Full Text Journal Articles in
Journal Contemp Clin Trials

Advertisement

Find full text journal articles






Using virtual agents to increase physical activity in young children with the virtual fitness buddy ecosystem: Study protocol for a cluster randomized trial.

Lindsay Hahn, Michael D Schmidt, Stephen L Rathbun, Kyle Johnsen, James J Annesi, Sun Joo Ahn,

BACKGROUND:Designing and implementing a truly self-determined physical activity (PA) intervention has required excessive amounts of labor and expenses that, until recently, have made it prohibitively costly to implement in the field at scale. METHODS:Guided by self-determination theory, and harnessing the power of consumer-grade interactive technologies, we developed the Virtual Fitness ... Read more >>

Contemp Clin Trials (Contemporary clinical trials)
[2020, :106181]

Cited: 0 times

View full text PDF listing >>



Safer use of antipsychotics in youth (SUAY) pragmatic trial protocol.

Robert B Penfold, Ella E Thompson, Robert J Hilt, Kelly J Kelleher, Nadine Schwartz, Arne Beck, Greg Clarke, James D Ralston, Andrea L Hartzler, R Yates Coley, Mary Akosile, Benedetto Vitiello, Gregory E Simon,

BACKGROUND:Programs such as the Pediatric Access Line in Washington state have shown decreases in antipsychotic medication use by youth with non-psychotic disorders. Program outcomes have been studied with observational designs. This manuscript describes the protocol for Targeted and Safer Use of Antipsychotics in Youth (SUAY), a randomized controlled trial of ... Read more >>

Contemp Clin Trials (Contemporary clinical trials)
[2020, :106184]

Cited: 0 times

View full text PDF listing >>



Advertisement

Innovation in the design of large-scale hybrid randomized clinical trials.

Pamela M Rist, Howard D Sesso, JoAnn E Manson,

Contemp Clin Trials (Contemporary clinical trials)
[2020, :106178]

Cited: 0 times

View full text PDF listing >>



Decídetexto: Mobile cessation support for latino smokers. study protocol for a randomized clinical trial.

Francisco Cartujano-Barrera, Evelyn Arana-Chicas, Delwyn Catley, Lisa Sanderson Cox, Francisco J Diaz, Edward F Ellerbeck, Kristi D Graves, Chinwe Ogedegbe, Ana Paula Cupertino,

INTRODUCTION:Latinos, the largest minority group in the U.S., experience tobacco-related disparities, including limited access to cessation resources. Evidence supports the efficacy of mobile interventions for smoking cessation, which may be greater among Latinos, the highest users of text messaging. OBJECTIVES:To describe the methodology of a randomized clinical trial to evaluate ... Read more >>

Contemp Clin Trials (Contemporary clinical trials)
[2020, :106188]

Cited: 0 times

View full text PDF listing >>



The European NAFLD Registry: A real-world longitudinal cohort study of nonalcoholic fatty liver disease.

Timothy Hardy, Kristy Wonders, Ramy Younes, Guruprasad P Aithal, Rocio Aller, Michael Allison, Pierre Bedossa, Fay Betsou, Jerome Boursier, M Julia Brosnan, Alastair Burt, Jeremy Cobbold, Helena Cortez-Pinto, Chris P Day, Jean-Francois Dufour, Mattias Ekstedt, Sven Francque, Stephen Harrison, Luca Miele, Patrik Nasr, George Papatheodoridis, Salvatore Petta, Dina Tiniakos, Richard Torstenson, Luca Valenti, Adriaan G Holleboom, Hannele Yki-Jarvinen, Andreas Geier, Manuel Romero-Gomez, Vlad Ratziu, Elisabetta Bugianesi, Jörn M Schattenberg, Quentin M Anstee, ,

Non-Alcoholic Fatty Liver Disease (NAFLD), a progressive liver disease that is closely associated with obesity, type 2 diabetes, hypertension and dyslipidaemia, represents an increasing global public health challenge. There is significant variability in the disease course: the majority exhibit only fat accumulation in the liver but a significant minority develop ... Read more >>

Contemp Clin Trials (Contemporary clinical trials)
[2020, 98:106175]

Cited: 0 times

View full text PDF listing >>



The design of a randomized controlled trial to evaluate multi-dimensional effects of a section 1115 Medicaid demonstration waiver with community engagement requirements.

