75 FR 11197 - Notice Pursuant to the National Cooperative Research and Production Act of 1993-Pistoia Alliance...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-10

...; CambridgeSoft, San Diego, CA; Merck, Boston, MA; Collaborative Drug Discovery, Burlingame, CA; Royal Society of Chemistry, Cambridge, UNITED KINGDOM; Thomson Reuters HealthCare and Science, Philadelphia, PA...

Electrolytes Test

MedlinePlus

... online at http://www.merck.com/mrkshared/mm_geriatrics/sec8/ch59.jsp. (1995-2004). Acid-Base Metabolism. The Merck Manual of Diagnosis and Therapy, Section 2. Endocrine And Metabolic Disorders, Chapter 12. ...

Evaluation of a 15-valent Pneumococcal Conjugate Vaccine in an Adult Rhesus Macaque Immunogenicity Model

PubMed Central

Xie, Jinfu; Kaufhold, Robin; Mcguinness, Debra; Zhang, Yuhua; Smith, William; Giovarelli, Cecelia; Winters, Michael; Musey, Luwy; Kosinski, Michael; Skinner, Julie

2017-01-01

Abstract Background Streptococcus pneumoniae (pneumococcus) is a leading cause of a variety of diseases, including bacteremia, meningitis, and pneumonia, among older adults in the United States. Immunization with pneumococcal vaccines is an effective way to prevent these diseases. In this study, we evaluated the immunogenicity of 15-valent pneumococcal conjugate vaccine (PCV15) in adult rhesus macaques. Methods Animals were intramuscularly immunized with PNEUMOVAX® 23 and PCV15 vaccine (5 animals/group) and sera were collected before immunization and 30, 60, and 90 days after the immunization. Sera were assayed using multiplexed electrochemiluminescent (ECL) assays to measure serotype-specific IgG antibodies to all vaccine serotypes and multiplexed opsonophagocytic killing assays (MOPA) to measure functional antibody responses to 15 vaccine serotypes. Results At day 30 post immunization, 16 out of the 23 serotypes in PNEUMOVAX 23 groups induced statistically significant higher ECL titers compared with pre bleed, ranging from 1.6-fold (19A) to 28.3-fold (15B). Compared with PNEUMOVAX 23, PCV15 induced much higher ECL titers. Thirteen out of the 15 serotypes in PCV15 groups induced statistically significant higher ECL titers compared with pre bleed, ranging from 7.4-fold (14) to 47.3-fold (4). The ECL antibody titers gradually decreased from day 30 to day 90 for both groups. We also compared the functional MOPA titers of the day 30 sera compared with pre bleed for 15 vaccine serotypes. Out of the 14 common vaccine serotypes, 7 serotypes in the PNEUMOVAX 23 immunized macaques had a >4 fold increase in MOPA titer, ranging from 4-fold (22F) to 3902-fold (33F) and 11 serotypes in the PCV15 immunized macaques had a >4-fold increase in MOPA titer, ranging from 6.3-fold (23F) to 4445-fold (7F). Twelve out of the 14 common serotypes in PCV15 group had higher MOPA titers compared with the PNEUMOVAX 23 group, although they didn’t reach statistical significance due to high variability. Conclusion These data demonstrate that a single dose of PCV15 is highly immunogenic in adult rhesus macaques and has better immunogenicity for most common serotypes compared with PNEUMOVAX 23. However, PNEUMOVAX 23 offers broader serotype coverage with 9 additional serotypes contained in the vaccine. Disclosures J. Xie, Merck & Co. Inc: Employee, Salary; R. Kaufhold, Merck & Co. Inc: Employee, Salary; D. Mcguinness, Merck & Co. Inc: Employee, Salary; Y. Zhang, Merck & Co. Inc.: Employee, Salary; W. Smith, Merck & Co. Inc.: Employee, Salary; C. Giovarelli, Merck & Co. Inc.: Employee, Salary; M. Winters, Merck & Co. Inc: Employee, Salary; L. Musey, Merck & Co. Inc: Employee, Salary; M. Kosinski, Merck & Co. Inc: Employee, Salary; J. Skinner, Merck & Co. Inc: Employee, Salary

Adnexal Torsion

MedlinePlus

... View The Professional Version For doctors and medical students Consumer Version Merck Manual Consumer Version × MERCK MANUAL - ... View The Professional Version For doctors and medical students Home Medical Topics Blood Disorders Bone, Joint, and ...

Cervical Myomas

MedlinePlus

... View The Professional Version For doctors and medical students Consumer Version Merck Manual Consumer Version × MERCK MANUAL - ... View The Professional Version For doctors and medical students Home Medical Topics Blood Disorders Bone, Joint, and ...

Cervical Stenosis

MedlinePlus

... View The Professional Version For doctors and medical students Consumer Version Merck Manual Consumer Version × MERCK MANUAL - ... View The Professional Version For doctors and medical students Home Medical Topics Blood Disorders Bone, Joint, and ...

Postpartum Infections

MedlinePlus

... View The Professional Version For doctors and medical students Consumer Version Merck Manual Consumer Version × MERCK MANUAL - ... View The Professional Version For doctors and medical students Home Medical Topics Blood Disorders Bone, Joint, and ...

Presidential Green Chemistry Challenge: 2006 Greener Synthetic Pathways Award

EPA Pesticide Factsheets

Presidential Green Chemistry Challenge 2006 award winner, Merck, discovered the asymmetric catalytic hydrogenation of unprotected enamines to make beta-amino acids. Merck applied this to synthesize sitagliptin (Januvia).

Postpartum Blood Clots

MedlinePlus

... View The Professional Version For doctors and medical students Consumer Version Merck Manual Consumer Version × MERCK MANUAL - ... View The Professional Version For doctors and medical students Home Medical Topics Blood Disorders Bone, Joint, and ...

Overview of Movement Disorders

MedlinePlus

... View The Professional Version For doctors and medical students Consumer Version Merck Manual Consumer Version × MERCK MANUAL - ... View The Professional Version For doctors and medical students Home Medical Topics Blood Disorders Bone, Joint, and ...

Polyps of the Cervix

MedlinePlus

... View The Professional Version For doctors and medical students Consumer Version Merck Manual Consumer Version × MERCK MANUAL - ... View The Professional Version For doctors and medical students Home Medical Topics Blood Disorders Bone, Joint, and ...

Research Tool Patents--Rumours of their Death are Greatly Exaggerated

ERIC Educational Resources Information Center

Carroll, Peter G.; Roberts, John S.

2006-01-01

Using a patented drug during clinical trials is not infringement [35 U.S.C. 271(e)(1)]. Merck v Integra enlarged this "safe harbour" to accommodate preclinical use of drugs and patented "research tools" if "reasonably related" to FDA approval. The decision allowed lower courts, should they wish, to find any use of a research tool, except for…

Vitamin B12 and Folate Test

MedlinePlus

... http://www.nlm.nih.gov . Accessed February 2014. Johnson, L. (Updated 2014 October). Folate. Merck Manual. Available ... intro.html through http://www.cc.nih.gov . Johnson, L. Vitamin B12. Merck Manual Second Home Edition, ...

Presidential Green Chemistry Challenge: 2005 Greener Synthetic Pathways Award (Merck & Co., Inc.)

EPA Pesticide Factsheets

Presidential Green Chemistry Challenge 2005 award winner, Merck, designed an atom-economical, energy- and water-saving, convergent synthesis for aprepitant, the active ingredient in Emend, a drug for nausea and vomiting.

Abnormal Position and Presentation of the Fetus

MedlinePlus

... View The Professional Version For doctors and medical students Consumer Version Merck Manual Consumer Version × MERCK MANUAL - ... View The Professional Version For doctors and medical students Home Medical Topics Blood Disorders Bone, Joint, and ...

Syrinx of the Spinal Cord and Brain Stem

MedlinePlus

... View The Professional Version For doctors and medical students Consumer Version Merck Manual Consumer Version × MERCK MANUAL - ... View The Professional Version For doctors and medical students Home Medical Topics Blood Disorders Bone, Joint, and ...

Medical therapy cost considerations for glaucoma.

PubMed

Fiscella, Richard G; Green, Amy; Patuszynski, Daniel H; Wilensky, Jacob

2003-07-01

To determine the calculated daily patient cost (cost minimization) of medical glaucoma therapy and review cost trends. Experimental, controlled, prospective study. The actual volume of various glaucoma medications or glaucoma medications with redesigned bottles was determined for most commercially available sizes of the tested products. The drops per milliliter based on the actual volume and the daily costs of the dosage schedules recommended by the manufacturers were compared. The cost of each bottle of medication was determined from the average wholesale price (AWP) in the United States. A comparison to 1999 prices where applicable will be analyzed to review costing trends. The generic timolol products (range, US dollars 0.38-US dollars 0.46 per day) were similar on a cost per day basis vs Betimol (Santen, Napa Valley, California, USA), Optipranolol (Bausch and Lomb Pharmaceuticals, Tampa, Florida, USA) and Timoptic (Merck, West Point, Pennsylvania, USA). Their percentage cost increase ranged from 5% to 22% since 1999, except for generic timolol XE gel-forming solution (48%). Betagan (Allergan, Irvine, California, USA), Betoptic S (Alcon Laboratories, Fort Worth, Texas, USA), and Ocupress (Novartis, Duluth, Georgia, USA) ranged from US dollars 0.88 to US dollars 1.11 per day, and their percentage cost increase ranged from 33% to 53%. Some brand-only products have raised their AWPs a greater percentage, including Betoptic S (37%), Iopidine (Alcon, Fort Worth, Texas, USA) (50%), Ocupress (Novartis Ophthalmics, Duluth, Georgia, USA) (53%), and Pilopine gel (Alcon, Fort Worth, Texas, USA) (32%). The mean cost per day for the topical carbonic anhydrase inhibitors Azopt (Alcon Laboratories; US dollars 1.33 per day) and Trusopt (Merck; US dollars 1.05 per day) differed from 1999 when prices were almost identical. Cosopt (Merck; timolol 0.5% plus dorzolamide 2%, US dollars 1.04 per day) was less than the cost of separate bottles of a topical carbonic anhydrase inhibitor and a beta-blocker. The selective alpha-2 agonist brimonidine 0.15% with Purite (Alphagan-P, Allergan, 5 ml) twice daily was US dollars 1.29 per day. The prostaglandin analogs were comparably priced with Lumigan (Allergan) US dollars 0.95 per day, Xalatan (Pharmacia and Upjohn, Kalamazoo, Michigan, USA) US dollars 1.25 per day, Travatan (Alcon Laboratories) US dollars 1.01 per day, and Rescula (Novartis) US dollars 0.90 per day. All generic timolol, Betimol, Optipranolol, Timoptic, and Timoptic XE (Merck) ranged from US dollars 0.38 to US dollars 0.50 per day. Other beta-blocker products were about twice as costly, ranging from US dollars 0.88 to US dollars 1.11 per day. Cosopt (US dollars 1.05 per day) was less costly than separate bottles of a topical beta-blocker and a topical carbonic anhydrase inhibitor dosed three times daily or twice daily. The prostaglandin analogs ranged from US dollars 0.90 per day (Rescula) to US dollars 1.25 per day (Xalatan). Newer glaucoma medications exhibit similar costs per day in many cases, compared with more traditional medications, especially with greater price increases in older brand-only products.

Science Instruction in Newark Public Schools. CPRE Research Report # RR-71

ERIC Educational Resources Information Center

Corcoran, Thomas B.; Gerry, Gail B.

2011-01-01

The Consortium for Policy Research in Education (CPRE) has prepared this report on the Newark Public Schools (NPS) for the Merck Institute for Science Education (MISE) to assist them with the development of a strategic plan for improving science education in the district. The data used in the report have been gathered and analyzed through the…

Genetics Home Reference: atypical hemolytic-uremic syndrome

MedlinePlus

... Kidney Diseases: Kidney Failure: Choosing a Treatment That's Right for You Educational Resources (6 links) Disease InfoSearch: Hemolytic uremic syndrome, atypical MalaCards: genetic atypical hemolytic-uremic syndrome Merck Manual Consumer Version: Overview of Anemia Merck Manual Consumer Version: ...

Hazardous Waste Cleanup: Merck Sharp & Dohme Corporation in Linden Cities, New Jersey

EPA Pesticide Factsheets

The Merck facility is located at 126 East Lincoln Avenue in Rahway and Linden Cities, Union County, New Jersey on 210 acres. The facility is bordered by residential and industrial areas. The company develops and produces pharmaceutical products.

Revised guidelines for good practice in IVF laboratories (2015).

PubMed

De los Santos, Maria José; Apter, Susanna; Coticchio, Giovanni; Debrock, Sophie; Lundin, Kersti; Plancha, Carlos E; Prados, Fernando; Rienzi, Laura; Verheyen, Greta; Woodward, Bryan; Vermeulen, Nathalie

2016-04-01

Which recommendations can be provided by the European Society of Human Reproduction and Embryology Special Interest Group (ESHRE SIG) Embryology to support laboratory specialists in the organization and management of IVF laboratories and the optimization of IVF patient care? Structured in 13 sections, the guideline development group formulated recommendations for good practice in the organization and management of IVF laboratories, and for good practice of the specific procedures performed within the IVF laboratory. NA. The guideline was produced by a group of 10 embryologists representing different European countries, settings and levels of expertise. The group evaluated the document of 2008, and based on this assessment, each group member rewrote one or more sections. Two 2-day meetings were organized during which each of the recommendations was discussed and rewritten until consensus within the guideline group was reached. After finalizing the draft, the members of the ESHRE SIG embryology were invited to review the guideline. NA. The guideline provides recommendations on the general organization of an IVF laboratory (staffing and direction, quality management, laboratory safety), and on the specific aspects of the procedures performed in IVF laboratories (Identification of patients and traceability of their reproductive cells, consumables, handling of biological material, oocyte retrieval, sperm preparation, insemination of oocytes, scoring for fertilization, embryo culture and transfer, and cryopreservation). A last section provides recommendations regarding an Emergency plan for IVF laboratories. Evidence on most of the issues described is scarce, and therefore it was decided not to perform a formal search for and assessment of scientific evidence. However, recommendations published in the EUTCD and relevant and recent documents, manuals and consensus papers were taken into account when formulating the recommendations. Despite the limitations, the guideline group is confident that this document will be helpful to directors and managers involved in the management and organization of IVF laboratories, but also to embryologists and laboratory technicians performing daily tasks. The guideline was developed and funded by ESHRE, covering expenses associated with the guideline meetings. The guideline group members did not receive payment. Dr Coticchio reports speaker's fees from IBSA and Cook, outside the submitted work; Dr Lundin reports grants from Vitrolife, personal fees from Merck Serono, non-financial support from Unisense, outside the submitted work; Dr. Rienzi reports personal fees from Merck Serono, personal fees from MSD, grants from GFI, outside the submitted work; the other authors had nothing to disclose. NA. © The Author 2016. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Immune Senescence Factors Associated with the Immunogenicity of a Live Attenuated Zoster Vaccine (ZV) in Older Adults

PubMed Central

Weinberg, Adriana; Schamder, Kenneth; Johnson, Michael; Popmihajlov, Zoran; Tovar-Salazar, Adriana; Caldas, Yupanqui; Pang, Lei; Cho, Alice; Levin, Myron

2017-01-01

Abstract Background ZV confers protection against herpes zoster by increasing the cell-mediated immunity (CMI) to varicella-zoster virus (VZV). ZV immunogenicity and protection decrease with increasing age. We investigated effects of age and immune senescence on ZV immunogenicity. Methods 399 adults ≥50 years had VZV T-cell helper 1 (Th1) CMI measured by ex vivo VZV-stimulated IL2/IFNg ELISPOT and blood T-cell nonspecific immune senescence by flow cytometric characterization of FOXP3, CD25, IL10, TGFb, PD1, CD28, CD57 and CD31 expression before and at 1, 6 and 52 weeks after ZV. In a subset of 95 vaccinees, VZV-stimulated T cell expression of CD107, Granzyme B, FOXP3, CD25, IL10, TGFb, CD39 and PD1 were also measured. Multivariate regression analysis was used to identify independent effects of age and immune senescence on VZV Th1 CMI (P < 0.025). Results IL2+ and IL2+IFNg+ Th1 memory VZV CMI peaked at 6 weeks after ZV and remained elevated at 1 year. Effectors, including VZV-specific IFNg+ Th1, and CD8+CD107+% and CD4+/CD8+Granzyme B+% cytotoxic T lymphocytes (CTL), peaked at 1 week, but only the IFNg+ Th1 effectors remained elevated at 1 year. There was also a transient increase in blood CD8+PD1+% exhausted T cells 1 week after ZV. Independent positive effects on peak memory Th1 VZV CMI included the baseline CMI and negative effects included blood CD4+FOXP3+% T regulatory (Treg) and CD8+PD1+% T exhausted cells. Independent positive effects on peak effector Th1 VZV CMI included baseline CMI and negative effects included blood CD8+CD25+FOXP3+% Treg. Age did not have an independent effect on peak CMI. Independent positive effects on persistent (1 year) memory Th1 included baseline CMI and negative effects included age, blood CD4+FOXP3+% Treg and CD8+PD1+% T exhausted cells. Persistent effector Th1 CMI was negatively affected by age only. Conclusion ZV generated VZV-specific Th1 and CTL responses. The early increase of CD8+ exhausted T cells in blood suggested that CTL responses to the vaccine virus may be compromised by immune senescence. The negative of age on VZV Th1 CMI was fully mediated by immune senescence at peak response, but age had a negative effect on CMI persistence that was independent from the markers of immune senescence included in this study. Disclosures A. Weinberg, merck: Grant Investigator, Research grant K. Schamder, merck: Grant Investigator, Research grant Z. Popmihajlov, Merck & Co., Inc.: Employee and Shareholder, Salary L. Pang, Merck: Employee and Shareholder, Salary M. Levin, merck: Grant Investigator and Scientific Advisor, Consulting fee and Research grant

Practices of excellent companies in the drug industry.

PubMed

Pringle, F; Kleiner, B H

1997-01-01

Examines excellence in three major pharmaceutical companies: Merck, Lilly, and Glaxo. Provides an overview of recent trends in the health care industry. Shows that although all three companies are facing tough competition and strict cost-containment pressures, they continue to develop innovative strategies for increasing the quality of their product offering. Analyses Merck's recent acquisition of Medco and its implications; also highlights Merck's "Vital Interests" programme. Discusses Lilly's recent purchase of PCS from McKesson Drug and Lilly's recent efforts to concentrate on its core business. Introduces Helix, Glaxo's new computer network for pharmacists and explains the benefits of this unique service, both to its users and the sponsor.

Too fast or not too fast: the FDA's approval of Merck's HPV vaccine Gardasil.

PubMed

Tomljenovic, Lucija; Shaw, Christopher A

2012-01-01

There are not many public health issues where views are as extremely polarized as those concerning vaccines, and Merck's HPV vaccine Gardasil is a case in point. Ever since gaining the FDA's approval in 2006, Merck has been heavily criticized for their overly aggressive marketing strategies and lobbying campaigns aimed at promoting Gardasil as a mandatory vaccine. Subsequently, questions have been raised as to whether it was appropriate for vaccine manufacturers to partake in public health policies when their conflicts of interests are so obvious. Some of their advertising campaign slogans, such as "cervical cancer kills x women per year" and "your daughter could become one less life affected by cervical cancer," seemed more designed to promote fear rather than evidence-based decision making about the potential benefits of the vaccine. Although, conflicts of interests do not necessarily mean that the product itself is faulty, marketing claims should be carefully examined against factual science data. Currently Gardasil vaccination is strongly recommended by the U.S. and other health authorities while public concerns about safety and efficacy of the vaccine appear to be increasing. This discrepancy leads to some important questions that need to be resolved. The current review examines key issues of this debate in light of currently available research evidence. © 2012 American Society of Law, Medicine & Ethics, Inc.

Ovarian hyperstimulation syndrome: review and new classification criteria for reporting in clinical trials.

