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 'Trials' source. Thu, 18 Mar 2010 14:40:19 +0100 http://www.medworm.com/index.php?rid=3348329&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F11%2F1%2F27 DiscussionThe aim of this study is to evaluate the effectiveness and safety of JinQi JiangTang (JQJT) tablets for the treatment of patients with pre-diabetes.Trial registrationChinese clinical trials register ChiCTR-TRC-00000401 (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=3348329 Wed, 10 Mar 2010 00:00:00 +0100 3348329 http://www.medworm.com/index.php?rid=3348330&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F11%2F1%2F26 This study will help answer the question whether the 3L compression system or the SS compression system is associated with better outcomes.Trial Registration: ACTRN12608000599370 (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=3348330 Tue, 09 Mar 2010 00:00:00 +0100 3348330 http://www.medworm.com/index.php?rid=3324712&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F11%2F1%2F23 Correction to Protocol for the PINCER trial: a cluster randomised trial comparing the effectiveness of a pharmacist-led IT-based intervention with simple feedback in reducing rates of clinically important errors in medicines management in general practices (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=3324712 Tue, 02 Mar 2010 00:00:00 +0100 3324712 http://www.medworm.com/index.php?rid=3313151&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F11%2F1%2F20 Conclusions: Our study highlighted the lack of consideration of applicability of results in systematic reviews of research into 2 public health priorities: tobacco consumption and HIV infection. (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=3313151 Fri, 26 Feb 2010 00:00:00 +0100 3313151 http://www.medworm.com/index.php?rid=3313150&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F11%2F1%2F21 Background: In Major Depressive Disorder (MDD), the traditional belief of a delayed onset of antidepressants' effects has lead to the concept of current guidelines that treatment durations should be between 3-8 weeks before medication change in case of insufficient outcome. Post hoc analyses of clinical trials, however, have shown that improvement usually occurs within the first 10-14 days of treatment and that such early improvement (Hamilton Depression Rating Scale [HAMD] decrease [greater than or equal to]20%) has a substantial predictive value for final treatment outcome. Even more important, non-improvement (HAMD decrease (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=3313150 Fri, 26 Feb 2010 00:00:00 +0100 3313150 http://www.medworm.com/index.php?rid=3299933&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F11%2F1%2F19 This study investigates whether long-term daily bright light prevents worsening of sleep-wake rhythms and depressive symptoms in elderly people with memory complaints. Patients with early Alzheimer's Disease (AD), Mild Cognitive Impairment (MCI) and Subjective Memory Complaints (SMC), between the ages of 50 and 75, are included in a randomized double-blind placebo-controlled trial. For the duration of two years, patients are exposed to ~10,000 lux in the active condition or ~300 lux in the placebo condition, daily, for two half-hour sessions at fixed times in the morning and evening. Neuropsychological, behavioral, physiological and endocrine measures are assessed at baseline and follow-up every five to six months.DiscussionIf bright light therapy attenuates the worsening of sleep-wake rhy... Trials journals http://www.medworm.com/rss/comments.php?id=3299933 Tue, 23 Feb 2010 00:00:00 +0100 3299933 http://www.medworm.com/index.php?rid=3296264&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F11%2F1%2F17 Conclusions: Our systematic search yielded only one technique or intervention shown to improve adherence to eligibility criteria during enrolment into RCTs. Given the potential harm involved in recruiting patients into a clinical trial in violation of key eligibility criteria, future research is needed to better inform those conducting clinical trials of how best to prevent enrolment errors (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=3296264 Tue, 23 Feb 2010 00:00:00 +0100 3296264 http://www.medworm.com/index.php?rid=3296263&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F11%2F1%2F18 DiscussionResults of this trial will help to clarify the potential beneficial effects of JCPs for people with BPD and provide information to design a definitive trial.Trial Registration: Current Controlled Trials ISRCTN12440268 (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=3296263 Tue, 23 Feb 2010 00:00:00 +0100 3296263 http://www.medworm.com/index.php?rid=3285693&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F11%2F1%2F15 DiscussionThe particular value of this trial is the adaptation of common design components to the very specific features of complex dental prosthetic treatments. The pilot trial proved to be indispensable because it led to a number of adjustments in the study protocol that considerably improved the practicability. The expected results are of high clinical relevance and will show the efficacy of two common treatment approaches in terms of oral health. An array of secondary outcome measures will deliver valuable supplementary information. If the results can be implemented in the clinical practice, the daily dental care should strongly profit thereof.Trial registration: The trial is registered at ClinicalTrials.gov under ISRCTN68590603 (pilot trial) and ISRCTN97265367 (main trial). (Source: T... Trials journals http://www.medworm.com/rss/comments.php?id=3285693 Fri, 19 Feb 2010 00:00:00 +0100 3285693 http://www.medworm.com/index.php?rid=3285692&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F11%2F1%2F16 DiscussionADDITION-Leicester is the largest multiethnic (targeting >30% South Asian recruitment) community T2DM and vascular risk screening programme in the UK. By assessing feasibility and efficacy of T2DM screening, it will inform national disease prevention policy and contribute significantly to our understanding of the health care needs of UK South Asians.Trial registration: Clinicaltrial.gov (NCT00318032). (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=3285692 Fri, 19 Feb 2010 00:00:00 +0100 3285692 http://www.medworm.com/index.php?rid=3264560&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F11%2F1%2F14 DiscussionThe baseline oral condition in healthy subjects in the 2 groups did not differ significantly. After rinsing with the mouthwash containing ClO2 for 7 days, morning bad breath decreased as measured by the OM and reduced the concentrations of H2S, CH3SH and (CH3)2S measured by GC, were found. Moreover ClO2 mouthwash used over a 7-day period appeared effective in reducing plaque, tongue coating accumulation and the counts of Fusobacterium nucleatum in saliva. Future research is needed to examine long-term effects, as well as effects on periodontal diseases and plaque accumulation in a well-defined sample of halitosis patients and broader population samples.Trial registration: ClinicalTrials.gov NCT00748943 (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=3264560 Fri, 12 Feb 2010 00:00:00 +0100 3264560 http://www.medworm.com/index.php?rid=3245463&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F11%2F1%2F11 Conclusions: This work demonstrates the importance of feasibility studies in preparation for multicentre clinical trials. It confirmed the uncertainty amongst clinicians and patients about the clinical question, enabled assessment of the number of potentially eligible patients, the proportion of patients and clinicians prepared to participate and aspects of trial design which might encourage this. It showed that a clinical trial was feasible, but only if patients were recruited from across United Kingdom. (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=3245463 Fri, 05 Feb 2010 00:00:00 +0100 3245463 http://www.medworm.com/index.php?rid=3218500&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F11%2F1%2F9 In recognition of the benefits of transparent reporting, many peer-reviewed journals require that their authors be prepared to share their raw, unprocessed data with other scientists and/or state the availability of raw data in published articles. But little information on how data should be prepared for publication - or sharing - has emerged. In clinical research patient privacy and consent for use of personal health information are key considerations, but agreed-upon definitions of what constitutes anonymised patient information do not appear to have been established. We aim to address this issue by providing practical guidance for those involved in the publication process, by proposing a minimum standard for de-identifying datasets for the purposes of publication in a peer-reviewed biom... Trials journals http://www.medworm.com/rss/comments.php?id=3218500 Fri, 29 Jan 2010 00:00:00 +0100 3218500 http://www.medworm.com/index.php?rid=3202737&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F11%2F1%2F8 Conclusions: The results of this trial will clarify whether the systematic use of B-vitamins improves the response of older adults to standard antidepressant treatment. We anticipate that our findings will have implications for clinical practice and health policy development.Trial RegistrationThe trial is registered with the Australian Clinical Trials Registry,trial number ACTRN12609000256279. (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=3202737 Mon, 25 Jan 2010 00:00:00 +0100 3202737 http://www.medworm.com/index.php?rid=3173815&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F11%2F1%2F5 DiscussionIf we can demonstrate important improvements in the quality of patient care as a result of a quality improvement programme, this could lead to a greater acceptance that such programmes should be incorporated into routine health training for health professionals and hospital managers.Trial registration: Clinicaltrials.gov NCT00716430 (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=3173815 Thu, 14 Jan 2010 00:00:00 +0100 3173815 http://www.medworm.com/index.php?rid=3165462&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F11%2F1%2F4 DiscussionADAPT will determine whether tailored but low-cost interventions can lead to sustainable increases in PA behaviours. The results may have implications for practitioners in designing and implementing theory-based physical activity promotion programs for this population.Clinical Trials Registration: ClinicalTrials.gov identifier: NCT00221234 (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=3165462 Tue, 12 Jan 2010 00:00:00 +0100 3165462 http://www.medworm.com/index.php?rid=3161345&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F11%2F1%2F3 DiscussionThe COMPARE study will provide important evidence of effects of losartan treatment in adult Marfan patient population. We expect losartan to significantly reduce the occurrence and progression of aortic dilatation. This trial investigates a wide spectrum of clinical, genetic and biochemical effects of losartan aiming to provide further insight in the pathogenesis and treatment of Marfan syndrome.Trial registrationNetherlands Trial Register NTR1423. (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=3161345 Tue, 12 Jan 2010 00:00:00 +0100 3161345 http://www.medworm.com/index.php?rid=3158570&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F11%2F1%2F2 A good questionnaire design for a clinical trial will minimise bias and maximise precision in the estimates of treatment effect within budget. Attempts to collect more data than will be analysed may risk reducing recruitment (reducing power) and increasing losses to follow-up (possibly introducing bias). The mode of administration can also impact on the cost, quality and completeness of data collected. There is good evidence for design features that improve data completeness but further research is required to evaluate strategies in clinical trials. Theory-based guidelines for style, appearance, and layout of self-administered questionnaires have been proposed but require evaluation. (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=3158570 Mon, 11 Jan 2010 00:00:00 +0100 3158570 http://www.medworm.com/index.php?rid=3150918&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F11%2F1%2F1 Background: Paclitaxel-eluting stents decrease angiographic and clinical restenosis following percutaneous coronary intervention compared to bare metal stents. TAXUS Element is a third-generation paclitaxel-eluting stent which incorporates a novel, thinner-strut, platinum-enriched metal alloy platform. The stent is intended to have enhanced radiopacity and improved deliverability compared to other paclitaxel-eluting stents. The safety and efficacy of the TAXUS Element stent are being evaluated in the pivotal PERSEUS clinical trials. Methods: The PERSEUS trials include two parallel studies of the TAXUS Element stent in single, de novo coronary atherosclerotic lesions. The PERSEUS Workhorse study is a prospective, randomized (3:1), single-blind, non-inferiority trial in subjects with lesion ... Trials journals http://www.medworm.com/rss/comments.php?id=3150918 Thu, 07 Jan 2010 00:00:00 +0100 3150918 http://www.medworm.com/index.php?rid=3116967&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F122 The objective is to establish the evaluation index system for the integration of TCM and western medicine. The evaluation indexes which include TCM items will specify the research design and methods.MethodNine medical centers in different cities in China will participate in the trial. A population of 340 patients with HF will be enrolled through a central randomized system for different test groups. Group A will be treated with only western medicine, while group B with western and Chinese medicine together. The study will last for 12 months from the date of enrollment. The cardiovascular death will be the primary outcome.DiscussionBy putting the protocol into practice, the clinical effects of TCM for HF will be identified scientifically, objectively as well as rationally. The proper index ... Trials journals http://www.medworm.com/rss/comments.php?id=3116967 Thu, 24 Dec 2009 00:00:00 +0100 3116967 http://www.medworm.com/index.php?rid=3116970&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F119 The objective of the study is to evaluate the efficacy of the screening strategy aimed at revascularization. A cost-effectiveness analysis will be performed at the end of the follow up.DiscussionThe study will provide useful information about prevention and treatment of diabetic patients at high risk of coronary events. It will be made clearer if detection of silent coronary artery disease has to be recommended and followed by treatment. Given the simplicity of the study protocol, it will be easily transferable to the real world.Trial registration: (ClinicalTrials.gov): NCT00547872 (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=3116970 Wed, 23 Dec 2009 00:00:00 +0100 3116970 http://www.medworm.com/index.php?rid=3116969&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F120 We present the rationale and study design of the WEB-based distress management program for implantable CARdioverter dEfibrillator patients (WEBCARE) trial. Methods: WEBCARE is a multi-center, multi-disciplinary, randomized, controlled behavioral intervention trial designed to examine the effectiveness of a web-based approach in terms of reducing levels of anxiety and device concerns and enhancing QoL. Consecutive patients hospitalized for the implantation of an ICD will be approached for study participation while in hospital and randomized to the intervention arm (n = 175) versus usual care (n = 175) at baseline (5-10 days post implantation). Patients will complete assessments of patient-centered outcomes at baseline, 14, 26, and 52 weeks after implantation. Patients randomized to the inte... Trials journals http://www.medworm.com/rss/comments.php?id=3116969 Wed, 23 Dec 2009 00:00:00 +0100 3116969 http://www.medworm.com/index.php?rid=3116968&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F121 Background: The standard of care for metastatic gastric cancer (MGC) is systemic chemotherapy which leads to a median survival of 6-15 months. Survival beyond 3 years is rare. For selected groups of patients with limited MGC, retrospective studies have shown improved overall survival following gastrectomy and metastasectomies including peritoneal stripping with continuous hyperthermic peritoneal perfusion (CHPP), liver resection, and pulmonary resection. Median survival after liver resection for MGC is up to 34 months, with a five year survival rate of 24.5%. Similarly, reported median survival after pulmonary resection of MGC is 21 months with long term survival of greater than 5 years a possibility. Several case reports and small studies have documented evidence of long-term survival in ... Trials journals http://www.medworm.com/rss/comments.php?id=3116968 Wed, 23 Dec 2009 00:00:00 +0100 3116968 http://www.medworm.com/index.php?rid=3112964&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F118 Conclusion: The inherent challenges of a rare clinical condition (pN1) and two substantially different therapy arms would limit the practicality of a classical randomized study. The concept of a Comprehensive Cohort Design combines the preference of a randomized study, with the option of careful data interpretation within an observational study.Trial registration: ClinicalTrials.gov: NCT00964977 (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=3112964 Wed, 23 Dec 2009 00:00:00 +0100 3112964 http://www.medworm.com/index.php?rid=3094265&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F116 Conclusions: Trial registration alone, without a requirement for full reporting of research results, does not appear to reduce a bias toward results and conclusions favoring new drugs in the clinical trials literature. Our findings support the inclusion of full results reporting in trial registers, as well as protocols to allow assessment of whether results have been completely reported. (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=3094265 Wed, 16 Dec 2009 00:00:00 +0100 3094265 http://www.medworm.com/index.php?rid=3086784&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F115 DiscussionSWABIMS is designed to give further information about the therapeutic effect of atorvastatin 40mg per os daily as add-on therapy to interferon beta-1b in patients with relapsing-remitting multiple sclerosis. Furthermore important safety and tolerability data will be generated.Trial Registration: http://www.clinicaltrials.gov. Identifier: NCT00942591; Swissmedic reference number: 2005DR2119 (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=3086784 Mon, 14 Dec 2009 00:00:00 +0100 3086784 http://www.medworm.com/index.php?rid=3083651&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F114 DiscussionThe proposed project will produce the best available evidence on the merits of increased cognitive activity as a strategy to prevent cognitive decline among older adults with MCI. We anticipate that the results of this study will have implications for the development of evidence-based preventive strategies to reduce the rate of cognitive decline amongst older people at risk of dementia.Trial registration: ACTRN12608000556347 (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=3083651 Mon, 14 Dec 2009 00:00:00 +0100 3083651 http://www.medworm.com/index.php?rid=3077369&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F113 Background: Bisphosphonates can reduce fracture risk in patients with osteoporosis, but many at-risk patients do not start or adhere to these medications. The aims of this study are to: (1) preliminarily evaluate the effect of an individualized 10-year osteoporotic fracture risk calculator and decision aid (OSTEOPOROSIS CHOICE) for postmenopausal women at risk for osteoporotic fractures; and (2) assess the feasibility and validity (i.e., absence of contamination) of patient-level randomization (vs. cluster randomization) in pilot trials of decision aid efficacy. Methods: This is a protocol for a parallel, 2-arm, randomized trial to compare an intervention group receiving OSTEOPOROSIS CHOICE to a control group receiving usual primary care. Postmenopausal women with bone mineral density T-sc... Trials journals http://www.medworm.com/rss/comments.php?id=3077369 Thu, 10 Dec 2009 00:00:00 +0100 3077369 http://www.medworm.com/index.php?rid=3054421&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F112 DiscussionThe results of this trial will be used as a basis for clarifying the efficacy of acupuncture for dry eye.Trial registration: ClinicalTrials.gov NCT00969280. (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=3054421 Thu, 03 Dec 2009 00:00:00 +0100 3054421 http://www.medworm.com/index.php?rid=3050090&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F109 Conclusions: This trial did not reach the planned sample size of 400 patients and consequently, the study power to detect an increase in the risk of serious adverse events was reduced. This trial provides no reliable evidence of benefit or harm and a larger trial would be needed to establish safety and effectiveness.This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN23625128. (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=3050090 Thu, 03 Dec 2009 00:00:00 +0100 3050090 http://www.medworm.com/index.php?rid=3050089&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F110 A response to and comment on The BRAIN TRIAL: a randomised, placebo controlled trial of a Bradykinin B2 receptor antagonist (Anatibant) in patients with traumatic brain injury, by Haleema Shakur, Ian Roberts, et al. (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=3050089 Thu, 03 Dec 2009 00:00:00 +0100 3050089 http://www.medworm.com/index.php?rid=3050088&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F111 A response to the letter regarding The BRAIN TRIAL: a randomized, placebo controlled trial of a Bradykinin B2 receptor antagonist (Anatibant) in patients with traumatic brain injury, by Mr Vincent Simmon President and CEO of Xytis Inc. (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=3050088 Thu, 03 Dec 2009 00:00:00 +0100 3050088 http://www.medworm.com/index.php?rid=3035167&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F108 The UK has a strong tradition of innovative evaluative health care research. There are, however, considerable forces impeding collaboration between clinicians, academics, patients and their advocates and industry. This paper argues that, if the UK is to regain a position at the forefront of clinical research into evaluation of care, some of these forces need to be overcome. Now, with explicit encouragement from funders within the UK's NHS, it is urgent that all parties discover better ways of working together so that more broad and meaningful research can be produced in a timely fashion. (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=3035167 Fri, 27 Nov 2009 00:00:00 +0100 3035167 http://www.medworm.com/index.php?rid=3017906&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F107 The objective of the POC-OP trial is to determine the effectiveness of point of care prothrombin time testing to reduce the administration of FFP. It is a patient and assessor blind, single center randomized controlled parallel group trial in 220 patients aged between 18 and 90 years undergoing major surgery (any type, except cardiac surgery and liver transplantation) with an estimated blood loss during surgery exceeding 20% of the calculated total blood volume or a requirement of FFP according to the judgment of the physicians in charge. Patients are randomized to usual care plus point of care prothrombin time testing or usual care alone without point of care testing. The primary outcome is the relative risk to receive any FFP perioperatively. The inclusion of 110 patients per group will ... Trials journals http://www.medworm.com/rss/comments.php?id=3017906 Mon, 23 Nov 2009 00:00:00 +0100 3017906 http://www.medworm.com/index.php?rid=3014095&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F105 We describe a feasibility study of randomizing head injured patients to hypertonic saline and dextran vs. normal saline administration in the out of hospital setting. Methods: This feasibility study employs a randomized, placebo-controlled design evaluating normal saline compared with a single dose of 250 ml of 7.5% hypertonic saline in 6% dextran 70 in the management of traumatic brain injuries. The primary feasibility endpoints of the trial were: 1) baseline survival rates for the treatment and control group to aid in the design of a definitive multicentre trial, 2) randomization compliance rate, 3) ease of protocol implementation in the out-of-hospital setting, and 4) adverse event rate of HSD infusion.The secondary objectives include measuring the effect of HSD in modulating the immuno... Trials journals http://www.medworm.com/rss/comments.php?id=3014095 Fri, 20 Nov 2009 00:00:00 +0100 3014095 http://www.medworm.com/index.php?rid=3001724&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F103 Conclusions: Although our trial failed to find significant differences in VAS, QALYs and ICERs based on VAS and QALYs at one-year follow-up, CEACs suggest that postural exercise therapy according to Mensendieck / Cesar has a higher probability of being cost-effective compared to regular physiotherapy; however further research is required.Trial registration: ISRCTN 15872455 (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=3001724 Tue, 17 Nov 2009 00:00:00 +0100 3001724 http://www.medworm.com/index.php?rid=3001723&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F104 Background: Preeclampsia (PE) is a common maternal disease that complicates 5 to 10% of pregnancies and remains as the major cause of maternal and neonatal mortality. Cost-effective interventions aimed at preventing the development of preeclampsia are urgently needed. However, the pathogenesis of PE is not well known. Multiple mechanisms such as oxidative stress, endothelial dysfunction and insulin