Kristin A Linn, Kristen Underhill, Erica L Dixon, Elizabeth F Bair, William J Ferrell, Margrethe E Montgomery, Kevin G Volpp, Atheendar S Venkataramani,

Section 1115 demonstration waivers provide a mechanism for states to implement changes to their Medicaid programs. While such waivers are mandated to include evaluations of their impact, randomization - the gold standard for assessing causality - has not typically been a consideration. In a critical departure, the Commonwealth of Kentucky ... Read more >>

Contemp Clin Trials (Contemporary clinical trials)
[2020, 98:106173]

Cited: 0 times

View full text PDF listing >>



A pharmacist intervention for monitoring and treating hypertension using bidirectional texting: PharmText BP.

Linnea A Polgreen, Barry L Carter, Philip M Polgreen, Peter M Snyder, Daniel K Sewell, Emine O Bayman, Shelby L Francis, Jacob E Simmering, Christopher Parker, Rachel Finkelstein,

BACKGROUND:New approaches are needed to better monitor blood pressure (BP) between physician visits, especially for patients in rural areas or for those who lack transportation. We have developed a custom-built bi-directional texting platform for home BP measurements that can then be managed by clinical pharmacists located remotely. The purpose of ... Read more >>

Contemp Clin Trials (Contemporary clinical trials)
[2020, 98:106169]

Cited: 0 times

View full text PDF listing >>



Identification of undiagnosed atrial fibrillation patients using a machine learning risk prediction algorithm and diagnostic testing (PULsE-AI): Study protocol for a randomised controlled trial.

Nathan R Hill, Chris Arden, Lee Beresford-Hulme, A John Camm, David Clifton, D Wyn Davies, Usman Farooqui, Jason Gordon, Lara Groves, Michael Hurst, Sarah Lawton, Steven Lister, Christian Mallen, Anne-Celine Martin, Phil McEwan, Kevin G Pollock, Jennifer Rogers, Belinda Sandler, Daniel M Sugrue, Alexander T Cohen,

Atrial fibrillation (AF) is associated with an increased risk of stroke, enhanced stroke severity, and other comorbidities. However, AF is often asymptomatic, and frequently remains undiagnosed until complications occur. Current screening approaches for AF lack either cost-effectiveness or diagnostic sensitivity; thus, there is interest in tools that could be used ... Read more >>

Contemp Clin Trials (Contemporary clinical trials)
[2020, :106191]

Cited: 0 times

View full text PDF listing >>



TOCIVID-19 - A multicenter study on the efficacy and tolerability of tocilizumab in the treatment of patients with COVID-19 pneumonia. Study protocol.

Maria Carmela Piccirillo, Paolo Ascierto, Luigi Atripaldi, Marco Cascella, Massimo Costantini, Giovanni Dolci, Nicola Facciolongo, Fiorentino Fraganza, AnnaMaria Marata, Marco Massari, Vincenzo Montesarchio, Cristina Mussini, Emanuele Alberto Negri, Roberto Parrella, Patrizia Popoli, Gerardo Botti, Laura Arenare, Paolo Chiodini, Ciro Gallo, Carlo Salvarani, Francesco Perrone,

BACKGROUND:Pneumonia is the most frequent complication of COVID-19, due to an aberrant host immune response that is associated with an acute respiratory distress syndrome, and, in most critical patients, with a "cytokine storm". IL-6 might play a key role in the cytokine storm and might be a potential target to ... Read more >>

Contemp Clin Trials (Contemporary clinical trials)
[2020, 98:106165]

Cited: 0 times

View full text PDF listing >>



Bayesian hierarchical model for safety signal detection in multiple clinical trials.

