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https://www.readbyqxmd.com/read/29346833/phase-1b-trial-of-ficlatuzumab-a-humanized-hepatocyte-growth-factor-inhibitory-monoclonal-antibody-in-combination-with-gefitinib-in-asian-patients-with-nsclc
#1
Eng-Huat Tan, Wan-Teck Lim, Myung-Ju Ahn, Quan-Sing Ng, Jin Seok Ahn, Daniel Shao-Weng Tan, Jong-Mu Sun, May Han, Francis C Payumo, Krista McKee, Wei Yin, Marc Credi, Shefali Agarwal, Jaroslaw Jac, Keunchil Park
Hepatocyte growth factor (HGF)/c-Met pathway dysregulation is a mechanism for epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs). Ficlatuzumab (AV-299; SCH 900105), a humanized IgG1 κ HGF inhibitory monoclonal antibody, prevents HGF/c-Met pathway ligand-mediated activation. This phase 1b study assessed the safety/tolerability, pharmacokinetics/pharmacodynamics, and antitumor activity of ficlatuzumab plus gefitinib in Asian patients with previously treated advanced non-small cell lung cancer (NSCLC)...
January 18, 2018: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/29346831/postoperative-reduction-of-intraventricular-hemorrhage-volume-single-versus-dual-catheter-drainage
#2
Syed Shahzad Hussain, Asif Raza, Saman Shahid, Hafiz Hamza Asif, Usman Ahmad, Naveed Ashraf
BACKGROUND/AIMS:  The use of single/dual external ventricular drains (EVD) for reducing intraventricular hemorrhage (IVH) is under investigation. A randomized controlled trial was conducted to compare postoperative reduction of IVH volume using single- and dual-catheter drainage in spontaneous IVH patients. We investigated factors that may influence an effective hematoma volume reduction by EVDs. MATERIALS AND METHODS:  The average cerebrospinal fluid (CSF) drainage volumes were analyzed...
January 18, 2018: Journal of Neurological Surgery. Part A, Central European Neurosurgery
https://www.readbyqxmd.com/read/29346731/direct-polymerization-of-the-arsenic-drug-penao-to-obtain-nanoparticles-with-high-thiol-reactivity-and-anti-cancer-efficiency
#3
Janina-Miriam Noy, Hongxu Lu, Philip Hogg, Jia-Lin Yang, Martina H Stenzel
PENAO (4-(N-(S-penicillaminylacetyl)amino) phenylarsonous acid), which is a mitochondria inhibitor that reacts with adenine nucleotide translocator (ANT), is currently being trialed in patients with solid tumors. To increase the stability of the drug, the formation of nanoparticles has been proposed. Herein, the direct synthesis of polymeric micelles based on the anti-cancer drug PENAO is presented. PENAO is readily available for amidation reaction to form PENAO MA (4-(N-(S-penicillaminylacetyl) amino) phenylarsonous acid methacrylamide) which undergoes RAFT (reversible addition fragmentation chin transfer) polymerization with poly(polyethylene glycol methyl ether methacrylate) (PEGMA) as comonomer and poly(methylmethacrylate) (pMMA) as chain transfer agent, resulting in p(MMA)-b-p(PEG-co-PENAO) block copolymers with 3-15 wt...
January 18, 2018: Bioconjugate Chemistry
https://www.readbyqxmd.com/read/29346679/risk-stratification-in-takotsubo-syndrome-a-role-of-mitral-annular-plane-systolic-excursion
#4
Ibrahim El-Battrawy, Uzair Ansari, Siegfried Lang, Christian Fastner, Xiaobo Zhou, Martin Borggrefe, Ibrahim Akin
Aims: Takotsubo syndrome (TTS) patients have a higher mortality rate than the general population. Our study was conducted to determine the short- and long-term outcome of TTS patients associated with a significantly compromised mitral annular plane systolic excursion (MAPSE) on hospital admission. Methods and results: Our institutional database constituted a collective of 53 patients diagnosed with TTS between 2003 and 2016. The patients were classified into two groups based on the MAPSE, with those presenting with a MAPSE <1 cm on admission categorized into one group (n = 20, 38%) and those presenting with MAPSE ≥1 cm (n = 33, 62%) categorized into another group...
