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Contemporary Clinical Trials

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https://www.readbyqxmd.com/read/28629993/increasing-the-efficiency-of-oncology-basket-trials-using-a-bayesian-approach
#1
Rong Liu, Zheyu Liu, Mercedeh Ghadessi, Richardus Vonk
With the rapid growth of targeted and immune-oncology therapies, novel statistical design approaches are needed to increase the flexibility and efficiency of early phase oncology trials. Basket trials enroll patients with defined biological deficiencies, but with multiple histologic tumor types (or indications), to discover in which indications the drug is active. In such designs different indications are typically analyzed independently. This, however, ignores potential biological similarities among the indications...
June 16, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28600158/lorcaserin-plus-lifestyle-modification-for-weight-loss-maintenance-rationale-and-design-for-a-randomized-controlled-trial
#2
Jena Shaw Tronieri, Nasreen Alfaris, Ariana M Chao, Rebecca L Pearl, Naji Alamuddin, Zayna M Bakizada, Robert I Berkowitz, Thomas A Wadden
BACKGROUND/AIMS: Few studies have examined the efficacy of recently approved medications for chronic weight management in facilitating the maintenance of lost weight. This paper provides an overview of the design and rationale for a trial investigating whether lorcaserin, when combined with behavioral weight loss maintenance sessions (WLM), will facilitate the maintenance of losses of ≥5% of initial weight. METHODS: In this two-phase trial, participants with obesity will enroll in a 14-week run-in diet program consisting of weekly group lifestyle modification sessions and a 1000-1200kcal/d meal replacement diet...
June 16, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28619649/the-school-inner-city-asthma-intervention-study-design-rationale-methods-and-lessons-learned
#3
Wanda Phipatanakul, Petros Koutrakis, Brent A Coull, Choong-Min Kang, Jack M Wolfson, Stephen T Ferguson, Carter R Petty, Mihail Samnaliev, Amparito Cunningham, William J Sheehan, Jonathan M Gaffin, Sachin N Baxi, Peggy S Lai, Perdita Permaul, Liming Liang, Peter S Thorne, Gary Adamkiewicz, Kasey J Brennan, Andrea A Baccarelli, Diane R Gold
Asthma is the most common chronic disease of childhood in the United States, causes significant morbidity, particularly in the inner-city, and accounts for billions of dollars in health care utilization. Home environments are established sources of exposure that exacerbate symptoms and home-based interventions are effective. However, elementary school children spend 7 to 12h a day in school, primarily in one classroom. From the observational School Inner-City Asthma Study we learned that student classroom-specific exposures are associated with worsening asthma symptoms and decline in lung function...
June 12, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28611008/the-female-athlete-body-fab-study-rationale-design-and-baseline-characteristics
#4
Tiffany M Stewart, Tarryn Pollard, Tom Hildebrandt, Robbie Beyl, Nicole Wesley, Lisa Smith Kilpela, Carolyn Black Becker
BACKGROUND: Eating Disorders (EDs) are serious psychiatric illnesses marked by psychiatric comorbidity, medical complications, and functional impairment. Research indicates that female athletes are often at greater risk for developing ED pathology versus non-athlete females. The Female Athlete Body (FAB) study is a three-site, randomized controlled trial (RCT) designed to assess the efficacy of a behavioral ED prevention program for female collegiate athletes when implemented by community providers...
June 10, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28611007/using-social-media-to-deliver-weight-loss-programming-to-young-adults-design-and-rationale-for-the-healthy-body-healthy-u-hbhu-trial
#5
Melissa A Napolitano, Jessica A Whiteley, Meghan N Mavredes, Jamie Faro, Loretta DiPietro, Laura L Hayman, Charles J Neighbors, Samuel Simmens
BACKGROUND: The transitional period from late adolescence to early adulthood is a vulnerable period for weight gain, with a twofold increase in overweight/obesity during this life transition. In the United States, approximately one-third of young adults have obesity and are at a high risk for weight gain. PURPOSE: To describe the design and rationale of a National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) sponsored randomized, controlled clinical trial, the Healthy Body Healthy U (HBHU) study, which compares the differential efficacy of three interventions on weight loss among young adults aged 18-35years...
