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https://www.readbyqxmd.com/read/28647377/establishing-rarity-in-the-context-of-orphan-medicinal-product-designation-in-the-european-union
#1
REVIEW
Stelios Tsigkos, Matthias Hoffer, Maria Sheean, Segundo Mariz, Kristina Larsson, Frauke Naumann-Winter, Laura Fregonese, Bruno Sepodes
In the European Union (EU) legislative framework for orphan medicinal product designation, establishing that a condition affects not more than five in 10 000 people is a prerequisite for applications based on rarity. Demonstrating this requirement to the Committee of Orphan Medicinal Products (COMP) can be a particularly challenging task for sponsors. Here, we identify and examine three common issues with the estimation of prevalence in orphan drug applications in the EU (the discernment between diagnosed and undiagnosed cases; the duration of the disease; and the need for an explicit contemporary conclusion) as critical factors for acceptable prevalence estimation...
June 21, 2017: Drug Discovery Today
https://www.readbyqxmd.com/read/28643528/modulating-release-of-ranibizumab-and-aflibercept-from-thiolated-chitosan-based-hydrogels-for-potential-treatment-of-ocular-neovascularization
#2
Miguel Moreno, Poh Yih Pow, Tan Su Teng Tabitha, Sonali Nirmal, Andreas Larsson, Krishna Radhakrishnan, Jayabalan Nirmal, Soo Tng Quah, Susana Geifman Shochat, Rupesh Agrawal, Subbu Venkatraman
BACKGROUND: This paper describes the synthesis of thiolated chitosan-based hydrogels with varying degrees of crosslinking that has been utilized to modulate release kinetics of two clinically relevant FDA-approved anti-VEGF protein drugs, ranibizumab and aflibercept. These hydrogels have been fabricated into disc shaped structures for potential use as patches on ocular surface. METHODS: Protein conformational changes and aggregation after loading and release was evaluated by circular dichroism (CD), steady-state tryptophan fluorescence spectroscopy, electrophoresis and size-exclusion chromatography (SEC)...
June 23, 2017: Expert Opinion on Drug Delivery
https://www.readbyqxmd.com/read/28642787/mutational-signatures-are-critical-for-proper-estimation-of-purifying-selection-pressures-in-cancer-somatic-mutation-data-when-using-the-dn-ds-metric
#3
Jimmy Van den Eynden, Erik Larsson
Large cancer genome sequencing initiatives have led to the identification of cancer driver genes based on signals of positive selection in somatic mutation data. Additionally, the identification of purifying (negative) selection has the potential to identify essential genes that may be of therapeutic interest. The most widely used way of quantifying selection pressures in protein-coding genes is the dN/dS metric, which compares non-synonymous to synonymous substitution rates. In this study, we examine whether and how this metric is influenced by the mutational processes that have been active during tumor evolution...
2017: Frontiers in Genetics
https://www.readbyqxmd.com/read/28642304/-clinical-and-inflammatory-characteristics-of-the-european-u-biopred-adult-severe-asthma-cohort-dominick-e-shaw-ana-r-sousa-stephen-j-fowler-louise-j-fleming-graham-roberts-julie-corfield-ioannis-pandis-aruna-t-bansal-elisabeth-h-bel-charles-auffray-chris-h
#4
https://www.readbyqxmd.com/read/28637741/the-closed-trial-clonidine-compared-with-midazolam-for-sedation-of-paediatric-patients-in-the-intensive-care-unit-study-protocol-for-a-multicentre-randomised-controlled-trial
#5
Antje Neubert, Manuel Alberto Baarslag, Monique van Dijk, Joost van Rosmalen, Joseph F Standing, Yucheng Sheng, Wolfgang Rascher, Deborah Roberts, Jackie Winslade, Louise Rawcliffe, Sara M Hanning, Tuuli Metsvaht, Viviana Giannuzzi, Peter Larsson, Pavla Pokorná, Alessandra Simonetti, Dick Tibboel
INTRODUCTION: Sedation is an essential part of paediatric critical care. Midazolam, often in combination with opioids, is the current gold standard drug. However, as it is a far-from-ideal agent, clonidine is increasingly being used in children. This drug is prescribed off-label for this indication, as many drugs in paediatrics are. Therefore, the CLOSED trial aims to provide data on the pharmacokinetics, safety and efficacy of clonidine for the sedation of mechanically ventilated patients in order to obtain a paediatric-use marketing authorisation...
