Abstract:
:There is increasing evidence that exposure of developing brains in animals, including nonhuman primates, to commonly-utilized anesthetic agents may cause adverse effects on cognition and behavior. In this paper, we summarize our methodology for a population-based, propensity-matched study to evaluate possible anesthesia-related sequelae in preschool children when evaluated in elementary or high school. A cohort of all children born in Olmsted County, Minnesota between the years 1994 and 2007 who are currently local residents has been identified. Existing medical records are being used to identify all episodes of exposure to general anesthesia prior to the age of 3 years (i.e., prior to their 3rd birthday). Children with multiple, single, and no anesthesia exposure are sampled for testing between the ages of 8 and 12 years or 15 and 19 years during the period 2012-2016. To match children in different exposure groups as closely as possible, sampling is guided by propensity-matching for the likelihood of receiving anesthesia. Selected children are invited to participate in a single 4-hour session of neuropsychological testing, including the National Center for Toxicological Research-Operant Test Battery, which has been used to study anesthetic neurotoxicity in nonhuman primates. The results of this testing will be compared among children with different anesthetic exposure histories. The expected products of this research will be a detailed phenotype of possible anesthetic-associated neurotoxicity in humans, utilizing a robust patient database and neuropsychological testing battery, and the first comparison of effects of anesthetic exposure in children and nonhuman primates performing nearly identical behavioral tasks.
journal_name
Contemp Clin Trialsjournal_title
Contemporary clinical trialsauthors
Gleich SJ,Flick R,Hu D,Zaccariello MJ,Colligan RC,Katusic SK,Schroeder DR,Hanson A,Buenvenida S,Wilder RT,Sprung J,Voigt RG,Paule MG,Chelonis JJ,Warner DOdoi
10.1016/j.cct.2014.12.020subject
Has Abstractpub_date
2015-03-01 00:00:00pages
45-54eissn
1551-7144issn
1559-2030pii
S1551-7144(14)00205-5journal_volume
41pub_type
杂志文章abstract::Competency-Based Approaches to Community Health (COACH) is a randomized controlled trial of a family-centered, community-based, and individually-tailored behavioral intervention for childhood obesity among Latino pre-school children. COACH focuses on improving personal agency for health behavior change by tailoring co...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2018.08.006
更新日期:2018-10-01 00:00:00
abstract:BACKGROUND:With increased internet accessibility worldwide, it is now possible to assemble individuals with rare diseases through web-based patient registries. However, the validity of participant-reported medical diagnoses is unknown. The objective of this study was to evaluate the accuracy of participant-reported Neu...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2014.12.006
更新日期:2015-01-01 00:00:00
abstract:BACKGROUND:Many of the health behaviors known to contribute to cardiometabolic risk and disease (CMRD), including physical activity, diet, sleep, and screen time, begin during childhood. Given the population-wide burden of CMRD, novel ways of assessing risk and providing feedback to support behavior change are needed. ...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2016.07.012
更新日期:2016-07-01 00:00:00
abstract::In order to better characterize the safety profile of investigational new drugs (INDs) during clinical development, more interest and attention have been paid to ongoing safety monitoring and evaluation. The 2015 US FDA IND safety reporting draft guidance compels sponsors to periodically evaluate unblinded safety data...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2019.06.022
更新日期:2019-08-01 00:00:00
abstract::Establishing a holistic approach for the enrollment of subjects into clinical trials that includes strategies for the recruitment of non-traditional and minority populations has been an elusive task. The existence of such a design, that is understood and embraced by investigators and the target communities, would stre...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2007.11.003
更新日期:2008-07-01 00:00:00
abstract:BACKGROUND:Evidence suggests that periodontitis is associated with prevalent and incident type 2 diabetes mellitus (T2DM), raising the question of whether periodontitis treatment may improve glycemic control in patients with T2DM. Meta-analyses of mostly small clinical trials suggest that periodontitis treatment result...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1016/j.cct.2013.09.010
更新日期:2013-11-01 00:00:00
