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Charlene M C Rodrigues, Jay Lucidarme, Ray Borrow, Andrew Smith, J Claire Cameron, E Richard Moxon, Martin C J Maiden
In September 2015, 4CMenB meningococcal vaccine was introduced into the United Kingdom infant immunization program without phase 3 trial information. Understanding the effect of this program requires enhanced surveillance of invasive meningococcal disease (IMD) Neisseria meningitidis isolates and comparison with prevaccination isolates. Bexsero Antigen Sequence Types (BASTs) were used to analyze whole-genome sequences of 3,073 prevaccine IMD N. meningitidis isolates obtained during 2010-2016. Isolates exhibited 803 BASTs among 31 clonal complexes...
April 2018: Emerging Infectious Diseases
Michihiro Hide, Atsushi Fukunaga, Junichi Maehara, Kazunori Eto, James Hao, Moshe Vardi, Yuji Nomoto
BACKGROUND: Hereditary angioedema (HAE) is characterized by paroxysmal edema of the skin, gastrointestinal mucosa, and upper respiratory tract. PURPOSE: This study investigated icatibant, a selective bradykinin B2 receptor antagonist, as treatment for Japanese patients with an acute HAE attack. METHODS: This was an open-label, single-arm, Phase 3 study of Japanese adults with HAE type I or II. Icatibant (30 mg) was administered (by a healthcare professional [HCP] or self-administered) as a subcutaneous injection in the abdomen...
2018: Arerugī, [Allergy]
Paola Queirolo, Francesco Spagnolo, Virginia Picasso, Laura Spano, Enrica Tanda, Valeria Fontana, Laura Giorello, Domenico Franco Merlo, Ester Simeone, Antonio Maria Grimaldi, Marcello Curvietto, Michele Del Vecchio, Paolo Bruzzi, Paolo Antonio Ascierto
Background: BRAF inhibitor vemurafenib achieves high response rate and an improvement in survival in patients with BRAF-mutated metastatic melanoma. However, median progression-free survival is only 6.9 months in the phase 3 study. Retrospective analyses suggest that treatment with BRAF inhibitors beyond initial progression might be associated with improved overall survival. We aimed to prospectively investigate the activity of prolonged treatment with vemurafenib and the addition of fotemustine in patients with systemic progression on prior single-agent BRAF inhibitor...
February 23, 2018: Oncotarget
Blanca Regina de la Paz Cota, Pedro Pablo Cepero Vega, Juan José Matus Navarrete, Gerardo Efrain Aguado Mulgado, José Juan Narváez Huerta, Enrique Lamadrid Bautista, Epifanio Fiscal Chauteco
PURPOSE: To demonstrate non-inferiority of eberconazole 1% otic solution to clotrimazole 1% solution, and to compare their safety profiles in the treatment of otomycosis. MATERIALS AND METHODS: Multicenter, randomized, double-blind, active treatment-controlled phase 3 clinical trial. One hundred and ninety patients with diagnosis of otomycosis were randomly assigned to eberconazole 1% otic solution or clotrimazole 1% solution. RESULTS: Baseline characteristics were comparable between both groups for age, gender, ethnicity, and clinical variables...
March 6, 2018: American Journal of Otolaryngology
Frederick Fasslrinner, Johannes Schetelig, Andreas Burchert, Michael Kramer, Rudolf Trenschel, Ute Hegenbart, Michael Stadler, Kerstin Schäfer-Eckart, Michael Bätzel, Hans Eich, Martin Stuschke, Rita Engenhart-Cabillic, Mechthild Krause, Peter Dreger, Andreas Neubauer, Gerhard Ehninger, Dietrich Beelen, Wolfgang E Berdel, Timo Siepmann, Matthias Stelljes, Martin Bornhäuser
BACKGROUND: The impact of the intensity of conditioning before allogeneic haemopoietic cell transplantation (HCT) has been studied in a randomised phase 3 trial comparing reduced-intensity conditioning with myeloablative conditioning in patients with acute myeloid leukaemia in first complete remission. Because of the short follow-up of the original trial, whether reduced-intensity conditioning increases the risk of late relapse compared with myeloablative conditioning remained unclear...
