Using artificial intelligence tools in answering important clinical questions: The KEYNOTE-183 multiple myeloma experience
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 imbalance in the number of deaths between arms. Clinically-led subgroup analyses are typically used to shed light on clinical findings. However, this approach is not always successful. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 18, 2020 Category: Radiology Authors: Jason J.Z. Liao, Mohammed Z.H. Farooqui, Patricia Marinello, Jonathan Hartzel, Keaven Anderson, Junshui Ma, Christine K. Gause Source Type: research
An adaptive clinical trial design for cocaine use disorder: Extended-release amphetamine salts for early behavioral intervention non-responders
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 risks. We aimed to find a model for determining the most appropriate patients for treatment with mixed amphetamine salts-extended-release (MAS-ER) for CUD using an adaptive trial design. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 18, 2020 Category: Radiology Authors: Derek Blevins, Kenneth M. Carpenter, Diana Martinez, John J. Mariani, Frances R. Levin Source Type: research
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
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 recurrent HD. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 17, 2020 Category: Radiology Authors: 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, St éphanie O. Breukink, On behalf of the Napoleon Trial Study Group Source Type: research
Innovation in the design of large-scale hybrid randomized clinical trials
(Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 17, 2020 Category: Radiology Authors: Pamela M. Rist, Howard D. Sesso, JoAnn E. Manson Source Type: research
Study protocol for a randomized controlled trial of mindfulness-based relapse prevention for opioid use disorders
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. This paper outlines a protocol for a randomized controlled trial of MBRP for opioid use disorders. MBRP is a group aftercare program that integrates mindfulness skills training with cognitive-behavioral relapse prevention strategies. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 17, 2020 Category: Radiology Authors: Heidi Zinzow, Lu Shi, Lior Rennert, Liwei Chen, Snehal Lopes, Lingling Zhang, Karyn Jones, Meenu Jindal, Claire Stam, Michael Mclain Source Type: research
Dec ídetexto: Mobile cessation support for latino smokers. study protocol for a randomized clinical trial
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. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 17, 2020 Category: Radiology Authors: 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 Source Type: research
Medical assistant health coaching ( “MAC”) for type 2 diabetes in diverse primary care settings: A pragmatic, cluster-randomized controlled trial protocol
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 the complex needs of individuals with diabetes. “Team-based” chronic care delivery is an alternative approach that supplements physician care with contact from allied health personnel in the primary care setting (e.g., medical assistants; MAs) who are specially trained to ...
Source: Contemporary Clinical Trials - October 10, 2020 Category: Radiology Authors: 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 Source Type: research
The vitamin D for COVID-19 (VIVID) trial: A pragmatic cluster-randomized design
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. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 9, 2020 Category: Radiology Authors: Rui Wang, Victor DeGruttola, Quanhong Lei, Kenneth H. Mayer, Susan Redline, Aditi Hazra, Samia Mora, Walter C. Willett, Davaasambuu Ganmaa, JoAnn E. Manson Source Type: research
The European NAFLD registry: A real-world longitudinal cohort study of nonalcoholic fatty liver disease
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 a necroinflammatory form of the disease (non-alcoholic steatohepatitis, NASH) that may progress to cirrhosis and hepatocellular carcinoma. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 8, 2020 Category: Radiology Authors: 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 Source Type: research
Semaglutide for the treatment of non-alcoholic steatohepatitis: Trial design and comparison of non-invasive biomarkers
We describe a trial of semaglutide treatment for NASH, identify key patient characteristics and compare the relationship of patient characteristics and non-invasive biomarkers/scores.NCT02970942 is a randomised, double-blind, placebo-controlled, multi-national Phase 2 trial of daily subcutaneous semaglutide (0.1 mg, 0.2 mg, 0.4 mg) in patients with biopsy-confirmed NASH, F1–F3 fibrosis, NAFLD Activity Score ≥ 4, and body mass index (BMI) > 25 kg/m2. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 8, 2020 Category: Radiology Authors: Stephen A. Harrison, Salvatore Calanna, Kenneth Cusi, Martin Linder, Takeshi Okanoue, Vlad Ratziu, Arun Sanyal, Anne-Sophie Sejling, Philip N. Newsome Source Type: research
A mHealth intervention to preserve and promote ideal cardiovascular health in college students: Design and protocol of a cluster randomized controlled trial
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 least 5 of the 7 components of cardiovascular health, this proportion falls to 16% by adulthood. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 6, 2020 Category: Radiology Authors: Angela F. Pfammatter, Katrina E. Champion, Laura E. Finch, Juned Siddique, Donald Hedeker, Bonnie Spring Source Type: research
A randomised, double-blind, placebo-controlled, multi-centre, dose-range, proof-of-concept, 24-week treatment study of lanifibranor in adult subjects with non-alcoholic steatohepatitis: Design of the NATIVE study
BackgroundNon-alcoholic steatohepatitis (NASH), a multifactorial disease, can progress to hepatic fibrosis and cirrhosis. The Peroxysomal Proliferator-Activated Receptors, PPAR α, β/δ and γ, play a central role in the regulation of glucose and lipid metabolism and of the inflammatory and fibrogenic pathways in liver and in other organs that all contribute to NASH pathogenesis. Lanifibranor (IVA337), a panPPAR agonist, by acting on these three different PPAR isotypes, c ombines pharmacological effects that could address the different components of the disease as demonstrated in preclinical models. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 6, 2020 Category: Radiology Authors: Francque Sven, Bedossa Pierre, F. Abdelmalek Manal, M. Anstee Quentin, Bugianesi Elisabetta, Ratziu Vlad, Huot-Marchand Philippe, Scherrer Bruno, Junien Jean-Louis, Broqua Pierre, Abitbol Jean-Louis Source Type: research
Facilitating smoking cessation using reduced nicotine cigarettes: Intervention development and RCT study design
Smoking cigarettes with substantially lower nicotine than conventional cigarettes prior to a quit attempt may reduce the reinforcing effects of smoking, which could facilitate smoking cessation through extinction learning. This paper describes the development of a smoking cessation intervention designed to optimize extinction processes using reduced nicotine cigarettes, as well as the design and methods for an ongoing randomized controlled trial (RCT) to evaluate this intervention. Qualitative methods and pilot testing were conducted to develop the novel facilitated extinction (FE) intervention, with a key focus on maximiz...
Source: Contemporary Clinical Trials - October 6, 2020 Category: Radiology Authors: Melissa R. Conn, Thomas H. Brandon, Yenis L. Lorenzo, Leslie E. Sawyer, Vani N. Simmons, Steven K. Sutton, Eric C. Donny, Dorothy Hatsukami, David J. Drobes Source Type: research
Protocol of a randomized trial of acceptance and commitment therapy for fatigue interference in metastatic breast cancer
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 shown potential for reducing symptom-related suffering in cancer patients. The current Phase II trial seeks to more definitively examine the efficacy of telephone-based ACT for women with metastatic breast cancer who are experiencing fatigue interference. (Source: C...
Source: Contemporary Clinical Trials - October 5, 2020 Category: Radiology Authors: 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 Source Type: research
A pharmacist intervention for monitoring and treating hypertension using bidirectional texting: PharmText BP
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 this study is to evaluate whether the BP texting approach combined with a pharmacist-based intervention improves BP management and to determine if the approach is cost effective. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 5, 2020 Category: Radiology Authors: 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 Source Type: research
