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Phase three study

Zohra Haned, Saad Moulay, Silvia Lacorte
Flexible poly(vinyl chloride) (PVC) is widely used in the pharmaceutical industry for the manufacture of medical devices (tubes, probes, bags, primary packaging, etc.). The objective of the present study was to develop a procedure to evaluate the migration potential of nine plastic additives in aqueous infusion bags (NaCl 0.9% and glucose 5%): five phthalates, one adipate, two alkylphenols, and benzophenone. Two types of materials were analyzed: (i) new and outdated plasticized PVC (containing 40% of diethylhexyl phthalate DEHP); and (ii) tri-laminate polyethylene-polyamide-polypropylene, a multilayer material presumably exempt from DEHP...
April 12, 2018: Journal of Pharmaceutical and Biomedical Analysis
Charles Savoldelli, Emmanuel Chamorey, Georges Bettega
Bilateral sagittal split osteotomy (BSSO) is a widely-performed procedure in orthognathic surgery for the correction of dentofacial deformity. Condylar positioning is a critical step during BSSO to maximize functional and morphological results. The unsuitable positioning of condyles represents one of the causative mechanisms that may induce temporomandibular joint noxious effects after BSSO. Repositioning devices can assist surgeons in maintaining the preoperative condylar position; however, empirical repositioning methods based on experience gained are still commonly used...
2018: PloS One
Satoshi Tanaka, Kei Ando, Kazuyoshi Kobayashi, Tetsuro Hida, Taisuke Seki, Takashi Hamada, Kenyu Ito, Mikito Tsushima, Masayoshi Morozumi, Masaaki Machino, Kyotaro Ota, Naoki Ishiguro, Yukiharu Hasegawa, Shiro Imagama
OBJECTIVES: The locomotive syndrome (LS) risk test has recently been advocated for the evaluation of physical ability. Phase angle measurement by bioelectrical impedance analysis (BIA) is an indicator of cellular health and muscle mass. We aimed to investigate how muscle mass and phase angle are related to LS risk stage. METHODS: A prospective cohort study was conducted in 311 patients who were undergoing a health checkup. All participants performed the two-step test, stand-up test, and 25-question geriatric locomotive function scale components of the LS risk test...
April 25, 2018: Modern Rheumatology
Shang Gao, O Zaharko, V Tsurkan, L Prodan, E Riordan, J Lago, B Fåk, A R Wildes, M M Koza, C Ritter, P Fouquet, L Keller, E Canévet, M Medarde, J Blomgren, C Johansson, S R Giblin, S Vrtnik, J Luzar, A Loidl, Ch Rüegg, T Fennell
Excitations in a spin ice behave as magnetic monopoles, and their population and mobility control the dynamics of a spin ice at low temperature. CdEr_{2}Se_{4} is reported to have the Pauling entropy characteristic of a spin ice, but its dynamics are three orders of magnitude faster than the canonical spin ice Dy_{2}Ti_{2}O_{7}. In this Letter we use diffuse neutron scattering to show that both CdEr_{2}Se_{4} and CdEr_{2}S_{4} support a dipolar spin ice state-the host phase for a Coulomb gas of emergent magnetic monopoles...
March 30, 2018: Physical Review Letters
Wanli Kang, Yilu Zhao, Pengxiang Wang, Zhe Li, Xiaoyu Hou, Zitong Huang, Hongbin Yang
Responsive wormlike micelles (WLMs) constructed by different carboxylic acids are fascinating. However, it is unknown how the position of the carboxylic groups alters the stimuli-response of wormlike micellar systems. Herein, three pH-responsive WLMs based on Gemini-like surfactants (named o-EAPA, m-EAPA, and p-EAPA) were formed and studied through the complexation of N-erucamidopropyl-N,N-dimethylamine (UC22AMPM) and o-phthalic acid (o-PA), m-phthalic acid (m-PA), or p-phthalic acid (p-PA) at the molar ratio of 2 : 1...
