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Contemporary Clinical Trials

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https://www.readbyqxmd.com/read/28414147/public-access-to-clinical-trials-lessons-from-an-organizational-implementation-of-policy
#1
Grant D Huang, Jane K Altemose, Timothy J O'Leary
Efforts to make clinical trials and their results more publicly available have been increasing in recent years. However, there is a need to better understand ways to achieve these goals aimed at benefiting a diverse set of stakeholders. Since 2005, the U.S. Department of Veterans Affairs Office of Research and Development (ORD), part of the nation's largest integrated health care system, has required the clinical trials its funds to be registered in ClinicalTrials.gov as a condition of the award. Furthermore, summary results of studies active since 2007 have been included in the registry...
April 13, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28412230/oral-health-4-life-design-and-methods-of-a-semi-pragmatic-randomized-trial-to-promote-oral-health-care-and-smoking-abstinence-among-tobacco-quitline-callers
#2
Jennifer B McClure, Paula R Blasi, Andrea Cook, Terry Bush, Paul Fishman, Jennifer Nelson, Melissa L Anderson, Sheryl L Catz
Smokers are at high risk for oral disease. As a result, they represent an important target group for population-level, public oral health promotion efforts. While dental health professionals often address smoking with their patients, no systematic efforts have been made to offer smokers an intervention to improve their use of oral health care. This paper details the rationale, design, and methods of a large, semi-pragmatic, randomized clinical trial designed to address this gap. Participants are recruited via the Oregon, Nebraska and Louisiana state-sponsored tobacco quitlines and randomized to receive standard quitline care versus standard care plus a multi-modal oral health promotion program (Oral Health 4 Life) integrated within the quitline services...
April 12, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28408335/optimizing-delivery-of-a-behavioral-pain-intervention-in-cancer-patients-using-a-sequential-multiple-assignment-randomized-trial-smart
#3
Sarah A Kelleher, Caroline S Dorfman, Jen C Plumb Vilardaga, Catherine Majestic, Joseph Winger, Vicky Gandhi, Christine Nunez, Alyssa Van Denburg, Rebecca A Shelby, Shelby D Reed, Susan Murphy, Marie Davidian, Eric B Laber, Gretchen G Kimmick, Kelly W Westbrook, Amy P Abernethy, Tamara J Somers
BACKGROUND/AIMS: Pain is common in cancer patients and results in lower quality of life, depression, poor physical functioning, financial difficulty, and decreased survival time. Behavioral pain interventions are effective and nonpharmacologic. Traditional randomized controlled trials (RCT) test interventions of fixed time and dose, which poorly represent successive treatment decisions in clinical practice. We utilize a novel approach to conduct a RCT, the sequential multiple assignment randomized trial (SMART) design, to provide comparative evidence of: 1) response to differing initial doses of a pain coping skills training (PCST) intervention and 2) intervention dose sequences adjusted based on patient response...
April 11, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28385653/optimizing-adaptive-design-for-phase-2-dose-finding-trials-incorporating-long-term-success-and-financial-considerations-a-case-study-for-neuropathic-pain
#4
Jingjing Gao, Narinder Nangia, Jia Jia, James Bolognese, Jaydeep Bhattacharyya, Nitin Patel
In this paper, we propose an adaptive randomization design for Phase 2 dose-finding trials to optimize Net Present Value (NPV) for an experimental drug. We replace the traditional fixed sample size design (Patel, et al., 2012) by this new design to see if NPV from the original paper can be improved. Comparison of the proposed design to the previous design is made via simulations using a hypothetical example based on a Diabetic Neuropathic Pain Study.