March 14, 2018: Lancet Haematology
Ramez N Eskander, James Kauderer, Krishnansu S Tewari, Robert S Mannel, Robert E Bristow, David M O'Malley, Stephen C Rubin, Gretchen E Glaser, Chad A Hamilton, Keiichi Fujiwara, Warner K Huh, Frederick Ueland, Jean-Marie Stephan, Robert A Burger
PURPOSE: We sought to determine the level of concordance among surgeons' assessment of residual disease (RD) and pre-treatment computed tomography (CT) findings among women who underwent optimal surgical cytoreduction for advanced stage ovarian cancer. METHODS: This is a post-trial ad hoc analysis of a phase 3 randomized clinical trial evaluating the impact of bevacizumab in primary and maintenance therapy for patients with advanced stage ovarian cancer following surgical cytoreduction...
March 14, 2018: Gynecologic Oncology
K A Honn, J M Hinson, P Whitney, H P A Van Dongen
In around-the-clock operations, reduced alertness due to circadian misalignment and sleep loss causes performance impairment, which can lead to catastrophic errors and accidents. There is mounting evidence that performance on different tasks is differentially affected, but the general principles underlying this differentiation are not well understood. One factor that may be particularly relevant is the degree to which tasks require executive control, that is, control over the initiation, monitoring, and termination of actions in order to achieve goals...
March 14, 2018: Accident; Analysis and Prevention
Chuanpu Hu, Zhenling Yao, Yang Chen, Bruce Randazzo, Liping Zhang, Zhenhua Xu, Amarnath Sharma, Honghui Zhou
Guselkumab, a human IgG1 monoclonal antibody that blocks interleukin-23, has been evaluated in one Phase 2 and two Phase 3 trials in patients with moderate-to-severe psoriasis, in which disease severity was assessed using Psoriasis Area and Severity Index (PASI) and Investigator's Global Assessment (IGA) scores. Through the application of landmark and longitudinal exposure-response (E-R) modeling analyses, we sought to predict the guselkumab dose-response (D-R) relationship using data from 1459 patients who participated in these trials...
March 16, 2018: Journal of Pharmacokinetics and Pharmacodynamics
Tomas Jelinek, Michael A Cromer, Jakob P Cramer, Deborah J Mills, Kenneth Lessans, Anthony W Gherardin, Elizabeth D Barnett, Stefan H F Hagmann, Helena H Askling, Sigrid Kiermayr, Vera Kadlecek, Susanne Eder-Lingelbach, Christian Taucher, Katrin L Dubischar
BACKGROUND: Young travelers to South-East Asia may be at risk for Japanese encephalitis (JE). METHODS: IXIARO® (0.25 ml or 0.5 ml, depending on age) were administrated to 100 travelers aged ≥ 2 months to < 18 years. Solicited AEs were collected for 7 days after each injection, unsolicited adverse events (AEs) for a total of 7 months. JE neutralizing antibodies were assessed in 64 subjects. RESULTS: The most common solicited local AEs were redness (3/12 subjects), induration and tenderness (both 1/12) with 0...
March 13, 2018: Travel Medicine and Infectious Disease
Alexander Egeberg, Jashin J Wu, Neil Korman, James A Solomon, Orin Goldblum, Fangyi Zhao, Lotus Mallbris
BACKGROUND: The impact of ixekizumab treatment for psoriasis on cardiovascular-related parameters in patients is unknown. OBJECTIVE: We investigated cardiovascular-related parameters in patients with psoriasis treated with ixekizumab. METHODS: In Phase 3 trials, patients with moderate-to-severe psoriasis were randomized and treated with placebo, ixekizumab, or etanercept during the induction period (Weeks 0-12; UNCOVER-1/-2/-3). At week 12, responders were re-randomized to receive placebo or ixekizumab through the maintenance period (Weeks 12-60; UNCOVER-1/-2)...