January 15, 2018: QJM: Monthly Journal of the Association of Physicians
https://www.readbyqxmd.com/read/29346644/genome-wide-analysis-of-disease-progression-in-age-related-macular-degeneration
#5
Qi Yan, Ying Ding, Yi Liu, Tao Sun, Lars G Fritsche, Traci Clemons, Rinki Ratnapriya, Michael L Klein, Richard J Cook, Yu Liu, Ruzong Fan, Lai Wei, Gonçalo R Abecasis, Anand Swaroop, Emily Y Chew, Daniel E Weeks, Wei Chen
Family- and population-based genetic studies have successfully identified multiple disease-susceptibility loci for Age-related Macular Degeneration (AMD), one of the first batch and most successful examples of genome-wide association study (GWAS). However, most genetic studies to date have focused on case-control studies of late AMD (choroidal neovascularization [CNV] or geographic atrophy [GA]). The genetic influences on disease progression are largely unexplored. We assembled unique resources to perform a genome-wide bivariate time-to-event analysis to test for association of time-to-late-AMD with ∼9 million variants on 2,721 Caucasians from a large multi-center randomized clinical trial, the Age-Related Eye Disease Study...
January 15, 2018: Human Molecular Genetics
https://www.readbyqxmd.com/read/29346579/web-based-cognitive-behavior-therapy-for-chronic-pain-patients-with-aberrant-drug-related-behavior-outcomes-from-a-randomized-controlled-trial
#6
Honoria Guarino, Chunki Fong, Lisa A Marsch, Michelle C Acosta, Cassandra Syckes, Sarah K Moore, Ricardo A Cruciani, Russell K Portenoy, Dennis C Turk, Andrew Rosenblum
Objective: There is high unmet need for effective behavioral treatments for chronic pain patients at risk for or with demonstrated histories of opioid misuse. Despite growing evidence supporting technology-based delivery of self-management interventions for chronic pain, very few such programs target co-occurring chronic pain and aberrant drug-related behavior. This randomized controlled trial evaluated the effectiveness of a novel, web-based self-management intervention, grounded in cognitive behavior therapy, for chronic pain patients with aberrant drug-related behavior...
January 13, 2018: Pain Medicine: the Official Journal of the American Academy of Pain Medicine
https://www.readbyqxmd.com/read/29346573/the-addition-of-bevacizumab-to-oxaliplatin-based-chemotherapy-impact-upon-hepatic-sinusoidal-injury-and-thrombocytopenia
#7
Michael J Overman, Renata Ferrarotto, Kanwal Raghav, Binsah George, Wei Qiao, Karime K Machado, Leonard B Saltz, Thibault Mazard, J N Vauthey, Paulo M Hoff, Brian Hobbs, Evelyn M Loyer, Scott Kopetz
Background: Oxaliplatin-based chemotherapy can cause hepatic sinusoidal injury (HSI), portal hypertension, and splenic sequestration of platelets. Evidence suggests that bevacizumab may protect against HSI. Methods: Two cohorts of metastatic colorectal cancer (CRC) were analyzed: a nonrandomized exploratory cohort of 184 patients treated at a single institution from 2003 to 2010 and a confirmatory cohort of 200 patients from a multi-institutional randomized trial (NO16966)...
January 15, 2018: Journal of the National Cancer Institute
https://www.readbyqxmd.com/read/29346524/-effects-of-a-primary-care-based-multifactorial-intervention-on-physical-and-cognitive-function-in-frail-elderly-individuals-a-randomized-controlled-trial
#8
Laura Romera-Liebana, Francesc Orfila, Josep Maria Segura, Jordi Real, Maria Lluïsa Fabra, Mercedes Möller, Santiago Lancho, Anna Ramirez, Nuria Marti, Montserrat Cullell, Nuria Bastida, Dolors Martinez, Maria Giné, Patricia Cendrós, Anna Bistuer, Elena Perez, Maria Assumpta Fabregat, Gonçal Foz
Background: Detecting and managing frailty at early stages can prevent disability and other adverse outcomes. The study aim was to evaluate whether a multifactorial intervention program could modify physical and cognitive frailty parameters in elderly individuals. Methods: We conducted a multicenter, randomized, single-blind, parallel-group trial in community-living pre-frail/frail elderly individuals in Barcelona. A total of 352 patients, aged ≥65 years old with positive frailty screening, was randomized into two groups to receive a 12-week multidisciplinary intervention or usual care, with concealed allocation...
