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First-in-human clinical studies

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https://www.readbyqxmd.com/read/28930847/guillain-barr%C3%A3-like-axonal-polyneuropathy-associated-with-toscana-virus-infection-a-case-report
#1
Eugenia Rota, Nicola Morelli, Paolo Immovilli, Paola De Mitri, Donata Guidetti
RATIONALE: Numerous cases of post-infectious Guillain-Barré syndrome (GBS) have been reported in the literature. Toscana virus (TOSV) is an arthropod-borne emerging pathogen in the Mediterranean area. PATIENT CONCERNS: A 40-year-old male patient was admitted to hospital for acute facial weakness, associated to numbness paraesthesias at lower and upper limbs. The neurological examination revealed facial diplegia and reduced tendon reflexes. The nerve conduction studies documented an acute motor and sensory axonal neuropathy (AMSAN); the lumbar puncture detected albuminocytologic dissociation...
September 2017: Medicine (Baltimore)
https://www.readbyqxmd.com/read/28930815/variability-in-usual-care-mechanical-ventilation-for-pediatric-acute-respiratory-distress-syndrome-time-for-a-decision-support-protocol
#2
Christopher J L Newth, Katherine A Sward, Robinder G Khemani, Kent Page, Kathleen L Meert, Joseph A Carcillo, Thomas P Shanley, Frank W Moler, Murray M Pollack, Heidi J Dalton, David L Wessel, John T Berger, Robert A Berg, Rick E Harrison, Richard Holubkov, Allan Doctor, J Michael Dean, Tammara L Jenkins, Carol E Nicholson
OBJECTIVES: Although pediatric intensivists philosophically embrace lung protective ventilation for acute lung injury and acute respiratory distress syndrome, we hypothesized that ventilator management varies. We assessed ventilator management by evaluating changes to ventilator settings in response to blood gases, pulse oximetry, or end-tidal CO2. We also assessed the potential impact that a pediatric mechanical ventilation protocol adapted from National Heart Lung and Blood Institute acute respiratory distress syndrome network protocols could have on reducing variability by comparing actual changes in ventilator settings to those recommended by the protocol...
September 19, 2017: Pediatric Critical Care Medicine
https://www.readbyqxmd.com/read/28929698/-randomized-controlled-study-sophora-flavescens-gel-in-treatment-of-cervical-hpv-infection
#3
Hong-da Zhao, Xiao-Ling Feng, Yan Zhao, Na Li
This study aimed to evaluate the efficacy of Sophora flavescens gel in treatment of cervical HPV infection. 120 patients with cervical HPV infections were selected from department of gynecology, the first affiliated hospital, Heilongjiang university of Chinese medicine. They were randomly divided into three groups: test group(S. flavescens gel, 40 cases), control group(human recombinant interferon α-2b gel, 40 cases) and combined application group(combination of the above two, 40 cases). The treatment course was three months in all three groups...
November 2016: Zhongguo Zhong Yao za Zhi, Zhongguo Zhongyao Zazhi, China Journal of Chinese Materia Medica
https://www.readbyqxmd.com/read/28929690/-development-of-a-cell-based-peroxisome-proliferator-activated-receptors-ppars-screening-model-and-its-application-for-evaluation-of-triterpenoids-isolate-from-alismatis-rhizoma
#4
Xiao-Yan Li, Xiao-Hua Wang, Xiao-Qiang Huang, Ting-Ting Wu, Wen Xu, Shui-Sheng Wu
Peroxisome proliferators activated receptors (PPARs) are closely related to human chronic disease, such as diabetes mellitus and the other metabolic diseases. In this study, a cell-based PPARs (PPAR α/β/γ) model was developed for the screening of PPARs agonists from Alismatis Rhizoma (AR). Firstly, 293T cells were transfected with the reconstructed plasmid pBind-PPAR (α, β, or γ)-LBD and reporter gene pGL4.35, and the known PPARs agonists were used as the positive control (fenofibrate for PPARα, L165041 for PPARβ, and rosiglitazone for PPARγ)...
