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Trial management

Becci A Akin, Thomas P McDonald
Evidence-supported parenting interventions (ESPIs) have expanded into child welfare because a growing research base has demonstrated positive results among children with serious emotional and behavioral problems. Despite a clear federal policy emphasis on reunification, few randomized trials have tested ESPIs with biological families of children in foster care; even fewer studies have investigated the distal outcomes of ESPIs. The aim of the current study was to examine the effects of Parent Management Training, Oregon (PMTO) model on reunification...
July 16, 2018: Child Abuse & Neglect
Wahid Bouida, Kaouthar Beltaief, Mohamed Amine Msolli, Noussaiba Azaiez, Houda Ben Soltane, Adel Sekma, Imen Trabelsi, Hamdi Boubaker, Mohamed Habib Grissa, Mehdi Methemem, Riadh Boukef, Zohra Dridi, Asma Belguith, Semir Nouira
OBJECTIVES: We aim to determine the benefit of two different doses magnesium sulfate (MgS) compared to placebo in rate control of rapid atrial fibrillation (AF) managed in the emergency department (ED). METHODS: We undertook a randomized, controlled, double-blind clinical trial in 3 university hospital EDs between August 2009 and December 2014. Patients >18years with rapid AF (>120 bpm) were enrolled and randomized to 9g intravenous MgS (High dose group, n=153), 4...
July 19, 2018: Academic Emergency Medicine: Official Journal of the Society for Academic Emergency Medicine
Daniel Fleming, Fred Musser, Dominic Reisig, Jeremy Greene, Sally Taylor, Megha Parajulee, Gus Lorenz, Angus Catchot, Jeffrey Gore, David Kerns, Scott Stewart, Deborah Boykin, Michael Caprio, Nathan Little
The primary management tactic for lepidopteran pests of cotton in the United States of America (USA) is the use of transgenic cotton that produces Bacillus thuringiensis Berliner (Bt) toxins. The primary target pests of this technology are Helicoverpa zea (Boddie) and Heliothis virescens (F.) in the eastern and central Cotton Belt of the USA. Concerns over the evolution of resistance in H. zea to Bt toxins and scrutiny of the necessity of Bt crops has escalated. We reviewed published and unpublished data from field trials of Bt cotton in the eastern and central Cotton Belt of the USA through 2015 to evaluate the effectiveness of Bt cotton (Bollgard, Bollgard II, WideStrike, WideStrike 3, and TwinLink)...
2018: PloS One
Hilary K Seligman, Morgan Smith, Sophie Rosenmoss, Michelle Berger Marshall, Elaine Waxman
OBJECTIVES: To determine whether food bank provision of self-management support and diabetes-appropriate food improves glycemic control among clients with diabetes. METHODS: We screened 5329 adults for diabetes at food pantries (n = 27) affiliated with food banks in Oakland, California; Detroit, Michigan; and Houston, Texas, between October 2015 and September 2016. We individually randomized 568 participants with hemoglobin A1c (HbA1c) 7.5% or greater to waitlist control or 6-month intervention including food, diabetes education, health care referral, and glucose monitoring...
July 19, 2018: American Journal of Public Health
Philip C Robinson, Nicola Dalbeth
Febuxostat is a potent non-purine selective xanthine oxidase inhibitor approved by the FDA in 2009 for management of hyperuricemia in people with gout. Areas covered: The authors summarize the pre-clinical studies and pivotal randomized controlled trials of febuxostat when used as a treatment for hyperuricaemia in gout Expert opinion: Febuxostat has clinical efficacy in serum urate lowering, and long-term use leads to improved outcomes such as gout flare frequency and tophus burden. Recently published post-approval placebo-controlled trials have demonstrated urate-lowering efficacy and safety of febuxostat in patients with chronic kidney disease, and reduced frequency of gout flares in people with early onset of gout...
July 19, 2018: Expert Opinion on Pharmacotherapy
Marinko Marušić, Antonio Klemenčić, Rosana Troskot Perić, Goran Hauser
Gastroesophageal variceal hemorrhage is the most important clinical event that results from portal hypertension. It is a lifethreatening condition that demands rapid and efficient treatment. The first step in bleeding control is hemodynamic stabilization and pharmacological treatment, which includes administration of vasoactive drugs and short-term antibiotic prophylaxis. After initial hemodynamic stabilization, endoscopic therapy should be performed. The first choice of endoscopic treatment for esophageal bleeding is endoscopic variceal ligation (EVL), or endoscopic injection sclerotherapy (EIS) if EVL cannot be performed...
April 2018: Acta Gastro-enterologica Belgica
Hui Liang, Xu Tian, Xiao-Ling Liu, Shu-Ya Wang, Yi Dai, Li Kang, Li-Sai Chen, Li-Fen Jin
BACKGROUND: Ankylosing spondylitis (AS) is an important factor to not only cause employment obstacle, but also result in serious social economic load. Several randomized controlled trials investigated the efficacy of group- versus home-based exercise programs in patients with AS. This systematic review will collect and summarize the available evidence to realize the effectiveness of group- and home-based programs in patients with AS. METHODS: A search in PubMed, Web of Science, EMBASE, and the Cochrane Library will be electronically performed by 2 independent investigators to capture all potential studies comparing group- and home-based in patients with AS...
