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https://www.readbyqxmd.com/read/29160099/safety-of-intradiaphragmatic-delivery-of-adeno-associated-virus-mediated-alpha-glucosidase-raav1-cmv-hgaa-gene-therapy-in-children-affected-by-pompe-disease
#1
Manuela Corti, Cristina Liberati, Barbara K Smith, Lee Ann Lawson, Ibrahim S Tuna, Thomas J Conlon, Kirsten E Erger, Saleem Islam, Roland Herzog, David D Fuller, Shelley Collins, Barry J Byrne
We conducted a first in human trial of diaphragmatic gene therapy (AAV1-CMV-GAA) to treat respiratory and neural dysfunction in early-onset Pompe disease. The primary objective of this study was to assess the safety of rAAV1-CMV-hGAA vector delivered to the diaphragm muscle of Pompe disease subjects with ventilatory insufficiency. Safety was assessed by measurement of change in serum chemistries and hematology, urinalysis, and immune response to GAA and AAV as well as change in level of health. Our data demonstrate that the AAV treatment was safe and there were no adverse events related to the study agent...
November 21, 2017: Human Gene Therapy. Clinical Development
https://www.readbyqxmd.com/read/29142168/background-data-on-nod-shi-scid-il-2r%C3%AE-null-mice-nog-mice
#2
Kenichiro Kasahara, Yachiyo Fukunaga, Saori Igura, Rie Andoh, Tsubasa Saito, Isamu Suzuki, Hiroyuki Kanemitsu, Daisuke Suzuki, Ken Goto, Daichi Nakamura, Masahiro Mochizuki, Masahiko Yasuda, Ryo Inoue, Kazutoshi Tamura, Mariko Nagatani
To obtain background data of NOD/Shi-scid IL-2Rγ(null) (NOG) mice, severely immunedeficient mice, a total of 120 animals were examined at 7, 26 and 52 weeks-old (20 mice/sex/group). The survival rate at 52 weeks-old was 95% (19/20) in both sexes. Clinically, circling behavior in one direction along the cage wall was observed in males after 8 weeks and females after 47 weeks-old, and hunchback position was found in males after 32 weeks-old. Hematologically, lymphocyte count markedly decreased at all ages, while white blood cell count increased in several mice at 52 weeks-old...
2017: Journal of Toxicological Sciences
https://www.readbyqxmd.com/read/29114436/preferred-names-preferred-pronouns-and-gender-identity-in-the-electronic-medical-record-and-laboratory-information-system-is-pathology-ready
#3
Katherine L Imborek, Nicole L Nisly, Michael J Hesseltine, Jana Grienke, Todd A Zikmund, Nicholas R Dreyer, John L Blau, Maia Hightower, Robert M Humble, Matthew D Krasowski
Background: Electronic medical records (EMRs) and laboratory information systems (LISs) commonly utilize patient identifiers such as legal name, sex, medical record number, and date of birth. There have been recommendations from some EMR working groups (e.g., the World Professional Association for Transgender Health) to include preferred name, pronoun preference, assigned sex at birth, and gender identity in the EMR. These practices are currently uncommon in the United States. There has been little published on the potential impact of these changes on pathology and LISs...
2017: Journal of Pathology Informatics
https://www.readbyqxmd.com/read/29107008/acute-and-a-28-day-repeated-dose-toxicity-study-of-total-flavonoids-from-clinopodium-chinense-benth-o-ktze-in-mice-and-rats
#4
Yonglin Gao, Yunzhi Wang, Kezhou Wang, Jing Zhu, Guisheng Li, Jingwei Tian, Chunmei Li, Zhenhua Wang, Ji Li, Albert W Lee, Chenghua Guo
Clinopodium chinense (Benth.) O. Ktze (Labiatae), known as 'Duanxueliu' in the Chinese Pharmacopoeia, has been widely used as a traditional Chinese medicine for the treatment of hemorrhagic disease. Total flavonoids from Clinopodium chinense (Benth.) O. Ktze (TFCC), the most active ingredient, possess a variety of properties, such as antioxygenation. Until now, evidence-based toxicity data on TFCC has been limited. This study evaluated the acute (in mice and rat) and the 28-day repeated-dose (in rat) toxicity study of TFCC, respectively...
