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Contemporary Clinical Trials

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https://www.readbyqxmd.com/read/27890522/design-and-challenges-of-a-randomized-clinical-trial-of-medical-expulsive-therapy-tamsulosin-for-urolithiasis-in-the-emergency-department
#1
Pamela K Burrows, Judd E Hollander, Allan B Wolfson, Michael C Kurz, Lorna Richards, Sara DiFiore, Phillip Watts, Nivedita Patkar, Jeremy Brown, Stephen Jackman, Ziya Kirkali, John W Kusek, Chloe Michel, Andrew C Meltzer
Urolithiasis or urinary stone disease has been estimated to affect about 1 in 11 Americans. Patients with urinary stone disease commonly present to the emergency department for management of their acute pain. In addition to providing analgesia, administration of drug (medical expulsive therapy) is often prescribed to assist passage of the urinary stone. In this methodology paper, we describe the design of a prospective, multi-center, randomized, double-blind placebo controlled clinical trial of the alpha-adrenergic blocker, tamsulosin, to evaluate its effectiveness as medical expulsive therapy...
November 23, 2016: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/27890521/financial-incentives-for-diabetes-prevention-in-a-medicaid-population-study-design-and-baseline-characteristics
#2
Jay Desai, Gretchen Taylor, Gabriela Vazquez-Benitez, Sara Vine, Julie Anderson, Joyce E Garrett, Todd Gilmer, Houa Vue-Her, Jeff Schiff, Sarah Rinn, Katelyn Engel, Amy Michael, Patrick J O'Connor
BACKGROUND: Medicaid beneficiaries at high risk for diabetes can benefit from the Diabetes Prevention Program (DPP) lifestyle intervention. The We Can Prevent Diabetes (WCPD) trial examined whether financial incentives are more effective than no financial incentives in sustaining participation in the DPP and increasing weight loss. Here we describe the study design and baseline characteristics. METHODS: The WCPD was a 3-arm group-randomized controlled trial. Medicaid beneficiaries were aged 18 to 74 years, had prediabetes or gestational diabetes, and were overweight or obese...
November 23, 2016: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/27888090/rationale-and-design-of-mi-care-the-mile-square-colorectal-cancer-screening-awareness-and-referral-and-education-project
#3
Joanna Buscemi, Yazmin San Miguel, Lisa Tussing-Humphreys, Elizabeth A Watts, Marian L Fitzgibbon, Karriem Watson, Robert A Winn, Kameron L Matthews, Yamile Molina
Although colorectal cancer (CRC) is largely preventable through identification of pre-cancerous polyps through various screening modalities, morbidity and mortality rates remain a challenge, especially in African-American, Latino, low-income and uninsured/underinsured patients. Barriers to screening include cost, access to health care facilities, lack of recommendation to screen, and psychosocial factors such as embarrassment, fear of the test, anxiety about testing preparation and fear of a cancer diagnosis...
November 22, 2016: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/27876616/protocol-for-three-parallel-multi-site-stepped-care-effectiveness-studies-for-unhealthy-alcohol-use-in-hiv-positive-patients
#4
E Jennifer Edelman, Stephen A Maisto, Nathan B Hansen, Christopher J Cutter, James Dziura, Lynn E Fiellin, Patrick G O'Connor, Roger Bedimo, Cynthia Gibert, Vincent C Marconi, David Rimland, Maria C Rodriguez-Barradas, Michael S Simberkoff, Amy C Justice, Kendall J Bryant, David A Fiellin
Unhealthy alcohol use is common among HIV-positive patients, yet effective evidence-based treatments are rarely provided in clinical settings providing HIV care. Further, given patient variability in response to initial treatments, stepped care approaches may be beneficial. We describe the rationale, aims and study design for the current StartingTreatment forEthanol inPrimary care Trials (STEP Trials); three parallel randomized controlled effectiveness trials being conducted in five Infectious Disease Clinics...
