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Randomized clinical trials

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https://www.readbyqxmd.com/read/28735464/radiation-dose-reduction-in-thoracic-and-lumbar-spine-instrumentation-using-navigation-based-on-an-intraoperative-cone-beam-ct-imaging-system-a-prospective-randomized-clinical-trial
#1
Nathalie Pireau, Virginie Cordemans, Xavier Banse, Nadia Irda, Sébastien Lichtherte, Ludovic Kaminski
PURPOSE: Spine surgery still remains a challenge for every spine surgeon, aware of the potential serious outcomes of misplaced instrumentation. Though many studies have highlighted that using intraoperative cone beam CT imaging and navigation systems provides higher accuracy than conventional freehand methods for placement of pedicle screws in spine surgery, few studies are concerned about how to reduce radiation exposure for patients with the use of such technology. One of the main focuses of this study is based on the ALARA principle (as low as reasonably achievable)...
July 22, 2017: European Spine Journal
https://www.readbyqxmd.com/read/28735463/impact-of-pioglitazone-on-bone-mineral-density-and-bone-marrow-fat-content
#2
L M Pop, I Lingvay, Q Yuan, X Li, B Adams-Huet, N M Maalouf
Pioglitazone use is associated with an increased risk of fractures. In this randomized, placebo-controlled study, pioglitazone use for 12 months was associated with a significant increase in bone marrow fat content at the femoral neck, accompanied by a significant decrease in total hip bone mineral density. The change in bone marrow fat with pioglitazone use was predominantly observed in female vs. male participants. INTRODUCTION: Use of the insulin sensitizer pioglitazone is associated with greater fracture incidence, although the underlying mechanisms are incompletely understood...
July 22, 2017: Osteoporosis International
https://www.readbyqxmd.com/read/28735036/proactive-tobacco-treatment-for-individuals-with-and-without-a-mental-health-diagnosis-secondary-analysis-of-a-pragmatic-randomized-controlled-trial
#3
Sandra J Japuntich, Scott E Sherman, Anne M Joseph, Barbara Clothier, Siamak Noorbaloochi, Elisheva Danan, Diana Burgess, Erin Rogers, Steven S Fu
INTRODUCTION: Individuals with (vs. without) mental illness use tobacco at higher rates and have more difficulty quitting. Treatment models for smokers with mental illness are needed. METHODS: This secondary analysis of the Victory Over Tobacco study [a pragmatic randomized clinical trial (N=5123) conducted in 2009-2011 of Proactive Care (proactive outreach plus connection to smoking cessation services) vs. Usual Care] tests the effectiveness of treatment assignment in participants with and without a mental health diagnosis on population-level, 6month prolonged abstinence at one year follow-up...
July 15, 2017: Addictive Behaviors
https://www.readbyqxmd.com/read/28734922/warfarin-use-is-associated-with-progressive-coronary-arterial-calcification-insights-from-serial-intravascular-ultrasound
#4
Jordan Andrews, Peter J Psaltis, Ozgur Bayturan, Mingyuan Shao, Brian Stegman, Mohamed Elshazly, Samir R Kapadia, E Murat Tuzcu, Steven E Nissen, Stephen J Nicholls, Rishi Puri
OBJECTIVES: This study compared serial changes in coronary percent atheroma volume (PAV) and calcium index (CaI) in patients with coronary artery disease who were treated with and without warfarin. BACKGROUND: Warfarin blocks the synthesis and activity of matrix Gla protein, a vitamin K-dependent inhibitor of arterial calcification. The longitudinal impact of warfarin on serial coronary artery calcification in vivo in humans is unknown. METHODS: In a post hoc patient-level analysis of 8 prospective randomized trials using serial coronary intravascular ultrasound examinations, this study compared changes in PAV and CaI in matched arterial segments in patients with coronary artery disease who were treated with (n = 171) and without (n = 4,129) warfarin during an 18- to 24-month period...
