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Contemporary Clinical Trials

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https://www.readbyqxmd.com/read/28188841/bayesian-clinical-trial-design-using-markov-models-with-applications-to-autoimmune-disease
#1
Barry S Eggleston, Joseph G Ibrahim, Diane Catellier
Immune Thrombocytopenia is an autoimmune disease associated with bleeding that is treated by increasing the platelet count to a level where the chance of uncontrollable bleeding is low. Failure occurs when platelet counts are not raised sufficiently (initial failure), or when high platelet counts are not maintained after initial success (relapse). In this paper, we propose a Bayesian clinical trial design that uses a Markov multistate model along with a power prior for the parameters which incorporates historical control data to estimate transition rates among two randomized groups as defined by the model...
February 7, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28185996/rationale-design-and-baseline-data-of-a-cross-national-randomized-trial-on-the-effect-of-built-shade-in-public-parks-for-sun-protection
#2
David B Buller, Suzanne Dobbinson, Dallas R English, Melanie Wakefield, Mary Klein Buller
Environments can be structured to reduce solar ultraviolet radiation (UV) exposure to prevent skin cancer. A prospective randomized trial is being conducted to test whether introducing shade sails in passive recreation areas (PRAs) in public parks will increase use and decrease UV exposure in the shaded compared to unshaded PRAs. Shade effects will be compared between Melbourne, Australia and Denver, USA. The trial enrolled 145 public parks with PRAs suitable for shade construction and randomized parks to intervention or control in a 1:3 ratio...
February 7, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28185995/study-protocol-community-links-to-establish-alcohol-recovery-clear-for-women-leaving-jail
#3
Jennifer E Johnson, Yael Chatav Schonbrun, Bradley Anderson, Megan Kurth, Christine Timko, Michael Stein
PURPOSE: This article describes the protocol for a randomized effectiveness trial of a method to link alcohol use disordered women who are in pretrial jail detention with post-release 12-step mutual help groups. BACKGROUND: Jails serve 15 times more people per year than do prisons and have very short stays, posing few opportunities for treatment or treatment planning. Alcohol use is associated with poor post-jail psychosocial and health outcomes including sexually transmitted diseases and HIV, especially for women...
February 7, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28185994/motivational-interviewing-to-improve-self-care-in-heart-failure-patients-motivate-hf-study-protocol-of-a-three-arm-multicenter-randomized-controlled-trial
#4
Ercole Vellone, Marco Paturzo, Fabio D'Agostino, Antonio Petruzzo, Stefano Masci, Davide Ausili, Paola Rebora, Rosaria Alvaro, Barbara Riegel
AIMS: Heart Failure (HF) self-care improves patient outcomes but trials designed to improve HF self-care have shown inconsistent results. Interventions may be more effective in improving self-care if they mobilize support from providers, promote self-efficacy, increase understanding of HF, increase the family involvement, and are individualized. All of these elements are emphasized in motivational interviewing (MI); few trials have been conducted using MI in HF patients and rarely have caregivers been involved in MI interventions...
February 7, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28185997/rationale-and-design-of-asteroid-2-a-randomized-placebo-and-active-comparator-controlled-study-to-assess-the-efficacy-and-safety-of-vilaprisan-in-patients-with-uterine-fibroids
#5
Christian Seitz, Žana Bumbuliene, Ana Rosa Costa, Oskari Heikinheimo, Andrea Heweker, Robert Hudeček, Yves Jacquemyn, Gian Benedetto Melis, Pooja Parashar, Tomasz Rechberger, Antonio Cano Sánchez, Bart Van Aken, János Zatik, Kristina Gemzell-Danielsson
BACKGROUND: Uterine fibroids (UFs) may be treated with progesterone receptor modulators (PRMs), which have been shown to reduce heavy menstrual bleeding and the size of UFs. To date, one PRM (ulipristal acetate) has received regulatory approval for the treatment of UFs; therapy comprises intermittent treatment courses of up to 3months each, followed by a break to allow two menstruations to occur. We report the design of ASTEROID (Assess Safety and efficacy of vilaprisan in patients with uTERine fibrOIDs) 2, a phase 2 study examining the efficacy and safety of a novel PRM, vilaprisan, in women with UFs...
