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Lyndon da Cruz, Kate Fynes, Odysseas Georgiadis, Julie Kerby, Yvonne H Luo, Ahmad Ahmado, Amanda Vernon, Julie T Daniels, Britta Nommiste, Shazeen M Hasan, Sakina B Gooljar, Amanda-Jayne F Carr, Anthony Vugler, Conor M Ramsden, Magda Bictash, Mike Fenster, Juliette Steer, Tricia Harbinson, Anna Wilbrey, Adnan Tufail, Gang Feng, Mark Whitlock, Anthony G Robson, Graham E Holder, Mandeep S Sagoo, Peter T Loudon, Paul Whiting, Peter J Coffey
Age-related macular degeneration (AMD) remains a major cause of blindness, with dysfunction and loss of retinal pigment epithelium (RPE) central to disease progression. We engineered an RPE patch comprising a fully differentiated, human embryonic stem cell (hESC)-derived RPE monolayer on a coated, synthetic basement membrane. We delivered the patch, using a purpose-designed microsurgical tool, into the subretinal space of one eye in each of two patients with severe exudative AMD. Primary endpoints were incidence and severity of adverse events and proportion of subjects with improved best-corrected visual acuity of 15 letters or more...
March 19, 2018: Nature Biotechnology
Mustafa Erdoğan Cicik, Cezmi Doğan, Osman Şevki Arslan
BACKGROUND: Development of endophthalmitis during cataract surgery is one of the most severe complications and it may also result in blindness and globe loss. AIMS: To evaluate the effect of an ophthalmic cefuroxime solution (Aprokam® ) that is prophylactically used in phacoemulsification surgery performed due to cataract that eventually occurs in patients with or without penetrating keratoplasty. STUDY DESIGN: Case-control study. METHODS: In this retrospective study, patients who had undergone penetrating keratoplasty and for whom phacoemulsification surgery was performed due to cataract and an intracameral ophthalmic cefuroxime solution (Aprokam® ) was administered for prophylaxis were evaluated in comparison with patients with cataract without keratoplasty...
March 15, 2018: Balkan Medical Journal
Natasha A Lannin, Louise Ada, Coralie English, Julie Ratcliffe, Maria Crotty
Rationale Although clinical practice guidelines recommend that management of moderate to severe spasticity include the use of botulinum toxin-A in conjunction with therapy, there is currently no evidence to support the addition of therapy. Aims To determine the effect and cost-benefit of adding evidence-based movement training to botulinum toxin-A. Sample size estimate A total of 136 participants will be recruited in order to be able to detect a between-group difference of seven points on the Goal Attainment Scale T-score with 80% power at a two-tailed significance level of 0...
January 1, 2018: International Journal of Stroke: Official Journal of the International Stroke Society
Irina Tammenmaa-Aho, Rosie Asher, Karla Soares-Weiser, Hanna Bergman
BACKGROUND: Tardive dyskinesia (TD) remains a troublesome adverse effect of conventional antipsychotic (neuroleptic) medication. It has been proposed that TD could have a component of central cholinergic deficiency. Cholinergic drugs have been used to treat TD. OBJECTIVES: To determine the effects of cholinergic drugs (arecoline, choline, deanol, lecithin, meclofenoxate, physostigmine, RS 86, tacrine, metoxytacrine, galantamine, ipidacrine, donepezil, rivastigmine, eptastigmine, metrifonate, xanomeline, cevimeline) for treating antipsychotic-induced TD in people with schizophrenia or other chronic mental illness...
March 19, 2018: Cochrane Database of Systematic Reviews
Conor P Kerley, Eamon Dolan, Philip E James, Liam Cormican
Dietary nitrate has been shown to increase nitrate/nitrite levels and decrease blood pressure (BP) in multiple populations. There are few reports among hypertensives and these reports have provided conflicting evidence. We aimed to assess the effect of daily nitrate compared with placebo in subjects with uncontrolled hypertension (HTN). On day 0, hypertensives wore an ambulatory BP monitor (ABPM) for 24 h and blood was taken. Subjects were then randomised to 7-d nitrate-rich beetroot juice (NO3 -) (12·9 mmol nitrate) followed by 7-d nitrate-depleted beetroot juice (0·5 mmol nitrate) or vice versa...
March 2018: British Journal of Nutrition
James D Neaton, Birgit Grund, Deborah Wentworth
BACKGROUND: Data monitoring committees for randomized clinical trials have the responsibility of safeguarding interests of trial participants. To do so, the data monitoring committee must receive reports on safety and efficacy to assess risk/benefit and on trial conduct to ensure that the study can achieve its goals. This article outlines the key components of reports to the data monitoring committee and the important role of the unblinded statistician in preparing those reports. METHODS: Most data monitoring committee meetings include open and closed sessions...