April 25, 2018: Soft Matter
Aspasia Kanellou, George C Anyfantis, Despoina Chriti, Grigorios Raptopoulos, Marinos Pitsikalis, Patrina Paraskevopoulou
We report the synthesis and characterization of synthetic polymer aerogels based on dendritic-type urethane-norbornene monomers. The core of those monomers is based either on an aromatic/rigid (TIPM/Desmodur RE), or an aliphatic/flexible (Desmodur N3300) triisocyanate. The terminal norbornene groups (three at the tip of each of the three branches) were polymerized via ROMP using the inexpensive 1st generation Grubbs catalyst. The polymerization/gelation conditions were optimized by varying the amount of the catalyst...
April 25, 2018: Molecules: a Journal of Synthetic Chemistry and Natural Product Chemistry
Lisa McManus, Jill A Fisher
BACKGROUND: Phase I trials test the safety and tolerability of investigational drugs and often use healthy volunteers as research participants. Adverse events (AEs) are collected in part through participants' self-reports of any symptoms they experience during the trial. In some cases, experiencing AEs can result in trial participation being terminated. Because of the economic incentives underlying their motivation to participate, there is concern that healthy volunteers routinely fail to report AEs and, thereby, jeopardize the validity of the trial results...
April 25, 2018: AJOB Empirical Bioethics
Sulabha Ramachandran, Daniel Parks, Milena Kurtinecz, David A Roth, Rafael Alfonso-Cristancho
AIM: To compare the efficacy of intravenous (IV) and subcutaneous (SC) belimumab plus standard therapy in patients with active, autoantibody-positive systemic lupus erythematosus and high disease activity (HDA). PATIENTS & METHODS: An indirect treatment comparison using patient-level data of patients with HDA from three belimumab IV Phase III randomized controlled trials (BLISS-52 [BEL110751]; BLISS-76 [BEL110752]; North-East Asia Study [BEL113750]) and one belimumab SC randomized controlled trial (BLISS-SC [BEL112341])...
April 25, 2018: Journal of Comparative Effectiveness Research
Wen-Jun Wang, Chao-Feng Zheng, Zhuang Liu, Yan-Hong Tan, Xiu-Hua Chen, Bin-Liang Zhao, Guo-Xia Li, Zhi-Fang Xu, Fang-Gang Ren, Yao-Fang Zhang, Jian-Mei Chang, Hong-Wei Wang
OBJECTIVE: The present study intended to establish a droplet digital PCR (dd-PCR) for monitoring minimal residual disease (MRD) in patients with BCR/ABL (P210)-positive CML, thereby achieving deep-level monitoring of tumor load and determining the efficacy for guided clinically individualized treatment. METHODS: Using dd-PCR and RT-qPCR, two cell suspensions were obtained from K562 cells and normal peripheral blood mononuclear cells by gradient dilution and were measured at the cellular level...
April 25, 2018: European Journal of Haematology
Mariangela Panebianco, Hemanshu Prabhakar, Anthony G Marson
BACKGROUND: Epilepsy is a central nervous system disorder (neurological disorder). Epileptic seizures are the result of excessive and abnormal cortical nerve cell electrical activity in the brain. Despite the development of more than 10 new antiepileptic drugs (AEDs) since the early 2000s, approximately a third of people with epilepsy remain resistant to pharmacotherapy, often requiring treatment with a combination of AEDs. In this review, we summarised the current evidence regarding rufinamide, a novel anticonvulsant medication, which, as a triazole derivative, is structurally unrelated to any other currently used anticonvulsant medication, when used as an add-on treatment for refractory epilepsy...
April 25, 2018: Cochrane Database of Systematic Reviews
H Nishihara, T Kyotani
Zeolite-templated carbons (ZTCs) are ordered microporous carbons synthesized by using zeolite as a sacrificial template. Unlike well-known ordered mesoporous carbons obtained by using mesoporous silica templates, ZTCs consist of curved and single-layer graphene frameworks, thereby affording uniform micropore size (ca. 1.2 nm), developed microporosity (∼1.7 cm3 g-1), very high surface area (∼4000 m2 g-1), good compatibility with chemical modification, and remarkable softness/elasticity. Thus, ZTCs have been used in many applications such as hydrogen storage, methane storage, CO2 capture, liquid-phase adsorption, catalysts, electrochemical capacitors, batteries, and fuel cells...
