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https://www.readbyqxmd.com/read/29145010/the-use-of-hardened-bone-cement-as-an-impaction-grafting-extender-for-revision-hip-arthroplasty
#1
Mark Ruddy, David P FitzPatrick, Kenneth T Stanton
Impaction bone grafting is a method of restoring bone stock to patients who have suffered significant bone loss due to revision total hip surgery. The procedure requires morsellised cancellous bone (MCB) to be impacted into the site of bone loss in order to stabilise the prosthesis with the aim of long term resorption and reintegration of the impacted bone graft. Due to financial cost and the potential to transmit disease, the use of supplementary material, known as an extender, is frequently used to increase the graft material volume...
November 13, 2017: Journal of the Mechanical Behavior of Biomedical Materials
https://www.readbyqxmd.com/read/29114213/visually-evoked-visual-auditory-changes-associated-with-auditory-performance-in-children-with-cochlear-implants
#2
Maojin Liang, Junpeng Zhang, Jiahao Liu, Yuebo Chen, Yuexin Cai, Xianjun Wang, Junbo Wang, Xueyuan Zhang, Suijun Chen, Xianghui Li, Ling Chen, Yiqing Zheng
Activation of the auditory cortex by visual stimuli has been reported in deaf children. In cochlear implant (CI) patients, a residual, more intense cortical activation in the frontotemporal areas in response to photo stimuli was found to be positively associated with poor auditory performance. Our study aimed to investigate the mechanism by which visual processing in CI users activates the auditory-associated cortex during the period after cochlear implantation as well as its relation to CI outcomes. Twenty prelingually deaf children with CI were recruited...
2017: Frontiers in Human Neuroscience
https://www.readbyqxmd.com/read/29113380/adjuvant-chemotherapy-for-muscle-invasive-bladder-cancer-a-systematic-review-and-network-meta-analysis-of-randomized-clinical-trials
#3
Hyung Suk Kim, Chang Wook Jeong, Cheol Kwak, Hyeon Hoe Kim, Ja Hyeon Ku
Although adjuvant chemotherapy (ACH) is widely used in clinical practice for the management of muscle-invasive bladder cancer (MIBC), a consensus has yet to be established on which ACH regimen is the most effective for improving postoperative survival. In this study, we aimed to systematically assess the optimal ACH regimen for improving survival outcomes in patients treated with radical cystectomy (RC) for MIBC. A comprehensive literature search was conducted in the PubMed, Embase, and the Cochrane Library databases for all articles published until December 2016 in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines...
October 6, 2017: Oncotarget
https://www.readbyqxmd.com/read/29109932/international-council-for-harmonisation-e6-r2-addendum-challenges-of-implementation
#4
Arun Bhatt
The International Council for Harmonisation (ICH) E6 - good clinical practice (GCP) (R2) addendum - was released in 2016 to encourage implementation of improved approaches for the management of clinical trials. The changes in different sections include new approaches - quality management system, risk-based monitoring with emphasis on human subject protection, and data integrity. The article discusses challenges in adoption and implementation of the changes in ICH GCP guideline for clinical trial stakeholders...
October 2017: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/29075711/an-inverted-supramolecular-amphiphile-and-its-step-wise-self-assembly-into-vesicular-networks
#5
Krishnananda Samanta, Elio Zellermann, Manfred Zähres, Christian Mayer, Carsten Schmuck
A host-guest interaction between a multi-cationic dendrimer 1 functionalized with 16 guanidiniocarbonyl pyrrole (GCP) groups on its surface and naphthalene diimide dicarboxylic acid (NDIDC) in a 1 : 8 ratio leads to the formation of a new type of inverted amphiphile. This amphiphile further self-assembles in a step-wise manner first into reverse micelles and then into reverse vesicles, which adhere to form an extensive 3D network several micrometers in length. Self-assembly is based on the aromatic stacking interactions of the surface-bound NDIDC...
November 15, 2017: Soft Matter
https://www.readbyqxmd.com/read/29023524/polymorphism-il-1rn-rs419598-reduces-the-susceptibility-to-generalized-periodontitis-in-a-population-of-european-descent
#6
Francisco Mesa, Esperanza Lanza, Llenalia García, Rafael Marfil-Alvarez, Antonio Magan-Fernandez
Interleukin (IL) 1-ra is a potent endogenous competitive inhibitor of IL-α and β and has an anti-inflammatory role. Study objectives were: 1) to assess the associations of IL-1RN genetic single nucleotide polymorphism (SNP) (rs419598) with generalized chronic periodontitis (GCP), generalized aggressive periodontitis (GAgP), and absence of periodontitis and 2) to assess its association with the load of five periodontopathogenic bacteria and periodontal clinical variables. A cross-sectional analytic study was conducted in 123 patients with GCP, 60 patients with GAgP, and 20 controls...
