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Randomized trial

Philippe Desmarais, Catherine Miville, Ángela Milán-Tomás, Quoc Dinh Nguyen, Carmen Ojeda-López, Mario Masellis, Sandra E Black, Danielle Molinari Andrade, Nathan Herrmann
OBJECTIVES: To analyze age representation trends over time in antiepileptic drug (AED) trials and to assess trial design elements as possible barriers to enrollment of elderly patients. MATERIALS AND METHODS: We searched MEDLINE, EMBASE, and PsycINFO, and meta-analyzed demographic data of cohorts enrolled in randomized controlled trials (RCTs) of AEDs published since 1991. Data analysis included trends of age representation over time and trial design elements associated with average age of enrolled cohorts...
March 6, 2018: Epilepsy Research
Débora Finger, Fábio Juner Lanferdini, Juliano Boufleur Farinha, Clarissa Müller Brusco, Lucas Helal, Francesco Pinto Boeno, Eduardo Lusa Cadore, Ronei Silveira Pinto
INTRODUCTION: Protein (PRO) combined with a carbohydrate (CHO) beverage may have an ergogenic effect on endurance performance. However, evidence regarding its efficacy on similar conditions to athletes' race day is still lacking. OBJECTIVE: To compare the effect of three different nutritional supplementation strategies on performance and muscle recovery in a duathlon protocol. METHODS: , 13 male athletes (29.7 ± 7.7 years) participated in three simulated Olympic-distance duathlons under three different, randomly assigned, supplementation regimens: carbohydrate drink (CHO, 75 g); isocaloric CHO plus protein drink (CHO+PRO, 60...
March 15, 2018: Applied Physiology, Nutrition, and Metabolism, Physiologie Appliquée, Nutrition et Métabolisme
Myung Han Hyun, Young-Sun Lee, Ji Hoon Kim, Chan Uk Lee, Young Kul Jung, Yeon Seok Seo, Hyung Joon Yim, Jong Eun Yeon, Kwan Soo Byun
According to the American Association for the Study of Liver Disease treatment guidelines for hepatocellular carcinoma (HCC), the role of surgery has been expanded beyond the Barcelona Clinic Liver Cancer (BCLC) algorithm. We compared primary hepatectomy (PH) with transarterial chemoembolization (TACE) in patients with intermediate to advanced (BCLC stage-B/C) stage HCC to determine the current evidence. Through database search, we included 18 high-quality studies (1 randomized controlled trial [RCT], 5 propensity-score matching non-randomized comparative trials [NRCT], and 12 NRCTs) that compared survival outcomes of 5,986 patients after PH and TACE...
March 15, 2018: Hepatology: Official Journal of the American Association for the Study of Liver Diseases
Sang Min Yoon, Baek-Yeol Ryoo, So Jung Lee, Jong Hoon Kim, Ji Hoon Shin, Ji Hyun An, Han Chu Lee, Young-Suk Lim
Importance: Patients with hepatocellular carcinoma showing macroscopic vascular invasion have a poor prognosis. Sorafenib is the sole treatment option for these patients, with unsatisfactory response and survival benefit. Combined treatment with transarterial chemoembolization (TACE) plus external beam radiotherapy (RT) has shown promising results for these patients in observational studies. Objective: To evaluate the efficacy and safety of TACE plus RT compared with sorafenib for patients with hepatocellular carcinoma and macroscopic vascular invasion...
March 15, 2018: JAMA Oncology
Cherian K Kandathil, Emily A Spataro, Katri Laimi, Sami P Moubayed, Sam P Most, Mikhail Saltychev
Importance: While functional rhinoplasty has been broadly studied, to our knowledge no systematic review and meta-analysis of lateral wall repair has been done previously. Objective: To evaluate the effectiveness of repair of the lateral nasal wall in adult patients with nasal airway obstruction. Data Sources: Medline, Embase, Cinahl, Central, Scopus, and Web of Science databases and reference lists were searched for clinical and observational studies...
March 15, 2018: JAMA Facial Plastic Surgery
Jeff M Michalski, Jennifer Moughan, James Purdy, Walter Bosch, Deborah W Bruner, Jean-Paul Bahary, Harold Lau, Marie Duclos, Matthew Parliament, Gerard Morton, Daniel Hamstra, Michael Seider, Michael I Lock, Malti Patel, Hiram Gay, Eric Vigneault, Kathryn Winter, Howard Sandler
Importance: Optimizing radiation therapy techniques for localized prostate cancer can affect patient outcomes. Dose escalation improves biochemical control, but no prior trials were powered to detect overall survival (OS) differences. Objective: To determine whether radiation dose escalation to 79.2 Gy compared with 70.2 Gy would improve OS and other outcomes in prostate cancer. Design, Setting, and Participants: The NRG Oncology/RTOG 0126 randomized clinical trial randomized 1532 patients from 104 North American Radiation Therapy Oncology Group institutions March 2002 through August 2008...
