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https://www.readbyqxmd.com/read/28733068/effects-of-eu-harmonization-policies-on-national-public-supervision-of-clinical-trials-a-dynamic-cycle-of-institutional-change-and-institutional-work
#1
Jacqueline C F van Oijen, Kor J Grit, Hester M van de Bovenkamp, Roland A Bal
BACKGROUND: The EU Clinical Trials Directive (EUCTD) and the EU Clinical Trials Regulation aim to harmonize good clinical practice (GCP) of clinical trials across Member States. Using the Netherlands as a case study, this paper analyzes how endeavours to implement the EUCTD set in motion a dynamic process of institutional change and institutional work. This process lead to substantial differences between policy and actual practice; therefore, it is important to learn more about the implementation of harmonization policies...
June 30, 2017: Health Policy
https://www.readbyqxmd.com/read/28730200/how-side-chains-affect-conformation-and-electrical-properties-of-poly-acrylic-acid-in-solution
#2
Xinlu Zhou, Kongshuang Zhao
To better understand the effect of side chains on the chain conformation and electrical properties of polyelectrolytes, dielectric measurements were carried out on solutions of poly(acrylic acid) (PAA), poly(acrylic acid)-graft-dodecyl (PAA-g-dodecyl), and poly(acrylic acid)-graft-poly(ethylene oxide) (PAA-g-PEO) over a wide concentration range. Double dielectric relaxations with counterion distribution were observed for these polymers and a refined double-layer polarization model was proposed to analyze these, by which valuable information about conformations and interfacial electrokinetic properties was obtained...
July 21, 2017: Physical Chemistry Chemical Physics: PCCP
https://www.readbyqxmd.com/read/28727270/efficacy-and-safety-of-pregabalin-for-painful-diabetic-peripheral-neuropathy-in-a-population-of-chinese-patients-a-randomized-placebo-controlled-trial
#3
Yiming Mu, Xiaomin Liu, Quanmin Li, Kangning Chen, Yu Liu, Xiaofeng Lv, Xiangjin Xu, Dongsheng Fan, Ningxiu Shang, Ruoyong Yang, Lynne Pauer, Changyu Pan
BACKGROUND: Limited information exists on the efficacy of pregabalin in Chinese patients with diabetic peripheral neuropathy (pDPN). METHODS: An 11-week, double-blind, placebo-controlled trial in Chinese pDPN patients randomized (1:1) to pregabalin 300 mg/day or placebo. Primary efficacy endpoint was change from baseline in mean daily pain score (0 = no pain;10 = worst possible pain). Secondary efficacy endpoints included overall weekly mean pain score, responder status, impression of change, pain intensity, and sleep...
July 20, 2017: Journal of Diabetes
https://www.readbyqxmd.com/read/28717168/dynamics-and-function-of-cxcr4-in-formation-of-the-granule-cell-layer-during-hippocampal-development
#4
Yuka Mimura-Yamamoto, Hiroshi Shinohara, Taichi Kashiwagi, Toru Sato, Seiji Shioda, Tatsunori Seki
In the developing hippocampus, granule cell progenitors (GCPs) arising in the ventricular zone (VZ) migrate to the subpial region, and form the granule cell layer (GCL) of the dentate gyrus (DG). To understand the mechanism of GCL formation, we investigated the dynamics and function of CXCR4 which is expressed by the GCPs and is a receptor of the CXCL12 chemokine secreted by cells surrounding the DG. In the VZ, CXCR4 was expressed on the plasma membrane of the GCPs. During their migration and in the DG, CXCR4 was internalized and accumulated as puncta close to the centrosomes, Golgi apparatus, and lysosomes...
July 17, 2017: Scientific Reports
https://www.readbyqxmd.com/read/28710219/comparison-of-propofol-and-dexmedetomidine-infused-overnight-to-treat-hyperactive-and-mixed-icu-delirium-a-protocol-for-the-basel-prodex-clinical-trial
#5
Alexa Hollinger, Katrin Ledergerber, Stefanie von Felten, Raoul Sutter, Stephan Rüegg, Lukas Gantner, Sibylle Zimmermann, Andrea Blum, Luzius A Steiner, Stephan Marsch, Martin Siegemund
BACKGROUND/OBJECTIVES: Delirium is a neurobehavioural disturbance that frequently develops particularly in the intensive care unit (ICU) population. It was first described more than half a century ago, where it was already discovered as a state that might come along with serious complications such as prolonged ICU and hospital stay, reduced quality of life and increased mortality. However, in most cases, there is still lack of proof for causal relationship. Its presence frequently remains unrecognised due to suggested predominance of the hypoactive form...
