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First-in-human clinical studies

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https://www.readbyqxmd.com/read/28212138/deep-learning-in-mammography-diagnostic-accuracy-of-a-multipurpose-image-analysis-software-in-the-detection-of-breast-cancer
#1
Anton S Becker, Magda Marcon, Soleen Ghafoor, Moritz C Wurnig, Thomas Frauenfelder, Andreas Boss
OBJECTIVES: The aim of this study was to evaluate the diagnostic accuracy of a multipurpose image analysis software based on deep learning with artificial neural networks for the detection of breast cancer in an independent, dual-center mammography data set. MATERIALS AND METHODS: In this retrospective, Health Insurance Portability and Accountability Act-compliant study, all patients undergoing mammography in 2012 at our institution were reviewed (n = 3228). All of their prior and follow-up mammographies from a time span of 7 years (2008-2015) were considered as a reference for clinical diagnosis...
February 16, 2017: Investigative Radiology
https://www.readbyqxmd.com/read/28211512/physiology-and-role-of-irisin-in-glucose-homeostasis
#2
REVIEW
Nikolaos Perakakis, Georgios A Triantafyllou, José Manuel Fernández-Real, Joo Young Huh, Kyung Hee Park, Jochen Seufert, Christos S Mantzoros
Irisin is a myokine that leads to increased energy expenditure by stimulating the 'browning' of white adipose tissue. In the first description of this hormone, increased levels of circulating irisin, which is cleaved from its precursor fibronectin type III domain-containing protein 5, were associated with improved glucose homeostasis by reducing insulin resistance. Consequently, several studies attempted to characterize the role of irisin in glucose regulation, but contradictory results have been reported, and even the existence of this hormone has been questioned...
February 17, 2017: Nature Reviews. Endocrinology
https://www.readbyqxmd.com/read/28211169/a-first-in-human-study-of-ds-1040-an-inhibitor-of-the-activated-form-of-thrombin-activatable-fibrinolysis-inhibitor-in-healthy-subjects
#3
Jin Zhou, Jarema Kochan, Ophelia Yin, Vance Warren, Cynthia Zamora, George Atiee, Joseph Pav, Yasushi Orihashi, Vijay Vashi, Victor Dishy
BACKGROUND: Current treatments for acute ischemic stroke and venous thromboembolism, such as recombinant tissue plasminogen activator and thrombectomy, are limited by a narrow time window and the risk of bleeding. DS-1040 is a novel low-molecular weight compound inhibiting the activated form of thrombin-activatable fibrinolysis inhibitor (TAFIa), developed as a fibrinolysis enhancer for treatment of thromboembolic diseases. OBJECTIVES: This first-in-human, randomized, placebo-controlled, three-part, phase 1 study was conducted to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of DS-1040 in healthy subjects...
February 17, 2017: Journal of Thrombosis and Haemostasis: JTH
https://www.readbyqxmd.com/read/28210899/interleukin-6-as-possible-early-marker-of-stress-response-after-femoral-fracture
#4
Goran Pesic, Jovana Jeremic, Tamara Nikolic, Vladimir Zivkovic, Ivan Srejovic, Aleksandra Vranic, Jovana Bradic, Branko Ristic, Aleksandar Matic, Nikola Prodanovic, Vladimir Jakovljevic
Bone fracture healing is a complex process which at best results in full recovery of function and structure of injured bone tissue, but all the mechanisms involved in this process, and their mutual interaction, are not fully understood. Despite advancement of surgical procedures, this type of fractures is still a major public health concern. In the last few decades, a lot of attention is focused on the oxygen-free radicals and inflammatory response markers as important factors of skeletal injury. Thus, the aim of the present study was to follow the changes in redox balance and inflammatory response in elderly patients with femoral fractures during the earliest stages of fracture healing, by measuring the values of the observed markers immediately after fracture, as well as the first, third, and seventh postoperative day...
February 16, 2017: Molecular and Cellular Biochemistry
https://www.readbyqxmd.com/read/28210626/osteogenic-differentiation-capacity-of-in-vitro-cultured-human-skeletal-muscle-for-expedited-bone-tissue-engineering
#5
Chunlei Miao, Lulu Zhou, Lufeng Tian, Yingjie Zhang, Wei Zhang, Fanghong Yang, Tianyi Liu, Shengjian Tang, Fangjun Liu
Expedited bone tissue engineering employs the biological stimuli to harness the intrinsic regenerative potential of skeletal muscle to trigger the reparative process in situ to improve or replace biological functions. When genetically modified with adenovirus mediated BMP2 gene transfer, muscle biopsies from animals have demonstrated success in regenerating bone within rat bony defects. However, it is uncertain whether the human adult skeletal muscle displays an osteogenic potential in vitro when a suitable biological trigger is applied...