March 15, 2018: JAMA Oncology
Franck Maunoury, Aurore Clément, Chizoba Nwankwo, Laurie Levy-Bachelot, Armand Abergel, Vincent Di Martino, Eric Thervet, Isabelle Durand-Zaleski
OBJECTIVE: To assess the cost-effectiveness of the elbasvir/grazoprevir (EBR/GZR) regimen in patients with genotype 1 chronic hepatitis C virus (HCV) infection with severe and end-stage renal disease compared to no treatment. DESIGN: This study uses a health economic model to estimate the cost-effectiveness of treating previously untreated and treatment experienced chronic hepatitis C patients who have severe and end stage renal disease with the elbasvir-grazoprevir regimen versus no treatment in the French context...
2018: PloS One
Kim C M Bul, Lisa L Doove, Ingmar H A Franken, Saskia Van der Oord, Pamela M Kato, Athanasios Maras
OBJECTIVE: The aim of the current study was to identify which subgroups of children with Attention Deficit Hyperactivity Disorder (ADHD) benefitted the most from playing a Serious Game (SG) intervention shown in a randomized trial to improve behavioral outcomes. METHOD: Pre-intervention characteristics [i.e., gender, age, intellectual level of functioning, medication use, computer experience, ADHD subtype, severity of inattention problems, severity of hyperactivity/impulsivity problems, comorbid Oppositional Defiant Disorder (ODD) and Conduct Disorder (CD) symptoms] were explored as potential moderators in a Virtual Twins (VT) analysis to identify subgroups for whom the SG intervention was most effective...
2018: PloS One
Ken Iseri, Masayuki Iyoda, Makoto Watanabe, Kei Matsumoto, Daisuke Sanada, Takashi Inoue, Shohei Tachibana, Takanori Shibata
INTRODUCTION: The clinical utility of denosumab for the treatment of glucocorticoid-induced osteoporosis (GIOP) has yet to be established. This study aimed to compare the effects of denosumab on bone mineral density (BMD) and bone turnover markers to those of alendronate in patients with GIOP. METHODS: A prospective, single-center study of 32 patients (18 men; median age, 66.0 years) with glomerular disease receiving prednisolone (PSL) who were diagnosed as having GIOP and had not received bisphosphonates before was conducted...
2018: PloS One
Leone de Voogd, Reinout W Wiers, Peter J de Jong, Robert J Zwitser, Elske Salemink
INTRODUCTION: Negatively biased interpretations play an important role in anxiety and depression, which are highly prevalent in adolescence, and changing such biases might thus reduce or prevent emotional disorders. We investigated the short- and long-term effects of an online interpretation bias modification training in unselected adolescents to explore its potential in preventing anxiety and depression. METHODS: Participants (N = 173) were randomly allocated to eight online sessions of interpretation or placebo training...
2018: PloS One
Yefu Zhang, Meimei Ji, Jiaojiao Zou, Tong Yuan, Jing Deng, Lina Yang, Mingzhi Li, Hong Qin, Jihua Chen, Qian Lin
Left-behind children (LBC) are a unique population in China, whose numbers have increased dramatically in recent years. Most caregivers of left-behind children (CLBC) are grandparents who lack knowledge about proper nutrition and food practice, putting LBC at greater risk for malnutrition. A cluster randomized controlled trial was carried to assess the effectiveness of the conditional cash transfer (CCT) program. Forty rural villages from Fenghuang County and Pingjiang County of Hunan province were selected...
March 15, 2018: International Journal of Environmental Research and Public Health
Carles Díez-López, Josep Comín-Colet, José González-Costello
PURPOSE OF REVIEW: Iron overload cardiomyopathy (IOC) is an important predictor of prognosis in a significant number of patients with hereditary hemochromatosis and hematologic diseases. Its prevalence is increasing because of improved treatment strategies, which significantly improve life expectancy. We will review diagnosis, treatment, and recent findings in the field. RECENT FINDINGS: The development of preclinical translational disease models during the last years have helped our understanding of specific disease pathophysiological pathways that might eventually change the outcomes of these patients...