March 13, 2018: Journal of the American Academy of Dermatology
Ana M Molina, Thomas E Hutson, Dmitry Nosov, Piotr Tomczak, Oleg Lipatov, Cora N Sternberg, Robert Motzer, Tim Eisen
BACKGROUND: Tivozanib is a selective inhibitor of vascular endothelial growth factor receptors 1, 2 and 3 tyrosine kinases. This open-label, crossover clinical study (AV-951-09-902) provided access to tivozanib for patients who progressed on sorafenib in TIVO-1, comparing tivozanib with sorafenib in patients with advanced renal cell carcinoma (RCC). METHODS: Patients enrolled in this single-arm, phase 2 crossover study were previously randomised to sorafenib on TIVO-1, progressed and then crossed over to tivozanib...
March 13, 2018: European Journal of Cancer
Hanrui Zhang
PURPOSE OF REVIEW: Lysosomal acid lipase (LAL), encoded by the LIPA gene, is an essential lysosomal enzyme that hydrolyzes cholesteryl ester and triglyceride delivered to the lysosome. This review highlights the novel pathophysiological role of LAL, the functional genomic discoveries of LIPA as a risk locus for coronary heart diseases (CHD), and the clinical advance in therapies for LAL deficiency. RECENT FINDINGS: The essential role of LAL in lipid metabolism has been confirmed in human and mice with LAL deficiency...
March 15, 2018: Current Opinion in Lipidology
George A Fisher, Edward M Wolin, Nilani Liyanage, Susan Pitman Lowenthal, Beloo Mirakhur, Rodney F Pommier, Montaser Shaheen, Aaron I Vinik
OBJECTIVE: This ELECT prospective analysis examined lanreotide depot/autogel for carcinoid syndrome (CS) symptom control in patients with neuroendocrine tumors (NETs) who were responsive to prior octreotide (prior octreotide group) compared with patients who were naïve to prior somatostatin analogue treatment (de novo group). METHODS: Adults with histopathologically confirmed NET and stable CS (diarrhea and/or flushing) were randomized to subcutaneous (SC) lanreotide 120 mg or placebo every 4 weeks for 16 weeks...
March 2018: Endocrine Practice
George Grunberger, Yehuda Handelsman, Zachary T Bloomgarden, Vivian A Fonseca, Alan J Garber, Richard A Haas, Victor L Roberts, Guillermo E Umpierrez
This document represents the official position of the American Association of Clinical Endocrinologists and American College of Endocrinology. Where there are no randomized controlled trials or specific U.S. FDA labeling for issues in clinical practice, the participating clinical experts utilized their judgment and experience. Every effort was made to achieve consensus among the committee members. Position statements are meant to provide guidance, but they are not to be considered prescriptive for any individual patient and cannot replace the judgment of a clinician...
March 2018: Endocrine Practice
Darren M Brenner, Ronald Fogel, Spencer D Dorn, Richard Krause, Paul Eng, Robert Kirshoff, Anhthu Nguyen, Robert A Crozier, Leslie Magnus, Patrick H Griffin
OBJECTIVES: Two identical, phase 3, randomized, double-blind, placebo-controlled trials evaluated the efficacy and safety of plecanatide in patients with irritable bowel syndrome with constipation (IBS-C). METHODS: Adults meeting Rome III criteria for IBS-C were randomized (1:1:1) to placebo or plecanatide (3 or 6 mg) for 12 weeks. The primary efficacy end point was the percentage of overall responders (patients reporting ≥30% reduction from baseline in worst abdominal pain plus an increase of ≥1 complete spontaneous bowel movement (CSBM)/week from baseline in the same week for ≥6 of 12 treatment weeks)...