October 30, 2017: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/29071018/a-90-day-inhalation-toxicity-study-of-ethyl-formate-in-rats
#5
Mi Ju Lee, Hyeon-Yeong Kim
Ethyl formate, a volatile solvent, has insecticidal and fungicidal properties and is suggested as a potential fumigant for stored crop and fruit. Its primary contact route is through the respiratory tract; however, reliable repeated toxicological studies focusing on the inhalation route have not been published to date. Therefore, the present study was conducted to investigate the safety of a 90-day repeated inhalation exposure in rats. Forty male and 40 female rats were exposed to ethyl formate vapor via inhalation at concentrations of 0, 66, 330, and 1,320 ppm for 6 hr/day, 5 days a week for 13 weeks...
October 2017: Toxicological Research
https://www.readbyqxmd.com/read/29054515/blood-transfusion-management-and-transfusion-related-outcomes-in-daratumumab-treated-patients-with-relapsed-or-refractory-multiple-myeloma
#6
Ajai Chari, Suzanne Arinsburg, Sundar Jagannath, Toshihisa Satta, Ivey Treadwell, Donna Catamero, Gillian Morgan, Huaibao Feng, Clarissa Uhlar, Imran Khan, Parul Doshi, Saad Usmani
INTRODUCTION: Daratumumab, a human CD38 monoclonal antibody approved for multiple myeloma (MM) treatment, binds red blood cells (RBCs), resulting in panagglutination in compatibility tests. Published mitigation methods avoid additional testing, ensuring timely release of blood products. Blood transfusion management and transfusion-related outcomes of daratumumab-treated patients in the SIRIUS study are reported, with emphasis on 2 clinical sites. PATIENTS AND METHODS: Patients had MM treated with ≥ 3 prior lines of therapy, including a proteasome inhibitor and an immunomodulatory drug, or were refractory to a proteasome inhibitor and an immunomodulatory drug...
September 19, 2017: Clinical Lymphoma, Myeloma & Leukemia
https://www.readbyqxmd.com/read/29046697/preclinical-safety-assessment-of-angelica-acutiloba-using-a-13-week-repeated-dose-oral-toxicity-study-in-rats
#7
Jun-Won Yun, Euna Kwon, Seung-Hyun Kim, Ji-Ran You, Yun-Soon Kim, In Ae Park, Hyeon Hoe Kim, Jeong-Hwan Che, Byeong-Cheol Kang
Angelica acutiloba (AA), a Japanese species of Danggui, has been used worldwide as a traditional herbal medicine with several bioactivities including anti-diabetic, anti-allergic, anti-inflammatory, anti-tumor, and anti-obesity. However, there is lack of toxicological data available to evaluate potential long-term toxicity and the no-observed-adverse-effect level (NOAEL) of AA extract in accordance with the test guidelines published by the Organization for Economic Cooperation and Development. In the 14-day repeat-dose toxicity study, no adverse effects on mortality, body weight change, clinical signs, and organ weights was found following repeat oral administration to rats for 14 days (125, 250, 500, 1000, and 2000 mg/kg body weight), leading that 2000 mg/kg is the highest recommended dose of AA extract for the 13-week repeat-dose oral toxicity study...