July 13, 2017: JACC. Cardiovascular Imaging
https://www.readbyqxmd.com/read/28734858/safety-review-of-5-grass-pollen-tablet-from-pooled-data-of-clinical-trials
#5
Thomas B Casale, Linda S Cox, Ulrich Wahn, David B K Golden, Brigitte Bons, Alain Didier
BACKGROUND: The 5-grass pollen sublingual tablet has been approved for the treatment of grass pollen-induced allergic rhinoconjunctivitis in subjects with or without intermittent asthma. OBJECTIVE: To provide a comprehensive analysis of the safety profile of the 5-grass tablet on the basis of pooled data from 8 clinical trials. METHODS: Subjects (5-65 years old) with medically confirmed grass pollen-induced allergic rhinoconjunctivitis were included in the double-blind studies...
July 19, 2017: Journal of Allergy and Clinical Immunology in Practice
https://www.readbyqxmd.com/read/28734823/evaluation-of-early-administration-of-simvastatin-in-the-prevention-and-treatment-of-delirium-in-critically-ill-patients-undergoing-mechanical-ventilation-modus-a-randomised-double-blind-placebo-controlled-trial
#6
Valerie J Page, Annalisa Casarin, E Wesley Ely, Xiao Bei Zhao, Cliona McDowell, Lynn Murphy, Daniel F McAuley
BACKGROUND: Delirium in critically ill patients is associated with poor clinical outcomes. Neuroinflammation might be an important mechanism in the pathogenesis of delirium, and since simvastatin has anti-inflammatory properties it might reduce delirium. We aimed to establish whether early treatment with simvastatin would decrease the time that survivors of critical illness spent in delirium or coma. METHODS: We undertook this randomised, double-blind, placebo-controlled trial in a general adult intensive care unit (ICU) in Watford General Hospital (Watford, UK)...
July 19, 2017: Lancet Respiratory Medicine
https://www.readbyqxmd.com/read/28734822/icotinib-versus-whole-brain-irradiation-in-patients-with-egfr-mutant-non-small-cell-lung-cancer-and-multiple-brain-metastases-brain-a-multicentre-phase-3-open-label-parallel-randomised-controlled-trial
#7
Jin-Ji Yang, Caicun Zhou, Yisheng Huang, Jifeng Feng, Sun Lu, Yong Song, Cheng Huang, Gang Wu, Li Zhang, Ying Cheng, Chengping Hu, Gongyan Chen, Li Zhang, Xiaoqing Liu, Hong Hong Yan, Fen Lai Tan, Wenzhao Zhong, Yi-Long Wu
BACKGROUND: For patients with non-small-cell lung cancer (NSCLC) and multiple brain metastases, whole-brain irradiation (WBI) is a standard-of-care treatment, but its effects on neurocognition are complex and concerning. We compared the efficacy of an epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI), icotinib, versus WBI with or without chemotherapy in a phase 3 trial of patients with EGFR-mutant NSCLC and multiple brain metastases. METHODS: We did a multicentre, open-label, parallel randomised controlled trial (BRAIN) at 17 hospitals in China...
July 19, 2017: Lancet Respiratory Medicine
https://www.readbyqxmd.com/read/28734660/efficacy-and-tolerability-of-combination-therapy-versus-monotherapy-with-candesartan-and-or-amlodipine-for-dose-finding-in-essential-hypertension-a-phase-ii-multicenter-randomized-double-blind-clinical-trial
#8
Il Suk Sohn, Chong-Jin Kim, Taehoon Ahn, Ho-Joong Youn, Hui-Kyung Jeon, Sang Hyun Ihm, Eun Joo Cho, Woo-Baek Chung, Shung Chull Chae, Woo-Shik Kim, Chang-Wook Nam, Seong-Mi Park, Ji-Yong Choi, Young-Kwon Kim, Taek-Jong Hong, Hae-Young Lee, Jang-Hyun Cho, Eun-Seok Shin, Jung-Han Yoon, Tae-Hyun Yang, Myung-Ho Jeong, Jun-Hee Lee, Joong-Il Park
PURPOSE: Intensive blood pressure (BP) lowering is important for the treatment of hypertension; however, it has been a challenge to achieve target BP in many patients. The purpose of this study was to explore the optimal dosage of a fixed-dose combination of candesartan cilexetil (CAN) and amlodipine besylate (AML), by examining the tolerability and efficacy of CAN/AML combination therapy compared with those of monotherapy with either drug in patients with essential hypertension. METHODS: This Phase II multicenter, randomized, double-blind clinical trial enrolled patients aged 19 years or older with essential hypertension, defined as a mean sitting diastolic BP (msDBP) between 95 and 115 mm Hg, and a mean sitting systolic BP (msSBP) of <200 mm Hg after a 2-week placebo run-in period...