resistance may contribute to its development. Regular aerobic exercise recovers endothelial function; improves insulin resistance and decreases oxidative stress. Therefore the purpose of this clinical trial is to determine the effect of regular aerobic exercise on endothelial function, on insulin resistance and on pregnancy outcome.Methods and design: 64 pregnant women will be included in a blin... Trials journals http://www.medworm.com/rss/comments.php?id=3001723 Tue, 17 Nov 2009 00:00:00 +0100 3001723 http://www.medworm.com/index.php?rid=2975267&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F101 The objectives of this study are: 1) to describe the reporting of subgroup analyses and claims of subgroup effects in randomized controlled trials, 2) to assess study characteristics associated with reporting of subgroup analyses and with claims of subgroup effects, and 3) to examine the analysis, and interpretation of subgroup effects for each study's primary outcome. Methods: We will conduct a systematic review of 464 randomized controlled human trials published in 2007 in the 118 Core Clinical Journals defined by the National Library of Medicine. We will randomly select journal articles, stratified in a 1:1 ratio by higher impact versus lower impact journals. According to 2007 ISI total citations, we consider the New England Journal of Medicine, JAMA, Lancet, Annals of Internal Medicine... Trials journals http://www.medworm.com/rss/comments.php?id=2975267 Mon, 09 Nov 2009 00:00:00 +0100 2975267 http://www.medworm.com/index.php?rid=2979237&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F100 The conduct of clinical trials in the UK has been affected by the recent introduction of managed clinical networks, clinical research networks and rigorous governance regulations. This commentary considers the challenges that these changes have posed for clinical triallists in the UK, based on experiences derived in the conduct of a multicentre neonatal clinical trial under the conditions that now prevail. We conclude that the considerable skills and knowledge that are now required to be an effective Principal Investigator should be recognised and that application processes, including issuing honorary contracts, should be simplified and centralised. (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=2979237 Wed, 04 Nov 2009 00:00:00 +0100 2979237 http://www.medworm.com/index.php?rid=2965255&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com The conduct of clinical trials in the UK has been affected by the recent introduction of managed clinical networks, clinical research networks and rigorous governance regulations. This commentary considers the challenges that these changes have posed for clinical triallists in the UK, based on experiences derived in the conduct of a multicentre neonatal clinical trial under the conditions that now prevail. We conclude that the considerable skills and knowledge that are now required to be an effective Principal Investigator should be recognised and that application processes, including issuing honorary contracts, should be simplified and centralised. (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=2965255 Wed, 04 Nov 2009 00:00:00 +0100 2965255 http://www.medworm.com/index.php?rid=2918090&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F98 DiscussionThe ECO-PLEASANT trial is the study not yet performed to directly compare the efficacy and safety of the Coroflex PleaseTM versus Taxus LiberteTM stent. On the basis of this trial, we will be able to find out whether the Coroflex PleaseTM stent is non-inferior to Taxus LiberteTM stent or not.Trial registration: ClinicalTrials.gov number, NCT00699543. (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=2918090 Thu, 22 Oct 2009 23:00:00 +0100 2918090 http://www.medworm.com/index.php?rid=2910379&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F96 Conclusion: Results of this trial will help clarify the value of two types of massage therapy for chronic low back pain.Trial registration: Clinical Trials.gov NCT 00371384. (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=2910379 Mon, 19 Oct 2009 23:00:00 +0100 2910379 http://www.medworm.com/index.php?rid=2896607&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F95 Conclusion: The list of clinical research categories as used for the survey could serve as a contribution to the, much needed, task of harmonisation and simplification of the regulatory requirements for clinical research in Europe. (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=2896607 Thu, 15 Oct 2009 23:00:00 +0100 2896607 http://www.medworm.com/index.php?rid=2906562&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F94 DiscussionThis is a randomised controlled patient and observer blinded two-group parallel trial designed to assess efficacy and safety of infrahepatic IVC clamping during elective hepatectomy.Trial registration: ClinicalTrials NCT00732979 (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=2906562 Mon, 12 Oct 2009 23:00:00 +0100 2906562 http://www.medworm.com/index.php?rid=2888408&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F94 DiscussionThis is a randomised controlled patient and observer blinded two-group parallel trial designed to assess efficacy and safety of infrahepatic IVC clamping during elective hepatectomy.Trial registration: ClinicalTrials NCT00732979 (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=2888408 Mon, 12 Oct 2009 23:00:00 +0100 2888408 http://www.medworm.com/index.php?rid=2840423&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F91 DiscussionThe COBBANA trial aims to assess, whether the haemostatic effect of Lyostypt is superior to Surgicel in suture hole bleedings of arterial bypass anastomoses.Trial registrationNCT00837954 (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=2840423 Mon, 28 Sep 2009 23:00:00 +0100 2840423 http://www.medworm.com/index.php?rid=2837342&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F90 This study has been designed to investigate whether intracoronary bolus administration of abciximab is more effective than intravenous bolus administration in improving myocardial perfusion in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention with thrombus aspiration. Methods: The Comparison of IntraCoronary versus intravenous abciximab administration during Emergency Reperfusion Of ST-segment elevation myocardial infarction (CICERO) trial is a single-center, prospective, randomized open-label trial with blinded evaluation of endpoints. A total of 530 patients with STEMI undergoing primary percutaneous coronary intervention are randomly assigned to either an intracoronary or intravenous bolus of weight-adjusted abciximab. The pri... Trials journals http://www.medworm.com/rss/comments.php?id=2837342 Sun, 27 Sep 2009 23:00:00 +0100 2837342 http://www.medworm.com/index.php?rid=2830037&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F89 Background: Anterior open treatment of the inguinal hernia with a tension free mesh has reduced the incidence of recurrence and direct postoperative pain. The Lichtenstein procedure rules nowadays as reference technique for hernia treatment. Not recurrences but chronic pain is the main postoperative complication in inguinal hernia repair after Lichtenstein's technique. Preliminary experiences with a soft mesh placed in the preperitoneal space showed good results and less chronic pain.MethodSThe TULIP is a double-blind randomised controlled trial in which 300 patients will be randomly allocated to anterior inguinal hernia repair according to Lichtenstein or the transinguinal preperitoneal technique with soft mesh. All unilateral primary inguinal hernia patients eligible for operation who me... Trials journals http://www.medworm.com/rss/comments.php?id=2830037 Thu, 24 Sep 2009 23:00:00 +0100 2830037 http://www.medworm.com/index.php?rid=2826297&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F88 DiscussionThis pragmatic clinical trial evaluating group follow-up after a structured education programme has been designed to have broad generalisability. The results should inform how best to manage the well educated patient with Type 1 diabetes in the real world of clinical practiceTrial registration: Current Controlled Trials ISRCTN79759174 (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=2826297 Tue, 22 Sep 2009 23:00:00 +0100 2826297 http://www.medworm.com/index.php?rid=2816683&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F87 This study protocol tests whether a novel structured mobile phone intervention can positively contribute to ART management in a resource-limited setting.Trial Registration Number: NCT00830622 (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=2816683 Mon, 21 Sep 2009 23:00:00 +0100 2816683 http://www.medworm.com/index.php?rid=2805893&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F85 The objective of this trial is to evaluate the effectiveness of the ALARM International Program (AIP) in reducing maternal mortality in referral hospitals in Senegal and Mali. Secondary goals include evaluation of the relationships between effectiveness and resource availability, service organization, medical practices, and satisfaction among health personnel. Methods: This is an international, multi-centre, controlled cluster-randomized trial of a complex intervention. The intervention is based on the concept of evidence-based practice and on a combination of two approaches aimed at improving the performance of health personnel: 1) Educational outreach visits; and 2) the implementation of facility-based maternal death reviews.The unit of intervention is the public health facility equipped... Trials journals http://www.medworm.com/rss/comments.php?id=2805893 Thu, 17 Sep 2009 23:00:00 +0100 2805893 http://www.medworm.com/index.php?rid=2791743&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F84 DiscussionIn contrast to former trials on information programs on the ICU-stay our intervention will take place in the ICU itself. This approach will ensure to compensate for memory effects due to anesthesia or preoperative stress. Further the results will be applicable to non-elective ICU-patients.Trial RegistrationClinicalTrials NCT00764933 (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=2791743 Sun, 13 Sep 2009 23:00:00 +0100 2791743 http://www.medworm.com/index.php?rid=2780215&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F83 DiscussionThe REFINE study is the first randomised controlled trial of bedside pressure sensors in elderly inpatients in an acute NHS Trust. We will assess whether falls can be successfully and cost effectively reduced using this technology, and report on its acceptability to both patients and staff.ISRCTN trial number : ISRCTN44972300. (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=2780215 Wed, 09 Sep 2009 23:00:00 +0100 2780215 http://www.medworm.com/index.php?rid=2764194&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F80 Conclusions: Based on differences in costs, small-incision cholecystectomy seems to be the preferred operative technique over the laparoscopic technique both from a hospital and societal cost perspective. Sick leave associated with convalescence after cholecystectomy in employed patients results in considerable costs to society.Trial registration ISRCTN Register, number ISRCTN67485658. (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=2764194 Thu, 03 Sep 2009 23:00:00 +0100 2764194 http://www.medworm.com/index.php?rid=2754794&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F79 Conclusions: The original participant information sheet may not have enabled patients fully to give valid consent. Participants seeing the revised sheet were better able to understand the trial. Those who write information for trial participants should take account of good practice in information design. Performance-based User Testing may be a useful method to indicate strengths and weaknesses in trial information. (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=2754794 Mon, 31 Aug 2009 23:00:00 +0100 2754794 http://www.medworm.com/index.php?rid=2732106&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F78 Conclusion: Psycho-educational treatment appears to be beneficial in diabetic patients with mild to moderate depressive symptoms, but its effects are comparable with the non-specific support given to the subjects in the control group.Trial registration: Current Controlled Trials ISRCTN58745372 (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=2732106 Tue, 25 Aug 2009 23:00:00 +0100 2732106 http://www.medworm.com/index.php?rid=2726181&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F77 This study will hopefully assist in contributing to the question of the efficacy of the timing of surgery in traumatic thoracolumbar SCI.RCT registration number: ISRCTN61263382 (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=2726181 Sun, 23 Aug 2009 23:00:00 +0100 2726181 http://www.medworm.com/index.php?rid=2723732&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F75 DiscussionThe important features of this trial include the randomization