April 25, 2018: Chemical Communications: Chem Comm
Yifan Zhu, Jie Hu, Xudong Fan, Jing Yang, Bin Liang, Xuefeng Zhu, Jianchun Cheng
The fine manipulation of sound fields is critical in acoustics yet is restricted by the coupled amplitude and phase modulations in existing wave-steering metamaterials. Commonly, unavoidable losses make it difficult to control coupling, thereby limiting device performance. Here we show the possibility of tailoring the loss in metamaterials to realize fine control of sound in three-dimensional (3D) space. Quantitative studies on the parameter dependence of reflection amplitude and phase identify quasi-decoupled points in the structural parameter space, allowing arbitrary amplitude-phase combinations for reflected sound...
April 24, 2018: Nature Communications
Robert Pertermann, Selvaraj Tamilarasan, Torsten Gursinsky, Giorgio Gambino, Jana Schuck, Claus Weinholdt, Hauke Lilie, Ivo Grosse, Ralph Peter Golbik, Vitantonio Pantaleo, Sven-Erik Behrens
Many viral suppressors (VSRs) counteract antiviral RNA silencing, a central component of the plant's immune response by sequestration of virus-derived antiviral small interfering RNAs (siRNAs). Here, we addressed how VSRs affect the activities of cellular microRNAs (miRNAs) during a viral infection by characterizing the interactions of two unrelated VSRs, the Tombusvirus p19 and the Cucumovirus 2b, with miRNA 162 (miR162), miR168, and miR403. These miRNAs regulate the expression of the important silencing factors Dicer-like protein 1 (DCL1) and Argonaute proteins 1 and 2 (AGO1 and AGO2), respectively...
April 24, 2018: MBio
Manish A Shah, Alexander N Starodub, Sunil Sharma, Jordan Berlin, Manish R Patel, Zev A Wainberg, Jorge Chaves, Michael S Gordon, Kevin Windsor, Carrie Baker Brachmann, Xi Huang, Greg Vosganian, Julia D Maltzman, Victoria Smith, Jeffrey A Silverman, Heinz-Josef Lenz, Johanna C Bendell
PURPOSE: Matrix metalloproteinase-9 (MMP9) is implicated in pro-tumorigenic processes. Andecaliximab (GS-5745, a monoclonal antibody targeting MMP9) was evaluated as monotherapy and in combination with mFOLFOX6. EXPERIMENTAL DESIGN: Three dosages of andecaliximab monotherapy (200, 600, and 1800 mg IV every 2 weeks [q2w]) were investigated in patients with advanced solid tumors (n=13 in a 3+3 design). After determining a recommended dose, patients with advanced HER2-negative gastric/gastroesophageal junction (GEJ) adenocarcinoma (n=40) received 800 mg andecaliximab + mFOLFOX6 q2w...
April 24, 2018: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
Jingyi Yu, Marcus M Seldin, Kai Fu, Shen Li, Larry Lam, Ping Wang, Yijie Wang, Dian Huang, Thang L Nguyen, Bowen Wei, Rajan P Kulkarni, Dino Di Carlo, Michael Teitell, Matteo Pellegrini, Aldons J Lusis, Arjun Deb
<u>Rationale:</u> Cardiac fibroblasts do not form a syncytium but reside in the interstitium between myocytes. This topological relationship between fibroblasts and myocytes is maintained throughout post-natal life until acute myocardial injury occurs, when fibroblasts are recruited to, proliferate and aggregate in the region of myocyte necrosis. The accumulation or aggregation of fibroblasts in the area of injury thus represents a unique event in the life cycle of the fibroblast but little is known about how changes in the topological arrangement of fibroblasts following cardiac injury affect fibroblast function...