Yafei Zhang, Shuai Sammy Yuan, Barry A Eagel, Hal Li, Li-An Lin, William W B Wang,

Clinical safety signal detection is of great importance in establishing the safety profile of new drugs and biologics during drug development. Bayesian hierarchical meta-analysis has proven to be a very effective method of identifying potential safety signals by considering the hierarchical structure of clinical safety data from multiple randomized clinical ... Read more >>

Contemp Clin Trials (Contemporary clinical trials)
[2020, :106183]

Cited: 0 times

View full text PDF listing >>



Infectious diseases epidemiology, quantitative methodology, and clinical research in the midst of the COVID-19 pandemic: Perspective from a European country

Geert Molenberghs, Marc Buyse, Steven Abrams, Niel Hens, Philippe Beutels, Christel Faes, Geert Verbeke, Pierre Van Damme, Herman Goossens, Thomas Neyens, Sereina Herzog, Heidi Theeten, Koen Pepermans, Ariel Alonso Abad, Ingrid Van Keilegom, Niko Speybroeck, Catherine Legrand, Stefanie De Buyser, Frank Hulstaert,

Starting from historic reflections, the current SARS-CoV-2 induced COVID-19 pandemic is examined from various perspectives, in terms of what it implies for the implementation of non-pharmaceutical interventions, the modeling and monitoring of the epidemic, the development of early-warning systems, the study of mortality, prevalence estimation, diagnostic and serological testing, vaccine ... Read more >>

Contemp Clin Trials (Contemporary clinical trials)
[2020, :]

Cited: 0 times

View full text PDF listing >>



Using artificial intelligence tools in answering important clinical questions: The KEYNOTE-183 multiple myeloma experience.

Jason J Z Liao, Mohammed Z H Farooqui, Patricia Marinello, Jonathan Hartzel, Keaven Anderson, Junshui Ma, Christine K Gause,

The phase III, randomized, active-controlled, multicenter, open-label KEYNOTE-183 study (NCT02576977) evaluating pomalidomide and low dose dexamethasone (standard-of-care [SOC]) with or without pembrolizumab in patients with refractory or relapsed and refractory multiple myeloma (rrMM) was placed on full clinical hold by the US FDA on July 03, 2017 due to an ... Read more >>

Contemp Clin Trials (Contemporary clinical trials)
[2020, :106179]

Cited: 0 times

View full text PDF listing >>



Intervention to promote physical activation and improve sleep and response feeding in infants for preventing obesity early in life, the baby-act trial: Rationale and design.

M Campos, J Pomeroy, M H Mays, A Lopez, C Palacios,

Infant obesity is increasing in the US, particularly among Hispanics. Rapid weight gain during infancy increases the risk of obesity later in life and could be prevented through multi-modal interventions addressing multiple risk factors through population-level programs. OBJECTIVES:1) determine the extent to which the intervention, compared with the usual care ... Read more >>

Contemp Clin Trials (Contemporary clinical trials)
[2020, :106185]

Cited: 0 times

View full text PDF listing >>



Effectiveness and cost-effectiveness of rubber band ligation versus sutured mucopexy versus haemorrhoidectomy in patients with recurrent haemorrhoidal disease (Napoleon trial): Study protocol for a multicentre randomized controlled trial.

Sara Z Kuiper, Carmen D Dirksen, Merel L Kimman, Sander M J Van Kuijk, Robin R Van Tol, Jean W M Muris, Angus J M Watson, Jose M C Maessen, Jarno Melenhorst, Stéphanie O Breukink, ,

BACKGROUND:Currently, there is no consensus regarding the best treatment option in recurrent haemorrhoidal disease (HD), due to a lack of solid evidence. The Napoleon trial aims to provide high-level evidence on the comparative effectiveness and cost-effectiveness of repeat rubber band ligation (RBL) versus sutured mucopexy versus haemorrhoidectomy in patients with ... Read more >>

Contemp Clin Trials (Contemporary clinical trials)
[2020, :106177]

Cited: 0 times

View full text PDF listing >>



Cognitive behavioral therapy for insomnia to enhance cognitive function and reduce the rate of Aβ deposition in older adults with symptoms of insomnia: A single-site randomized pilot clinical trial protocol.

