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Ji Yeon Hong, Eun Ja Choi, Sun Young Choi, Kapsok Li, Beom Joon Kim
BACKGROUND: Comparative research on the characteristics of filler products is limited, especially in the preclinical analysis of hyaluronic acid (HA) fillers. OBJECTIVE: This study was performed to compare the preclinical characteristics, clinical efficacy, and safety of a new HA filler, IDHF-001, with Restylane SubQ in the treatment of nasolabial folds (NLFs). METHODS: Viscoelasticity and injection force were evaluated. Ninety-one subjects were enrolled in this randomized, patient/evaluator-blind, intraindividual clinical study...
March 13, 2018: Dermatologic Surgery: Official Publication for American Society for Dermatologic Surgery [et Al.]
Hiroshi Nakatani, Paul Gomes, Ron Bradford, Qiang Guo, Eleonora Safyan, David A Hollander
PURPOSE: To compare alcaftadine and olopatadine ophthalmic solutions, and vehicle for preventing allergen-mediated conjunctivitis in Japanese subjects. METHODS: Japanese cedar pollen-sensitive subjects were randomized to alcaftadine 0.25%, olopatadine 0.1%, or vehicle. Ocular itching was assessed at 3, 5 (primary outcome), 7, and 15 min post-conjunctival allergen challenge (CAC) and conjunctival hyperemia assessed at 7, 15 (secondary outcome), and 20 min post-CAC...
March 15, 2018: Ocular Immunology and Inflammation
David S Wang
No abstract text is available yet for this article.
May 2017: Journal of Urology
Síle F Molloy, Cecilia Kanyama, Robert S Heyderman, Angela Loyse, Charles Kouanfack, Duncan Chanda, Sayoki Mfinanga, Elvis Temfack, Shabir Lakhi, Sokoine Lesikari, Adrienne K Chan, Neil Stone, Newton Kalata, Natasha Karunaharan, Kate Gaskell, Mary Peirse, Jayne Ellis, Chimwemwe Chawinga, Sandrine Lontsi, Jean-Gilbert Ndong, Philip Bright, Duncan Lupiya, Tao Chen, John Bradley, Jack Adams, Charles van der Horst, Joep J van Oosterhout, Victor Sini, Yacouba N Mapoure, Peter Mwaba, Tihana Bicanic, David G Lalloo, Duolao Wang, Mina C Hosseinipour, Olivier Lortholary, Shabbar Jaffar, Thomas S Harrison
BACKGROUND: Cryptococcal meningitis accounts for more than 100,000 human immunodeficiency virus (HIV)-related deaths per year. We tested two treatment strategies that could be more sustainable in Africa than the standard of 2 weeks of amphotericin B plus flucytosine and more effective than the widely used fluconazole monotherapy. METHODS: We randomly assigned HIV-infected adults with cryptococcal meningitis to receive an oral regimen (fluconazole [1200 mg per day] plus flucytosine [100 mg per kilogram of body weight per day] for 2 weeks), 1 week of amphotericin B (1 mg per kilogram per day), or 2 weeks of amphotericin B (1 mg per kilogram per day)...
March 15, 2018: New England Journal of Medicine
Enrique Gómez-Barrena, Norma G Padilla-Eguiluz, Cristina Avendaño-Solá, Concepción Payares-Herrera, Ana Velasco-Iglesias, Ferran Torres, Philippe Rosset, Florian Gebhard, Nicola Baldini, Juan C Rubio-Suarez, Eduardo García-Rey, José Cordero-Ampuero, Javier Vaquero-Martin, Francisco Chana, Fernando Marco, Javier García-Coiradas, Pedro Caba-Dessoux, Pablo de la Cuadra, Philippe Hernigou, Charles-Henri Flouzat-Lachaniette, François Gouin, Didier Mainard, Jean Michel Laffosse, Miriam Kalbitz, Ingo Marzi, Norbert Südkamp, Ulrich Stöckle, Gabriela Ciapetti, Davide Maria Donati, Luigi Zagra, Ugo Pazzaglia, Guido Zarattini, Rodolfo Capanna, Fabio Catani
ORTHOUNION is a multicentre, open, comparative, three-arm, randomized clinical trial (EudraCT number 2015-000431-32) to compare the efficacy, at one and two years, of autologous human bone marrow-derived expanded mesenchymal stromal cell (hBM-MSC) treatments versus iliac crest autograft (ICA) to enhance bone healing in patients with diaphyseal and/or metaphysodiaphyseal fracture (femur, tibia, and humerus) status of atrophic or oligotrophic nonunion (more than 9 months after the acute fracture, including recalcitrant cases after failed treatments)...
