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Clinical trials

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
Paola Mosconi, Cinzia Colombo, Anna Roberto, Giulia Candiani, Maria Teresa Greco, Roberto Satolli, Carlo Castellani
Background: Health technology assessment and ethical issues have to be dealt with in deciding on national carrier screening for cystic fibrosis (CF)-the most frequent severe autosomal recessive disease in Caucasian populations and several stakeholders need to be involved. A citizens' jury is one way to ask citizens to deliberate on controversial topics in the interests of a society. The aims of this project were to gather opinions about CF carrier screening through citizens' jury deliberations and to match them with the findings of a large online consultation survey open to the general population, people with CF and families and health professionals...
March 19, 2018: European Journal of Public Health
Daniel G Couch, Henry Maudslay, Brett Doleman, Jonathan N Lund, Saoirse E O'Sullivan
Background: Clinical trials investigating the use of cannabinoid drugs for the treatment of intestinal inflammation are anticipated secondary to preclinical literature demonstrating efficacy in reducing inflammation. Methods: We systematically reviewed publications on the benefit of drugs targeting the endo-cannabinoid system in intestinal inflammation. We collated studies examining outcomes for meta-analysis from EMBASE, MEDLINE and Pubmed until March 2017. Quality was assessed according to mSTAIR and SRYCLE score...
March 19, 2018: Inflammatory Bowel Diseases
Britt Christensen, Ruben J Colman, Dejan Micic, Peter R Gibson, Sarah R Goeppinger, Andres Yarur, Christopher R Weber, Russell D Cohen, David T Rubin
Background: Vedolizumab is approved for moderate to severe Crohn's disease (CD) and ulcerative colitis (UC). We present prospective, 1-year data of the real-world effectiveness and safety of vedolizumab in inflammatory bowel disease. Methods: Consecutive patients receiving vedolizumab for treatment of UC or CD with at least 14 weeks of follow-up, regardless of outcome, were included. Patients had clinical activity scores (Harvey-Bradshaw Index [HBI] or Simple Clinical Colitis Activity Index [SCCAI]) and inflammatory markers prospectively measured at baseline and weeks 14, 30, and 52...
March 19, 2018: Inflammatory Bowel Diseases
E A Elgindy, H Sibai, M I Mostafa, A Gibreel, E Darwish, H Maghraby
STUDY QUESTION: In ICSI patients with high risk of ovarian hyperstimulation syndrome (OHSS), are antagonist cycles triggered by gonadotropin releasing hormone (GNRH) agonist with a specialized luteal support regimen associated with comparable ongoing pregnancy rate (OPR) and less OHSS than those triggered by hCG? SUMMARY ANSWER: In antagonist ICSI cycles, GnRH agonist triggering with a specialized luteal support regimen is associated with comparable OPR to those triggered by hCG but may be less likely to be associated with OHSS...
March 19, 2018: Human Reproduction
Claire M Keene, Arjen Dondorp, Jane Crawley, Eric O Ohuma, Mavuto Mukaka
Background: Malaria burdens global health systems, and management with limited resources requires robust treatment guidelines and comprehensive planning. Expected length of stay (LOS) is useful in health-system planning, and factors influencing it can be targeted to reduce admission time and optimise service delivery. Methods: A secondary survival analysis of 1217 adult severe malaria patients from the South-East Asia Quinine Artesunate Malaria Trial, using a competing-risk approach...
March 19, 2018: Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
John F Seymour, Thomas J Kipps, Barbara Eichhorst, Peter Hillmen, James D'Rozario, Sarit Assouline, Carolyn Owen, John Gerecitano, Tadeusz Robak, Javier De la Serna, Ulrich Jaeger, Guillaume Cartron, Marco Montillo, Rod Humerickhouse, Elizabeth A Punnoose, Yan Li, Michelle Boyer, Kathryn Humphrey, Mehrdad Mobasher, Arnon P Kater
BACKGROUND: Venetoclax inhibits BCL2, an antiapoptotic protein that is pathologically overexpressed and that is central to the survival of chronic lymphocytic leukemia cells. We evaluated the efficacy of venetoclax in combination with rituximab in patients with relapsed or refractory chronic lymphocytic leukemia. METHODS: In this randomized, open-label, phase 3 trial, we randomly assigned 389 patients to receive venetoclax for up to 2 years (from day 1 of cycle 1) plus rituximab for the first 6 months (venetoclax-rituximab group) or bendamustine plus rituximab for 6 months (bendamustine-rituximab group)...
March 22, 2018: New England Journal of Medicine
Donna Franklin, Franz E Babl, Luregn J Schlapbach, Ed Oakley, Simon Craig, Jocelyn Neutze, Jeremy Furyk, John F Fraser, Mark Jones, Jennifer A Whitty, Stuart R Dalziel, Andreas Schibler
BACKGROUND: High-flow oxygen therapy through a nasal cannula has been increasingly used in infants with bronchiolitis, despite limited high-quality evidence of its efficacy. The efficacy of high-flow oxygen therapy through a nasal cannula in settings other than intensive care units (ICUs) is unclear. METHODS: In this multicenter, randomized, controlled trial, we assigned infants younger than 12 months of age who had bronchiolitis and a need for supplemental oxygen therapy to receive either high-flow oxygen therapy (high-flow group) or standard oxygen therapy (standard-therapy group)...
March 22, 2018: New England Journal of Medicine
S Rusta-Sallehy, M Gooderham, K Papp
Interleukin (IL)-17 is important in the pathophysiology of psoriasis and has proven to be an effective therapeutic target. Brodalumab, the third commercially available IL-17 antagonist, was approved by the US FDA in February 2017 for the treatment of moderate-tosevere plaque psoriasis. As brodalumab enters the marketplace, it is imperative to investigate its safety profile. We conducted a safety assessment of brodalumab using publically available adverse event data from phase II and III clinical trials. The most common adverse events were nasopharyngitis, upper respiratory tract infection, and candidiasis...
