Improving diabetes care: Multi-component CArdiovascular Disease Risk Reduction Strategies for People with Diabetes in South Asia - The CARRS Multi-center Translation Trial

PubMed Central

Shah, Seema; Singh, Kavita; Ali, Mohammed K.; Mohan, V.; Kadir, Muhammad Masood; Unnikrishnan, A.G.; Sahay, Rakesh Kumar; Varthakavi, Premlata; Dharmalingam, Mala; Viswanathan, Vijay; Masood, Qamar; Bantwal, Ganapathi; Khadgawat, Rajesh; Desai, Ankush; Sethi, Bipin Kumar; Shivashankar, Roopa; Ajay, Vamadevan S; Reddy, K. Srinath; Narayan, K.M. Venkat; Prabhakaran, Dorairaj; Tandon, Nikhil

2012-01-01

Aims Cardiovascular disease (CVD) is the leading cause of morbidity and mortality in people with diabetes in South Asia. The CARRS translation trial tests the effectiveness, cost-effectiveness, and sustainability of a clinic-based multi-component CVD risk reduction intervention among people with diabetes in India and Pakistan. Methods We randomly assigned 1,146 adults with diabetes recruited from 10 urban clinic sites, to receive usual care by physicians or to receive an integrated multi-component CVD risk reduction intervention. The intervention involves electronic health record management, decision-support prompts to the healthcare team, and the support of a care coordinator to actively facilitate patient and provider adherence to evidence-based guidelines. The primary outcome is a composite of multiple CVD risk factor control (blood glucose and either blood pressure or cholesterol, or all three). Other outcomes include control of the individual CVD risk factors, process and patient-centered measures, cost-effectiveness, and acceptability/feasibility. Conclusion The CARRS translation trial tests a low-cost diabetes care delivery model in urban South Asia to achieve comprehensive cardio-metabolic disease case-management of high-risk patients (clinicaltrials.gov number: NCT01212328). PMID:23084280

Design considerations and rationale of a multi-center trial to sustain weight loss: the Weight Loss Maintenance Trial.

PubMed

Brantley, Phillip; Appel, Lawrence; Hollis, Jack; Stevens, Victor; Ard, Jamy; Champagne, Catherine; Elmer, Patricia; Harsha, David; Myers, Valerie; Proschan, Michael; William, Vollmer; Svetkey, Laura

2008-01-01

The Weight Loss Maintenance Trial (WLM) is a multi-center, randomized, controlled trial that compares the effects of two 30-month maintenance interventions, i.e., Personal Contact (PC) and Interactive Technology (IT) to a self-directed usual care control group (SD), in overweight or obese individuals who are at high risk for cardiovascular disease. This paper provides an overview of the design and methods, and design considerations and lessons learned from this trial. All participants received a 6-month behavioral weight loss program consisting of weekly group sessions. Participants who lost 4 kg were randomized to one of three conditions (PC, IT, or SD). The PC condition provided monthly contacts with an interventionist primarily via telephone and quarterly face-to-face visits. The IT condition provided frequent, individualized contact through a tailored, website system. Both the PC and IT maintenance programs encouraged the DASH dietary pattern and employed theory-based behavioral techniques to promote maintenance. Design considerations included choice of study population, frequency and type of intervention visits, and choice of primary outcome. Overweight or obese persons with CVD risk factors were studied. The pros and cons of studying this population while excluding others are presented. We studied intervention contact strategies that made fewer demands on participant time and travel, while providing frequent opportunities for interaction. The primary outcome variable for the trial was change in weight from randomization to end of follow-up (30 months). Limits to generalizability are discussed. Individuals in need of weight loss strategies may have been excluded due to barriers associated with internet use. Other participants may have been excluded secondary to a comorbid condition. This paper highlights the design and methods of WLM and informs readers of discussions of critical issues and lessons learned from the trial.

Cumulative recruitment experience in two large single-center randomized, controlled clinical trials.

PubMed

Galbreath, Autumn Dawn; Smith, Brad; Wood, Pamela; Forkner, Emma; Peters, Jay I

2008-05-01

Trial recruitment is challenging for researchers, who frequently overestimate the pool of qualified, willing participants. Little has been written about recruitment and the comparative success of recruitment strategies. We describe one center's experience with recruitment in two regional single-center clinical trials with a combined total of 1971 participants. The heart failure trial was conducted between 1999 and 2003. The asthma trial was performed between 2003 and 2006. Trial databases were queried for referral source of each individual. Data were analyzed for effectiveness of referral source using three measures: percentage of enrollment due to that source, subject commitment to the trial (retention rate), and economics (cost per enrollee). 47.8% of CHF enrollees came from computer-generated lists or from healthcare provider referrals. Average marketing cost for enrollees and completers was $29.20 and $41.96 respectively. The most economical marketing strategy was self-referral in response to flyers. Most asthma participants (53.5%) were referred from healthcare providers, mailings to lists from local healthcare institutions, or self-referred in response to flyers. Average marketing cost for enrollees and completers was $20.44 and $38.10 respectively. The most economical marketing strategy was patient mailings. Retention rates were not markedly different among referral sources in either trial. In order to be considered effective, a recruitment strategy must demonstrate a balance between response to recruitment, retention rates, and economics. Despite the differences between these two clinical trials, the most effective recruitment strategies in both trials were mailings to locally-generated, targeted lists, and referrals from healthcare providers.

A Paradox-based data collection and management system for multi-center randomized clinical trials.

PubMed

Abdellatif, Mazen; Reda, Domenic J

2004-02-01

We have developed a Paradox-based data collection and management system for large-scale multi-site randomized clinical trials. The system runs under Windows operating system and integrates Symantec pcAnywhere32 telecommunications software for data transmission and remote control sessions, PKZIP utility for the compression/decompression of transmitted data, and Stat/Transfer for exporting the centralized Paradox database for analyses. We initially developed this system for VA Cooperative Study #399 'The Effect of Antiarrhythmic Therapy in Maintaining Stability of Sinus Rhythm in Atrial Fibrillation', which collects over 1000 variables on 706 patients at 20 sites. Patient intake for this 5-year study began in March of 1998. We have also developed an enhanced version of this system, which is being used in the NIH-funded 'Glucosamine/Chondroitin Arthritis Intervention Trial (GAIT)' that collects over 1200 variables on 1588 patients at 13 sites. Patient intake for this 4-year study began in October of 2000.

[Qilin Pills for idiopathic oligoasthenospermia: A multi-centered randomized double-blind controlled clinical trial].

PubMed

Mao, Jia-Ming; Jiang, Hui; Wang, Chuan-Hang; Ning, Ke-Qin; Liu, Ji-Hong; Yang, Shu-Wen; Li, Hai-Song; Zhou, Shao-Hu; Zhang, Zhi-Chao; Xu, Ji-Xiu; Huang, Yong-Han

2017-03-01

To evaluate the clinical efficacy and safety of Qilin Pills in the treatment of oligoasthenospermia in infertile men. This multi-centered randomized double-blind controlled clinical trial included 216 infertile males with oligoasthenospermia, 108 in the trial group and the other 108 in the control, the former treated with Qilin Pills at the dose of 6 g tid while the latter with Wuziyanzong Pills at 6 g bid, both for 12 weeks. We examined the total sperm count, sperm motility and the count of progressively motile sperm of the patients before and at 4, 8 and 12 weeks after medication and evaluated the safety of the drug based on the adverse events and the laboratory results of blood and urine routine examinations and liver and kidney function tests. Compared with the baseline, the patients in the trial group showed a significant time-dependent improvement after 4, 8 and 12 weeks of medication in sperm motility (21.75% vs 27.54%, 29.04% and 32.95%, P <0.05), total sperm count (156.27 ×106 vs 177.33, 188.18 and 205.44 ×106, P <0.05), and the count of progressively motile sperm (32.08 ×10⁶/ml vs 46.33, 50.98 and 61.10 ×10⁶/ml, P <0.05). The three parameters above were also improved in the controls, but more significantly in the trial group (P <0.05). Qilin Pills can evidently improve the semen quality of oligoasthenospermia patients with no obvious adverse events.

The C-seal trial: colorectal anastomosis protected by a biodegradable drain fixed to the anastomosis by a circular stapler, a multi-center randomized controlled trial

PubMed Central

2012-01-01

Background Anastomotic leakage is a major complication in colorectal surgery and with an incidence of 11% the most common cause of morbidity and mortality. In order to reduce the incidence of anastomotic leakage the C-seal is developed. This intraluminal biodegradable drain is stapled to the anastomosis with a circular stapler and prevents extravasation of intracolonic content in case of an anastomotic dehiscence. The aim of this study is to evaluate the efficacy of the C-seal in reducing anastomotic leakage in stapled colorectal anastomoses, as assessed by anastomotic leakage leading to invasive treatment within 30 days postoperative. Methods The C-seal trial is a prospective multi-center randomized controlled trial with primary endpoint, anastomotic leakage leading to re-intervention within 30 days after operation. In this trial 616 patients will be randomized to the C-seal or control group (1:1), stratified by center, anastomotic height (proximal or distal of peritoneal reflection) and the intention to create a temporary deviating ostomy. Interim analyses are planned after 50% and 75% of patient inclusion. Eligible patients are at least 18 years of age, have any colorectal disease requiring a colorectal anastomosis to be made with a circular stapler in an elective setting, with an ASA-classification < 4. Oral mechanical bowel preparation is mandatory and patients with signs of peritonitis are excluded. The C-seal student team will perform the randomization procedure, supports the operating surgeon during the C-seal application and achieves the monitoring of the trial. Patients are followed for one year after randomization en will be analyzed on an intention to treat basis. Discussion This Randomized Clinical trial is designed to evaluate the effectiveness of the C-seal in preventing clinical anastomotic leakage. Trial registration NTR3080 PMID:23153188

A multi-center study on the regenerative effects of erythropoietin in burn and scalding injuries: study protocol for a randomized controlled trial.

PubMed

Günter, Christina Irene; Bader, Augustinus; Dornseifer, Ulf; Egert, Silvia; Dunda, Sebastian; Grieb, Gerrit; Wolter, Thomas; Pallua, Norbert; von Wild, Tobias; Siemers, Frank; Mailänder, Peter; Thamm, Oliver; Ernert, Carsten; Steen, Michael; Sievers, Reiner; Reichert, Bert; Rahmanian-Schwarz, Afshin; Schaller, Hans; Hartmann, Bernd; Otte, Max; Kehl, Victoria; Ohmann, Christian; Jelkmann, Wolfgang; Machens, Hans-Günther

2013-05-03

Although it was initially assumed that erythropoietin (EPO) was a hormone that only affected erythropoiesis, it has now been proposed that EPO plays an additional key role in the regulation of acute and chronic tissue damage. This is a large, prospective, randomized, double-blind, multi-center study, funded by the German Federal Ministry of Education and Research, and fully approved by the designated ethics committee. The trial, which is to investigate the effects of EPO in severely burned patients, is in its recruitment phase and is being carried out in 13 German burn care centers. A total of 150 patients are to be enrolled to receive study medication every other day for 21 days (EPO 150 IU/kg body weight or placebo). A follow-up of one year is planned. The primary endpoint of this study is the time until complete re-epithelialization of a defined skin graft donor site is reached. Furthermore, clinical parameters such as wound healing, scar formation (using the Vancouver scar scale), laboratory values, quality of life (SF-36), angiogenic effects, and gene- and protein-expression patterns are to be determined. The results will be carefully evaluated for gender differences. We are seeking new insights into the mechanisms of wound healing in thermally injured patients and more detailed information about the role EPO plays, specifically in these complex interactions. We additionally expect that the biomimetic effects of EPO will be useful in the treatment of acute thermal dermal injuries. EudraCT Number: 2006-002886-38, Protocol Number: 0506, ISRCT Number: http://controlled-trials.com/ISRCTN95777824/ISRCTN95777824.

Many multicenter trials had few events per center, requiring analysis via random-effects models or GEEs.

PubMed

Kahan, Brennan C; Harhay, Michael O

2015-12-01

Adjustment for center in multicenter trials is recommended when there are between-center differences or when randomization has been stratified by center. However, common methods of analysis (such as fixed-effects, Mantel-Haenszel, or stratified Cox models) often require a large number of patients or events per center to perform well. We reviewed 206 multicenter randomized trials published in four general medical journals to assess the average number of patients and events per center and determine whether appropriate methods of analysis were used in trials with few patients or events per center. The median number of events per center/treatment arm combination for trials using a binary or survival outcome was 3 (interquartile range, 1-10). Sixteen percent of trials had less than 1 event per center/treatment combination, 50% fewer than 3, and 63% fewer than 5. Of the trials which adjusted for center using a method of analysis which requires a large number of events per center, 6% had less than 1 event per center-treatment combination, 25% fewer than 3, and 50% fewer than 5. Methods of analysis that allow for few events per center, such as random-effects models or generalized estimating equations (GEEs), were rarely used. Many multicenter trials contain few events per center. Adjustment for center using random-effects models or GEE with model-based (non-robust) standard errors may be beneficial in these scenarios. Copyright © 2015 Elsevier Inc. All rights reserved.

Managing Multi-center Flow Cytometry Data for Immune Monitoring

PubMed Central

White, Scott; Laske, Karoline; Welters, Marij JP; Bidmon, Nicole; van der Burg, Sjoerd H; Britten, Cedrik M; Enzor, Jennifer; Staats, Janet; Weinhold, Kent J; Gouttefangeas, Cécile; Chan, Cliburn

2014-01-01

With the recent results of promising cancer vaccines and immunotherapy1–5, immune monitoring has become increasingly relevant for measuring treatment-induced effects on T cells, and an essential tool for shedding light on the mechanisms responsible for a successful treatment. Flow cytometry is the canonical multi-parameter assay for the fine characterization of single cells in solution, and is ubiquitously used in pre-clinical tumor immunology and in cancer immunotherapy trials. Current state-of-the-art polychromatic flow cytometry involves multi-step, multi-reagent assays followed by sample acquisition on sophisticated instruments capable of capturing up to 20 parameters per cell at a rate of tens of thousands of cells per second. Given the complexity of flow cytometry assays, reproducibility is a major concern, especially for multi-center studies. A promising approach for improving reproducibility is the use of automated analysis borrowing from statistics, machine learning and information visualization21–23, as these methods directly address the subjectivity, operator-dependence, labor-intensive and low fidelity of manual analysis. However, it is quite time-consuming to investigate and test new automated analysis techniques on large data sets without some centralized information management system. For large-scale automated analysis to be practical, the presence of consistent and high-quality data linked to the raw FCS files is indispensable. In particular, the use of machine-readable standard vocabularies to characterize channel metadata is essential when constructing analytic pipelines to avoid errors in processing, analysis and interpretation of results. For automation, this high-quality metadata needs to be programmatically accessible, implying the need for a consistent Application Programming Interface (API). In this manuscript, we propose that upfront time spent normalizing flow cytometry data to conform to carefully designed data models enables

A multi-center study on the regenerative effects of erythropoietin in burn and scalding injuries: study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Although it was initially assumed that erythropoietin (EPO) was a hormone that only affected erythropoiesis, it has now been proposed that EPO plays an additional key role in the regulation of acute and chronic tissue damage. Via the inhibition of inflammatory reactions and of apoptosis, stem cell recruitment, advancement of angiogenesis and growth factor release, EPO enhances healing and thus restitutio ad integrum after trauma. Human skin contains EPO receptors and is able to synthesize EPO. We therefore hypothesize that EPO is able to optimize wound healing in thermally injured patients. Methods/Design This is a large, prospective, randomized, double-blind, multi-center study, funded by the German Federal Ministry of Education and Research, and fully approved by the designated ethics committee. The trial, which is to investigate the effects of EPO in severely burned patients, is in its recruitment phase and is being carried out in 13 German burn care centers. A total of 150 patients are to be enrolled to receive study medication every other day for 21 days (EPO 150 IU/kg body weight or placebo). A follow-up of one year is planned. The primary endpoint of this study is the time until complete re-epithelialization of a defined skin graft donor site is reached. Furthermore, clinical parameters such as wound healing, scar formation (using the Vancouver scar scale), laboratory values, quality of life (SF-36), angiogenic effects, and gene- and protein-expression patterns are to be determined. The results will be carefully evaluated for gender differences. Discussion We are seeking new insights into the mechanisms of wound healing in thermally injured patients and more detailed information about the role EPO plays, specifically in these complex interactions. We additionally expect that the biomimetic effects of EPO will be useful in the treatment of acute thermal dermal injuries. Trial registration EudraCT Number: 2006-002886-38, Protocol Number: 0506, ISRCT

Information on center characteristics as costs' determinants in multicenter clinical trials: is modeling center effect worth the effort?

PubMed

Petrinco, Michele; Pagano, Eva; Desideri, Alessandro; Bigi, Riccardo; Ghidina, Marco; Ferrando, Alberto; Cortigiani, Lauro; Merletti, Franco; Gregori, Dario

2009-01-01

Several methodological problems arise when health outcomes and resource utilization are collected at different sites. To avoid misleading conclusions in multi-center economic evaluations the center effect needs to be taken into adequate consideration. The aim of this article is to compare several models, which make use of a different amount of information about the enrolling center. To model the association of total medical costs with the levels of two sets of covariates, one at patient and one at center level, we considered four statistical models, based on the Gamma model in the class of the Generalized Linear Models with a log link, which use different amount of information on the enrolling centers. Models were applied to Cost of Strategies after Myocardial Infarction data, an international randomized trial on costs of uncomplicated acute myocardial infarction (AMI). The simple center effect adjustment based on a single random effect results in a more conservative estimation of the parameters as compared with approaches which make use of deeper information on the centers characteristics. This study shows, with reference to a real multicenter trial, that center information cannot be neglected and should be collected and inserted in the analysis, better in combination with one or more random effect, taking into account in this way also the heterogeneity among centers because of unobserved centers characteristics.

Multi-level assessment protocol (MAP) for adoption in multi-site clinical trials

PubMed Central

Guydish, J.; Manser, S.T.; Jessup, M.; Tajima, B.; Sears, C.; Montini, T.

2010-01-01

The National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) is intended to test promising drug abuse treatment models in multi-site clinical trials, and to support adoption of new interventions into clinical practice. Using qualitative research methods we asked: How might the technology of multi-site clinical trials be modified to better support adoption of tested interventions? A total of 42 participants, representing 8 organizational levels ranging from clinic staff to clinical trial leaders, were interviewed about their role in the clinical trial, its interactions with clinics, and intervention adoption. Among eight clinics participating in the clinical trial, we found adoption of the tested intervention in one clinic only. In analysis of interview data we identified four conceptual themes which are likely to affect adoption and may be informative in future multi-site clinical trials. We offer the conclusion that planning for adoption in the early stages of protocol development will better serve the aim of integrating new interventions into practice. PMID:20890376

[The specialty clinical centers within the structure of the regional multi-specialty hospital].

PubMed

Fadeev, M G

2008-01-01

The analysis of the functioning of the regional referral clinical center of hand surgery, the eye injury center, the pediatric burns center and the neurosurgical center situated on the basis of large multi-field hospitals of the City of Ekaterinburg is presented. Such common conditions of their activity as experienced manpower availability and medical Academy chairs maintenance are revealed. The special referral clinical centers organized prior to the perstroyka and reformation, continue to function successfully providing high-tech medical care to the patients of the megapolis and to the inhabitants of the Sverdlovskaya Oblast. The effectiveness and perspectiveness of further functioning of the special referral clinical centers embedded into the structure of the municipal multi-field hospitals in the conditions of health reforms is demonstrated.

A multi-stage drop-the-losers design for multi-arm clinical trials.

PubMed

Wason, James; Stallard, Nigel; Bowden, Jack; Jennison, Christopher

2017-02-01

Multi-arm multi-stage trials can improve the efficiency of the drug development process when multiple new treatments are available for testing. A group-sequential approach can be used in order to design multi-arm multi-stage trials, using an extension to Dunnett's multiple-testing procedure. The actual sample size used in such a trial is a random variable that has high variability. This can cause problems when applying for funding as the cost will also be generally highly variable. This motivates a type of design that provides the efficiency advantages of a group-sequential multi-arm multi-stage design, but has a fixed sample size. One such design is the two-stage drop-the-losers design, in which a number of experimental treatments, and a control treatment, are assessed at a prescheduled interim analysis. The best-performing experimental treatment and the control treatment then continue to a second stage. In this paper, we discuss extending this design to have more than two stages, which is shown to considerably reduce the sample size required. We also compare the resulting sample size requirements to the sample size distribution of analogous group-sequential multi-arm multi-stage designs. The sample size required for a multi-stage drop-the-losers design is usually higher than, but close to, the median sample size of a group-sequential multi-arm multi-stage trial. In many practical scenarios, the disadvantage of a slight loss in average efficiency would be overcome by the huge advantage of a fixed sample size. We assess the impact of delay between recruitment and assessment as well as unknown variance on the drop-the-losers designs.

Multi-center, randomized, placebo-controlled trial of nocturnal oxygen therapy in chronic obstructive pulmonary disease: a study protocol for the INOX trial.

PubMed

Lacasse, Yves; Bernard, Sarah; Sériès, Frédéric; Nguyen, Van Hung; Bourbeau, Jean; Aaron, Shawn; Maltais, François

2017-01-09

Long-term oxygen therapy (LTOT) is the only component of the management of chronic obstructive pulmonary disease (COPD) that improves survival in patients with severe daytime hypoxemia. LTOT is usually provided by a stationary oxygen concentrator and is recommended to be used for at least 15-18 h a day. Several studies have demonstrated a deterioration in arterial blood gas pressures and oxygen saturation during sleep in patients with COPD, even in those not qualifying for LTOT. The suggestion has been made that the natural progression of COPD to its end stages of chronic pulmonary hypertension, severe hypoxemia, right heart failure, and death is dependent upon the severity of desaturation occurring during sleep. The primary objective of the International Nocturnal Oxygen (INOX) trial is to determine, in patients with COPD not qualifying for LTOT but who present significant nocturnal arterial oxygen desaturation, whether nocturnal oxygen provided for a period of 3 years decreases mortality or delay the prescription of LTOT. The INOX trial is a 3-year, multi-center, placebo-controlled, randomized trial of nocturnal oxygen therapy added to usual care. Eligible patients are those with a diagnosis of COPD supported by a history of past smoking and obstructive disease who fulfill our definition of significant nocturnal oxygen desaturation (i.e., ≥ 30% of the recording time with transcutaneous arterial oxygen saturation < 90% on either of two consecutive recordings). Patients allocated in the control group receive room air delivered by a concentrator modified to deliver 21% oxygen. The comparison is double blind. The primary outcome is a composite of mortality from all cause or requirement for LTOT. Secondary outcomes include quality of life and utility measures, costs from a societal perspective and compliance with oxygen therapy. The follow-up period is intended to last at least 3 years. The benefits of LTOT have been demonstrated whereas those of nocturnal oxygen

Music therapy in Huntington's disease: a protocol for a multi-center randomized controlled trial.

PubMed

van Bruggen-Rufi, Monique; Vink, Annemieke; Achterberg, Wilco; Roos, Raymund

2016-07-26

Huntington's disease is a progressive, neurodegenerative disease with autosomal dominant inheritance, characterized by motor disturbances, cognitive decline and behavioral and psychological symptoms. Since there is no cure, all treatment is aimed at improving quality of life. Music therapy is a non-pharmacological intervention, aiming to improve the quality of life, but its use and efficacy in patients with Huntington's disease has hardly been studied. In this article, a protocol is described to study the effects of music therapy in comparison with a control intervention to improve quality of life through stimulating expressive and communicative skills. By targeting these skills we assume that the social-cognitive functioning will improve, leading to a reduction in behavioral problems, resulting in an overall improvement of the quality of life in patients with Huntington's disease. The study is designed as a multi-center single-blind randomised controlled intervention trial. Sixty patients will be randomised using centre-stratified block-permuted randomisation. Patients will be recruited from four long-term care facilities specialized in Huntington's disease-care in The Netherlands. The outcome measure to assess changes in expressive and communication skills is the Behaviour Observation Scale Huntington and changes in behavior will be assessed by the Problem Behaviour Assesment-short version and by the BOSH. Measurements take place at baseline, then 8, 16 (end of intervention) and 12 weeks after the last intervention (follow-up). This randomized controlled study will provide greater insight into the effectiveness of music therapy on activities of daily living, social-cognitive functioning and behavior problems by improving expressive and communication skills, thus leading to a better quality of life for patients with Huntington's disease. Netherlands Trial Register: NTR4904 , registration date Nov. 15, 2014.

Change in clinical indices following laser or scalpel treatment for periodontitis: A split-mouth, randomized, multi-center trial

NASA Astrophysics Data System (ADS)

Harris, David M.; Nicholson, Dawn M.; McCarthy, Delwin; Yukna, Raymond A.; Reynolds, Mark A.; Greenwell, Henry; Finley, James; McCawley, Thomas K.; Xenoudi, Pinelopi; Gregg, Robert H.

2014-02-01

Data are presented from a multi-center, prospective, longitudinal, clinical trial comparing four different treatments for periodontitis, (1) the LANAPTM protocol utilizing a FR pulsed-Nd:YAG laser; (2) flap surgery using the Modified Widman technique (MWF); (3) traditional scaling and root planing (SRP); and (4) coronal debridement (CD). Each treatment was randomized to a different quadrant. Fifty-one (54) subjects were recruited at five centers that included both private practice and university-based investigators. At 6-months and 12 months post-treatment the LANAPTM protocol and MWF yielded equivalent results based on changes in probing depths. The major difference observed between the two procedures was that patients reported significantly greater comfort following the LANAP™ procedure than following the MWF (P<0.001). There was greater reduction in bleeding in the LANAPTM quadrant than in the other three at both 6 and 12 months. Improvements following SRP were better than expected at 6 months and continued to improve, providing outcomes that were equivalent to both LANAPTM and MWF at 12 months. The improvement in the SRP quadrants suggests the hypothesis that an aspect of the LANAPTM protocol generated a significant, positive and unanticipated systemic (or trans-oral) effect on sub-gingival wound healing.

Pivot/Remote: a distributed database for remote data entry in multi-center clinical trials.

PubMed

Higgins, S B; Jiang, K; Plummer, W D; Edens, T R; Stroud, M J; Swindell, B B; Wheeler, A P; Bernard, G R

1995-01-01

1. INTRODUCTION. Data collection is a critical component of multi-center clinical trials. Clinical trials conducted in intensive care units (ICU) are even more difficult because the acute nature of illnesses in ICU settings requires that masses of data be collected in a short time. More than a thousand data points are routinely collected for each study patient. The majority of clinical trials are still "paper-based," even if a remote data entry (RDE) system is utilized. The typical RDE system consists of a computer housed in the CC office and connected by modem to a centralized data coordinating center (DCC). Study data must first be recorded on a paper case report form (CRF), transcribed into the RDE system, and transmitted to the DCC. This approach requires additional monitoring since both the paper CRF and study database must be verified. The paper-based RDE system cannot take full advantage of automatic data checking routines. Much of the effort (and expense) of a clinical trial is ensuring that study data matches the original patient data. 2. METHODS. We have developed an RDE system, Pivot/Remote, that eliminates the need for paper-based CRFs. It creates an innovative, distributed database. The database resides partially at the study clinical centers (CC) and at the DCC. Pivot/Remote is descended from technology introduced with Pivot [1]. Study data is collected at the bedside with laptop computers. A graphical user interface (GUI) allows the display of electronic CRFs that closely mimic the normal paper-based forms. Data entry time is the same as for paper CRFs. Pull-down menus, displaying the possible responses, simplify the process of entering data. Edit checks are performed on most data items. For example, entered dates must conform to some temporal logic imposed by the study. Data must conform to some acceptable range of values. Calculations, such as computing the subject's age or the APACHE II score, are automatically made as the data is entered. Data

CONCEPTT: Continuous Glucose Monitoring in Women with Type 1 Diabetes in Pregnancy Trial: A multi-center, multi-national, randomized controlled trial - Study protocol.

PubMed

Feig, Denice S; Asztalos, Elizabeth; Corcoy, Rosa; De Leiva, Alberto; Donovan, Lois; Hod, Moshe; Jovanovic, Lois; Keely, Erin; Kollman, Craig; McManus, Ruth; Murphy, Kellie; Ruedy, Katrina; Sanchez, J Johanna; Tomlinson, George; Murphy, Helen R

2016-07-18

Women with type 1 diabetes strive for optimal glycemic control before and during pregnancy to avoid adverse obstetric and perinatal outcomes. For most women, optimal glycemic control is challenging to achieve and maintain. The aim of this study is to determine whether the use of real-time continuous glucose monitoring (RT-CGM) will improve glycemic control in women with type 1 diabetes who are pregnant or planning pregnancy. A multi-center, open label, randomized, controlled trial of women with type 1 diabetes who are either planning pregnancy with an HbA1c of 7.0 % to ≤10.0 % (53 to ≤ 86 mmol/mol) or are in early pregnancy (<13 weeks 6 days) with an HbA1c of 6.5 % to ≤10.0 % (48 to ≤ 86 mmol/mol). Participants will be randomized to either RT-CGM alongside conventional intermittent home glucose monitoring (HGM), or HGM alone. Eligible women will wear a CGM which does not display the glucose result for 6 days during the run-in phase. To be eligible for randomization, a minimum of 4 HGM measurements per day and a minimum of 96 hours total with 24 hours overnight (11 pm-7 am) of CGM glucose values are required. Those meeting these criteria are randomized to RT- CGM or HGM. A total of 324 women will be recruited (110 planning pregnancy, 214 pregnant). This takes into account 15 and 20 % attrition rates for the planning pregnancy and pregnant cohorts and will detect a clinically relevant 0.5 % difference between groups at 90 % power with 5 % significance. Randomization will stratify for type of insulin treatment (pump or multiple daily injections) and baseline HbA1c. Analyses will be performed according to intention to treat. The primary outcome is the change in glycemic control as measured by HbA1c from baseline to 24 weeks or conception in women planning pregnancy, and from baseline to 34 weeks gestation during pregnancy. Secondary outcomes include maternal hypoglycemia, CGM time in, above and below target (3.5-7.8 mmol/l), glucose

Protocolized fluid therapy in brain-dead donors: The multi-center randomized MOnIToR trial

PubMed Central

Al-Khafaji, Ali; Elder, Michele; Lebovitz, Daniel J; Murugan, Raghavan; Souter, Michael; Stuart, Susan; Wahed, Abdus S.; Keebler, Ben; Dils, Dorrie; Mitchell, Stephanie; Shutterly, Kurt; Wilkerson, Dawn; Pearse, Rupert; Kellum, John A

2015-01-01

BACKGROUND Critical shortages of organs for transplantation jeopardize many lives. Observational data suggest that better fluid management for deceased organ donors could increase organ recovery. We conducted the first large multi-center randomized trial in brain-dead donors to determine whether protocolized fluid therapy increases organs transplanted. METHODS We randomly assigned donors to either protocolized or usual care in eight organ procurement organizations. A “protocol-guided fluid therapy” algorithm targeting cardiac index, mean arterial pressure and pulse pressure variation was used. Our primary outcome was the number of organs transplanted per donor and our primary analysis was intention-to-treat. Secondary analyses included: 1) modified intention-to-treat where only subjects able to receive the intervention were included, and 2) twelve-month survival in transplant recipients. The study was stopped early. RESULTS We enrolled 556 donors; 279 protocolized care, 277 usual care. Groups had similar characteristics at baseline. The study protocol could be implemented in 76% of subjects randomized to the intervention. There was no significant difference in mean number of organs transplanted per donor: 3.39 organs per donor, (95%CI: 3.14-3.63) with protocolized care, compared to usual care 3.29 (95%CI: 3.04-3.54) (mean difference, 0.1, 95%CI: -0.25 to 0.45; p=0.56). In modified intention-to-treat analysis the mean number of organs increased (3.52 organs per donor, 95%CI: 3.23-3.8) but was not statistically significant (mean difference, 0.23, 95%CI: -0.15-0.61; p=0.23). Among the 1430 recipients of organs from study subjects, with data available, 56 deaths (7.8%) occurred in the protocolized care arm and 56 (7.9%) in the usual care arm in the first year (Hazard Ratio: 0.97, p=0.86). CONCLUSIONS In brain-dead organ donors, protocol-guided fluid therapy compared to usual care may not increase the number of organs transplanted per donor. PMID:25583616

Trends in the application of dynamic allocation methods in multi-arm cancer clinical trials.

PubMed

Pond, Gregory R; Tang, Patricia A; Welch, Stephen A; Chen, Eric X

2010-06-01

Dynamic allocation (DA) methods which attempt to balance baseline prognostic factors between treatment arms, can be used in multi-arm clinical trials to sequentially allocate patients to treatment. Although some experts express concern regarding the validity of inference from trials using DA, others believe DA methods produce more credible results. A review of published multi-arm cancer clinical trials was conducted to explore the frequency of DA use in oncology. Multi-arm phase III clinical trials of at least 100 patients per arm, published in 13 major oncology journals from 1995-2005 were manually reviewed. Information about reported use of DA methods, or randomization via random permuted blocks (PB), was extracted along with trial characteristics. Of 476 published clinical trials, 112 (23.5%) reported using some form of DA method, while 103 (21.6%) reported using PB methods. Most trials (403 or 84.7%) reported stratifying on at least one baseline factor. The mean number of stratification factors was 2.70 per trial, and 78.6% of DA trials reported 3 or more stratification factors compared with 30.2% of non-DA trials (p < 0.001). The frequency of DA use increased over time, with 20.2%, 21.3%, 25.8%, 28.8% and 38.9% of trials reported use in 1995-2001, 2002, 2003, 2004, and 2005, respectively. Use of DA methods was more frequently reported in trials involving an academic co-operative group (28.4% vs. 13.8%), however, no difference was observed between industry-funded and other-funded trials (24.0% vs. 23.2%) or geographical region (19.7% of North American trials, 26.2% of European trials and 21.7% of multinational/other trials). As a retrospective analysis, the true frequency of DA use is likely underreported. Few trials gave complete details of the allocation method used, thus it is possible some manuscripts reported incorrect allocation methods. Journals were selected which were assumed to publish most large, multi-arm clinical trials in cancer from 1995

Multi-Institution Research Centers: Planning and Management Challenges

ERIC Educational Resources Information Center

Spooner, Catherine; Lavey, Lisa; Mukuka, Chilandu; Eames-Brown, Rosslyn

2016-01-01

Funding multi-institution centers of research excellence (CREs) has become a common means of supporting collaborative partnerships to address specific research topics. However, there is little guidance for those planning or managing a multi-institution CRE, which faces specific challenges not faced by single-institution research centers. We…

Resolving controversies in hip fracture care: the need for large collaborative trials in hip fractures.

PubMed

Bhandari, Mohit; Sprague, Sheila; Schemitsch, Emil H

2009-07-01

Hip fractures are a significant cause of morbidity and mortality worldwide and the burden of disability associated with hip fractures globally vindicate the need for high-quality research to advance the care of patients with hip fractures. Historically, large, multi-centre randomized controlled trials have been rare in the orthopaedic trauma literature. Similar to other medical specialties, orthopaedic research is currently undergoing a paradigm shift from single centre initiatives to larger collaborative groups. This is evident with the establishment of several collaborative groups in Canada, in the United States, and in Europe, which has proven that multi-centre trials can be extremely successful in orthopaedic trauma research.Despite ever increasing literature on the topic of his fractures, the optimal treatment of hip fractures remains unknown and controversial. To resolve this controversy large multi-national collaborative randomized controlled trials are required. In 2005, the International Hip Fracture Research Collaborative was officially established following funding from the Canadian Institute of Health Research International Opportunity Program with the mandate of resolving controversies in hip fracture management. This manuscript will describe the need, the information, the organization, and the accomplishments to date of the International Hip Fracture Research Collaborative.

Metformin in women with type 2 diabetes in pregnancy (MiTy): a multi-center randomized controlled trial.

PubMed

Feig, Denice S; Murphy, Kellie; Asztalos, Elizabeth; Tomlinson, George; Sanchez, Johanna; Zinman, Bernard; Ohlsson, Arne; Ryan, Edmond A; Fantus, I George; Armson, Anthony B; Lipscombe, Lorraine L; Barrett, Jon F R

2016-07-19

The incidence of type 2 diabetes in pregnancy is rising and rates of serious adverse maternal and fetal outcomes remain high. Metformin is a biguanide that is used as first-line treatment for non-pregnant patients with type 2 diabetes. We hypothesize that metformin use in pregnancy, as an adjunct to insulin, will decrease adverse outcomes by reducing maternal hyperglycemia, maternal insulin doses, maternal weight gain and gestational hypertension/pre-eclampsia. In addition, since metformin crosses the placenta, metformin treatment of the fetus may have a direct beneficial effect on neonatal outcomes. Our aim is to compare the effectiveness of the addition of metformin to insulin, to standard care (insulin plus placebo) in women with type 2 diabetes in pregnancy. The MiTy trial is a multi-centre randomized trial currently enrolling pregnant women with type 2 diabetes, who are on insulin, between the ages of 18-45, with a gestational age of 6 weeks 0 days to 22 weeks 6 days. In this randomized, double-masked, parallel placebo-controlled trial, after giving informed consent, women are randomized to receive either metformin 1,000 mg twice daily or placebo twice daily. A web-based block randomization system is used to assign women to metformin or placebo in a 1:1 ratio, stratified for site and body mass index. The primary outcome is a composite neonatal outcome of pregnancy loss, preterm birth, birth injury, moderate/severe respiratory distress, neonatal hypoglycemia, or neonatal intensive care unit admission longer than 24 h. Secondary outcomes are large for gestational age, cord blood gas pH < 7.0, congenital anomalies, hyperbilirubinemia, sepsis, hyperinsulinemia, shoulder dystocia, fetal fat mass, as well as maternal outcomes: maternal weight gain, maternal insulin doses, maternal glycemic control, maternal hypoglycemia, gestational hypertension, preeclampsia, cesarean section, number of hospitalizations during pregnancy, and duration of hospital stays

Accounting for center in the Early External Cephalic Version trials: an empirical comparison of statistical methods to adjust for center in a multicenter trial with binary outcomes.

PubMed

Reitsma, Angela; Chu, Rong; Thorpe, Julia; McDonald, Sarah; Thabane, Lehana; Hutton, Eileen

2014-09-26

Clustering of outcomes at centers involved in multicenter trials is a type of center effect. The Consolidated Standards of Reporting Trials Statement recommends that multicenter randomized controlled trials (RCTs) should account for center effects in their analysis, however most do not. The Early External Cephalic Version (EECV) trials published in 2003 and 2011 stratified by center at randomization, but did not account for center in the analyses, and due to the nature of the intervention and number of centers, may have been prone to center effects. Using data from the EECV trials, we undertook an empirical study to compare various statistical approaches to account for center effect while estimating the impact of external cephalic version timing (early or delayed) on the outcomes of cesarean section, preterm birth, and non-cephalic presentation at the time of birth. The data from the EECV pilot trial and the EECV2 trial were merged into one dataset. Fisher's exact method was used to test the overall effect of external cephalic version timing unadjusted for center effects. Seven statistical models that accounted for center effects were applied to the data. The models included: i) the Mantel-Haenszel test, ii) logistic regression with fixed center effect and fixed treatment effect, iii) center-size weighted and iv) un-weighted logistic regression with fixed center effect and fixed treatment-by-center interaction, iv) logistic regression with random center effect and fixed treatment effect, v) logistic regression with random center effect and random treatment-by-center interaction, and vi) generalized estimating equations. For each of the three outcomes of interest approaches to account for center effect did not alter the overall findings of the trial. The results were similar for the majority of the methods used to adjust for center, illustrating the robustness of the findings. Despite literature that suggests center effect can change the estimate of effect in

Towards large scale multi-target tracking

NASA Astrophysics Data System (ADS)

Vo, Ba-Ngu; Vo, Ba-Tuong; Reuter, Stephan; Lam, Quang; Dietmayer, Klaus

2014-06-01

Multi-target tracking is intrinsically an NP-hard problem and the complexity of multi-target tracking solutions usually do not scale gracefully with problem size. Multi-target tracking for on-line applications involving a large number of targets is extremely challenging. This article demonstrates the capability of the random finite set approach to provide large scale multi-target tracking algorithms. In particular it is shown that an approximate filter known as the labeled multi-Bernoulli filter can simultaneously track one thousand five hundred targets in clutter on a standard laptop computer.

Multi-Center Trial of Baclofen for Abstinence Initiation in Severe Cocaine Dependent Individuals

PubMed Central

Kahn, Roberta; Biswas, Kousick; Childress, Anna-Rose; Shoptaw, Steve; Fudala, Paul J.; Gorgon, Liza; Montoya, Ivan; Collins, Joseph; McSherry, Frances; Li, Shou-Hua; Chiang, Nora; Alathari, Husam; Watson, Donnie; Liberto, Joseph; Beresford, Thomas; Stock, Christopher; Wallace, Christopher; Gruber, Valerie; Elkashef, Ahmed

2009-01-01

Background Cocaine dependence is a major public health problem for which there is no FDA-approved pharmacological treatment. Baclofen is a GABAB receptor agonist that in preclinical and early pilot clinical trials has shown promise for the treatment of cocaine dependence. The purpose of this multi-site, double-blind study, was to compare the safety and efficacy of baclofen (60 mg/day) versus placebo in an 8-week treatment of individuals with severe cocaine dependence. The primary outcome measure was subjects' self-reported cocaine use substantiated by urine benzoylecgonine (BE). Analysis of the data did not show a significant difference between the groups treated with baclofen and placebo. The current results do not support a role for 60mg baclofen in treating cocaine dependence in the population studied. The contrast of this result to earlier, preclinical and human pilot data with baclofen may reflect the trial's focus on severe cocaine-dependent users, and/or the need for a higher baclofen dose. Baclofen's potential as a relapse prevention agent was not tested by the current design, but may be a useful target for future studies. PMID:19414226

Tracking and tracing of participants in two large cancer screening trials.

PubMed

Marcus, Pamela M; Childs, Jeffery; Gahagan, Betsy; Gren, Lisa H

2012-07-01

Many clinical trials rely on participant report to first learn about study events. It is therefore important to have current contact information and the ability to locate participants should information become outdated. The Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial (PLCO) and the Lung Screening Study (LSS) component of the National Lung Screening Trial, two large randomized cancer screening trials, enrolled almost 190,000 participants on whom annual contact was necessary. Ten screening centers participated in both trials. Centers developed methods to track participants and trace them when necessary. We describe the methods used to keep track of participants and trace them when lost, and the extent to which each method was used. Screening center coordinators were asked, using a self-administered paper questionnaire, to rate the extent to which specific tracking and tracing methods were used. Many methods were used by the screening centers, including telephone calls, mail, and internet searches. The most extensively used methods involved telephoning the participant on his or her home or cell phone, or telephoning a person identified by the participant as someone who would know about the participant's whereabouts. Internet searches were used extensively as well; these included searches on names, reverse-lookup searches (on addresses or telephone numbers) and searches of the Social Security Death Index. Over time, the percentage of participants requiring tracing decreased. Telephone communication and internet services were useful in keeping track of PLCO and LSS participants and tracing them when contact information was no longer valid. Published by Elsevier Inc.

[Efficacy of Weitan Waifu patch on the postsurgical gastroparesis syndrome of gastrointestinal cancer: a multi-center trial].

PubMed

Zhou, Q; Zuo, M H; Li, Q W; Tian, Y T; Xie, Y B; Wang, Y B; Yang, G Y; Ye, Y J; Guo, P; Liu, J P; Liu, Z L; An, C; Zhou, T; Tian, Z; Liu, C B; Hu, Y; Chi, X Y; Shen, Y; Xia, Y; Hu, K W

2017-12-23

Objective: To investigate the safety and efficacy of the Weitan Waifu patch on the postsurgical gastroparesis syndrome (PGS) of gastrointestinal cancer. Methods: The multi-center, double-blind, randomized controlled trial was conducted with superiority design. Patients with PGS of gastrointestinal cancer diagnosed in 4 AAA hospitals and the abdominal symptom manifested as cold syndrome by Chinese local syndrome differentiation were recruited. These patients were randomly divided into two groups according to 1∶1 proportion. Placebo or Weitan Waifu patch was applied in control group or intervention group, respectively, based on the basic treatments, including nutrition support, gastrointestinal decompression, promoting gastric dynamics medicine.Two acupuncture points (Zhongwan and Shenque) were stuck with placebo in control group or patch in treatment group. The intervention course was 14 days or reached the effective standard. Results: From July 15, 2013 to Jun 3, 2015, 128 participants were recruited and 120 eligible cases were included in the full analysis set (FAS), and 60 cases in each group. 88 cases were included in the per-protocol set (PPS), including 45 cases in the treatment group and 43 cases in the control group. In the FAS, the clinical effective rate in the treatment group was 68.3%, significantly superior than 41.7% of the control group ( P =0.003). The medium time of effective therapy in the treatment group was 8 days, significantly shorter than 10 days in the control group ( P =0.017). In the FAS, 3 adverse events occurred in the treatment group, including mild to moderate decrustation, pruritus and nausea. The incidence rate of adverse events was 5.0% (3/60) and these symptoms were spontaneously remitted after drug withdrawal. No severe adverse events were observed in the control group. There was no significant difference between these two groups ( P =0.244). Conclusion: Weitan Waifu patch is a safely and effectively therapeutic method for

Alternative Fuels Data Center: Electric Vehicle Charging for Multi-Unit

Science.gov Websites

Dwellings Electric Vehicle Charging for Multi-Unit Dwellings to someone by E-mail Share Alternative Fuels Data Center: Electric Vehicle Charging for Multi-Unit Dwellings on Facebook Tweet about Alternative Fuels Data Center: Electric Vehicle Charging for Multi-Unit Dwellings on Twitter Bookmark

Flexible trial design in practice - stopping arms for lack-of-benefit and adding research arms mid-trial in STAMPEDE: a multi-arm multi-stage randomized controlled trial

PubMed Central

2012-01-01

Background Systemic Therapy for Advanced or Metastatic Prostate cancer: Evaluation of Drug Efficacy (STAMPEDE) is a randomized controlled trial that follows a novel multi-arm, multi-stage (MAMS) design. We describe methodological and practical issues arising with (1) stopping recruitment to research arms following a pre-planned intermediate analysis and (2) adding a new research arm during the trial. Methods STAMPEDE recruits men who have locally advanced or metastatic prostate cancer who are starting standard long-term hormone therapy. Originally there were five research and one control arms, each undergoing a pilot stage (focus: safety, feasibility), three intermediate ‘activity’ stages (focus: failure-free survival), and a final ‘efficacy’ stage (focus: overall survival). Lack-of-sufficient-activity guidelines support the pairwise interim comparisons of each research arm against the control arm; these pre-defined activity cut-off becomes increasingly stringent over the stages. Accrual of further patients continues to the control arm and to those research arms showing activity and an acceptable safety profile. The design facilitates adding new research arms should sufficiently interesting agents emerge. These new arms are compared only to contemporaneously recruited control arm patients using the same intermediate guidelines in a time-delayed manner. The addition of new research arms is subject to adequate recruitment rates to support the overall trial aims. Results (1) Stopping Existing Therapy: After the second intermediate activity analysis, recruitment was discontinued to two research arms for lack-of-sufficient activity. Detailed preparations meant that changes were implemented swiftly at 100 international centers and recruitment continued seamlessly into Activity Stage III with 3 remaining research arms and the control arm. Further regulatory and ethical approvals were not required because this was already included in the initial trial design. (2

Consistency of clinical biomechanical measures between three different institutions: implications for multi-center biomechanical and epidemiological research.

PubMed

Myer, Gregory D; Wordeman, Samuel C; Sugimoto, Dai; Bates, Nathaniel A; Roewer, Benjamin D; Medina McKeon, Jennifer M; DiCesare, Christopher A; Di Stasi, Stephanie L; Barber Foss, Kim D; Thomas, Staci M; Hewett, Timothy E

2014-05-01

Multi-center collaborations provide a powerful alternative to overcome the inherent limitations to single-center investigations. Specifically, multi-center projects can support large-scale prospective, longitudinal studies that investigate relatively uncommon outcomes, such as anterior cruciate ligament injury. This project was conceived to assess within- and between-center reliability of an affordable, clinical nomogram utilizing two-dimensional video methods to screen for risk of knee injury. The authors hypothesized that the two-dimensional screening methods would provide good-to-excellent reliability within and between institutions for assessment of frontal and sagittal plane biomechanics. Nineteen female, high school athletes participated. Two-dimensional video kinematics of the lower extremity during a drop vertical jump task were collected on all 19 study participants at each of the three facilities. Within-center and between-center reliability were assessed with intra- and inter-class correlation coefficients. Within-center reliability of the clinical nomogram variables was consistently excellent, but between-center reliability was fair-to-good. Within-center intra-class correlation coefficient for all nomogram variables combined was 0.98, while combined between-center inter-class correlation coefficient was 0.63. Injury risk screening protocols were reliable within and repeatable between centers. These results demonstrate the feasibility of multi-site biomechanical studies and establish a framework for further dissemination of injury risk screening algorithms. Specifically, multi-center studies may allow for further validation and optimization of two-dimensional video screening tools. 2b.

Financial management of a large multisite randomized clinical trial.

PubMed

Sheffet, Alice J; Flaxman, Linda; Tom, MeeLee; Hughes, Susan E; Longbottom, Mary E; Howard, Virginia J; Marler, John R; Brott, Thomas G

2014-08-01

The Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) received five years' funding ($21 112 866) from the National Institutes of Health to compare carotid stenting to surgery for stroke prevention in 2500 randomized participants at 40 sites. Herein we evaluate the change in the CREST budget from a fixed to variable-cost model and recommend strategies for the financial management of large-scale clinical trials. Projections of the original grant's fixed-cost model were compared to the actual costs of the revised variable-cost model. The original grant's fixed-cost budget included salaries, fringe benefits, and other direct and indirect costs. For the variable-cost model, the costs were actual payments to the clinical sites and core centers based upon actual trial enrollment. We compared annual direct and indirect costs and per-patient cost for both the fixed and variable models. Differences between clinical site and core center expenditures were also calculated. Using a variable-cost budget for clinical sites, funding was extended by no-cost extension from five to eight years. Randomizing sites tripled from 34 to 109. Of the 2500 targeted sample size, 138 (5·5%) were randomized during the first five years and 1387 (55·5%) during the no-cost extension. The actual per-patient costs of the variable model were 9% ($13 845) of the projected per-patient costs ($152 992) of the fixed model. Performance-based budgets conserve funding, promote compliance, and allow for additional sites at modest additional cost. Costs of large-scale clinical trials can thus be reduced through effective management without compromising scientific integrity. © 2014 The Authors. International Journal of Stroke © 2014 World Stroke Organization.

Flexible trial design in practice - stopping arms for lack-of-benefit and adding research arms mid-trial in STAMPEDE: a multi-arm multi-stage randomized controlled trial.

PubMed

Sydes, Matthew R; Parmar, Mahesh K B; Mason, Malcolm D; Clarke, Noel W; Amos, Claire; Anderson, John; de Bono, Johann; Dearnaley, David P; Dwyer, John; Green, Charlene; Jovic, Gordana; Ritchie, Alastair W S; Russell, J Martin; Sanders, Karen; Thalmann, George; James, Nicholas D

2012-09-15

Systemic Therapy for Advanced or Metastatic Prostate cancer: Evaluation of Drug Efficacy (STAMPEDE) is a randomized controlled trial that follows a novel multi-arm, multi-stage (MAMS) design. We describe methodological and practical issues arising with (1) stopping recruitment to research arms following a pre-planned intermediate analysis and (2) adding a new research arm during the trial. STAMPEDE recruits men who have locally advanced or metastatic prostate cancer who are starting standard long-term hormone therapy. Originally there were five research and one control arms, each undergoing a pilot stage (focus: safety, feasibility), three intermediate 'activity' stages (focus: failure-free survival), and a final 'efficacy' stage (focus: overall survival). Lack-of-sufficient-activity guidelines support the pairwise interim comparisons of each research arm against the control arm; these pre-defined activity cut-off becomes increasingly stringent over the stages. Accrual of further patients continues to the control arm and to those research arms showing activity and an acceptable safety profile. The design facilitates adding new research arms should sufficiently interesting agents emerge. These new arms are compared only to contemporaneously recruited control arm patients using the same intermediate guidelines in a time-delayed manner. The addition of new research arms is subject to adequate recruitment rates to support the overall trial aims. (1) Stopping Existing Therapy: After the second intermediate activity analysis, recruitment was discontinued to two research arms for lack-of-sufficient activity. Detailed preparations meant that changes were implemented swiftly at 100 international centers and recruitment continued seamlessly into Activity Stage III with 3 remaining research arms and the control arm. Further regulatory and ethical approvals were not required because this was already included in the initial trial design.(2) Adding New Therapy: An application to

Assessing the challenges of multi-scope clinical research sites: an example from NIH HIV/AIDS clinical trials networks.

PubMed

Rosas, Scott R; Cope, Marie T; Villa, Christie; Motevalli, Mahnaz; Utech, Jill; Schouten, Jeffrey T

2014-04-01

Large-scale, multi-network clinical trials are seen as a means for efficient and effective utilization of resources with greater responsiveness to new discoveries. Formal structures instituted within the National Institutes of Health (NIH) HIV/AIDS Clinical Trials facilitate collaboration and coordination across networks and emphasize an integrated approach to HIV/AIDS vaccine, prevention and therapeutics clinical trials. This study examines the joint usage of clinical research sites as means of gaining efficiency, extending capacity, and adding scientific value to the networks. A semi-structured questionnaire covering eight clinical management domains was administered to 74 (62% of sites) clinical site coordinators at single- and multi-network sites to identify challenges and efficiencies related to clinical trials management activities and coordination with multi-network units. Overall, respondents at multi-network sites did not report more challenges than single-network sites, but did report unique challenges to overcome including in the areas of study prioritization, community engagement, staff education and training, and policies and procedures. The majority of multi-network sites reported that such affiliations do allow for the consolidation and cost-sharing of research functions. Suggestions for increasing the efficiency or performance of multi-network sites included streamlining standards and requirements, consolidating protocol activation methods, using a single cross-network coordinating centre, and creating common budget and payment mechanisms. The results of this assessment provide important information to consider in the design and management of multi-network configurations for the NIH HIV/AIDS Clinical Trials Networks, as well as others contemplating and promoting the concept of multi-network settings. © 2013 John Wiley & Sons Ltd.

[Why multi-national clinical trials now?--Industry perspective].

PubMed

Miki, Satoshi

2007-02-01

Clinical trial environment in Japan has issues such as high clinical development cost, resource-intensive and time-consuming preparation for clinical trial conduct in each clinical site, long "White Space" and slow speed in pt.recruitment. As a result of the Guideline revision in Nov., 2005, overseas' Phase III data is now usable as pivotal data for NDA submissions. Therefore, acceleration of "hollowing out of clinical trails for registration in Japan has been the significant concern. Under such circumstances, the possible solution would be to participate in the Multi-National Clinical Trials." While other Asian countries, EU and the US have rich precedents and experiences in conducting Multi-National Clinical Trials, Japan was left alone and other Asian countries do not need any collaboration with Japan. It is proposed that Japan take initiative to set up the network such as "Asian Clinical Trial Group" and collaborate with other Asian countries from the beginning of early stage development. Eventually, Asia should become the third region to create clinical evidence, same as to EU and the US.

The use of DRG for identifying clinical trials centers with high recruitment potential: a feasability study.

PubMed

Aegerter, Philippe; Bendersky, Noelle; Tran, Thi-Chien; Ropers, Jacques; Taright, Namik; Chatellier, Gilles

2014-01-01

Recruitment of large samples of patients is crucial for evidence level and efficacy of clinical trials (CT). Clinical Trial Recruitment Support Systems (CTRSS) used to estimate patient recruitment are generally specific to Hospital Information Systems and few were evaluated on a large number of trials. Our aim was to assess, on a large number of CT, the usefulness of commonly available data as Diagnosis Related Groups (DRG) databases in order to estimate potential recruitment. We used the DRG database of a large French multicenter medical institution (1.2 million inpatient stays and 400 new trials each year). Eligibility criteria of protocols were broken down into in atomic entities (diagnosis, procedures, treatments...) then translated into codes and operators recorded in a standardized form. A program parsed the forms and generated requests on the DRG database. A large majority of selection criteria could be coded and final estimations of number of eligible patients were close to observed ones (median difference = 25). Such a system could be part of the feasability evaluation and center selection process before the start of the clinical trial.

Center-defined unacceptable HLA antigens facilitate transplants for sensitized patients in a multi-center kidney exchange program.

PubMed

Baxter-Lowe, L A; Cecka, M; Kamoun, M; Sinacore, J; Melcher, M L

2014-07-01

Multi-center kidney paired donation (KPD) is an exciting new transplant option that has not yet approached its full potential. One barrier to progress is accurate virtual crossmatching for KPD waitlists with many highly sensitized patients. Virtual crossmatch results from a large multi-center consortium, the National Kidney Registry (NKR), were analyzed to determine the effectiveness of flexible center-specific criteria for virtual crossmatching. Approximately two-thirds of the patients on the NKR waitlist are highly sensitized (>80% CPRA). These patients have antibodies against HLA-A (63%), HLA-B (66%), HLA-C (41%), HLA-DRB1 (60%), HLA-DRB3/4/5 (18-22%), HLA-DQB1 (54%) and HLA-DPB1 (26%). With donors typed for these loci before activation, 91% of virtual crossmatches accurately predicted an acceptable cell-based donor crossmatch. Failed virtual crossmatches were attributed to equivocal virtual crossmatches (46%), changes in HLA antibodies (21%), antibodies against HLA-DQA (6%), transcription errors (6%), suspected non-HLA antibodies (5%), allele-specific antibodies (1%) and unknown causes (15%). Some failed crossmatches could be prevented by modifiable factors such as more frequent assessment of HLA antibodies, DQA1 typing of donors and auditing data entry. Importantly, when transplant centers have flexibility to define crossmatch criteria, it is currently feasible to use virtual crossmatching for highly sensitized patients to reliably predict acceptable cell-based crossmatches. © Copyright 2014 The American Society of Transplantation and the American Society of Transplant Surgeons.

Accounting for correlation in network meta-analysis with multi-arm trials.

PubMed

Franchini, A J; Dias, S; Ades, A E; Jansen, J P; Welton, N J

2012-06-01

Multi-arm trials (trials with more than two arms) are particularly valuable forms of evidence for network meta-analysis (NMA). Trial results are available either as arm-level summaries, where effect measures are reported for each arm, or as contrast-level summaries, where the differences in effect between arms compare with the control arm chosen for the trial. We show that likelihood-based inference in both contrast-level and arm-level formats is identical if there are only two-arm trials, but that if there are multi-arm trials, results from the contrast-level format will be incorrect unless correlations are accounted for in the likelihood. We review Bayesian and frequentist software for NMA with multi-arm trials that can account for this correlation and give an illustrative example of the difference in estimates that can be introduced if the correlations are not incorporated. We discuss methods of imputing correlations when they cannot be derived from the reported results and urge trialists to report the standard error for the control arm even if only contrast-level summaries are reported. Copyright © 2012 John Wiley & Sons, Ltd. Copyright © 2012 John Wiley & Sons, Ltd.

Facilitating large-scale clinical trials: in Asia.

PubMed

Choi, Han Yong; Ko, Jae-Wook

2010-01-01

The number of clinical trials conducted in Asian countries has started to increase as a result of expansion of the pharmaceutical market in this area. There is a growing opportunity for large-scale clinical trials because of the large number of patients, significant market potential, good quality of data, and the cost effective and qualified medical infrastructure. However, for carrying out large-scale clinical trials in Asia, there are several major challenges, including the quality control of data, budget control, laboratory validation, monitoring capacity, authorship, staff training, and nonstandard treatment that need to be considered. There are also several difficulties in collaborating on international trials in Asia because Asia is an extremely diverse continent. The major challenges are language differences, diversity of patterns of disease, and current treatments, a large gap in the experience with performing multinational trials, and regulatory differences among the Asian countries. In addition, there are also differences in the understanding of global clinical trials, medical facilities, indemnity assurance, and culture, including food and religion. To make regional and local data provide evidence for efficacy through the standardization of these differences, unlimited effort is required. At this time, there are no large clinical trials led by urologists in Asia, but it is anticipated that the role of urologists in clinical trials will continue to increase. Copyright © 2010 Elsevier Inc. All rights reserved.

Phase I clinical trial will test multi-targeted immunotherapy in common childhood cancer | Center for Cancer Research

Cancer.gov

Chimeric antigen receptor (CAR) T-cell immunotherapy targeting the protein CD19 has shown promise in treating acute lymphoblastic leukemia (ALL). CD22-CAR T-cell therapy has yielded similarly encouraging results, but many patients relapse after either therapy. In an upcoming phase I clinical trial, Center for Cancer Research investigators will test a new strategy—treating

A multi-center randomized controlled trial to compare a self-ligating bracket with a conventional bracket in a UK population: Part 1: Treatment efficiency.

PubMed

O'Dywer, Lian; Littlewood, Simon J; Rahman, Shahla; Spencer, R James; Barber, Sophy K; Russell, Joanne S

2016-01-01

To use a two-arm parallel trial to compare treatment efficiency between a self-ligating and a conventional preadjusted edgewise appliance system. A prospective multi-center randomized controlled clinical trial was conducted in three hospital orthodontic departments. Subjects were randomly allocated to receive treatment with either a self-ligating (3M SmartClip) or conventional (3M Victory) preadjusted edgewise appliance bracket system using a computer-generated random sequence concealed in opaque envelopes, with stratification for operator and center. Two operators followed a standardized protocol regarding bracket bonding procedure and archwire sequence. Efficiency of each ligation system was assessed by comparing the duration of treatment (months), total number of appointments (scheduled and emergency visits), and number of bracket bond failures. One hundred thirty-eight subjects (mean age 14 years 11 months) were enrolled in the study, of which 135 subjects (97.8%) completed treatment. The mean treatment time and number of visits were 25.12 months and 19.97 visits in the SmartClip group and 25.80 months and 20.37 visits in the Victory group. The overall bond failure rate was 6.6% for the SmartClip and 7.2% for Victory, with a similar debond distribution between the two appliances. No significant differences were found between the bracket systems in any of the outcome measures. No serious harm was observed from either bracket system. There was no clinically significant difference in treatment efficiency between treatment with a self-ligating bracket system and a conventional ligation system.

Multi-task Gaussian process for imputing missing data in multi-trait and multi-environment trials.

PubMed

Hori, Tomoaki; Montcho, David; Agbangla, Clement; Ebana, Kaworu; Futakuchi, Koichi; Iwata, Hiroyoshi

2016-11-01

A method based on a multi-task Gaussian process using self-measuring similarity gave increased accuracy for imputing missing phenotypic data in multi-trait and multi-environment trials. Multi-environmental trial (MET) data often encounter the problem of missing data. Accurate imputation of missing data makes subsequent analysis more effective and the results easier to understand. Moreover, accurate imputation may help to reduce the cost of phenotyping for thinned-out lines tested in METs. METs are generally performed for multiple traits that are correlated to each other. Correlation among traits can be useful information for imputation, but single-trait-based methods cannot utilize information shared by traits that are correlated. In this paper, we propose imputation methods based on a multi-task Gaussian process (MTGP) using self-measuring similarity kernels reflecting relationships among traits, genotypes, and environments. This framework allows us to use genetic correlation among multi-trait multi-environment data and also to combine MET data and marker genotype data. We compared the accuracy of three MTGP methods and iterative regularized PCA using rice MET data. Two scenarios for the generation of missing data at various missing rates were considered. The MTGP performed a better imputation accuracy than regularized PCA, especially at high missing rates. Under the 'uniform' scenario, in which missing data arise randomly, inclusion of marker genotype data in the imputation increased the imputation accuracy at high missing rates. Under the 'fiber' scenario, in which missing data arise in all traits for some combinations between genotypes and environments, the inclusion of marker genotype data decreased the imputation accuracy for most traits while increasing the accuracy in a few traits remarkably. The proposed methods will be useful for solving the missing data problem in MET data.

A MULTI-CENTER CLUSTER-RANDOMIZED TRIAL OF A MULTI-FACTORIAL INTERVENTION TO IMPROVE ANTIHYPERTENSIVE MEDICATION ADHERENCE AND BLOOD PRESSURE CONTROL AMONG PATIENTS AT HIGH CARDIOVASCULAR RISK (The COM99 study)*

PubMed Central

Pladevall, Manel; Brotons, Carlos; Gabriel, Rafael; Arnau, Anna; Suarez, Carmen; de la Figuera, Mariano; Marquez, Emilio; Coca, Antonio; Sobrino, Javier; Divine, George; Heisler, Michele; Williams, L Keoki

2010-01-01

Background Medication non-adherence is common and results in preventable disease complications. This study assesses the effectiveness of a multifactorial intervention to improve both medication adherence and blood pressure control and to reduce cardiovascular events. Methods and Results In this multi-center, cluster-randomized trial, physicians from hospital-based hypertension clinics and primary care centers across Spain were randomized to receive and provide the intervention to their high-risk patients. Eligible patients were ≥50 years of age, had uncontrolled hypertension, and had an estimated 10-year cardiovascular risk greater than 30%. Physicians randomized to the intervention group counted patients’ pills, designated a family member to support adherence behavior, and provided educational information to patients. The primary outcome was blood pressure control at 6 months. Secondary outcomes included both medication adherence and a composite end-point of all cause mortality and cardiovascular-related hospitalizations. Seventy-nine physicians and 877 patients participated in the trial. The mean duration of follow-up was 39 months. Intervention patients were less likely to have an uncontrolled systolic blood pressure (odds ratio 0.62; 95% confidence interval [CI] 0.50–0.78) and were more likely to be adherent (OR 1.91; 95% CI 1.19–3.05) when compared with control group patients at 6 months. After five years 16% of the patients in the intervention group and 19% in the control group met the composite end-point (hazard ratio 0.97; 95% CI 0.67–1.39). Conclusions A multifactorial intervention to improve adherence to antihypertensive medication was effective in improving both adherence and blood pressure control, but it did not appear to improve long-term cardiovascular events. PMID:20823391

Integrating Automation into a Multi-Mission Operations Center

NASA Technical Reports Server (NTRS)

Surka, Derek M.; Jones, Lori; Crouse, Patrick; Cary, Everett A, Jr.; Esposito, Timothy C.

2007-01-01

NASA Goddard Space Flight Center's Space Science Mission Operations (SSMO) Project is currently tackling the challenge of minimizing ground operations costs for multiple satellites that have surpassed their prime mission phase and are well into extended mission. These missions are being reengineered into a multi-mission operations center built around modern information technologies and a common ground system infrastructure. The effort began with the integration of four SMEX missions into a similar architecture that provides command and control capabilities and demonstrates fleet automation and control concepts as a pathfinder for additional mission integrations. The reengineered ground system, called the Multi-Mission Operations Center (MMOC), is now undergoing a transformation to support other SSMO missions, which include SOHO, Wind, and ACE. This paper presents the automation principles and lessons learned to date for integrating automation into an existing operations environment for multiple satellites.

[YANG's pricking-cupping therapy for knee osteoarthritis: a multi-center randomized controlled trial].

PubMed

Wang, Bo; Liu, Xiru; Hu, Zhihai; Sun, Aijun; Ma, Yanwen; Chen Yingying; Zhang, Xuzhi; Liu, Meiling; Wang, Yi; Wang, Shuoshuo; Zhang, Yunjia; Li, Yijing; Shen, Weidong

2016-02-01

To evaluate the clinical efficacy of YANG's pricking-cupping therapy for knee osteoar thritis (KOA). Methods This was a multi-center randomized parallel controlled trial. One hundred and seventy one patients with KOA were randomly allocated to a pricking-cupping group (89 cases) and a conventional acu puncture group (82 cases). Neixiyan (EX-LE 4), Dubi (ST 35) and ashi points were selected in the two groups. Patients in the pricking-cupping group were treated with YANG's pricking-cupping therapy; the seven-star needles were used to perform pricking at acupoints, then cupping was used until slight bleeding was observed. Patients in the conventional acupuncture group were treated with semi-standardized filiform needle therapy. The treatment was given for 4 weeks (from a minimum of 5 times to a maximum of 10 times). The follow-up visit was 4 weeks. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the visual analogue scale (VAS) were adopted for the efficacy assessments. The pain score, stiffness score, physical function score and total score of WOMAC were all reduced after 4-week treatment and during follow-up visit in the two groups (all P<0. 0001). Except that the difference of stiffness score between the two groups was not significant after 4-week treatment (P>0. 05), each score and total score of WOMAC in the pricking-cupping group were lower than those in the conventional acupuncture group after 4-week treatment and during follow-up visit (P<0. 0001, P<0. 01). After 2-week treatment, 4-week treatment and during follow-up visit, the VAS was all reduced compared with that before treatment (all P<0. 0001) ; with the increase of the treatment, the reducing trend of VAS was more significant (P<0. 0001). The scores of VAS in the pricking-cupping group were lower than those in the conventional acupuncture group after 4-week treatment and during follow-up visit (P < 0. 01, P <0. 0001). CONCLUSION The YANG's pricking-cupping and conventional

Correcting for multiple-testing in multi-arm trials: is it necessary and is it done?

PubMed

Wason, James M S; Stecher, Lynne; Mander, Adrian P

2014-09-17

Multi-arm trials enable the evaluation of multiple treatments within a single trial. They provide a way of substantially increasing the efficiency of the clinical development process. However, since multi-arm trials test multiple hypotheses, some regulators require that a statistical correction be made to control the chance of making a type-1 error (false-positive). Several conflicting viewpoints are expressed in the literature regarding the circumstances in which a multiple-testing correction should be used. In this article we discuss these conflicting viewpoints and review the frequency with which correction methods are currently used in practice. We identified all multi-arm clinical trials published in 2012 by four major medical journals. Summary data on several aspects of the trial design were extracted, including whether the trial was exploratory or confirmatory, whether a multiple-testing correction was applied and, if one was used, what type it was. We found that almost half (49%) of published multi-arm trials report using a multiple-testing correction. The percentage that corrected was higher for trials in which the experimental arms included multiple doses or regimens of the same treatments (67%). The percentage that corrected was higher in exploratory than confirmatory trials, although this is explained by a greater proportion of exploratory trials testing multiple doses and regimens of the same treatment. A sizeable proportion of published multi-arm trials do not correct for multiple-testing. Clearer guidance about whether multiple-testing correction is needed for multi-arm trials that test separate treatments against a common control group is required.

Solution of multi-center molecular integrals of Slater-type orbitals

NASA Technical Reports Server (NTRS)

Tai, H.

1989-01-01

The troublesome multi-center molecular integrals of Slater-type orbitals (STO) in molecular physics calculations can be evaluated by using the Fourier transform and proper coupling of the two center exchange integrals. A numerical integration procedure is then readily rendered to the final expression in which the integrand consists of well known special functions of arguments containing the geometrical arrangement of the nuclear centers and the exponents of the atomic orbitals. A practical procedure was devised for the calculation of a general multi-center molecular integrals coupling arbitrary Slater-type orbitals. Symmetry relations and asymptotic conditions are discussed. Explicit expressions of three-center one-electron nuclear-attraction integrals and four-center two-electron repulsion integrals for STO of principal quantum number n=2 are listed. A few numerical results are given for the purpose of comparison.

Publication and reporting of clinical trial results: cross sectional analysis across academic medical centers.

PubMed

Chen, Ruijun; Desai, Nihar R; Ross, Joseph S; Zhang, Weiwei; Chau, Katherine H; Wayda, Brian; Murugiah, Karthik; Lu, Daniel Y; Mittal, Amit; Krumholz, Harlan M

2016-02-17

To determine rates of publication and reporting of results within two years for all completed clinical trials registered in ClinicalTrials.gov across leading academic medical centers in the United States. Cross sectional analysis. Academic medical centers in the United States. Academic medical centers with 40 or more completed interventional trials registered on ClinicalTrials.gov. Using the Aggregate Analysis of ClinicalTrials.gov database and manual review, we identified all interventional clinical trials registered on ClinicalTrials.gov with a primary completion date between October 2007 and September 2010 and with a lead investigator affiliated with an academic medical center. The proportion of trials that disseminated results, defined as publication or reporting of results on ClinicalTrials.gov, overall and within 24 months of study completion. We identified 4347 interventional clinical trials across 51 academic medical centers. Among the trials, 1005 (23%) enrolled more than 100 patients, 1216 (28%) were double blind, and 2169 (50%) were phase II through IV. Overall, academic medical centers disseminated results for 2892 (66%) trials, with 1560 (35.9%) achieving this within 24 months of study completion. The proportion of clinical trials with results disseminated within 24 months of study completion ranged from 16.2% (6/37) to 55.3% (57/103) across academic medical centers. The proportion of clinical trials published within 24 months of study completion ranged from 10.8% (4/37) to 40.3% (31/77) across academic medical centers, whereas results reporting on ClinicalTrials.gov ranged from 1.6% (2/122) to 40.7% (72/177). Despite the ethical mandate and expressed values and mission of academic institutions, there is poor performance and noticeable variation in the dissemination of clinical trial results across leading academic medical centers. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go

Pain after pediatric otorhinolaryngologic surgery: a prospective multi-center trial.

PubMed

Guntinas-Lichius, Orlando; Volk, Gerd Fabian; Geissler, Katharina; Komann, Marcus; Meissner, Winfried

2014-07-01

The purpose of this study was to describe postoperative pain within the first day after pediatric otorhinolaryngologic surgery and to identify factors influencing postoperative pain. Using a prospective evaluation and a Web-based multi-center registry, children ≥4 years of age (n = 365) rated their pain using questionnaires of the project Quality Improvement in Postoperative Pain Treatment for Children including faces numeric rating scales (FNRS, 0-10) for the determination of patient's pain on ambulation and his/her maximal and minimal pain within 8 h after day case surgery or at the first postoperative day for inpatient cases. Additionally, functional interference and therapy-related side effects were assessed. Half of the children were 4 or 5 years of age. The predominant types of surgery were adenoidectomy and tonsillectomy ± ear ventilation tubes. Although analgesics were applied preoperatively, intraoperatively, in the recovery room and on ward, maximal pain within the first day after surgery reached 4.4 ± 3.3 (FNRS). Pain was highest after oral surgery, especially after tonsillectomy and nose surgery. 39% of the children reported pain interference with breathing (39%). The most frequent side effect was drowsiness (55%). Multivariate analysis revealed that maximal pain was independently associated with the non-standardized use of opioids in the recovery room, or use of non-opioid or opioids on ward. Analgesia and perioperative pain management in pediatric otorhinolaryngologic surgery seems to be highly variable. Tonsillectomy and nose surgery are very painful. After otorhinolaryngologic surgery many children seem to receive less analgesia than needed or ineffective analgesic drug regimes.

Smart Care Based on Telemonitoring and Telemedicine for Type 2 Diabetes Care: Multi-center Randomized Controlled Trial.

PubMed

Jeong, Ji Yun; Jeon, Jae-Han; Bae, Kwi-Hyun; Choi, Yeon-Kyung; Park, Keun-Gyu; Kim, Jung-Guk; Won, Kyu Chang; Cha, Bong Soo; Ahn, Chul Woo; Kim, Dong Won; Lee, Chang Hee; Lee, In-Kyu

2018-01-17

This study was performed to determine the effectiveness of the Smart Care service on glucose control based on telemedicine and telemonitoring compared with conventional treatment in patients with type 2 diabetes. This 24-week prospective multi-center randomized controlled trial involved 338 adult patients with type 2 diabetes at four university hospitals in South Korea. The patients were randomly assigned to a control group (group A, n = 113), a telemonitoring group (group B, n = 113), or a telemedicine group (group C, n = 112). Patients in the telemonitoring group visited the outpatient clinic regularly, accompanied by an additional telemonitoring service that included remote glucose monitoring with automated patient decision support by text. Remote glucose monitoring was identical in the telemedicine group, but assessment by outpatient visits was replaced by video conferencing with an endocrinologist. The adjusted net reductions in HbA1c concentration after 24 weeks were similar in the conventional, telemonitoring, and telemedicine groups (-0.66% ± 1.03% vs. -0.66% ± 1.09% vs. -0.81% ± 1.05%; p > 0.05 for each pairwise comparison). Fasting glucose concentrations were lower in the telemonitoring and telemedicine groups than in the conventional group. Rates of hypoglycemia were lower in the telemedicine group than in the other two groups, and compliance with medication was better in the telemonitoring and telemedicine than in the conventional group. No serious adverse events were associated with telemedicine. Telehealthcare was as effective as conventional care at improving glycemia in patients with type 2 diabetes without serious adverse effects.

Perspectives on barriers and facilitators to minority recruitment for clinical trials among cancer center leaders, investigators, research staff, and referring clinicians: enhancing minority participation in clinical trials (EMPaCT).

