Editorial Board
(Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - November 21, 2019 Category: Radiology Source Type: research
Web-based cognitive-behavioral intervention for pain in pediatric acute recurrent and chronic pancreatitis: Protocol of a multicenter randomized controlled trial from the study of chronic pancreatitis, diabetes and pancreatic cancer (CPDPC)
Abdominal pain is common and is associated with high disease burden and health care costs in pediatric acute recurrent and chronic pancreatitis (ARP/CP). Despite the strong central component of pain in ARP/CP and the efficacy of psychological therapies for other centralized pain syndromes, no studies have evaluated psychological pain interventions in children with ARP/CP. The current trial seeks to 1) evaluate the efficacy of a psychological pain intervention for pediatric ARP/CP, and 2) examine baseline patient-specific genetic, clinical, and psychosocial characteristics that may predict or moderate treatment response. (S...
Source: Contemporary Clinical Trials - November 18, 2019 Category: Radiology Authors: Tonya M. Palermo, Caitlin Murray, Homer Aalfs, Maisam Abu-El-Haija, Bradley Barth, Melena D. Bellin, Kate Ellery, Douglas S. Fishman, Cheryl E. Gariepy, Matthew J. Giefer, Praveen Goday, Tanja Gonska, Melvin B. Heyman, Sohail Z. Husain, Tom K. Lin, Quin Y Source Type: research
Adapting home telehealth group appointment model (CoYoT1 clinic) for a low SES, publicly insured, minority young adult population with type 1 diabetes
As more individuals from diverse backgrounds are diagnosed with Type 1 Diabetes (T1D), the need to address resulting disparities in diabetes outcomes among these populations also escalates. Although young adulthood proves challenging for all patients with diabetes, young adults (YA) from racial/ethnic minorities and low socioeconomic backgrounds face even greater T1D management obstacles. The poorer outcomes in these populations drive an urgent need for alternative care models to improve YA's engagement in their T1D clinical care and address barriers to improved health outcomes. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - November 17, 2019 Category: Radiology Authors: Jennifer K. Raymond, Mark W. Reid, Steven Fox, Jaquelin Flores Garcia, Debbie Miller, Daniel Bisno, Jennifer L. Fogel, Subramanian Krishnan, Elizabeth A. Pyatak Source Type: research
The Nutritious Eating with Soul (NEW Soul) Study: Study design and methods of a two-year randomized trial comparing culturally adapted soul food vegan vs. omnivorous diets among African American adults at risk for heart disease
Previous research has found that African American (AA) vegetarians/vegans have a significantly lower body mass index and risk of hypertension compared to omnivores. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - November 15, 2019 Category: Radiology Authors: Gabrielle Turner-McGrievy, Sara Wilcox, Edward A. Frongillo, Angela Murphy, Brent Hutto, Kim Williams, Anthony Crimarco, Mary Wilson, Marty Davey Source Type: research
An efficient Bayesian platform trial design for borrowing adaptively from historical control data in lymphoma
To reduce a clinical trial's cost and ethical risk to its enrollees, some oncology trial designers have suggested borrowing information from similar but already completed trials to reduce the number of patients needed for the current study. Motivated by competing drug therapies for lymphoma, we propose a Bayesian adaptive “platform” trial design that uses commensurate prior methods at interim analyses to borrow adaptively from the control group of an earlier-starting trial. The design adjusts the trial's randomization ratio in favor of the novel treatment when the interim posterior indicates commensurability of t he tw...
Source: Contemporary Clinical Trials - November 14, 2019 Category: Radiology Authors: James Normington, Jiawen Zhu, Federico Mattiello, Somnath Sarkar, Brad Carlin Source Type: research
CHECK: A randomized trial evaluating the efficacy and cost-effectiveness of home visitation in pediatric weight loss treatment
Socioeconomically-disadvantaged households have a high prevalence of pediatric overweight/obesity, and also face barriers to accessing weight loss treatment in healthcare settings. Delivering family-based pediatric weight loss treatment in the home setting may enhance its efficacy by facilitating treatment attendance, enabling more tailored treatment recommendations informed by observations of the home environment, and increasing accountability. This paper describes the design of the Creating Health Environments for Chicago Kids (CHECK) Trial, which evaluates the efficacy, cost-effectiveness, and mechanisms of home visitat...