abstract::An instrumental variable (IV) estimator has been widely used to estimate causal effects among compliers in randomized trials with noncompliance. The estimator of complier average treatment effect can be expressed as a ratio of two unbiased estimators but the ratio estimator is not unbiased. The bias of IV estimator ca...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2012.03.013
更新日期:2012-07-01 00:00:00
abstract:BACKGROUND:In 2007, we commenced the Healthy Beginnings Trial (HBT) Phase 1 study, which is the first randomised controlled trial (RCT) to test the effectiveness of an early childhood obesity intervention in children aged up to 2 years. The results were promising with significant improvements in infant feeding practice...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1016/j.cct.2011.11.008
更新日期:2012-03-01 00:00:00
abstract:UNLABELLED:Latinos bear a disproportionate burden of the dual pandemic of obesity and diabetes. However, successful interventions addressing this disparity through primary care are lacking. To address this gap, the 5-year Vida Sana (Healthy Life) study tests a culturally adapted and technology-enhanced group-based Diab...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2016.03.003
更新日期:2016-05-01 00:00:00
abstract:OBJECTIVE:To explore a better administration way through comparison of the pharmacodynamics of cisatracurium administered by continuous infusion or intermittent bolus injection. METHODS:Thirty patients (ASAI-II) who had no neuromuscular disease and underwent selective surgery under general anesthesia were randomly div...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2012.01.002
更新日期:2012-05-01 00:00:00
abstract:INTRODUCTION:Focal therapy (FT) targets individual areas of cancer within the prostate, providing oncological control with minimal side-effects. Early evidence demonstrates encouraging short-medium-term outcomes. With no randomized controlled trials (RCT) comparing FT to radical therapies, Comparative Healthcare Resear...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2020.105999
更新日期:2020-06-01 00:00:00
abstract:AIMS:To outline the study design, outcome measures, protocol and baseline characteristics of enrolled participants of Texas (TX) Sprouts, a one-year school-based gardening, nutrition, and cooking cluster randomized trial. METHODS:Eight schools were randomly assigned to the TX Sprouts intervention and eight schools to ...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2019.105834
更新日期:2019-10-01 00:00:00
abstract:PURPOSE:African-American women (AAW) are more likely to be metabolically unhealthy than White women (WW). Metabolic syndrome (MetS) is associated with increased breast cancer risk and mortality from breast cancer is greater in AAW compared to WW. Data show MetS affects health-related quality of life (HRQoL). Exercise s...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2018.02.005
更新日期:2018-04-01 00:00:00
abstract::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., b...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2013.08.013
更新日期:2013-11-01 00:00:00
abstract:INTRODUCTION:Focal ablation therapy is playing an increasing role in oncology and may reduce the toxicity of current surgical treatments while achieving adequate oncological benefit. Irreversible electroporation (IRE) has been proposed to be tissue-selective with potential advantages compared with current thermal-ablat...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2015.05.002
更新日期:2015-07-01 00:00:00
abstract::Dosing is potentially the most important decision that must be made when building or refining behavioral interventions. In this paper, we propose standardized terminology and reporting of dosing information, which would inform intervention development, refinement for dissemination, and systematic reviews of dose-respo...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,评审
doi:10.1016/j.cct.2012.07.011
更新日期:2012-11-01 00:00:00
abstract: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 aim...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1016/j.cct.2015.10.006
更新日期:2015-11-01 00:00:00
abstract:BACKGROUND:Although people who inject drugs (PWID) having the highest incidence and prevalence of hepatitis C virus (HCV) in the US, HCV treatment is rarely provided to PWID due to assumptions about poor adherence and reinfection risk. As direct-acting antiviral agents (DAAs) have achieved sustained virologic response ...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1016/j.cct.2019.105859
更新日期:2019-12-01 00:00:00
abstract:BACKGROUND:Patients with progressive kidney disease experience increasing physiologic and psychosocial stressors and declining health-related quality of life (HRQOL). METHODS:We conducted a randomized, active-controlled, open-label trial to test whether a Mindfulness-based Stress Reduction (MBSR) program delivered in ...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2017.03.014
