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First-in-human clinical studies

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https://www.readbyqxmd.com/read/28531912/from-bench-to-market-preparing-human-pluripotent-stem-cells-derived-cardiomyocytes-for-various-applications
#1
REVIEW
Sung-Hwan Moon, Daekyeong Bae, Taek-Hee Jung, Eun-Bin Chung, Young-Hoon Jeong, Soon-Jung Park, Hyung-Min Chung
Human cardiomyocytes (CMs) cease to proliferate and remain terminally differentiated thereafter, when humans reach the mid-20s. Thus, any damages sustained by myocardium tissue are irreversible, and they require medical interventions to regain functionality. To date, new surgical procedures and drugs have been developed, albeit with limited success, to treat various heart diseases including myocardial infarction. Hence, there is a pressing need to develop more effective treatment methods to address the increasing mortality rate of the heart diseases...
May 30, 2017: International Journal of Stem Cells
https://www.readbyqxmd.com/read/28531827/safety-and-performance-of-the-second-generation-enlightn%C3%A2-renal-denervation-system-in-patients-with-drug-resistant-uncontrolled-hypertension
#2
Stephen G Worthley, Gerard T Wilkins, Mark W Webster, Joseph K Montarello, Sinny Delacroix, Robert J Whitbourn, Roderic J Warren
BACKGROUND AND AIMS: Catheter-based renal denervation for the treatment of drug-resistant hypertension has been intensively investigated in recent years. To date, only limited data have been published using multi-electrode radiofrequency ablation systems that can deliver lesions with a pre-determined pattern. This study was designed to evaluate the safety and performance of the second generation EnligHTN™ Renal Denervation System. METHODS: This first-in-human, prospective, multi-center, non-randomized study included 39 patients (62% male, mean age 63 years, and mean baseline office blood pressure 174/93 mmHg) with drug-resistant hypertension...
May 3, 2017: Atherosclerosis
https://www.readbyqxmd.com/read/28529594/an-active-molecule-from-pulsatilla-chinensis-pulsatilla-saponin-a-induces-apoptosis-and-inhibits-tumor-growth-of-human-colon-cancer-cells-without-or-with-5-fu
#3
Liming Xu, Guilian Cheng, Yi Lu, Shaofeng Wang
Colon cancer is one of the common types of digestive malignancy. The efficacy of the first-line chemotherapy drug for colon cancer, fluorouracil (5-FU), remains limited in clinical settings due to poor efficacy and significant side effects. In the present study, the anticancer activity of an active compound from Pulsatilla chinensis extracts, Pulsatilla saponin A (PsA), was isolated and examined in vitro and in vivo. It was demonstrated that PsA significantly inhibited the growth of human colon cancer HT-29 cells...
May 2017: Oncology Letters
https://www.readbyqxmd.com/read/28528692/insulin-like-growth-factor-igf-axis-in-cancerogenesis
#4
REVIEW
Aldona Kasprzak, Wojciech Kwasniewski, Agnieszka Adamek, Anna Gozdzicka-Jozefiak
Determination of the role of insulin-like growth factor (IGF) family components in carcinogenesis of several human tumors is based on numerous epidemiological and pre-clinical studies, experiments in vivo and in vitro and on attempts at application of drugs affecting the IGF axis. Investigative hypotheses in original studies were based on biological functions manifested by the entire family of IGF (ligands, receptors, linking proteins, adaptor molecules). In the context of carcinogenesis the most important functions of IGF family involve intensification of proliferation and inhibition of cell apoptosis and effect on cell transformation through synthesis of several regulatory proteins...
April 2017: Mutation Research
https://www.readbyqxmd.com/read/28528452/tumor-suppressor-protein-p53-exerts-negative-transcriptional-regulation-on-human-sodium-iodide-symporter-gene-expression-in-breast-cancer
#5
Madhura G Kelkar, Bhushan Thakur, Abhishek Derle, Sushmita Chatterjee, Pritha Ray, Abhijit De
PURPOSE: Aberrant expression of human sodium iodide symporter (NIS) in breast cancer (BC) is well documented but the transcription factors (TF) regulating its aberrant expression is poorly known. We identify the presence of three p53 binding sites on the human NIS promoter sequence by conducting genome-wide TF analysis, and further investigate their regulatory role. METHODS: The differences in transcription and translation were measured by real-time PCR, luciferase reporter assay, site-directed mutagenesis, in vivo optical imaging, and chromatin immunoprecipitation...