PubMed

Durant, Raegan W; Wenzel, Jennifer A; Scarinci, Isabel C; Paterniti, Debora A; Fouad, Mona N; Hurd, Thelma C; Martin, Michelle Y

2014-04-01

The study of disparities in minority recruitment to cancer clinical trials has focused primarily on inquiries among minority populations. Yet very little is known about the perceptions of individuals actively involved in minority recruitment to clinical trials within cancer centers. Therefore, the authors assessed the perspectives of cancer center clinical and research personnel on barriers and facilitators to minority recruitment. In total, 91 qualitative interviews were conducted at 5 US cancer centers among 4 stakeholder groups: cancer center leaders, principal investigators, research staff, and referring clinicians. All interviews were recorded and transcribed. Qualitative analyses of response data was focused on identifying prominent themes related to barriers and facilitators to minority recruitment. The perspectives of the 4 stakeholder groups were largely overlapping with some variations based on their unique roles in minority recruitment. Four prominent themes were identified: 1) racial and ethnic minorities are influenced by varying degrees of skepticism related to trial participation, 2) potential minority participants often face multilevel barriers that preclude them from being offered an opportunity to participate in a clinical trial, 3) facilitators at both the institutional and participant level potentially encourage minority recruitment, and 4) variation between internal and external trial referral procedures may limit clinical trial opportunities for racial and ethnic minorities. Multilevel approaches are needed to address barriers and optimize facilitators within cancer centers to enhance minority recruitment for cancer clinical trials. © 2014 American Cancer Society.

Flexible sequential designs for multi-arm clinical trials.

PubMed

Magirr, D; Stallard, N; Jaki, T

2014-08-30

Adaptive designs that are based on group-sequential approaches have the benefit of being efficient as stopping boundaries can be found that lead to good operating characteristics with test decisions based solely on sufficient statistics. The drawback of these so called 'pre-planned adaptive' designs is that unexpected design changes are not possible without impacting the error rates. 'Flexible adaptive designs' on the other hand can cope with a large number of contingencies at the cost of reduced efficiency. In this work, we focus on two different approaches for multi-arm multi-stage trials, which are based on group-sequential ideas, and discuss how these 'pre-planned adaptive designs' can be modified to allow for flexibility. We then show how the added flexibility can be used for treatment selection and sample size reassessment and evaluate the impact on the error rates in a simulation study. The results show that an impressive overall procedure can be found by combining a well chosen pre-planned design with an application of the conditional error principle to allow flexible treatment selection. Copyright © 2014 John Wiley & Sons, Ltd.

Phase I clinical trial will test multi-targeted immunotherapy in common childhood cancer | Center for Cancer Research

Cancer.gov

Chimeric antigen receptor (CAR) T-cell immunotherapy targeting the protein CD19 has shown promise in treating acute lymphoblastic leukemia (ALL). CD22-CAR T-cell therapy has yielded similarly encouraging results, but many patients relapse after either therapy. In an upcoming phase I clinical trial, Center for Cancer Research investigators will test a new strategy—treating patients with a CAR T-cell therapy that targets CD19 and CD22 simultaneously.

Real-time adaptive ramp metering : phase I, MILOS proof of concept (multi-objective, integrated, large-scale, optimized system).

DOT National Transportation Integrated Search

2006-12-01

Over the last several years, researchers at the University of Arizonas ATLAS Center have developed an adaptive ramp : metering system referred to as MILOS (Multi-Objective, Integrated, Large-Scale, Optimized System). The goal of this project : is ...

A multi-center randomized trial of two different intravenous fluids during labor

PubMed Central

DAPUZZO-ARGIRIOU, Lisa M.; SMULIAN, John C.; ROCHON, Meredith L.; GALDI, Luisa; KISSLING, Jessika M.; SCHNATZ, Peter F.; RIOS, Angel GONZALEZ; AIROLDI, James; CARRILLO, Mary Anne; MAINES, Jaimie; KUNSELMAN, Allen R.; REPKE, John; LEGRO, Richard S.

2017-01-01

Objective To determine if the intrapartum use of a 5% glucose-containing intravenous solution decreases the chance of a cesarean delivery for women presenting in active labor. Methods This was a multi-center, prospective, single (patient) blind, randomized study design implemented at 4 obstetric residency programs in Pennsylvania. Singleton, term, consenting women presenting in active spontaneous labor with a cervical dilation of <6cm were randomized to lactated Ringer's with or without 5% glucose (LR versus D5LR) as their maintenance intravenous fluid. The primary outcome was the cesarean birth rate. Secondary outcomes included labor characteristics, as well as maternal or neonatal complications. Results There were 309 women analyzed. Demographic variables and admitting cervical dilation were similar among study groups. There was no significant difference in the cesarean delivery rate for the D5LR group (23/153 or 15.0%) versus the LR arm (18/156 or 11.5%), [RR (95%CI) of 1.32 (0.75, 2.35), P=0.34]. There were no differences in augmentation rates or intrapartum complications. Conclusions The use of intravenous fluid containing 5% dextrose does not lower the chance of cesarean delivery for women admitted in active labor. PMID:25758624

Open reduction and internal fixation versus casting for highly comminuted and intra-articular fractures of the distal radius (ORCHID): protocol for a randomized clinical multi-center trial.

PubMed

Bartl, Christoph; Stengel, Dirk; Bruckner, Thomas; Rossion, Inga; Luntz, Steffen; Seiler, Christoph; Gebhard, Florian

2011-03-22

Fractures of the distal radius represent the most common fracture in elderly patients, and often indicate the onset of symptomatic osteoporosis. A variety of treatment options is available, including closed reduction and plaster casting, K-wire-stabilization, external fixation and open reduction and internal fixation (ORIF) with volar locked plating. The latter is widely promoted by clinicians and hardware manufacturers. Closed reduction and cast stabilization for six weeks is a simple, convenient, and ubiquitously available intervention. In contrast, ORIF requires hospitalization, but allows for functional rehabilitation.Given the lack of randomized controlled trials, it remains unclear whether ORIF leads to better functional outcomes one year after injury than closed reduction and casting. ORCHID (Open reduction and internal fixation versus casting for highly comminuted intra-articular fractures of the distal radius) is a pragmatic, randomized, multi-center, clinical trial with two parallel treatment arms. It is planned to include 504 patients in 15 participating centers throughout Germany over a three-year period. Patients are allocated by a central web-based randomization tool.The primary objective is to determine differences in the Short Form 36 (SF-36) Physical Component Score (PCS) between volar locked plating and closed reduction and casting of intraarticular, comminuted distal radius fractures in patients > 65 years of age one year after the fracture. Secondary outcomes include differences in other SF-36 dimensions, the EuroQol-5D questionnaire, the Disability of the Arm, Shoulder, and Hand (DASH) instrument. Also, the range of motion in the affected wrist, activities of daily living, complications (including secondary ORIF and revision surgery), as well as serious adverse events will be assessed. Data obtained during the trial will be used for later health-economic evaluations. The trial architecture involves a central statistical unit, an independent

Challenges in Credentialing Institutions and Participants in Advanced Technology Multi-institutional Clinical Trials

DOE Office of Scientific and Technical Information (OSTI.GOV)

Ibbott, Geoffrey S.; Followill, David S.; Molineu, H. Andrea

The Radiological Physics Center (RPC) has functioned continuously for 38 years to assure the National Cancer Institute and the cooperative groups that institutions participating in multi-institutional trials can be expected to deliver radiation treatments that are clinically comparable to those delivered by other institutions in the cooperative groups. To accomplish this, the RPC monitors the machine output, the dosimetry data used by the institutions, the calculation algorithms used for treatment planning, and the institutions' quality control procedures. The methods of monitoring include on-site dosimetry review by an RPC physicist and a variety of remote audit tools. The introduction of advancedmore » technology clinical trials has prompted several study groups to require participating institutions and personnel to become credentialed, to ensure their familiarity and capability with techniques such as three-dimensional conformal radiotherapy, intensity-modulated radiotherapy, stereotactic body radiotherapy, and brachytherapy. The RPC conducts a variety of credentialing activities, beginning with questionnaires to evaluate an institution's understanding of the protocol and their capabilities. Treatment-planning benchmarks are used to allow the institution to demonstrate their planning ability and to facilitate a review of the accuracy of treatment-planning systems under relevant conditions. The RPC also provides mailable anthropomorphic phantoms to verify tumor dose delivery for special treatment techniques. While conducting these reviews, the RPC has amassed a large amount of data describing the dosimetry at participating institutions. Representative data from the monitoring programs are discussed, and examples are presented of specific instances in which the RPC contributed to the discovery and resolution of dosimetry errors.« less

Efficacy and Safety of Frozen Blood for Transfusion in Trauma Patients - A Multi-Center Trial

DTIC Science & Technology

2015-04-01

threshold are based on a randomized controlled trial by Hébert et al . that showed that critically ill patients who are not actively bleeding should not...causes of increased morbidity and mortality in several studies [23-28]. In a large study, Malone et al . assessed the effect of blood transfusion on...strong independent predictor of mortality. Another study published by Murrell et al . did not find an association between the dose of aged blood and

Factorial versus multi-arm multi-stage designs for clinical trials with multiple treatments.

PubMed

Jaki, Thomas; Vasileiou, Despina

2017-02-20

When several treatments are available for evaluation in a clinical trial, different design options are available. We compare multi-arm multi-stage with factorial designs, and in particular, we will consider a 2 × 2 factorial design, where groups of patients will either take treatments A, B, both or neither. We investigate the performance and characteristics of both types of designs under different scenarios and compare them using both theory and simulations. For the factorial designs, we construct appropriate test statistics to test the hypothesis of no treatment effect against the control group with overall control of the type I error. We study the effect of the choice of the allocation ratios on the critical value and sample size requirements for a target power. We also study how the possibility of an interaction between the two treatments A and B affects type I and type II errors when testing for significance of each of the treatment effects. We present both simulation results and a case study on an osteoarthritis clinical trial. We discover that in an optimal factorial design in terms of minimising the associated critical value, the corresponding allocation ratios differ substantially to those of a balanced design. We also find evidence of potentially big losses in power in factorial designs for moderate deviations from the study design assumptions and little gain compared with multi-arm multi-stage designs when the assumptions hold. © 2016 The Authors. Statistics in Medicine Published by John Wiley & Sons Ltd. © 2016 The Authors. Statistics in Medicine Published by John Wiley & Sons Ltd.

[Genotypes distribution of hepatitis C virus through multi-center, large sample studies among chronic hepatitis C patients in Chinese Han population].

PubMed

Nie, Hong-ming; Chen, Jian-jie; Wang, Rong; Wang, Cheng-bao; Dong, Hui-lin; Chen, Yi-yun

2012-05-01

To understand the distribution of hepatitis C virus (HCV) genotypes in China. A national multi-center, large sample epidemiological survey was carried out and certified by an international third-party testing organization. Internationally accepted method for sequencing analysis of viral genotype was used. Patients were those suffered from the 4 major genotypes of chronic hepatitis C, including nine subtypes, which were dominated by genotype 1 (69.6%), with type 1b in particular (accounting for 68.38%). Among the rare gene-6, we saw more subtypes of 6a. In the south, central, and north areas, there was no significant difference seen between the south and the north areas in the distribution of the genotype 1. However, the rate of gene type 2a increased gradually from south to north. In terms of less common type of gene 3b and gene-6, they were seen mainly in the southern provinces. In China, Patients with chronic hepatitis C had 4 HCV genotypes, with 9 subtypes. The rarely seen genotypes 3b and 6 were mainly distributed in the southern provinces.

Serum reference interval of ARCHITECT alpha-fetoprotein in healthy Chinese Han adults: Sub-analysis of a prospective multi-center study.

PubMed

Yan, Cunling; Yang, Jia; Wei, Lianhua; Hu, Jian; Song, Jiaqi; Wang, Xiaoqin; Han, Ruilin; Huang, Ying; Zhang, Wei; Soh, Andrew; Beshiri, Agim; Fan, Zhuping; Zheng, Yijie; Chen, Wei

2018-02-01

Alpha-fetoprotein (AFP) has been widely used in clinical practice for decades. However, large-scale survey of serum reference interval for ARCHITECT AFP is still absent in Chinese population. This study aimed to measure serum AFP levels in healthy Chinese Han subjects, which is a sub-analysis of an ongoing prospective, cross-sectional, multi-center study (ClinicalTrials.gov Identifier: NCT03047603). This analysis included a total of 530 participants (41.43±12.14years of age on average, 48.49% males), enrolled from 5 regional centers. Serum AFP level was measured by ARCHITECT immunoassay. Statistical analysis was performed using SAS 9.4 and R software. AFP distribution did not show significant correlation with age or sex. The overall median and interquartile range of AFP was 2.87 (2.09, 3.83) ng/mL. AFP level did not show a trend of increasing with age. The new reference interval was 2.0-7.07ng/mL (LOQ- 97.5th percentiles). The reference interval for ARCHITECT AFP is updated with the data of adequate number of healthy Han adults. This new reference interval is more practical and applicable in Chinese adults. Copyright © 2017 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

Large Margin Multi-Modal Multi-Task Feature Extraction for Image Classification.

PubMed

Yong Luo; Yonggang Wen; Dacheng Tao; Jie Gui; Chao Xu

2016-01-01

The features used in many image analysis-based applications are frequently of very high dimension. Feature extraction offers several advantages in high-dimensional cases, and many recent studies have used multi-task feature extraction approaches, which often outperform single-task feature extraction approaches. However, most of these methods are limited in that they only consider data represented by a single type of feature, even though features usually represent images from multiple modalities. We, therefore, propose a novel large margin multi-modal multi-task feature extraction (LM3FE) framework for handling multi-modal features for image classification. In particular, LM3FE simultaneously learns the feature extraction matrix for each modality and the modality combination coefficients. In this way, LM3FE not only handles correlated and noisy features, but also utilizes the complementarity of different modalities to further help reduce feature redundancy in each modality. The large margin principle employed also helps to extract strongly predictive features, so that they are more suitable for prediction (e.g., classification). An alternating algorithm is developed for problem optimization, and each subproblem can be efficiently solved. Experiments on two challenging real-world image data sets demonstrate the effectiveness and superiority of the proposed method.

A randomized, double blind, controlled, multi center study of Ilaparazole in the treatment of reflux esophagitis-Phase III clinical trial.

PubMed

Xue, Yan; Qin, Xianghong; Zhou, Liya; Lin, Sanren; Wang, Ling; Hu, Haitang; Xia, Jielai

2018-05-01

Proton pump inhibitors (PPIs) are the main drugs for the treatment of reflux esophagitis. Phase II clinical trials showed that, compared with Esomeprazole, the new PPI Ilaparazole is great in terms of efficacy for reflux symptoms relief and curling for esophagitis. The aim of this study was to confirm suitable dose of Ilaparazole in the treatment of reflux esophagitis. This study used a randomized, double-blind, parallel positive drug control, multi-center design. A total of 537patients diagnosed as reflux esophagitis by gastroscopy were randomly divided into Ilaparazole group (n = 322, Ilaparazole 10 mg QD) and esomeprazole group (n = 215, Esomeprazole 40 mg QD). The patients in the two groups were treated for 8 weeks. Heartburn and reflux symptoms prior to treatment, and 2, 4 and 8 weeks after the treatment were assessed. Gastroscopy was performed after 4 weeks of treatment. Unhealed patients within 4 weeks underwent gastroscopy again at the end of 8 weeks. A total of 471 cases completed the treatment. In Esomeprazole and Ilaparazole groups. After 8 weeks treatment, the healing rate in Esomeprazole group and Ilaparazole group were 82.79% (94.94%) and 83.54% (92.50%), respectively. The corresponding rate difference [Ilaparazole-esomeprazole] was 0.75% (-2.44%) and the two-sided 95% CI was -5.72 to 7.22 (-6.90 to 2.01). The symptom disappearance rates for FAS (PPS) were 75.81% (82.02%) and 76.71% (80.36%) P = 0.8223 (0.7742). Adverse reactions related to the drugs were: 10.70% and 11.80%, (P = 0.7817). The efficacy and safety of Ilaparazole (10 mg/day) in treating reflux esophagitis was similar to esomeprazole (40 mg/day). Ilaparazole (10 mg/day) can be used in the treatment of esophagitis. The clinical trial registration number of the study is NCT 02860624. Copyright © 2018. Published by Elsevier Inc.

Authorship issues in multi-centre clinical trials: the importance of making an authorship contract.

PubMed

Rosenberg, Jacob; Burcharth, Jakob; Pommergaard, Hans-Christian; Vinther, Siri

2015-02-01

Discussions about authorship often arise in multi-centre clinical trials. Such trials may involve up to hundreds of contributors of whom some will eventually co-author the final publication. It is, however, often impossible to involve all contributors in the manuscript process sufficiently for them to qualify for authorship as defined by the International Committee of Medical Journal Editors. Therefore, rules for authorship in multi-centre trials are strongly recommended. We propose two contracts to prevent conflicts regarding authorship; both are freely available for use without pay but with reference to the original source.

Effects of D2 or combined D1/D2 receptor antagonism on the methamphetamine-induced one-trial and multi-trial behavioral sensitization of preweanling rats

PubMed Central

Mohd-Yusof, Alena; Veliz, Ana; Rudberg, Krista N.; Stone, Michelle J.; Gonzalez, Ashley E.; McDougall, Sanders A.

2015-01-01

Rationale There is suggestive evidence that the neural mechanisms mediating one-trial and multi-trial behavioral sensitization differ, especially when the effects of various classes of dopamine (DA) agonists are examined. Objective The purpose of the present study was to determine the role of the D2 receptor for the induction of one-trial and multi-trial methamphetamine sensitization in preweanling rats. Methods In a series of experiments, rats were injected with saline or raclopride (a selective D2 receptor antagonist), either alone or in combination with SCH23390 (a selective D1 receptor antagonist), 15 min prior to treatment with the indirect DA agonist methamphetamine. Acute control groups were given two injections of saline. This pretreatment regimen occurred on either postnatal days (PD) 13–16 (multi-trial) or PD 16 (one-trial). On PD 17, rats were challenged with methamphetamine and locomotor sensitization was determined. Results Blockade of D2 or D1/D2 receptors reduced or prevented, respectively, the induction of multi-trial methamphetamine sensitization in young rats, while the same manipulations had minimal effects on one-trial behavioral sensitization. Conclusions DA antagonist treatment differentially affected the methamphetamine-induced sensitized responding of preweanling rats depending on whether a one-trial or multi-trial procedure was used. The basis for this effect is uncertain, but there was some evidence that repeated DA antagonist treatment caused nonspecific changes that produced a weakened sensitized response. Importantly, DA antagonist treatment did not prevent the one-trial behavioral sensitization of preweanling rats. The latter result brings into question whether DA receptor stimulation is necessary for the induction of psychostimulant-induced behavioral sensitization during early ontogeny. PMID:26650612

A multi-center, randomized, double blind placebo-controlled trial of estrogens to prevent Alzheimer’s disease and loss of memory in women: design and baseline characteristics

PubMed Central

Sano, Mary; Jacobs, Diane; Andrews, Howard; Bell, Karen; Graff-Radford, Neill; Lucas, John; Rabins, Peter; Bolla, Karen; Tsai, Wei-Yan; Cross, Peter; Andrews, Karen; Costa, Rosann; Luo, Xiaodong

2012-01-01

Background Observational studies and small clinical trials suggested that hormone replacement therapy (HRT) decreases risk of cognitive loss and Alzheimer’s disease (AD) in postmenopausal women and may have value in primary prevention. Purpose A clinical trial was designed to determine if HRT delays AD or memory loss. This report describes the rationale and original design of the trial and details extensive modifications that were required to respond to unanticipated findings that emerged from other studies during the course of the trial. Methods The trial was designed as a multi-center, placebo-controlled primary prevention trial for women 65 years of age or older with a family history of dementia. Recruitment from local sites was supplemented by centralized efforts to use names of Medicare beneficiaries. Inclusion criteria included good general health and intact memory functioning. Participants were randomized to HRT or placebo in a 1:1 ratio. Assignment was stratified by hysterectomy status and site. The primary outcomes were incident AD and memory decline on neuropsychological testing. Results Enrollment began in March 1998. In response to the Women’s Health Initiative (WHI) May 2002 report of increased incidence of heart disease, stroke, pulmonary embolism, and breast cancer among women randomized to HRT, participants were re-consented with a revised consent form. Procedural modifications, including discontinuation of study medication and a modification of the planned primary outcome based on a final enrollment below the target enrollment (N = 477), were enacted in response to the subsequent WHI Memory Study report of increased risk of dementia and poorer cognitive function with HRT. The mean length of treatment exposure prior to discontinuation was 2.14 years. Participants’ mean age at baseline was 72.8; mean education was 14.2 years. Minority participation was 19% and 34% had a hysterectomy. The study continues to follow these participants for a total

Multi-center Airborne Coherent Atmospheric Wind Sensor (MACAWS)

NASA Technical Reports Server (NTRS)

Rhothermel, Jeffry; Jones, W. D.; Dunkin, J. A.; Mccaul, E. W., Jr.

1993-01-01

This effort involves development of a calibrated, pulsed coherent CO2 Doppler lidar, followed by a carefully-planned and -executed program of multi-dimensional wind velocity and aerosol backscatter measurements from the NASA DC-8 research aircraft. The lidar, designated as the Multi-center Airborne Coherent Atmospheric Wind Sensor (MACAWS), will be applicable to two research areas. First, MACAWS will enable specialized measurements of atmospheric dynamical processes in the planetary boundary layer and free troposphere in geographic locations and over scales of motion not routinely or easily accessible to conventional sensors. The proposed observations will contribute fundamentally to a greater understanding of the role of the mesoscale, helping to improve predictive capabilities for mesoscale phenomena and to provide insights into improving model parameterizations of sub-grid scale processes within large-scale circulation models. As such, it has the potential to contribute uniquely to major, multi-institutional field programs planned for the mid 1990's. Second, MACAWS measurements can be used to reduce the degree of uncertainty in performance assessments and algorithm development for NASA's prospective Laser Atmospheric Wind Sounder (LAWS), which has no space-based instrument heritage. Ground-based lidar measurements alone are insufficient to address all of the key issues. To minimize costs, MACAWS is being developed cooperatively by the lidar remote sensing groups of the Jet Propulsion Laboratory, NOAA Wave Propagation Laboratory, and MSFC using existing lidar hardware and manpower resources. Several lidar components have already been exercised in previous airborne lidar programs (for example, MSFC Airborne Doppler Lidar System (ADLS) used in 1981,4 Severe Storms Wind Measurement Program; JPL Airborne Backscatter Lidar Experiment (ABLE) used in 1989,90 Global Backscatter Experiment Survey Missions). MSFC has been given responsibility for directing the overall

Multi-site randomized controlled trial of a child-centered physical activity program, a parent-centered dietary-modification program, or both in overweight children: the HIKCUPS study.

PubMed

Okely, Anthony D; Collins, Clare E; Morgan, Philip J; Jones, Rachel A; Warren, Janet M; Cliff, Dylan P; Burrows, Tracy L; Colyvas, Kim; Steele, Julie R; Baur, Louise A

2010-09-01

To evaluate whether a child-centered physical activity program, combined with a parent-centered dietary program, was more efficacious than each treatment alone, in preventing unhealthy weight-gain in overweight children. An assessor-blinded randomized controlled trial involving 165 overweight/obese 5.5- to 9.9- year-old children. Participants were randomly assigned to 1 of 3 interventions: a parent-centered dietary program (Diet); a child-centered physical activity program (Activity); or a combination of both (Diet+Activity). All groups received 10 weekly face-to-face sessions followed by 3 monthly relapse-prevention phone calls. Analysis was by intention-to-treat. The primary outcome was change in body mass index z-score at 6 and 12 months (n=114 and 106, respectively). Body mass index z-scores were reduced at 12-months in all groups, with the Diet (mean [95% confidence interval]) (-0.39 [-0.51 to 0.27]) and Diet + Activity (-0.32, [-0.36, -0.23]) groups showing a greater reduction than the Activity group (-0.17 [-0.28, -0.06]) (P=.02). Changes in other outcomes (waist circumference and metabolic profile) were not statistically significant among groups. Relative body weight decreased at 6 months and was sustained at 12 months through treatment with a child-centered physical activity program, a parent-centered dietary program, or both. The greatest effect was achieved when a parent-centered dietary component was included. Copyright (c) 2010 Mosby, Inc. All rights reserved.

Examining multi-session brief intervention for substance use in primary care: research methods of a randomized controlled trial.

PubMed

Chambers, Jaclyn E; Brooks, Adam C; Medvin, Rachel; Metzger, David S; Lauby, Jennifer; Carpenedo, Carolyn M; Favor, Kevin E; Kirby, Kimberly C

2016-04-18

interventions to impact substance use has great potential, but research findings have been mixed. By conducting a large-scale randomized controlled trial in real-world health centers, this study will answer important questions about the effectiveness of expanded BIs for patients who screen positive for risky substance use in primary care. Trial registration NCT01751672.

Multi-Center Traffic Management Advisor Operational Field Test Results

NASA Technical Reports Server (NTRS)

Farley, Todd; Landry, Steven J.; Hoang, Ty; Nickelson, Monicarol; Levin, Kerry M.; Rowe, Dennis W.

2005-01-01

The Multi-Center Traffic Management Advisor (McTMA) is a research prototype system which seeks to bring time-based metering into the mainstream of air traffic control (ATC) operations. Time-based metering is an efficient alternative to traditional air traffic management techniques such as distance-based spacing (miles-in-trail spacing) and managed arrival reservoirs (airborne holding). While time-based metering has demonstrated significant benefit in terms of arrival throughput and arrival delay, its use to date has been limited to arrival operations at just nine airports nationally. Wide-scale adoption of time-based metering has been hampered, in part, by the limited scalability of metering automation. In order to realize the full spectrum of efficiency benefits possible with time-based metering, a much more modular, scalable time-based metering capability is required. With its distributed metering architecture, multi-center TMA offers such a capability.

Center Planning and Development: Multi-User Spaceport Initiatives

NASA Technical Reports Server (NTRS)

Kennedy, Christopher John

2015-01-01

The Vehicle Assembly building at NASAs Kennedy Space Center has been used since 1966 to vertically assemble every launch vehicle, since the Apollo Program, launched from Launch Complex 39 (LC-39). After the cancellation of the Constellation Program in 2010 and the retirement of the Space Shuttle Program in 2011, the VAB faced an uncertain future. As the Space Launch System (SLS) gained a foothold as the future of American spaceflight to deep space, NASA was only using a portion of the VABs initial potential. With three high bays connected to the Crawler Way transportation system, the potential exists for up to three rockets to be simultaneously processed for launch. The Kennedy Space Center (KSC) Master plan, supported by the Center Planning and Development (CPD) Directorate, is guiding Kennedy toward a 21st century multi-user spaceport. This concept will maintain Kennedy as the United States premier gateway to space and provide multi-user operations through partnerships with the commercial aerospace industry. Commercial aerospace companies, now tasked with transporting cargo and, in the future, astronauts to the International Space Station (ISS) via the Commercial Resupply Service (CRS) and Commercial Crew Program (CCP), are a rapidly growing industry with increasing capabilities to make launch operations more economical for both private companies and the government. Commercial operations to Low Earth Orbit allow the government to focus on travel to farther destinations through the SLS Program. With LC-39B designated as a multi-use launch pad, companies seeking to use it will require an integration facility to assemble, integrate, and test their launch vehicle. An Announcement for Proposals (AFP) was released in June, beginning the process of finding a non-NASA user for High Bay 2 (HB2) and the Mobile Launcher Platforms (MLPs). An Industry Day, a business meeting and tour for interested companies and organizations, was also arranged to identify and answer any

Closed Large Cell Clouds

Atmospheric Science Data Center

2013-04-19

article title:  Closed Large Cell Clouds in the South Pacific ... the Multi-angle Imaging SpectroRadiometer (MISR) provide an example of very large scale closed cells, and can be contrasted with the  ... MD. The MISR data were obtained from the NASA Langley Research Center Atmospheric Science Data Center in Hampton, VA. Image ...

Post-trial follow-up methodology in large randomized controlled trials: a systematic review protocol.

PubMed

Llewellyn-Bennett, Rebecca; Bowman, Louise; Bulbulia, Richard

2016-12-15

Clinical trials typically have a relatively short follow-up period, and may both underestimate potential benefits of treatments investigated, and fail to detect hazards, which can take much longer to emerge. Prolonged follow-up of trial participants after the end of the scheduled trial period can provide important information on both efficacy and safety outcomes. This protocol describes a systematic review to qualitatively compare methods of post-trial follow-up used in large randomized controlled trials. A systematic search of electronic databases and clinical trial registries will use a predefined search strategy. All large (more than 1000 adult participants) randomized controlled trials will be evaluated. Two reviewers will screen and extract data according to this protocol with the aim of 95% concordance of papers checked and discrepancies will be resolved by a third reviewer. Trial methods, participant retention rates and prevalence of missing data will be recorded and compared. The potential for bias will be evaluated using the Cochrane Risk of Bias tool (applied to the methods used during the in-trial period) with the aim of investigating whether the quality of the post-trial follow-up methodology might be predicted by the quality of the methods used for the original trial. Post-trial follow-up can provide valuable information about the long-term benefits and hazards of medical interventions. However, it can be logistically challenging and costly. The aim of this systematic review is to describe how trial participants have been followed-up post-trial in order to inform future post-trial follow-up designs. Not applicable for PROSPERO registration.

Smartphone application for multi-phasic interventional trials in psychiatry: Technical design of a smart server.

PubMed

Zhang, Melvyn W B; Ho, Roger C M

2017-01-01

Smartphones and their accompanying applications are currently widely utilized in various healthcare interventions. Prior to the deployment of these tools for healthcare intervention, typically, proof of concept feasibility studies, as well as randomized trials are conducted to determine that these tools are efficacious prior to their actual implementation. In the field of psychiatry, most of the current interventions seek to compare smartphone based intervention against conventional care. There remains a paucity of research evaluating different forms of interventions using a single smartphone application. In the field of nutrition, there has been recent pioneering research demonstrating how a multi-phasic randomized controlled trial could be conducted using a single smartphone application. Despite the innovativeness of the previous smartphone conceptualization, there remains a paucity of technical information underlying the conceptualization that would support a multi-phasic interventional trial. It is thus the aim of the current technical note to share insights into an innovative server design that would enable the delivery of multi-phasic trials.

Heterogeneous variances in multi-environment yield trials for corn hybrids

USDA-ARS?s Scientific Manuscript database

Recent developments in statistics and computing have enabled much greater levels of complexity in statistical models of multi-environment yield trial data. One particular feature of interest to breeders is simultaneously modeling heterogeneity of variances among environments and cultivars. Our obj...

Implementation-effectiveness trial of an ecological intervention for physical activity in ethnically diverse low income senior centers.

PubMed

Rich, Porchia; Aarons, Gregory A; Takemoto, Michelle; Cardenas, Veronica; Crist, Katie; Bolling, Khalisa; Lewars, Brittany; Sweet, Cynthia Castro; Natarajan, Loki; Shi, Yuyan; Full, Kelsie M; Johnson, Eileen; Rosenberg, Dori E; Whitt-Glover, Melicia; Marcus, Bess; Kerr, Jacqueline

2017-07-18

As the US population ages, there is an increasing need for evidence based, peer-led physical activity programs, particularly in ethnically diverse, low income senior centers where access is limited. The Peer Empowerment Program 4 Physical Activity' (PEP4PA) is a hybrid Type II implementation-effectiveness trial that is a peer-led physical activity (PA) intervention based on the ecological model of behavior change. The initial phase is a cluster randomized control trial randomized to either a peer-led PA intervention or usual center programming. After 18 months, the intervention sites are further randomized to continued support or no support for another 6 months. This study will be conducted at twelve senior centers in San Diego County in low income, diverse communities. In the intervention sites, 24 peer health coaches and 408 adults, aged 50 years and older, are invited to participate. Peer health coaches receive training and support and utilize a tablet computer for delivery and tracking. There are several levels of intervention. Individual components include pedometers, step goals, counseling, and feedback charts. Interpersonal components include group walks, group sharing and health tips, and monthly celebrations. Community components include review of PA resources, walkability audit, sustainability plan, and streetscape improvements. The primary outcome of interest is intensity and location of PA minutes per day, measured every 6 months by wrist and hip accelerometers and GPS devices. Secondary outcomes include blood pressure, physical, cognitive, and emotional functioning. Implementation measures include appropriateness & acceptability (perceived and actual fit), adoption & penetration (reach), fidelity (quantity & quality of intervention delivered), acceptability (satisfaction), costs, and sustainability. Using a peer led implementation strategy to deliver a multi-level community based PA program can enhance program adoption, implementation, and

Family Access to a Dentist Study (FADS): A Multi-Center Randomized Controlled Trial

PubMed Central

Nelson, Suchitra; Riedy, Christine; Albert, Jeffrey M; Lee, Wonik; Slusar, Mary Beth; Curtan, Shelley; Ferretti, Gerald; Cunha-Cruz, Joana; Milgrom, Peter

2015-01-01

Introduction Many low-income parent/caregivers do not understand the importance of cavity-free primary (baby) teeth and the chronic nature of dental caries (tooth decay). As a consequence, dental preventive and treatment utilization is low even when children are screened in schools and referred for care. This study aims to test a referral letter and Dental Information Guide (DIG) designed using the Common-Sense Model of Self-Regulation (CSM) framework to improve caregivers’ illness perception of dental caries and increase utilization of care by children with restorative dental needs. Methods A multi-site randomized controlled trial with caregivers of Kindergarten to 4th grade children in urban Ohio and rural Washington State will compare five arms: (1) CSM referral letter alone; (2) CSM referral letter + DIG; (3) reduced CSM referral letter alone; (4) reduced CSM referral letter + DIG; (5) standard (control) referral. At baseline, children will be screened at school to determine restorative dental needs. If in need of treatment, caregivers will be randomized to study arms and an intervention packet will be sent home. The primary outcome will be dental care based on a change in oral health status by clinical examination 7 months post-screening (ICDAS sealant codes 1 and 2; restoration codes 3–8; extraction). Enrollment commenced summer 2015 with results in summer 2016. Conclusion This study uses the CSM framework to develop and test behavioral interventions to increase dental utilization among low-income caregivers. If effective this simple intervention has broad applicability in clinical and community-based settings. PMID:26500170

Family Access to a Dentist Study (FADS): A multi-center randomized controlled trial.

PubMed

Nelson, Suchitra; Riedy, Christine; Albert, Jeffrey M; Lee, Wonik; Slusar, Mary Beth; Curtan, Shelley; Ferretti, Gerald; Cunha-Cruz, Joana; Milgrom, Peter

2015-11-01

Many low-income parent/caregivers do not understand the importance of cavity-free primary (baby) teeth and the chronic nature of dental caries (tooth decay). As a consequence, dental preventive and treatment utilization is low even when children are screened in schools and referred for care. This study aims to test a referral letter and Dental Information Guide (DIG) designed using the Common-Sense Model of Self-Regulation (CSM) framework to improve caregivers' illness perception of dental caries and increase utilization of care by children with restorative dental needs. A multi-site randomized controlled trial with caregivers of Kindergarten to 4th grade children in urban Ohio and rural Washington State will compare five arms: (1) CSM referral letter alone; (2) CSM referral letter+DIG; (3) reduced CSM referral letter alone; (4) reduced CSM referral letter+DIG; and (5) standard (control) referral. At baseline, children will be screened at school to determine restorative dental needs. If in need of treatment, caregivers will be randomized to study arms and an intervention packet will be sent home. The primary outcome will be dental care based on a change in oral health status by clinical examination 7 months post-screening (ICDAS sealant codes 1 and 2; restoration codes 3-8; extraction). Enrollment commenced summer 2015 with results in summer 2016. This study uses the CSM framework to develop and test behavioral interventions to increase dental utilization among low-income caregivers. If effective this simple intervention has broad applicability in clinical and community-based settings. Copyright © 2015 Elsevier Inc. All rights reserved.

Prospective multi-center study of an automatic online seizure detection system for epilepsy monitoring units.

PubMed

Fürbass, F; Ossenblok, P; Hartmann, M; Perko, H; Skupch, A M; Lindinger, G; Elezi, L; Pataraia, E; Colon, A J; Baumgartner, C; Kluge, T

2015-06-01

A method for automatic detection of epileptic seizures in long-term scalp-EEG recordings called EpiScan will be presented. EpiScan is used as alarm device to notify medical staff of epilepsy monitoring units (EMUs) in case of a seizure. A prospective multi-center study was performed in three EMUs including 205 patients. A comparison between EpiScan and the Persyst seizure detector on the prospective data will be presented. In addition, the detection results of EpiScan on retrospective EEG data of 310 patients and the public available CHB-MIT dataset will be shown. A detection sensitivity of 81% was reached for unequivocal electrographic seizures with false alarm rate of only 7 per day. No statistical significant differences in the detection sensitivities could be found between the centers. The comparison to the Persyst seizure detector showed a lower false alarm rate of EpiScan but the difference was not of statistical significance. The automatic seizure detection method EpiScan showed high sensitivity and low false alarm rate in a prospective multi-center study on a large number of patients. The application as seizure alarm device in EMUs becomes feasible and will raise the efficiency of video-EEG monitoring and the safety levels of patients. Copyright © 2014 International Federation of Clinical Neurophysiology. Published by Elsevier Ireland Ltd. All rights reserved.

The QUASAR reproducibility study, Part II: Results from a multi center Arterial Spin Labeling test-retest Study

PubMed Central

Petersen, Esben Thade; Mouridsen, Kim; Golay, Xavier

2009-01-01

Arterial Spin Labeling (ASL) is a method to measure perfusion using magnetically labeled blood water as an endogenous tracer. Being fully non-invasive, this technique is attractive for longitudinal studies of cerebral blood flow in healthy and diseased individuals, or as a surrogate marker of metabolism. So far, ASL has been restricted mostly to specialist centers due to a generally low SNR of the method and potential issues with user-dependent analysis needed to obtain quantitative measurement of cerebral blood flow (CBF). Here, we evaluated a particular implementation of ASL (called Quantitative STAR labeling of Arterial Regions or QUASAR), a method providing user independent quantification of CBF in a large test-retest study across sites from around the world, dubbed “The QUASAR reproducibility study”. Altogether, 28 sites located in Asia, Europe and North America participated and a total of 284 healthy volunteers were scanned. Minimal operator dependence was assured by using an automatic planning tool and its accuracy and potential usefulness in multi-center trials was evaluated as well. Accurate repositioning between sessions was achieved with the automatic planning tool showing mean displacements of 1.87±0.95mm and rotations of 1.56±0.66°. Mean gray matter CBF was 47.4±7.5 [ml/100g/min] with a between subject standard variation SDb = 5.5 [ml/100g/min] and a within subject standard deviation SDw = 4.7 [ml/100g/min]. The corresponding repeatability was 13.0 [ml/100g/min] and was found to be within the range of previous studies. PMID:19660557

The QUASAR reproducibility study, Part II: Results from a multi-center Arterial Spin Labeling test-retest study.

PubMed

Petersen, Esben Thade; Mouridsen, Kim; Golay, Xavier

2010-01-01

Arterial Spin Labeling (ASL) is a method to measure perfusion using magnetically labeled blood water as an endogenous tracer. Being fully non-invasive, this technique is attractive for longitudinal studies of cerebral blood flow in healthy and diseased individuals, or as a surrogate marker of metabolism. So far, ASL has been restricted mostly to specialist centers due to a generally low SNR of the method and potential issues with user-dependent analysis needed to obtain quantitative measurement of cerebral blood flow (CBF). Here, we evaluated a particular implementation of ASL (called Quantitative STAR labeling of Arterial Regions or QUASAR), a method providing user independent quantification of CBF in a large test-retest study across sites from around the world, dubbed "The QUASAR reproducibility study". Altogether, 28 sites located in Asia, Europe and North America participated and a total of 284 healthy volunteers were scanned. Minimal operator dependence was assured by using an automatic planning tool and its accuracy and potential usefulness in multi-center trials was evaluated as well. Accurate repositioning between sessions was achieved with the automatic planning tool showing mean displacements of 1.87+/-0.95 mm and rotations of 1.56+/-0.66 degrees . Mean gray matter CBF was 47.4+/-7.5 [ml/100 g/min] with a between-subject standard variation SD(b)=5.5 [ml/100 g/min] and a within-subject standard deviation SD(w)=4.7 [ml/100 g/min]. The corresponding repeatability was 13.0 [ml/100 g/min] and was found to be within the range of previous studies.

Expanding the Use of Time-Based Metering: Multi-Center Traffic Management Advisor

NASA Technical Reports Server (NTRS)

Landry, Steven J.; Farley, Todd; Hoang, Ty

2005-01-01

Time-based metering is an efficient air traffic management alternative to the more common practice of distance-based metering (or "miles-in-trail spacing"). Despite having demonstrated significant operational benefit to airspace users and service providers, time-based metering is used in the United States for arrivals to just nine airports and is not used at all for non-arrival traffic flows. The Multi-Center Traffic Management Advisor promises to bring time-based metering into the mainstream of air traffic management techniques. Not constrained to operate solely on arrival traffic, Multi-Center Traffic Management Advisor is flexible enough to work in highly congested or heavily partitioned airspace for any and all traffic flows in a region. This broader and more general application of time-based metering is expected to bring the operational benefits of time-based metering to a much wider pool of beneficiaries than is possible with existing technology. It also promises to facilitate more collaborative traffic management on a regional basis. This paper focuses on the operational concept of the Multi-Center Traffic Management Advisor, touching also on its system architecture, field test results, and prospects for near-term deployment to the United States National Airspace System.

Recruitment for health disparities preventive intervention trials: the early childhood caries collaborating centers.

PubMed

Tiwari, Tamanna; Casciello, Alana; Gansky, Stuart A; Henshaw, Michelle; Ramos-Gomez, Francisco; Rasmussen, Margaret; Garcia, Raul I; Albino, Judith; Batliner, Terrence S

2014-08-07

Four trials of interventions designed to prevent early childhood caries are using community-engagement strategies to improve recruitment of low-income, racial/ethnic minority participants. The trials are being implemented by 3 centers funded by the National Institute of Dental and Craniofacial Research and known as the Early Childhood Caries Collaborating Centers (EC4): the Center for Native Oral Health Research at the University of Colorado, the Center to Address Disparities in Children's Oral Health at the University of California San Francisco, and the Center for Research to Evaluate and Eliminate Dental Disparities at Boston University. The community contexts for the EC4 trials include urban public housing developments, Hispanic communities near the US-Mexican border, and rural American Indian reservations. These communities have a high prevalence of early childhood caries, suggesting the need for effective, culturally acceptable interventions. Each center's intervention(s) used community-based participatory research approaches, identified community partners, engaged the community through various means, and developed communication strategies to enhance recruitment. All 3 centers have completed recruitment. Each center implemented several new strategies and approaches to enhance recruitment efforts, such as introducing new communication techniques, using media such as radio and newspapers to spread awareness about the studies, and hosting community gatherings. Using multiple strategies that build trust in the community, are sensitive to cultural norms, and are adaptable to the community environment can enhance recruitment in underserved communities.

Solar powered oxygen systems in remote health centers in Papua New Guinea: a large scale implementation effectiveness trial.

PubMed

Duke, Trevor; Hwaihwanje, Ilomo; Kaupa, Magdalynn; Karubi, Jonah; Panauwe, Doreen; Sa'avu, Martin; Pulsan, Francis; Prasad, Peter; Maru, Freddy; Tenambo, Henry; Kwaramb, Ambrose; Neal, Eleanor; Graham, Hamish; Izadnegahdar, Rasa

2017-06-01

Pneumonia is the largest cause of child deaths in Papua New Guinea (PNG), and hypoxaemia is the major complication causing death in childhood pneumonia, and hypoxaemia is a major factor in deaths from many other common conditions, including bronchiolitis, asthma, sepsis, malaria, trauma, perinatal problems, and obstetric emergencies. A reliable source of oxygen therapy can reduce mortality from pneumonia by up to 35%. However, in low and middle income countries throughout the world, improved oxygen systems have not been implemented at large scale in remote, difficult to access health care settings, and oxygen is often unavailable at smaller rural hospitals or district health centers which serve as the first point of referral for childhood illnesses. These hospitals are hampered by lack of reliable power, staff training and other basic services. We report the methodology of a large implementation effectiveness trial involving sustainable and renewable oxygen and power systems in 36 health facilities in remote rural areas of PNG. The methodology is a before-and after evaluation involving continuous quality improvement, and a health systems approach. We describe this model of implementation as the considerations and steps involved have wider implications in health systems in other countries. The implementation steps include: defining the criteria for where such an intervention is appropriate, assessment of power supplies and power requirements, the optimal design of a solar power system, specifications for oxygen concentrators and other oxygen equipment that will function in remote environments, installation logistics in remote settings, the role of oxygen analyzers in monitoring oxygen concentrator performance, the engineering capacity required to sustain a program at scale, clinical guidelines and training on oxygen equipment and the treatment of children with severe respiratory infection and other critical illnesses, program costs, and measurement of processes and

Solar powered oxygen systems in remote health centers in Papua New Guinea: a large scale implementation effectiveness trial

PubMed Central

Duke, Trevor; Hwaihwanje, Ilomo; Kaupa, Magdalynn; Karubi, Jonah; Panauwe, Doreen; Sa’avu, Martin; Pulsan, Francis; Prasad, Peter; Maru, Freddy; Tenambo, Henry; Kwaramb, Ambrose; Neal, Eleanor; Graham, Hamish; Izadnegahdar, Rasa

2017-01-01

Background Pneumonia is the largest cause of child deaths in Papua New Guinea (PNG), and hypoxaemia is the major complication causing death in childhood pneumonia, and hypoxaemia is a major factor in deaths from many other common conditions, including bronchiolitis, asthma, sepsis, malaria, trauma, perinatal problems, and obstetric emergencies. A reliable source of oxygen therapy can reduce mortality from pneumonia by up to 35%. However, in low and middle income countries throughout the world, improved oxygen systems have not been implemented at large scale in remote, difficult to access health care settings, and oxygen is often unavailable at smaller rural hospitals or district health centers which serve as the first point of referral for childhood illnesses. These hospitals are hampered by lack of reliable power, staff training and other basic services. Methods We report the methodology of a large implementation effectiveness trial involving sustainable and renewable oxygen and power systems in 36 health facilities in remote rural areas of PNG. The methodology is a before–and after evaluation involving continuous quality improvement, and a health systems approach. We describe this model of implementation as the considerations and steps involved have wider implications in health systems in other countries. Results The implementation steps include: defining the criteria for where such an intervention is appropriate, assessment of power supplies and power requirements, the optimal design of a solar power system, specifications for oxygen concentrators and other oxygen equipment that will function in remote environments, installation logistics in remote settings, the role of oxygen analyzers in monitoring oxygen concentrator performance, the engineering capacity required to sustain a program at scale, clinical guidelines and training on oxygen equipment and the treatment of children with severe respiratory infection and other critical illnesses, program costs, and

Ensuring treatment fidelity in a multi-site behavioral intervention study: implementing NIH Behavior Change Consortium recommendations in the SMART trial.

PubMed

Robb, Sheri L; Burns, Debra S; Docherty, Sharron L; Haase, Joan E

2011-11-01

The Stories and Music for Adolescent/Young Adult Resilience during Transplant (SMART) study (R01NR008583; U10CA098543; U10CA095861) is an ongoing multi-site Children's Oncology Group randomized clinical trial testing the efficacy of a therapeutic music video intervention for adolescents/young adults (11-24 years of age) with cancer undergoing stem cell transplant. Treatment fidelity strategies from our trial are consistent with the National Institutes of Health (NIH) Behavior Change Consortium Treatment Fidelity Workgroup (BCC) recommendations and provide a successful working model for treatment fidelity implementation in a large, multi-site behavioral intervention study. In this paper, we summarize 20 specific treatment fidelity strategies used in the SMART trial and how these strategies correspond with NIH BCC recommendations in five specific areas: (1) study design, (2) training providers, (3) delivery of treatment, (4) receipt of treatment, and (5) enactment of treatment skills. Increased use and reporting of treatment fidelity procedures is essential in advancing the reliability and validity of behavioral intervention research. The SMART trial provides a strong model for the application of fidelity strategies to improve scientific findings and addresses the absence of published literature, illustrating the application of BCC recommendations in behavioral intervention studies. Copyright © 2010 John Wiley & Sons, Ltd.

Multi-optical mine detection: results from a field trial

NASA Astrophysics Data System (ADS)

Letalick, Dietmar; Tolt, Gustav; Sjökvist, Stefan K.; Nyberg, Sten; Grönwall, Christina; Andersson, Pierre; Linderhed, Anna; Forssell, Göran; Larsson, Håkan; Uppsäll, Magnus

2006-05-01

As a part of the Swedish mine detection project MOMS, an initial field trial was conducted at the Swedish EOD and Demining Centre (SWEDEC). The purpose was to collect data on surface-laid mines, UXO, submunitions, IED's, and background with a variety of optical sensors, for further use in the project. Three terrain types were covered: forest, gravel road, and an area which had recovered after total removal of all vegetation some years before. The sensors used in the field trial included UV, VIS, and NIR sensors as well as thermal, multi-spectral, and hyper-spectral sensors, 3-D laser radar and polarization sensors. Some of the sensors were mounted on an aerial work platform, while others were placed on tripods on the ground. This paper describes the field trial and the presents some initial results obtained from the subsequent analysis.

Independent but coordinated trials: insights from the practice-based Opportunities for Weight Reduction Trials Collaborative Research Group.

PubMed

Yeh, Hsin-Chieh; Clark, Jeanne M; Emmons, Karen E; Moore, Reneé H; Bennett, Gary G; Warner, Erica T; Sarwer, David B; Jerome, Gerald J; Miller, Edgar R; Volger, Sheri; Louis, Thomas A; Wells, Barbara; Wadden, Thomas A; Colditz, Graham A; Appel, Lawrence J

2010-08-01

The National Heart, Lung, and Blood Institute (NHLBI) funded three institutions to conduct effectiveness trials of weight loss interventions in primary care settings. Unlike traditional multi-center clinical trials, each study was established as an independent trial with a distinct protocol. Still, efforts were made to coordinate and standardize several aspects of the trials. The three trials formed a collaborative group, the 'Practice-based Opportunities for Weight Reduction (POWER) Trials Collaborative Research Group.' We describe the common and distinct features of the three trials, the key characteristics of the collaborative group, and the lessons learned from this novel organizational approach. The Collaborative Research Group consists of three individual studies: 'Be Fit, Be Well' (Washington University in St. Louis/Harvard University), 'POWER Hopkins' (Johns Hopkins), and 'POWER-UP' (University of Pennsylvania). There are a total of 15 participating clinics with ~1100 participants. The common primary outcome is change in weight at 24 months of follow-up, but each protocol has trial-specific elements including different interventions and different secondary outcomes. A Resource Coordinating Unit at Johns Hopkins provides administrative support. The Collaborative Research Group established common components to facilitate potential cross-site comparisons. The main advantage of this approach is to develop and evaluate several interventions, when there is insufficient evidence to test one or two approaches, as would be done in a traditional multi-center trial. The challenges of the organizational design include the complex decision-making process, the extent of potential data pooling, time intensive efforts to standardize reports, and the additional responsibilities of the DSMB to monitor three distinct protocols.

Development of a Multi-Centre Clinical Trial Data Archiving and Analysis Platform for Functional Imaging

NASA Astrophysics Data System (ADS)

Driscoll, Brandon; Jaffray, David; Coolens, Catherine

2014-03-01

Purpose: To provide clinicians & researchers participating in multi-centre clinical trials with a central repository for large volume dynamic imaging data as well as a set of tools for providing end-to-end testing and image analysis standards of practice. Methods: There are three main pieces to the data archiving and analysis system; the PACS server, the data analysis computer(s) and the high-speed networks that connect them. Each clinical trial is anonymized using a customizable anonymizer and is stored on a PACS only accessible by AE title access control. The remote analysis station consists of a single virtual machine per trial running on a powerful PC supporting multiple simultaneous instances. Imaging data management and analysis is performed within ClearCanvas Workstation® using custom designed plug-ins for kinetic modelling (The DCE-Tool®), quality assurance (The DCE-QA Tool) and RECIST. Results: A framework has been set up currently serving seven clinical trials spanning five hospitals with three more trials to be added over the next six months. After initial rapid image transfer (+ 2 MB/s), all data analysis is done server side making it robust and rapid. This has provided the ability to perform computationally expensive operations such as voxel-wise kinetic modelling on very large data archives (+20 GB/50k images/patient) remotely with minimal end-user hardware. Conclusions: This system is currently in its proof of concept stage but has been used successfully to send and analyze data from remote hospitals. Next steps will involve scaling up the system with a more powerful PACS and multiple high powered analysis machines as well as adding real-time review capabilities.

Economic analysis of centralized vs. decentralized electronic data capture in multi-center clinical studies.

PubMed

Walden, Anita; Nahm, Meredith; Barnett, M Edwina; Conde, Jose G; Dent, Andrew; Fadiel, Ahmed; Perry, Theresa; Tolk, Chris; Tcheng, James E; Eisenstein, Eric L

2011-01-01

New data management models are emerging in multi-center clinical studies. We evaluated the incremental costs associated with decentralized vs. centralized models. We developed clinical research network economic models to evaluate three data management models: centralized, decentralized with local software, and decentralized with shared database. Descriptive information from three clinical research studies served as inputs for these models. The primary outcome was total data management costs. Secondary outcomes included: data management costs for sites, local data centers, and central coordinating centers. Both decentralized models were more costly than the centralized model for each clinical research study: the decentralized with local software model was the most expensive. Decreasing the number of local data centers and case book pages reduced cost differentials between models. Decentralized vs. centralized data management in multi-center clinical research studies is associated with increases in data management costs.

Economic burden of clinical trials in lung cancer in a German Comprehensive Cancer Center.

PubMed

Kron, F; Kostenko, A; Scheffler, M; Müller, D; Glossmann, J-P; Fischer, R; Michels, S; Nogova, L; Hallek, M; Zander, T; Wolf, J

2017-06-01

The recent success of individualized lung cancer therapy has triggered fundamental changes in clinical research strategies. To date there is a strong focus on early proof of concept trials in genetically preselected small patient subgroups. This analysis focuses on the economic burden caused by such trials for advanced lung cancer patients in a German Comprehensive Cancer Center (CCC). The profit margins between recruiting groups with ≤3 and >3 patients were compared. Clinical and economic data from clinical trials for advanced lung cancer (LC), pharma-sponsored trials (PhST) as well as investigator initiated trials (IIT), conducted between 2011 and 2015 at the Center for Integrated Oncology (CIO) Cologne, were analyzed using a profit-center calculation model. 161 patients were enrolled in 27 clinical trials. The key economic parameter determining costs and payments was the 'trial visits'. In comparison of the two groups (A≤3; B>3 patients enrolled) we found negative profit margins for the low recruiting group (€ -1444). Concerning the number of visits significant differences were found between PhST and IIT (p=0.009). Additionally, sub-analysis show structural differences in cost composition by conducting PhST and IIT. Trials with low patient numbers and IIT, do not cover the cost. To ensure adequate, cost-covering compensation by pharmaceutical companies CCCs have to thoroughly calculate the cost of early proof of concept trials. The findings of this study also underline the need for novel structures in public funding for investigator-initiated clinical trials in precision medicine. Copyright © 2017 Elsevier B.V. All rights reserved.

A Multi-Center, Randomized, Double-Blind Placebo-Controlled Trial of Intravenous-Ibuprofen (IV-Ibuprofen) for Treatment of Pain in Post-Operative Orthopedic Adult Patients

PubMed Central

Singla, Neil; Rock, Amy; Pavliv, Leo

2010-01-01

Objective To determine whether pre- and post-operative administration of intravenous ibuprofen (IV-ibuprofen) can significantly decrease pain and morphine use when compared with placebo in adult orthopedic surgical patients. Design This was a multi-center, randomized, double-blind placebo-controlled trial. Setting This study was completed at eight hospitals; six in the United States and two in South Africa. Patients A total of 185 adult patients undergoing elective orthopedic surgery. Interventions Patients were randomized to receive either 800 mg IV-ibuprofen or placebo every 6 hours, with the first dose administered pre-operatively. Additionally, all patients had access to intravenous morphine for rescue. Outcome Measures Efficacy of IV-ibuprofen was demonstrated by measuring the patient's self assessment of pain using a visual analog scale (VAS; assessed with movement and at rest) and a verbal response scale (VRS). Morphine consumption during the post-operative period was also assessed. Results In the immediate post-operative period, there was a 25.8% reduction in mean area under the curve-VAS assessed with movement (AUC-VASM) in patients receiving IV-ibuprofen (P < 0.001); a 31.8% reduction in mean AUC-VAS assessed at rest (AUC-VASR; P < 0.001) and a 20.2% reduction in mean VRS (P < 0.001) compared to those receiving placebo. Patients receiving IV-ibuprofen used 30.9% less morphine (P < 0.001) compared to those receiving placebo. Similar treatment emergent adverse events occurred in both study groups and there were no significant differences in the incidence of serious adverse events. Conclusion Pre- and post-operative administration of IV-ibuprofen significantly reduced both pain and morphine use in orthopedic surgery patients in this prospective randomized placebo-controlled trial. PMID:20609131

Impact of copula directional specification on multi-trial evaluation of surrogate endpoints

PubMed Central

Renfro, Lindsay A.; Shang, Hongwei; Sargent, Daniel J.

2014-01-01

Evaluation of surrogate endpoints using patient-level data from multiple trials is the gold standard, where multi-trial copula models are used to quantify both patient-level and trial-level surrogacy. While limited consideration has been given in the literature to copula choice (e.g., Clayton), no prior consideration has been given to direction of implementation (via survival versus distribution functions). We demonstrate that evenwith the “correct” copula family, directional misspecification leads to biased estimates of patient-level and trial-level surrogacy. We illustrate with a simulation study and a re-analysis of disease-free survival as a surrogate for overall survival in early stage colon cancer. PMID:24905465

Computer Assisted Multi-Center Creation of Medical Knowledge Bases

PubMed Central

Giuse, Nunzia Bettinsoli; Giuse, Dario A.; Miller, Randolph A.

1988-01-01

Computer programs which support different aspects of medical care have been developed in recent years. Their capabilities range from diagnosis to medical imaging, and include hospital management systems and therapy prescription. In spite of their diversity these systems have one commonality: their reliance on a large body of medical knowledge in computer-readable form. This knowledge enables such programs to draw inferences, validate hypotheses, and in general to perform their intended task. As has been clear to developers of such systems, however, the creation and maintenance of medical knowledge bases are very expensive. Practical and economical difficulties encountered during this long-term process have discouraged most attempts. This paper discusses knowledge base creation and maintenance, with special emphasis on medical applications. We first describe the methods currently used and their limitations. We then present our recent work on developing tools and methodologies which will assist in the process of creating a medical knowledge base. We focus, in particular, on the possibility of multi-center creation of the knowledge base.

Economic Analysis of Centralized vs. Decentralized Electronic Data Capture in Multi-Center Clinical Studies

PubMed Central

Walden, Anita; Nahm, Meredith; Barnett, M. Edwina; Conde, Jose G.; Dent, Andrew; Fadiel, Ahmed; Perry, Theresa; Tolk, Chris; Tcheng, James E.; Eisenstein, Eric L.

2012-01-01

Background New data management models are emerging in multi-center clinical studies. We evaluated the incremental costs associated with decentralized vs. centralized models. Methods We developed clinical research network economic models to evaluate three data management models: centralized, decentralized with local software, and decentralized with shared database. Descriptive information from three clinical research studies served as inputs for these models. Main Outcome Measures The primary outcome was total data management costs. Secondary outcomes included: data management costs for sites, local data centers, and central coordinating centers. Results Both decentralized models were more costly than the centralized model for each clinical research study: the decentralized with local software model was the most expensive. Decreasing the number of local data centers and case book pages reduced cost differentials between models. Conclusion Decentralized vs. centralized data management in multi-center clinical research studies is associated with increases in data management costs. PMID:21335692

The association between physiologic dead-space fraction and mortality in subjects with ARDS enrolled in a prospective multi-center clinical trial.

PubMed

Kallet, Richard H; Zhuo, Hanjing; Liu, Kathleen D; Calfee, Carolyn S; Matthay, Michael A

2014-11-01

We tested the association between pulmonary dead-space fraction (ratio of dead space to tidal volume [V(D)/V(T)]) and mortality in subjects with ARDS (Berlin definition, P(aO2)/F(IO2) ≤ 300 mm Hg; PEEP ≥ 5 cm H2O) enrolled into a clinical trial incorporating lung-protective ventilation. We conducted a prospective, multi-center study at medical-surgical ICUs in the United States. A total of 126 ALI subjects with acute lung injury were enrolled into a phase 3 randomized, placebo-controlled study of aerosolized albuterol. V(D)/V(T) and pulmonary mechanics were measured within 4 h of enrollment and repeated daily on study days 1 and 2 in subjects requiring arterial blood gases for clinical management. At baseline, non-survivors had a trend toward higher V(D)/V(T) compared with survivors (0.62 ± 0.11 vs 0.56 ± 0.11, respectively, P = .08). Differences in V(D)/V(T) between non-survivors and survivors became significant on study days 1 (0.64 ± 0.12 vs 0.55 ± 0.11, respectively, P = .01) and 2 (0.67 ± 0.12 vs 0.56 ± 0.11, respectively, P = .004). Likewise, the association between VD/VT and mortality was significant on study day 1 (odds ratio per 0.10 change in V(D)/V(T) [95% CI]: 6.84 [1.62-28.84] P = .01; and study day 2: 4.90 [1.28-18.73] P = .02) after adjusting for V(D)/V(T), P(aO2)/F(IO2), oxygenation index, vasopressor use, and the primary risk for ARDS. Using a Cox proportional hazard model, V(D)/V(T) was associated with a trend toward higher mortality (HR = 4.37 [CI 0.99-19.32], P = .052) that became significant when the analysis was adjusted for daily oxygenation index (HR = 1.74 [95% CI 1.12-3.35] P = .04). Markedly elevated V(D)/V(T) (≥ 0.60) in early ARDS is associated with higher mortality. Measuring V(D)/V(T) may be useful in identifying ARDS patients at increased risk of death who are enrolled into a therapeutic trial. Copyright © 2014 by Daedalus Enterprises.

Clinical staging and operative reporting for multi-institutional trials in head and neck squamous cell carcinoma.

PubMed

Weymuller, E A

1997-12-01

A Strategic Planning Conference (jointly supported by NCI and NIDCD) was convened to consider potential improvements in surgical patient data for multi-institutional trials. The thesis underlying this project is that inadequacies in staging, pretreatment patient stratification, and the details of surgical resection may have obscured the detection of treatment effect. The goals of this project were multiple: (1) to consider the utility of new clinical stratification variables, (2) to increase the precision of tumor staging, and (3) to improve operative reporting for multi-institutional trials in head and neck cancer. The conference attendees came to a number of important conclusions: (1) TNM status is inadequate for describing head and neck cancer in a multi-institutional trial setting. A detailed anatomic reporting scheme is proposed; (2) comorbidity measures should be included as patient descriptors, especially those that meet the criteria "definitely important and easy to obtain"; (3) surgical reporting in multi-institutional trials should use a format that is compatible with computer analysis and use the same items as the revised (anatomic) staging system; (4) the surgeon should be personally responsible for data coding and should interact directly with the pathologist in marking the surgical specimen; (5) pathologic reporting should use an anatomic template identical to the staging and operative reporting formats.

Field-scale multi-phase LNAPL remediation: Validating a new computational framework against sequential field pilot trials.

PubMed

Sookhak Lari, Kaveh; Johnston, Colin D; Rayner, John L; Davis, Greg B

2018-03-05

Remediation of subsurface systems, including groundwater, soil and soil gas, contaminated with light non-aqueous phase liquids (LNAPLs) is challenging. Field-scale pilot trials of multi-phase remediation were undertaken at a site to determine the effectiveness of recovery options. Sequential LNAPL skimming and vacuum-enhanced skimming, with and without water table drawdown were trialled over 78days; in total extracting over 5m 3 of LNAPL. For the first time, a multi-component simulation framework (including the multi-phase multi-component code TMVOC-MP and processing codes) was developed and applied to simulate the broad range of multi-phase remediation and recovery methods used in the field trials. This framework was validated against the sequential pilot trials by comparing predicted and measured LNAPL mass removal rates and compositional changes. The framework was tested on both a Cray supercomputer and a cluster. Simulations mimicked trends in LNAPL recovery rates (from 0.14 to 3mL/s) across all remediation techniques each operating over periods of 4-14days over the 78day trial. The code also approximated order of magnitude compositional changes of hazardous chemical concentrations in extracted gas during vacuum-enhanced recovery. The verified framework enables longer term prediction of the effectiveness of remediation approaches allowing better determination of remediation endpoints and long-term risks. Copyright © 2017 Commonwealth Scientific and Industrial Research Organisation. Published by Elsevier B.V. All rights reserved.

77 FR 12598 - Notice Correction; A Multi-Center International Hospital-Based Case-Control Study of Lymphoma in...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-01

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Notice Correction; A Multi-Center International Hospital-Based Case-Control Study of Lymphoma in Asia (AsiaLymph) (NCI) The Federal... project titled, ``A multi-center international hospital-based case-control study of lymphoma in Asia (Asia...

How can healthcare organizations implement patient-centered care? Examining a large-scale cultural transformation.

PubMed

Bokhour, Barbara G; Fix, Gemmae M; Mueller, Nora M; Barker, Anna M; Lavela, Sherri L; Hill, Jennifer N; Solomon, Jeffrey L; Lukas, Carol VanDeusen

2018-03-07

Healthcare organizations increasingly are focused on providing care which is patient-centered rather than disease-focused. Yet little is known about how best to transform the culture of care in these organizations. We sought to understand key organizational factors for implementing patient-centered care cultural transformation through an examination of efforts in the US Department of Veterans Affairs. We conducted multi-day site visits at four US Department of Veterans Affairs medical centers designated as leaders in providing patient-centered care. We conducted qualitative semi-structured interviews with 108 employees (22 senior leaders, 42 middle managers, 37 front-line providers and 7 staff). Transcripts of audio recordings were analyzed using a priori codes based on the Consolidated Framework for Implementation Research. We used constant comparison analysis to synthesize codes into meaningful domains. Sites described actions taken to foster patient-centered care in seven domains: 1) leadership; 2) patient and family engagement; 3) staff engagement; 4) focus on innovations; 5) alignment of staff roles and priorities; 6) organizational structures and processes; 7) environment of care. Within each domain, we identified multi-faceted strategies for implementing change. These included efforts by all levels of organizational leaders who modeled patient-centered care in their interactions and fostered willingness to try novel approaches to care amongst staff. Alignment and integration of patient centered care within the organization, particularly surrounding roles, priorities and bureaucratic rules, remained major challenges. Transforming healthcare systems to focus on patient-centered care and better serve the "whole" patient is a complex endeavor. Efforts to transform healthcare culture require robust, multi-pronged efforts at all levels of the organization; leadership is only the beginning. Challenges remain for incorporating patient-centered approaches in the

The role of dosimetry audit in lung SBRT multi-centre clinical trials.

PubMed

Clark, Catharine H; Hurkmans, Coen W; Kry, Stephen F

2017-12-01

Stereotactic Body Radiotherapy (SBRT) in the lung is a challenging technique which requires high quality clinical trials to answer the un-resolved clinical questions. Quality assurance of these clinical trials not only ensures the safety of the treatment of the participating patients but also minimises the variation in treatment, thus allowing the lowest number of patient treatments to answer the trial question. This review addresses the role of dosimetry audits in the quality assurance process and considers what can be done to ensure the highest accuracy of dose calculation and delivery and it's assessment in multi-centre trials. Copyright © 2017 Associazione Italiana di Fisica Medica. Published by Elsevier Ltd. All rights reserved.

A multi-element psychosocial intervention for early psychosis (GET UP PIANO TRIAL) conducted in a catchment area of 10 million inhabitants: study protocol for a pragmatic cluster randomized controlled trial

PubMed Central

2012-01-01

Background Multi-element interventions for first-episode psychosis (FEP) are promising, but have mostly been conducted in non-epidemiologically representative samples, thereby raising the risk of underestimating the complexities involved in treating FEP in ‘real-world’ services. Methods/Design The Psychosis early Intervention and Assessment of Needs and Outcome (PIANO) trial is part of a larger research program (Genetics, Endophenotypes and Treatment: Understanding early Psychosis - GET UP) which aims to compare, at 9 months, the effectiveness of a multi-component psychosocial intervention versus treatment as usual (TAU) in a large epidemiologically based cohort of patients with FEP and their family members recruited from all public community mental health centers (CMHCs) located in two entire regions of Italy (Veneto and Emilia Romagna), and in the cities of Florence, Milan and Bolzano. The GET UP PIANO trial has a pragmatic cluster randomized controlled design. The randomized units (clusters) are the CMHCs, and the units of observation are the centers’ patients and their family members. Patients in the experimental group will receive TAU plus: 1) cognitive behavioral therapy sessions, 2) psycho-educational sessions for family members, and 3) case management. Patient enrolment will take place over a 1-year period. Several psychopathological, psychological, functioning, and service use variables will be assessed at baseline and follow-up. The primary outcomes are: 1) change from baseline to follow-up in positive and negative symptoms’ severity and subjective appraisal; 2) relapse occurrences between baseline and follow-up, that is, episodes resulting in admission and/or any case-note records of re-emergence of positive psychotic symptoms. The expected number of recruited patients is about 400, and that of relatives about 300. Owing to the implementation of the intervention at the CMHC level, the blinding of patients, clinicians, and raters is not possible

The Effectiveness of Off Campus Multi-Institutional Teaching Centers as Perceived by Students

ERIC Educational Resources Information Center

Flores-Mejorado, Dina; Edmonson, Stacey; Fisher, Alice

2008-01-01

The purpose of this study was to examine and compare the perceptions of undergraduate and graduate students of a selected state university in Texas attending the Multi Institutional Teaching Center (MITC)/The University Center (TUC) or the main campus regarding the effectiveness of student services. As universities face limited resources and…

Exercise, manual therapy, and use of booster sessions in physical therapy for knee osteoarthritis: a multi-center, factorial randomized clinical trial.

PubMed

Fitzgerald, G K; Fritz, J M; Childs, J D; Brennan, G P; Talisa, V; Gil, A B; Neilson, B D; Abbott, J H

2016-08-01

(1) Do treatment effects differ between participants receiving manual therapy (MT) with exercise compared to subjects who don't, (2) are treatment effects sustained better when participants receive booster sessions compared to those who don't over a one year period in subjects with knee osteoarthritis (KOA)? Multi-center, 2 × 2 factorial randomized clinical trial. 300 participants with knee OA were randomized to four groups: exercise-no boosters (Ex), exercise-with boosters (Ex+B), manual therapy+exercise-no boosters (MT+Ex), manual therapy+exercise-with boosters (MT+Ex+B). The primary outcome was the Western Ontario and McMaster osteoarthritis index (WOMAC) at 1 year. Secondary outcomes included knee pain, physical performance tests, and proportions of participants meeting treatment responder criteria. There were no differences between groups on the WOMAC at 1 year or on any performance-based measures. Secondary analyses indicated a) better scores on the WOMAC and greater odds of being a treatment responder at 9 weeks for participants receiving MT, b) greater odds of being a treatment responder at 1 year for participants receiving boosters. Exploratory interaction analysis suggested knee pain decreases for participants receiving boosters and increases for participants not receiving boosters from 9 weeks to 1 year. MT or use of boosters with exercise did not result in additive improvement in the primary outcome at 1 year. Secondary outcomes suggest MT may have some short term benefit, and booster sessions may improve responder status and knee pain at 1 year. However, the role of booster sessions remains unclear in sustaining treatment effects and warrants further study. gov (NCT01314183). Copyright © 2016 Osteoarthritis Research Society International. All rights reserved.

Activity File of Learning Center and Classroom Multi-Cultural Activities.

ERIC Educational Resources Information Center

Riverside Unified School District, CA.

The cards in this file are representative samples of the types of activities developed by teachers involved in a Title I funded learning center of multi-cultural classroom activities for elementary school students. The five cultures that are stuoied are those of blacks, Asian Americans, native Americans, Mexican Americans, and Anglos. A…

Coronary CT angiography using 64 detector rows: methods and design of the multi-centre trial CORE-64.

PubMed

Miller, Julie M; Dewey, Marc; Vavere, Andrea L; Rochitte, Carlos E; Niinuma, Hiroyuki; Arbab-Zadeh, Armin; Paul, Narinder; Hoe, John; de Roos, Albert; Yoshioka, Kunihiro; Lemos, Pedro A; Bush, David E; Lardo, Albert C; Texter, John; Brinker, Jeffery; Cox, Christopher; Clouse, Melvin E; Lima, João A C

2009-04-01

Multislice computed tomography (MSCT) for the noninvasive detection of coronary artery stenoses is a promising candidate for widespread clinical application because of its non-invasive nature and high sensitivity and negative predictive value as found in several previous studies using 16 to 64 simultaneous detector rows. A multi-centre study of CT coronary angiography using 16 simultaneous detector rows has shown that 16-slice CT is limited by a high number of nondiagnostic cases and a high false-positive rate. A recent meta-analysis indicated a significant interaction between the size of the study sample and the diagnostic odds ratios suggestive of small study bias, highlighting the importance of evaluating MSCT using 64 simultaneous detector rows in a multi-centre approach with a larger sample size. In this manuscript we detail the objectives and methods of the prospective "CORE-64" trial ("Coronary Evaluation Using Multidetector Spiral Computed Tomography Angiography using 64 Detectors"). This multi-centre trial was unique in that it assessed the diagnostic performance of 64-slice CT coronary angiography in nine centres worldwide in comparison to conventional coronary angiography. In conclusion, the multi-centre, multi-institutional and multi-continental trial CORE-64 has great potential to ultimately assess the per-patient diagnostic performance of coronary CT angiography using 64 simultaneous detector rows.

Multi-center randomized controlled trial of cognitive treatment, placebo, oxybutynin, bladder training, and pelvic floor training in children with functional urinary incontinence.

PubMed

van Gool, Jan D; de Jong, Tom P V M; Winkler-Seinstra, Pauline; Tamminen-Möbius, Tytti; Lax, Hildegard; Hirche, Herbert; Nijman, Rien J M; Hjälmås, Kelm; Jodal, Ulf; Bachmann, Hannsjörg; Hoebeke, Piet; Walle, Johan Vande; Misselwitz, Joachim; John, Ulrike; Bael, An

2014-06-01

Functional urinary incontinence causes considerable morbidity in 8.4% of school-age children, mainly girls. To compare oxybutynin, placebo, and bladder training in overactive bladder (OAB), and cognitive treatment and pelvic floor training in dysfunctional voiding (DV), a multi-center controlled trial was designed, the European Bladder Dysfunction Study. Seventy girls and 27 boys with clinically diagnosed OAB and urge incontinence were randomly allocated to placebo, oxybutynin, or bladder training (branch I), and 89 girls and 16 boys with clinically diagnosed DV to either cognitive treatment or pelvic floor training (branch II). All children received standardized cognitive treatment, to which these interventions were added. The main outcome variable was daytime incontinence with/without urinary tract infections. Urodynamic studies were performed before and after treatment. In branch I, the 15% full response evolved to cure rates of 39% for placebo, 43% for oxybutynin, and 44% for bladder training. In branch II, the 25% full response evolved to cure rates of 52% for controls and 49% for pelvic floor training. Before treatment, detrusor overactivity (OAB) or pelvic floor overactivity (DV) did not correlate with the clinical diagnosis. After treatment these urodynamic patterns occurred de novo in at least 20%. The mismatch between urodynamic patterns and clinical symptoms explains why cognitive treatment was the key to success, not the added interventions. Unpredictable changes in urodynamic patterns over time, the response to cognitive treatment, and the gender-specific prevalence suggest social stress might be a cause for the symptoms, mediated by corticotropin-releasing factor signaling pathways. © 2013 Wiley Periodicals, Inc.

Development of quality control and instrumentation performance metrics for diffuse optical spectroscopic imaging instruments in the multi-center clinical environment

NASA Astrophysics Data System (ADS)

Keene, Samuel T.; Cerussi, Albert E.; Warren, Robert V.; Hill, Brian; Roblyer, Darren; Leproux, AnaÑ--s.; Durkin, Amanda F.; O'Sullivan, Thomas D.; Haghany, Hosain; Mantulin, William W.; Tromberg, Bruce J.

2013-03-01

Instrument equivalence and quality control are critical elements of multi-center clinical trials. We currently have five identical Diffuse Optical Spectroscopic Imaging (DOSI) instruments enrolled in the American College of Radiology Imaging Network (ACRIN, #6691) trial located at five academic clinical research sites in the US. The goal of the study is to predict the response of breast tumors to neoadjuvant chemotherapy in 60 patients. In order to reliably compare DOSI measurements across different instruments, operators and sites, we must be confident that the data quality is comparable. We require objective and reliable methods for identifying, correcting, and rejecting low quality data. To achieve this goal, we developed and tested an automated quality control algorithm that rejects data points below the instrument noise floor, improves tissue optical property recovery, and outputs a detailed data quality report. Using a new protocol for obtaining dark-noise data, we applied the algorithm to ACRIN patient data and successfully improved the quality of recovered physiological data in some cases.

