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https://www.readbyqxmd.com/read/28913822/improved-glycemic-control-in-a-patient-group-performing-7-point-profile-self-monitoring-of-blood-glucose-and-intensive-data-documentation-an-open-label-multicenter-observational-study
#1
Jochen Sieber, Frank Flacke, Manuela Link, Cornelia Haug, Guido Freckmann
INTRODUCTION: Regular self-monitoring of blood glucose (SMBG) is recommended as an integral part of therapy for all patients with diabetes treated with insulin. In the current study, the effects on glycemic control of taking 7-point SMBG profiles and using a diabetes management system (DMA) on a smartphone were investigated. METHODS: In a 12-week, open-label, multicenter, observational study, 51 patients [26 with type 1 diabetes mellitus (T1DM) and 25 with type 2 diabetes mellitus (T2DM)] were instructed to perform SMBG at least seven times a day using DMA combined with the iBGStar (®) SMBG system...
September 14, 2017: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/28894310/chemical-stability-of-plerixafor-after-opening-of-single-use-vial
#2
Jack T Seki, Andrea Bozovic, Roy Lee, Rita Kwong, Eshetu G Atenafu, Anna Xu, Jin-Hyeun Huh
BACKGROUND: The addition of the immunostimulant plerixafor to the current standard-of-care regimens of granulocyte colony-stimulating growth factor with or without chemotherapy has improved clinical results in terms of successful stem cell mobilization and the outcomes of stem cell transplant in various settings. With this medical innovation has come an added financial cost for institutions where stem cell transplants are routinely performed, and there may be a further financial burden when the contents of partial vials of the drug are wasted, given that plerixafor vials (Mozobil, Sanofi-Aventis Canada Inc) are currently deemed suitable only for single use...
July 2017: Canadian Journal of Hospital Pharmacy
https://www.readbyqxmd.com/read/28886178/ethics-approval-in-applications-for-open-access-clinical-trial-data-an-analysis-of-researcher-statements-to-clinicalstudydatarequest-com
#3
Derek So, Bartha M Knoppers
Although there are a number of online platforms for patient-level clinical trial data sharing from industry sponsors, they are not very harmonized regarding the role of local ethics approval in the research proposal review process. The first and largest of these platforms is ClinicalStudyDataRequest.com (CSDR), which includes over three thousand trials from thirteen sponsors including GlaxoSmithKline, Novartis, Roche, Sanofi, and Bayer. CSDR asks applicants to state whether they have received ethics approval for their research proposal, but in most cases does not require that they submit evidence of approval...
2017: PloS One
https://www.readbyqxmd.com/read/28882438/biodistribution-and-safety-of-a-live-attenuated-tetravalent-dengue-vaccine-in-the-cynomolgus-monkey
#4
Guillaume Ravel, Nathalie Mantel, Jeremy Silvano, Alexandra Rogue, Bruno Guy, Nicholas Jackson, Nicolas Burdin
BACKGROUND: The first licensed dengue vaccine is a recombinant, live, attenuated, tetravalent dengue virus vaccine (CYD-TDV; Sanofi Pasteur). This study assessed the biodistribution, shedding, and toxicity of CYD-TDV in a non-human primate model as part of the nonclinical safety assessment program for the vaccine. METHODS: Cynomolgus monkeys were given one subcutaneous injection of either one human dose (5log10 CCID50/serotype) of CYD-TDV or saline control. Study endpoints included clinical observations, body temperature, body weight, food consumption, clinical pathology, immunogenicity, and post-mortem examinations including histopathology...
