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Randomized control trials

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
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
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
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.]
Stefanos Farfaras, Ninni Sernert, Lars Rostgard Christensen, Erling K Hallström, Jüri-Toomas Kartus
BACKGROUND: The long-term outcome after the treatment of subacromial impingement syndrome (SAIS) with either nonsurgical or surgical methods has not been thoroughly investigated. Hypothesis/Purpose: The purpose was to evaluate the long-term clinical outcome and the presence of rotator cuff injuries and osteoarthritis (OA) after the surgical and nonsurgical treatment of SAIS. The hypothesis was that, at a minimum 10 years after the initial treatment, patients who had undergone acromioplasty would have a better clinical outcome and run a lower risk of developing rotator cuff ruptures and OA as compared with those treated with physical therapy...
March 1, 2018: American Journal of Sports Medicine
Tine K Jensen, Tonje Holt, Silje Mørup Ormhaug, Krister W Fjermestad, Tore Wentzel-Larsen
Posttraumatic stress symptoms (PTSS) are associated with serious impairments in psychological, social, and academic functioning in youth. The aim of this study was to investigate whether changes in posttraumatic cognitions mediate treatment effects. Participants were multitraumatized youth (N = 156, mean age = 15.1 years, range = 10-18; 79.5% girls) randomly assigned to receive trauma-focused cognitive-behavioral therapy (TF-CBT) or treatment-as-usual (TAU). Mixed-effects models were applied to investigate the impact of treatment conditions on posttraumatic cognitions...
March 2018: Journal of Counseling Psychology
Jeffrey T Sakamoto, Heather Burrell Ward, Joao Ricardo Nickenig Vissoci, Stephanie A Eucker
STUDY OBJECTIVE: Pain is a common complaint in the Emergency Department (ED). Its management currently depends heavily on pharmacologic treatment, but evidence suggests non-pharmacologic interventions may be beneficial. The purpose of this systematic review and meta-analysis was to assess whether non-pharmacologic interventions in the ED are effective in reducing pain. METHODS: We conducted a systematic review of the literature on all types of non-pharmacologic interventions in the ED with pain reduction as an outcome...
March 15, 2018: Academic Emergency Medicine: Official Journal of the Society for Academic Emergency Medicine
Lone Baandrup, Bjørn H Ebdrup, Jesper Ø Rasmussen, Jane Lindschou, Christian Gluud, Birte Y Glenthøj
BACKGROUND: Prolonged treatment with benzodiazepines is common practice despite clinical recommendations of short-term use. Benzodiazepines are used by approximately 4% of the general population, with increased prevalence in psychiatric populations and the elderly. After long-term use it is often difficult to discontinue benzodiazepines due to psychological and physiological dependence. This review investigated if pharmacological interventions can facilitate benzodiazepine tapering. OBJECTIVES: To assess the benefits and harms of pharmacological interventions to facilitate discontinuation of chronic benzodiazepine use...
March 15, 2018: Cochrane Database of Systematic Reviews
Benjamin S Killen, Krista L Zelizney, Xin Ye
CONTEXT: Static stretching (SS) and self-administered foam rolling (SAFR) are both effective techniques often used in rehabilitation settings to improve one's range-of-motion (ROM). However, their effects on non-intervened contralateral limb's performance remain equivocal. OBJECTIVE: To examine the acute effects of unilateral hamstrings SS and SAFR on the contralateral hip flexion passive ROM and the strength performance. DESIGN: Randomized crossover trial...
March 15, 2018: Journal of Sport Rehabilitation
Bruno Romeo, Lisa Blecha, Katia Locatelli, Amine Benyamina, Catherine Martelli
The objective of this meta-analysis is to assess the efficacy and safety of partial and complete dopamine agonists in the treatment of acute mood disorder episodes. Randomized, double-blind and placebo-controlled trials of dopamine agonists in the treatment of acute mood disorder episodes were identified in the MEDLINE and PsycINFO databases and included in the meta-analysis. In monotherapy of mania, improved remission rates were found for cariprazine (odds ratio (OR): 2.08, P < 0.01) and for high-dose aripiprazole (OR: 3...
March 1, 2018: Journal of Psychopharmacology
Cristina Remondi, Francesco Sesti, Giuseppe Sorrenti, Giovannella Venezia, Roberto Sorge, Adalgisa Pietropolli, Beatrice Silvi, Emilio Piccione
OBJECTIVE: The aim of this study was to compare 22 Fr unipolar resectoscope with the traditional 26 Fr unipolar resectoscope in endometrial polypectomy performed under paracervical block anesthesia. METHODS: The trial took place in Gynecologic Unit, Department of Surgery, Tor Vergata University Hospital, Rome. Inclusion criteria were: diagnosis of endometrial polyps <3 cm at office hysteroscopy; agreement of patients to perform surgery under paracervical block anesthesia but not in office setting...
March 15, 2018: Minimally Invasive Therapy & Allied Technologies: MITAT
Izabela Krejtz, Paweł Holas, Marzena Rusanowska, John B Nezlek
OBJECTIVE: The present study examined the effectiveness of online positive attention bias modification training (ABMT) in inducing positive attention and positive interpretational biases in depressed individuals. METHOD: Clinically depressed individuals (n = 60) were randomly assigned to one of two conditions of 14-day online ABMT. In the positive ABMT condition, a probe replaced positive stimuli in 100% of trials. In the control condition, the probe replaced positive stimuli in 50% of trials...
March 15, 2018: Journal of Clinical Psychology
Christina Krudy, Kavita Shah Arora
The United States, along with other resource-rich countries, leads global health care by advancing medical care through randomized controlled trials (RCTs). While most medical research is conducted in these resource-rich areas, RCTs, including replications of previous trials, are additionally carried out in low- and middle-income countries. On the basis of positive findings from several RCTs conducted in high-income countries, the Antenatal Corticosteroids Trial (ACT) evaluated the effectiveness of antenatal corticosteroids in reducing neonatal mortality in low- and middle-income countries...
March 1, 2018: AMA Journal of Ethics
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