance to the success of a randomized clinical trial to maintain the balance of baseline characteristics (covariates) that could potentially confound the outcomes of the trial. Various randomization methods have been proposed to increase the likelihood of having balanced covariates at the end of a trial, most of which only apply to categorical covariates. An optimization approach to maintaining the balance of multiple covariates in randomized clinical trials is proposed, which is applicable to both continuous and categorical covariates and allows the covariates to be ranked according to their clinical importance as perceived by the clinical trial practitioners. Simulation results show that the proposed algorithm significantly outperforms the standard randomizat... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=4880068 Sun, 27 Mar 2011 23:00:00 +0100 4880068 http://www.medworm.com/index.php?rid=4880067&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411000516%2Fabstract%3Frss%3Dyes Abstract: Methods to easily, accurately, and efficiently obtain data in an ICU-based clinical trial can be challenging in this high-tech setting. Patient medical status and the dynamic nature of this clinical setting further complicate data collection. The purpose of this paper is to describe the modifications of commercially available headphones and the application of a data logging device to capture frequency and length of protocol use (music listening or headphones only for noise cancellation) without burdening participants or busy ICU nurses. With the automatic capture of protocol use by research participants, there have been no instances of lost data for this clinical trial. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=4880067 Sun, 27 Mar 2011 23:00:00 +0100 4880067 http://www.medworm.com/index.php?rid=4880062&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411000541%2Fabstract%3Frss%3Dyes Conclusions: Younger and less educated women were more difficult to retain in these microbicide trials. But these same traits may be associated with higher HIV infection rates. Enhanced retention methods focused on those at highest risk of non-retention and possibly infection will optimize study efficiency and validity. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=4880062 Sun, 27 Mar 2011 23:00:00 +0100 4880062 http://www.medworm.com/index.php?rid=4880061&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS155171441100053X%2Fabstract%3Frss%3Dyes Abstract: Introduction: Recruitment and retention of lactating women require unique strategies to prevent high attrition. The purpose of this report is to identify successful recruitment strategies and evaluate demographic and lifestyle characteristics associated with study completion.Methods: A randomized, controlled trial was initiated to test the hypothesis that lactating women adhering to a Mediterranean diet will show a significant reduction in anthropometric measurements as compared to lactating women randomized to the USDA's MyPyramid diet for Pregnancy and Breastfeeding (control diet). Measurements were collected at baseline, 2months, and 4months. Recruitment methods and baseline characteristics of completers and non-completers are described.Results: The largest percentage of women... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=4880061 Sun, 27 Mar 2011 23:00:00 +0100 4880061 http://www.medworm.com/index.php?rid=4880060&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411000528%2Fabstract%3Frss%3Dyes Conclusions: Proactive recruitment of smokers in the social networks of lung cancer patients is challenging. In this study, the majority of family members and friends declined to participate. Enlisting immediate female family members and friends, who live close to the patient as agents to proactively recruit other network members into smoking cessation trials could be used to extend reach of cessation interventions to patients' social networks. Moreover, further consideration should be given to the appropriate timing of approaching network smokers to consider cessation. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=4880060 Sun, 27 Mar 2011 23:00:00 +0100 4880060 http://www.medworm.com/index.php?rid=4880059&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411000498%2Fabstract%3Frss%3Dyes Conclusions: This research highlights the importance of: (1) dedicated compliance trial personnel in an adequate ratio to trial subjects; (2) inclusion in protocols of direct methods of measuring compliance; (3) prompt analysis of compliance data; (4) piloting of compliance data collection tools and (5) self-report paper diaries having questionable feasibility as a compliance data collection tool. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=4880059 Sun, 27 Mar 2011 23:00:00 +0100 4880059 http://www.medworm.com/index.php?rid=4655679&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411000450%2Fabstract%3Frss%3Dyes Conclusion: This report describes the first multicenter prospective study of a computerized safety surveillance system to monitor and evaluate the safety of new cardiovascular devices. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=4655679 Wed, 16 Mar 2011 00:00:00 +0100 4655679 http://www.medworm.com/index.php?rid=4655678&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411000462%2Fabstract%3Frss%3Dyes Recalls of several commonly used implantable medical devices after US Food and Drug Administration (FDA) approval have led to increasing scrutiny of the tools and techniques employed for assuring post-marketing medical device safety. The most established surveillance methods rely on a mix of mandatory and voluntary adverse event reporting systems, such as the MedSun system, MedWatch and the “Adverse Event Reporting System”. However, these systems are limited by their inability to assess accurate event rates due to event under-reporting and a lack of information regarding the total number of devices implanted. Other more recent mechanisms for monitoring the safety of devices, including mandated post-approval clinical registries, have been implemented to address the need to detect long t... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=4655678 Mon, 14 Mar 2011 00:00:00 +0100 4655678 http://www.medworm.com/index.php?rid=4655700&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411000449%2Fabstract%3Frss%3Dyes Conclusion: This intervention addresses childhood obesity prevention by using a family-based, synergistic approach, targeting at-risk children and their mothers during key transitional periods, and enhancing maternal self-regulation and responsive parenting as a foundation for health behavior change. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=4655700 Mon, 07 Mar 2011 00:00:00 +0100 4655700 http://www.medworm.com/index.php?rid=4655680&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411000437%2Fabstract%3Frss%3Dyes Abstract: It is not uncommon for a participant to withdraw from a randomized controlled trial (RCT). The withdrawal of a participant results in missing data and the potential for withdrawal bias. Data withdrawal, or a request from a participant to withdraw all of their previously collected data from a study, is particularly problematic because it leaves little opportunity to characterize or statistically address those that have withdrawn to minimize withdrawal bias. The aim of this commentary is to (1) provide a synthesis of available information on the ethical and methodological issues related to data withdrawal in RCTs and (2) provide some suggestions on how to minimize the impact of data withdrawal during the execution or analysis phases of an RCT. We searched PubMed, EMBASE and JSTOR f... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=4655680 Mon, 07 Mar 2011 00:00:00 +0100 4655680 http://www.medworm.com/index.php?rid=4655683&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411000073%2Fabstract%3Frss%3Dyes Conclusion: Instituting education programs based on the reasons reported by women for seeking enrollment in more than one trial and using a shared central database system to identify co-enrollments have effectively prevented further co-enrollments. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=4655683 Mon, 28 Feb 2011 00:00:00 +0100 4655683 http://www.medworm.com/index.php?rid=4655701&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411000425%2Fabstract%3Frss%3Dyes This study design will provide data to estimate the potential benefits and harms of using the Sedimentation Sign to guide surgical decisions. The observed proportion of discordant test results will help inform the design of future randomised controlled trials of the Sedimentation Sign. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=4655701 Thu, 24 Feb 2011 00:00:00 +0100 4655701 http://www.medworm.com/index.php?rid=4655699&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411000401%2Fabstract%3Frss%3Dyes Conclusions: Challenges remain in designing newly-diagnosed prostate cancer trials. Adaptive seamless design is time-saving and a cost-effective design in the development of novel medical therapies, but requires a specified statistical plan in the decision process involved. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=4655699 Thu, 24 Feb 2011 00:00:00 +0100 4655699 http://www.medworm.com/index.php?rid=4655687&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411000413%2Fabstract%3Frss%3Dyes Abstract: Successful recruitment and retention on trials is critical to ensuring that adequate power is conferred, results are generalisable and trials are completed within the allocated time and resources. Nested within an existing pragmatic randomised controlled trial a process evaluation was conducted to explore the reasons for a much higher than anticipated recruitment (120% of required sample size) and retention rate (96% completed follow-up).A questionnaire was designed to ascertain patient's views on reasons affecting consent and retention. 148 patients still enrolled in the trial at their final follow-up were either given or mailed a questionnaire of which 102 were returned (69%). 96% rated the written information as very or somewhat important in their decision to consent. Verbal i... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=4655687 Thu, 24 Feb 2011 00:00:00 +0100 4655687 http://www.medworm.com/index.php?rid=4655688&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411000140%2Fabstract%3Frss%3Dyes Abstract: Reaching out to medically underserved racial/ethnic groups is a key challenge in population research. To increase their participation opportunities, we asked adults attending community events to complete a survey about their health concerns and invited them to join a registry of individuals agreeing to future study invitation. Approximately 66% of the 2298 survey responders joined the registry. Multivariate analysis showed that Hispanics were more likely to agree to contact than Whites. Agreers endorsed a wider range of health concerns than non‐agreers. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=4655688 Thu, 17 Feb 2011 00:00:00 +0100 4655688 http://www.medworm.com/index.php?rid=4655698&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411000127%2Fabstract%3Frss%3Dyes Abstract: Purpose: There have been recent recommendations to use percentage change in tumor burden (dTB) as a primary endpoint in randomized Phase II trials. We assessed whether dTB is better for the decision to start a Phase III trial than is progression-free survival (PFS).Methods: We repeatedly sampled patients from six large randomized trials to obtain simulated Phase II trials. We derived PFS and dTB endpoints on the trial patients and determined the fraction of simulated trials with positive results for each endpoint. We supplemented these analyses with regression analyses to assess the ability of PFS and dTB to predict overall survival (OS).Results: The best PFS endpoint included tumor assessments through 6months after the last patient enrolled. With 70 patients in each simulated Ph... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=4655698 Mon, 14 Feb 2011 00:00:00 +0100 4655698 http://www.medworm.com/index.php?rid=4655697&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411000103%2Fabstract%3Frss%3Dyes Abstract: Autosomal dominant polycystic kidney disease (ADPKD) is the most common genetic kidney condition and is associated with important renal and cardiovascular manifestations in childhood. Renal cystic disease can be documented in some cases as early as in utero. Early intervention is critical if the long-term complications of this condition, including end-stage renal disease, are to be ameliorated. Here we describe our ongoing randomized double-blind placebo-controlled phase III clinical trial to assess the effect of pravastatin treatment on renal and cardiovascular disease progression in 107 children and young adults age 8–22years with ADPKD who are receiving the angiotensin converting enzyme inhibitor lisinopril. Baseline demographic and laboratory data are provided. Results of t... Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=4655697 Mon, 14 Feb 2011 00:00:00 +0100 4655697 http://www.medworm.com/index.php?rid=4655686&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411000097%2Fabstract%3Frss%3Dyes Conclusions: Successful participant recruitment and retention approaches need to be specific and consistent with clinical staff buy in throughout the project. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=4655686 Mon, 14 Feb 2011 00:00:00 +0100 4655686 http://www.medworm.com/index.php?rid=4655684&cid=s_35484_37_f&fid=35484&url=http%3A%2F%2Fwww.contemporaryclinicaltrials.com%2Farticle%2FPIIS1551714411000139%2Fabstract%3Frss%3Dyes Conclusion: A simple in-house training program is easy to implement and may help to improve GCP compliance. (Source: Contemporary Clinical Trials) Contemporary Clinical Trials journals http://www.medworm.com/rss/comments.php?id=4655684 Mon, 14 Feb 2011 00:00:00 +0100 4655684