September 4, 2017: Vaccine
https://www.readbyqxmd.com/read/28864138/comparison-of-different-rabbit-anti-thymocyte-globulin-formulations-in-allogeneic-stem-cell-transplantation-systematic-literature-review-and-network-meta-analysis
#5
Nico Gagelmann, Francis Ayuk, Christine Wolschke, Nicolaus Kröger
Since 2000, phase III randomized controlled trials (RCT) investigated the efficacy of rabbit anti-thymocyte globulins (ATG) in patients following allogeneic stem cell transplantation (allo-SCT). However, comparisons of different ATG formulations are lacking. Our aim was to synthesize all efficacy evidence, enabling a comparison of all available formulations of rabbit ATG in the allo-SCT setting. We performed a systematic literature review to identify all available phase III RCT evidence. We searched the Cochrane Library, MEDLINE, MEDLINE In-Process and the website www...
August 29, 2017: Biology of Blood and Marrow Transplantation
https://www.readbyqxmd.com/read/28854079/identification-of-patients-with-statin-intolerance-in-a-managed-care-plan-a-comparison-of-2-claims-based-algorithms
#6
Brandon K Bellows, Amy M Sainski-Nguyen, Cody J Olsen, Susan H Boklage, Scott Charland, Matthew P Mitchell, Diana I Brixner
BACKGROUND: While statins are safe and efficacious, some patients may experience statin intolerance or treatment-limiting adverse events. Identifying patients with statin intolerance may allow optimal management of cardiovascular event risk through other strategies. Recently, an administrative claims data (ACD) algorithm was developed to identify patients with statin intolerance and validated against electronic medical records. However, how this algorithm compared with perceptions of statin intolerance by integrated delivery networks remains largely unknown...
September 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28843391/-management-of-bone-and-mineral-metabolism-disorders-before-the-dialysis-stage-remains-still-perfectible-data-from-the-french-phosphorus-and-calcium-survey-photo-graphe
#7
Guillaume Jean, Éric Daugas, Hubert Roth, Tilman Drueke, Jean-Louis Bouchet, Thierry Hannedouche, Gérard London, Denis Fouque
Only limited data is available on the management of the chronic kidney disease-associated bone and mineral metabolism disorder (CKD-MBD) in the pre-dialysis stages of CKD in France. A better knowledge of current management habits could lead to an improvement in the implementation of international recommendations (KDIGO). The 3rd version of the French Phosphorus and Calcium Survey Photo-Graphe (Sanofi) included a cohort of CKD stages 4 and 5 patients, whose aim was to examine the prevalence of CKD-MBD and the quality of its management in patients under the care of 62 nephrologists from over 20 geographical regions in France...
August 23, 2017: Néphrologie & Thérapeutique
https://www.readbyqxmd.com/read/28842165/chronic-kidney-disease-basal-insulin-glargine-and-health-outcomes-in-people-with-dysglycemia-the-origin-study
#8
Vasilios Papademetriou, Eric S Nylen, Michael Doumas, Jeff Probstfield, Johannes F E Mann, Richard E Gilbert, Hertzel C Gerstein
BACKGROUND: Early stages of chronic kidney disease are associated with an increased cardiovascular risk in patients with established type 2 diabetes and macrovascular disease. The role of early stages of chronic kidney disease on macrovascular outcomes in prediabetes and early type two diabetes mellitus is not known. In the Outcome Reduction with an Initial Glargine Intervention (ORIGIN) trial, the introduction of insulin had no effect on cardiovascular outcomes compared to standard therapy...
August 22, 2017: American Journal of Medicine
https://www.readbyqxmd.com/read/28834304/sofosbuvir-as-treatment-against-dengue
#9
Chye Sheng Gan, See Khai Lim, Chin Fei Chee, Rohana Yusof, Choon Han Heh
Dengvaxia(®) (CTD-TDV), the only licensed tetravalent dengue vaccine by Sanofi Pasteur was made available since 2015. However, administration of CTD-TDV in general has not received the prequalification recommendation from the World Health Organization. Having a universal anti-dengue agent for treatment will therefore beneficial. Accordingly, the development of nucleoside inhibitors specific to dengue viral polymerase that perturb dengue infection has been studied by many. Alternatively, we have used a marketed anti-HCV prodrug sofosbuvir to study it's in silico and in vitro effects against dengue...