January 16, 2018: Journals of Gerontology. Series A, Biological Sciences and Medical Sciences
https://www.readbyqxmd.com/read/29346519/final-results-of-a-multi-institutional-phase-ii-trial-of-re-irradiation-with-concurrent-weekly-cisplatin-and-cetuximab-for-recurrent-or-second-primary-squamous-cell-carcinoma-of-the-head-and-neck
#9
M J Awan, L Nedzi, D Wang, V Tumati, B Sumer, X-J Xie, I Smith, J Truelson, R Hughes, L L Myers, P Lavertu, S Wong, M Yao
Background: The optimal regimen of chemotherapy and re-irradiation (re-XRT) for recurrent head and neck squamous cell carcinoma (HNSCC) is controversial. We report the final outcomes of a multi-center Phase II trial evaluating cetuximab and cisplatin-based chemotherapy concurrent with re-XRT for patients with recurrent HNSCC. Methods and Materials: Patients with unresectable recurrent disease or positive margins after salvage surgery arising within a previously irradiated field with KPS≥70 were eligible for this trial...
January 15, 2018: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/29346507/activity-and-safety-of-afatinib-in-a-window-pre-operative-eortc-study-in-patients-with-squamous-cell-carcinoma-of-the-head-and-neck-scchn
#10
J P Machiels, P Bossi, J Menis, M Lia, C Fortpied, Y Liu, R Lhommel, M Lemort, S Schmitz, S Canevari, L De Cecco, M Guzzo, R Bianchi, P Quattrone, F Crippa, T Duprez, Y Lalami, M Quiriny, N de Saint Aubain, P M Clement, R Coropciuc, E Hauben, L F Licitra
Background: To investigate the activity and safety of afatinib in the pre-operative treatment of squamous cell carcinoma of the head and neck (SCCHN). Patients and methods: This study was an open-label, randomized, multicenter, phase II window of opportunity trial. Treatment-naïve SCCHN patients selected for primary curative surgery were randomized (5:1 ratio) to receive afatinib during 14 days (day -15 until day -1) before surgery (day 0) or no treatment. Tumor biopsies, 2-[fluorine-18]-fluoro-2-deoxy-D-glucose positron emission tomography (FDG-PET), and magnetic resonance imaging (MRI) were performed at diagnosis and just before surgery...
January 15, 2018: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/29346499/repeatability-and-agreement-of-visual-acuity-using-the-etdrs-number-chart-landolt-c-chart-or-etdrs-alphabet-chart-in-eyes-with-or-without-sight-threatening-diseases
#11
Voraporn Chaikitmongkol, Onnisa Nanegrungsunk, Direk Patikulsila, Paisan Ruamviboonsuk, Neil M Bressler
Importance: The Early Treatment Diabetic Retinopathy Study (ETDRS) alphabet chart is not feasible for measuring best-corrected visual acuity (BCVA) for individuals who are unfamiliar with the Roman alphabet. The ETDRS Landolt C chart is an alternative, but it may not reflect true BCVA among those with confusion between left and right. The ETDRS number chart might overcome these limitations, but little is known regarding its reliability. Objective: To evaluate repeatability and agreement of BCVA using the ETDRS number chart or Landolt C chart compared with ETDRS alphabet charts in healthy and diseased eyes...
