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Trial methodology

Afarin Rahimi-Movaghar, Jaleh Gholami, Laura Amato, Leila Hoseinie, Reza Yousefi-Nooraie, Masoumeh Amin-Esmaeili
BACKGROUND: Pharmacologic therapies for management of heroin withdrawal have been studied and reviewed widely. Opium dependence is generally associated with less severe dependence and milder withdrawal symptoms than heroin. The evidence on withdrawal management of heroin might therefore not be exactly applicable for opium. OBJECTIVES: To assess the effectiveness and safety of various pharmacologic therapies for the management of the acute phase of opium withdrawal...
June 21, 2018: Cochrane Database of Systematic Reviews
Qinyi Bao, Lina Chen, Zhiyu Lu, Yongyan Ma, Lili Guo, Shuaishuai Zhang, Xiaoping Huang, Suling Xu, Liemin Ruan
BACKGROUND: Several studies were conducted to investigate the association between eczema and risk of depression. This was important because the care of patients with eczema might be inadequate if their psychological problems were not also recognized and treated. However, these studies had some inherent limitations such as small sample sizes or lack of controlling for potential confounders. Further, little was known about psychological co-morbidity of eczema from a global perspective. METHODS: We conducted a systematic literature search in PubMed (1966 through January 26th 2017), Cochrane Library (the Cochrane central register of controlled trials, up to January 26th 2017), Scopus (up to December 31st 2016) and Embase (1980 through January 26th 2017) supplemented by manual searches of bibliographies and conference proceedings...
May 15, 2018: Journal of Affective Disorders
Anna Wilkins, Christine Stuttle, Shama Hassan, Claire Blanchard, Clare Cruickshank, Clare Griffin, Jake Probert, Catherine M Corbishley, Chris Parker, David Dearnaley, Emma Hall
Background: This article presents the methodology for tissue sample collection in Trans-CHHiP, the main translational study within the CHHiP (Conventional or Hypofractionated High dose intensity modulated radiotherapy in Prostate cancer, ISRCTN 97182923) trial. The CHHiP trial randomised 3216 men with localised prostate cancer to 3 different radiotherapy fractionation schedules. Trans-CHHiP aims to identify biomarkers of fraction sensitivity. Methods: We outline the process of tissue collection, including central review by a study-specific specialist uropathologist and comparison of the centrally-assigned Gleason grade group with that assigned by the recruiting-centre pathologist...
March 2018: Clinical and Translational Radiation Oncology
Marco Annunziata, Luigi Guida, Livia Nastri, Angelantonio Piccirillo, Linda Sommese, Claudio Napoli
Prevention of alveolar bone resorption after tooth extraction may be useful for implant rehabilitation of the edentulous site minimizing the future need for bone augmentation procedures. A number of studies have investigated the efficacy of autologous platelet concentrates for the preservation of the alveolar bone volume after tooth extraction. Although encouraging results have been published, the available data are still controversial. The aim of the present systematic review was to assess the effect of platelet concentrates on alveolar socket preservation after tooth extraction...
May 2018: Transfusion Medicine and Hemotherapy
Richard A Brown, Kathleen M Palm Reed, Erika Litvin Bloom, Haruka Minami, David R Strong, Carl W Lejuez, Michael J Zvolensky, Steven C Hayes
We previously developed a distress tolerance (DT)-based treatment that showed promising results for smokers with a history of early lapse. In the current study, we conducted a randomized controlled trial of this DT treatment for a general population of smokers not limited to those with a history of early lapse. We randomized 116 participants (41% female) to DT or standard treatment (ST). Both treatments included 1 individual session during Week 1 followed by 7 group sessions during Weeks 2-9 (quit date at Session 4), two 20-min phone sessions, and 8 weeks of transdermal nicotine patch...
June 2018: Psychology of Addictive Behaviors: Journal of the Society of Psychologists in Addictive Behaviors
Maria Quigley, Nicholas D Embleton, William McGuire
BACKGROUND: When sufficient maternal breast milk is not available, alternative forms of enteral nutrition for preterm or low birth weight (LBW) infants are donor breast milk or artificial formula. Donor breast milk may retain some of the non-nutritive benefits of maternal breast milk for preterm or LBW infants. However, feeding with artificial formula may ensure more consistent delivery of greater amounts of nutrients. Uncertainty exists about the balance of risks and benefits of feeding formula versus donor breast milk for preterm or LBW infants...