April 4, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28366780/design-of-a-pragmatic-trial-in-minority-children-presenting-to-the-emergency-department-with-uncontrolled-asthma-the-chicago-plan
#5
Jerry A Krishnan, Molly A Martin, Cortland Lohff, Giselle S Mosnaim, Helen Margellos-Anast, Julie A DeLisa, Kate McMahon, Kim Erwin, Leslie S Zun, Michael L Berbaum, Michael McDermott, Nina E Bracken, Rajesh Kumar, S Margaret Paik, Sharmilee M Nyenhuis, Stacy Ignoffo, Valerie G Press, Zachary E Pittsenbarger, Trevonne M Thompson
Among children with asthma, black children are two to four times as likely to have an emergency department (ED) visit and die from asthma, respectively, compared to white children in the United States. Despite the availability of evidence-based asthma management guidelines, minority children are less likely than white children to receive or use effective options for asthma care. The CHICAGO Plan is a three-arm multi-center randomized pragmatic trial of children 5 to 11years old presenting to the ED with uncontrolled asthma that compares: [1] an ED-focused intervention to improve the quality of care on discharge to home, [2] the same ED-focused intervention together with a home-based community health worker (CHW)-led intervention, and [3] enhanced usual care...
March 31, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28344183/teen-heed-design-of-a-clinical-community-youth-diabetes-prevention-intervention
#6
Nita Vangeepuram, Narissa Williams, Jeremy Constable, Lindsey Waldman, Patricia Lopez-Belin, LaTanya Phelps-Waldropt, Carol R Horowitz
No abstract text is available yet for this article.
March 23, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28342990/telephone-adapted-mindfulness-based-stress-reduction-tmbsr-for-patients-awaiting-kidney-transplantation
#7
Cynthia R Gross, Maryanne Reilly-Spong, Taehwan Park, Ruizhi Zhao, Olga V Gurvich, Hassan N Ibrahim
BACKGROUND: Patients with progressive kidney disease experience increasing physiologic and psychosocial stressors and declining health-related quality of life (HRQOL). METHODS: We conducted a randomized, active-controlled, open-label trial to test whether a Mindfulness-based Stress Reduction (MBSR) program delivered in a novel workshop-teleconference format would reduce symptoms and improve HRQOL in patients awaiting kidney transplantation. Sixty-three transplant candidates were randomized to one of two arms: i) telephone-adapted MBSR (tMBSR, an 8-week program of meditation and yoga); or ii) a telephone-based support group (tSupport)...
March 22, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28342989/patient-engagement-and-study-design-of-prop-up-a-multi-site-patient-centered-prospective-observational-study-of-patients-undergoing-hepatitis-c-treatment
#8
Donna M Evon, Carol E Golin, Paul Stewart, Michael W Fried, Shani Alston, Bryce Reeve, Anna S Lok, Richard K Sterling, Joseph K Lim, Nancy Reau, Souvik Sarkar, David R Nelson, K R Reddy, Adrian M Di Bisceglie
BACKGROUND: New highly efficacious direct-acting antiviral (DAA) therapies are available to treat chronic hepatitis C viral (HCV) infection. Real-world, patient-centered data on harms and benefits associated with these therapies are needed. METHODS: PROP UP is a multi-center prospective observational study that plans to enroll 1600 patients starting treatment with recently-approved DAA regimens. Informed by extensive input from a HCV patient engagement group who prioritized outcomes most important to them, patient-reported outcomes will be characterized using surveys at five time points: Baseline (T1), treatment week 4 (T2), end of treatment (T3), 12weeks post-treatment (T4), 12months post-treatment (T5)...
March 22, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28342988/an-anti-inflammatory-dietary-intervention-to-reduce-breast-cancer-recurrence-risk-study-design-and-baseline-data
#9
Amelie G Ramirez, Dorothy Long Parma, Edgar Muñoz, Kristin D Mendoza, Crystel Harb, Alan E C Holden, Michael Wargovich
U.S. breast cancer survivors (BCSs) are expected to increase to 4 million in the next 5-10years. Cancer recurrence risk is highest among obese survivors. Inflammatory (Pro-I) biomarkers including C-reactive protein (CRP), Interleukins -3, -6, and -8 (IL-3, IL-6, IL-8), and Tumor Necrosis Factor (TNF)-α have been associated with cancer recurrence risk. Nutritional interventions aimed at reducing inflammation (INF) may contribute to reduced cancer recurrence risk, but studies have been limited to animal models...