January 18, 2018: JAMA Ophthalmology
https://www.readbyqxmd.com/read/29346478/differentiation-syndrome-associated-with-enasidenib-a-selective-inhibitor-of-mutant-isocitrate-dehydrogenase-2-analysis-of-a-phase-1-2-study
#12
Amir T Fathi, Courtney D DiNardo, Irina Kline, Laurie Kenvin, Ira Gupta, Eyal C Attar, Eytan M Stein, Stephane de Botton
Importance: Enasidenib mesylate, a mutant isocitrate dehydrogenase 2 (IDH2) protein inhibitor that promotes differentiation of leukemic myeloblasts, was recently approved by the US Food and Drug Administration for use in relapsed/refractory (R/R) mutant IDH2 acute myeloid leukemia (AML). During the first study of enasidenib in humans, a minority of patients with advanced myeloid neoplasms experienced unexpected signs/symptoms of a differentiation syndrome (DS), a potentially lethal entity...
January 18, 2018: JAMA Oncology
https://www.readbyqxmd.com/read/29346473/treatment-for-alcohol-dependence-in-primary-care-compared-to-outpatient-specialist-treatment-a-randomized-controlled-trial
#13
Sara Wallhed Finn, Anders Hammarberg, Sven Andreasson
Aim: To investigate if treatment for alcohol dependence in primary care is as effective as specialist addiction care. Method: Randomized controlled non-inferiority trial, between groups parallel design, not blinded. The non-inferiority limit was set to 50 grams of alcohol per week. About 288 adults fulfilling ICD-10 criteria for alcohol dependence were randomized to treatment in primary care (men n = 82, women n = 62) or specialist care (men n = 77, women n = 67)...
January 16, 2018: Alcohol and Alcoholism: International Journal of the Medical Council on Alcoholism
https://www.readbyqxmd.com/read/29346438/colonization-of-the-cervicovaginal-space-with-gardnerella-vaginalis-leads-to-local-inflammation-and-cervical-remodeling-in-pregnant-mice
#14
Luz-Jeannette Sierra, Amy G Brown, Guillermo O Barilá, Lauren Anton, Carrie E Barnum, Snehal S Shetye, Louis J Soslowsky, Michal A Elovitz
The role of the cervicovaginal (CV) microbiome in regulating cervical function during pregnancy is poorly understood. Gardnerella vaginalis (G. vaginalis) is the most common bacteria associated with the diagnosis of bacterial vaginosis (BV). While BV has been associated with preterm birth (PTB), clinical trials targeting BV do not decrease PTB rates. It remains unknown if G. vaginalis is capable of triggering molecular, biomechanical and cellular events that could lead to PTB. The objective of this study was to determine if cervicovaginal colonization with G...
2018: PloS One
https://www.readbyqxmd.com/read/29346409/prediction-of-absolute-risk-of-acute-graft-versus-host-disease-following-hematopoietic-cell-transplantation
#15
Catherine Lee, Sebastien Haneuse, Hai-Lin Wang, Sherri Rose, Stephen R Spellman, Michael Verneris, Katharine C Hsu, Katharina Fleischhauer, Stephanie J Lee, Reza Abdi
Allogeneic hematopoietic cell transplantation (HCT) is the treatment of choice for a variety of hematologic malignancies and disorders. Unfortunately, acute graft-versus-host disease (GVHD) is a frequent complication of HCT. While substantial research has identified clinical, genetic and proteomic risk factors for acute GVHD, few studies have sought to develop risk prediction tools that quantify absolute risk. Such tools would be useful for: optimizing donor selection; guiding GVHD prophylaxis, post-transplant treatment and monitoring strategies; and, recruitment of patients into clinical trials...
2018: PloS One
https://www.readbyqxmd.com/read/29346407/relaxin-reverses-inflammatory-and-immune-signals-in-aged-hearts
#16
Brian Martin, Beth Ann Gabris-Weber, Rajiv Reddy, Guillermo Romero, Ansuman Chattopadhyay, Guy Salama
BACKGROUND: 'Healthy' aging drives structural and functional changes in the heart including maladaptive electrical remodeling, fibrosis and inflammation, which lower the threshold for cardiovascular diseases such as heart failure (HF) and atrial fibrillation (AF). Despite mixed results in recent clinical trials, Relaxin-therapy for 2-days could reduce mortality by 37% at 180-days post-treatment, in patients with acute decompensated HF. Relaxin's short life-span (hours) but long-lasting protective actions led us to test the hypothesis that relaxin acts at a genomic level to reverse maladaptive remodeling in aging and HF...