2018: Stem Cells International
Dennis T Ko, Harlan M Krumholz, Jack V Tu, Peter C Austin, Therese A Stukel, Maria Koh, Alice Chong, Jose Francisco de Melo, Cynthia A Jackevicius
BACKGROUND: Clopidogrel is one of the most commonly prescribed medications because of its ability to improve clinical outcomes for a broad range of cardiovascular conditions. After patent protection expired for Plavix in 2012, many healthcare systems adopted generic clopidogrel as a strategy to reduce healthcare costs. METHODS AND RESULTS: We conducted a population-based observational study to determine whether generic clopidogrel was noninferior to Plavix. Patients who were hospitalized with an acute coronary syndrome (ACS) from 2009 to 2014 in Ontario, Canada, >65 years, survived ≥7 days after discharge, were eligible for inclusion...
March 2018: Circulation. Cardiovascular Quality and Outcomes
Temitope Adebayo, Michael Abendroth, Gaytri Gupta Elera, Allen Kunselman, Elizabeth Sinz, Amanda Ely, Amr Elkamshoushy, Ajay Soni
PURPOSE: To demonstrate that a nonbiologic strabismus surgery simulator is not inferior to a biologic wet lab for teaching the key steps of strabismus surgery. METHODS: A total of 41 medical students were randomly assigned to one of two groups: biologic wet lab or nonbiologic simulator. The students trained according to the group's protocol then participated in a recorded final assessment using a realistic strabismus surgery model. Two independent reviewers, masked to training method, graded the video recordings using three scoring systems: the International Council of Ophthalmology Approved-Ophthalmology Surgical Competency Assessment Rubric for Strabismus Surgery (ICO-OSCAR), the Global Rating Scale of Objective Structured Assessment of Technical Skills (OSATS), and the Alphabetic Summary Scale (ASS)...
March 10, 2018: Journal of AAPOS: the Official Publication of the American Association for Pediatric Ophthalmology and Strabismus
Joseph Acquaye, Michael S Borofsky
PURPOSE OF REVIEW: As benign prostatic hypertrophy (BPH) becomes a more common disease, there has been a dramatic rise in the number of investigational procedures being developed to manage it. We seek to present an overview of the most recently developed treatments and present clinical data related to application wherever available. RECENT FINDINGS: As a greater number of treatments become available for BPH, improved diagnostic testing could prove beneficial in helping guide patient selection...
March 9, 2018: Current Opinion in Urology
Livio Mordasini, Marco Moschini, Agostino Mattei, Christophe Iselin
PURPOSE OF REVIEW: GreenLight photoselective vaporization (GL-PV) is now established in the treatment of benign prostatic enlargement. The present review outlines the available technical armamentarium and summarizes the current best evidence on functional and safety outcomes. Moreover, future technical developments and refinements are presented. RECENT FINDINGS: GL-PV has evolved to be the most commonly performed procedure, second to conventional transurethral resection of the prostate (TURP) for surgical management of benign prostatic obstruction (BPO)...
March 9, 2018: Current Opinion in Urology
Muge Cevik, Chloe Orkin
PURPOSE OF REVIEW: In an era when virological efficacy approaches 100%, novel antiretroviral (ARV) therapies must deliver better tolerability, safety, and convenient coformulated regimens. We review the phase II and III clinical data on the fixed dose combination (FDC) darunavir (DRV) 800mg / cobicistat (COBI/C) 150 mg / emtricitabine (F/FTC) 200 mg / tenofovir alafenamide fumarate (TAF) 10mg (D/C/F/TAF) for the treatment of HIV-1 infection. RECENT FINDINGS: In an exploratory phase II study, D/C/F/TAF FDC demonstrated similar virological efficacy to darunavir/cobicistat FDC + F /tenofovir disoproxil fumarate (TDF) FDC in treatment-naive HIV-1-infected individuals with favorable bone and renal outcomes...