PubMed

Humaidan, P; Nelson, S M; Devroey, P; Coddington, C C; Schwartz, L B; Gordon, K; Frattarelli, J L; Tarlatzis, B C; Fatemi, H M; Lutjen, P; Stegmann, B J

2016-09-01

What is an objective approach that employs measurable and reproducible physiologic changes as the basis for the classification of ovarian hyperstimulation syndrome (OHSS) in order to facilitate more accurate reporting of incidence rates within and across clinical trials? The OHSS flow diagram is an objective approach that will facilitate consistent capture, classification and reporting of OHSS within and across clinical trials. OHSS is a potentially life-threatening iatrogenic complication of the early luteal phase and/or early pregnancy after ovulation induction (OI) or ovarian stimulation (OS). The clinical picture of OHSS (the constellation of symptoms associated with each stage of the disease) is highly variable, hampering its appropriate classification in clinical trials. Although some degree of ovarian hyperstimulation is normal after stimulation, the point at which symptoms transition from those anticipated to those of a disease state is nebulous. An OHSS working group, comprised of subject matter experts and clinical researchers who have significantly contributed to the field of fertility, was convened in April and November 2014. The OHSS working group was tasked with reaching a consensus on the definition and the classification of OHSS for reporting in clinical trials. The group engaged in targeted discussion regarding the scientific background of OHSS, the criteria proposed for the definition and the rationale for universal adoption. An agreement was reached after discussion with all members. One of the following conditions must be met prior to making the diagnosis of OHSS in the context of a clinical trial: (i) the subject has undergone OS (either controlled OS or OI) AND has received a trigger shot for final oocyte maturation (e.g. hCG, GnRH agonist [GnRHa] or kisspeptin) followed by either fresh transfer or segmentation (cryopreservation of embryos) or (ii) the subject has undergone OS or OI AND has a positive pregnancy test. All study patients who develop symptoms of OHSS should undergo a thorough examination. An OHSS flow diagram was designed to be implemented for all subjects with pelvic or abdominal complaints, such as lower abdominal discomfort or distention, nausea, vomiting and diarrhea, and/or for subjects suspected of having OHSS. The diagnosis of OHSS should be based on the flow diagram. This classification system is primarily intended to address the needs of the clinical investigator undertaking clinical trials in the field of OS and may not be applicable for the use in clinical practice or with OHSS occurring under natural circumstances. The proposed OHSS classification system will enable an accurate estimate of the incidence and severity of OHSS within and across clinical trials performed in women with infertility. Financial support for the advisory group meetings was provided by Merck & Co., Inc., Kenilworth, NJ, USA. P.H. reports unrestricted research grants from MSD, Merck and Ferring, and honoraria for lectures from MSD, Merck and IBSA. S.M.N. reports that he has received fees and grant support from the following companies (in alphabetic order): Beckman Coulter, Besins, EMD Serono, Ferring Pharmaceuticals, Finox, MSD and Roche Diagnostics over the previous 5 years. P.D., C.C.C., J.L.F., H.M.F., and P.L. report no relationships that present a potential conflict of interest. B.C.T. grants and honorarium from Merck Serono; unrestricted research grants, travel grants and honorarium, and participation in a company-sponsored speaker's bureau from Merck Sharp & Dohme; grants, travel grants, honoraria and advisory board membership from IBSA; travel grants from Ferring; and advisory board membership from Ovascience. L.B.S. reports current employment with Merck & Co, Inc., Kenilworth, NJ, USA, and owns stock in the company. K.G. and B.J.S. report prior employment with Merck & Co., Inc., Kenilworth, NJ, USA, and own stock in the company. All reported that competing interests are outside the submitted work. No other relationships or activities exist that could appear to have influenced the submitted work. Not applicable. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology 2016. This work is written by (a) US Government employee(s) and is in the public domain in the US.

Pharmaceutical companies' role in state vaccination policymaking: the case of human papillomavirus vaccination.

PubMed

Mello, Michelle M; Abiola, Sara; Colgrove, James

2012-05-01

We sought to investigate roles that Merck & Co Inc played in state human papillomavirus (HPV) immunization policymaking, to elicit key stakeholders' perceptions of the appropriateness of these activities, and to explore implications for relationships between health policymakers and industry. We used a series of state case studies combining data from key informant interviews with analysis of media reports and archival materials. We interviewed 73 key informants in 6 states that were actively engaged in HPV vaccine policy deliberations. Merck promoted school-entry mandate legislation by serving as an information resource, lobbying legislators, drafting legislation, mobilizing female legislators and physician organizations, conducting consumer marketing campaigns, and filling gaps in access to the vaccine. Legislators relied heavily on Merck for scientific information. Most stakeholders found lobbying by vaccine manufacturers acceptable in principle, but perceived that Merck had acted too aggressively and nontransparently in this case. Although policymakers acknowledge the utility of manufacturers' involvement in vaccination policymaking, industry lobbying that is overly aggressive, not fully transparent, or not divorced from financial contributions to lawmakers risks undermining the prospects for legislation to foster uptake of new vaccines.

Comparison of two types of dipsticks to measure vaginal pH in clinical practice.

PubMed

Donders, Gilbert G G; Caeyers, Tinne; Tydhof, Priska; Riphagen, Ine; van den Bosch, Thierry; Bellen, Gert

2007-10-01

To assess the practical use of two dispsticks for measuring vaginal pH with a range 4-7 (Merck and Macherey Nagel in the diagnosis of vaginal infections. Routine gynaecological clinic in the General Hospital H Hart in Tienen and vulvo-vaginitis clinic in the University Hospital Gasthuisberg in Leuven, Belgium. After oral consent was obtained, 101 unselected consecutive women presenting for gynaecologic examination between 15 January 2004 and 15 February 2004 were included in an observational study. Vaginal smears were taken from the upper vaginal wall for pH measurement and for fresh wet mount examination by phase contrast microscopy for diagnosing lactobacillary grades and presence of pathogens. The observed color change of two different pH strips were compared with the color scale provided by the company by a junior investigator who was not familiar with the technique, nor with the pathology of the patient. The difficulty of the measurement was scored semi-quantitatively by assessing the time and effort necessary to decide on the correct pH. Using the Macherey-Nagel method, the mean pH score was lower in women with normal flora and in women with vaginal infections than when the Merck method was used, but the difference was not significant. The pH became progressively more abnormal with increasing lactobacillary grades, a correlation that was similar for both tests. The reading of the pH sticks was significantly simpler and quicker with Macherey-Nagel than with Merck. Although difficult readings with Merck strips were four times more frequent in the group of women with abnormal flora than in women with normal flora, this difference was not significant. (1) In both tests (Macherey-Nagel and Merck) the pH was more abnormal (higher) with increasing lactobacillary grades (declining number of lactobacillary morphotypes). (2) The Macherey-Nagel sticks are more user-friendly than Merck's.

32nd National Medicinal Chemistry Symposium--medicinal chemistry developments for neurodegeneration, diabetes and cancer.

PubMed

Gater, Deborah

2010-08-01

The 32nd National Medicinal Chemistry Symposium, held in Minneapolis, MN, USA, included topics covering new developments in the field of medicinal chemistry. This conference report highlights selected presentations on NR2B subtype-selective NMDA receptor antagonists from Merck; selective neuronal nitric oxide synthase inhibitors from Northwestern University; novel GPR119 agonists, suchas GSK-1292263A (GlaxoSmithKline plc), PSN-821 ((OSI) Prosidion) and MBX-2982 (Metabolex Inc); a small-molecule Bcl inhibitor,navitoclax (Abbott Laboratories); and p53-targeting agents from sanofi-aventis and Ascenta Therapeutics Inc, including AT-219.

Pharmaceutical Companies’ Role in State Vaccination Policymaking: The Case of Human Papillomavirus Vaccination

PubMed Central

Abiola, Sara; Colgrove, James

2012-01-01

Objectives. We sought to investigate roles that Merck & Co Inc played in state human papillomavirus (HPV) immunization policymaking, to elicit key stakeholders’ perceptions of the appropriateness of these activities, and to explore implications for relationships between health policymakers and industry. Methods. We used a series of state case studies combining data from key informant interviews with analysis of media reports and archival materials. We interviewed 73 key informants in 6 states that were actively engaged in HPV vaccine policy deliberations. Results. Merck promoted school-entry mandate legislation by serving as an information resource, lobbying legislators, drafting legislation, mobilizing female legislators and physician organizations, conducting consumer marketing campaigns, and filling gaps in access to the vaccine. Legislators relied heavily on Merck for scientific information. Most stakeholders found lobbying by vaccine manufacturers acceptable in principle, but perceived that Merck had acted too aggressively and nontransparently in this case. Conclusions. Although policymakers acknowledge the utility of manufacturers’ involvement in vaccination policymaking, industry lobbying that is overly aggressive, not fully transparent, or not divorced from financial contributions to lawmakers risks undermining the prospects for legislation to foster uptake of new vaccines. PMID:22420796

Preparation and characterization of trihydroxamic acid functionalized carbon materials for the removal of Cu(II) ions from aqueous solution

NASA Astrophysics Data System (ADS)

Godino-Salido, M. Luz; Santiago-Medina, Antonio; López-Garzón, Rafael; Gutiérrez-Valero, María D.; Arranz-Mascarós, Paloma; López de la Torre, M. Dolores; Domingo-García, María; López-Garzón, F. Javier

2016-11-01

The main objective of this study is to prepare and characterize two functionalizated carbon materials with enhanced adsorptive properties for Cu(II). Thus, two novel hybrid materials have been prepared by a non-covalent functionalization method based on the adsorption of a pyrimidine-desferrioxamine-B conjugate compound (H4L) on two activated carbons, ACs (labelled Merck and F). The adsorption of H4L on the ACs is pH-dependent and highly irreversible. This is due to strong π-π interactions between the arene centers of the ACs and the pyrimidine moiety of H4L. The textural characterization of the AC/H4L hybrids shows large decreases of their surface areas. Thus the values of Merck and F are 1031 and 1426 m2/g respectively, while these of Merck/H4L and F/H4L hybrids are 200 and 322 m2/g. An important decrease in the micropore volumes is also found, due to the blockage of narrow porosity produced by the adsorption of H4L molecules. The ACs/H4L hybrids show larger adsorption capacities for Cu(II) (0.105(4) and 0.13(2) mmol/g, at pH 2.0, and 0.20(3) and 0.242(9) mmol/g, at pH 5.5, for Merck/H4L and F/H4L, respectively) than those of the ACs (0.024(6) and 0.096(9) mmol/g, at pH 2.0, and 0.10(2) and 0.177(8) mmol/g, at pH 5.5, for Merck and F respectively), which is explained on the basis of the complexing ability of the trihydroxamic acid functions. The desorption of Cu(II) from the ACs/H4L/Cu(II) materials in acid solution allows the regeneration of most active sites (78.5% in the case of Merck/H4L/Cu(II) and 83.0% in the case of F/H4L/Cu(II)).

Changes in the use profile of Mectizan: 1987-1997.

PubMed

Brown, K R

1998-04-01

The usually conservative approach of Merck & Co. to drug development became even more so in the Mectizan (ivermectin, MSD) programme because of adverse experiences following 'extra-label' use in Collie dogs and the discovery of a low threshold for acute neurotoxicity in CF-1 mice. Although a very cautious approach and rapid development programme ensued, Merck remained conservative and excluded children under the age of 5 years, pregnant women, and mother who were nursing children under the age of 3 months from treatment. A subsequent, more relaxed set of standards was based on vast human clinical experience, inadvertent use in hundreds of pregnant women without ill-effect, and new laboratory information indicating that the presence of a protective blood-brain barrier protein component (P-glycoprotein) helped to stop Mectizan from crossing the placenta and from crossing the blood-brain barrier in most animal species, including humans. This has allowed more groups to be included in Mectizan treatments: pregnant women living in areas where the risk of loss of sight because of onchocerciasis is very high; and women who are nursing children as young as 1 week of age. Mass distribution of the drug continues to be largely under community control and the likelihood of serious adverse experiences related to finding a human population with unusually low levels of P-glycoprotein (or no P-glycoprotein) seems remote.

Gangliosides During Tumor Progression in Patients With Prostate Cancer

DTIC Science & Technology

2004-07-01

plates (10xlO cm) precoated with Silica Gel 60 ( glass or aluminium backing) (E. Merck, Darmstadt, Germany) were used. Two dimensional HPTLC was...Investigation, 15 (1997) 491-499. 16 16. T. Shiraishi, M. T. Kinter, S. E. Mills, M. C. Lippert , G. S. Bova, W. W. Jr. Young, The glycosphingolipids of human...described earlier (21, 22). HPTLC plates (1 Ox1 0 cm) precoated with silica gel 60 ( glass or aluminum backing) (E. Merck, Darmstadt, Germany) were

ASP Strategies and Appropriate Antibiotic Use

PubMed Central

Lee, Brian R; Tribble, Alison; Handy, Lori; Gerber, Jeffrey S; Hersh, Adam L; Kronman, Matthew; Terrill, Cindy; Newland, Jason

2017-01-01

Abstract Background The Infectious Diseases Society of America (IDSA) recommends hospitals implement antimicrobial stewardship programs (ASP) in order to decrease inappropriate antibiotic use due to the rise in antibiotic-resistant infections. Data are limited on the extent to which different ASP strategies influence appropriate antibiotic use. Methods We conducted an online survey in 2016 of U.S. Children’s Hospitals to collect hospital-level information on dedicated ASP effort, ASP monitoring activities, use of audit-feedback, formulary restrictions, rapid diagnostics, etc. During the same period the ASP teams at these hospitals completed 3 point prevalence surveys that documented details on all admitted patients 0–17 years receiving any antibiotics, determined what ASP modifications could be made, and if the antibiotic was appropriate. We employed hierarchical, multivariable logit models to examine which ASP-related, hospital-level strategies were associated with appropriate antibiotic use. Results Thirty hospitals participated. A total of 6,921 patients were included, representing 10,068 total antibiotics. Of these orders, 8,554 (85.0%) were categorized as appropriate, though this varied across sites (range: 68-92%). Additionally, 78.2% of antibiotics did not have recommended modifications. Appropriate antibiotic use was significantly higher for hospitals that relied on rapid diagnostics (aOR: 1.6; P < 0.001) or monitored their days of therapy (DOT) rate (aOR: 1.4; P < 0.001), whereas the presence of either audit-feedback (aOR: 1.04; P = 0.75) or formulary restrictions (aOR: 0.83; P = 0.059) were not associated. Having annual education for all prescribers had increased likelihood of antibiotics having no modification recommendations (aOR: 1.45; P = 0.037). Total ASP FTE was not correlated with hospital-level percent appropriate use (corr: −0.05; P = 0.79) or antibiotic modification recommendations (corr: −0.08; P = 0.67). Conclusion Routine monitoring of DOT rates and utilization of rapid diagnostics were associated with appropriate antibiotic use. Additional analysis is needed to understand additional factors that can aid hospitals in developing and maintaining ASPs to reduce inappropriate antibiotic use. Disclosures B. R. Lee, Merck: Grant Investigator, Grant recipient. PCORI: Grant Investigator, Grant recipient. C. Terrill, Merck: Grant Investigator, Research grant Allergan: Grant Investigator, Research grant. J. Newland, Merck: Grant Investigator, Research grant. Allergan: Grant Investigator, Research grant

Interview: from Down's syndrome to basic epigenetics and back again.

PubMed

Lawrence, Jeanne; Telfer, Caroline

2013-12-01

Dr Jeanne Lawrence talks to Caroline Telfer, Commissioning Editor. Dr Jeanne Lawrence is an internationally recognized leader in the study of chromosome regulation by noncoding RNA and nuclear and genome organization. Her research bridges fundamental questions about genome regulation with clinical implications of recent advances in epigenetics. Her interest in chromosome structure and regulation has been a theme throughout her career and she has been honored for her work developing sensitive FISH technology for the detection of single copy genes, as well as RNAs. Her laboratory's publications include the initial demonstration of cell type-specific gene organization with nuclear subdomains; the novel biology of a noncoding RNA, XIST, which coats a whole X-chromosome to induce its silencing; and a new architectural role for a large noncoding RNA to scaffold a nuclear body. Her laboratory's work on epigenetic chromosome regulation in stem cells led to recent studies regarding unanticipated roles of repeat sequences in normal chromosome regulation and deregulation in cancer. Most recently, her laboratory has demonstrated a new approach to translate the basic mechanism of X-chromosome inactivation to correct a chromosomal dosage imbalance in patient-derived cells with trisomy 21 (Down's syndrome). Dr Lawrence has received awards from numerous agencies, including a Research Career Development Award from the National Center for Human Genome Research, career awards from the American Society of Cell Biology, the German Society for Biochemistry, the Muscular Dystrophy Association and a John Merck Fund Translational Research Award. She has served on the NIH National Advisory Council for Human Genome Research, numerous study sections and is currently a monitoring editor for the Journal of Cell Biology. Dr Lawrence has a BA in Biology and Music from Stephens College (MO, USA), a MS in Human Genetics and Genetic Counseling from Rutgers University (NJ, USA) and a PhD in Developmental Biology from Brown University (RI, USA). She is currently a Professor and Interim Chair of the Department of Cell and Developmental Biology at the University of Massachusetts Medical School (MA, USA).

Medicine patent pool--pharma philanthropy or PR?

PubMed

De Luca, Carmela

2015-01-01

Merck recently signed an agreement with The Medicines Patent Pool (MPP) to license intellectual property relating to pediatric formulations of its integrase HIV drug, raltegravir (Ral) (the 'Agreement'). The Agreement is alleged to clear the way for cheaper formulations for use in developing and some middle income countries and allows for the development of novel pediatric formulations of Ral as well as novel combinations. Merck's license is royalty free and under the terms of the Agreement, manufacturers anywhere in the world who meet the quality assurance criteria, can manufacture and sell pediatric versions of the drug in the licensed countries under the agreed conditions without paying a royalty to Merck. The Agreement covers at least 92 countries and MPP reports that 98.1% of children with HIV in the developing world live in the included countries. The Agreement has been criticized as a public relations exercise. The article asks if the criticism is justified and explores several aspects of the Agreement in addressing the question.

Elastase inhibitors as potential therapies for ELANE-associated neutropenia.

PubMed

Makaryan, Vahagn; Kelley, Merideth L; Fletcher, Breanna; Bolyard, Audrey Anna; Aprikyan, A Andrew; Dale, David C

2017-10-01

Mutations in ELANE , the gene for neutrophil elastase (NE), a protease expressed early in neutrophil development, are the most frequent cause of cyclic (CyN) and severe congenital neutropenia (SCN). We hypothesized that inhibitors of NE, acting either by directly inhibiting enzymatic activity or as chaperones for the mutant protein, might be effective as therapy for CyN and SCN. We investigated β-lactam-based inhibitors of human NE (Merck Research Laboratories, Kenilworth, NJ, USA), focusing on 1 inhibitor called MK0339, a potent, orally absorbed agent that had been tested in clinical trials and shown to have a favorable safety profile. Because fresh, primary bone marrow cells are rarely available in sufficient quantities for research studies, we used 3 cellular models: patient-derived, induced pluripotent stem cells (iPSCs); HL60 cells transiently expressing mutant NE; and HL60 cells with regulated expression of the mutant enzyme. In all 3 models, the cells expressing the mutant enzyme had reduced survival as measured with annexin V and FACS. Coincubation with the inhibitors, particularly MK0339, promoted cell survival and increased formation of mature neutrophils. These studies suggest that cell-permeable inhibitors of neutrophil elastase show promise as novel therapies for ELANE -associated neutropenia. © Society for Leukocyte Biology.

Guest authorship and ghostwriting in publications related to rofecoxib: a case study of industry documents from rofecoxib litigation.

PubMed

Ross, Joseph S; Hill, Kevin P; Egilman, David S; Krumholz, Harlan M

2008-04-16

Authorship in biomedical publication provides recognition and establishes accountability and responsibility. Recent litigation related to rofecoxib provided a unique opportunity to examine guest authorship and ghostwriting, practices that have been suspected in biomedical publication but for which there is little documentation. To characterize different types and the extent of guest authorship and ghostwriting in 1 case study. Court documents originally obtained during litigation related to rofecoxib against Merck & Co Inc. Documents were created predominantly between 1996 and 2004. In addition, publicly available articles related to rofecoxib identified via MEDLINE. All documents were reviewed by one author, with selected review by coauthors, using an iterative process of review, discussion, and rereview of documents to identify information related to guest authorship or ghostwriting. Approximately 250 documents were relevant to our review. For the publication of clinical trials, documents were found describing Merck employees working either independently or in collaboration with medical publishing companies to prepare manuscripts and subsequently recruiting external, academically affiliated investigators to be authors. Recruited authors were frequently placed in the first and second positions of the authorship list. For the publication of scientific review papers, documents were found describing Merck marketing employees developing plans for manuscripts, contracting with medical publishing companies to ghostwrite manuscripts, and recruiting external, academically affiliated investigators to be authors. Recruited authors were commonly the sole author on the manuscript and offered honoraria for their participation. Among 96 relevant published articles, we found that 92% (22 of 24) of clinical trial articles published a disclosure of Merck's financial support, but only 50% (36 of 72) of review articles published either a disclosure of Merck sponsorship or a disclosure of whether the author had received any financial compensation from the company. This case-study review of industry documents demonstrates that clinical trial manuscripts related to rofecoxib were authored by sponsor employees but often attributed first authorship to academically affiliated investigators who did not always disclose industry financial support. Review manuscripts were often prepared by unacknowledged authors and subsequently attributed authorship to academically affiliated investigators who often did not disclose industry financial support.

Prevalence and Cost of Subsequent Fractures Among U.S. Patients with an Incident Fracture.