February 6, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28159703/cognitive-behavioral-therapy-for-insomnia-in-stable-heart-failure-protocol-for-a-randomized-controlled-trial
#6
Nancy S Redeker, Andrea K Knies, Christopher Hollenbeak, H Klar Yaggi, John Cline, Laura Andrews, Daniel Jacoby, Anna Sullivan, Meghan O'Connell, Joanne Iennaco, Lisa Finoia, Sangchoon Jeon
BACKGROUND: Chronic insomnia is associated with disabling symptoms and decrements in functional performance. It may contribute to the development of heart failure (HF) and incident mortality. In our previous work, cognitive-behavioral therapy for insomnia (CBT-I), compared to HF self-management education, provided as an attention control condition, was feasible, acceptable, and had large effects on insomnia and fatigue among HF patients. OBJECTIVES: The purpose of this randomized controlled trial (RCT) is to evaluate the sustained effects of group CBT-I compared with HF self-management education (attention control) on insomnia severity, sleep characteristics, daytime symptoms, symptom clusters, functional performance, and health care utilization among patients with stable HF...
January 31, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28153768/physical-activity-behavior-change-for-older-veterans-after-dysvascular-amputation
#7
Matthew J Miller, Jennifer Stevens-Lapsley, Thomas T Fields, David Coons, Susan Bray-Hall, William Sullivan, Cory L Christiansen
OBJECTIVE: Determine the feasibility of using a physical-activity behavior-change (PABC) intervention for increasing physical activity and reducing disability in Veterans 1-5years following dysvascular lower-limb amputation (LLA). DESIGN: Cross-over, feasibility trial SETTING: VA Geriatric Research Education and Clinical Center and Veterans Homes PARTICIPANTS: 32 Veterans with dysvascular LLA (1-5years after major LLA) INTERVENTION: The home-based study, using telerehabilitation technology, is intended to reduce participant burden by removing transportation and time barriers...
January 31, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28132876/study-protocol-the-technology-enhanced-coaching-tec-program-to-improve-diabetes-outcomes-a-randomized-controlled-trial
#8
Michele Heisler, Rebecca Mase, Brianne Brown, Shayla Wilson, Pamela J Reeves
No abstract text is available yet for this article.
January 27, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28126455/a-coaching-by-telephone-intervention-for-veterans-and-care-team-engagement-activate-a-study-protocol-for-a-hybrid-type-i-effectiveness-implementation-randomized-controlled-trial
#9
Eugene Z Oddone, Laura J Damschroder, Jennifer Gierisch, Maren Olsen, Angela Fagerlin, Linda Sanders, Jordan Sparks, Marsha Turner, Carrie May, Felicia McCant, David Curry, Courtney White-Clark, Karen Juntilla
INTRODUCTION: A large proportion of deaths and many illnesses can be attributed to three modifiable risk factors: tobacco use, overweight/obesity, and physical inactivity. Health risk assessments (HRAs) are widely available online but have not been consistently used in healthcare systems to activate patients to participate in prevention programs aimed at improving lifestyle behaviors. OBJECTIVES: The goal of this study is to test whether adding telephone-based coaching to use of a comprehensive HRA increases at-risk patients' activation and enrollment into a prevention program compared to HRA use alone...
January 24, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28011388/dietary-intervention-for-glucose-tolerance-in-teens-dig-it-protocol-of-a-randomized-controlled-trial-using-health-coaching-to-prevent-youth-onset-type-2-diabetes
#10
Kelly A Wagner, Ethan Braun, Seth M Armah, Diarmuid Horan, Lisa G Smith, Julie Pike, Wanzhu Tu, Marc T Hamilton, Edward J Delp, Wayne W Campbell, Carol J Boushey, Tamara S Hannon, Nana Gletsu-Miller
BACKGROUND: Youth-onset type 2 diabetes (T2D) is a disease that is newly emerging and behavioral strategies for its prevention are limited. Interventions that target the lifestyle behaviors of adolescents, to improve poor dietary quality and reduce excessive sedentariness, promise to reduce the risk of developing T2D. Health coaching is effective for promoting healthy behaviors in patients who have chronic disease, but few experimental studies are in adolescents. This randomized controlled trial, in adolescents with prediabetes, will determine the effectiveness of a health coaching intervention to facilitate adoption of healthy diet and activity behaviors that delay or prevent development of T2D...