November 2016: Zhongguo Zhong Yao za Zhi, Zhongguo Zhongyao Zazhi, China Journal of Chinese Materia Medica
https://www.readbyqxmd.com/read/28929423/oxidative-stress-in-inflammatory-cells-of-patient-with-rheumatoid-arthritis-clinical-efficacy-of-dietary-antioxidants
#5
REVIEW
Asis Bala, Chaitali Mondal, Pallab Kanti Haldar, Bidita Khandelwal
Rheumatoid arthritis (RA) is an autoimmune disease responsible for significant human morbidity in modern life. However, oxidative stress is one of the key markers for determining pathophysiology of patients with RA. The interaction between cellular immune system and body's endogenous and/or exogenous antigens produce reactive oxygen species (ROS) and reactive nitrogen species (RNS) in autoimmune disease like RA. ROS and RNS include highly toxic superoxide (O2(-)) and peroxynitrite (ONOO(-)) radicals, which activate the signaling cascades of inflammatory cells to synthesize pro-inflammatory cytokines and chemokines...
September 19, 2017: Inflammopharmacology
https://www.readbyqxmd.com/read/28929372/clinical-equivalence-with-g-csf-biosimilars-methodologic-approach-in-a-neo-adjuvant-setting-in-non-metastatic-breast-cancer
#6
REVIEW
A Krendyukov, M Schiestl, N Höbel, M Aapro
Biosimilars are biological medicines that have been shown to be similar to a reference biological medicine that has already been approved for use. Development of biosimilars is based on a "totality of evidence" approach that involves a series of steps by which biosimilars must demonstrate similarity to a reference product in all aspects of the drug and eliminate any remaining uncertainties. Clinical studies are then considered confirmatory and are performed to show that there are no clinically meaningful differences compared with the reference product in a sensitive patient population...
September 20, 2017: Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer
https://www.readbyqxmd.com/read/28929209/upper-urinary-tract-effects-after-irreversible-electroporation-ire-of-human-localised-renal-cell-carcinoma-rcc-in-the-irene-pilot-phase-2a-ablate-and-resect-study
#7
J J Wendler, M Pech, J Köllermann, B Friebe, S Siedentopf, S Blaschke, D Schindele, M Porsch, D Baumunk, J Jürgens, F Fischbach, J Ricke, M Schostak, M Böhm, U B Liehr
PURPOSE: Irreversible electroporation (IRE) is a new potential ablation modality for small renal masses. Animal experiments have shown preservation of the urine-collecting system (UCS). The purpose of this clinical study was to perform the first evaluation and comparison of IRE's effects on the renal UCS by using urinary cytology, magnetic-resonance imaging, and resection histology in men after IRE of pT1a renal-cell carcinoma (RCC). METHODS: Seven patients with biopsy-proven RCC pT1a cN0cM0 underwent IRE in a phase 2a pilot ablate-and-resect study (IRENE trial)...
September 19, 2017: Cardiovascular and Interventional Radiology
https://www.readbyqxmd.com/read/28928740/microbiome-derived-lipopolysaccharide-enriched-in-the-perinuclear-region-of-alzheimer-s-disease-brain
#8
Yuhai Zhao, Lin Cong, Vivian Jaber, Walter J Lukiw
Abundant clinical, epidemiological, imaging, genetic, molecular, and pathophysiological data together indicate that there occur an unusual inflammatory reaction and a disruption of the innate-immune signaling system in Alzheimer's disease (AD) brain. Despite many years of intense study, the origin and molecular mechanics of these AD-relevant pathogenic signals are still not well understood. Here, we provide evidence that an intensely pro-inflammatory bacterial lipopolysaccharide (LPS), part of a complex mixture of pro-inflammatory neurotoxins arising from abundant Gram-negative bacilli of the human gastrointestinal (GI) tract, are abundant in AD-affected brain neocortex and hippocampus...