procedures (controlled by a central randomization system), a standardized protocol of acupuncture manipulation, and the fact that this is the first multicenter randomized trial of FD and acupuncture to be performed in China. The results of this trial will determine whether acupuncture is an effective treatment for FD and whether using different acupoints or different meridians leads to differences in clinical efficacy.Trial registration number: Clinical Trials.gov Identifier: NCT00599677. (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=2723732 Sat, 22 Aug 2009 23:00:00 +0100 2723732 http://www.medworm.com/index.php?rid=2723731&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F76 Conclusions: Prospective participants in an online clinical trial encountered a number of barriers to enrollment that led them to request help from study staff. Questions about the complex enrollment process itself were common. In a complex multi-step enrollment process, providing personalized feedback to potential participants indicating their status within the enrollment process may be beneficial.Trial Registration: ClinicalTrials.gov NCT00729040 (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=2723731 Sat, 22 Aug 2009 23:00:00 +0100 2723731 http://www.medworm.com/index.php?rid=2717998&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F74 Background: Tinnitus, the perception of sound and noise in absence of an auditory stimulus, has been shown to be associated with maladaptive neuronal reorganization and increased activity of the temporoparietal cortex. Transient modulation of tinnitus by repetitive transcranial magnetic stimulation (rTMS) indicated that this area is critically involved in the pathophysiology of tinnitus and suggested new treatment strategies. However, the therapeutic efficacy of rTMS in tinnitus is still unclear, individual response is variable, and the optimal stimulation area disputable. Recently, continuous Theta burst stimulation (cTBS) has been put forward as an effective rTMS protocol for the reduction of pathologically enhanced cortical excitability. Methods: 48 patients with chronic subjective tinn... Trials journals http://www.medworm.com/rss/comments.php?id=2717998 Thu, 20 Aug 2009 23:00:00 +0100 2717998 http://www.medworm.com/index.php?rid=2714222&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F73 Conclusions: Our findings suggest use of moderate doses of clonidine in acute organophosphate poisoning can be used without causing frequent clinical problems but that higher doses are associated with a high incidence of hypotension requiring intervention. Further studies are needed to study the efficacy of clonidine as an antidote in organophosphate poisoning.Trial registration: Current Controlled Trial ISRCTN89917816. (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=2714222 Wed, 19 Aug 2009 23:00:00 +0100 2714222 http://www.medworm.com/index.php?rid=2714223&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F72 This study will help to answer the question whether the "early total care" or the damage control" concept is associated with better outcome.Trial registration: Current Controlled Trials ISRCTN10321620 (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=2714223 Tue, 18 Aug 2009 23:00:00 +0100 2714223 http://www.medworm.com/index.php?rid=2701070&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F69 Background: The standard way to stop smoking is to stop abruptly on a quit day with no prior reduction in consumption of cigarettes. Many smokers feel that reduction is natural and if reduction programmes were offered, many more might take up treatment. Few trials of reduction versus abrupt cessation have been completed. Most are small, do not use pharmacotherapy, and do not meet the standards necessary to obtain a marketing authorisation for a pharmacotherapy.Design/MethodsWe will conduct a non-inferiority randomised trial of rapid reduction versus standard abrupt cessation among smokers who want to stop smoking. In the reduction arm, participants will be advised to reduce smoking consumption by half in the first week and to 25% of baseline in the second, leading up to a quit day at which... Trials journals http://www.medworm.com/rss/comments.php?id=2701070 Thu, 13 Aug 2009 23:00:00 +0100 2701070 http://www.medworm.com/index.php?rid=2701069&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F70 Conclusion: The present analysis suggests a clinical superiority of injectable diacetylmorphine compared to oral methadone in the treatment of severely affected heroin injectors not benefiting sufficiently from the available treatments.Trial Registration: Current Controlled Trials ISRCTN52023186 (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=2701069 Thu, 13 Aug 2009 23:00:00 +0100 2701069 http://www.medworm.com/index.php?rid=2701068&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F71 This study aims to tackle some of the main barriers to use of stop smoking services and adherence to treatment programmes by redesigning service delivery to be more acceptable to these adult male populations. The study compares the effectiveness of trained Pakistani and Bangladeshi smoking cessation workers operating in an outreach capacity ('clinic + outreach') with standard care ('clinic only') to improve access to and success of National Health Service smoking cessation services. Methods: This is a pilot cluster randomised controlled trial based in Birmingham, UK. Super output areas of Birmingham will be identified in which more than 10% of the population are of Pakistani and/or Bangladeshi origin. From these areas, 'natural geographical communities' will be identified. Sixteen aggregat... Trials journals http://www.medworm.com/rss/comments.php?id=2701068 Thu, 13 Aug 2009 23:00:00 +0100 2701068 http://www.medworm.com/index.php?rid=2697668&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F68 Conclusions: The intervention did not change the primary outcome or most secondary outcomes. Recruitment targets were not achieved and the under-recruitment of practices and patients alongside a selection bias of participating GPs, prohibit definite conclusions, but the CI indicates a non-effectiveness of the intervention in this sample. We describe the lessons learned from conducting the trial for the future planning and conduct of confirmatory trials in primary care.Trial registration number: ISRCTN08601529. (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=2697668 Wed, 12 Aug 2009 23:00:00 +0100 2697668 http://www.medworm.com/index.php?rid=2689992&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F67 Conclusion: The findings from this small scale quasi-randomised trial showed that exercise therapy was effective in improving activities of daily living and perceived health status in patients with Parkinson's disease. Indeed, exercise therapy could be offered to patients with Parkinson disease, considering that it is low in cost and usually has no negative side effects.Trial registration: Current Controlled Trials ISRCTN98825027 (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=2689992 Mon, 10 Aug 2009 23:00:00 +0100 2689992 http://www.medworm.com/index.php?rid=2661651&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F65 DiscussionThe DIAPERIO trial will provide insight into the question of whether periodontal treatment could lead to an improvement in glycaemic control in metabolically unbalanced diabetic patients suffering from periodontitis. The results of this trial will help to provide evidence-based recommendations for clinicians and a draft framework for designing national health policies.Trial registrationCurrent Controlled Trials ISRCTN15334496 (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=2661651 Sat, 01 Aug 2009 23:00:00 +0100 2661651 http://www.medworm.com/index.php?rid=2655423&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F63 Background: Continuous medical education is traditionally reliant to a large extent on self-directed learning based on individuals' perceived learning priorities. Evidence suggests that this ability to self-assess is limited, and more so in the least competent. Therefore, it may be of benefit to utilise some form of external assessment for this purpose. Many diabetes educational programmes have been introduced, but few have been assessed for their benefit in a systematic manner. As diabetes is an increasingly prevalent disease, methods for the dissemination and understanding of clinical guidelines need to be explored for their effectiveness. This paper describes the study design of a randomised controlled trial to evaluate the effectiveness of using an interactive online Diabetes Needs Ass... Trials journals http://www.medworm.com/rss/comments.php?id=2655423 Wed, 29 Jul 2009 23:00:00 +0100 2655423 http://www.medworm.com/index.php?rid=2655422&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F64 DiscussionOur Cochrane review (2005) on reminiscence therapy for people with dementia did not identify any rigorous trials or economic analyses in this field.Trial Registration: ISRCTN42430123 (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=2655422 Wed, 29 Jul 2009 23:00:00 +0100 2655422 http://www.medworm.com/index.php?rid=2647190&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F62 DiscussionThe CE-MARC study is a prospective, diagnostic accuracy cohort study of 750 patients assessing the performance of a multi-parametric CMR study in detecting CHD using invasive X-ray coronary angiography as the reference standard and comparing it with ETT and SPECT.Trial Registration: Current Controlled Trials ISRCTN77246133 (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=2647190 Tue, 28 Jul 2009 23:00:00 +0100 2647190 http://www.medworm.com/index.php?rid=2647191&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F61 Background: Cluster randomized trials are an increasingly important methodological tool in health research. In cluster randomized trials, intact social units or groups of individuals, such as medical practices, schools, or entire communities -- rather than individual themselves -- are randomly allocated to intervention or control conditions, while outcomes are then observed on individual cluster members. The substantial methodological differences between cluster randomized trials and conventional randomized trials pose serious challenges to the current conceptual framework for research ethics. The ethical implications of randomizing groups rather than individuals are not addressed in current research ethics guidelines, nor have they even been thoroughly explored. The main objectives of thi... Trials journals http://www.medworm.com/rss/comments.php?id=2647191 Mon, 27 Jul 2009 23:00:00 +0100 2647191 http://www.medworm.com/index.php?rid=2643112&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F60 Background: Prospective, international, multi-centre, randomised (1:1) trial to evaluate the clinical impact of percutaneous transluminal renal artery stenting (PTRAS) on the impaired renal function measured by the estimated glomerular filtration rate (eGFR) in patients with haemodynamically significant atherosclerotic renal artery stenosis. Methods: Patients will be randomised to receive either PTRAS using the Dynamic Renal Stent system plus best medical treatment or best medical treatment. Renal stenting will be performed under angiographic imaging. For patients randomised to best medical treatment the degree of stenosis measured by renal duplex sonography (RDS) will be confirmed by MR angio or multi-slice CT where possible. Best medical treatment will be initiated at randomisation or po... Trials journals http://www.medworm.com/rss/comments.php?id=2643112 Sun, 26 Jul 2009 23:00:00 +0100 2643112 http://www.medworm.com/index.php?rid=2640885&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F59 This study examines whether an internet-based self-help intervention with a coach is more effective than the same intervention without a coach in terms of clinical outcomes, drop-out and economic costs. Moreover, we will investigate which level of support by a coach is more effective compared to other levels of support. Methods: In this randomized controlled trial, a total of 500 subjects (18 year and older) from the general population with mild to moderate depression and/or anxiety will be assigned to one of five conditions: (1) web-based problem solving through the internet (self-examination therapy) without a coach; (2) the same as 1, but with the possibility to ask help from a coach on the initiative of the respondent (on demand, by email); (3) the same as 1, but with weekly scheduled ... Trials journals http://www.medworm.com/rss/comments.php?id=2640885 Sun, 26 Jul 2009 23:00:00 +0100 2640885 http://www.medworm.com/index.php?rid=2640886&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F58 Conclusion: Most perioperative standards within the centres participating in the DISPACT trial are in accordance with current available evidence. The need for drainages requires further investigation.Clinical trial registration: ISRCTN 18452029 (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=2640886 