December 21, 2016: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28011387/the-kidney-and-periodontal-disease-kapd-study-a-pilot-randomized-controlled-trial-testing-the-effect-of-non-surgical-periodontal-therapy-on-chronic-kidney-disease
#11
Vanessa Grubbs, Faviola Garcia, Bonnie L Jue, Eric Vittinghoff, Mark Ryder, David Lovett, Jacqueline Carrillo, Steven Offenbacher, Peter Ganz, Kirsten Bibbins-Domingo, Neil R Powe
INTRODUCTION: Chronic kidney disease (CKD) remains a prevalent public health problem that disproportionately affects minorities and the poor, despite intense efforts targeting traditional risk factors. Periodontal diseases are common bacterial plaque-induced inflammatory conditions that can respond to treatment and have been implicated as a CKD risk factor. However there is limited evidence that treatment of periodontal disease slows the progression of CKD. METHODS/DESIGN: We describe the protocol of the Kidney and Periodontal Disease (KAPD) study, a 12-month un-blinded, randomized, controlled pilot trial with two intent-to-treat treatment arms: 1...
December 20, 2016: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28007633/the-go-actiwe-randomized-controlled-trial-an-interdisciplinary-study-designed-to-investigate-the-health-effects-of-active-commuting-and-leisure-time-physical-activity
#12
Mads Rosenkilde, Martin Bæk Petersen, Anne Sofie Gram, Jonas Salling Quist, Jonas Winther, Simon Due Kamronn, Desirée Hornbæk Milling, Jakob Eg Larsen, Astrid Pernille Jespersen, Bente Stallknecht
Regular physical activity is efficacious for improving metabolic health in overweight and obese individuals, yet, many adults lead sedentary lives. Most exercise interventions have targeted leisure time, but physical activity also takes place in other domains of everyday life. Active commuting represents a promising alternative to increase physical activity, but it has yet to be established whether active commuting conveys health benefits on par with leisure time physical activity (LTPA). A 6-month randomized controlled trial was designed to investigate the effects of increased physical activity in transport (bicycling) or leisure time domains (moderate or vigorous intensity endurance exercise)...
December 19, 2016: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/27979753/healthy-caregivers-healthy-children-hc2-phase-2-integrating-culturally-sensitive-childhood-obesity-prevention-strategies-into-childcare-center-policies
#13
Sarah E Messiah, Cynthia Lebron, Rhoda Moise, M Sunil Mathew, Krystal Sardinas, Catherina Chang, Joanne Palenzuela, Jennifer Walsh, Karla P Shelnutt, Rachel Spector, Fiorella Altare, Ruby Natale
OBJECTIVE: Despite the high prevalence of obesity among preschool-aged children, most states lack childcare center (CCC) nutrition and physical activity policies. The Healthy Caregivers, Healthy Children (HC) Phase 2 project is examining the relationship between the CCC nutrition and physical activity environment and child dietary intake/physical activity patterns and body mass index (BMI). PARTICIPANTS: A total of 24 "Quality Counts" (Miami Dade County, Florida's Quality Rating Improvement System [QRIS)]) CCCs serving low resource families with ≥50 2-to-5year olds attending have been randomized to either intervention (n=12) or control (n=12)...
December 12, 2016: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/27940188/effectiveness-of-adjunctive-personalised-psychosocial-intervention-for-non-response-to-opioid-agonist-treatment-study-protocol-for-a-pragmatic-randomised-controlled-trial
#14
John Marsden, Garry Stillwell, Jennifer Hellier, Anne Marie Brown, Sarah Byford, Michael Kelleher, Joanne Kelly, Caroline Murphy, James Shearer, Luke Mitcheson
INTRODUCTION: Opioid use disorder (OUD) is a debilitating and relapsing psychiatric disorder; opioid agonist therapy (OAT) is the front-line, evidence-supported treatment. A substantial number of patients relapse or continue to use heroin or other illicit drugs during OAT. There is considerable heterogeneity in the OAT-resistant sub-population, with many behavioural moderators of treatment response. We have developed a personalised psychosocial intervention (PSI) targeting these individuals...
December 8, 2016: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/27940185/surrogacy-of-progression-free-survival-for-overall-survival-in-metastatic-breast-cancer-studies-meta-analyses-of-published-studies
#15
Madan G Kundu, Suddhasatta Acharyya
PURPOSE: PFS is often used as a surrogate endpoint for OS in metastatic breast cancer studies. We have evaluated the association of treatment effect on PFS with significant HROS (and how this association is affected by other factors) in published prospective metastatic breast cancer studies. METHODS: A systematic literature search in PubMed identified prospective metastatic breast cancer studies. Treatment effects on PFS were determined using hazard ratio (HRPFS), increase in median PFS (ΔMEDPFS) and % increase in median PFS (%ΔMEDPFS)...