PubMed

Weaver, Jessica; Sajjan, Shiva; Lewiecki, E Michael; Harris, Steven T; Marvos, Panagiotis

2017-04-01

The prevalence and cost of subsequent fractures among patients with an incident fracture are not well defined. To assess the prevalence of, and costs associated with, subsequent fractures in the year after an incident fracture. This was a retrospective claims database analysis using data from Humana Medicare Advantage claims (Medicare group) and Optum Insight Clinformatics Data Mart commercial claims (commercial group). Patients included in the study had a claim for a qualifying fracture occurring between January 2008 and December 2013 (index fracture), were continuously enrolled in the health plan for ≥ 1 year before and after the index fracture, and were aged ≥ 65 years in the Medicare group or ≥ 50 years in the commercial group at the time of the index fracture. Subsequent fractures were identified by ICD-9-CM codes and were defined as the second fracture occurring ≥ 3 to ≤ 12 months after the index fracture (≥ 6 to ≤ 12 months for fractures at the same site as the index fracture). Rates of subsequent fractures were calculated as the number of patients who had a subsequent fracture divided by the total sample size. After propensity matching of demographic and clinical variables, we determined the total medical and pharmacy costs accrued within 1 year of the index fracture by patients with and without a subsequent fracture. Health care costs were compared between patients with and without a subsequent fracture using McNemar's test. A total of 45,603 patients were included in the Medicare group, and 54,145 patients were included in the commercial group. In the Medicare group, 7,604 (16.7%) patients experienced a subsequent fracture. The proportion of patients with a subsequent fracture was highest among patients with multiple index fractures (26.2%, n = 905), followed by those with hip (25.5%, n = 1,280) and vertebral (20.2%, n = 1,908) index fractures. In the commercial group, 6,256 (11.6%) patients experienced a subsequent fracture. The proportion of patients with a subsequent fracture paralleled those observed in the Medicare group: 24.5% (n = 808) in patients with multiple index fractures, 22.0% (n = 525) in those with hip fracture, and 14.5% (n = 841) in those with vertebral fracture. For vertebral, hip, and nonhip nonvertebral fractures, subsequent fractures were most frequently of the same type as the index fracture. The mean total health care cost (sum of medical and pharmacy costs) in the year following the incident fracture for the Medicare group was $27,844 and differed significantly between patients with and without a subsequent fracture ($34,897 vs. $20,790; P < 0.001). The mean total health care cost in the year following the incident fracture for the commercial group was $29,316 and also differed significantly between patients with and without a subsequent fracture ($39,501 vs. $19,131; P < 0.001). Among patients with an incident fracture, those who experienced a subsequent fracture in the following year had significantly higher health care costs than those who did not. A subsequent fracture is most likely to be of the same type as the initial fracture. This study was funded by Merck & Co. Other than through the employer relationships disclosed here, Merck & Co did not have a role in the study design, data collection, interpretation of the data, in writing of the manuscript, or in the decision to submit the manuscript for publication. Weaver and Marvos are employees of Merck & Co. Sajjan was an employee of Merck & Co. and owned stock in the company at the time of the study. Lewiecki has received consulting and/or speaker honoraria from Merck, AbbVie, AgNovos Healthcare, Alexion Pharmaceuticals, Amgen, Eli Lilly and Company, Radius Health, Shire, and TheraNova. Lewiecki has received research grant support from Merck, Amgen, and Eli Lilly and Company and serves as a board member for the National Osteoporosis Foundation, the International Society for Clinical Densitometry, and the Osteoporosis Foundation of New Mexico. Harris has received consulting honoraria from Merck, Alexion Pharmaceuticals, Amgen, Eli Lilly and Company, Gilead Sciences, Primus Pharmaceuticals, and Radius Health. Study concept and design were contributed by Weave and Sajjan. Lewiecki collected the data, and data interpretation was performed by all the authors. The manuscript was written and revised by Weaver, Lewiecki, and Harris.

Diagnosis and Treatment of Osteoporosis Before and After Fracture: A Side-by-Side Analysis of Commercially Insured and Medicare Advantage Osteoporosis Patients.

PubMed

Weaver, Jessica; Sajjan, Shiva; Lewiecki, E Michael; Harris, Steven T

2017-07-01

Although treatment for osteoporosis is recommended by U.S. clinical guidelines, a lack of diagnosis and treatment is common among patients with osteoporotic fractures. To determine the rates of osteoporosis diagnosis and treatment before and after various types of fractures. This was a retrospective claims analysis using data from the Humana Medicare Advantage claims (Medicare group) and Optum Insight Clinformatics Data Mart commercial claims (Commercial group). Patients included in the study had a claim for a qualifying fracture occurring between January 2008 and December 2013 (the index fracture), were continuously enrolled in the health plan for ≥ 1 year before and after the index fracture, and were aged ≥ 65 years in the Medicare group or ≥ 50 years in the Commercial group at the time of the index fracture. Fragility fractures and osteoporosis diagnoses were identified from ICD-9-CM codes. Treatment for osteoporosis included oral and injectable therapies identified by National Drug Code numbers and Healthcare Common Procedure Coding System codes. Diagnosis and treatment rates were assessed during the 1-year periods before and after the index fracture. All analyses were conducted by fracture type (vertebral, hip, nonhip/nonvertebral [NHNV], and multiple), with stratification by age and sex. No comparisons were made between the Medicare and Commercial groups; rather, McNemar tests were used to compare prefracture versus postfracture diagnosis and treatment rates within each group. For inclusion in the Medicare group, 45,603 patients were identified, and 54,145 patients were identified for the Commercial group. In the prefracture period, the osteoporosis diagnosis rates ranged from 12.0% (NHNV) to 21.5% (vertebral) in the Medicare group and from 5.3% (NHNV) to 12.1% (vertebral) in the Commercial group. In the postfracture period, diagnosis rates significantly increased (P < 0.001)-and nearly doubled-for all fracture types but did not exceed 42.1% (vertebral) in the Medicare group and 27.7% (vertebral) in the Commercial group. Pre-index treatment rates were similarly low, ranging from 9.4% (hip) to 16.6% (vertebral) among Medicare patients, and 7.5% (NHNV) to 14.4% (vertebral) in Commercial patients. Osteoporosis treatment rates improved significantly in the postfracture year, ranging from 12.5% (NHNV) to 26.5% (vertebral) among Medicare patients, and 8.3% (NHNV) to 21.4% (vertebral) in Commercial patients. Larger increases in diagnosis rates and smaller increases in treatment rates were observed in stratified analyses of men and women and of different age groups, with women and older patients having higher overall rates of diagnosis and treatment before and after fracture. In men and women, osteoporosis diagnosis rates were low before the index fracture and improved substantially after the fracture, yet still remained low overall (under 50%). Osteoporosis treatment rates among patients experiencing a fracture were low before the index fracture and improved only minimally afterwards. This study was funded by Merck & Co. Other than through the employer relationship disclosed here, Merck & Co. did not have a role in the study design, data collection, interpretation of the data, in writing of the manuscript, or in the decision to submit the manuscript for publication. Weaver is an employee of Merck & Co. Sajjan was an employee of Merck & Co. and owned stock in the company at the time of the study. Lewiecki has received consulting and/or speaker honoraria from Merck & Co., AbbVie, AgNovos Healthcare, Alexion Pharmaceuticals, Amgen, Eli Lilly and Company, Radius Health, Shire, and TheraNova, along with research grant support from Merck & Co., Amgen, and Eli Lilly and Company, and serves as a board member for the National Osteoporosis Foundation, the International Society for Clinical Densitometry, and the Osteoporosis Foundation of New Mexico. Harris has received consulting honoraria from Merck & Co., Alexion Pharmaceuticals, Amgen, Eli Lilly and Company, Gilead Sciences, Primus Pharmaceuticals, and Radius Health. Study concept and design were contributed by Weaver and Sajjan. Sajjan collected the data, and data interpretation was performed by all the authors. The manuscript was written and revised by Weaver, Lewiecki, and Harris.

Discordance of SHEA/IDSA Clostridium difficile Disease Severity Scale in Solid Organ Transplant Patients

PubMed Central

Lee, Tiffany; McCoy, Christopher; Alonso, Carolyn D; Snyder, Graham M; Rogers, Christin; Richards, Katelyn; Hirsch, Elizabeth B; Mahoney, Monica V

2017-01-01

Abstract Background Solid organ transplant (SOT) patients are at high risk for Clostridium difficile infections (CDI) due to chronic immunosuppression and a propensity to receive antimicrobials. Management of CDI in SOT patients poses unique challenges as this population has disease-altered clinical and laboratory parameters. The objective of this study was to assess concordance between various CDI severity scales and the Society for Healthcare Epidemiology of America/Infectious Diseases Society of America (SHEA/IDSA) guidelines. Methods This retrospective study included all SOT recipients with a first CDI episode following transplant and time-matched (2:1) to non-SOT patients experiencing first CDI episodes between 2008 and 2016. The primary endpoint was concordance rates of CDI episodes considered mild-moderate or severe/severe-complicated in published CDI scales compared with the SHEA/IDSA guidelines. We also sought to compare the distribution of CDI severity across all scales between SOT and non-SOT patients. Results Overall, 32 SOT patients and 64 non-SOT patients were included. The SOT group had significantly higher leukopenia rates at CDI diagnosis; however, the magnitude of serum creatinine change did not differ between groups. According to the SHEA/IDSA scale, CDI episodes in SOT recipients were categorized as mild-moderate and severe/severe-complicated in 23 (72%) and 9 (28%) patients, respectively. Overall concordance rates among SHEA/IDSA guidelines and other scales ranged from 28% to 72%. Concordance rates were highest for mild-moderate CDI with Belmares and for severe/severe-complicated CDI with ESCMID (Table 1). No scale evenly categorized SOT and non-SOT patients across all severities (Figure 1). Conclusion Severity scales with heavy emphasis on white blood cell counts may not adequately categorize SOT patients. Immunocompromised status may need to be considered on its own when categorizing CDI severity and prescribing therapy. Table 1 Number (%) of Severity Classification-Concordant CDI Episodes, in Comparison to SHEA/IDSA Guidelines Overall n = 32 Mild/Moderate n = 23 Severe or Severe-Complicated n = 9 AST 23 (71.9) 18 (78.3) 5 (55.6) ESCMID 9 (28.1) 0 9 (100) Zar 20 (62.5) 13 (56.5) 7 (77.8) Belmares 22 (68.8) 22 (95.7) 0 Disclosures C. D. Alonso, Merck: Grant Investigator and Scientific Advisor, Research grant sanofi pasteur: Investigator and Scientific Advisor, Research support GSK: Investigator, Research support; E. B. Hirsch, Merck: Grant Investigator, Grant recipient The Medicines Company: Speaker’s Bureau, Speaker honorarium

FERC ruling highlights differences between notification and certification procedures for qualifying facilities

DOE Office of Scientific and Technical Information (OSTI.GOV)

Not Available

1984-06-01

On June 15, the FERC dismissed a motion by the Puerto Rico Electric Power Authority (PREPA) to intervene to challenge the filing of Merck, Sharp and Dohme Quimica De Puerto Rico, Inc. (Merck), for qualifying status under PURPA. (Docket QF 84-188). The FERC's reason for dismissing the motion for intervention was that the Merck submission was not a true application for certification, but rather, merely a notice that the proposed facility would in fact be a qualifying facility. Under FERC rules, a qualifying cogenerator or small power producer may follow either of two procedures: (1) an application procedure, under whichmore » the FERC will rule on whether a particular facility is a qualifying facility, or (2) a notification procedure, under which FERC does not rule. The application is a voluntary, optional procedure, provided by FERC for situations in which a potential qualifying facility requires affirmative certification, typically for financing purposes. Otherwise, merely filing a notification is sufficient for a qualifying facility to be able to take advantage of the benefits of PURPA.« less

Corifollitropin alfa followed by highly purified HMG versus recombinant FSH in young poor ovarian responders: a multicentre randomized controlled clinical trial.

PubMed

Drakopoulos, Panagiotis; Vuong, Thi Ngoc Lan; Ho, Ngoc Anh Vu; Vaiarelli, Alberto; Ho, Manh Tuong; Blockeel, Christophe; Camus, Michel; Lam, Anh Tuan; van de Vijver, Arne; Humaidan, Peter; Tournaye, Herman; Polyzos, Nikolaos P

2017-11-01

Does administration of corifollitropin alfa followed by highly purified (hp) HMG result in higher ongoing pregnancy rates compared with daily recombinant FSH (rFSH) in young poor responders? Corifollitropin alfa followed by hp-HMG does not increase ongoing pregnancy rates compared with rFSH in young poor responders, although more supernumerary cryopreserved embryos were obtained with corifollitropin alfa and hp-HMG. Poor ovarian response remains one of the main therapeutic challenges in women undergoing ovarian stimulation, given that very low live birth rates of 6% have been reported in this particular group of infertile patients. Nevertheless, concerns have been raised that a degree of heterogeneity remains, as the prognostic effect of individual factors is still unclear, particularly for the young poor responder group. The rationale for conducting the current randomized trial was based on the results of a previous pilot study demonstrating promising results with the administration of hp-HMG following corifollitropin alpha in women younger than 40 years of age, fulfilling the 'Bologna' criteria. A multicenter, phase III, superiority, randomized trial was conducted using a parallel two-arm design. The study included 152 patients younger than 40 years old and fulfilling the 'Bologna' criteria for poor ovarian response, from one tertiary referral centre in Europe and one tertiary referral centre in Asia. Enrolment was performed from March 2013 to May 2016. Eligible patients were randomized to either administration of 150 μg corifollitropin alfa followed by 300 IU hp-HMG (Group A) or to 300 IU of daily recombinant FSH (Group B) in a fixed GnRH antagonist protocol. The randomization sequence was created using a computer generated randomization list stratified by centre, using 1:1 allocation. The primary outcome was ongoing pregnancy rate (defined as the presence of an intrauterine gestational sac with an embryonic pole demonstrating cardiac activity at 9-10 weeks of gestation). Secondary outcomes included embryo cryopreservation rates, clinical and biochemical pregnancy rates and number of oocytes retrieved. Overall, 152 poor ovarian responders defined by the 'Bologna' criteria were included in the study. Using an intention-to treat analysis, the ongoing pregnancy rates did not differ significantly between Group A 11/77 (14.3%) and Group B 11/70 (15.7%), absolute difference: -0.4 (-11.5 to 10.8), OR = 0.9 (0.4-2.4). Biochemical and clinical pregnancy rates, live birth rates and the number of oocytes retrieved were also comparable between the two groups. Nevertheless, more patients in the corifollitropin alfa group had cryopreserved embryos compared to the rFSH group [22 (28.6%) versus 10 (14.3%), OR = 2.4 (1.01-5.5)]. Incidentally, Asian patients had significantly lower cancellation rates compared to European poor responders [2/64 (3.1%) versus 17/83 (20.4%), OR = 0.12 (0.03-0.5)]. This discrepancy could be explained by the fact that Asian women were better prognosis patients than European patients, with significantly lower FSH [9.8 (5.3) versus 11.5 (5.4), P = 0.017] and significantly higher AMH [1.1 (0.9) versus 0.4 (0.3), P-value <0.001] levels. Ongoing pregnancy rates close to 14% for both treatment groups differ significantly from the hypothesized primary outcome rates used in the power calculation. Therefore, our randomized trial might have been underpowered to detect smaller differences. The use of multiple secondary outcomes and multiple comparisons could have increased a Type 1 error. Finally, although the chance of selection biases remains low given the nature of the infertile population, the open-label design could have been a limitation. Poor ovarian response represents a challenge and although a specific protocol may have increased the number of cryopreserved embryos, no difference was observed in ongoing pregnancy rates. Our study, being one of the largest RCTs in 'Bologna' criteria poor responders, highlights that baseline characteristics may play a crucial role in clinical prognosis of this population. Given that ovarian stimulation using novel protocols does not seem to significantly increase pregnancy rates even in young women, we suggest that future clinical research should focus on increasing the number of recruitable follicles and on oocyte quality rather than evaluating different stimulation protocols. No external funding was used for this study. P.D., N.L.V., N.A.V.H., A.V., M.T.H., M.C., A.T.L. and A.V.V. have no conflict of interest to report. C.B. has received unrestricted research grants from MSD and Ferring as well as honoraria for lectures from Abbott, MSD, Merck and Ferring. P.H has received unrestricted research grants from MSD, Merck and Ferring as well as honoraria for lectures from Merck, MSD and IBSA. H.T. has received unrestricted research grants from MSD, Merck, Ferring, Cook, Roche Diagnostics, Besins International and Goodlife as well as consultation fees for research project in female infertility from Merck Finox, Abbott and ObsEva. N.P.P. has received unrestricted research grants from MSD, Ferring, Roche Diagnostics and Besins International as well as honoraria for lectures from MSD, Merck and Ferring. The EUDRACT number of the trial was 2013-000583-29 and the study was registered at clinicaltrials.gov (NCT01816321). 19 February 2013. 28 February 2013. © The Author 2017. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com

[The early history of "Ecstasy"].

PubMed

Benzenhöfer, U; Passie, T

2006-01-01

There is no consensus in the literature regarding the early history of MDMA (Methylendioxymethamphetamine, so-called "Ecstasy"). Various authors credit the first synthesis of MDMA to the German chemist Fritz Haber, but it appears neither in his doctoral thesis (Berlin 1891) nor in his accompanying articles. The man who first synthesized MDMA was the chemist Dr. Anton Köllisch, who worked for the German pharmaceutical company Merck. He created MDMA as a by-product while trying to synthesize hydrastinin, a styptic substance. In 1912, Merck filed to patent the applied method of preparation. The patent was issued in 1914, yet no pharmaceutical testing followed at that time.

Precipitation Rate Investigation on synthesis of precipitated calcium carbonate

NASA Astrophysics Data System (ADS)

Sulistiyono, E.; Handayani, M.; Firdiyono, F.; Fajariani, E. N.

2018-03-01

Study on the formation of precipitated calcium carbonate from natural limestone Sukabumi with the influenced of various parameters such as precipitation rate, concentration of CaCl2 and amplitudes were investigated. We also investigated the result with the precipitated calcium carbonate from Merck (p.a) for comparison. The higher concentration of CaCl2 would give effect to the lower of the precipitation rate. It was observed that precipitation rate of calcium carbonate from limestone Sukabumi at concentration of 0.08 molar was 3.66 cm/minutes and showing the optimum condition, while the precipitation rate of calcium carbonate Merck at the concentration 0.08 molar was 3.53 cm/minutes. The characterization of precipitated calcium carbonate was done using X-ray fluorescence (XRF) and scanning electron microscope (SEM). The characterization using XRF showed that CaO content of precipitated calcium carbonate from natural limestone Sukabumi had high purity of 99.16%. The particle distribution using scanning electron microscope (SEM) showed that precipitated calcium carbonate from natural limestone Sukabumi revealed 1.79 µm – 11.46 µm, meanwhile the particle distribution of precipitated calcium carbonate Merck showed larger particles with the size of 3.22 µm – 10.68 µm.

Leg Swelling

MedlinePlus

... painful swelling. Sterns RH. Pathophysiology and etiology of edema in adults. www.uptodate.com/home. Accessed Dec. 29, 2016. Edema. Merck Manual Professional Version. http://www.merckmanuals.com/ ...

The Impact of Chemical Probes in Drug Discovery: A Pharmaceutical Industry Perspective.

PubMed

Garbaccio, Robert M; Parmee, Emma R

2016-01-21

Chemical probes represent an important component of both academic and pharmaceutical drug discovery research. As a complement to prior reviews that have defined this scientific field, we aim to provide an industry perspective on the value of having high-quality chemical probes throughout the course of preclinical research. By studying examples from the internal Merck pipeline, we recognize that these probes require significant collaborative investment to realize their potential impact in clarifying the tractability and translation of a given therapeutic target. This perspective concludes with recommendations for chemical probe discovery aimed toward maximizing their potential to identify targets that result in the successful delivery of novel therapeutics. Copyright © 2016 Elsevier Ltd. All rights reserved.

Diketo acids derivatives as integrase inhibitors: the war against the acquired immunodeficiency syndrome.

PubMed

Henao-Mejia, Jorge; Góez, Yenny; Patiño, Pablo; Rugeles, Maria T

2006-06-01

Since the human immunodeficiency virus was identified as etiological agent of the acquired immunodeficiency syndrome, great advances have been accomplished in the therapeutic field leading to reduced morbidity and mortality among infected patients. However, the high mutation rate of the viral genome generates strains resistant to multiple drugs, pointing to the importance of finding new therapeutic targets. Among the HIV structural genes, the POL gene codes for three essential enzymes: reverse transcriptase, protease, and integrase; nineteen of the twenty drugs currently approved by the Food and Drug Administration to treat this viral infection, inhibit the reverse transcriptase and the protease. Although intense research has been carried out in this area during the last 10 years, HIV integrase inhibitors are not yet approved for clinical use; however the fact that presence of this enzyme is a sine qua non for a productive HIV life cycle joined to its unique properties makes it a promissory target for anti-HIV therapy. Many compounds have been claimed to inhibit integrase in vitro; however, few of them have proven to have antiviral activity and low cytotoxicity in cell systems. Diketoacid derivatives are the most promising integrase inhibitors so far reported. Initially discovered independently by Shionogi & Co. and the Merck Research Laboratories, these compounds are highly specific for the integrase with potent antiviral activity in vitro and in vivo, and low cytotoxicity in cell cultures. Some of these compounds have recently entered clinical trials. Due to the high relevance of integrase inhibitors, and specifically of diketoacid derivatives, we review the latest findings and patents in this important field of research.

Translational Medicine Guide transforms drug development processes: the recent Merck experience.