June 21, 2017: BMJ Open
https://www.readbyqxmd.com/read/28636894/effects-of-hpmc-substituent-pattern-on-water-up-take-polymer-and-drug-release-an-experimental-and-modelling-study
#6
Diego Caccavo, Gaetano Lamberti, Anna Angela Barba, Susanna Abrahmsén-Alami, Anna Viridén, Anette Larsson
The purpose of this study was to investigate the hydration behavior of two matrix formulations containing the cellulose derivative hydroxypropyl methylcellulose (HPMC). The two HPMC batches investigated had different substitution pattern along the backbone; the first one is referred to as heterogeneous and the second as homogenous. The release of both the drug molecule theophylline and the polymer was determined. Additionally, the water concentrations at different positions in the swollen gel layers were determined by Magnetic Resonance Imaging...
June 18, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28634233/structural-analyses-of-human-thymidylate-synthase-reveal-a-site-that-may-control-conformational-switching-between-active-and-inactive-states
#7
Dan Chen, Anna Jansson, Daniel Sim, Andreas Larsson, Pär Nordlund
Thymidylate synthase (TS) is the sole enzyme responsible for de novo biosynthesis of thymidylate (TMP) and is essential for cell proliferation and survival. Inhibition of human TS (hTS) has been extensively investigated for cancer chemotherapy, but several aspects of its activity and regulation are still uncertain. In this study, we performed comprehensive structural and biophysical studies of hTS using crystallography and thermal shift assay and provided the first detailed structural information on the conformational changes induced by ligand binding to the hTS active site...
June 20, 2017: Journal of Biological Chemistry
https://www.readbyqxmd.com/read/28633628/olfactory-testing-in-consecutive-patients-referred-with-suspected-dementia
#8
Ib Thrane Christensen, Elna-Marie Larsson, Ida E Holm, Ole B F Nielsen, Stig Andersen
BACKGROUND: Alzheimer's disease (AD) is the most common cause of dementia and early and accurate diagnosis is important. Olfactory dysfunction is an early sign of AD. The contribution by test of olfactory function has been surveyed in AD vs a line of conditions but remains to be settled in the workup of unselected patients referred with suspected dementia. METHODS: We performed a two-step investigation: first, a comparative study of healthy controls and probable AD patients to test the applicability of the chosen scents (cuisine study); second, a study of consecutive patients referred to our geriatric outpatient clinic for suspected dementia with the investigating personnel blinded to the results of the Olfactory Test (blinded study)...
June 20, 2017: BMC Geriatrics
https://www.readbyqxmd.com/read/28633463/the-body-odor-disgust-scale-bods-development-and-validation-of-a-novel-olfactory-disgust-assessment
#9
Marco Tullio Liuzza, Torun Lindholm, Caitlin Hawley, Marie Gustafsson Sendén, Ingrid Ekström, Mats J Olsson, Maria Larsson, Jonas K Olofsson
Disgust plays a crucial role in the avoidance of pathogen threats. In many species, body odors provide important information related to health and disease, and body odors are potent elicitors of disgust in humans. With this background, valid assessments of body odor disgust sensitivity are warranted. In the present article, we report the development and psychometric validation of the Body Odor Disgust Scale (BODS), a measure suited to assess individual differences in disgust reaction to a variety of body odors...
July 1, 2017: Chemical Senses
https://www.readbyqxmd.com/read/28632153/fabrication-and-characterization-of-plasmonic-nanopores-with-cavities-in-the-solid-support
#10
Bita Malekian, Kunli Xiong, Gustav Emilsson, Jenny Andersson, Cecilia Fager, Eva Olsson, Elin M Larsson-Langhammer, Andreas B Dahlin
Plasmonic nanostructures are widely used for various sensing applications by monitoring changes in refractive index through optical spectroscopy or as substrates for surface enhanced Raman spectroscopy. However, in most practical situations conventional surface plasmon resonance is preferred for biomolecular interaction analysis because of its high resolution in surface coverage and the simple single-material planar interface. Still, plasmonic nanostructures may find unique sensing applications, for instance when the nanoscale geometry itself is of interest...