July 13, 2017: BMJ Open
https://www.readbyqxmd.com/read/28697436/fe3o4-nanoparticles-modified-by-cd-containing-star-polymer-for-mri-and-drug-delivery
#6
Ruitao Cha, Juanjuan Li, Yang Liu, Yifan Zhang, Qian Xie, Mingming Zhang
Fe3O4 nanoparticles with ultrasmall sizes show good T1 or T1+T2 contrast abilities, and have attracted considerable interest in the field of magnetic resonance imaging (MRI) contrast agents. For effective biomedical applications, the colloidal stability and biocompatibility of the Fe3O4 nanoparticles need to be improved without reducing MRI relaxivity. In this paper, star polymers were used as coating materials to modify Fe3O4 nanoparticles in view of their dense molecular architecture with moderate flexibility...
June 30, 2017: Colloids and Surfaces. B, Biointerfaces
https://www.readbyqxmd.com/read/28676458/vitamin-d-deficiency-and-sex-specific-dysregulation-of-placental-inflammation
#7
Nancy Q Liu, Dean P Larner, Qingqiang Yao, Rene F Chun, Yuxin Ouyang, Rui Zhou, Jennifer A Tamblyn, Carol L Wagner, Martin Hewison
To investigate an immunomodulatory role for vitamin D in pregnancy we used mice raised on vitamin D-sufficient (SUFF), or -deficient (DEF) diets. At embryonic day 14, pregnant mice received intraperitoneal injection of lipopolysaccharide (LPS) or vehicle for 24hrs, with age-matched non-pregnant mice as controls. In non-pregnant mice, 6 serum analytes (IL-1β, IL-18, MDC/CCL22, MIP-1α/CCL3, EGF, IgA) were lower in DEF mice. In pregnant DEF mice only GH was higher. In non-pregnant mice LPS induced 28 analytes, with 5 (IL-18, IP-10/CXCL10, MCP-1/CCL2, MIP-1β/CCL4, MIP-3β/CCL19) being highest in DEF mice...
July 1, 2017: Journal of Steroid Biochemistry and Molecular Biology
https://www.readbyqxmd.com/read/28670483/best-practices-in-social-and-behavioral-research-report-from-the-enhancing-clinical-research-professional-s-training-and-qualifications-project
#8
Susan L Murphy, Christine Byks-Jazayeri, Nancy Calvin-Naylor, Vic Divecha, Elizabeth Anderson, Brenda Eakin, Alecia Fair, Laura Denton
INTRODUCTION: This article discusses the process of defining competencies and development of a best practices training course for investigators and clinical research coordinators who conduct social and behavioral research. METHODS: The first project phase established recommendations for training in Good Clinical Practice (GCP) and was done in conjunction with representatives from 62 Clinical and Translational Science Award (CTSA) hubs. Diversity in behavioral clinical trials and differences in regulation of behavioral trials compared with clinical trials involving drugs, devices, or biologics necessitated a separate Social and Behavioral Work Group...
February 2017: Journal of clinical and translational science
https://www.readbyqxmd.com/read/28664271/-changes-in-the-german-medicinal-product-act-imposed-by-the-eu-regulation-on-clinical-trials
#9
REVIEW
Lars Nickel, Yvonne Seibel, Marion Frech, Thomas Sudhop
The entry into force of Regulation (EU) No. 536/2014 of the European Parliament, the Council of 16 April 2014 for clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC necessitated amendments to the national legislation on medicinal products. These changes mainly concern the sixth chapter of the German Medicinal Products Act (Arzneimittelgesetz, AMG) and the elimination of the GCP (good clinical practice) ordinance for clinical trials that will be covered by the regulation in the future...
June 29, 2017: Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz
https://www.readbyqxmd.com/read/28659162/acupuncture-paired-with-herbal-medicine-for-prediabetes-study-protocol-for-a-randomized-controlled-trial
#10
Xinger Li, Haiyan Liu, Huiping Feng, Zhongren Xian, Yanhong Chen, Jianping Chen, Chunzhi Tang, Xinsheng Lai, Xiaoling Lan, Huanzhen Huang, Dongdong Yu
BACKGROUND: Type-2 diabetes has become a major disease and is known to seriously impair people's health worldwide. Prediabetes includes impaired fasting glucose (IFG) and impaired glucose tolerance (IGT) and is the most critical period for preventing type-2 diabetes, as it can be identified and reversed. Studies in the past decade have indicated that acupuncture and Chinese herbal medicine may be beneficial for treating prediabetes. However, a randomized controlled trial (RCT) should be conducted to obtain more clinical evidence on this topic...