Sat, 25 Jul 2009 23:00:00 +0100 2640886 http://www.medworm.com/index.php?rid=2635937&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F57 DiscussionThere is considerable debate about the clinical and cost effectiveness of anti-dementia drugs. DOMINO-AD seeks to provide clear evidence on the best treatment strategies for those managing patients at a particularly important clinical transition point.Trial registrationCurrent controlled trials ISRCTN49545035 (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=2635937 Thu, 23 Jul 2009 23:00:00 +0100 2635937 http://www.medworm.com/index.php?rid=2623628&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F56 Conclusions: While the launch of the WHO minimum data set seemed to positively influence registries with better standardisation of approaches, individual registry entries are largely incomplete. Initiatives to ensure quality assurance of registries and trial data should be encouraged. Peer reviewers and editors should scrutinise clinical trial registration records to ensure consistency with WHO's core content requirements when considering trial-related publications. (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=2623628 Tue, 21 Jul 2009 23:00:00 +0100 2623628 http://www.medworm.com/index.php?rid=2604051&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F55 The number of reports of clinical trials grows by hundreds every week. However, this does not mean that people making decisions about health care are finding it easier to obtain reliable knowledge for these decisions. Some of the information is unreliable. Systematic reviews are helping to resolve this by bringing together the research on a topic, appraising and summarising it. But the quality of these reviews depends greatly on the quality of the studies, and this usually means the quality of their reports. If there are fundamental flaws within a study, such as the use of inappropriate 'randomisation' techniques in the context of reviews of the effects of interventions, the reviewers will not be able to fix these. Worse still, if they are not aware of underlying flaws, they might make inc... Trials journals http://www.medworm.com/rss/comments.php?id=2604051 Wed, 15 Jul 2009 23:00:00 +0100 2604051 http://www.medworm.com/index.php?rid=2599791&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F54 This study consists of a multi-centre (two centres in Korea and two centres in China), randomised, controlled trial with three parallel arms (active acupuncture, sham acupuncture, and waitlist group). The active acupuncture and sham acupuncture groups will receive real or sham acupuncture treatment, respectively, three times per week for a total of 12 sessions over four weeks. Post-treatment follow-up will be performed a month later to complement these 12 acupuncture sessions. Participants in the waitlist group will not receive real or sham acupuncture treatments during this period but will only be required to keep recording their symptoms in a daily diary. After four weeks, the same treatment given to the active acupuncture group will be provided to the waitlist group.DiscussionThis trial... Trials journals http://www.medworm.com/rss/comments.php?id=2599791 Mon, 13 Jul 2009 23:00:00 +0100 2599791 http://www.medworm.com/index.php?rid=2596200&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F53 This study seeks to address this paucity by evaluating the most routinely used interventions amongst drug users within UK prisons.Methods / DesignThis study uses randomised controlled trial methodology to compare the open use of buprenorphine and methadone for opiate detoxification, given in the context of routine care, within three UK prisons. Prisoners who are eligible and give informed consent will be entered into the trial. The primary outcome will be abstinence status eight days after detoxification, as determined by a urine test. Secondary outcomes will be recorded during the detoxification and then at one, three and six months post-detoxification.Trial registration: Current Controlled Trials ISRCTN58823759 (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=2596200 Mon, 13 Jul 2009 23:00:00 +0100 2596200 http://www.medworm.com/index.php?rid=2589975&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F52 Conclusions: The majority of RCTs reported the flow of participants well after randomisation, although only two-thirds included a complete flow chart and there was great variability over the definition of "lost to follow up". Reporting of participant eligibility was poor, making assessments of recruitment practice and external validity difficult. Reporting of participant flow throughout RCTs could be improved by small changes to the CONSORT chart. (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=2589975 Thu, 09 Jul 2009 23:00:00 +0100 2589975 http://www.medworm.com/index.php?rid=2582231&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F51 Background: Fractures of the proximal humerus are common injuries and account for 4-5 percent of all fractures, second only to hip and wrist fractures. The incidence is positively correlated with age and osteoporosis, and is likely to increase. Displaced four-part fractures are among the most severe injuries, accounting for 2-10 percent of proximal humeral fractures. The optimal intervention is disputed. Two previous randomised trials were very small and involved a noticeable risk of bias, and systematic reviews consequently conclude that there is inadequate basis for evidence-based treatment decisions.We aim to compare the effect of osteosynthesis with angle-stable plate with non-surgical management, and the effect of primary hemiarthroplasty with both osteosynthesis and non-surgical mana... Trials journals http://www.medworm.com/rss/comments.php?id=2582231 Tue, 07 Jul 2009 23:00:00 +0100 2582231 http://www.medworm.com/index.php?rid=2578494&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F50 Conclusions: Restricted postoperative IV fluid management, as performed in this trial, in patients undergoing major abdominal surgery appears harmful as it is accompanied by an increased risk of major postoperative complications and a prolonged postoperative hospital stay.Trial registration: Current Controlled Trials ISRCTN16719551 (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=2578494 Mon, 06 Jul 2009 23:00:00 +0100 2578494 http://www.medworm.com/index.php?rid=2574567&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F49 DiscussionA better understanding of the extent to which tRCTs exaggerate treatment effects and of the factors associated with the magnitude of this bias can optimize trial design and data monitoring charters, and may aid in the interpretation of the results from trials stopped early for benefit. (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=2574567 Sun, 05 Jul 2009 23:00:00 +0100 2574567 http://www.medworm.com/index.php?rid=2572300&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F48 Explanatory and pragmatic trials represent ends of a continuum of attitudes about clinical trial design. Recent literature argues that pragmatic trials are more informative about clinical care in the real world. Although there is place for more pragmatic studies to inform clinical practice and health policy decision-making, we are concerned that it is generally under-appreciated that extrapolating the results of broadly inclusive pragmatic trials to the care of real patients may often be as problematic as extrapolating the results of narrowly focused explanatory or efficacy trials. Simplistic interpretation of pragmatic trials runs the risk of driving harmful policies. (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=2572300 Sun, 05 Jul 2009 23:00:00 +0100 2572300 http://www.medworm.com/index.php?rid=2565437&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F47 Background: Coronary Artery Bypass Graft operation for ischemic heart disease provides improved quality of life and, in some patients, prolonged survival. Concern has, however, been raised about complications that may be related to the use of cardiopulmonary by-pass (CPB) and aortic cross-clamping. It has been hypothesized that when coronary artery by-pass grafting is performed without the use of CPB, the rate of serious complications is reduced. Methods: The trial is designed as an open, randomized, controlled, clinical trial with blinded assessment of end-points. Patients at or above 70 years of age, referred for surgical myocardial revascularisation, are included and randomised to receive coronary artery by-pass grafting either with or without the use of CPB and aortic cross-clamping. F... Trials journals http://www.medworm.com/rss/comments.php?id=2565437 Fri, 03 Jul 2009 23:00:00 +0100 2565437 http://www.medworm.com/index.php?rid=2565438&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F46 Conclusion: Most reports of randomized controlled trials published in Chinese journals lacked an adequate description of randomization. Similarly, most so called 'randomized controlled trials' were not real randomized controlled trials owing toa lack of adequate understanding on the part of the authors of rigorous clinical trial design. All randomized controlled trials of pre-market drug clinical trial included in this research were authentic. Randomized controlled trials conducted by authors in high level hospitals, especially in hospitals affiliated to medical universities had a higher rate of authenticity. That so many non- randomized controlled trials were published as randomized controlled trials reflected the fact that peer review needs to be improved and a good practice guide for pe... Trials journals http://www.medworm.com/rss/comments.php?id=2565438 Wed, 01 Jul 2009 23:00:00 +0100 2565438 http://www.medworm.com/index.php?rid=2551375&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F45 Conclusion: There was no detectable benefit for the prophylactic administration of oral NAC over an aggressive hydration protocol in patients with DM and CKD.Trial registration: NCT00808795 (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=2551375 Sun, 28 Jun 2009 23:00:00 +0100 2551375 http://www.medworm.com/index.php?rid=2491624&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F44 Conclusions: Monetary incentives may be an effective way to increase the proportion of postal questionnaires returned and minimise loss to follow-up in clinical trials.Trial registration number: ISRCTN61305297 (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=2491624 Sun, 21 Jun 2009 23:00:00 +0100 2491624 http://www.medworm.com/index.php?rid=2491625&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F43 Background: Some patients will experience more or less benefit from treatment than the averages reported from clinical trials; such variation in therapeutic outcome is termed heterogeneity of treatment effects (HTE). Identifying HTE is necessary to individualize treatment. The degree to which heterogeneity is sought and analyzed correctly in the general medical literature is unknown. We undertook this literature sample to track the use of HTE analyses over time, examine the appropriateness of the statistical methods used, and explore the predictors of such analyses. Methods: Articles were selected through a probability sample of randomized controlled trials (RCTs) published in Annals of Internal Medicine, BMJ, JAMA, The Lancet, and NEJM during odd numbered months of 1994, 1999, and 2004. R... Trials journals http://www.medworm.com/rss/comments.php?id=2491625 Thu, 18 Jun 2009 23:00:00 +0100 2491625 http://www.medworm.com/index.php?rid=2491627&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F41 DiscussionPreliminary descriptive studies have suggested that statins (lovastatin) may have anti HIV-1 activity and that their administration is safe,with the potential effect of controlling HIV-1 replication in chronically infected individuals who had not received antiretroviral medications. Considering that there is limited clinical data available on this topic, all these findings warrant further evaluation to determine if long-term administration of statins may benefit the virological and immunological evolution in HIV-1-infected individuals before the use of antiretroviral therapy is required.Trial registration: Registration number NCT00721305. (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=2491627 Wed, 17 Jun 2009 23:00:00 +0100 2491627 http://www.medworm.com/index.php?rid=2491626&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F42 Background: Heart failure patients with implantable defibrillators (ICD) frequently visit the clinic for routine device monitoring. Moreover, in the case of clinical events, such as ICD shocks or alert notifications for changes in cardiac status or safety issues, they often visit the emergency department or the clinic for an unscheduled visit. These planned and unplanned visits place a great burden on healthcare providers.Internet-based remote device interrogation systems, which give physicians remote access to patients' data, are being proposed in order to reduce routine and interim visits and to detect and notify