2017: BioMed Research International
https://www.readbyqxmd.com/read/28210247/genome-insight-and-comparative-pathogenomic-analysis-of-nesterenkonia-jeotgali-strain-cd08_7-isolated-from-duodenal-mucosa-of-celiac-disease-patient
#6
Atul M Chander, Ramesan G Nair, Gurwinder Kaur, Rakesh Kochhar, Devinder K Dhawan, Sanjay K Bhadada, Shanmugam Mayilraj
Species of the genus Nesterenkonia have been isolated from different ecological niches, especially from saline habitats and reported as weak human pathogens causing asymptomatic bacteraemia. Here, for the first time we are reporting the genome sequence and pathogenomic analysis of a strain designated as CD08_7 isolated from the duodenal mucosa of a celiac disease patient, identified as Nesterenkonia jeotgali. To date, only five strains of the genus Nesterenkonia (N. massiliensis strain NP1(T), Nesterenkonia sp...
2017: Frontiers in Microbiology
https://www.readbyqxmd.com/read/28210010/evaluation-and-treatment-of-anemia-in-premature-infants
#7
Edo Hasanbegovic, Nermana Cengic, Snijezana Hasanbegovic, Jasmina Heljic, Ismail Lutolli, Edin Begic
INTRODUCTION: Anemia in preterm infants is the pathophysiological process with greater and more rapid decline in hemoglobin compared to the physiological anemia in infants. There is a need for transfusions and administration of human recombinant erythropoietin. AIM: To determine the frequency of anemia in premature infants at the Pediatric Clinic, University Clinical Center Sarajevo, as well as parameter values in the blood count of premature infants and to explore a relationship between blood transfusions with the advent of intraventricular hemorrhage (determine treatment outcome in preterm infants)...
December 2016: Medical Archives
https://www.readbyqxmd.com/read/28209994/reversal-of-the-apoptotic-resistance-of-non-small-cell-lung-carcinoma-towards-trail-by-natural-product-toosendanin
#8
Xin Li, Ming You, Yong-Jian Liu, Lin Ma, Pei-Pei Jin, Ri Zhou, Zhao-Xin Zhang, Baojin Hua, Xiao-Jun Ji, Xiao-Ying Cheng, Fangzhou Yin, Yan Chen, Wu Yin
Tumor necrosis factor-related apoptosis-inducing ligand (TRAIL) selectively triggers cancer cell death via its association with death receptors on the cell membrane, but exerts negligible side effects on normal cells. However, some non-small-cell lung carcinoma (NSCLC) patients exhibited resistance to TRAIL treatment in clinical trials, and the mechanism varies. In this study, we described for the first time that toosendanin (TSN), a triterpenoid derivative used in Chinese medicine for pain management, could significantly sensitize human primary NSCLC cells or NSCLC cell lines to TRAIL-mediated apoptosis both in vitro and in vivo, while showing low toxicity against human primary cells or tissues...
February 17, 2017: Scientific Reports
https://www.readbyqxmd.com/read/28209906/first-evaluation-of-pet-based-human-biodistribution-and-dosimetry-of-18-f-faza-a-tracer-for-imaging-tumor-hypoxia
#9
Savi Annarita, Elena Incerti, Federico Fallanca, Valentino Bettinardi, Francesca Rossetti, Cristina Monterisi, Antonia Compierchio, Giampiero Negri, Piero Zannini, Luigi Gianolli, Maria Picchio
Fluorine-18 labelled fluoroazomycinarabinoside ((18)F-FAZA) is a positron emission tomography (PET) biomarker for non-invasive identification of regional tumor hypoxia. Aim of the present Phase I study was to firstly evaluate in non-small cell lung cancer patients the human biodistribution and dosimetry of (18)F-FAZA. Methods: Five patients awaiting surgical resection after histologically proven or radiologically suspected non-small cell lung cancer were prospectively enrolled for the study. The patients underwent a PET/computed tomography (CT) study after the injection of 371±32 MBq of (18)F-FAZA...
February 16, 2017: Journal of Nuclear Medicine: Official Publication, Society of Nuclear Medicine
https://www.readbyqxmd.com/read/28209559/irreversible-electroporation-for-the-ablation-of-renal-cell-carcinoma-a-prospective-human-in-vivo-study-protocol-ideal-phase-2b
#10
Mara Buijs, Krijn P van Lienden, Peter Gk Wagstaff, Matthijs Jv Scheltema, Daniel M de Bruin, Patricia J Zondervan, Otto M van Delden, Ton G van Leeuwen, Jean Jmch de la Rosette, M Pilar Laguna
BACKGROUND: Irreversible electroporation (IRE) is an emerging technique delivering electrical pulses to ablate tissue, with the theoretical advantage to overcome the main shortcomings of conventional thermal ablation. Recent short-term research showed that IRE for the ablation of renal masses is a safe and feasible treatment option. In an ablate and resect design, histopathological analysis 4 weeks after radical nephrectomy demonstrated that IRE-targeted renal tumors were completely covered by ablation zone...