Lessons learned: Infrastructure development and financial management for large, publicly funded, international trials.

PubMed

Larson, Gregg S; Carey, Cate; Grarup, Jesper; Hudson, Fleur; Sachi, Karen; Vjecha, Michael J; Gordin, Fred

2016-04-01

Randomized clinical trials are widely recognized as essential to address worldwide clinical and public health research questions. However, their size and duration can overwhelm available public and private resources. To remain competitive in international research settings, advocates and practitioners of clinical trials must implement practices that reduce their cost. We identify approaches and practices for large, publicly funded, international trials that reduce cost without compromising data integrity and recommend an approach to cost reporting that permits comparison of clinical trials. We describe the organizational and financial characteristics of The International Network for Strategic Initiatives in Global HIV Trials, an infectious disease research network that conducts multiple, large, long-term, international trials, and examine challenges associated with simple and streamlined governance and an infrastructure and financial management model that is based on performance, transparency, and accountability. It is possible to reduce costs of participants' follow-up and not compromise clinical trial quality or integrity. The International Network for Strategic Initiatives in Global HIV Trials network has successfully completed three large HIV trials using cost-efficient practices that have not adversely affected investigator enthusiasm, accrual rates, loss-to-follow-up, adherence to the protocol, and completion of data collection. This experience is relevant to the conduct of large, publicly funded trials in other disease areas, particularly trials dependent on international collaborations. New approaches, or creative adaption of traditional clinical trial infrastructure and financial management tools, can render large, international clinical trials more cost-efficient by emphasizing structural simplicity, minimal up-front costs, payments for performance, and uniform algorithms and fees-for-service, irrespective of location. However, challenges remain. They

Electronic data capture and DICOM data management in multi-center clinical trials

NASA Astrophysics Data System (ADS)

Haak, Daniel; Page, Charles-E.; Deserno, Thomas M.

2016-03-01

Providing eligibility, efficacy and security evaluation by quantitative and qualitative disease findings, medical imaging has become increasingly important in clinical trials. Here, subject's data is today captured in electronic case reports forms (eCRFs), which are offered by electronic data capture (EDC) systems. However, integration of subject's medical image data into eCRFs is insufficiently supported. Neither integration of subject's digital imaging and communications in medicine (DICOM) data, nor communication with picture archiving and communication systems (PACS), is possible. This aggravates the workflow of the study personnel, in special regarding studies with distributed data capture in multiple sites. Hence, in this work, a system architecture is presented, which connects an EDC system, a PACS and a DICOM viewer via the web access to DICOM objects (WADO) protocol. The architecture is implemented using the open source tools OpenClinica, DCM4CHEE and Weasis. The eCRF forms the primary endpoint for the study personnel, where subject's image data is stored and retrieved. Background communication with the PACS is completely hidden for the users. Data privacy and consistency is ensured by automatic de-identification and re-labelling of DICOM data with context information (e.g. study and subject identifiers), respectively. The system is exemplarily demonstrated in a clinical trial, where computer tomography (CT) data is de-centrally captured from the subjects and centrally read by a chief radiologists to decide on inclusion of the subjects in the trial. Errors, latency and costs in the EDC workflow are reduced, while, a research database is implicitly built up in the background.

The MRC CRASH trial--a large, simple randomised trial of steroids in head injury.

PubMed

Wasserberg, J

2004-01-01

CRASH (Corticosteroid randomisation after significant head injury) is a prospective multi-centre randomised double blind study of methylprednisolone versus placebo in mild, moderate and severe head injury. Patients are eligible up to 8 hours from injury. To date the CRASH trial has recruited 9000 patients. The trial is recruiting from 200 hospitals in 50 countries with another 100 centres planning to join the trial. The target for recruitment is 20,000 patients by 2006. The trial is wholly funded by the Medical Research Council of Great Britain and is multidisciplinary, involving doctors and nurses from a range of specialities. A recent systematic review of corticosteroids in head injury demonstrated a risk of death in the corticosteroid treated group 2% lower than in the control group. The 95% confidence interval ranges from a 60%, lower mortality to a 2% higher mortality. This result is compatible with there being no real benefit, but it is also compatible with there being a small benefit of a few percent. An improvement in mortality of 2% would theoretically save 10,000 lives per 500,000 patients treated. The global impact of such a treatment effect would be significant as the number of head injuries world-wide continues to rise.

Recruitment strategies and challenges in a large intervention trial: Systolic Blood Pressure Intervention Trial.

PubMed

Ramsey, Thomas M; Snyder, Joni K; Lovato, Laura C; Roumie, Christianne L; Glasser, Steven P; Cosgrove, Nora M; Olney, Christine M; Tang, Rocky H; Johnson, Karen C; Still, Carolyn H; Gren, Lisa H; Childs, Jeffery C; Crago, Osa L; Summerson, John H; Walsh, Sandy M; Perdue, Letitia H; Bankowski, Denise M; Goff, David C

2016-06-01

The Systolic Blood Pressure Intervention Trial is a multicenter, randomized clinical trial of 9361 participants with hypertension who are ≥50 years old. The trial is designed to evaluate the effect of intensive systolic blood pressure control (systolic blood pressure goal <120 mm Hg) compared to standard control (systolic blood pressure goal <140 mm Hg) on cardiovascular events using commonly prescribed antihypertensive medications and lifestyle modification. To describe the recruitment strategies and lessons learned during recruitment of the Systolic Blood Pressure Intervention Trial cohort and five targeted participant subgroups: pre-existing cardiovascular disease, pre-existing chronic kidney disease, age ≥75 years, women, and minorities. In collaboration with the National Institutes of Health Project Office and Systolic Blood Pressure Intervention Trial Coordinating Center, five Clinical Center Networks oversaw clinical site selection, recruitment, and trial activities. Recruitment began on 8 November 2010 and ended on 15 March 2013 (about 28 months). Various recruitment strategies were used, including mass mailing, brochures, referrals from healthcare providers or friends, posters, newspaper ads, radio ads, and electronic medical record searches. Recruitment was scheduled to last 24 months to enroll a target of 9250 participants; in just over 28 months, the trial enrolled 9361 participants. The trial screened 14,692 volunteers, with 33% of initial screens originating from the use of mass mailing lists. Screening results show that participants also responded to recruitment efforts through referral by Systolic Blood Pressure Intervention Trial staff, healthcare providers, or friends (45%); brochures or posters placed in clinic waiting areas (15%); and television, radio, newspaper, Internet ads, or toll-free numbers (8%). The overall recruitment yield (number randomized/number screened) was 64% (9361 randomized/14,692 screened), 77% for those

Cancer Clinical Trials at the National Institutes of Health Clinical Center

MedlinePlus

... Data Conducting Clinical Trials Statistical Tools and Data Terminology Resources NCI Data Catalog Cryo-EM NCI's Role ... fosters interaction and collaboration among clinicians and researchers. Medical Care at the Clinical Center Is Free Another ...

Application of person-centered analytic methodology in longitudinal research: exemplars from the Women's Health Initiative Clinical Trial data.

PubMed

Zaslavsky, Oleg; Cochrane, Barbara B; Herting, Jerald R; Thompson, Hilaire J; Woods, Nancy F; Lacroix, Andrea

2014-02-01

Despite the variety of available analytic methods, longitudinal research in nursing has been dominated by use of a variable-centered analytic approach. The purpose of this article is to present the utility of person-centered methodology using a large cohort of American women 65 and older enrolled in the Women's Health Initiative Clinical Trial (N = 19,891). Four distinct trajectories of energy/fatigue scores were identified. Levels of fatigue were closely linked to age, socio-demographic factors, comorbidities, health behaviors, and poor sleep quality. These findings were consistent regardless of the methodological framework. Finally, we demonstrated that energy/fatigue levels predicted future hospitalization in non-disabled elderly. Person-centered methods provide unique opportunities to explore and statistically model the effects of longitudinal heterogeneity within a population. © 2013 Wiley Periodicals, Inc.

Lessons learned: Infrastructure development and financial management for large, publically funded, international trials

PubMed Central

Larson, Gregg S; Carey, Cate; Grarup, Jesper; Hudson, Fleur; Sachi, Karen; Vjecha, Michael J; Gordin, Fred

2015-01-01

Background/Aims Randomized clinical trials are widely recognized as essential to address world-wide clinical and public health research questions. However, for many conditions, their size and duration can overwhelm available public and private resources. To remain competitive in international research settings, advocates and practitioners of clinical trials must implement practices that reduce their cost. We identify approaches and practices for large, publicly-funded, international trials that reduce cost without compromising data integrity, and recommend an approach to cost reporting that permits comparison of clinical trials. Methods We describe the organizational and financial characteristics of INSIGHT, an infectious disease research network that conducts multiple, large, long-term, international trials, and examine challenges associated with simple and streamlined governance and an infrastructure and financial management model that is based on performance, transparency, and accountability. Results It is possible to reduce costs of participant follow-up and not compromise clinical trial quality or integrity. The INSIGHT network has successfully completed four large HIV trials using cost-efficient practices that have not adversely affected investigator enthusiasm, accrual rates, loss-to-follow-up, adherence to the protocol, and completion of data collection. This experience is relevant to the conduct of large, publically funded trials in other disease areas, particularly trials dependent on international collaborations. Conclusion New approaches, or creative adaption of traditional clinical trial infrastructure and financial management tools, can render large, international clinical trials more cost-efficient by emphasizing structural simplicity; minimal up-front costs; payments for performance; and uniform algorithms and fees-for-service, irrespective of location. However, challenges remain. They include institutional resistance to financial change, growing

MiDas: Automatic Extraction of a Common Domain of Discourse in Sleep Medicine for Multi-center Data Integration

PubMed Central

Sahoo, Satya S.; Ogbuji, Chimezie; Luo, Lingyun; Dong, Xiao; Cui, Licong; Redline, Susan S.; Zhang, Guo-Qiang

2011-01-01

Clinical studies often use data dictionaries with controlled sets of terms to facilitate data collection, limited interoperability and sharing at a local site. Multi-center retrospective clinical studies require that these data dictionaries, originating from individual participating centers, be harmonized in preparation for the integration of the corresponding clinical research data. Domain ontologies are often used to facilitate multi-center data integration by modeling terms from data dictionaries in a logic-based language, but interoperability among domain ontologies (using automated techniques) is an unresolved issue. Although many upper-level reference ontologies have been proposed to address this challenge, our experience in integrating multi-center sleep medicine data highlights the need for an upper level ontology that models a common set of terms at multiple-levels of abstraction, which is not covered by the existing upper-level ontologies. We introduce a methodology underpinned by a Minimal Domain of Discourse (MiDas) algorithm to automatically extract a minimal common domain of discourse (upper-domain ontology) from an existing domain ontology. Using the Multi-Modality, Multi-Resource Environment for Physiological and Clinical Research (Physio-MIMI) multi-center project in sleep medicine as a use case, we demonstrate the use of MiDas in extracting a minimal domain of discourse for sleep medicine, from Physio-MIMI’s Sleep Domain Ontology (SDO). We then extend the resulting domain of discourse with terms from the data dictionary of the Sleep Heart and Health Study (SHHS) to validate MiDas. To illustrate the wider applicability of MiDas, we automatically extract the respective domains of discourse from 6 sample domain ontologies from the National Center for Biomedical Ontologies (NCBO) and the OBO Foundry. PMID:22195180

MiDas: automatic extraction of a common domain of discourse in sleep medicine for multi-center data integration.

PubMed

Sahoo, Satya S; Ogbuji, Chimezie; Luo, Lingyun; Dong, Xiao; Cui, Licong; Redline, Susan S; Zhang, Guo-Qiang

2011-01-01

Clinical studies often use data dictionaries with controlled sets of terms to facilitate data collection, limited interoperability and sharing at a local site. Multi-center retrospective clinical studies require that these data dictionaries, originating from individual participating centers, be harmonized in preparation for the integration of the corresponding clinical research data. Domain ontologies are often used to facilitate multi-center data integration by modeling terms from data dictionaries in a logic-based language, but interoperability among domain ontologies (using automated techniques) is an unresolved issue. Although many upper-level reference ontologies have been proposed to address this challenge, our experience in integrating multi-center sleep medicine data highlights the need for an upper level ontology that models a common set of terms at multiple-levels of abstraction, which is not covered by the existing upper-level ontologies. We introduce a methodology underpinned by a Minimal Domain of Discourse (MiDas) algorithm to automatically extract a minimal common domain of discourse (upper-domain ontology) from an existing domain ontology. Using the Multi-Modality, Multi-Resource Environment for Physiological and Clinical Research (Physio-MIMI) multi-center project in sleep medicine as a use case, we demonstrate the use of MiDas in extracting a minimal domain of discourse for sleep medicine, from Physio-MIMI's Sleep Domain Ontology (SDO). We then extend the resulting domain of discourse with terms from the data dictionary of the Sleep Heart and Health Study (SHHS) to validate MiDas. To illustrate the wider applicability of MiDas, we automatically extract the respective domains of discourse from 6 sample domain ontologies from the National Center for Biomedical Ontologies (NCBO) and the OBO Foundry.

Growing Right Onto Wellness (GROW): A Family-Centered, Community-Based Obesity Prevention Randomized Controlled Trial for Preschool Child-Parent Pairs

PubMed Central

Po’e, Eli K.; Heerman, William J.; Mistry, Rishi S.; Barkin, Shari L.

2013-01-01

Growing Right Onto Wellness (GROW) is a randomized controlled trial that tests the efficacy of a family-centered, community-based, behavioral intervention to prevent childhood obesity among preschool-aged children. Focusing on parent-child pairs, GROW utilizes a multi-level framework, which accounts for macro (i.e., built-environment) and micro (i.e., genetics) level systems that contribute to the childhood obesity epidemic. Six hundred parent-child pairs will be randomized to a 3-year healthy lifestyle intervention or a 3-year school readiness program. Eligible children are enrolled between ages 3 and 5, are from minority communities, and are not obese. The principal site for the GROW intervention is local community recreation centers and libraries. The primary outcome is childhood Body Mass Index (BMI) trajectory at the end of the three-year study period. In addition to other anthropometric measurements, mediators and moderators of growth are considered, including genetics, accelerometry, and diet recall. GROW is a staged intensity intervention, consisting of intensive, maintenance, and sustainability phases. Throughout the study, parents build skills in nutrition, physical activity, and parenting, concurrently forming new social networks. Participants are taught goal-setting, self-monitoring, and problem solving techniques to facilitate sustainable behavior change. The GROW curriculum uses low health literacy communication and social media to communicate key health messages. The control arm is administered to both control and intervention participants. By conducting this trial in public community centers, and by implementing a family-centered approach to sustainable healthy childhood growth, we aim to develop an exportable community-based intervention to address the expanding public health crisis of pediatric obesity. PMID:24012890

Considerations for Managing Large-Scale Clinical Trials.

ERIC Educational Resources Information Center

Tuttle, Waneta C.; And Others

1989-01-01

Research management strategies used effectively in a large-scale clinical trial to determine the health effects of exposure to Agent Orange in Vietnam are discussed, including pre-project planning, organization according to strategy, attention to scheduling, a team approach, emphasis on guest relations, cross-training of personnel, and preparing…

A new automatic algorithm for quantification of myocardial infarction imaged by late gadolinium enhancement cardiovascular magnetic resonance: experimental validation and comparison to expert delineations in multi-center, multi-vendor patient data.

PubMed

Engblom, Henrik; Tufvesson, Jane; Jablonowski, Robert; Carlsson, Marcus; Aletras, Anthony H; Hoffmann, Pavel; Jacquier, Alexis; Kober, Frank; Metzler, Bernhard; Erlinge, David; Atar, Dan; Arheden, Håkan; Heiberg, Einar

2016-05-04

Late gadolinium enhancement (LGE) cardiovascular magnetic resonance (CMR) using magnitude inversion recovery (IR) or phase sensitive inversion recovery (PSIR) has become clinical standard for assessment of myocardial infarction (MI). However, there is no clinical standard for quantification of MI even though multiple methods have been proposed. Simple thresholds have yielded varying results and advanced algorithms have only been validated in single center studies. Therefore, the aim of this study was to develop an automatic algorithm for MI quantification in IR and PSIR LGE images and to validate the new algorithm experimentally and compare it to expert delineations in multi-center, multi-vendor patient data. The new automatic algorithm, EWA (Expectation Maximization, weighted intensity, a priori information), was implemented using an intensity threshold by Expectation Maximization (EM) and a weighted summation to account for partial volume effects. The EWA algorithm was validated in-vivo against triphenyltetrazolium-chloride (TTC) staining (n = 7 pigs with paired IR and PSIR images) and against ex-vivo high resolution T1-weighted images (n = 23 IR and n = 13 PSIR images). The EWA algorithm was also compared to expert delineation in 124 patients from multi-center, multi-vendor clinical trials 2-6 days following first time ST-elevation myocardial infarction (STEMI) treated with percutaneous coronary intervention (PCI) (n = 124 IR and n = 49 PSIR images). Infarct size by the EWA algorithm in vivo in pigs showed a bias to ex-vivo TTC of -1 ± 4%LVM (R = 0.84) in IR and -2 ± 3%LVM (R = 0.92) in PSIR images and a bias to ex-vivo T1-weighted images of 0 ± 4%LVM (R = 0.94) in IR and 0 ± 5%LVM (R = 0.79) in PSIR images. In multi-center patient studies, infarct size by the EWA algorithm showed a bias to expert delineation of -2 ± 6 %LVM (R = 0.81) in IR images (n = 124) and 0 ± 5%LVM (R = 0.89) in

Multi-Quadrant Biopsy Technique Improves Diagnostic Ability in Large Heterogeneous Renal Masses.

PubMed

Abel, E Jason; Heckman, Jennifer E; Hinshaw, Louis; Best, Sara; Lubner, Meghan; Jarrard, David F; Downs, Tracy M; Nakada, Stephen Y; Lee, Fred T; Huang, Wei; Ziemlewicz, Timothy

2015-10-01

Percutaneous biopsy obtained from a single location is prone to sampling error in large heterogeneous renal masses, leading to nondiagnostic results or failure to detect poor prognostic features. We evaluated the accuracy of percutaneous biopsy for large renal masses using a modified multi-quadrant technique vs a standard biopsy technique. Clinical and pathological data for all patients with cT2 or greater renal masses who underwent percutaneous biopsy from 2009 to 2014 were reviewed. The multi-quadrant technique was defined as multiple core biopsies from at least 4 separate solid enhancing areas in the tumor. The incidence of nondiagnostic findings, sarcomatoid features and procedural complications was recorded, and concordance between biopsy specimens and nephrectomy pathology was compared. A total of 122 biopsies were performed for 117 tumors in 116 patients (46 using the standard biopsy technique and 76 using the multi-quadrant technique). Median tumor size was 10 cm (IQR 8-12). Biopsy was nondiagnostic in 5 of 46 (10.9%) standard and 0 of 76 (0%) multi-quadrant biopsies (p=0.007). Renal cell carcinoma was identified in 96 of 115 (82.0%) tumors and nonrenal cell carcinoma tumors were identified in 21 (18.0%). One complication occurred using the standard biopsy technique and no complications were reported using the multi-quadrant technique. Sarcomatoid features were present in 23 of 96 (23.9%) large renal cell carcinomas studied. Sensitivity for identifying sarcomatoid features was higher using the multi-quadrant technique compared to the standard biopsy technique at 13 of 15 (86.7%) vs 2 of 8 (25.0%) (p=0.0062). The multi-quadrant percutaneous biopsy technique increases the ability to identify aggressive pathological features in large renal tumors and decreases nondiagnostic biopsy rates. Copyright © 2015 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

Independent but Coordinated Trials: Insights from the Practice Based Opportunities for Weight Reduction (POWER) Trials Collaborative Research Group

PubMed Central

Yeh, Hsin-Chieh; Clark, Jeanne M.; Emmons, Karen M.; Moore, Renee H.; Bennett, Gary G; Warner, Erica T.; Sarwer, Davis B.; Jerome, Gerald J; Miller, Edgar R; Volger, Sheri; Louis, Thomas A.; Wells, Barbara; Wadden, Thomas A.; Colditz, Graham A.; Appel, Lawrence J.

2011-01-01

Background The National Heart, Lung, and Blood Institute (NHLBI) funded three institutions to conduct effectiveness trials of weight loss interventions in primary care settings. Unlike traditional multi-center clinical trials, each study was established as an independent trial with a distinct protocol. Still, efforts were made to coordinate and standardize several aspects of the trials. The three trials formed a collaborative group, the “Practice Based Opportunities for Weight Reduction (POWER) Trials Collaborative Research Group.” Purpose We describe the common and distinct features of the three trials, the key characteristics of the collaborative group, and the lessons learned from this novel organizational approach. Methods The Collaborative Research Group consists of three individual studies: “Be Fit, Be Well“(Washington University in St. Louis/Harvard University), “POWER Hopkins” (Johns Hopkins), and “POWER-UP” (University of Pennsylvania). There are a total of 15 participating clinics with ~1,100 participants. The common primary outcome is change in weight at 24 months of follow-up, but each protocol has trial-specific elements including different interventions and different secondary outcomes. A Resource Coordinating Unit at Johns Hopkins provides administrative support. Results The Collaborative Research Group established common components to facilitate potential cross-site comparisons. The main advantage of this approach is to develop and evaluate several interventions, when there is insufficient evidence to test one or two approaches, as would be done in a traditional multi-center trial. Limitations The challenges of the organizational design include the complex decision making process, the extent of potential data pooling, time intensive efforts to standardize reports, and the additional responsibilities of the DSMB to monitor three distinct protocols. Conclusions The POWER Trials Collaborative Research Group is a case study of an

Efficacy of the Lunch is in the Bag intervention to increase parents' packing of healthy bag lunches for young children: a cluster-randomized trial in early care and education centers.

PubMed

Roberts-Gray, Cindy; Briley, Margaret E; Ranjit, Nalini; Byrd-Williams, Courtney E; Sweitzer, Sara J; Sharma, Shreela V; Palafox, Maria Romo; Hoelscher, Deanna M

2016-01-08

Lunches that parents pack for their young children to eat at school or the Early Care and Education (ECE) center fall short of recommended standards. Lunch is in the Bag is a multi-level behavioral nutrition intervention to increase parents' packing of fruit, vegetables, and whole grains in their children's lunches. Designed for implementation in ECE centers, the five-week long intervention is followed three months later with a one-week booster. Efficacy of Lunch is in the Bag was tested in cluster randomized trial. Participants were 633 families from 30 ECE centers (15 intervention, 15 control) across Austin, San Antonio, and Houston, Texas, USA. Primary outcomes were servings of fruit, vegetables, and whole grains observed in the children's parent-packed bag lunches. Servings of refined grains, meats/beans/eggs/nuts, dairy, chips, and sweets also were observed. Data were collected at baseline, post-intervention (6-week follow-up), pre-booster (22-weeks follow-up), and post-booster (28-week follow-up). Time-by-treatment interactions were analyzed separately for each of the food groups using multi-level models to compare changes from baseline. Analyses were adjusted for relevant demographic variables and clustering within centers and parents. The intervention effected increases from baseline to 6-week follow-up in vegetables (0.17 servings, SE = 0.04, P < 0.001) and whole grains (0.30 servings, SE = 0.13, P = 0.018). The increase in whole grains was maintained through the 28-week follow-up (0.34 servings, SE = 0.13, P = 0.009). Fruit averaged more than 1.40 servings with no differences between groups or across time. The intervention prevented increase in sweets (-0.43 servings, SE = 0.11, P < .001, at the 22-week follow-up). Parents persisted, however, in packing small amounts of vegetables (averages of 0.41 to 0.52 servings) and large amounts of sweets and chips (averages of 1.75 to 1.99 servings). The need for and positive effects

Coordinating Centers in Cancer-Epidemiology Research: The Asia Cohort Consortium Coordinating Center

PubMed Central

Rolland, Betsy; Smith, Briana R; Potter, John D

2011-01-01

Although it is tacitly recognized that a good Coordinating Center (CC) is essential to the success of any multi-site collaborative project, very little study has been done on what makes a CC successful, why some CCs fail, or how to build a CC that meets the needs of a given project. Moreover, very little published guidance is available, as few CCs outside the clinical-trial realm write about their work. The Asia Cohort Consortium (ACC) is a collaborative cancer-epidemiology research project that has made strong scientific and organizational progress over the past three years by focusing its CC on the following activities: collaboration development; operations management; statistical and data management; and communications infrastructure and tool development. Our hope is that, by sharing our experience building the ACC CC, we can begin a conversation about what it means to run a coordinating center for multi-institutional collaboration in cancer epidemiology, help other collaborative projects solve some of the issues associated with collaborative research, and learn from others. PMID:21803842

Economic benefits of sponsored clinical trials on pharmaceutical expenditures at a medical center in Taiwan.

PubMed

Shen, Li-Jiuan; Chou, Hua; Huang, Chih-Fen; Chou, Guann-Miaw; Chan, Wing Kai; Wu, Fe-Lin Lin

2011-07-01

Concerns exist regarding the additional cost of patient care when patients are enrolled in clinical trials at hospitals. To assess the avoidance of drug costs by conducting sponsored clinical trials, a retrospective analysis evaluating drug cost avoidance in all sponsored clinical trials was conducted in 2008 at the most prominent medical center in Taiwan. The National Health Insurance (NHI) reimbursement prices of either the investigated drugs or the standardized drug therapy for each specific disease were used to calculate the cost avoidance. Drug cost avoidance from sponsored clinical trials per year, per trial, per patient, in different therapeutic areas, and in different phases was analyzed. Three quarters of the cost avoidance in drug expenditures from 194 sponsored clinical trials were estimated. All cost values are in US Dollars. Around $11.2 million was avoided at the center in 2008. The average value of cost avoidance was $58,000/trial-year or $3,900/participant-year. The early-phase trials and phase III trials accounted for 25% and 56% of all trials, respectively, while they constituted 32% and 49% of the total costs avoided, respectively. The most frequently conducted and highest cost-avoiding trials were those for antineoplastic agents, especially targeted therapy which accounted for 85% of the total cost avoidance of anti-cancer trials. This study demonstrates the profoundly positive economic impact on the healthcare system in Taiwan by sponsored clinical trials. To understand the trend of economic benefits of the trials on pharmaceutical expenditure, it would be important to analyze the cost avoidance of trials regularly in an institution. Copyright © 2011 Elsevier Inc. All rights reserved.

Follow-up of colorectal cancer patients after resection with curative intent-the GILDA trial.

PubMed

Grossmann, Erik M; Johnson, Frank E; Virgo, Katherine S; Longo, Walter E; Fossati, Rolando

2004-01-01

Surgery remains the primary treatment of colorectal cancer. Data are lacking to delineate the optimal surveillance strategy following resection. A large-scale multi-center European study is underway to address this issue (Gruppo Italiano di Lavoro per la Diagnosi Anticipata-GILDA). Following primary surgery with curative intent, stratification, and randomization at GILDA headquarters, colon cancer patients are then assigned to a more intensive or less intensive surveillance regimen. Rectal cancer patients undergoing curative resection are similarly randomized, with their follow-up regimens placing more emphasis on detection of local recurrence. Target recruitment for the study will be 1500 patients to achieve a statistical power of 80% (assuming an alpha of 0.05 and a hazard-rate reduction of >24%). Since the trial opened in 1998, 985 patients have been randomized from 41 centers as of February 2004. There were 496 patients randomized to the less intensive regimens, and 489 randomized to the more intensive regimens. The mean duration of follow-up is 14 months. 75 relapses (15%) and 32 deaths (7%) had been observed in the two more intensive follow-up arms, while 64 relapses (13%) and 24 deaths (5%) had been observed in the two less intensive arms as of February 2004. This trial should provide the first evidence based on an adequately powered randomized trial to determine the optimal follow-up strategy for colorectal cancer patients. This trial is open to US centers, and recruitment continues.

Laser treatment in patients with bilateral large drusen: the complications of age-related macular degeneration prevention trial.

PubMed

2006-11-01

To evaluate the efficacy and safety of low-intensity laser treatment in the prevention of visual acuity (VA) loss among participants with bilateral large drusen. Multicenter randomized clinical trial. One eye of each participant was assigned to treatment, and the contralateral eye was assigned to observation. A total of 1052 participants who had > or =10 large (>125 microm) drusen and VA> or =20/40 in each eye enrolled through 22 clinical centers. The initial laser treatment protocol specified 60 barely visible burns applied in a grid pattern within an annulus between 1500 and 2500 mum from the foveal center. At 12 months, eyes assigned to treatment that had sufficient drusen remaining were retreated with 30 burns by targeting drusen within an annulus between 1000 and 2000 mum from the foveal center. Proportion of eyes at 5 years with loss of > or =3 lines of VA from baseline. Secondary outcome measures included the development of choroidal neovascularization or geographic atrophy (GA), change in contrast threshold, change in critical print size, and incidence of ocular adverse events. At 5 years, 188 (20.5%) treated eyes and 188 (20.5%) observed eyes had VA scores > or = 3 lines worse than at the initial visit (P = 1.00). Cumulative 5-year incidence rates for treated and observed eyes were 13.3% and 13.3% (P = 0.95) for choroidal neovascularization and 7.4% and 7.8% (P = 0.64) for GA, respectively. The contrast threshold doubled in 23.9% of treated eyes and in 20.5% of observed eyes (P = 0.40). The critical print size doubled in 29.6% of treated eyes and in 28.4% of observed eyes (P = 0.70). Seven treated eyes and 14 observed eyes had an adverse event of a > or =6-line loss in VA in the absence of late age-related macular degeneration or cataract. As applied in the Complications of Age-Related Macular Degeneration Prevention Trial, low-intensity laser treatment did not demonstrate a clinically significant benefit for vision in eyes of people with bilateral large

Effects of unstratified and centre-stratified randomization in multi-centre clinical trials.

PubMed

Anisimov, Vladimir V

2011-01-01

This paper deals with the analysis of randomization effects in multi-centre clinical trials. The two randomization schemes most often used in clinical trials are considered: unstratified and centre-stratified block-permuted randomization. The prediction of the number of patients randomized to different treatment arms in different regions during the recruitment period accounting for the stochastic nature of the recruitment and effects of multiple centres is investigated. A new analytic approach using a Poisson-gamma patient recruitment model (patients arrive at different centres according to Poisson processes with rates sampled from a gamma distributed population) and its further extensions is proposed. Closed-form expressions for corresponding distributions of the predicted number of the patients randomized in different regions are derived. In the case of two treatments, the properties of the total imbalance in the number of patients on treatment arms caused by using centre-stratified randomization are investigated and for a large number of centres a normal approximation of imbalance is proved. The impact of imbalance on the power of the study is considered. It is shown that the loss of statistical power is practically negligible and can be compensated by a minor increase in sample size. The influence of patient dropout is also investigated. The impact of randomization on predicted drug supply overage is discussed. Copyright © 2010 John Wiley & Sons, Ltd.

A multi-resolution strategy for a multi-objective deformable image registration framework that accommodates large anatomical differences

NASA Astrophysics Data System (ADS)

Alderliesten, Tanja; Bosman, Peter A. N.; Sonke, Jan-Jakob; Bel, Arjan

2014-03-01

Currently, two major challenges dominate the field of deformable image registration. The first challenge is related to the tuning of the developed methods to specific problems (i.e. how to best combine different objectives such as similarity measure and transformation effort). This is one of the reasons why, despite significant progress, clinical implementation of such techniques has proven to be difficult. The second challenge is to account for large anatomical differences (e.g. large deformations, (dis)appearing structures) that occurred between image acquisitions. In this paper, we study a framework based on multi-objective optimization to improve registration robustness and to simplify tuning for specific applications. Within this framework we specifically consider the use of an advanced model-based evolutionary algorithm for optimization and a dual-dynamic transformation model (i.e. two "non-fixed" grids: one for the source- and one for the target image) to accommodate for large anatomical differences. The framework computes and presents multiple outcomes that represent efficient trade-offs between the different objectives (a so-called Pareto front). In image processing it is common practice, for reasons of robustness and accuracy, to use a multi-resolution strategy. This is, however, only well-established for single-objective registration methods. Here we describe how such a strategy can be realized for our multi-objective approach and compare its results with a single-resolution strategy. For this study we selected the case of prone-supine breast MRI registration. Results show that the well-known advantages of a multi-resolution strategy are successfully transferred to our multi-objective approach, resulting in superior (i.e. Pareto-dominating) outcomes.

SU-F-P-13: NRG Oncology Medical Physics Manpower Survey Quantifying Support Demands for Multi Institutional Clinical Trials

DOE Office of Scientific and Technical Information (OSTI.GOV)

Monroe, J; Case Western Reserve University; Boparai, K

Purpose: A survey was taken by NRG Oncology to assess Full Time Equivalent (FTE) contributions to multi institutional clinical trials by medical physicists.No current quantification of physicists’ efforts in FTE units associated with clinical trials is available. The complexity of multi-institutional trials increases with new technologies and techniques. Proper staffing may directly impact the quality of trial data and outcomes. The demands on physics time supporting clinical trials needs to be assessed. Methods: The NRG Oncology Medical Physicist Subcommittee created a sixteen question survey to obtain this FTE data. IROC Houston distributed the survey to their list of 1802 contactmore » physicists. Results: After three weeks, 363 responded (20.1% response). 187 (51.5%) institutions reporting external beam participation were processed. There was a wide range in number of protocols active and supported at each institution. Of the 187 clinics, 134 (71.7%) participate in 0 to 10 trials, 28 (15%) in 11 to 20 trials, 10 (5.3%) in 21 to 30 trials, 9 (4.8%) had 40 to 75 trials. On average, physicist spent 2.7 hours (SD: 6.0) per week supervising or interacting with clinical trial staff. 1.25 hours (SD: 3.37), 1.83 hours (SD: 4.13), and 0.64 hours(SD: 1.13) per week were spent on patient simulation, reviewing treatment plans, and maintaining a DICOM server, respectively. For all protocol credentialing activities, physicist spent an average of 37.05 hours (SD: 96.94) yearly. To support dosimetrists, clinicians, and therapists, physicist spend on average 2.07 hours (SD: 3.52) per week just reading protocols. Physicist attended clinical trial meetings for on average 1.13 hours (SD: 1.85) per month. Conclusion: Responding physicists spend a nontrivial amount of time: 8.8 hours per week (0.22 FTE) supporting, on average, 9 active multi-institutional clinical trials.« less

Leadership Practices of Clinical Trials Office Leaders in Academic Health Centers

ERIC Educational Resources Information Center

Naser, Diana D.

2012-01-01

In the ever-changing clinical research environment, academic health centers seek leaders who are visionary and innovative. Clinical trials offices across the country are led by individuals who are charged with promoting growth and change in order to maximize performance, develop unique research initiatives, and help institutions achieve a…

Family, Community and Clinic Collaboration to Treat Overweight and Obese Children: Stanford GOALS -- a Randomized Controlled Trial of a Three-Year, Multi-Component, Multi-Level, Multi-Setting Intervention

PubMed Central

Robinson, Thomas N.; Matheson, Donna; Desai, Manisha; Wilson, Darrell M.; Weintraub, Dana L.; Haskell, William L.; McClain, Arianna; McClure, Samuel; Banda, Jorge; Sanders, Lee M.; Haydel, K. Farish; Killen, Joel D.

2013-01-01

Objective To test the effects of a three-year, community-based, multi-component, multi-level, multi-setting (MMM) approach for treating overweight and obese children. Design Two-arm, parallel group, randomized controlled trial with measures at baseline, 12, 24, and 36 months after randomization. Participants Seven through eleven year old, overweight and obese children (BMI ≥ 85th percentile) and their parents/caregivers recruited from community locations in low-income, primarily Latino neighborhoods in Northern California. Interventions Families are randomized to the MMM intervention versus a community health education active-placebo comparison intervention. Interventions last for three years for each participant. The MMM intervention includes a community-based after school team sports program designed specifically for overweight and obese children, a home-based family intervention to reduce screen time, alter the home food/eating environment, and promote self-regulatory skills for eating and activity behavior change, and a primary care behavioral counseling intervention linked to the community and home interventions. The active-placebo comparison intervention includes semi-annual health education home visits, monthly health education newsletters for children and for parents/guardians, and a series of community-based health education events for families. Main Outcome Measure Body mass index trajectory over the three-year study. Secondary outcome measures include waist circumference, triceps skinfold thickness, accelerometer-measured physical activity, 24-hour dietary recalls, screen time and other sedentary behaviors, blood pressure, fasting lipids, glucose, insulin, hemoglobin A1c, C-reactive protein, alanine aminotransferase, and psychosocial measures. Conclusions The Stanford GOALS trial is testing the efficacy of a novel community-based multi-component, multi-level, multi-setting treatment for childhood overweight and obesity in low-income, Latino families

Family, community and clinic collaboration to treat overweight and obese children: Stanford GOALS-A randomized controlled trial of a three-year, multi-component, multi-level, multi-setting intervention.

PubMed

Robinson, Thomas N; Matheson, Donna; Desai, Manisha; Wilson, Darrell M; Weintraub, Dana L; Haskell, William L; McClain, Arianna; McClure, Samuel; Banda, Jorge A; Sanders, Lee M; Haydel, K Farish; Killen, Joel D

2013-11-01

To test the effects of a three-year, community-based, multi-component, multi-level, multi-setting (MMM) approach for treating overweight and obese children. Two-arm, parallel group, randomized controlled trial with measures at baseline, 12, 24, and 36 months after randomization. Seven through eleven year old, overweight and obese children (BMI ≥ 85th percentile) and their parents/caregivers recruited from community locations in low-income, primarily Latino neighborhoods in Northern California. Families are randomized to the MMM intervention versus a community health education active-placebo comparison intervention. Interventions last for three years for each participant. The MMM intervention includes a community-based after school team sports program designed specifically for overweight and obese children, a home-based family intervention to reduce screen time, alter the home food/eating environment, and promote self-regulatory skills for eating and activity behavior change, and a primary care behavioral counseling intervention linked to the community and home interventions. The active-placebo comparison intervention includes semi-annual health education home visits, monthly health education newsletters for children and for parents/guardians, and a series of community-based health education events for families. Body mass index trajectory over the three-year study. Secondary outcome measures include waist circumference, triceps skinfold thickness, accelerometer-measured physical activity, 24-hour dietary recalls, screen time and other sedentary behaviors, blood pressure, fasting lipids, glucose, insulin, hemoglobin A1c, C-reactive protein, alanine aminotransferase, and psychosocial measures. The Stanford GOALS trial is testing the efficacy of a novel community-based multi-component, multi-level, multi-setting treatment for childhood overweight and obesity in low-income, Latino families. © 2013 Elsevier Inc. All rights reserved.

Multi-port versus single-port cholecystectomy: results of a multi-centre, randomised controlled trial (MUSIC trial).

PubMed

Arezzo, Alberto; Passera, Roberto; Bullano, Alberto; Mintz, Yoav; Kedar, Asaf; Boni, Luigi; Cassinotti, Elisa; Rosati, Riccardo; Fumagalli Romario, Uberto; Sorrentino, Mario; Brizzolari, Marco; Di Lorenzo, Nicola; Gaspari, Achille Lucio; Andreone, Dario; De Stefani, Elena; Navarra, Giuseppe; Lazzara, Salvatore; Degiuli, Maurizio; Shishin, Kirill; Khatkov, Igor; Kazakov, Ivan; Schrittwieser, Rudolf; Carus, Thomas; Corradi, Alessio; Sitzman, Guenther; Lacy, Antonio; Uranues, Selman; Szold, Amir; Morino, Mario

2017-07-01

Single-port laparoscopic surgery as an alternative to conventional laparoscopic cholecystectomy for benign disease has not yet been accepted as a standard procedure. The aim of the multi-port versus single-port cholecystectomy trial was to compare morbidity rates after single-access (SPC) and standard laparoscopy (MPC). This non-inferiority phase 3 trial was conducted at 20 hospital surgical departments in six countries. At each centre, patients were randomly assigned to undergo either SPC or MPC. The primary outcome was overall morbidity within 60 days after surgery. Analysis was by intention to treat. The study was registered with ClinicalTrials.gov (NCT01104727). The study was conducted between April 2011 and May 2015. A total of 600 patients were randomly assigned to receive either SPC (n = 297) or MPC (n = 303) and were eligible for data analysis. Postsurgical complications within 60 days were recorded in 13 patients (4.7 %) in the SPC group and in 16 (6.1 %) in the MPC group (P = 0.468); however, single-access procedures took longer [70 min (range 25-265) vs. 55 min (range 22-185); P < 0.001]. There were no significant differences in hospital length of stay or pain VAS scores between the two groups. An incisional hernia developed within 1 year in six patients in the SPC group and in three in the MPC group (P = 0.331). Patients were more satisfied with aesthetic results after SPC, whereas surgeons rated the aesthetic results higher after MPC. No difference in quality of life scores, as measured by the gastrointestinal quality of life index at 60 days after surgery, was observed between the two groups. In selected patients undergoing cholecystectomy for benign gallbladder disease, SPC is non-inferior to MPC in terms of safety but it entails a longer operative time. Possible concerns about a higher risk of incisional hernia following SPC do not appear to be justified. Patient satisfaction with aesthetic results was greater after SPC than after

Not a load of rubbish: simulated field trials in large-scale containers.

PubMed

Hohmann, M; Stahl, A; Rudloff, J; Wittkop, B; Snowdon, R J

2016-09-01

Assessment of yield performance under fluctuating environmental conditions is a major aim of crop breeders. Unfortunately, results from controlled-environment evaluations of complex agronomic traits rarely translate to field performance. A major cause is that crops grown over their complete lifecycle in a greenhouse or growth chamber are generally constricted in their root growth, which influences their response to important abiotic constraints like water or nutrient availability. To overcome this poor transferability, we established a plant growth system comprising large refuse containers (120 L 'wheelie bins') that allow detailed phenotyping of small field-crop populations under semi-controlled growth conditions. Diverse winter oilseed rape cultivars were grown at field densities throughout the crop lifecycle, in different experiments over 2 years, to compare seed yields from individual containers to plot yields from multi-environment field trials. We found that we were able to predict yields in the field with high accuracy from container-grown plants. The container system proved suitable for detailed studies of stress response physiology and performance in pre-breeding populations. Investment in automated large-container systems may help breeders improve field transferability of greenhouse experiments, enabling screening of pre-breeding materials for abiotic stress response traits with a positive influence on yield. © 2016 John Wiley & Sons Ltd.

Center for Space Construction

NASA Technical Reports Server (NTRS)

Su, Renjeng

1998-01-01

The Center for Space Construction (CSC) at University of Colorado at Boulder is one of eight University Space Engineering Research Centers established by NASA in 1988. The mission of the Center is to conduct research into space technology and to directly contribute to space engineering education. The Center reports to the Department of Aerospace Engineering Sciences and resides in the College of Engineering and Applied Sciences. The College has a long and successful track record of cultivating multi-disciplinary research and education programs. The Center for Space Construction represents prominent evidence of this record. The basic concept on which the Center was founded is the in-space construction of large space systems, such as space stations, interplanetary space vehicles, and extraterrestrial space structures. Since 1993, the scope of CSC research has evolved to include the design and construction of all spacecraft, large and small. With the broadened scope our research projects seek to impact the technological basis for spacecraft such as remote sensing satellites, communication satellites and other special-purpose spacecraft, as well as large space platforms. A summary of accomplishments, including student participation and degrees awarded, during the contract period is presented.

Limited accessibility to designs and results of Japanese large-scale clinical trials for cardiovascular diseases.

PubMed

Sawata, Hiroshi; Ueshima, Kenji; Tsutani, Kiichiro

2011-04-14

Clinical evidence is important for improving the treatment of patients by health care providers. In the study of cardiovascular diseases, large-scale clinical trials involving thousands of participants are required to evaluate the risks of cardiac events and/or death. The problems encountered in conducting the Japanese Acute Myocardial Infarction Prospective (JAMP) study highlighted the difficulties involved in obtaining the financial and infrastructural resources necessary for conducting large-scale clinical trials. The objectives of the current study were: 1) to clarify the current funding and infrastructural environment surrounding large-scale clinical trials in cardiovascular and metabolic diseases in Japan, and 2) to find ways to improve the environment surrounding clinical trials in Japan more generally. We examined clinical trials examining cardiovascular diseases that evaluated true endpoints and involved 300 or more participants using Pub-Med, Ichushi (by the Japan Medical Abstracts Society, a non-profit organization), websites of related medical societies, the University Hospital Medical Information Network (UMIN) Clinical Trials Registry, and clinicaltrials.gov at three points in time: 30 November, 2004, 25 February, 2007 and 25 July, 2009. We found a total of 152 trials that met our criteria for 'large-scale clinical trials' examining cardiovascular diseases in Japan. Of these, 72.4% were randomized controlled trials (RCTs). Of 152 trials, 9.2% of the trials examined more than 10,000 participants, and 42.8% examined between 1,000 and 10,000 participants. The number of large-scale clinical trials markedly increased from 2001 to 2004, but suddenly decreased in 2007, then began to increase again. Ischemic heart disease (39.5%) was the most common target disease. Most of the larger-scale trials were funded by private organizations such as pharmaceutical companies. The designs and results of 13 trials were not disclosed. To improve the quality of clinical

Benefits Analysis of Multi-Center Dynamic Weather Routes

NASA Technical Reports Server (NTRS)

Sheth, Kapil; McNally, David; Morando, Alexander; Clymer, Alexis; Lock, Jennifer; Petersen, Julien

2014-01-01

Dynamic weather routes are flight plan corrections that can provide airborne flights more than user-specified minutes of flying-time savings, compared to their current flight plan. These routes are computed from the aircraft's current location to a flight plan fix downstream (within a predefined limit region), while avoiding forecasted convective weather regions. The Dynamic Weather Routes automation has been continuously running with live air traffic data for a field evaluation at the American Airlines Integrated Operations Center in Fort Worth, TX since July 31, 2012, where flights within the Fort Worth Air Route Traffic Control Center are evaluated for time savings. This paper extends the methodology to all Centers in United States and presents benefits analysis of Dynamic Weather Routes automation, if it was implemented in multiple airspace Centers individually and concurrently. The current computation of dynamic weather routes requires a limit rectangle so that a downstream capture fix can be selected, preventing very large route changes spanning several Centers. In this paper, first, a method of computing a limit polygon (as opposed to a rectangle used for Fort Worth Center) is described for each of the 20 Centers in the National Airspace System. The Future ATM Concepts Evaluation Tool, a nationwide simulation and analysis tool, is used for this purpose. After a comparison of results with the Center-based Dynamic Weather Routes automation in Fort Worth Center, results are presented for 11 Centers in the contiguous United States. These Centers are generally most impacted by convective weather. A breakdown of individual Center and airline savings is presented and the results indicate an overall average savings of about 10 minutes of flying time are obtained per flight.

Intraclass Correlations for Three-Level Multi-Site Cluster-Randomized Trials of Science Achievement

ERIC Educational Resources Information Center

Westine, Carl D.

2015-01-01

A cluster-randomized trial (CRT) relies on random assignment of intact clusters to treatment conditions, such as classrooms or schools (Raudenbush & Bryk, 2002). One specific type of CRT, a multi-site CRT (MSCRT), is commonly employed in educational research and evaluation studies (Spybrook & Raudenbush, 2009; Spybrook, 2014; Bloom,…

Recruitment strategies and challenges in a large intervention trial: Systolic Blood Pressure Intervention Trial (SPRINT)

PubMed Central

Ramsey, Thomas M; Snyder, Joni K; Lovato, Laura C; Roumie, Christianne L; Glasser, Steven P; Cosgrove, Nora M; Olney, Christine M; Tang, Rocky H; Johnson, Karen C; Still, Carolyn H; Gren, Lisa H; Childs, Jeffery C; Crago, Osa L; Summerson, John H; Walsh, Sandy M; Perdue, Letitia H; Bankowski, Denise M; Goff, David C

2016-01-01

Background The Systolic Blood Pressure Intervention Trial (SPRINT) is a multicenter, randomized clinical trial of 9,361 participants with hypertension who are ≥ 50 years old. The trial is designed to evaluate the effect of intensive systolic blood pressure control (systolic blood pressure goal <120 mm Hg) compared to standard control (systolic blood pressure goal <140 mm Hg) on cardiovascular events using commonly prescribed antihypertensive medications and lifestyle modification. Objective To describe the recruitment strategies and lessons learned during recruitment of the SPRINT cohort and five targeted participant subgroups: pre-existing cardiovascular disease, pre-existing chronic kidney disease, age ≥ 75 years, women, and minorities. Methods In collaboration with the National Institutes of Health Project Office and SPRINT Coordinating Center, five Clinical Center Networks oversaw clinical site selection, recruitment, and trial activities. Recruitment began November 8, 2010 and ended March 15, 2013 (about 28 months). Various recruitment strategies were used, including mass mailing, brochures, referrals from healthcare providers or friends, posters, newspaper ads, radio ads, and electronic medical record searches. Results Recruitment was scheduled to last 24 months to enroll a target of 9,250 participants; in just over 28 months, the trial enrolled 9,361 participants. The trial screened 14,692 volunteers, with 33% of initial screens originating from the use of mass mailing lists. Screening results show that participants also responded to recruitment efforts through referral by SPRINT staff, healthcare providers, or friends (45%); brochures or posters placed in clinic waiting areas (15%); and television, radio, newspaper, internet ads, or toll-free numbers (8%). The overall recruitment yield (number randomized /number screened) was 64% (9,361 randomized /14,692 screened), 77% for those with cardiovascular disease, 79% for those with chronic kidney disease, 70

Scalable Triadic Analysis of Large-Scale Graphs: Multi-Core vs. Multi-Processor vs. Multi-Threaded Shared Memory Architectures

DOE Office of Scientific and Technical Information (OSTI.GOV)

Chin, George; Marquez, Andres; Choudhury, Sutanay

2012-09-01

Triadic analysis encompasses a useful set of graph mining methods that is centered on the concept of a triad, which is a subgraph of three nodes and the configuration of directed edges across the nodes. Such methods are often applied in the social sciences as well as many other diverse fields. Triadic methods commonly operate on a triad census that counts the number of triads of every possible edge configuration in a graph. Like other graph algorithms, triadic census algorithms do not scale well when graphs reach tens of millions to billions of nodes. To enable the triadic analysis ofmore » large-scale graphs, we developed and optimized a triad census algorithm to efficiently execute on shared memory architectures. We will retrace the development and evolution of a parallel triad census algorithm. Over the course of several versions, we continually adapted the code’s data structures and program logic to expose more opportunities to exploit parallelism on shared memory that would translate into improved computational performance. We will recall the critical steps and modifications that occurred during code development and optimization. Furthermore, we will compare the performances of triad census algorithm versions on three specific systems: Cray XMT, HP Superdome, and AMD multi-core NUMA machine. These three systems have shared memory architectures but with markedly different hardware capabilities to manage parallelism.« less

The British antibiotic and silver-impregnated catheters for ventriculoperitoneal shunts multi-centre randomised controlled trial (the BASICS trial): study protocol

PubMed Central

2014-01-01

Background Insertion of a ventriculoperitoneal shunt (VPS) for the treatment of hydrocephalus is one of the most common neurosurgical procedures in the UK, but failures caused by infection occur in approximately 8% of primary cases. VPS infection is associated with considerable morbidity and mortality and its management results in substantial cost to the health service. Antibiotic-impregnated (rifampicin and clindamycin) and silver-impregnated VPS have been developed to reduce infection rates. Whilst there is some evidence showing that such devices may lead to a reduction in VPS infection, there are no randomised controlled trials (RCTs) to support their routine use. Methods/design Overall, 1,200 patients will be recruited from 17 regional neurosurgical units in the UK and Ireland. Patients of any age undergoing insertion of their first VPS are eligible. Patients with previous indwelling VPS, active and on-going cerebrospinal fluid (CSF) or peritoneal infection, multiloculated hydrocephalus requiring multiple VPS or neuroendoscopy, and ventriculoatrial or ventriculopleural shunt planned will be excluded. Patients will be randomised 1:1:1 to either standard silicone (comparator), antibiotic-impregnated, or silver-impregnated VPS. The primary outcome measure is time to VPS infection. Secondary outcome measures include time to VPS failure of any cause, reason for VPS failure (infection, mechanical failure, or patient failure), types of bacterial VPS infection (organism type and antibiotic resistance), and incremental cost per VPS failure averted. Discussion The British antibiotic and silver-impregnated catheters for ventriculoperitoneal shunts multi-centre randomised controlled trial (the BASICS trial) is the first multi-centre RCT designed to determine whether antibiotic or silver-impregnated VPS reduce early shunt infection compared to standard silicone VPS. The results of this study will be used to inform current neurosurgical practice and may potentially benefit

Are large clinical trials in orthopaedic trauma justified?

PubMed

Sprague, Sheila; Tornetta, Paul; Slobogean, Gerard P; O'Hara, Nathan N; McKay, Paula; Petrisor, Brad; Jeray, Kyle J; Schemitsch, Emil H; Sanders, David; Bhandari, Mohit

2018-04-20

The objective of this analysis is to evaluate the necessity of large clinical trials using FLOW trial data. The FLOW pilot study and definitive trial were factorial trials evaluating the effect of different irrigation solutions and pressures on re-operation. To explore treatment effects over time, we analyzed data from the pilot and definitive trial in increments of 250 patients until the final sample size of 2447 patients was reached. At each increment we calculated the relative risk (RR) and associated 95% confidence interval (CI) for the treatment effect, and compared the results that would have been reported at the smaller enrolments with those seen in the final, adequately powered study. The pilot study analysis of 89 patients and initial incremental enrolments in the FLOW definitive trial favored low pressure compared to high pressure (RR: 1.50, 95% CI: 0.75-3.04; RR: 1.39, 95% CI: 0.60-3.23, respectively), which is in contradiction to the final enrolment, which found no difference between high and low pressure (RR: 1.04, 95% CI: 0.81-1.33). In the soap versus saline comparison, the FLOW pilot study suggested that re-operation rate was similar in both the soap and saline groups (RR: 0.98, 95% CI: 0.50-1.92), whereas the FLOW definitive trial found that the re-operation rate was higher in the soap treatment arm (RR: 1.28, 95% CI: 1.04-1.57). Our findings suggest that studies with smaller sample sizes would have led to erroneous conclusions in the management of open fracture wounds. NCT01069315 (FLOW Pilot Study) Date of Registration: February 17, 2010, NCT00788398 (FLOW Definitive Trial) Date of Registration: November 10, 2008.

Evaluation of a multi-arm multi-stage Bayesian design for phase II drug selection trials - an example in hemato-oncology.

PubMed

Jacob, Louis; Uvarova, Maria; Boulet, Sandrine; Begaj, Inva; Chevret, Sylvie

2016-06-02

Multi-Arm Multi-Stage designs aim at comparing several new treatments to a common reference, in order to select or drop any treatment arm to move forward when such evidence already exists based on interim analyses. We redesigned a Bayesian adaptive design initially proposed for dose-finding, focusing our interest in the comparison of multiple experimental drugs to a control on a binary criterion measure. We redesigned a phase II clinical trial that randomly allocates patients across three (one control and two experimental) treatment arms to assess dropping decision rules. We were interested in dropping any arm due to futility, either based on historical control rate (first rule) or comparison across arms (second rule), and in stopping experimental arm due to its ability to reach a sufficient response rate (third rule), using the difference of response probabilities in Bayes binomial trials between the treated and control as a measure of treatment benefit. Simulations were then conducted to investigate the decision operating characteristics under a variety of plausible scenarios, as a function of the decision thresholds. Our findings suggest that one experimental treatment was less efficient than the control and could have been dropped from the trial based on a sample of approximately 20 instead of 40 patients. In the simulation study, stopping decisions were reached sooner for the first rule than for the second rule, with close mean estimates of response rates and small bias. According to the decision threshold, the mean sample size to detect the required 0.15 absolute benefit ranged from 63 to 70 (rule 3) with false negative rates of less than 2 % (rule 1) up to 6 % (rule 2). In contrast, detecting a 0.15 inferiority in response rates required a sample size ranging on average from 23 to 35 (rules 1 and 2, respectively) with a false positive rate ranging from 3.6 to 0.6 % (rule 3). Adaptive trial design is a good way to improve clinical trials. It allows

Revisiting the Robustness of PET-Based Textural Features in the Context of Multi-Centric Trials.

PubMed

Bailly, Clément; Bodet-Milin, Caroline; Couespel, Solène; Necib, Hatem; Kraeber-Bodéré, Françoise; Ansquer, Catherine; Carlier, Thomas

2016-01-01

This study aimed to investigate the variability of textural features (TF) as a function of acquisition and reconstruction parameters within the context of multi-centric trials. The robustness of 15 selected TFs were studied as a function of the number of iterations, the post-filtering level, input data noise, the reconstruction algorithm and the matrix size. A combination of several reconstruction and acquisition settings was devised to mimic multi-centric conditions. We retrospectively studied data from 26 patients enrolled in a diagnostic study that aimed to evaluate the performance of PET/CT 68Ga-DOTANOC in gastro-entero-pancreatic neuroendocrine tumors. Forty-one tumors were extracted and served as the database. The coefficient of variation (COV) or the absolute deviation (for the noise study) was derived and compared statistically with SUVmax and SUVmean results. The majority of investigated TFs can be used in a multi-centric context when each parameter is considered individually. The impact of voxel size and noise in the input data were predominant as only 4 TFs presented a high/intermediate robustness against SUV-based metrics (Entropy, Homogeneity, RP and ZP). When combining several reconstruction settings to mimic multi-centric conditions, most of the investigated TFs were robust enough against SUVmax except Correlation, Contrast, LGRE, LGZE and LZLGE. Considering previously published results on either reproducibility or sensitivity against delineation approach and our findings, it is feasible to consider Homogeneity, Entropy, Dissimilarity, HGRE, HGZE and ZP as relevant for being used in multi-centric trials.

Performance evaluation of multi-stratum resources integrated resilience for software defined inter-data center interconnect.

PubMed

Yang, Hui; Zhang, Jie; Zhao, Yongli; Ji, Yuefeng; Wu, Jialin; Lin, Yi; Han, Jianrui; Lee, Young

2015-05-18

Inter-data center interconnect with IP over elastic optical network (EON) is a promising scenario to meet the high burstiness and high-bandwidth requirements of data center services. In our previous work, we implemented multi-stratum resources integration among IP networks, optical networks and application stratums resources that allows to accommodate data center services. In view of this, this study extends to consider the service resilience in case of edge optical node failure. We propose a novel multi-stratum resources integrated resilience (MSRIR) architecture for the services in software defined inter-data center interconnect based on IP over EON. A global resources integrated resilience (GRIR) algorithm is introduced based on the proposed architecture. The MSRIR can enable cross stratum optimization and provide resilience using the multiple stratums resources, and enhance the data center service resilience responsiveness to the dynamic end-to-end service demands. The overall feasibility and efficiency of the proposed architecture is experimentally verified on the control plane of our OpenFlow-based enhanced SDN (eSDN) testbed. The performance of GRIR algorithm under heavy traffic load scenario is also quantitatively evaluated based on MSRIR architecture in terms of path blocking probability, resilience latency and resource utilization, compared with other resilience algorithms.

How Can the Evidence from Global Large-scale Clinical Trials for Cardiovascular Diseases be Improved?

PubMed

Sawata, Hiroshi; Tsutani, Kiichiro

2011-06-29

Clinical investigations are important for obtaining evidence to improve medical treatment. Large-scale clinical trials with thousands of participants are particularly important for this purpose in cardiovascular diseases. Conducting large-scale clinical trials entails high research costs. This study sought to investigate global trends in large-scale clinical trials in cardiovascular diseases. We searched for trials using clinicaltrials.gov (URL: http://www.clinicaltrials.gov/) using the key words 'cardio' and 'event' in all fields on 10 April, 2010. We then selected trials with 300 or more participants examining cardiovascular diseases. The search revealed 344 trials that met our criteria. Of 344 trials, 71% were randomized controlled trials, 15% involved more than 10,000 participants, and 59% were funded by industry. In RCTs whose results were disclosed, 55% of industry-funded trials and 25% of non-industry funded trials reported statistically significant superiority over control (p = 0.012, 2-sided Fisher's exact test). Our findings highlighted concerns regarding potential bias related to funding sources, and that researchers should be aware of the importance of trial information disclosures and conflicts of interest. We should keep considering management and training regarding information disclosures and conflicts of interest for researchers. This could lead to better clinical evidence and further improvements in the development of medical treatment worldwide.

Bayesian adaptive bandit-based designs using the Gittins index for multi-armed trials with normally distributed endpoints.

PubMed

Smith, Adam L; Villar, Sofía S

2018-01-01

Adaptive designs for multi-armed clinical trials have become increasingly popular recently because of their potential to shorten development times and to increase patient response. However, developing response-adaptive designs that offer patient-benefit while ensuring the resulting trial provides a statistically rigorous and unbiased comparison of the different treatments included is highly challenging. In this paper, the theory of Multi-Armed Bandit Problems is used to define near optimal adaptive designs in the context of a clinical trial with a normally distributed endpoint with known variance. We report the operating characteristics (type I error, power, bias) and patient-benefit of these approaches and alternative designs using simulation studies based on an ongoing trial. These results are then compared to those recently published in the context of Bernoulli endpoints. Many limitations and advantages are similar in both cases but there are also important differences, specially with respect to type I error control. This paper proposes a simulation-based testing procedure to correct for the observed type I error inflation that bandit-based and adaptive rules can induce.

A novel rapid and selective enzymatic debridement agent for burn wound management: a multi-center RCT.

PubMed

Rosenberg, Lior; Krieger, Yuval; Bogdanov-Berezovski, Alex; Silberstein, Eldad; Shoham, Yaron; Singer, Adam J

2014-05-01

Excisional debridement followed by autografting is the standard of care (SOC) for deep burns, but is associated with serious potential complications. Conservative, non-surgical and current enzymatic debridement methods are inefficiently slow. We determined whether a non-surgical option of rapid enzymatic debridement with the debriding enzyme NexoBrid™ (NXB) would reduce need for surgery while achieving similar esthetic and functional outcomes as SOC. We conducted a multi-center, open-label, randomized, controlled clinical trial including patients aged 4-55 years with deep partial and full thickness burns covering 5-30% of their total body surface area (TBSA). Patients were randomly assigned to burn debridement with NXB (applied for 4h) or SOC, which included surgical excisional or non-surgical debridement. NXB significantly reduced the time from injury to complete débridement (2.2 vs. 8.7 days, P<0.0001), need for surgery (24.5% vs. 70.0%, P<0.0001), the area of burns excised (13.1% vs. 56.7%, P<0.0001) and the need for autografting (17.9% vs. 34.1%, P=0.01). Scar quality and quality of life scores were similar in both study groups as were the rates of adverse events. Enzymatic débridement with NXB resulted in reduced need for and extent of surgery compared with SOC while achieving comparable long-term results in patients with deep burns. Clinical Trials.gov NCT00324311. Copyright © 2013 Elsevier Ltd and ISBI. All rights reserved.

Video Game Rehabilitation for Outpatient Stroke (VIGoROUS): protocol for a multi-center comparative effectiveness trial of in-home gamified constraint-induced movement therapy for rehabilitation of chronic upper extremity hemiparesis.

PubMed

Gauthier, Lynne V; Kane, Chelsea; Borstad, Alexandra; Strahl, Nancy; Uswatte, Gitendra; Taub, Edward; Morris, David; Hall, Alli; Arakelian, Melissa; Mark, Victor

2017-06-08

Constraint-Induced Movement therapy (CI therapy) is shown to reduce disability, increase use of the more affected arm/hand, and promote brain plasticity for individuals with upper extremity hemiparesis post-stroke. Randomized controlled trials consistently demonstrate that CI therapy is superior to other rehabilitation paradigms, yet it is available to only a small minority of the estimated 1.2 million chronic stroke survivors with upper extremity disability. The current study aims to establish the comparative effectiveness of a novel, patient-centered approach to rehabilitation utilizing newly developed, inexpensive, and commercially available gaming technology to disseminate CI therapy to underserved individuals. Video game delivery of CI therapy will be compared against traditional clinic-based CI therapy and standard upper extremity rehabilitation. Additionally, individual factors that differentially influence response to one treatment versus another will be examined. This protocol outlines a multi-site, randomized controlled trial with parallel group design. Two hundred twenty four adults with chronic hemiparesis post-stroke will be recruited at four sites. Participants are randomized to one of four study groups: (1) traditional clinic-based CI therapy, (2) therapist-as-consultant video game CI therapy, (3) therapist-as-consultant video game CI therapy with additional therapist contact via telerehabilitation/video consultation, and (4) standard upper extremity rehabilitation. After 6-month follow-up, individuals assigned to the standard upper extremity rehabilitation condition crossover to stand-alone video game CI therapy preceded by a therapist consultation. All interventions are delivered over a period of three weeks. Primary outcome measures include motor improvement as measured by the Wolf Motor Function Test (WMFT), quality of arm use for daily activities as measured by Motor Activity Log (MAL), and quality of life as measured by the Quality of Life in

Multi-level discriminative dictionary learning with application to large scale image classification.

PubMed

Shen, Li; Sun, Gang; Huang, Qingming; Wang, Shuhui; Lin, Zhouchen; Wu, Enhua

2015-10-01

The sparse coding technique has shown flexibility and capability in image representation and analysis. It is a powerful tool in many visual applications. Some recent work has shown that incorporating the properties of task (such as discrimination for classification task) into dictionary learning is effective for improving the accuracy. However, the traditional supervised dictionary learning methods suffer from high computation complexity when dealing with large number of categories, making them less satisfactory in large scale applications. In this paper, we propose a novel multi-level discriminative dictionary learning method and apply it to large scale image classification. Our method takes advantage of hierarchical category correlation to encode multi-level discriminative information. Each internal node of the category hierarchy is associated with a discriminative dictionary and a classification model. The dictionaries at different layers are learnt to capture the information of different scales. Moreover, each node at lower layers also inherits the dictionary of its parent, so that the categories at lower layers can be described with multi-scale information. The learning of dictionaries and associated classification models is jointly conducted by minimizing an overall tree loss. The experimental results on challenging data sets demonstrate that our approach achieves excellent accuracy and competitive computation cost compared with other sparse coding methods for large scale image classification.

Efficacy of brief behavioral counselling by allied health professionals to promote physical activity in people with peripheral arterial disease (BIPP): study protocol for a multi-center randomized controlled trial.

PubMed

Burton, Nicola W; Ademi, Zanfina; Best, Stuart; Fiatarone Singh, Maria A; Jenkins, Jason S; Lawson, Kenny D; Leicht, Anthony S; Mavros, Yorgi; Noble, Yian; Norman, Paul; Norman, Richard; Parmenter, Belinda J; Pinchbeck, Jenna; Reid, Christopher M; Rowbotham, Sophie E; Yip, Lisan; Golledge, Jonathan

2016-11-09

Physical activity is recommended for people with peripheral arterial disease (PAD), and can improve walking capacity and quality of life; and reduce pain, requirement for surgery and cardiovascular events. This trial will assess the efficacy of a brief behavioral counselling intervention delivered by allied health professionals to improve physical activity in people with PAD. This is a multi-center randomised controlled trial in four cities across Australia. Participants (N = 200) will be recruited from specialist vascular clinics, general practitioners and research databases and randomised to either the control or intervention group. Both groups will receive usual medical care, a written PAD management information sheet including advice to walk, and four individualised contacts from a protocol-trained allied health professional over 3 months (weeks 1, 2, 6, 12). The control group will receive four 15-min telephone calls with general discussion about PAD symptoms and health and wellbeing. The intervention group will receive behavioral counselling via two 1-h face-to-face sessions and two 15-min telephone calls. The counselling is based on the 5A framework and will promote interval walking for 3 × 40 min/week. Assessments will be conducted at baseline, and 4, 12 and 24 months by staff blinded to participant allocation. Objectively assessed outcomes include physical activity (primary), sedentary behavior, lower limb body function, walking capacity, cardiorespiratory fitness, event-based claudication index, vascular interventions, clinical events, cardiovascular function, circulating markers, and anthropometric measures. Self-reported outcomes include physical activity and sedentary behavior, walking ability, pain severity, and health-related quality of life. Data will be analysed using an intention-to-treat approach. An economic evaluation will assess whether embedding the intervention into routine care would likely be value for money. A cost

The LIPPSMAck POP (Lung Infection Prevention Post Surgery - Major Abdominal - with Pre-Operative Physiotherapy) trial: study protocol for a multi-centre randomised controlled trial.

PubMed

Boden, Ianthe; Browning, Laura; Skinner, Elizabeth H; Reeve, Julie; El-Ansary, Doa; Robertson, Iain K; Denehy, Linda

2015-12-15

Post-operative pulmonary complications are a significant problem following open upper abdominal surgery. Preliminary evidence suggests that a single pre-operative physiotherapy education and preparatory lung expansion training session alone may prevent respiratory complications more effectively than supervised post-operative breathing and coughing exercises. However, the evidence is inconclusive due to methodological limitations. No well-designed, adequately powered, randomised controlled trial has investigated the effect of pre-operative education and training on post-operative respiratory complications, hospital length of stay, and health-related quality of life following upper abdominal surgery. The Lung Infection Prevention Post Surgery - Major Abdominal- with Pre-Operative Physiotherapy (LIPPSMAck POP) trial is a pragmatic, investigator-initiated, bi-national, multi-centre, patient- and assessor-blinded, parallel group, randomised controlled trial, powered for superiority. Four hundred and forty-one patients scheduled for elective open upper abdominal surgery at two Australian and one New Zealand hospital will be randomised using concealed allocation to receive either i) an information booklet or ii) an information booklet, plus one additional pre-operative physiotherapy education and training session. The primary outcome is respiratory complication incidence using standardised diagnostic criteria. Secondary outcomes include hospital length of stay and costs, pneumonia diagnosis, intensive care unit readmission and length of stay, days/h to mobilise >1 min and >10 min, and, at 6 weeks post-surgery, patient reported complications, health-related quality of life, and physical capacity. The LIPPSMAck POP trial is a multi-centre randomised controlled trial powered and designed to investigate whether a single pre-operative physiotherapy session prevents post-operative respiratory complications. This trial standardises post-operative assisted ambulation and

Measuring clinical trial transparency: an empirical analysis of newly approved drugs and large pharmaceutical companies.

PubMed

Miller, Jennifer E; Wilenzick, Marc; Ritcey, Nolan; Ross, Joseph S; Mello, Michelle M

2017-12-05

To define a series of clinical trial transparency measures and apply them to large pharmaceutical and biotechnology companies and their 2014 FDA-approved drugs. Cross-sectional descriptive analysis of all clinical trials supporting 2014 Food and Drugs Administration (FDA)-approved new drug applications (NDAs) for novel drugs sponsored by large companies. Data from over 45 sources, including Drugs@FDA.gov, ClinicalTrials.gov, corporate and international registries; PubMed, Google Scholar, EMBASE, corporate press releases, Securities and Exchange Commission (SEC) filings and personal communications with drug manufacturers. Trial registration, results reporting, clinical study report (CSR) synopsis sharing, biomedical journal publication, and FDA Amendments Acts (FDAAA) compliance, analysed on the drug level. The FDA approved 19 novel new drugs, sponsored by 11 large companies, involving 553 trials, in 2014. We analysed 505 relevant trials. Per drug, a median of 100% (IQR 86%-100%) of trials in patients were registered, 71% (IQR 57%-100%) reported results or shared a CSR synopsis, 80% (70%-100%) were published and 96% (80%-100%) were publicly available in some form by 13 months after FDA approval. Disclosure rates were lower at FDA approval (65%) and improved significantly by 6 months post FDA approval. Per drug, a median of 100% (IQR 75%-100%) of FDAAA-applicable trials were compliant. Half of reviewed drugs had publicly disclosed results for all trials in patients in our sample. One trial was uniquely registered in a corporate registry, and not ClinicalTrials.gov; 0 trials were uniquely registered in international registries. Among large pharmaceutical companies and new drugs, clinical trial transparency is high based on several standards, although opportunities for improvement remain. Transparency is markedly higher for trials in patients than among all trials supporting drug approval, including trials in healthy volunteers. Ongoing efforts to publicly track

Measuring clinical trial transparency: an empirical analysis of newly approved drugs and large pharmaceutical companies

PubMed Central

Miller, Jennifer E; Wilenzick, Marc; Ritcey, Nolan; Ross, Joseph S; Mello, Michelle M

2017-01-01

Objectives To define a series of clinical trial transparency measures and apply them to large pharmaceutical and biotechnology companies and their 2014 FDA-approved drugs. Design Cross-sectional descriptive analysis of all clinical trials supporting 2014 Food and Drugs Administration (FDA)-approved new drug applications (NDAs) for novel drugs sponsored by large companies. Data sources Data from over 45 sources, including Drugs@FDA.gov, ClinicalTrials.gov, corporate and international registries; PubMed, Google Scholar, EMBASE, corporate press releases, Securities and Exchange Commission (SEC) filings and personal communications with drug manufacturers. Outcome measures Trial registration, results reporting, clinical study report (CSR) synopsis sharing, biomedical journal publication, and FDA Amendments Acts (FDAAA) compliance, analysed on the drug level. Results The FDA approved 19 novel new drugs, sponsored by 11 large companies, involving 553 trials, in 2014. We analysed 505 relevant trials. Per drug, a median of 100% (IQR 86%–100%) of trials in patients were registered, 71% (IQR 57%–100%) reported results or shared a CSR synopsis, 80% (70%–100%) were published and 96% (80%–100%) were publicly available in some form by 13 months after FDA approval. Disclosure rates were lower at FDA approval (65%) and improved significantly by 6 months post FDA approval. Per drug, a median of 100% (IQR 75%–100%) of FDAAA-applicable trials were compliant. Half of reviewed drugs had publicly disclosed results for all trials in patients in our sample. One trial was uniquely registered in a corporate registry, and not ClinicalTrials.gov; 0 trials were uniquely registered in international registries. Conclusions Among large pharmaceutical companies and new drugs, clinical trial transparency is high based on several standards, although opportunities for improvement remain. Transparency is markedly higher for trials in patients than among all trials supporting drug approval

Exposure to a multi-level multi-component childhood obesity prevention community-randomized controlled trial: patterns, determinants, and implications.

PubMed

Trude, Angela Cristina Bizzotto; Kharmats, Anna Yevgenyevna; Jones-Smith, Jessica C; Gittelsohn, Joel

2018-05-22

For community interventions to be effective in real-world conditions, participants need to have sufficient exposure to the intervention. It is unclear how the dose and intensity of the intervention differ among study participants in low-income areas. We aimed to understand patterns of exposure to different components of a multi-level multi-component obesity prevention program to inform our future impact analyses. B'more Healthy Communities for Kids (BHCK) was a community-randomized controlled trial implemented in 28 low-income zones in Baltimore in two rounds (waves). Exposure to three different intervention components (corner store/carryout restaurants, social media/text messaging, and youth-led nutrition education) was assessed via post-intervention interviews with 385 low-income urban youths and their caregivers. Exposure scores were generated based on self-reported viewing of BHCK materials (posters, handouts, educational displays, and social media posts) and participating in activities, including taste tests during the intervention. For each intervention component, points were assigned for exposure to study materials and activities, then scaled (0-1 range), yielding an overall BHCK exposure score [youths: mean 1.1 (range 0-7.6 points); caregivers: 1.1 (0-6.7), possible highest score: 13]. Ordered logit regression analyses were used to investigate correlates of youths' and caregivers' exposure level (quartile of exposure). Mean intervention exposure scores were significantly higher for intervention than comparison youths (mean 1.6 vs 0.5, p < 0.001) and caregivers (mean 1.6 vs 0.6, p < 0.001). However, exposure scores were low in both groups and 10% of the comparison group was moderately exposed to the intervention. For each 1-year increase in age, there was a 33% lower odds of being highly exposed to the intervention (odds ratio 0.77, 95% confidence interval 0.69; 0.88) in the unadjusted and adjusted model controlling for youths' sex and household

Multi-Vehicle Cooperative Control Research at the NASA Armstrong Flight Research Center, 2000-2014

NASA Technical Reports Server (NTRS)

Hanson, Curt

2014-01-01

A brief introductory overview of multi-vehicle cooperative control research conducted at the NASA Armstrong Flight Research Center from 2000 - 2014. Both flight research projects and paper studies are included. Since 2000, AFRC has been almost continuously pursuing research in the areas of formation flight for drag reduction and automated cooperative trajectories. An overview of results is given, including flight experiments done on the FA-18 and with the C-17. Other multi-vehicle cooperative research is discussed, including small UAV swarming projects and automated aerial refueling.

Multi-innovation auto-constructed least squares identification for 4 DOF ship manoeuvring modelling with full-scale trial data.