June 10, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28611006/intensive-versus-moderate-atorvastatin-therapy-and-one-year-graft-patency-after-cabg-rationale-and-design-of-the-active-aggressive-cholesterol-therapy-to-inhibit-vein-graft-events-randomized-controlled-trial-nct01528709
#6
Alexander Kulik, Amy M Abreu, Viviana Boronat, Marc Ruel
RATIONALE: Saphenous vein graft disease remains a major limitation of coronary artery bypass graft surgery (CABG). Statin therapy inhibits the development of vein graft disease and improves outcomes after CABG. However, it is unclear whether treatment with high-dose statins will further slow the process of vein graft disease and improve graft patency, as compared to conventional moderate doses. Therefore, the goal of this study will be to evaluate the efficacy of high-dose statin therapy versus moderate-dose statin therapy for the prevention of saphenous vein graft occlusion following CABG...
June 10, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28600159/building-research-in-diet-and-cognition-the-bridge-randomized-controlled-trial
#7
Lisa Tussing-Humphreys, Melissa Lamar, James A Blumenthal, Michael Babyak, Giamila Fantuzzi, Lara Blumstein, Linda Schiffer, Marian L Fitzgibbon
Obesity has been linked to cognitive impairment, cognitive decline and dementia. Given that 38.5% of U.S. adults 60years and older are obese and these numbers are rapidly increasing, strategies to decouple obesity from cognitive decline are needed. Innovative lifestyle strategies that may postpone the onset of subclinical symptoms or even arrest the transition to overt dementia in at-risk individuals are critically needed. Poor diet is central to the development of obesity and diet may affect cognition. Adherence to a Mediterranean Diet (MedDiet) is associated with reduced risk of cognitive impairment and dementia...
June 7, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28600161/a-problem-solving-intervention-for-cardiovascular-disease-risk-reduction-in-veterans-protocol-for-a-randomized-controlled-trial
#8
Jason A Nieuwsma, Laura O Wray, Corrine I Voils, Jennifer M Gierisch, Margaret Dundon, Cynthia J Coffman, George L Jackson, Rhonda Merwin, Christina Vair, Karen Juntilla, Courtney White-Clark, Amy S Jeffreys, Amy Harris, Michael Owings, Johnpatrick Marr, David Edelman
BACKGROUND: Health behaviors related to diet, tobacco usage, physical activity, medication adherence, and alcohol use are highly determinative of risk for developing cardiovascular disease. This paper describes a study protocol to evaluate a problem-solving intervention that aims to help patients at risk for developing cardiovascular disease address barriers to adopting positive health behaviors in order to reduce cardiovascular risk. METHODS: Eligible patients are adults enrolled in Veterans Affairs (VA) health care who have not experienced a cardiovascular event but are at elevated risk based on their Framingham Risk Score (FRS)...
June 6, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28600160/family-based-obesity-prevention-for-infants-design-of-the-mothers-others-randomized-trial
#9
Heather M Wasser, Amanda L Thompson, Chirayath M Suchindran, Eric A Hodges, Barbara D Goldman, Eliana M Perrin, Myles S Faith, Cynthia M Bulik, M Jane Heinig, Margaret E Bentley
OBJECTIVE: Our goal is to test the efficacy of a family-based, multi-component intervention focused on infants of African-American (AA) mothers and families, a minority population at elevated risk for pediatric obesity, versus a child safety attention-control group to promote healthy weight gain patterns during the first two years of life. DESIGN, PARTICIPANTS, AND METHODS: The design is a two-group randomized controlled trial among 468 AA pregnant women in central North Carolina...
June 6, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28576734/protocol-for-the-match-study-mindfulness-and-tai-chi-for-cancer-health-a-preference-based-multi-site-randomized-comparative-effectiveness-trial-cet-of-mindfulness-based-cancer-recovery-mbcr-vs-tai-chi-qigong-tcq-for-cancer-survivors
#10
Linda E Carlson, Erin L Zelinski, Michael Speca, Lynda G Balneaves, Jennifer M Jones, Daniel Santa Mina, Peter M Wayne, Tavis S Campbell, Janine Giese-Davis, Peter Faris, Jennifer Zwicker, Kamala Patel, Tara L Beattie, Steve Cole, Kirsti Toivonen, Jill Nation, Philip Peng, Bruce Thong, Raimond Wong, Sunita Vohra
PURPOSE: A growing number of cancer survivors suffer high levels of distress, depression and stress, as well as sleep disturbance, pain and fatigue. Two different mind-body interventions helpful for treating these problems are Mindfulness-Based Cancer Recovery (MBCR) and Tai Chi/Qigong (TCQ). However, while both interventions show efficacy compared to usual care, they have never been evaluated in the same study or directly compared. This study will be the first to incorporate innovative design features including patient choice while evaluating two interventions to treat distressed cancer survivors...