PubMed

Dolgos, Hugues; Trusheim, Mark; Gross, Dietmar; Halle, Joern-Peter; Ogden, Janet; Osterwalder, Bruno; Sedman, Ewen; Rossetti, Luciano

2016-03-01

Merck is implementing a question-based Translational Medicine Guide (TxM Guide) beginning as early as lead optimization into its stage-gate drug development process. Initial experiences with the TxM Guide, which is embedded into an integrated development plan tailored to each development program, demonstrated opportunities to improve target understanding, dose setting (i.e., therapeutic index), and patient subpopulation selection with more robust and relevant early human-based evidence, and increased use of biomarkers and simulations. The TxM Guide is also helping improve organizational learning, costs, and governance. It has also shown the need for stronger external resources for validating biomarkers, demonstrating clinical utility, tracking natural disease history, and biobanking. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

Evaluation of the immunogenicity of the quadrivalent HPV vaccine using 2 versus 3 doses at month 21: An epidemiological surveillance mechanism for alternate vaccination schemes

PubMed Central

Hernández-Ávila, Mauricio; Torres-Ibarra, Leticia; Stanley, Margaret; Salmerón, Jorge; Cruz-Valdez, Aurelio; Muñoz, Nubia; Herrero, Rolando; Villaseñor-Ruíz, Ignacio F; Lazcano-Ponce, Eduardo

2016-01-01

The cost of HPV vaccines and the need for 3 doses remains a barrier for their inclusion in routine vaccination schedules for girls in low and middle income countries. In a non-inferiority study, we aimed to compare the immunogenicity of a standard 3 doses and a 2 doses schedule. We enrolled 450 participants in an open-label non-randomized clinical trial to evaluate the immunogenicity induced at different ages by the licensed HPV6/11/16/18 quadrivalent vaccine in a 2 doses schedule (0–6 months, n = 150 girls aged 9–10 y) and 3 doses schedule (0, 2, and 6 months; n = 150 girls aged 9–10 y and n=150 women aged 18 to 24 years). To assess the antibody response, blood samples were obtained at Month 7 and 21 after the first vaccination from participants in all study groups. cLIA testing was performed at Merck Research Laboratories. Antibody levels were expressed as milli-Merck units (mMU) per ml. Primary outcome was non-inferiority (95% CI, lower bound >0.5) of the geometric mean titers (GMT) ratios for HPV6, HPV11, HPV16 and HPV18 antibodies 7 and 21 months after the first dose among girls receiving 2 doses compared with young women and girls receiving 3 doses. All vaccinees were seropositive for both HPV16 and HPV18 antibodies at month 7. At month 21, 98.5 and 56.6% of women 18–24 y old were seropositive for HPV16 and 18, respectively. For girls in the three doses group, seropositivity rates were 99.3 and 86.3% for HPV16 and 18, respectively. For girls in the two doses group rates were 99.3 and 70.2% for HPV16 and 18, respectively. The two doses schedule was non-inferior compared to the 3 doses schedule in same-age girls and to the group of adult women after 21 months of the first vaccine dose. Our results are in agreement with similar trials evaluating the immune response of a 2 doses schedule of both HPV vaccines, supporting the recent WHO recommendation as well as the Mexican policy to incorporate the 2 doses schedule for girls aged 9–11 y. PMID:26211489

Immunization for Women

MedlinePlus

... Overview Vaccine Safety Vaccine Safety Overview Monitoring How ... by an independent educational grant from Merck and an educational grant from Sanofi Pasteur U.S. ACOG does not allow companies to ...

Genetics Home Reference: nonsyndromic congenital nail disorder 10

MedlinePlus

... Nails MalaCards: nail disorder, nonsyndromic congenital, 10 Merck Manual Consumer Version: Deformities, Dystrophies, and Discoloration of the Nails Orphanet: Autosomal recessive nail dysplasia Patient Support ...

Genetics Home Reference: Fabry disease

MedlinePlus

... Sheet (PDF) Disease InfoSearch: Fabry Disease Emory University School of Medicine (PDF) International Center for Fabry Disease, Mount Sinai School of Medicine MalaCards: fabry disease Merck Manual Consumer ...

Weight reduction intervention for obese infertile women prior to IVF: a randomized controlled trial.

PubMed

Einarsson, Snorri; Bergh, Christina; Friberg, Britt; Pinborg, Anja; Klajnbard, Anna; Karlström, Per-Olof; Kluge, Linda; Larsson, Ingrid; Loft, Anne; Mikkelsen-Englund, Anne-Lis; Stenlöf, Kaj; Wistrand, Anna; Thurin-Kjellberg, Ann

2017-08-01

Does an intensive weight reduction programme prior to IVF increase live birth rates for infertile obese women? An intensive weight reduction programme resulted in a large weight loss but did not substantially affect live birth rates in obese women scheduled for IVF. Among obese women, fertility and obstetric outcomes are influenced negatively with increased risk of miscarriage and a higher risk of maternal and neonatal complications. A recent large randomized controlled trial found no effect of lifestyle intervention on live birth in infertile obese women. A prospective, multicentre, randomized controlled trial was performed between 2010 and 2016 in the Nordic countries. In total, 962 women were assessed for eligibility and 317 women were randomized. Computerized randomization with concealed allocation was performed in the proportions 1:1 to one of two groups: weight reduction intervention followed by IVF-treatment or IVF-treatment only. One cycle per patient was included. Nine infertility clinics in Sweden, Denmark and Iceland participated. Women under 38 years of age planning IVF, and having a BMI ≥30 and <35 kg/m2 were randomized to two groups: an intervention group (160 patients) with weight reduction before IVF, starting with 12 weeks of a low calorie liquid formula diet (LCD) of 880 kcal/day and thereafter weight stabilization for 2-5 weeks, or a control group (157 patients) with IVF only. In the full analysis set (FAS), the live birth rate was 29.6% (45/152) in the weight reduction and IVF group and 27.5% (42/153) in the IVF only group. The difference was not statistically significant (difference 2.2%, 95% CI: 12.9 to -8.6, P = 0.77). The mean weight change was -9.44 (6.57) kg in the weight reduction and IVF group as compared to +1.19 (1.95) kg in the IVF only group, being highly significant (P < 0.0001). Significantly more live births were achieved through spontaneous pregnancies in the weight reduction and IVF group, 10.5% (16) as compared to the IVF only group 2.6% (4) (P = 0.009). Miscarriage rates and gonadotropin dose used for IVF stimulation did not differ between groups. Two subgroup analyses were performed. The first compared women with PCOS in the two randomized groups, and the second compared women in the weight reduction group reaching BMI ≤ 25 kg/m2 or reaching a weight loss of at least five BMI units to the IVF only group. No statistical differences in live birth rates between the groups in either subgroup analysis were found. The study was not powered to detect a small increase in live births due to weight reduction and was not blinded for the patients or physician. Further, the intervention group had a longer time to achieve a spontaneous pregnancy, but were therefore slightly older than the control group at IVF. The study only included women with a BMI lower than 35 kg/m2. The study suggests that weight loss for obese women (BMI: 30-34.9 kg/m2) may not rectify the outcome in IVF cycles, although a significant higher number of spontaneous conceptions occurred in the weight loss group. Also, the study suggests that intensive weight reduction with LCD treatment does not negatively affects the results. The study was funded by Sahlgrenska University Hospital (ALFGBG-70 940), Merck AB, Solna, Sweden (an affiliate of Merck KGaA, Darmstadt, Germany), Impolin AB, Hjalmar Svensson Foundation and Jane and Dan Olsson Foundation. Dr Thurin-Kjellberg reports grants from Merck, non-financial support from Impolin AB, during the conduct of the study, and personal fees from Merck outside the submitted work. Dr Friberg reports personal fees from Ferring, Merck, MSD, Finox and personal fees from Studentlitteratur, outside the submitted work. Dr Englund reports personal fees from Ferring, and non-financial support from Merck, outside the submitted work. Dr Bergh reports and has been reimbursed for: writing a newsletter twice a year (Ferring), lectures (Ferring, MSD, Merck), and Nordic working group meetings (Finox). Dr Karlström reports lectures (Ferring, Finox, Merck, MSD) and Nordic working group meetings (Ferring). Ms Kluge, Dr Einarsson, Dr Pinborg, Dr Klajnbard, Dr Stenlöf, Dr Larsson, Dr Loft and Dr Wistrand have nothing to disclose. ClinicalTrials.gov number, NCT01566929. 23-03-2012. 05-10-2010. © The Author 2017. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com

Green Chemistry Challenge: 2017 Greener Synthetic Pathways Award

EPA Pesticide Factsheets

Green Chemistry Challenge 2017 award winners, Merck, developed a novel asymmetric aza-Michael cyclization, employing a chemically stable and fully recyclable organocatalyst to make Letermovir, an antiviral drug

The relationship between pediatric combination vaccines and market effects.

PubMed

Behzad, Banafsheh; Jacobson, Sheldon H; Jokela, Janet A; Sewell, Edward C

2014-06-01

We explored market factors that affect pediatric combination vaccine uptake in the US public-sector pediatric vaccine market. We specifically examined how Pediarix and Pentacel earned a place in the 2009-2012 lowest overall cost formulary. Direct competition between Pediarix and Pentacel is driven by the indirect presence of the Merck Haemophilus influenzae type b vaccine and the Recommended Childhood Immunization Schedule requirement for a hepatitis B birth dose. The resulting analysis suggests that Pentacel would never have earned a place in the lowest overall cost formulary for 2009-2012 federal contract prices for any cost of an injection unless the Merck H influenzae type b advantage was ignored and the hepatitis B birth dose administration cost was recognized by health care providers in designing the lowest overall cost formularies.

The Relationship Between Pediatric Combination Vaccines and Market Effects

PubMed Central

Behzad, Banafsheh; Jokela, Janet A.; Sewell, Edward C.

2014-01-01

We explored market factors that affect pediatric combination vaccine uptake in the US public-sector pediatric vaccine market. We specifically examined how Pediarix and Pentacel earned a place in the 2009–2012 lowest overall cost formulary. Direct competition between Pediarix and Pentacel is driven by the indirect presence of the Merck Haemophilus influenzae type b vaccine and the Recommended Childhood Immunization Schedule requirement for a hepatitis B birth dose. The resulting analysis suggests that Pentacel would never have earned a place in the lowest overall cost formulary for 2009–2012 federal contract prices for any cost of an injection unless the Merck H influenzae type b advantage was ignored and the hepatitis B birth dose administration cost was recognized by health care providers in designing the lowest overall cost formularies. PMID:24825198

Cost-Effectiveness of Pembrolizumab Versus Ipilimumab in Ipilimumab-Naïve Patients with Advanced Melanoma in the United States.

PubMed

Wang, Jingshu; Chmielowski, Bartosz; Pellissier, James; Xu, Ruifeng; Stevinson, Kendall; Liu, Frank Xiaoqing

2017-02-01

Recent clinical trials have shown that pembrolizumab significantly prolonged progression-free survival and overall survival compared with ipilimumab in ipilimumab-naïve patients with unresectable or metastatic melanoma. However, there has been no published evidence on the cost-effectiveness of pembrolizumab for this indication. To assess the long-term cost-effectiveness of pembrolizumab versus ipilimumab in ipilimumab-naïve patients with unresectable or meta-static melanoma from a U.S. integrated health system perspective. A partitioned-survival model was developed, which divided overall survival time into progression-free survival and postprogression survival. The model used Kaplan-Meier estimates of progression-free survival and overall survival from a recent randomized phase 3 study (KEYNOTE-006) that compared pembrolizumab and ipilimumab. Extrapolation of progression-free survival and overall survival beyond the clinical trial was based on parametric functions and literature data. The base-case time horizon was 20 years, and costs and health outcomes were discounted at a rate of 3% per year. Clinical data-including progression-free survival and overall survival data spanning a median follow-up time of 15 months, as well as quality of life and adverse event data from the ongoing KEYNOTE-006 trial-and cost data from public sources were used to populate the model. Costs included those of drug acquisition, treatment administration, adverse event management, and disease management of advanced melanoma. The incremental cost-effectiveness ratio (ICER) expressed as cost difference per quality-adjusted life-year (QALY) gained was the main outcome, and a series of sensitivity analyses were performed to test the robustness of the results. In the base case, pembrolizumab was projected to increase the life expectancy of U.S. patients with advanced melanoma by 1.14 years, corresponding to a gain of 0.79 discounted QALYs over ipilimumab. The model also projected an average increase of $63,680 in discounted perpatient costs of treatment with pembrolizumab versus ipilimumab. The corresponding ICER was $81,091 per QALY ($68,712 per life-year) over a 20-year time horizon. With $100,000 per QALY as the threshold, when input parameters were varied in deterministic one-way sensitivity analyses, the use of pembrolizumab was cost-effective relative to ipilimumab in most ranges. Further, in a comprehensive probabilistic sensitivity analysis, the ICER was cost-effective in 83% of the simulations. Compared with ipilimumab, pembrolizumab had higher expected QALYs and was cost-effective for the treatment of patients with unresectable or metastatic melanoma from a U.S. integrated health system perspective. This study was supported by funding from Merck & Co., which reviewed and approved the manuscript before journal submission. Wang, Pellissier, Xu, Stevinson, and Liu are employees of, and own stock in, Merck & Co. Chmielowski has served as a paid consultant for Merck & Co. and received a consultant fee for clinical input in connection with this study. Chmielowski also reports receiving advisory board and speaker bureau fees from multiple major pharmaceutical companies. Wang led the modeling and writing of the manuscript. Chmielowski, Xu, Stevinson, and Pellissier contributed substantially to the modeling design and methodology. Liu led the data collection work and contributed substantially to writing the manuscript. In conducting the analysis and writing the manuscript, the authors followed Merck publication polices and the "cost-effectiveness analysis alongside clinical trials-good research practices and the CHEERS reporting format as recommended by the International Society for Pharmacoeconomics and Outcomes Research.

Radiation Injury to the Brain

MedlinePlus

... healthy cells. The Merck Manual states the following: Radiation Injury to the Nervous System: The nervous system can be damaged by radiation therapy. Acute and subacute transient symptoms may develop early, but ...

Malocclusion (Misaligned Teeth)

MedlinePlus

... the Professional version Also of Interest Test your knowledge Which of the following increases the likelihood of ... Learn more about our commitment to Global Medical Knowledge . Merck Manuals About Disclaimer Permissions Privacy Contributors Terms ...

Wheezing

MedlinePlus

... in adults. http://www.uptodate.com/home. Accessed March 24, 2017. Oo S, et al. The wheezing child: An ... Elsevier Saunders; 2017. http://www.clinicalkey.com. Accessed March 24, 2017. Wheezing. Merck Manual Professional Version. http://www. ...

Abscess in the Lungs

MedlinePlus

... the Professional version Also of Interest Test your knowledge Which of the following automatically closes during swallowing, ... Learn more about our commitment to Global Medical Knowledge . Merck Manuals About Disclaimer Permissions Privacy Contributors Terms ...

78 FR 54658 - Allergenic Products Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-05

... Vernal Grass, Perennial Ryegrass, Timothy Grass, Orchard Grass, and Kentucky Bluegrass Mixed Pollens... Grastek, a Timothy Grass Pollen Allergen Extract tablet for sublingual use, manufactured by Merck. FDA...

Head Trauma: First Aid

MedlinePlus

... id=258&terms=cpr. Accessed Oct. 8, 2014. Traumatic brain injury. The Merck Manual Professional Edition. http://www.merckmanuals.com/professional/injuries_poisoning/traumatic_brain_injury_tbi/traumatic_brain_injury.html. Accessed Oct. 8, ...

HCV Treatment Initiation in Patients with Chronic Kidney Disease: Results from ERCHIVES

PubMed Central

Butt, Adeel; Ren, Yanjie; Puenpatom, Amy; Arduino, Jean Marie; Kumar, Ritesh; Abou-Samra, Abdul-Badi

2017-01-01

Abstract Background Newer directing antiviral agents against HCV (DAAs) are safe and efficacious in persons with chronic kidney disease (CKD). Whether availability of these newer DAAs has resulted in more persons with CKD initiating HCV treatment remains unknown. Methods We identified HCV+ persons in ERCHIVES. We excluded HIV+ and HBsAg+ and those with missing HCV RNA and eGFR data. We determined the CKD stage according to National Kidney Foundation criteria. We determined the number of persons initiated on any of the approved DAA-regimen (defined as >14 days of DAA prescription). Logistic regression analyses was used to determine factors associated with treatment initiation. Results Among 76,513 evaluable persons, 21.1% initiated DAA treatment. Initiation rates differed significantly by CKD stage: 21.1% (15,136/68,469) for eGFR>90mL/minute/1.73m2 and CKD stage-2; 14.0% 9853/6,086) for CKD stage 3; and 7.6% (148/1,958) for CKD stage-4/5. Those with CKD stage-3 were 35% less likely and those with CKD stage-4/5 were 65% less likely to initiate treatment with a DAA compared with those with baseline eGFR>90mL/minute/1.73m2. Those with Body Mass Index (BMI)>30 were more likely to initiate treatment (OR 1.24, 95% CI 1.19,1.29). Treatment initiation was less likely in HCV genotype 2 or 3 and those with diabetes (OR 0.82, 95% CI 0.78,0.86), cardiovascular disease (OR 0.73, 95% CI 0.68,0.78), alcohol abuse or dependence (OR 0.75, 95% CI 0.72,0.78) or cirrhosis (OR 0.85, 95% CI 0.80,0.89) at baseline. Conclusion Persons with more advanced CKD are less likely to receive treatment for HCV. Strategies are needed to improve treatment rates in the HCV/CKD population. Disclosures A. Butt, Merck: Investigator, Grant recipient. A. Puenpatom, Merck: Employee, Salary. J. M. Arduino, Merck: Employee, Salary. R. Kumar, Merck: Employee, Salary

Presidential Green Chemistry Challenge: 2010 Greener Reaction Conditions Award

EPA Pesticide Factsheets

Presidential Green Chemistry Challenge 2010 award winners, Merck & Co. and Codexis, developed an enzymatic synthesis for sitagliptin (Januvia) that reduces waste, improves yield and safety, and eliminates a metal catalyst.

Genetics Home Reference: Snyder-Robinson syndrome

MedlinePlus

... syndromic, snyder-robinson type Merck Manual Home Health Handbook for Patients & Caregivers: Osteoporosis Orphanet: X-linked intellectual ... in X-linked intellectual disability (Snyder-Robinson syndrome). Methods Mol Biol. 2011;720:437-45. doi: 10. ...

Recurrent Cellulitis: How Can I Prevent It?

MedlinePlus

... to prevent recurrent cellulitis? Answers from Lawrence E. Gibson, M.D. To help prevent recurrent episodes of ... treatment to prevent recurrent infections. With Lawrence E. Gibson, M.D. Cellulitis. Merck Manual Professional Version. http:// ...

A PC-Based Free Text DSS for Health Care

NASA Technical Reports Server (NTRS)

Grams, Ralph R.; Buchanan, Paul; Massey, James K.; Jin, Ming

1987-01-01

A free Decision Support System(DST) has been constructed for health care professional that allows the analysis of complex medical cases and the creation of diagnostic list of potential diseases for clinical evaluation.The system uses a PC-based text management system specifically designed for desktop operation. The texts employed in the decision support package include the Merck Manual (published by Merck Sharpe & Dohme) and Control of Communicable Diseas in Man (published by the American Public Health Association). The background and design of the database are discussed along with a structured analysis procedure for handling free text DSS system. A case study is presented to show the application of this technology and conclusions are drawn in the summary that point to expanded areas of professional intention and new frontiers yet to be explored in this rapidly progressing field.

Genetics Home Reference: intervertebral disc disease

MedlinePlus

... periodic or chronic pain in the back or neck. Pain is often worse when sitting, bending, twisting, or ... Version: Low Back Pain Merck Manual Consumer Version: Neck Pain Patient Support and Advocacy Resources (3 links) American ...

Vitamin D Test

MedlinePlus

... disease. If your results show you have an excess of (too much) vitamin D, it is most likely due to taking ... 2 screens]. Available from: ... Merck & Co. Inc.; c2017. Vitamin D [cited 2017 Apr 10]; [about 2 screens]. ...

Genetics Home Reference: progressive familial intrahepatic cholestasis

MedlinePlus

... the vein that supplies blood to the liver (portal hypertension), and an enlarged liver and spleen (hepatosplenomegaly). There ... Manual Consumer Version: Cholestasis Merck Manual Consumer Version: Portal Hypertension Orphanet: Progressive familial intrahepatic cholestasis Patient Support and ...

Pembrolizumab Injection

MedlinePlus

... with an immunomodulatory agent as compared to the control group (see statistical analysis section below). Merck & Co., Inc. was made aware of the issue through an external data monitoring committee recommendation and suspended the ... and http://www.fda.gov/Drugs/DrugSafety.

Workplace safety and health improvements through a labor/management training and collaboration.

PubMed

Mahan, Bruce; Morawetz, John; Ruttenberg, Ruth; Workman, Rick

2013-01-01

Seven hundred thirty-nine workers at Merck's Stonewall plant in Elkton, Virginia, have a safer and healthier workplace because four of them were enthusiastic about health and safety training they received from the union's training center in Cincinnati, Ohio. What emerged was not only that all 739 plant employees received OSHA 10-hour General Industry training, but that it was delivered by "OSHA-authorized" members of the International Chemical Workers Union Council who worked at the plant. Merck created a new full-time position in its Learning and Development Department and filled it with one of the four workers who had received the initial training. Strong plant leadership promoted discussions both during the training, in evaluation, and in newly energized joint labor-management meetings following the training. These discussions identified safety and health issues needing attention. Then, in a new spirit of trust and collaboration, major improvements occurred.