2018: PloS One
https://www.readbyqxmd.com/read/29346385/combined-effectiveness-of-anthelmintic-chemotherapy-and-wash-among-hiv-infected-adults
#17
Arianna R Means, Lisette van Lieshout, Eric Brienen, Krista Yuhas, James P Hughes, Paul Ndungu, Benson Singa, Judd L Walson
INTRODUCTION: Current global helminth control guidelines focus on regular deworming of targeted populations for morbidity control. However, water, sanitation, and hygiene (WASH) interventions may also be important for reducing helminth transmission. We evaluated the impact of different potential helminth protective packages on infection prevalence, including repeated treatment with albendazole and praziquantel with and without WASH access. METHODOLOGY/PRINCIPAL FINDINGS: We conducted a cohort study nested within a randomized trial of empiric deworming of HIV-infected adults in Kenya...
January 2018: PLoS Neglected Tropical Diseases
https://www.readbyqxmd.com/read/29346378/evaluating-the-impact-of-a-virtual-clinic-on-patient-experience-personal-and-provider-costs-of-care-in-urinary-incontinence-a-randomised-controlled-trial
#18
Georgina Jones, Victoria Brennan, Richard Jacques, Hilary Wood, Simon Dixon, Stephen Radley
OBJECTIVE: To evaluate the impact of using a 'virtual clinic' on patient experience and cost in the care of women with urinary incontinence. MATERIALS AND METHODS: Women, aged > 18 years referred to a urogynaecology unit were randomised to either (1) A Standard Clinic or (2) A Virtual Clinic. Both groups completed a validated, web-based interactive, patient-reported outome measure (ePAQ-Pelvic Floor), in advance of their appointment followed by either a telephone consultation (Virtual Clinic) or face-to-face consultation (Standard Care)...
2018: PloS One
https://www.readbyqxmd.com/read/29346377/assessing-the-feasibility-of-interrupting-the-transmission-of-soil-transmitted-helminths-through-mass-drug-administration-the-deworm3-cluster-randomized-trial-protocol
#19
Kristjana Hrönn Ásbjörnsdóttir, Sitara S Rao Ajjampur, Roy M Anderson, Robin Bailey, Iain Gardiner, Katherine E Halliday, Moudachirou Ibikounle, Khumbo Kalua, Gagandeep Kang, D Timothy J Littlewood, Adrian J F Luty, Arianna Rubin Means, William Oswald, Rachel L Pullan, Rajiv Sarkar, Fabian Schär, Adam Szpiro, James E Truscott, Marleen Werkman, Elodie Yard, Judd L Walson
ClinicalTrials.gov NCT03014167.
January 2018: PLoS Neglected Tropical Diseases
https://www.readbyqxmd.com/read/29346376/evaluating-the-sustainability-scalability-and-replicability-of-an-sth-transmission-interruption-intervention-the-deworm3-implementation-science-protocol
#20
Arianna Rubin Means, Sitara S R Ajjampur, Robin Bailey, Katya Galactionova, Marie-Claire Gwayi-Chore, Katherine Halliday, Moudachirou Ibikounle, Sanjay Juvekar, Khumbo Kalua, Gagandeep Kang, Pallavi Lele, Adrian J F Luty, Rachel Pullan, Rajiv Sarkar, Fabian Schär, Fabrizio Tediosi, Bryan J Weiner, Elodie Yard, Judd Walson
Hybrid trials that include both clinical and implementation science outcomes are increasingly relevant for public health researchers that aim to rapidly translate study findings into evidence-based practice. The DeWorm3 Project is a series of hybrid trials testing the feasibility of interrupting the transmission of soil transmitted helminths (STH), while conducting implementation science research that contextualizes clinical research findings and provides guidance on opportunities to optimize delivery of STH interventions...
January 2018: PLoS Neglected Tropical Diseases
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