Catherine F Siengsukon, Eryen Nelson, Cierra Williams-Cooke, Rebecca Ludwig, Eber Silveira Beck, Eric D Vidoni, Jonathan D Mahnken, Suzanne Stevens, Michelle Drerup, Jared Bruce, Jeffrey M Burns,

Lifestyle interventions to increase exercise and improve diet have been the focus of recent clinical trials to potentially prevent Alzheimer's disease (AD) [1,2]. However, despite the strong links between sleep disruptions, cognitive decline, and AD, sleep enhancement has yet to be targeted as a lifestyle intervention to prevent AD. A ... Read more >>

Contemp Clin Trials (Contemporary clinical trials)
[2020, :106190]

Cited: 0 times

View full text PDF listing >>



Treatment of comorbid sleep disorders and posttraumatic stress disorder in active duty military: Design and methodology of a randomized clinical trial.

Daniel J Taylor, Kristi E Pruiksma, Jim Mintz, Danica C Slavish, Sophie Wardle-Pinkston, Hannah Tyler, Katherine A Dondanville, Stacey Young-McCaughan, Michael K Scullin, Karin L Nicholson, Brett T Litz, Jessica R Dietch, Douglas E Williamson, Terence M Keane, Alan L Peterson, Patricia A Resick, ,

Many individuals with posttraumatic stress disorder (PTSD) also suffer from insomnia and nightmares, which may be symptoms of PTSD or constitute partially independent comorbid disorders. Sleep disturbances are resistant to current treatments for PTSD, and those suffering from PTSD, insomnia, and nightmares have worse PTSD treatment outcomes. In addition, insomnia ... Read more >>

Contemp Clin Trials (Contemporary clinical trials)
[2020, :106186]

Cited: 0 times

View full text PDF listing >>



An adaptive clinical trial design for cocaine use disorder: Extended-release amphetamine salts for early behavioral intervention non-responders.

Derek Blevins, Kenneth M Carpenter, Diana Martinez, John J Mariani, Frances R Levin,

BACKGROUND/AIMS:Cocaine use disorder (CUD) persists as a major public health problem in the United States. Response to evidence-based behavioral treatment has been shown to be predicted by dopaminergic dysfunction. Amphetamine formulations modulate dopaminergic systems and are one of the few agents with positive clinical findings but are associated with unique ... Read more >>

Contemp Clin Trials (Contemporary clinical trials)
[2020, 98:106187]

Cited: 0 times

View full text PDF listing >>



Study protocol for a randomized controlled trial of mindfulness-based relapse prevention for opioid use disorders.

Heidi Zinzow, Lu Shi, Lior Rennert, Liwei Chen, Snehal Lopes, Lingling Zhang, Karyn Jones, Meenu Jindal, Claire Stam, Michael Mclain,

The opioid misuse epidemic has reached a crisis level in the United States. Though mindfulness-based relapse prevention (MBRP) has been shown as effective in treating substance use disorders, there is limited research on its application to opioid use disorders specifically, and there is a need to understand the underlying mechanisms. ... Read more >>

Contemp Clin Trials (Contemporary clinical trials)
[2020, :106182]

Cited: 0 times

View full text PDF listing >>



The vitamin D for COVID-19 (VIVID) trial: A pragmatic cluster-randomized design.

Rui Wang, Victor DeGruttola, Quanhong Lei, Kenneth H Mayer, Susan Redline, Aditi Hazra, Samia Mora, Walter C Willett, Davaasambuu Ganmaa, JoAnn E Manson,

OBJECTIVES:To determine the effect of vitamin D supplementation on disease progression and post-exposure prophylaxis for COVID-19 infection. We hypothesize that high-dose vitamin D3 supplementation will reduce risk of hospitalization/death among those with recently diagnosed COVID-19 infection and will reduce risk of COVID-19 infection among their close household contacts. METHODS:We report ... Read more >>

Contemp Clin Trials (Contemporary clinical trials)
[2020, :106176]

Cited: 0 times

View full text PDF listing >>



Semaglutide for the treatment of non-alcoholic steatohepatitis: Trial design and comparison of non-invasive biomarkers.

Stephen A Harrison, Salvatore Calanna, Kenneth Cusi, Martin Linder, Takeshi Okanoue, Vlad Ratziu, Arun Sanyal, Anne-Sophie Sejling, Philip N Newsome,

Non-alcoholic steatohepatitis (NASH) is a chronic liver disease. There is a clear need to develop pharmacological treatment for patients with NASH as well as biomarkers that can diagnose the disease. We describe a trial of semaglutide treatment for NASH, identify key patient characteristics and compare the relationship of patient characteristics ... Read more >>

Contemp Clin Trials (Contemporary clinical trials)
[2020, :106174]

Cited: 0 times

View full text PDF listing >>



A mHealth intervention to preserve and promote ideal cardiovascular health in college students: Design and protocol of a cluster randomized controlled trial.