Source: Contemporary Clinical Trials - November 14, 2019 Category: Radiology Authors: B.M. Appelhans, S.A. French, L.E. Bradley, K. Lui, I. Janssen, D. Richardson Source Type: research
A physician-initiated double-blind, randomised, placebo-controlled, phase 2 study evaluating the efficacy and safety of inhibition of NADPH oxidase with the first-in-class Nox-1/4 inhibitor, GKT137831, in adults with type 1 diabetes and persistently elevated urinary albumin excretion: protocol and statistical considerations
Kidney disease caused by type 1 diabetes can progress to end stage renal disease and can increase mortality risk. Nicotinamide adenine dinucleotide phosphate (NADPH) oxidase (Nox) plays a major role in producing oxidative stress in the kidney in diabetes, and its activity is attenuated by GKT137831, an oral Nox inhibitor with predominant inhibitory action on Nox-1 and Nox − 4. Previous studies have demonstrated renoprotective effects with GKT137831 in various experimental models of type 1 diabetes-related kidney disease. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - November 14, 2019 Category: Radiology Authors: Anne T. Reutens, Karin Jandeleit-Dahm, Merlin Thomas, Leon A. Bach, Peter G. Colman, Timothy M.E. Davis, Michael D'Emden, Elif I. Ekinci, Greg Fulcher, Peter Shane Hamblin, Mark A. Kotowicz, Richard J. MacIsaac, Claire Morbey, David Simmons, Georgia Solda Source Type: research
A Phase II randomized controlled trial for lung and diaphragm protective ventilation (Real-time Effort Driven VENTilator management)
Lung Protective mechanical ventilation (MV) of critically ill adults and children is lifesaving but it may decrease diaphragm contraction and promote Ventilator Induced Diaphragm Dysfunction (VIDD). An ideal MV strategy would balance lung and diaphragm protection. Building off a Phase I pilot study, we are conducting a Phase II controlled clinical trial that seeks to understand the evolution of VIDD in critically ill children and test whether a novel computer-based approach (Real-time Effort Driven ventilator management (REDvent)) can balance lung and diaphragm protective ventilation to reduce time on MV. (Source: Contempo...
Source: Contemporary Clinical Trials - November 14, 2019 Category: Radiology Authors: Robinder G. Khemani, Justin Hotz RCP, Margaret Klein, Jeni Kwok, Caron Park, Christiane Lane, Erin Smith RCP, Kristen Kohler RCP, Anil Suresh RCP, Dinnel Medina RCP, Patrick A. Ross, Timothy Deakers, Fernando Beltramo, Lara Nelson, Shilpa Shah, Anoopindar Source Type: research
The N-AcetylCysteine and RAMipril in Takotsubo Syndrome Trial (NACRAM): Rationale and design of a randomised controlled trial of sequential N-Acetylcysteine and ramipril for the management of Takotsubo Syndrome
Takotsubo Syndrome(TTS), contrary to historical reports, is now increasingly recognised to be associated with substantial mortality and morbidity, both in the short- and long-term. Although TTS is often precipitated by a catecholamine “pulse”, in-hospital hypotension is a common occurrence, increasing the risk of mortality. Furthermore, despite the transient catecholamine stimulus, there is increasing evidence that there are significant long term sequelae, including persistently impaired left ventricular(LV) systolic dysfunct ion, myocardial oedema with fibrosis, as well as persistent impairment of quality of life. (So...