August 21, 2017: Chemical Biology & Drug Design
https://www.readbyqxmd.com/read/28821454/low-dose-antithymocyte-globulin-for-graft-versus-host-disease-prophylaxis-in-matched-unrelated-allogeneic-hematopoietic-stem-cell-transplantation
#10
Adam Bryant, Ranjeeta Mallick, Lothar Huebsch, David Allan, Harold Atkins, Grizel Anstee, Mitchell Sabloff, Nicholas Scrivens, Dawn Maze, Chris Bredeson, Natasha Kekre
Graft-versus-host disease (GVHD) is a leading cause of morbidity and mortality in allogeneic hematopoietic stem cell transplantation (alloHCT). Prophylactic in vivo T cell depletion with antithymocyte globulin (ATG) has been associated with decreased GVHD rates in many alloHCT settings. Despite decades of clinical study, optimal ATG dosing has not been established. Understanding that higher rates of GVHD are observed with matched unrelated donor (MUD) versus matched related donor (MRD) alloHCT, at our institution MUD alloHSCT recipients have historically had low-dose Thymoglobulin (total dose, 2...
August 15, 2017: Biology of Blood and Marrow Transplantation
https://www.readbyqxmd.com/read/28814660/sustained-immune-tolerance-induction-in-enzyme-replacement-therapy-treated-crim-negative-patients-with-infantile-pompe-disease
#11
Zoheb B Kazi, Ankit K Desai, Kathryn L Berrier, R Bradley Troxler, Raymond Y Wang, Omar A Abdul-Rahman, Pranoot Tanpaiboon, Nancy J Mendelsohn, Eli Herskovitz, David Kronn, Michal Inbar-Feigenberg, Catherine Ward-Melver, Michelle Polan, Punita Gupta, Amy S Rosenberg, Priya S Kishnani
BACKGROUND: Cross-reactive immunological material-negative (CRIM-negative) infantile Pompe disease (IPD) patients develop an immune response against enzyme replacement therapy (ERT) with alglucosidase alfa that nullifies ERT efficacy. Prophylactic immune tolerance induction (ITI) with rituximab, methotrexate, and IVIG successfully prevents development of deleterious rhGAA IgG antibodies; however, safety, likelihood of success, and long-term efficacy of ITI in a larger cohort remain unknown...
August 17, 2017: JCI Insight
https://www.readbyqxmd.com/read/28749924/update-temporary-total-depletion-of-u-s-licensed-yellow-fever-vaccine-for-civilian-travelers-addressed-by-investigational-new-drug-use-of-imported-stamaril-vaccine
#12
Mark D Gershman, Mark J Sotir
Sanofi Pasteur, the manufacturer of the only yellow fever vaccine (YF-VAX) licensed in the United States, has announced that their stock of YF-VAX is totally depleted as of July 24, 2017. YF-VAX for civilian use will be unavailable for ordering from Sanofi Pasteur until mid-2018, when their new manufacturing facility is expected to be completed. However, YF-VAX might be available at some clinics for several months, until remaining supplies at those sites are exhausted. In anticipation of this temporary total depletion, in 2016, Sanofi Pasteur submitted an expanded access investigational new drug application to the Food and Drug Administration to allow for importation and use of Stamaril...
July 28, 2017: MMWR. Morbidity and Mortality Weekly Report
https://www.readbyqxmd.com/read/28736045/comparative-effectiveness-of-high-dose-versus-standard-dose-influenza-vaccination-on-numbers-of-us-nursing-home-residents-admitted-to-hospital-a-cluster-randomised-trial
#13
Stefan Gravenstein, H Edward Davidson, Monica Taljaard, Jessica Ogarek, Pedro Gozalo, Lisa Han, Vincent Mor
BACKGROUND: Immune responses to influenza vaccines decline with age, reducing clinical effectiveness. We compared the effect of the more immunogenic high-dose trivalent influenza vaccine with a standard-dose vaccine to identify the effect on reducing hospital admissions of nursing home residents in the USA. METHODS: We did a single-blind, pragmatic, comparative effectiveness, cluster-randomised trial with a 2 × 2 factorial design. Medicare-certified nursing homes in the USA located within 50 miles of a Centers for Disease Control and Prevention influenza reporting city were recruited, so long as the facilities were not located in a hospital, had more than 50 long-stay residents, had less than 20% of the population aged under 65 years, and were not already planning to administer the high-dose influenza vaccine to residents...