June 28, 2017: Trials
https://www.readbyqxmd.com/read/28652934/phytochemical-rich-medicinal-plant-extracts-suppress-bacterial-antigens-induced-inflammation-in-human-tonsil-epithelial-cells
#11
Niluni M Wijesundara, Satvir Sekhon-Loodu, Hp Vasantha Rupasinghe
BACKGROUND: Pharyngitis is an inflammatory condition of the pharynx and associated structures commonly caused by the Group A streptococci (GAS). There is a growing interest in discovering plant-based anti-inflammatory compounds as potential alternatives to conventional drugs. This study evaluated anti-inflammatory activity of phytochemical-rich extracts prepared from 12 herbal plants using human tonsil epithelial cells (HTonEpiC) in vitro. METHODS: The HTonEpiC were induced by a mixture of lipoteichoic acid (LTA) and peptidoglycan (PGN) (10 µg/mL; bacterial antigens) for 4 h and then exposed to ethanol extracts (EE) or aqueous extracts (AE) for 20 h...
2017: PeerJ
https://www.readbyqxmd.com/read/28641421/effective-empirical-corrections-for-basis-set-superposition-error-in-the-def2-svpd-basis-gcp-and-dft-c
#12
Jonathon Witte, Jeffrey B Neaton, Martin Head-Gordon
With the aim of mitigating the basis set error in density functional theory (DFT) calculations employing local basis sets, we herein develop two empirical corrections for basis set superposition error (BSSE) in the def2-SVPD basis, a basis which-when stripped of BSSE-is capable of providing near-complete-basis DFT results for non-covalent interactions. Specifically, we adapt the existing pairwise geometrical counterpoise (gCP) approach to the def2-SVPD basis, and we develop a beyond-pairwise approach, DFT-C, which we parameterize across a small set of intermolecular interactions...
June 21, 2017: Journal of Chemical Physics
https://www.readbyqxmd.com/read/28636358/transferable-atom-centered-potentials-for-the-correction-of-basis-set-incompleteness-errors-in-density-functional-theory
#13
A Otero-de-la-Roza, Gino A DiLabio
Recent progress in the accurate calculation of noncovalent interactions has enabled density-functional theory (DFT) to model systems relevant in biological and supramolecular chemistry. The application of DFT methods using atom-centered Gaussian basis sets to large systems is limited by the number of basis functions required to accurately model thermochemistry and, in particular, weak intermolecular interactions. Basis set incompleteness error (BSIE) arising from the use of incomplete basis sets leads to erroneous intermolecular energies, bond dissociation energies, and structures...
July 21, 2017: Journal of Chemical Theory and Computation
https://www.readbyqxmd.com/read/28633908/dynamics-of-the-cell-division-orientation-of-granule-cell-precursors-during-cerebellar-development
#14
Satoshi Miyashita, Toma Adachi, Mariko Yamashita, Takayuki Sota, Mikio Hoshino
The cerebellar granule cell (GC) system provides a good model for studying neuronal development. In the external granule layer (EGL), granule cell precursors (GCPs) rapidly and continuously divide to produce numerous GCs as well as GCPs. In some brain regions, the orientation of cell division affects daughter cell fate, thus the direction of GCP division is related to whether it produces a GCP or a GC. Therefore, we tried to characterize the orientation of GCP division from embryonic to postnatal stages and to identify an environmental cue that regulates the orientation...
June 17, 2017: Mechanisms of Development
https://www.readbyqxmd.com/read/28618104/effect-of-two-different-polishing-systems-on-fluoride-release-surface-roughness-and-bacterial-adhesion-of-newly-developed-restorative-materials
#15
Gokcen Deniz Bayrak, Nuket Sandalli, Senem Selvi-Kuvvetli, Nursen Topcuoglu, Guven Kulekci
OBJECTIVES: To evaluate the effects of two different polishing systems on fluoride release, surface roughness and bacterial adhesion of five restorative materials MATERIALS AND METHODS: The study groups were comprised of five different restorative materials, Beautifil II (B); GCP Glass Fill (G); Amalgomer CR (A); Dyract XP (D); Fuji IX GP (F) and 21 specimens were prepared from each material. Each group was divided into three subgroups according to the polishing system: Mylar (control) (C), Sof-lex (S), and Enhance-Pogo (EP)...