November 20, 2016: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/27838475/enhance-design-and-rationale-of-a-randomized-controlled-trial-for-promoting-enduring-happiness-well-being
#5
Kostadin Kushlev, Samantha J Heintzelman, Lesley D Lutes, Derrick Wirtz, Shigehiro Oishi, Ed Diener
Individuals who are higher in subjective well-being not only feel happier, they are more likely have fulfilling relationships, increased work performance and income, better physical health, and longer lives. Over the past several decades, the science of subjective well-being has produced insights into these benefits of happiness, and-recognizing their importance-has begun to examine the factors that lead to greater well-being, from cultivating strong relationships to pursuing meaningful goals. However, studies to date have typically focused on improving subjective well-being by intervening with singular constructs, using primarily college student populations, and were short-term in nature...
November 9, 2016: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/27838474/a-response-adaptive-design-of-initial-therapy-for-emergency-department-patients-with-heart-failure
#6
Sijin Wen, Jing Ning, Sean Collins, Donald Berry
Finding safe and effective treatments for acute heart failure syndrome (AHFS) is a high priority. More than 80% of patients with AHFS who present to emergency departments are treated identically with intravenous diuretics, despite recognition of the syndrome's heterogeneity. We hypothesize that matching patient profiles with "personalized" AHFS treatments will improve outcomes. Matching multiple heterogeneous clinical profiles with a number of potentially effective treatments requires an adaptive trial design that can adjust for these complexities...
November 9, 2016: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/27836508/impact-of-probiotics-for-reducing-infections-in-veterans-improve-study-protocol-for-a-double-blind-randomized-controlled-trial-to-reduce-carriage-of-staphylococcus-aureus
#7
Shoshannah Eggers, Anna Barker, Susan Valentine, Timothy Hess, Megan Duster, Nasia Safdar
BACKGROUND: Staphylococcus aureus (S. aureus) is an organism of great public health importance, causing 20,000 deaths annually. Decolonization of patients with S. aureus may prevent infections, yet current options are limited to antimicrobials that promote antibiotic resistance and can cause adverse side effects. Probiotics have potential to reduce colonization of pathogenic bacteria, representing a promising alternative for S. aureus decolonization, but thus far lack rigorous evaluation...
November 9, 2016: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/27836507/use-of-a-multi-level-mixed-methods-approach-to-study-the-effectiveness-of-a-primary-care-progressive-return-to-activity-protocol-after-acute-mild-traumatic-brain-injury-concussion-in-the-military
#8
Emma Gregory, Therese A West, Wesley R Cole, Jason M Bailie, Karen L McCulloch, Mark L Ettenhofer, Amy Cecchini, Felicia M Qashu
The large number of U.S. service members diagnosed with concussion/mild traumatic brain injury each year underscores the necessity for clear and effective clinical guidance for managing concussion. Relevant research continues to emerge supporting a gradual return to pre-injury activity levels without aggravating symptoms; however, available guidance does not provide detailed standards for this return to activity process. To fill this gap, the Defense and Veterans Brain Injury Center released a recommendation for primary care providers detailing a step-wise return to unrestricted activity during the acute phase of concussion...
November 9, 2016: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/27836506/evaluating-community-health-centers-adoption-of-a-new-global-capitation-payment-echange-study-protocol
#9
H Angier, J P O'Malley, M Marino, K J McConnell, E Cottrell, R L Jacob, S Likumahuwa-Ackman, J Heintzman, N Huguet, S R Bailey, J E DeVoe
Primary care patient-centered medical homes (PCMHs) are an effective healthcare delivery model. Evidence regarding the most effective payment models for increased coordination efforts is sparse. This protocol paper describes the evaluation of an Alternative Payment Methodology (APM) implemented in a subset of Oregon community health centers (CHCs), using a prospective matched observational design. The APM is a primary care payment reform intervention that changed Oregon's Medicaid payment for several CHCs from fee-for-service reimbursement to a per-member-per-month capitated payment...
November 9, 2016: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/27836505/a-randomized-clinical-trial-on-the-effects-of-progestin-contraception-in-the-genital-tract-of-hiv-infected-and-uninfected-women-in-lilongwe-malawi-addressing-evolving-research-priorities
#10
Athena P Kourtis, Lisa Haddad, Jennifer Tang, Lameck Chinula, Stacey Hurst, Jeffrey Wiener, Sascha Ellington, Julie A E Nelson, Amanda Corbett, Kristina De Paris, Caroline C King, Mina Hosseinipour, Irving F Hoffman, Denise J Jamieson
Hormonal contraception is central in the prevention of unintended pregnancy; however there are concerns that certain methods may increase the risk of HIV acquisition and transmission. Hormonal contraceptives may modify the genital mucosa in several ways, however the mechanisms are incompletely understood. Few studies have examined genital HIV shedding prospectively before and after initiation of hormonal contraception. The effects of hormonal contraception on genital HIV shedding in the setting of antiretroviral therapy (ART) are also unknown...