Angela F Pfammatter, Katrina E Champion, Laura E Finch, Juned Siddique, Donald Hedeker, Bonnie Spring,

BACKGROUND:Cardiovascular disease (CVD) remains the leading cause of death globally. Seven health factors are associated with ideal cardiovascular health: being a non-smoker; not overweight; physically active; having a healthy diet; and normal blood pressure; fasting plasma glucose and cholesterol. Whereas approximately half of U.S. youth have ideal levels in at ... Read more >>

Contemp Clin Trials (Contemporary clinical trials)
[2020, 98:106162]

Cited: 0 times

View full text PDF listing >>



Real-world experiences with generating real-world evidence: Case Studies from PCORI's pragmatic clinical Studies program.

Mark D Neuman, Michael D Kappelman, Elliot Israel, Susan S Ellenberg, Cindy Girman, Jess Robb, Allie Rabinowitz, Anne Trontell,

BACKGROUND:Over the last decade, randomized studies evaluating outcomes of health care interventions conducted in real-world settings-often termed "pragmatic trials"-have come to be seen as an important means of obtaining relevant, actionable evidence to guide health care decisions. Despite extensive writing on methodological considerations in pragmatic trial design, limited information exists ... Read more >>

Contemp Clin Trials (Contemporary clinical trials)
[2020, 98:106171]

Cited: 0 times

View full text PDF listing >>



Medical assistant health coaching ("MAC") for type 2 diabetes in diverse primary care settings: A pragmatic, cluster-randomized controlled trial protocol.

Addie L Fortmann, Athena Philis-Tsimikas, Johanna A Euyoque, Taylor L Clark, Daniela G Vital, Haley Sandoval, Julia I Bravin, Kimberly L Savin, Jennifer A Jones, Scott Roesch, Todd Gilmer, Thomas Bodenheimer, James Schultz, Linda C Gallo,

In the US, nearly 11% of adults were living with diagnosed diabetes in 2017, and significant type 2 diabetes (T2D) disparities are experienced by socioeconomically disadvantaged, racial/ethnic minority populations, including Hispanics. The standard 15-min primary care visit does not allow for the ongoing self-management support that is needed to meet ... Read more >>

Contemp Clin Trials (Contemporary clinical trials)
[2020, :106164]

Cited: 0 times

View full text PDF listing >>



Protocol of a randomized trial of acceptance and commitment therapy for fatigue interference in metastatic breast cancer.

Catherine E Mosher, Ellen Krueger, Adam T Hirsh, Kathy D Miller, Tarah J Ballinger, Anna Maria Storniolo, Bryan P Schneider, Erin V Newton, Victoria L Champion, Shelley A Johns,

Fatigue interference with activities, mood, and cognition is one of the most prevalent and distressing concerns of metastatic breast cancer patients. To date, there are no evidence-based interventions for reducing fatigue interference in metastatic breast cancer and other advanced cancer populations. In pilot studies, Acceptance and Commitment Therapy (ACT) has ... Read more >>

Contemp Clin Trials (Contemporary clinical trials)
[2020, 98:106168]

Cited: 0 times

View full text PDF listing >>



CITY health II - using entertainment education and social media to reduce HIV among emerging adults: A protocol paper for the beat HIVe project.

Susan L Davies, Tamika L Smith, Bailey Murphy, M Scott Crawford, Kathryn A Kaiser, Olivio J Clay,

BACKGROUND:Despite multiple efforts to reduce HIV rates among African American young adults, a significant racial disparity persists and continues to grow among this population. New approaches are needed to reach this at-risk group and engage them in prevention efforts. The Community Influences Transitions of Youth Health (CITY Health II) study ... Read more >>

Contemp Clin Trials (Contemporary clinical trials)
[2020, :106167]

Cited: 0 times

View full text PDF listing >>



Advertisement

Disclaimer
0.9945 s