June 20, 2018: Cochrane Database of Systematic Reviews
Liye Zou, Albert Yeung, Chunxiao Li, Shin-Yi Chiou, Nan Zeng, Huey-Ming Tzeng, Lin Wang, Zhanbing Ren, Taquesha Dean, Garrett Anthony Thomas
Objective : We performed a systematic review with meta-analysis and meta-regression to determine if mind⁻body movements (MBM) could be effective in rehabilitating balance function among stroke survivors. Methods : A literature search was conducted using major Chinese and English electronic databases from an inception until January 2018. Randomized controlled studies were included in our meta-analysis. Data was independently extracted by two review authors using a pre-developed table and confirmed by a third party to reach a consensus...
June 20, 2018: International Journal of Environmental Research and Public Health
Natalie J Collins, Christian J Barton, Marienke van Middelkoop, Michael J Callaghan, Michael Skovdal Rathleff, Bill T Vicenzino, Irene S Davis, Christopher M Powers, Erin M Macri, Harvi F Hart, Danilo de Oliveira Silva, Kay M Crossley
Patellofemoral pain affects a large proportion of the population, from adolescents to older adults, and carries a substantial personal and societal burden. An international group of scientists and clinicians meets biennially at the International Patellofemoral Research Retreat to share research findings related to patellofemoral pain conditions and develop consensus statements using best practice methods. This consensus statement, from the 5th International Patellofemoral Research Retreat held in Australia in July 2017, focuses on exercise therapy and physical interventions (eg, orthoses, taping and manual therapy) for patellofemoral pain...
June 20, 2018: British Journal of Sports Medicine
Kamala Thriemer, Albino Bobogare, Benedikt Ley, Clarice Samo Gudo, Mohammad Shafiul Alam, Nick M Anstey, Elizabeth Ashley, J Kevin Baird, Charlotte Gryseels, Elodie Jambert, Marcus Lacerda, Ferdinand Laihad, Jutta Marfurt, Ayodhia Pitaloka Pasaribu, Jeanne Rini Poespoprodjo, Inge Sutanto, Walter R Taylor, Christel van den Boogaard, Katherine E Battle, Lek Dysoley, Prakash Ghimire, Bill Hawley, Jimee Hwang, Wasif Ali Khan, Rose Nani Binti Mudin, Maria Endang Sumiwi, Rukhsana Ahmed, M M Aktaruzzaman, Kiran Raj Awasthi, Azucena Bardaji, David Bell, Leonard Boaz, Faustina Helen Burdam, Daniel Chandramohan, Qin Cheng, Keobouphaphone Chindawongsa, Janice Culpepper, Santasabuj Das, Raffy Deray, Meghna Desai, Gonzalo Domingo, Wang Duoquan, Stephan Duparc, Rustini Floranita, Emily Gerth-Guyette, Rosalind E Howes, Cecilia Hugo, George Jagoe, Elvieda Sariwati, Sanya Tahmina Jhora, Wu Jinwei, Harin Karunajeewa, Enny Kenangalem, Bibek Kumar Lal, Chandra Landuwulang, Emmanuel Le Perru, Sang-Eun Lee, Leo Sora Makita, James McCarthy, Asrat Mekuria, Neelima Mishra, Esau Naket, Simone Nambanya, Johnny Nausien, Thang Ngo Duc, Thuan Nguyen Thi, Rinitis Noviyanti, Daniel Pfeffer, Gao Qi, Annisa Rahmalia, Stephen Rogerson, Iriani Samad, Jetsumon Sattabongkot, Ari Satyagraha, Dennis Shanks, Surender Nath Sharma, Carol Hopkins Sibley, Ali Sungkar, Din Syafruddin, Arunansu Talukdar, Joel Tarning, Feiko Ter Kuile, Suman Thapa, Minerva Theodora, Tho Tran Huy, Edward Waramin, Govert Waramori, Adugna Woyessa, Chansuda Wongsrichanalai, Nguyen Xuan Xa, Joon Sup Yeom, Lukas Hermawan, Angela Devine, Spike Nowak, Indra Jaya, Supargiyono Supargiyono, Koen Peeters Grietens, Ric N Price
The goal to eliminate malaria from the Asia-Pacific by 2030 will require the safe and widespread delivery of effective radical cure of malaria. In October 2017, the Asia Pacific Malaria Elimination Network Vivax Working Group met to discuss the impediments to primaquine (PQ) radical cure, how these can be overcome and the methodological difficulties in assessing clinical effectiveness of radical cure. The salient discussions of this meeting which involved 110 representatives from 18 partner countries and 21 institutional partner organizations are reported...