alert conditions earlier. Methods: The EVOLVO study is a prospective, randomized, parallel, unblinded, multicenter clinical trial designed to compare remote ICD management with ... Trials journals http://www.medworm.com/rss/comments.php?id=2491626 Wed, 17 Jun 2009 23:00:00 +0100 2491626 http://www.medworm.com/index.php?rid=2480194&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F39 Conclusions: It is possible to use the MAMS design to initiate and undertake large scale cancer trials. The results from STAMPEDE will not be known for some years but the lessons learned from running a MAMS trial are shared in the hope that other researchers will use this exciting and efficient method to perform further randomised controlled trials.Trial registrationISRCTN78818544NCT00268476 (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=2480194 Thu, 11 Jun 2009 04:00:00 +0100 2480194 http://www.medworm.com/index.php?rid=2480193&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F40 DiscussionWe aim to make our objectives and methods transparent. The results of this study may have important implications for both clinical trialists and users of the medical literature. (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=2480193 Thu, 11 Jun 2009 04:00:00 +0100 2480193 http://www.medworm.com/index.php?rid=2460609&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F38 DiscussionThe first patient entered the trial on September, 2008. Up to April 7, 2009, 810 patients had been included in 35 centers. The mean age was 69 (Standard deviation: 10), 18% had a baseline serum creatinine >1.5mg/dL, 57% were diabetics and 13% had a history of heart failure. The ongoing ACT Trial is the largest multicentre RCT that will determine whether acetylcysteine is effective in decreasing the risk of CIN in patients at risk undergoing angiography. (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=2460609 Thu, 04 Jun 2009 04:00:00 +0100 2460609 http://www.medworm.com/index.php?rid=2460610&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F37 Randomised controlled trials are the best research design for decisions about the effect of different interventions but randomisation does not, of itself, promote the applicability of a trial's results to situations other than the precise one in which the trial was done. While methodologists and trialists have rightly paid great attention to internal validity, much less has been given to applicability.This narrative review is aimed at those planning to conduct trials, and those aiming to use the information in them. It is intended to help the former group make their trials more widely useful and to help the latter group make more informed decisions about the wider use of existing trials. We review the differences between the design of most randomised trials (which have an explanatory attit... Trials journals http://www.medworm.com/rss/comments.php?id=2460610 Wed, 03 Jun 2009 04:00:00 +0100 2460610 http://www.medworm.com/index.php?rid=2444364&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F36 Background: Vitamin D does not only regulate calcium homeostasis but also plays an important role as an immune modulator. It influences the immune system through the induction of immune shifts and regulatory cells resulting in immunologic tolerance. As such, vitamin D is thought to exert beneficial effects within the transplant setting, especially in kidney transplant recipients, considering the high prevalence of vitamin D deficiency in kidney transplant recipients. Methods: The VITA-D study, a randomized, placebo-controlled, double-blind study with two parallel groups including a total of 200 kidney transplant recipients, is designed to investigate the immunomodulatory and renoprotective effects of cholecalciferol (vitamin D3) within the transplant setting. Kidney transplant recipients f... Trials journals http://www.medworm.com/rss/comments.php?id=2444364 Fri, 29 May 2009 04:00:00 +0100 2444364 http://www.medworm.com/index.php?rid=2437882&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F35 Conclusions: Acta Psychiatrica Scandinavica is a major source of trials. The standard of reporting is similar to other journals but better adherence to CONSORT would ensure higher quality of reports and better dissemination. (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=2437882 Wed, 27 May 2009 04:00:00 +0100 2437882 http://www.medworm.com/index.php?rid=2434572&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F34 Background: In the developmental stage of laparoscopic cholecystectomy (LC) it was considered 'unsafe' or 'technically difficult' to perform laparoscopic cholecystectomy for acute cholecystitis (AC). With increasing experience in laparoscopic surgery, a number of centers have reported on the use of laparoscopic cholecystectomy for acute cholecystitis, suggesting that it is technically feasible but at the expense of a high conversion rate, which can be up to 35 per cent and common bile duct lesions.The HARMONIC SCALPEL(R) (H) is the leading ultrasonic cutting and coagulating surgical device, offering surgeons important benefits including: minimal lateral thermal tissue damage, minimal charring and desiccation.Harmonic Scalpel technology reduces the need for ligatures with simultaneous cutti... Trials journals http://www.medworm.com/rss/comments.php?id=2434572 Tue, 26 May 2009 04:00:00 +0100 2434572 http://www.medworm.com/index.php?rid=2425367&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F33 Conclusions: A greater level of awareness about the practice and pitfalls of outcome based subgroup analysis is needed. When required, such an analysis should maintain the integrity of randomization. This issue needs greater practical and methodologic attention than has been accorded to it thus far. (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=2425367 Wed, 20 May 2009 04:00:00 +0100 2425367 http://www.medworm.com/index.php?rid=2419607&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F31 DiscussionThe implementation of the protocol presented here shows that it is possible to create a network of community psychiatric services that accept the idea of using their everyday clinical practice to produce randomised knowledge. The employed pragmatic attitude allowed to randomly allocate more than 100 individuals, which means that this study is the largest antipsychotic combination trial conducted so far in Western countries. We expect that the current project, by generating evidence on whether it is clinically useful to combine clozapine with aripiprazole rather than with haloperidol, provides physicians with a solid evidence base to be directly applied in the routine care of patients with schizophrenia. (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=2419607 Fri, 15 May 2009 04:00:00 +0100 2419607 http://www.medworm.com/index.php?rid=2419606&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F32 Background: The incidence of gallstones and gallbladder sludge is known to be higher in patients after gastrectomy than in general population. This higher incidence is probably related to surgical dissection of the vagus nerve branches and the anatomical gastrointestinal reconstruction. Therefore, some surgeons perform routine concomitant cholecystectomy during standard surgery for gastric malignancies. However, not all the patients who are diagnosed to have cholelithiasis after gastric cancer surgery will develop symptoms or require additional surgical treatments and a standard laparoscopic cholecystectomy is feasible even in those patients who underwent previous gastric surgery. At the present, no randomized study has been published and the decision of gallbladder management is left to e... Trials journals http://www.medworm.com/rss/comments.php?id=2419606 Fri, 15 May 2009 04:00:00 +0100 2419606 http://www.medworm.com/index.php?rid=2393308&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F30 Amlexanox has been developed as a 5% topical oral paste for the treatment of patients with RAS in most European countries. However, it is not available in China yet or has not been generally accepted in clinical treatment. To explore the effectiveness of amlexanox oral adhesive pellicles in the treatment of minor recurrent aphthous ulcers, and compare it with amlexanox oral adhesive tablets for analysing the difference between the two dosage forms of amlexanox, a randomized, blinded, placebo controlled, parallel, multicenter clinical study was designed. A total of 216 patients with Minnor recurrent aphthous ulcers (MiRAU) were recruited and randomized to amlexanox pellicles or placebo pellicles. Pellicles were consecutively applied 4 times per day for five days. The size and pain level of ... Trials journals http://www.medworm.com/rss/comments.php?id=2393308 Wed, 06 May 2009 04:00:00 +0100 2393308 http://www.medworm.com/index.php?rid=2393309&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F29 Conclusions: Several harm-related data were not adequately accounted for in articles of randomized controlled trials assessing stents for percutaneous coronary intervention. Trials manuscript: 5534201182098351 (T80802P) (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=2393309 Mon, 04 May 2009 04:00:00 +0100 2393309 http://www.medworm.com/index.php?rid=2384329&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F28 DiscussionAt the time of submission of this article, 72 general practices have been recruited (36 in each arm of the trial) and the interventions have been delivered. Analysis has not yet been undertaken. Trial registration: Current controlled trials ISRCTN21785299 (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=2384329 Fri, 01 May 2009 04:00:00 +0100 2384329 http://www.medworm.com/index.php?rid=2384330&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F27 Conclusions Reports of crossover trials frequently omit important methodological issues in design, analysis, and presentation. Guidelines for the conduct and reporting of crossover trials might improve the conduct and reporting of studies using this important trial design. (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=2384330 Thu, 30 Apr 2009 04:00:00 +0100 2384330 http://www.medworm.com/index.php?rid=2371478&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F26 DiscussionThe PORTSSS trial will provide high quality evidence to determine the most appropriate kind of counselling which should be provided via the NHS Smoking Helpline and also whether or not an additional offer of cost-free NRT is effective and cost effective for smoking cessation. Trial Registration (clinicaltrials.gov): NCT00775944 (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=2371478 Tue, 28 Apr 2009 04:00:00 +0100 2371478 http://www.medworm.com/index.php?rid=2360670&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F25 DiscussionThe study design and the long term clinical practice of acupuncturists guarantee a high external validity for the results. The results of our trial will be helpful to supply the evidence on the efficacy of acupuncture for migraine prophylaxis in China. Trial Registration: The trial is registered at Controlled Clinical Trials: ISRCTN49839714. (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=2360670 Fri, 24 Apr 2009 04:00:00 +0100 2360670 http://www.medworm.com/index.php?rid=2360672&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F23 DiscussionThe study design surmounts the disadvantages of previous studies in that it provides a randomized controlled design, a large sample size, adequate inclusion criteria, an adequate treatment protocol, and a clear separation of the treatment conditions in order to avoid contamination. Nevertheless, the study has to deal with difficulties specific to the psychopathology of anorexia nervosa. The treatment protocol allows for dealing with the typically occurring medical complications without dropping patients from the protocol. However, because patients are difficult to recruit and often ambivalent about treatment, a drop-out rate of 30% is assumed for sample size calculation. Due to the ethical problem of denying active treatment to patients with anorexia nervosa, the control group is... Trials journals http://www.medworm.com/rss/comments.php?id=2360672 Thu, 23 Apr 2009 04:00:00 +0100 2360672 http://www.medworm.com/index.php?rid=2360671&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F24 DiscussionIt is necessary to assess the effectiveness of pharmacological and psychological treatments for pain catastrophizing in fibromyalgia. This randomized clinical trial will determine whether both treatments are effective for this important prognostic variable in patients with fibromyalgia. Trial registration: Current Controlled Trials ISRCTN10804772. (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=2360671 Thu, 23 Apr 2009 04:00:00 +0100 2360671 http://www.medworm.com/index.php?rid=2350779&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F22 We describe an ongoing four-year prospective, randomized clinical trial comparing the effectiveness of an empirically supported treatment for major depressive disorder, Behavioral