Workplace Safety and Health Improvements Through a Labor/Management Training and Collaboration

PubMed Central

Mahan, Bruce; Morawetz, John; Ruttenberg, Ruth; Workman, Rick

2014-01-01

Seven hundred thirty-nine workers at Merck's Stonewall plant in Elkton, Virginia, have a safer and healthier workplace because four of them were enthusiastic about health and safety training they received from the union's training center in Cincinnati, Ohio. What emerged was not only that all 739 plant employees received OSHA 10-hour General Industry training, but that it was delivered by “OSHA-authorized” members of the International Chemical Workers Union Council who worked at the plant. Merck created a new fulltime position in its Learning and Development Department and hired one of the four workers who had received the initial training. Strong plant leadership promoted discussions both during the training, in evaluation, and in newly energized joint labor-management meetings following the training. These discussions identified safety and health issues needing attention. Then, in a new spirit of trust and collaboration, major improvements occurred. PMID:24704812

The patient-consumer-advocate nexus: the marketing and dissemination of gardasil, the human papillomavirus vaccine, in the United States.

PubMed

Gottlieb, Samantha D

2013-09-01

The 2006 availability of Merck's human papillomavirus (HPV) vaccine, Gardasil, in the United States provides an opportunity to examine the pharmaceutical company's creation of patient awareness for one of the most common sexually transmitted infections and its related cancer. In spite of the ubiquity of gynecological screening, prior to the vaccine's dissemination, most U.S. women were not familiar with either the infection or its association with cancer. Merck's role in encouraging a patient advocacy community mimics existing breast cancer patient advocacy culture in the United States while also demonstrating marked popular culture differences between the two women's health concerns and their respective advocacy groups. This article draws on ethnographic fieldwork with an HPV/cervical cancer advocacy organization to demonstrate how the group and its members engaged in an activism of awareness that disavows larger political aims. © 2013 by the American Anthropological Association.

Appropriateness of Antibiotic Prescribing in U. S. Children’s Hospitals: A National Point Prevalence Survey

PubMed Central

Tribble, Alison; Lee, Brian; Handy, Lori; Gerber, Jeffrey S; Hersh, Adam L; Kronman, Matthew; Terrill, Cindy; Newland, Jason

2017-01-01

Abstract Background Multiple studies estimate that inappropriate antibiotic prescribing ranges from 30–50% in hospitalized patients, but few have included pediatric patients. Pediatric studies characterizing inappropriate prescribing are needed to target and improve antimicrobial stewardship program (ASP) efforts. Methods Cross-sectional analysis of antimicrobial prescribing at 30 U.S. children’s hospitals. Participating hospitals were academic, tertiary care hospitals in the Sharing Antimicrobial Reports for Pediatric Stewardship (SHARPS) collaborative. Subjects were children 0–17 years with an active antibiotic order at 0800 on a single day during three consecutive calendar quarters (Q3 2016 – Q1 2017). Each hospital’s ASP used a standardized survey to collect data on antibiotic orders and evaluate appropriateness. Data were pooled from the three surveys. The primary outcome was the pooled estimate for the percentage of prescriptions classified as inappropriate. Secondary outcomes were pooled estimates for indication, reason for inappropriate use, and ASP review status for each antibiotic. Results Of 19,598 children hospitalized on survey days, 6,922 (35%) had ≥1 active antibiotic order. Median age of children receiving antibiotics was 3.7 years (0.5, 10.9). Figures 1 and 2 show the most common antibiotics and indications. Of all antibiotic orders, 1,514 (15%) were classified as inappropriate, and 19% of patients with antibiotic orders had at least one inappropriate order. The most common reasons for inappropriate use were bug-drug mismatch (26%), surgical prophylaxis > 24 hours (18%) and unnecessary duplicate therapy (12%). ASPs would not have routinely reviewed 50% of all inappropriate orders. An additional 22% of inappropriate orders were for antibiotics typically reviewed by ASPs, but were yet to be reviewed at the time of the survey. Conclusion Across 30 children’s hospitals, approximately 1 in 3 hospitalized children is receiving an antibiotic at any given time. Almost 20% of these children are receiving inappropriate therapy, and a substantial portion of inappropriate use is not captured by current ASP practices. Figures 1 and 2: Disclosures C. Terrill, Merck: Grant Investigator, Research grant; Allergan: Grant Investigator, Research grant; J. Newland, Merck: Grant Investigator, Research grant; Allergan: Grant Investigator, Research grant.

The Children's Inn at NIH Anniversary Key Messages | NIH MedlinePlus the Magazine

MedlinePlus

... Past Issues / Summer 2014 Table of Contents Anniversary Key Messages Playground and Park at The Children's Inn ... and commitment, and the merging of public and private resources. Merck generously donated $3.7 million for ...

Rapid Quantification of Four Anthocyanins in Red Grape Wine by Hydrophilic Interaction Liquid Chromatography/Triple Quadrupole Linear Ion Trap Mass Spectrometry.

PubMed

Sun, Yongming; Xia, Biqi; Chen, Xiangzhun; Duanmu, Chuansong; Li, Denghao; Han, Chao

2015-01-01

The identification and quantification of four anthocyanins (cyanidin-3-O-glucoside, peonidin-3-O-glucoside, delphinidin-3-O-glucoside, and malvidin-3-O-glucoside) in red grape wine were carried out by hydrophilic interaction liquid chromatography/triple quadrupole linear ion trap MS (HILIC/QTrap-MS/MS). Samples were diluted directly and separated on a Merck ZIC HILIC column with 20 mM ammonium acetate solution-acetonitrile mobile phase. Quantitative data acquisition was carried out in the multiple reaction monitoring mode. Additional identification and confirmation of target compounds were performed using the enhanced product ion mode of the linear ion trap. The LOQs were in the range 0.05-1.0 ng/mL. The average recoveries were in the range 94.6 to 104.5%. The HILIC/QTrap-MS/MS platform offers the best sensitivity and specificity for characterization and quantitative determination of the four anthocyanins in red grape wines and fulfills the quality criteria for routine laboratory application.

Three perspectives on partnering to close the care gap.

PubMed

Tsuyuki, Ross T; Sebestyen, Norma; Davis, Sheila; Rondos, Spyro

2015-11-01

Given their frontline relationship with patients, community pharmacists fill a vital role in our healthcare system. This article offers three perspectives on how a team-based approach, which integrates the community pharmacist, can enhance patient care and reduce system costs. It is the success of these partnership models which have helped drive system-level change. It offers reflections by Dr. Ross T. Tsuyuki, among Canada's leading researchers on the subject, and presents some findings over his 20-year partnership with Merck in Canada. Dr. Tsuyuki's peer-reviewed studies have been largely centred in Alberta, one province in which the scope of practice for pharmacists has been expanded. © 2015 Collège canadien des leaders en santé

A randomized controlled, non-inferiority trial of modified natural versus artificial cycle for cryo-thawed embryo transfer.

PubMed

Groenewoud, E R; Cohlen, B J; Al-Oraiby, A; Brinkhuis, E A; Broekmans, F J M; de Bruin, J P; van den Dool, G; Fleisher, K; Friederich, J; Goddijn, M; Hoek, A; Hoozemans, D A; Kaaijk, E M; Koks, C A M; Laven, J S E; van der Linden, P J Q; Manger, A P; Slappendel, E; Spinder, T; Kollen, B J; Macklon, N S

2016-07-01

Are live birth rates (LBRs) after artificial cycle frozen-thawed embryo transfer (AC-FET) non-inferior to LBRs after modified natural cycle frozen-thawed embryo transfer (mNC-FET)? AC-FET is non-inferior to mNC-FET with regard to LBRs, clinical and ongoing pregnancy rates (OPRs) but AC-FET does result in higher cancellation rates. Pooling prior retrospective studies of AC-FET and mNC-FET results in comparable pregnancy and LBRs. However, these results have not yet been confirmed by a prospective randomized trial. In this non-inferiority prospective randomized controlled trial (acronym 'ANTARCTICA' trial), conducted from February 2009 to April 2014, 1032 patients were included of which 959 were available for analysis. The primary outcome of the study was live birth. Secondary outcomes were clinical and ongoing pregnancy, cycle cancellation and endometrium thickness. A cost-efficiency analysis was performed. This study was conducted in both secondary and tertiary fertility centres in the Netherlands. Patients included in this study had to be 18-40 years old, had to have a regular menstruation cycle between 26 and 35 days and frozen-thawed embryos to be transferred had to derive from one of the first three IVF or IVF-ICSI treatment cycles. Patients with a uterine anomaly, a contraindication for one of the prescribed medications in this study or patients undergoing a donor gamete procedure were excluded from participation. Patients were randomized based on a 1:1 allocation to either one cycle of mNC-FET or AC-FET. All embryos were cryopreserved using a slow-freeze technique. LBR after mNC-FET was 11.5% (57/495) versus 8.8% in AC-FET (41/464) resulting in an absolute difference in LBR of -0.027 in favour of mNC-FET (95% confidence interval (CI) -0.065-0.012; P = 0.171). Clinical pregnancy occurred in 94/495 (19.0%) patients in mNC-FET versus 75/464 (16.0%) patients in AC-FET (odds ratio (OR) 0.8, 95% CI 0.6-1.1, P = 0.25). 57/495 (11.5%) mNC-FET resulted in ongoing pregnancy versus 45/464 (9.6%) AC-FET (OR 0.7, 95% CI 0.5-1.1, P = 0.15). χ(2) test confirmed the lack of superiority. Significantly more cycles were cancelled in AC-FET (124/464 versus 101/495, OR 1.4, 95% CI 1.1-1.9, P = 0.02). The costs of each of the endometrial preparation methods were comparable (€617.50 per cycle in NC-FET versus €625.73 per cycle in AC-FET, P = 0.54). The minimum of 1150 patients required for adequate statistical power was not achieved. Moreover, LBRs were lower than anticipated in the sample size calculation. LBRs after AC-FET were not inferior to those achieved by mNC-FET. No significant differences in clinical and OPR were observed. The costs of both treatment approaches were comparable. An educational grant was received during the conduct of this study. Merck Sharpe Dohme had no influence on the design, execution and analyses of this study. E.R.G. received an education grant by Merck Sharpe Dohme (MSD) during the conduct of the present study. B.J.C. reports grants from MSD during the conduct of the study. A.H. reports grants from MSD and Ferring BV the Netherlands and personal fees from MSD. Grants from ZonMW, the Dutch Organization for Health Research and Development. J.S.E.L. reports grants from Ferring, MSD, Organon, Merck Serono and Schering-Plough during the conduct of the study. F.J.M.B. receives monetary compensation as member of the external advisory board for Merck Serono, consultancy work for Gedeon Richter, educational activities for Ferring BV, research cooperation with Ansh Labs and a strategic cooperation with Roche on automated anti Mullerian hormone assay development. N.S.M. reports receiving monetary compensations for external advisory and speaking work for Ferring BV, MSD, Anecova and Merck Serono during the conduct of the study. All reported competing interests are outside the submitted work. No other relationships or activities that could appear to have influenced the submitted work. Netherlands trial register, number NTR 1586. 13 January 2009. 20 April 2009. © The Author 2016. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

A randomized controlled, non-inferiority trial of modified natural versus artificial cycle for cryo-thawed embryo transfer

PubMed Central

Groenewoud, E.R.; Cohlen, B.J.; Al-Oraiby, A.; Brinkhuis, E.A.; Broekmans, F.J.M.; de Bruin, J.P.; van den Dool, G.; Fleisher, K.; Friederich, J.; Goddijn, M.; Hoek, A.; Hoozemans, D.A.; Kaaijk, E.M.; Koks, C.A.M.; Laven, J.S.E.; van der Linden, P.J.Q.; Manger, A.P.; Slappendel, E.; Spinder, T.; Kollen, B.J.; Macklon, N.S.

2016-01-01

Abstract STUDY QUESTION Are live birth rates (LBRs) after artificial cycle frozen-thawed embryo transfer (AC-FET) non-inferior to LBRs after modified natural cycle frozen-thawed embryo transfer (mNC-FET)? SUMMARY ANSWER AC-FET is non-inferior to mNC-FET with regard to LBRs, clinical and ongoing pregnancy rates (OPRs) but AC-FET does result in higher cancellation rates. WHAT IS ALREADY KNOWN Pooling prior retrospective studies of AC-FET and mNC-FET results in comparable pregnancy and LBRs. However, these results have not yet been confirmed by a prospective randomized trial. STUDY DESIGN, SIZE AND DURATION In this non-inferiority prospective randomized controlled trial (acronym ‘ANTARCTICA’ trial), conducted from February 2009 to April 2014, 1032 patients were included of which 959 were available for analysis. The primary outcome of the study was live birth. Secondary outcomes were clinical and ongoing pregnancy, cycle cancellation and endometrium thickness. A cost-efficiency analysis was performed. PARTICIPANT/MATERIALS, SETTING, METHODS This study was conducted in both secondary and tertiary fertility centres in the Netherlands. Patients included in this study had to be 18–40 years old, had to have a regular menstruation cycle between 26 and 35 days and frozen-thawed embryos to be transferred had to derive from one of the first three IVF or IVF–ICSI treatment cycles. Patients with a uterine anomaly, a contraindication for one of the prescribed medications in this study or patients undergoing a donor gamete procedure were excluded from participation. Patients were randomized based on a 1:1 allocation to either one cycle of mNC-FET or AC-FET. All embryos were cryopreserved using a slow-freeze technique. MAIN RESULTS AND THE ROLE OF CHANCE LBR after mNC-FET was 11.5% (57/495) versus 8.8% in AC-FET (41/464) resulting in an absolute difference in LBR of −0.027 in favour of mNC-FET (95% confidence interval (CI) −0.065–0.012; P = 0.171). Clinical pregnancy occurred in 94/495 (19.0%) patients in mNC-FET versus 75/464 (16.0%) patients in AC-FET (odds ratio (OR) 0.8, 95% CI 0.6–1.1, P = 0.25). 57/495 (11.5%) mNC-FET resulted in ongoing pregnancy versus 45/464 (9.6%) AC-FET (OR 0.7, 95% CI 0.5–1.1, P = 0.15). χ2 test confirmed the lack of superiority. Significantly more cycles were cancelled in AC-FET (124/464 versus 101/495, OR 1.4, 95% CI 1.1–1.9, P = 0.02). The costs of each of the endometrial preparation methods were comparable (€617.50 per cycle in NC-FET versus €625.73 per cycle in AC-FET, P = 0.54). LIMITATIONS, REASONS FOR CAUTION The minimum of 1150 patients required for adequate statistical power was not achieved. Moreover, LBRs were lower than anticipated in the sample size calculation. WIDER IMPLICATIONS OF THE FINDINGS LBRs after AC-FET were not inferior to those achieved by mNC-FET. No significant differences in clinical and OPR were observed. The costs of both treatment approaches were comparable. STUDY FUNDING/COMPETING INTEREST(S) An educational grant was received during the conduct of this study. Merck Sharpe Dohme had no influence on the design, execution and analyses of this study. E.R.G. received an education grant by Merck Sharpe Dohme (MSD) during the conduct of the present study. B.J.C. reports grants from MSD during the conduct of the study. A.H. reports grants from MSD and Ferring BV the Netherlands and personal fees from MSD. Grants from ZonMW, the Dutch Organization for Health Research and Development. J.S.E.L. reports grants from Ferring, MSD, Organon, Merck Serono and Schering-Plough during the conduct of the study. F.J.M.B. receives monetary compensation as member of the external advisory board for Merck Serono, consultancy work for Gedeon Richter, educational activities for Ferring BV, research cooperation with Ansh Labs and a strategic cooperation with Roche on automated anti Mullerian hormone assay development. N.S.M. reports receiving monetary compensations for external advisory and speaking work for Ferring BV, MSD, Anecova and Merck Serono during the conduct of the study. All reported competing interests are outside the submitted work. No other relationships or activities that could appear to have influenced the submitted work. TRIAL REGISTRATION NUMBER Netherlands trial register, number NTR 1586. TRIAL REGISTRATION DATE 13 January 2009. FIRST PATIENT INCLUDED 20 April 2009. PMID:27179265

Streptomycin, Schatz v. Waksman, and the balance of credit for discovery.

PubMed

Kingston, William

2004-07-01

A recent article in Nature, arguing that "the misallocation of credit is endemic in science," used Selman Waksman as an illustration, claiming that the true discoverer of streptomycin was one of his graduate students. The article received wide publicity and seriously damaged Waksman's great reputation. What actually happened was that the success of penicillin stimulated Merck to fund research by Waksman, a soil scientist, into the collection of actinomycetes that he had assembled over thirty years. He applied the systematic, uncreative testing techniques that had made the German pharmaceutical industry so successful to these, and streptomycin was discovered within a matter of months. Work in the Mayo Institute then showed that it was marvelously effective against tuberculosis, and Waksman received the Nobel Prize for it in 1952. The test that turned out to be the crucial one could have been carried out by any of several students, but the lucky one was Albert Schatz. He then sued the university for a share of the royalties payable by Merck and also petitioned the Nobel committee to include him in the award. Although he obtained a very substantial out-of-court settlement, this probably damaged his subsequent academic career, and he has never ceased to argue his case for recognition, of which the Nature article is a reflection. To claim that Waksman took credit properly due to Schatz is to fail to understand that once pharmaceutical research had become primarily a matter of large-scale, routine testing, little individual creativity was left in this work. Credit for any successful results must therefore be given to whoever is the originator or director of a particular program. Nature refused to publish evidence that this case could not be used as an example of misallocation of credit for discovery. This in itself illustrates that editors of scientific journals should be every bit as mindful of scientists' reputations as they are of scientific facts.

Budget-Impact Analysis of Alternative Herpes Zoster Vaccine Strategies: A U.S. HMO Perspective.

PubMed

Graham, Jonathan; Mauskopf, Josephine; Kawai, Kosuke; Johnson, Kelly D; Xu, Ruifeng; Acosta, Camilo J

2016-07-01

A herpes zoster vaccine has been approved by the FDA for use in prevention of herpes zoster in individuals who are aged 50 years or older. The Advisory Committee on Immunization Practices (ACIP) recommends vaccination only in individuals who are aged 60 years and older. To (a) estimate the overall budget and health impact of either the introduction of a new vaccination strategy (individuals over the age of 50 years vs. individuals over the age of 60 years) within a hypothetical health plan or simply an increase in coverage within the population aged 60 years and over and (b) discern what effect copayments and changes to copayments have on the health plan's budget. A decision-analytic economic model was developed to inform managed care decision makers of the potential effect on costs and outcomes associated with the use of the herpes zoster vaccine for prevention of herpes zoster (i.e., simple zoster or shingles). The model took a U.S. payer perspective. The number of eligible patients entering the model was estimated by considering the age distribution of the plan population and the percentage of patients contraindicated for vaccination (i.e., those who were immunocompromised or who had a history of anaphylactic/anaphylactoid reaction to gelatin, neomycin, or any other component of the vaccine). Eligible patients were vaccinated based on the projected uptake rates among the unvaccinated population in 2 possible vaccination scenarios: (1) a vaccination strategy in which only individuals over age 60 years can be vaccinated and (2) a vaccination strategy in which individuals over age 50 years can be vaccinated. Vaccination was assumed to reverse the age-related decline in immunity against zoster. The population vaccinated each year was estimated based on the uptake rates (percentage of the eligible unvaccinated that are vaccinated) required to reach a target annual coverage (percentage ever vaccinated). Patients could experience costs and outcomes related to vaccination or related to herpes zoster. Specifically, vaccination could cause adverse events that would require the use of health care resources. Patients who developed zoster could experience postherpetic neuralgia or develop nonpain complications that would require the use of health care resources. Vaccine costs, zoster cases (with and without postherpetic neuralgia or nonpain complication), and vaccine-related adverse events for the 2 vaccination scenarios were estimated for each budget year. For a managed care organization population of 5 million members, the model estimated that a vaccination program that included patients over age 50 years instead of a program limiting vaccination to those over age 60 years was associated with a decrease in the number of patients developing zoster (2,372-3,392 cases avoided over 5 years). Annual incremental per-member-per-month (PMPM) costs associated with this vaccination program change were estimated to range from $0.08 to $0.14. When the vaccination program was kept at age 60 years and over and coverage was increased, the model estimated that the annual incremental PMPM costs ranged from $0.04 to $0.06. Differences in costs were driven primarily by vaccination costs. The results of the scenario analyses showed that lower vaccination costs because of the application of copayments for a managed care organization reduced the magnitude of the total cost increase associated with the increase in uptake. Vaccinating individuals aged 50 to 59 years with the herpes zoster vaccine would likely have an impact on a health plan's budget because of the expected increase in the total number of individuals being vaccinated in the population, with limited cost savings because of fewer cases of herpes zoster. Higher coverage of vaccinations resulted in a greater increase in total costs each year. However, increasing coverage would also result in a decrease in the number of individuals developing zoster and associated postherpetic neuralgia and nonpain complications over the next 5 years. Merck & Co. funded this study/research and was involved in all stages of study conduct, including analysis of the data. Merck & Co. also undertook all costs associated with the development and publication of this manuscript. Graham and Mauskopf (and/or their institutions) received research funding from Merck & Co. to develop the budget-impact estimates and for other research studies. Johnson, Xu, and Acosta are employees of Merck & Co. Kawai was employed by Merck & Co. during part of the time of this study. Graham and Mauskopf were primarily responsible for the design and programming of the economic model, identification and final selection of the input parameter values, interpretation of the study results, and preparation of the study report. Johnson, Kawai, Xu, and Acosta contributed to model design, input parameter estimation, interpretation of the results, and review of and revisions to the study report. All authors had access to the data, participated in the development of this manuscript, and gave final approval before submission. All authors have agreed to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Validation of stationary phases in (111)In-pentetreotide planar chromatography.