March 22, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28341249/how-many-tumor-indications-should-be-initially-screened-in-development-of-next-generation-immunotherapies
#10
Cong Chen, Qiqi Deng, Linchen He, Devan Mehrotra, Eric H Rubin, Robert A Beckman
An experimental oncology immunotherapy may have the potential to be effective in a large number of tumor indications. We have considered a staggered approach for efficacy screening in subjects with an unmet medical need. A cohort of tumor indications is selected for the first wave investigation and the second wave investigation in a different cohort of tumor indications is initiated only after the drug has been demonstrated to be effective in the first wave. The effectiveness of an experimental immunotherapy is unknown at the planning stage, and the assumptions at the planning stage are subject to revision later on...
March 21, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28341227/corrigendum-to-design-and-methods-of-a-double-blind-randomized-placebo-controlled-trial-of-extended-release-naltrexone-for-alcohol-dependent-and-hazardous-drinking-prisoners-with-hiv-who-are-transitioning-to-the-community-contemp-clin-trials-2014-209-218
#11
https://www.readbyqxmd.com/read/28330753/rationale-and-study-protocol-for-the-patient-centered-outcome-aid-pcoa-randomized-controlled-trial-a-personalized-decision-tool-for-newly-diagnosed-ovarian-cancer-patients
#12
L Wenzel, D Mukamel, K Osann, L Havrilesky, L Sparks, J Lipscomb, A A Wright, J Walker, R Alvarez, L Van Le, K Robison, R Bristow, R Morgan, B J Rimel, H Ladd, S Hsieh, A Wahi, D Cohn
No abstract text is available yet for this article.
March 19, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28325511/corrigendum-to-the-electronic-medication-complete-communication-emc2-study-rationale-and-methods-for-a-randomized-controlled-trial-of-a-strategy-to-promote-medication-safety-in-ambulatory-care-contemp-clin-trials-2016-72-77
#13
Stacy Cooper Bailey, Michael K Paasche-Orlow, William G Adams, Samantha A Brokenshire, Laura A Hedlund, Ryan P Hickson, Christine U Oramasionwu, Amy L Moore, Danielle M McCarthy, Laura M Curtis, Mary J Kwasny, Michael S Wolf
No abstract text is available yet for this article.
March 16, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28315481/a-patient-advocate-to-facilitate-access-and-improve-communication-care-and-outcomes-in-adults-with-moderate-or-severe-asthma-rationale-design-and-methods-of-a-randomized-controlled-trial
#14
Andrea J Apter, Knashawn H Morales, Xiaoyan Han, Luzmercy Perez, Jingru Huang, Grace Ndicu, Anna Localio, Alyssa Nardi, Heather Klusaritz, Marisa Rogers, Alexis Phillips, Zuleyha Cidav, J Sanford Schwartz
Few interventions to improve asthma outcomes have targeted low-income minority adults. Even fewer have focused on the real-world practice where care is delivered. We adapted a patient navigator, here called a Patient Advocate (PA), a term preferred by patients, to facilitate and maintain access to chronic care for adults with moderate or severe asthma and prevalent co-morbidities recruited from clinics serving low-income urban neighborhoods. We describe the planning, design, methodology (informed by patient and provider focus groups), baseline results, and challenges of an ongoing randomized controlled trial of 312 adults of a PA intervention implemented in a variety of practices...
March 14, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28315480/evaluation-of-mhealth-strategies-to-optimize-adherence-and-efficacy-of-option-b-prevention-of-mother-to-child-hiv-transmission-rationale-design-and-methods-of-a-3-armed-randomized-controlled-trial
#15
Alison L Drake, Jennifer A Unger, Keshet Ronen, Daniel Matemo, Trevor Perrier, Brian DeRenzi, Barbra A Richardson, John Kinuthia, Grace John-Stewart
BACKGROUND: Lifelong antiretroviral therapy (ART) (Option B+) is recommended for all HIV-infected pregnant/postpartum women, but high adherence is required to maximize HIV prevention potential and maintain maternal health. Mobile health (mHealth) interventions may provide treatment adherence support for women during, and beyond, the pregnancy and postpartum periods. METHODS AND DESIGN: We are conducting an unblinded, triple-arm randomized clinical trial (Mobile WACh X) of one-way short message service (SMS) vs...