September 2017: Laboratory Animal Research
https://www.readbyqxmd.com/read/28972742/ultrasmall-paramagnetic-iron-oxide-nanoprobe-targeting-epidermal-growth-factor-receptor-for-in-vivo-magnetic-resonance-imaging-of-hepatocellular-carcinoma
#8
Yan Chen, Quan Zhou, Xue Li, Fa Wang, Kevin Heist, Rork Kuick, Scott R Owens, Thomas D Wang
Hepatocellular carcinoma (HCC) is a common worldwide cancer that is rising rapidly in incidence. MRI is a powerful noninvasive imaging modality for HCC detection, but lack of specific contrast agents limits visualization of small tumors. EGFR is frequently overexpressed in HCC and is a promising target. Peptides have fast binding kinetics, short circulatory half-life, low imaging background, high vascular permeability, and enhanced tissue diffusion for deep tumor penetration. We demonstrate a peptide specific for EGFR labeled with an ultrasmall paramagnetic iron oxide (UPIO) nanoparticle with 3...
October 20, 2017: Bioconjugate Chemistry
https://www.readbyqxmd.com/read/28966104/citrus-aurantium-bitter-orange-extract-safety-assessment-by-acute-and-14-day-oral-toxicity-studies-in-rats-and-the-ames-test-for-mutagenicity
#9
N S Deshmukh, S J Stohs, C C Magar, S B Kadam
The primary active constituent in bitter orange extract (BOE) is p-synephrine. This study assessed the safety of a BOE standardized to 50% p-synephrine following short-term exposure to rats and by the Ames Test. Following 5000 mg/kg of the extract orally to female rats all animals survived. Administration at 2000 mg/kg to female rats for four days yielded no signs of toxicity. Five male and five female rats were administered the BOE at 0, 250, 500, 1000 and 2000 mg/kg/day for 14 days. No significant effects were observed at any dose with respect to body weights, food intake, absolute and relative organ weights, hematology, clinical chemistry, and pathology...
September 28, 2017: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/28959621/health-effects-following-subacute-exposure-to-geogenic-dust-collected-from-active-drainage-surfaces-nellis-dunes-recreation-area-las-vegas-nv
#10
Jamie C DeWitt, Brenda J Buck, Dirk Goossens, Yuanxin Teng, James Pollard, Brett T McLaurin, Russell Gerads, Deborah E Keil
The specific health effects of direct inhalation of fine minerogenic dusts generated by natural soil surfaces remain poorly known and relatively little researched. To learn more about this exposure and its contribution to human health effects, we surveyed surface sediment and characterized dust from the Nellis Dunes Recreation Area (NDRA) in Clark County, Nevada, a popular off-road vehicle (ORV) recreational site. Dry drainage systems at NDRA are commonly used as natural trail systems for ORV recreation; these surfaces also are characterized by high concentrations of heavy metals...
2017: Toxicology Reports
https://www.readbyqxmd.com/read/28959620/ninety-day-oral-toxicity-study-of-rice-derived-%C3%AE-oryzanol-in-sprague-dawley-rats
#11
Seol-Hee Moon, Duyeol Kim, Norihito Shimizu, Tadashi Okada, Shoketsu Hitoe, Hiroshi Shimoda
A 90-day oral toxicity study of γ-oryzanol, a rice-derived triterpenoid ferulate, was performed by oral gavage administration to male and female Sprague-Dawley rats at doses of 0, 1000, and 2000 mg/kg body weight/day. All rats administered γ-oryzanol survived throughout the study period. Both male and female rats showed no toxicologically significant changes of the general signs, examination findings, body weight, food consumption, functional observational battery results, ophthalmological findings, urinalysis, hematology tests, clinical chemistry tests, organ weights, and necropsy findings...
2017: Toxicology Reports
https://www.readbyqxmd.com/read/28902958/nonregenerative-immune-mediated-anemia-associated-with-a-diffuse-large-b-cell-lymphoma-in-a-captive-jaguar-panthera-onca
#12
Monika A Keresztes, Manfred Henrich, Penelope Baloi, Sascha Gerst, Jens-Christian Rudnick, Judith Langenstein, Andreas Moritz, Natali Bauer
An 18-year-old male castrated jaguar (Panthera onca) was presented with anorexia and continuous bleeding from the oral cavity after a history of fighting with the partner animal. Clinical evaluation revealed ulcerating lesions on the gingiva and hard palate and a hematoma on the tongue. Computed tomography of the head and endoscopic examination of the esophagus and stomach were unremarkable. Hematology and clinical chemistry revealed severe nonregenerative anemia, mild thrombocytopenia, and moderate azotemia...