September 2017: Lancet Respiratory Medicine
https://www.readbyqxmd.com/read/28716893/which-dengue-vaccine-approach-is-the-most-promising-and-should-we-be-concerned-about-enhanced-disease-after-vaccination-there-is-only-one-true-winner
#14
Scott B Halstead
The scientific community now possesses information obtained directly from human beings that makes it possible to understand why breakthrough-enhanced dengue virus (DENV) infections occurred in children receiving Sanofi Pasteur's Dengvaxia tetravalent live attenuated vaccine and to predict the possibility of breakthrough-enhanced DENV infections following immunization with two other tetravalent live attenuated vaccines now in phase III testing. Based upon recent research, Dengvaxia, lacking DENV nonstructural protein antigens, did not protect seronegatives because it failed to raise a competent T-cell response and/or antibodies to NS1...
July 17, 2017: Cold Spring Harbor Perspectives in Biology
https://www.readbyqxmd.com/read/28716892/which-dengue-vaccine-approach-is-the-most-promising-and-should-we-be-concerned-about-enhanced-disease-after-vaccination-questions-raised-by-the-development-and-implementation-of-dengue-vaccines-example-of-the-sanofi-pasteur-tetravalent-dengue-vaccine
#15
Bruno Guy
Dengue is a still-growing public health concern in many tropical and subtropical regions of the world. The development and implementation of an effective dengue vaccine in these regions is a high priority. This insight focuses on the expected characteristics of a safe and efficacious vaccine, referring to the clinical experience obtained during the development of the first tetravalent dengue vaccine from Sanofi Pasteur, now licensed in several endemic countries. Safety and efficacy data from both short- and long-term follow-up of large-scale efficacy studies will be discussed, as well as the next steps following vaccine introduction...
July 17, 2017: Cold Spring Harbor Perspectives in Biology
https://www.readbyqxmd.com/read/28716402/the-role-of-low-dose-anti-thymocyte-globulin-as-standard-prophylaxis-in-mismatched-and-matched-unrelated-hematopoietic-peripheral-stem-cell-transplantation-for-hematologic-malignancies
#16
Ioanna Sakellari, Ioannis Batsis, Zoi Bousiou, Despina Mallouri, Varnavas Constantinou, Eleni Gavriilaki, Christos Smias, Evangelia Yannaki, Panayotis Kaloyannidis, Giorgos Papaioannou, Niki Stavroyianni, Antonia Syrigou, Damianos Sotiropoulos, Asimina Fylaktou, Aliki Tsompanakou, Riad Saloum, Achilles Anagnostopoulos
INTRODUCTION: Anti-thymocyte globulin (ATG)-based immunosuppressive therapy is often used in allogeneic hematopoietic cell transplantation to reduce incidence and severity of graft-versus-host disease (GVHD). PATIENTS AND METHODS: In our observational study, ATG (rabbit, Thymoglobulin; Sanofi, 5 mg/kg) was administered as a standardized part of the conditioning in 97 patients with a median age of 34 years (range, 14-58 years), allotransplanted for hematologic malignancies from matched (8/8; n = 52) and allele or antigen mismatched (7/8; n = 43 and 6/8; n = 2) unrelated donors...