更新日期:2017-06-01 00:00:00
abstract::Although progress has been made to elucidate the effects of exercise as a strategy for reducing obesity and related cardiometabolic risk factors, the specific exercise exposures required to achieve optimal benefit continue to be the source of considerable uncertainty and debate. Despite the inference of a dose-depende...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2012.10.010
更新日期:2013-01-01 00:00:00
abstract::College student alcohol use and associated negative consequences are clear public health problems with consequences including damage to self, others, and institutions. This paper describes the protocol of a research study designed to answer a number of important questions in the development of an adaptive preventive i...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2020.106089
更新日期:2020-09-01 00:00:00
abstract:BACKGROUND:Mammographic breast density is one of the strongest risk factors for breast cancer after age and family history. Mandatory breast density disclosure policies are increasing nationally without clear guidance on how to communicate density status to women. Coupling density disclosure with personalized risk coun...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1016/j.cct.2017.02.009
更新日期:2017-05-01 00:00:00
abstract::Breast cancer is the most common invasive cancer among women in developed countries. Obesity is a major risk factor for breast cancer recurrence and mortality in both pre- and postmenopausal women. Co-morbid medical conditions are common among breast cancer survivors. The Exercise and Nutrition to Enhance Recovery and...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2012.12.003
更新日期:2013-03-01 00:00:00
abstract:BACKGROUND:Despite controversy about paying research subjects, little is known about actual practices in the U.S., including what type of studies offer payment, to what type of subjects, and how amounts are determined. OBJECTIVE:To document current U.S. practices regarding payment to research subjects. METHODS:The pr...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2005.02.003
更新日期:2005-06-01 00:00:00
abstract:OBJECTIVE:Feasibility of a clinical-trial comparing a low-glycaemic diet with a low-calorie healthy eating approach at achieving weight loss and reducing the risk of endometrial cancer in women with PCOS. DESIGN:A pilot Randomised-Controlled-Trial using different recruitment strategies. SETTING:A University Hospital ...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2009.05.001
更新日期:2009-09-01 00:00:00
abstract::Numerous studies have attempted to identify successful dietary strategies for weight loss, and many have focused on Low-Fat vs. Low-Carbohydrate comparisons. Despite relatively small between-group differences in weight loss found in most previous studies, researchers have consistently observed relatively large between...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2016.12.021
更新日期:2017-02-01 00:00:00
abstract::Patients with malignant disease enrolled in trials of thrombotic disorders may experience competing events such as death. The occurrence of a competing event may prevent the thrombotic event from being observed. Standard survival analysis techniques ignore competing risks, resulting in possible bias and distorted infe...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2011.07.005
更新日期:2011-11-01 00:00:00
abstract::The most relevant randomized controlled trials of interferon-alpha (IFN) for naive patients with chronic hepatitis C (CHC) published in a decade, just before appearance of pegylated IFN trials in 2000, were included in this paper. Its purpose is to review the relationship between sustained biochemical response in acti...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,meta分析
doi:10.1016/j.cct.2004.12.009
更新日期:2005-04-01 00:00:00
abstract:BACKGROUND:In a recent publication, the International Guidelines for Groin Hernia Management by the European Hernia Society (EHS) recognized the need to individualize and tailor the surgical approach for hernia repair. There may be different opportunities for optimization of the surgical technique for surgeons performi...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,多中心研究
doi:10.1016/j.cct.2019.105853
更新日期:2019-11-01 00:00:00
abstract::Recruiting sufficient patients within an acceptable time horizon is an issue for most clinical trials and is especially challenging in the field of rare diseases. It is therefore an attractive option to include historical data from previous (pilot) trials in the current study thus reducing the recruitment burden. In c...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2017.07.013
更新日期:2017-12-01 00:00:00