September 13, 2017: Veterinary Clinical Pathology
https://www.readbyqxmd.com/read/28884794/pathology-evaluation-of-developmental-phenotypes-in-neonatal-and-juvenile-mice
#13
Brad Bolon, Susan Newbigging, Kelli L Boyd
Necropsy (or autopsy) is the post mortem dissection of an animal to examine and collect organs and tissues in order to understand the effects and causes of disease. The systematic harvesting of samples at necropsy is an essential step in defining the reason for an unexpected death and in characterizing the features (i.e., phenotype) of a newly discovered condition. Phenotypic evaluation of young (neonatal and juvenile) mice emphasizes morphologic (macroscopic and microscopic) techniques and biochemical (clinical chemistry, hematologic, and molecular) analyses...
September 8, 2017: Current Protocols in Mouse Biology
https://www.readbyqxmd.com/read/28870685/evaluation-of-the-safety-of-a-genetically-modified-das-444%C3%A3-6-6-soybean-meal-and-hulls-in-a-90-day-dietary-toxicity-study-in-rats
#14
Sabitha Papineni, Jennifer A Murray, Ekmay Ricardo, Christina M Dunville, Radha Krishna Sura, Johnson Thomas
A 90-day sub chronic toxicity study was conducted in rats to evaluate the safety of genetically modified DAS-444Ø6-6 soybeans expressing herbicide tolerant proteins when compared with its conventional comparators (non-transgenic near isoline control soybean and three commercially available non-transgenic line control soybeans). Rats were given diets formulated with either 10% or 20% w/w of soybean meal and 1% or 2% hulls of DAS-444Ø6-6 soybean with an equivalent amount of hulls from an isoline non-transgenic control soybean for at least 90 days...
September 1, 2017: Food and Chemical Toxicology
https://www.readbyqxmd.com/read/28853177/recent-advances-in-ce-and-microchip-ce-in-clinical-applications-2014-to-mid-2017
#15
Terry M Phillips
CE and microchip CE (ME)are powerful tools for the analysis of a number of different analytes and have been applied to a variety of clinical fields and human samples. This review will present an overview of the most recent applications of these techniques to different areas of clinical medicine during the period of 2014 to mid-2017. CE and ME have been applied to clinical chemistry, drug detection and monitoring, hematology, infectious diseases, oncology, endocrinology, neonatology, nephrology, and genetic screening...
August 29, 2017: Electrophoresis
https://www.readbyqxmd.com/read/28843693/leukocyte-profile-gene-expression-acute-phase-response-and-metabolite-status-of-cows-with-sole-hemorrhages
#16
Keelin O'Driscoll, Matthew McCabe, Bernadette Earley
Sole hemorrhages result from disruption to normal claw horn formation and are caused by a variety of internal and external factors. Evidence suggests that they are painful, although they do not usually cause clinical lameness and are difficult to detect by observing cow gait. Little is known about how or whether sole hemorrhages affect the cow systemically. This study compared hematology profile, leukocyte gene expression, and physiological responses of cows with no/mild hemorrhages (category 1; n = 17), moderate hemorrhages (category 2; n = 18), and severe hemorrhages (category 3; n = 12)...