May 20, 2017: Breast Cancer Research and Treatment
https://www.readbyqxmd.com/read/28528185/simvastatin-ameliorate-memory-deficits-and-inflammation-in-clinical-and-mouse-model-of-alzheimer-s-disease-via-modulating-the-expression-of-mir-106b
#6
Wenzhong Huang, Zhenyu Li, Liandong Zhao, Wei Zhao
BACKGROUND: Alzheimer's disease (AD) as a neurodegenerative brain disorder is a devastating pathology leading to disastrous cognitive impairments and dementia, and several studies have shown that AD is closely related to the inflammation, so anti-inflammatory treatment may provide therapeutic benefits. In this study, the effect of simvastatin on inflammation was investigated and the underlying mechanisms were explored. METHODS: First, we tested the effect of simvastatin on AD in clinical research...
May 18, 2017: Biomedicine & Pharmacotherapy, Biomédecine & Pharmacothérapie
https://www.readbyqxmd.com/read/28528181/overexpression-of-long-noncoding-rna-h19-indicates-a-poor-prognosis-for-cholangiocarcinoma-and-promotes-cell-migration-and-invasion-by-affecting-epithelial-mesenchymal-transition
#7
Yi Xu, Zhidong Wang, Xingming Jiang, Yunfu Cui
Cholangiocarcinoma (CCA) is a deadly disease that poorly responds to chemotherapy and radiotherapy and whose incidence has increased worldwide. Furthermore, long noncoding RNAs (lncRNAs) play important roles in multiple biological processes, including tumorigenesis. Specifically, H19, the first discovered lncRNA, has been reported to be overexpressed in diverse human carcinomas, but the overall biological role and clinical significance of H19 in CCA remains unknown. In the present study, expression levels of H19 were investigated in CCA tissues and cell lines and were correlated with clinicopathological features...
May 18, 2017: Biomedicine & Pharmacotherapy, Biomédecine & Pharmacothérapie
https://www.readbyqxmd.com/read/28527892/outbreak-of-zika-virus-infection-in-singapore-an-epidemiological-entomological-virological-and-clinical-analysis
#8
(no author information available yet)
BACKGROUND: An outbreak of Zika virus infection was detected in Singapore in August, 2016. We report the first comprehensive analysis of a national response to an outbreak of Zika virus infection in Asia. METHODS: In the first phase of the outbreak, patients with suspected Zika virus infection were isolated in two national referral hospitals until their serum tested negative for the virus. Enhanced vector control and community engagement measures were deployed in disease clusters, including stepped-up mosquito larvicide and adulticide use, community participation in source reduction (destruction of mosquito breeding sites), and work with the local media to promote awareness of the outbreak...
May 17, 2017: Lancet Infectious Diseases
https://www.readbyqxmd.com/read/28527575/coup-tf-genes-human-diseases-and-the-development-of-the-central-nervous-system-in-murine-models
#9
Xiong Yang, Su Feng, Ke Tang
COUP-TFI and -TFII are members of the steroid/thyroid nuclear receptor superfamily. Recent clinical studies reveal that COUP-TFI gene mutations are associated with Bosch-Boonstra-Schaaf optic atrophy syndrome displaying symptoms of optic atrophy, intellectual disability, hypotonia, seizure, autism spectrum disorders, oromotor dysfunction, thin corpus callosum, or hearing defects, and COUP-TFII gene mutations lead to congenital heart defects and/or congenital diaphragmatic hernia with developmental delay and mental defects...
2017: Current Topics in Developmental Biology
https://www.readbyqxmd.com/read/28527054/understanding-migraine-as-a-cycling-brain-syndrome-reviewing-the-evidence-from-functional-imaging
#10
Arne May
Due to the clinical picture and also based on early imaging data (Weiller et al. Nat Med 1:658-660, 1995), the brainstem and midbrain structures have been intensely discussed as possible driving or generating structures in migraine. The fact that the brainstem activation persisted after treatment makes it unlikely that this activation was only due to increased activity of the endogenous anti-nociceptive system. It was consequently (and somewhat simplifying) coined the "migraine generator". Since then several studies have focussed on this region when investigating episodic, but also chronic migraine...
May 2017: Neurological Sciences
https://www.readbyqxmd.com/read/28526974/the-health-equity-scholars-program-innovation-in-the-leaky-pipeline
#11
Carole C Upshur, Diedra M Wrighting, Gonzalo Bacigalupe, Joan Becker, Laura Hayman, Barbara Lewis, Sylvia Mignon, Megan E Rokop, Elizabeth Sweet, Marie Idali Torres, Paul Watanabe, Cedric Woods
Despite attempts to increase enrollment of under-represented minorities (URMs: primarily Black/African American, Hispanic/Latino, and Native American students) in health professional programs, limited progress has been made. Compelling reasons to rectify this situation include equity for URMs, better prepared health professionals when programs are diverse, better quality and access to health care for UMR populations, and the need for diverse talent to tackle difficult questions in health science and health care delivery...