June 15, 2017: Journal of Esthetic and Restorative Dentistry
https://www.readbyqxmd.com/read/28606539/polysaccharides-with-immunomodulating-activity-from-roots-of-gentiana-crassicaulis
#16
Yuan-Feng Zou, Yu-Ping Fu, Xing-Fu Chen, Ingvild Austarheim, Kari Tvete Inngjerdingen, Chao Huang, Fei-Yi Lei, Xu Song, Lixia Li, Gang Ye, Lemlem Dugassa Eticha, Zhongqiong Yin, Berit Smestad Paulsen
Two polysaccharides, GCP-I-I and GCP-II-I, were obtained from 100°C water extracts of Gentiana crassicaulis roots by DEAE anion exchange chromatography and gel filtration. The results from methanolysis, methylation, FT-IR and NMR, indicated that these two fractions are typical pectic polysaccharides, with HG and RG-I regions and AG-I/AG-II side chains, and some of the galacturonic acid units of fraction GCP-I-I were methyl esterified. Fractions GCP-I-I and GCP-II-I, both exhibited potent complement fixation, and fraction GCP-I-I was more potent than positive control BPII...
September 15, 2017: Carbohydrate Polymers
https://www.readbyqxmd.com/read/28598048/hepatotoxicity-in-hiv-patients-an-observational-study-in-patients-from-tertiary-care-centre-of-western-india
#17
Smrati Bajpai, Kavita Joshi
OBJECTIVE: HIV AIDS has currently become a chronic manageable condition with HAART, but with its chronicity and lifelong therapy currently the adverse drug reactions to these drugs are the main concern for any treating physician. Hepatotoxicity is one of the prime concerns of any physician managing HIV patients. We observe a number of patients reporting hepatotoxicity in our cohort and this had great impact on the efficacy and intake of the HAART drugs, this led us to explore this area and to find out the prevalence and etiologies in our cohort...
May 2017: Journal of the Association of Physicians of India
https://www.readbyqxmd.com/read/28588969/it-is-time-to-revise-the-international-good-clinical-practices-guidelines-recommendations-from-non-commercial-north-south-collaborative-trials
#18
Raffaella Ravinetto, Halidou Tinto, Ermias Diro, Joseph Okebe, Yodi Mahendradhata, Suman Rijal, Eduardo Gotuzzo, Pascal Lutumba, Alain Nahum, Katelijne De Nys, Minne Casteels, Marleen Boelaert
The Good Clinical Practices (GCP) codes of the WHO and the International Conference of Harmonization set international standards for clinical research. But critics argue that they were written without consideration for the challenges faced in low and middle income countries (LMICs). Based on our field experience in LMICs, we developed a non-exhaustive set of recommendations for the improvement of GCP. These cover 3 domains: ethical, legal and operational, and 8 specific issues: the double ethical review of 'externally sponsored' trials; the informed consent procedure in minors and in illiterate people; post-trial access to newly-developed products for the trial communities; the role of communities as key research actors; the definition of sponsor; and the guidance for contractual agreements, laboratory quality management systems, and quality assurance of investigational medicinal products...
November 2016: BMJ Global Health
https://www.readbyqxmd.com/read/28537222/the-revision-of-the-ich-good-clinical-practice-guidelines-a-missed-opportunity
#19
Raffaella Ravinetto
The Guideline for Good Clinical Practice (GCP) of the International Conference of Harmonisation (ICH) is an international standard for the ethical and scientific quality of the designing, conducting, recording and reporting of trials that involve the participation of human subjects. Today, most regulators and funding agencies follow the ICH guidelines. These were drawn up by a small number of regulatory agencies and drug companies from high-income countries and do not pay sufficient heed to the problematic aspects of clinical trials in the low- and middle-income countries...
May 23, 2017: Indian Journal of Medical Ethics
https://www.readbyqxmd.com/read/28512690/translational-studies-on-a-ready-to-use-intramuscular-injection-of-penethamate-for-bovine-mastitis
#20
I G Tucker, R Jain, F Alawi, K Nanjan, O Bork
Bovine mastitis caused by bacterial infections of the mammary gland (udder) of dairy cows is a costly pathology for the dairy industry due to direct and indirect losses in production. Penethamate, a pro-drug of benzylpenicillin, is used by intramuscular injection (IM). The existing products are powders which must be reconstituted in water-for-injection and this presents difficulties in the field. Penethamate is too unstable to be formulated as an aqueous formulation but a chemically stable suspension formulation was possible in certain oils; however, some literature suggests that such formulations would have unacceptable prolonged release...
May 16, 2017: Drug Delivery and Translational Research
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