July 19, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28734623/eight-year-follow-up-of-the-clopidogrel-after-surgery-for-coronary-artery-disease-cascade-trial
#9
Ali Hage, Pierre Voisine, Fernanda Erthal, Éric Larose, David Glineur, Benjamin Chow, Hugo Tremblay, Jacqueline Fortier, Gifferd Ko, Dai Une, Michael Farkouh, Thierry G Mesana, Michel LeMay, Alexander Kulik, Marc Ruel
OBJECTIVE: In this 8 years' follow-up study, we evaluated the long-term outcomes of the addition of clopidogrel to aspirin during the first year after coronary artery bypass grafting, versus aspirin plus placebo, with respect to survival, major adverse cardiac, or major cerebrovascular events, including revascularization, functional status, graft patency, and native coronary artery disease progression. METHODS: In the initial Clopidogrel After Surgery for Coronary Artery Disease trial, 113 patients were randomized to receive either daily clopidogrel (n = 56) or placebo (n = 57), in addition to aspirin, in a double-blind fashion for 1 year after coronary artery bypass grafting...
June 24, 2017: Journal of Thoracic and Cardiovascular Surgery
https://www.readbyqxmd.com/read/28734620/treatment-of-dogs-with-compensated-myxomatous-mitral-valve-disease-with-spironolactone-a-pilot-study
#10
M J Hezzell, A Boswood, J López-Alvarez, N Lötter, J Elliott
OBJECTIVES: Spironolactone improves outcome in dogs with advanced myxomatous mitral valve disease (MMVD). Its efficacy in preclinical MMVD is unknown. The hypothesis was the administration of spironolactone to dogs with compensated MMVD demonstrating risk factors for poorer prognosis will decrease the rate of disease progression. The aim was to provide pilot data to evaluate preliminary effects and sample size calculation for a definitive clinical trial. ANIMALS: Twenty-five client-owned dogs with MMVD with at least one of the following; left atrial to aortic ratio (LA:Ao) ≥ 1...
July 19, 2017: Journal of Veterinary Cardiology: the Official Journal of the European Society of Veterinary Cardiology
https://www.readbyqxmd.com/read/28734167/mindfulness-practice-moderates-the-relationship-between-craving-and-substance-use-in-a-clinical-sample
#11
Matthew C Enkema, Sarah Bowen
Relapse following treatment for substance use disorders is highly prevalent, and craving has been shown to be a primary predictor of relapse. Mindfulness-Based Relapse Prevention (MBRP) is a psychosocial aftercare program integrating mindfulness and cognitive-behavioral approaches, aimed at reducing the risk and severity of relapse. Results from a recent randomized clinical trial demonstrate enhanced remission resilience for MBRP participants versus both cognitive-behavioral and treatment-as-usual controls...