PubMed

Zhang, Guoqing; Zhang, Xianku; Pang, Hongshuai

2015-09-01

This research is concerned with the problem of 4 degrees of freedom (DOF) ship manoeuvring identification modelling with the full-scale trial data. To avoid the multi-innovation matrix inversion in the conventional multi-innovation least squares (MILS) algorithm, a new transformed multi-innovation least squares (TMILS) algorithm is first developed by virtue of the coupling identification concept. And much effort is made to guarantee the uniformly ultimate convergence. Furthermore, the auto-constructed TMILS scheme is derived for the ship manoeuvring motion identification by combination with a statistic index. Comparing with the existing results, the proposed scheme has the significant computational advantage and is able to estimate the model structure. The illustrative examples demonstrate the effectiveness of the proposed algorithm, especially including the identification application with full-scale trial data. Copyright © 2015 ISA. Published by Elsevier Ltd. All rights reserved.

Fair comparison of complexity between a multi-band CAP and DMT for data center interconnects.

PubMed

Wei, J L; Sanchez, C; Giacoumidis, E

2017-10-01

We present, to the best of our knowledge, the first known detailed analysis and fair comparison of complexity of a 56 Gb/s multi-band carrierless amplitude and phase (CAP) and discrete multi-tone (DMT) over 80 km dispersion compensation fiber-free single-mode fiber links based on intensity modulation and direct detection for data center interconnects. We show that the matched finite impulse response filters and inverse fast Fourier transform (IFFT)/FFT take the majority of the complexity of the multi-band CAP and DMT, respectively. The choice of the multi-band CAP sub-band count and the DMT IFFT/FFT size makes significant impact on the system complexity or performance, and trade-off must be considered.

Revisiting the Robustness of PET-Based Textural Features in the Context of Multi-Centric Trials

PubMed Central

Bailly, Clément; Bodet-Milin, Caroline; Couespel, Solène; Necib, Hatem; Kraeber-Bodéré, Françoise; Ansquer, Catherine; Carlier, Thomas

2016-01-01

Purpose This study aimed to investigate the variability of textural features (TF) as a function of acquisition and reconstruction parameters within the context of multi-centric trials. Methods The robustness of 15 selected TFs were studied as a function of the number of iterations, the post-filtering level, input data noise, the reconstruction algorithm and the matrix size. A combination of several reconstruction and acquisition settings was devised to mimic multi-centric conditions. We retrospectively studied data from 26 patients enrolled in a diagnostic study that aimed to evaluate the performance of PET/CT 68Ga-DOTANOC in gastro-entero-pancreatic neuroendocrine tumors. Forty-one tumors were extracted and served as the database. The coefficient of variation (COV) or the absolute deviation (for the noise study) was derived and compared statistically with SUVmax and SUVmean results. Results The majority of investigated TFs can be used in a multi-centric context when each parameter is considered individually. The impact of voxel size and noise in the input data were predominant as only 4 TFs presented a high/intermediate robustness against SUV-based metrics (Entropy, Homogeneity, RP and ZP). When combining several reconstruction settings to mimic multi-centric conditions, most of the investigated TFs were robust enough against SUVmax except Correlation, Contrast, LGRE, LGZE and LZLGE. Conclusion Considering previously published results on either reproducibility or sensitivity against delineation approach and our findings, it is feasible to consider Homogeneity, Entropy, Dissimilarity, HGRE, HGZE and ZP as relevant for being used in multi-centric trials. PMID:27467882

Predictors of Colorectal Cancer Screening Prior to Implementation of a Large Pragmatic Trial in Federally Qualified Health Centers.

PubMed

Petrik, Amanda F; Le, Thuy; Keast, Erin; Rivelli, Jennifer; Bigler, Keshia; Green, Beverly; Vollmer, William M; Coronado, Gloria

2018-02-01

Colorectal cancer screening can prevent cancer deaths. Federally qualified health centers serve a unique patient population that often is not screened. Knowing who in this environment is getting screened via fecal testing and via colonoscopy can assist in tailoring intervention to raise rates of colorectal cancer screening. We examined patient-level and neighborhood-level characteristics associated with being up to date with colorectal cancer screening guidelines. We also examined associations between these factors and being screened with a fecal test. We observed an increase in colorectal cancer screening rates from 2010 to 2015. Adjusted analyses revealed that the following factors were significantly associated with colorectal cancer screening: aged 65 or older, having any type of insurance, previous outpatient visits, and current or other preventive screenings. Among adults aged 50-75 who were up to date with colorectal cancer screening, factors associated with use of fecal testing, as opposed to colonoscopy, were: being younger, speaking a non-English language, being uninsured, having prior office visits, and having had a flu shot in past year. Our findings may inform clinic-based effort to raise rates of colorectal cancer screening, especially in the community clinic setting. ClinicalTrials.gov , NCT01742065.

Mobile access to virtual randomization for investigator-initiated trials.

PubMed

Deserno, Thomas M; Keszei, András P

2017-08-01

becomes available for investigator-initiated trials and potentially for large multi-center trials.

Development and implementation of an integrated, multi-modality, user-centered interactive dietary change program

PubMed Central

Glasgow, Russell E.; Christiansen, Steve; Smith, K. Sabina; Stevens, Victor J.; Toobert, Deborah J.

2009-01-01

Computer-tailored behavior change programs offer the potential for reaching large populations at a much lower cost than individual or group-based programs. However, few of these programs to date appear to integrate behavioral theory with user choice, or combine different electronic modalities. We describe the development of an integrated CD-ROM and interactive voice response dietary change intervention that combines behavioral problem-solving theory with a high degree of user choice. The program, WISE CHOICES, is being evaluated as part of an ongoing trial. This paper describes the program development, emphasizing how user preferences are accommodated, and presents implementation and user satisfaction data. The program was successfully implemented; the linkages among the central database, the CD-ROM and the automated telephone components were robust, and participants liked the program almost as well as a counselor-delivered dietary change condition. Multi-modality programs that emphasize the strengths of each approach appear to be feasible. Future research is needed to determine the program impact and cost-effectiveness compared with counselor-delivered intervention. PMID:18711204

A Qualitative Study of Motivations for Minority Recruitment in Cancer Clinical Trials Across Five NCI-Designated Cancer Centers.

PubMed

Simoni, Zachary R; Martin, Michelle; Wenzel, Jennifer A; Cook, Elise D; Konety, Badrinath; Vickers, Selwyn M; Chen, Moon S; Foaud, Mona N; Durant, Raegan W

2016-11-08

Minority enrollment in cancer clinical trials is traditionally low. In light of this fact, numerous studies have investigated barriers to recruitment and retention within minority populations. However, very little research has investigated the importance of clinicians' and researchers' motivations for minority recruitment in cancer clinical trials. Therefore, we sought to examine motivations for minority recruitment across four professional stakeholder groups (principal investigators, clinicians, research staff, and Cancer Center leaders) at five National Cancer Institute (NCI)-designated Comprehensive Cancer Centers. This study is based on the data from 91 qualitative interviews conducted across the five NCI-designated Comprehensive Cancer Centers to investigate stakeholders' motivations for minority recruitment in cancer clinical trials. Emergent themes include (a) minority recruitment increases generalizability of cancer clinical trials, (b) minority recruitment is motivated by social justice, (c) some institutions promote minority recruitment through the use of supplemental financial support, (d) federal funding requirements for minority inclusion in clinical research motivate investigators to focus on minority recruitment, and (e) some stakeholders favor a more race-neutral approach to participant recruitment rather than an emphasis on targeted minority recruitment. The perspectives of clinical and research stakeholders potentially inform the assessment of existing strategies and the development of new strategies to increase motivation for minority recruitment in cancer clinical trials.

The child and adolescent psychiatry trials network (CAPTN): infrastructure development and lessons learned

PubMed Central

Shapiro, Mark; Silva, Susan G; Compton, Scott; Chrisman, Allan; DeVeaugh-Geiss, Joseph; Breland-Noble, Alfiee; Kondo, Douglas; Kirchner, Jerry; March, John S

2009-01-01

Background In 2003, the National Institute of Mental Health funded the Child and Adolescent Psychiatry Trials Network (CAPTN) under the Advanced Center for Services and Intervention Research (ACSIR) mechanism. At the time, CAPTN was believed to be both a highly innovative undertaking and a highly speculative one. One reviewer even suggested that CAPTN was "unlikely to succeed, but would be a valuable learning experience for the field." Objective To describe valuable lessons learned in building a clinical research network in pediatric psychiatry, including innovations intended to decrease barriers to research participation. Methods The CAPTN Team has completed construction of the CAPTN network infrastructure, conducted a large, multi-center psychometric study of a novel adverse event reporting tool, and initiated a large antidepressant safety registry and linked pharmacogenomic study focused on severe adverse events. Specific challenges overcome included establishing structures for network organization and governance; recruiting over 150 active CAPTN participants and 15 child psychiatry training programs; developing and implementing procedures for site contracts, regulatory compliance, indemnification and malpractice coverage, human subjects protection training and IRB approval; and constructing an innovative electronic casa report form (eCRF) running on a web-based electronic data capture system; and, finally, establishing procedures for audit trail oversight requirements put forward by, among others, the Food and Drug Administration (FDA). Conclusion Given stable funding for network construction and maintenance, our experience demonstrates that judicious use of web-based technologies for profiling investigators, investigator training, and capturing clinical trials data, when coupled to innovative approaches to network governance, data management and site management, can reduce the costs and burden and improve the feasibility of incorporating clinical research into

Multi-hadron spectroscopy in a large physical volume

NASA Astrophysics Data System (ADS)

Bulava, John; Hörz, Ben; Morningstar, Colin

2018-03-01

We demonstrate the effcacy of the stochastic LapH method to treat all-toall quark propagation on a Nf = 2 + 1 CLS ensemble with large linear spatial extent L = 5:5 fm, allowing us to obtain the benchmark elastic isovector p-wave pion-pion scattering amplitude to good precision already on a relatively small number of gauge configurations. These results hold promise for multi-hadron spectroscopy at close-to-physical pion mass with exponential finite-volume effects under control.

The effect of class size in grades K-3 on adult earnings, employment, and disability status: evidence from a multi-center randomized controlled trial.

PubMed

Wilde, Elizabeth Ty; Finn, Jeremy; Johnson, Gretchen; Muennig, Peter

2011-11-01

Early education interventions have been forwarded as a means for reducing social disparities in income and health in adulthood. We explore whether a successful early education intervention, which occurred between 1985 and 1989, improved the employment rates, earnings and health of blacks relative to whites through 2008. We used data from Project STAR (Student Teacher Achievement Ratio), a four-year multi-center randomized controlled trial of reduced class sizes in Tennessee involving 11,601 students. Students were initially randomized within 79 schools to classes with 22-25 or 13-17 students. We linked subject records to Social Security Administration (SSA) earnings and disability data collected between 1997 and 2008-when the majority of subjects were between the ages of 18 and 28. We focused our analysis on annual, rather than cumulative, measures of earnings and employment because educational attainment after high school might reduce earnings through age 23. We considered three or more years of statistically significant positive (or negative) annual impacts to be a meaningful effect. Project STAR improved cognition and high school graduation rates. These benefits were primarily realized among low-income and minority students. These early education benefits did not translate into reduced disability claims in adulthood for treated subjects. However, exposure to small class size increased employment for blacks, and increased earnings for black males (p<0.05). Exposure to small classes also led to an increase in earnings for white males. However, white females exposed to small classes experienced a net decline in earnings and employment across the later years of follow up (p<0.05), offsetting any gains by white males. Exposure to small class size in grades K-3 appears to improve earnings and employment for black males and earnings for white males, while reducing employment and earnings among white females.

Need, utilization, and configuration of a large, multi-G centrifuge on the Space Station

NASA Technical Reports Server (NTRS)

Bonting, Sjoerd L.

1987-01-01

A large, multi-g centrifuge is required on the Space Station (1) to provide valid 1-g controls for the study of zero-g effects on animals and plants and to study readaptation to 1 g; (2) to store animals at 1 g prior to short-term zero-g experimentation; (3) to permit g-level threshold studies of gravity effects. These requirements can be met by a 13-ft-diam., center-mounted centrifuge, on which up to 48 modular habitats with animals (squirrel monkey, rat, mouse) and plants are attached. The advantages of locating this centrifuge with the vivarium, a common environmental control and life support system, a general-purpose work station and storage of food, water, and supplies in an attached short module, are elaborated. Servicing and operation of the centrifuge, as well as minimizing its impact on other Space Station functions are also considered.

US Navy Submarine Sea Trial of NASA developed Multi-Gas Monitor

NASA Technical Reports Server (NTRS)

Mudgett, Paul D.; Manney, Joshua A.; Smith, Matthew J.; O'Connor, Sara Jane; Pilgrim, Jeffrey S.

2017-01-01

During a successful 2 year technology demonstration of the tunable diode laser spectroscopy (TDLS) based Multi-Gas Monitor (MGM) on the International Space Station (ISS), we began discussing with the US Navy the possibility of conducting a sea trial of an MGM on a submarine. The sea trial would also include a gas chromatography/differential mobility spectrometer based Air Quality Monitor (AQM), which is used operationally on ISS for volatile organic compound analysis. AQM preparation and results will be the subject of a separate paper. The Navy's interest in testing NASA equipment in general relates to their ongoing search for better air monitoring technology. NASA's goal is studying submarines as closed environment analogs to spacecraft. MGM's core technology was developed by Vista Photonics Inc. using Small Business Innovation Research (SBIR) grants and expanded for various applications using NASA program funding. The MGM measures oxygen, carbon dioxide, ammonia and water vapor in ambient air, displays concentrations with temperature and pressure, and stores 30 second moving averages. The sea trial involves collocating the instrument with the Central Atmosphere Monitoring System (CAMS Mk II) of the submarine, connecting it to rack power prior to departure, and letting it run during the entire 90 day patrol. All data is stored within MGM, with no connection to the vessel data bus. Crew intervention is limited to checking MGM periodically to see that it is working and power cycling if necessary. After the trial is over, the unit with its data will be retrieved. Post sea trial calibration check and data analysis are planned and results will be compared with both CAMS Mk II data and results from MGM's ISS technology demonstration. Since the sea trial itself has been delayed, this paper describes the preparation of MGM for the sea trial and also provides a summary of the latest data from the ISS MGM technology demonstration.

Development of a cancer clinical trials multi-media intervention: clinical trials: are they right for you?

PubMed

Wells, Kristen J; Quinn, Gwendolyn P; Meade, Cathy D; Fletcher, Michelle; Tyson, Dinorah Martinez; Jim, Heather; Jacobsen, Paul B

2012-08-01

To describe processes used to develop a multi-media psycho-educational intervention to prepare patients for a discussion about cancer clinical trials (CTs). Guided by a Steering Committee, formative research was conducted to develop an informative and engaging tool about cancer CTs. Twenty-three patients and caregivers participated in formative in-depth interviews to elicit information about perceptions of cancer CTs to inform production of a new media product. Formative research revealed participants had concerns about experimentation, held beliefs that cancer CTs were for patients who had no other treatment options, and wanted a balance of information about pros and cons of CT participation. The value of physicians as credible spokespersons and the use of patients as role-models were supported. Using iterative processes, the production team infused the results into creation of a multimedia psycho-educational intervention titled Clinical Trials: Are they Right for You? An intervention, developed through an iterative consumer-focused process involving multiple stakeholders and formative research, may result in an engaging informative product. If found to be efficacious, Clinical Trials: Are they Right for You? is a low-cost and easily disseminated multimedia psycho-educational intervention to assist cancer patients with making an informed decision about cancer CTs. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Study protocol of the Diabetes and Depression Study (DAD): a multi-center randomized controlled trial to compare the efficacy of a diabetes-specific cognitive behavioral group therapy versus sertraline in patients with major depression and poorly controlled diabetes mellitus

PubMed Central

2013-01-01

Background Depression is common in diabetes and associated with hyperglycemia, diabetes related complications and mortality. No single intervention has been identified that consistently leads to simultaneous improvement of depression and glycemic control. Our aim is to analyze the efficacy of a diabetes-specific cognitive behavioral group therapy (CBT) compared to sertraline (SER) in adults with depression and poorly controlled diabetes. Methods/Design This study is a multi-center parallel arm randomized controlled trial currently in its data analysis phase. We included 251 patients in 70 secondary care centers across Germany. Key inclusion criteria were: type 1 or 2 diabetes, major depression (diagnosed with the Structured Clinical Interview for DSM-IV, SCID) and hemoglobin A1C >7.5% despite current insulin therapy. During the initial phase, patients received either 50–200 mg/d sertraline or 10 CBT sessions aiming at the remission of depression and enhanced adherence to diabetes treatment and coping with diabetes. Both groups received diabetes treatment as usual. After 12 weeks of this initial open-label therapy, only the treatment-responders (50% depression symptoms reduction, Hamilton Depression Rating Scale, 17-item version [HAMD]) were included in the subsequent one year study phase and represented the primary analysis population. CBT-responders received no further treatment, while SER-responders obtained a continuous, flexible-dose SER regimen as relapse prevention. Adherence to treatment was analyzed using therapeutic drug monitoring (measurement of sertraline and N-desmethylsertraline concentrations in blood serum) and by counting the numbers of CBT sessions received. Outcome assessments were conducted by trained psychologists blinded to group assignment. Group differences in HbA1c (primary outcome) and depression (HAMD, secondary outcome) between 1-year follow-up and baseline will be analyzed by ANCOVA controlling for baseline values. As primary

A pragmatic multi-centre randomised controlled trial of fluid loading and level of dependency in high-risk surgical patients undergoing major elective surgery: trial protocol

PubMed Central

2010-01-01

Background Patients undergoing major elective or urgent surgery are at high risk of death or significant morbidity. Measures to reduce this morbidity and mortality include pre-operative optimisation and use of higher levels of dependency care after surgery. We propose a pragmatic multi-centre randomised controlled trial of level of dependency and pre-operative fluid therapy in high-risk surgical patients undergoing major elective surgery. Methods/Design A multi-centre randomised controlled trial with a 2 * 2 factorial design. The first randomisation is to pre-operative fluid therapy or standard regimen and the second randomisation is to routine intensive care versus high dependency care during the early post-operative period. We intend to recruit 204 patients undergoing major elective and urgent abdominal and thoraco-abdominal surgery who fulfil high-risk surgical criteria. The primary outcome for the comparison of level of care is cost-effectiveness at six months and for the comparison of fluid optimisation is the number of hospital days after surgery. Discussion We believe that the results of this study will be invaluable in determining the future care and clinical resource utilisation for this group of patients and thus will have a major impact on clinical practice. Trial Registration Trial registration number - ISRCTN32188676 PMID:20398378

Retention Strategies for Health Disparities Preventive Trials: Findings from the Early Childhood Caries Collaborating Centers

PubMed Central

Garcia, Raul I.; Tiwari, Tamanna; Ramos-Gomez, Francisco; Heaton, Brenda; Orozco, Mario; Rasmussen, Margaret; Braun, Patricia; Henshaw, Michelle; Borrelli, Belinda; Albino, Judith; Vargas, Clemencia; Diamond, Courtney; Gebel, Christina; Batliner, Terrence S.; Barker, Judith; Gregorich, Steven; Gansky, Stuart A.

2017-01-01

Objectives To identify successful strategies for retention of participants in multi-year, community-based randomized controlled trials (RCTs) aiming to reduce early childhood caries in health disparities populations from diverse racial/ethnic backgrounds and across diverse geographic settings. Methods Four RCTs conducted by the Early Childhood Caries Collaborating Centers (EC4), an initiative of the National Institute of Dental and Craniofacial Research, systematically collected information on the success of various strategies implemented to promote participant retention in each RCT. The observational findings from this case series of four RCTs were tabulated and the strategies rated by study staff. Results Participant retention at 12 months of follow-up ranged from 52.8% to 91.7%, and at 24 months ranged from 53.6% to 85.9, across the four RCT. For the three RCT that had a 36 month follow-up, retention ranged from 53.6% to 85.1%. Effectiveness of different participant retention strategies varied widely across the RCT. Conclusions Findings from this case series study may help to guide the design of future RCTs to maximize retention of study participants and yield needed data on effective interventions to reduce oral health disparities. PMID:27759164

US Navy Submarine Sea Trial of NASA developed Multi-Gas Monitor

NASA Technical Reports Server (NTRS)

Mudgett, Paul D.; Manney, Joshua A.; Pilgrim, Jeffrey S.

2017-01-01

During a successful 2 year technology demonstration of the tunable diode laser spectroscopy (TDLS) based Multi-Gas Monitor (MGM) on the International Space Station (ISS), we began discussing with the US Navy the possibility of conducting a sea trial of an MGM on a submarine. The sea trial would also include a gas chromatography/differential mobility spectrometer based Air Quality Monitor (AQM), which is used operationally on ISS for select volatile organic compounds. AQM results will be the subject of a separate paper. The Navy’s interest in testing NASA equipment is in a planned update to the environmental monitoring equipment used aboard submarines. NASA’s goal is studying submarines as closed environment analogs to spacecraft. MGM’s core technology was developed by Vista Photonics Inc using Small Business Innovation Research (SBIR) grants and expanded for various applications using NASA program funding. The MGM measures oxygen, carbon dioxide, ammonia and water vapor in ambient air, displays concentrations with temperature and pressure, and stores 30 second moving averages. The sea trial involves colocating the instrument with the Central Air Monitor (CAM) and connecting it to rack power prior to departure, and letting it run during the entire sea trial of a few months duration. All data stored is inside MGM, with no connection to the vessel data bus. Crew intervention is limited to checking MGM periodically to see that it is working and power cycling if the display is OFF. After the trial is over, the unit with its data will be retrieved. Post sea trial calibration check and data analysis are planned and results will be compared with both CAM data and results from MGM’s ISS technology demonstration.

Preconception maternal nutrition: a multi-site randomized controlled trial

PubMed Central

2014-01-01

Background Research directed to optimizing maternal nutrition commencing prior to conception remains very limited, despite suggestive evidence of its importance in addition to ensuring an optimal nutrition environment in the periconceptional period and throughout the first trimester of pregnancy. Methods/Study design This is an individually randomized controlled trial of the impact on birth length (primary outcome) of the time at which a maternal nutrition intervention is commenced: Arm 1: ≥ 3 mo preconception vs. Arm 2: 12-14 wk gestation vs. Arm 3: none. 192 (derived from 480) randomized mothers and living offspring in each arm in each of four research sites (Guatemala, India, Pakistan, Democratic Republic of the Congo). The intervention is a daily 20 g lipid-based (118 kcal) multi-micronutient (MMN) supplement. Women randomized to receive this intervention with body mass index (BMI) <20 or whose gestational weight gain is low will receive an additional 300 kcal/d as a balanced energy-protein supplement. Researchers will visit homes biweekly to deliver intervention and monitor compliance, pregnancy status and morbidity; ensure prenatal and delivery care; and promote breast feeding. The primary outcome is birth length. Secondary outcomes include: fetal length at 12 and 34 wk; incidence of low birth weight (LBW); neonatal/infant anthropometry 0-6 mo of age; infectious disease morbidity; maternal, fetal, newborn, and infant epigenetics; maternal and infant nutritional status; maternal and infant microbiome; gut inflammatory biomarkers and bioactive and nutritive compounds in breast milk. The primary analysis will compare birth Length-for-Age Z-score (LAZ) among trial arms (independently for each site, estimated effect size: 0.35). Additional statistical analyses will examine the secondary outcomes and a pooled analysis of data from all sites. Discussion Positive results of this trial will support a paradigm shift in attention to nutrition of all females of

A guide to multi-centre ethics for surgical research in Australia and New Zealand.

PubMed

Boult, Maggi; Fitzpatrick, Kate; Maddern, Guy; Fitridge, Robert

2011-03-01

This paper describes existing inconsistencies as well as the disparate processes and logistics required when obtaining ethics approval in Australia and New Zealand in order to initiate a multi-centre bi-national surgical trial. The endovascular aortic aneurysm repair trial is a large multi-centre trial that aims to obtain pre- and post-operative data from patients in hospitals across Australia and New Zealand. As the trial was research based, ethics applications were submitted to all hospitals where surgeons wished to be involved in the trial. Few ethics committees have embraced attempts to simplify the application process for multi-centre trials. There was limited mutual review between Human Research Ethics Committees necessitating the submission of multiple applications. Though the use of the National Ethics Application Form in ethical review is increasing, some Human Research Ethics Committees do not accept it in its entirety; many require site-specific applications or sections of the Common Application Form modules. Queensland, New South Wales and New Zealand were the easiest systems to prepare, submit and lodge ethics applications because of their understanding and accommodation of reviewing multi-centred trials. The time, expense and complexity of obtaining ethics approval for multi-centre research projects are impediments to their establishment and reduce the time available for research. Australia is working to implement a system named the Harmonisation of Multi-centre Ethical Review to ease the process of obtaining multi-centre ethics clearance. Our experience suggests there will be some teething problems with implementation and acceptance. © 2010 The Authors. ANZ Journal of Surgery © 2010 Royal Australasian College of Surgeons.

Anthropic prediction for a large multi-jump landscape

DOE Office of Scientific and Technical Information (OSTI.GOV)

Schwartz-Perlov, Delia, E-mail: delia@perlov.com

2008-10-15

The assumption of a flat prior distribution plays a critical role in the anthropic prediction of the cosmological constant. In a previous paper we analytically calculated the distribution for the cosmological constant, including the prior and anthropic selection effects, in a large toy 'single-jump' landscape model. We showed that it is possible for the fractal prior distribution that we found to behave as an effectively flat distribution in a wide class of landscapes, but only if the single-jump size is large enough. We extend this work here by investigating a large (N{approx}10{sup 500}) toy 'multi-jump' landscape model. The jump sizesmore » range over three orders of magnitude and an overall free parameter c determines the absolute size of the jumps. We will show that for 'large' c the distribution of probabilities of vacua in the anthropic range is effectively flat, and thus the successful anthropic prediction is validated. However, we argue that for small c, the distribution may not be smooth.« less

ImTK: an open source multi-center information management toolkit

NASA Astrophysics Data System (ADS)

Alaoui, Adil; Ingeholm, Mary Lou; Padh, Shilpa; Dorobantu, Mihai; Desai, Mihir; Cleary, Kevin; Mun, Seong K.

2008-03-01

The Information Management Toolkit (ImTK) Consortium is an open source initiative to develop robust, freely available tools related to the information management needs of basic, clinical, and translational research. An open source framework and agile programming methodology can enable distributed software development while an open architecture will encourage interoperability across different environments. The ISIS Center has conceptualized a prototype data sharing network that simulates a multi-center environment based on a federated data access model. This model includes the development of software tools to enable efficient exchange, sharing, management, and analysis of multimedia medical information such as clinical information, images, and bioinformatics data from multiple data sources. The envisioned ImTK data environment will include an open architecture and data model implementation that complies with existing standards such as Digital Imaging and Communications (DICOM), Health Level 7 (HL7), and the technical framework and workflow defined by the Integrating the Healthcare Enterprise (IHE) Information Technology Infrastructure initiative, mainly the Cross Enterprise Document Sharing (XDS) specifications.

Study protocol of the Diabetes and Depression Study (DAD): a multi-center randomized controlled trial to compare the efficacy of a diabetes-specific cognitive behavioral group therapy versus sertraline in patients with major depression and poorly controlled diabetes mellitus.

PubMed

Petrak, Frank; Herpertz, Stephan; Albus, Christian; Hermanns, Norbert; Hiemke, Christoph; Hiller, Wolfgang; Kronfeld, Kai; Kruse, Johannes; Kulzer, Bernd; Ruckes, Christian; Müller, Matthias J

2013-08-06

Depression is common in diabetes and associated with hyperglycemia, diabetes related complications and mortality. No single intervention has been identified that consistently leads to simultaneous improvement of depression and glycemic control. Our aim is to analyze the efficacy of a diabetes-specific cognitive behavioral group therapy (CBT) compared to sertraline (SER) in adults with depression and poorly controlled diabetes. This study is a multi-center parallel arm randomized controlled trial currently in its data analysis phase. We included 251 patients in 70 secondary care centers across Germany. Key inclusion criteria were: type 1 or 2 diabetes, major depression (diagnosed with the Structured Clinical Interview for DSM-IV, SCID) and hemoglobin A1C >7.5% despite current insulin therapy. During the initial phase, patients received either 50-200 mg/d sertraline or 10 CBT sessions aiming at the remission of depression and enhanced adherence to diabetes treatment and coping with diabetes. Both groups received diabetes treatment as usual. After 12 weeks of this initial open-label therapy, only the treatment-responders (50% depression symptoms reduction, Hamilton Depression Rating Scale, 17-item version [HAMD]) were included in the subsequent one year study phase and represented the primary analysis population. CBT-responders received no further treatment, while SER-responders obtained a continuous, flexible-dose SER regimen as relapse prevention. Adherence to treatment was analyzed using therapeutic drug monitoring (measurement of sertraline and N-desmethylsertraline concentrations in blood serum) and by counting the numbers of CBT sessions received. Outcome assessments were conducted by trained psychologists blinded to group assignment. Group differences in HbA1c (primary outcome) and depression (HAMD, secondary outcome) between 1-year follow-up and baseline will be analyzed by ANCOVA controlling for baseline values. As primary hypothesis we expect that CBT

The Evolution of a Multi-Instructional Teaching Center (MITC) in a Metropolitan University System.

ERIC Educational Resources Information Center

Bell, David P.; Hayes, Edward J.; Hugetz, Edward T.; Ivancevich, John M.; Smith, Don N.; Woods, Molly R.

1998-01-01

The University of Houston (Texas) and its four campuses have adopted a "co-opetition" approach to create a multi-instructional teaching center to deliver educational programs and courses in the Houston metropolitan area. It has been found that citizens, legislators, administrators, faculty, and students all benefit, without sacrificing…

Lessons learned in the conduct of a global, large simple trial of treatments indicated for schizophrenia.

PubMed

Kolitsopoulos, Francesca M; Strom, Brian L; Faich, Gerald; Eng, Sybil M; Kane, John M; Reynolds, Robert F

2013-03-01

Large, "practical" or streamlined trials (LSTs) are used to study the effectiveness and/or safety of medicines in real world settings with minimal study imposed interventions. While LSTs have benefits over traditional randomized clinical trials and observational studies, there are inherent challenges to their conduct. Enrollment and follow-up of a large study sample of patients with mental illness pose a particular difficulty. To assist in overcoming operational barriers in future LSTs in psychiatry, this paper describes the recruitment and observational follow-up strategies used for the ZODIAC study, an international, open-label LST, which followed 18,239 persons randomly assigned to one of two treatments indicated for schizophrenia for 1 year. ZODIAC enrolled patients in 18 countries in North America, South America, Europe, and Asia using broad study entry criteria and required minimal clinical care intervention. Recruitment of adequate numbers and continued engagement of both study centers and subjects were significant challenges. Strategies implemented to mitigate these in ZODIAC include global study expansion, study branding, field coordinator and site relations programs, monthly site newsletters, collection of alternate contact information, conduct of national death index (NDI) searches, and frequent sponsor, contract research organization (CRO) and site interaction to share best practices and address recruitment challenges quickly. We conclude that conduct of large LSTs in psychiatric patient populations is feasible, but importantly, realistic site recruitment goals and maintaining site engagement are key factors that need to be considered in early study planning and conduct. Copyright © 2012 Elsevier Inc. All rights reserved.

HD-MTL: Hierarchical Deep Multi-Task Learning for Large-Scale Visual Recognition.

PubMed

Fan, Jianping; Zhao, Tianyi; Kuang, Zhenzhong; Zheng, Yu; Zhang, Ji; Yu, Jun; Peng, Jinye

2017-02-09

In this paper, a hierarchical deep multi-task learning (HD-MTL) algorithm is developed to support large-scale visual recognition (e.g., recognizing thousands or even tens of thousands of atomic object classes automatically). First, multiple sets of multi-level deep features are extracted from different layers of deep convolutional neural networks (deep CNNs), and they are used to achieve more effective accomplishment of the coarseto- fine tasks for hierarchical visual recognition. A visual tree is then learned by assigning the visually-similar atomic object classes with similar learning complexities into the same group, which can provide a good environment for determining the interrelated learning tasks automatically. By leveraging the inter-task relatedness (inter-class similarities) to learn more discriminative group-specific deep representations, our deep multi-task learning algorithm can train more discriminative node classifiers for distinguishing the visually-similar atomic object classes effectively. Our hierarchical deep multi-task learning (HD-MTL) algorithm can integrate two discriminative regularization terms to control the inter-level error propagation effectively, and it can provide an end-to-end approach for jointly learning more representative deep CNNs (for image representation) and more discriminative tree classifier (for large-scale visual recognition) and updating them simultaneously. Our incremental deep learning algorithms can effectively adapt both the deep CNNs and the tree classifier to the new training images and the new object classes. Our experimental results have demonstrated that our HD-MTL algorithm can achieve very competitive results on improving the accuracy rates for large-scale visual recognition.

Cosmetic outcomes of laparoendoscopic single-site hysterectomy compared with multi-port surgery: randomized controlled trial.

PubMed

Song, Taejong; Cho, Juhee; Kim, Tae-Joong; Kim, Im-Ryung; Hahm, Tae Soo; Kim, Byoung-Gie; Bae, Duk-Soo

2013-01-01

To compare cosmetic satisfaction with laparoendoscopic single-site surgery (LESS) compared with multi-port surgery. Randomized controlled trial (Canadian Task Force classification I). University hospital. Twenty women who underwent laparoscopically-assisted vaginal hysterectomy (LAVH) via LESS or multi-port surgery. Laparoendoscopic single-site surgery or multi-port surgery. Cosmetic satisfaction was assessed using the Body Image Questionnaire at baseline and at 1, 4, and 24 weeks after surgery. Of the 20 LESS procedures, 1 was converted to multi-port surgery because of severe adhesions, and 1 woman assigned to undergo multi-port surgery was lost to follow-up. The 2 surgery groups did not differ in clinical demographic data and surgical results or postoperative pain scores at 12, 24, and 36 hours. Compared with the multi-port group, the LESS group reported significantly higher cosmetic satisfaction at 1, 4, and 24 weeks after surgery (p < .01). Compared with multi-port surgery, LESS is not only a feasible approach with comparable operative outcomes but also has an advantage insofar as cosmetic outcome. Copyright © 2013 AAGL. Published by Elsevier Inc. All rights reserved.

Virtualized Multi-Mission Operations Center (vMMOC) and its Cloud Services

NASA Technical Reports Server (NTRS)

Ido, Haisam Kassim

2017-01-01

His presentation will cover, the current and future, technical and organizational opportunities and challenges with virtualizing a multi-mission operations center. The full deployment of Goddard Space Flight Centers (GSFC) Virtualized Multi-Mission Operations Center (vMMOC) is nearly complete. The Space Science Mission Operations (SSMO) organizations spacecraft ACE, Fermi, LRO, MMS(4), OSIRIS-REx, SDO, SOHO, Swift, and Wind are in the process of being fully migrated to the vMMOC. The benefits of the vMMOC will be the normalization and the standardization of IT services, mission operations, maintenance, and development as well as ancillary services and policies such as collaboration tools, change management systems, and IT Security. The vMMOC will also provide operational efficiencies regarding hardware, IT domain expertise, training, maintenance and support.The presentation will also cover SSMO's secure Situational Awareness Dashboard in an integrated, fleet centric, cloud based web services fashion. Additionally the SSMO Telemetry as a Service (TaaS) will be covered, which allows authorized users and processes to access telemetry for the entire SSMO fleet, and for the entirety of each spacecrafts history. Both services leverage cloud services in a secure FISMA High and FedRamp environment, and also leverage distributed object stores in order to house and provide the telemetry. The services are also in the process of leveraging the cloud computing services elasticity and horizontal scalability. In the design phase is the Navigation as a Service (NaaS) which will provide a standardized, efficient, and normalized service for the fleet's space flight dynamics operations. Additional future services that may be considered are Ground Segment as a Service (GSaaS), Telemetry and Command as a Service (TCaaS), Flight Software Simulation as a Service, etc.

Data Management and Site-Visit Monitoring of the Multi-Center Registry in the Korean Neonatal Network.

PubMed

Choi, Chang Won; Park, Moon Sung

2015-10-01

The Korean Neonatal Network (KNN), a nationwide prospective registry of very-low-birth-weight (VLBW, < 1,500 g at birth) infants, was launched in April 2013. Data management (DM) and site-visit monitoring (SVM) were crucial in ensuring the quality of the data collected from 55 participating hospitals across the country on 116 clinical variables. We describe the processes and results of DM and SVM performed during the establishment stage of the registry. The DM procedure included automated proof checks, electronic data validation, query creation, query resolution, and revalidation of the corrected data. SVM included SVM team organization, identification of unregistered cases, source document verification, and post-visit report production. By March 31, 2015, 4,063 VLBW infants were registered and 1,693 queries were produced. Of these, 1,629 queries were resolved and 64 queries remain unresolved. By November 28, 2014, 52 participating hospitals were visited, with 136 site-visits completed since April 2013. Each participating hospital was visited biannually. DM and SVM were performed to ensure the quality of the data collected for the KNN registry. Our experience with DM and SVM can be applied for similar multi-center registries with large numbers of participating centers.

Anti-HMGCR antibodies as a biomarker for immune-mediated necrotizing myopathies: A history of statins and experience from a large international multi-center study.

PubMed

Musset, Lucile; Allenbach, Yves; Benveniste, Olivier; Boyer, Olivier; Bossuyt, Xavier; Bentow, Chelsea; Phillips, Joe; Mammen, Andrew; Van Damme, Philip; Westhovens, René; Ghirardello, Anna; Doria, Andrea; Choi, May Y; Fritzler, Marvin J; Schmeling, Heinrike; Muro, Yoshinao; García-De La Torre, Ignacio; Ortiz-Villalvazo, Miguel A; Bizzaro, Nicola; Infantino, Maria; Imbastaro, Tiziana; Peng, Qinglin; Wang, Guochun; Vencovský, Jiří; Klein, Martin; Krystufkova, Olga; Franceschini, Franco; Fredi, Micaela; Hue, Sophie; Belmondo, Thibaut; Danko, Katalin; Mahler, Michael

2016-10-01

In an effort to find naturally occurring substances that reduce cholesterol by inhibiting 3-hydroxy-3-methylglutaryl-coenzyme A reductase (HMGCR), statins were first discovered by Endo in 1972. With the widespread prescription and use of statins to decrease morbidity from myocardial infarction and stroke, it was noted that approximately 5% of all statin users experienced muscle pain and weakness during treatment. In a smaller proportion of patients, the myopathy progressed to severe morbidity marked by proximal weakness and severe muscle wasting. Remarkably, Mammen and colleagues were the first to discover that the molecular target of statins, 3-hydroxy-3-methylglutaryl coenzyme A reductase (HMGCR), is an autoantibody target in patients that develop an immune-mediated necrotizing myopathy (IMNM). These observations have been confirmed in a number of studies but, until today, a multi-center, international study of IMNM, related idiopathic inflammatory myopathies (IIM), other auto-inflammatory conditions and controls has not been published. Accordingly, an international, multi-center study investigated the utility of anti-HMGCR antibodies in the diagnosis of statin-associated IMNM in comparison to different forms of IIM and controls. This study included samples from patients with different forms of IIM (n=1250) and patients with other diseases (n=656) that were collected from twelve sites and tested for anti-HMGCR antibodies by ELISA. This study confirmed that anti-HMGCR autoantibodies, when found in conjunction with statin use, characterize a subset of IIM who are older and have necrosis on muscle biopsy. Taken together, the data to date indicates that testing for anti-HMGCR antibodies is important in the differential diagnosis of IIM and might be considered for future classification criteria. Copyright © 2016. Published by Elsevier B.V.

Stroke Trials Registry

MedlinePlus

... Trials News About Neurology Image Library Search The Internet Stroke Center Trials Registry Clinical Trials Interventions Conditions ... UT Southwestern Medical Center. Copyright © 1997-2011 - The Internet Stroke Center. All rights reserved. The information contained ...

High grade anal intraepithelial neoplasia among HIV-1-infected men screening for a multi-center clinical trial of a human papillomavirus vaccine

PubMed Central

Wilkin, Timothy; Lee, Jeannette Y.; Lensing, Shelly Y.; Stier, Elizabeth A.; Goldstone, Stephen E.; Berry, J. Michael; Jay, Naomi; Aboulafia, David M.; Einstein, Mark H.; Saah, Alfred; Mitsuyasu, Ronald T.; Palefsky, Joel M.

2013-01-01

Purpose High-grade anal intraepithelial neoplasia (HGAIN) is the precursor lesion to invasive anal cancer. HPV vaccination holds great promise for preventing anal cancer. Methods We examined 235 HIV-1-infected men screening for participation in a multi-site clinical trial of a quadrivalent HPV vaccine. All participants had anal swabs obtained for HPV testing and cytology, and high resolution anoscopy with biopsies of visible lesions to assess for HGAIN. Results HPV 16 and 18 were detected in 23% and 10%, respectively; abnormal anal cytology was found in 56% and HGAIN in 30%. HGAIN prevalence was significantly higher in those with HPV 16 detection compared to those without (38% vs. 17%, P=.01). Use of antiretroviral therapy, nadir and current CD4+ cell count were not associated with abnormal anal cytology or HGAIN. Conclusion HGAIN is highly prevalent in HIV-infected men. Further studies are needed on treatment and prevention of HGAIN. PMID:23611828

Multi-Instrument Tools and Services to Access NASA Earth Science Data from the GSFC Earth Sciences Data and Information Services Center

NASA Technical Reports Server (NTRS)

Kempler, Steve; Leptoukh, Greg; Lynnes, Chris

2010-01-01

The presentation purpose is to describe multi-instrument tools and services that facilitate access and usability of NASA Earth science data at Goddard Space Flight Center (GSFC). NASA's Earth observing system includes 14 satellites. Topics include EOSDIS facilities and system architecture, and overview of GSFC Earth Science Data and Information Services Center (GES DISC) mission, Mirador data search, Giovanni, multi-instrument data exploration, Google Earth[TM], data merging, and applications.

Person-centered care planning and service engagement: a study protocol for a randomized controlled trial.

PubMed

Stanhope, Victoria; Tondora, Janis; Davidson, Larry; Choy-Brown, Mimi; Marcus, Steven C

2015-04-22

Service disengagement is a pervasive challenge the mental health care system faces. Mental health services are of little value should persons with mental illnesses continue to opt out of receiving them. Consumers attribute disengagement from care to an absence of choice in their treatment. In response, the mental health system is adopting a person-centered model, based upon recovery principles, to engage consumers more actively in their care. Person-centered care planning is a promising practice involving collaboration to develop and implement an actionable plan to assist the person in achieving personal recovery goals. This study design combines a parallel-group randomized controlled trial of community mental health organizations with qualitative methods to assess the effectiveness of person-centered care planning. Participants at 14 sites in Delaware and Connecticut will be randomized to treatment as usual or the person-centered care planning intervention. Participants will be in leadership (n = 70) or supervisory or direct care (n = 210) roles. The person-centered care planning intervention involves intensive staff training and 12 months of ongoing technical assistance. Quantitative survey data will be collected at baseline, 6 months and 12 months measuring person-centered care planning competency and organizational factors. Consumer outcomes (engagement, medication adherence, functioning and consumer satisfaction) will be assessed by Medicaid and state-level data. Qualitative data focused on process factors will include staff and consumer interviews and focus groups. In this intent-to-treat analysis, we will use mixed-effects multivariate regression models to evaluate the differential impact of the person-centered care planning intervention on each consumer and implementation outcome as well as the extent to which clinician assessments of organizational factors are associated with the implementation outcome. Mixed methods will triangulate and strengthen the

Clinical trial will investigate targeted radionuclide therapy for inoperable rare tumors | Center for Cancer Research

Cancer.gov

In an upcoming phase II clinical trial, Center for Cancer Research investigators will explore the ability of a targeted radioactive drug to treat inoperable pheochromocytoma and paraganglioma, both rare tumors.  Learn more...

Moral imperialism and multi-centric clinical trials in peripheral countries.

PubMed

Garrafa, Volnei; Lorenzo, Claudio

2008-10-01

Moral imperialism is expressed in attempts to impose moral standards from one particular culture, geopolitical region or culture onto other cultures, regions or countries. Examples of Direct Moral Imperialism can be seen in various recurrent events involving multi-centric clinical trials promoted by developed (central) countries in poor and developing (peripheral) countries, particularly projects related to the theory of double standards in research. After the WMA General Assembly refused to change the Helsinki Declaration - which would have given moral recognition to the above mentioned theory - the USA abandoned the declaration and began to promote regional seminars in peripheral countries with the aim of "training" researchers on ethical perspectives that reflect America's best interests. Individuals who received such training became transmitters of these central countries' ideas across the peripheral countries, representing a form of Indirect Moral Imperialism. The paper proposes the establishment of regulatory and social control systems for clinical trials implemented in peripheral countries, through the formulation of ethical norms that reflect the specific contexts of these countries, along with the drawing up and validation of their own national norms.

New clinical trial tests safety and efficacy of combination therapy in ovarian cancer and other women's malignancies | Center for Cancer Research

Cancer.gov

The Center for Cancer Research has opened a new clinical trial in ovarian cancer that will test the safety and efficacy a therapy combining two drugs.   The phase I trial will test a combination therapy for ovarian, fallopian tube, and peritoneal cancers and is enrolling patients at the NIH Clinical Center. Learn more...  

Fever Control Management Is Preferable to Mild Therapeutic Hypothermia in Traumatic Brain Injury Patients with Abbreviated Injury Scale 3-4: A Multi-Center, Randomized Controlled Trial.

PubMed

Hifumi, Toru; Kuroda, Yasuhiro; Kawakita, Kenya; Yamashita, Susumu; Oda, Yasutaka; Dohi, Kenji; Maekawa, Tsuyoshi

2016-06-01

In our prospective, multi-center, randomized controlled trial (RCT)-the Brain Hypothermia (B-HYPO) study-we could not show any difference on neurological outcomes in patients probably because of the heterogeneity in the severity of their traumatic condition. We therefore aimed to clarify and compare the effectiveness of the two therapeutic temperature management regimens in severe (Abbreviated Injury Scale [AIS] 3-4) or critical trauma patients (AIS 5). In the present post hoc B-HYPO study, we re-evaluated data based on the severity of trauma as AIS 3-4 or AIS 5 and compared Glasgow Outcome Scale score and mortality at 6 months by per-protocol analyses. Consequently, 135 patients were enrolled. Finally, 129 patients, that is, 47 and 31 patients with AIS 3-4 and 36 and 15 patients with AIS 5 were allocated to the mild therapeutic hypothermia (MTH) and fever control groups, respectively. No significant intergroup differences were observed with regard to age, gender, scores on head computed tomography (CT) scans, and surgical operation for traumatic brain injury (TBI), except for Injury Severity Score (ISS) in AIS 5. The fever control group demonstrated a significant reduction of TBI-related mortality compared with the MTH group (9.7% vs. 34.0%, p = 0.02) and an increase of favorable neurological outcomes (64.5% vs. 51.1%, p = 0.26) in patients with AIS 3-4, although the latter was not statistically significant. There was no difference in mortality or favorable outcome in patients with AIS 5. Fever control may be considered instead of MTH in patients with TBI (AIS 3-4).

Impact of a Parenting Program in a High-Risk, Multi-Ethnic Community: The PALS Trial

ERIC Educational Resources Information Center

Scott, Stephen; O'Connor, Thomas G.; Futh, Annabel; Matias, Carla; Price, Jenny; Doolan, Moira

2010-01-01

Background: Parenting programs have been shown to work when delivered to motivated ethnic majority parents in demonstration projects, but comparatively little is known about their impact when delivered to high-risk, multi-ethnic populations by routine local services. Methods: The Primary Age Learning Skills (PALS) trial was a randomized controlled…

Practical Aspects of Designing and Conducting Validation Studies Involving Multi-study Trials.

PubMed

Coecke, Sandra; Bernasconi, Camilla; Bowe, Gerard; Bostroem, Ann-Charlotte; Burton, Julien; Cole, Thomas; Fortaner, Salvador; Gouliarmou, Varvara; Gray, Andrew; Griesinger, Claudius; Louhimies, Susanna; Gyves, Emilio Mendoza-de; Joossens, Elisabeth; Prinz, Maurits-Jan; Milcamps, Anne; Parissis, Nicholaos; Wilk-Zasadna, Iwona; Barroso, João; Desprez, Bertrand; Langezaal, Ingrid; Liska, Roman; Morath, Siegfried; Reina, Vittorio; Zorzoli, Chiara; Zuang, Valérie

This chapter focuses on practical aspects of conducting prospective in vitro validation studies, and in particular, by laboratories that are members of the European Union Network of Laboratories for the Validation of Alternative Methods (EU-NETVAL) that is coordinated by the EU Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM). Prospective validation studies involving EU-NETVAL, comprising a multi-study trial involving several laboratories or "test facilities", typically consist of two main steps: (1) the design of the validation study by EURL ECVAM and (2) the execution of the multi-study trial by a number of qualified laboratories within EU-NETVAL, coordinated and supported by EURL ECVAM. The approach adopted in the conduct of these validation studies adheres to the principles described in the OECD Guidance Document on the Validation and International Acceptance of new or updated test methods for Hazard Assessment No. 34 (OECD 2005). The context and scope of conducting prospective in vitro validation studies is dealt with in Chap. 4 . Here we focus mainly on the processes followed to carry out a prospective validation of in vitro methods involving different laboratories with the ultimate aim of generating a dataset that can support a decision in relation to the possible development of an international test guideline (e.g. by the OECD) or the establishment of performance standards.

Study of multi-functional precision optical measuring system for large scale equipment

NASA Astrophysics Data System (ADS)

Jiang, Wei; Lao, Dabao; Zhou, Weihu; Zhang, Wenying; Jiang, Xingjian; Wang, Yongxi

2017-10-01

The effective application of high performance measurement technology can greatly improve the large-scale equipment manufacturing ability. Therefore, the geometric parameters measurement, such as size, attitude and position, requires the measurement system with high precision, multi-function, portability and other characteristics. However, the existing measuring instruments, such as laser tracker, total station, photogrammetry system, mostly has single function, station moving and other shortcomings. Laser tracker needs to work with cooperative target, but it can hardly meet the requirement of measurement in extreme environment. Total station is mainly used for outdoor surveying and mapping, it is hard to achieve the demand of accuracy in industrial measurement. Photogrammetry system can achieve a wide range of multi-point measurement, but the measuring range is limited and need to repeatedly move station. The paper presents a non-contact opto-electronic measuring instrument, not only it can work by scanning the measurement path but also measuring the cooperative target by tracking measurement. The system is based on some key technologies, such as absolute distance measurement, two-dimensional angle measurement, automatically target recognition and accurate aiming, precision control, assembly of complex mechanical system and multi-functional 3D visualization software. Among them, the absolute distance measurement module ensures measurement with high accuracy, and the twodimensional angle measuring module provides precision angle measurement. The system is suitable for the case of noncontact measurement of large-scale equipment, it can ensure the quality and performance of large-scale equipment throughout the process of manufacturing and improve the manufacturing ability of large-scale and high-end equipment.

Multi-thread parallel algorithm for reconstructing 3D large-scale porous structures

NASA Astrophysics Data System (ADS)

Ju, Yang; Huang, Yaohui; Zheng, Jiangtao; Qian, Xu; Xie, Heping; Zhao, Xi

2017-04-01

Geomaterials inherently contain many discontinuous, multi-scale, geometrically irregular pores, forming a complex porous structure that governs their mechanical and transport properties. The development of an efficient reconstruction method for representing porous structures can significantly contribute toward providing a better understanding of the governing effects of porous structures on the properties of porous materials. In order to improve the efficiency of reconstructing large-scale porous structures, a multi-thread parallel scheme was incorporated into the simulated annealing reconstruction method. In the method, four correlation functions, which include the two-point probability function, the linear-path functions for the pore phase and the solid phase, and the fractal system function for the solid phase, were employed for better reproduction of the complex well-connected porous structures. In addition, a random sphere packing method and a self-developed pre-conditioning method were incorporated to cast the initial reconstructed model and select independent interchanging pairs for parallel multi-thread calculation, respectively. The accuracy of the proposed algorithm was evaluated by examining the similarity between the reconstructed structure and a prototype in terms of their geometrical, topological, and mechanical properties. Comparisons of the reconstruction efficiency of porous models with various scales indicated that the parallel multi-thread scheme significantly shortened the execution time for reconstruction of a large-scale well-connected porous model compared to a sequential single-thread procedure.

Randomized controlled trials and neuro-oncology: should alternative designs be considered?

PubMed

Mansouri, Alireza; Shin, Samuel; Cooper, Benjamin; Srivastava, Archita; Bhandari, Mohit; Kondziolka, Douglas

2015-09-01

Deficiencies in design and reporting of randomized controlled trials (RCTs) hinders interpretability and critical appraisal. The reporting quality of recent RCTs in neuro-oncology was analyzed to assess adequacy of design and reporting. The MEDLINE and EMBASE databases were searched to identify non-surgical RCTs (years 2005-2014, inclusive). The CONSORT and Jadad scales were used to assess the quality of design/reporting. Studies published in 2005-2010 were compared as a cohort against studies published in 2011-2014, in terms of general characteristics and reporting quality. A PRECIS-based scale was used to designate studies on the pragmatic-explanatory continuum. Spearman's test was used to assess correlations. Regression analysis was used to assess associations. Overall 68 RCTs were identified. Studies were often chemotherapy-based (n = 41 studies) focusing upon high grade gliomas (46 %) and metastases (41 %) as the top pathologies. Multi-center trials (71 %) were frequent. The overall median CONSORT and Jadad scores were 34.5 (maximum 44) and 2 (maximum 5), respectively; these scores were similar in radiation and chemotherapy-based trials. Major areas of deficiency pertained to allocation concealment, implementation of methods, and blinding whereby less than 20 % of articles fulfilled all criteria. Description of intervention, random sequence generation, and the details regarding recruitment were also deficient; less than 50 % of studies fulfilled all criteria. Description of sample size calculations and blinding improved in later published cohorts. Journal impact factor was significantly associated with higher quality (p = 0.04). Large academic consortia, multi-center designs, ITT analysis, collaboration with biostatisticians, larger sample sizes, and studies with pragmatic objectives were more likely to achieve positive primary outcomes on univariate analysis; none of these variables were significant on multivariate analysis. Deficiencies in the

A multi-centre randomised trial to compare the effectiveness of geriatrician-led admission avoidance hospital at home versus inpatient admission.

PubMed

Shepperd, Sasha; Cradduck-Bamford, Andrea; Butler, Chris; Ellis, Graham; Godfrey, Mary; Gray, Alastair; Hemsley, Anthony; Khanna, Pradeep; Langhorne, Peter; McCaffrey, Patricia; Mirza, Lubena; Pushpangadan, Maj; Ramsay, Scott; Schiff, Rebekah; Stott, David; Young, John; Yu, Ly-Mee

2017-10-23

There is concern that existing models of acute hospital care will become unworkable as the health service admits an increasing number of frail older people with complex health needs, and that there is inadequate evidence to guide the planning of acute hospital level services. We aim to evaluate whether geriatrician-led admission avoidance to hospital at home is an effective alternative to hospital admission. We are conducting a multi-site randomised open trial of geriatrician-led admission avoidance hospital at home, compared with admission to hospital. We are recruiting older people with markers of frailty or prior dependence who have been referred to admission avoidance hospital at home for an acute medical event. This includes patients presenting with delirium, functional decline, dependence, falls, immobility or a background of dementia presenting with physical disease. Participants are randomised using a computerised random number generator to geriatrician-led admission avoidance hospital at home or a control group of inpatient admission in a 2:1 ratio in favour of the intervention. The primary endpoint 'living at home' (the inverse of death or living in a residential care setting) is measured at 6 months follow-up, and we also collect data on this outcome at 12 months. Secondary outcomes include the incidence of delirium, mortality, new long-term residential care, cognitive impairment, activities of daily living, quality of life and quality-adjusted survival, length of stay, readmission or transfer to hospital. We will conduct a parallel economic evaluation, and a process evaluation that includes an interview study to explore the experiences of patients and carers. Health systems around the world are examining how to provide acute hospital-level care to older adults in greater numbers with a fixed or shrinking hospital resource. This trial is the first large multi-site randomised trial of geriatrician-led admission avoidance hospital at home, and will

Large Scale Document Inversion using a Multi-threaded Computing System.

PubMed

Jung, Sungbo; Chang, Dar-Jen; Park, Juw Won

2017-06-01

Current microprocessor architecture is moving towards multi-core/multi-threaded systems. This trend has led to a surge of interest in using multi-threaded computing devices, such as the Graphics Processing Unit (GPU), for general purpose computing. We can utilize the GPU in computation as a massive parallel coprocessor because the GPU consists of multiple cores. The GPU is also an affordable, attractive, and user-programmable commodity. Nowadays a lot of information has been flooded into the digital domain around the world. Huge volume of data, such as digital libraries, social networking services, e-commerce product data, and reviews, etc., is produced or collected every moment with dramatic growth in size. Although the inverted index is a useful data structure that can be used for full text searches or document retrieval, a large number of documents will require a tremendous amount of time to create the index. The performance of document inversion can be improved by multi-thread or multi-core GPU. Our approach is to implement a linear-time, hash-based, single program multiple data (SPMD), document inversion algorithm on the NVIDIA GPU/CUDA programming platform utilizing the huge computational power of the GPU, to develop high performance solutions for document indexing. Our proposed parallel document inversion system shows 2-3 times faster performance than a sequential system on two different test datasets from PubMed abstract and e-commerce product reviews. •Information systems➝Information retrieval • Computing methodologies➝Massively parallel and high-performance simulations.

Multi-resonance peaks fiber Bragg gratings based on largely-chirped structure

NASA Astrophysics Data System (ADS)

Chen, Chao; Zhang, Xuan-Yu; Wei, Wei-Hua; Chen, Yong-Yi; Qin, Li; Ning, Yong-Qiang; Yu, Yong-Sen

2018-04-01

A composite fiber Bragg grating (FBG) with multi-resonance peaks (MRPs) has been realized by using femtosecond (fs) laser point-by-point inscription in single-mode fiber. This device contains a segment of largely-chirped gratings with the ultrahigh chirp coefficients and a segment of uniform high-order gratings. The observed MRPs are distributed in an ultra-broadband wavelength range from 1200 nm to 1700 nm in the form of quasi-period or multi-peak-group. For the 8th-order MRPs-FBG, we studied the axial strain and high-temperature sensing characteristics of different resonance peaks experimentally. Moreover, we have demonstrated a multi-wavelength fiber lasers with three-wavelength stable output by using a 9th-order MRPs-FBG as the wavelength selector. This work is significant for the fabrication and functionalization of FBGs with complicated spectra characteristics.

Lung-MAP Launches: First Precision Medicine Trial From National Clinical Trials Network

Cancer.gov

A unique public-private collaboration today announced the initiation of the Lung Cancer Master Protocol (Lung-MAP) trial, a multi-drug, multi-arm, biomarker-driven clinical trial for patients with advanced squamous cell lung cancer. Squamous cell carcinom

New clinical trial explores precision treatment for advanced pancreatic cancer | Center for Cancer Research

Cancer.gov

A new phase II clinical trial to assess the safety and efficacy of a drug called selumetinib for treating patients with advanced pancreatic cancer whose tumors harbor a specific genetic marker has opened at the Center for Cancer Research and is currently recruiting participants. Read more...

Examining Changes to Center of Pressure During the First Trials of Wii Gameplay.

PubMed

Reed-Jones, Rebecca; Carvalho, Laura; Sanderson, Chelsey; Montelpare, William; Murray, Nicholas; Powell, Douglas

2017-02-01

Use of the Nintendo Wii™ as a balance assessment and rehabilitation tool continues to grow. One advantage of the Wii is that games can serve as a virtual reality training tool; however, a disadvantage of the Wii is the human-machine interface and the learning effect over multiple trials. The purpose of this study was to assess changes in postural control during Wii gameplay over a series of trials in novice players. Thirty-one university athletes (aged 18-25 years) completed four trials of the Nintendo Wii Fit™ soccer heading (SH) balance game. Center of pressure (COP) was calculated in the anterior-posterior (AP) and medial-lateral (ML) directions for each 70-second time trial at 1000 Hz. COP was assessed using six linear and two nonlinear measures. Repeated measures analysis of variances compared COP measures over the four trials. Significant differences in COP magnitude and velocity were found between trials 1 and 2 in the ML direction. No significant effects of trial were found in the AP direction. In contrast, a measure of the overall area of COP using an ellipse method revealed a significant reduction to COP area between trials 3 and 4. No significant differences between trials were observed in nonlinear measures. These results demonstrate how magnitude and velocity measures of COP control stabilize after the first trial of Wii SH game play in novice young adults. As Wii rehabilitation focuses on individuals with balance difficulties, an important consideration when using the game as an assessment tool is that more than four trials may be required to capture learning in these populations. In addition, contrasting results from ellipse measurement methods point to the use of multiple measures for robust description of COP behavior. This work provides understanding of normative postural control responses with further research in clinical populations needed.

Implementation of a multi-threaded framework for large-scale scientific applications

DOE PAGES

Sexton-Kennedy, E.; Gartung, Patrick; Jones, C. D.; ...

2015-05-22

The CMS experiment has recently completed the development of a multi-threaded capable application framework. In this paper, we will discuss the design, implementation and application of this framework to production applications in CMS. For the 2015 LHC run, this functionality is particularly critical for both our online and offline production applications, which depend on faster turn-around times and a reduced memory footprint relative to before. These applications are complex codes, each including a large number of physics-driven algorithms. While the framework is capable of running a mix of thread-safe and 'legacy' modules, algorithms running in our production applications need tomore » be thread-safe for optimal use of this multi-threaded framework at a large scale. Towards this end, we discuss the types of changes, which were necessary for our algorithms to achieve good performance of our multithreaded applications in a full-scale application. Lastly performance numbers for what has been achieved for the 2015 run are presented.« less

Involving older people in a multi-centre randomised trial of a complex intervention in pre-hospital emergency care: implementation of a collaborative model.

PubMed

Koniotou, Marina; Evans, Bridie Angela; Chatters, Robin; Fothergill, Rachael; Garnsworthy, Christopher; Gaze, Sarah; Halter, Mary; Mason, Suzanne; Peconi, Julie; Porter, Alison; Siriwardena, A Niroshan; Toghill, Alun; Snooks, Helen

2015-07-10

Health services research is expected to involve service users as active partners in the research process, but few examples report how this has been achieved in practice in trials. We implemented a model to involve service users in a multi-centre randomised controlled trial in pre-hospital emergency care. We used the generic Standard Operating Procedure (SOP) from our Clinical Trials Unit (CTU) as the basis for creating a model to fit the context and population of the SAFER 2 trial. In our model, we planned to involve service users at all stages in the trial through decision-making forums at 3 levels: 1) strategic; 2) site (e.g. Wales; London; East Midlands); 3) local. We linked with charities and community groups to recruit people with experience of our study population. We collected notes of meetings alongside other documentary evidence such as attendance records and study documentation to track how we implemented our model. We involved service users at strategic, site and local level. We also added additional strategic level forums (Task and Finish Groups and Writing Days) where we included service users. Service user involvement varied in frequency and type across meetings, research stages and locations but stabilised and increased as the trial progressed. Involving service users in the SAFER 2 trial showed how it is feasible and achievable for patients, carers and potential patients sharing the demographic characteristics of our study population to collaborate in a multi-centre trial at the level which suited their health, location, skills and expertise. A standard model of involvement can be tailored by adopting a flexible approach to take account of the context and complexities of a multi-site trial. Current Controlled Trials ISRCTN60481756. Registered: 13 March 2009.

Clinical trials in rheumatoid arthritis: a status report from the ClinicalTrials.gov website.

PubMed

Paul, Jisna R; Ranganathan, Prabha

2012-06-01

The aims of this study are to describe the characteristics of clinical trials in rheumatoid arthritis (RA) listed in ClinicalTrials.gov and examine existing trends in study design, funding sources, outcomes, and drugs under investigation. We conducted a survey of ongoing clinical trials in RA registered in the ClinicalTrials.gov website. We used the advanced search option and applied the following inclusion criteria, "rheumatoid arthritis", "open studies", "interventional", and "adults 18 years or older". Of 127 eligible trials, 53.5% of the studies were either phase 3 or 4, and 40.2% were phase 1, 2, and 2/3. Two-thirds of the trials were randomized (70.9%), and over half were, in addition, double-blinded (53.5%) and placebo-controlled (53.5%). Universities were listed as the primary sponsor for 18.9% of the trials and pharmaceutical industry for 73.2%. Majority of the trials were multi-center studies (93%) conducted outside the United States (54.3%). The most frequently used endpoint was drug efficacy (54.3%) followed by drug safety (25.2%). Most industry-funded trials were open for less than 12 months, whereas most university-funded trials were open for more than 24 months (58% each). Biologic therapies were the focus of most trials in the registry (78.5%). Randomized, double-blinded, placebo-controlled, phase 3 and 4 trials form the majority of ongoing clinical trials in RA. The preponderance of industry funding of RA trials and the short duration of such trials are troubling trends which need to be addressed.

RAAS inhibitors and cardiovascular protection in large scale trials.

PubMed

von Lueder, Thomas G; Krum, Henry

2013-04-01

Hypertension, coronary artery disease and heart failure affect over half of the adult population in most Western societies, and are prime causes of CV morbidity and mortality. With the ever-increasing worldwide prevalence of CV disease due to ageing and the "diabetes" pandemic, guideline groups have recognized the importance of achieving cardioprotection in affected individuals as well as in those at risk for future CV events. The renin-angiotensin-aldosterone system (RAAS) is the most important system controlling blood pressure (BP), cardiovascular and renal function in man. As our understanding of the crucial role of RAAS in the pathogenesis of most, if not all, CV disease has expanded over the past decades, so has the development of drugs targeting its individual components. Angiotensin-converting enzyme inhibitors (ACEi), Ang-II receptor blockers (ARB), and mineralcorticoid receptor antagonists (MRA) have been evaluated in large clinical trials for their potential to mediate cardioprotection, singly or in combination. Direct renin inhibitors are currently under scrutiny, as well as novel dual-acting RAAS-blocking agents. Herein, we review the evidence generated from large-scale clinical trials of cardioprotection achieved through RAAS-blockade.

Effect of trial-to-trial variability on optimal event-related fMRI design: Implications for Beta-series correlation and multi-voxel pattern analysis

PubMed Central

Abdulrahman, Hunar; Henson, Richard N.

2016-01-01

Functional magnetic resonance imaging (fMRI) studies typically employ rapid, event-related designs for behavioral reasons and for reasons associated with statistical efficiency. Efficiency is calculated from the precision of the parameters (Betas) estimated from a General Linear Model (GLM) in which trial onsets are convolved with a Hemodynamic Response Function (HRF). However, previous calculations of efficiency have ignored likely variability in the neural response from trial to trial, for example due to attentional fluctuations, or different stimuli across trials. Here we compare three GLMs in their efficiency for estimating average and individual Betas across trials as a function of trial variability, scan noise and Stimulus Onset Asynchrony (SOA): “Least Squares All” (LSA), “Least Squares Separate” (LSS) and “Least Squares Unitary” (LSU). Estimation of responses to individual trials in particular is important for both functional connectivity using “Beta-series correlation” and “multi-voxel pattern analysis” (MVPA). Our simulations show that the ratio of trial-to-trial variability to scan noise impacts both the optimal SOA and optimal GLM, especially for short SOAs < 5 s: LSA is better when this ratio is high, whereas LSS and LSU are better when the ratio is low. For MVPA, the consistency across voxels of trial variability and of scan noise is also critical. These findings not only have important implications for design of experiments using Beta-series regression and MVPA, but also statistical parametric mapping studies that seek only efficient estimation of the mean response across trials. PMID:26549299

A Multi-state Model for Designing Clinical Trials for Testing Overall Survival Allowing for Crossover after Progression

PubMed Central

Xia, Fang; George, Stephen L.; Wang, Xiaofei

2015-01-01

In designing a clinical trial for comparing two or more treatments with respect to overall survival (OS), a proportional hazards assumption is commonly made. However, in many cancer clinical trials, patients pass through various disease states prior to death and because of this may receive treatments other than originally assigned. For example, patients may crossover from the control treatment to the experimental treatment at progression. Even without crossover, the survival pattern after progression may be very different than the pattern prior to progression. The proportional hazards assumption will not hold in these situations and the design power calculated on this assumption will not be correct. In this paper we describe a simple and intuitive multi-state model allowing for progression, death before progression, post-progression survival and crossover after progression and apply this model to the design of clinical trials for comparing the OS of two treatments. For given values of the parameters of the multi-state model, we simulate the required number of deaths to achieve a specified power and the distribution of time required to achieve the requisite number of deaths. The results may be quite different from those derived using the usual PH assumption. PMID:27239255

Post-Discharge Care of Pediatric Traumatic Brain Injury in Argentina: A Multi-Center Randomized Controlled Trial

PubMed Central

Carney, Nancy A.; Petroni, Gustavo J.; Luján, Silvia B.; Ballarini, Nicolás M.; Faguaga, Gabriela A.; du Coudray, Hugo E. M.; Huddleston, Amy E.; Baggio, Gloria M.; Becerra, Juan M.; Busso, Leonardo O.; Dikmen, Sureyya S.; Falcone, Roberto; García, Mirta E.; Carrillo, Osvaldo R. González; Medici, Paula L.; Quaglino, Marta B.; Randisi, Carina A.; Sáenz, Silvia S.; Temkin, Nancy R.; Vanella, Elida E.

2016-01-01

Objective To develop, in partnership with families of children with traumatic brain injury (TBI), a post-discharge intervention that is effective, simple and sustainable. Design Randomized Controlled Trial Setting Seven Level 1 Pediatric Trauma Centers in Argentina. Patients Persons less than 19 years of age admitted to one of the study hospitals with a diagnosis of severe, moderate, or complicated mild TBI, and were discharged alive. Interventions Patients were randomly assigned to either the Intervention or Standard Care group. A specially trained Community Resource Coordinator (CRC) was assigned to each family in the Intervention group. We hypothesized that children with severe, moderate, and complicated mild TBI who received the intervention would have significantly better functional outcomes at 6-months post-discharge than those who received standard care. We further hypothesized there would be a direct correlation between patient outcome and measures of family function. Measurements and Main Results The primary outcome measure was a composite measured at 6-months post-injury. There were 308 patients included in the study; 61% male. Forty-four percent sustained a complicated mild TBI, 18% moderate, and 38% severe. Sixty-five percent of the patients were 8 years old or younger, and over 70% were transported to the hospital without ambulance assistance. There was no significant difference between groups on the primary outcome measure. There was a statistically significant correlation between the primary outcome measure and scores on the Family Impact Module of the PedsQL (ρ= 0.57; p < 0.0001). Children with better outcomes lived with families reporting better function at 6-months post-injury. Conclusions While no significant effect of the intervention was demonstrated, this study represents the first conducted in Latin America that documents the complete course of treatment for pediatric patients with TBI spanning hospital transport through hospital care and

Chronic gastritis in China: a national multi-center survey.

PubMed

Du, Yiqi; Bai, Yu; Xie, Pei; Fang, Jingyuan; Wang, Xiaozhong; Hou, Xiaohua; Tian, Dean; Wang, Chengdang; Liu, Yandi; Sha, Weihong; Wang, Bangmao; Li, Yanqing; Zhang, Guoliang; Li, Yan; Shi, Ruihua; Xu, Jianming; Li, Youming; Huang, Minghe; Han, Shengxi; Liu, Jie; Ren, Xu; Xie, Pengyan; Wang, Zhangliu; Cui, Lihong; Sheng, Jianqiu; Luo, Hesheng; Wang, Zhaohui; Zhao, Xiaoyan; Dai, Ning; Nie, Yuqiang; Zou, Yiyou; Xia, Bing; Fan, Zhining; Chen, Zhitan; Lin, Sanren; Li, Zhao-Shen

2014-02-07

Chronic gastritis is one of the most common findings at upper endoscopy in the general population, and chronic atrophic gastritis is epidemiologically associated with the occurrence of gastric cancer. However, the current status of diagnosis and treatment of chronic gastritis in China is unclear. A multi-center national study was performed; all patients who underwent diagnostic upper endoscopy for evaluation of gastrointestinal symptoms from 33 centers were enrolled. Data including sex, age, symptoms and endoscopic findings were prospectively recorded. Totally 8892 patients were included. At endoscopy, 4389, 3760 and 1573 patients were diagnosed to have superficial gastritis, erosive gastritis, and atrophic gastritis, respectively. After pathologic examination, it is found that atrophic gastritis, intestinal metaplasia and dysplasia were prevalent, which accounted for 25.8%, 23.6% and 7.3% of this patient population. Endoscopic features were useful for predicting pathologic atrophy (PLR = 4.78), but it was not useful for predicting erosive gastritis. Mucosal-protective agents and PPI were most commonly used medications for chronic gastritis. The present study suggests non-atrophic gastritis is the most common endoscopic finding in Chinese patients with upper GI symptoms. Precancerous lesions, including atrophy, intestinal metaplasia and dysplasia are prevalent in Chinese patients with chronic gastritis, and endoscopic features are useful for predicting pathologic atrophy.

Multi-atlas learner fusion: An efficient segmentation approach for large-scale data.

PubMed

Asman, Andrew J; Huo, Yuankai; Plassard, Andrew J; Landman, Bennett A

2015-12-01

We propose multi-atlas learner fusion (MLF), a framework for rapidly and accurately replicating the highly accurate, yet computationally expensive, multi-atlas segmentation framework based on fusing local learners. In the largest whole-brain multi-atlas study yet reported, multi-atlas segmentations are estimated for a training set of 3464 MR brain images. Using these multi-atlas estimates we (1) estimate a low-dimensional representation for selecting locally appropriate example images, and (2) build AdaBoost learners that map a weak initial segmentation to the multi-atlas segmentation result. Thus, to segment a new target image we project the image into the low-dimensional space, construct a weak initial segmentation, and fuse the trained, locally selected, learners. The MLF framework cuts the runtime on a modern computer from 36 h down to 3-8 min - a 270× speedup - by completely bypassing the need for deformable atlas-target registrations. Additionally, we (1) describe a technique for optimizing the weak initial segmentation and the AdaBoost learning parameters, (2) quantify the ability to replicate the multi-atlas result with mean accuracies approaching the multi-atlas intra-subject reproducibility on a testing set of 380 images, (3) demonstrate significant increases in the reproducibility of intra-subject segmentations when compared to a state-of-the-art multi-atlas framework on a separate reproducibility dataset, (4) show that under the MLF framework the large-scale data model significantly improve the segmentation over the small-scale model under the MLF framework, and (5) indicate that the MLF framework has comparable performance as state-of-the-art multi-atlas segmentation algorithms without using non-local information. Copyright © 2015 Elsevier B.V. All rights reserved.

A model for rigorously applying the Exploration, Preparation, Implementation, Sustainment (EPIS) framework in the design and measurement of a large scale collaborative multi-site study.

PubMed

Becan, Jennifer E; Bartkowski, John P; Knight, Danica K; Wiley, Tisha R A; DiClemente, Ralph; Ducharme, Lori; Welsh, Wayne N; Bowser, Diana; McCollister, Kathryn; Hiller, Matthew; Spaulding, Anne C; Flynn, Patrick M; Swartzendruber, Andrea; Dickson, Megan F; Fisher, Jacqueline Horan; Aarons, Gregory A

2018-04-13

This paper describes the means by which a United States National Institute on Drug Abuse (NIDA)-funded cooperative, Juvenile Justice-Translational Research on Interventions for Adolescents in the Legal System (JJ-TRIALS), utilized an established implementation science framework in conducting a multi-site, multi-research center implementation intervention initiative. The initiative aimed to bolster the ability of juvenile justice agencies to address unmet client needs related to substance use while enhancing inter-organizational relationships between juvenile justice and local behavioral health partners. The EPIS (Exploration, Preparation, Implementation, Sustainment) framework was selected and utilized as the guiding model from inception through project completion; including the mapping of implementation strategies to EPIS stages, articulation of research questions, and selection, content, and timing of measurement protocols. Among other key developments, the project led to a reconceptualization of its governing implementation science framework into cyclical form as the EPIS Wheel. The EPIS Wheel is more consistent with rapid-cycle testing principles and permits researchers to track both progressive and recursive movement through EPIS. Moreover, because this randomized controlled trial was predicated on a bundled strategy method, JJ-TRIALS was designed to rigorously test progress through the EPIS stages as promoted by facilitation of data-driven decision making principles. The project extended EPIS by (1) elucidating the role and nature of recursive activity in promoting change (yielding the circular EPIS Wheel), (2) by expanding the applicability of the EPIS framework beyond a single evidence-based practice (EBP) to address varying process improvement efforts (representing varying EBPs), and (3) by disentangling outcome measures of progression through EPIS stages from the a priori established study timeline. The utilization of EPIS in JJ-TRIALS provides a model

Exchanging large data object in multi-agent systems

NASA Astrophysics Data System (ADS)

Al-Yaseen, Wathiq Laftah; Othman, Zulaiha Ali; Nazri, Mohd Zakree Ahmad

2016-08-01

One of the Business Intelligent solutions that is currently in use is the Multi-Agent System (MAS). Communication is one of the most important elements in MAS, especially for exchanging large low level data between distributed agents (physically). The Agent Communication Language in JADE has been offered as a secure method for sending data, whereby the data is defined as an object. However, the object cannot be used to send data to another agent in a different location. Therefore, the aim of this paper was to propose a method for the exchange of large low level data as an object by creating a proxy agent known as a Delivery Agent, which temporarily imitates the Receiver Agent. The results showed that the proposed method is able to send large-sized data. The experiments were conducted using 16 datasets ranging from 100,000 to 7 million instances. However, for the proposed method, the RAM and the CPU machine had to be slightly increased for the Receiver Agent, but the latency time was not significantly different compared to the use of the Java Socket method (non-agent and less secure). With such results, it was concluded that the proposed method can be used to securely send large data between agents.