March 14, 2018: Current Opinion in Cardiology
Daniel L Riddle, Mark P Jensen, Dennis Ang, James Slover, Robert Perera, Levent Dumenci
BACKGROUND: Pain-coping strategies and appraisals are responses to the pain experience. They can influence patient-reported and physical performance outcome measures in a variety of disorders, but the associations between a comprehensive profile of pain-coping responses and preoperative pain/function and physical performance measures in patients scheduled for knee arthroplasty have not been examined. Patients with moderate to high pain catastrophizing (a pain appraisal approach associated with an exaggerated focus on the threat value of pain) may represent an excellent study population in which to address this knowledge gap...
April 2018: Clinical Orthopaedics and related Research
Peter Kranke, Sergio D Bergese, Harold S Minkowitz, Timothy I Melson, David G Leiman, Keith A Candiotti, Ngai Liu, Leopold Eberhart, Ashraf S Habib, Jan Wallenborn, Anthony L Kovac, Pierre Diemunsch, Gabriel Fox, Tong J Gan
BACKGROUND: Postoperative nausea and vomiting causes distress for patients and can prolong care requirements. Consensus guidelines recommend use of multiple antiemetics from different mechanistic classes as prophylaxis in patients at high risk of postoperative nausea and vomiting. The prophylactic efficacy of the dopamine D2/D3 antagonist amisulpride in combination with other antiemetics was investigated. METHODS: This double-blind, randomized, placebo-controlled, international, multicenter trial was conducted in 1,147 adult surgical patients having three or four postoperative nausea and vomiting risk factors...
March 15, 2018: Anesthesiology
Wuxiang Xie, Fanfan Zheng, Evangelos Evangelou, Ou Liu, Zhenchun Yang, Queenie Chan, Paul Elliott, Yangfeng Wu
OBJECTIVE: To systematically evaluate the efficacy of five commonly used blood pressure-lowering drugs in reducing cardiovascular events among patients with nonacute cardiovascular disease, but without heart failure. METHODS: We searched PubMed, EMBASE, and Cochrane Central Register of Controlled Trials on 18 March 2017. The primary outcome was fatal and nonfatal cardiovascular events, and the secondary outcomes were all-cause death, fatal and nonfatal myocardial infarction, and stroke...
March 14, 2018: Journal of Hypertension
Annie Liu, Alexis Botkin, Christian Murray, David Goldstein, Stefan O P Hofer, Nowell Solish, Jessica Kitchen, An-Wen Chan
BACKGROUND: Lentigo maligna is an in situ form of cutaneous melanoma that commonly arises on the head and neck. Various surgical and nonsurgical treatment options are available but no randomized trials exist to guide practice. OBJECTIVE: To determine the current treatment practices for lentigo maligna of the head and neck in Ontario, Canada. MATERIALS AND METHODS: Cross-sectional survey of dermatologists, plastic surgeons, and head and neck surgeons...
March 13, 2018: Dermatologic Surgery: Official Publication for American Society for Dermatologic Surgery [et Al.]
Chetan Gohal, Ajaykumar Shanmugaraj, Patrick Tate, Nolan S Horner, Asheesh Bedi, Anthony Adili, Moin Khan
CONTEXT: Knee osteoarthritis affects 9.3 million adults over age 45 years in the United States. There is significant disability associated with this condition. Given the potential complications and the significant cost to the health care system with the dramatic increase in total knee arthroplasties performed for this condition, assessment of the efficacy of nonoperative modalities, such as offloading knee braces, is essential as part of optimizing nonoperative treatment for this condition...
March 1, 2018: Sports Health
Marie Fallon, Jane Walker, Lesley Colvin, Aryelly Rodriguez, Gordon Murray, Michael Sharpe
Purpose Pain is suboptimally managed in patients with cancer. We aimed to compare the effect of a policy of adding a clinician-delivered bedside pain assessment and management tool (Edinburgh Pain Assessment and management Tool [EPAT]) to usual care (UC) versus UC alone on pain outcomes. Patients and Methods In a two-arm, parallel group, cluster randomized (1:1) trial, we observed pain outcomes in 19 cancer centers in the United Kingdom and then randomly assigned the centers to either implement EPAT or to continue UC...
March 15, 2018: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
Cha-Nam Shin, Elizabeth Reifsnider, Darya McClain, Mihyun Jeong, David P McCormick, Michael Moramarco
BACKGROUND: Most Hispanic infants are fed formula during the first 6 weeks, and although 80% of Hispanic women initiate breastfeeding, rates of exclusive breastfeeding are much lower. Research aim: The purpose was to examine the influence of acculturation and cultural values on the breastfeeding practices of pregnant women of Mexican descent participating in the Special Supplemental Nutrition Program for Women, Infants, and Children who were enrolled in a prospective randomized clinical trial that aimed to reduce child obesity...
March 1, 2018: Journal of Human Lactation: Official Journal of International Lactation Consultant Association
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