2017: Frontiers in Immunology
https://www.readbyqxmd.com/read/28928397/atorvastatin-but-not-pravastatin-impairs-mitochondrial-function-in-human-pancreatic-islets-and-rat-%C3%AE-cells-direct-effect-of-oxidative-stress
#9
Francesca Urbano, Marco Bugliani, Agnese Filippello, Alessandra Scamporrino, Stefania Di Mauro, Antonino Di Pino, Roberto Scicali, Davide Noto, Agata Maria Rabuazzo, Maurizio Averna, Piero Marchetti, Francesco Purrello, Salvatore Piro
Statins are a class of drugs widely prescribed as frontline therapy for lowering plasma LDL-cholesterol in cardiovascular risk prevention. Several clinical reports have recently suggested an increased risk of type 2 diabetes associated with chronic use of these drugs. The pathophysiology of this effect remains to be fully elucidated but impaired β-cell function constitutes a potential mechanism. The aim of this study was to explore the effect of a chronic treatment with lipophilic and hydrophilic statins on β-cell function, using human pancreatic islets and rat insulin-secreting INS-1 cells; we particularly focused on the role of mitochondria and oxidative stress...
September 19, 2017: Scientific Reports
https://www.readbyqxmd.com/read/28928053/development-of-correction-formula-for-field-potential-duration-of-human-induced-pluripotent-stem-cell-derived-cardiomyocytes-sheets
#10
Hiroko Izumi-Nakaseko, Yasunari Kanda, Yuji Nakamura, Mihoko Hagiwara-Nagasawa, Takeshi Wada, Kentaro Ando, Atsuhiko T Naito, Yuko Sekino, Atsushi Sugiyama
Human induced pluripotent stem cell-derived cardiomyocytes (hiPSC-CMs) have been used in many studies to assess proarrhythmic risks of chemical compounds. In those studies, field potential durations (FPD) of hiPSC-CMs have been corrected by clinically used Fridericia's and/or Bazett's formulae, however, the rationale for the use of these formulae has not been well established. In the present study, we developed a correction formula for experiments using hiPSC-CMs. First, we analyzed the effect of beating rate on FPD in the hiPSC-CMs sheets with electrical stimuli and a HCN channel inhibitor zatebradine...
September 6, 2017: Journal of Pharmacological Sciences
https://www.readbyqxmd.com/read/28927774/chronic-intestinal-pseudo-obstruction-in-a-child-with-treacher-collins-syndrome
#11
E Giabicani, J Lemale, L Dainese, S Boudjemaa, A Coulomb, P Tounian, B Dubern
BACKGROUND: Treacher Collins syndrome (TCS) mainly presents with severe craniofacial developmental abnormalities characterized by a combination of bilateral downward-slanting palpebral fissures, colobomas of the lower eyelids, hypoplasia of the facial bones, cleft palate, malformation of the external ears, atresia of the external auditory canals, and bilateral conductive hearing loss. It is due to mutations in Treacher Collins syndrome 1 (TCOF1) (5q32-q33.1) and Polymerase RNA 1 polypeptides D and C (POLR1D [13q12...
September 15, 2017: Archives de Pédiatrie: Organe Officiel de la Sociéte Française de Pédiatrie
https://www.readbyqxmd.com/read/28927474/first-detection-and-characterization-of-salmonella-spp-in-poultry-and-swine-raised-in-backyard-production-systems-in-central-chile
#12
R Alegria-Moran, D Rivera, V Toledo, A I Moreno-Switt, C Hamilton-West
Little is known about Salmonella serovars circulating in backyard poultry and swine populations worldwide. Backyard production systems (BPS) that raise swine and/or poultry are distributed across Chile, but are more heavily concentrated in central Chile, where industrialized systems are in close contact with BPS. This study aims to detect and identify circulating Salmonella serovars in poultry and swine raised in BPS. Bacteriological Salmonella isolation was carried out for 1744 samples collected from 329 BPS in central Chile...
