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Contemporary Clinical Trials

Sarah H Ailey, Arlene M Miller, Olimpia Paun, Michael Schoeny, Tricia Johnson, Teresa Moro, Arthur Nezu, Tamar Heller, Janet Melby
Aggressive/challenging behaviors (A/CB) are a major public health problem for individuals with intellectual disabilities (ID). A leading reason for psychiatric hospitalizations and incarcerations, such behaviors are costly to the health care system, agencies, and families. Social problem-solving (SPS) training programs for individuals with ID have had positive behavioral results, but most were conducted in clinical or forensic settings. None was a community-based preventive intervention, none examined whether the behaviors decreased in residential and work settings, and none addressed cost-effectiveness...
July 18, 2018: Contemporary Clinical Trials
J Fanning, M T Opina, I Leng, M F Lyles, B J Nicklas, W J Rejeski
Promoting lasting weight loss among older adults is an important public health challenge. Participation in physical activity aids in weight loss and is important for the maintenance of physical function and quality of life. However, traditional intensive lifestyle interventions place a focus on discrete bouts of structured activity, leaving much of the remainder of the day for sedentary behavior. Structured exercise and weight loss programs often produce short-term weight loss that is typically followed by weight regain, and older adults are more likely to regain weight as fat mass rather than lean mass...
July 16, 2018: Contemporary Clinical Trials
Dmitry Ponomarev, Vladimir Boboshko, Vladimir Shmyrev, Igor Kornilov, Ilya Bondarenko, Ilya Soynov, Alexey Voytov, Stanislav Polyanskih, Oleg Strunin, Alexander Bogachev, Giovanni Landoni, Caetano Nigro Neto, Gretel Oliveira Nicolau, Zhang Wen, Mikhail Evdokimov, Shahrijar Sulejmanov, Aleksei Chernogrivov, Alexander Karaskov, Vladimir Lomivorotov
No abstract text is available yet for this article.
July 14, 2018: Contemporary Clinical Trials
Keith C Norris, M Edwina Barnett, Yuan-Xiang Meng, David Martins, Susanne B Nicholas, Gary H Gibbons, Jae Eun Lee
Cardiovascular Disease (CVD) and related disorders remain a leading cause of health disparities and premature death for African Americans. Hypovitaminosis D is disproportionately prevalent in African Americans and has been linked to CVD and CVD risk factors including hypertension, diabetes, and obesity. Thus, hypovitaminosis D may represent a common pathway influencing CV risk factors in a select subgroup of persons. The purpose of this paper is to report the study design of a prospective eight week prospective double-blind randomized, placebo-controlled trial (n = 330 allocated 2:1 to intervention vs...
July 13, 2018: Contemporary Clinical Trials
Lisa M Lowenstein, Kamisha Escoto, Viola B Leal, Linda Bailey, Terry B Bevers, Scott B Cantor, Paul M Cinciripini, Lianne Epstein, Angelina Esparza, Myrna Godoy, Ashley J Housten, Heather Lin, Pamela Luckett, Reginald F Munden, Vance A Rabius, Robert J Volk
PURPOSE: We describe the methods, stakeholder engagement, and lessons learned from a study comparing the a video decision aid to standard educational materials on lung cancer screening decisions. METHODS: The study followed rigorous methodology standards from the Patient-Centered Outcomes Research Institute. The importance of patient-centeredness and patient/stakeholder engagement are reflected across the study's conceptualization, execution, interpretation, and dissemination efforts...
July 13, 2018: Contemporary Clinical Trials
Jennifer Dahne, Amy E Wahlquist, Amy S Boatright, Elizabeth Garrett-Mayer, Douglas O Fleming, Robert Davis, Brent Egan, Matthew J Carpenter
BACKGROUND: Primary care is the most important point of healthcare contact for smokers. Brief physician advice to quit, based on the 5As/AAR model, offers some efficacy but is inconsistently administered and has limited population impact. Nicotine replacement therapy (NRT) sampling, defined as provision of a brief NRT starter kit, when added to the 5As/AAR, is well-suited to primary care because it is simple, brief, and can be provided to all smokers. This article describes the design and methods of an ongoing comparative effectiveness trial testing standard care vs...
July 12, 2018: Contemporary Clinical Trials
Martha A Q Curley, R Scott Watson, Amy M Cassidy, Cheryl Burns, Rachel L Delinger, Derek C Angus, Lisa A Asaro, David Wypij, Sue R Beers
There is increasing concern that sedatives commonly used during critical illness may be neurotoxic during the period of early brain development. The Sedation strategy and cognitive outcome after critical illness in early childhood (RESTORE-cognition) study is a prospective cohort study designed to examine the relationships between sedative exposure during pediatric critical illness and long-term neurocognitive outcomes. We assess multiple domains of neurocognitive function 2.5-5 years post-hospital discharge, at a single time point and depending on participant and clinician availability, in up to 500 subjects who had normal baseline cognitive function, were aged 2 weeks to 8 years at pediatric intensive care unit admission, and were enrolled in a cluster randomized controlled trial of a sedation protocol (the RESTORE trial; U01 HL086622 and HL086649)...