July 2018: Medicine (Baltimore)
Shari L Wade, Gary Bedell, Jessica A King, Michele Jacquin, Lyn S Turkstra, Juliet Haarbauer-Krupa, Jeremy Johnson, Ralph Salloum, Megan E Narad
PURPOSE/OBJECTIVE: Our goal was to examine the feasibility and preliminary efficacy of an app-based coaching intervention (Social Participation and Navigation; SPAN) to help survivors of acquired brain injury attain social participation goals. Research Method/Design: This is a nonrandomized pilot trial of SPAN, including 15 adolescents (9 with traumatic brain injury, 6 with brain tumor) between the ages of 14-22. The SPAN intervention consisted of a mobile app to support the development and implementation of social participation goals, weekly video-conference coaching sessions to identify goals and step-by-step action plans, and online didactic materials...
July 19, 2018: Rehabilitation Psychology
Abid Kazi, Alyse Fazzi, Nicolle M Krebs, Aimee J Merchlinski, Brenda Kline, Susan Veldheer, John P Richie, Jonathan Foulds, Tonya Lane, Eric C Donny, Joshua E Muscat
Investigational tobacco products, specifically variable nicotine content research cigarettes (SPECTRUM), are available through the National Institute of Drug Abuse Drug Supply Program. Randomized controlled trials using research cigarettes are intended to support tobacco regulatory science research. The current paper provides an in-depth look into managing research cigarettes for two multi-site clinical trials and the design of a computer-based Cigarette Management System (CMS). The paper provides guidance intended for any investigator using similar products on the operating procedures under Good Clinical Practice standards and describes features of the CMS...
September 2018: Contemporary Clinical Trials Communications
Somayyeh Asghari, Maryam Rafraf, Laleh Farzin, Mohammad Asghari-Jafarabadi, Seyed-Mostafa Ghavami, Mohammad-Hossein Somi
Purpose: Despite a proposed role for oxidative stress in the pathogenesis of nonalcoholic fatty liver disease (NAFLD), antioxidant approaches have not been sufficiently investigated in human NAFLD management. Resveratrol has been reported to possess a wide range of biological functions, including antioxidant activities. This study aimed to evaluate the effects of resveratrol supplementation on oxidative/anti-oxidative status in patients with NAFLD. Methods: This randomized, double-blind, placebo-controlled clinical trial was conducted on 60 patients with NAFLD (males and females) aged 20 to 60 years, and body mass index (BMI) of 25-35 kg/m2...
June 2018: Advanced Pharmaceutical Bulletin
Abdulkareem M Albekairy, Wesam S Abdel-Razaq, Abdulmalik M Alkatheri, Tariq M Al Debasi, Nouf E Al Otaibi, Amjad M Qandil
The use of immunosuppressants to reduce the likelihood of acute graft rejections is a cornerstone in the post-transplantation management of recipients. However, these agents were always associated with increased risk of deleterious effects such as infections vulnerability and comorbidities. The objective of this review is to discuss the impact of different immunosuppression strategies used in liver transplant recipients (LTRs) on the recurrence of hepatitis C virus (HCV) infections after transplantation. Traditionally, corticosteroids were a mainstay in immunosuppressive regimens in LTRs...
July 2018: International Journal of Health Sciences
Yi Li, Pengbin Yin, Houchen Lv, Yutong Meng, Licheng Zhang, Peifu Tang
Purpose: The debate is still ongoing on the effectiveness and safety of erythropoietin (EPO) treatment in orthopedic surgeries. Specifically, previous studies have not compared the dynamic change of hemoglobin (Hb) levels between different transfusion methods. Besides, complications or side effects of this alternative have not been quantitatively analyzed. We conducted a meta-analysis and systemic review to evaluate the efficacy of EPO on Hb levels observed during the whole perioperative period as well as the volume of allogeneic blood transfusion (ABT), the risk of venous thromboembolism, and application frequency of ABT in hip and knee surgery...
2018: Therapeutics and Clinical Risk Management
Kristy Yuan, Scott Eric Kasner
The patent foramen ovale (PFO), given its high prevalence in the general population and especially in patients with cryptogenic stroke, has long generated investigation and debate on its propensity for stroke by paradoxical embolism and its management for stroke prevention. The pendulum has swung for percutaneous PFO closure for secondary stroke prevention in cryptogenic stroke. Based on a review of current evidence, the benefit from PFO closure relies on careful patient selection: those under the age of 60 years with few to no vascular risk factors and embolic-appearing stroke deemed cryptogenic after thorough evaluation...