February 16, 2017: JMIR Research Protocols
https://www.readbyqxmd.com/read/28209170/lincrnafezf1-as1-represses-p21-expression-to-promote-gastric-cancer-proliferation-through-lsd1-mediated-h3k4me2-demethylation
#11
Yan-Wen Liu, Rui Xia, Kai Lu, Min Xie, Fen Yang, Ming Sun, Wei De, Cailian Wang, Guozhong Ji
BACKGROUND: Although the prognosis of gastric cancer patients have a favorable progression, there are some patients with unusual patterns of locoregional and systemic recurrence. Therefore, a better understanding of early molecular events of the disease is needed. Current evidences demonstrate that long noncoding RNAs (lncRNAs) may be an important class of functional regulators involved in human gastric cancers development. Our previous studies suggest that HOTAIR contributes to gastric cancer development, and the overexpression of HOTAIR predicts a poor prognosis...
February 16, 2017: Molecular Cancer
https://www.readbyqxmd.com/read/28209158/gene-regulatory-network-underlying-the-immortalization-of-epithelial-cells
#12
Luis Fernando Méndez-López, Jose Davila-Velderrain, Elisa Domínguez-Hüttinger, Christian Enríquez-Olguín, Juan Carlos Martínez-García, Elena R Alvarez-Buylla
BACKGROUND: Tumorigenic transformation of human epithelial cells in vitro has been described experimentally as the potential result of spontaneous immortalization. This process is characterized by a series of cell-state transitions, in which normal epithelial cells acquire first a senescent state which is later surpassed to attain a mesenchymal stem-like phenotype with a potentially tumorigenic behavior. In this paper we aim to provide a system-level mechanistic explanation to the emergence of these cell types, and to the time-ordered transition patterns that are common to neoplasias of epithelial origin...
February 16, 2017: BMC Systems Biology
https://www.readbyqxmd.com/read/28209134/first-clinical-experience-in-14-patients-treated-with-advos-a-study-on-feasibility-safety-and-efficacy-of-a-new-type-of-albumin-dialysis
#13
Wolfgang Huber, Benedikt Henschel, Roland Schmid, Ahmed Al-Chalabi
BACKGROUND: Liver failure (LF) is associated with prolonged hospital stay, increased cost and substantial mortality. Due to the limited number of donor organs, extracorporeal liver support is suggested as an appealing concept to "bridge to transplant" or to avoid transplant in case of recovery. ADVanced Organ Support (ADVOS) is a new type of albumin dialysis, that provides rapid regeneration of toxin-binding albumin by two purification circuits altering the binding capacities of albumin by biochemical (changing of pH) and physical (changing of temperature) modulation of the dialysate...
February 16, 2017: BMC Gastroenterology
https://www.readbyqxmd.com/read/28203454/mir-328-may-be-considered-as-an-oncogene-in-human-invasive-breast-carcinoma
#14
Alihossein Saberi, Amir Danyaei, Niloofar Neisi, Maryam Dastoorpoor, Mohammad Javad Tahmasbi Birgani
BACKGROUND: The recent investigations have rendered microRNAs (miRs) as a novel biomarker in cancer research. In fact, alteration in miR expression may be associated with tumor suppression, tumorigenesis, metastasis, and poor prognosis in human breast cancer (BC). OBJECTIVES: The aim of this clinical experimental study was to measure the miR-328 expression level in breast cancer tissues, at first. Then, we tried to find out any possible correlation between miR-328 and prognostic and predictive biomarkers in BC...
November 2016: Iranian Red Crescent Medical Journal
https://www.readbyqxmd.com/read/28203289/epidemiological-molecular-characterization-and-antibiotic-resistance-of-salmonella-enterica-serovars-isolated-from-chicken-farms-in-egypt
#15
Hanem El-Sharkawy, Amin Tahoun, Abd El-Galiel A El-Gohary, Moshira El-Abasy, Fares El-Khayat, Trudi Gillespie, Yukio Kitade, Hafez M Hafez, Heinrich Neubauer, Hosny El-Adawy
BACKGROUND: Salmonella is one of major causes of foodborne outbreaks globally. This study was conducted to estimate the prevalence, typing and antibiotic susceptibilities of Salmonella enterica serovars isolated from 41 broiler chicken farms located in Kafr El-Sheikh Province in Northern Egypt during 2014-2015. The clinical signs and mortalities were observed. RESULTS: In total 615 clinical samples were collected from broiler flocks from different organs (liver, intestinal content and gall bladder)...
