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Contemporary Clinical Trials

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https://www.readbyqxmd.com/read/28533194/mortality-in-cardiac-surgery-myriad-a-randomized-controlled-trial-of-volatile-anesthetics-rationale-and-design
#1
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 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 Ryha, 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
#2
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
#3
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/28495620/vitamin-c-to-decrease-the-effects-of-smoking-in-pregnancy-on-infant-lung-function-vcsip-rationale-design-and-methods-of-a-randomized-controlled-trial-of-vitamin-c-supplementation-in-pregnancy-for-the-primary-prevention-of-effects-of-in-utero-tobacco-smoke-exposure
#4
Cindy T McEvoy, Kristin F Milner, Ashley J Scherman, Diane G Schilling, Christina J Tiller, Brittany Vuylsteke, Lyndsey E Shorey-Kendrick, Eliot R Spindel, Robert Schuff, Julie Mitchell, Dawn Peters, Jill Metz, David Haas, Keith Jackson, Robert S Tepper, Cynthia D Morris
Despite strong anti-smoking efforts, at least 12% of American women cannot quit smoking when pregnant resulting in >450,000 smoke-exposed infants born yearly. Smoking during pregnancy is the largest preventable cause of childhood respiratory illness including wheezing and asthma. Recent studies have shown a protective effect of vitamin C supplementation on the lung function of offspring exposed to in utero smoke in a non-human primate model and an initial human trial. Vitamin C to Decrease the Effects of Smoking in Pregnancy on Infant Lung Function (VCSIP) is a randomized, double-blind, placebo-controlled trial to evaluate pulmonary function at 3months of age in infants delivered to pregnant smokers randomized to 500mg/day of vitamin C versus placebo during pregnancy...
May 8, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28495619/the-respire-trials-two-phase-iii-randomized-multicentre-placebo-controlled-trials-of-ciprofloxacin-dry-powder-for-inhalation-ciprofloxacin-dpi-in-non-cystic-fibrosis-bronchiectasis
#5
Timothy Aksamit, Tiemo-Joerg Bandel, Margarita Criollo, Anthony De Soyza, J Stuart Elborn, Elisabeth Operschall, Eva Polverino, Katrin Roth, Kevin L Winthrop, Robert Wilson
The primary goals of long-term disease management in non-cystic fibrosis bronchiectasis (NCFB) are to reduce the number of exacerbations, and improve quality of life. However, currently no therapies are licensed for this. Ciprofloxacin Dry Powder for Inhalation (Ciprofloxacin DPI) has potential to be the first long-term intermittent therapy approved to reduce exacerbations in NCFB patients. The RESPIRE programme consists of two international phase III prospective, parallel-group, randomized, double-blinded, multicentre, placebo-controlled trials of the same design...
May 8, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28483498/design-of-a-randomized-trial-to-determine-the-optimum-protein-intake-to-preserve-lean-body-mass-and-to-optimize-response-to-a-promyogenic-anabolic-agent-in-older-men-with-physical-functional-limitation
#6
Shalender Bhasin, Caroline M Apovian, Thomas G Travison, Karol Pencina, Grace Huang, Lynn L Moore, Wayne W Campbell, Andrew Howland, Ruo Chen, Martha R Singer, Mitali Shah, Richard Eder, Haley Schram, Richelle Bearup, Yusnie M Beleva, Ashley C McCarthy, Zhouying Li, Erin Woodbury, Jennifer McKinnon, Thomas W Storer, Shehzad Basaria
The dietary protein allowance for older men to maintain lean body mass and muscle strength and to accrue optimal anabolic responses to promyogenic stimuli is poorly characterized. The OPTIMEN trial was designed to assess in older men with moderate physical dysfunction and insufficient habitual protein intake (<recommended dietary allowance, RDA, 0.8g·kg(-1)·d(-1)) the efficacy of consuming diets containing 163% RDA (1.3g·kg(-1)·d(-1)) for protein, compared to RDA, to increase lean mass, muscle performance, and physical function...