March 9, 2018: Current Opinion in HIV and AIDS
Ray Y Chen, Laura E Via, Lori E Dodd, Gerhard Walzl, Stephanus T Malherbe, André G Loxton, Rodney Dawson, Robert J Wilkinson, Friedrich Thienemann, Michele Tameris, Mark Hatherill, Andreas H Diacon, Xin Liu, Jin Xing, Xiaowei Jin, Zhenya Ma, Shouguo Pan, Guolong Zhang, Qian Gao, Qi Jiang, Hong Zhu, Lili Liang, Hongfei Duan, Taeksun Song, David Alland, Michael Tartakovsky, Alex Rosenthal, Christopher Whalen, Michael Duvenhage, Ying Cai, Lisa C Goldfeder, Kriti Arora, Bronwyn Smith, Jill Winter, Clifton E Barry Iii
Background : By the early 1980s, tuberculosis treatment was shortened from 24 to 6 months, maintaining relapse rates of 1-2%. Subsequent trials attempting shorter durations have failed, with 4-month arms consistently having relapse rates of 15-20%. One trial shortened treatment only among those without baseline cavity on chest x-ray and whose month 2 sputum culture converted to negative. The 4-month arm relapse rate decreased to 7% but was still significantly worse than the 6-month arm (1.6%, P<0.01).  We hypothesize that PET/CT characteristics at baseline, PET/CT changes at one month, and markers of residual bacterial load will identify patients with tuberculosis who can be cured with 4 months (16 weeks) of standard treatment...
November 6, 2017: Gates Open Res
William B White, Kenneth G Saag, Michael A Becker, Jeffrey S Borer, Philip B Gorelick, Andrew Whelton, Barbara Hunt, Majin Castillo, Lhanoo Gunawardhana
Background Cardiovascular risk is increased in patients with gout. We compared cardiovascular outcomes associated with febuxostat, a nonpurine xanthine oxidase inhibitor, with those associated with allopurinol, a purine base analogue xanthine oxidase inhibitor, in patients with gout and cardiovascular disease. Methods We conducted a multicenter, double-blind, noninferiority trial involving patients with gout and cardiovascular disease; patients were randomly assigned to receive febuxostat or allopurinol and were stratified according to kidney function...
March 12, 2018: New England Journal of Medicine
Alberto Falk Delgado, Anna Falk Delgado
Recently, in the four top journals of humanities, an institutional bias towards publication of authors from Harvard and Yale was shown. The New England Journal of Medicine (NEJM) is today the highest ranked general medical journal. It is unknown if there exists institutional bias favoring publication of articles originating from Harvard University, since the NEJM is produced by the Massachusetts Medical Society with close connections to the Harvard University. We examined if studies originating from the Harvard University published in the NEJM were noninferior in terms of citation rates compared to articles with an origin outside Harvard University...
2018: Scientometrics
Mandeep R Mehra, Daniel J Goldstein, Nir Uriel, Joseph C Cleveland, Melana Yuzefpolskaya, Christopher Salerno, Mary N Walsh, Carmelo A Milano, Chetan B Patel, Gregory A Ewald, Akinobu Itoh, David Dean, Arun Krishnamoorthy, William G Cotts, Antone J Tatooles, Ulrich P Jorde, Brian A Bruckner, Jerry D Estep, Valluvan Jeevanandam, Gabriel Sayer, Douglas Horstmanshof, James W Long, Sanjeev Gulati, Eric R Skipper, John B O'Connell, Gerald Heatley, Poornima Sood, Yoshifumi Naka
Background In an early analysis of this trial, use of a magnetically levitated centrifugal continuous-flow circulatory pump was found to improve clinical outcomes, as compared with a mechanical-bearing axial continuous-flow pump, at 6 months in patients with advanced heart failure. Methods In a randomized noninferiority and superiority trial, we compared the centrifugal-flow pump with the axial-flow pump in patients with advanced heart failure, irrespective of the intended goal of support (bridge to transplantation or destination therapy)...
March 11, 2018: New England Journal of Medicine
Andrew Bromley, Anna Plitt
Venous thromboembolism (VTE), which includes both deep vein thrombosis and pulmonary embolism (PE), is a very common disorder with high risk for recurrence and is associated with significant morbidity and mortality. The non-vitamin K oral anticoagulants (NOACs), which include dabigatran, rivaroxaban, apixaban, and edoxaban, have been shown to be noninferior to conventional anticoagulant therapy for the prevention of recurrent VTE and are associated with more favorable bleeding risk. Evidence from the treatment of VTE with traditional therapy (low molecular weight heparin and vitamin K antagonists) implies that extended or indefinite treatment reduces risk of recurrence...
