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Randomized placebo

Oscar J Ponce, Gabriela Spencer-Bonilla, Neri Alvarez-Villalobos, Valentina Serrano, Naykky Singh-Ospina, Rene Rodriguez-Gutierrez, Alejandro Salcido-Montenegro, Raed Benkhadra, Larry J Prokop, Shalender Bhasin, Juan P Brito
Context: The efficacy and safety of testosterone replacement therapy (TRT) in hypogonadal men remain incompletely understood. Objective: To conduct a systematic review and meta-analysis of randomized clinical trials (RCT) to determine the effects of TRT on patient-important outcomes and adverse events in hypogonadal men. Data Sources: We searched Ovid MEDLINE, Ovid EMBASE, Ovid Cochrane Database of Systematic Reviews, Ovid Cochrane Central Register of Controlled Trials, and Scopus from inception to March 2th, 2017...
March 17, 2018: Journal of Clinical Endocrinology and Metabolism
Il Ju Choi, Myeong-Cherl Kook, Young-Il Kim, Soo-Jeong Cho, Jong Yeul Lee, Chan Gyoo Kim, Boram Park, Byung-Ho Nam
BACKGROUND: Patients with early gastric cancers that are limited to gastric mucosa or submucosa usually have an advanced loss of mucosal glandular tissue (glandular atrophy) and are at high risk for subsequent (metachronous) development of new gastric cancer. The long-term effects of treatment to eradicate Helicobacter pylori on histologic improvement and the prevention of metachronous gastric cancer remain unclear. METHODS: In this prospective, double-blind, placebo-controlled, randomized trial, we assigned 470 patients who had undergone endoscopic resection of early gastric cancer or high-grade adenoma to receive either H...
March 22, 2018: New England Journal of Medicine
Fleur P Paling, Karina Olsen, Kristin Ohneberg, Martin Wolkewitz, Vance G Fowler, Mark J DiNubile, Hasan S Jafri, Frangiscos Sifakis, Marc J M Bonten, Stephan J Harbarth, Jan A J W Kluytmans
BACKGROUND: Identifying patients undergoing cardiothoracic surgery at high risk of Staphylococcus aureus surgical site infection (SSI) is a prerequisite for implementing effective preventive interventions. The objective of this study was to develop a risk prediction model for S. aureus SSI or bacteremia after cardiothoracic surgery based on pre-operative variables. MATERIALS/METHODS: Data from the Merck Phase IIb/III S. aureus vaccine (V710-P003) clinical trial were analyzed...
2018: PloS One
Frederique E C M Peeters, Manouk J W van Mourik, Steven J R Meex, Jan Bucerius, Simon M Schalla, Suzanne C Gerretsen, Casper Mihl, Marc R Dweck, Leon J Schurgers, Joachim E Wildberger, Harry J G M Crijns, Bas L J H Kietselaer
BASIK2 is a prospective, double-blind, randomized placebo-controlled trial investigating the effect of vitamin K2 (menaquinone-7;MK7) on imaging measurements of calcification in the bicuspid aortic valve (BAV) and calcific aortic valve stenosis (CAVS). BAV is associated with early development of CAVS. Pathophysiologic mechanisms are incompletely defined, and the only treatment available is valve replacement upon progression to severe symptomatic stenosis. Matrix Gla protein (MGP) inactivity is suggested to be involved in progression...
March 21, 2018: Nutrients
Sangkwan Lee, Seon-Jong Kim
BACKGROUND: Arthritis is the most common disease in elderly individuals. Many medications for osteoarthritis treatment have the potential for side effects. Using a bioinformatics tool and preclinical studies, ChondroT, 5 herbal complexes, was identified from Ganghwaljetongyeum, which is a18 herbal complex, which has often used to treat osteoarthritis. The goal of this study is to evaluate short-term safety of ChondroT. METHODS: This will be a multicenter, randomized, double-blind, and placebo-controlled trial...
March 2018: Medicine (Baltimore)
Karen E Elkind-Hirsch, Martha S Paterson, Donna Shaler, Hanh C Gutowski
OBJECTIVE: Our pilot study examined the effectiveness of sitagliptin-metformin (SITA-MET), metformin (MET), and placebo (P) therapy on fasting and post-glucose challenge glucose levels in postpartum women with prior gestational diabetes mellitus (GDM) and impaired glucose regulation. METHODS: Prediabetic women (N = 36, age 18 to 42 years) with recent GDM were randomized to P (one pill twice a day), MET (1,000 mg twice a day), or SITA-MET (50 mg SITA, 1,000 mg MET twice a day) for 16 weeks in a single-blind fashion...