2017: PloS One
https://www.readbyqxmd.com/read/29018526/design-of-the-pf-ild-trial-a-double-blind-randomised-placebo-controlled-phase-iii-trial-of-nintedanib-in-patients-with-progressive-fibrosing-interstitial-lung-disease
#7
Kevin R Flaherty, Kevin K Brown, Athol U Wells, Emmanuelle Clerisme-Beaty, Harold R Collard, Vincent Cottin, Anand Devaraj, Yoshikazu Inoue, Florence Le Maulf, Luca Richeldi, Hendrik Schmidt, Simon Walsh, William Mezzanotte, Rozsa Schlenker-Herceg
600 patients aged ≥18 years will be randomised in a 1:1 ratio to nintedanib or placebo. Patients with diagnosis of IPF will be excluded. The study population will be enriched with two-thirds having a usual interstitial pneumonia-like pattern on HRCT. The primary endpoint is the annual rate of decline in forced vital capacity over 52 weeks. The main secondary endpoints are the absolute change from baseline in King's Brief Interstitial Lung Disease Questionnaire total score, time to first acute interstitial lung disease exacerbation or death and time to all-cause mortality over 52 weeks...
2017: BMJ Open Respiratory Research
https://www.readbyqxmd.com/read/28974424/lkb1-regulates-granule-cell-migration-and-cortical-folding-of-the-cerebellar-cortex
#8
Kaitlyn E Ryan, Patrick S Kim, Jonathan T Fleming, Emily Brignola, Frances Y Cheng, Ying Litingtung, Chin Chiang
Cerebellar growth and foliation require the Hedgehog-driven proliferation of granule cell precursors (GCPs) in the external granule layer (EGL). However, that increased or extended GCP proliferation generally does not elicit ectopic folds suggests that additional determinants control cortical expansion and foliation during cerebellar development. Here, we find that genetic loss of the serine-threonine kinase Liver Kinase B1 (Lkb1) in GCPs increased cerebellar cortical size and foliation independent of changes in proliferation or Hedgehog signaling...
December 1, 2017: Developmental Biology
https://www.readbyqxmd.com/read/28967979/peptide-based-probes-with-an-artificial-anion-binding-motif-for-direct-fluorescence-switch-on-detection-of-nucleic-acid-in-cells
#9
Debabrata Maity, Marija Matković, Shang Li, Martin Ehlers, Junchen Wu, Ivo Piantanida, Carsten Schmuck
This work reports two new peptide-based fluorescence probes (1 and 2) for the detection of ds-DNA at physiological pH. Probes 1 and 2 contain a fluorophore, either amino-naphthalimide or diethyl-aminocoumarin, respectively, and two identical peptide arms each equipped with a guanidiniocarbonylpyrrole (GCP) anion-binding motif. These probes show "switch-on" fluorescence response upon binding to ds-DNA, whereby they can differentiate between various types of polynucleotides. For instance, they exhibit more pronounced fluorescence response for AT-rich polynucleotides than GC-rich polynucleotides, and both give only negligible response to ds-RNA...
October 2, 2017: Chemistry: a European Journal
https://www.readbyqxmd.com/read/28965106/safety-and-efficacy-of-aneurysm-treatment-with-web-in-the-cumulative-population-of-three-prospective-multicenter-series
#10
Laurent Pierot, Jacques Moret, Xavier Barreau, Istvan Szikora, Denis Herbreteau, Francis Turjman, Markus Holtmannspötter, Anne-Christine Januel, Vincent Costalat, Jens Fiehler, Joachim Klisch, Jean-Yves Gauvrit, Werner Weber, Hubert Desal, Stéphane Velasco, Thomas Liebig, Luc Stockx, Joachim Berkefeld, Andrew Molyneux, James Byrne, Laurent Spelle
BACKGROUND: Flow disruption with the WEB is an innovative endovascular approach for treatment of wide-neck bifurcation aneurysms. Initial studies have shown a low complication rate with good efficacy. PURPOSE: To report clinical and anatomical results of the WEB treatment in the cumulative population of three Good Clinical Practice (GCP) studies: WEBCAST (WEB Clinical Assessment of Intrasaccular Aneurysm), French Observatory, and WEBCAST-2. METHODS: WEBCAST, French Observatory, and WEBCAST-2 are single-arm, prospective, multicenter, GCP studies dedicated to the evaluation of WEB treatment...