March 15, 2018: American Journal of Gastroenterology
M Killer-Oberpfalzer, N Kocer, C J Griessenauer, H Janssen, T Engelhorn, M Holtmannspötter, J H Buhk, T Finkenzeller, G Fesl, J Trenkler, W Reith, A Berlis, K Hausegger, M Augustin, C Islak, B Minnich, M Möhlenbruch
BACKGROUND AND PURPOSE: Endoluminal reconstruction with flow-diverting stents represents a widely accepted technique for the treatment of complex intracranial aneurysms. This European registry study analyzed the initial experience of 15 neurovascular centers with the Flow-Redirection Intraluminal Device (FRED) system. MATERIALS AND METHODS: Consecutive patients with intracranial aneurysms treated with the FRED between February 2012 and March 2015 were retrospectively reviewed...
March 15, 2018: AJNR. American Journal of Neuroradiology
Ahmet F Oner, Tiraje Celkan, Çetin Timur, Miranda Norton, Kaan Kavaklı
Hereditary factor X (FX) deficiency is a rare bleeding disorder more prevalent in countries with high rates of consanguineous marriage. In a prospective, open-label, multicentre, phase 3 study, 25 IU/kg pdFX was administered as on-demand treatment or short-term prophylaxis for 6 months-2 years. In Turkish subjects (N=6), 60.7% of bleeds were minor. A mean of 1.03 infusions was used to treat each bleed, and mean total dose per bleed was 25.38 IU/kg. Turkish subjects ratedpdFX efficacy as excellent or good for all 84 assessable bleeds; investigators judged overall pdFX efficacy to be excellent or good in all subjects...
March 16, 2018: Turkish Journal of Haematology: Official Journal of Turkish Society of Haematology
Raju Kapoor, Pei-Ran Ho, Nolan Campbell, Ih Chang, Aaron Deykin, Fiona Forrestal, Nisha Lucas, Bei Yu, Douglas L Arnold, Mark S Freedman, Myla D Goldman, Hans-Peter Hartung, Eva Kubala Havrdová, Douglas Jeffery, Aaron Miller, Finn Sellebjerg, Diego Cadavid, Dan Mikol, Deborah Steiner
BACKGROUND: Although several disease-modifying treatments are available for relapsing multiple sclerosis, treatment effects have been more modest in progressive multiple sclerosis and have been observed particularly in actively relapsing subgroups or those with lesion activity on imaging. We sought to assess whether natalizumab slows disease progression in secondary progressive multiple sclerosis, independent of relapses. METHODS: ASCEND was a phase 3, randomised, double-blind, placebo-controlled trial (part 1) with an optional 2 year open-label extension (part 2)...
March 12, 2018: Lancet Neurology
Robyn K Pollom, Timothy Costigan, Lyndon B Lacaya, Liza L Ilag, Priscilla A Hollander
INTRODUCTION: To compare efficacy and safety of Basaglar® [insulin glargine 100 units/mL; LY insulin glargine (LY IGlar)] to Lantus® [insulin glargine 100 units/mL; SA insulin glargine (SA IGlar)] in older (≥ 65 years) or younger (< 65 years) patients with type 2 diabetes (T2D). METHODS: This subgroup analysis of a phase 3, randomized, double-blind, multinational, 24-week study compared LY IGlar and SA IGlar on several clinical efficacy (change in glycated hemoglobin (A1c), basal insulin dose, weight) and safety outcomes (incidence of adverse events, insulin antibodies, hypoglycemia incidence and rates) in patients either ≥ 65 or < 65 years...
March 14, 2018: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
James H Rimmer, Cassandra Herman, Brooks Wingo, Kevin Fontaine, Tapan Mehta
BACKGROUND: Hybrid research designs targeting adults with neurologic disability are critical for improving the efficiency of models that can identify, track and intervene on identified health issues. METHODS: Our Russian doll framework encompasses three study phases. Phase 1 involves prospectively following a cohort of participants with disability to examine the relationships between rates of health and functional deficits (e.g., pain, fatigue, deconditioning), functional measures (e...
March 14, 2018: BMC Medical Research Methodology
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