PubMed

Moreno-Ortega, E; Mena-Bares, L M; Maza-Muret, F R; Hidalgo-Ramos, F J; Vallejo-Casas, J A

2013-01-01

Since Pall-German stopped manufacturing ITLC-SG, it has become necessary to validate alternative stationary phases. To validate different stationary phases versus ITLC-SG Pall-Gelman in the determination of the radiochemical purity (RCP) of (111)In-pentetreotide ((111)In-Octreoscan) by planar chromatography. We conducted a case-control study, which included 66 (111)In-pentetreotide preparations. We determined the RCP by planar chromatography, using a freshly prepared solution of 0,1M sodium citrate (pH 5) and the following stationary phases: ITLC-SG (Pall-Gelman) (reference method), iTLC-SG (Varian), HPTLC silica gel 60 (Merck), Whatman 1, Whatman 3MM and Whatman 17. For each of the methods, we calculated: PRQ, relative front values (RF) of the radiopharmaceutical and free (111)In, chromatographic development time, resolution between peaks. We compared the results obtained with the reference method. The statistical analysis was performed using the SPSS program. The p value was calculated for the study of statistical significance. The highest resolution is obtained with HPTLC silica gel 60 (Merck). However, the chromatographic development time is too long (mean=33.62minutes). Greater resolution is obtained with iTLC-SG (Varian) than with the reference method, with lower chromatographic development time (mean=3.61minutes). Very low resolutions are obtained with Whatman paper, essentially with Whatman 1 and 3MM. Therefore, we do not recommend their use. Although iTLC-SG (Varian) and HPTLC silica gel 60 (Merck) are suitable alternatives to ITLC-SG (Pall-Gelman) in determining the RCP of (111)In-pentetreotide, iTLC-SG (Varian) is the method of choice due to its lower chromatographic development time. Copyright © 2012 Elsevier España, S.L. and SEMNIM. All rights reserved.

Serum AMH levels in healthy women from BRCA1/2 mutated families: are they reduced?

PubMed

van Tilborg, Theodora C; Derks-Smeets, Inge A P; Bos, Anna M E; Oosterwijk, Jan C; van Golde, Ron J; de Die-Smulders, Christine E; van der Kolk, Lizet E; van Zelst-Stams, Wendy A G; Velthuizen, Maria E; Hoek, Annemieke; Eijkemans, Marinus J C; Laven, Joop S E; Ausems, Margreet G E M; Broekmans, Frank J M

2016-11-01

Do BRCA1/2 mutation carriers have a compromised ovarian reserve compared to proven non-carriers, based on serum anti-Müllerian hormone (AMH) levels? BRCA1/2 mutation carriers do not show a lower serum AMH level in comparison to proven non-carriers, after adjustment for potential confounders. It has been suggested that the BRCA genes play a role in the process of ovarian reserve depletion, although previous studies have shown inconsistent results regarding the association between serum AMH levels and BRCA mutation status. Hence, it is yet unclear whether BRCA1/2 mutation carriers may indeed be at risk of a reduced reproductive lifespan. STUDY DESIGN, SIZE, DURATION: A multicenter, cross-sectional study was performed between January 2012 and February 2015 in 255 women. We needed to include 120 BRCA1/2 mutation carriers and 120 proven non-carriers to demonstrate a difference in AMH levels of 0.40 µg/l (SD ± 0.12 µg/l, two-sided alpha-error 0.05, power 80%). Healthy women aged 18-45 years who were referred to the Clinical Genetics Department and applied for predictive BRCA1/2 testing because of a familial BRCA1/2 mutation were asked to participate. A cross-sectional assessment was performed by measuring serum AMH levels and filling out a questionnaire. Multivariate linear regression analyses adjusted for age, current smoking and current hormonal contraceptive use were performed on log-transformed serum AMH levels. Out of 823 potentially eligible women, 421 (51.2%) were willing to participate, and of those, 166 (39%) did not meet our inclusion criteria. Two hundred and fifty-five women were available for analyses; 124 BRCA1/2 mutation carriers and 131 proven non-carriers. The median [range] AMH level in carriers was 1.90 µg/l [0.11-19.00] compared to 1.80 µg/l [0.11-10.00] in non-carriers (P = 0.34). Adjusted linear regression analysis revealed no reduction in AMH level in the carriers (relative change = 0.98 (95%CI, 0.77-1.22); P = 0.76). Participants were relatively young. Power was insufficient to analyze BRCA1 and BRCA2 mutation carriers separately. AMH levels may have been influenced by the use of hormonal contraceptives, though similar proportions of carriers and non-carriers were current users and adjustments were made to correct for potential confounding in our analysis. Limitations of the current analysis and limitations of the existing literature argue for prospective, well-controlled follow-up studies with recurrent AMH measurements to determine whether carriers might be at risk for low ovarian reserve and to definitively guide care. This study was partially financially supported by a personal grant for Inge A.P. Derks-Smeets, kindly provided by the Dutch Cancer Society (Grant Number UM 2011-5249). Theodora C. van Tilborg, Inge A.P. Derks-Smeets, Anna M.E. Bos, Jan C. Oosterwijk, Christine E. de Die-Smulders, Lizet E. van der Kolk, Wendy A.G. van Zelst-Stams, Maria E. Velthuizen, Marinus J.C. Eijkemans and Margreet G.E.M. Ausems have nothing to disclose. Ron J. van Golde has received unrestricted research grants from Ferring and Merck Serono, outside the submitted work. Annemieke Hoek received an unrestricted educational grant from Ferring pharmaceutical BV, The Netherlands and a speaker's fee for post graduate education from MSD pharmaceutical company, outside the submitted work. Joop S.E. Laven has received unrestricted research grants from Ferring, Merck Serono, Merck Sharpe & Dome, Organon, and Schering Plough, outside the submitted work. Frank J.M. Broekmans is a member of the external advisory board for Merck Serono (The Netherlands), outside the submitted work. NTR no. 4324. © The Author 2016. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Techniques used for IUI: is it time for a change?

PubMed

Lemmens, L; Kos, S; Beijer, C; Braat, D D M; Nelen, W L D M; Wetzels, A M M

2017-09-01

Are the guidelines for the technical aspects of IUI (WHO, 2010) still in accordance with the current literature? In general, the laboratory guidelines of the World Health Organization (WHO) are a suitable protocol, although the evidence is not always conclusive and some changes are advisable. Lack of standardization of the technical procedures required for IUI might result in inter-laboratory variation in pregnancy rates. Most centers still use their own materials and methods even though some guidelines are available. A structural review focusing on the association between pregnancy rates and the procedures of semen collection (e.g. ejaculatory abstinence, collection place), semen processing (e.g. preparation method, temperature during centrifugation/storage), insemination (e.g. timing of IUI, bed rest after IUI) and the equipment used. A literature search was performed in Medline and the Cochrane library. When no adequate studies of the impact of a parameter on pregnancy results were found, its association with sperm parameters was reviewed. For most variables, the literature review revealed a low level of evidence, a limited number of studies and/or an inadequate outcome measure. Moreover, the comparison of procedures (i.e. semen preparation technique, time interval between semen, collection, processing and IUI) revealed no consensus about their results. It was not possible to develop an evidence-based, optimal IUI treatment protocol. The included studies exhibited a lack of standardization in inclusion criteria and methods used. This review emphasizes the need for more knowledge about and standardization of assisted reproduction technologies. Our literature search indicates that some of the recommendations in the laboratory guidelines could be adapted to improve standardization, comfort, quality control and to cut costs. The Dutch Foundation for Quality Assessment in Medical Laboratories (SKML), Nijmegen, The Netherlands. S.K. and W.N. have no conflicts of interest to disclose. C.B. and A.W. are members of the board of the SKML. With a grant from SKML, L.L. was paid for her time to perform the research and write the publication. D.B. received grants from Merck Serono, Ferring and MSD, outside the submitted work. N/A. © The Author 2017. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com

Dropout is a problem in lifestyle intervention programs for overweight and obese infertile women: a systematic review.

PubMed

Mutsaerts, M A Q; Kuchenbecker, W K H; Mol, B W; Land, J A; Hoek, A

2013-04-01

What are the dropout rates in lifestyle intervention programs (LIPs) for overweight and obese infertile women and can intervention- or patient-related baseline factors associated with dropout be identified in these women? The median dropout rate was 24% in overweight and obese infertile women who participated in a LIP; clinical useful intervention or patient-related factors associated with dropout could not be identified. Overweight and obese infertile women might improve their chance of conception when they improve their lifestyle and lose weight. Dropout from LIPs reduces the chance of losing considerable weight and is therefore considered to be an important limiting factor of the success of LIPs. This systematic review included 15 studies published between January 1980 and December 2012. The included studies investigated the effect of LIPs for overweight and obese infertile women with infertility. From these studies, dropout rates and intervention- and patient-related baseline factors associated with dropout, as well as weight loss and pregnancy rates, were recorded. There were 15 studies identified, of which 10 reported dropout rates. The median dropout rate was 24% (range: 0-31%). Four studies reported baseline characteristics of women who dropped out, but modifiable predictors of dropout could not be identified. Weight loss and pregnancy rates were lower in women who dropped out than in women who completed the LIPs. There were limited numbers of studies investigating patient-related factors associated with dropout. The heterogeneity in the studies precluded us from drawing firm conclusions on the relation between the type of intervention and dropout. Dropout from LIPs is a major drawback because it predisposes to less weight loss and lower pregnancy rates. Identification of predictors of dropout is needed to identify overweight and obese infertile women who are prone for dropout. These women might benefit from extra support and monitoring, to potentially increasing adherence rates, weight loss and pregnancy chances. M.A.Q.M. was supported by a research grant from the Dutch Organization for Health Research and Development (ZonMw). The department of obstetrics and gynaecology received research grants from Merck Sharpe and Dohme BV, feering pharmaceuticals, Merck Serono, the Netherlands.

Performance of a time-resolved fluorescence immunoassay for measuring varicella-zoster virus immunoglobulin G levels in adults and comparison with commercial enzyme immunoassays and Merck glycoprotein enzyme immunoassay.

PubMed

Maple, P A C; Gray, J; Breuer, J; Kafatos, G; Parker, S; Brown, D

2006-02-01

Highly sensitive and specific, quantitative assays are needed to detect varicella-zoster virus (VZV) immunoglobulin G in human sera, particularly for determining immune status and response following vaccination. A time-resolved fluorescence immunoassay (TRFIA) has been developed, and its performance was compared to that of two commercial enzyme immunoassays (EIAs) and Merck glycoprotein EIA (gpEIA). The TRFIA had equivalent sensitivity (97.8%) and high specificity (93.5%) in relation to gpEIA. A commercial (Behring) EIA compared favorably with TRFIA in terms of sensitivity (98.4%) but had lower specificity (80.7%). Another commercial EIA (Diamedix) had high specificity (97.1%) but low sensitivity (76.4%) compared to TRFIA if equivocal test results were treated as negative for VZV antibody. A novel feature of the TRFIA was that the cutoff was generated using population mixture modeling and was expressed in mIU/ml, as the assay was calibrated using the British standard VZV antibody.

An evaluation of computer-aided disproportionality analysis for post-marketing signal detection.

PubMed

Lehman, H P; Chen, J; Gould, A L; Kassekert, R; Beninger, P R; Carney, R; Goldberg, M; Goss, M A; Kidos, K; Sharrar, R G; Shields, K; Sweet, A; Wiholm, B E; Honig, P K

2007-08-01

To understand the value of computer-aided disproportionality analysis (DA) in relation to current pharmacovigilance signal detection methods, four products were retrospectively evaluated by applying an empirical Bayes method to Merck's post-marketing safety database. Findings were compared with the prior detection of labeled post-marketing adverse events. Disproportionality ratios (empirical Bayes geometric mean lower 95% bounds for the posterior distribution (EBGM05)) were generated for product-event pairs. Overall (1993-2004 data, EBGM05> or =2, individual terms) results of signal detection using DA compared to standard methods were sensitivity, 31.1%; specificity, 95.3%; and positive predictive value, 19.9%. Using groupings of synonymous labeled terms, sensitivity improved (40.9%). More of the adverse events detected by both methods were detected earlier using DA and grouped (versus individual) terms. With 1939-2004 data, diagnostic properties were similar to those from 1993 to 2004. DA methods using Merck's safety database demonstrate sufficient sensitivity and specificity to be considered for use as an adjunct to conventional signal detection methods.

Hazardous Waste Cleanup: Merial Barceloneta, LLC in Barceloneta, Puerto Rico

EPA Pesticide Factsheets

The Merck, Sharp & Dohme Química de Puerto Rico Ltd (MSDQ) facility is located at Road #2 km. 56.7, in the Municipality of Barceloneta, Puerto Rico. The facility is located approximately three miles south of the Atlantic Ocean and 38 miles due west of San

Being Selfish: Taking Personal Responsibility for Excellence

ERIC Educational Resources Information Center

Johnson, Larry

2013-01-01

Nordstrom department stores, Disney, Lands' End, and the Merck pharmaceutical company to name a few. Many books and articles have been written in the past 20 years about the factors that such companies have in common. The oft-named factors are (1) a focus on the customer,…

Transdermal testosterone pretreatment in poor responders undergoing ICSI: a randomized clinical trial.

PubMed

Bosdou, J K; Venetis, C A; Dafopoulos, K; Zepiridis, L; Chatzimeletiou, K; Anifandis, G; Mitsoli, A; Makedos, A; Messinis, I E; Tarlatzis, B C; Kolibianakis, E M

2016-05-01

Does pretreatment with transdermal testosterone increase the number of cumulus-oocyte complexes (COCs) retrieved by more than 1.5 in poor responders undergoing intracytoplasmic sperm injection (ICSI), using recombinant follicle stimulating hormone (FSH) and gonadotrophin releasing hormone agonists (GnRHa)? Testosterone pretreatment failed to increase the number of COCs by more than 1.5 as compared with no pretreatment in poor responders undergoing ICSI (difference between medians: 0.0, 95% CI: -1.0 to +1.0). Androgens are thought to play an important role in early follicular development by enhancing ovarian sensitivity to FSH. In a recent meta-analysis, testosterone pretreatment resulted in an increase of 1.5 COCs as compared with no pretreatment. However, this effect was based on the analysis of only two randomized controlled trials (RCTs) including 163 patients. Evidently, there is a need for additional RCTs that will allow firmer conclusions to be drawn. The present RCT was designed to detect a difference of 1.5 COCs (sample size required = 48 patients). From 02/2014 until 04/2015, 50 poor responders fulfilling the Bologna criteria have been randomized (using a randomization list) to either testosterone pretreatment for 21 days ( ITALIC! n = 26) or no pretreatment ( ITALIC! n = 24). All patients underwent a long follicular GnRHa protocol. Recombinant FSH stimulation was started on Day 22 following GnRHa initiation. In the testosterone pretreatment group, a daily dose of 10 mg of testosterone gel was applied transdermally for 21 days starting from GnRHa initiation. Results are expressed as median (interquartile range). No differences in baseline characteristics were observed between the two groups compared. Testosterone levels [median (interquartile range)] were significantly higher in the testosterone pretreatment on the day of initiation of FSH stimulation [114 (99.5) ng/dl versus 20 (20) ng/dl, respectively, ITALIC! P < 0.001]. Duration of FSH stimulation [median (interquartile range)] was similar between the groups compared [12.5 (3.0) days versus 12 (3.0) days, respectively, ITALIC! P = 0.52]. The number of COCs retrieved [median (interquartile range)] was not different between the testosterone pretreatment and the no pretreatment groups [3.5 (4.0) versus 3.0 (3.0), 95% CI for the median: 2.0-5.0 versus 2.7-4.3, respectively; difference between medians: 0.0, 95% CI: +1.0 to -1.0). Similarly no differences were observed regarding fertilization rates [median (interquartile range)] [66.7% (32.5) versus 66.7% (42.9), respectively, ITALIC! P = 0.97] and live birth rates per randomized patient (7.7% versus 8.3%, respectively, rate difference: -0.6%, 95% CI: -19.0 to +16.9). The study was not powered to detect differences less than 1.5 COCs, although it is doubtful whether these differences would be clinically relevant. Moreover, due to sample size restrictions, no conclusions can be drawn regarding the probability of live birth. The results of this randomized clinical trial, suggesting that pretreatment with 10 mg of transdermal testosterone for 21 days does not improve ovarian response by more than 1.5 oocytes, could be used to more accurately consult patients with poor ovarian response. However, an improvement in IVF outcome using a higher dose of testosterone or a longer pretreatment period cannot be excluded. The study was partially funded by a Scholarship from the Academy of Athens. C.A.V. reports personal fees and non-financial support from Merck, Sharp and Dome, personal fees and non-financial support from Merck Serono, personal fees and non-financial support from IPSEN Hellas S.A., outside the submitted work. B.C.T. reports grants from Merck Serono, grants from Merck Sharp & Dohme, personal fees from Merck Serono, personal fees from Merck Sharp & Dohme, personal fees from IBSA & Ferring, outside the submitted work. NCT01961336. 10 October 2013. 02/2014. © The Author 2016. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Cumulus cells surrounding oocytes with high developmental competence exhibit down-regulation of phosphoinositol 1,3 kinase/protein kinase B (PI3K/AKT) signalling genes involved in proliferation and survival

PubMed Central

Artini, P G; Tatone, C; Sperduti, S; D’Aurora, M; Franchi, S; Di Emidio, G; Ciriminna, R; Vento, M; Di Pietro, C; Stuppia, L; Gatta, V

2017-01-01

Abstract STUDY QUESTION Is the phosphoinositol 1,3-kinase/protein kinase B (PI3K/AKT) pathway expression profile in cumulus cells (CCs) a potential marker of oocyte competence and predictive of pregnancy outcome? SUMMARY ANSWER Eleven genes (AKT1, ARHGEF7, BCL2L1, CCND1, E2F1, HRAS, KCNH2, PIK3C2A, SHC1, SOS1 and SPP1) in the PI3K/AKT pathway were significantly down-regulated in CCs from oocytes that went on to produce a pregnancy compared to CCs associated with a negative outcome. WHAT IS KNOWN ALREADY The PI3K/AKT pathway plays a pivotal role in the interdependence and continuous feedback between the oocyte and CCs. STUDY DESIGN SIZE, DURATION The expression analysis of 92 transcripts in the PI3K/AKT pathway in CCs from patients with negative or positive pregnancy outcome, after single embryo transfer, was performed. Mouse CCs target gene expression was conducted to associate the expression profile of PI3K/AKT pathway to oocyte developmental profile. PARTICIPANTS/MATERIALS, SETTING, METHODS Fifty-five good prognosis IVF patients who had been referred to IVF or intracytoplasmic sperm injection treatment for male-factor infertility or tubal disease were enroled. CCs from single cumulus-oocyte complexes (COCs) from 16 patients who underwent a single embryo transfer were analyzed. Twenty-five CD-1 mice were used to assess gene expression in CCs associated with oocytes with different competence in relation to hCG priming. A total 220 human COCs were collected. The RNA extracted from CCs of 16 selected patients was used to analyze PI3K/AKT pathway gene expression employing a 96-well custom TaqMan Array. Expression data of CCs associated to positive IVF outcome were compared to data from negative outcome samples. Mice were sacrificed after 9, 12, 15, 21 and 24 h post-hCG administration to obtain CCs from MII oocytes with different developmental competence. Akt1, Bcl2l2 and Shc1 expression were tested in the collected mouse CCs. In addition, the expression of upstream regulator ESR1, the gene encoding for the oestrogen receptor ERβ, and the downstream effectors of the pathway FOXO1, FOXO3 and FOXO4 was evaluated in human and mouse samples. MAIN RESULTS AND THE ROLE OF CHANCE Transcripts involved in the PI3K Signaling Pathway were selectively modulated according to the IVF/ICSI outcome of the oocyte. Eleven transcripts in this pathway were significantly down-regulated in all samples of CCs from oocytes with positive when compared those with a negative outcome. These outcomes were confirmed in mouse CCs associated with oocytes at different maturation stages. Expression data revealed that the down-regulation of ESR1 could be related to oocyte competence and is likely to be the driver of expression changes highlighted in the PI3K/AKT pathway. LIMITATIONS REASONS FOR CAUTION Small sample size and retrospective design. WIDER IMPLICATIONS OF THE FINDINGS The CCs expression profile of PI3K/AKT signaling genes, disclosed a specific CCs gene signature related to oocyte competence. It could be speculated that CCs associated with competent oocytes have completed their role in sustaining oocyte development and are influencing their fate in response to metabolic and hormonal changes by de-activating anti-apoptotic signals. STUDY FUNDING/COMPETING INTEREST(S) Supported by Merck Serono an affiliate of Merck KGaA, Darmstadt, Germany (research grant for the laboratory session; Merck KGaA reviewed the manuscript for medical accuracy only before journal submission. The authors are fully responsible for the content of this manuscript, and the views and opinions described in the publication reflect solely those of the authors). The authors declare no conflict of interest. PMID:29087515

A community approach to health.