March 1, 2018: Clinical Trials: Journal of the Society for Clinical Trials
Karla Soares-Weiser, John Rathbone, Yusuke Ogawa, Kiyomi Shinohara, Hanna Bergman
BACKGROUND: Antipsychotic (neuroleptic) medication is used extensively to treat people with chronic mental illnesses. Its use, however, is associated with adverse effects, including movement disorders such as tardive dyskinesia (TD) - a problem often seen as repetitive involuntary movements around the mouth and face. This review, one in a series examining the treatment of TD, covers miscellaneous treatments not covered elsewhere. OBJECTIVES: To determine whether drugs, hormone-, dietary-, or herb-supplements not covered in other Cochrane reviews on TD treatments, surgical interventions, electroconvulsive therapy, and mind-body therapies were effective and safe for people with antipsychotic-induced TD...
March 19, 2018: Cochrane Database of Systematic Reviews
J S Gomes, A P Trevizol, D V Ducos, A Gadelha, B B Ortiz, A O Fonseca, H T Akiba, C C Azevedo, L S P Guimaraes, P Shiozawa, Q Cordeiro, A Lacerda, A M Dias
Background: The lack of efficacy of pharmacological treatments for cognitive and negative symptoms in schizophrenia highlights the need for new interventions. We investigated the effects of tDCS on working memory and negative symptoms in patients with schizophrenia. Method: Double-blinded, randomized, sham-controlled clinical trial, investigating the effects of 10 sessions of tDCS in schizophrenia subjects. Stimulation used 2 mA, for 20 min, with electrodes of 25 cm2 wrapped in cotton material soaked in saline solution...
June 2018: Schizophrenia Research. Cognition
François Jacques, Adrian Schembri, Avi Nativ, Chantal Paquette, Pawel Kalinowski
Background: Both prolonged-release fampridine (PRF) and enabling active motor training (EAMT) are beneficial in multiple sclerosis (MS) patients. Their combined effect is, however, understudied. Objective: The objective of this paper is to determine if PRF augments the beneficial effect of EAMT in MS patients as opposed to placebo. Method: This is a pilot, randomized, placebo-controlled, double-blind 14-week study. Participants were randomly assigned to receive PRF 10 mg BID ( n  = 21) or placebo ( n  = 20)...
January 2018: Multiple Sclerosis Journal—Experimental, Translational and Clinical
Sheylla M Felau, Lucas P Sales, Marina Y Solis, Ana Paula Hayashi, Hamilton Roschel, Ana Lúcia Sá-Pinto, Danieli Castro Oliveira De Andrade, Keyla Y Katayama, Maria Claudia Irigoyen, Fernanda Consolim-Colombo, Eloisa Bonfa, Bruno Gualano, Fabiana B Benatti
Endothelial cells are thought to play a central role in the pathogenesis of antiphospholipid syndrome (APS). Omega-3 polyunsaturated fatty acid (n-3 PUFA) supplementation has been shown to improve endothelial function in a number of diseases; thus, it could be of high clinical relevance in APS. The aim of this study was to evaluate the efficacy of n-3 PUFA supplementation on endothelial function (primary outcome) of patients with primary APS (PAPS). A 16-week randomized clinical trial was conducted with 22 adult women with PAPS...
2018: Frontiers in Immunology
Lisa Wagels, Mikhail Votinov, Thilo Kellermann, Albrecht Eisert, Cordian Beyer, Ute Habel
Testosterone affects human social behavior in various ways. While testosterone effects are generally associated with muscular strength and aggressiveness, human studies also point towards enhanced status-seeking motives after testosterone administration. The current study tested the causal influence of exogenous testosterone on male behavior during a competitive provocation paradigm. In this double blind, randomized, placebo (PL)-controlled study, 103 males were assigned to a PL or testosterone group receiving a colorless PL or testosterone gel...
2018: Frontiers in Behavioral Neuroscience
C O S Sorzano, E Fernández-Giménez, V Peredo-Robinson, J Vargas, T Majtner, G Caffarena, J Otón, J L Vilas, J M de la Rosa-Trevín, R Melero, J Gómez-Blanco, J Cuenca, L Del Cano, P Conesa, R Marabini, J M Carazo
The introduction of Direct Electron Detector (DED) videos in the Electron Microscope field has boosted Single Particle Analysis to a point in which it is currently considered to be a key technique in Structural Biology. In this article we introduce an approach to estimate the DED camera gain at each pixel from the movies themselves. This gain is needed to have the set of recorded frames into a coherent gray level range, homogeneous over the whole image. The algorithm does not need any other input than the DED movie itself, being capable of providing an estimate of the camera gain image, helping to identify dead pixels and cases of incorrectly calibrated cameras...