May 5, 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
#7
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
#8
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
#9
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/28479218/the-fit-study-design-and-rationale-for-a-cluster-randomized-trial-of-school-based-bmi-screening-and-reporting
#10
Kristine A Madsen, Jennifer Linchey, Lorrene Ritchie, Hannah R Thompson
BACKGROUND: In the U.S., 25 states conduct body mass index (BMI) screening in schools, just under half of which report results to parents. While some experts recommend the practice, evidence demonstrating its efficacy to reduce obesity is lacking, and concerns about weight-related stigma have been raised. METHODS/DESIGN: The Fit Study is a 3-arm cluster-randomized trial assessing the effectiveness of school-based BMI screening and reporting in reducing pediatric obesity and identifying unintended consequences...
May 4, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28479217/physiological-and-psychological-effects-of-testosterone-during-severe-energy-deficit-and-recovery-a-study-protocol-for-a-randomized-placebo-controlled-trial-for-optimizing-performance-for-soldiers-ops
#11
Stefan M Pasiakos, Claire E Berryman, J Philip Karl, Harris R Lieberman, Jeb S Orr, Lee M Margolis, John A Caldwell, Andrew J Young, Monty A Montano, William J Evans, Oshin Vartanian, Owen T Carmichael, Kishore M Gadde, Melissa Harris, Jennifer C Rood
BACKGROUND: The physiological consequences of severe energy deficit include hypogonadism and the loss of fat-free mass. Prolonged energy deficit also impacts physical performance, mood, attentiveness, and decision-making capabilities. This study will determine whether maintaining a eugonadal state during severe, sustained energy deficit attenuates physiological decrements and maintains mental performance. This study will also assess the effects of normalizing testosterone levels during severe energy deficit and recovery on gut health and appetite regulation...
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
#12
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
https://www.readbyqxmd.com/read/28458054/a-bayesian-interval-dose-finding-design-addressingockham-s%C3%A2-razor-%C3%A2-mtpi-2
#13
Wentian Guo, Sue-Jane Wang, Shengjie Yang, Henry Lynn, Yuan Ji
There has been an increasing interest in using interval-based Bayesian designs for dose finding, one of which is the modified toxicity probability interval (mTPI) method. We show that the decision rules in mTPI correspond to an optimal rule under a formal Bayesian decision theoretic framework. However, the probability models in mTPI are overly sharpened by the Ockham's razor, which, while in general helps with parsimonious statistical inference, leads to undesirable decisions from safety perspective. We propose a new framework that blunts the Ockham's razor, and demonstrate the superior performance of the new method, called mTPI-2...
April 27, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28455234/optimal-adaptive-group-sequential-design-with-flexible-timing-of-sample-size-determination
#14
Lu Cui, Lanju Zhang, Bo Yang
Flexible sample size designs, including group sequential and sample size re-estimation designs, have been used as alternatives to fixed sample size designs to achieve more robust statistical power and better trial efficiency. In this work, a new representation of sample size re-estimation design suggested by Cui et al is introduced as an adaptive group sequential design with flexible timing of sample size determination. This generalized adaptive group sequential design allows one time sample size determination either before the start of or in the mid-course of a clinical study...
April 25, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28455233/example-based-illustrations-of-design-conduct-analysis-and-result-interpretation-of-multi-regional-clinical-trials
#15
Hui Quan, Xuezhou Mao, Yoko Tanaka, Bruce Binkowitz, Gang Li, Josh Chen, Ji Zhang, Peng-Liang Zhao, Soo Peter Ouyang, Mark Chang
Extensive research has been conducted in the Multi-Regional Clinical Trial (MRCT) area. To effectively apply an appropriate approach to a MRCT, we need to synthesize and understand the features of different approaches. In this paper, examples are used to illustrate considerations regarding design, conduct, analysis and interpretation of result of MRCTs. We start with a brief discussion of region definitions and the scenarios where different regions have differing requirements for a MRCT. We then compare different designs and models as well as the corresponding interpretation of the results...
April 25, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28455232/bayesian-randomized-clinical-trials-from-fixed-to-adaptive-design
#16
REVIEW
Guosheng Yin, Chi Kin Lam, Haolun Shi
Randomized controlled studies are the gold standard for phase III clinical trials. Using α-spending functions to control the overall type I error rate, group sequential methods are well established and have been dominating phase III studies. Bayesian randomized design, on the other hand, can be viewed as a complement instead of competitive approach to the frequentist methods. For the fixed Bayesian design, the hypothesis testing can be cast in the posterior probability or Bayes factor framework, which has a direct link to the frequentist type I error rate...