Activation, delivered either via in-home videoconferencing technology ("Telepsychology") or traditional face-to-face services ("Same-Room"). Our hypothesis is that in-home Telepsychology service delivery will be equally effective as the traditional mode (Same-Room). Two-hundred twenty-four (224) male and female elderly participants will be administered protocol-driven individual Behavioral Activation therapy for depression over an 8-week period; and subjects will be followed for 12-months to ascertain longer-term effects of the treatment on three outcomes domains: (1) clinical outcomes (symptom severity, social f... Trials journals http://www.medworm.com/rss/comments.php?id=2350779 Mon, 20 Apr 2009 04:00:00 +0100 2350779 http://www.medworm.com/index.php?rid=2334743&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F21 Conclusions: Multi-arm, multi-stage trials are an effective way of speeding up the therapy evaluation process. The design performs well in terms of the type I and II error rates. (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=2334743 Fri, 17 Apr 2009 04:00:00 +0100 2334743 http://www.medworm.com/index.php?rid=2311366&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F20 DiscussionThis is the first study of prevention of depression in patients after acute coronary syndrome with a selective serotonin reuptake inhibitor. Trial registration: www.ClinicalTrials.gov. Identifier: NCT00140257 (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=2311366 Tue, 07 Apr 2009 04:00:00 +0100 2311366 http://www.medworm.com/index.php?rid=2311367&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F19 We presented the development phase of this anaesthesiological on-going trial. The recruitment started December 4th, 2007 and up to 4th, December 2008, 314 patients have been enrolled. (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=2311367 Mon, 06 Apr 2009 04:00:00 +0100 2311367 http://www.medworm.com/index.php?rid=2311369&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F18 Background: Depression Care for People with Cancer is a complex intervention delivered by specially trained cancer nurses, under the supervision of a psychiatrist. It is given as a supplement to the usual care for depression, which patients receive from their general practitioner and cancer service. In a 'proof of concept' trial (Symptom Management Research Trials in Oncology-1) Depression Care for People with Cancer improved depression more than usual care alone. The second Symptom Management Research Trial in Oncology (SMaRT Oncology-2 Trial) will test its effectiveness and cost-effectiveness in a 'real world' setting.DesignA two arm parallel group multi-centre randomised controlled trial. Trial Procedures 500 patients will be recruited through established systematic Symptom Monitoring S... Trials journals http://www.medworm.com/rss/comments.php?id=2311369 Mon, 30 Mar 2009 04:00:00 +0100 2311369 http://www.medworm.com/index.php?rid=2278711&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F17 Many research-funding agencies now require open access to the results of research they have funded, and some also require that researchers make available the raw data generated from that research. Similarly, the journal Trials aims to address inadequate reporting in randomised controlled trials, and in order to fulfil this objective, the journal is working with the scientific and publishing communities to try to establish best practice for publishing raw data from clinical trials in peer-reviewed biomedical journals. Common issues encountered when considering raw data for publication include patient privacy - unless explicit consent for publication is obtained - and ownership, but agreed-upon policies for tackling these concerns do not appear to be addressed in the guidance or mandates cur... Trials journals http://www.medworm.com/rss/comments.php?id=2278711 Wed, 18 Mar 2009 04:00:00 +0100 2278711 http://www.medworm.com/index.php?rid=2252293&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F15 Conclusions: Payment of clinicians beyond expenses is perceived to be a less important motivating factor than researching important, salient questions, and facilitating research by reducing bureaucracy and delay. (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=2252293 Tue, 10 Mar 2009 04:00:00 +0100 2252293 http://www.medworm.com/index.php?rid=2252292&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F16 This study was funded by the Health Department of the Andalusian Regional Government and by the Healthcare Research Fund of the Carlos III Healthcare Institute (Spanish Ministry of Health). Trial Registration: Current Controlled Trials ISRCTN41082378 (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=2252292 Tue, 10 Mar 2009 04:00:00 +0100 2252292 http://www.medworm.com/index.php?rid=2239811&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F14 Conclusions: The proposed clinically-integrated randomized trial may allow us to enlarge dramatically the number of clinical questions that can be addressed by randomization. (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=2239811 Thu, 05 Mar 2009 05:00:00 +0100 2239811 http://www.medworm.com/index.php?rid=2199818&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F12 ObjectiveMetformin has had a 'black box' contraindication in diabetic patients with heart failure (HF), but many believe it to be the treatment of choice in this setting. Therefore, we attempted to conduct a pilot study to evaluate the feasibility of undertaking a large randomized controlled trial with clinical endpoints.Study DesignThe pilot study was a randomized double blinded placebo controlled trial. Patients with HF and type 2 diabetes were screened in hospitals and HF clinics in Edmonton, Alberta, Canada (population ~1 million). Major exclusion criteria included the current use of insulin or high dose metformin, decreased renal function, or a glycosylated hemoglobin (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=2199818 Mon, 09 Feb 2009 05:00:00 +0100 2199818 http://www.medworm.com/index.php?rid=2172410&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F12 ObjectiveMetformin has had a 'black box' contraindication in diabetic patients with heart failure (HF), but many believe it to be the treatment of choice in this setting. Therefore, we attempted to conduct a pilot study to evaluate the feasibility of undertaking a large randomized controlled trial with clinical endpoints. Study Design: The pilot study was a randomized double blinded placebo controlled trial. Patients with HF and type 2 diabetes were screened in hospitals and HF clinics in Edmonton, Alberta, Canada (population ~ 1 million). Major exclusion criteria included the current use of insulin or high dose metformin, decreased renal function, or a glycosylated hemoglobin (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=2172410 Mon, 09 Feb 2009 05:00:00 +0100 2172410 http://www.medworm.com/index.php?rid=2167155&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F9 This article will consider the design, conduct and analysis of a randomised controlled trial of a surgical intervention. The issues will be reviewed under three headings: the timing of the evaluation, defining the research question and trial design issues. Recommendations on the conduct of future surgical RCTs are made. Collaboration between research and surgical communities is needed to address the distinct issues raised by the assessment of surgical interventions and enable the conduct of appropriate and well designed trials. (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=2167155 Fri, 06 Feb 2009 05:00:00 +0100 2167155 http://www.medworm.com/index.php?rid=2167154&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F10%2F1%2F10 DiscussionGiven the social context in which self-management occurs, interventions that teach spouses to provide instrumental and emotional support may help patients initiate and adhere to behaviors that lower their LDL-C levels. Moreover, allowing patients to retain autonomy by deciding which behaviors they would like to change and how may improve adherence and clinical outcomes. Trial Registration: The ClinicalTrials.gov registration number is NCT00321789. (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=2167154 Fri, 06 Feb 2009 05:00:00 +0100 2167154 http://www.medworm.com/index.php?rid=2137196&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F9%2F1%2F74 Background: Adhesive small intestine occlusion [ASIO] is an important cause of hospital admission placing a substantial burden on healthcare systems worldwide. Often times, ASIO is associated with significant morbidity and mortality.Icodextrin 4% solution [Adept, Shire Pharmaceuticals, UK] is a high-molecular-weight a-1,4 glucose polymer that is approved in Europe for use as an intra-operative lavage and a post-operative instillate to reduce the occurrence of post-surgery intra-abdominal adhesions.There are no randomized trials on the use of this solution to prevent adhesions after ASIO operation in current medical literature.The current clinical study evaluates the safety and effectiveness of Icodextrin 4% for decreasing the incidence, extent, and severity of adhesions in patients after a... Trials journals http://www.medworm.com/rss/comments.php?id=2137196 Thu, 18 Dec 2008 05:00:00 +0100 2137196 http://www.medworm.com/index.php?rid=2052176&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F9%2F1%2F74 Background: Adhesive small intestine occlusion (ASIO) is an important cause of hospital admission placing a substantial burden on healthcare systems worldwide. Often times, ASIO is associated with significant morbidity and mortality. Icodextrin 4% solution (Adept, Shire Pharmaceuticals, UK) is a high-molecular-weight a-1,4 glucose polymer that is approved in Europe for use as an intra-operative lavage and a post-operative instillate to reduce the occurrence of post-surgery intra-abdominal adhesions. There are no randomized trials on the use of this solution to prevent adhesions after ASIO operation in current medical literature. The current clinical study evaluates the safety and effectiveness of Icodextrin 4% for decreasing the incidence, extent, and severity of adhesions in patients aft... Trials journals http://www.medworm.com/rss/comments.php?id=2052176 Thu, 18 Dec 2008 05:00:00 +0100 2052176 http://www.medworm.com/index.php?rid=2026292&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F9%2F1%2F71 Conclusion: In this explorative study, ClO2 mouthwash was effective at reducing morning malodor for 4 hours when used by healthy subjects. Trial registration: ClinicalTrials.gov NCT00655772 (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=2026292 Tue, 09 Dec 2008 05:00:00 +0100 2026292 http://www.medworm.com/index.php?rid=2010806&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F9%2F1%2F70 This study consists of a multi-center randomized controlled trial with 2 parallel arms. Participants included in the study will meet the following criteria: 1) a documented daily average hot flush score [greater than or equal to]10 for one week prior to the screening visit 2) not taking HRT and other pharmaceutical therapies which might affect hot flushes or other vasomotor symptoms. While maintaining usual care, the treatment group will receive acupuncture 3 times a week, for a total of 12 sessions over 4 weeks. The control group will receive usual care alone during the same period. Post-treatment follow-up will be performed one month after completing 12 sessions of acupuncture.DiscussionThis trial will provide evidence for the effectiveness of acupuncture as a treatment for hot flushes.... Trials journals http://www.medworm.com/rss/comments.php?id=2010806 Wed, 03 Dec 2008 05:00:00 +0100 2010806 http://www.medworm.com/index.php?rid=1996102&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F9%2F1%2F67 This study was designed to evaluate the (cost) effectiveness of an early intervention based on cognitive behavioural principles. The strong external validity is one of the strengths of the study design. Trial registration: Current Controlled Trials ISRCTN33407455. (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=1996102 Thu, 27 Nov 2008 05:00:00 +0100 1996102 http://www.medworm.com/index.php?rid=1989777&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F9%2F1%2F66 Conclusion: Our review indicates that there is a need to provide more detailed guidance for those conducting and reporting clinical trials to help prevent the selective reporting of results. Statements found in the guidelines generally refer to publication bias rather than outcome reporting bias. Current guidelines need to be updated and include the statement that all primary and secondary outcomes prespecified in the protocol should be fully reported and should not be selected for inclusion in the final report based on their results. (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=1989777 Tue, 25 Nov 2008 05:00:00 +0100 1989777 http://www.medworm.com/index.php?rid=1974547&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F9%2F1%2F63 Conclusion: There is an urgent