March 15, 2018: Journal of Structural Biology
Alexander Kulik, Amy M Abreu, Viviana Boronat, Nicholas T Kouchoukos, Marc Ruel
RATIONALE: Saphenous vein graft disease remains a major limitation of coronary artery bypass graft surgery (CABG). Up to 20% of vein grafts will occlude within the first year after CABG despite standard aspirin antiplatelet therapy. However, more potent postoperative platelet inhibition with ticagrelor may improve graft patency. The goal of this study will be to evaluate the efficacy of ticagrelor, as compared to aspirin, for the prevention of saphenous vein graft occlusion following CABG...
March 15, 2018: Contemporary Clinical Trials
Christy L M Hui, William G Honer, Edwin H M Lee, Wing Chung Chang, Sherry K W Chan, Emily S M Chen, Edwin P F Pang, Simon S Y Lui, Dicky W S Chung, Wai Song Yeung, Roger M K Ng, William T L Lo, Peter B Jones, Pak Sham, Eric Y H Chen
BACKGROUND: The long-term consequences of discontinuing antipsychotic medication after successful treatment of first-episode psychosis are not well studied. We assess the relation between early maintenance therapy decisions in first-episode psychosis and the subsequent clinical outcome at 10 years. METHODS: This is a 10 year follow-up study, spanning Sept 5, 2003, to Dec 30, 2014, of a randomised, double-blind trial in seven centres in Hong Kong in which 178 patients with first-episode psychosis with full positive symptom resolution after at least 1 year of antipsychotic treatment were given maintenance treatment (n=89; oral quetiapine 400 mg daily) or early treatment discontinuation (n=89; placebo) for 12 months...
March 15, 2018: Lancet Psychiatry
Cristina Grávalos, Alfredo Carrato, María Tobeña, Mercedes Rodriguez-Garrote, Gemma Soler, José Mª Vieitez, Luis Robles, Manuel Valladares-Ayerbes, Eduardo Polo, Mª Luisa Limón, Mª José Safont, Eva Martínez de Castro, Pilar García-Alfonso, Enrique Aranda
INTRODUCTION: The aim of this study was to evaluate the efficacy and safety of maintenance therapy with axitinib versus placebo following induction therapy in patients with metastatic colorectal cancer (mCRC). PATIENTS AND METHODS: In this double-blinded, phase II trial, patients with mCRC who had not progressed after 6 to 8 months of first-line chemotherapy were randomized to receive axitinib (5 mg twice a day) (arm A) or placebo (arm B). RESULTS: Forty-nine patients were included: 25 in arm A and 24 in arm B...
February 17, 2018: Clinical Colorectal Cancer
Mika J Mäkelä, Pär Gyllfors, Erkka Valovirta, Maria A Steffensen, Pernille M Grønager, Johannes Savolainen, Lone Winther
PURPOSE: The SQ tree sublingual immunotherapy (SLIT)-tablet containing allergen extracts with the major allergen Bet v 1 from birch pollen is currently being developed for the treatment of tree pollen-induced allergic rhinitis/conjunctivitis with or without asthma. The aim of this Phase II trial was to investigate the dose-related efficacy and safety of the SQ tree SLIT-tablet. METHODS: This study was a randomized, parallel-group, double-blind, placebo-controlled, multi-national trial conducted in Europe...
March 15, 2018: Clinical Therapeutics
M-P Ledoux, J Denis, Y Nivoix, R Herbrecht
Isavuconazole, the active moiety of its prodrug isavuconazonium, is a new extended-spectrum triazole whose activity against yeasts, molds, including Aspergillus and mucorales, and dimorphic fungi has been shown in vitro and in preclinical models. The most relevant pharmacokinetics features are water-solubility of the prodrug, rapid cleavage of the prodrug into active moiety and cleavage product by plasmatic esterases, high oral bioavailability of isavuconazole with an extensive penetration into most tissues and a good safety profile even in case of renal impairment...
March 15, 2018: Journal de Mycologie Médicale
Sarah M Jacobs, Colin P McInnis, Matthew Kapeles, Shu-Hong Chang
PURPOSE: Severe vision loss is a risk of orbital surgery which physicians should counsel patients about, but the overall risk rate is unknown. This research was conducted to determine the risk of severe vision loss related to orbital surgery. DESIGN: Retrospective review. PARTICIPANTS: Patients who underwent orbital surgery at either of 2 academic medical centers between January 1994 and December 2014. METHODS: A billing database search was conducted to identify all patients who had orbital surgery during the study period, cross-checked against diagnostic codes related to vision loss...
March 15, 2018: Ophthalmology
Cory S Inman, Kelly R Bijanki, David I Bass, Robert E Gross, Stephan Hamann, Jon T Willie
The amygdala is a key structure mediating emotional processing. Few studies have used direct electrical stimulation of the amygdala in humans to examine stimulation-elicited physiological and emotional responses, and the nature of such effects remains unclear. Determining the effects of electrical stimulation of the amygdala has important theoretical implications for current discrete and dimensional neurobiological theories of emotion, which differ substantially in their predictions about the emotional effects of such stimulation...
March 15, 2018: Neuropsychologia
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
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