May 19, 2017: Journal of Racial and Ethnic Health Disparities
https://www.readbyqxmd.com/read/28526658/nonclinical-pharmacology-and-toxicology-of-the-first-biosimilar-insulin-glargine-drug-product-basaglar-%C3%A2-abasaglar-%C3%A2-approved-in-the-european-union
#12
Richard A Byrd, Rebecca A Owens, Jamie L Blackbourne, David E Coutant, Mark W Farmen, M Dodson Michael, Julie S Moyers, A Eric Schultze, Michael K Sievert, Niraj K Tripathi, John L Vahle
Basaglar(®)/Abasaglar(®) (Lilly insulin glargine [LY IGlar]) is a long-acting human insulin analogue drug product granted marketing authorisation as a biosimilar to Lantus(®) (Sanofi insulin glargine [SA IGlar]) by the European Medicines Agency. We assessed the similarity of LY IGlar to the reference drug product, European Union-sourced SA IGlar (EU-SA IGlar), using nonclinical in vitro and in vivo studies. No biologically relevant differences were observed for receptor binding affinity at either the insulin or insulin-like growth factor-1 (IGF-1) receptors, or in assays of functional or de novo lipogenic activity...
May 16, 2017: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/28526628/heparin-based-hydrogels-induce-human-renal-tubulogenesis-in-vitro
#13
Heather M Weber, Mikhail V Tsurkan, Valentina Magno, Uwe Freudenberg, Carsten Werner
Dialysis or kidney transplantation is the only therapeutic option for end stage renal disease. Accordingly, there is a large unmet clinical need for new causative therapeutic treatments. Obtaining robust models that mimic the complex nature of the human kidney is a critical step in the development of new therapeutic strategies. Here we establish a synthetic in vitro human renal tubulogenesis model based on a tunable glycosaminoglycan-hydrogel platform. In this system, renal tubulogenesis can be modulated by the adjustment of hydrogel mechanics and degradability, growth factor signaling, and the presence of insoluble adhesion cues, potentially providing new insights for regenerative therapy...
May 16, 2017: Acta Biomaterialia
https://www.readbyqxmd.com/read/28526098/first-description-of-bartonella-koehlerae-infection-in-a-spanish-dog-with-infective-endocarditis
#14
María-Dolores Tabar, Laura Altet, Ricardo G Maggi, Jaume Altimira, Xavier Roura
BACKGROUND: Bartonella koehlerae has been recently described as a new cat- and cat fleas-associated agent of culture-negative human endocarditis. It has been also encountered in one dog from Israel and six dogs from the USA, but other clinically relevant reports involving this bacterium are lacking. RESULTS: A 7-year-old intact male mixed dog presented with clinico-pathological signs consistent with mitral endocarditis and cutaneous hemangiosarcoma. Molecular studies revealed the presence of Bartonella koehlerae DNA in samples from blood and mitral valve tissue...
May 19, 2017: Parasites & Vectors
https://www.readbyqxmd.com/read/28525984/study-protocol-evaluation-of-the-probiotic-lactobacillus-fermentum-cect5716-for-the-prevention-of-mastitis-in-breastfeeding-women-a-randomised-controlled-trial
#15
Diana M Bond, Jonathan M Morris, Natasha Nassar
BACKGROUND: Mastitis and accompanying pain have been associated with the cessation of breastfeeding. Mastitis is an inflammatory condition of the breast and may be a result of decreased immunity and a lowered resistance to infection. Mastitis affects up to one in five breastfeeding women with most episodes occurring in the first 6-8 weeks postpartum. Antibiotics are often used in the treatment of mastitis, but have not been popular or proven effective as a preventative agent. The WHO has highlighted significant concerns relating to adverse harms of antibiotic use with the production of antibiotic-resistant strains of disease organisms...