April 24, 2018: Circulation Research
Hao Li, Fang Fang, Yunqi Liu, Liangmin Xue, Meng Wang, Ying Guo, Xiaowei Wang, Chao Tian, Junyi Liu, Zhili Zhang
Bridge homologation of the previously reported nonclassical two-carbon-bridged antifolate, 2,4-diamino-6-phenethylpyrido[3,2-d]pyrimidine (wm-5a), afforded the three-, four- and five-carbon-bridged antifolate analogues 3.1-3.5, 4.1-4.2 and 5.1-5.5. The target compounds, with substituents at various positions on the carbon bridges, were efficiently synthesized by aldol condensation or Wittig reaction and followed by reduction. Elongation of the two-carbon bridge to three-, four- or five-carbon bridges, and also saturation of the carbon bridges, provided compounds with good inhibitory activity against recombinant human DHFR (rhDHFR)...
April 19, 2018: Bioorganic & Medicinal Chemistry
Mikkel T Steinberg, Jan-Aage Olsen, Morten Eriksen, Andres Neset, Per Andreas Norseng, Jo Kramer-Johansen, Bjarne Madsen Hardig, Lars Wik
BACKGROUND: Experimental active compression-decompression (ACD) CPR is associated with increased haemodynamic outcomes compared to standard mechanical chest compressions. Since no clinically available mechanical chest compression device is capable of ACD-CPR, we modified the LUCAS 2 (Physio-Control, Lund, Sweden) to deliver ACD-CPR, hypothesising it would improve haemodynamic outcomes compared with standard LUCAS CPR on pigs with cardiac arrest. METHODS: The modified LUCAS delivering 5 cm compressions with or without 2 cm active decompression above anatomical chest level was studied in a randomized crossover design on 19 Norwegian domestic pigs...
April 24, 2018: Scandinavian Journal of Trauma, Resuscitation and Emergency Medicine
Marta G Silva, Nicolas F Villarino, Donald P Knowles, Carlos E Suarez
Babesia bovis, Babesia bigemina and Theileria equi are worldwide tick-borne hemoprotozoan that cause diseases characterized by fever, anemia, weight loss and abortion. A common feature of these diseases are transition from acute to chronic phases, in which parasites may persist in the host for life, and becoming a reservoir for tick transmission. The live-attenuated vaccines for B. bovis and B. bigemina are not available for worldwide use due to legal restrictions and other concerns such as potential erythrocyte antigen and pathogen contamination, and a vaccine for T...
April 17, 2018: International Journal for Parasitology, Drugs and Drug Resistance
Xuesong Wang, Yilun Xing, Lian Luo, Rongjie Yu
Risky driving behavior is one of the main causes of commercial vehicle related crashes. In order to achieve safer vehicle operation, safety education for drivers is often provided. However, the education programs vary in quality and may not always be successful in reducing crash rates. Behavior-Based Safety (BBS) education is a popular approach found effective by numerous studies, but even this approach varies as to the combination of frequency, mode and content used by different education providers. This study therefore evaluates and compares the effectiveness of BBS education methods...
April 21, 2018: Accident; Analysis and Prevention
Cong Wang, Xudong Gao, Ramesh Kumar Santhanam, Zhongqin Chen, Yue Chen, Leilei Xu, Chunli Wang, Nicola Ferri, Haixia Chen
In the present study, the antioxidant activity, anti-glycation activity, α-amylase, α-glucosidase inhibitory activity of polysaccharides from Inonotus obliquus (UIOPS) and its chromium (III) complex (UIOPC) were investigated. Their protective effects against H2 O2 -induced oxidative damages in hepatic L02 cells were also assessed. Results demonstrated that UIOPC and UIOPS exhibited remarkable DPPH scavenging activity, ferric reducing power and hemolysis inhibitory activity. UIOPC also showed significant inhibitory capacity on α-amylase and α-glucosidase than UIOPS (P < 0...
April 21, 2018: Food and Chemical Toxicology
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