September 30, 2017: Journal of Neurointerventional Surgery
https://www.readbyqxmd.com/read/28948401/d-a-3d-t-3-and-d-g-3d-c-3-b-dna-mini-helixes-the-dft-m06-2x-and-dft-b97-d3-comparison-of-geometrical-and-energetic-characteristics
#11
Leonid Gorb, Tatiana A Zubatiuk, Roman Zubatyuk, Dmytro Hovorun, Jerzy Leszczynski
We report the comprehensive DFT based comparison of geometrical and energetic parameters of the d(A)3·d(T)3 and d(G)3·d(C)3 nucleic acid mini-helixes performed at B97-D3 and M06-2× levels of theory. We studied the ability of mini-helixes to retain the conformation of B-DNA in the gas phase and under the influence of water bulk, uncompensated charges, and counter-ions. The def2-SV(P) and 6-31G(d,p) basis sets have been used for B97-D3 and M06-2× calculations, correspondently. To estimate basis set superposition error, the recently developed semi-empirical procedure that calls geometrical counterpoise type correction for inter- and intra-molecular basis set superposition error (gcp) has been used in the case of def2-SV(P) basis set...
September 26, 2017: Journal of Molecular Modeling
https://www.readbyqxmd.com/read/28943560/serum-biomarkers-for-the-diagnosis-of-eosinophilic-esophagitis-and-eosinophilic-gastroenteritis
#12
Shunji Ishihara, Tetsuo Shoda, Norihisa Ishimura, Shoichiro Ohta, Junya Ono, Yoshinori Azuma, Eiko Okimoto, Kenji Izuhara, Ichiro Nomura, Kenji Matsumoto, Yoshikazu Kinoshita
Objective Clinically useful serum biomarkers for the diagnosis and monitoring of eosinophilic gastrointestinal diseases are not available. This study was conducted to examine the possible value of eosinophil-related proteins as serum biomarkers. Methods The serum concentrations of 49 cytokines, chemokines, and other proteins were measured in 29 patients with eosinophilic gastrointestinal diseases and 80 controls. Results The levels of interleukin (IL)-5, IL-33, eotaxin-3, and thymic stromal lymphopoietin (TSLP), previously reported as possible biomarkers of eosinophilic esophagitis, were not significantly elevated in the serum...
November 1, 2017: Internal Medicine
https://www.readbyqxmd.com/read/28914486/a-systematic-structure-activity-study-of-a-new-type-of-small-peptidic-transfection-vector-reveals-the-importance-of-a-special-oxo-anion-binding-motif-for-gene-delivery
#13
Sandra Junghänel, Sarah Karczewski, Sandra Bäcker, Shirley K Knauer, Carsten Schmuck
We discovered a new class of artificial peptidic transfection vectors based on an artificial anion-binding motif, the guanidiniocarbonylpyrrole (GCP) cation. This new type of vector is surprisingly smaller than traditional systems, and our previous work suggested that the GCP group was important for promoting critical endosomal escape. We now present here a systematic comparison of similar DNA ligands featuring our GCP oxo-anion-binding motif with DNA ligands only consisting of naturally occurring amino acids...
September 15, 2017: Chembiochem: a European Journal of Chemical Biology
https://www.readbyqxmd.com/read/28893317/perceived-barriers-and-facilitators-to-risk-based-monitoring-in-academic-led-clinical-trials-a-mixed-methods-study
#14
Caroline Hurley, Carol Sinnott, Mike Clarke, Patricia Kearney, Emmy Racine, Joseph Eustace, Frances Shiely
BACKGROUND: In November 2016, the ICH published a requirement for sponsors to develop a systematic, prioritised, risk-based approach to monitoring clinical trials. This approach is more commonly known as risk-based monitoring (RBM). However, recent evidence suggests that a 'gold standard', validated approach to RBM does not exist and it is unclear how sponsors will introduce RBM into their organisations. A first step needed to inform the implementation of RBM is to explore academic trialists' readiness and ability to perform RBM...