November 9, 2016: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/27818283/a-tailored-video-intervention-to-reduce-smoking-and-environmental-tobacco-exposure-during-and-after-pregnancy-rationale-design-and-methods-of-baby-s-breath
#11
Patricia Markham Risica, Adam Gavarkovs, Donna R Parker, Ernestine Jennings, Maureen Phipps
Low-cost interventions to decrease environmental tobacco smoke (ETS) exposure of pregnant women and their newborns are needed to lower health risks of exposed fetuses and infants. Baby's Breath is a tailored video intervention developed and tested in a randomized controlled trial. The study aimed to test the efficacy of tailored video versus usual care approaches to reduce the ETS exposure of fetuses of low-income women during and after pregnancy; and to assess this intervention separately among non-smoking and smoking women...
November 4, 2016: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/27810602/weight-management-for-adolescents-with-intellectual-and-developmental-disabilities-rationale-and-design-for-an-18month-randomized-trial
#12
J E Donnelly, L T Ptomey, J R Goetz, D K Sullivan, C A Gibson, J L Greene, R H Lee, M S Mayo, J J Honas, R A Washburn
Adolescents with intellectual and developmental disabilities (IDD) are an underserved group in need of weight management. However, information regarding effective weight management for this group is limited, and is based primarily on results from small, non-powered, non-randomized trials that were not conducted in accordance with current weight management guidelines. Additionally, the comparative effectiveness of emerging dietary approaches, such as portion-controlled meals (PCMs) or program delivery strategies such as video chat using tablet computers have not been evaluated...
October 31, 2016: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/27789414/a-theory-based-implementation-program-for-alcohol-screening-and-brief-interventions-asbi-in-general-practices-planned-development-and-study-protocol-of-a-cluster-randomized-controlled-trial
#13
L Abidi, A Oenema, M J J M Candel, D van de Mheen
BACKGROUND: Previous studies have shown that alcohol screening and brief intervention (ASBI) in general practices can lead to significant reductions in alcohol consumption among patients, yet ASBI is rarely implemented into routine clinical practice. The aim of this paper is to describe the development and evaluation of an ASBI implementation program aimed at increasing ASBI delivery rates of general practitioners (GPs) and decreasing patients' alcohol consumption. METHODS/DESIGN: This study protocol describes the step-wise development and evaluation of an ASBI implementation program...
October 24, 2016: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/27777129/add-aspirin-a-phase-iii-double-blind-placebo-controlled-randomised-trial-assessing-the-effects-of-aspirin-on-disease-recurrence-and-survival-after-primary-therapy-in-common-non-metastatic-solid-tumours
#14
Christopher Coyle, Fay H Cafferty, Samuel Rowley, Mairead MacKenzie, Lindy Berkman, Sudeep Gupta, C S Pramesh, Duncan Gilbert, Howard Kynaston, David Cameron, Richard H Wilson, Alistair Ring, Ruth E Langley
BACKGROUND: There is a considerable body of pre-clinical, epidemiological and randomised data to support the hypothesis that aspirin has the potential to be an effective adjuvant cancer therapy. METHODS: Add-Aspirin is a phase III, multi-centre, double-blind, placebo-controlled randomised trial with four parallel cohorts. Patients who have undergone potentially curative treatment for breast (n=3100), colorectal (n=2600), gastro-oesophageal (n=2100) or prostate cancer (n=2120) are registered into four tumour specific cohorts...
October 21, 2016: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/27777128/learning-about-activity-and-understanding-nutrition-for-child-health-launch-rationale-design-and-implementation-of-a-randomized-clinical-trial-of-a-family-based-pediatric-weight-management-program-for-preschoolers
#15
Lori J Stark, Stephanie Spear Filigno, Christopher Bolling, Megan B Ratcliff, Jessica C Kichler, Shannon L Robson, Stacey L Simon, Mary Beth McCullough, Lisa M Clifford, Cathleen O Stough, Cynthia Zion, Richard F Ittenbach
Obesity affects nearly 2 million preschool age children in the United States and is not abating. However, research on interventions for already obese preschoolers is limited. To address this significant gap in the literature, we developed an intervention targeting obesity reduction in 2 to 5year olds, Learning about Activity and Understanding Nutrition for Child Health (LAUNCH). This paper describes the rationale, design, participant enrollment, and implementation of a 3-arm randomized, parallel-group clinical trial comparing LAUNCH to a motivational-interviewing intervention (MI) and standard care (STC), respectively...