PubMed

Hagland, M

1997-01-01

Improving the health and well-being of a community may seem like a daunting task-particularly when you consider the vast number of factors that can influence the quality of life of a neighborhood or a region. It's not impossible, however, as six widely different communities across the U.S. are discovering. The Accelerating Community Transformation (ACT) project--now underway by The Healthcare Forum through a five-year, $5 million grant from pharmaceutical joint venture Astra Merck Inc.--is an innovative attempt to create real-life learning laboratories in communities as diverse as an inner-city neighborhood on the west side of Chicago; the small southern town of Aiken, S.C.: the semi-desert city of San Bernardino, Calif.; a corner of America's heartland where Missouri, Kansas. Nebraska and Iowa meet; the new town of Celebration, Fla.; and St. Louis, Mo. The goals: to evaluate and accelerate community-wide efforts that result in healthier, more desirable places for people to live, work and play; to build community capacity; and to achieve measurable improved health and quality of life outcomes.

Transdermal flunixin meglumine minimally alters neutrophil functionality in beef heifers administered a respiratory disease challenge

USDA-ARS?s Scientific Manuscript database

The objectives were to determine the effects of altering time of transdermal flunixin meglumine (BTD; Banamine Transdermal, Merck Animal Health) administration relative to a viral-bacterial challenge in beef heifers. Thirty-two heifers (170 ± 21.1 kg BW) were assigned to one of four treatments: 1) C...

Acute metabolic responses to a combined viral-bacterial respiratory disease challenge in heifers administered transdermal flunixin meglumine

USDA-ARS?s Scientific Manuscript database

A trial was conducted to determine effects of altering time of transdermal flunixin meglumine (BTD; Banamine Transdermal, Merck Animal Health, Summit, NJ) administration relative to a viral-bacterial respiratory disease challenge in beef heifers. Thirty-two healthy heifers (170±21.1 kg BW) were assi...

In vitro versus in vivo concordance: a case study of the replacement of an animal potency test with an immunochemical assay.

PubMed

Schofield, T

2002-01-01

Early in its development, the potency of Merck's recombinant hepatitis B vaccine, RECOMBIVAX HB, was monitored using an assay performed in mice. A specification was determined to be the lowest potency which induced acceptable response in clinical trials. As a post-licensing commitment, Merck was asked to replace its mouse potency assay with an in vitro procedure for product release in the US market. Early studies with a commercial enzyme immunoassay (EIA) yielded highly variable results. That assay, combined with a sample pretreatment step, proved more dependable and predictive of potency in the mouse assay. Based on measurements made on manufactured materials, combined with experiments contrived to yield a wide range of reactivity in the two assays, concordance was established between the EIA and the mouse potency assay. This concordance was used to calibrate a specification for the in vitro assay that is predictive of a satisfactory response in vivo. Data from clinical trials established a correspondence between human immunogenicity and these potency markers.

Pressurized planar electrochromatography, high-performance thin-layer chromatography and high-performance liquid chromatography--comparison of performance.

PubMed

Płocharz, Paweł; Klimek-Turek, Anna; Dzido, Tadeusz H

2010-07-16

Kinetic performance, measured by plate height, of High-Performance Thin-Layer Chromatography (HPTLC), High-Performance Liquid Chromatography (HPLC) and Pressurized Planar Electrochromatography (PPEC) was compared for the systems with adsorbent of the HPTLC RP18W plate from Merck as the stationary phase and the mobile phase composed of acetonitrile and buffer solution. The HPLC column was packed with the adsorbent, which was scrapped from the chromatographic plate mentioned. An additional HPLC column was also packed with adsorbent of 5 microm particle diameter, C18 type silica based (LiChrosorb RP-18 from Merck). The dependence of plate height of both HPLC and PPEC separating systems on flow velocity of the mobile phase and on migration distance of the mobile phase in TLC system was presented applying test solute (prednisolone succinate). The highest performance, amongst systems investigated, was obtained for the PPEC system. The separation efficiency of the systems investigated in the paper was additionally confirmed by the separation of test component mixture composed of six hormones. 2010 Elsevier B.V. All rights reserved.

Effectiveness and Safety of Sofosbuvir/Ledipasvir and Paritaprevir/ritonavir/Ombitasvir + Dasabuvir in Patients with Chronic Kidney Diseases: Results from ERCHIVES

PubMed Central

Butt, Adeel; Ren, Yanjie; Puenpatom, Amy; Arduino, Jean Marie; Kumar, Ritesh; Abou-Samra, Abdul-Badi

2017-01-01

Abstract Background Chronic kidney disease (CKD) was a relative contraindication to HCV treatment in the interferon/ribavirin era due to poor tolerability and lower efficacy. Our aim was to determine the effectiveness treatment completion, and safety of sofosbuvir/ledipasvir (SOF/LDV) and paritaprevir/ritonavir/ombitasvir/dasabuvir (PrOD) regimens in persons with CKD. Methods We identified all persons started on a SOF/LDV or PrOD regimen in ERCHIVES before 30 April 2016. We excluded those with missing HCV genotype, or eGFR values. We determined treatment completion, sustained virologic response (SVR) rates and proportion of persons with worseningrenal function or developing grade 3/4 anemia. Results We identified 9,837 persons on SOF/LDV, 3,826 on SOF/LDV+RBV, 1,017 on PrOD and 2,944 on PrOD+RBV. Genotype 1a was the predominant genotype for SOF/LDV+RBV (77.3% no RBV; 70.0% with RBV) and PrOD+RBV (79.5%) groups, while only 4.3% of PrOD with no RBV group were genotype 1a. Among treated patients, the prevalence of patients with stage 4–5 CKD was 0.8% (SOF/LDV + RBV), 1.1% (SOF/LDVno RBV), 2.2% (PrOD +RBV) and 5.4% (PrOD no RBV). Among 13,663 total persons on SOF/LDV, 67.8% completed treatment while the treatment completion rate of those on PrOD was 74.0% (N = 2,932/3,961) (Table 1). The overall SVR rates of persons on SOF/LDV or PrOD regimens were 96.3%. A drop in treatment completion rates was seen in CKD stage 4–5 and those on PrOD+RBV, but the impact of RBV on SVR was unclear. While about one-third of the persons with a CKD stage 1–2 experienced a >10 mL/minute/1,73m2, about 15% decline among those with CKD stage 3. The incidence of grade3/4 anemia by CKD stages increased significantly across the treatment groups. Grade 3/4 anemia ranged from 9.7% (SOF/LDV) to 21.8% (PrOD) among patients with CKD stage 4–5 (Table 2). Conclusion SVR rates among persons treated with SOF/LDV or PrOD were high in the CKD population despite 22% not completing the treatment regimen. Incidence of grade3/4 anemia increased significantly in CKD stage 4–5 across the treatment groups. Disclosures A. Butt, Merck: Investigator, Grant recipient.A. Puenpatom, Merck: Employee, Salary. J. M. Arduino, Merck: Employee, Salary. R. Kumar, Merck: Employee, Salary

Androgen levels in women with various forms of ovarian dysfunction: associations with cardiometabolic features.

PubMed

Daan, N M P; Jaspers, L; Koster, M P H; Broekmans, F J M; de Rijke, Y B; Franco, O H; Laven, J S E; Kavousi, M; Fauser, B C J M

2015-10-01

Are differences in androgen levels among women with various forms of ovarian dysfunction associated with cardiometabolic abnormalities? Androgen levels differed substantially between women with and without ovarian dysfunction, and increased androgen levels were associated with impaired cardiometabolic features in all women irrespective of their clinical condition. Sex steroid hormones play important roles in the development of cardiovascular diseases (CVD). Extremes of low as well as high androgen levels have been associated with increased CVD risk in both men and women. This cross-sectional study included 680 women with polycystic ovary syndrome (PCOS), premature ovarian insufficiency (POI), natural post-menopausal women (NM), or regular menstrual cycles (RC) (170 women per group). Measurements of serum testosterone, androstenedione and dehydroepiandrosterone sulfate were performed using liquid chromatography-tandem mass spectrometry. Assessments were taken of body mass index (BMI), blood pressure, lipid profiles, glucose, insulin and SHBG, and the bioactive fraction of circulating testosterone was calculated using the free androgen index (FAI). PCOS women were hyperandrogenic [median FAI = 4.9 (IQR 3.6-7.4)], and POI women were hypoandrogenic [FAI = 1.2 (0.8-1.7)], compared with RC women [FAI = 1.7 (1.1-2.8)], after adjustment for age, ethnicity, smoking and BMI (P < 0.001). After adjustment for age, there were no significant differences in androgens between POI and NM (P = 0.15) women and between NM and RC (P = 0.27) women, the latter indicating that chronological aging rather than ovarian aging influences the differences between pre- and post-menopausal women. A high FAI was associated with elevated triglycerides (β log FAI for PCOS: 0.45, P < 0.001, POI: 0.25, P < 0.001, NM: 0.20, P = 0.002), insulin (β log FAI for PCOS: 0.77, POI: 0.44, NM: 0.40, all P < 0.001), HOMA-IR (β log FAI for PCOS: 0.82, POI: 0.46, NM: 0.47, all P < 0.001) and mean arterial pressure (β log FAI for PCOS: 0.05, P = 0.002, POI: 0.07, P < 0.001, NM: 0.04, P = 0.04) in all women; with increased glucose (β log FAI for PCOS: 0.05, P = 0.003, NM: 0.07, P < 0.001) and decreased high-density lipoprotein (β log FAI for PCOS: -0.23, P < 0.001, NM: -0.09, P = 0.03) in PCOS and NM women; and with increased low-density lipoprotein (β log FAI for POI: 0.083, P = 0.041) in POI women. Adjustment for BMI attenuated the observed associations. Associations between FAI and cardiometabolic features were the strongest in PCOS women, even after adjustment for BMI. Associations between androgen levels and cardiometabolic features were assessed in PCOS, POI and NM women only, due to a lack of available data in RC women. Due to the cross-sectional design of the current study, the potential associations between androgen levels and actual future cardiovascular events could not be assessed. This study affirms the potent effect of androgens on cardiometabolic features, indicating that androgens should indeed be regarded as important denominators of women's health. Future research regarding the role of androgens in the development of CVD and potential modulatory effects of BMI is required. N.M.P.D. is supported by the Dutch Heart Foundation (grant number 2013T083). L.J. and O.H.F. work in ErasmusAGE, a center for aging research across the life course, funded by Nestlé Nutrition (Nestec Ltd), Metagenics Inc. and AXA. M.K. is supported by the AXA Research Fund. Nestlé Nutrition (Nestec Ltd), Metagenics Inc. and AXA had no role in the design and conduct of the study; the collection, management, analysis and interpretation of the data; or the preparation, review or approval of the manuscript. J.S.E.L. has received fees and grant support from the following companies (in alphabetical order): Ferring, Merck-Serono, Merck Sharpe & Dome, Organon, Schering Plough and Serono. In the last 5 years, B.C.J.M.F. has received fees and grant support from the following companies (in alphabetic order); Actavis, COGI, Euroscreen, Ferring, Finox, Genovum, Gedeon-Richter, Merck-Serono, OvaScience, Pantharei Bioscience, PregLem, Roche, Uteron and Watson laboratories. With regard to potential conflicts of interest, there is nothing further to disclose. © The Author 2015. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

40 CFR 52.2454 - Prevention of significant deterioration of air quality for Merck & Co., Inc.'s Stonewall Plant in...

Code of Federal Regulations, 2010 CFR

2010-07-01

.... Significant modifications for the purposes of this section are defined as changes to an existing process unit... responsible official that to his belief, based on reasonable inquiry, the information submitted in the report.... (1) Permit modifications that require public participation. For any change that does not meet the...

40 CFR 52.2454 - Prevention of significant deterioration of air quality for Merck & Co., Inc.'s Stonewall Plant in...

Code of Federal Regulations, 2014 CFR

2014-07-01

... significant deterioration of air quality preconstruction review requirements for the following pollutants only... (PM2.5) regulated as PM2.5; however, the preconstruction review requirements of § 52.21, or other preconstruction review requirements that the Administrator approves as part of the plan, shall remain in effect...

40 CFR 52.2454 - Prevention of significant deterioration of air quality for Merck & Co., Inc.'s Stonewall Plant in...

Code of Federal Regulations, 2013 CFR

2013-07-01

... significant deterioration of air quality preconstruction review requirements for the following pollutants only... (PM2.5) regulated as PM2.5; however, the preconstruction review requirements of § 52.21, or other preconstruction review requirements that the Administrator approves as part of the plan, shall remain in effect...

Acute immunological responses to a combined viral-bacterial respiratory disease challenge in heifers administered transdermal flunixin meglumine

USDA-ARS?s Scientific Manuscript database

Time of flunixin meglumine transdermal (FTD; Finadyne Transdermal, Merck Animal Health, Summit, NJ) administration relative to a viral-bacterial challenge was evaluated in beef heifers. Thirty-two beef heifers (170 ± 21.1 kg BW) were randomly assigned to one of four treatments: 1) Control (CON), rec...

The Inquiry Based Science and Technology Education Program (IN-STEP): The Evaluation of the First Year

ERIC Educational Resources Information Center

Corcoran, Thomas B.

2008-01-01

This is the first report on the evaluation of the Inquiry Based Science and Technology Education Program (IN-STEP), an innovative and ambitious science education initiative for lower secondary schools being undertaken by a public-private partnership in Thailand funded by MSD-Thailand, an affiliate of Merck & Co. IN-STEP is a public-private…

RotaTeq (sanofi pasteur/Wistar Institute/Children's Hospital of Philadelphia).

PubMed

Desselberger, Ulrich

2005-02-01

Sanofi pasteur MSD (a joint venture between Merck & Co and sanofi pasteur (formerly Aventis Pasteur)), in collaboration with the Wistar Institute and the Children's Hospital of Philadelphia, is developing RotaTeq, an oral liquid pentavalent vaccine for the potential prevention of rotavirus infection-related disorders, such as infant diarrhea and malabsorption. Phase III trials had commenced by March 2001.

Zinc Methionine Supplementation Impacts Gene and Protein Expression in Calf-fed Holstein Steers with Miniaml Impact on Feedlot Performance

USDA-ARS?s Scientific Manuscript database

Calf-fed Holstein steers were supplemented with a zinc (Zn) methionine supplement (ZnMet; ZINPRO®; Zinpro Corporation, Eden Prairie, MN) for 115±5 days prior to harvest along with zilpaterol hydrochloride (ZH; Zilmax®; Merck Animal Health, Summit, NJ) for the last 20 days with a 3 day withdrawal to ...

Confessions of a pharmaceutical company: voice, narrative, and gendered dialectics in the case of Gardasil.

PubMed

Malkowski, Jennifer

2014-01-01

Despite the fact that both men and women carry the human papillomavirus (HPV) and jointly contribute to its status as an epidemic, the promotion of Gardasil, a vaccine that blocks infection from four strains of HPV, has largely been designated as a women's-only health issue. The following case study contributes to ongoing efforts in the field of health communication to identify problematic assumptions informing contemporary health policy and practices. Specifically, I analyze how Merck Pharmaceuticals, the creator of Gardasil, strategically imbues direct-to-consumer advertisements with contradiction to preserve traditional notions of both women and medicine. I found that three gendered dialectics characterize Merck's efforts to invoke complacency among female consumers: public/secret, education/ignorance, and structured/individualist. In the case of the HPV vaccination, the implications of these dialectics are the perpetuation of complacency among female audiences that threatens both the success of this particular technology and the overall status of women and health. In line with conclusions offered by Thompson (2010a), this study extends a call for health and communication scholars to continue to deconstruct dominant medical discourses and presents possibilities for re-storying narratives that mediate women's experiences with health.

Efavirenz DuPont Pharmaceuticals Co.

PubMed

Dong, B J

1998-10-01

Efavirenz is the lead compound of a series of benzoxazinones originally developed by DuPont Merck. It is a non-nucleoside reverse transcriptase inhibitor (NNRTI) under development for the potential treatment of viral infections, including HIV. In June 1998, the company submitted an NDA to the US FDA for the use of efavirenz (as Sustiva) for the treatment of HIV infection [289361]. In July 1998, DuPont purchased Merck's interest in DuPont Merck and the company's name changed to DuPont Pharmaceuticals. The two companies decided to continue to share marketing rights to Sustiva (to be marketed by Merck as Stocrin outside the US, Canada, and certain European countries) [291738]. As of October 1997, triple combination studies of efavirenz were ongoing, or planned, with nelfinavir, indinavir or ritonavir, or other retroviral inhibitors, for the treatment of opportunistic and pediatric viral infections [265945]. Efavirenz is also being evaluated as monotherapy and in combination with zidovudine (Retrovir, AZT) and lamivudine (Epivir, 3TC) (qv). Results of a study in eight HIV-infected patients, reported at the 12th World AIDS Conference in July 1998, showed that efavirenz administration, in dual and triple combinations, achieved HIV-RNA levels in plasma and cerebrospinal fluid (CSF) below the level of detection (fewer than 400 copies/ml) [290881,293994]. In March 1998, Merck signed a letter of intent with Trimeris to conduct a trial of efavirenz in combination with Trimeris's HIV fusion inhibitor, T-20, (qv). The trial will enroll up to 48 HIV-infected individuals at three sites in the US. All enrolled patients will be those who have begun to fail their existing triple combination therapy. Prior exposure to NNRTIs and protease inhibitors, other than indinavir, will be among the exclusion criteria for the study. The first 10 days of the study were planned as a dose-optimization period to assess the safety, pharmacokinetics and antiviral activity of multiple ascending doses of T-20. After completion of this period, subjects will be eligible to participate in an extension period of at least six months, during which T-20 will be administered in combination with efavirenz and two protease inhibitors [281696]. A 137-patient phase III study showed that efavirenz, in combination with zidovudine and lamivudine, caused significant reduction in viral levels and increased CD4 cell levels. The results were presented at the Sixth European Conference on Clinical Aspects and Treatment of HIV Infection (Hamburg, Germany, October 1997) [265945]. At the Fourth Conference on Retroviruses and Opportunistic Infections, in January 1997, data were presented from a clinical trial of efavirenz in combination with indinavir, which showed that, in 82% of the patients, viral load was reduced to undetectable levels, as measured by the Amplicor assay [231410]. Further retrospective analysis showed that the viral load was a significant predictor of long-term (over 52 weeks) viral suppression [265945]. A double-blind, phase II pilot study of efavirenz showed significant activity in HIV-RNA suppression and CD4 cell recovery when evaluated for two weeks alone, and even better results when used in combination with indinavir (Crixivan, qv); 80% of patients achieved HIV-RNA below level of quantification and CD4 cell count elevation averaging 140 cells/mm3. The study evaluated 16 patients for 12 weeks and is ongoing [219671,227966]. A total of 21 patients received indinavir (800 mg, eight hourly) for two weeks, followed by combination therapy with efavirenz (200 mg, once daily). Another group of nine patients received indinavir alone for 26 weeks, followed by the addition of stavudine (Zerit) and efavirenz. In combination use, indinavir dosing was 1.0 g every eight hours. At 26 weeks, approximately 40% of the patients receiving indinavir alonehad plasma levels below 400 copies/ml of HIV-RNA. After stavudine and efavirenz were added, and following 16 weeks of the triple combination, 83% of the patients had plasma levels below 400 copies/ml [247754].

Presence of human papillomavirus in semen in relation to semen quality.

PubMed

Luttmer, Roosmarijn; Dijkstra, Maaike G; Snijders, Peter J F; Hompes, Peter G A; Pronk, Divera T M; Hubeek, Isabelle; Berkhof, Johannes; Heideman, Daniëlle A M; Meijer, Chris J L M

2016-02-01

Is the presence of human papillomavirus (HPV) in semen associated with impairment of semen quality? In a large cohort of males seeking fertility evaluation, no associations were observed between seminal HPV presence and semen parameters. HPV is commonly detected in semen samples. Whether the presence of HPV is related to impairment of semen quality, remains unclear. This cross-sectional study included a cohort of 430 males. Male partners in couples seeking fertility evaluation provided one semen sample per person. Semen samples were tested for HPV-DNA using GP5+/6+-PCR. Sperm concentration was counted and motility was assessed in a Makler counting chamber at a magnification of ×200. The presence of antisperm antibodies was assessed by a mixed agglutination reaction (MAR)-test. Overall HPV was detected in 14.9% (64/430) of semen samples, including 2.1% (9/430) that contained both high-risk (hr) HPV and low-risk (lr) HPV types, 8.8% (38/430) with exclusively hrHPV types and 4.0% (17/430) with exclusively lrHPV types. The presence of HPV in semen was not associated with the age of the participants, seminal pH, semen volume, total sperm count, sperm concentration, progressive motility or the presence of antisperm antibodies. This study did not observe an association between HPV presence in semen and impairment of semen quality. However, we cannot exclude an effect of seminal HPV on early embryo development and clinical reproductive outcomes. As HPV is frequently present in semen, screening of donor semen for HPV should be considered to prevent iatrogenic cervical HPV infections in the recipient. However our findings do not support standardized HPV testing of semen in the diagnostic work-up of subfertile couples. This study was sponsored by an unrestricted grant of Stichting Researchfonds Pathology Amsterdam, the Netherlands. P.J.F.S. has been on the speakers bureau of Roche, Gen-Probe, Abbott, Qiagen and Seegene and has been a consultant for Crucell B.V. J.B. has been on the speakers bureau of Qiagen and has been a consultant for Roche, DDL Diagnostic Laboratory, GlaxoSmithKline and Merck. D.A.M.H. has been member of the scientific advisory boards of Amgen and Pfizer, and has been on the speakers bureau of Hologic/Gen-Probe. C.J.L.M.M. has been on the speakers bureau of GlaxoSmithKline, Qiagen, Merck, Roche, Menarini and Seegene, has served occasionally on the scientific advisory board of GlaxoSmithKline, Qiagen, Merck, Roche and Genticel, and has occasionally been a consultant for Qiagen. Formerly, C.J.L.M.M. was a minority shareholder of Delphi Biosciences, which bankrupted in 2014. C.J.L.M.M. is a minority shareholder of Diassay B.V. P.J.F.S., D.A.M.H. and C.J.L.M.M. have minority stake in Self-Screen B.V., a spin-off company of VU University Medical Center. R.L., M.G.D., P.G.A.H., D.T.M.P., and I.H. do not have any conflicts of interest to disclose. Not applicable. © The Author 2016. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Randomized, open trial comparing a modified double-lumen needle follicular flushing system with a single-lumen aspiration needle in IVF patients with poor ovarian response.