2017: Gut Pathogens
https://www.readbyqxmd.com/read/28203112/bone-contusion-progression-from-traumatic-knee-injury-association-of-rate-of-contusion-resolution-with-injury-severity
#16
Douglas R Pedersen, Georges Y El-Khoury, Dan R Thedens, Mothana Saad-Eldine, Phinit Phisitkul, Annunziato Amendola
BACKGROUND: Bone contusions are frequently encountered in magnetic resonance imaging (MRI) evaluation of knee anterior cruciate ligament (ACL) injuries. Their role as indicators of injury severity remains unclear, primarily due to indeterminate levels of joint injury forces and to a lack of preinjury imaging. PURPOSE: The purpose of this study was to 1) quantify bone contusion pathogenesis following traumatic joint injuries using fixed imaging follow-ups, and 2) assess the feasibility of using longitudinal bone contusion volumes as an indicator of knee injury severity...
2017: Open Access Journal of Sports Medicine
https://www.readbyqxmd.com/read/28202767/genotype-specific-evolution-of-hepatitis-e-virus
#17
Adam B Brayne, Bethany L Dearlove, James S Lester, Sergei L Kosakovsky Pond, Simon D W Frost
Hepatitis E virus (HEV) is the most common cause of acute viral hepatitis globally. HEV comprises four genotypes with different geographic distributions and host ranges. We utilise this natural case-control study for investigating the evolution of zoonotic viruses compared to single host viruses, using 244 near full length HEV genomes. Genome wide estimates of dN/dS located a region of overlapping reading frames, which is subject to positive selection in genotypes 3 and 4. The open reading frames (ORFs) involved have functions related to host-pathogen interaction, so genotype specific evolution of these regions may reflect their fitness...
February 15, 2017: Journal of Virology
https://www.readbyqxmd.com/read/28196330/decellularized-human-dental-pulp-as-a-scaffold-for-regenerative-endodontics
#18
J S Song, K Takimoto, M Jeon, J Vadakekalam, N B Ruparel, A Diogenes
Teeth undergo postnatal organogenesis relatively late in life and only complete full maturation a few years after the crown first erupts in the oral cavity. At this stage, development can be arrested if the tooth organ is damaged by either trauma or caries. Regenerative endodontic procedures (REPs) are a treatment alternative to conventional root canal treatment for immature teeth. These procedures rely on the transfer of apically positioned stem cells, including stem cells of the apical papilla (SCAP), into the root canal system...
February 1, 2017: Journal of Dental Research
https://www.readbyqxmd.com/read/28196111/epidemiological-assessment-of-the-severity-of-dengue-epidemics-in-french-guiana
#19
Claude Flamand, Camille Fritzell, Christelle Prince, Philippe Abboud, Vanessa Ardillon, Luisiane Carvalho, Magalie Demar, Rachida Boukhari, Martine Papaix-Puech, Narcisse Elenga, Dominique Rousset, Séverine Matheus, Mathieu Nacher, Philippe Quenel, Félix Djossou
BACKGROUND: Dengue fever is the most important arboviral infection that affects humans, particularly in tropical and subtropical regions. Here, we provide the first comprehensive overview of the severity of dengue epidemics in French Guiana. METHODOLOGY/PRINCIPAL FINDINGS: We monitored hospitalized cases between 2008 and 2013. Detailed clinical features and biological parameters were collected on a daily basis from all cases. Among the 1,356 cases, 216 (16%) were classified according to the WHO 2009 classification as dengue without warning signs (WS), 926 (68%) were classified as dengue with WS and 214 (16%) were classified as severe dengue...
2017: PloS One
https://www.readbyqxmd.com/read/28195756/persistence-of-zika-virus-in-body-fluids-preliminary-report
#20
Gabriela Paz-Bailey, Eli S Rosenberg, Kate Doyle, Jorge Munoz-Jordan, Gilberto A Santiago, Liore Klein, Janice Perez-Padilla, Freddy A Medina, Stephen H Waterman, Carlos Garcia Gubern, Luisa I Alvarado, Tyler M Sharp
Background To estimate the frequency and duration of detectable Zika virus (ZIKV) RNA in human body fluids, we prospectively assessed a cohort of newly infected participants in Puerto Rico. Methods We evaluated samples obtained from 150 participants (including 55 men) in whom ZIKV RNA was detected on reverse-transcriptase-polymerase-chain-reaction (RT-PCR) assay in urine or blood in an enhanced arboviral clinical surveillance site. We collected serum, urine, saliva, semen, and vaginal secretions weekly for the first month and then at 2, 4, and 6 months...
February 14, 2017: New England Journal of Medicine
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