Source: Contemporary Clinical Trials - November 14, 2019 Category: Radiology Authors: Gao Jing Ong, Thanh Ha Nguyen, Jeanette Stansborough, Sven Surikow, Gnanadevan Mahadavan, Matthew Worthley, John Horowitz Source Type: research
A pilot multisite study of patient navigation for pregnant women with opioid use disorder
The opioid crisis continues to affect pregnant and postpartum women the United States, with the number of pregnant women diagnosed with opioid use disorder (OUD) quadrupling over the last decade. The associated increase in morbidity and mortality among mother and baby warrants prompt, targeted intervention efforts that improve engagement, linkage of care, and treatment retention. Patient navigation (PN) is a chronic care intervention that can directly address this need by helping women identify medical, behavioral, and psychosocial care goals. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - November 11, 2019 Category: Radiology Authors: Gerald Cochran, Marcela Smid, Elizabeth E. Krans, M. Aryana Bryan, Adam J. Gordon, Brad Lundahl, John Silipigni, Benjamin Haaland, Ralph Tarter Source Type: research
A randomized, double-blind, multicenter, phase 2b study to evaluate the safety and efficacy of a combination of tropifexor and cenicriviroc in patients with nonalcoholic steatohepatitis and liver fibrosis: Study design of the TANDEM trial
Nonalcoholic steatohepatitis (NASH) is a multifactorial disease involving different contributing mechanisms, with no approved therapies so far. Tropifexor (TXR), a farnesoid X receptor agonist, and cenicriviroc (CVC), a chemokine receptor types 2/5 antagonist, target the steatotic, inflammatory, and/or fibrotic pathways involved in NASH. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - November 11, 2019 Category: Radiology Authors: Marcos Pedrosa, Star Seyedkazemi, Sven Francque, Arun Sanyal, Mary Rinella, Michael Charlton, Rohit Loomba, Vlad Ratziu, Jossy Kochuparampil, Laurent Fischer, Sujata Vaidyanathan, Quentin M. Anstee Source Type: research
Protocol for a systematically-developed, phase I/II, single-blind randomized controlled trial of treadmill walking exercise training effects on cognition and brain function in persons with multiple sclerosis
Slowed cognitive processing speed (CPS) is a common and debilitating consequence of multiple sclerosis (MS) that is notoriously difficult to treat. As such, we undertook a systematic line of research that indicated that supervised, progressive treadmill walking exercise (TMWX) training might improve CPS and brain functioning among fully-ambulatory persons with MS. The current study will be the first adequately-powered, single-blind randomized controlled trial (RCT) that examines the efficacy of 12-weeks of TMWX training compared with an active control condition on CPS, thalamocortical brain connectivity (based on resting-s...
Source: Contemporary Clinical Trials - November 4, 2019 Category: Radiology Authors: Brian M. Sandroff, M. David Diggs, Marcas M. Bamman, Gary R. Cutter, Jessica F. Baird, C. Danielle Jones, John R. Rinker, Glenn R. Wylie, John DeLuca, Robert W. Motl Source Type: research
Editorial Board
(Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 31, 2019 Category: Radiology Source Type: research
Preventing diabetes with digital health and coaching for translation and scalability (PREDICTS): A type 1 hybrid effectiveness-implementation trial protocol
Diabetes prevention remains a top public health priority; digital approaches are potential solutions to existing scalability and accessibility challenges. There remains a gap in our understanding of the relationship between effectiveness, costs, and potential for sustained implementation of digital diabetes prevention strategies within typical healthcare settings. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 31, 2019 Category: Radiology Authors: Fabio A. Almeida, Tzeyu L. Michaud, Kathryn E. Wilson, Robert J. Schwab, Cody Goessl, Gwenndolyn C. Porter, Fabiana A. Brito, Greg Evans, Emily V. Dressler, Ashley E. Boggs, Jeffrey A. Katula, Cynthia Castro Sweet, Paul A. Estabrooks Source Type: research
Bayesian Cancer clinical trial designs with subgroup-specific decisions
Two illustrative applications are presented of Bayesian clinical trial designs that make adaptive subgroup-specific decisions based on elicited utilities of patient outcomes to quantify risk-benefit trade-offs. The first design is for a randomized trial to evaluate effects of nutritional prehabilitation on post-operative morbidity in esophageal cancer patients undergoing surgery. The second design is for a dose-finding trial of natural killer cells to treat advanced hematologic malignancies, with five time-to-event outcomes. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 31, 2019 Category: Radiology Authors: Peter F. Thall Tags: Review Source Type: research