July 11, 2018: Contemporary Clinical Trials
Rae Jean Proeschold-Bell, Donna M Evon, Christina Makarushka, John B Wong, Santanu K Datta, Jia Yao, Ashwin A Patkar, Paolo Mannelli, Terra Hodge, Susanna Naggie, Julius M Wilder, Michael W Fried, Donna Niedzwiecki, Andrew J Muir
INTRODUCTION: Among patients with hepatitis C virus (HCV) infection, alcohol synergistically increases the risk of cirrhosis, hepatocellular carcinoma, and death. Randomized controlled trials of integrated models of HCV-alcohol treatment have been recommended but only performed in patients with severe alcohol use disorders. OBJECTIVES: This pragmatic randomized controlled trial seeks to compare clinical effectiveness and cost-effectiveness of integrated alcohol treatment compared to enhanced treatment as usual (TAU) on alcohol consumption and economic outcomes among patients ever infected with HCV...
July 10, 2018: Contemporary Clinical Trials
Frank J Penedo, Michael H Antoni, Patricia I Moreno, Lara Traeger, Dolores Perdomo, Jason Dahn, Gregory E Miller, Steve Cole, Julian Orjuela, Edgar Pizarro, Betina Yanez
Almost 2.8 million men in the U.S. are living with prostate cancer (PC), accounting for 40% of all male cancer survivors. Men diagnosed with prostate cancer may experience chronic and debilitating treatment side effects, including sexual and urinary dysfunction, pain and fatigue. Side effects can be stressful and can also lead to poor psychosocial functioning. Prior trials reveal that group-based cognitive behavioral stress and self-management (CBSM) is effective in reducing stress and mitigating some of these symptoms, yet little is known about the effects of culturally-translated CBSM among Spanish-speaking men with PC...
July 9, 2018: Contemporary Clinical Trials
Cong Chen, Xiaoyun Nicole Li, Wen Li, Robert A Beckman
It is well documented in this genomic era that an investigational new drug may have greater treatment effect in a biomarker positive population than in the biomarker negative population. However, limited by preclinical data and early phase clinical data, a lot of Phase 3 confirmatory trials are initiated without fully understanding the biomarker effect. In this article, we will investigate the impact of adaptive population expansion on the overall Type I error in two statistical designs. The endpoint for making the adaptive decision can be different from the primary endpoint of the study...
July 5, 2018: Contemporary Clinical Trials
Robert W Motl, Brian M Sandroff, Brooks C Wingo, Justin McCroskey, Lara A Pilutti, Gary R Cutter, Rachel E Bollaert, Edward McAuley
BACKGROUND: We propose a phase-III, randomized controlled trial(RCT) that examines the effectiveness of a behavioral intervention based on social cognitive theory(SCT) and delivered through the Internet using e-learning approaches for increasing physical activity and secondary outcomes (e.g., symptoms) in a large sample of people with multiple sclerosis (MS) residing throughout the United States. METHODS/DESIGN: The proposed phase-III trial will use a parallel group, RCT design that examines the effect of a 6-month behavioral intervention for increasing physical activity and secondarily improving mobility, cognition, symptoms, and quality of life(QOL) in persons with MS...
June 26, 2018: Contemporary Clinical Trials
Valentina Nekljudova, Sibylle Loibl, Gunter von Minckwitz, Andreas Schneeweiss, Stefan Glück, Richard Crane, Huiling Li, Xiaolong Luo
BACKGROUND: The US Food and Drug Administration and European Medicines Agency have published guidance for industry on the use of pathologic complete response (pCR) as a surrogate endpoint to accelerate the regulatory approval of neoadjuvant agents in high-risk early-stage breast cancer (EBC). Three meta-analyses, the CTNeoBC consortium (Cortazar 2014), Berruti [22], and Korn (2016), evaluated the association between the pCR odds ratio and the event hazards ratio but did not identify strong trial-level associations...
June 26, 2018: Contemporary Clinical Trials
Wen-Chih Wu, Melanie Parent, Sandesh Dev, Rene Hearns, Tracey H Taveira, Lisa Cohen, Jeneen Shell-Boyd, Jeri Jewett-Tennant, Vanessa Marshall, Julie Gee, Kimberley Schaub, Sharon LaForest, Sherry Ball
A primary goal of this research project is to better understand how shared medical appointments (SMAs) can improve the health status and decrease hospitalization and death for patients recently discharged with heart failure (HF) by providing education, disease state monitoring, medication titration, and social support to patients and their caregivers. We propose a 3-site randomized-controlled efficacy trial with mixed methods to test a SMA intervention, versus usual care. Patients within 12 weeks of a HF hospitalization will be randomized to receive either HF-SMA (intervention arm) with optional co-participation with their caregivers, versus usual care (control arm)...