October 21, 2016: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/27777126/design-of-a-long-term-follow-up-effectiveness-immunogenicity-and-safety-study-of-women-who-received-the-9-valent-human-papillomavirus-vaccine
#16
Alain Luxembourg, Susanne K Kjaer, Mari Nygard, Misoo C Ellison, Thomas Group, J Brooke Marshall, David Radley, Alfred Saah
The 9-valent human papillomavirus (HPV) (9vHPV) vaccine targets four HPV types (6/11/16/18) also covered by the quadrivalent HPV (qHPV) vaccine and five additional types (31/33/45/52/58). Vaccine efficacy to prevent HPV infection and disease was established in a Phase III clinical study in women 16-26years of age. A long-term follow-up (LTFU) study has been initiated as an extension of the Phase III clinical study to assess effectiveness of the 9vHPV vaccine up to at least 14years after the start of vaccination...
October 21, 2016: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/27769897/evaluating-a-novel-health-system-intervention-for-chronic-kidney-disease-care-using-the-re-aim-framework-insights-after-two-years
#17
Denise M Hynes, Michael J Fischer, Linda A Schiffer, Rani Gallardo, Ifeanyi Beverly Chukwudozie, Anna Porter, Michael Berbaum, Jennifer Earheart, Marian L Fitzgibbon
INTRODUCTION: Using a quasi-experimental design, we implemented the Patient-Centered Medical Home for Kidney Disease (PCMH-KD), a comprehensive, multidisciplinary care team to improve quality of life and healthcare coordination for adult chronic hemodialysis (CHD) patients. This paper highlights our experience in the first two years of the study. We focus on the process dimensions of Reach, Adoption, and Implementation within the context of the RE-AIM framework. MATERIALS AND METHODS: We established a new PCMH-KD model at two outpatient dialysis centers...
October 18, 2016: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/27756567/study-design-and-methodology-for-a-multicentre-randomised-controlled-trial-of-transcranial-direct-current-stimulation-as-a-treatment-for-unipolar-and-bipolar-depression
#18
Angelo Alonzo, Scott Aaronson, Marom Bikson, Mustafa Husain, Sarah Lisanby, Donel Martin, Shawn M McClintock, William M McDonald, John O'Reardon, Zeinab Esmailpoor, Colleen Loo
Transcranial Direct Current Stimulation (tDCS) is a new, non-invasive neuromodulation approach for treating depression that has shown promising efficacy. The aim of this trial was to conduct the first international, multicentre randomised controlled trial of tDCS as a treatment for unipolar and bipolar depression. The study recruited 120 participants across 6 sites in the USA and Australia. Participants received active or sham tDCS (2.5mA, 20 sessions of 30min duration over 4weeks), followed by a 4-week open label active treatment phase and a 4-week taper phase...
October 15, 2016: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/27743800/corrigendum-to-extended-release-naltrexone-opioid-treatment-at-jail-reentry-xor-contemp-clin-trials-49-2016-57-64
#19
Ryan D McDonald, Babak Tofighi, Eugene Laska, Keith Goldfeld, Wanda Bonilla, Mara Flannery, Nadina Santana-Correa, Christopher W Johnson, Neil Leibowitz, John Rotrosen, Marc N Gourevitch, Joshua D Lee
No abstract text is available yet for this article.
October 13, 2016: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/27729206/corrigendum-to-interim-methadone-and-patient-navigation-in-jail-rationale-and-design-of-a-randomized-clinical-trial-contemp-clin-trials-49-2016-21-28
#20
Robert P Schwartz, Sharon M Kelly, Shannon G Mitchell, Laura Dunlap, Gary A Zarkin, Anjalee Sharma, Kevin E O'Grady, Jerome H Jaffe
No abstract text is available yet for this article.
October 8, 2016: Contemporary Clinical Trials
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