June 20, 2018: Malaria Journal
Sophie Guilmin-Crépon, Jean-Claude Carel, Julien Schroedt, Erwan Scornet, Corinne Alberti, Nadia Tubiana-Rufi
BACKGROUND: Glycemic variability (GV) can be used to assess glycemic control in diabetes, but there is no clear consensus concerning the methods to use for its assessment. Methodological differences have resulted in differences in the outcome of GV metrics used in research studies, controversies over clinical impact, and an absence of integration into routine care. AIM: To identify the indicators of GV most meaningful for clinicians, patients, and clinical researchers...
June 2018: Diabetes Technology & Therapeutics
Fabio Mangiacapra, Edoardo Bressi, Alessandro Sticchi, Carmine Morisco, Emanuele Barbato
The presence and extent of myocardial ischemia are the major determinants of prognosis in patients with coronary artery disease (CAD). Unlike coronary angiography alone, fractional flow reserve (FFR) has enabled interventional cardiologists to accurately determine whether coronary atherosclerotic plaques are responsible for myocardial ischemia, and therefore deserve to be revascularized. Areas covered: An overview on the role of FFR in the diagnosis and treatment of coronary artery disease, as well as the potential related controversies is provided...
June 20, 2018: Expert Review of Cardiovascular Therapy
Yibing Zhang, Min Li, Xiangjun Li, Tong Zhang, Meng Qin, Liqun Ren
Background: Several studies have attempted to relate the bioactive alkaloid with atherosclerotic cardiovascular diseases prevention in animal models, providing inconsistent results. Moreover, the direct anti-atherosclerotic effects of alkaloid have hardly been studied in patients. Therefore, the aim of this systematic review was to assess the reported effects of alkaloids on aortic atherosclerosis in ApoE-/- mouse models. Methods : Pubmed and Embase were searched to identify studies which estimated the effect of isolated alkaloids on atherosclerosis in apolipoprotein E deficient mice...
2018: Frontiers in Pharmacology
Yan He, Tao Guo, Hui Guan, Jingjing Wang, Yu Sun, Xingchen Peng
Purpose: In this study, we attempted to compare the efficacy and toxicity of concurrent chemoradiotherapy (CCRT) with radiotherapy alone (RT) for locoregionally advanced nasopharyngeal carcinoma (LANPC) in the era of intensity-modulated radiotherapy (IMRT) by meta-analysis. Materials and methods: We searched databases, and all randomized controlled trials meeting the inclusion criteria were utilized for a meta-analysis with RevMan 5.3 based on the Cochrane methodology...
2018: Cancer Management and Research
Mojgan Amiri, Reza Ghiasvand, Mojtaba Kaviani, Scott C Forbes, Amin Salehi-Abargouei
BACKGROUND/OBJECTIVES: Chocolate milk (CM) contains carbohydrates, proteins, and fat, as well as water and electrolytes, which may be ideal for post-exercise recovery. We systematically reviewed the evidence regarding the efficacy of CM compared to either water or other "sport drinks" on post-exercise recovery markers. SUBJECTS/METHODS: PubMed, Scopus, and Google scholar were explored up to April 2017 for controlled trials investigating the effect of CM on markers of recovery in trained athletes...