March 2018: Skin Therapy Letter
Nancy A Gonzales, Michaeline Jensen, Jenn Yun Tein, Jessie J Wong, Larry E Dumka, Anne Marie Mauricio
Importance: Substance abuse preventive interventions frequently target middle school students and demonstrate efficacy to prevent early onset and use of alcohol and illicit drugs. However, evidence of sustained results to prevent later patterns of alcohol misuse and more serious alcohol abuse disorders has been lacking, particularly for US Latino populations. Objective: To test whether a universal middle school prevention program can reduce the frequency of alcohol misuse and rates of alcohol use disorder 5 years after implementation with a Mexican American sample...
March 21, 2018: JAMA Psychiatry
Gabriella Maria Pitt Gameiro Sales, Izabel Crystine Pereira Barbosa, Laura Maia Sampaio Canejo Neta, Paloma Lopes de Melo, Raphael de Azevedo Leitão, Hugo Moura de Albuquerque Melo
INTRODUCTION: Chikungunya (CHIK) is a tropical arbovirus, transmitted by the female mosquito Aedes aegypti and Aedes albopictus. In Brazil, there have been cases reported since 2014. The initial manifestations of this virus are sudden onset high fever, headache, chills, rashes, myalgia and intense joint pain. Usually, CHIK presents the acute and chronic phases, the latter characterized by bilateral polyarthralgia, which can last for months or even years. During this period, autoimmune diseases can be triggered, making the picture even more complicated...
January 2018: Revista da Associação Médica Brasileira
Rupert W Major, Mark R I Cheng, Robert A Grant, Saran Shantikumar, Gang Xu, Issaam Oozeerally, Nigel J Brunskill, Laura J Gray
BACKGROUND AND OBJECTIVES: Chronic kidney disease (CKD) is a global health burden and is independently associated with increased cardiovascular disease risk. Assessment of cardiovascular risk in the general population using prognostic models based on routinely collected risk factors is embedded in clinical practice. In CKD, prognostic models may misrepresent risk due to the interplay of traditional atherosclerotic and non-traditional risk factors. This systematic review's aim was to identify routinely collected risk factors for inclusion in a CKD-specific cardiovascular prognostic model...
2018: PloS One
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
Riccardo Moia, Fary Diop, Chiara Favini, Ahad Ahmed Kodipad, Gianluca Gaidano
Chronic lymphocytic leukemia (CLL) is a highly heterogeneous disease. Deregulation of apoptosis is a major pathogenetic feature, and represents a therapeutic target. TP53 disrupted patients are categorized as high risk patients and are treated with novel target therapies. Among these new drugs, venetoclax, an orally bioavailable BCL2 inhibitor, has shown high efficacy also in relapsed/refractory CLL with TP53 disruption. Venetoclax has also been tested in combination with other drugs without compromising venetoclax dose and with a good safety profile...
March 21, 2018: Expert Review of Hematology
Papatpong Phermsang-Ngarm, Chairat Charoemratrote
OBJECTIVES: To compare tooth movement achieved, time required for alignment, root resorption, and alveolar bone thickness changes during initial dental alignment between groups treated with 0.012-inch preformed heat-activated or customized nickel titanium (NiTi) archwires. MATERIALS AND METHODS: Thirty-two subjects (mean age 19.8 ± 1.7 years) with severe crowding of maxillary anterior teeth had premolar extractions and were randomly allocated into control and experimental groups receiving preformed heat-activated and customized NiTi archwires, respectively...
March 21, 2018: Angle Orthodontist
Wei An, Aisaiti Ainiwaer, Patiguli Wusiman, Gulibusitan Ali, Adili Moming
PURPOSE: The study proposed to determine the superiority between different fixation methods in the mandibular angle fractures (MAFs) and to evaluate best option for surgeon and patient. METHODS: A systematic review was conducted according to PRISMA guidelines, examining Medline-Ovid, Embase, and Pubmed databases. The quality of studies was assessed, and the odds risk (OR) with its corresponding 95% confidence interval (CI) was assessed to measure the effect size...
March 20, 2018: Journal of Craniofacial Surgery
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No abstract text is available yet for this article.
March 2018: Medicine (Baltimore)
Zipei Cao, Lijuan Wei, Weizhi Zhu, Xuping Yao
BACKGROUND: Reduction of cyclin-dependent kinase inhibitor 2A (CDKN2A) (p16 and p14) expression through DNA methylation has been reported in prostate cancer (PCa). This meta-analysis was conducted to assess the difference of p16 and p14 methylation between PCa and different histological types of nonmalignant controls and the correlation of p16 or p14 methylation with clinicopathological features of PCa. METHODS: According to the preferred reporting items for systematic reviews and meta-analyses (PRISMA) statement criteria, articles were searched in PubMed, Embase, EBSCO, Wanfang, and CNKI databases...
March 2018: Medicine (Baltimore)
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)
Wei Wang, Dong Xing, Yingjian Song, Feiyu Liu
BACKGROUND: Esophageal cancer is one of the worst malignant digestive neoplasms with poor treatment outcomes. Definitive concurrent chemoradiotherapy (CRT) has become the standard nonsurgical treatment option for locally advanced esophageal cancer. The chemotherapeutic drugs 5-fluorouracil and cisplatin have been most commonly used in CRT of esophageal cancer. However, radiotherapy combined with 5-FU/cisplatin often delivers severe toxicity to patients. S-1 as an oral chemotherapeutic drug exhibits higher anti-tumor activity, less adverse effects, and better biological availability...
March 2018: Medicine (Baltimore)
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