June 2018: Stroke and Vascular Neurology
A Ross Naylor
The European Society for Vascular Surgery (ESVS) has recently prepared updated guidelines for the management of patients with symptomatic and asymptomatic atherosclerotic carotid artery disease, with specific reference to the roles of best medical therapy, carotid endarterectomy (CEA) and carotid artery stenting (CAS). In symptomatic patients, there is a drive towards performing carotid interventions as soon as possible after onset of symptoms. This is because it is now recognised that the highest risk period for recurrent stroke is the first 7-14 days after onset of symptoms...
June 2018: Stroke and Vascular Neurology
Ao Yu, David Adelson, David Mills
Diabetes affects 422 million people and directly caused 4.9 million deaths according to the global report on diabetes in 2014. Type 2 diabetes accounts for 90% of people with diabetes around the world. Chinese herbal medicine treatment for diabetes has more than 2000-year history in China. An increasing number of people around the world are trying to manage type 2 diabetes with Chinese herbal medicine. However, there is a lack of evidence to decide if Chinese herbal medicine is effective and safe when compared with other interventions for the treatment of type 2 diabetes We identified 58 randomized controlled trials involving 6637 participants with type 2 diabetes with trial periods lasting from 8 weeks to 1 year (average 12 weeks)...
January 2018: Journal of evidence-based integrative medicine
Marilena Durazzo, Silvia Bonetto, Sharmila Fagoonee, Anna Morgando, Rinaldo Pellicano
BACKGROUND: Primary Biliary Cholangitis (PBC) is an autoimmune cholestatic liver disease with unknown etiology. The prognosis of patients affected by PBC is heterogeneous, with a relevant improvement achieved after the introduction of ursodeoxycolic acid (UDCA). Since in the last years obeticholic acid (OCA) has been approved for the combined treatment of PBC, in patient nonresponders to UDCA or as monotherapy in those intolerant to UDCA, we evaluated the response to UDCA in a cohort of patients with PBC managed in a specialistic setting...
July 18, 2018: Minerva Medica
Shin Nishio, Satomi Aihara, Mototsugu Shimokawa, Akira Fujishita, Shuichi Taniguchi, Toru Hachisuga, Shintaro Yanazume, Hiroaki Kobayashi, Fumihiro Murakami, Fumitaka Numa, Kohei Kotera, Naofumi Okura, Naoyuki Toki, Masatoshi Yokoyama, Kimio Ushijima
OBJECTIVE: Palonosetron is effective for the management of acute and delayed chemotherapy-induced nausea and vomiting (CINV). While emetogenic carboplatin-based chemotherapy is widely used to treat gynecologic cancers, few studies have evaluated the antiemetic effectiveness of palonosetron in this setting. METHODS: A multicenter, single-arm, open-label phase II trial was conducted to evaluate the safety and effectiveness of palonosetron in controlling CINV in patients with gynecologic cancer...
May 15, 2018: Journal of Gynecologic Oncology
Wendy M Reinke, Keith C Herman, Nianbo Dong
This group randomized controlled trial (RCT) evaluated the efficacy of the Incredible Years Teacher Classroom Management Program (IY TCM) on student social behavioral and academic outcomes among a large diverse sample of students within an urban context. Participants included 105 teachers and 1817 students in kindergarten to third grade. Three-level hierarchical linear models (HLM) were conducted to examine the overall treatment effects on teacher-reported student behavior and academic outcomes. In addition, multi-level moderation analyses were conducted to examine whether the treatment effects on student outcomes differed by demographic variables and pretest measures of social emotional and disruptive behavior and academics...
July 19, 2018: Prevention Science: the Official Journal of the Society for Prevention Research
Maria Lohan, Áine Aventin, Mike Clarke, Rhonda M Curran, Clíona McDowell, Ashley Agus, Lisa McDaid, Chris Bonell, Honor Young
The World Health Organisation advocates a direct focus on adolescent men in reducing adolescent pregnancy; however, no trials have been conducted. This trial (ISRCTN11632300; NCT02092480) determines whether a novel Relationship and Sexuality Educational intervention, If I Were Jack, is acceptable and feasible to implement in mixed sex UK classrooms. The intervention is a teacher-delivered intervention that emphasises male alongside female  responsibility in preventing unintended pregnancies and is designed to prevent unprotected sex...
July 18, 2018: Prevention Science: the Official Journal of the Society for Prevention Research
Chen-Chen Kuo, Ruey-Hsia Wang, Hsiu-Hung Wang, Chun-Hua Li
PURPOSE: This meta-analysis aimed to evaluate the efficacy and safety of propolis mouthwash in cancer patients with therapy-induced oral mucositis. METHODS: This was a systematic review of randomized control trails (RCTs). We searched ten electronic databases for studies published prior to April 06, 2017. The included RCTs were published in English and Chinese. The Jadad score was used to evaluate the quality of the articles identified. Two reviewers independently evaluated each of the studies...
July 19, 2018: Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer
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