June 29, 2017: Drug and Alcohol Dependence
https://www.readbyqxmd.com/read/28734154/reducing-alcohol-consumption-to-minimize-weight-gain-and-facilitate-smoking-cessation-among-military-beneficiaries
#12
Mark B Sobell, Alan L Peterson, Linda Carter Sobell, Antoinette Brundige, Christopher M Hunter, Christine M Hunter, Jeffrey L Goodie, Sangeeta Agrawal, Ann S Hrysko-Mullen, William C Isler
INTRODUCTION: Smoking cessation-related weight gain can have significant negative health and career consequences for military personnel. Alcohol reduction combined with smoking cessation may decrease weight gain and relapse. METHOD: A randomized clinical trial of military beneficiaries compared a standard smoking cessation (i.e., brief informational) intervention (N=159), with a brief motivational smoking cessation intervention that emphasized reduced drinking to lessen caloric intake and minimize weight gain (N=158)...
June 30, 2017: Addictive Behaviors
https://www.readbyqxmd.com/read/28734105/effects-of-median-nerve-neural-mobilization-in-treating-cervicobrachial-pain-a-randomized-waiting-list-controlled-clinical-trial
#13
David Rodríguez-Sanz, Daniel López-López, Francisco Unda-Solano, Carlos Romero-Morales, Irene Sanz-Corbalán, Hector Beltrán-Alacreu, César Calvo-Lobo
BACKGROUND: There is a current lack of sufficiently high-quality randomized controlled clinical trials that measure the effectiveness of neural tissue mobilization techniques such as median nerve neural mobilization (MNNM) and their specific effects on cervicobrachial pain (CP). This study aim was to compare the effectiveness of MNNM in subjects with CP versus a waiting list control group (WLCG). METHODS: A single-blinded, parallel, randomized controlled clinical trial was performed (NCT02596815)...
July 22, 2017: Pain Practice: the Official Journal of World Institute of Pain
https://www.readbyqxmd.com/read/28734043/enabling-reduction-of-low-grade-inflammation-in-seniors-pilot-study-concept-rationale-and-design
#14
Todd M Manini, Stephen D Anton, Daniel P Beavers, Jane A Cauley, Mark A Espeland, Roger A Fielding, Stephen B Kritchevsky, Christiaan Leeuwenburgh, Kristina H Lewis, Christine Liu, Mary M McDermott, Michael E Miller, Russell P Tracy, Jeremy D Walston, Barbara Radziszewska, Jane Lu, Cindy Stowe, Samuel Wu, Anne B Newman, Walter T Ambrosius, Marco Pahor
OBJECTIVES: To test two interventions to reduce interleukin (IL)-6 levels, an indicator of low-grade chronic inflammation and an independent risk factor for impaired mobility and slow walking speed in older adults. DESIGN: The ENabling Reduction of low-Grade Inflammation in SEniors (ENRGISE) Pilot Study was a multicenter, double-blind, placebo-controlled randomized pilot trial of two interventions to reduce IL-6 levels. SETTING: Five university-based research centers...
July 22, 2017: Journal of the American Geriatrics Society
https://www.readbyqxmd.com/read/28733854/process-evaluation-of-a-clinical-trial-to-test-school-support-as-hiv-prevention-among-orphaned-adolescents-in-western-kenya
#15
Denise Dion Hallfors, Hyunsan Cho, Shane Hartman, Isabella Mbai, Carolyne Atieno Ouma, Carolyn Tucker Halpern
Orphaned adolescents are a large and vulnerable population in sub-Saharan Africa, at higher risk for HIV than non-orphans. Yet prevention of new infection is critical for adolescents since they are less likely than adults to enter and remain in treatment and are the only age group with rising AIDS death rates. We report process evaluation for a randomized controlled trial (RCT) testing support to stay in school (tuition, uniform, nurse visits) as an HIV prevention strategy for orphaned Kenyan adolescents. The RCT found no intervention effect on HIV/HSV-2 biomarker outcomes...