Fever Control Management Is Preferable to Mild Therapeutic Hypothermia in Traumatic Brain Injury Patients with Abbreviated Injury Scale 3–4: A Multi-Center, Randomized Controlled Trial

PubMed Central

Kuroda, Yasuhiro; Kawakita, Kenya; Yamashita, Susumu; Oda, Yasutaka; Dohi, Kenji; Maekawa, Tsuyoshi

2016-01-01

Abstract In our prospective, multi-center, randomized controlled trial (RCT)—the Brain Hypothermia (B-HYPO) study—we could not show any difference on neurological outcomes in patients probably because of the heterogeneity in the severity of their traumatic condition. We therefore aimed to clarify and compare the effectiveness of the two therapeutic temperature management regimens in severe (Abbreviated Injury Scale [AIS] 3–4) or critical trauma patients (AIS 5). In the present post hoc B-HYPO study, we re-evaluated data based on the severity of trauma as AIS 3–4 or AIS 5 and compared Glasgow Outcome Scale score and mortality at 6 months by per-protocol analyses. Consequently, 135 patients were enrolled. Finally, 129 patients, that is, 47 and 31 patients with AIS 3–4 and 36 and 15 patients with AIS 5 were allocated to the mild therapeutic hypothermia (MTH) and fever control groups, respectively. No significant intergroup differences were observed with regard to age, gender, scores on head computed tomography (CT) scans, and surgical operation for traumatic brain injury (TBI), except for Injury Severity Score (ISS) in AIS 5. The fever control group demonstrated a significant reduction of TBI-related mortality compared with the MTH group (9.7% vs. 34.0%, p = 0.02) and an increase of favorable neurological outcomes (64.5% vs. 51.1%, p = 0.26) in patients with AIS 3–4, although the latter was not statistically significant. There was no difference in mortality or favorable outcome in patients with AIS 5. Fever control may be considered instead of MTH in patients with TBI (AIS 3–4). PMID:26413933

Multi-level structure in the large scale distribution of optically luminous galaxies

NASA Astrophysics Data System (ADS)

Deng, Xin-fa; Deng, Zu-gan; Liu, Yong-zhen

1992-04-01

Fractal dimensions in the large scale distribution of galaxies have been calculated with the method given by Wen et al. [1] Samples are taken from CfA redshift survey in northern and southern galactic [2] hemisphere in our analysis respectively. Results from these two regions are compared with each other. There are significant differences between the distributions in these two regions. However, our analyses do show some common features of the distributions in these two regions. All subsamples show multi-level fractal character distinctly. Combining it with the results from analyses of samples given by IRAS galaxies and results from samples given by redshift survey in pencil-beam fields, [3,4] we suggest that multi-level fractal structure is most likely to be a general and important character in the large scale distribution of galaxies. The possible implications of this character are discussed.

Study protocol for a multi-center, randomized controlled trial to develop Japanese denture adhesive guidelines for patients with complete dentures: the Denture Adhesive Guideline trial: study protocol for a randomized controlled trial.

PubMed

Kimoto, Suguru; Kawai, Yasuhiko; Gunji, Atsuko; Kondo, Hisatomo; Nomura, Taro; Murakami, Tomohiko; Tsuboi, Akito; Hong, Guang; Minakuchi, Shunsuke; Sato, Yusuke; Ohwada, Gaku; Suzuki, Tetsuya; Kimoto, Katsuhiko; Hoshi, Noriyuki; Saita, Makiko; Yoneyama, Yoshikazu; Sato, Yohei; Morokuma, Masakazu; Okazaki, Joji; Maeda, Takeshi; Nakai, Kenichiro; Ichikawa, Tetsuo; Nagao, Kan; Fujimoto, Keiko; Murata, Hiroshi; Kurogi, Tadafumi; Yoshida, Kazuhiro; Nishimura, Masahiro; Nishi, Yasuhiro; Murakami, Mamoru; Hosoi, Toshio; Hamada, Taizo

2016-10-18

Denture adhesives, characterized as medical products in 1935 by the American Dental Association, have been considered useful adjuncts for improving denture retention and stability. However, many dentists in Japan are hesitant to acknowledge denture adhesives in daily practice because of the stereotype that dentures should be inherently stable, without the aid of adhesives. The aim of this study is to verify the efficacy of denture adhesives to establish guidelines for Japanese users. The null hypothesis is that the application of denture adhesives, including the cream and powder types, or a control (isotonic sodium chloride solution) would not produce different outcomes nor would they differentially improve the set outcomes between baseline and day 4 post-application. This ten-center, randomized controlled trial with parallel groups is ongoing. Three hundred edentulous patients with complete dentures will be allocated to three groups (cream-type adhesive, powder-type adhesive, and control groups). The participants will wear their dentures with the denture adhesive for 4 days, including during eight meals (three breakfasts, two lunches, and three dinners). The baseline measurements and final measurements for the denture adhesives will be performed on the first day and after breakfast on the fourth day. The primary outcome is a general satisfaction rating for the denture. The secondary outcomes are denture satisfaction ratings for various denture functions, occlusal bite force, resistance to dislodgement, masticatory performance, perceived chewing ability, and oral health-related quality of life. Between-subjects comparisons among the three groups and within-subjects comparisons of the pre- and post-intervention measurements will be performed. Furthermore, a multiple regression analysis will be performed. The main analyses will be based on the intention-to-treat principle. A sample size of 100 subjects per group, including an assumed dropout rate of 10 %, will be

Large Scale Document Inversion using a Multi-threaded Computing System

PubMed Central

Jung, Sungbo; Chang, Dar-Jen; Park, Juw Won

2018-01-01

Current microprocessor architecture is moving towards multi-core/multi-threaded systems. This trend has led to a surge of interest in using multi-threaded computing devices, such as the Graphics Processing Unit (GPU), for general purpose computing. We can utilize the GPU in computation as a massive parallel coprocessor because the GPU consists of multiple cores. The GPU is also an affordable, attractive, and user-programmable commodity. Nowadays a lot of information has been flooded into the digital domain around the world. Huge volume of data, such as digital libraries, social networking services, e-commerce product data, and reviews, etc., is produced or collected every moment with dramatic growth in size. Although the inverted index is a useful data structure that can be used for full text searches or document retrieval, a large number of documents will require a tremendous amount of time to create the index. The performance of document inversion can be improved by multi-thread or multi-core GPU. Our approach is to implement a linear-time, hash-based, single program multiple data (SPMD), document inversion algorithm on the NVIDIA GPU/CUDA programming platform utilizing the huge computational power of the GPU, to develop high performance solutions for document indexing. Our proposed parallel document inversion system shows 2-3 times faster performance than a sequential system on two different test datasets from PubMed abstract and e-commerce product reviews. CCS Concepts •Information systems➝Information retrieval • Computing methodologies➝Massively parallel and high-performance simulations. PMID:29861701

'Away Days' in multi-centre randomised controlled trials: a questionnaire survey of their use and a case study on the effect of one Away Day on patient recruitment.

PubMed

Jefferson, Laura; Cook, Liz; Keding, Ada; Brealey, Stephen; Handoll, Helen; Rangan, Amar

2015-11-06

'Away Days' (trial promotion and training events for trial site personnel) are a well-established method used by trialists to encourage engagement of research sites in the recruitment of patients to multi-centre randomised controlled trials (RCTs). We explored the use of Away Days in multi-centre RCTs and analysed the effect on patient recruitment in a case study. Members of the United Kingdom Trial Managers' Network were surveyed in June 2013 to investigate their experiences in the design and conduct of Away Days in RCTs. We used data from a multi-centre pragmatic surgical trial to explore the effects of an Away Day on the screening and recruitment of patients. A total of 94 people responded to the survey. The majority (78%), who confirmed had organised an Away Day previously, found them to be useful. This is despite their costs.. There was no evidence, however, from the analysis of data from a surgical trial that attendance at an Away Day increased the number of patients screened or recruited at participating sites. Although those responsible for managing RCTs in the UK tend to believe that trial Away Days are beneficial, evidence from a multi-centre surgical trial shows no improvement on a key indicator of trial success. This points to the need to carefully consider the aims, design and conduct of Away Days. Further more rigorous research nested within RCTs would be valuable to evaluate the design and conduct of Away Days. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Quality aspects of the Wegener Center multi-satellite GPS radio occultation record OPSv5.6

NASA Astrophysics Data System (ADS)

Angerer, Barbara; Ladstädter, Florian; Scherllin-Pirscher, Barbara; Schwärz, Marc; Steiner, Andrea K.; Foelsche, Ulrich; Kirchengast, Gottfried

2017-12-01

The demand for high-quality atmospheric data records, which are applicable in climate studies, is undisputed. Using such records requires knowledge of the quality and the specific characteristics of all contained data sources. The latest version of the Wegener Center (WEGC) multi-satellite Global Positioning System (GPS) radio occultation (RO) record, OPSv5.6, provides globally distributed upper-air satellite data of high quality, usable for climate and other high-accuracy applications. The GPS RO technique has been deployed in several satellite missions since 2001. Consistency among data from these missions is essential to create a homogeneous long-term multi-satellite climate record. In order to enable a qualified usage of the WEGC OPSv5.6 data set we performed a detailed analysis of satellite-dependent quality aspects from 2001 to 2017. We present the impact of the OPSv5.6 quality control on the processed data and reveal time-dependent and satellite-specific quality characteristics. The highest quality data are found for MetOp (Meteorological Operational satellite) and GRACE (Gravity Recovery and Climate Experiment). Data from FORMOSAT-3/COSMIC (Formosa Satellite mission-3/Constellation Observing System for Meteorology, Ionosphere, and Climate) are also of high quality. However, comparatively large day-to-day variations and satellite-dependent irregularities need to be taken into account when using these data. We validate the consistency among the various satellite missions by calculating monthly mean temperature deviations from the multi-satellite mean, including a correction for the different sampling characteristics. The results are highly consistent in the altitude range from 8 to 25 km, with mean temperature deviations less than 0.1 K. At higher altitudes the OPSv5.6 RO temperature record is increasingly influenced by the characteristics of the bending angle initialization, with the amount of impact depending on the receiver quality.

Building trust and diversity in patient-centered oncology clinical trials: An integrated model.

PubMed

Hurd, Thelma C; Kaplan, Charles D; Cook, Elise D; Chilton, Janice A; Lytton, Jay S; Hawk, Ernest T; Jones, Lovell A

2017-04-01

contract. Contract renegotiation occurs in response to cyclical changes within the trust relationship throughout trial participation. The Integrated Model of Trust offers a novel framework to interrogate the process by which diverse populations and clinical trial teams build trust. To our knowledge, this is the first model of trust-building in clinical trials that frames trust development through integrated clinical and business perspectives. By focusing on the process, rather than outcomes of trust-building diverse trial participants, clinical trials teams, participants, and cancer centers may be able to better understand, measure, and manage their trust relationships in real time. Ultimately, this may foster increased recruitment and retention of diverse populations to clinical trials.

Utilization of a Clinical Trial Management System for the Whole Clinical Trial Process as an Integrated Database: System Development

PubMed Central

Park, Yu Rang; Yoon, Young Jo; Koo, HaYeong; Yoo, Soyoung; Choi, Chang-Min; Beck, Sung-Ho

2018-01-01

implemented and used by 881 internal and external users for managing 11,645 studies and 146,943 subjects. Conclusions The CTMS was introduced in the Asan Medical Center to manage the large amounts of data involved with clinical trial operations. Inter- and intraunit control of data and resources can be easily conducted through the CTMS system. To our knowledge, this is the first CTMS developed in-house at an academic medical center side which can enhance the efficiency of clinical trial management in compliance with privacy and security laws. PMID:29691212

A Retrospective Belgian Multi-Center MRI Biomarker Study in Alzheimer's Disease (REMEMBER).

PubMed

Niemantsverdriet, Ellis; Ribbens, Annemie; Bastin, Christine; Benoit, Florence; Bergmans, Bruno; Bier, Jean-Christophe; Bladt, Roxanne; Claes, Lene; De Deyn, Peter Paul; Deryck, Olivier; Hanseeuw, Bernard; Ivanoiu, Adrian; Lemper, Jean-Claude; Mormont, Eric; Picard, Gaëtane; Salmon, Eric; Segers, Kurt; Sieben, Anne; Smeets, Dirk; Struyfs, Hanne; Thiery, Evert; Tournoy, Jos; Triau, Eric; Vanbinst, Anne-Marie; Versijpt, Jan; Bjerke, Maria; Engelborghs, Sebastiaan

2018-01-01

Magnetic resonance imaging (MRI) acquisition/processing techniques assess brain volumes to explore neurodegeneration in Alzheimer's disease (AD). We examined the clinical utility of MSmetrix and investigated if automated MRI volumes could discriminate between groups covering the AD continuum and could be used as a predictor for clinical progression. The Belgian Dementia Council initiated a retrospective, multi-center study and analyzed whole brain (WB), grey matter (GM), white matter (WM), cerebrospinal fluid (CSF), cortical GM (CGM) volumes, and WM hyperintensities (WMH) using MSmetrix in the AD continuum. Baseline (n = 887) and follow-up (FU, n = 95) T1-weighted brain MRIs and time-linked neuropsychological data were available. The cohort consisted of cognitively healthy controls (HC, n = 93), subjective cognitive decline (n = 102), mild cognitive impairment (MCI, n = 379), and AD dementia (n = 313). Baseline WB and GM volumes could accurately discriminate between clinical diagnostic groups and were significantly decreased with increasing cognitive impairment. MCI patients had a significantly larger change in WB, GM, and CGM volumes based on two MRIs (n = 95) compared to HC (FU>24months, p = 0.020). Linear regression models showed that baseline atrophy of WB, GM, CGM, and increased CSF volumes predicted cognitive impairment. WB and GM volumes extracted by MSmetrix could be used to define the clinical spectrum of AD accurately and along with CGM, they are able to predict cognitive impairment based on (decline in) MMSE scores. Therefore, MSmetrix can support clinicians in their diagnostic decisions, is able to detect clinical disease progression, and is of help to stratify populations for clinical trials.

Clinical Trials in Dentistry: A Cross-sectional Analysis of World Health Organization-International Clinical Trial Registry Platform.

PubMed

Sivaramakrishnan, Gowri; Sridharan, Kannan

2016-06-01

Clinical trials are the back bone for evidence-based practice (EBP) and recently EBP has been considered the best source of treatment strategies available. Clinical trial registries serve as databases of clinical trials. As regards to dentistry in specific data on the number of clinical trials and their quality is lacking. Hence, the present study was envisaged. Clinical trials registered in WHO-ICTRP (http://apps.who.int/trialsearch/AdvSearch.aspx) in dental specialties were considered. The details assessed from the collected trials include: Type of sponsors; Health condition; Recruitment status; Study design; randomization, method of randomization and allocation concealment; Single or multi-centric; Retrospective or prospective registration; and Publication status in case of completed studies. A total of 197 trials were identified. Maximum trials were from United States (n = 30) and United Kingdom (n = 38). Seventy six trials were registered in Clinical Trials.gov, 54 from International Standards of Reporting Clinical Trials, 13 each from Australia and New Zealand Trial Register and Iranian Registry of Clinical Trials, 10 from German Clinical Trial Registry, eight each from Brazilian Clinical Trial Registry and Nederland's Trial Register, seven from Japan Clinical Trial Registry, six from Clinical Trial Registry of India and two from Hong Kong Clinical Trial Registry. A total of 78.7% studies were investigator-initiated and 64% were completed while 3% were terminated. Nearly four-fifths of the registered trials (81.7%) were interventional studies of which randomized were the large majority (94.4%) with 63.2% being open label, 20.4% using single blinding technique and 16.4% were doubled blinded. The number, methodology and the characteristics of clinical trials in dentistry have been noted to be poor especially in terms of being conducted multi-centrically, employing blinding and the method for randomization and allocation concealment. More emphasis has to be

NRG Oncology medical physicists' manpower survey quantifying support demands for multi-institutional clinical trials.

PubMed

Monroe, James I; Boparai, Karan; Xiao, Ying; Followill, David; Galvin, James M; Klein, Eric E; Low, Daniel A; Moran, Jean M; Zhong, Haoyu; Sohn, Jason W

2018-02-04

A survey was created by NRG to assess a medical physicists' percent full time equivalent (FTE) contribution to multi-institutional clinical trials. A 2012 American Society for Radiation Oncology report, "Safety Is No Accident," quantified medical physics staffing contributions in FTE factors for clinical departments. No quantification of FTE effort associated with clinical trials was included. To address this lack of information, the NRG Medical Physics Subcommittee decided to obtain manpower data from the medical physics community to quantify the amount of time medical physicists spent supporting clinical trials. A survey, consisting of 16 questions, was designed to obtain information regarding physicists' time spent supporting clinical trials. The survey was distributed to medical physicists at 1996 radiation therapy institutions included on the membership rosters of the 5 National Clinical Trials Network clinical trial groups. Of the 451 institutions who responded, 50% (226) reported currently participating in radiation therapy trials. On average, the designated physicist at each institution spent 2.4 hours (standard deviation [SD], 5.5) per week supervising or interacting with clinical trial staff. On average, 1.2 hours (SD, 3.1), 1.8 hours (SD, 3.9), and 0.6 hours (SD, 1.1) per week were spent on trial patient simulations, treatment plan reviews, and maintaining a Digital Imaging and Communications in Medicine server, respectively. For all trial credentialing activities, physicists spent an average of 32 hours (SD, 57.2) yearly. Reading protocols and supporting dosimetrists, clinicians, and therapists took an average of 2.1 hours (SD, 3.4) per week. Physicists also attended clinical trial meetings, on average, 1.2 hours (SD, 1.9) per month. On average, physicist spent a nontrivial total of 9 hours per week (0.21 FTE) supporting an average of 10 active clinical trials. This time commitment indicates the complexity of radiation therapy clinical trials and should

Large multi-centre pilot randomized controlled trial testing a low-cost, tailored, self-help smoking cessation text message intervention for pregnant smokers (MiQuit).

PubMed

Naughton, Felix; Cooper, Sue; Foster, Katharine; Emery, Joanne; Leonardi-Bee, Jo; Sutton, Stephen; Jones, Matthew; Ussher, Michael; Whitemore, Rachel; Leighton, Matthew; Montgomery, Alan; Parrott, Steve; Coleman, Tim

2017-07-01

To estimate the effectiveness of pregnancy smoking cessation support delivered by short message service (SMS) text message and key parameters needed to plan a definitive trial. Multi-centre, parallel-group, single-blinded, individual randomized controlled trial. Sixteen antenatal clinics in England. Four hundred and seven participants were randomized to the intervention (n = 203) or usual care (n = 204). Eligible women were < 25 weeks gestation, smoked at least one daily cigarette (> 5 pre-pregnancy), were able to receive and understand English SMS texts and were not already using text-based cessation support. All participants received a smoking cessation leaflet; intervention participants also received a 12-week programme of individually tailored, automated, interactive, self-help smoking cessation text messages (MiQuit). Seven smoking outcomes, including validated continuous abstinence from 4 weeks post-randomization until 36 weeks gestation, design parameters for a future trial and cost-per-quitter. Using the validated, continuous abstinence outcome, 5.4% (11 of 203) of MiQuit participants were abstinent versus 2.0% (four of 204) of usual care participants [odds ratio (OR) = 2.7, 95% confidence interval (CI) = 0.93-9.35]. The Bayes factor for this outcome was 2.23. Completeness of follow-up at 36 weeks gestation was similar in both groups; provision of self-report smoking data was 64% (MiQuit) and 65% (usual care) and abstinence validation rates were 56% (MiQuit) and 61% (usual care). The incremental cost-per-quitter was £133.53 (95% CI = -£395.78 to 843.62). There was some evidence, although not conclusive, that a text-messaging programme may increase cessation rates in pregnant smokers when provided alongside routine NHS cessation care. © 2017 The Authors. Addiction published by John Wiley & Sons Ltd on behalf of Society for the Study of Addiction.

Impact of the European Clinical Trials Directive on academic clinical research.

PubMed

Baeyens, A J

2004-01-01

With the adoption of the Clinical Trials Directive it was Europe's intention to make the performance of multi-national clinical trials in Europe easier through the harmonization of the regulatory procedures. As the Directive was mainly conceived to facilitate the performance of multi-national clinical trials to develop new drugs, it is to be determined to what extent academic clinical trials will be concerned by the Directive and more importantly what will be its impact on daily academic clinical research. Contrary to several national regulations the scope of the Directive is very large only excluding non-interventional trials. This implies that most of the academic clinical trials will be concerned by the Directive. Besides the handling of the regulatory procedures in the different countries, issues related to insurance, labeling requirements and provision of the investigational medical products will expose the academic sponsor to additional administrative and financial challenges that will have to be handled appropriately, as the academic sponsors will be controlled by Inspectors regarding their compliance with the new regulations to come.

COACH trial: A randomized controlled trial of nurse practitioner/community health worker cardiovascular disease risk reduction in urban community health centers: Rationale and design

PubMed Central

Allen, Jerilyn K; Himmelfarb, Cheryl R Dennison; Szanton, Sarah L; Bone, Lee; Hill, Martha N; Levine, David M

2011-01-01

Background Despite well-publicized guidelines on the appropriate management of cardiovascular disease (CVD) and type 2 diabetes, implementation of risk-reducing practices remains poor. This paper describes the rationale and design of a randomized controlled clinical trial evaluating the effectiveness of a comprehensive program of CVD risk reduction delivered by nurse practitioner (NP)/community health worker (CHW) teams versus enhanced usual care in improving the proportion of patients in urban community health centers who achieve goal levels recommended by national guidelines for lipids, blood pressure, HbA1c and prescription of appropriate medications. Methods The COACH (Community Outreach and Cardiovascular Health) trial is a randomized controlled trial in which patients at federally-qualified community health centers were randomly assigned to one of two groups: comprehensive intensive management of CVD risk factors for one year by a NP/CHW team or an enhanced usual care control group. Results A total of 3899 patients were assessed for eligibility and 525 were randomized. Groups were comparable at baseline on sociodemographic and clinical characteristics with the exception of statistically significant differences in total cholesterol and hemoglobin A1c. Conclusions This study is a novel amalgam of multilevel interdisciplinary strategies to translate highly efficacious therapies to low-income federally-funded health centers that care for patients who carry a disproportionate burden of CVD, type 2 diabetes and uncontrolled CVD risk factors. The impact of such a community clinic-based intervention is potentially enormous. PMID:21241828

COACH trial: a randomized controlled trial of nurse practitioner/community health worker cardiovascular disease risk reduction in urban community health centers: rationale and design.

PubMed

Allen, Jerilyn K; Himmelfarb, Cheryl R Dennison; Szanton, Sarah L; Bone, Lee; Hill, Martha N; Levine, David M

2011-05-01

Despite well-publicized guidelines on the appropriate management of cardiovascular disease (CVD) and type 2 diabetes, implementation of risk-reducing practices remains poor. This paper describes the rationale and design of a randomized controlled clinical trial evaluating the effectiveness of a comprehensive program of CVD risk reduction delivered by nurse practitioner (NP)/community health worker (CHW) teams versus enhanced usual care in improving the proportion of patients in urban community health centers who achieve goal levels recommended by national guidelines for lipids, blood pressure, HbA1c and prescription of appropriate medications. The COACH (Community Outreach and Cardiovascular Health) trial is a randomized controlled trial in which patients at federally-qualified community health centers were randomly assigned to one of two groups: comprehensive intensive management of CVD risk factors for one year by a NP/CHW team or an enhanced usual care control group. A total of 3899 patients were assessed for eligibility and 525 were randomized. Groups were comparable at baseline on sociodemographic and clinical characteristics with the exception of statistically significant differences in total cholesterol and hemoglobin A1c. This study is a novel amalgam of multilevel interdisciplinary strategies to translate highly efficacious therapies to low-income federally-funded health centers that care for patients who carry a disproportionate burden of CVD, type 2 diabetes and uncontrolled CVD risk factors. The impact of such a community clinic-based intervention is potentially enormous. Copyright © 2011 Elsevier Inc. All rights reserved.

Sensitivity analysis for missing dichotomous outcome data in multi-visit randomized clinical trial with randomization-based covariance adjustment.

PubMed

Li, Siying; Koch, Gary G; Preisser, John S; Lam, Diana; Sanchez-Kam, Matilde

2017-01-01

Dichotomous endpoints in clinical trials have only two possible outcomes, either directly or via categorization of an ordinal or continuous observation. It is common to have missing data for one or more visits during a multi-visit study. This paper presents a closed form method for sensitivity analysis of a randomized multi-visit clinical trial that possibly has missing not at random (MNAR) dichotomous data. Counts of missing data are redistributed to the favorable and unfavorable outcomes mathematically to address possibly informative missing data. Adjusted proportion estimates and their closed form covariance matrix estimates are provided. Treatment comparisons over time are addressed with Mantel-Haenszel adjustment for a stratification factor and/or randomization-based adjustment for baseline covariables. The application of such sensitivity analyses is illustrated with an example. An appendix outlines an extension of the methodology to ordinal endpoints.

Efficacy of cocaine contingency management in heroin-assisted treatment: Results of a randomized controlled trial.

PubMed

Blanken, Peter; Hendriks, Vincent M; Huijsman, Ineke A; van Ree, Jan M; van den Brink, Wim

2016-07-01

To determine the efficacy of contingency management (CM), targeting cocaine use, as an add-on intervention for heroin dependent patients in supervised heroin-assisted treatment (HAT) with frequent cocaine use. Multi-center, open-label, parallel group, randomized controlled trial. Twelve specialized addiction treatment centers for HAT in The Netherlands; April 2006-January 2011. 214 chronic, treatment-refractory heroin dependent patients in HAT, with frequent cocaine use. Routine, daily supervised diacetylmorphine treatment, co-prescribed with oral methadone (HAT), with and without 6 months contingency management for cocaine use as an add-on intervention; HAT+CM and HAT-only, respectively. Primary outcome was the longest, uninterrupted duration of cocaine abstinence, based upon laboratory urinalysis. Secondary outcome measures included other cocaine-related measures, treatment retention in HAT, and multi-domain health-related treatment response. In an intention-to-treat analysis, HAT+CM was more effective than HAT-only in promoting longer, uninterrupted duration of cocaine abstinence (3.7 weeks versus 1.6 weeks; negative binomial regression: Exp(B)=2.34, 95%-CI: 1.70-3.23; p<0.001). This result remained significant in sensitivity analyses and was supported by all secondary, cocaine-related outcome measures. Treatment retention in HAT was high (91.6%) with no difference between the groups. The improvement in multi-domain health-related treatment response during the trial was numerically higher in HAT+CM (from 37.4% to 53.1%; +15.7%) than in HAT-only (from 44.5% to 46.5%; +2.0%), but this difference was statistically not significant. Contingency management is an effective add-on intervention to promote longer, uninterrupted periods of cocaine abstinence in chronic, treatment-refractory heroin dependent patients in heroin-assisted treatment with frequent cocaine use. The trial has been registered in The Netherlands National Trial Register under clinical trial

Challenges and potential solutions to meeting accrual goals in a Phase II chemoprevention trial for prostate cancer.

PubMed

Kumar, Nagi; Crocker, Theresa; Smith, Tiffany; Pow-Sang, Julio; Spiess, Philippe E; Egan, Kathleen; Quinn, Gwen; Schell, Michael; Sebti, Said; Kazi, Aslam; Chuang, Tian; Salup, Raoul; Helal, Mohamed; Zagaja, Gregory; Trabulsi, Edouard; McLarty, Jerry; Fazili, Tajammul; Williams, Christopher R; Schreiber, Fred; Slaton, Joel; Anderson, J Kyle

2012-03-01

The goal of this report is to describe the on going strategies, successes, challenges and solutions for recruitment in this multi-center, phase II chemoprevention trial targeting men at high risk for prostate cancer. We developed and implemented a multi-center clinical trial in institutions with supportive infrastructure, lead by a recruitment team of experienced and committed physicians and clinical trial staff, implementing multi-media and community outreach strategies to meet recruitment goals. Screening logs were reviewed to identify trends as well as patient, protocol and infrastructure -related barriers impacting accrual and revisions to protocol implemented. Between January 2008 and February 2011 a total of 3547 individuals were prescreened with 94% (n=3092) determined to be ineligible based on diagnosis of cancer or benign biopsy results. Of these, 216 were considered eligible for further screening with 52% (n=113) declining to participate due to patient related factors and 14% (n=29) eliminated due to protocol-related criteria for exclusion. Ninety-four (94) subjects consented to participate with 34% of these subjects (n=74) meeting all eligibility criteria to be randomized to receive study agent or placebo. Across all sites, 99% of the recruitment of subjects in this clinical trial is via physician recruitment and referral with less than 1% responding to other recruitment strategies. A contemporary approach to subject recruitment and frequent evaluation is needed to assure responsiveness to emerging challenges to accrual and the evolving scientific literature. A focus on investing on improving systems for physician recruitment may be key to meeting recruitment target in chemoprevention trials. Copyright © 2011 Elsevier Inc. All rights reserved.

Challenges and Potential Solutions to Meeting Accrual Goals in a Phase II Chemoprevention Trial for Prostate Cancer

PubMed Central

Kumar, Nagi; Crocker, Theresa; Smith, Tiffany; Pow-Sang, Julio; Spiess, Philippe E.; Egan, Kathleen; Quinn, Gwen; Schell, Michael; Sebti, Said; Kazi, Aslam; Chuang, Tian; Salup, Raoul; Helal, Mohamed; Zagaja, Gregory; Trabulsi, Edouard; McLarty, Jerry; Fazili, Tajammul; Williams, Christopher R.; Schreiber, Fred; Slaton, Joel; Anderson, J Kyle

2011-01-01

Objective The goal of this report is to describe the on going strategies, successes, challenges and solutions for recruitment in this multi-center, phase II chemoprevention trial targeting men at high risk for prostate cancer. Methods We developed and implemented a multi-center clinical trial in institutions with supportive infrastructure, lead by a recruitment team of experienced and committed physicians and clinical trial staff, implementing multi-media and community outreach strategies to meet recruitment goals. Screening logs were reviewed to identify trends as well as patient, protocol and infrastructure -related barriers impacting accrual and revisions to protocol implemented. Results Between January 2008 and February 2011 a total of 3547 individuals were prescreened with 94% (n=3092) determined to be ineligible based on diagnosis of cancer or benign biopsy results. Of these, 216 were considered eligible for further screening with 52% (n=113) declining to participate due to patient related factors and 14% (n=29) eliminated due to protocol-related criteria for exclusion. Ninety four (94) subjects consented to participate with 34% of these subjects (n=74) meeting all eligibility criteria to be randomized to receive study agent or placebo. Across all sites, 99% of the recruitment of subjects in this clinical trial is via physician recruitment and referral with less than 1% responding to other recruitment strategies. Conclusion A contemporary approach to subject recruitment and frequent evaluation is needed to assure responsiveness to emerging challenges to accrual and the evolving scientific literature. A focus on investing on improving systems for physician recruitment may be key to meeting recruitment target in chemoprevention trials. PMID:22101219

Application of quantum-dot multi-wavelength lasers and silicon photonic ring resonators to data-center optical interconnects

NASA Astrophysics Data System (ADS)

Beckett, Douglas J. S.; Hickey, Ryan; Logan, Dylan F.; Knights, Andrew P.; Chen, Rong; Cao, Bin; Wheeldon, Jeffery F.

2018-02-01

Quantum dot comb sources integrated with silicon photonic ring-resonator filters and modulators enable the realization of optical sub-components and modules for both inter- and intra-data-center applications. Low-noise, multi-wavelength, single-chip, laser sources, PAM4 modulation and direct detection allow a practical, scalable, architecture for applications beyond 400 Gb/s. Multi-wavelength, single-chip light sources are essential for reducing power dissipation, space and cost, while silicon photonic ring resonators offer high-performance with space and power efficiency.

Multi-criteria clinical decision support: A primer on the use of multiple criteria decision making methods to promote evidence-based, patient-centered healthcare.

PubMed

Dolan, James G

2010-01-01

Current models of healthcare quality recommend that patient management decisions be evidence-based and patient-centered. Evidence-based decisions require a thorough understanding of current information regarding the natural history of disease and the anticipated outcomes of different management options. Patient-centered decisions incorporate patient preferences, values, and unique personal circumstances into the decision making process and actively involve both patients along with health care providers as much as possible. Fundamentally, therefore, evidence-based, patient-centered decisions are multi-dimensional and typically involve multiple decision makers.Advances in the decision sciences have led to the development of a number of multiple criteria decision making methods. These multi-criteria methods are designed to help people make better choices when faced with complex decisions involving several dimensions. They are especially helpful when there is a need to combine "hard data" with subjective preferences, to make trade-offs between desired outcomes, and to involve multiple decision makers. Evidence-based, patient-centered clinical decision making has all of these characteristics. This close match suggests that clinical decision support systems based on multi-criteria decision making techniques have the potential to enable patients and providers to carry out the tasks required to implement evidence-based, patient-centered care effectively and efficiently in clinical settings.The goal of this paper is to give readers a general introduction to the range of multi-criteria methods available and show how they could be used to support clinical decision-making. Methods discussed include the balance sheet, the even swap method, ordinal ranking methods, direct weighting methods, multi-attribute decision analysis, and the analytic hierarchy process (AHP).

Multi-criteria clinical decision support: A primer on the use of multiple criteria decision making methods to promote evidence-based, patient-centered healthcare

PubMed Central

Dolan, James G.

2010-01-01

Current models of healthcare quality recommend that patient management decisions be evidence-based and patient-centered. Evidence-based decisions require a thorough understanding of current information regarding the natural history of disease and the anticipated outcomes of different management options. Patient-centered decisions incorporate patient preferences, values, and unique personal circumstances into the decision making process and actively involve both patients along with health care providers as much as possible. Fundamentally, therefore, evidence-based, patient-centered decisions are multi-dimensional and typically involve multiple decision makers. Advances in the decision sciences have led to the development of a number of multiple criteria decision making methods. These multi-criteria methods are designed to help people make better choices when faced with complex decisions involving several dimensions. They are especially helpful when there is a need to combine “hard data” with subjective preferences, to make trade-offs between desired outcomes, and to involve multiple decision makers. Evidence-based, patient-centered clinical decision making has all of these characteristics. This close match suggests that clinical decision support systems based on multi-criteria decision making techniques have the potential to enable patients and providers to carry out the tasks required to implement evidence-based, patient-centered care effectively and efficiently in clinical settings. The goal of this paper is to give readers a general introduction to the range of multi-criteria methods available and show how they could be used to support clinical decision-making. Methods discussed include the balance sheet, the even swap method, ordinal ranking methods, direct weighting methods, multi-attribute decision analysis, and the analytic hierarchy process (AHP) PMID:21394218

A highly efficient multi-core algorithm for clustering extremely large datasets

PubMed Central

2010-01-01

Background In recent years, the demand for computational power in computational biology has increased due to rapidly growing data sets from microarray and other high-throughput technologies. This demand is likely to increase. Standard algorithms for analyzing data, such as cluster algorithms, need to be parallelized for fast processing. Unfortunately, most approaches for parallelizing algorithms largely rely on network communication protocols connecting and requiring multiple computers. One answer to this problem is to utilize the intrinsic capabilities in current multi-core hardware to distribute the tasks among the different cores of one computer. Results We introduce a multi-core parallelization of the k-means and k-modes cluster algorithms based on the design principles of transactional memory for clustering gene expression microarray type data and categorial SNP data. Our new shared memory parallel algorithms show to be highly efficient. We demonstrate their computational power and show their utility in cluster stability and sensitivity analysis employing repeated runs with slightly changed parameters. Computation speed of our Java based algorithm was increased by a factor of 10 for large data sets while preserving computational accuracy compared to single-core implementations and a recently published network based parallelization. Conclusions Most desktop computers and even notebooks provide at least dual-core processors. Our multi-core algorithms show that using modern algorithmic concepts, parallelization makes it possible to perform even such laborious tasks as cluster sensitivity and cluster number estimation on the laboratory computer. PMID:20370922

[The Coordinating Centers for Clinical Trials (KKS) and the KKS Network: competence for clinical research].

PubMed

Ohmann, Christian; Bruns, Insa; Wolff, Stephanie

2010-01-01

The Network of the Coordination Centers for Clinical Trials (CTCs; Koordinierungszentren für Klinische Studien(KKS)) comprises 17 institutions working as scientific service provider for universities, study groups, the pharmaceutical and medical devices industry as well as additional clients associated with clinical research. The CTCs have established planning and conduct of clinical trials according to Good Clinical Practice (GCP) guidelines,with a wide range of study support in academia. One focus according to indications is cancer. Expertise in hematological/oncological research can be requested nationwide and cross-institutional. The KKS network currently cooperates with medical societies and other, even European networks in 20 countries and has been established as a strong platform for oncological trials. Copyright © 2010 S. Karger AG, Basel.

Study of Tranexamic Acid During Air Medical Prehospital Transport (STAAMP) Trial

DTIC Science & Technology

2017-10-01

Distribution Unlimited The views, opinions and/or findings contained in this report are those of the author(s) and should not be construed as an...ABSTRACT Multi-center, prospective, randomized, blinded, controlled interventional trial focusing on patients with concern for bleeding who are ...retraining scenarios were provided and are currently being converted into a quiz for distribution to the pre-hospital crews). 4. KEY RESEARCH

Innovating information-delivery for potential clinical trials participants. What do patients want from multi-media resources?

PubMed

Shneerson, Catherine; Windle, Richard; Cox, Karen

2013-01-01

To discover whether the provision of clinical trials information via a multi-media platform could better meet the needs, preferences and practices of potential cancer trial participants. A mixed qualitative and quantitative questionnaire was delivered to 72 participants from cancer support groups to elicit views on the provision and design features of multimedia resources in delivering clinical trials information. Perceived lack of information is an expressed barrier to clinical trials participation. Multimedia resources were viewed positively as a way to address this barrier by most potential clinical trials participants; in particular by helping to align information to individual needs, promote active engagement with information, and by allowing more control of the learning experience. Whilst text remained the most valued attribute of any resource, other highly rated attributes included the resource being simple to use, easily accessible, having a clear focus, incorporating examples and visual aids, and being interactive. Provision of support for the learning resource was also rated highly. As in other areas, such as education, multimedia resources may enhance the delivery and acceptance of information regarding clinical trials. Better alignment of information may have a positive impact on recruitment and retention into clinical trials. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Inverse treatment planning for spinal robotic radiosurgery: an international multi-institutional benchmark trial.

PubMed

Blanck, Oliver; Wang, Lei; Baus, Wolfgang; Grimm, Jimm; Lacornerie, Thomas; Nilsson, Joakim; Luchkovskyi, Sergii; Cano, Isabel Palazon; Shou, Zhenyu; Ayadi, Myriam; Treuer, Harald; Viard, Romain; Siebert, Frank-Andre; Chan, Mark K H; Hildebrandt, Guido; Dunst, Jürgen; Imhoff, Detlef; Wurster, Stefan; Wolff, Robert; Romanelli, Pantaleo; Lartigau, Eric; Semrau, Robert; Soltys, Scott G; Schweikard, Achim

2016-05-08

Stereotactic radiosurgery (SRS) is the accurate, conformal delivery of high-dose radiation to well-defined targets while minimizing normal structure doses via steep dose gradients. While inverse treatment planning (ITP) with computerized optimization algorithms are routine, many aspects of the planning process remain user-dependent. We performed an international, multi-institutional benchmark trial to study planning variability and to analyze preferable ITP practice for spinal robotic radiosurgery. 10 SRS treatment plans were generated for a complex-shaped spinal metastasis with 21 Gy in 3 fractions and tight constraints for spinal cord (V14Gy < 2 cc, V18Gy < 0.1 cc) and target (coverage > 95%). The resulting plans were rated on a scale from 1 to 4 (excellent-poor) in five categories (constraint compliance, optimization goals, low-dose regions, ITP complexity, and clinical acceptability) by a blinded review panel. Additionally, the plans were mathemati-cally rated based on plan indices (critical structure and target doses, conformity, monitor units, normal tissue complication probability, and treatment time) and compared to the human rankings. The treatment plans and the reviewers' rankings varied substantially among the participating centers. The average mean overall rank was 2.4 (1.2-4.0) and 8/10 plans were rated excellent in at least one category by at least one reviewer. The mathematical rankings agreed with the mean overall human rankings in 9/10 cases pointing toward the possibility for sole mathematical plan quality comparison. The final rankings revealed that a plan with a well-balanced trade-off among all planning objectives was preferred for treatment by most par-ticipants, reviewers, and the mathematical ranking system. Furthermore, this plan was generated with simple planning techniques. Our multi-institutional planning study found wide variability in ITP approaches for spinal robotic radiosurgery. The participants', reviewers', and mathematical match

Baseline Morbidity in 2,990 Adult African Volunteers Recruited to Characterize Laboratory Reference Intervals for Future HIV Vaccine Clinical Trials

PubMed Central

Stevens, Wendy; Kamali, Anatoli; Karita, Etienne; Anzala, Omu; Sanders, Eduard J.; Jaoko, Walter; Kaleebu, Pontiano; Mulenga, Joseph; Dally, Len; Fast, Pat; Gilmour, Jill; Farah, Bashir; Birungi, Josephine; Hughes, Peter; Manigart, Olivier; Stevens, Gwynn; Yates, Sarah; Thomson, Helen; von Lieven, Andrea; Krebs, Marietta; Price, Matt A.; Stoll-Johnson, Lisa; Ketter, Nzeera

2008-01-01

Background An understanding of the health of potential volunteers in Africa is essential for the safe and efficient conduct of clinical trials, particularly for trials of preventive technologies such as vaccines that enroll healthy individuals. Clinical safety laboratory values used for screening, enrolment and follow-up of African clinical trial volunteers have largely been based on values derived from industrialized countries in Europe and North America. This report describes baseline morbidity during recruitment for a multi-center, African laboratory reference intervals study. Methods Asymptomatic persons, aged 18–60 years, were invited to participate in a cross-sectional study at seven sites (Kigali, Rwanda; Masaka and Entebbe, Uganda; Kangemi, Kenyatta National Hospital and Kilifi, Kenya; and Lusaka, Zambia). Gender equivalency was by design. Individuals who were acutely ill, pregnant, menstruating, or had significant clinical findings were not enrolled. Each volunteer provided blood for hematology, immunology, and biochemistry parameters and urine for urinalysis. Enrolled volunteers were excluded if found to be positive for HIV, syphilis or Hepatitis B and C. Laboratory assays were conducted under Good Clinical Laboratory Practices (GCLP). Results and Conclusions Of the 2990 volunteers who were screened, 2387 (80%) were enrolled, and 2107 (71%) were included in the analysis (52% men, 48% women). Major reasons for screening out volunteers included abnormal findings on physical examination (228/603, 38%), significant medical history (76, 13%) and inability to complete the informed consent process (73, 13%). Once enrolled, principle reasons for exclusion from analysis included detection of Hepatitis B surface antigen (106/280, 38%) and antibodies against Hepatitis C (95, 34%). This is the first large scale, multi-site study conducted to the standards of GCLP to describe African laboratory reference intervals applicable to potential volunteers in clinical

Chronic gastritis in China: a national multi-center survey

PubMed Central

2014-01-01

Background Chronic gastritis is one of the most common findings at upper endoscopy in the general population, and chronic atrophic gastritis is epidemiologically associated with the occurrence of gastric cancer. However, the current status of diagnosis and treatment of chronic gastritis in China is unclear. Methods A multi-center national study was performed; all patients who underwent diagnostic upper endoscopy for evaluation of gastrointestinal symptoms from 33 centers were enrolled. Data including sex, age, symptoms and endoscopic findings were prospectively recorded. Results Totally 8892 patients were included. At endoscopy, 4389, 3760 and 1573 patients were diagnosed to have superficial gastritis, erosive gastritis, and atrophic gastritis, respectively. After pathologic examination, it is found that atrophic gastritis, intestinal metaplasia and dysplasia were prevalent, which accounted for 25.8%, 23.6% and 7.3% of this patient population. Endoscopic features were useful for predicting pathologic atrophy (PLR = 4.78), but it was not useful for predicting erosive gastritis. Mucosal-protective agents and PPI were most commonly used medications for chronic gastritis. Conclusions The present study suggests non-atrophic gastritis is the most common endoscopic finding in Chinese patients with upper GI symptoms. Precancerous lesions, including atrophy, intestinal metaplasia and dysplasia are prevalent in Chinese patients with chronic gastritis, and endoscopic features are useful for predicting pathologic atrophy. PMID:24502423

Optimization of multi-environment trials for genomic selection based on crop models.

PubMed

Rincent, R; Kuhn, E; Monod, H; Oury, F-X; Rousset, M; Allard, V; Le Gouis, J

2017-08-01

We propose a statistical criterion to optimize multi-environment trials to predict genotype × environment interactions more efficiently, by combining crop growth models and genomic selection models. Genotype × environment interactions (GEI) are common in plant multi-environment trials (METs). In this context, models developed for genomic selection (GS) that refers to the use of genome-wide information for predicting breeding values of selection candidates need to be adapted. One promising way to increase prediction accuracy in various environments is to combine ecophysiological and genetic modelling thanks to crop growth models (CGM) incorporating genetic parameters. The efficiency of this approach relies on the quality of the parameter estimates, which depends on the environments composing this MET used for calibration. The objective of this study was to determine a method to optimize the set of environments composing the MET for estimating genetic parameters in this context. A criterion called OptiMET was defined to this aim, and was evaluated on simulated and real data, with the example of wheat phenology. The MET defined with OptiMET allowed estimating the genetic parameters with lower error, leading to higher QTL detection power and higher prediction accuracies. MET defined with OptiMET was on average more efficient than random MET composed of twice as many environments, in terms of quality of the parameter estimates. OptiMET is thus a valuable tool to determine optimal experimental conditions to best exploit MET and the phenotyping tools that are currently developed.

Hand-suture versus stapling for closure of loop ileostomy: HASTA-Trial: a study rationale and design for a randomized controlled trial

PubMed Central

2011-01-01

Background Colorectal cancer is the second most common tumor in developed countries, with a lifetime prevalence of 5%. About one third of these tumors are located in the rectum. Surgery in terms of low anterior resection with mesorectal excision is the central element in the treatment of rectal cancer being the only option for definite cure. Creating a protective diverting stoma prevents complications like anastomotic failure and meanwhile is the standard procedure. Bowel obstruction is one of the main and the clinically and economically most relevant complication following closure of loop ileostomy. The best surgical technique for closure of loop ileostomy has not been defined yet. Methods/Design A study protocol was developed on the basis of the only randomized controlled mono-center trial to solve clinical equipoise concerning the optimal surgical technique for closure of loop ileostomy after low anterior resection due to rectal cancer. The HASTA trial is a multi-center pragmatic randomized controlled surgical trial with two parallel groups to compare hand-suture versus stapling for closure of loop ileostomy. It will include 334 randomized patients undergoing closure of loop ileostomy after low anterior resection with protective ileostomy due to rectal cancer in approximately 20 centers consisting of German hospitals of all level of health care. The primary endpoint is the rate of bowel obstruction within 30 days after ileostomy closure. In addition, a set of surgical and general variables including quality of life will be analyzed with a follow-up of 12 months. An investigators meeting with a practical session will help to minimize performance bias and enforce protocol adherence. Centers are monitored centrally as well as on-site before and during recruitment phase to assure inclusion, treatment and follow up according to the protocol. Discussion Aim of the HASTA trial is to evaluate the efficacy of hand-suture versus stapling for closure of loop ileostomy in

Measurement of multi-jet cross sections in proton-proton collisions at a 7 TeV center-of-mass energy

NASA Astrophysics Data System (ADS)