May 19, 2017: BMC Pregnancy and Childbirth
https://www.readbyqxmd.com/read/28525410/sm22-a-plasma-biomarker-for-human-transmural-intestinal-ischemia
#16
Dirk H S M Schellekens, Kostan W Reisinger, Kaatje Lenaerts, M'hamed Hadfoune, Steven W Olde Damink, Wim A Buurman, Cornelis H C Dejong, Joep P M Derikx
OBJECTIVE: To evaluate the diagnostic potential of smooth muscle protein of 22 kDa (SM22) as plasma biomarker for the detection of transmural intestinal ischemia. BACKGROUND: Acute mesenteric ischemia is an abdominal emergency requiring rapid diagnosis and treatment. Especially, detection of transmural damage is imperative because it mandates emergency surgery. Since early clinical and radiological signs are nonspecific, there is an urgent need for accurate biomarkers...
May 18, 2017: Annals of Surgery
https://www.readbyqxmd.com/read/28524233/bortezomib-sensitizes-human-osteosarcoma-cells-to-adriamycin-induced-apoptosis-through-ros-dependent-activation-of-p-eif2%C3%AE-atf4-chop-axis
#17
Miao Xian, Handi Cao, Ji Cao, Xuejing Shao, Difeng Zhu, Ning Zhang, Ping Huang, Weixu Li, Bo Yang, Meidan Ying, Qiaojun He
Osteosarcoma is the most common bone cancer, and chemotherapy is currently indispensable for its treatment. Adriamycin has been claimed to be the most effective agent for osteosarcoma, however, the outcome of adriamycin chemotherapy remains unsatisfactory. Here, we reported a potent combination therapy that bortezomib, a proteasome inhibitor, enhances adriamycin-induced apoptosis to eliminate osteosarcoma cells and we revealed that the activation of p-eIF2α/ATF4/CHOP axis is the underlying associated mechanisms...
May 19, 2017: International Journal of Cancer. Journal International du Cancer
https://www.readbyqxmd.com/read/28523582/first-in-human-radiation-dosimetry-of-68-ga-nodaga-rgdyk
#18
Silvano Gnesin, Periklis Mitsakis, Francesco Cicone, Emmanuel Deshayes, Vincent Dunet, Augusto F Gallino, Marek Kosinski, Sébastien Baechler, Franz Buchegger, David Viertl, John O Prior
BACKGROUND: Integrin-targeting radiopharmaceuticals have potential broad applications, spanning from cancer theranostics to cardiovascular diseases. We have previously reported preclinical dosimetry results of (68)Ga-NODAGA-RGDyK in mice. This study presents the first human dosimetry of (68)Ga-NODAGA-RGDyK in the five consecutive patients included in a clinical imaging protocol of carotid atherosclerotic plaques. Five male patients underwent whole-body time-of-flight (TOF) PET/CT scans 10, 60 and 120 min after tracer injection (200 MBq)...
December 2017: EJNMMI Research
https://www.readbyqxmd.com/read/28521752/synthesis-characterization-and-biological-verification-of-anti-her2-indocyanine-green-doxorubicin-loaded-polyethyleneimine-coated-perfluorocarbon-double-nanoemulsions-for-targeted-photochemotherapy-of-breast-cancer-cells
#19
Yu-Hsiang Lee, Yun-Ting Ma
BACKGROUND: Breast cancer is the most frequently diagnosed cancer and the leading cause of cancer death among females worldwide. Among various types of breast cancer, the human epidermal growth factor receptor 2 (HER2)-overexpressing breast cancer is known to be more aggressive and often resistant to medicinal treatment, leading to an insufficient prognosis and poor susceptibility to chemotherapy and/or hormonal therapy in the current clinic. These circumstances implicate that developing an improved therapeutic strategy rather than persistently changing the anticancer drugs for trying is truly needed to successfully cure this type of breast cancer...
May 18, 2017: Journal of Nanobiotechnology
https://www.readbyqxmd.com/read/28521388/non-targeted-high-resolution-mass-spectrometry-strategy-for-simultaneous-monitoring-of-xenobiotics-and-endogenous-compounds-in-green-sea-turtles-on-the-great-barrier-reef
#20
Amy L Heffernan, Maria M Gómez-Ramos, Caroline Gaus, Soumini Vijayasarathy, Ian Bell, Christine Hof, Jochen F Mueller, Maria J Gómez-Ramos
Chemical contamination poses a threat to ecosystem, biota and human health, and identifying these hazards is a complex challenge. Traditional hazard identification relies on a priori-defined targets of limited chemical scope, and is generally inappropriate for exploratory studies such as explaining toxicological effects in environmental systems. Here we present a non-target high resolution mass spectrometry environmental monitoring study with multivariate statistical analysis to simultaneously detect biomarkers of exposure (e...
May 14, 2017: Science of the Total Environment
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