September 11, 2017: Trials
https://www.readbyqxmd.com/read/28870379/esource-for-clinical-trials-implementation-and-evaluation-of-a-standards-based-approach-in-a-real-world-trial
#15
Jean-Francois Ethier, Vasa Curcin, Mark M McGilchrist, Sarah N Lim Choi Keung, Lei Zhao, Anna Andreasson, Piotr Bródka, Radoslaw Michalski, Theodoros N Arvanitis, Nikolaos Mastellos, Anita Burgun, Brendan C Delaney
OBJECTIVE: The Learning Health System (LHS) requires integration of research into routine practice. 'eSource' or embedding clinical trial functionalities into routine electronic health record (EHR) systems has long been put forward as a solution to the rising costs of research. We aimed to create and validate an eSource solution that would be readily extensible as part of a LHS. MATERIALS AND METHODS: The EU FP7 TRANSFoRm project's approach is based on dual modelling, using the Clinical Research Information Model (CRIM) and the Clinical Data Integration Model of meaning (CDIM) to bridge the gap between clinical and research data structures, using the CDISC Operational Data Model (ODM) standard...
October 2017: International Journal of Medical Informatics
https://www.readbyqxmd.com/read/28829191/the-cd14-rs2569190-tt-genotype-is-associated-with-chronic-periodontitis
#16
Dilshi Ishaan, Harinath Parthasarathy, Deepa Ponnaiyan, Anupama Tadepalli
AIM: The genetic variation in the CD14 rs2569190 promoter region contributes to the susceptibility of developing periodontitis. Since, CD14 gene polymorphism studies among various ethnic populations have produced conflicting results, the present study was designed to unearth the association between the CD14 rs2569190 gene polymorphism and generalized chronic periodontitis (GCP) in a South Indian population of Tamil ethnicity. METHODS: Polymorphisms in the CD14 rs2569190 promoter region were analyzed in 96 subjects who were periodontally healthy and 96 patients with GCP...
September 2017: Genetic Testing and Molecular Biomarkers
https://www.readbyqxmd.com/read/28828310/role-of-accreditation-in-quality-improvement-of-institutional-review-board
#17
Abhidnya Vasant Desai, Rohini W Hawaldar, Jigeeshu V Divatia
AIM: The aim of this study was to evaluate the process of accreditation resulting in improvement of the Institutional Review Board (IRB) functioning. METHODOLOGY: Randomly selected projects from years 2007 (before accreditation), 2010 (after accreditation), and 2013 (after reaccreditation) were evaluated to assess parameters, namely, submission of good clinical practices (GCPs), completeness of IRB submission form, fulfillment of quorum, documentation of the declaration of conflict of interests, and submission of the status reports...
July 2017: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/28739539/medication-reviews-bridging-healthcare-medbridge-study-protocol-for-a-pragmatic-cluster-randomised-crossover-trial
#18
Thomas G H Kempen, Maria Bertilsson, Karl-Johan Lindner, Johanna Sulku, Elisabet I Nielsen, Angelica Högberg, Tomas Vikerfors, Håkan Melhus, Ulrika Gillespie
BACKGROUND: Mismanaged prescribing and use of medication among elderly puts major pressure on current healthcare systems. Performing a medication review, a structured critical examination of a patient's medications, during hospital stay with active follow-up into primary care could optimise treatment benefit and minimise harm. However, a lack of high quality evidence inhibits widespread implementation. This manuscript describes the rationale and design of a pragmatic cluster-randomised, crossover trial to fulfil this need for evidence...
July 21, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28736344/tfos-dews-ii-clinical-trial-design-report
#19
REVIEW
Gary D Novack, Penny Asbell, Stefano Barabino, Michael V W Bergamini, Joseph B Ciolino, Gary N Foulks, Michael Goldstein, Michael A Lemp, Stefan Schrader, Craig Woods, Fiona Stapleton
The development of novel therapies for Dry Eye Disease (DED) is formidable, and relatively few treatments evaluated have been approved for marketing. In this report, the Subcommittee reviewed challenges in designing and conducting quality trials, with special reference to issues in trials in patients with DED and present the regulatory perspective on DED therapies. The Subcommittee reviewed the literature and while there are some observations about the possible reasons why so many trials have failed, there is no obvious single reason other than the lack of correlation between signs and symptoms in DED...
July 2017: Ocular Surface
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
#20
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...
September 2017: Health Policy
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