May 30, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28571997/rationale-and-design-of-the-enhancing-outcomes-through-goal-assessment-and-generating-engagement-in-diabetes-mellitus-engage-dm-pragmatic-trial
#11
Julie C Lauffenburger, Jennifer Lewey, Saira Jan, Gina Nanchanatt, Sagar Makanji, Christina A Ferro, John Sheehan, Eric Wittbrodt, Kyle Morawski, Jessica Lee, Roya Ghazinouri, Niteesh K Choudhry
BACKGROUND: Poor glycemic control among patients with diabetes may stem from poor medication and lifestyle adherence or a failure to appropriately intensify therapy. A patient-centered approach could discern the most likely possibility and would then, as appropriate, address patient barriers to non-adherence (using behavioral interviewing methods such as motivational interviewing) or help facilitate choices among treatment augmentation options (using methods such as shared decision-making)...
May 29, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28571996/the-effect-of-the-use-of-a-tnf-alpha-inhibitor-in-hypothermic-machine-perfusion-on-kidney-function-after-transplantation
#12
Piotr Diuwe, Piotr Domagala, Magdalena Durlik, Janusz Trzebicki, Andrzej Chmura, Artur Kwiatkowski
One of the most important problems in transplantation medicine is the ischemia/reperfusion injury of the organs to be transplanted. The aim of the present study was to assess the effect of tumor necrosis factor-alpha (TNF-alpha) inhibitor etanercept on the machine perfusion hypothermia of renal allograft kidney function and organ perfusion. No statistically significant differences were found in the impact of the applied intervention on kidney machine perfusion during which the average flow and vascular resistance were evaluated...
May 29, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28545934/cure-modeling-in-real-time-prediction-how-much-does-it-help
#13
Gui-Shuang Ying, Qiang Zhang, Yu Lan, Yimei Li, Daniel F Heitjan
Various parametric and nonparametric modeling approaches exist for real-time prediction in time-to-event clinical trials. Recently, Chen (2016 BMC Biomedical Research Methodology 16) proposed a prediction method based on parametric cure-mixture modeling, intending to cover those situations where it appears that a non-negligible fraction of subjects is cured. In this article we apply a Weibull cure-mixture model to create predictions, demonstrating the approach in RTOG 0129, a randomized trial in head-and-neck cancer...
May 22, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28533194/mortality-in-cardiac-surgery-myriad-a-randomized-controlled-trial-of-volatile-anesthetics-rationale-and-design
#14
Giovanni Landoni, Vladimir Lomivorotov, Antonio Pisano, Caetano Nigro Neto, Umberto Benedetto, Giuseppe Biondi Zoccai, Marco Gemma, Samuele Frassoni, Felice Eugenio Agrò, Massimo Baiocchi, Filomena R Barbosa Gomes Galas, Andrei Bautin, Nikola Bradic, Cristiana Carollo, Giuseppe Crescenzi, Abeer M Elnakera, Mohamed R El-Tahan, Evgeny Fominskiy, Ahmed G Farag, Gordana Gazivoda, Stefano Gianni, Evgeny Grigoryev, Fabio Guarracino, Sidik Hanafi, Weiqing Huang, Gudrun Kunst, Jan Kunstyr, Chong Lei, Rosalba Lembo, Zhi-Jian Li, Valery Likhvantsev, Andrey Lozovskiy, Jun Ma, Fabrizio Monaco, Paolo Navalesi, Bukamal Nazar, Vadim Pasyuga, Elena Porteri, Colin Royse, Laura Ruggeri, Hynek Riha, Fernanda Santos Silva, Luca Severi, Vladimir Shmyrev, Nikolay Uvaliev, Cheng Bin Wang, Chew-Yin Wang, Dario Winterton, Chow-Yen Yong, Jingui Yu, Rinaldo Bellomo, Alberto Zangrillo
OBJECTIVE: There is initial evidence that the use of volatile anesthetics can reduce the postoperative release of cardiac troponin I, the need for inotropic support, and the number of patients requiring prolonged hospitalization following coronary artery bypass graft (CABG) surgery. Nevertheless, small randomized controlled trials have failed to demonstrate a survival advantage. Thus, whether volatile anesthetics improve the postoperative outcome of cardiac surgical patients remains uncertain...