need to reduce the prevalence of TB in communities highly affected by HIV. Potential interventions are complex and require innovative trial designs to provide the rigorous evidence needed to inform health policy makers and to ensure that resources are used optimally.Trial RegistrationNumber: ISRCTN36729271 (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=1974547 Fri, 07 Nov 2008 05:00:00 +0100 1974547 http://www.medworm.com/index.php?rid=1938438&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F9%2F1%2F63 Conclusion: There is an urgent need to reduce the prevalence of TB in communities highly affected by HIV. Potential interventions are complex and require innovative trial designs to provide the rigorous evidence needed to inform health policy makers and to ensure that resources are used optimally. Trial Registration Number: ISRCTN36729271 (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=1938438 Fri, 07 Nov 2008 05:00:00 +0100 1938438 http://www.medworm.com/index.php?rid=1933776&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F9%2F1%2F62 DiscussionThis paper outlines the protocol for a pragmatic randomised trial of a multi-faceted, community-based intervention to optimize the implementation of evidence based management for patients at risk for falls and osteoporosis. Trial Registration: This trial has been registered with clinicaltrials.gov (ID: NCT00465387) (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=1933776 Tue, 04 Nov 2008 05:00:00 +0100 1933776 http://www.medworm.com/index.php?rid=1905293&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F9%2F1%2F60 Background: Totally Implantable Access Ports (TIAP) are being extensively used world-wide and can be expected to further gain importance with the introduction of new neoadjuvant and adjuvant treatments in oncology. Two different techniques for the implantation can be selected: A direct puncture of a central vein and the utilization of a Seldinger device or the surgical Venae sectio. It is still unclear which technique has the optimal benefit/risk ratio for the patient.DesignA single-center, expertise based randomized, controlled superiority trial to compare two different TIAP implantation techniques. 100 patients will be included and randomized pre-operatively. All patients aged 18 years or older scheduled for primary elective implantation of a TIAP under local anesthesia who signed the in... Trials journals http://www.medworm.com/rss/comments.php?id=1905293 Fri, 24 Oct 2008 04:00:00 +0100 1905293 http://www.medworm.com/index.php?rid=1900872&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F9%2F1%2F58 Discussion This trial assesses benefits and harms of a high inspiratory oxygen fraction, and the trial may be generalizable to a general surgical population undergoing laparotomy. Trial registration ClinicalTrials.gov identifier: NCT00364741. (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=1900872 Wed, 22 Oct 2008 04:00:00 +0100 1900872 http://www.medworm.com/index.php?rid=1836990&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F9%2F1%2F55 Background: Renal failure is a frequent complication of multiple myeloma and when severe is associated with a greatly increased morbidity and mortality. The principal cause of severe renal failure in this setting is cast nephropathy, a direct consequence of high concentrations of monoclonal free light chains (FLCs) in the patient's serum. FLC removal by extended haemodialysis, using a high cut-off dialyser, has recently been described as a novel therapeutic option in this setting. Methods: The EUropean trial of free LIght chain removal by exTEnded haemodialysis in cast nephropathy (EuLITE) trial is a prospective, randomised, multicentre, open label clinical trial to investigate the clinical benefit of FLC removal haemodialysis in patients with cast nephropathy, dialysis dependent acute r... Trials journals http://www.medworm.com/rss/comments.php?id=1836990 Sun, 28 Sep 2008 04:00:00 +0100 1836990 http://www.medworm.com/index.php?rid=1725870&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F9%2F1%2F50 DiscussionThe paper provides an overview of the Trial Design, the rationale for the research methodology chosen and how the Trial was implemented in a GP environment. The evaluation protocol and data collection processes took into account the large number of patients, the broad range of practice types distributed over a large geographic area, and the inclusion of pathology test results from multiple pathology laboratories.The evaluation protocol developed reflects the complexity of the Trial setting, the Trial Design and the approach taken within the funding provided. The PoCT Trial is regarded as a pragmatic RCT, evaluating the effectiveness of implementing PoCT in GP and every effort was made to ensure that, in these circumstances, internal and external validity was maintained.Trial Regi... Trials journals http://www.medworm.com/rss/comments.php?id=1725870 Wed, 06 Aug 2008 04:00:00 +0100 1725870 http://www.medworm.com/index.php?rid=1663692&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F9%2F1%2F47 ObjectiveIt was aimed to review the literature and make a meta-analysis of the trials on both upfront, switching, and sequencing anastrozole in the adjuvant treatment of early breast cancer. Methods: The PubMed, ClinicalTrials.gov and Cochrane databases were systematically reviewed for randomized-controlled trials comparing anastrozole with tamoxifen in the adjuvant treatment of early breast cancer. Results: The combined hazard rate of 4 trials for event-free survival (EFS) was 0.77 (95%CI: 0.70-0.85) (P (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=1663692 Tue, 29 Jul 2008 04:00:00 +0100 1663692 http://www.medworm.com/index.php?rid=1645471&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F9%2F1%2F45 Conclusions: An update of national and European regulations is required to enable implementation of the emergency trial consent model referred to in GCP guidelines. (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=1645471 Mon, 21 Jul 2008 04:00:00 +0100 1645471 http://www.medworm.com/index.php?rid=1634647&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F9%2F1%2F44 Conclusion: The PROMISS trial aims to shed new light on the effect of Off-Pump as compared to On-Pump coronary artery bypass surgery on graft patency, assessed by multidetector computed tomography, in unselected patients with multivessel coronary artery disease. (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=1634647 Thu, 17 Jul 2008 04:00:00 +0100 1634647 http://www.medworm.com/index.php?rid=1560127&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F9%2F1%2F37 Background: Intravenous recombinant tissue plasminogen activator (rt-PA) is approved for use in selected patients with ischaemic stroke within 3 hours of symptom onset. IST-3 seeks to determine whether a wider range of patients may benefit.DesignInternational, multi-centre, prospective, randomized, open, blinded endpoint (PROBE) trial of intravenous rt-PA in acute ischaemic stroke. Suitable patients must be assessed and able to start treatment within 6 hours of developing symptoms, and brain imaging must have excluded intracerebral haemorrhage. With 1000 patients, the trial can detect a 7% absolute difference in the primary outcome. With3500 patients, it can detect a 4.0% absolute benefit & with 6000, (mostly treated between 3 & 6 hours), it can detect a 3% benefit.Trial proceduresPatients... Trials journals http://www.medworm.com/rss/comments.php?id=1560127 Tue, 17 Jun 2008 04:00:00 +0100 1560127 http://www.medworm.com/index.php?rid=1525532&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F9%2F1%2F37 Background: Intravenous recombinant tissue plasminogen activator (rt-PA) is approved for use in selected patients with ischaemic stroke within 3 hours of symptom onset. IST-3 seeks to determine whether a wider range of patients may benefit. DesignInternational, multi-centre, prospective, randomized, open, blinded endpoint (PROBE) trial of intravenous rt-PA in acute ischaemic stroke. Suitable patients must be assessed and able to start treatment within 6 hours of developing symptoms, and brain imaging must have excluded intracerebral haemorrhage. With 1000 patients, the trial can detect a 7% absolute difference in the primary outcome. With 3500 patients, it can detect a 4.0% absolute benefit & with 6000, (mostly treated between 3 & 6 hours), it can detect a 3% benefit. Trial procedures: P... Trials journals http://www.medworm.com/rss/comments.php?id=1525532 Tue, 17 Jun 2008 04:00:00 +0100 1525532 http://www.medworm.com/index.php?rid=1507512&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F9%2F1%2F35 Conclusions: Baseline socio-demographic and medical characteristics of participants are totally comparable in the four randomized groups. Trial registration: Current Controlled Trials ISRCTN41926726 (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=1507512 Tue, 10 Jun 2008 04:00:00 +0100 1507512 http://www.medworm.com/index.php?rid=1460764&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F9%2F1%2F30 It has been demonstrated that patients enrolled in clinical trials frequently have a large degree of variation in their baseline risk for the outcome of interest. Thus, some have suggested that clinical trial results should routinely be stratified by outcome risk using risk models, since the summary results may otherwise be misleading. However, variation in competing risk is another dimension of risk heterogeneity that may also underlie treatment effect heterogeneity. Understanding the effects of competing risk heterogeneity may be especially important for pragmatic comparative effectiveness trials, which seek to include traditionally excluded patients, such as the elderly or complex patients with multiple comorbidities. Indeed, the observed effect of an intervention is dependent on the ra... Trials journals http://www.medworm.com/rss/comments.php?id=1460764 Thu, 22 May 2008 04:00:00 +0100 1460764 http://www.medworm.com/index.php?rid=1453965&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F9%2F1%2F27 n/a (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=1453965 Mon, 19 May 2008 04:00:00 +0100 1453965 http://www.medworm.com/index.php?rid=1406660&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F9%2F1%2F23 DiscussionComputer tailored personal feedback, adapted to reading levels and motivation to quit, is a simple and inexpensive intervention which could be widely replicated and delivered cost effectively to a large proportion of the smoking population. Given its recruitment potential, a modest success rate could have a large effect on public health. The intervention also fits into the broader scope of tobacco control, by prompting more quit attempts, and increasing referrals to specialised services. The provision of this option to smokers in primary care can complement existing services, and work synergistically with other measures to produce more quitters and reduce the prevalence of smoking in the UK. Trial registration: Current Controlled Trials ISRCTN05385712 (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=1406660 Tue, 29 Apr 2008 04:00:00 +0100 1406660 http://www.medworm.com/index.php?rid=1396066&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F9%2F1%2F22 Conclusions: Reporting of RCTs in China requires substantial improvement to meet the targets of the CONSORT statement. The conduct of Chinese RCTs cannot be directly inferred from the standard of reporting; however without good reporting the methods of the trials cannot be clearly ascertained. (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=1396066 Thu, 24 Apr 2008 04:00:00 +0100 1396066 http://www.medworm.com/index.php?rid=1393638&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F9%2F1%2F21 Background: A major barrier to accessing free government-provided antiretroviral treatment (ART) in South Africa is the shortage of suitably skilled health professionals. Current South African guidelines recommend that only doctors should prescribe ART, even though most primary care is provided by nurses. We have developed an effective method of educational outreach to primary care nurses in South Africa. Evidence is needed as to whether primary care nurses, with suitable training and managerial support, can initiate and continue to prescribe and monitor ART in the majority of ART-eligible adults. Methods/design: This is a protocol for a pragmatic cluster randomised trial to evaluate the effectiveness of a complex intervention based on and supporting nurse-led antiretroviral treatment (AR... Trials journals http://www.medworm.com/rss/comments.php?id=1393638 Wed, 23 Apr 2008 04:00:00 +0100 1393638 http://www.medworm.com/index.php?rid=1382206&cid=s_34098_22_f&fid=34098&url=http%3A%2F%2Fwww.trialsjournal.com%2Fcontent%2F9%2F1%2F20 Conclusions: Journals should be more explicit in their recommendations and expectations of authors regarding the CONSORT Statement and related CONSORT extensions papers. (Source: Trials) Trials journals http://www.medworm.com/rss/comments.php?id=1382206 Fri, 18 Apr 2008 04:00:00 +0100 1382206