Aad, G.; Abbott, B.; Abdallah, J.; Abdelalim, A. A.; Abdesselam, A.; Abdinov, O.; Abi, B.; Abolins, M.; Abramowicz, H.; Abreu, H.; Acerbi, E.; Acharya, B. S.; Adams, D. L.; Addy, T. N.; Adelman, J.; Aderholz, M.; Adomeit, S.; Adragna, P.; Adye, T.; Aefsky, S.; Aguilar-Saavedra, J. A.; Aharrouche, M.; Ahlen, S. P.; Ahles, F.; Ahmad, A.; Ahsan, M.; Aielli, G.; Akdogan, T.; Åkesson, T. P. A.; Akimoto, G.; Akimov, A. V.; Akiyama, A.; Alam, M. S.; Alam, M. A.; Albrand, S.; Aleksa, M.; Aleksandrov, I. N.; Alessandria, F.; Alexa, C.; Alexander, G.; Alexandre, G.; Alexopoulos, T.; Alhroob, M.; Aliev, M.; Alimonti, G.; Alison, J.; Aliyev, M.; Allport, P. P.; Allwood-Spiers, S. E.; Almond, J.; Aloisio, A.; Alon, R.; Alonso, A.; Alviggi, M. G.; Amaral, P.; Amelung, C.; Ammosov, V. V.; Amorim, A.; Amorós, G.; Amram, N.; Anastopoulos, C.; Andari, N.; Andeen, T.; Anders, C. F.; Anderson, K. J.; Andreazza, A.; Andrei, V.; Andrieux, M.-L.; Anduaga, X. S.; Angerami, A.; Anghinolfi, F.; Anjos, N.; Annovi, A.; Antonaki, A.; Antonelli, M.; Antonelli, S.; Antonov, A.; Antos, J.; Anulli, F.; Aoun, S.; Aperio Bella, L.; Apolle, R.; Arabidze, G.; Aracena, I.; Arai, Y.; Arce, A. T. H.; Archambault, J. P.; Arfaoui, S.; Arguin, J.-F.; Arik, E.; Arik, M.; Armbruster, A. J.; Arnaez, O.; Arnault, C.; Artamonov, A.; Artoni, G.; Arutinov, D.; Asai, S.; Asfandiyarov, R.; Ask, S.; Åsman, B.; Asquith, L.; Assamagan, K.; Astbury, A.; Astvatsatourov, A.; Atoian, G.; Aubert, B.; Auerbach, B.; Auge, E.; Augsten, K.; Aurousseau, M.; Austin, N.; Avolio, G.; Avramidou, R.; Axen, D.; Ay, C.; Azuelos, G.; Azuma, Y.; Baak, M. A.; Baccaglioni, G.; Bacci, C.; Bach, A. M.; Bachacou, H.; Bachas, K.; Bachy, G.; Backes, M.; Backhaus, M.; Badescu, E.; Bagnaia, P.; Bahinipati, S.; Bai, Y.; Bailey, D. C.; Bain, T.; Baines, J. T.; Baker, O. K.; Baker, M. D.; Baker, S.; Baltasar Dos Santos Pedrosa, F.; Banas, E.; Banerjee, P.; Banerjee, Sw.; Banfi, D.; Bangert, A.; Bansal, V.; Bansil, H. S.; Barak, L.; Baranov, S. P.; Barashkou, A.; Barbaro Galtieri, A.; Barber, T.; Barberio, E. L.; Barberis, D.; Barbero, M.; Bardin, D. Y.; Barillari, T.; Barisonzi, M.; Barklow, T.; Barlow, N.; Barnett, B. M.; Barnett, R. M.; Baroncelli, A.; Barone, G.; Barr, A. J.; Barreiro, F.; Barreiro Guimarães da Costa, J.; Barrillon, P.; Bartoldus, R.; Barton, A. E.; Bartsch, D.; Bartsch, V.; Bates, R. L.; Batkova, L.; Batley, J. R.; Battaglia, A.; Battistin, M.; Battistoni, G.; Bauer, F.; Bawa, H. S.; Beare, B.; Beau, T.; Beauchemin, P. H.; Beccherle, R.; Bechtle, P.; Beck, H. P.; Beckingham, M.; Becks, K. H.; Beddall, A. J.; Beddall, A.; Bedikian, S.; Bednyakov, V. A.; Bee, C. P.; Begel, M.; Behar Harpaz, S.; Behera, P. K.; Beimforde, M.; Belanger-Champagne, C.; Bell, P. J.; Bell, W. H.; Bella, G.; Bellagamba, L.; Bellina, F.; Bellomo, M.; Belloni, A.; Beloborodova, O.; Belotskiy, K.; Beltramello, O.; Ben Ami, S.; Benary, O.; Benchekroun, D.; Benchouk, C.; Bendel, M.; Benedict, B. H.; Benekos, N.; Benhammou, Y.; Benjamin, D. P.; Benoit, M.; Bensinger, J. R.; Benslama, K.; Bentvelsen, S.; Berge, D.; Bergeaas Kuutmann, E.; Berger, N.; Berghaus, F.; Berglund, E.; Beringer, J.; Bernardet, K.; Bernat, P.; Bernhard, R.; Bernius, C.; Berry, T.; Bertin, A.; Bertinelli, F.; Bertolucci, F.; Besana, M. I.; Besson, N.; Bethke, S.; Bhimji, W.; Bianchi, R. M.; Bianco, M.; Biebel, O.; Bieniek, S. P.; Biesiada, J.; Biglietti, M.; Bilokon, H.; Bindi, M.; Binet, S.; Bingul, A.; Bini, C.; Biscarat, C.; Bitenc, U.; Black, K. M.; Blair, R. E.; Blanchard, J.-B.; Blanchot, G.; Blazek, T.; Blocker, C.; Blocki, J.; Blondel, A.; Blum, W.; Blumenschein, U.; Bobbink, G. J.; Bobrovnikov, V. B.; Bocchetta, S. S.; Bocci, A.; Boddy, C. R.; Boehler, M.; Boek, J.; Boelaert, N.; Böser, S.; Bogaerts, J. A.; Bogdanchikov, A.; Bogouch, A.; Bohm, C.; Boisvert, V.; Bold, T.; Boldea, V.; Bolnet, N. M.; Bona, M.; Bondarenko, V. G.; Boonekamp, M.; Boorman, G.; Booth, C. N.; Bordoni, S.; Borer, C.; Borisov, A.; Borissov, G.; Borjanovic, I.; Borroni, S.; Bos, K.; Boscherini, D.; Bosman, M.; Boterenbrood, H.; Botterill, D.; Bouchami, J.; Boudreau, J.; Bouhova-Thacker, E. V.; Boulahouache, C.; Bourdarios, C.; Bousson, N.; Boveia, A.; Boyd, J.; Boyko, I. R.; Bozhko, N. I.; Bozovic-Jelisavcic, I.; Bracinik, J.; Braem, A.; Branchini, P.; Brandenburg, G. W.; Brandt, A.; Brandt, G.; Brandt, O.; Bratzler, U.; Brau, B.; Brau, J. E.; Braun, H. M.; Brelier, B.; Bremer, J.; Brenner, R.; Bressler, S.; Breton, D.; Britton, D.; Brochu, F. M.; Brock, I.; Brock, R.; Brodbeck, T. J.; Brodet, E.; Broggi, F.; Bromberg, C.; Brooijmans, G.; Brooks, W. K.; Brown, G.; Brown, H.; Bruckman de Renstrom, P. A.; Bruncko, D.; Bruneliere, R.; Brunet, S.; Bruni, A.; Bruni, G.; Bruschi, M.; Buanes, T.; Bucci, F.; Buchanan, J.; Buchanan, N. J.; Buchholz, P.; Buckingham, R. M.; Buckley, A. G.; Buda, S. I.; Budagov, I. A.; Budick, B.; Büscher, V.; Bugge, L.; Buira-Clark, D.; Bulekov, O.; Bunse, M.; Buran, T.; Burckhart, H.; Burdin, S.; Burgess, T.; Burke, S.; Busato, E.; Bussey, P.; Buszello, C. P.; Butin, F.; Butler, B.; Butler, J. M.; Buttar, C. M.; Butterworth, J. M.; Buttinger, W.; Byatt, T.; Cabrera Urbán, S.; Caforio, D.; Cakir, O.; Calafiura, P.; Calderini, G.; Calfayan, P.; Calkins, R.; Caloba, L. P.; Caloi, R.; Calvet, D.; Calvet, S.; Camacho Toro, R.; Camarri, P.; Cambiaghi, M.; Cameron, D.; Campana, S.; Campanelli, M.; Canale, V.; Canelli, F.; Canepa, A.; Cantero, J.; Capasso, L.; Capeans Garrido, M. D. M.; Caprini, I.; Caprini, M.; Capriotti, D.; Capua, M.; Caputo, R.; Caramarcu, C.; Cardarelli, R.; Carli, T.; Carlino, G.; Carminati, L.; Caron, B.; Caron, S.; Carrillo Montoya, G. D.; Carter, A. A.; Carter, J. R.; Carvalho, J.; Casadei, D.; Casado, M. P.; Cascella, M.; Caso, C.; Castaneda Hernandez, A. M.; Castaneda-Miranda, E.; Castillo Gimenez, V.; Castro, N. F.; Cataldi, G.; Cataneo, F.; Catinaccio, A.; Catmore, J. R.; Cattai, A.; Cattani, G.; Caughron, S.; Cauz, D.; Cavalleri, P.; Cavalli, D.; Cavalli-Sforza, M.; Cavasinni, V.; Ceradini, F.; Cerqueira, A. S.; Cerri, A.; Cerrito, L.; Cerutti, F.; Cetin, S. A.; Cevenini, F.; Chafaq, A.; Chakraborty, D.; Chan, K.; Chapleau, B.; Chapman, J. D.; Chapman, J. W.; Chareyre, E.; Charlton, D. G.; Chavda, V.; Cheatham, S.; Chekanov, S.; Chekulaev, S. V.; Chelkov, G. A.; Chelstowska, M. A.; Chen, C.; Chen, H.; Chen, S.; Chen, T.; Chen, X.; Cheng, S.; Cheplakov, A.; Chepurnov, V. F.; Cherkaoui El Moursli, R.; Chernyatin, V.; Cheu, E.; Cheung, S. L.; Chevalier, L.; Chiefari, G.; Chikovani, L.; Childers, J. T.; Chilingarov, A.; Chiodini, G.; Chizhov, M. V.; Choudalakis, G.; Chouridou, S.; Christidi, I. A.; Christov, A.; Chromek-Burckhart, D.; Chu, M. L.; Chudoba, J.; Ciapetti, G.; Ciba, K.; Ciftci, A. K.; Ciftci, R.; Cinca, D.; Cindro, V.; Ciobotaru, M. D.; Ciocca, C.; Ciocio, A.; Cirilli, M.; Ciubancan, M.; Clark, A.; Clark, P. J.; Cleland, W.; Clemens, J. C.; Clement, B.; Clement, C.; Clifft, R. W.; Coadou, Y.; Cobal, M.; Coccaro, A.; Cochran, J.; Coe, P.; Cogan, J. G.; Coggeshall, J.; Cogneras, E.; Cojocaru, C. D.; Colas, J.; Colijn, A. P.; Collard, C.; Collins, N. J.; Collins-Tooth, C.; Collot, J.; Colon, G.; Conde Muiño, P.; Coniavitis, E.; Conidi, M. C.; Consonni, M.; Consorti, V.; Constantinescu, S.; Conta, C.; Conventi, F.; Cook, J.; Cooke, M.; Cooper, B. D.; Cooper-Sarkar, A. M.; Cooper-Smith, N. J.; Copic, K.; Cornelissen, T.; Corradi, M.; Corriveau, F.; Cortes-Gonzalez, A.; Cortiana, G.; Costa, G.; Costa, M. J.; Costanzo, D.; Costin, T.; Côté, D.; Coura Torres, R.; Courneyea, L.; Cowan, G.; Cowden, C.; Cox, B. E.; Cranmer, K.; Crescioli, F.; Cristinziani, M.; Crosetti, G.; Crupi, R.; Crépé-Renaudin, S.; Cuciuc, C.-M.; Cuenca Almenar, C.; Cuhadar Donszelmann, T.; Cuneo, S.; Curatolo, M.; Curtis, C. J.; Cwetanski, P.; Czirr, H.; Czyczula, Z.; D'Auria, S.; D'Onofrio, M.; D'Orazio, A.; Da Silva, P. V. M.; Da Via, C.; Dabrowski, W.; Dai, T.; Dallapiccola, C.; Dam, M.; Dameri, M.; Damiani, D. S.; Danielsson, H. O.; Dannheim, D.; Dao, V.; Darbo, G.; Darlea, G. L.; Daum, C.; Dauvergne, J. P.; Davey, W.; Davidek, T.; Davidson, N.; Davidson, R.; Davies, E.; Davies, M.; Davison, A. R.; Davygora, Y.; Dawe, E.; Dawson, I.; Dawson, J. W.; Daya, R. K.; De, K.; de Asmundis, R.; De Castro, S.; De Castro Faria Salgado, P. E.; De Cecco, S.; de Graat, J.; De Groot, N.; de Jong, P.; De La Taille, C.; De la Torre, H.; De Lotto, B.; De Mora, L.; De Nooij, L.; De Oliveira Branco, M.; De Pedis, D.; de Saintignon, P.; De Salvo, A.; De Sanctis, U.; De Santo, A.; De Vivie De Regie, J. B.; Dean, S.; Dedovich, D. V.; Degenhardt, J.; Dehchar, M.; Deile, M.; Del Papa, C.; Del Peso, J.; Del Prete, T.; Dell'Acqua, A.; Dell'Asta, L.; Della Pietra, M.; della Volpe, D.; Delmastro, M.; Delpierre, P.; Delruelle, N.; Delsart, P. A.; Deluca, C.; Demers, S.; Demichev, M.; Demirkoz, B.; Deng, J.; Denisov, S. P.; Derendarz, D.; Derkaoui, J. E.; Derue, F.; Dervan, P.; Desch, K.; Devetak, E.; Deviveiros, P. O.; Dewhurst, A.; DeWilde, B.; Dhaliwal, S.; Dhullipudi, R.; Di Ciaccio, A.; Di Ciaccio, L.; Di Girolamo, A.; Di Girolamo, B.; Di Luise, S.; Di Mattia, A.; Di Micco, B.; Di Nardo, R.; Di Simone, A.; Di Sipio, R.; Diaz, M. A.; Diblen, F.; Diehl, E. B.; Dietrich, J.; Dietzsch, T. A.; Diglio, S.; Dindar Yagci, K.; Dingfelder, J.; Dionisi, C.; Dita, P.; Dita, S.; Dittus, F.; Djama, F.; Djilkibaev, R.; Djobava, T.; do Vale, M. A. B.; Do Valle Wemans, A.; Doan, T. K. O.; Dobbs, M.; Dobinson, R.; Dobos, D.; Dobson, E.; Dobson, M.; Dodd, J.; Doglioni, C.; Doherty, T.; Doi, Y.; Dolejsi, J.; Dolenc, I.; Dolezal, Z.; Dolgoshein, B. A.; Dohmae, T.; Donadelli, M.; Donega, M.; Donini, J.; Dopke, J.; Doria, A.; Dos Anjos, A.; Dosil, M.; Dotti, A.; Dova, M. T.; Dowell, J. D.; Doxiadis, A. D.; Doyle, A. T.; Drasal, Z.; Drees, J.; Dressnandt, N.; Drevermann, H.; Driouichi, C.; Dris, M.; Dubbert, J.; Dubbs, T.; Dube, S.; Duchovni, E.; Duckeck, G.; Dudarev, A.; Dudziak, F.; Dührssen, M.; Duerdoth, I. P.; Duflot, L.; Dufour, M.-A.; Dunford, M.; Duran Yildiz, H.; Duxfield, R.; Dwuznik, M.; Dydak, F.; Dzahini, D.; Düren, M.; Ebenstein, W. L.; Ebke, J.; Eckert, S.; Eckweiler, S.; Edmonds, K.; Edwards, C. A.; Edwards, N. C.; Ehrenfeld, W.; Ehrich, T.; Eifert, T.; Eigen, G.; Einsweiler, K.; Eisenhandler, E.; Ekelof, T.; El Kacimi, M.; Ellert, M.; Elles, S.; Ellinghaus, F.; Ellis, K.; Ellis, N.; Elmsheuser, J.; Elsing, M.; Ely, R.; Emeliyanov, D.; Engelmann, R.; Engl, A.; Epp, B.; Eppig, A.; Erdmann, J.; Ereditato, A.; Eriksson, D.; Ernst, J.; Ernst, M.; Ernwein, J.; Errede, D.; Errede, S.; Ertel, E.; Escalier, M.; Escobar, C.; Espinal Curull, X.; Esposito, B.; Etienne, F.; Etienvre, A. I.; Etzion, E.; Evangelakou, D.; Evans, H.; Fabbri, L.; Fabre, C.; Fakhrutdinov, R. M.; Falciano, S.; Falou, A. C.; Fang, Y.; Fanti, M.; Farbin, A.; Farilla, A.; Farley, J.; Farooque, T.; Farrington, S. M.; Farthouat, P.; Fassnacht, P.; Fassouliotis, D.; Fatholahzadeh, B.; Favareto, A.; Fayard, L.; Fazio, S.; Febbraro, R.; Federic, P.; Fedin, O. L.; Fedorko, W.; Fehling-Kaschek, M.; Feligioni, L.; Fellmann, D.; Felzmann, C. U.; Feng, C.; Feng, E. J.; Fenyuk, A. B.; Ferencei, J.; Ferland, J.; Fernando, W.; Ferrag, S.; Ferrando, J.; Ferrara, V.; Ferrari, A.; Ferrari, P.; Ferrari, R.; Ferrer, A.; Ferrer, M. L.; Ferrere, D.; Ferretti, C.; Ferretto Parodi, A.; Fiascaris, M.; Fiedler, F.; Filipčič, A.; Filippas, A.; Filthaut, F.; Fincke-Keeler, M.; Fiolhais, M. C. N.; Fiorini, L.; Firan, A.; Fischer, G.; Fischer, P.; Fisher, M. J.; Fisher, S. M.; Flechl, M.; Fleck, I.; Fleckner, J.; Fleischmann, P.; Fleischmann, S.; Flick, T.; Flores Castillo, L. R.; Flowerdew, M. J.; Föhlisch, F.; Fokitis, M.; Fonseca Martin, T.; Forbush, D. A.; Formica, A.; Forti, A.; Fortin, D.; Foster, J. M.; Fournier, D.; Foussat, A.; Fowler, A. J.; Fowler, K.; Fox, H.; Francavilla, P.; Franchino, S.; Francis, D.; Frank, T.; Franklin, M.; Franz, S.; Fraternali, M.; Fratina, S.; French, S. T.; Froeschl, R.; Froidevaux, D.; Frost, J. A.; Fukunaga, C.; Fullana Torregrosa, E.; Fuster, J.; Gabaldon, C.; Gabizon, O.; Gadfort, T.; Gadomski, S.; Gagliardi, G.; Gagnon, P.; Galea, C.; Gallas, E. J.; Gallas, M. V.; Gallo, V.; Gallop, B. J.; Gallus, P.; Galyaev, E.; Gan, K. K.; Gao, Y. S.; Gapienko, V. A.; Gaponenko, A.; Garberson, F.; Garcia-Sciveres, M.; García, C.; García Navarro, J. E.; Gardner, R. W.; Garelli, N.; Garitaonandia, H.; Garonne, V.; Garvey, J.; Gatti, C.; Gaudio, G.; Gaumer, O.; Gaur, B.; Gauthier, L.; Gavrilenko, I. L.; Gay, C.; Gaycken, G.; Gayde, J.-C.; Gazis, E. N.; Ge, P.; Gee, C. N. P.; Geerts, D. A. A.; Geich-Gimbel, Ch.; Gellerstedt, K.; Gemme, C.; Gemmell, A.; Genest, M. H.; Gentile, S.; George, M.; George, S.; Gerlach, P.; Gershon, A.; Geweniger, C.; Ghazlane, H.; Ghez, P.; Ghodbane, N.; Giacobbe, B.; Giagu, S.; Giakoumopoulou, V.; Giangiobbe, V.; Gianotti, F.; Gibbard, B.; Gibson, A.; Gibson, S. M.; Gilbert, L. M.; Gilchriese, M.; Gilewsky, V.; Gillberg, D.; Gillman, A. R.; Gingrich, D. M.; Ginzburg, J.; Giokaris, N.; Giordano, R.; Giorgi, F. M.; Giovannini, P.; Giraud, P. F.; Giugni, D.; Giunta, M.; Giusti, P.; Gjelsten, B. K.; Gladilin, L. K.; Glasman, C.; Glatzer, J.; Glazov, A.; Glitza, K. W.; Glonti, G. L.; Godfrey, J.; Godlewski, J.; Goebel, M.; Göpfert, T.; Goeringer, C.; Gössling, C.; Göttfert, T.; Goldfarb, S.; Goldin, D.; Golling, T.; Golovnia, S. N.; Gomes, A.; Gomez Fajardo, L. S.; Gonçalo, R.; Goncalves Pinto Firmino Da Costa, J.; Gonella, L.; Gonidec, A.; Gonzalez, S.; González de la Hoz, S.; Gonzalez Silva, M. L.; Gonzalez-Sevilla, S.; Goodson, J. J.; Goossens, L.; Gorbounov, P. A.; Gordon, H. A.; Gorelov, I.; Gorfine, G.; Gorini, B.; Gorini, E.; Gorišek, A.; Gornicki, E.; Gorokhov, S. A.; Goryachev, V. N.; Gosdzik, B.; Gosselink, M.; Gostkin, M. I.; Gouanère, M.; Gough Eschrich, I.; Gouighri, M.; Goujdami, D.; Goulette, M. P.; Goussiou, A. G.; Goy, C.; Grabowska-Bold, I.; Grabski, V.; Grafström, P.; Grah, C.; Grahn, K.-J.; Grancagnolo, F.; Grancagnolo, S.; Grassi, V.; Gratchev, V.; Grau, N.; Gray, H. M.; Gray, J. A.; Graziani, E.; Grebenyuk, O. G.; Greenfield, D.; Greenshaw, T.; Greenwood, Z. D.; Gregor, I. M.; Grenier, P.; Griffiths, J.; Grigalashvili, N.; Grillo, A. A.; Grinstein, S.; Grishkevich, Y. V.; Grivaz, J.-F.; Grognuz, J.; Groh, M.; Gross, E.; Grosse-Knetter, J.; Groth-Jensen, J.; Grybel, K.; Guarino, V. J.; Guest, D.; Guicheney, C.; Guida, A.; Guillemin, T.; Guindon, S.; Guler, H.; Gunther, J.; Guo, B.; Guo, J.; Gupta, A.; Gusakov, Y.; Gushchin, V. N.; Gutierrez, A.; Gutierrez, P.; Guttman, N.; Gutzwiller, O.; Guyot, C.; Gwenlan, C.; Gwilliam, C. B.; Haas, A.; Haas, S.; Haber, C.; Hackenburg, R.; Hadavand, H. K.; Hadley, D. R.; Haefner, P.; Hahn, F.; Haider, S.; Hajduk, Z.; Hakobyan, H.; Haller, J.; Hamacher, K.; Hamal, P.; Hamilton, A.; Hamilton, S.; Han, H.; Han, L.; Hanagaki, K.; Hance, M.; Handel, C.; Hanke, P.; Hansen, J. R.; Hansen, J. B.; Hansen, J. D.; Hansen, P. H.; Hansson, P.; Hara, K.; Hare, G. A.; Harenberg, T.; Harkusha, S.; Harper, D.; Harrington, R. D.; Harris, O. M.; Harrison, K.; Hartert, J.; Hartjes, F.; Haruyama, T.; Harvey, A.; Hasegawa, S.; Hasegawa, Y.; Hassani, S.; Hatch, M.; Hauff, D.; Haug, S.; Hauschild, M.; Hauser, R.; Havranek, M.; Hawes, B. M.; Hawkes, C. M.; Hawkings, R. J.; Hawkins, D.; Hayakawa, T.; Hayden, D.; Hayward, H. S.; Haywood, S. J.; Hazen, E.; He, M.; Head, S. J.; Hedberg, V.; Heelan, L.; Heim, S.; Heinemann, B.; Heisterkamp, S.; Helary, L.; Heller, M.; Hellman, S.; Helsens, C.; Henderson, R. C. W.; Henke, M.; Henrichs, A.; Henriques Correia, A. M.; Henrot-Versille, S.; Henry-Couannier, F.; Hensel, C.; Henß, T.; Hernandez, C. M.; Hernández Jiménez, Y.; Herrberg, R.; Hershenhorn, A. D.; Herten, G.; Hertenberger, R.; Hervas, L.; Hessey, N. P.; Hidvegi, A.; Higón-Rodriguez, E.; Hill, D.; Hill, J. C.; Hill, N.; Hiller, K. H.; Hillert, S.; Hillier, S. J.; Hinchliffe, I.; Hines, E.; Hirose, M.; Hirsch, F.; Hirschbuehl, D.; Hobbs, J.; Hod, N.; Hodgkinson, M. C.; Hodgson, P.; Hoecker, A.; Hoeferkamp, M. R.; Hoffman, J.; Hoffmann, D.; Hohlfeld, M.; Holder, M.; Holmes, A.; Holmgren, S. O.; Holtsch, A.; Holy, T.; Holzbauer, J. L.; Homma, Y.; Hong, T. M.; Hooft van Huysduynen, L.; Horazdovsky, T.; Horn, C.; Horner, S.; Horton, K.; Hostachy, J.-Y.; Hou, S.; Houlden, M. A.; Hoummada, A.; Howarth, J.; Howell, D. F.; Hristova, I.; Hrivnac, J.; Hruska, I.; Hryn'ova, T.; Hsu, P. J.; Hsu, S.-C.; Huang, G. S.; Hubacek, Z.; Hubaut, F.; Huegging, F.; Huffman, T. B.; Hughes, E. W.; Hughes, G.; Hughes-Jones, R. E.; Huhtinen, M.; Hurst, P.; Hurwitz, M.; Husemann, U.; Huseynov, N.; Huston, J.; Huth, J.; Iacobucci, G.; Iakovidis, G.; Ibbotson, M.; Ibragimov, I.; Ichimiya, R.; Iconomidou-Fayard, L.; Idarraga, J.; Idzik, M.; Iengo, P.; Igonkina, O.; Ikegami, Y.; Ikeno, M.; Ilchenko, Y.; Iliadis, D.; Imbault, D.; Imhaeuser, M.; Imori, M.; Ince, T.; Inigo-Golfin, J.; Ioannou, P.; Iodice, M.; Ionescu, G.; Irles Quiles, A.; Ishii, K.; Ishikawa, A.; Ishino, M.; Ishmukhametov, R.; Issever, C.; Istin, S.; Itoh, Y.; Ivashin, A. V.; Iwanski, W.; Iwasaki, H.; Izen, J. M.; Izzo, V.; Jackson, B.; Jackson, J. N.; Jackson, P.; Jaekel, M. R.; Jain, V.; Jakobs, K.; Jakobsen, S.; Jakubek, J.; Jana, D. K.; Jankowski, E.; Jansen, E.; Jantsch, A.; Janus, M.; Jarlskog, G.; Jeanty, L.; Jelen, K.; Jen-La Plante, I.; Jenni, P.; Jeremie, A.; Jež, P.; Jézéquel, S.; Jha, M. K.; Ji, H.; Ji, W.; Jia, J.; Jiang, Y.; Jimenez Belenguer, M.; Jin, G.; Jin, S.; Jinnouchi, O.; Joergensen, M. D.; Joffe, D.; Johansen, L. G.; Johansen, M.; Johansson, K. E.; Johansson, P.; Johnert, S.; Johns, K. A.; Jon-And, K.; Jones, G.; Jones, R. W. L.; Jones, T. W.; Jones, T. J.; Jonsson, O.; Joram, C.; Jorge, P. M.; Joseph, J.; Ju, X.; Juranek, V.; Jussel, P.; Kabachenko, V. V.; Kabana, S.; Kaci, M.; Kaczmarska, A.; Kadlecik, P.; Kado, M.; Kagan, H.; Kagan, M.; Kaiser, S.; Kajomovitz, E.; Kalinin, S.; Kalinovskaya, L. V.; Kama, S.; Kanaya, N.; Kaneda, M.; Kanno, T.; Kantserov, V. A.; Kanzaki, J.; Kaplan, B.; Kapliy, A.; Kaplon, J.; Kar, D.; Karagoz, M.; Karnevskiy, M.; Karr, K.; Kartvelishvili, V.; Karyukhin, A. N.; Kashif, L.; Kasmi, A.; Kass, R. D.; Kastanas, A.; Kataoka, M.; Kataoka, Y.; Katsoufis, E.; Katzy, J.; Kaushik, V.; Kawagoe, K.; Kawamoto, T.; Kawamura, G.; Kayl, M. S.; Kazanin, V. A.; Kazarinov, M. Y.; Keates, J. R.; Keeler, R.; Kehoe, R.; Keil, M.; Kekelidze, G. D.; Kelly, M.; Kennedy, J.; Kenney, C. J.; Kenyon, M.; Kepka, O.; Kerschen, N.; Kerševan, B. P.; Kersten, S.; Kessoku, K.; Ketterer, C.; Keung, J.; Khakzad, M.; Khalil-zada, F.; Khandanyan, H.; Khanov, A.; Kharchenko, D.; Khodinov, A.; Kholodenko, A. G.; Khomich, A.; Khoo, T. J.; Khoriauli, G.; Khoroshilov, A.; Khovanskiy, N.; Khovanskiy, V.; Khramov, E.; Khubua, J.; Kim, H.; Kim, M. S.; Kim, P. C.; Kim, S. H.; Kimura, N.; Kind, O.; King, B. T.; King, M.; King, R. S. B.; Kirk, J.; Kirsch, G. P.; Kirsch, L. E.; Kiryunin, A. E.; Kisielewska, D.; Kittelmann, T.; Kiver, A. M.; Kiyamura, H.; Kladiva, E.; Klaiber-Lodewigs, J.; Klein, M.; Klein, U.; Kleinknecht, K.; Klemetti, M.; Klier, A.; Klimentov, A.; Klingenberg, R.; Klinkby, E. B.; Klioutchnikova, T.; Klok, P. F.; Klous, S.; Kluge, E.-E.; Kluge, T.; Kluit, P.; Kluth, S.; Kneringer, E.; Knobloch, J.; Knoops, E. B. F. G.; Knue, A.; Ko, B. R.; Kobayashi, T.; Kobel, M.; Kocian, M.; Kocnar, A.; Kodys, P.; Köneke, K.; König, A. C.; Koenig, S.; Köpke, L.; Koetsveld, F.; Koevesarki, P.; Koffas, T.; Koffeman, E.; Kohn, F.; Kohout, Z.; Kohriki, T.; Koi, T.; Kokott, T.; Kolachev, G. M.; Kolanoski, H.; Kolesnikov, V.; Koletsou, I.; Koll, J.; Kollar, D.; Kollefrath, M.; Kolya, S. D.; Komar, A. A.; Komaragiri, J. R.; Komori, Y.; Kondo, T.; Kono, T.; Kononov, A. I.; Konoplich, R.; Konstantinidis, N.; Kootz, A.; Koperny, S.; Kopikov, S. V.; Korcyl, K.; Kordas, K.; Koreshev, V.; Korn, A.; Korol, A.; Korolkov, I.; Korolkova, E. V.; Korotkov, V. A.; Kortner, O.; Kortner, S.; Kostyukhin, V. V.; Kotamäki, M. J.; Kotov, S.; Kotov, V. M.; Kotwal, A.; Kourkoumelis, C.; Kouskoura, V.; Koutsman, A.; Kowalewski, R.; Kowalski, T. Z.; Kozanecki, W.; Kozhin, A. S.; Kral, V.; Kramarenko, V. A.; Kramberger, G.; Krasel, O.; Krasny, M. W.; Krasznahorkay, A.; Kraus, J.; Kreisel, A.; Krejci, F.; Kretzschmar, J.; Krieger, N.; Krieger, P.; Kroeninger, K.; Kroha, H.; Kroll, J.; Kroseberg, J.; Krstic, J.; Kruchonak, U.; Krüger, H.; Kruker, T.; Krumshteyn, Z. V.; Kruth, A.; Kubota, T.; Kuehn, S.; Kugel, A.; Kuhl, T.; Kuhn, D.; Kukhtin, V.; Kulchitsky, Y.; Kuleshov, S.; Kummer, C.; Kuna, M.; Kundu, N.; Kunkle, J.; Kupco, A.; Kurashige, H.; Kurata, M.; Kurochkin, Y. A.; Kus, V.; Kuykendall, W.; Kuze, M.; Kuzhir, P.; Kvasnicka, O.; Kvita, J.; Kwee, R.; La Rosa, A.; La Rotonda, L.; Labarga, L.; Labbe, J.; Lablak, S.; Lacasta, C.; Lacava, F.; Lacker, H.; Lacour, D.; Lacuesta, V. R.; Ladygin, E.; Lafaye, R.; Laforge, B.; Lagouri, T.; Lai, S.; Laisne, E.; Lamanna, M.; Lampen, C. L.; Lampl, W.; Lancon, E.; Landgraf, U.; Landon, M. P. J.; Landsman, H.; Lane, J. L.; Lange, C.; Lankford, A. J.; Lanni, F.; Lantzsch, K.; Laplace, S.; Lapoire, C.; Laporte, J. F.; Lari, T.; Larionov, A. V.; Larner, A.; Lasseur, C.; Lassnig, M.; Lau, W.; Laurelli, P.; Lavorato, A.; Lavrijsen, W.; Laycock, P.; Lazarev, A. B.; Lazzaro, A.; Le Dortz, O.; Le Guirriec, E.; Le Maner, C.; Le Menedeu, E.; Lebedev, A.; Lebel, C.; LeCompte, T.; Ledroit-Guillon, F.; Lee, H.; Lee, J. S. H.; Lee, S. C.; Lee, L.; Lefebvre, M.; Legendre, M.; Leger, A.; LeGeyt, B. C.; Legger, F.; Leggett, C.; Lehmacher, M.; Lehmann Miotto, G.; Lei, X.; Leite, M. A. L.; Leitner, R.; Lellouch, D.; Lellouch, J.; Leltchouk, M.; Lendermann, V.; Leney, K. J. C.; Lenz, T.; Lenzen, G.; Lenzi, B.; Leonhardt, K.; Leontsinis, S.; Leroy, C.; Lessard, J.-R.; Lesser, J.; Lester, C. G.; Leung Fook Cheong, A.; Levêque, J.; Levin, D.; Levinson, L. J.; Levitski, M. S.; Lewandowska, M.; Lewis, A.; Lewis, G. H.; Leyko, A. M.; Leyton, M.; Li, B.; Li, H.; Li, S.; Li, X.; Liang, Z.; Liang, Z.; Liberti, B.; Lichard, P.; Lichtnecker, M.; Lie, K.; Liebig, W.; Lifshitz, R.; Lilley, J. N.; Limbach, C.; Limosani, A.; Limper, M.; Lin, S. C.; Linde, F.; Linnemann, J. T.; Lipeles, E.; Lipinsky, L.; Lipniacka, A.; Liss, T. M.; Lissauer, D.; Lister, A.; Litke, A. M.; Liu, C.; Liu, D.; Liu, H.; Liu, J. B.; Liu, M.; Liu, S.; Liu, Y.; Livan, M.; Livermore, S. S. A.; Lleres, A.; Llorente Merino, J.; Lloyd, S. L.; Lobodzinska, E.; Loch, P.; Lockman, W. S.; Lockwitz, S.; Loddenkoetter, T.; Loebinger, F. K.; Loginov, A.; Loh, C. W.; Lohse, T.; Lohwasser, K.; Lokajicek, M.; Loken, J.; Lombardo, V. P.; Long, R. E.; Lopes, L.; Lopez Mateos, D.; Losada, M.; Loscutoff, P.; Lo Sterzo, F.; Losty, M. J.; Lou, X.; Lounis, A.; Loureiro, K. F.; Love, J.; Love, P. A.; Lowe, A. J.; Lu, F.; Lubatti, H. J.; Luci, C.; Lucotte, A.; Ludwig, A.; Ludwig, D.; Ludwig, I.; Ludwig, J.; Luehring, F.; Luijckx, G.; Lumb, D.; Luminari, L.; Lund, E.; Lund-Jensen, B.; Lundberg, B.; Lundberg, J.; Lundquist, J.; Lungwitz, M.; Lupi, A.; Lutz, G.; Lynn, D.; Lys, J.; Lytken, E.; Ma, H.; Ma, L. L.; Macana Goia, J. A.; Maccarrone, G.; Macchiolo, A.; Maček, B.; Machado Miguens, J.; Macina, D.; Mackeprang, R.; Madaras, R. J.; Mader, W. F.; Maenner, R.; Maeno, T.; Mättig, P.; Mättig, S.; Magalhaes Martins, P. J.; Magnoni, L.; Magradze, E.; Mahalalel, Y.; Mahboubi, K.; Mahout, G.; Maiani, C.; Maidantchik, C.; Maio, A.; Majewski, S.; Makida, Y.; Makovec, N.; Mal, P.; Malecki, Pa.; Malecki, P.; Maleev, V. P.; Malek, F.; Mallik, U.; Malon, D.; Maltezos, S.; Malyshev, V.; Malyukov, S.; Mameghani, R.; Mamuzic, J.; Manabe, A.; Mandelli, L.; Mandić, I.; Mandrysch, R.; Maneira, J.; Mangeard, P. S.; Manjavidze, I. D.; Mann, A.; Manning, P. M.; Manousakis-Katsikakis, A.; Mansoulie, B.; Manz, A.; Mapelli, A.; Mapelli, L.; March, L.; Marchand, J. F.; Marchese, F.; Marchiori, G.; Marcisovsky, M.; Marin, A.; Marino, C. P.; Marroquim, F.; Marshall, R.; Marshall, Z.; Martens, F. K.; Marti-Garcia, S.; Martin, A. J.; Martin, B.; Martin, B.; Martin, F. F.; Martin, J. P.; Martin, Ph.; Martin, T. A.; Martin dit Latour, B.; Martinez, M.; Martinez Outschoorn, V.; Martyniuk, A. C.; Marx, M.; Marzano, F.; Marzin, A.; Masetti, L.; Mashimo, T.; Mashinistov, R.; Masik, J.; Maslennikov, A. L.; Maß, M.; Massa, I.; Massaro, G.; Massol, N.; Mastrandrea, P.; Mastroberardino, A.; Masubuchi, T.; Mathes, M.; Matricon, P.; Matsumoto, H.; Matsunaga, H.; Matsushita, T.; Mattravers, C.; Maugain, J. M.; Maxfield, S. J.; Maximov, D. A.; May, E. N.; Mayne, A.; Mazini, R.; Mazur, M.; Mazzanti, M.; Mazzoni, E.; Mc Kee, S. P.; McCarn, A.; McCarthy, R. L.; McCarthy, T. G.; McCubbin, N. A.; McFarlane, K. W.; Mcfayden, J. A.; McGlone, H.; Mchedlidze, G.; McLaren, R. A.; Mclaughlan, T.; McMahon, S. J.; McPherson, R. A.; Meade, A.; Mechnich, J.; Mechtel, M.; Medinnis, M.; Meera-Lebbai, R.; Meguro, T.; Mehdiyev, R.; Mehlhase, S.; Mehta, A.; Meier, K.; Meinhardt, J.; Meirose, B.; Melachrinos, C.; Mellado Garcia, B. R.; Mendoza Navas, L.; Meng, Z.; Mengarelli, A.; Menke, S.; Menot, C.; Meoni, E.; Mercurio, K. M.; Mermod, P.; Merola, L.; Meroni, C.; Merritt, F. S.; Messina, A.; Metcalfe, J.; Mete, A. S.; Meuser, S.; Meyer, C.; Meyer, J.-P.; Meyer, J.; Meyer, J.; Meyer, T. C.; Meyer, W. T.; Miao, J.; Michal, S.; Micu, L.; Middleton, R. P.; Miele, P.; Migas, S.; Mijović, L.; Mikenberg, G.; Mikestikova, M.; Mikuž, M.; Miller, D. W.; Miller, R. J.; Mills, W. J.; Mills, C.; Milov, A.; Milstead, D. A.; Milstein, D.; Minaenko, A. A.; Miñano, M.; Minashvili, I. A.; Mincer, A. I.; Mindur, B.; Mineev, M.; Ming, Y.; Mir, L. M.; Mirabelli, G.; Miralles Verge, L.; Misiejuk, A.; Mitrevski, J.; Mitrofanov, G. Y.; Mitsou, V. A.; Mitsui, S.; Miyagawa, P. S.; Miyazaki, K.; Mjörnmark, J. U.; Moa, T.; Mockett, P.; Moed, S.; Moeller, V.; Mönig, K.; Möser, N.; Mohapatra, S.; Mohn, B.; Mohr, W.; Mohrdieck-Möck, S.; Moisseev, A. M.; Moles-Valls, R.; Molina-Perez, J.; Monk, J.; Monnier, E.; Montesano, S.; Monticelli, F.; Monzani, S.; Moore, R. W.; Moorhead, G. F.; Mora Herrera, C.; Moraes, A.; Morais, A.; Morange, N.; Morel, J.; Morello, G.; Moreno, D.; Moreno Llácer, M.; Morettini, P.; Morii, M.; Morin, J.; Morita, Y.; Morley, A. K.; Mornacchi, G.; Morone, M.-C.; Morozov, S. V.; Morris, J. D.; Morvaj, L.; Moser, H. G.; Mosidze, M.; Moss, J.; Mount, R.; Mountricha, E.; Mouraviev, S. V.; Moyse, E. J. W.; Mudrinic, M.; Mueller, F.; Mueller, J.; Mueller, K.; Müller, T. A.; Muenstermann, D.; Muijs, A.; Muir, A.; Munwes, Y.; Murakami, K.; Murray, W. J.; Mussche, I.; Musto, E.; Myagkov, A. G.; Myska, M.; Nadal, J.; Nagai, K.; Nagano, K.; Nagasaka, Y.; Nairz, A. M.; Nakahama, Y.; Nakamura, K.; Nakano, I.; Nanava, G.; Napier, A.; Nash, M.; Nation, N. R.; Nattermann, T.; Naumann, T.; Navarro, G.; Neal, H. A.; Nebot, E.; Nechaeva, P. Yu.; Negri, A.; Negri, G.; Nektarijevic, S.; Nelson, A.; Nelson, S.; Nelson, T. K.; Nemecek, S.; Nemethy, P.; Nepomuceno, A. A.; Nessi, M.; Nesterov, S. Y.; Neubauer, M. S.; Neusiedl, A.; Neves, R. M.; Nevski, P.; Newman, P. R.; Nguyen Thi Hong, V.; Nickerson, R. B.; Nicolaidou, R.; Nicolas, L.; Nicquevert, B.; Niedercorn, F.; Nielsen, J.; Niinikoski, T.; Nikiforov, A.; Nikolaenko, V.; Nikolaev, K.; Nikolic-Audit, I.; Nikolopoulos, K.; Nilsen, H.; Nilsson, P.; Ninomiya, Y.; Nisati, A.; Nishiyama, T.; Nisius, R.; Nodulman, L.; Nomachi, M.; Nomidis, I.; Nordberg, M.; Nordkvist, B.; Norton, P. R.; Novakova, J.; Nozaki, M.; Nožička, M.; Nozka, L.; Nugent, I. M.; Nuncio-Quiroz, A.-E.; Nunes Hanninger, G.; Nunnemann, T.; Nurse, E.; Nyman, T.; O'Brien, B. J.; O'Neale, S. W.; O'Neil, D. C.; O'Shea, V.; Oakham, F. G.; Oberlack, H.; Ocariz, J.; Ochi, A.; Oda, S.; Odaka, S.; Odier, J.; Ogren, H.; Oh, A.; Oh, S. H.; Ohm, C. C.; Ohshima, T.; Ohshita, H.; Ohska, T. K.; Ohsugi, T.; Okada, S.; Okawa, H.; Okumura, Y.; Okuyama, T.; Olcese, M.; Olchevski, A. G.; Oliveira, M.; Oliveira Damazio, D.; Oliver Garcia, E.; Olivito, D.; Olszewski, A.; Olszowska, J.; Omachi, C.; Onofre, A.; Onyisi, P. U. E.; Oram, C. J.; Oreglia, M. J.; Oren, Y.; Orestano, D.; Orlov, I.; Oropeza Barrera, C.; Orr, R. S.; Ortega, E. O.; Osculati, B.; Ospanov, R.; Osuna, C.; Otero y Garzon, G.; Ottersbach, J. P.; Ouchrif, M.; Ould-Saada, F.; Ouraou, A.; Ouyang, Q.; Owen, M.; Owen, S.; Øye, O. K.; Ozcan, V. E.; Ozturk, N.; Pacheco Pages, A.; Padilla Aranda, C.; Paganis, E.; Paige, F.; Pajchel, K.; Palestini, S.; Pallin, D.; Palma, A.; Palmer, J. D.; Pan, Y. B.; Panagiotopoulou, E.; Panes, B.; Panikashvili, N.; Panitkin, S.; Pantea, D.; Panuskova, M.; Paolone, V.; Papadelis, A.; Papadopoulou, Th. D.; Paramonov, A.; Park, W.; Parker, M. A.; Parodi, F.; Parsons, J. A.; Parzefall, U.; Pasqualucci, E.; Passeri, A.; Pastore, F.; Pastore, Fr.; Pásztor, G.; Pataraia, S.; Patel, N.; Pater, J. R.; Patricelli, S.; Pauly, T.; Pecsy, M.; Pedraza Morales, M. I.; Peleganchuk, S. V.; Peng, H.; Pengo, R.; Penson, A.; Penwell, J.; Perantoni, M.; Perez, K.; Perez Cavalcanti, T.; Perez Codina, E.; Pérez García-Estañ, M. T.; Perez Reale, V.; Perini, L.; Pernegger, H.; Perrino, R.; Perrodo, P.; Persembe, S.; Peshekhonov, V. D.; Peters, O.; Petersen, B. A.; Petersen, J.; Petersen, T. C.; Petit, E.; Petridis, A.; Petridou, C.; Petrolo, E.; Petrucci, F.; Petschull, D.; Petteni, M.; Pezoa, R.; Phan, A.; Phillips, A. W.; Phillips, P. W.; Piacquadio, G.; Piccaro, E.; Piccinini, M.; Pickford, A.; Piec, S. M.; Piegaia, R.; Pilcher, J. E.; Pilkington, A. D.; Pina, J.; Pinamonti, M.; Pinder, A.; Pinfold, J. L.; Ping, J.; Pinto, B.; Pirotte, O.; Pizio, C.; Placakyte, R.; Plamondon, M.; Plano, W. G.; Pleier, M.-A.; Pleskach, A. V.; Poblaguev, A.; Poddar, S.; Podlyski, F.; Poggioli, L.; Poghosyan, T.; Pohl, M.; Polci, F.; Polesello, G.; Policicchio, A.; Polini, A.; Poll, J.; Polychronakos, V.; Pomarede, D. M.; Pomeroy, D.; Pommès, K.; Pontecorvo, L.; Pope, B. G.; Popeneciu, G. A.; Popovic, D. S.; Poppleton, A.; Porter, R.; Posch, C.; Pospelov, G. E.; Pospisil, S.; Potrap, I. N.; Potter, C. J.; Potter, C. T.; Poulard, G.; Poveda, J.; Prabhu, R.; Pralavorio, P.; Prasad, S.; Pravahan, R.; Prell, S.; Pretzl, K.; Pribyl, L.; Price, D.; Price, L. E.; Price, M. J.; Prichard, P. M.; Prieur, D.; Primavera, M.; Prokofiev, K.; Prokoshin, F.; Protopopescu, S.; Proudfoot, J.; Prudent, X.; Przysiezniak, H.; Psoroulas, S.; Ptacek, E.; Purdham, J.; Purohit, M.; Puzo, P.; Pylypchenko, Y.; Qian, J.; Qian, Z.; Qin, Z.; Quadt, A.; Quarrie, D. R.; Quayle, W. B.; Quinonez, F.; Raas, M.; Radescu, V.; Radics, B.; Rador, T.; Ragusa, F.; Rahal, G.; Rahimi, A. M.; Rahm, D.; Rajagopalan, S.; Rammensee, M.; Rammes, M.; Ramstedt, M.; Randrianarivony, K.; Ratoff, P. N.; Rauscher, F.; Rauter, E.; Raymond, M.; Read, A. L.; Rebuzzi, D. M.; Redelbach, A.; Redlinger, G.; Reece, R.; Reeves, K.; Reichold, A.; Reinherz-Aronis, E.; Reinsch, A.; Reisinger, I.; Reljic, D.; Rembser, C.; Ren, Z. L.; Renaud, A.; Renkel, P.; Rescigno, M.; Resconi, S.; Resende, B.; Reznicek, P.; Rezvani, R.; Richards, A.; Richter, R.; Richter-Was, E.; Ridel, M.; Rieke, S.; Rijpstra, M.; Rijssenbeek, M.; Rimoldi, A.; Rinaldi, L.; Rios, R. R.; Riu, I.; Rivoltella, G.; Rizatdinova, F.; Rizvi, E.; Robertson, S. H.; Robichaud-Veronneau, A.; Robinson, D.; Robinson, J. E. M.; Robinson, M.; Robson, A.; Rocha de Lima, J. G.; Roda, C.; Roda Dos Santos, D.; Rodier, S.; Rodriguez, D.; Rodriguez Garcia, Y.; Roe, A.; Roe, S.; Røhne, O.; Rojo, V.; Rolli, S.; Romaniouk, A.; Romanov, V. M.; Romeo, G.; Romero Maltrana, D.; Roos, L.; Ros, E.; Rosati, S.; Rosbach, K.; Rose, M.; Rosenbaum, G. A.; Rosenberg, E. I.; Rosendahl, P. L.; Rosselet, L.; Rossetti, V.; Rossi, E.; Rossi, L. P.; Rossi, L.; Rotaru, M.; Roth, I.; Rothberg, J.; Rousseau, D.; Royon, C. R.; Rozanov, A.; Rozen, Y.; Ruan, X.; Rubinskiy, I.; Ruckert, B.; Ruckstuhl, N.; Rud, V. I.; Rudolph, G.; Rühr, F.; Ruggieri, F.; Ruiz-Martinez, A.; Rulikowska-Zarebska, E.; Rumiantsev, V.; Rumyantsev, L.; Runge, K.; Runolfsson, O.; Rurikova, Z.; Rusakovich, N. A.; Rust, D. R.; Rutherfoord, J. P.; Ruwiedel, C.; Ruzicka, P.; Ryabov, Y. F.; Ryadovikov, V.; Ryan, P.; Rybar, M.; Rybkin, G.; Ryder, N. C.; Rzaeva, S.; Saavedra, A. F.; Sadeh, I.; Sadrozinski, H. F.-W.; Sadykov, R.; Safai Tehrani, F.; Sakamoto, H.; Salamanna, G.; Salamon, A.; Saleem, M.; Salihagic, D.; Salnikov, A.; Salt, J.; Salvachua Ferrando, B. M.; Salvatore, D.; Salvatore, F.; Salvucci, A.; Salzburger, A.; Sampsonidis, D.; Samset, B. H.; Sandaker, H.; Sander, H. G.; Sanders, M. P.; Sandhoff, M.; Sandoval, T.; Sandstroem, R.; Sandvoss, S.; Sankey, D. P. C.; Sansoni, A.; Santamarina Rios, C.; Santoni, C.; Santonico, R.; Santos, H.; Saraiva, J. G.; Sarangi, T.; Sarkisyan-Grinbaum, E.; Sarri, F.; Sartisohn, G.; Sasaki, O.; Sasaki, T.; Sasao, N.; Satsounkevitch, I.; Sauvage, G.; Sauvan, J. B.; Savard, P.; Savinov, V.; Savu, D. O.; Savva, P.; Sawyer, L.; Saxon, D. H.; Says, L. P.; Sbarra, C.; Sbrizzi, A.; Scallon, O.; Scannicchio, D. A.; Schaarschmidt, J.; Schacht, P.; Schäfer, U.; Schaepe, S.; Schaetzel, S.; Schaffer, A. C.; Schaile, D.; Schamberger, R. D.; Schamov, A. G.; Scharf, V.; Schegelsky, V. A.; Scheirich, D.; Schernau, M.; Scherzer, M. I.; Schiavi, C.; Schieck, J.; Schioppa, M.; Schlenker, S.; Schlereth, J. L.; Schmidt, E.; Schmieden, K.; Schmitt, C.; Schmitt, S.; Schmitz, M.; Schneider, M.; Schöning, A.; Schott, M.; Schouten, D.; Schovancova, J.; Schram, M.; Schroeder, C.; Schroer, N.; Schuh, S.; Schuler, G.; Schultes, J.; Schultz-Coulon, H.-C.; Schulz, H.; Schumacher, J. W.; Schumacher, M.; Schumm, B. A.; Schune, Ph.; Schwanenberger, C.; Schwartzman, A.; Schwemling, Ph.; Schwienhorst, R.; Schwierz, R.; Schwindling, J.; Scott, W. G.; Searcy, J.; Sedykh, E.; Segura, E.; Seidel, S. C.; Seiden, A.; Seifert, F.; Seixas, J. M.; Sekhniaidze, G.; Seliverstov, D. M.; Sellden, B.; Sellers, G.; Seman, M.; Semprini-Cesari, N.; Serfon, C.; Serin, L.; Seuster, R.; Severini, H.; Sevior, M. E.; Sfyrla, A.; Shabalina, E.; Shamim, M.; Shan, L. Y.; Shank, J. T.; Shao, Q. T.; Shapiro, M.; Shatalov, P. B.; Shaver, L.; Shaw, C.; Shaw, K.; Sherman, D.; Sherwood, P.; Shibata, A.; Shichi, H.; Shimizu, S.; Shimojima, M.; Shin, T.; Shmeleva, A.; Shochet, M. J.; Short, D.; Shupe, M. A.; Sicho, P.; Sidoti, A.; Siebel, A.; Siegert, F.; Siegrist, J.; Sijacki, Dj.; Silbert, O.; Silva, J.; Silver, Y.; Silverstein, D.; Silverstein, S. B.; Simak, V.; Simard, O.; Simic, Lj.; Simion, S.; Simmons, B.; Simonyan, M.; Sinervo, P.; Sinev, N. B.; Sipica, V.; Siragusa, G.; Sisakyan, A. N.; Sivoklokov, S. Yu.; Sjölin, J.; Sjursen, T. B.; Skinnari, L. A.; Skovpen, K.; Skubic, P.; Skvorodnev, N.; Slater, M.; Slavicek, T.; Sliwa, K.; Sloan, T. J.; Sloper, J.; Smakhtin, V.; Smirnov, S. Yu.; Smirnova, L. N.; Smirnova, O.; Smith, B. C.; Smith, D.; Smith, K. M.; Smizanska, M.; Smolek, K.; Snesarev, A. A.; Snow, S. W.; Snow, J.; Snuverink, J.; Snyder, S.; Soares, M.; Sobie, R.; Sodomka, J.; Soffer, A.; Solans, C. A.; Solar, M.; Solc, J.; Soldatov, E.; Soldevila, U.; Solfaroli Camillocci, E.; Solodkov, A. A.; Solovyanov, O. V.; Sondericker, J.; Soni, N.; Sopko, V.; Sopko, B.; Sorbi, M.; Sosebee, M.; Soukharev, A.; Spagnolo, S.; Spanò, F.; Spighi, R.; Spigo, G.; Spila, F.; Spiriti, E.; Spiwoks, R.; Spousta, M.; Spreitzer, T.; Spurlock, B.; St. Denis, R. D.; Stahl, T.; Stahlman, J.; Stamen, R.; Stanecka, E.; Stanek, R. W.; Stanescu, C.; Stapnes, S.; Starchenko, E. A.; Stark, J.; Staroba, P.; Starovoitov, P.; Staude, A.; Stavina, P.; Stavropoulos, G.; Steele, G.; Steinbach, P.; Steinberg, P.; Stekl, I.; Stelzer, B.; Stelzer, H. J.; Stelzer-Chilton, O.; Stenzel, H.; Stevenson, K.; Stewart, G. A.; Stillings, J. A.; Stockmanns, T.; Stockton, M. C.; Stoerig, K.; Stoicea, G.; Stonjek, S.; Strachota, P.; Stradling, A. R.; Straessner, A.; Strandberg, J.; Strandberg, S.; Strandlie, A.; Strang, M.; Strauss, E.; Strauss, M.; Strizenec, P.; Ströhmer, R.; Strom, D. M.; Strong, J. A.; Stroynowski, R.; Strube, J.; Stugu, B.; Stumer, I.; Stupak, J.; Sturm, P.; Soh, D. A.; Su, D.; Subramania, H. S.; Succurro, A.; Sugaya, Y.; Sugimoto, T.; Suhr, C.; Suita, K.; Suk, M.; Sulin, V. V.; Sultansoy, S.; Sumida, T.; Sun, X.; Sundermann, J. E.; Suruliz, K.; Sushkov, S.; Susinno, G.; Sutton, M. R.; Suzuki, Y.; Svatos, M.; Sviridov, Yu. M.; Swedish, S.; Sykora, I.; Sykora, T.; Szeless, B.; Sánchez, J.; Ta, D.; Tackmann, K.; Taffard, A.; Tafirout, R.; Taga, A.; Taiblum, N.; Takahashi, Y.; Takai, H.; Takashima, R.; Takeda, H.; Takeshita, T.; Talby, M.; Talyshev, A.; Tamsett, M. C.; Tanaka, J.; Tanaka, R.; Tanaka, S.; Tanaka, S.; Tanaka, Y.; Tani, K.; Tannoury, N.; Tappern, G. P.; Tapprogge, S.; Tardif, D.; Tarem, S.; Tarrade, F.; Tartarelli, G. F.; Tas, P.; Tasevsky, M.; Tassi, E.; Tatarkhanov, M.; Taylor, C.; Taylor, F. E.; Taylor, G. N.; Taylor, W.; Teixeira Dias Castanheira, M.; Teixeira-Dias, P.; Temming, K. K.; Ten Kate, H.; Teng, P. K.; Terada, S.; Terashi, K.; Terron, J.; Terwort, M.; Testa, M.; Teuscher, R. J.; Thadome, J.; Therhaag, J.; Theveneaux-Pelzer, T.; Thioye, M.; Thoma, S.; Thomas, J. P.; Thompson, E. N.; Thompson, P. D.; Thompson, P. D.; Thompson, A. S.; Thomson, E.; Thomson, M.; Thun, R. P.; Tic, T.; Tikhomirov, V. O.; Tikhonov, Y. A.; Timmermans, C. J. W. P.; Tipton, P.; Tisserant, S.; Tobias, J.; Toczek, B.; Todorov, T.; Todorova-Nova, S.; Toggerson, B.; Tojo, J.; Tokár, S.; Tokunaga, K.; Tokushuku, K.; Tollefson, K.; Tomoto, M.; Tompkins, L.; Toms, K.; Tong, G.; Tonoyan, A.; Topfel, C.; Topilin, N. D.; Torchiani, I.; Torrence, E.; Torres, H.; Torró Pastor, E.; Toth, J.; Touchard, F.; Tovey, D. R.; Traynor, D.; Trefzger, T.; Tremblet, L.; Tricoli, A.; Trigger, I. M.; Trincaz-Duvoid, S.; Trinh, T. N.; Tripiana, M. F.; Trischuk, W.; Trivedi, A.; Trocmé, B.; Troncon, C.; Trottier-McDonald, M.; Trzupek, A.; Tsarouchas, C.; Tseng, J. C.-L.; Tsiakiris, M.; Tsiareshka, P. V.; Tsionou, D.; Tsipolitis, G.; Tsiskaridze, V.; Tskhadadze, E. G.; Tsukerman, I. I.; Tsulaia, V.; Tsung, J.-W.; Tsuno, S.; Tsybychev, D.; Tua, A.; Tuggle, J. M.; Turala, M.; Turecek, D.; Turk Cakir, I.; Turlay, E.; Turra, R.; Tuts, P. M.; Tykhonov, A.; Tylmad, M.; Tyndel, M.; Tyrvainen, H.; Tzanakos, G.; Uchida, K.; Ueda, I.; Ueno, R.; Ugland, M.; Uhlenbrock, M.; Uhrmacher, M.; Ukegawa, F.; Unal, G.; Underwood, D. G.; Undrus, A.; Unel, G.; Unno, Y.; Urbaniec, D.; Urkovsky, E.; Urrejola, P.; Usai, G.; Uslenghi, M.; Vacavant, L.; Vacek, V.; Vachon, B.; Vahsen, S.; Valenta, J.; Valente, P.; Valentinetti, S.; Valkar, S.; Valladolid Gallego, E.; Vallecorsa, S.; Valls Ferrer, J. A.; van der Graaf, H.; van der Kraaij, E.; Van Der Leeuw, R.; van der Poel, E.; van der Ster, D.; Van Eijk, B.; van Eldik, N.; van Gemmeren, P.; van Kesteren, Z.; van Vulpen, I.; Vandelli, W.; Vandoni, G.; Vaniachine, A.; Vankov, P.; Vannucci, F.; Varela Rodriguez, F.; Vari, R.; Varnes, E. W.; Varouchas, D.; Vartapetian, A.; Varvell, K. E.; Vassilakopoulos, V. I.; Vazeille, F.; Vegni, G.; Veillet, J. J.; Vellidis, C.; Veloso, F.; Veness, R.; Veneziano, S.; Ventura, A.; Ventura, D.; Venturi, M.; Venturi, N.; Vercesi, V.; Verducci, M.; Verkerke, W.; Vermeulen, J. C.; Vest, A.; Vetterli, M. C.; Vichou, I.; Vickey, T.; Viehhauser, G. H. A.; Viel, S.; Villa, M.; Villaplana Perez, M.; Vilucchi, E.; Vincter, M. G.; Vinek, E.; Vinogradov, V. B.; Virchaux, M.; Viret, S.; Virzi, J.; Vitale, A.; Vitells, O.; Viti, M.; Vivarelli, I.; Vives Vaque, F.; Vlachos, S.; Vlasak, M.; Vlasov, N.; Vogel, A.; Vokac, P.; Volpi, G.; Volpi, M.; Volpini, G.; von der Schmitt, H.; von Loeben, J.; von Radziewski, H.; von Toerne, E.; Vorobel, V.; Vorobiev, A. P.; Vorwerk, V.; Vos, M.; Voss, R.; Voss, T. T.; Vossebeld, J. H.; Vranjes, N.; Vranjes Milosavljevic, M.; Vrba, V.; Vreeswijk, M.; Vu Anh, T.; Vuillermet, R.; Vukotic, I.; Wagner, W.; Wagner, P.; Wahlen, H.; Wakabayashi, J.; Walbersloh, J.; Walch, S.; Walder, J.; Walker, R.; Walkowiak, W.; Wall, R.; Waller, P.; Wang, C.; Wang, H.; Wang, H.; Wang, J.; Wang, J.; Wang, J. C.; Wang, R.; Wang, S. M.; Warburton, A.; Ward, C. P.; Warsinsky, M.; Watkins, P. M.; Watson, A. T.; Watson, M. F.; Watts, G.; Watts, S.; Waugh, A. T.; Waugh, B. M.; Weber, J.; Weber, M.; Weber, M. S.; Weber, P.; Weidberg, A. R.; Weigell, P.; Weingarten, J.; Weiser, C.; Wellenstein, H.; Wells, P. S.; Wen, M.; Wenaus, T.; Wendler, S.; Weng, Z.; Wengler, T.; Wenig, S.; Wermes, N.; Werner, M.; Werner, P.; Werth, M.; Wessels, M.; Weydert, C.; Whalen, K.; Wheeler-Ellis, S. J.; Whitaker, S. P.; White, A.; White, M. J.; White, S.; Whitehead, S. R.; Whiteson, D.; Whittington, D.; Wicek, F.; Wicke, D.; Wickens, F. J.; Wiedenmann, W.; Wielers, M.; Wienemann, P.; Wiglesworth, C.; Wiik, L. A. M.; Wijeratne, P. A.; Wildauer, A.; Wildt, M. A.; Wilhelm, I.; Wilkens, H. G.; Will, J. Z.; Williams, E.; Williams, H. H.; Willis, W.; Willocq, S.; Wilson, J. A.; Wilson, M. G.; Wilson, A.; Wingerter-Seez, I.; Winkelmann, S.; Winklmeier, F.; Wittgen, M.; Wolter, M. W.; Wolters, H.; Wooden, G.; Wosiek, B. K.; Wotschack, J.; Woudstra, M. J.; Wraight, K.; Wright, C.; Wrona, B.; Wu, S. L.; Wu, X.; Wu, Y.; Wulf, E.; Wunstorf, R.; Wynne, B. M.; Xaplanteris, L.; Xella, S.; Xie, S.; Xie, Y.; Xu, C.; Xu, D.; Xu, G.; Yabsley, B.; Yamada, M.; Yamamoto, A.; Yamamoto, K.; Yamamoto, S.; Yamamura, T.; Yamaoka, J.; Yamazaki, T.; Yamazaki, Y.; Yan, Z.; Yang, H.; Yang, U. K.; Yang, Y.; Yang, Y.; Yang, Z.; Yanush, S.; Yao, W.-M.; Yao, Y.; Yasu, Y.; Ybeles Smit, G. V.; Ye, J.; Ye, S.; Yilmaz, M.; Yoosoofmiya, R.; Yorita, K.; Yoshida, R.; Young, C.; Youssef, S.; Yu, D.; Yu, J.; Yu, J.; Yuan, L.; Yurkewicz, A.; Zaets, V. G.; Zaidan, R.; Zaitsev, A. M.; Zajacova, Z.; Zalite, Yo. K.; Zanello, L.; Zarzhitsky, P.; Zaytsev, A.; Zeitnitz, C.; Zeller, M.; Zemla, A.; Zendler, C.; Zenin, A. V.; Zenin, O.; Ženiš, T.; Zenonos, Z.; Zenz, S.; Zerwas, D.; Zevi della Porta, G.; Zhan, Z.; Zhang, D.; Zhang, H.; Zhang, J.; Zhang, X.; Zhang, Z.; Zhao, L.; Zhao, T.; Zhao, Z.; Zhemchugov, A.; Zheng, S.; Zhong, J.; Zhou, B.; Zhou, N.; Zhou, Y.; Zhu, C. G.; Zhu, H.; Zhu, Y.; Zhuang, X.; Zhuravlov, V.; Zieminska, D.; Zimmermann, R.; Zimmermann, S.; Zimmermann, S.; Ziolkowski, M.; Zitoun, R.; Živković, L.; Zmouchko, V. V.; Zobernig, G.; Zoccoli, A.; Zolnierowski, Y.; Zsenei, A.; zur Nedden, M.; Zutshi, V.; Zwalinski, L.

2011-11-01

Inclusive multi-jet production is studied in proton-proton collisions at a center-of-mass energy of 7 TeV, using the ATLAS detector. The data sample corresponds to an integrated luminosity of 2.4 pb-1. Results on multi-jet cross sections are presented and compared to both leading-order plus parton-shower Monte Carlo predictions and to next-to-leading-order QCD calculations.

Measurement of multi-jet cross sections in proton–proton collisions at a 7 TeV center-of-mass energy

DOE PAGES

Aad, G.; Abbott, B.; Abdallah, J.; ...

2011-11-15

Inclusive multi-jet production is studied in proton–proton collisions at a center-of-mass energy of 7 TeV, using the ATLAS detector. The data sample corresponds to an integrated luminosity of 2.4 pb -1. Results on multi-jet cross sections are presented and compared to both leading-order plus parton-shower Monte Carlo predictions and to next-to-leading-order QCD calculations.

Automated daily quality control analysis for mammography in a multi-unit imaging center.

PubMed

Sundell, Veli-Matti; Mäkelä, Teemu; Meaney, Alexander; Kaasalainen, Touko; Savolainen, Sauli

2018-01-01

Background The high requirements for mammography image quality necessitate a systematic quality assurance process. Digital imaging allows automation of the image quality analysis, which can potentially improve repeatability and objectivity compared to a visual evaluation made by the users. Purpose To develop an automatic image quality analysis software for daily mammography quality control in a multi-unit imaging center. Material and Methods An automated image quality analysis software using the discrete wavelet transform and multiresolution analysis was developed for the American College of Radiology accreditation phantom. The software was validated by analyzing 60 randomly selected phantom images from six mammography systems and 20 phantom images with different dose levels from one mammography system. The results were compared to a visual analysis made by four reviewers. Additionally, long-term image quality trends of a full-field digital mammography system and a computed radiography mammography system were investigated. Results The automated software produced feature detection levels comparable to visual analysis. The agreement was good in the case of fibers, while the software detected somewhat more microcalcifications and characteristic masses. Long-term follow-up via a quality assurance web portal demonstrated the feasibility of using the software for monitoring the performance of mammography systems in a multi-unit imaging center. Conclusion Automated image quality analysis enables monitoring the performance of digital mammography systems in an efficient, centralized manner.

Large space antenna communications systems: Integrated Langley Research Center/Jet Propulsion Laboratory development activities. 2: Langley Research Center activities

NASA Technical Reports Server (NTRS)

Cambell, T. G.; Bailey, M. C.; Cockrell, C. R.; Beck, F. B.

1983-01-01

The electromagnetic analysis activities at the Langley Research Center are resulting in efficient and accurate analytical methods for predicting both far- and near-field radiation characteristics of large offset multiple-beam multiple-aperture mesh reflector antennas. The utilization of aperture integration augmented with Geometrical Theory of Diffraction in analyzing the large reflector antenna system is emphasized.

Hybrid Solution-Adaptive Unstructured Cartesian Method for Large-Eddy Simulation of Detonation in Multi-Phase Turbulent Reactive Mixtures

DTIC Science & Technology

2012-03-27

pulse- detonation engines ( PDE ), stage separation, supersonic cav- ity oscillations, hypersonic aerodynamics, detonation induced structural...ADAPTIVE UNSTRUCTURED CARTESIAN METHOD FOR LARGE-EDDY SIMULATION OF DETONATION IN MULTI-PHASE TURBULENT REACTIVE MIXTURES 5b. GRANT NUMBER FA9550...CCL Report TR-2012-03-03 Hybrid Solution-Adaptive Unstructured Cartesian Method for Large-Eddy Simulation of Detonation in Multi-Phase Turbulent

Multi-Center Implementation of NPR 7123.1A: A Collaborative Effort

NASA Technical Reports Server (NTRS)

Hall, Phillip B.; McNelis, Nancy B.

2011-01-01

Collaboration efforts between MSFC and GRC Engineering Directorates to implement the NASA Systems Engineering (SE) Engine have expanded over the past year to include other NASA Centers. Sharing information on designing, developing, and deploying SE processes has sparked further interest based on the realization that there is relative consistency in implementing SE processes at the institutional level. This presentation will provide a status on the ongoing multi-center collaboration and provide insight into how these NPR 7123.1A SE-aligned directives are being implemented and managed to better support the needs of NASA programs and projects. NPR 7123.1A, NASA Systems Engineering Processes and Requirements, was released on March 26, 2007 to clearly articulate and establish the requirements on the implementing organization for performing, supporting, and evaluating SE activities. In early 2009, MSFC and GRC Engineering Directorates undertook a collaborative opportunity to share their research and work associated with developing, updating and revising their SE process policy to comply and align with NPR 7123.1A. The goal is to develop instructions, checklists, templates, and procedures for each of the 17 SE process requirements so that systems engineers will be a position to define work that is process-driven. Greater efficiency and more effective technical management will be achieved due to consistency and repeatability of SE process implementation across and throughout each of the NASA centers. An added benefit will be to encourage NASA centers to pursue and collaborate on joint projects as a result of using common or similar processes, methods, tools, and techniques.

The Development of the Multi-Center Traffic Management Advisor (MCTMA): Traffic Flow Management Research in a Multi-Facility Environment

NASA Technical Reports Server (NTRS)

Lee, Katharine K.; Davis, Thomas J.; Levin, Kerry M.; Rowe, Dennis W.

2001-01-01

The Traffic Management Advisor (TMA) is a decision-support tool for traffic managers and air traffic controllers that provides traffic flow visualization and other flow management tools. TMA creates an efficiently sequenced and safely spaced schedule for arrival traffic that meets but does not exceed specified airspace system constraints. TMA is being deployed at selected facilities throughout the National Airspace System in the US as part of the FAA's Free Flight Phase 1 program. TMA development and testing, and its current deployment, focuses on managing the arrival capacity for single major airports within single terminal areas and single en route centers. The next phase of development for this technology is the expansion of the TMA capability to complex facilities in which a terminal area or airport is fed by multiple en route centers, thus creating a multicenter TMA functionality. The focus of the multi-center TMA (McTMA) development is on the busy facilities in the Northeast comdor of the US. This paper describes the planning and development of McTMA and the challenges associated with adapting a successful traffic flow management tool for a very complex airspace.

Patient-centered clinical trials.

PubMed

Chaudhuri, Shomesh E; Ho, Martin P; Irony, Telba; Sheldon, Murray; Lo, Andrew W

2018-02-01

We apply Bayesian decision analysis (BDA) to incorporate patient preferences in the regulatory approval process for new therapies. By assigning weights to type I and type II errors based on patient preferences, the significance level (α) and power (1-β) of a randomized clinical trial (RCT) for a new therapy can be optimized to maximize the value to current and future patients and, consequently, to public health. We find that for weight-loss devices, potentially effective low-risk treatments have optimal αs larger than the traditional one-sided significance level of 5%, whereas potentially less effective and riskier treatments have optimal αs below 5%. Moreover, the optimal RCT design, including trial size, varies with the risk aversion and time-to-access preferences and the medical need of the target population. Copyright © 2017 Elsevier Ltd. All rights reserved.

A Multi-center Comparison of the Safety of Oral versus Intravenous Acetylcysteine for Treatment of Acetaminophen Overdose

PubMed Central

2010-01-01

Oral and intravenous (IV) acetylcysteine are used for treatment of acetaminophen poisoning. The objective of this multi-center study was to compare the safety of these two routes of administration. METHODS We conducted a multi-center chart review of all patients treated with acetylcysteine for acetaminophen poisoning. The primary safety outcome was the percentage of patients with of acetylcysteine-related adverse events. RESULTS A total of 503 subjects were included in the safety analysis (306 IV only, 145 oral only and 52 both routes).There were no serious adverse events related to acetylcysteine for either route. Nausea and vomiting were the most common related adverse events and were more common with oral treatment (23% vs 9%). Anaphylactoid reactions were more common with IV administration (6% vs 2%). Conclusions Intravenous and oral acetylcysteine are both associated with minimal side effects and are safe for treatment of acetaminophen toxicity. PMID:20524832

Patient-centered disease management (PCDM) for heart failure: study protocol for a randomised controlled trial.

PubMed

Bekelman, David B; Plomondon, Mary E; Sullivan, Mark D; Nelson, Karin; Hattler, Brack; McBryde, Connor; Lehmann, Kenneth G; Potfay, Jonathan; Heidenreich, Paul; Rumsfeld, John S

2013-07-09

Chronic heart failure (HF) disease management programs have reported inconsistent results and have not included comorbid depression management or specifically focused on improving patient-reported outcomes. The Patient Centered Disease Management (PCDM) trial was designed to test the effectiveness of collaborative care disease management in improving health status (symptoms, functioning, and quality of life) in patients with HF who reported poor HF-specific health status. Patients with a HF diagnosis at four VA Medical Centers were identified through population-based sampling. Patients with a Kansas City Cardiomyopathy Questionnaire (KCCQ, a measure of HF-specific health status) score of < 60 (heavy symptom burden and impaired quality of life) were invited to enroll in the PCDM trial. Enrolled patients were randomized to receive usual care or the PCDM intervention, which included: (1) collaborative care management by VA clinicians including a nurse, cardiologist, internist, and psychiatrist, who worked with patients and their primary care providers to provide guideline-concordant care management, (2) home telemonitoring and guided patient self-management support, and (3) screening and treatment for comorbid depression. The primary study outcome is change in overall KCCQ score. Secondary outcomes include depression, medication adherence, guideline-based care, hospitalizations, and mortality. The PCDM trial builds on previous studies of HF disease management by prioritizing patient health status, implementing a collaborative care model of health care delivery, and addressing depression, a key barrier to optimal disease management. The study has been designed as an 'effectiveness trial' to support broader implementation in the healthcare system if it is successful. Unique identifier: NCT00461513.

Counseling African Americans to Control Hypertension (CAATCH) Trial: A Multi-level Intervention to Improve Blood Pressure Control in Hypertensive African Americans

PubMed Central

Ogedegbe, Gbenga; Tobin, Jonathan N.; Fernandez, Senaida; Gerin, William; Diaz-Gloster, Marleny; Cassells, Andrea; Khalida, Chamanara; Pickering, Thomas; Schoenthaler, Antoinette; Ravenell, Joseph

2009-01-01

Background Despite strong evidence of effective interventions targeted at blood pressure (BP) control, there is little evidence on the translation of these approaches to routine clinical practice in care of hypertensive African Americans. The goal of this study is to evaluate the effectiveness of a multi-level, multi-component, evidence-based intervention compared to usual care in improving BP control among hypertensive African Americans who receive care in Community Health Centers (CHCs). The primary outcomes are BP control rate at 12 months; and maintenance of intervention one year after the trial. The secondary outcomes are within-patient change in BP from baseline to 12 months and cost effectiveness of the intervention. Methods and Results Counseling African Americans to Control Hypertension (CAATCH) is a group randomized clinical trial with two conditions: Intervention Condition (IC) and Usual Care (UC). Thirty CHCs were randomly assigned equally to the IC group (N=15) or the UC group (N=15). The intervention is comprised of three components targeted at patients (interactive computerized hypertension education; home BP monitoring; and monthly behavioral counseling on lifestyle modification) and two components targeted at physicians (monthly case rounds based on JNC-7 guidelines; chart audit and provision of feedback on clinical performance and patients’ home BP readings). All outcomes are assessed at quarterly study visits for one year. Chart review is conducted at 24 months to evaluate maintenance of intervention effects and sustainability of the intervention. Conclusions Poor BP control is one of the major reasons for the mortality gap between African Americans and whites. Findings from this study, if successful, will provide salient information needed for translation and dissemination of evidence-based interventions targeted at BP control into clinical practice for this high-risk population. PMID:20031845

Adopting a Patient-Centered Approach to Primary Outcome Analysis of Acute Stroke Trials Using a Utility-Weighted Modified Rankin Scale.

PubMed

Chaisinanunkul, Napasri; Adeoye, Opeolu; Lewis, Roger J; Grotta, James C; Broderick, Joseph; Jovin, Tudor G; Nogueira, Raul G; Elm, Jordan J; Graves, Todd; Berry, Scott; Lees, Kennedy R; Barreto, Andrew D; Saver, Jeffrey L

2015-08-01

Although the modified Rankin Scale (mRS) is the most commonly used primary end point in acute stroke trials, its power is limited when analyzed in dichotomized fashion and its indication of effect size challenging to interpret when analyzed ordinally. Weighting the 7 Rankin levels by utilities may improve scale interpretability while preserving statistical power. A utility-weighted mRS (UW-mRS) was derived by averaging values from time-tradeoff (patient centered) and person-tradeoff (clinician centered) studies. The UW-mRS, standard ordinal mRS, and dichotomized mRS were applied to 11 trials or meta-analyses of acute stroke treatments, including lytic, endovascular reperfusion, blood pressure moderation, and hemicraniectomy interventions. Utility values were 1.0 for mRS level 0; 0.91 for mRS level 1; 0.76 for mRS level 2; 0.65 for mRS level 3; 0.33 for mRS level 4; 0 for mRS level 5; and 0 for mRS level 6. For trials with unidirectional treatment effects, the UW-mRS paralleled the ordinal mRS and outperformed dichotomous mRS analyses. Both the UW-mRS and the ordinal mRS were statistically significant in 6 of 8 unidirectional effect trials, whereas dichotomous analyses were statistically significant in 2 to 4 of 8. In bidirectional effect trials, both the UW-mRS and ordinal tests captured the divergent treatment effects by showing neutral results, whereas some dichotomized analyses showed positive results. Mean utility differences in trials with statistically significant positive results ranged from 0.026 to 0.249. A UW-mRS performs similar to the standard ordinal mRS in detecting treatment effects in actual stroke trials and ensures the quantitative outcome is a valid reflection of patient-centered benefits. © 2015 American Heart Association, Inc.

Techniques for extracting single-trial activity patterns from large-scale neural recordings

PubMed Central

Churchland, Mark M; Yu, Byron M; Sahani, Maneesh; Shenoy, Krishna V

2008-01-01

Summary Large, chronically-implanted arrays of microelectrodes are an increasingly common tool for recording from primate cortex, and can provide extracellular recordings from many (order of 100) neurons. While the desire for cortically-based motor prostheses has helped drive their development, such arrays also offer great potential to advance basic neuroscience research. Here we discuss the utility of array recording for the study of neural dynamics. Neural activity often has dynamics beyond that driven directly by the stimulus. While governed by those dynamics, neural responses may nevertheless unfold differently for nominally identical trials, rendering many traditional analysis methods ineffective. We review recent studies – some employing simultaneous recording, some not – indicating that such variability is indeed present both during movement generation, and during the preceding premotor computations. In such cases, large-scale simultaneous recordings have the potential to provide an unprecedented view of neural dynamics at the level of single trials. However, this enterprise will depend not only on techniques for simultaneous recording, but also on the use and further development of analysis techniques that can appropriately reduce the dimensionality of the data, and allow visualization of single-trial neural behavior. PMID:18093826

At left, center just at edge of photograph are large ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

At left, center just at edge of photograph are large organization boards with small cardboard cards which can be moved to different slots. Historical photographs show Edison using these boards to manage production of photographs and other items within the Edison companies. - Thomas A. Edison Laboratories, Building No. 5, Main Street & Lakeside Avenue, West Orange, Essex County, NJ

Using Minitel Network and New Software Engineering Techniques for Randomized Clinical Trials Management

PubMed Central

Lepage, E.; Tavernier, H.; Bouhaddou, O.; Jais, JP.; Gisselbrecht, C.; Aurengo, A.; Boiron, M.

1989-01-01

The usual Randomized Clinical Trials (RCT) management using an anachronic procedure involving a flowsheet exchange between the remote centers and the coordinating center presents a number of inadequacies. Eligibility criteria are not always verified by the coordinating center before inclusion in the trial and randomization. Laboratory tests and therapeutic adjustments are frequently decided from memory by the clinician which often leads to data oversight and variability of therapeutic decisions. This results in protocol deviations and alteration of the efficiency of the RCT. HICREN is a medical consultation system designed to take into account the different difficulties encountered during RCT driving. The system integrates a clinical database with artificial intelligence technics to manage clinical trial data on non-expensive and widely available Minitel® terminals. Randomization is then possible, after eligibility criteria are satisfied, anytime and anywhere in France through the national telematic network. HICREN also includes an intuitive graphic interface to increase physician's compliance: a user friendly dialogue manager supports on line data entry with multi-windowing facilities and pull down menus. Interactive data validation is achieved through an interface to dedicated C programs. Patient follow up is achieved by an expert system that proposes appropriate dose of treatment according to the rules defined in the trial. At present, HICREN is implemented on the CISARC system for conducting three randomized clinical trials and one epidemiologic study.

Utilization of a Clinical Trial Management System for the Whole Clinical Trial Process as an Integrated Database: System Development.

PubMed

Park, Yu Rang; Yoon, Young Jo; Koo, HaYeong; Yoo, Soyoung; Choi, Chang-Min; Beck, Sung-Ho; Kim, Tae Won

2018-04-24

external users for managing 11,645 studies and 146,943 subjects. The CTMS was introduced in the Asan Medical Center to manage the large amounts of data involved with clinical trial operations. Inter- and intraunit control of data and resources can be easily conducted through the CTMS system. To our knowledge, this is the first CTMS developed in-house at an academic medical center side which can enhance the efficiency of clinical trial management in compliance with privacy and security laws. ©Yu Rang Park, Young Jo Yoon, HaYeong Koo, Soyoung Yoo, Chang-Min Choi, Sung-Ho Beck, Tae Won Kim. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 24.04.2018.

A Prospective Multi-Center Audit of Nutrition Support Parameters Following Burn Injury.

PubMed

Kurmis, Rochelle; Heath, Kathryn; Ooi, Selena; Munn, Zachary; Forbes, Sharon; Young, Vicki; Rigby, Paul; Wood, Kate; Phillips, Frances; Greenwood, John

2015-01-01

The importance of nutrition support delivery to the severe burn-injured patient is well recognized, however, nutrition provision to the patient may be sub optimal in practice. The aim of this study was to conduct a prospective multi-center audit across Australia and New Zealand using the Joanna Briggs Institute Burns Node Nutrition audit criteria. Thirty-four patients with severe burn injury (≥20% TBSA in adults and ≥10% TBSA in children) were identified on admission or on referral to the Dietitian at the eight participating Burn Units between February 1, 2012 and April 30, 2012 for inclusion in the study. De-identified patient data was analyzed using the Joanna Briggs Institute, Practical Application of Clinical Evidence System. Compliance with individual audit criterion ranged from 33 to 100%. Provision of prescribed enteral feed volumes and weekly weighing of patients were highlighted as key areas for clinical improvement. Clinical audit is a valuable tool for evaluating current practice against best evidence to ensure that quality patient care is delivered. The use of the Joanna Briggs Institute Burns Node audit criteria has allowed for a standardized multi-center audit to be conducted. Improving nutrition support delivery in burn patients was identified as a key area requiring ongoing clinical improvement across Australia and New Zealand. Clinician feedback on use of the audit criteria will allow for future refinement of individual criterion, and presentation of results of this audit has resulted in a review of the Bi-National Burns Registry nutrition quality indicators.

Multi-slice ptychography with large numerical aperture multilayer Laue lenses

DOE PAGES

Ozturk, Hande; Yan, Hanfei; He, Yan; ...

2018-05-09

Here, the highly convergent x-ray beam focused by multilayer Laue lenses with large numerical apertures is used as a three-dimensional (3D) probe to image layered structures with an axial separation larger than the depth of focus. Instead of collecting weakly scattered high-spatial-frequency signals, the depth-resolving power is provided purely by the intense central cone diverged from the focused beam. Using the multi-slice ptychography method combined with the on-the-fly scan scheme, two layers of nanoparticles separated by 10 μm are successfully reconstructed with 8.1 nm lateral resolution and with a dwell time as low as 0.05 s per scan point. Thismore » approach obtains high-resolution images with extended depth of field, which paves the way for multi-slice ptychography as a high throughput technique for high-resolution 3D imaging of thick samples.« less

Multi-slice ptychography with large numerical aperture multilayer Laue lenses

DOE Office of Scientific and Technical Information (OSTI.GOV)

Ozturk, Hande; Yan, Hanfei; He, Yan

Here, the highly convergent x-ray beam focused by multilayer Laue lenses with large numerical apertures is used as a three-dimensional (3D) probe to image layered structures with an axial separation larger than the depth of focus. Instead of collecting weakly scattered high-spatial-frequency signals, the depth-resolving power is provided purely by the intense central cone diverged from the focused beam. Using the multi-slice ptychography method combined with the on-the-fly scan scheme, two layers of nanoparticles separated by 10 μm are successfully reconstructed with 8.1 nm lateral resolution and with a dwell time as low as 0.05 s per scan point. Thismore » approach obtains high-resolution images with extended depth of field, which paves the way for multi-slice ptychography as a high throughput technique for high-resolution 3D imaging of thick samples.« less

49 CFR 174.63 - Portable tanks, IM portable tanks, IBCs, Large Packagings, cargo tanks, and multi-unit tank car...

Code of Federal Regulations, 2014 CFR

2014-10-01

... 49 Transportation 2 2014-10-01 2014-10-01 false Portable tanks, IM portable tanks, IBCs, Large Packagings, cargo tanks, and multi-unit tank car tanks. 174.63 Section 174.63 Transportation Other....63 Portable tanks, IM portable tanks, IBCs, Large Packagings, cargo tanks, and multi-unit tank car...

49 CFR 174.63 - Portable tanks, IM portable tanks, IBCs, Large Packagings, cargo tanks, and multi-unit tank car...

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 2 2010-10-01 2010-10-01 false Portable tanks, IM portable tanks, IBCs, Large Packagings, cargo tanks, and multi-unit tank car tanks. 174.63 Section 174.63 Transportation Other....63 Portable tanks, IM portable tanks, IBCs, Large Packagings, cargo tanks, and multi-unit tank car...

49 CFR 174.63 - Portable tanks, IM portable tanks, IBCs, Large Packagings, cargo tanks, and multi-unit tank car...

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 2 2011-10-01 2011-10-01 false Portable tanks, IM portable tanks, IBCs, Large Packagings, cargo tanks, and multi-unit tank car tanks. 174.63 Section 174.63 Transportation Other....63 Portable tanks, IM portable tanks, IBCs, Large Packagings, cargo tanks, and multi-unit tank car...

49 CFR 174.63 - Portable tanks, IM portable tanks, IBCs, Large Packagings, cargo tanks, and multi-unit tank car...

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 2 2013-10-01 2013-10-01 false Portable tanks, IM portable tanks, IBCs, Large Packagings, cargo tanks, and multi-unit tank car tanks. 174.63 Section 174.63 Transportation Other....63 Portable tanks, IM portable tanks, IBCs, Large Packagings, cargo tanks, and multi-unit tank car...

49 CFR 174.63 - Portable tanks, IM portable tanks, IBCs, Large Packagings, cargo tanks, and multi-unit tank car...

Code of Federal Regulations, 2012 CFR

2012-10-01

... 49 Transportation 2 2012-10-01 2012-10-01 false Portable tanks, IM portable tanks, IBCs, Large Packagings, cargo tanks, and multi-unit tank car tanks. 174.63 Section 174.63 Transportation Other....63 Portable tanks, IM portable tanks, IBCs, Large Packagings, cargo tanks, and multi-unit tank car...

Single-Trial Classification of Multi-User P300-Based Brain-Computer Interface Using Riemannian Geometry.

PubMed

Korczowski, L; Congedo, M; Jutten, C

2015-08-01

The classification of electroencephalographic (EEG) data recorded from multiple users simultaneously is an important challenge in the field of Brain-Computer Interface (BCI). In this paper we compare different approaches for classification of single-trials Event-Related Potential (ERP) on two subjects playing a collaborative BCI game. The minimum distance to mean (MDM) classifier in a Riemannian framework is extended to use the diversity of the inter-subjects spatio-temporal statistics (MDM-hyper) or to merge multiple classifiers (MDM-multi). We show that both these classifiers outperform significantly the mean performance of the two users and analogous classifiers based on the step-wise linear discriminant analysis. More importantly, the MDM-multi outperforms the performance of the best player within the pair.

Recruitment of participants to a multiple sclerosis trial: The CombiRx experience

PubMed Central

Bhanushali, Minal J; Gustafson, Tarah; Powell, Steve; Conwit, Robin A; Wolinsky, Jerry S; Cutter, Gary R; Lublin, Fred; Cofield, Stacey S

2014-01-01

Background and Purpose: Participant recruitment is central to all clinical trials. Any delay in recruitment affects the completion and ultimate success of the trial. We report our experience with patient screening and randomization in CombiRx, which may inform the design of other trials. CombiRx was a multi-center, phase III, double-blind, randomized clinical trial comparing the combined use of interferon beta-1a and glatiramer acetate to either agent alone in patients with relapsing-remitting multiple sclerosis (RRMS). This trial was launched in January 2005 in 69 centers in the U.S. and Canada under a co-operative agreement with the National Institute of Neurological Disorders and Stroke (NINDS). The goal was to recruit 1000 patients over 1.5 years after a 6 month startup period. Instead, the investigators required 4.25 years to enroll 1008 patients. Methods: During this trial, we assessed the effectiveness of various recruitment strategies, utility of rescreening prior screen failures, and potential factors and strategies used in study conduct, research and infrastructure, all of which affected recruitment of participants and ultimately time to completion of CombiRx. We particularly were interested in the variability in time to site initiation between academic centers and private practice sites. Results: Physicians who were directly involved in the medical care of patients with RRMS were the primary source of patients recruited to CombiRx. A flexible study design that allowed for re-screening of the initial screen failures after a period of time was useful due to the relapsing/remitting course of the disease. Academic centers took longer to implement the trial than the private practice centers, but once sites were approved for enrollment, there was no important difference in the number of participants enrolled. Limitations: The CombiRx trial was conducted during a period when multiple new medications were being tested, thus affecting the pace of recruitment and

"Less Clicking, More Watching": Results from the User-Centered Design of a Multi-Institutional Web Site for Art and Culture.

ERIC Educational Resources Information Center

Vergo, John; Karat, Clare-Marie; Karat, John; Pinhanez, Claudio; Arora, Renee; Cofino, Thomas; Riecken, Doug; Podlaseck, Mark

This paper summarizes a 10-month long research project conducted at the IBM T.J. Watson Research Center aimed at developing the design concept of a multi-institutional art and culture web site. The work followed a user-centered design (UCD) approach, where interaction with prototypes and feedback from potential users of the web site were sought…

Collaborative translational research leading to multicenter clinical trials in Duchenne muscular dystrophy: the Cooperative International Neuromuscular Research Group (CINRG).

PubMed

Escolar, Diana M; Henricson, Erik K; Pasquali, Livia; Gorni, Ksenija; Hoffman, Eric P

2002-10-01

Progress in the development of rationally based therapies for Duchenne muscular dystrophy has been accelerated by encouraging multidisciplinary, multi-institutional collaboration between basic science and clinical investigators in the Cooperative International Research Group. We combined existing research efforts in pathophysiology by a gene expression profiling laboratory with the efforts of animal facilities capable of conducting high-throughput drug screening and toxicity testing to identify safe and effective drug compounds that target different parts of the pathophysiologic cascade in a genome-wide drug discovery approach. Simultaneously, we developed a clinical trial coordinating center and an international network of collaborating physicians and clinics where those drugs could be tested in large-scale clinical trials. We hope that by bringing together investigators at these facilities and providing the infrastructure to support their research, we can rapidly move new bench discoveries through animal model screening and into therapeutic testing in humans in a safe, timely and cost-effective setting.

Construct, Concurrent and Predictive Validity of the URICA: Data from Two Multi-site Clinical Trials

PubMed Central

Field, Craig A.; Adinoff, Bryon; Harris, T. Robert; Ball, Samuel A.; Carroll, Kathleen M.

2011-01-01

Background A better understanding of how to measure motivation to change and how it relates to behavior change in patients with drug and alcohol dependence would broaden our understanding of the role of motivation in addiction treatment. Methods Two multi-site, randomized clinical trials comparing brief motivational interventions with standard care were conducted in the National Institute on Drug Abuse Clinical Trials Network. Patients with primary drug dependence and alcohol dependence entering outpatient treatment participated in a study of either Motivational Enhancement Therapy (n=431) or Motivational Interviewing (n=423). The construct, concurrent, and predictive validity of two composite measures of motivation to change derived from the University of Rhode Island Change Assessment (URICA): Readiness to Change (RTC) and Committed Action (CA) were evaluated. Results Confirmatory factor analysis confirmed the a priori factor structure of the URICA. RTC was significantly associated with measures of addiction severity at baseline (r=.12-.52, p<.05). Although statistically significant (p<.01), the correlations between treatment outcomes and RTC were low (r=-.15 and -18). Additional analyses did not support a moderating or mediating effect of motivation on treatment retention or substance use. Conclusions The construct validity of the URICA was confirmed separately in a large sample of drug- and alcohol-dependent patients. However, evidence for the predictive validity of composite scores was very limited and there were no moderating or mediating effects of either measure on treatment outcome. Thus, increased motivation to change, as measured by the composite scores of motivation derived from the URICA, does not appear to influence treatment outcome. PMID:19157723

Design of telehealth trials--introducing adaptive approaches.

PubMed

Law, Lisa M; Wason, James M S

2014-12-01

The field of telehealth and telemedicine is expanding as the need to improve efficiency of health care becomes more pressing. The decision to implement a telehealth system is generally an expensive undertaking that impacts a large number of patients and other stakeholders. It is therefore extremely important that the decision is fully supported by accurate evaluation of telehealth interventions. Numerous reviews of telehealth have described the evidence base as inconsistent. In response they call for larger, more rigorously controlled trials, and trials which go beyond evaluation of clinical effectiveness alone. The aim of this paper is to discuss various ways in which evaluation of telehealth could be improved by the use of adaptive trial designs. We discuss various adaptive design options, such as sample size reviews and changing the study hypothesis to address uncertain parameters, group sequential trials and multi-arm multi-stage trials to improve efficiency, and enrichment designs to maximise the chances of obtaining clear evidence about the telehealth intervention. There is potential to address the flaws discussed in the telehealth literature through the adoption of adaptive approaches to trial design. Such designs could lead to improvements in efficiency, allow the evaluation of multiple telehealth interventions in a cost-effective way, or accurately assess a range of endpoints that are important in the overall success of a telehealth programme. Copyright © 2014 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

The costs and effectiveness of large Phase III pre-licensure vaccine clinical trials.

PubMed

Black, Steven

2015-01-01

Prior to the 1980s, most vaccines were licensed based upon safety and effectiveness studies in several hundred individuals. Beginning with the evaluation of Haemophilus influenzae type b conjugate vaccines, much larger pre-licensure trials became common. The pre-licensure trial for Haemophilus influenzae oligosaccharide conjugate vaccine had more than 60,000 children and that of the seven-valent pneumococcal conjugate vaccine included almost 38,000 children. Although trial sizes for both of these studies were driven by the sample size required to demonstrate efficacy, the sample size requirements for safety evaluations of other vaccines have subsequently increased. With the demonstration of an increased risk of intussusception following the Rotashield brand rotavirus vaccine, this trend has continued. However, routinely requiring safety studies of 20,000-50,000 or more participants has two major downsides. First, the cost of performing large safety trials routinely prior to licensure of a vaccine is very large, with some estimates as high at US$200 million euros for one vaccine. This high financial cost engenders an opportunity cost whereby the number of vaccines that a company is willing or able to develop to meet public health needs becomes limited by this financial barrier. The second downside is that in the pre-licensure setting, such studies are very time consuming and delay the availability of a beneficial vaccine substantially. One might argue that in some situations, this financial commitment is warranted such as for evaluations of the risk of intussusception following newer rotavirus vaccines. However, it must be noted that while an increased risk of intussusception was not identified in large pre-licensure studies, in post marketing evaluations an increased risk of this outcome has been identified. Thus, even the extensive pre-licensure evaluations conducted did not identify an associated risk. The limitations of large Phase III trials have also been

Patient-centered disease management (PCDM) for heart failure: study protocol for a randomised controlled trial

PubMed Central

2013-01-01

Background Chronic heart failure (HF) disease management programs have reported inconsistent results and have not included comorbid depression management or specifically focused on improving patient-reported outcomes. The Patient Centered Disease Management (PCDM) trial was designed to test the effectiveness of collaborative care disease management in improving health status (symptoms, functioning, and quality of life) in patients with HF who reported poor HF-specific health status. Methods/design Patients with a HF diagnosis at four VA Medical Centers were identified through population-based sampling. Patients with a Kansas City Cardiomyopathy Questionnaire (KCCQ, a measure of HF-specific health status) score of < 60 (heavy symptom burden and impaired quality of life) were invited to enroll in the PCDM trial. Enrolled patients were randomized to receive usual care or the PCDM intervention, which included: (1) collaborative care management by VA clinicians including a nurse, cardiologist, internist, and psychiatrist, who worked with patients and their primary care providers to provide guideline-concordant care management, (2) home telemonitoring and guided patient self-management support, and (3) screening and treatment for comorbid depression. The primary study outcome is change in overall KCCQ score. Secondary outcomes include depression, medication adherence, guideline-based care, hospitalizations, and mortality. Discussion The PCDM trial builds on previous studies of HF disease management by prioritizing patient health status, implementing a collaborative care model of health care delivery, and addressing depression, a key barrier to optimal disease management. The study has been designed as an ‘effectiveness trial’ to support broader implementation in the healthcare system if it is successful. Trial registration Unique identifier: NCT00461513 PMID:23837415

Managing multicentre clinical trials with open source.

PubMed

Raptis, Dimitri Aristotle; Mettler, Tobias; Fischer, Michael Alexander; Patak, Michael; Lesurtel, Mickael; Eshmuminov, Dilmurodjon; de Rougemont, Olivier; Graf, Rolf; Clavien, Pierre-Alain; Breitenstein, Stefan

2014-03-01

Multicentre clinical trials are challenged by high administrative burden, data management pitfalls and costs. This leads to a reduced enthusiasm and commitment of the physicians involved and thus to a reluctance in conducting multicentre clinical trials. The purpose of this study was to develop a web-based open source platform to support a multi-centre clinical trial. We developed on Drupal, an open source software distributed under the terms of the General Public License, a web-based, multi-centre clinical trial management system with the design science research approach. This system was evaluated by user-testing and well supported several completed and on-going clinical trials and is available for free download. Open source clinical trial management systems are capable in supporting multi-centre clinical trials by enhancing efficiency, quality of data management and collaboration.

TERMTrial--terminology-based documentation systems for cooperative clinical trials.

PubMed

Merzweiler, A; Weber, R; Garde, S; Haux, R; Knaup-Gregori, P

2005-04-01

Within cooperative groups of multi-center clinical trials a standardized documentation is a prerequisite for communication and sharing of data. Standardizing documentation systems means standardizing the underlying terminology. The management and consistent application of terminology systems is a difficult and fault-prone task, which should be supported by appropriate software tools. Today, documentation systems for clinical trials are often implemented as so-called Remote-Data-Entry-Systems (RDE-systems). Although there are many commercial systems, which support the development of RDE-systems there is none offering a comprehensive terminological support. Therefore, we developed the software system TERMTrial which consists of a component for the definition and management of terminology systems for cooperative groups of clinical trials and two components for the terminology-based automatic generation of trial databases and terminology-based interactive design of electronic case report forms (eCRFs). TERMTrial combines the advantages of remote data entry with a comprehensive terminological control.

Building Successful Relationships in the PLCO Cancer Screening Trial

PubMed Central

Marcus, Pamela M.; Broski, Karen G.; Buys, Saundra S.; Childs, Jeffery; Church, Timothy R.; Gohagan, John K.; Gren, Lisa H.; Higgins, Darlene; Jaggi, Rachel; Jenkins, Victoria; Johnson, Christine C.; Lappe, Karen; O’Brien, Barbara; Ogden, Sheryl L.; Prorok, Philip C.; Reding, Douglas; Shambaugh, Vicki; Yokochi, Lance A.; Yurgalevitch, Susan

2017-01-01

Biomedical research cannot succeed without funding, knowledgeable staff, and appropriate infrastructure. There are however equally important but intangible factors that are rarely considered in planning large multidisciplinary endeavors or evaluating their success. The Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial required extensive collaborations between individuals from many fields, including clinicians, clinical trialists, and administrators; it also addressed questions across the spectrum of cancer prevention and control, In this manuscript, we examine the experiences and opinions of trial staff regarding the building of successful relationships in PLCO. We summarize, in narrative form, data collected using open-ended questionnaires that were administered to the National Cancer Institute project officers, coordinating center staff, screening center principal investigators, and screening center coordinators in 2015, about 3 years after publication of the final primary trial manuscript. Trust, respect, listening to others, and in-person interaction were frequently mentioned as crucial to building successful relationships. PMID:26238208

Early experiences in establishing a regional quantitative imaging network for PET/CT clinical trials.

PubMed

Doot, Robert K; Thompson, Tove; Greer, Benjamin E; Allberg, Keith C; Linden, Hannah M; Mankoff, David A; Kinahan, Paul E

2012-11-01

The Seattle Cancer Care Alliance (SCCA) is a Pacific Northwest regional network that enables patients from community cancer centers to participate in multicenter oncology clinical trials where patients can receive some trial-related procedures at their local center. Results of positron emission tomography (PET) scans performed at community cancer centers are not currently used in SCCA Network trials since clinical trials customarily accept results from only trial-accredited PET imaging centers located at academic and large hospitals. Oncologists would prefer the option of using standard clinical PET scans from Network sites in multicenter clinical trials to increase accrual of patients for whom additional travel requirements for imaging are a barrier to recruitment. In an effort to increase accrual of rural and other underserved populations to Network trials, researchers and clinicians at the University of Washington, SCCA and its Network are assessing the feasibility of using PET scans from all Network sites in their oncology clinical trials. A feasibility study is required because the reproducibility of multicenter PET measurements ranges from approximately 3% to 40% at national academic centers. Early experiences from both national and local PET phantom imaging trials are discussed, and next steps are proposed for including patient PET scans from the emerging regional quantitative imaging network in clinical trials. There are feasible methods to determine and characterize PET quantitation errors and improve data quality by either prospective scanner calibration or retrospective post hoc corrections. These methods should be developed and implemented in multicenter clinical trials employing quantitative PET imaging of patients. Copyright © 2012 Elsevier Inc. All rights reserved.

Dust Temperatures and Opacities in the Central Parsec of the Galactic Center Modeled from Analysis of Multi-Wavelength Mid-Infrared Images

NASA Technical Reports Server (NTRS)

Varosi, F.; Gezari, D.; Dwek, E.; Telesco, C.