December 8, 2016: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/27940183/randomized-controlled-dissemination-study-of-community-to-clinic-navigation-to-promote-crc-screening-study-design-and-implications
#16
Linda Larkey, Laura Szalacha, Patricia Herman, Julie Gonzalez, Usha Menon
INTRODUCTION: Regular screening facilitates early diagnosis of colorectal cancer (CRC) and reduction of CRC morbidity and mortality. Screening rates for minorities and low-income populations remain suboptimal. Provider referral for CRC screening is one of the strongest predictors of adherence, but referrals are unlikely among those who have no clinic home (common among poor and minority populations). METHODS/STUDY DESIGN: This group randomized controlled study will test the effectiveness of an evidence based tailored messaging intervention in a community-to-clinic navigation context compared to no navigation...
December 7, 2016: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28153769/letter-to-the-editor-in-response-to-n-folschweiller-v-berlaimont-sr-skinner-cm-wheeler-n-karkada-f-struyf-m-ryser-letter-to-the-editor-in-response-to-o-m-bautista-a-luxembourg-deconstructing-the-measure-of-vaccine-efficacy-against-disease-irrespective-of-hpv
#17
LETTER
https://www.readbyqxmd.com/read/28104470/a-cluster-randomized-trial-of-a-primary-palliative-care-intervention-connect-for-patients-with-advanced-cancer-protocol-and-key-design-considerations
#18
Claire L Becker, Robert M Arnold, Seo Young Park, Margaret Rosenzweig, Thomas J Smith, Douglas B White, Kenneth J Smith, Yael Schenker
BACKGROUND: The addition of specialty palliative care to standard oncology care improves outcomes for patients with advanced cancer and their caregivers, but many lack access to specialty care services. Primary palliative care-meaning basic palliative care services provided by clinicians who are not palliative care specialists-is an alternative approach that has not been rigorously evaluated. METHODS: A cluster randomized, controlled trial of the CONNECT (Care management by Oncology Nurses to address supportive care needs) intervention, an oncology nurse-led care management approach to providing primary palliative care for patients with advanced cancer and their family caregivers, is currently underway at 16 oncology practices in Western Pennsylvania...
March 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28104469/culturally-grounded-diabetes-prevention-program-for-obese-latino-youth-rationale-design-and-methods
#19
Allison N Williams, Yolanda P Konopken, Colleen S Keller, Felipe Gonzalez Castro, Kimberly J Arcoleo, Estela Barraza, Donald L Patrick, Micah L Olson, Gabriel Q Shaibi
BACKGROUND: Type 2 diabetes (T2D) disproportionately impacts Latino youth yet few diabetes prevention programs address this important source of health disparities. OBJECTIVES: To address this knowledge gap, we describe the rationale, design, and methodology underpinning a culturally-grounded T2D prevention program for obese Latino youth. The study aims to: 1) to test the efficacy of the intervention for reducing T2D risk, 2) explore potential mediators and moderators of changes in health behaviors and health outcomes and, 3) examine the incremental cost-effectiveness for reducing T2D risk...
March 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28089764/promoting-weight-maintenance-with-electronic-health-record-tools-in-a-primary-care-setting-baseline-results-from-the-maintain-pc-trial
#20
Molly B Conroy, Cindy L Bryce, Kathleen M McTigue, Dana Tudorascu, Bethany Barone Gibbs, Diane Comer, Rachel Hess, Kimberly Huber, Laurey R Simkin-Silverman, Gary S Fischer
Maintaining weight loss is a significant challenge in combating obesity. The goal of Maintaining Activity and Nutrition through Technology-Assisted Innovation in Primary Care (MAINTAIN-pc) is to evaluate the use of tools delivered through an electronic health record (EHR) and patient portal, with or without health coach support, to help primary care patients maintain weight loss. EHR tools include flowsheets, standardized surveys, and secure patient messaging. Inclusion criteria were age 18-75years, voluntary 5% weight loss in the past 2years with prior BMI≥25kg/m(2), and no bariatric procedures in past 5years...
March 2017: Contemporary Clinical Trials
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