November 2017: Journal of Dairy Science
https://www.readbyqxmd.com/read/28808212/recent-advances-in-arsenic-trioxide-encapsulated-nanoparticles-as-drug-delivery-agents-to-solid-cancers
#17
Anam Akhtar, Scarlet Xiaoyan Wang, Lucy Ghali, Celia Bell, Xuesong Wen
Since arsenic trioxide was first approved as the front line therapy for acute promyelocytic leukemia 25 years ago, its anti-cancer properties for various malignancies have been under intense investigation. However, the clinical successes of arsenic trioxide in treating hematological cancers have not been translated to solid cancers. This is due to arsenic's rapid clearance by the body's immune system before reaching the tumor site. Several attempts have henceforth been made to increase its bioavailability toward solid cancers without increasing its dosage albeit without much success...
January 19, 2017: Journal of Biomedical Research
https://www.readbyqxmd.com/read/28808204/safety-immunogenicity-and-cross-species-protection-of-a-plasmid-dna-encoding-plasmodium-falciparum-sera5-polypeptide-microbial-epitopes-and-chemokine-genes-in-mice-and-olive-baboons
#18
Nyamongo Onkoba, Ruth M Mumo, Horace Ochanda, Charles Omwandho, Hastings S Ozwara, Thomas G Egwang
Incorporation of biomolecular epitopes to malarial antigens should be explored in the development of strain-transcending malarial vaccines. The present study sought to determine safety, immunogenicity and cross-species efficacy ofPlasmodium falciparum serine repeat antigen 5 polypeptide co-expressed with epitopes of Bacille-Calmette Guerin (BCG), tetanus toxoid (TT) and a chemokine gene. Olive baboons and BALB/c mice were randomly assigned into vaccine and control groups. The vaccine group animals were primed and boosted twice with pIRES plasmids encoding the SERA5+ BCG+ TT alone, or with either CCL5 or CCL20 and the control group with pIRES plasmid vector backbone...
July 13, 2017: Journal of Biomedical Research
https://www.readbyqxmd.com/read/28796812/toxicological-and-bio-distribution-profile-of-a-gm-csf-expressing-double-targeted-chimeric-oncolytic-adenovirus-oncos-102-support-for-clinical-studies-on-advanced-cancer-treatment
#19
Lukasz Kuryk, Lotta Vassilev, Tuuli Ranki, Akseli Hemminki, Aila Karioja-Kallio, Onerva Levälampi, Antti Vuolanto, Vincenzo Cerullo, Sari Pesonen
The purpose of this work was to carry out preclinical toxicity and bio-distribution studies required for regulatory approval of a clinical trial application for Phase I clinical studies of ONCOS-102 (Ad5/3-D24-GM-CSF) for therapy of advanced cancers (NCT01598129). The study design, route of administration and dosage differs from the clinical protocol and in more detail, investigate bio-distribution and toxicological profile of ONCOS-102 treatment in animal model. The study was carried out in 300 hamsters divided into nine test groups-three bio-distribution groups and six groups for analysis of toxicity...
2017: PloS One
https://www.readbyqxmd.com/read/28783210/monocyte-count-at-onset-predicts-poststroke-outcomes-during-a-90-day-follow-up
#20
Luca Liberale, Fabrizio Montecucco, Aldo Bonaventura, Ilaria Casetta, Silva Seraceni, Alessandro Trentini, Marina Padroni, Franco Dallegri, Enrico Fainardi, Federico Carbone
BACKGROUND: Acute ischaemic stroke (AIS) triggers both systemic and neurovascular inflammation, influencing poststroke recovery. In smokers with AIS, inflammation might be further upregulated, increasing ischaemia/reperfusion injury. Here, the predictive value of leucocyte and adhesion molecules levels on poststroke outcomes was investigated. MATERIALS AND METHODS: A total of 89 patients with AIS (n = 30 smokers and n = 59 nonsmokers) were recruited and evaluated 1, 7 and 90 days after the onset to assess stroke severity by the National Institute of Health Stroke Scale (NIHSS) score as well as clinical recovery at 90 days by the modified Rankin Scale (mRS)...
August 7, 2017: European Journal of Clinical Investigation
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