2016-01-01

We have analyzed multi-wavelength mid-infrared images of the central parsec of the Galactic Center using a two-temperature line-of-sight (LOS) radiative transfer model at each pixel of the images, giving maps of temperatures, luminosities and opacities of the hot, warm, cold (dark)dust components. The data consists of images at nine wavelengths in the mid-infrared (N-band and Q-band) from the Thermal Region Camera and Spectrograph (T-ReCS) instrument operating at the Gemini South Observatory. The results of the LOS modeling indicate that the extinction optical depth is quite large and varies substantially over the FOV. The high-resolution images of the central parsec of the Galactic center region were obtained with T-ReCS at Gemini South in January 2004. These images provide nearly diffraction-limited resolution (approx. 0.5) of the central parsec. The T-ReCS images were taken with nine filters (3.8, 4.7, 7.7, 8.7, 9.7, 10.3, 12.3, 18.3 and 24.5m), over a field-of-view (FOV) of 20 x 20 arcsec.

Evaluations of treatment efficacy of depression from perspective of both patients' symptoms and general sense of mental health and wellbeing: A large scale, multi-centered, longitudinal study in China.

PubMed

Zeng, Qingzhi; Wang, Wei Chun; Fang, Yiru; Mellor, David; Mccabe, Marita; Byrne, Linda; Zuo, Sai; Xu, Yifeng

2016-07-30

Relying on the absence, presence of level of symptomatology may not provide an adequate indication of the effects of treatment for depression, nor sufficient information for the development of treatment plans that meet patients' needs. Using a prospective, multi-centered, and observational design, the present study surveyed a large sample of outpatients with depression in China (n=9855). The 17-item Hamilton Rating Scale for Depression (HRSD-17) and the Remission Evaluation and Mood Inventory Tool (REMIT) were administered at baseline, two weeks later and 4 weeks, to assess patients' self-reported symptoms and general sense of mental health and wellbeing. Of 9855 outpatients, 91.3% were diagnosed as experiencing moderate to severe depression. The patients reported significant improvement over time on both depressive symptoms and general sense after 4-week treatment. The effect sizes of change in general sense were lower than those in symptoms at both two week and four week follow-up. Treatment effects on both general sense and depressive symptomatology were associated with demographic and clinical factors. The findings indicate that a focus on both general sense of mental health and wellbeing in addition to depressive symptomatology will provide clinicians, researchers and patients themselves with a broader perspective of the status of patients. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Advanced and recurring thymic carcinoma is target of new clinical trial | Center for Cancer Research

Cancer.gov

Adults diagnosed with thymic carcinoma who overexpress the protein mesothelin may be eligible to participate in a new clinical trial at the NIH Clinical Center. The study will look at the safety and effectiveness of an investigational drug, anetumab ravtansine, developed by Bayer HealthCare Pharmaceuticals. The drug works by binding to mesothelin, therefore overexpression of

Practical issues and lessons learned from multi-regional clinical trials via case examples: a Japanese perspective.

PubMed

Ando, Yuki; Hamasaki, Toshimitsu

2010-01-01

The multi-regional clinical trials (MRCTs) being administered in different regions of the world now play a major role in providing evidence for the efficacy and safety of new drugs amidst the simultaneous global development and worldwide registration of such drugs, in support of the expeditious availability of medical products to patients. However, such trials present considerable challenges as far as quality, design, implementation, analysis, and interpretation are concerned. In this article, we share our observations and lessons learned from the design, implementation, analysis, and interpretation of some MRCTs with case examples. Current Japanese regulatory guidance on MRCTs is introduced along with some suggestions for design, implementation, and interpretation. Copyright © 2010 John Wiley & Sons, Ltd.

Performance evaluation of multi-stratum resources integration based on network function virtualization in software defined elastic data center optical interconnect.

PubMed

Yang, Hui; Zhang, Jie; Ji, Yuefeng; Tian, Rui; Han, Jianrui; Lee, Young

2015-11-30

Data center interconnect with elastic optical network is a promising scenario to meet the high burstiness and high-bandwidth requirements of data center services. In our previous work, we implemented multi-stratum resilience between IP and elastic optical networks that allows to accommodate data center services. In view of this, this study extends to consider the resource integration by breaking the limit of network device, which can enhance the resource utilization. We propose a novel multi-stratum resources integration (MSRI) architecture based on network function virtualization in software defined elastic data center optical interconnect. A resource integrated mapping (RIM) scheme for MSRI is introduced in the proposed architecture. The MSRI can accommodate the data center services with resources integration when the single function or resource is relatively scarce to provision the services, and enhance globally integrated optimization of optical network and application resources. The overall feasibility and efficiency of the proposed architecture are experimentally verified on the control plane of OpenFlow-based enhanced software defined networking (eSDN) testbed. The performance of RIM scheme under heavy traffic load scenario is also quantitatively evaluated based on MSRI architecture in terms of path blocking probability, provisioning latency and resource utilization, compared with other provisioning schemes.

Computer modeling with randomized-controlled trial data informs the development of person-centered aged care homes.

PubMed

Chenoweth, Lynn; Vickland, Victor; Stein-Parbury, Jane; Jeon, Yun-Hee; Kenny, Patricia; Brodaty, Henry

2015-10-01

To answer questions on the essential components (services, operations and resources) of a person-centered aged care home (iHome) using computer simulation. iHome was developed with AnyLogic software using extant study data obtained from 60 Australian aged care homes, 900+ clients and 700+ aged care staff. Bayesian analysis of simulated trial data will determine the influence of different iHome characteristics on care service quality and client outcomes. Interim results: A person-centered aged care home (socio-cultural context) and care/lifestyle services (interactional environment) can produce positive outcomes for aged care clients (subjective experiences) in the simulated environment. Further testing will define essential characteristics of a person-centered care home.

Enhancing Learning Management Systems Utility for Blind Students: A Task-Oriented, User-Centered, Multi-Method Evaluation Technique

ERIC Educational Resources Information Center

Babu, Rakesh; Singh, Rahul

2013-01-01

This paper presents a novel task-oriented, user-centered, multi-method evaluation (TUME) technique and shows how it is useful in providing a more complete, practical and solution-oriented assessment of the accessibility and usability of Learning Management Systems (LMS) for blind and visually impaired (BVI) students. Novel components of TUME…

Effects of the Caregiver Interaction Profile Training on Caregiver-Child Interactions in Dutch Child Care Centers: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Helmerhorst, Katrien O.; Riksen-Walraven, J. Marianne; Fukkink, Ruben G.; Tavecchio, Louis W. C.; Gevers Deynoot-Schaub, Mirjam J. J. M.

2017-01-01

Background: Previous studies underscore the need to improve caregiver-child interactions in early child care centers. Objective: In this study we used a randomized controlled trial to examine whether a 5-week video feedback training can improve six key interactive skills of caregivers in early child care centers: Sensitive responsiveness, respect…

Connecting Smartphone and Wearable Fitness Tracker Data with a Nationally Used Electronic Health Record System for Diabetes Education to Facilitate Behavioral Goal Monitoring in Diabetes Care: Protocol for a Pragmatic Multi-Site Randomized Trial

PubMed Central

Coleman, Deidra Carroll; Kanter, Justin; Ummer, Brad; Siminerio, Linda

2018-01-01

education or 2) standard education enhanced with the connected system. Data collection for the 3-month pragmatic trial is completed. Data analysis is in progress. Conclusions If results of the pragmatic multi-site clinical trial show preliminary efficacy and usability of the connected system, a large-scale implementation trial will be conducted. Trial Registration ClinicalTrials.gov NCT02664233; https://clinicaltrials.gov/ct2/show/NCT02664233 (Archived by WebCite at http://www.webcitation.org/6yDEwXHo5) PMID:29610111

Comparison of Characteristics and Outcomes of Trial Participants and Nonparticipants: Example of Blood and Marrow Transplant Clinical Trials Network 0201 Trial.

PubMed

Khera, Nandita; Majhail, Navneet S; Brazauskas, Ruta; Wang, Zhiwei; He, Naya; Aljurf, Mahmoud D; Akpek, Görgün; Atsuta, Yoshiko; Beattie, Sara; Bredeson, Christopher N; Burns, Linda J; Dalal, Jignesh D; Freytes, César O; Gupta, Vikas; Inamoto, Yoshihiro; Lazarus, Hillard M; LeMaistre, Charles F; Steinberg, Amir; Szwajcer, David; Wingard, John R; Wirk, Baldeep; Wood, William A; Joffe, Steven; Hahn, Theresa E; Loberiza, Fausto R; Anasetti, Claudio; Horowitz, Mary M; Lee, Stephanie J

2015-10-01

Controversy surrounds the question of whether clinical trial participants have better outcomes than comparable patients who are not treated on a trial. We explored this question using a recent large, randomized, multicenter study comparing peripheral blood (PB) with bone marrow transplantation from unrelated donors, conducted by the Blood and Marrow Transplant Clinical Trials Network (BMT CTN). We compared characteristics and outcomes of study participants (n = 494) and nonparticipants (n = 1384) who appeared eligible and received similar treatment without enrolling on the BMT CTN trial at participating centers during the study time period. Data were obtained from the Center for International Blood and Marrow Transplant Research. Outcomes were compared between the 2 groups using Cox proportional hazards regression models. No significant differences in age, sex, disease distribution, race/ethnicity, HLA matching, comorbidities, and interval from diagnosis to hematopoietic cell transplantation were seen between the participants and nonparticipants. Nonparticipants were more likely to have lower performance status, lower risk disease, and older donors, and to receive myeloablative conditioning and antithymocyte globulin. Nonparticipants were also more likely to receive PB grafts, the intervention tested in the trial (66% versus 50%, P < .001). Overall survival, transplantation-related mortality, and incidences of acute or chronic graft-versus-host disease were comparable between the 2 groups though relapse was higher (hazard ratio, 1.22; 95% confidence interval, 1.02 to 1.46; P = .028) in nonparticipants. Despite differences in certain baseline characteristics, survival was comparable between study participants and nonparticipants. The results of the BMT CTN trial appear generalizable to the population of trial-eligible patients. Copyright © 2015 American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.

[Features of Clinical Register of Chinese Medicine and Pharmacy Based on ClinicalTrials.gov. (USA)].

PubMed

Lu, Peng-fei; Liao, Xing; Xie, Yan-ming; Wang, Zhi-guo

2015-11-01

In recent 10 years, clinical trials of Chinese medicine and pharmacy (cMP) at clinicalTrials.gov.(USA) are gradually increasing. In order to analyze features of CMP clinical register, ClinicalTrials.gov register database were comprehensively retrieved in this study. Included clinical trials were input one item after another using EXCEL. A final of 348 CMP clinical trials were included. Results showed that China occupied the first place in CMP clinical register, followed by USA. CMP clinical trials, sponsored mainly by colleges/universities and hospitals, mostly covered interventional studies on evaluating safety/effectiveness of CMP. The proportions of studies, sponsored by mainland China and companies, recruitment trials and multi-center clinical trials in interventional trials were increasing. The proportions of studies sponsored by Hong Kong and Taiwan, research completed trials, unclear research status, phase III clinical trials, and published research trials in interventional trials were decreasing. Published ratios of CMP clinical trials were quite low. There were more missing types and higher proportions in trial register information.

Nonparametric estimation of median survival times with applications to multi-site or multi-center studies.

PubMed

Rahbar, Mohammad H; Choi, Sangbum; Hong, Chuan; Zhu, Liang; Jeon, Sangchoon; Gardiner, Joseph C

2018-01-01

We propose a nonparametric shrinkage estimator for the median survival times from several independent samples of right-censored data, which combines the samples and hypothesis information to improve the efficiency. We compare efficiency of the proposed shrinkage estimation procedure to unrestricted estimator and combined estimator through extensive simulation studies. Our results indicate that performance of these estimators depends on the strength of homogeneity of the medians. When homogeneity holds, the combined estimator is the most efficient estimator. However, it becomes inconsistent when homogeneity fails. On the other hand, the proposed shrinkage estimator remains efficient. Its efficiency decreases as the equality of the survival medians is deviated, but is expected to be as good as or equal to the unrestricted estimator. Our simulation studies also indicate that the proposed shrinkage estimator is robust to moderate levels of censoring. We demonstrate application of these methods to estimating median time for trauma patients to receive red blood cells in the Prospective Observational Multi-center Major Trauma Transfusion (PROMMTT) study.

Testing homogeneity of proportion ratios for stratified correlated bilateral data in two-arm randomized clinical trials.

PubMed

Pei, Yanbo; Tian, Guo-Liang; Tang, Man-Lai

2014-11-10

Stratified data analysis is an important research topic in many biomedical studies and clinical trials. In this article, we develop five test statistics for testing the homogeneity of proportion ratios for stratified correlated bilateral binary data based on an equal correlation model assumption. Bootstrap procedures based on these test statistics are also considered. To evaluate the performance of these statistics and procedures, we conduct Monte Carlo simulations to study their empirical sizes and powers under various scenarios. Our results suggest that the procedure based on score statistic performs well generally and is highly recommended. When the sample size is large, procedures based on the commonly used weighted least square estimate and logarithmic transformation with Mantel-Haenszel estimate are recommended as they do not involve any computation of maximum likelihood estimates requiring iterative algorithms. We also derive approximate sample size formulas based on the recommended test procedures. Finally, we apply the proposed methods to analyze a multi-center randomized clinical trial for scleroderma patients. Copyright © 2014 John Wiley & Sons, Ltd.

Effectiveness and cost-effectiveness of body psychotherapy in the treatment of negative symptoms of schizophrenia – a multi-centre randomised controlled trial

PubMed Central

2013-01-01

Background Negative symptoms of schizophrenia are frequently associated with poor long term outcomes. Established interventions have little, if any, positive effects on negative symptoms. Arts Therapies such as Body Psychotherapy (BPT) have been suggested to reduce negative symptoms, but the existing evidence is limited. In a small exploratory trial a manualised form of group BPT led to significantly lower negative symptom levels both at the end of treatment and at 4 months follow-up as compared to supportive counseling. We designed a large multi-site trial to assess the effectiveness of a manualised BPT intervention in reducing negative symptoms, compared to an active control. Methods/Design In a randomised controlled trial, 256 schizophrenic outpatients with negative symptoms will be randomly allocated either to BPT or Pilates groups. In both conditions, patients will be offered two 90 minutes sessions per week in groups of about 8 patients over a period of 10 weeks. Outcomes are assessed at the end of treatment and at six months follow-up. The primary outcome is severity of negative symptoms, as measured by the Positive and Negative Symptom Scale (PANSS), whilst a range of secondary outcome measures include general psychopathology, social contacts, and quality of life. We will also assess the cost-effectiveness of the intervention. Discussion The study aims to evaluate the effectiveness of a promising form of group therapy which may help alleviate negative symptoms that are associated with unfavourable long-term outcomes and have so far been difficult to treat. If the trial is successful, it will add a new and effective option in the treatment of negative symptoms. Group BPT is manualised, might be attractive to many patients because of its unusual approach, and could potentially be rolled out to services at relatively little additional cost. Trial registration Current Controlled Trials ISRCTN84216587 PMID:23317474

Photogrammetric Technique for Center of Gravity Determination

NASA Technical Reports Server (NTRS)

Jones, Thomas W.; Johnson, Thomas H.; Shemwell, Dave; Shreves, Christopher M.

2012-01-01

A new measurement technique for determination of the center of gravity (CG) for large scale objects has been demonstrated. The experimental method was conducted as part of an LS-DYNA model validation program for the Max Launch Abort System (MLAS) crew module. The test was conducted on the full scale crew module concept at NASA Langley Research Center. Multi-camera photogrammetry was used to measure the test article in several asymmetric configurations. The objective of these measurements was to provide validation of the CG as computed from the original mechanical design. The methodology, measurement technique, and measurement results are presented.

The SDSS-III Multi-object Apo Radial-velocity Exoplanet Large-area Survey

NASA Astrophysics Data System (ADS)

Ge, Jian; Mahadevan, S.; Lee, B.; Wan, X.; Zhao, B.; van Eyken, J.; Kane, S.; Guo, P.; Ford, E. B.; Agol, E.; Gaudi, S.; Fleming, S.; Crepp, J.; Cohen, R.; Groot, J.; Galvez, M.; Liu, J.; Ford, H.; Schneider, D.; Seager, S.; Hawley, S. L.; Weinberg, D.; Eisenstein, D.

2007-12-01

As part of SDSS-III survey in 2008-2014, the Multi-object APO Radial-Velocity Exoplanet Large-area Survey (MARVELS) will conduct the largest ground-based Doppler planet survey to date using the SDSS telescope and new generation multi-object Doppler instruments with 120 object capability and 10-20 m/s Doppler precision. The baseline survey plan is to monitor a total of 11,000 V=8-12 stars ( 10,000 main sequence stars and 1000 giant stars) over 800 square degrees over the 6 years. The primary goal is to produce a large, statistically well defined sample of giant planets ( 200) with a wide range of masses ( 0.2-10 Jupiter masses) and orbits (1 day-2 years) drawn from a large of host stars with a diverse set of masses, compositions, and ages for studying the diversity of extrasolar planets and constraining planet formation, migration & dynamical evolution of planetary systems. The survey data will also be used for providing a statistical sample for theoretical comparison and discovering rare systems and identifying signposts for lower-mass or more distant planets. Early science results from the pilot program will be reported. We would like to thank the SDSS MC for allocation of the telescope time and the W.M. Keck Foundation, NSF, NASA and UF for support.

Center Size and Center Performance.

ERIC Educational Resources Information Center

Helburn, Suzanne; Morris, John

1996-01-01

Examined the impact of child care center size on cost, quality, and profits per child. Examined centers ranging from 40 to 80 children and found total cost and revenue per child were similar for small, medium, and large centers. Found profits per child were highest in large centers and that there was no relationship between center quality and…

Fast track multi-discipline treatment (FTMDT trial) versus conventional treatment in colorectal cancer--the design of a prospective randomized controlled study

PubMed Central

2011-01-01

Background Laparoscopy-assisted surgery, fast-track perioperative treatment are both increasingly used in colorectal cancer treatment, for their short-time benefits of enhanced recovery and short hospital stays. However, the benefits of the integration of the Laparoscopy-assisted surgery, fast-track perioperative treatment, and even with the Xelox chemotherapy, are still unknown. In this study, the three treatments integration is defined as "Fast Track Multi-Discipline Treatment Model" for colorectal cancer and this model extends the benefits to the whole treatment process of colorectal cancer. The main purpose of the study is to explore the feasibility of "Fast Track Multi-Discipline Treatment" model in treatment of colorectal cancer. Methods The trial is a prospective randomized controlled study with 2 × 2 balanced factorial design. Patients eligible for the study will be randomized to 4 groups: (I) Laparoscopic surgery with fast track perioperative treatment and Xelox chemotherapy; (II) Open surgery with fast track perioperative treatment and Xelox chemotherapy; (III) Laparoscopic surgery with conventional perioperative treatment and mFolfox6 chemotherapy; (IV) Open surgery with conventional perioperative treatment and mFolfox6 chemotherapy. The primary endpoint of this study is the hospital stays. The secondary endpoints are the quality of life, chemotherapy related adverse events, surgical complications and hospitalization costs. Totally, 340 patients will be enrolled with 85 patients in each group. Conclusions The study initiates a new treatment model "Fast Track Multi-Discipline Treatment" for colorectal cancer, and will provide feasibility evidence on the new model "Fast Track Multi-Discipline Treatment" for patients with colorectal cancer. Trial registration ClinicalTrials.gov: NCT01080547 PMID:22111914

Implications of HIV PrEP Trials Results

PubMed Central

Anton, Peter; Fletcher, Courtney V.; DeGruttola, Victor; McGowan, Ian; Becker, Stephen; Zwerski, Sheryl; Burns, David

2011-01-01

Abstract Six randomized clinical trials have been implemented to examine the efficacy of tenofovir disoproxil fumarate (TDF) and/or TDF/emtricitabine (TDF/FTC) as preexposure prophylaxis for HIV-1 infection (PrEP). Although largely complementary, the six trials have many similar features. As the earliest results become available, an urgent question may arise regarding whether changes should be made in the conduct of the other trials. To consider this in advance, a Consultation on the Implications of HIV Pre-Exposure Prophylaxis (PrEP) Trials Results sponsored by the Division of AIDS (DAIDS) of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), and the Bill and Melinda Gates Foundation (BMGF) was held on January 29, 2010, at the Natcher Conference Center, NIH, Bethesda, MD. Participants included basic scientists, clinical researchers (including investigators performing the current PrEP trials), and representatives from the U.S. Food and Drug Administration (FDA) and the agencies sponsoring the trials: the U.S. Centers for Disease Control and Prevention (CDC), the U.S. Agency for International Development (USAID), the BMGF, and the U.S. NIH. We report here a summary of the presentations and highlights of salient discussion topics from this workshop. PMID:20969483

QIN. Early experiences in establishing a regional quantitative imaging network for PET/CT clinical trials

PubMed Central

Doot, Robert K.; Thompson, Tove; Greer, Benjamin E.; Allberg, Keith C.; Linden, Hannah M.; Mankoff, David A.; Kinahan, Paul E.

2012-01-01

The Seattle Cancer Care Alliance (SCCA) is a Pacific Northwest regional network that enables patients from community cancer centers to participate in multicenter oncology clinical trials where patients can receive some trial-related procedures at their local center. Results of positron emission tomography (PET) scans performed at community cancer centers are not currently used in SCCA Network trials since clinical trials customarily accept results from only trial-accredited PET imaging centers located at academic and large hospitals. Oncologists would prefer the option of using standard clinical PET scans from Network sites in multicenter clinical trials to increase accrual of patients for whom additional travel requirements for imaging is a barrier to recruitment. In an effort to increase accrual of rural and other underserved populations to Network trials, researchers and clinicians at the University of Washington, SCCA and its Network are assessing feasibility of using PET scans from all Network sites in their oncology clinical trials. A feasibility study is required because the reproducibility of multicenter PET measurements ranges from approximately 3% to 40% at national academic centers. Early experiences from both national and local PET phantom imaging trials are discussed and next steps are proposed for including patient PET scans from the emerging regional quantitative imaging network in clinical trials. There are feasible methods to determine and characterize PET quantitation errors and improve data quality by either prospective scanner calibration or retrospective post hoc corrections. These methods should be developed and implemented in multicenter clinical trials employing quantitative PET imaging of patients. PMID:22795929

Follow YOUR Heart: development of an evidence-based campaign empowering older women with HIV to participate in a large-scale cardiovascular disease prevention trial.

PubMed

Zanni, Markella V; Fitch, Kathleen; Rivard, Corinne; Sanchez, Laura; Douglas, Pamela S; Grinspoon, Steven; Smeaton, Laura; Currier, Judith S; Looby, Sara E

2017-03-01

Women's under-representation in HIV and cardiovascular disease (CVD) research suggests a need for novel strategies to ensure robust representation of women in HIV-associated CVD research. To elicit perspectives on CVD research participation among a community-sample of women with or at risk for HIV, and to apply acquired insights toward the development of an evidence-based campaign empowering older women with HIV to participate in a large-scale CVD prevention trial. In a community-based setting, we surveyed 40 women with or at risk for HIV about factors which might facilitate or impede engagement in CVD research. We applied insights derived from these surveys into the development of the Follow YOUR Heart campaign, educating women about HIV-associated CVD and empowering them to learn more about a multi-site HIV-associated CVD prevention trial: REPRIEVE. Endorsed best methods for learning about a CVD research study included peer-to-peer communication (54%), provider communication (46%) and video-based communication (39%). Top endorsed non-monetary reasons for participating in research related to gaining information (63%) and helping others (47%). Top endorsed reasons for not participating related to lack of knowledge about studies (29%) and lack of request to participate (29%). Based on survey results, the REPRIEVE Follow YOUR Heart campaign was developed. Interwoven campaign components (print materials, video, web presence) offer provider-based information/knowledge, peer-to-peer communication, and empowerment to learn more. Campaign components reflect women's self-identified motivations for research participation - education and altruism. Investigation of factors influencing women's participation in HIV-associated CVD research may be usefully applied to develop evidence-based strategies for enhancing women's enrollment in disease-specific large-scale trials. If proven efficacious, such strategies may enhance conduct of large-scale research studies across disciplines.

Photometric Calibration and Image Stitching for a Large Field of View Multi-Camera System

PubMed Central

Lu, Yu; Wang, Keyi; Fan, Gongshu

2016-01-01

A new compact large field of view (FOV) multi-camera system is introduced. The camera is based on seven tiny complementary metal-oxide-semiconductor sensor modules covering over 160° × 160° FOV. Although image stitching has been studied extensively, sensor and lens differences have not been considered in previous multi-camera devices. In this study, we have calibrated the photometric characteristics of the multi-camera device. Lenses were not mounted on the sensor in the process of radiometric response calibration to eliminate the influence of the focusing effect of uniform light from an integrating sphere. Linearity range of the radiometric response, non-linearity response characteristics, sensitivity, and dark current of the camera response function are presented. The R, G, and B channels have different responses for the same illuminance. Vignetting artifact patterns have been tested. The actual luminance of the object is retrieved by sensor calibration results, and is used to blend images to make panoramas reflect the objective luminance more objectively. This compensates for the limitation of stitching images that are more realistic only through the smoothing method. The dynamic range limitation of can be resolved by using multiple cameras that cover a large field of view instead of a single image sensor with a wide-angle lens. The dynamic range is expanded by 48-fold in this system. We can obtain seven images in one shot with this multi-camera system, at 13 frames per second. PMID:27077857

Expression of endogenous proteins in maize hybrids in a multi-location field trial in India.

PubMed

Gutha, Linga R; Purushottam, Divakar; Veeramachaneni, Aruna; Tigulla, Sarita; Kodappully, Vikas; Enjala, Chandana; Rajput, Hitendrasinh; Anderson, Jennifer; Hong, Bonnie; Schmidt, Jean; Bagga, Shveta

2018-05-17

Genetically modified (GM) crops undergo large scale multi-location field trials to characterize agronomics, composition, and the concentration of newly expressed protein(s) [herein referred to as transgenic protein(s)]. The concentration of transgenic proteins in different plant tissues and across the developmental stages of the plant is considered in the safety assessment of GM crops. Reference or housekeeping proteins are expected to maintain a relatively stable expression pattern in healthy plants given their role in cellular functions. Understanding the effects of genotype, growth stage and location on the concentration of endogenous housekeeping proteins may provide insight into the contribution these factors could have on transgenic protein concentrations in GM crops. The concentrations of three endogenous proteins (actin, elongation factor 1-alpha, and glyceraldehyde 3-phosphate dehydrogenase) were measured in several different maize hybrids grown across multiple field locations over 2 years. Leaf samples were collected from healthy plants at three developmental stages across the growing seasons, and protein concentrations were quantified by indirect enzyme-linked immunosorbent assay (ELISA) for each protein. In general, the concentrations of these three endogenous proteins were relatively consistent across hybrid backgrounds, when compared within one growth stage and location (2-26%CV), whereas the concentrations of proteins in the same hybrid and growth stage across different locations were more variable (12-64%CV). In general, the protein concentrations in 2013 and 2014 show similar trends in variability. Some degree of variability in protein concentrations should be expected for both transgenic and endogenous plant-expressed proteins. In the case of GM crops, the potential variation in protein concentrations due to location effects is captured in the current model of multi-location field testing.

Assessing intervention fidelity in a multi-level, multi-component, multi-site program: the Children's Healthy Living (CHL) program.

PubMed

Butel, Jean; Braun, Kathryn L; Novotny, Rachel; Acosta, Mark; Castro, Rose; Fleming, Travis; Powers, Julianne; Nigg, Claudio R

2015-12-01

Addressing complex chronic disease prevention, like childhood obesity, requires a multi-level, multi-component culturally relevant approach with broad reach. Models are lacking to guide fidelity monitoring across multiple levels, components, and sites engaged in such interventions. The aim of this study is to describe the fidelity-monitoring approach of The Children's Healthy Living (CHL) Program, a multi-level multi-component intervention in five Pacific jurisdictions. A fidelity-monitoring rubric was developed. About halfway during the intervention, community partners were randomly selected and interviewed independently by local CHL staff and by Coordinating Center representatives to assess treatment fidelity. Ratings were compared and discussed by local and Coordinating Center staff. There was good agreement between the teams (Kappa = 0.50, p < 0.001), and intervention improvement opportunities were identified through data review and group discussion. Fidelity for the multi-level, multi-component, multi-site CHL intervention was successfully assessed, identifying adaptations as well as ways to improve intervention delivery prior to the end of the intervention.

A multi-centre, parallel group superiority trial of silk therapeutic clothing compared to standard care for the management of eczema in children (CLOTHES Trial): study protocol for a randomised controlled trial.

PubMed

Harrison, Eleanor F; Haines, Rachel H; Cowdell, Fiona; Sach, Tracey H; Dean, Taraneh; Pollock, Ian; Burrows, Nigel P; Buckley, Hannah; Batchelor, Jonathan; Williams, Hywel C; Lawton, Sandra; Brown, Sara J; Bradshaw, Lucy E; Ahmed, Amina; Montgomery, Alan A; Mitchell, Eleanor J; Thomas, Kim S

2015-09-02

Eczema is a chronic, itchy skin condition that can have a large impact on the quality of life of patients and their families. People with eczema are often keen to try out non-pharmacological therapies like silk therapeutic garments that could reduce itching or the damage caused by scratching. However, the effectiveness and cost-effectiveness of these garments in the management of eczema has yet to be proven. The CLOTHES Trial will test the hypothesis that 'silk therapeutic garments plus standard eczema care' is superior to 'standard care alone' for children with moderate to severe eczema. Parallel group, observer-blind, pragmatic, multi-centre randomised controlled trial of 6 months' duration. Three hundred children aged 1 to 15 years with moderate to severe eczema will be randomised (1:1) to receive silk therapeutic garments plus standard eczema care, or standard eczema care alone. Primary outcome is eczema severity, as assessed by trained and blinded investigators at 2, 4 and 6 months (using the Eczema Area and Severity Index (EASI)). Secondary outcomes include: patient-reported eczema symptoms (collected weekly for 6 months to capture long-term control); global assessment of severity; quality of life of the child, family and main carer; use of standard eczema treatments (emollients, corticosteroids applied topically, calcineurin inhibitors applied topically and wet wraps); frequency of infections; and cost-effectiveness. The acceptability and durability of the clothing will also be assessed, as will adherence to wearing the garments. A nested qualitative study will assess the views of a subset of children wearing the garments and their parents, and those of healthcare providers and commissioners. Randomisation uses a computer-generated sequence of permuted blocks of randomly varying size, stratified by recruiting hospital and child's age (< 2 years; 2 to 5 years; > 5 years), and concealed using a secure web-based system. The sequence of treatment allocations

Effectiveness and cost-effectiveness of body psychotherapy in the treatment of negative symptoms of schizophrenia--a multi-centre randomised controlled trial.

PubMed

Priebe, Stefan; Savill, Mark; Reininghaus, Ulrich; Wykes, Til; Bentall, Richard; Lauber, Christoph; McCrone, Paul; Röhricht, Frank; Eldridge, Sandra

2013-01-14

Negative symptoms of schizophrenia are frequently associated with poor long term outcomes. Established interventions have little, if any, positive effects on negative symptoms. Arts Therapies such as Body Psychotherapy (BPT) have been suggested to reduce negative symptoms, but the existing evidence is limited. In a small exploratory trial a manualised form of group BPT led to significantly lower negative symptom levels both at the end of treatment and at 4 months follow-up as compared to supportive counseling. We designed a large multi-site trial to assess the effectiveness of a manualised BPT intervention in reducing negative symptoms, compared to an active control. In a randomised controlled trial, 256 schizophrenic outpatients with negative symptoms will be randomly allocated either to BPT or Pilates groups. In both conditions, patients will be offered two 90 minutes sessions per week in groups of about 8 patients over a period of 10 weeks. Outcomes are assessed at the end of treatment and at six months follow-up. The primary outcome is severity of negative symptoms, as measured by the Positive and Negative Symptom Scale (PANSS), whilst a range of secondary outcome measures include general psychopathology, social contacts, and quality of life. We will also assess the cost-effectiveness of the intervention. The study aims to evaluate the effectiveness of a promising form of group therapy which may help alleviate negative symptoms that are associated with unfavourable long-term outcomes and have so far been difficult to treat. If the trial is successful, it will add a new and effective option in the treatment of negative symptoms. Group BPT is manualised, might be attractive to many patients because of its unusual approach, and could potentially be rolled out to services at relatively little additional cost. Current Controlled Trials ISRCTN84216587.

Biomarkers for Early Detection of Clinically Relevant Prostate Cancer: A Multi-Institutional Validation Trial

DTIC Science & Technology

2017-10-01

been shown in many studies to improve predictive accuracy for cancer on initial biopsy,3,7-9 and to be correlated with more aggressive cancer at...our multi-center, prospectively accrued prostate cancer active surveillance cohort – the Canary Prostate Active Surveillance Study (PASS). We are in...objective of the study is to utilize analytically validated assays that take into account tumor heterogeneity to measure biomarkers in specimens that were

Elastic all-optical multi-hop interconnection in data centers with adaptive spectrum allocation

NASA Astrophysics Data System (ADS)

Hong, Yuanyuan; Hong, Xuezhi; Chen, Jiajia; He, Sailing

2017-01-01

In this paper, a novel flex-grid all-optical interconnect scheme that supports transparent multi-hop connections in data centers is proposed. An inter-rack all-optical multi-hop connection is realized with an optical loop employed at flex-grid wavelength selective switches (WSSs) in an intermediate rack rather than by relaying through optical-electric-optical (O-E-O) conversions. Compared with the conventional O-E-O based approach, the proposed all-optical scheme is able to off-load the traffic at intermediate racks, leading to a reduction of the power consumption and cost. The transmission performance of the proposed flex-grid multi-hop all-optical interconnect scheme with various modulation formats, including both coherently detected and directly detected approaches, are investigated by Monte-Carlo simulations. To enhance the spectrum efficiency (SE), number-of-hop adaptive bandwidth allocation is introduced. Numerical results show that the SE can be improved by up to 33.3% at 40 Gbps, and by up to 25% at 100 Gbps. The impact of parameters, such as targeted bit error rate (BER) level and insertion loss of components, on the transmission performance of the proposed approach are also explored. The results show that the maximum SE improvement of the adaptive approach over the non-adaptive one is enhanced with the decrease of the targeted BER levels and the component insertion loss.

A Medical Television Center; a Guide to Organizing a Large Television Center in Health Science Educational Institutions. Monograph 5.

ERIC Educational Resources Information Center

Potts, Robert E.

Guidelines are presented for establishing large television centers in health science education institutions. Television distribution systems are described, and staff, equipment, space and budgetary requirements are discussed. Included are: (1) a proposed chart of organizational development and job descriptions; (2) suggested equipment purchases;…

The impact of a large-scale power outage on hemodialysis center operations.

PubMed

Abir, Mahshid; Jan, Sophia; Jubelt, Lindsay; Merchant, Raina M; Lurie, Nicole

2013-12-01

On June 29, 2012, mid-Atlantic storms resulted in a large-scale power outage affecting up to three million people across multiple (US) states. Hemodialysis centers are dependent on electricity to provide dialysis care to end-stage renal disease patients. The objective of this study was to determine how the power outage impacted operations in a sample of hemodialysis centers in the impacted regions. The sample consisted of all hemodialysis centers located in the District of Columbia and a total of five counties with the largest power losses in West Virginia, Virginia, and Maryland. A semi-structured interview guide was developed, and the charge nurse or supervisor in each facility was interviewed. The survey questions addressed whether their centers lost power, if so, for how long, where their patients received dialysis, whether their centers had backup generators, and if so, whether they had any problems operating them, and whether their center received patients from other centers if they had power. Calls were placed to 90 dialysis centers in the sampled areas and a 90% response rate was achieved. Overall, hemodialysis operations at approximately 30% (n = 24) of the centers queried were impacted by the power outage. Of the 36 centers that lost power, 31% (n = 11) referred their patients to other dialysis centers, 22% (n = 8) accommodated their patients during a later shift or on a different day; the rest of the centers either experienced brief power outages that did not affect operations or experienced a power outage on days that the center is usually closed. Some centers in the study cohort reported receiving patients from other centers for dialysis 33% (n = 27). Thirty-two percent (n = 26) of the centers queried had backup generators on site. Eleven percent (n = 4) of the centers experiencing power outages reported that backup generators were brought in by their parent companies. Comprehensive emergency planning for dialysis centers should include provisions for

A hybrid binary particle swarm optimization for large capacitated multi item multi level lot sizing (CMIMLLS) problem

NASA Astrophysics Data System (ADS)

Mishra, S. K.; Sahithi, V. V. D.; Rao, C. S. P.

2016-09-01

The lot sizing problem deals with finding optimal order quantities which minimizes the ordering and holding cost of product mix. when multiple items at multiple levels with all capacity restrictions are considered, the lot sizing problem become NP hard. Many heuristics were developed in the past have inevitably failed due to size, computational complexity and time. However the authors were successful in the development of PSO based technique namely iterative improvement binary particles swarm technique to address very large capacitated multi-item multi level lot sizing (CMIMLLS) problem. First binary particle Swarm Optimization algorithm is used to find a solution in a reasonable time and iterative improvement local search mechanism is employed to improvise the solution obtained by BPSO algorithm. This hybrid mechanism of using local search on the global solution is found to improve the quality of solutions with respect to time thus IIBPSO method is found best and show excellent results.

Modifying the clinical research infrastructure at a dedicated clinical trials unit: assessment of trial development, activation, and participant accrual

PubMed Central

Tang, Chad; Hess, Kenneth R.; Sanders, Dwana; Davis, Suzanne; Buzdar, Aman; Kurzrock, Razelle; Lee, J. Jack; Meric-Bernstam, Funda; Hong, David

2017-01-01

Purpose Information on processes for trials assessing investigational therapeutics is sparse. We assessed the trial development processes within the Department of Investigational Cancer Therapeutics (ICT) at MD Anderson Cancer Center and analyzed their effects on the trial activation timeline and enrollment. Experimental Design Data were from a prospectively maintained registry that tracks all clinical studies at MD Anderson. From this database we identified 2,261 activated phase I-III trials; 221 were done at the ICT. ICT trials were matched to trials from other MD Anderson departments by phase, sponsorship, and submission year. Trial performance metrics were compared with paired Wilcoxon signed rank tests. Results We identified 3 facets of the ICT research infrastructure: parallel processing of trial approval steps; a physician-led research team; and regular weekly meetings to foster research accountability. Separate analyses were conducted stratified by sponsorship (industry [133 ICT and 133 non-ICT trials] or institutional [68 ICT and 68 non-ICT trials]). ICT trial development was faster from IRB approval to activation (median difference of 1.1 months for industry-sponsored trials vs. 2.3 months for institutional) and from activation to first enrollment (median difference of 0.3 months for industry vs. 1.2 months for institutional) (all matched P<0.05). ICT trials also accrued more patients (median difference of 8 participants for industry vs. 33.5 for institutional) quicker (median difference 4.8 participants/year for industry vs. 11.1 for institutional) (all matched P<0.05). Conclusions Use of a clinical research–focused infrastructure within a large academic cancer center was associated with efficient trial development and participant accrual. PMID:27852698

Adopting a Patient-Centered Approach to Primary Outcome Analysis of Acute Stroke Trials by Use of a Utility-Weighted Modified Rankin Scale

PubMed Central

Chaisinanunkul, Napasri; Adeoye, Opeolu; Lewis, Roger J.; Grotta, James C.; Broderick, Joseph; Jovin, Tudor G.; Nogueira, Raul G.; Elm, Jordan; Graves, Todd; Berry, Scott; Lees, Kennedy R.; Barreto, Andrew D.; Saver, Jeffrey L.

2015-01-01

Background and Purpose Although the modified Rankin Scale (mRS) is the most commonly employed primary endpoint in acute stroke trials, its power is limited when analyzed in dichotomized fashion and its indication of effect size challenging to interpret when analyzed ordinally. Weighting the seven Rankin levels by utilities may improve scale interpretability while preserving statistical power. Methods A utility weighted mRS (UW-mRS) was derived by averaging values from time-tradeoff (patient centered) and person-tradeoff (clinician centered) studies. The UW-mRS, standard ordinal mRS, and dichotomized mRS were applied to 11 trials or meta-analyses of acute stroke treatments, including lytic, endovascular reperfusion, blood pressure moderation, and hemicraniectomy interventions. Results Utility values were: mRS 0–1.0; mRS 1 - 0.91; mRS 2 - 0.76; mRS 3 - 0.65; mRS 4 - 0.33; mRS 5 & 6 - 0. For trials with unidirectional treatment effects, the UW-mRS paralleled the ordinal mRS and outperformed dichotomous mRS analyses. Both the UW-mRS and the ordinal mRS were statistically significant in six of eight unidirectional effect trials, while dichotomous analyses were statistically significant in two to four of eight. In bidirectional effect trials, both the UW-mRS and ordinal tests captured the divergent treatment effects by showing neutral results whereas some dichotomized analyses showed positive results. Mean utility differences in trials with statistically significant positive results ranged from 0.026 to 0.249. Conclusion A utility-weighted mRS performs similarly to the standard ordinal mRS in detecting treatment effects in actual stroke trials and ensures the quantitative outcome is a valid reflection of patient-centered benefits. PMID:26138130

Multi-GNSS PPP-RTK: From Large- to Small-Scale Networks.

PubMed

Nadarajah, Nandakumaran; Khodabandeh, Amir; Wang, Kan; Choudhury, Mazher; Teunissen, Peter J G

2018-04-03

Precise point positioning (PPP) and its integer ambiguity resolution-enabled variant, PPP-RTK (real-time kinematic), can benefit enormously from the integration of multiple global navigation satellite systems (GNSS). In such a multi-GNSS landscape, the positioning convergence time is expected to be reduced considerably as compared to the one obtained by a single-GNSS setup. It is therefore the goal of the present contribution to provide numerical insights into the role taken by the multi-GNSS integration in delivering fast and high-precision positioning solutions (sub-decimeter and centimeter levels) using PPP-RTK. To that end, we employ the Curtin PPP-RTK platform and process data-sets of GPS, BeiDou Navigation Satellite System (BDS) and Galileo in stand-alone and combined forms. The data-sets are collected by various receiver types, ranging from high-end multi-frequency geodetic receivers to low-cost single-frequency mass-market receivers. The corresponding stations form a large-scale (Australia-wide) network as well as a small-scale network with inter-station distances less than 30 km. In case of the Australia-wide GPS-only ambiguity-float setup, 90% of the horizontal positioning errors (kinematic mode) are shown to become less than five centimeters after 103 min. The stated required time is reduced to 66 min for the corresponding GPS + BDS + Galieo setup. The time is further reduced to 15 min by applying single-receiver ambiguity resolution. The outcomes are supported by the positioning results of the small-scale network.

Pre-referral rectal artesunate in severe malaria: flawed trial.

PubMed

Hirji, Karim F; Premji, Zulfiqarali G

2011-08-08

Immediate injectable treatment is essential for severe malaria. Otherwise, the afflicted risk lifelong impairment or death. In rural areas of Africa and Asia, appropriate care is often miles away. In 2009, Melba Gomes and her colleagues published the findings of a randomized, placebo-controlled trial of rectal artesunate for suspected severe malaria in such remote areas. Enrolling nearly 18,000 cases, the aim was to evaluate whether, as patients were in transit to a health facility, a pre-referral artesunate suppository blocked disease progression sufficiently to reduce these risks. The affirmative findings of this, the only trial on the issue thus far, have led the WHO to endorse rectal artesunate as a pre-referral treatment for severe malaria. In the light of its public health importance and because its scientific quality has not been assessed for a systematic review, our paper provides a detailed evaluation of the design, conduct, analysis, reporting, and practical features of this trial. We performed a checklist-based and an in-depth evaluation of the trial. The evaluation criteria were based on the CONSORT statement for reporting clinical trials, the clinical trial methodology literature, and practice in malaria research. Our main findings are: The inclusion and exclusion criteria and the sample size justification are not stated. Many clearly ineligible subjects were enrolled. The training of the recruiters does not appear to have been satisfactory. There was excessive between center heterogeneity in design and conduct. Outcome evaluation schedule was not defined, and in practice, became too wide. Large gaps in the collection of key data were evident. Primary endpoints were inconsistently utilized and reported; an overall analysis of the outcomes was not done; analyses of time to event data had major flaws; the stated intent-to-treat analysis excluded a third of the randomized subjects; the design-indicated stratified or multi-variate analysis was not done

Nutrition and physical activity randomized control trial in child care centers improves knowledge, policies, and children’s body mass index

PubMed Central

2014-01-01

Background To address the public health crisis of overweight and obese preschool-age children, the Nutrition And Physical Activity Self Assessment for Child Care (NAP SACC) intervention was delivered by nurse child care health consultants with the objective of improving child care provider and parent nutrition and physical activity knowledge, center-level nutrition and physical activity policies and practices, and children’s body mass index (BMI). Methods A seven-month randomized control trial was conducted in 17 licensed child care centers serving predominantly low income families in California, Connecticut, and North Carolina, including 137 child care providers and 552 families with racially and ethnically diverse children three to five years old. The NAP SACC intervention included educational workshops for child care providers and parents on nutrition and physical activity and consultation visits provided by trained nurse child care health consultants. Demographic characteristics and pre - and post-workshop knowledge surveys were completed by providers and parents. Blinded research assistants reviewed each center’s written health and safety policies, observed nutrition and physical activity practices, and measured randomly selected children’s nutritional intake, physical activity, and height and weight pre- and post-intervention. Results Hierarchical linear models and multiple regression models assessed individual- and center-level changes in knowledge, policies, practices and age- and sex-specific standardized body mass index (zBMI), controlling for state, parent education, and poverty level. Results showed significant increases in providers’ and parents’ knowledge of nutrition and physical activity, center-level improvements in policies, and child-level changes in children’s zBMI based on 209 children in the intervention and control centers at both pre- and post-intervention time points. Conclusions The NAP SACC intervention, as delivered by

Advanced and recurring thymic carcinoma is target of new clinical trial | Center for Cancer Research

Cancer.gov

Adults diagnosed with thymic carcinoma who overexpress the protein mesothelin may be eligible to participate in a new clinical trial at the NIH Clinical Center. The study will look at the safety and effectiveness of an investigational drug, anetumab ravtansine, developed by Bayer HealthCare Pharmaceuticals. The drug works by binding to mesothelin, therefore overexpression of the protein could be useful for targeting cancer cells. Read more...

Sensitivity of the Modified Children's Yale-Brown Obsessive Compulsive Scale to Detect Change: Results from Two Multi-Site Trials

ERIC Educational Resources Information Center

Scahill, Lawrence; Sukhodolsky, Denis G.; Anderberg, Emily; Dimitropoulos, Anastasia; Dziura, James; Aman, Michael G.; McCracken, James; Tierney, Elaine; Hallett, Victoria; Katz, Karol; Vitiello, Benedetto; McDougle, Christopher

2016-01-01

Repetitive behavior is a core feature of autism spectrum disorder. We used 8-week data from two federally funded, multi-site, randomized trials with risperidone conducted by the Research Units on Pediatric Psychopharmacology Autism Network to evaluate the sensitivity of the Children's Yale-Brown Obsessive Compulsive Scale modified for autism…

Rationale and design of A Trial of Sertraline vs. Cognitive Behavioral Therapy for End-stage Renal Disease Patients with Depression (ASCEND).

PubMed

Hedayati, S Susan; Daniel, Divya M; Cohen, Scott; Comstock, Bryan; Cukor, Daniel; Diaz-Linhart, Yaminette; Dember, Laura M; Dubovsky, Amelia; Greene, Tom; Grote, Nancy; Heagerty, Patrick; Katon, Wayne; Kimmel, Paul L; Kutner, Nancy; Linke, Lori; Quinn, Davin; Rue, Tessa; Trivedi, Madhukar H; Unruh, Mark; Weisbord, Steven; Young, Bessie A; Mehrotra, Rajnish

2016-03-01

Major Depressive Disorder (MDD) is highly prevalent in patients with End Stage Renal Disease (ESRD) treated with maintenance hemodialysis (HD). Despite the high prevalence and robust data demonstrating an independent association between depression and poor clinical and patient-reported outcomes, MDD is under-treated when identified in such patients. This may in part be due to the paucity of evidence confirming the safety and efficacy of treatments for depression in this population. It is also unclear whether HD patients are interested in receiving treatment for depression. ASCEND (Clinical Trials Identifier Number NCT02358343), A Trial of Sertraline vs. Cognitive Behavioral Therapy (CBT) for End-stage Renal Disease Patients with Depression, was designed as a multi-center, 12-week, open-label, randomized, controlled trial of prevalent HD patients with comorbid MDD or dysthymia. It will compare (1) a single Engagement Interview vs. a control visit for the probability of initiating treatment for comorbid depression in up to 400 patients; and (2) individual chair-side CBT vs. flexible-dose treatment with a selective serotonin reuptake inhibitor, sertraline, for improvement of depressive symptoms in 180 of the up to 400 patients. The evolution of depressive symptoms will also be examined in a prospective longitudinal cohort of 90 HD patients who choose not to be treated for depression. We discuss the rationale and design of ASCEND, the first large-scale randomized controlled trial evaluating efficacy of non-pharmacologic vs. pharmacologic treatment of depression in HD patients for patient-centered outcomes. Published by Elsevier Inc.

Rationale and Design of A Trial of Sertraline vs. Cognitive Behavioral Therapy for End-stage Renal Disease Patients with Depression (ASCEND)

PubMed Central

Hedayati, S. Susan; Daniel, Divya M.; Cohen, Scott; Comstock, Bryan; Cukor, Daniel; Diaz-Linhart, Yaminette; Dember, Laura M.; Dubovsky, Amelia; Greene, Tom; Grote, Nancy; Heagerty, Patrick; Katon, Wayne; Kimmel, Paul L.; Kutner, Nancy; Linke, Lori; Quinn, Davin; Rue, Tessa; Trivedi, Madhukar H.; Unruh, Mark; Weisbord, Steven; Young, Bessie A.; Mehrotra, Rajnish

2015-01-01

Major Depressive Disorder (MDD) is highly prevalent in patients with End Stage Renal Disease (ESRD) treated with maintenance hemodialysis (HD). Despite the high prevalence and robust data demonstrating an independent association between depression and poor clinical and patient-reported outcomes, MDD is under-treated when identified in such patients. This may in part be due to the paucity of evidence confirming the safety and efficacy of treatments for depression in this population. It is also unclear whether HD patients are interested in receiving treatment for depression. ASCEND (Clinical Trials Identifier Number NCT02358343), A Trial of Sertraline vs. Cognitive Behavioral Therapy (CBT) for End-stage Renal Disease Patients with Depression, was designed as a multi-center, 12-week, open-label, randomized, controlled trial of prevalent HD patients with comorbid MDD or dysthymia. It will compare (1) a single Engagement Interview vs. a control visit for the probability of initiating treatment for comorbid depression in up to 400 patients; and (2) individual chair-side CBT vs. flexible-dose treatment with a selective serotonin reuptake inhibitor, sertraline, for improvement of depressive symptoms in 180 of the up to 400 patients. The evolution of depressive symptoms will also be examined in a prospective longitudinal cohort of 90 HD patients who choose not to be treated for depression. We discuss the rationale and design of ASCEND, the first large-scale randomized controlled trial evaluating efficacy of non-pharmacologic vs. pharmacologic treatment of depression in HD patients for patient-centered outcomes. PMID:26621218

Remission of rheumatoid arthritis and potential determinants: a national multi-center cross-sectional survey.

PubMed

Wang, Guan-Ying; Zhang, Sa-Li; Wang, Xiu-Ru; Feng, Min; Li, Chun; An, Yuan; Li, Xiao-Feng; Wang, Li-Zhi; Wang, Cai-Hong; Wang, Yong-Fu; Yang, Rong; Yan, Hui-Ming; Wang, Guo-Chun; Lu, Xin; Liu, Xia; Zhu, Ping; Chen, Li-Na; Jin, Hong-Tao; Liu, Jin-Ting; Guo, Hui-Fang; Chen, Hai-Ying; Xie, Jian-Li; Wei, Ping; Wang, Jun-Xiang; Liu, Xiang-Yuan; Sun, Lin; Cui, Liu-Fu; Shu, Rong; Liu, Bai-Lu; Yu, Ping; Zhang, Zhuo-Li; Li, Guang-Tao; Li, Zhen-Bin; Yang, Jing; Li, Jun-Fang; Jia, Bin; Zhang, Feng-Xiao; Tao, Jie-Mei; Lin, Jin-Ying; Wei, Mei-Qiu; Liu, Xiao-Min; Ke, Dan; Hu, Shao-Xian; Ye, Cong; Han, Shu-Ling; Yang, Xiu-Yan; Li, Hao; Huang, Ci-Bo; Gao, Ming; Lai, Bei; Cheng, Yong-Jing; Li, Xing-Fu; Song, Li-Jun; Yu, Xiao-Xia; Wang, Ai-Xue; Wu, Li-Jun; Wang, Yan-Hua; He, Lan; Sun, Wen-Wen; Gong, Lu; Wang, Xiao-Yuan; Wang, Yi; Zhao, Yi; Li, Xiao-Xia; Wang, Yan; Zhang, Yan; Su, Yin; Zhang, Chun-Fang; Mu, Rong; Li, Zhan-Guo

2015-02-01

The aim of this study is to investigate the remission rate of rheumatoid arthritis (RA) in China and identify its potential determinants. A multi-center cross-sectional study was conducted from July 2009 to January 2012. Data were collected by face-to-face interviews of the rheumatology outpatients in 28 tertiary hospitals in China. The remission rates were calculated in 486 RA patients according to different definitions of remission: the Disease Activity Score in 28 joints (DAS28), the Simplified Disease Activity Index (SDAI), the Clinical Disease Activity Index (CDAI), and the American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean definition. Potential determinants of RA remission were assessed by univariate and multivariate analyses. The remission rates of RA from this multi-center cohort were 8.6% (DAS28), 8.4% (SDAI), 8.2% (CDAI), and 6.8% (Boolean), respectively. Favorable factors associated with remission were: low Health Assessment Questionnaire (HAQ) score, absence of rheumatoid factor (RF) and anti-cyclic citrullinated peptide (anti-CCP), and treatment of methotrexate (MTX) and hydroxychloroquine (HCQ). Younger age was also predictive for the DAS28 and the Boolean remission. Multivariate analyses revealed a low HAQ score, the absence of anti-CCP, and the treatment with HCQ as independent determinants of remission. The clinical remission rate of RA patients was low in China. A low HAQ score, the absence of anti-CCP, and HCQ were significant independent determinants for RA remission.

Effect Sizes and Primary Outcomes in Large-Budget, Cardiovascular-Related Behavioral Randomized Controlled Trials Funded by NIH Since 1980

PubMed Central

Irvin, Veronica L.; Kaplan, Robert M.

2015-01-01

Purpose We reviewed large-budget, National Institutes of Health (NIH)-supported randomized controlled trials (RCTs) with behavioral interventions to assess (1) publication rates, (2) trial registration, (3) use of objective measures, (4) significant behavior and physiological change, and (5) effect sizes. Methods We identified large-budget grants (>$500,000/year) funded by NIH (National Heart Lung and Blood Institute (NHLBI) or National Institute of Diabetes & Digestive and Kidney Diseases (NIDDK)) for cardiovascular disease (dates January 1, 1980 to December 31, 2012). Among 106 grants that potentially met inclusion criteria, 20 studies were not published and 48 publications were excluded, leaving 38 publications for analysis. ClinicalTrials.gov abstracts were used to determine whether outcome measures had been pre-specified. Results Three fourths of trials were registered in ClinicalTrials.gov and all published pre-specified outcomes. Twenty-six trials reported a behavioral outcome with 81 % reporting significant improvements for the target behavior. Thirty-two trials reported a physiological outcome. All were objectively measured, and 81 % reported significant benefit. Seventeen trials reported morbidity outcomes, and seven reported a significant benefit. Nine trials assessed mortality, and all were null for this outcome. Conclusions Behavioral trials complied with trial registration standards. Most reported a physiological benefit, but few documented morbidity or mortality benefits. PMID:26507906

Improving academic leadership and oversight in large industry-sponsored clinical trials: the ARO-CRO model

PubMed Central

Goldenberg, Neil A.; Spyropoulos, Alex C.; Halperin, Jonathan L.; Kessler, Craig M.; Schulman, Sam; Turpie, Alexander G. G.; Skene, Allan M.; Cutler, Neal R.

2011-01-01

Standards for clinical trial design, execution, and publication have increased in recent years. However, the current structure for interaction among the pharmaceutical sponsor funding a drug or device development program, the contract research organization (CRO) that typically assists in executing the trial, regulatory agencies, and academicians, provides inadequate leadership and oversight of the development process. Conventional academic steering committees are not provided with the independent infrastructure by which to verify statistical analyses and conclusions regarding safety and efficacy. We propose an alternative approach centered on partnerships between CROs and university-based academic research organizations (AROs). In this model, the ARO takes responsibility for processes that address journal requirements and regulatory expectations for independent academic oversight (including oversight of Steering Committee and Data and Safety Monitoring Board activities), whereas the CRO provides infrastructure for efficient trial execution, site monitoring, and data management. The ARO engages academic experts throughout the trial process and minimizes conflicts of interest in individual industry relationships via diversification of sponsors, agents, and therapeutic areas. Although numerous models can be entertained, the ARO-CRO model is uniquely structured to meet the demand for greater assurance of integrity in clinical trials and the needs of each stakeholder in the process. PMID:21068436

Sham-controlled, randomized, feasibility trial of acupuncture for prevention of radiation-induced xerostomia among patients with nasopharyngeal carcinoma

PubMed Central

Meng, Zhiqiang; Garcia, M. Kay; Hu, Chaosu; Chiang, Joseph; Chambers, Mark; Rosenthal, David I.; Peng, Huiting; Wu, Caijun; Zhao, Qi; Zhao, Genming; Liu, Luming; Spelman, Amy; Palmer, J. Lynn; Wei, Qi; Cohen, Lorenzo

2013-01-01

Background Xerostomia (dry mouth) after head/neck radiation is a common problem among cancer patients. Quality of life (QOL) is impaired, and available treatments are of little benefit. This trial determined the feasibility of conducting a sham-controlled trial of acupuncture and whether acupuncture could prevent xerostomia among head/neck patients undergoing radiotherapy. Methods A sham controlled, feasibility trial was conducted at Fudan University Shanghai Cancer Center, Shanghai, China among patients with nasopharyngeal carcinoma undergoing radiotherapy. To determine feasibility of a sham procedure, 23 patients were randomized to real acupuncture (N = 11) or to sham acupuncture (N = 12). Patients were treated 3 times/week during their course of radiotherapy. Subjective measures were the Xerostomia Questionnaire (XQ) and MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN). Objective measures were unstimulated whole salivary flow rates (UWSFR) and stimulated salivary flow rates (SSFR). Patients were followed for 1 month after radiotherapy. Results XQ scores for acupuncture were significantly lower than sham controls starting in week 3 and lasted through the 1-month follow-up (all P’s < 0.001 except for week 3, which was 0.006), with clinically significant differences as follows: week 6 – RR 0.28 [95% CI, 0.10, 0.79]; week 11- RR 0.17 [95% CI, 0.03, 1.07]. Similar findings were seen for MDASI-HN scores and MDASI-Intrusion scores. Group differences for UWSFR and SSFR were not found. Conclusions In this small pilot study, true acupuncture given concurrently with radiotherapy significantly reduced xerostomia symptoms and improved QOL when compared with sham acupuncture. Large-scale, multi-center, randomized, placebo-controlled trials are now needed. PMID:22285177

A multi-center, randomized, clinical trial comparing adhesive polyurethane foam dressing and adhesive hydrocolloid dressing in patients with grade II pressure ulcers in primary care and nursing homes

PubMed Central

2013-01-01

Background Pressure ulcers (PrUs) are ischemic wounds in the skin and underlying tissues caused by long-standing pressure force over an external bone or cartilaginous surface. PrUs are an important challenge for the overall health system because can prolong patient hospitalization and reduce quality of life. Moreover, 95% of PrUs are avoidable, suggesting they are caused by poor quality care assistance. PrUs are also costly, increasing national costs. For example, they represent about 5% of overall annual health expenses in Spain. Stages I and II PrUs have a combined prevalence of 65%. According main clinical guidelines, stage II PrUs (PrU-IIs) are usually treated by applying special dressings (polyurethane or hydrocolloid). However, little scientific evidence regarding their efficacy has been identified in scientific literature. Our aim is to assess the comparative efficacy of adhesive polyurethane foam and hydrocolloid dressings in the treatment of PrU-IIs in terms of healed ulcer after 8 weeks of follow-up. Methods/design This paper describes the development and evaluation protocol of a randomized clinical trial of two parallel treatment arms. A total of 820 patients with at least 1 PrU-II will be recruited from primary health care and home care centers. All patients will receive standardized healing procedures and preventive measures (e.g. positional changes and pressure-relieving support surfaces), following standardized procedures. The main outcome will be the percentage of wounds healed after 8 weeks. Secondary outcomes will include cost-effectiveness, as evaluated by cost per healed ulcer and cost per treated patient and safety evaluated by adverse events. Discussion This trial will address the hypothesis that hydrocolloid dressings will heal at least 10% more stage II PrUs and be more cost-effective than polyurethane foam dressings after 8 weeks. Trial registration This trial has been registered with controlled-trials number ISCRCTN57842461 and Eudra

Pediatric oncology clinical trial participation where the geography is vast: Development of a clinical research system for tertiary and satellite centers in Ontario, Canada.

PubMed

Alexander, Sarah; Greenberg, Mark; Malkin, David; Portwine, Carol; Johnston, Donna; Silva, Mariana; Zelcer, Shayna; Sonshine, Samantha; Manzo, Janet; Bennett, Carla; Brodeur-Robb, Kathy; Deveault, Catherine; Ramachandran, Nivetha; Gibson, Paul

2018-04-01

Opportunities for participation in clinical trials are a core component of the care of children with cancer. In Ontario, many pediatric patients live long distances from their cancer center. This paper describes the work that was done in order to allow patients participating in Children's Oncology Group trials to receive care, including research protocol related care, jointly between the tertiary pediatric cancer center and the closer-to-home satellite center. The system is a pragmatic risk-based model, supporting excellence in care while ensuring good conduct of the research in compliance with applicable regulations and guidelines, including ethics oversight. © 2017 Wiley Periodicals, Inc.

Maintenance Cognitive Stimulation Therapy (CST) for dementia: A single-blind, multi-centre, randomized controlled trial of Maintenance CST vs. CST for dementia

PubMed Central

2010-01-01

Background Psychological treatments for dementia are widely used in the UK and internationally, but only rarely have they been standardised, adequately evaluated or systematically implemented. There is increasing recognition that psychosocial interventions may have similar levels of effectiveness to medication, and both can be used in combination. Cognitive Stimulation Therapy (CST) is a 7-week cognitive-based approach for dementia that has been shown to be beneficial for cognition and quality of life and is cost-effective, but there is less conclusive evidence for the effects of CST over an extended period. Methods/Design This multi-centre, pragmatic randomised controlled trial (RCT) to assess the effectiveness and cost-effectiveness of Maintenance CST groups for dementia compares a intervention group who receive CST for 7 weeks followed by the Maintenance CST programme once a week for 24 weeks with the control group who receive CST for 7 weeks, followed by treatment as usual for 24 weeks. The primary outcome measures are quality of life of people with dementia assessed by the QoL-AD and cognition assessed by the ADAS-Cog. Secondary outcomes include the person with dementia's mood, behaviour, activities of daily living, ability to communicate and costs; as well as caregiver health-related quality of life. Using a 5% significance level, comparison of 230 participants will yield 80% power to detect a standardised difference of 0.39 on the ADAS-Cog between the groups. The trial includes a cost-effectiveness analysis from a public sector perspective. Discussion A pilot study of longer-term Maintenance CST, offering 16 weekly sessions of maintenance following the initial CST programme, previously found a significant improvement in cognitive function (MMSE) for those on the intervention group. The study identified the need for a large-scale, multi-centre RCT to define the potential longer-term benefits of continuing the therapy. This study aims to provide definitive

Widefield TSCSPC-systems with large-area-detectors: application in simultaneous multi-channel-FLIM

NASA Astrophysics Data System (ADS)

Stepanov, Sergei; Bakhlanov, Sergei; Drobchenko, Evgeny; Eckert, Hann-Jörg; Kemnitz, Klaus

2010-11-01

Novel proximity-type Time- and Space-Correlated Single Photon Counting (TSCSPC) crossed-delay-line (DL)- and multi-anode (MA)-systems of outstanding performance and homogeneity were developed, using large-area detector heads of 25 and 40 mm diameter. Instrument response functions IRF(space) = (60 +/- 5) μm FWHM and IRF(time) = (28 +/- 3) ps FWHM were achieved over the full 12 cm2 area of the detector. Deadtime at throughput of 105 cps is 10% for "high-resolution" system and 5% in the "video"-system at 106 cps, at slightly reduced time- and space resolution. A fluorescence lifetime of (3.5 +/- 1) ps can be recovered from multi-exponential dynamics of a single living cyanobacterium (Acaryochloris marina). The present large-area detectors are particularly useful in simultaneous multichannel applications, such as 2-colour anisotropy or 4-colour lifetime imaging, utilizing dual- or quad-view image splitters. The long-term stability, low- excitation-intensity (< 100 mW/cm2) widefield systems enable minimal-invasive observation, without significant bleaching or photodynamic reactions, thus allowing long-period observation of up to several hours in living cells.

The Helicobacter Eradication Aspirin Trial (HEAT): A Large Simple Randomised Controlled Trial Using Novel Methodology in Primary Care.

PubMed

Dumbleton, Jennifer S; Avery, Anthony J; Coupland, Carol; Hobbs, F D Richard; Kendrick, Denise; Moore, Michael V; Morris, Clive; Rubin, Greg P; Smith, Murray D; Stevenson, Diane J; Hawkey, Chris J

2015-09-01

is important medically, because aspirin is so widely used, and methodologically, as a successful trial would show that large-scale studies of important clinical outcomes can be conducted at a fraction of the cost of those conducted by industry, which in turn will help to ensure that trials of primarily medical rather than commercial interest can be conducted successfully in the UK.

A Patient-Centered Approach to Informed Consent: Results from a Survey and Randomized Trial.

PubMed

Krishnamurti, Tamar; Argo, Nichole

2016-08-01

Traditional informed consent documents tend to be too lengthy and technical to facilitate proper patient engagement. Patient-centered, short informed consent content could be equally informative, while minimizing patient burden and producing greater patient engagement. This study aimed to develop and evaluate patient-centered, patient-designed paper and video informed consent formats. Two studies were conducted. In study 1, 118 self-identifying asthma patients recruited from a national, online pool completed survey tasks from their personal computers. Participants in study 1 were randomly assigned to examine sections of a standard informed consent document for an asthma trial and to select information they deemed critical to their decision making. In study 2, a sample of 83 self-identifying asthma patients completed experimental tasks in a university laboratory. Participants in study 2 were randomly assigned to a full informed consent document; a shortened, patient-designed informed consent document created from study 1; or a video with content matched to the shortened paper form. Study 1 yielded a more readable, concise version of a standard informed consent document (5 v. 17 pages). This shortened, patient-designed form closely met normative criteria for good clinical practice. In study 2, participants who viewed either the shortened paper consent or video reported greater engagement than those viewing the standard paper consent, without lowered performance on any other decision-relevant variables (i.e., comprehension, judged risk/benefit, feelings of trust). The video consent format did not cause increased enrollment. Results suggest that providing concise informed consent content, systematically developed from patients' self-reported information needs, may be more effective at engaging and informing clinical trial participants than the traditional consent approach, without detriment to trial comprehension, risk assessment, or enrollment. © The Author(s) 2016.

Nonparametric estimation of median survival times with applications to multi-site or multi-center studies

PubMed Central

Choi, Sangbum; Hong, Chuan; Zhu, Liang; Jeon, Sangchoon; Gardiner, Joseph C.

2018-01-01

We propose a nonparametric shrinkage estimator for the median survival times from several independent samples of right-censored data, which combines the samples and hypothesis information to improve the efficiency. We compare efficiency of the proposed shrinkage estimation procedure to unrestricted estimator and combined estimator through extensive simulation studies. Our results indicate that performance of these estimators depends on the strength of homogeneity of the medians. When homogeneity holds, the combined estimator is the most efficient estimator. However, it becomes inconsistent when homogeneity fails. On the other hand, the proposed shrinkage estimator remains efficient. Its efficiency decreases as the equality of the survival medians is deviated, but is expected to be as good as or equal to the unrestricted estimator. Our simulation studies also indicate that the proposed shrinkage estimator is robust to moderate levels of censoring. We demonstrate application of these methods to estimating median time for trauma patients to receive red blood cells in the Prospective Observational Multi-center Major Trauma Transfusion (PROMMTT) study. PMID:29772007

A multi-center, randomized, clinical trial comparing adhesive polyurethane foam dressing and adhesive hydrocolloid dressing in patients with grade II pressure ulcers in primary care and nursing homes.

PubMed

Guillén-Solà, Mireia; Soler Mieras, Aina; Tomàs-Vidal, Antònia M

2013-12-21

Pressure ulcers (PrUs) are ischemic wounds in the skin and underlying tissues caused by long-standing pressure force over an external bone or cartilaginous surface. PrUs are an important challenge for the overall health system because can prolong patient hospitalization and reduce quality of life. Moreover, 95% of PrUs are avoidable, suggesting they are caused by poor quality care assistance. PrUs are also costly, increasing national costs. For example, they represent about 5% of overall annual health expenses in Spain. Stages I and II PrUs have a combined prevalence of 65%. According main clinical guidelines, stage II PrUs (PrU-IIs) are usually treated by applying special dressings (polyurethane or hydrocolloid). However, little scientific evidence regarding their efficacy has been identified in scientific literature. Our aim is to assess the comparative efficacy of adhesive polyurethane foam and hydrocolloid dressings in the treatment of PrU-IIs in terms of healed ulcer after 8 weeks of follow-up. This paper describes the development and evaluation protocol of a randomized clinical trial of two parallel treatment arms. A total of 820 patients with at least 1 PrU-II will be recruited from primary health care and home care centers. All patients will receive standardized healing procedures and preventive measures (e.g. positional changes and pressure-relieving support surfaces), following standardized procedures. The main outcome will be the percentage of wounds healed after 8 weeks. Secondary outcomes will include cost-effectiveness, as evaluated by cost per healed ulcer and cost per treated patient and safety evaluated by adverse events. This trial will address the hypothesis that hydrocolloid dressings will heal at least 10% more stage II PrUs and be more cost-effective than polyurethane foam dressings after 8 weeks. This trial has been registered with controlled-trials number ISCRCTN57842461 and EudraCT 2012-003945-14.

SU-E-T-480: Radiobiological Dose Comparison of Single Fraction SRS, Multi-Fraction SRT and Multi-Stage SRS of Large Target Volumes Using the Linear-Quadratic Formula

DOE Office of Scientific and Technical Information (OSTI.GOV)

Ding, C; Hrycushko, B; Jiang, S

2014-06-01

Purpose: To compare the radiobiological effect on large tumors and surrounding normal tissues from single fraction SRS, multi-fractionated SRT, and multi-staged SRS treatment. Methods: An anthropomorphic head phantom with a centrally located large volume target (18.2 cm{sup 3}) was scanned using a 16 slice large bore CT simulator. Scans were imported to the Multiplan treatment planning system where a total prescription dose of 20Gy was used for a single, three staged and three fractionated treatment. Cyber Knife treatment plans were inversely optimized for the target volume to achieve at least 95% coverage of the prescription dose. For the multistage plan,more » the target was segmented into three subtargets having similar volume and shape. Staged plans for individual subtargets were generated based on a planning technique where the beam MUs of the original plan on the total target volume are changed by weighting the MUs based on projected beam lengths within each subtarget. Dose matrices for each plan were export in DICOM format and used to calculate equivalent dose distributions in 2Gy fractions using an alpha beta ratio of 10 for the target and 3 for normal tissue. Results: Singe fraction SRS, multi-stage plan and multi-fractionated SRT plans had an average 2Gy dose equivalent to the target of 62.89Gy, 37.91Gy and 33.68Gy, respectively. The normal tissue within 12Gy physical dose region had an average 2Gy dose equivalent of 29.55Gy, 16.08Gy and 13.93Gy, respectively. Conclusion: The single fraction SRS plan had the largest predicted biological effect for the target and the surrounding normal tissue. The multi-stage treatment provided for a more potent biologically effect on target compared to the multi-fraction SRT treatments with less biological normal tissue than single-fraction SRS treatment.« less

Outcomes Associated with In-Center Nocturnal Hemodialysis from a Large Multicenter Program

PubMed Central

Wang, Weiling; Lester, Keith; Ofsthun, Norma; Lazarus, J. Michael; Hakim, Raymond M.

2010-01-01

Background and objectives: The objective of this study was to evaluate epidemiology and outcomes of a large in-center nocturnal hemodialysis (INHD) program. Design, setting, participants, & measurements: This case-control study compared patients who were on thrice-weekly INHD from 56 Fresenius Medical Care, North America facilities with conventional hemodialysis patients from 244 facilities within the surrounding geographic area. All INHD cases and conventional hemodialysis control subjects who were active as of January 1, 2007, were followed until December 31, 2007, for evaluation of mortality and hospitalization. Results: As of January 1, 2007, 655 patients had been on INHD for 51 ± 73 d. Patients were younger, there were more male and black patients, and vintage was longer, but they had less diabetes compared with 15,334 control subjects. Unadjusted hazard ratio was 0.59 for mortality and 0.76 for hospitalization. After adjustment for case mix and access type, only hospitalization remained significant. Fewer INHD patients were hospitalized (48 versus 59%) with a normalized rate of 9.6 versus 13.5 hospital days per patient-year. INHD patients had greater interdialytic weight gains but lower BP. At baseline, hemoglobin values were similar, whereas albumin and phosphorus values favored INHD. Mean equilibrated Kt/V was higher in INHD patients related to longer treatment time, despite lower blood and dialysate flow rates. Conclusions: Patients who were on INHD exhibited excellent quality indicators, with better survival and lower hospitalization rates. The relative contributions of patient selection versus effect of therapy on outcomes remain to be elucidated in prospective clinical trials. PMID:19965529

The development of a revised version of multi-center molecular Ornstein-Zernike equation

NASA Astrophysics Data System (ADS)

Kido, Kentaro; Yokogawa, Daisuke; Sato, Hirofumi

2012-04-01

Ornstein-Zernike (OZ)-type theory is a powerful tool to obtain 3-dimensional solvent distribution around solute molecule. Recently, we proposed multi-center molecular OZ method, which is suitable for parallel computing of 3D solvation structure. The distribution function in this method consists of two components, namely reference and residue parts. Several types of the function were examined as the reference part to investigate the numerical robustness of the method. As the benchmark, the method is applied to water, benzene in aqueous solution and single-walled carbon nanotube in chloroform solution. The results indicate that fully-parallelization is achieved by utilizing the newly proposed reference functions.

Modifying the Clinical Research Infrastructure at a Dedicated Clinical Trials Unit: Assessment of Trial Development, Activation, and Participant Accrual.

PubMed

Tang, Chad; Hess, Kenneth R; Sanders, Dwana; Davis, Suzanne E; Buzdar, Aman U; Kurzrock, Razelle; Lee, J Jack; Meric-Bernstam, Funda; Hong, David S

2017-03-15

Purpose: Information on processes for trials assessing investigational therapeutics is sparse. We assessed the trial development processes within the Department of Investigational Cancer Therapeutics (ICT) at MD Anderson Cancer Center (Houston, TX) and analyzed their effects on the trial activation timeline and enrolment. Experimental Design: Data were from a prospectively maintained registry that tracks all clinical studies at MD Anderson. From this database, we identified 2,261 activated phase I-III trials; 221 were done at the ICT. ICT trials were matched to trials from other MD Anderson departments by phase, sponsorship, and submission year. Trial performance metrics were compared with paired Wilcoxon signed rank tests. Results: We identified three facets of the ICT research infrastructure: parallel processing of trial approval steps; a physician-led research team; and regular weekly meetings to foster research accountability. Separate analyses were conducted stratified by sponsorship [industry (133 ICT and 133 non-ICT trials) or institutional (68 ICT and 68 non-ICT trials)]. ICT trial development was faster from IRB approval to activation (median difference of 1.1 months for industry-sponsored trials vs. 2.3 months for institutional) and from activation to first enrolment (median difference of 0.3 months for industry vs. 1.2 months for institutional; all matched P < 0.05). ICT trials also accrued more patients (median difference of 8 participants for industry vs. 33.5 for institutional) quicker (median difference 4.8 participants/year for industry vs. 11.1 for institutional; all matched P < 0.05). Conclusions: Use of a clinical research-focused infrastructure within a large academic cancer center was associated with efficient trial development and participant accrual. Clin Cancer Res; 23(6); 1407-13. ©2016 AACR . ©2016 American Association for Cancer Research.