April 25, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28450194/design-and-baseline-data-from-a-pcori-funded-randomized-controlled-trial-of-family-centered-tailoring-of-diabetes-self-management-resources
#17
Rosanna Fiallo-Scharer, Mari Palta, Betty A Chewning, Tim Wysocki, Tosha B Wetterneck, Elizabeth D Cox
This article describes the methodology, recruitment, participant characteristics, and sustained, intensive stakeholder engagement for Project ACE (Achieving control, Connecting resources, Empowering families). Project ACE is a randomized controlled trial of children and youth ages 8-16 with type 1 diabetes evaluating the impact of tailored self-management resources on hemoglobin A1c (A1c) and quality of life (QOL). Despite strong evidence that controlling A1c reduces long-term complications, <25% of US youth with type 1 diabetes meet A1c targets...
April 24, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28450193/developing-standardized-corticosteroid-treatment-for-duchenne-muscular-dystrophy
#18
Michela Guglieri, Kate Bushby, Michael P McDermott, Kimberly A Hart, Rabi Tawil, William B Martens, Barbara E Herr, Elaine McColl, Jennifer Wilkinson, Janbernd Kirschner, Wendy M King, Michele Eagle, Mary W Brown, Tracey Willis, Deborah Hirtz, Perry B Shieh, Volker Straub, Anne-Marie Childs, Emma Ciafaloni, Russell J Butterfield, Iain Horrocks, Stefan Spinty, Kevin M Flanigan, Nancy L Kuntz, Giovanni Baranello, Helen Roper, Leslie Morrison, Jean K Mah, Adnan Y Manzur, Craig M McDonald, Ulrike Schara, Maja von der Hagen, Richard J Barohn, Craig Campbell, Basil T Darras, Richard S Finkel, Giuseppe Vita, Imelda Hughes, Tiziana Mongini, Elena Pegoraro, Matthew Wicklund, Ekkehard Wilichowski, W Bryan Burnette, James F Howard, Hugh J McMillan, Mathula Thangarajh, Robert C Griggs
Despite corticosteroids being the only treatment documented to improve strength and function in boys with Duchenne muscular dystrophy (DMD) corticosteroid prescription is inconsistent and in some countries, corticosteroids are not prescribed. We are conducting a clinical trial that (1) compares the 3 most frequently prescribed corticosteroid regimes; (2) standardizes treatment of DMD complications; and (3) standardizes prevention of corticosteroid side effects. Investigators at 38 sites in 5 countries plan to recruit 300 boys aged 4-7 who are randomly assigned to one of three regimens: daily prednisone; daily deflazacort; or intermittent prednisone (10days on/10days off)...
April 24, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28445783/jump-starting-shared-medical-appointments-for-diabetes-with-weight-management-rationale-and-design-of-a-randomized-controlled-trial
#19
Matthew J Crowley, David Edelman, Corrine I Voils, Matthew L Maciejewski, Cynthia J Coffman, Amy S Jeffreys, Marsha J Turner, Leslie A Gaillard, Teresa A Hinton, Elizabeth Strawbridge, Jennifer Zervakis, Anna Beth Barton, William S Yancy
BACKGROUND: Rates of glycemic control remain suboptimal nationwide. Medication intensification for diabetes can have undesirable side effects (weight gain, hypoglycemia), which offset the benefits of glycemic control. A Shared Medical Appointment (SMA) intervention for diabetes that emphasizes weight management could improve glycemic outcomes and reduce weight while simultaneously lowering diabetes medication needs, resulting in less hypoglycemia and better quality of life. We describe the rationale and design for a study evaluating a novel SMA intervention for diabetes that primarily emphasizes low-carbohydrate diet-focused weight management...
April 23, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28414147/public-access-to-clinical-trials-lessons-from-an-organizational-implementation-of-policy
#20
Grant D Huang, Jane K Altemose, Timothy J O'Leary
Efforts to make clinical trials and their results more publicly available have been increasing in recent years. However, there is a need to better understand ways to achieve these goals aimed at benefiting a diverse set of stakeholders. Since 2005, the U.S. Department of Veterans Affairs Office of Research and Development (ORD), part of the nation's largest integrated health care system, has required the clinical trials its funds to be registered in ClinicalTrials.gov as a condition of the award. Furthermore, summary results of studies active since 2007 have been included in the registry...
April 13, 2017: Contemporary Clinical Trials
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