June 20, 2017: Sensors
https://www.readbyqxmd.com/read/28631533/u-can-a-prospective-longitudinal-collection-of-biomaterials-and-clinical-information-from-adult-cancer-patients-in-sweden
#11
Bengt Glimelius, Beatrice Melin, Gunilla Enblad, Irina Alafuzoff, Anna Beskow, Håkan Ahlström, Anna Bill-Axelson, Helgi Birgisson, Ove Björ, Per-Henrik Edqvist, Tony Hansson, Thomas Helleday, Per Hellman, Kerstin Henriksson, Göran Hesselager, Magnus Hultdin, Michael Häggman, Martin Höglund, Håkan Jonsson, Chatarina Larsson, Henrik Lindman, Ingrid Ljuslinder, Stephanie Mindus, Peter Nygren, Fredrik Pontén, Katrine Riklund, Richard Rosenquist, Fredrik Sandin, Jochen M Schwenk, Roger Stenling, Karin Stålberg, Peter Stålberg, Christer Sundström, Camilla Thellenberg Karlsson, Bengt Westermark, Anders Bergh, Lena Claesson-Welsh, Richard Palmqvist, Tobias Sjöblom
BACKGROUND: Progress in cancer biomarker discovery is dependent on access to high-quality biological materials and high-resolution clinical data from the same cases. To overcome current limitations, a systematic prospective longitudinal sampling of multidisciplinary clinical data, blood and tissue from cancer patients was therefore initiated in 2010 by Uppsala and Umeå Universities and involving their corresponding University Hospitals, which are referral centers for one third of the Swedish population...
June 20, 2017: Acta Oncologica
https://www.readbyqxmd.com/read/28628917/anatomical-characteristics-of-facial-nerve-and-cochlea-interaction
#12
Nadine Schart-Morén, Sune Larsson, Helge Rask-Andersen, Hao Li
OBJECTIVE: The aim was to study the relationship between the labyrinthine portion (LP) of the facial canal and the cochlea in human inner ear molds and temporal bones using micro-CT and 3D rendering. A reduced cochlea-facial distance may spread electric currents from the cochlear implant to the LP and cause facial nerve stimulation. Influencing factors may be the topographic anatomy and otic capsule properties. METHODS: An archival collection of human temporal bones underwent micro-CT and 3D reconstruction...
June 20, 2017: Audiology & Neuro-otology
https://www.readbyqxmd.com/read/28628468/dapsa-das28-and-mda-predict-long-term-treatment-regime-in-psoriatic-arthritis-the-swedish-early-psoriatic-arthritis-cohort
#13
Ulla Lindqvist, Mona-Lisa Wernroth, Tomas Husmark, Per Larsson, Mats Geijer, Annika Teleman, Elke Theander, Gerd-Marie Alenius
OBJECTIVES: To describe treatment patterns in the Swedish early psoriatic arthritis cohort (SwePsA) of the mono-/oligo-arthritic (M/O) and polyarthritis (P) and identify early predictive factors for treatment with disease-modifying anti-rheumatic (DMARD), non-steroidal anti-inflammatory drugs (NSAID), and tumour necrosis factor inhibition (TNFi) after 5 years. METHODS: Data for 198 M/O and P PsA were obtained within the programme for SwePsA. Multinomial and binary logistic regression analyses were used to assess the association between early predictive factors and treatment after 5 years adjusted for age at inclusion...
June 16, 2017: Clinical and Experimental Rheumatology
https://www.readbyqxmd.com/read/28627817/turbidimetric-determination-of-fecal-calprotectin-using-two-table-top-chemistry-analyzers-mindray-bs-200e-and-cobas%C3%A2-c111
#14
Aleksandra Mandic-Havelka, Tom Nilsen, Kathrin Sunde, Maria Norell, Lars O Hansson, Anders Larsson
BACKGROUND: Fecal calprotectin assays are widely used in diagnosis and monitoring of inflammatory bowel disease (IBD) in patients with suspected IBD. The most frequently used technique is ELISA and microtiter plates. Turbidimetric assays for analysis of fecal calprotectin can significantly reduce turnaround time. Many laboratories may be reluctant to run fecal samples on their large chemistry analyzers. The aim of this study was to evaluate fecal calprotectin particle enhanced turbidimetric immunoassay (PETIA) on smaller chemistry analyzers that could be dedicated for fecal samples...
May 1, 2017: Clinical Laboratory
https://www.readbyqxmd.com/read/28623824/dietary-nitrate-attenuates-renal-ischemia-reperfusion-injuries-by-modulation-of-immune-responses-and-reduction-of-oxidative-stress
#15
Ting Yang, Xing-Mei Zhang, Laura Tarnawski, Maria Peleli, Zhengbing Zhuge, Niccolo Terrando, Robert A Harris, Peder S Olofsson, Erik Larsson, A Erik G Persson, Jon O Lundberg, Eddie Weitzberg, Mattias Carlstrom
Ischemia-reperfusion (IR) injury involves complex pathological processes in which reduction of nitric oxide (NO) bioavailability is suggested as a key factor. Inorganic nitrate can form NO in vivo via NO synthase-independent pathways and may thus provide beneficial effects during IR. Herein we evaluated the effects of dietary nitrate supplementation in a renal IR model. Male mice (C57BL/6J) were fed nitrate-supplemented chow (1.0mmol/kg/day) or standard chow for two weeks prior to 30min ischemia and during the reperfusion period...