July 21, 2017: Prevention Science: the Official Journal of the Society for Prevention Research
https://www.readbyqxmd.com/read/28733827/adding-adjuvant-systemic-treatment-after-neoadjuvant-therapy-in-breast-cancer-review-of-the-data
#16
REVIEW
Shetal A Patel, Angela DeMichele
PURPOSE OF REVIEW: Residual disease after neoadjuvant chemotherapy is a poor prognostic factor; however, proven strategies to reduce recurrence risk and improve overall survival in this patient population are limited. Previous studies of residual disease have illustrated the importance of tumor intrinsic subtypes in treatment response and mechanisms of resistance. This review summarizes the rationale for various therapeutic approaches as well as completed and ongoing clinical trials for this high-risk group of patients...
August 2017: Current Oncology Reports
https://www.readbyqxmd.com/read/28733799/a-toddler-parenting-intervention-in-primary-care-for-caregivers-with-depression-symptoms
#17
Rhonda C Boyd, Marsha Gerdes, Brooke Rothman, Susan L Dougherty, Russell Localio, James P Guevara
Caregiver depression impacts parenting behaviors and has deleterious effects on child behavior. Evidence-based interventions to address parenting have not been adapted for use with depressed caregivers in pediatric primary care settings. Our study examined the feasibility and explored outcomes of an evidence-based parenting program implemented in primary care and adapted for caregivers with depressive symptoms caring for toddlers. We conducted a randomized controlled trial with a wait-list control. Participants were caregivers who screened positive for depressive symptoms in pediatric settings with a toddler...
July 21, 2017: Journal of Primary Prevention
https://www.readbyqxmd.com/read/28733782/catheter-ablation-of-atrial-fibrillation-an-overview-for-clinicians
#18
REVIEW
Nebojša Mujović, Milan Marinković, Radoslaw Lenarczyk, Roland Tilz, Tatjana S Potpara
Catheter ablation (CA) of atrial fibrillation (AF) is currently one of the most commonly performed electrophysiology procedures. Ablation of paroxysmal AF is based on the elimination of triggers by pulmonary vein isolation (PVI), while different strategies for additional AF substrate modification on top of PVI have been proposed for ablation of persistent AF. Nowadays, various technologies for AF ablation are available. The radiofrequency point-by-point ablation navigated by electro-anatomical mapping system and cryo-balloon technology are comparable in terms of the efficacy and safety of the PVI procedure...
July 21, 2017: Advances in Therapy
https://www.readbyqxmd.com/read/28733754/the-influence-of-imagery-capacity-in-motor-performance-improvement
#19
Célia Ruffino, Charalambos Papaxanthis, Florent Lebon
Motor imagery (MI) training improves motor performance, but the inter-individual variability of this improvement remains still unexplored. In this study, we tested the influence of imagery ability on the performance improvement following MI training. Twenty participants were randomly distributed into the MI or control group. They actually performed, at pre- and post-test sessions, a revisited version of the Nine Hole Peg Test, a speed-accuracy trade-off task, commonly used in clinics. Between the tests, the MI group mentally trained on the task (5 blocks of 10 trials), while the control group watched a non-emotional documentary...
July 21, 2017: Experimental Brain Research. Experimentelle Hirnforschung. Expérimentation Cérébrale
https://www.readbyqxmd.com/read/28733270/evaluating-a-web-based-coaching-program-using-electronic-health-records-for-patients-with-chronic-obstructive-pulmonary-disease-in-china-randomized-controlled-trial
#20
Lan Wang, Lin He, Yanxia Tao, Li Sun, Hong Zheng, Yashu Zheng, Yuehao Shen, Suyan Liu, Yue Zhao, Yaogang Wang
BACKGROUND: Chronic obstructive pulmonary disease (COPD) is now the fourth leading cause of death in the world, and it continues to increase in developing countries. The World Health Organization expects COPD to be the third most common cause of death in the world by 2020. Effective and continuous postdischarge care can help patients to maintain good health. The use of electronic health records (EHRs) as an element of community health care is new technology in China. OBJECTIVE: The aim of this study was to develop and evaluate a Web-based coaching program using EHRs for physical function and health-related quality of life for patients with COPD in China...
July 21, 2017: Journal of Medical Internet Research
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