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V A Fleetwood, J Lusciks, J Poirier, M Hertl, E Y Chan
Background. The PHS increased risk donor (IRD) is underutilized in liver transplantation. We aimed to examine the posttransplant outcomes in recipients of increased-risk organs. Methods. We analyzed 228,040 transplants in the Organ Procurement and Transplantation Network database from 2004 to 2013. Endpoints were graft failure and death. Results were controlled for demographics and comorbidities. Statistical analysis utilized Fisher's test and logistic regression. Results. 58,816 patients were identified (5,534 IRD, 53,282 non-IRD)...
2016: Journal of Transplantation
Antonio J Salazar, Javier A Romero, Oscar A Bernal, Angela P Moreno, Sofía C Velasco, Xavier A Díaz
Objective. The aim of this study was to evaluate and compare the clinical performance of different alternatives to implement low-cost screening telemammography. We compared computed radiography, film printed images, and digitized films produced with a specialized film digitizer and a digital camera. Material and Methods. The ethics committee of our institution approved this study. We assessed the equivalence of the clinical performance of observers for cancer detection. The factorial design included 70 screening patients, four technological alternatives, and cases interpreted by seven radiologists, for a total of 1,960 observations...
2016: International Journal of Telemedicine and Applications
Loretta B Szczotka-Flynn, Sara Debanne, Beth Ann Benetz, Tawnya Wilson, Noel Brennan
PURPOSE: This study hypothesized that a traditional high-water contact lens of moderate oxygen transmissibility (Dk/t) is noninferior to common silicone hydrogel (SH) lenses worn for daily wear with respect to measures of hypoxic stress. METHODS: Thirty-six habitual contact lens wearers completed wear of three lens types worn in a randomized order: etafilcon A (ACUVUE 2, control), lotrafilcon B (Air Optix Aqua), and comfilcon A (Biofinity). Central corneal thickness (CT) and limbal hyperemia were measured >2 hr after waking and after 6 to 8 hr of wear on days 1 and 7...
October 20, 2016: Eye & Contact Lens
Lesley J Scott
Intravenous ceftaroline fosamil (Zinforo™), a prodrug that is rapidly converted to its active metabolite ceftaroline, is approved for use in adults and children (from 2 months of age) with complicated skin and soft tissue infections (cSSTIs) or community-acquired pneumonia (CAP). In several multinational trials, ceftaroline fosamil was an effective and generally well tolerated treatment in adult and paediatric patients with cSSTIs or CAP. In the phase 3 CANVAS trials, ceftaroline fosamil treatment was noninferior to vancomycin plus aztreonam in adults with cSSTIs...
October 20, 2016: Drugs
Jevon R Puckett, John W Pickering, Suetonia C Palmer, John L McCall, Michal T Kluger, Janak De Zoysa, Zoltan H Endre, Mattias Soop
OBJECTIVE: To determine whether a low perioperative minimum urine output target is safe and fluid sparing when compared with the standard target. BACKGROUND: A minimum hourly urine output of 0.5 mL/kg is a key target guiding perioperative fluid therapy. Few data support this standard practice, which may contribute to perioperative fluid overloading. METHODS: We randomized patients without significant risk factors for acute kidney injury undergoing elective colectomy to a minimum urine output target of 0...
October 19, 2016: Annals of Surgery
Gregory D Huhn, Pablo Tebas, Joel Gallant, Timothy Wilkin, Andrew Cheng, Mingjin Yan, Lijie Zhong, Christian Callebaut, Joseph M Custodio, Marshall W Fordyce, Moupali Das, Scott McCallister
BACKGROUND: HIV-infected, treatment-experienced adults with a history of prior resistance and regimen failure can be virologically suppressed but may require multi-tablet regimens associated with lower adherence and potential resistance development. METHODS: We enrolled HIV-infected, virologically suppressed adults with 2- to 3-class drug resistance and at least 2 prior regimen failures into this phase 3, open-label, randomized study. The primary endpoint was the percentage of participants with HIV-1 RNA <50 copies/mL at week 24 (FDA snapshot algorithm)...
October 6, 2016: Journal of Acquired Immune Deficiency Syndromes: JAIDS
Yuko M Komesu, Rebecca G Rogers, Robert E Sapien, Ronald M Schrader, Timothy Simmerman-Sierra, Andrew R Mayer, Loren H Ketai
INTRODUCTION AND HYPOTHESIS: We describe the rationale and methodology for a study comparing mind-body treatment and pharmacotherapy in women with urgency urinary incontinence (UUI). To explore brain associations in UUI, a subset of patients will also undergo functional magnetic resonance imaging (fMRI). We hypothesize that hypnotherapy, a mind-body intervention, will be at least as effective as pharmacotherapy in treating UUI. We also hypothesize that fMRI findings will change following treatment, with changes potentially differing between groups...