March 14, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28315479/biopsychosocial-influence-on-shoulder-pain-rationale-and-protocol-for-a-pre-clinical-trial
#16
Steven Z George, Roland Staud, Paul A Borsa, Samuel S Wu, Margaret R Wallace, Warren H Greenfield, Lauren N Mackie, Roger B Fillingim
BACKGROUND: Chronic musculoskeletal pain conditions are a prevalent and disabling problem. Preventing chronic musculoskeletal pain requires multifactorial treatment approaches that address its complex etiology. Prior cohort studies identified a high risk subgroup comprised of variation in COMT genotype and pain catastrophizing. This subgroup had increased chance of heightened pain responses (in a pre-clinical model) and higher 12month post-operatives pain intensity ratings (in a clinical model)...
March 14, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28315478/improving-palliative-care-through-teamwork-impactt-in-nursing-homes-study-design-and-baseline-findings
#17
Helena Temkin-Greener, Susan Ladwig, Zhiqiu Ye, Sally A Norton, Dana B Mukamel
BACKGROUND: The 2014 Institute of Medicine report recommended that healthcare providers caring for individuals with advanced illness have basic palliative care competencies in communication, inter-professional collaboration, and symptom management. Nursing homes, where one in three American decedents live and die, have fallen short of these competency goals. We implemented an intervention study to examine the efficacy of nursing home-based integrated palliative care teams in improving the quality of care processes and outcomes for residents at the end of life...
March 14, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28302569/successful-strategies-to-improve-follow-up-for-longitudinal-birth-cohort-studies
#18
LETTER
Eileen C O'Brien, Aisling A Geraghty, Fionnuala M McAuliffe
No abstract text is available yet for this article.
March 14, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28279782/a-prospective-study-investigating-the-impact-of-multiparametric-mri-in-biopsy-na%C3%A3-ve-patients-with-clinically-suspected-prostate-cancer-the-prokomb-study
#19
Alexander D J Baur, Thomas Henkel, Manfred Johannsen, Thomas Speck, Lothar Weißbach, Bernd Hamm, Frank König
BACKGROUND: In patients with suspected prostate cancer (PCa) according to current guidelines systematic transrectal ultrasound (TRUS)-guided biopsy of the prostate is performed to verify or rule out PCa. However, TRUS-guided biopsy can result in underdetection of clinically significant cancers as well as diagnosis of clinically insignificant cancers. Multiparametric MRI (mpMRI) might improve the diagnostic pathway and help to avoid unnecessary biopsies. DESIGN AND METHODS: The PROKOMB (Prostata - Kooperatives MRT-Projekt Berlin) study is a prospective two-arm multicentre study designed to evaluate the potential role of mpMRI as a triage test before biopsy...
March 6, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28257920/a-web-based-personalized-risk-communication-and-decision-making-tool-for-women-with-dense-breasts-design-and-methods-of-a-randomized-controlled-trial-within-an-integrated-health-care-system
#20
Sarah Knerr, Karen J Wernli, Kathleen Leppig, Kelly Ehrlich, Amanda L Graham, David Farrell, Chalanda Evans, George Luta, Marc D Schwartz, Suzanne C O'Neill
BACKGROUND: Mammographic breast density is one of the strongest risk factors for breast cancer after age and family history. Mandatory breast density disclosure policies are increasing nationally without clear guidance on how to communicate density status to women. Coupling density disclosure with personalized risk counseling and decision support through a web-based tool may be an effective way to allow women to make informed, values-consistent risk management decisions without increasing distress...
February 28, 2017: Contemporary Clinical Trials
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