June 9, 2017: Redox Biology
https://www.readbyqxmd.com/read/28621266/melflufen-a-peptidase-potentiated-alkylating-agent-in-clinical-trials
#16
REVIEW
Malin Wickström, Peter Nygren, Rolf Larsson, Johan Harmenberg, Jakob Lindberg, Per Sjöberg, Markus Jerling, Fredrik Lehmann, Paul Richardson, Kenneth Anderson, Dharminder Chauhan, Joachim Gullbo
Aminopeptidases like aminopeptidase N (APN, also known as CD13) play an important role not only in normal cellular functioning but also in the development of cancer, including processes like tumor cell invasion, differentiation, proliferation, apoptosis, motility, and angiogenesis. An increased expression of APN has been described in several types of human malignancies, especially those characterized by fast-growing and aggressive phenotypes, suggesting APN as a potential therapeutic target.Melphalan flufenamide ethyl ester (melflufen, previously denoted J1) is a peptidase-potentiated alkylating agent...
June 8, 2017: Oncotarget
https://www.readbyqxmd.com/read/28620101/barcodes-show-family-trees-in-all
#17
Jonas Larsson
No abstract text is available yet for this article.
June 15, 2017: Blood
https://www.readbyqxmd.com/read/28619993/low-extracellular-potassium-prolongs-repolarization-and-evokes-early-afterdepolarization-in-human-induced-pluripotent-stem-cell-derived-cardiomyocytes
#18
Jukka Kuusela, Kim Larsson, Disheet Shah, Chandra Prajapati, Katriina Aalto-Setälä
Long QT syndrome (LQTS) is characterized by a prolonged QT-interval on electrocardiogram and by increased risk of sudden death. One of the most common and potentially life-threatening electrolyte disturbances is hypokalemia, characterized by low concentrations of K(+) Using a multielectrode array platform and current clamp technique, we investigated the effect of low extracellular K(+) concentration ([K(+)]Ex) on the electrophysiological properties of hiPSC-derived cardiomyocytes (CMs) generated from a healthy control subject (WT) and from two symptomatic patients with type 1 of LQTS carrying G589D (LQT1A) or IVS7-2A>G mutation (LQT1B) in KCNQ1 The baseline prolongations of field potential durations (FPDs) and action potential durations (APDs) were longer in LQT1-CMs than in WT-CMs...
June 15, 2017: Biology Open
https://www.readbyqxmd.com/read/28619037/ifn-%C3%AE-1-with-th17-axis-cytokines-and-ifn-%C3%AE-define-different-subsets-in-systemic-lupus-erythematosus-sle
#19
Vilija Oke, Susanna Brauner, Anders Larsson, Johanna Gustafsson, Agneta Zickert, Iva Gunnarsson, Elisabet Svenungsson
BACKGROUND: Interferon (IFN)-α is thought to have a pivotal role in systemic lupus erythematosus (SLE), and type III IFNs (IFN-λ) were recently also associated with SLE. In this study, we measured levels of IFN-α, IFN-λ1, and related cytokines, such as IL-17A, IL-23, and interferon-γ-induced protein 10 (IP-10), in a Karolinska University Hospital cohort of patients with SLE and control subjects. The objective of the study was to investigate if cytokine measurements could identify different subsets of patients with active SLE and higher disease damage...
June 15, 2017: Arthritis Research & Therapy
https://www.readbyqxmd.com/read/28618072/to-break-the-weight-gain-a-qualitative-study-on-the-experience-of-school-nurses-working-with-overweight-children-in-elementary-school
#20
Stina Thorstensson, Carola Blomgren, Annelie J Sundler, Margaretha Larsson
AIMS AND OBJECTIVES: This article describes the experiences of school nurses working with overweight school children. BACKGROUND: School nurses play an important role in health promotion of overweight children. Lifestyle changes and interventions to address being overweight can improve health outcomes and decrease the risk for future health problems. DESIGN: A descriptive and qualitative design with a phenomenological approach was used. Data were gathered through interviews with school nurses working with overweight school children in Swedish elementary school; the data were subsequently analysed for meanings...
June 15, 2017: Journal of Clinical Nursing
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