March 10, 2018: Cardiology and Therapy
Otavio Berwanger, Jose C Nicolau, Antonio C Carvalho, Lixin Jiang, Shaun G Goodman, Stephen J Nicholls, Alexander Parkhomenko, Oleg Averkov, Carlos Tajer, Germán Malaga, Jose F K Saraiva, Francisco A Fonseca, Fábio A De Luca, Helio P Guimaraes, Pedro G M de Barros E Silva, Lucas P Damiani, Denise M Paisani, Camila M R Lasagno, Carolina T Candido, Nanci Valeis, Diogo D F Moia, Leopoldo S Piegas, Christopher B Granger, Harvey D White, Renato D Lopes
Importance: The bleeding safety of ticagrelor in patients with ST-elevation myocardial infarction treated with fibrinolytic therapy remains uncertain. Objective: To evaluate the short-term safety of ticagrelor when compared with clopidogrel in patients with ST-elevation myocardial infarction treated with fibrinolytic therapy. Design, Setting and Participants: We conducted a multicenter, randomized, open-label with blinded end point adjudication trial that enrolled 3799 patients (younger than 75 years) with ST-segment elevation myocardial infarction receiving fibrinolytic therapy in 152 sites from 10 countries from November 2015 through November 2017...
March 11, 2018: JAMA Cardiology
Diane C McLaughlin, Margaret M Margretta, William D Freeman
INTRODUCTION: We hypothesized that a nocturnist advanced practice provider (APP) model compared with overnight neurocritical care coverage with general critical care physicians and neurology residents would provide similar patient outcomes, as measured by patient mortality. METHODS: This study is a retrospective review of healthcare outcomes of aneurysmal subarachnoid hemorrhage (aSAH) patients from 2013 and 2016, after implementation of specialty-trained neurocritical care nocturnist APPs...
April 2018: Journal of Neuroscience Nursing: Journal of the American Association of Neuroscience Nurses
William O'Riordan, Alison McManus, Juri Teras, Ivan Poromanski, Maria Cruz-Saldariagga, Megan Quintas, Laura Lawrence, ShuJui Liang, Sue Cammarata
Background: Delafloxacin is an IV/oral anionic fluoroquinolone with activity against Gram-positive (including MRSA), Gram-negative, atypical and anaerobic organisms. It is approved in the US for acute bacterial skin and skin structure infections caused by designated susceptible Gram-positive and Gram-negative organisms, and is in development for the treatment of community-acquired bacterial pneumonia. Methods: A multicenter, randomized, double-blind trial of 850 adults with ABSSSI compared delafloxacin 300 mg IV Q12h for 3 days with a switch to 450 mg oral delafloxacin, to vancomycin 15 mg/kg IV with aztreonam for 5-14 days...
March 6, 2018: Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
Martín de Santibañes, Juan Glinka, Pablo Pelegrini, Fernando A Alvarez, Cristina Elizondo, Diego Giunta, Laura Barcan, Lionel Simoncini, Nora Cáceres Dominguez, Victoria Ardiles, Oscar Mazza, Rodrigo Sanchez Claria, Eduardo de Santibañes, Juan Pekolj
BACKGROUND: Acute calculous cholecystitis (ACC) is the most common complication of cholelithiasis. Laparoscopic cholecystectomy (LC) is the gold standard treatment in mild and moderate forms. Currently there is consensus for the use of antibiotics in the preoperative phase of ACC. However, the need for antibiotic therapy after surgery remains undefined with a low level of scientific evidence. METHODS: The CHART (Cholecystectomy Antibiotic Randomised Trial) study is a single-center, prospective, double blind, and randomized trial...
March 2, 2018: Surgery
Chunbo Li, Zhiyuan Dai, Huimin Shu
BACKGROUND: Pelvic organ prolapse (POP) is a common health problem. The lifetime risk of undergoing surgery for prolapse is 11%. POP significantly affects the effects on quality of life and activities of daily living. Laparoscopic sacrocolpopexy (LSC) has been viewed as the gold standard treatment for women with POP who desire reconstructive surgery. However, LSC is associated with technical difficulties, resulting in a long learning curve and operative time. Recently, our team introduced a new laparoscopic technique of inguinal ligament suspension (LILS) and had confirmed its safety and efficacy in treating vaginal vault prolapse...
March 5, 2018: Trials
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