September 20, 2017: Epidemiology and Infection
https://www.readbyqxmd.com/read/28927095/high-expression-of-mage-a9-is-associated-with-unfavorable-survival-in-esophageal-squamous-cell-carcinoma
#13
Yu Qi, Ke Xin Cao, Fu Chen Xing, Chun Yang Zhang, Qi Huang, Kai Wu, Feng Biao Wen, Song Zhao, Xin Li
Melanoma-associated antigens (MAGEs) are a group of well-characterized members of the cancer/testis antigen family, which are expressed in a variety of malignant tumors. MAGE-A9, a subfamily of MAGE-As, has been studied in a number of types of cancer and have been associated with unfavorable survival outcome. However, the expression of MAGE-A9 in human esophageal squamous cell carcinoma (ESCC) and association of MAGE-A9 with the clinicopathological characteristics of ESCC, particularly prognostic characteristics, remains unknown...
September 2017: Oncology Letters
https://www.readbyqxmd.com/read/28926579/cervical-screening-with-primary-hpv-testing-or-cytology-in-a-population-of-women-in-which-those-aged-33-years-or-younger-had-previously-been-offered-hpv-vaccination-results-of-the-compass-pilot-randomised-trial
#14
Karen Canfell, Michael Caruana, Val Gebski, Jessica Darlington-Brown, Stella Heley, Julia Brotherton, Dorota Gertig, Chloe J Jennett, Annabelle Farnsworth, Jeffrey Tan, C David Wrede, Philip E Castle, Marion Saville
BACKGROUND: Using primary human papillomavirus (HPV) testing for cervical screening increases detection of high-grade cervical intraepithelial neoplastic lesions and invasive cancer (cervical intraepithelial neoplasia grade 2+ [CIN2+]) compared to cytology, but no evaluation has been conducted in a population previously offered HPV vaccination. We aimed to assess colposcopy referral and CIN2+ detection rates for HPV-screened versus cytology-screened women in Australia's HPV-vaccinated population (by 2014, resident women ≤33 years had been age-eligible for HPV vaccination, with 3-dose uptake across age cohorts being about 50%-77%)...
September 2017: PLoS Medicine
https://www.readbyqxmd.com/read/28926137/metabolic-profile-of-rhizoma-coptidis-in-human-plasma-determined-using-ultra-high-performance-liquid-chromatography-coupled-with-high-resolution-mass-spectrometry
#15
Qing-Shan Zhang, Gao-Wa Wang, Zhi-Qiang Han, Xiang-Mei Chen, Risu Na, Haburi Jin, Ping Li, Renbatu Bu
RATIONALE: Rhizoma coptidis extract and its alkaloids show various pharmacological activities, but its metabolic profile in human plasma has not been thoroughly investigated. In the present research, the metabolism of Rhizoma coptidis at a clinical dose (5 g/60 kg/day) was systematically analyzed to determine its biotransformation processes in human plasma. METHODS: In this research, the metabolites of Rhizoma coptidis in human plasma after oral administration of Rhizoma coptidis extract at a clinical dose were investigated using ultra high-performance liquid chromatography (UHPLC) coupled with high-resolution LTQ-Orbitrap mass spectrometry...
September 19, 2017: Rapid Communications in Mass Spectrometry: RCM
https://www.readbyqxmd.com/read/28925992/efficacy-of-combining-ing4-and-trail-genes-in-cancer-targeting-gene-virotherapy-strategy-first-evidence-in-preclinical-hepatocellular-carcinoma
#16
A G El-Shemi, A M Ashshi, E Oh, B-K Jung, M Basalamah, A Alsaegh, C-O Yun
Current treatments of hepatocellular carcinoma (HCC) are ineffective and unsatisfactory in many aspects. Cancer-targeting gene virotherapy using oncolytic adenoviruses (OAds) armed with anticancer genes has shown efficacy and safety in clinical trials. Nowadays, both inhibitor of growth 4 (ING4); as a multimodal tumor suppressor gene, and tumor necrosis factor-related apoptosis-inducing ligand (TRAIL); as potent-apoptosis inducing gene, are experiencing a renaissance in cancer gene therapy. Herein we investigated the antitumor activity and safety of mono-and combined therapy with OAds armed with ING4 (Ad-ΔB/ING4) and TRAIL (Ad-ΔB/TRAIL) gene, respectively, on preclinical models of human HCC...