March 21, 2018: Endocrine Practice
Raquel González, Clara Pons-Duran, Mireia Piqueras, John J Aponte, Feiko O Ter Kuile, Clara Menéndez
BACKGROUND: The World Health Organization recommends intermittent preventive treatment in pregnancy (IPTp) with sulfadoxine-pyrimethamine for malaria for all women who live in moderate to high malaria transmission areas in Africa. However, parasite resistance to sulfadoxine-pyrimethamine has been increasing steadily in some areas of the region. Moreover, HIV-infected women on cotrimoxazole prophylaxis cannot receive sulfadoxine-pyrimethamine because of potential drug interactions. Thus, there is an urgent need to identify alternative drugs for prevention of malaria in pregnancy...
March 21, 2018: Cochrane Database of Systematic Reviews
Alexandra M Minnis, Sarah T Roberts, Kawango Agot, Rachel Weinrib, Khatija Ahmed, Kgahlisho Manenzhe, Fredrick Owino, Ariane van der Straten
End-user input is critical to inform development of multipurpose prevention technology (MPT) products that prevent HIV and pregnancy. The TRIO Study, conducted in Kenya and South Africa, enrolled 277 HIV-negative women aged 18-30 in a randomized cross-over study to use each placebo MPT (daily oral tablets, monthly injections, and monthly vaginal ring) for one month. At the end of each month, participants rated how much they liked using the product on a 5-point Likert scale (5 = liked very much). We compared mean ratings using paired t-tests and examined sociodemographic-, attribute-, and behavior-related characteristics associated with ratings using multivariable linear regression and data from in-depth interviews...
March 20, 2018: AIDS and Behavior
Heather M O'Leary, Walter E Kaufmann, Katherine V Barnes, Kshitiz Rakesh, Kush Kapur, Daniel C Tarquinio, Nicole G Cantwell, Katherine J Roche, Suzanne A Rose, Alexandra C Walco, Natalie M Bruck, Grace A Bazin, Ingrid A Holm, Mark E Alexander, Lindsay C Swanson, Lauren M Baczewski, Juan M Mayor Torres, Charles A Nelson, Mustafa Sahin
Objective: To measure the efficacy of mecasermin (recombinant human insulin-like growth factor 1, rhIGF-1), for treating symptoms of Rett syndrome (RTT) in a pediatric population using a double-blind crossover study design. Methods: Thirty girls with classic RTT in postregression stage were randomly assigned to placebo or rhIGF-1 in treatment period 1 and crossed over to the opposite assignment for period 2 (both 20 weeks), separated by a 28-week washout period...
March 2018: Annals of Clinical and Translational Neurology
Saber Jan, Braveen Ragunanthan, Sandra R DiBrito, Omolabake Alabi, Maria Gutierrez
Background: Cefepime is a fourth-generation cephalosporin antibiotic used to treat a variety of infections. The US Food and Drug Administration approved its use in certain types of infections among pediatric patients, and yet there have been mixed data about its efficacy and safety in this population. Objective: The objective of this review is to compare efficacy and all-cause mortality of cefepime to other clinically indicated antibiotics among children. Methods: We conducted a systematic search of MEDLINE, EMBASE, CENTRAL, LILACS, and clinicaltrials...
2018: Frontiers in Pediatrics
Felix Müller, Patrick C Dolder, André Schmidt, Matthias E Liechti, Stefan Borgwardt
LSD is an ambiguous substance, said to mimic psychosis and to improve mental health in people suffering from anxiety and depression. Little is known about the neuronal correlates of altered states of consciousness induced by this substance. Limited previous studies indicated profound changes in functional connectivity of resting state networks after the administration of LSD. The current investigation attempts to replicate and extend those findings in an independent sample. In a double-blind, randomized, cross-over study, 100 μg LSD and placebo were orally administered to 20 healthy participants...
2018: NeuroImage: Clinical
Lanlan Zhang, Chengzhong Wang, Wei Li
Objective: To evaluate clinical efficacy, safety, and tolerability of levetiracetam as mono- or adjunctive therapy in the treatment of children and adolescents with epilepsy. Materials and methods: We performed a meta-analysis of randomized controlled trials published from January 2007 to December 2016 in the databases Web of Science, Medline, Embase, Cochrane Library, and PubMed, Bing, Baidu, Google Scholar, Chinese National Knowledge Infrastructure (CNKI), and Wanfang Data...
2018: Neuropsychiatric Disease and Treatment
Zhipeng Zhu, Hongmei Zhou, Yunjian Ni, Cheng Wu, Caijun Zhang, Xiaoyan Ling
Purpose: Cardiac surgery patients always present with atrial fibrillation (AF) after admission to the intensive care unit, leading to high mortality and lengthy hospitalization. Dexmedetomidine (DEX) is a popular medication used for sedation in the intensive care unit; however, whether it can reduce AF needs to be analyzed. Materials and methods: Three primary databases, Medline, Embase (Ovid SP) and the Cochrane Central Register of Controlled Trials (CENTRAL), were searched...