June 29, 2017: Clinical Lymphoma, Myeloma & Leukemia
https://www.readbyqxmd.com/read/28707285/burden-of-atopic-dermatitis-in-the-united-states-analysis-of-healthcare-claims-data-in-the-commercial-medicare-and-medi-cal-databases
#17
Sulena Shrestha, Raymond Miao, Li Wang, Jingdong Chao, Huseyin Yuce, Wenhui Wei
INTRODUCTION: Comparative data on the burden of atopic dermatitis (AD) in adults relative to the general population are limited. We performed a large-scale evaluation of the burden of disease among US adults with AD relative to matched non-AD controls, encompassing comorbidities, healthcare resource utilization (HCRU), and costs, using healthcare claims data. The impact of AD disease severity on these outcomes was also evaluated. METHODS: Adult AD patients in the Commercial (n = 83,106), Medicare (n = 31,060), and Medi-Cal (n = 5550) databases were matched (1:1) to non-AD controls by demographic characteristics...
July 13, 2017: Advances in Therapy
https://www.readbyqxmd.com/read/28674959/treatment-persistence-and-clinical-outcomes-of-tumor-necrosis-factor-inhibitor-cycling-or-switching-to-a-new-mechanism-of-action-therapy-real-world-observational-study-of-rheumatoid-arthritis-patients-in-the-united-states-with-prior-tumor-necrosis-factor-inhibitor
#18
Wenhui Wei, Keith Knapp, Li Wang, Chieh-I Chen, Gary L Craig, Karen Ferguson, Sergio Schwartzman
INTRODUCTION: To examine treatment persistence and clinical outcomes associated with switching from a tumor necrosis factor inhibitor (TNFi) to a medication with a new mechanism of action (MOA) (abatacept, anakinra, rituximab, tocilizumab, or tofacitinib) versus cycling to another TNFi (adalimumab, certolizumab pegol, etanercept, golimumab, or infliximab) among patients with rheumatoid arthritis. METHODS: This retrospective, longitudinal study included patients with rheumatoid arthritis in the JointMan(®) US clinical database who received a TNFi in April 2010 or later and either cycled to a TNFi or switched to a new MOA therapy by March 2015...
July 3, 2017: Advances in Therapy
https://www.readbyqxmd.com/read/28644824/mechanism-underlying-acupuncture-ameliorated-depressive-behaviors-by-enhancing-glial-glutamate-transporter-in-chronic-unpredictable-mild-stress-cums-rats
#19
Ding Luo, Rui Ma, Yanan Wu, Xuechun Zhang, Yue Liu, Lin Wang, Wenbin Fu
BACKGROUND Major depressive disorder (MDD) is a recurrent mental illness worldwide. The glutamatergic neurotransmission system is now a target for antidepressant therapy because it takes part in synaptic plasticity and cognition in physical condition and has a potential excitatory neurotoxicity in pathological conditions. Glial glutamate transporter EAAT2 performs 90% of Glu neurotransmission. Therefore, the aim of the study was to evaluate the effect of acupuncture on depressive behaviors and EAAT2 in CUMS...
June 23, 2017: Medical Science Monitor: International Medical Journal of Experimental and Clinical Research
https://www.readbyqxmd.com/read/28623551/which-patients-will-benefit-from-a-switch-in-therapy-from-premixed-insulin-to-insulin-glargine-plus-oral-antidiabetic-drugs-further-analysis-of-the-lantus-registry-study
#20
Shi Bu, Xuelian Zhang, Haiqing Zhu, Ying Shuai, Xiaoyan Xing, Wenying Yang
INTRODUCTION: This subgroup analysis of data from the 16-week Lantus Registry Study in China investigated the characteristics of patients with type 2 diabetes mellitus (T2DM) associated with clinical benefits of transitioning therapy from premixed insulin to insulin glargine (100 U/ml) plus oral antidiabetic drugs (OADs). METHODS: The modified intention-to-treat population of the Lantus Registry Study, comprising 1847 patients with T2DM, were included in the current subgroup analyses...
August 2017: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
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