October 17, 2016: International Urogynecology Journal
Robert Flisiak, Mitchell Shiffman, Juan Arenas, Hugo Cheinquer, Igor Nikitin, Yuping Dong, Khurram Rana, Subasree Srinivasan
BACKGROUND: A randomized, double-blind, multinational, phase 3 study was conducted comparing the efficacy and safety of peginterferon lambda-1a (Lambda)/ribavirin (RBV)/telaprevir (TVR) vs. peginterferon alfa-2a (Alfa)/RBV/TVR in patients with chronic hepatitis C virus (HCV) genotype-1 (GT-1) infection. METHODS: Patients (treatment-naïve or relapsers on prior Alfa/RBV treatment) were randomly assigned in a 2:1 ratio to receive Lambda/RBV/TVR or Alfa/RBV/TVR. Total duration of treatment was either 24 or 48 weeks (response-guided treatment), with TVR administered for the first 12 weeks...
2016: PloS One
Narathorn Suwanvesh, Jittima Manonai, Areepan Sophonsritsuk, Wichai Cherdshewasart
OBJECTIVES: To compare the effects of a 12-week treatment with Pueraria mirifica (PM) gel or a conjugated estrogen cream on vaginal maturation index, vaginal symptom score, vaginal health assessment score, and vaginal flora in postmenopausal women. METHODS: In a prospective, noninferiority, randomized controlled study, 82 postmenopausal women with at least one vulvovaginal symptom, that is, dryness, soreness, irritation, dyspareunia, or discharge, were recruited...
October 3, 2016: Menopause: the Journal of the North American Menopause Society
Guoxin Fan, Xinbo Wu, Shunzhi Yu, Qi Sun, Xiaofei Guan, Hailong Zhang, Xin Gu, Shisheng He
The aim of this study was to directly compare the clinical outcomes of posterior lumbar interbody fusion (PLIF) and minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF) in three-level lumbar spinal stenosis. This retrospective study involved a total of 60 patients with three-level degenerative lumbar spinal stenosis who underwent MIS-TLIF or PLIF from January 2010 to February 2012. Back and leg visual analog scale (VAS), Oswestry Disability Index (ODI), and Short Form-36 (SF-36) scale were used to assess the pain, disability, and health status before surgery and postoperatively...
2016: BioMed Research International
Roy Fleischmann, Michael Schiff, Désirée van der Heijde, Cesar Ramos-Remus, Alberto Spindler, Marina Stanislav, Cristiano A F Zerbini, Sirel Gurbuz, Christina Dickson, Stephanie de Bono, Douglas Schlichting, Scott Beattie, Wen-Ling Kuo, Terence Rooney, William Macias, Tsutomu Takeuchi
Objective This Phase 3 study evaluated baricitinib, an oral Janus kinase (JAK)1/JAK2 inhibitor, as monotherapy or combined with methotrexate (MTX) compared to MTX in patients with active rheumatoid arthritis (RA) with no or minimal prior conventional synthetic disease-modifying anti-rheumatic drugs (DMARDs) and naive to biologic DMARDs. Methods Patients (N=588) were randomized 4:3:4 (MTX: baricitinib 4 mg once daily: baricitinib 4 mg + MTX) for 52 weeks. The primary endpoint assessment was noninferiority of baricitinib monotherapy to MTX based on American College of Rheumatology 20% (ACR20) response at Week 24...
October 9, 2016: Arthritis & Rheumatology
Hitoshi Katai, Junki Mizusawa, Hiroshi Katayama, Masakazu Takagi, Takaki Yoshikawa, Takeo Fukagawa, Masanori Terashima, Kazunari Misawa, Shin Teshima, Keisuke Koeda, Souya Nunobe, Norimasa Fukushima, Takashi Yasuda, Yoshito Asao, Yoshiyuki Fujiwara, Mitsuru Sasako
BACKGROUNDS: No confirmatory randomized controlled trials (RCTs) have evaluated the efficacy of laparoscopy-assisted distal gastrectomy (LADG) compared with open distal gastrectomy (ODG). We performed an RCT to confirm that LADG is not inferior to ODG in efficacy. METHODS: We conducted a multi-institutional RCT. Eligibility criteria included histologically proven gastric adenocarcinoma in the middle or lower third of the stomach, clinical stage I tumor. Patients were preoperatively randomized to ODG or LADG...
October 7, 2016: Gastric Cancer
Dordi Austeng, Tora Sund Morken, Stine Bolme, Turid Follestad, Vidar Halsteinli
BACKGROUND: Intravitreal injections (IVI) of anti-vascular endothelial growth factor (anti-VEGF) now improve or stabilize visual acuity in a number of previously untreatable eye diseases, of which the main are age-related macular degeneration, retinal vein occlusion and diabetic macular edema. Most patients require multiple injections over lengthy periods of time and the prevalence of treatable conditions is increasing. Anti-VEGF IVI normally administered by physicians, therefore represent a considerable workload on ophthalmologic clinics and will continue to do so in the near future...