Multi-GNSS PPP-RTK: From Large- to Small-Scale Networks

PubMed Central

Nadarajah, Nandakumaran; Wang, Kan; Choudhury, Mazher

2018-01-01

Precise point positioning (PPP) and its integer ambiguity resolution-enabled variant, PPP-RTK (real-time kinematic), can benefit enormously from the integration of multiple global navigation satellite systems (GNSS). In such a multi-GNSS landscape, the positioning convergence time is expected to be reduced considerably as compared to the one obtained by a single-GNSS setup. It is therefore the goal of the present contribution to provide numerical insights into the role taken by the multi-GNSS integration in delivering fast and high-precision positioning solutions (sub-decimeter and centimeter levels) using PPP-RTK. To that end, we employ the Curtin PPP-RTK platform and process data-sets of GPS, BeiDou Navigation Satellite System (BDS) and Galileo in stand-alone and combined forms. The data-sets are collected by various receiver types, ranging from high-end multi-frequency geodetic receivers to low-cost single-frequency mass-market receivers. The corresponding stations form a large-scale (Australia-wide) network as well as a small-scale network with inter-station distances less than 30 km. In case of the Australia-wide GPS-only ambiguity-float setup, 90% of the horizontal positioning errors (kinematic mode) are shown to become less than five centimeters after 103 min. The stated required time is reduced to 66 min for the corresponding GPS + BDS + Galieo setup. The time is further reduced to 15 min by applying single-receiver ambiguity resolution. The outcomes are supported by the positioning results of the small-scale network. PMID:29614040

Angular description for 3D scattering centers

NASA Astrophysics Data System (ADS)

Bhalla, Rajan; Raynal, Ann Marie; Ling, Hao; Moore, John; Velten, Vincent J.

2006-05-01

The electromagnetic scattered field from an electrically large target can often be well modeled as if it is emanating from a discrete set of scattering centers (see Fig. 1). In the scattering center extraction tool we developed previously based on the shooting and bouncing ray technique, no correspondence is maintained amongst the 3D scattering center extracted at adjacent angles. In this paper we present a multi-dimensional clustering algorithm to track the angular and spatial behaviors of 3D scattering centers and group them into features. The extracted features for the Slicy and backhoe targets are presented. We also describe two metrics for measuring the angular persistence and spatial mobility of the 3D scattering centers that make up these features in order to gather insights into target physics and feature stability. We find that features that are most persistent are also the most mobile and discuss implications for optimal SAR imaging.

Multi-strategic intervention to enhance implementation of healthy canteen policy: a randomised controlled trial.

PubMed

Wolfenden, Luke; Nathan, Nicole; Janssen, Lisa M; Wiggers, John; Reilly, Kathryn; Delaney, Tessa; Williams, Christopher M; Bell, Colin; Wyse, Rebecca; Sutherland, Rachel; Campbell, Libby; Lecathelinais, Christophe; Oldmeadow, Chris; Freund, Megan; Yoong, Sze Lin

2017-01-11

Internationally, governments have implemented school-based nutrition policies to restrict the availability of unhealthy foods from sale. The aim of the trial was to assess the effectiveness of a multi-strategic intervention to increase implementation of a state-wide healthy canteen policy. The impact of the intervention on the energy, total fat, and sodium of children's canteen purchases and on schools' canteen revenue was also assessed. Australian primary schools with a canteen were randomised to receive a 12-14-month, multi-strategic intervention or to a no intervention control group. The intervention sought to increase implementation of a state-wide healthy canteen policy which required schools to remove unhealthy items (classified as 'red' or 'banned') from regular sale and encouraged schools to 'fill the menu' with healthy items (classified as 'green'). The intervention strategies included allocation of a support officer to assist with policy implementation, engagement of school principals and parent committees, consensus processes with canteen managers, training, provision of tools and resources, academic detailing, performance feedback, recognition and marketing initiatives. Data were collected at baseline (April to September, 2013) and at completion of the implementation period (November, 2014 to April, 2015). Seventy schools participated in the trial. Relative to control, at follow-up, intervention schools were significantly more likely to have menus without 'red' or 'banned' items (RR = 21.11; 95% CI 3.30 to 147.28; p ≤ 0.01) and to have at least 50% of menu items classified as 'green' (RR = 3.06; 95% CI 1.64 to 5.68; p ≤ 0.01). At follow-up, student purchases from intervention school canteens were significantly lower in total fat (difference = -1.51 g; 95% CI -2.84 to -0.18; p = 0.028) compared to controls, but not in energy (difference = -132.32 kJ; 95% CI -280.99 to 16.34; p = 0.080) or sodium (difference = -46

Architecture design of a generic centralized adjudication module integrated in a web-based clinical trial management system

PubMed Central

Zhao, Wenle; Pauls, Keith

2015-01-01

Background Centralized outcome adjudication has been used widely in multi-center clinical trials in order to prevent potential biases and to reduce variations in important safety and efficacy outcome assessments. Adjudication procedures could vary significantly among different studies. In practice, the coordination of outcome adjudication procedures in many multicenter clinical trials remains as a manual process with low efficiency and high risk of delay. Motivated by the demands from two large clinical trial networks, a generic outcome adjudication module has been developed by the network’s data management center within a homegrown clinical trial management system. In this paper, the system design strategy and database structure are presented. Methods A generic database model was created to transfer different adjudication procedures into a unified set of sequential adjudication steps. Each adjudication step was defined by one activate condition, one lock condition, one to five categorical data items to capture adjudication results, and one free text field for general comments. Based on this model, a generic outcome adjudication user interface and a generic data processing program were developed within a homegrown clinical trial management system to provide automated coordination of outcome adjudication. Results By the end of 2014, this generic outcome adjudication module had been implemented in 10 multicenter trials. A total of 29 adjudication procedures were defined with the number of adjudication steps varying from 1 to 7. The implementation of a new adjudication procedure in this generic module took an experienced programmer one or two days. A total of 7,336 outcome events had been adjudicated and 16,235 adjudication step activities had been recorded. In a multicenter trial, 1144 safety outcome event submissions went through a three-step adjudication procedure and reported a median of 3.95 days from safety event case report form submission to adjudication

Mono and multi-objective optimization techniques applied to a large range of industrial test cases using Metamodel assisted Evolutionary Algorithms

NASA Astrophysics Data System (ADS)

Fourment, Lionel; Ducloux, Richard; Marie, Stéphane; Ejday, Mohsen; Monnereau, Dominique; Massé, Thomas; Montmitonnet, Pierre

2010-06-01

The use of material processing numerical simulation allows a strategy of trial and error to improve virtual processes without incurring material costs or interrupting production and therefore save a lot of money, but it requires user time to analyze the results, adjust the operating conditions and restart the simulation. Automatic optimization is the perfect complement to simulation. Evolutionary Algorithm coupled with metamodelling makes it possible to obtain industrially relevant results on a very large range of applications within a few tens of simulations and without any specific automatic optimization technique knowledge. Ten industrial partners have been selected to cover the different area of the mechanical forging industry and provide different examples of the forming simulation tools. It aims to demonstrate that it is possible to obtain industrially relevant results on a very large range of applications within a few tens of simulations and without any specific automatic optimization technique knowledge. The large computational time is handled by a metamodel approach. It allows interpolating the objective function on the entire parameter space by only knowing the exact function values at a reduced number of "master points". Two algorithms are used: an evolution strategy combined with a Kriging metamodel and a genetic algorithm combined with a Meshless Finite Difference Method. The later approach is extended to multi-objective optimization. The set of solutions, which corresponds to the best possible compromises between the different objectives, is then computed in the same way. The population based approach allows using the parallel capabilities of the utilized computer with a high efficiency. An optimization module, fully embedded within the Forge2009 IHM, makes possible to cover all the defined examples, and the use of new multi-core hardware to compute several simulations at the same time reduces the needed time dramatically. The presented examples

MultiFacet: A Faceted Interface for Browsing Large Multimedia Collections

DOE Office of Scientific and Technical Information (OSTI.GOV)

Henry, Michael J.; Hampton, Shawn D.; Endert, Alexander

2013-10-31

Faceted browsing is a common technique for exploring collections where the data can be grouped into a number of pre-defined categories, most often generated from textual metadata. Historically, faceted browsing has been applied to a single data type such as text or image data. However, typical collections contain multiple data types, such as information from web pages that contain text, images, and video. Additionally, when browsing a collection of images and video, facets are often created based on the metadata which may be incomplete, inaccurate, or missing altogether instead of the actual visual content contained within those images and video.more » In this work we address these limitations by presenting MultiFacet, a faceted browsing interface that supports multiple data types. MultiFacet constructs facets for images and video in a collection from the visual content using computer vision techniques. These visual facets can then be browsed in conjunction with text facets within a single interface to reveal relationships and phenomena within multimedia collections. Additionally, we present a use case based on real-world data, demonstrating the utility of this approach towards browsing a large multimedia data collection.« less

Creative music therapy to promote brain structure, function, and neurobehavioral outcomes in preterm infants: a randomized controlled pilot trial protocol.

PubMed

Haslbeck, Friederike Barbara; Bucher, Hans-Ulrich; Bassler, Dirk; Hagmann, Cornelia

2017-01-01

Preterm birth is associated with increased risk of neurological impairment and deficits in cognition, motor function, and behavioral problems. Limited studies indicate that multi-sensory experiences support brain development in preterm infants. Music appears to promote neurobiological processes and neuronal learning in the human brain. Creative music therapy (CMT) is an individualized, interactive therapeutic approach based on the theory and methods of Nordoff and Robbins. CMT may promote brain development in preterm infants via concurrent interaction and meaningful auditory stimulation. We hypothesize that preterm infants who receive creative music therapy during neonatal intensive care admission will have developmental benefits short- and long-term brain function. A prospective, randomized controlled single-center pilot trial involving 60 clinically stable preterm infants under 32 weeks of gestational age is conducted in preparation for a multi-center trial. Thirty infants each are randomized to either standard neonatal intensive care or standard care with CMT. Music therapy intervention is approximately 20 min in duration three times per week. A trained music therapist sings for the infants in lullaby style, individually entrained and adjusted to the infant's rhythm and affect. Primary objectives of this study are feasibility of protocol implementation and investigating the potential mechanism of efficacy for this new intervention. To examine the effect of this new intervention, non-invasive, quantitative magnetic resonance imaging (MRI) methods at corrected age and standardized neurodevelopmental assessments using the Bayley Scales of Infant and Toddler Development third edition at a corrected age of 24 months and Kaufman Assessment Battery for Children at 5 years will be performed. All assessments will be performed and analyzed by blinded experts. To our knowledge, this is the first randomized controlled clinical trial to systematically examine possible

Planning multi-arm screening studies within the context of a drug development program

PubMed Central

Wason, James M S; Jaki, Thomas; Stallard, Nigel

2013-01-01

Screening trials are small trials used to decide whether an intervention is sufficiently promising to warrant a large confirmatory trial. Previous literature examined the situation where treatments are tested sequentially until one is considered sufficiently promising to take forward to a confirmatory trial. An important consideration for sponsors of clinical trials is how screening trials should be planned to maximize the efficiency of the drug development process. It has been found previously that small screening trials are generally the most efficient. In this paper we consider the design of screening trials in which multiple new treatments are tested simultaneously. We derive analytic formulae for the expected number of patients until a successful treatment is found, and propose methodology to search for the optimal number of treatments, and optimal sample size per treatment. We compare designs in which only the best treatment proceeds to a confirmatory trial and designs in which multiple treatments may proceed to a multi-arm confirmatory trial. We find that inclusion of a large number of treatments in the screening trial is optimal when only one treatment can proceed, and a smaller number of treatments is optimal when more than one can proceed. The designs we investigate are compared on a real-life set of screening designs. Copyright © 2013 John Wiley & Sons, Ltd. PMID:23529936

Clinical trial shows safety and effectiveness of new combination immunotherapy for advanced liver cancer | Center for Cancer Research

Cancer.gov

A recently completed phase I clinical trial at the NIH Clinical Center in Bethesda, Maryland, demonstrates that a combination of two immunotherapy drugs to target hepatocellular carcinoma (HCC) was well-tolerated and shrunk tumors in a larger percentage of patients than the standard monotherapy.  Read more...

Rationale for the tinnitus retraining therapy trial.

PubMed

Formby, Craig; Scherer, Roberta

2013-01-01

The Tinnitus Retraining Therapy Trial (TRTT) is a National Institutes of Health-sponsored, multi-centered, placebo-controlled, randomized trial evaluating the efficacy of tinnitus retraining therapy (TRT) and its component parts, directive counseling and sound therapy, as treatments for subjective debilitating tinnitus in the military. The TRTT will enroll 228 individuals at an allocation ratio of 1:1:1 to: (1) directive counseling and sound therapy using conventional sound generators; (2) directive counseling and placebo sound generators; or (3) standard of care as administered in the military. Study centers include a Study Chair's Office, a Data Coordinating Center, and six Military Clinical Centers with treatment and data collection standardized across all clinics. The primary outcome is change in Tinnitus Questionnaire (TQ) score assessed longitudinally at 3, 6, 12, and 18-month follow-up visits. Secondary outcomes include: Change in TQ sub-scales, Tinnitus Handicap Inventory, Tinnitus Functional Index, and TRT interview visual analog scale; audiometric and psychoacoustic measures; and change in quality of life. The TRTT will evaluate TRT efficacy by comparing TRT (directive counseling and conventional sound generators) with standard of care; directive counseling by comparing directive counseling plus placebo sound generators versus standard of care; and sound therapy by comparing conventional versus placebo sound generators. We hypothesize that full TRT will be more efficacious than standard of care, directive counseling and placebo sound generators more efficacious than standard of care, and conventional more efficacious than placebo sound generators in habituating the tinnitus awareness, annoyance, and impact on the study participant's life.

Rationale for the tinnitus retraining therapy trial

PubMed Central

Formby, Craig; Scherer, Roberta

2013-01-01

The Tinnitus Retraining Therapy Trial (TRTT) is a National Institutes of Health-sponsored, multi-centered, placebo-controlled, randomized trial evaluating the efficacy of tinnitus retraining therapy (TRT) and its component parts, directive counseling and sound therapy, as treatments for subjective debilitating tinnitus in the military. The TRTT will enroll 228 individuals at an allocation ratio of 1:1:1 to: (1) directive counseling and sound therapy using conventional sound generators; (2) directive counseling and placebo sound generators; or (3) standard of care as administered in the military. Study centers include a Study Chair’s Office, a Data Coordinating Center, and six Military Clinical Centers with treatment and data collection standardized across all clinics. The primary outcome is change in Tinnitus Questionnaire (TQ) score assessed longitudinally at 3, 6, 12, and 18-month follow-up visits. Secondary outcomes include: Change in TQ sub-scales, Tinnitus Handicap Inventory, Tinnitus Functional Index, and TRT interview visual analog scale; audiometric and psychoacoustic measures; and change in quality of life. The TRTT will evaluate TRT efficacy by comparing TRT (directive counseling and conventional sound generators) with standard of care; directive counseling by comparing directive counseling plus placebo sound generators versus standard of care; and sound therapy by comparing conventional versus placebo sound generators. We hypothesize that full TRT will be more efficacious than standard of care, directive counseling and placebo sound generators more efficacious than standard of care, and conventional more efficacious than placebo sound generators in habituating the tinnitus awareness, annoyance, and impact on the study participant’s life. PMID:23571304

Large-scale delamination of multi-layers transition metal carbides and carbonitrides “MXenes”

DOE PAGES

Naguib, Michael; Unocic, Raymond R.; Armstrong, Beth L.; ...

2015-04-17

Herein we report on a general approach to delaminate multi-layered MXenes using an organic base to induce swelling that in turn weakens the bonds between the MX layers. Simple agitation or mild sonication of the swollen MXene in water resulted in the large-scale delamination of the MXene layers. The delamination method is demonstrated for vanadium carbide, and titanium carbonitrides MXenes.

Photographic Reading Center of the Idiopathic Intracranial Hypertension Treatment Trial (IIHTT): Methods and Baseline Results

PubMed Central

Fischer, William S.; Wall, Michael; McDermott, Michael P.; Kupersmith, Mark J.; Feldon, Steven E.

2015-01-01

Purpose. To describe the methods used by the Photographic Reading Center (PRC) of the Idiopathic Intracranial Hypertension Treatment Trial (IIHTT) and to report baseline assessments of papilledema severity in participants. Methods. Stereoscopic digital images centered on the optic disc and the macula were collected using certified personnel and photographic equipment. Certification of the camera system included standardization and calibration using a model eye. Lay readers assessed disc photos of all eyes using the Frisén grade and performed quantitative measurements of papilledema. Frisén grades by PRC were compared with site investigator clinical grades. Spearman rank correlations were used to quantify associations among disc features and selected clinical variables. Results. Frisén grades according to the PRC and site investigator's grades, matched exactly in 48% of the study eyes and 42% of the fellow eyes and within one grade in 94% of the study eyes and 92% of the fellow eyes. Frisén grade was strongly correlated (r > 0.65, P < 0.0001) with quantitative measures of disc area. Cerebrospinal fluid pressure was weakly associated with Frisén grade and disc area determinations (r ≤ 0.31). Neither Frisén grade nor any fundus feature was associated with perimetric mean deviation. Conclusions. In a prospective clinical trial, lay readers agreed reasonably well with physicians in assessing Frisén grade. Standardization of camera systems enhanced consistency of photographic quality across study sites. Images were affected more by sensors with poor dynamic range than by poor resolution. Frisén grade is highly correlated with quantitative assessment of disc area. (ClinicalTrials.gov number, NCT01003639.) PMID:26024112

Photographic Reading Center of the Idiopathic Intracranial Hypertension Treatment Trial (IIHTT): Methods and Baseline Results.

PubMed

Fischer, William S; Wall, Michael; McDermott, Michael P; Kupersmith, Mark J; Feldon, Steven E

2015-05-01

To describe the methods used by the Photographic Reading Center (PRC) of the Idiopathic Intracranial Hypertension Treatment Trial (IIHTT) and to report baseline assessments of papilledema severity in participants. Stereoscopic digital images centered on the optic disc and the macula were collected using certified personnel and photographic equipment. Certification of the camera system included standardization and calibration using a model eye. Lay readers assessed disc photos of all eyes using the Frisén grade and performed quantitative measurements of papilledema. Frisén grades by PRC were compared with site investigator clinical grades. Spearman rank correlations were used to quantify associations among disc features and selected clinical variables. Frisén grades according to the PRC and site investigator's grades, matched exactly in 48% of the study eyes and 42% of the fellow eyes and within one grade in 94% of the study eyes and 92% of the fellow eyes. Frisén grade was strongly correlated (r > 0.65, P < 0.0001) with quantitative measures of disc area. Cerebrospinal fluid pressure was weakly associated with Frisén grade and disc area determinations (r ≤ 0.31). Neither Frisén grade nor any fundus feature was associated with perimetric mean deviation. In a prospective clinical trial, lay readers agreed reasonably well with physicians in assessing Frisén grade. Standardization of camera systems enhanced consistency of photographic quality across study sites. Images were affected more by sensors with poor dynamic range than by poor resolution. Frisén grade is highly correlated with quantitative assessment of disc area. (ClinicalTrials.gov number, NCT01003639.).

Statistical analysis plan for the Laser-1st versus Drops-1st for Glaucoma and Ocular Hypertension Trial (LiGHT): a multi-centre randomised controlled trial.

PubMed

Vickerstaff, Victoria; Ambler, Gareth; Bunce, Catey; Xing, Wen; Gazzard, Gus

2015-11-11

The LiGHT trial (Laser-1st versus Drops-1st for Glaucoma and Ocular Hypertension Trial) is a multicentre randomised controlled trial of two treatment pathways for patients who are newly diagnosed with open-angle glaucoma (OAG) and ocular hypertension (OHT). The main hypothesis for the trial is that lowering intraocular pressure (IOP) with selective laser trabeculoplasty (SLT) as the primary treatment ('Laser-1st') leads to a better health-related quality of life than for those started on IOP-lowering drops as their primary treatment ('Medicine-1st') and that this is associated with reduced costs and improved tolerability of treatment. This paper describes the statistical analysis plan for the study. The LiGHT trial is an unmasked, multi-centre randomised controlled trial. A total of 718 patients (359 per arm) are being randomised to two groups: medicine-first or laser-first treatment. Outcomes are recorded at baseline and at 6-month intervals up to 36 months. The primary outcome measure is health-related quality of life (HRQL) at 36 months measured using the EQ-5D-5L. The main secondary outcome is the Glaucoma Utility Index. We plan to analyse the patient outcome data according to the group to which the patient was originally assigned. Methods of statistical analysis are described, including the handling of missing data, the covariates used in the adjusted analyses and the planned sensitivity analyses. The trial was registered with the ISRCTN register on 23/07/2012, number ISRCTN32038223 .

Center-Specific Factors Associated with Peritonitis Risk-A Multi-Center Registry Analysis.

PubMed

Nadeau-Fredette, Annie-Claire; Johnson, David W; Hawley, Carmel M; Pascoe, Elaine M; Cho, Yeoungjee; Clayton, Philip A; Borlace, Monique; Badve, Sunil V; Sud, Kamal; Boudville, Neil; McDonald, Stephen P

♦ Previous studies have reported significant variation in peritonitis rates across dialysis centers. Limited evidence is available to explain this variability. The aim of this study was to assess center-level predictors of peritonitis and their relationship with peritonitis rate variations. ♦ All incident peritoneal dialysis (PD) patients treated in Australia between October 2003 and December 2013 were included. Data were accessed through the Australia and New Zealand Dialysis and Transplant Registry. The primary outcome was peritonitis rate, evaluated in a mixed effects negative binomial regression model. Peritonitis-free survival was assessed as a secondary outcome in a Cox proportional hazards model. ♦ Overall, 8,711 incident PD patients from 51 dialysis centers were included in the study. Center-level predictors of lower peritonitis rates included smaller center size, high proportion of PD, low peritoneal equilibration test use at PD start, and low proportion of hospitalization for peritonitis. In contrast, a low proportion of automated PD exposure, high icodextrin exposure and low or high use of antifungal prophylaxis at the time of peritonitis were associated with a higher peritonitis rate. Similar results were obtained for peritonitis-free survival. Overall, accounting for center-level characteristics appreciably decreased peritonitis variability among dialysis centers (p = 0.02). ♦ This study identified specific center-level characteristics associated with the variation in peritonitis risk. Whether these factors are directly related to peritonitis risk or surrogate markers for other center characteristics is uncertain and should be validated in further studies. Copyright © 2016 International Society for Peritoneal Dialysis.

Chinese herbal medicine formula for acute asthma: A multi-center, randomized, double-blind, proof-of-concept trial.

PubMed

Zhang, Hong Ping; Wang, Lei; Wang, Zhen; Xu, Xian Rong; Zhou, Xian Mei; Liu, Gang; He, Lv Yuan; Wang, Jun; Hsu, Alan; Li, Wei Min; Wang, Gang

2018-07-01

Despite advances in asthma management, exacerbations constitute a significant health economic burden. To observe the efficacy and safety of Chinese herbal medicine formula entitled PingchuanYiqi (PCYQ) granule, on acute asthma and to explore its possible mechanism. This proof-of-concept study consisted of a randomized, double-blind, placebo-controlled trial in patients with acute asthma (n = 300). Participants with acute mild-to-moderate asthma recruited from seven centers in China were randomly assigned to receive PCYQ or placebo. The primary outcomes were PEF (L/min) and total asthma symptom scores. Furthermore, a panel of cytokines including serum IL-4, IL-5, IL-6, IL-8, IL-1β, IL-17A, IFN-α, IFN-β, IFN-γ, CRP, CCL-5, IP-10, and PGD 2 levels was detected using ELISA. The PCYQ (n = 139) significantly improved the morning PEF on day 4 (349.73 ± 93.92 vs. 313.56 ± 92.91 L/min, P = 0.004) and day 7 (360.42 ± 94.39 vs. 329.52 ± 95.97 L/min, P = 0.023), and the evening PEF on day 4 (352.65 ± 95.47 vs. 320.58 ± 95.30 L/min, P = 0.012) and day 7 (360.42 ± 94.39 vs. 336.86 ± 95.59 L/min, P = 0.029) in comparison with the placebo (n = 143). The PCYQ also improved the clinical symptoms scores and reduced the puffs of short-acting β 2 -agonist (all P < 0.05). Furthermore, the PCYQ statistically reduced IL-5, IL-8, IL-1β and PGD 2 in serum. The PCYQ as the Chinese herbal medicine formula significantly improves lung function and symptoms of acute asthma, and reduces SABA dosage possibly via decrease of inflammatory biomarkers such as IL-5, IL-8, IL-1β and PGD 2 . ISRCTN61674768 (http://www.isrctn.com/). Copyright © 2018. Published by Elsevier Ltd.

The development and test of ultra-large-format multi-anode microchannel array detector systems

NASA Technical Reports Server (NTRS)

Timothy, J. G.

1984-01-01

The specific tasks that were accomplished with each of the key elements of the multi-anode microchannel array detector system are described. The modes of operation of position-sensitive electronic readout systems for use with high-gain microchannel plates are described and their performance characteristics compared and contrasted. Multi-anode microchannel array detector systems with formats as large as 256 x 1024 pixels are currently under evaluation. Preliminary performance data for sealed ultraviolet and visible-light detector tubes show that the detector systems have unique characteristics which make them complementary to photoconductive array detectors, such as CCDs, and superior to alternative pulse-counting detector systems employing high-gain MCPs.

Effects of Person-Centered Physical Therapy on Fatigue-Related Variables in Persons With Rheumatoid Arthritis: A Randomized Controlled Trial.

PubMed

Feldthusen, Caroline; Dean, Elizabeth; Forsblad-d'Elia, Helena; Mannerkorpi, Kaisa

2016-01-01

To examine effects of person-centered physical therapy on fatigue and related variables in persons with rheumatoid arthritis (RA). Randomized controlled trial. Hospital outpatient rheumatology clinic. Persons with RA aged 20 to 65 years (N=70): intervention group (n=36) and reference group (n=34). The 12-week intervention, with 6-month follow-up, focused on partnership between participant and physical therapist and tailored health-enhancing physical activity and balancing life activities. The reference group continued with regular activities; both groups received usual health care. Primary outcome was general fatigue (visual analog scale). Secondary outcomes included multidimensional fatigue (Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional Questionnaire) and fatigue-related variables (ie, disease, health, function). At posttest, general fatigue improved more in the intervention group than the reference group (P=.042). Improvement in median general fatigue reached minimal clinically important differences between and within groups at posttest and follow-up. Improvement was also observed for anxiety (P=.0099), and trends toward improvements were observed for most multidimensional aspects of fatigue (P=.023-.048), leg strength/endurance (P=.024), and physical activity (P=.023). Compared with the reference group at follow-up, the intervention group improvement was observed for leg strength/endurance (P=.001), and the trends toward improvements persisted for physical (P=.041) and living-related (P=.031) aspects of fatigue, physical activity (P=.019), anxiety (P=.015), self-rated health (P=.010), and self-efficacy (P=.046). Person-centered physical therapy focused on health-enhancing physical activity and balancing life activities showed significant benefits on fatigue in persons with RA. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Safety and effectiveness of minimally invasive sacroiliac joint fusion in women with persistent post-partum posterior pelvic girdle pain: 12-month outcomes from a prospective, multi-center trial.

PubMed

Capobianco, Robyn; Cher, Daniel

2015-01-01

Postpartum posterior pelvic girdle pain (PPGP) affects nearly 20 % of women who experience back pain in the peripartum period. The sacroiliac joint is a source of this pain in 75 % of women with persistent PPGP. A subset of women will fail to obtain acceptable pain relief from the current array of non-surgical treatment options. The purpose of this study is to assess the safety and effectiveness of minimally invasive sacroiliac (SI) joint fusion in women with chronic SI joint dysfunction whose pain began in the peri-partum period whose symptoms were recalcitrant to non-surgical management. A sub-group analysis of subjects with sacroiliac joint disruption and/or degenerative sacroiliitis enrolled in a prospective, multi-center trial of SI joint fusion was performed. Subjects with PPGP were identified and compared with women without PPGP and with men. Of 172 enrolled subjects, 52 were male, 100 were females without PPGP and 20 females had PPGP. PPGP subjects were significantly younger (43.3 years, vs. 52.8 for females without PPGP and 50.5 for men, p = 0.002). There were no differences in any other demographic or baseline clinical measure. Women with PPGP experienced a significant improvement in pain (-51 mm on VAS), function (-20.6 pts on ODI) and quality of life (SF-36 PCS +10.4, MCS +7.2, EQ-5D +0.31) at 12 months after surgery. These improvements were characteristic of the overall study results; no difference was detected between sub-groups. The sacroiliac joint can be a source of pain in women with persistent PPGP and should be investigated as a pain generator. In this study, women with carefully diagnosed chronic SI joint pain from PPGP recalcitrant to conservative therapies experienced clinically beneficially improvements in pain, disability and quality of life after minimally invasive SI joint fusion using a series of triangular porous plasma spray coated implants.

A fast learning method for large scale and multi-class samples of SVM

NASA Astrophysics Data System (ADS)

Fan, Yu; Guo, Huiming

2017-06-01

A multi-class classification SVM(Support Vector Machine) fast learning method based on binary tree is presented to solve its low learning efficiency when SVM processing large scale multi-class samples. This paper adopts bottom-up method to set up binary tree hierarchy structure, according to achieved hierarchy structure, sub-classifier learns from corresponding samples of each node. During the learning, several class clusters are generated after the first clustering of the training samples. Firstly, central points are extracted from those class clusters which just have one type of samples. For those which have two types of samples, cluster numbers of their positive and negative samples are set respectively according to their mixture degree, secondary clustering undertaken afterwards, after which, central points are extracted from achieved sub-class clusters. By learning from the reduced samples formed by the integration of extracted central points above, sub-classifiers are obtained. Simulation experiment shows that, this fast learning method, which is based on multi-level clustering, can guarantee higher classification accuracy, greatly reduce sample numbers and effectively improve learning efficiency.

Multi-muscle synergies in an unusual postural task: quick shear force production.

PubMed

Robert, Thomas; Zatsiorsky, Vladimir M; Latash, Mark L

2008-05-01

We considered a hypothetical two-level hierarchy participating in the control of vertical posture. The framework of the uncontrolled manifold (UCM) hypothesis was used to explore the muscle groupings (M-modes) and multi-M-mode synergies involved in the stabilization of a time profile of the shear force in the anterior-posterior direction. Standing subjects were asked to produce pulses of shear force into a target using visual feedback while trying to minimize the shift of the center of pressure (COP). Principal component analysis applied to integrated muscle activation indices identified three M-modes. The composition of the M-modes was similar across subjects and the two directions of the shear force pulse. It differed from the composition of M-modes described in earlier studies of more natural actions associated with large COP shifts. Further, the trial-to-trial M-mode variance was partitioned into two components: one component that does not affect a particular performance variable (V(UCM)), and its orthogonal component (V(ORT)). We argued that there is a multi-M-mode synergy stabilizing this particular performance variable if V(UCM) is higher than V(ORT). Overall, we found a multi-M-mode synergy stabilizing both shear force and COP coordinate. For the shear force, this synergy was strong for the backward force pulses and nonsignificant for the forward pulses. An opposite result was found for the COP coordinate: the synergy was stronger for the forward force pulses. The study shows that M-mode composition can change in a task-specific way and that two different performance variables can be stabilized using the same set of elemental variables (M-modes). The different dependences of the ΔV indices for the shear force and COP coordinate on the force pulse direction supports applicability of the principle of superposition (separate controllers for different performance variables) to the control of different mechanical variables in postural tasks. The M

Regional gray matter atrophy in relapsing remitting multiple sclerosis: baseline analysis of multi-center data.

PubMed

Datta, Sushmita; Staewen, Terrell D; Cofield, Stacy S; Cutter, Gary R; Lublin, Fred D; Wolinsky, Jerry S; Narayana, Ponnada A

2015-03-01

Regional gray matter (GM) atrophy in multiple sclerosis (MS) at disease onset and its temporal variation can provide objective information regarding disease evolution. An automated pipeline for estimating atrophy of various GM structures was developed using tensor based morphometry (TBM) and implemented on a multi-center sub-cohort of 1008 relapsing remitting MS (RRMS) patients enrolled in a Phase 3 clinical trial. Four hundred age and gender matched healthy controls were used for comparison. Using the analysis of covariance, atrophy differences between MS patients and healthy controls were assessed on a voxel-by-voxel analysis. Regional GM atrophy was observed in a number of deep GM structures that included thalamus, caudate nucleus, putamen, and cortical GM regions. General linear regression analysis was performed to analyze the effects of age, gender, and scanner field strength, and imaging sequence on the regional atrophy. Correlations between regional GM volumes and expanded disability status scale (EDSS) scores, disease duration (DD), T2 lesion load (T2 LL), T1 lesion load (T1 LL), and normalized cerebrospinal fluid (nCSF) were analyzed using Pearson׳s correlation coefficient. Thalamic atrophy observed in MS patients compared to healthy controls remained consistent within subgroups based on gender and scanner field strength. Weak correlations between thalamic volume and EDSS (r=-0.133; p<0.001) and DD (r=-0.098; p=0.003) were observed. Of all the structures, thalamic volume moderately correlated with T2 LL (r=-0.492; P-value<0.001), T1 LL (r=-0.473; P-value<0.001) and nCSF (r=-0.367; P-value<0.001). Copyright © 2015 Elsevier B.V. All rights reserved.

Analysis of yield and oil from a series of canola breeding trials. Part II. Exploring variety by environment interaction using factor analysis.

PubMed

Cullis, B R; Smith, A B; Beeck, C P; Cowling, W A

2010-11-01

Exploring and exploiting variety by environment (V × E) interaction is one of the major challenges facing plant breeders. In paper I of this series, we presented an approach to modelling V × E interaction in the analysis of complex multi-environment trials using factor analytic models. In this paper, we develop a range of statistical tools which explore V × E interaction in this context. These tools include graphical displays such as heat-maps of genetic correlation matrices as well as so-called E-scaled uniplots that are a more informative alternative to the classical biplot for large plant breeding multi-environment trials. We also present a new approach to prediction for multi-environment trials that include pedigree information. This approach allows meaningful selection indices to be formed either for potential new varieties or potential parents.

Using information technology to improve the quality and efficiency of clinical trial research in academic medical centers.

PubMed

Hardison, C D; Schnetzer, T

1999-01-01

In the area of clinical trial research, academic medical centers (AMCs) need to create additional capacity and improve performance on vital indicators to attract more studies, as they are currently losing their share to stand-alone research sites. Through the utilization of information technology, AMCs will be in a better position to fend off the competitive threats to their clinical research dollars. Most AMCs are in an enviable position to leverage the value of information technology because of the existing people, processes, and technologies that probably already exist throughout the AMC. The challenge, then, is to deploy these resources in a different manner to support clinical trial research.

A Multi-center Milestone Study of Clinical Vertebral CT Segmentation

PubMed Central

Yao, Jianhua; Burns, Joseph E.; Forsberg, Daniel; Seitel, Alexander; Rasoulian, Abtin; Abolmaesumi, Purang; Hammernik, Kerstin; Urschler, Martin; Ibragimov, Bulat; Korez, Robert; Vrtovec, Tomaž; Castro-Mateos, Isaac; Pozo, Jose M.; Frangi, Alejandro F.; Summers, Ronald M.; Li, Shuo

2017-01-01

A multiple center milestone study of clinical vertebra segmentation is presented in this paper. Vertebra segmentation is a fundamental step for spinal image analysis and intervention. The first half of the study was conducted in the spine segmentation challenge in 2014 International Conference on Medical Image Computing and Computer Assisted Intervention (MICCAI) Workshop on Computational Spine Imaging (CSI 2014). The objective was to evaluate the performance of several state-of-the-art vertebra segmentation algorithms on computed tomography (CT) scans using ten training and five testing dataset, all healthy cases; the second half of the study was conducted after the challenge, where additional 5 abnormal cases are used for testing to evaluate the performance under abnormal cases. Dice coefficients and absolute surface distances were used as evaluation metrics. Segmentation of each vertebra as a single geometric unit, as well as separate segmentation of vertebra substructures, was evaluated. Five teams participated in the comparative study. The top performers in the study achieved Dice coefficient of 0.93 in the upper thoracic, 0.95 in the lower thoracic and 0.96 in the lumbar spine for healthy cases, and 0.88 in the upper thoracic, 0.89 in the lower thoracic and 0.92 in the lumbar spine for osteoporotic and fractured cases. The strengths and weaknesses of each method as well as future suggestion for improvement are discussed. This is the first multi-center comparative study for vertebra segmentation methods, which will provide an up-to-date performance milestone for the fast growing spinal image analysis and intervention. PMID:26878138

Reflecting on the methodological challenges of recruiting to a United Kingdom-wide, multi-centre, randomised controlled trial in gynaecology outpatient settings

PubMed Central

2013-01-01

Background Successful recruitment of participants to any trial is central to its success. Trial results are routinely published, and recruitment is often cited to be slower and more difficult than anticipated. This article reflects on the methodological challenges of recruiting women with prolapse attending United Kingdom (UK) gynaecology outpatient clinics to a multi-centre randomised controlled trial (RCT) of physiotherapy, and the systems put in place in an attempt to address them. Methods Gynaecology outpatients with symptomatic prolapse were to be recruited over a 16-month period from 14 UK hospitals and one New Zealand hospital. Eligible women were informed about the trial by their gynaecologist and informed consent was obtained by the central trial office. Recruitment difficulties were encountered early on, and a number of strategies were employed to try to improve recruitment. Results Some strategies were more successful than others and they differed in the resources required. Actions that facilitated recruitment included increasing recruiting centres to 23 UK and two international hospitals, good centre support, using processes embedded in clinical practice, and good communication between the trial office, collaborators and participants. Collaborator incentives, whereby staff involved received the benefit immediately, were more successful than a nominal monetary payment per woman randomised. Barriers to recruitment included fewer eligible women than anticipated, patient’s preference to receive active treatment rather than allocation to the control group, lack of support staff and high staff turnover. Geographical variations in Primary Care Trust Research Management and Governance approval systems and general practitioner (GP) referral procedures also impacted negatively on recruitment. Conclusions Our article reflects on the methodological challenges of recruiting to a multi-centre RCT in a UK gynaecology setting. Effective interventions included

Audiovisual biofeedback breathing guidance for lung cancer patients receiving radiotherapy: a multi-institutional phase II randomised clinical trial.

PubMed

Pollock, Sean; O'Brien, Ricky; Makhija, Kuldeep; Hegi-Johnson, Fiona; Ludbrook, Jane; Rezo, Angela; Tse, Regina; Eade, Thomas; Yeghiaian-Alvandi, Roland; Gebski, Val; Keall, Paul J

2015-07-18

There is a clear link between irregular breathing and errors in medical imaging and radiation treatment. The audiovisual biofeedback system is an advanced form of respiratory guidance that has previously demonstrated to facilitate regular patient breathing. The clinical benefits of audiovisual biofeedback will be investigated in an upcoming multi-institutional, randomised, and stratified clinical trial recruiting a total of 75 lung cancer patients undergoing radiation therapy. To comprehensively perform a clinical evaluation of the audiovisual biofeedback system, a multi-institutional study will be performed. Our methodological framework will be based on the widely used Technology Acceptance Model, which gives qualitative scales for two specific variables, perceived usefulness and perceived ease of use, which are fundamental determinants for user acceptance. A total of 75 lung cancer patients will be recruited across seven radiation oncology departments across Australia. Patients will be randomised in a 2:1 ratio, with 2/3 of the patients being recruited into the intervention arm and 1/3 in the control arm. 2:1 randomisation is appropriate as within the interventional arm there is a screening procedure where only patients whose breathing is more regular with audiovisual biofeedback will continue to use this system for their imaging and treatment procedures. Patients within the intervention arm whose free breathing is more regular than audiovisual biofeedback in the screen procedure will remain in the intervention arm of the study but their imaging and treatment procedures will be performed without audiovisual biofeedback. Patients will also be stratified by treating institution and for treatment intent (palliative vs. radical) to ensure similar balance in the arms across the sites. Patients and hospital staff operating the audiovisual biofeedback system will complete questionnaires to assess their experience with audiovisual biofeedback. The objectives of this

Ray Casting of Large Multi-Resolution Volume Datasets

NASA Astrophysics Data System (ADS)

Lux, C.; Fröhlich, B.

2009-04-01

High quality volume visualization through ray casting on graphics processing units (GPU) has become an important approach for many application domains. We present a GPU-based, multi-resolution ray casting technique for the interactive visualization of massive volume data sets commonly found in the oil and gas industry. Large volume data sets are represented as a multi-resolution hierarchy based on an octree data structure. The original volume data is decomposed into small bricks of a fixed size acting as the leaf nodes of the octree. These nodes are the highest resolution of the volume. Coarser resolutions are represented through inner nodes of the hierarchy which are generated by down sampling eight neighboring nodes on a finer level. Due to limited memory resources of current desktop workstations and graphics hardware only a limited working set of bricks can be locally maintained for a frame to be displayed. This working set is chosen to represent the whole volume at different local resolution levels depending on the current viewer position, transfer function and distinct areas of interest. During runtime the working set of bricks is maintained in CPU- and GPU memory and is adaptively updated by asynchronously fetching data from external sources like hard drives or a network. The CPU memory hereby acts as a secondary level cache for these sources from which the GPU representation is updated. Our volume ray casting algorithm is based on a 3D texture-atlas in GPU memory. This texture-atlas contains the complete working set of bricks of the current multi-resolution representation of the volume. This enables the volume ray casting algorithm to access the whole working set of bricks through only a single 3D texture. For traversing rays through the volume, information about the locations and resolution levels of visited bricks are required for correct compositing computations. We encode this information into a small 3D index texture which represents the current octree

Multi-Stakeholder Collaboration in the Redesign of Family-Centered Rounds Process

PubMed Central

Xie, Anping; Carayon, Pascale; Cartmill, Randi; Li, Yaqiong; Cox, Elizabeth D.; Plotkin, Julie A.; Kelly, Michelle M.

2014-01-01

A human factors approach to healthcare system redesign emphasizes the involvement of multiple healthcare stakeholders (e.g., patients and families, healthcare providers) in the redesign process. This study explores the experience of multiple stakeholders with collaboration in a healthcare system redesign project. Interviews were conducted with ten stakeholder representatives who participated in the redesign of the family-centered rounds process in a pediatric hospital. Qualitative interview data were analyzed using a phenomenological approach. A model of collaborative healthcare system redesign was developed, which defined four phases (i.e., setup of the redesign team, preparation for meetings, collaboration in meetings, follow-up after meetings) and two outcomes (i.e., team outcomes, redesign outcomes) of the collaborative process. Challenges to multi-stakeholder collaboration in healthcare system redesign, such as need to represent all relevant stakeholders, scheduling of meetings and managing different perspectives, were identified. PMID:25124394

Epidemiology, surgical management and early postoperative outcome in a cohort of gastric cancer patients of a tertiary referral center in relation to multi-center quality assurance studies.

PubMed

Garlipp, Benjamin; Schwalenberg, Jens; Adolf, Daniela; Lippert, Hans; Meyer, Frank

2011-03-01

The aim of the study was to analyze epidemiologic parameters, treatment-related data and prognostic factors in the management of gastric cancer patients of a university surgical center under conditions of routine clinical care before the onset of the era of multimodal therapies. By analyzing our data in relation with multi-center quality assurance trials [German Gastric Cancer Study - GGCS (1992) and East German Gastric Cancer Study - EGGCS (2004)] we aimed at providing an instrument of internal quality control at our institution as well as a base for comparison with future analyses taking into account the implementation of evolving (multimodal) therapies and their influence on treatment results. Retrospective analysis of prospectively gathered data of gastric cancer patients treated at a single institution during a defined 10-year time period with multivariate analysis of risk factors for early postoperative outcome. From 04/01/1993 through 03/31/2003, a total of 328 gastric cancer patients were treated. In comparison with the EGGCS cohort there was a larger proportion of patients with locally advanced and proximally located tumors. 272 patients (82.9%) underwent surgery with curative intent; in 88.4% of these an R0 resection was achieved (EGGCS/GGCS: 82.5%/71.5%). 68.2% of patients underwent preoperative endoluminal ultrasound (EUS) (EGGCS: 27.4%); the proportion of patients undergoing EUS increased over the study period. Diagnostic accuracy of EUS for T stage was 50.6% (EGGCS: 42.6%). 77.2% of operated patients with curative intent underwent gastrectomy (EGGCS/GGCS: 79.8%/71.1%). Anastomotic leaks at the esophagojejunostomy occurred slightly more frequently (8.8%) than in the EGGCS (5.9%) and GGCS (7.2%); however, postoperative morbidity (36.1%) and early postoperative mortality (5.3%) were not increased compared to the multi-center quality assurance study results (EGGCS morbidity, 45%); EGGCS/GGCS mortality, 8%/8.9%). D2 lymphadenectomy was performed in 72

Parent satisfaction in a multi-site acute trial of risperidone in children with autism: a social validity study.

PubMed

Tierney, Elaine; Aman, Michael; Stout, David; Pappas, Krista; Arnold, L Eugene; Vitiello, Benedetto; Scahill, Lawrence; McDougle, Christopher; McCracken, James; Wheeler, Courtney; Martin, Andres; Posey, David; Shah, Bhavik

2007-03-01

Subjects who view experimental procedures as worthwhile are more likely to participate in clinical trials and comply with study procedures. Designing studies that consider the consumer's perspective will help to forge a better alliance between participants and researchers. Participant satisfaction is seldom assessed in pharmacological research. In this paper, we report on parent satisfaction in a randomized clinical trial in children with autistic disorder and severely disruptive behavior. Parents of 101 children with autism who had participated in a multi-site 8-week double-blind clinical trial of risperidone were given a questionnaire at the end to elicit their perceptions of the appropriateness and acceptability of clinical trial procedures. Ninety-six (95.0%) parents returned the questionnaire. Of these, 80.0 to 96.8%, depending on the question, expressed satisfaction with their child's research participation regardless of treatment outcome or assignment to active drug or placebo. In all, 90.5% of parents indicated that they would "definitely" recommend the clinical trial to other families with similar children. A total of 92.7% indicated that they would rejoin the clinical trial if they had to do it all over again. Ethnic minority subjects were more satisfied than white participants with the use of "learning tests". Parents of children participating in this trial were highly satisfied and supportive of the clinical trial procedures. Random assignment to drug or placebo and the clinical response of their children did not appear to influence their views. Further satisfaction studies of this sort are encouraged.

User-centered design of multi-gene sequencing panel reports for clinicians.

PubMed

Cutting, Elizabeth; Banchero, Meghan; Beitelshees, Amber L; Cimino, James J; Fiol, Guilherme Del; Gurses, Ayse P; Hoffman, Mark A; Jeng, Linda Jo Bone; Kawamoto, Kensaku; Kelemen, Mark; Pincus, Harold Alan; Shuldiner, Alan R; Williams, Marc S; Pollin, Toni I; Overby, Casey Lynnette

2016-10-01

The objective of this study was to develop a high-fidelity prototype for delivering multi-gene sequencing panel (GS) reports to clinicians that simulates the user experience of a final application. The delivery and use of GS reports can occur within complex and high-paced healthcare environments. We employ a user-centered software design approach in a focus group setting in order to facilitate gathering rich contextual information from a diverse group of stakeholders potentially impacted by the delivery of GS reports relevant to two precision medicine programs at the University of Maryland Medical Center. Responses from focus group sessions were transcribed, coded and analyzed by two team members. Notification mechanisms and information resources preferred by participants from our first phase of focus groups were incorporated into scenarios and the design of a software prototype for delivering GS reports. The goal of our second phase of focus group, to gain input on the prototype software design, was accomplished through conducting task walkthroughs with GS reporting scenarios. Preferences for notification, content and consultation from genetics specialists appeared to depend upon familiarity with scenarios for ordering and delivering GS reports. Despite familiarity with some aspects of the scenarios we proposed, many of our participants agreed that they would likely seek consultation from a genetics specialist after viewing the test reports. In addition, participants offered design and content recommendations. Findings illustrated a need to support customized notification approaches, user-specific information, and access to genetics specialists with GS reports. These design principles can be incorporated into software applications that deliver GS reports. Our user-centered approach to conduct this assessment and the specific input we received from clinicians may also be relevant to others working on similar projects. Copyright © 2016 Elsevier Inc. All rights

A multicenter, randomized controlled trial of immediate total-body CT scanning in trauma patients (REACT-2)

PubMed Central

2012-01-01

Background Computed tomography (CT) scanning has become essential in the early diagnostic phase of trauma care because of its high diagnostic accuracy. The introduction of multi-slice CT scanners and infrastructural improvements made total-body CT scanning technically feasible and its usage is currently becoming common practice in several trauma centers. However, literature provides limited evidence whether immediate total-body CT leads to better clinical outcome then conventional radiographic imaging supplemented with selective CT scanning in trauma patients. The aim of the REACT-2 trial is to determine the value of immediate total-body CT scanning in trauma patients. Methods/design The REACT-2 trial is an international, multicenter randomized clinical trial. All participating trauma centers have a multi-slice CT scanner located in the trauma room or at the Emergency Department (ED). All adult, non-pregnant, severely injured trauma patients according to predefined criteria will be included. Patients in whom direct scanning will hamper necessary cardiopulmonary resuscitation or who require an immediate operation because of imminent death (both as judged by the trauma team leader) are excluded. Randomization will be computer assisted. The intervention group will receive a contrast-enhanced total-body CT scan (head to pelvis) during the primary survey. The control group will be evaluated according to local conventional trauma imaging protocols (based on ATLS guidelines) supplemented with selective CT scanning. Primary outcome will be in-hospital mortality. Secondary outcomes are differences in mortality and morbidity during the first year post trauma, several trauma work-up time intervals, radiation exposure, general health and quality of life at 6 and 12 months post trauma and cost-effectiveness. Discussion The REACT-2 trial is a multicenter randomized clinical trial that will provide evidence on the value of immediate total-body CT scanning during the primary

Connecting Smartphone and Wearable Fitness Tracker Data with a Nationally Used Electronic Health Record System for Diabetes Education to Facilitate Behavioral Goal Monitoring in Diabetes Care: Protocol for a Pragmatic Multi-Site Randomized Trial.

PubMed

Wang, Jing; Coleman, Deidra Carroll; Kanter, Justin; Ummer, Brad; Siminerio, Linda

2018-04-02

the connected system. Data collection for the 3-month pragmatic trial is completed. Data analysis is in progress. If results of the pragmatic multi-site clinical trial show preliminary efficacy and usability of the connected system, a large-scale implementation trial will be conducted. ClinicalTrials.gov NCT02664233; https://clinicaltrials.gov/ct2/show/NCT02664233 (Archived by WebCite at http://www.webcitation.org/6yDEwXHo5). ©Jing Wang, Deidra Carroll Coleman, Justin Kanter, Brad Ummer, Linda Siminerio. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 02.04.2018.

Multi-Image or Lap-Dissolve Slide Techniques and Visual Images in the Large Lecture Section.

ERIC Educational Resources Information Center

Bodner, George M.; And Others

1984-01-01

Advantages and disadvantages of using multi-image or lap-dissolve (LD) slide techniques in large lecture sections are discussed. Production, use, and evaluation of LD programs are also discussed. Indicates that these programs are an effective way of improving instruction on visually oriented topics. (JN)

Gait training assisted by multi-channel functional electrical stimulation early after stroke: study protocol for a randomized controlled trial.

PubMed

van Bloemendaal, Maijke; Bus, Sicco A; de Boer, Charlotte E; Nollet, Frans; Geurts, Alexander C H; Beelen, Anita

2016-10-01

Many stroke survivors suffer from paresis of lower limb muscles, resulting in compensatory gait patterns characterised by asymmetries in spatial and temporal parameters and reduced walking capacity. Functional electrical stimulation has been used to improve walking capacity, but evidence is mostly limited to the orthotic effects of peroneal functional electrical stimulation in the chronic phase after stroke. The aim of this study is to investigate the therapeutic effects of up to 10 weeks of multi-channel functional electrical stimulation (MFES)-assisted gait training on the restoration of spatiotemporal gait symmetry and walking capacity in subacute stroke patients. In a proof-of-principle study with a randomised controlled design, 40 adult patients with walking deficits who are admitted for inpatient rehabilitation within 31 days since the onset of stroke are randomised to either MFES-assisted gait training or conventional gait training. Gait training is delivered in 30-minute sessions each workday for up to 10 weeks. The step length symmetry ratio is the primary outcome. Blinded assessors conduct outcome assessments at baseline, every 2 weeks during the intervention period, immediately post intervention and at 3-month follow-up. This study aims to provide preliminary evidence for the feasibility and effectiveness of MFES-assisted gait rehabilitation early after stroke. Results will inform the design of a larger multi-centre trial. This trial is registered at the Netherlands Trial Register (number NTR4762 , registered 28 August 2014).

The At Home/Chez Soi trial protocol: a pragmatic, multi-site, randomised controlled trial of a Housing First intervention for homeless individuals with mental illness in five Canadian cities

PubMed Central

Streiner, David L; Adair, Carol; Aubry, Tim; Barker, Jayne; Distasio, Jino; Hwang, Stephen W; Komaroff, Janina; Latimer, Eric; Somers, Julian; Zabkiewicz, Denise M

2011-01-01

Introduction Housing First is a complex housing and support intervention for homeless individuals with mental health problems. It has a sufficient knowledge base and interest to warrant a test of wide-scale implementation in various settings. This protocol describes the quantitative design of a Canadian five city, $110 million demonstration project and provides the rationale for key scientific decisions. Methods A pragmatic, mixed methods, multi-site field trial of the effectiveness of Housing First in Vancouver, Winnipeg, Toronto, Montreal and Moncton, is randomising approximately 2500 participants, stratified by high and moderate need levels, into intervention and treatment as usual groups. Quantitative outcome measures are being collected over a 2-year period and a qualitative process evaluation is being completed. Primary outcomes are housing stability, social functioning and, for the economic analyses, quality of life. Hierarchical linear modelling is the primary data analytic strategy. Ethics and dissemination Research ethics board approval has been obtained from 11 institutions and a safety and adverse events committee is in place. The results of the multi-site analyses of outcomes at 12 months and 2 years will be reported in a series of core scientific journal papers. Extensive knowledge exchange activities with non-academic audiences will occur throughout the duration of the project. Trial registration number This study has been registered with the International Standard Randomised Control Trial Number Register and assigned ISRCTN42520374. PMID:22102645

Healthy apple program to support child care centers to alter nutrition and physical activity practices and improve child weight: a cluster randomized trial.

PubMed

Stookey, Jodi D; Evans, Jane; Chan, Curtis; Tao-Lew, Lisa; Arana, Tito; Arthur, Susan

2017-12-19

North Carolina Nutrition and Physical Activity Self-Assessment for Child Care (NAP SACC) resources improve child body mass index (BMI) when the resources are introduced by nurses to child care providers, and offered with workshops and incentives. In San Francisco, public health and child care agencies partnered to adapt NAP SACC resources into an annual "Healthy Apple" quality improvement program (HAP). This cluster randomized controlled trial pilot-tested integration of the HAP with bi-annual public health screenings by nurses. All child care centers that participated in Child Care Health Program (CCHP) screenings in San Francisco in 2011-2012 were offered routine services plus HAP in 2012-2013 (CCHP + HAP, n = 19) or routine services with delayed HAP in 2014-2015 (CCHP + HAP Delayed, n = 24). Intention-to-treat analyses (robust SE or mixed models) used 4 years of screening data from 12 to 17 CCHP + HAP and 17 to 20 CCHP + HAP Delayed centers, regarding 791 to 945 children ages 2 to 5y, annually. Year-specific, child level models tested if children in CCHP + HAP centers had greater relative odds of exposure to 3 index best practices and smaller Autumn-to-Spring changes in BMI percentile and z-score than children in CCHP + HAP Delayed centers, controlling for age, sex, and Autumn status. Multi-year, child care center level models tested if HAP support modified year-to-year changes (2013-2014 and 2014-2015 vs 2011-2012) in child care center annual mean Autumn-to-Spring BMI changes. In 2011-2012, the CCHP + HAP and CCHP + HAP Delayed centers had similar index practices (<15% of children were exposed to a physical activity curriculum, staff joining in active play, and drinking water pitchers) and annual BMI changes. In 2013-2014: 60% of children in CCHP + HAP centers were exposed to the 3 index practices vs 19% in CCHP + HAP Delayed centers; Mean (SE) child BMI percentile (-2.6 (0.9), p = 0.003) and z

Rehabilitation for the management of knee osteoarthritis using comprehensive traditional Chinese medicine in community health centers: study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background It is becoming increasingly necessary for community health centers to make rehabilitation services available to patients with osteoarthritis of the knee. However, for a number of reasons, including a lack of expertise, the small size of community health centers and the availability of only simple medical equipment, conventional rehabilitation therapy has not been widely used in China. Consequently, most patients with knee osteoarthritis seek treatment in high-grade hospitals. However, many patients cannot manage the techniques that they were taught in the hospital. Methods such as acupuncture, tuina, Chinese medical herb fumigation-washing and t’ai chi are easy to do and have been reported to have curative effects in those with knee osteoarthritis. To date, there have been no randomized controlled trials validating comprehensive traditional Chinese medicine for the rehabilitation of knee osteoarthritis in a community health center. Furthermore, there is no standard rehabilitation protocol using traditional Chinese medicine for knee osteoarthritis. The aim of the current study is to develop a comprehensive rehabilitation protocol using traditional Chinese medicine for the management of knee osteoarthritis in a community health center. Method/design This will be a randomized controlled clinical trial with blinded assessment. There will be a 4-week intervention utilizing rehabilitation protocols from traditional Chinese medicine and conventional therapy. Follow-up will be conducted for a period of 12 weeks. A total of 722 participants with knee osteoarthritis will be recruited. Participants will be randomly divided into two groups: experimental and control. Primary outcomes will include range of motion, girth measurement, the visual analogue scale, and results from the manual muscle, six-minute walking and stair-climbing tests. Secondary outcomes will include average daily consumption of pain medication, ability to perform daily tasks and health

Quality of Reporting Randomized Controlled Trials in Five Leading Neurology Journals in 2008 and 2013 Using the Modified "Risk of Bias" Tool.

PubMed

Zhai, Xiao; Cui, Jin; Wang, Yiran; Qu, Zhiquan; Mu, Qingchun; Li, Peiwen; Zhang, Chaochao; Yang, Mingyuan; Chen, Xiao; Chen, Ziqiang; Li, Ming

2017-03-01

To examine the risk of bias of methodological quality of reporting randomized clinical trials (RCTs) in major neurology journals before and after the update (2011) of Cochrane risk of bias tool. RCTs in 5 leading neurology journals in 2008 and 2013 were searched systematically. Characteristics were extracted based on the list of the modified Cochrane Collaboration's tool. Country, number of patients, type of intervention, and funding source also were examined for further analysis. A total of 138 RCTs were enrolled in this study. The rates of following a trial plan were 61.6% for the allocation generation, 52.9% for the allocation concealment, 84.8% for the blinding of the participants or the personnel, 34.8% for the blinding of outcome assessment, 78.3% for the incomplete outcome data, and 67.4% for the selective reporting. A significant setback was found in "the selective reporting" in 2013 than that in 2008. Trials performed by multi-centers and on a large scale had significantly more "low risk of bias" trials. Not only the number of surgical trials (5.8%) was much less than that of trials using drugs (73.9%), but also the reporting quality of surgical trials were worse (P = 0.008). Finally, only 17.4% trials met the criterion of "low risk of bias." The modified "risk of bias" tool is an improved version for assessment. Methodological quality of reporting RCTs in the 5neurology journals is unsatisfactory, especially that for surgical RCTs, and it could be further improved. Copyright © 2017 Elsevier Inc. All rights reserved.

Clinical trial investigates experimental drug for advanced pancreatic cancer | Center for Cancer Research

Cancer.gov

The pancreas, a large gland that sits behind the stomach, produces enzymes that aid digestion and hormones that regulate blood sugar. Pancreatic cancer develops when cells that make up the ducts in the pancreas start to grow out of control. Udo Rudloff, M.D., is leading a clinical trial of a combination immunotherapy regimen to optimally help the immune system attack the tumor.

Large-Scale, Multi-Sensor Atmospheric Data Fusion Using Hybrid Cloud Computing

NASA Astrophysics Data System (ADS)

Wilson, Brian; Manipon, Gerald; Hua, Hook; Fetzer, Eric

2014-05-01

NASA's Earth Observing System (EOS) is an ambitious facility for studying global climate change. The mandate now is to combine measurements from the instruments on the "A-Train" platforms (AIRS, AMSR-E, MODIS, MISR, MLS, and CloudSat) and other Earth probes to enable large-scale studies of climate change over decades. Moving to multi-sensor, long-duration analyses of important climate variables presents serious challenges for large-scale data mining and fusion. For example, one might want to compare temperature and water vapor retrievals from one instrument (AIRS) to another (MODIS), and to a model (ECMWF), stratify the comparisons using a classification of the "cloud scenes" from CloudSat, and repeat the entire analysis over 10 years of data. To efficiently assemble such datasets, we are utilizing Elastic Computing in the Cloud and parallel map-reduce-based algorithms. However, these problems are Data Intensive computing so the data transfer times and storage costs (for caching) are key issues. SciReduce is a Hadoop-like parallel analysis system, programmed in parallel python, that is designed from the ground up for Earth science. SciReduce executes inside VMWare images and scales to any number of nodes in a hybrid Cloud (private eucalyptus & public Amazon). Unlike Hadoop, SciReduce operates on bundles of named numeric arrays, which can be passed in memory or serialized to disk in netCDF4 or HDF5. Multi-year datasets are automatically "sharded" by time and space across a cluster of nodes so that years of data (millions of files) can be processed in a massively parallel way. Input variables (arrays) are pulled on-demand into the Cloud using OPeNDAP URLs or other subsetting services, thereby minimizing the size of the cached input and intermediate datasets. We are using SciReduce to automate the production of multiple versions of a ten-year A-Train water vapor climatology under a NASA MEASURES grant. We will present the architecture of SciReduce, describe the

Large-Scale, Parallel, Multi-Sensor Atmospheric Data Fusion Using Cloud Computing

NASA Astrophysics Data System (ADS)

Wilson, B. D.; Manipon, G.; Hua, H.; Fetzer, E.

2013-05-01

NASA's Earth Observing System (EOS) is an ambitious facility for studying global climate change. The mandate now is to combine measurements from the instruments on the "A-Train" platforms (AIRS, AMSR-E, MODIS, MISR, MLS, and CloudSat) and other Earth probes to enable large-scale studies of climate change over decades. Moving to multi-sensor, long-duration analyses of important climate variables presents serious challenges for large-scale data mining and fusion. For example, one might want to compare temperature and water vapor retrievals from one instrument (AIRS) to another (MODIS), and to a model (ECMWF), stratify the comparisons using a classification of the "cloud scenes" from CloudSat, and repeat the entire analysis over 10 years of data. To efficiently assemble such datasets, we are utilizing Elastic Computing in the Cloud and parallel map/reduce-based algorithms. However, these problems are Data Intensive computing so the data transfer times and storage costs (for caching) are key issues. SciReduce is a Hadoop-like parallel analysis system, programmed in parallel python, that is designed from the ground up for Earth science. SciReduce executes inside VMWare images and scales to any number of nodes in the Cloud. Unlike Hadoop, SciReduce operates on bundles of named numeric arrays, which can be passed in memory or serialized to disk in netCDF4 or HDF5. Figure 1 shows the architecture of the full computational system, with SciReduce at the core. Multi-year datasets are automatically "sharded" by time and space across a cluster of nodes so that years of data (millions of files) can be processed in a massively parallel way. Input variables (arrays) are pulled on-demand into the Cloud using OPeNDAP URLs or other subsetting services, thereby minimizing the size of the cached input and intermediate datasets. We are using SciReduce to automate the production of multiple versions of a ten-year A-Train water vapor climatology under a NASA MEASURES grant. We will

Large-Scale, Parallel, Multi-Sensor Atmospheric Data Fusion Using Cloud Computing

NASA Astrophysics Data System (ADS)

Wilson, B. D.; Manipon, G.; Hua, H.; Fetzer, E. J.

2013-12-01

NASA's Earth Observing System (EOS) is an ambitious facility for studying global climate change. The mandate now is to combine measurements from the instruments on the 'A-Train' platforms (AIRS, AMSR-E, MODIS, MISR, MLS, and CloudSat) and other Earth probes to enable large-scale studies of climate change over decades. Moving to multi-sensor, long-duration analyses of important climate variables presents serious challenges for large-scale data mining and fusion. For example, one might want to compare temperature and water vapor retrievals from one instrument (AIRS) to another (MODIS), and to a model (MERRA), stratify the comparisons using a classification of the 'cloud scenes' from CloudSat, and repeat the entire analysis over 10 years of data. To efficiently assemble such datasets, we are utilizing Elastic Computing in the Cloud and parallel map/reduce-based algorithms. However, these problems are Data Intensive computing so the data transfer times and storage costs (for caching) are key issues. SciReduce is a Hadoop-like parallel analysis system, programmed in parallel python, that is designed from the ground up for Earth science. SciReduce executes inside VMWare images and scales to any number of nodes in the Cloud. Unlike Hadoop, SciReduce operates on bundles of named numeric arrays, which can be passed in memory or serialized to disk in netCDF4 or HDF5. Figure 1 shows the architecture of the full computational system, with SciReduce at the core. Multi-year datasets are automatically 'sharded' by time and space across a cluster of nodes so that years of data (millions of files) can be processed in a massively parallel way. Input variables (arrays) are pulled on-demand into the Cloud using OPeNDAP URLs or other subsetting services, thereby minimizing the size of the cached input and intermediate datasets. We are using SciReduce to automate the production of multiple versions of a ten-year A-Train water vapor climatology under a NASA MEASURES grant. We will

Generalizing Evidence From Randomized Clinical Trials to Target Populations

PubMed Central

Cole, Stephen R.; Stuart, Elizabeth A.

2010-01-01

Properly planned and conducted randomized clinical trials remain susceptible to a lack of external validity. The authors illustrate a model-based method to standardize observed trial results to a specified target population using a seminal human immunodeficiency virus (HIV) treatment trial, and they provide Monte Carlo simulation evidence supporting the method. The example trial enrolled 1,156 HIV-infected adult men and women in the United States in 1996, randomly assigned 577 to a highly active antiretroviral therapy and 579 to a largely ineffective combination therapy, and followed participants for 52 weeks. The target population was US people infected with HIV in 2006, as estimated by the Centers for Disease Control and Prevention. Results from the trial apply, albeit muted by 12%, to the target population, under the assumption that the authors have measured and correctly modeled the determinants of selection that reflect heterogeneity in the treatment effect. In simulations with a heterogeneous treatment effect, a conventional intent-to-treat estimate was biased with poor confidence limit coverage, but the proposed estimate was largely unbiased with appropriate confidence limit coverage. The proposed method standardizes observed trial results to a specified target population and thereby provides information regarding the generalizability of trial results. PMID:20547574

Process evaluation results from the HEALTHY nutrition intervention to modify the total school food environment

USDA-ARS?s Scientific Manuscript database

The process evaluation of HEALTHY, a large multi-center trial to decrease type 2 diabetes mellitus in middle school children, monitored the implementation of the intervention to ascertain the extent that components were delivered and received as intended. The purpose of this article is to report the...

Genomic Selection in Multi-environment Crop Trials.

PubMed

Oakey, Helena; Cullis, Brian; Thompson, Robin; Comadran, Jordi; Halpin, Claire; Waugh, Robbie

2016-05-03

Genomic selection in crop breeding introduces modeling challenges not found in animal studies. These include the need to accommodate replicate plants for each line, consider spatial variation in field trials, address line by environment interactions, and capture nonadditive effects. Here, we propose a flexible single-stage genomic selection approach that resolves these issues. Our linear mixed model incorporates spatial variation through environment-specific terms, and also randomization-based design terms. It considers marker, and marker by environment interactions using ridge regression best linear unbiased prediction to extend genomic selection to multiple environments. Since the approach uses the raw data from line replicates, the line genetic variation is partitioned into marker and nonmarker residual genetic variation (i.e., additive and nonadditive effects). This results in a more precise estimate of marker genetic effects. Using barley height data from trials, in 2 different years, of up to 477 cultivars, we demonstrate that our new genomic selection model improves predictions compared to current models. Analyzing single trials revealed improvements in predictive ability of up to 5.7%. For the multiple environment trial (MET) model, combining both year trials improved predictive ability up to 11.4% compared to a single environment analysis. Benefits were significant even when fewer markers were used. Compared to a single-year standard model run with 3490 markers, our partitioned MET model achieved the same predictive ability using between 500 and 1000 markers depending on the trial. Our approach can be used to increase accuracy and confidence in the selection of the best lines for breeding and/or, to reduce costs by using fewer markers. Copyright © 2016 Oakey et al.

Publication and non-publication of clinical trials: longitudinal study of applications submitted to a research ethics committee.

PubMed

von Elm, Erik; Röllin, Alexandra; Blümle, Anette; Huwiler, Karin; Witschi, Mark; Egger, Matthias

2008-04-05

Not all clinical trials are published, which may distort the evidence that is available in the literature. We studied the publication rate of a cohort of clinical trials and identified factors associated with publication and nonpublication of results. We analysed the protocols of randomized clinical trials of drug interventions submitted to the research ethics committee of University Hospital (Inselspital) Bern, Switzerland from 1988 to 1998. We identified full articles published up to 2006 by searching the Cochrane CENTRAL database (issue 02/2006) and by contacting investigators. We analyzed factors associated with the publication of trials using descriptive statistics and logistic regression models. 451 study protocols and 375 corresponding articles were analyzed. 233 protocols resulted in at least one publication, a publication rate of 52%. A total of 366 (81%) trials were commercially funded, 47 (10%) had non-commercial funding. 346 trials (77%) were multi-centre studies and 272 of these (79%) were international collaborations. In the adjusted logistic regression model non-commercial funding (Odds Ratio [OR] 2.42, 95% CI 1.14-5.17), multi-centre status (OR 2.09, 95% CI 1.03-4.24), international collaboration (OR 1.87, 95% CI 0.99-3.55) and a sample size above the median of 236 participants (OR 2.04, 95% CI 1.23-3.39) were associated with full publication. In this cohort of applications to an ethics committee in Switzerland, only about half of clinical drug trials were published. Large multi-centre trials with non-commercial funding were more likely to be published than other trials, but most trials were funded by industry.

Design and verification of wide-band, simultaneous, multi-frequency, tuning circuits for large moment transmitter loops

NASA Astrophysics Data System (ADS)

Dvorak, Steven L.; Sternberg, Ben K.; Feng, Wanjie

2017-03-01

In this paper we discuss the design and verification of wide-band, multi-frequency, tuning circuits for large-moment Transmitter (TX) loops. Since these multi-frequency, tuned-TX loops allow for the simultaneous transmission of multiple frequencies at high-current levels, they are ideally suited for frequency-domain geophysical systems that collect data while moving, such as helicopter mounted systems. Furthermore, since multi-frequency tuners use the same TX loop for all frequencies, instead of using separate tuned-TX loops for each frequency, they allow for the use of larger moment TX loops. In this paper we discuss the design and simulation of one- and three-frequency tuned TX loops and then present measurement results for a three-frequency, tuned-TX loop.

A Large-Scale Multi-Hop Localization Algorithm Based on Regularized Extreme Learning for Wireless Networks.

PubMed

Zheng, Wei; Yan, Xiaoyong; Zhao, Wei; Qian, Chengshan

2017-12-20

A novel large-scale multi-hop localization algorithm based on regularized extreme learning is proposed in this paper. The large-scale multi-hop localization problem is formulated as a learning problem. Unlike other similar localization algorithms, the proposed algorithm overcomes the shortcoming of the traditional algorithms which are only applicable to an isotropic network, therefore has a strong adaptability to the complex deployment environment. The proposed algorithm is composed of three stages: data acquisition, modeling and location estimation. In data acquisition stage, the training information between nodes of the given network is collected. In modeling stage, the model among the hop-counts and the physical distances between nodes is constructed using regularized extreme learning. In location estimation stage, each node finds its specific location in a distributed manner. Theoretical analysis and several experiments show that the proposed algorithm can adapt to the different topological environments with low computational cost. Furthermore, high accuracy can be achieved by this method without setting complex parameters.

Nutrition and physical activity randomized control trial in child care centers improves knowledge, policies, and children's body mass index.

PubMed

Alkon, Abbey; Crowley, Angela A; Neelon, Sara E Benjamin; Hill, Sherika; Pan, Yi; Nguyen, Viet; Rose, Roberta; Savage, Eric; Forestieri, Nina; Shipman, Linda; Kotch, Jonathan B

2014-03-01

To address the public health crisis of overweight and obese preschool-age children, the Nutrition And Physical Activity Self Assessment for Child Care (NAP SACC) intervention was delivered by nurse child care health consultants with the objective of improving child care provider and parent nutrition and physical activity knowledge, center-level nutrition and physical activity policies and practices, and children's body mass index (BMI). A seven-month randomized control trial was conducted in 17 licensed child care centers serving predominantly low income families in California, Connecticut, and North Carolina, including 137 child care providers and 552 families with racially and ethnically diverse children three to five years old. The NAP SACC intervention included educational workshops for child care providers and parents on nutrition and physical activity and consultation visits provided by trained nurse child care health consultants. Demographic characteristics and pre - and post-workshop knowledge surveys were completed by providers and parents. Blinded research assistants reviewed each center's written health and safety policies, observed nutrition and physical activity practices, and measured randomly selected children's nutritional intake, physical activity, and height and weight pre- and post-intervention. Hierarchical linear models and multiple regression models assessed individual- and center-level changes in knowledge, policies, practices and age- and sex-specific standardized body mass index (zBMI), controlling for state, parent education, and poverty level. Results showed significant increases in providers' and parents' knowledge of nutrition and physical activity, center-level improvements in policies, and child-level changes in children's zBMI based on 209 children in the intervention and control centers at both pre- and post-intervention time points. The NAP SACC intervention, as delivered by trained child health professionals such as child care

Reflecting on the methodological challenges of recruiting to a United Kingdom-wide, multi-centre, randomised controlled trial in gynaecology outpatient settings.

PubMed

Dickson, Sylvia; Logan, Janet; Hagen, Suzanne; Stark, Diane; Glazener, Cathryn; McDonald, Alison M; McPherson, Gladys

2013-11-15

Successful recruitment of participants to any trial is central to its success. Trial results are routinely published, and recruitment is often cited to be slower and more difficult than anticipated. This article reflects on the methodological challenges of recruiting women with prolapse attending United Kingdom (UK) gynaecology outpatient clinics to a multi-centre randomised controlled trial (RCT) of physiotherapy, and the systems put in place in an attempt to address them. Gynaecology outpatients with symptomatic prolapse were to be recruited over a 16-month period from 14 UK hospitals and one New Zealand hospital. Eligible women were informed about the trial by their gynaecologist and informed consent was obtained by the central trial office. Recruitment difficulties were encountered early on, and a number of strategies were employed to try to improve recruitment. Some strategies were more successful than others and they differed in the resources required. Actions that facilitated recruitment included increasing recruiting centres to 23 UK and two international hospitals, good centre support, using processes embedded in clinical practice, and good communication between the trial office, collaborators and participants. Collaborator incentives, whereby staff involved received the benefit immediately, were more successful than a nominal monetary payment per woman randomised. Barriers to recruitment included fewer eligible women than anticipated, patient's preference to receive active treatment rather than allocation to the control group, lack of support staff and high staff turnover. Geographical variations in Primary Care Trust Research Management and Governance approval systems and general practitioner (GP) referral procedures also impacted negatively on recruitment. Our article reflects on the methodological challenges of recruiting to a multi-centre RCT in a UK gynaecology setting. Effective interventions included increasing the number of recruiting centres and

Multi-granularity Bandwidth Allocation for Large-Scale WDM/TDM PON

NASA Astrophysics Data System (ADS)

Gao, Ziyue; Gan, Chaoqin; Ni, Cuiping; Shi, Qiongling

2017-12-01

WDM (wavelength-division multiplexing)/TDM (time-division multiplexing) PON (passive optical network) is being viewed as a promising solution for delivering multiple services and applications, such as high-definition video, video conference and data traffic. Considering the real-time transmission, QoS (quality of services) requirements and differentiated services model, a multi-granularity dynamic bandwidth allocation (DBA) in both domains of wavelengths and time for large-scale hybrid WDM/TDM PON is proposed in this paper. The proposed scheme achieves load balance by using the bandwidth prediction. Based on the bandwidth prediction, the wavelength assignment can be realized fairly and effectively to satisfy the different demands of various classes. Specially, the allocation of residual bandwidth further augments the DBA and makes full use of bandwidth resources in the network. To further improve the network performance, two schemes named extending the cycle of one free wavelength (ECoFW) and large bandwidth shrinkage (LBS) are proposed, which can prevent transmission from interruption when the user employs more than one wavelength. The simulation results show the effectiveness of the proposed scheme.

Large-for-size liver transplant: a single-center experience.