September 19, 2017: Gene Therapy
https://www.readbyqxmd.com/read/28923897/controlled-human-malaria-infection-applications-advances-and-challenges
#17
Danielle I Stanisic, James S McCarthy, Michael F Good
Controlled Human Malaria Infection (CHMI) entails deliberate infection with malaria parasites either by mosquito bite or direct injection of sporozoites or parasitised erythrocytes. When required, the resulting blood-stage infection is curtailed by the administration of anti-malarial drugs. Inducing a malaria infection via inoculation with infected blood was first used as a treatment (malariotherapy) for neurosyphilis in Europe and the United States in the early 1900s. More recently, CHMI has been applied to the fields of malaria vaccine and drug development where it is used to evaluate products in well-controlled early phase proof-of-concept clinical studies thus facilitating progression of only the most promising candidates for further evaluation in malaria-endemic areas...
September 18, 2017: Infection and Immunity
https://www.readbyqxmd.com/read/28923537/metagenomic-shotgun-sequencing-and-unbiased-metabolomic-profiling-identify-specific-human-gut-microbiota-and-metabolites-associated-with-immune-checkpoint-therapy-efficacy-in-melanoma-patients
#18
Arthur E Frankel, Laura A Coughlin, Jiwoong Kim, Thomas W Froehlich, Yang Xie, Eugene P Frenkel, Andrew Y Koh
This is the first prospective study of the effects of human gut microbiota and metabolites on immune checkpoint inhibitor (ICT) response in metastatic melanoma patients. Whereas many melanoma patients exhibit profound response to ICT, there are fewer options for patients failing ICT-particularly with BRAF-wild-type disease. In preclinical studies, specific gut microbiota promotes regression of melanoma in mice. We therefore conducted a study of the effects of pretreatment gut microbiota and metabolites on ICT Response Evaluation Criteria in Solid Tumors response in 39 metastatic melanoma patients treated with ipilimumab, nivolumab, ipilimumab plus nivolumab (IN), or pembrolizumab (P)...
September 14, 2017: Neoplasia: An International Journal for Oncology Research
https://www.readbyqxmd.com/read/28923277/animal-models-of-ischaemic-stroke-and-characterisation-of-the-ischaemic-penumbra
#19
REVIEW
Christopher McCabe, Mariana M Arroja, Emma Reid, I Mhairi Macrae
Over the past forty years, animal models of focal cerebral ischaemia have allowed us to identify the critical cerebral blood flow thresholds responsible for irreversible cell death, electrical failure, inhibition of protein synthesis, energy depletion and thereby the lifespan of the potentially salvageable penumbra. They have allowed us to understand the intricate biochemical and molecular mechanisms within the 'ischaemic cascade' that initiate cell death in the first minutes, hours and days following stroke...
September 16, 2017: Neuropharmacology
https://www.readbyqxmd.com/read/28923217/current-challenges-in-the-management-of-breast-cancer-brain-metastases
#20
REVIEW
Ciara C O'Sullivan, Nicole N Davarpanah, Jame Abraham, Susan E Bates
Approximately 50% of patients with advanced human epidermal growth factor 2 (HER2)-positive breast cancer and triple-negative breast cancer (TNBC) ultimately develop breast cancer brain metastases (BCBM), which are associated with significant morbidity and mortality. The advent of HER2-directed therapy resulted in greatly improved survival outcomes, but unfortunately at the price of an increased cumulative incidence of BCBM. We review challenges in the management of BCBM, and potential treatment strategies, including novel agents such as poly-adenosine diphosphate (ADP) ribose polymerase (PARP) inhibitors (olaparib, veliparib), cyclin-dependent kinase 4/6 (CDK4/6) inhibitors (palbociclib, abemaciclib), and taxane derivatives (eg, ANG1005 and TPI-287)...
April 2017: Seminars in Oncology
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