October 1, 2016: BMC Ophthalmology
Gonzalo Hernández, Concepción Vaquero, Laura Colinas, Rafael Cuena, Paloma González, Alfonso Canabal, Susana Sanchez, Maria Luisa Rodriguez, Ana Villasclaras, Rafael Fernández
Importance: High-flow conditioned oxygen therapy delivered through nasal cannulae and noninvasive mechanical ventilation (NIV) may reduce the need for reintubation. Among the advantages of high-flow oxygen therapy are comfort, availability, lower costs, and additional physiopathological mechanisms. Objective: To test if high-flow conditioned oxygen therapy is noninferior to NIV for preventing postextubation respiratory failure and reintubation in patients at high risk of reintubation...
October 5, 2016: JAMA: the Journal of the American Medical Association
Sean E Collins, Philip M Grant, Francois Uwinkindi, Annie Talbot, Eric Seruyange, Deborah Slamowitz, Adeline Mugeni, Eric Remera, Simon Pierre Niyonsenga, Josbert Nyirimigabo, Jean Paul Uwizihiwe, Pierre Dongier, Ribakare Muhayimpundu, Jean-Baptiste Mazarati, Andrew Zolopa, Sabin Nsanzimana
Background.  Many human immunodeficiency virus (HIV)-infected patients remain on nevirapine-based antiretroviral therapy (ART) despite safety and efficacy concerns. Switching to a rilpivirine-based regimen is an alternative, but there is little experience with rilpivirine in sub-Saharan Africa where induction of rilpivirine metabolism by nevirapine, HIV subtype, and dietary differences could potentially impact efficacy. Methods.  We conducted an open-label noninferiority study of virologically suppressed (HIV-1 ribonucleic acid [RNA] < 50 copies/mL) HIV-1-infected Rwandan adults taking nevirapine plus 2 nucleos(t)ide reverse-transcriptase inhibitors...
September 2016: Open Forum Infectious Diseases
Katsuhiro Toda
No abstract text is available yet for this article.
2016: Pain Research and Treatment
Audrey L Blewer, Mary E Putt, Lance B Becker, Barbara J Riegel, Jiaqi Li, Marion Leary, Judy A Shea, James N Kirkpatrick, Robert A Berg, Vinay M Nadkarni, Peter W Groeneveld, Benjamin S Abella
BACKGROUND: Cardiopulmonary resuscitation (CPR) training rates in the United States are low, highlighting the need to develop CPR educational approaches that are simpler, with broader dissemination potential. The minimum training required to ensure long-term skill retention remains poorly characterized. We compared CPR skill retention among laypersons randomized to training with video-only (VO; no manikin) with those trained with a video self-instruction kit (VSI; with manikin). We hypothesized that VO training would be noninferior to the VSI approach with respect to chest compression (CC) rate...
October 4, 2016: Circulation. Cardiovascular Quality and Outcomes
Yvette N Lamb, Gillian M Keating
A 3-monthly formulation of intramuscular paliperidone palmitate (3-monthly paliperidone palmitate) has recently been approved for the maintenance treatment of schizophrenia in adult patients in the EU (Trevicta(®)), following earlier approval in the USA (Invega Trinza(®)). This narrative review discusses the clinical use of 3-monthly paliperidone palmitate in the maintenance treatment of schizophrenia in adult patients and summarizes its pharmacological properties. The efficacy of the 3-monthly paliperidone palmitate formulation as a maintenance treatment for schizophrenia has been demonstrated in well designed, phase III trials...
October 3, 2016: Drugs
Amelia Deitchman, Daniel de Jong, April Barbour, Hartmut Derendorf
With resistance of S. aureus, the most prevalent identified pathogen in skin and soft tissue infections, on the rise, the need for safe, effective, and well-tolerated antibiotics is crucial. Ceftobiprole medocaril (BAL-5788), ceftobiprole's parenteral prodrug, is a bactericidal cephalosporin with broad Gram-positive and Gram-negative activity that has shown to be well-tolerated and noninferior to vancomycin and vancomycin plus ceftazidime in the treatment of MRSA complicated skin and skin structure infections (cSSSIs) in clinical trials...
October 2, 2016: Expert Review of Anti-infective Therapy
Todd J Kowalski, Shanu N Kothari, Michelle A Mathiason, Andrew J Borgert
BACKGROUND: Despite substantial prevention efforts, surgical site infections (SSIs) remain the most common health care-associated infection. It is unclear whether the Centers for Disease Control and Prevention recommendation to leave hair intact preoperatively reduces SSIs. STUDY DESIGN: A single-center, prospective, randomized, clinical trial was conducted from October 2009 to February 2015 in a 325-bed multispecialty, tertiary care teaching hospital to test the noninferiority of clipping hair to no hair removal in the prevention of SSIs...
April 23, 2016: Journal of the American College of Surgeons
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