June 19, 2018: European Journal of Clinical Nutrition
Chaudhry M S Sarwar, Muthiah Vaduganathan, Stefan D Anker, Stefano Coiro, Lampros Papadimitriou, Joel Saltz, Elinor R Schoenfeld, Richard L Clark, Wilfried Dinh, Frank Kramer, Mihai Gheorghiade, Gregg C Fonarow, Javed Butler
Cardiovascular disease is the leading cause of mortality and morbidity globally. With widespread and growing use of smart phones and mobile devices, the use of mobile health (mHealth) in transmission of physiologic parameters and patient-referred symptoms to healthcare providers and researchers, as well as reminders and care plan applications from providers to patients, has potential to revolutionize both clinical care and the conduct of clinical trials with improved designs, data capture, and potentially lower costs...
June 12, 2018: International Journal of Cardiology
F Rieder, D Bettenworth, C Ma, C E Parker, L A Williamson, S A Nelson, G van Assche, A Di Sabatino, Y Bouhnik, R W Stidham, A Dignass, G Rogler, S A Taylor, J Stoker, J Rimola, M E Baker, J G Fletcher, J Panes, W J Sandborn, B G Feagan, V Jairath
BACKGROUND: Fibrotic stricture is a common complication of Crohn's disease (CD) affecting approximately half of all patients. No specific anti-fibrotic therapies are available; however, several therapies are currently under evaluation. Drug development for the indication of stricturing CD is hampered by a lack of standardised definitions, diagnostic modalities, clinical trial eligibility criteria, endpoints and treatment targets in stricturing CD. AIM: To standardise definitions, diagnosis and treatment targets for anti-fibrotic stricture therapies in Chron's disease...
June 19, 2018: Alimentary Pharmacology & Therapeutics
Jiajie Yu, Wenwen Chen, Shidong Chen, Pengli Jia, Guanyue Su, Youping Li, Xin Sun
BACKGROUND: Randomized controlled trial (RCT) testing surgical intervention faced challenges due to complexities of surgery and made it more difficult for surgeons and methodologists than pharmaceutical providers to build a well-design, conduct RCT. OBJECTIVE: We conducted a cross-sectional survey to address the methodological challenges of RCTs on surgical intervention and offer potential solutions. METHODS: We searched PubMed in order to summarize 2-arm parallel randomized trials for surgical interventions published in 2013...
June 18, 2018: Annals of Surgery
Torsten Skov, Eggert Stockfleth, Rolf-Markus Szeimies, Brian Berman
INTRODUCTION: Actinic keratosis is regarded as a chronic disease of the skin and, although fluctuating, is chronically progressive. Approval of new products for the treatment of actinic keratosis requires the use of a standard methodology in clinical trials which emphasize complete clearance of all actinic keratoses in a treatment field in a defined time span and the evaluation of long-term efficacy in terms of recurrence rate among completely cleared patients. METHODS: Analysis of data from six previously published clinical trials in patients with actinic keratosis...
June 18, 2018: Dermatology and Therapy
Paula Tâmara Vieira Teixeira Pereira, Andréa Dias Reis, Renata Rodrigues Diniz, Franciléia Andrade Lima, Richard Diego Leite, Mayara Cristina Pinto da Silva, Rosane Nassar Meireles Guerra, Érica Brandão de Moraes Vieira, João Batista Santos Garcia
PURPOSE: Cancer-related fatigue (CRF) is defined as a distressing, persistent, and subjective sense of physical or emotional and/or cognitive exhaustion. The treatment of CRF includes pharmacological and non-pharmacological therapies; dietary strategies with promising results have also been used. This study aimed to identify dietary supplements that improve fatigue in patients with breast cancer. METHODS: A systematic review of the literature was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement...
June 18, 2018: Breast Cancer Research and Treatment
Ronald L Koretz
Probiotic usage has become popular with both medical practitioners and the community in general; patients commonly seek advice regarding what, if any, such preparation would be useful for their own diseases. Since such advice should be evidence-based, identified randomized clinical trials (RCTs) for a number of gastrointestinal conditions were reviewed; the data were organized by individual probiotic genera/species. Only trials in adults were considered. Most of the identified RCTs were small and low-quality, so any conclusions to be drawn will be limited at least by methodologic problems...
June 19, 2018: American Journal of Gastroenterology
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