June 22, 2018: Contemporary Clinical Trials
Christopher W Kahler, Anthony Surace, E F Rebecca, B A Gordon, Patricia A Cioe, Nichea S Spillane, Acacia Parks, Beth C Bock, Richard A Brown
BACKGROUND: Despite reductions in cigarette smoking in the U.S., improvements in the efficacy of smoking cessation treatments are needed, as rates of sustained abstinence remain disappointingly low. Both low positive affect and high negative affect contribute to smoking relapse and constitute viable targets for smoking cessation interventions. Although some clinical trials have evaluated interventions to address depression as a smoking relapse risk factor, very few have focused on positive affect...
June 21, 2018: Contemporary Clinical Trials
Kristen M Cunanan, Joseph S Koopmeiners
Traditionally, Phase I oncology trials evaluate the safety profile of a novel agent and identify a maximum tolerable dose based on toxicity alone. With the development of biologically targeted agents, investigators believe the efficacy of a novel agent may plateau or diminish before reaching the maximum tolerable dose while toxicity continues to increase. This motivates dose-finding based on the simultaneous evaluation of toxicity and efficacy. Previously, we investigated hierarchical modeling in the context of Phase I dose-escalation studies for multiple populations and found borrowing strength across populations improved operating characteristics...
June 21, 2018: Contemporary Clinical Trials
Sepali Guruge, Kenneth Po-Lun Fung, Souraya Sidani, David Este, Marina Morrow, Kwame McKenzie, Josephine Pui-Hing Wong
BACKGROUND: The available evidence on interventions addressing the stigma of mental illness is limited because of small samples, lack of diversity in study samples, and exclusion of people living with mental illness. To date, no published studies have evaluated anti-stigma interventions for Asian men in Canada. Aim This paper describes the protocol of a study to evaluate psychological and collective empowerment interventions (ACT, CEE, and ACT+CEE) in addressing self-stigma and social stigma in Asian communities in three urban settings in Canada: Toronto, Calgary and Vancouver...
June 19, 2018: Contemporary Clinical Trials
Bev Zabler, Pei-Yun Tsai, Michael Fendrich, Young Cho, Murad Taani, Rachel Schiffman
No abstract text is available yet for this article.
June 14, 2018: Contemporary Clinical Trials
N Metrebian, T Weaver, S Pilling, J Hellier, S Byford, J Shearer, L Mitcheson, M Astbury, P Bijral, N Bogdan, O Bowden-Jones, E Day, J Dunn, E Finch, S Forshall, A Glasper, G Morse, S Akhtar, J Bajaria, C Bennett, E Bishop, V Charles, C Davey, R Desai, C Goodfellow, F Haque, N Little, H McKechnie, J Morris, F Mosler, J Mutz, R Pauli, D Poovendran, E Slater, J Strang
There are approximately 256,000 heroin and other opiate users in England of whom 155,000 are in treatment for heroin (or opiate) addiction. The majority of people in treatment receive opiate substitution treatment (OST) (methadone and buprenorphine). However, OST suffers from high attrition and persistent heroin use even whilst in treatment. Contingency management (CM) is a psychological intervention based on the principles of operant conditioning. It is delivered as an adjunct to existing evidence based treatments to amplify patient benefit and involves the systematic application of positive reinforcement (financial or material incentives) to promote behaviours consistent with treatment goals...
June 13, 2018: Contemporary Clinical Trials
Polly Ryan, Paula Papanek, Mary Ellen Csuka, Melissa E Brown, Sarah Hopkins, Shelly Lynch, Victoria Scheer, Andrea Schlidt, Ke Yan, Pippa Simpson, Ray Hoffman
BACKGROUND: Osteoporosis is a prevalent and debilitating condition affecting >50% of post-menopausal women. Yet, a low percentage of women regularly engage in health promoting behaviors associated with osteoporosis prevention. Complex, multidimensional, m-Health interventions hold promise to effect engagement in health behavior change related to calcium and vitamin D intake, balance, core and leg strength, and physical activity. METHODS: Striving to be Strong study (R01NR013913-01) tests the efficacy of a research and theory based, patient centered, dynamically tailored intervention delivered via smart phone apps...
June 9, 2018: Contemporary Clinical Trials
Jeffrey Thiboutot, Hans J Lee, Gerard A Silvestri, Alex Chen, Momen M Wahidi, Christopher R Gilbert, Nicholas J Pastis, Jenna Los, Alexa M Barriere, Christopher Mallow, Benjamin Salwen, Marcus J Dinga, Eric L Flenaugh, Jason A Akulian, Roy Semaan, Lonny B Yarmus
BACKGROUND: Pulmonary nodules are a common but difficult issue for physicians as most identified on imaging are benign but those identified early that are cancerous are potentially curable. Multiple diagnostic options are available, ranging from radiographic surveillance, minimally invasive biopsy (bronchoscopy or transthoracic biopsy) to more invasive surgical biopsy/resection. Each technique has differences in diagnostic yield and complication rates with no established gold standard...
June 7, 2018: Contemporary Clinical Trials
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