May 19, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28526265/guessing-strategies-for-treatment-prediction-under-restricted-randomization-with-unequal-allocation
#15
LETTER
Wenle Zhao, Colin C Everett, Yanqiu Weng, Vance W Berger
No abstract text is available yet for this article.
May 16, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28522422/statistical-design-for-a-confirmatory-trial-with-a-continuous-predictive-biomarker-a-case-study
#16
Adarsh Joshi, Jenny Zhang, Liang Fang
With targeted therapies, it is often hypothesized that their effect may be specific to the subpopulation in which the target pathway is activated. We consider the problem of designing a confirmatory trial when the biological hypothesis of the experimental therapy is strongly supported by the pre-clinical data but limited clinical data is available to pre-define a subpopulation based on a biomarker with continuous values. The study design is further complicated if interim evaluations of the biomarker-based subpopulations are also being considered...
May 15, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28479221/do-baby-teeth-really-matter-changing-parental-perception-and-increasing-dental-care-utilization-for-young-children
#17
Suchitra Nelson, Mary Beth Slusar, Jeffrey M Albert, Christine A Riedy
INTRODUCTION: Parent/caregivers' inability to recognize the importance of baby teeth has been associated with inadequate self-management of children's oral health (i.e. lower likelihood of preventive dental visits) which may result in dental caries and the need for more expensive caries-related restorative treatment under general anesthesia. Health behavior theories aid researchers in understanding the impact and effectiveness of interventions on changing health behaviors and health outcomes...
May 4, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28479220/electronic-medication-complete-communication-strategy-for-opioid-prescriptions-in-the-emergency-department-rationale-and-design-for-a-three-arm-provider-randomized-trial
#18
Danielle M McCarthy, D Mark Courtney, Patrick M Lank, Kenzie A Cameron, Andrea M Russell, Laura M Curtis, Kwang-Youn A Kim, Surrey M Walton, Enid Montague, Abbie L Lyden, Stephanie J Gravenor, Michael S Wolf
BACKGROUND: Thousands of people die annually from prescription opioid overdoses; however there are few strategies to ensure patients receive medication risk information at the time of prescribing. OBJECTIVES: To compare the effectiveness of the Emergency Department (ED) Electronic Medication Complete Communication (EMC(2)) Opioid Strategy (with and without text messaging) to promote safe medication use and improved patient knowledge as compared to usual care. METHODS: The ED EMC(2) Opioid Strategy consists of 5 automated components to promote safe medication use: 1) physician reminder to counsel, 2) inbox message sent on to the patient's primary care physician, 3) pharmacist message on the prescription to counsel, 4) MedSheet supporting prescription information, and 5) patient-centered Take-Wait-Stop wording of prescription instructions...
May 4, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28479219/enhancing-the-efficacy-of-a-smoking-quit-line-in-the-military-study-rationale-design-and-methods-of-the-freedom-quit-line
#19
Melissa A Little, Jon O Ebbert, Zoran Bursac, Gerald W Talcott, Lauren Talley, Karen M LeRoy, Catherine R Womack, Ann S Hryshko-Mullen, Robert C Klesges
No abstract text is available yet for this article.
May 4, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28479216/design-and-implementation-of-a-factorial-randomized-controlled-trial-of-methadone-maintenance-therapy-and-an-evidence-based-behavioral-intervention-for-incarcerated-people-living-with-hiv-and-opioid-dependence-in-malaysia
#20
Alexander R Bazazi, Jeffrey A Wickersham, Martin P Wegman, Gabriel J Culbert, Veena Pillai, Roman Shrestha, Haider Al-Darraji, Michael M Copenhaver, Adeeba Kamarulzaman, Frederick L Altice
Incarcerated people living with HIV and opioid dependence face enormous challenges to accessing evidence-based treatment during incarceration and after release into the community, placing them at risk of poor HIV treatment outcomes, relapse to opioid use and accompanying HIV transmission risk behaviors. Here we describe in detail the design and implementation of Project Harapan, a prospective clinical trial conducted among people living with HIV and opioid dependence who transitioned from prison to the community in Malaysia from 2010 to 2014...
May 4, 2017: Contemporary Clinical Trials
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