2018: Drug Design, Development and Therapy
Jolien Fleur Leijenaar, Geert Jan Groeneveld, Wiesje Maria van der Flier, Philip Scheltens, Erica Surya Klaassen, Henry Chanoch Weinstein, Geert Jan Biessels, Frederik Barkhof, Niels Daniël Prins
BACKGROUND: People with vascular cognitive impairment (VCI) constitute a clinically heterogeneous group, but previous symptomatic drug trials in VCI did not take this clinical heterogeneity into account. Executive dysfunction and memory impairment are the cognitive domains that are most frequently impaired in VCI, and these impairments are likely to reflect vascular damage to specific neurotransmitter systems, which opens the possibility for targeted symptomatic treatment directed at specific neurotransmitters...
March 20, 2018: JMIR Research Protocols
Andrzej Żyluk, Piotr Puchalski
Complex regional pain syndrome (CRPS) is a descriptive term for a complex of symptoms and signs typically occurring following trauma of the extremity. Typical symptomatology includes severe pain, swelling, vasomotor instability and functional impairment of the affected limb. At present there is no one, effective method of treatment of the condition. A large number of treatments have been investigated but major multicentre randomized controlled trials are lacking. This study presents the results of a systematic review of the evidence on effectiveness of treatment methods in CRPS...
March 12, 2018: Neurologia i Neurochirurgia Polska
Qiong Wang, Yi-Ru Wang, Qing-Yun Jia, Li Liu, Chong-Qing Xu, Xiao-Yun Wang, Min Yao, Xue-Jun Cui, Qi Shi, Yong-Jun Wang, Qian-Qian Liang
BACKGROUND: Rheumatoid arthritis (RA) is a chronic autoimmune disease characterized by swelling and painful joints, eventually leading to joint destruction. There is still a lack of effective therapy to treat RA. The Juanbi pill is a Chinese medicine that has been widely used to treat active RA in China for hundreds of years, relieving pain and protecting the affected joints from malformation. However, there is no solid evidence to show the effect of the Juanbi pill on the management of active RA...
March 20, 2018: Trials
Rasha Babiker, Khalifa Elmusharaf, Michael B Keogh, Amal M Saeed
BACKGROUND: There is a strong association between cardiometabolic risk and adipose tissue dysfunction with great consequences on type 2 diabetic patients. Visceral Adiposity Index (VAI) is an indirect clinical marker of adipose tissue dysfunction. Gum Arabic (GA) is a safe dietary fiber, an exudate of Acacia Senegal. Gum Arabic had shown lipid lowering effect in both humans and animals. The aim of this trial was to determine the effect of GA supplementation on anthropometric obesity marker, Visceral Adiposity Index (VAI) and blood pressure in patients with type 2 diabetes mellitus...
March 20, 2018: Lipids in Health and Disease
Xinyuan Li, Lijun Zhu, Chunkui Zhou, Jing Liu, Heqian Du, Chenglin Wang, Shaokuan Fang
OBJECTIVE: To investigate the efficacy and tolerability of duloxetine during short-term treatment in adults with generalized anxiety disorder (GAD). METHODS: We conducted a comprehensive literature review of the PubMed, Embase, Cochrane Central Register of Controlled Trials, Web of Science, and ClinicalTrials databases for randomized controlled trials(RCTs) comparing duloxetine or duloxetine plus other antipsychotics with placebo for the treatment of GAD in adults...
2018: PloS One
Jieun Yoon, Akihiro Kanamori, Keisuke Fujii, Hiroko Isoda, Tomohiro Okura
PURPOSE: Maslinic acid (MA) is a component derived from a natural olive-based extract known to have pharmacological functions that include suppressing inflammation. This study examined how MA, in conjunction with whole-body vibration training (WBVT), can improve knee and muscle function in elderly women with knee osteoarthritis (OA). METHODS: The study was a double-blinded, placebo-controlled, randomized intervention study that enrolled individuals with knee pain...
2018: PloS One
Kunal N Karmali, Donald M Lloyd-Jones, Joep van der Leeuw, David C Goff, Salim Yusuf, Alberto Zanchetti, Paul Glasziou, Rodney Jackson, Mark Woodward, Anthony Rodgers, Bruce C Neal, Eivind Berge, Koon Teo, Barry R Davis, John Chalmers, Carl Pepine, Kazem Rahimi, Johan Sundström
BACKGROUND: Clinical practice guidelines have traditionally recommended blood pressure treatment based primarily on blood pressure thresholds. In contrast, using predicted cardiovascular risk has been advocated as a more effective strategy to guide treatment decisions for cardiovascular disease (CVD) prevention. We aimed to compare outcomes from a blood pressure-lowering treatment strategy based on predicted cardiovascular risk with one based on systolic blood pressure (SBP) level. METHODS AND FINDINGS: We used individual participant data from the Blood Pressure Lowering Treatment Trialists' Collaboration (BPLTTC) from 1995 to 2013...
March 2018: PLoS Medicine
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