PubMed

von Horn, Kyra; Depenbusch, Marion; Schultze-Mosgau, Askan; Griesinger, Georg

2017-04-01

Is a modified double-lumen aspiration needle system with follicular flushing able to increase the mean oocyte yield by at least one in poor response IVF patients as compared to single-lumen needle aspiration without flushing? Follicular flushing with the modified flushing system did not increase the number of oocytes, but increased the procedure duration. Most studies on follicular flushing were performed with conventional double-lumen needles in patients who were normal responders. Overall, these studies indicated no benefit of follicular flushing. Prospective, single-centre, randomized, controlled, open, superiority trial comparing the 17 G Steiner-Tan Needle® flushing system with a standard 17 G single-lumen aspiration needle (Gynetics®); time frame February 2015-March 2016. Eighty IVF patients, 18-45 years, BMI >18 kg/m2 to <35 kg/m2, presenting with ≤ five follicles >10 mm in both ovaries at the end of the follicular phase were randomized to either aspirating and flushing each follicle 3× with the Steiner-Tan-Needle® automated flushing system (n = 40) or a conventional single-lumen needle aspiration (n = 40). Primary outcome was the number of cumulus-oocyte-complexes (COCs). Procedure duration, burden (Depression Anxiety and Stress Scale; DASS-21) and post-procedure pain were also assessed. Flushing was not superior with a mean (SD) number of COCs of 2.4 (2.0) and 3.1 (2.3) in the Steiner-Tan Needle® and in the Gynectics® group, respectively (mean difference -0.7, 95% CI: 0.3 to -1.6; P = 0.27). Likewise no differences were observed in metaphase II  oocytes, two pronuclear oocytes, number of patients having an embryo transfer and DASS 21 scores. The procedure duration was significantly 2-fold increased. Testing for differences in the number of patients achieving an embryo transfer or differences in pregnancy rate would require a much larger sample size. The use of follicular flushing is unlikely to benefit the prognosis of patients with poor ovarian response. The Steiner-Tan Needles® and the flushing system were provided for free by the manufacturer. K.v.H. has received personal fees from Finox and non-financial support from Merck-Serono; M.D. has received personal fees from Finox and non-financial support from Merck-Serono. A.S.-M. has received personal fees and non-financial support from M.D., Ferring, Merck-Serono, Finox, TEVA. G.G. has received personal fees and non-financial support from M.D., Ferring, Merck-Serono, Finox, TEVA, IBSA, Glycotope, as well as personal fees from VitroLife, NMC Healthcare LLC, ReprodWissen LLC and ZIVA LLC. NCT 02365350 (clinicaltrials.gov). Sixth of February 2015. Ninth of February 2015. © The Author 2017. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

Comparison of Pharmacist and Physician Managed Annual Medicare Wellness Services.

PubMed

Sewell, Mary Jean; Riche, Daniel M; Fleming, Joshua W; Malinowski, Scott S; Jackson, R Terry

2016-12-01

Medicare Annual Wellness Visits (AWV) are a benefit provided for Medicare beneficiaries to increase focus on wellness and preventive measures. Pharmacists can conduct AWVs, which offers a potential avenue for outpatient revenue generation. To compare a composite of interventions and screenings and revenue generated by a pharmacist with those made by a physician during a subsequent AWV. A report generated through the electronic health record was used to determine AWVs conducted by a pharmacist or 3 participating physicians from December 2013 to March 2016, including revenue generated. Through electronic chart review, documentation was accessed to quantify and categorize the number and types of referrals, health advice, laboratory tests, procedures, vaccinations, and screenings that were recommended during each patient's AWV. The pharmacist performed 19 subsequent visits, and the 3 physicians performed 89 subsequent visits. Overall, the composite of interventions and screenings was significantly higher in the pharmacist group than the physician group (P = 0.03). More interventions were made in the areas of health advice (P = 0.020), vaccine recommendations (P = 0.009), and screenings in the pharmacist group (P < 0.001). The physicians ordered significantly more laboratory tests per visit (P < 0.001). The pharmacist was reimbursed on average $105 per visit versus $99 per visit for the physicians. Pharmacist-provided AWVs are at least comparable to those provided by physicians and offer an additional access point for valuable services for Medicare beneficiaries. There was no financial contribution to this study. Riche reports participation in the Speaker's Bureau for Merck and the Speaker's Bureau and Advisory Board for Novo Nordisk. The authors have no other conflicts of interest to report pertinent to this research. This data has not been previously published in any other location. Richie, Sewell, Malinowski, Jackson, and Fleming were involved in study design and manuscript preparation/approval. Jackson was involved in data collection, and Richie and Sewell were involved in data collection and data analysis. Sewell and Richie had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Rotavirus vaccine effectiveness in Hong Kong children.

PubMed

Yeung, Karene Hoi Ting; Tate, Jacqueline E; Chan, Ching Ching; Chan, Martin C W; Chan, Paul K S; Poon, Kin Hung; Siu, Sylvia Luen Yee; Fung, Genevieve Po Gee; Ng, Kwok Leung; Chan, Iris Mei Ching; Yu, Pui Tak; Ng, Chi Hang; Lau, Yu Lung; Nelson, E Anthony S

2016-09-22

Rotavirus is a common infectious cause of childhood hospitalisation in Hong Kong. Rotavirus vaccines have been used in the private sector since licensure in 2006 but have not been incorporated in the government's universal Childhood Immunisation Programme. This study aimed to evaluate rotavirus vaccine effectiveness against hospitalisation. This case-control study was conducted in the 2014/2015 rotavirus season in six public hospitals. Hospitalised acute gastroenteritis patients meeting inclusion criteria were recruited and copies of their immunisation records were collected. Case-patients were defined as enrolled subjects with stool specimens obtained in the first 48h of hospitalisation that tested positive for rotavirus, whereas control-patients were those with stool specimens obtained in the first 48h of hospitalisation testing negative for rotavirus. Vaccine effectiveness for administration of at least one dose of either Rotarix(®) (GlaxoSmithKline Biologicals) or RotaTeq(®) (Merck Research Laboratories) was calculated as 1 minus the odds ratio for rotavirus vaccination history for case-patients versus control-patients. Among the 525 eligible subjects recruited, immunisation records were seen in 404 (77%) subjects. 31% (162/525 and 126/404) tested positive for rotavirus. In the 404 subjects assessed for vaccine effectiveness, 2.4% and 24% received at least 1 dose of either rotavirus vaccine in case- and control-patients respectively. The unmatched vaccine effectiveness against hospitalisation for administration of at least one dose of either rotavirus vaccines was 92% (95% confidence interval [CI]: 75%, 98%). The matched analyses by age only and both age and admission date showed 96% (95% CI: 72%, 100%) and 89% (95% CI: 51%, 97%) protection against rotavirus hospitalisation respectively. Rotavirus vaccine is highly effective in preventing hospitalisation from rotavirus disease in young Hong Kong children. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

Individualized versus standard FSH dosing in women starting IVF/ICSI: an RCT. Part 2: The predicted hyper responder.

PubMed

Oudshoorn, Simone C; van Tilborg, Theodora C; Eijkemans, Marinus J C; Oosterhuis, G Jur E; Friederich, Jaap; van Hooff, Marcel H A; van Santbrink, Evert J P; Brinkhuis, Egbert A; Smeenk, Jesper M J; Kwee, Janet; de Koning, Corry H; Groen, Henk; Lambalk, Cornelis B; Mol, Ben Willem J; Broekmans, Frank J M; Torrance, Helen L

2017-12-01

Does a reduced FSH dose in women with a predicted hyper response, apparent from a high antral follicle count (AFC), who are scheduled for IVF/ICSI lead to a different outcome with respect to cumulative live birth rate and safety? Although in women with a predicted hyper response (AFC > 15) undergoing IVF/ICSI a reduced FSH dose (100 IU per day) results in similar cumulative live birth rates and a lower occurrence of any grade of ovarian hyperstimulation syndrome (OHSS) as compared to a standard dose (150 IU/day), a higher first cycle cancellation rate and similar severe OHSS rate were observed. Excessive ovarian response to controlled ovarian stimulation (COS) for IVF/ICSI may result in increased rates of cycle cancellation, the occurrence of OHSS and suboptimal live birth rates. In women scheduled for IVF/ICSI, an ovarian reserve test (ORT) can be used to predict response to COS. No consensus has been reached on whether ORT-based FSH dosing improves effectiveness and safety in women with a predicted hyper response. Between May 2011 and May 2014, we performed an open-label, multicentre RCT in women with regular menstrual cycles and an AFC > 15. Women with polycystic ovary syndrome (Rotterdam criteria) were excluded. The primary outcome was ongoing pregnancy achieved within 18 months after randomization and resulting in a live birth. Secondary outcomes included the occurrence of OHSS and cost-effectiveness. Since this RCT was embedded in a cohort study assessing over 1500 women, we expected to randomize 300 predicted hyper responders. Women with an AFC > 15 were randomized to an FSH dose of 100 IU or 150 IU/day. In both groups, dose adjustment was allowed in subsequent cycles (maximum 25 IU in the reduced and 50 IU in the standard group) based on pre-specified criteria. Both effectiveness and cost-effectiveness were evaluated from an intention-to-treat perspective. We randomized 255 women to a daily FSH dose of 100 IU and 266 women to a daily FSH dose of 150 IU. The cumulative live birth rate was 66.3% (169/255) in the reduced versus 69.5% (185/266) in the standard group (relative risk (RR) 0.95 [95%CI, 0.85-1.07], P = 0.423). The occurrence of any grade of OHSS was lower after a lower FSH dose (5.2% versus 11.8%, RR 0.44 [95%CI, 0.28-0.71], P = 0.001), but the occurrence of severe OHSS did not differ (1.3% versus 1.1%, RR 1.25 [95%CI, 0.38-4.07], P = 0.728). As dose reduction was not less expensive (€4.622 versus €4.714, delta costs/woman €92 [95%CI, -479-325]), there was no dominant strategy in the economic analysis. Despite our training programme, the AFC might have suffered from inter-observer variation. Although strict cancellation criteria were provided, selective cancelling in the reduced dose group (for poor response in particular) cannot be excluded as observers were not blinded for the FSH dose and small dose adjustments were allowed in subsequent cycles. However, as first cycle live birth rates did not differ from the cumulative results, the open design probably did not mask a potential benefit for the reduced dosing group. As this RCT was embedded in a larger cohort study, the power in this study was unavoidably lower than it should be. Participants had a relatively low BMI from an international perspective, which may limit generalization of the findings. In women with a predicted hyper response scheduled for IVF/ICSI, a reduced FSH dose does not affect live birth rates. A lower FSH dose did reduce the incidence of mild and moderate OHSS, but had no impact on severe OHSS. Future research into ORT-based dosing in women with a predicted hyper response should compare various safety management strategies and should be powered on a clinically relevant safety outcome while assessing non-inferiority towards live birth rates. This trial was funded by The Netherlands Organization for Health Research and Development (ZonMW, Project Number 171102020). SCO, TCvT and HLT received an unrestricted research grant from Merck Serono (the Netherlands). CBL receives grants from Merck, Ferring and Guerbet. BWJM is supported by a NHMRC Practitioner Fellowship (GNT1082548) and reports consultancy for OvsEva, Merck and Guerbet. FJMB receives monetary compensation as a member of the external advisory board for Ferring pharmaceutics BV and Merck Serono for consultancy work for Gedeon Richter (Belgium) and Roche Diagnostics (Switzerland) and for a research cooperation with Ansh Labs (USA). All other authors have nothing to declare. Registered at the ICMJE-recognized Dutch Trial Registry (www.trialregister.nl). Registration number: NTR2657. 20 December 2010. 12 May 2011. © The Author 2017. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com

Positive Fungal Cultures in Burn Patients: A Multicenter Review

DTIC Science & Technology

2008-02-01

These factors include neutropenia, systemic ste- roids, central venous access,39 TPN, hemodialysis, diabetes mellitus, and urinary catheterization .40...burn treatment exposes patients to multiple other risks for fungal infection, including central venous lines, uri- nary catheters, prolonged...patients with central venous *See appendix for complete list of participants and institutions. This work was supported in part by a grant from Merck & Co

Human vaccines & immunotherapeutics: news.

PubMed

Riedmann, Eva M

2013-07-01

Recent advances in the development of immunotherapeutic mAbs for cancer New vaccine reduces malaria infection by 72% Bavarian Nordic's cancer immunotherapy shows promise in colorectal cancer Chinese HFMD vaccine shows high efficacy in Phase 3 Two-dose regimen of Merck's Gardasil looks effective Accelerating influenza vaccine development using synthetic biology A key role for gut microbes in vaccination Understanding of and attitudes towards vaccines: a study in teenagers.

Hilic MS/MS determination of amino acids in herbs of Fumaria schleicheri L., Ocimum basilicum L., and leaves of Corylus avellana L.

PubMed

Prokopenko, Yuliya; Jakštas, Valdas; Žvikas, Vaidotas; Georgiyants, Victoriya; Ivanauskas, Liudas

2018-05-18

The aim of research was to study the content of amino acids using in extracts of Fumaria schleicheri L., Ocimum basilicum L., and Corylus avellana L. by HILIC MS/MS method. Separation of amino acids in the samples was carried out with Acquity H-class UPLC system (Waters, Milford, USA) equipped with SeQuant ZIC-Hilic collumn (2.1 × 150 mm, 3.5 μm) (Merck Millipore, Darmstadt, Germany). The MS/MS fragment ion chromatograms of the test solutions established the presence of 19 amino acids. The obtained results have shown that O. basilicum L. characterized the highest concentrations of different neurogenic amino acids (128.1 mg/kg), comparing with F. schleicheri L. and C. avellana L. (57.72 and 52.91 mg/kg, respectively).

Benchmarking new frontiers in managed care pharmacy.

PubMed

Pigg, Cynthia; Cihak, Joan

2008-04-01

In 2006, the Foundation for Managed Care Pharmacy-a nonprofit charitable trust affiliated with the Academy of Managed Care Pharmacy-sponsored a survey that was conducted by The HSM Group, a national healthcare market research and consulting firm, and supported by an unrestricted grant from Merck & Co. The survey was repeated in 2007 and was designed to track the evolution of new healthcare trends, gauge the role of managed care pharmacy experts in these trends and the initiatives evolving from them, and disseminate that information to the various stakeholders of the industry. The authors examine the responses of 186 respondents from 71 national health plans, 54 pharmacy benefit management companies, as well as several hospitals, health systems, physician groups, or pharmacies. Survey findings highlight emerging trends in healthcare today and provide insight into the role of managed care pharmacy experts in today's healthcare environment, as well as other variables that may affect the future of the US healthcare delivery system.

Cancer vaccine THERATOPE- Biomira.

PubMed

2003-01-01

Biomira is developing a therapeutic cancer vaccine [THERATOPE] for treatment of breast and other cancers. This profile has been selected from R&D Insight, a pharmaceutical intelligence database produced by Adis International Ltd. THERATOPE consists of the mucin antigen, sialyl-Tn (STn), a carbohydrate located on the surface of breast, colorectal and ovarian cancer cells, conjugated to keyhole limpet haemocyanin (KLH). Merck KGaA has acquired a worldwide licence to THERATOPE for treatment of breast cancer. Under the terms of the licence, Biomira and Merck KGaA, via its US affiliate, EMD Pharmaceuticals, will jointly market the vaccine in the US. Merck KGaA holds exclusive marketing rights for the rest of the world, except in Canada (where Biomira retains rights), Israel and the Palestine Autonomy Area. Merck KGaA is now collaborating on phase III development for breast cancer. Biomira stands to receive $US150 million in licence, milestone payments and equity investments. The development costs will be shared between the two companies in North America but Merck KGaA will be solely responsible for these costs in countries outside the US. Previously, Chiron Corporation had purchased a licence to THERATOPE in 1997; however, Chiron terminated this agreement in June 2000. Under the terms of the termination, Biomira paid Chiron $US2.25 million to compensate the company for its investment in the development of THERATOPE. In addition, Biomira will make another payment of $US3.25 million to Chiron upon FDA approval of the vaccine. No further payments or royalties will be made. In the third quarter of 2002, an independent review of interim data from the trial was conducted. This was the fifth scheduled review of the data by the Independent Data Safety Monitoring Board (DSMB), all of which produced a positive response. Following the completion of the review, the DSMB stated that the trial should continue and that it had no safety concerns regarding this trial. Although the data, to which Biomira and Merck KgaA are blinded, did not meet the predetermined statistical significance for either endpoint at the time of the review, both companies have chosen to continue with the trial. Biomira has since announced that the p-value for the interim survival analysis was set at 0.01, while it is set at 0.03 for final survival analysis. The tighter criteria was set for the interim analysis to potentially give the companies the opportunity of applying for marketing approval earlier than expected. Final analysis of the trial will take place in mid-2003. If these analyses indicate therapeutic efficacy, Biomira will meet the FDA and Canadian regulatory officials to obtain marketing approval for the vaccine for breast cancer under the accelerated review guidelines. Assuming a best-case scenario, the vaccine could be filed for approval in 2004. The phase III trial was initiated following positive preliminary results achieved in a bridging study in patients with metastatic breast cancer in the US and UK. Biomira announced final results of the bridging study in May 1999. The results confirmed that antibody titres against the STn antigen were significantly higher in patients treated with the improved formulation of THERATOPE, compared with the corresponding titres of patients in the phase II trials of the old formulation of THERATOPE. In September 2002, the first patient was enrolled in a phase II THERATOPE trial, which is enrolling patients with metastatic breast cancer who are taking either an aromatase inhibitor or fulvestrant. Approximately 95 patients will be enrolled in the trial at up to 12 US sites. The study is primarily designed to evaluate THERATOPE's ability to induce an immune response in these patients. However, the safety and tolerability of the aromatase inhibitor plus THERATOPE, and the fulvestrant plus THERATOPE combinations will also be evaluated. The trial has not been designed to evaluate the efficacy of the two combinations. The US FDA has granted fast-track status tranted fast-track status to THERATOPE for development as an adjunct to first-line combination chemotherapy in responding patients with metastatic breast cancer. A phase II trial in patients with metastatic colorectal cancer has been completed in the US; positive preliminary results from this trial were released in May 2001. On 24 November 1999, Biomira announced that it had licensed two patents covering methods of preventing growth of cancer cells expressing a mucin-type glycoprotein. The patents have been issued in the US and are pending in Japan and Canada. When issued in Japan, the patents will provide additional protection for THERATOPE in that country. The patents were licensed from Dr Sen-itiroh Hakomori of the Biomembrane Institute in Seattle, with whom Biomira has also entered into a research collaboration. Biomira announced in April 2003 that following examination of its re-issue application by the US Patent and Trademark Office, its patent 5798090 was re-issued (RE 38046) with additional claims. These additional claims represent broader patent coverage. The additional coverage will last until 2015. Earlier, in February 2000, Biomira announced an expansion of equity line for up to $US100 million; a 3-fold rise that was done without any additional shares of Biomira stock being issued. In June 2002, Biomira stated that it believes the market size for THERATOPE in the US, Europe and Japan to be approximately 184000 patients for the indication of metastatic breast cancer, of which the US would be 100000, Europe 75000 and Japan 9000. For the indication of colorectal cancer, the total market population for THERATOPE is expected to be 183000 patients, of which the US has been estimated at 100000, Europe 75000 and Japan 9000.

Modulation of Beta-catenin Activity with PKD1 in Prostate Cancer

DTIC Science & Technology

2012-04-01

2010 initiative), NIH (NCI RO1, NCRR COBRE ) and pharmaceutical industries (Merck Pharmaceuticals, Investigator Initiated Grant). 15. SUBJECT TERMS...cellular division and loss of cellular adhesion – the two fundamental hallmarks of a cancer cell. We have previously made two important discoveries in...another important protein in cancer cells, β-catenin. These preliminary discoveries in prostate cancer have led us to put forth the current proposal

Echoing down from Wall St. Proposed new accounting standards could bring new guidelines for not-for-profits; conflicts between boards, CFOs could result. Merck, Allegheny, HBO & Co.

PubMed

Jaklevic, Mary Chris; Becker, Cinda; Morrissey, John

2002-07-15

The cause of good governance in healthcare got a boost when President Bush lectured power brokers on Wall Street last week, saying he would aggressively pursue unscrupulous executives. The healthcare industry, which has been trying to scrub clean its own image, is no stranger to the kind of scandals plaguing other industries.

Are drug companies living up to their human rights responsibilities? The Merck perspective.

PubMed

Ritter, Geralyn S

2010-09-28

The human rights responsibilities of drug companies have been considered for years by nongovernmental organizations, but were most sharply defined in a report by the UN Special Rapporteur on the right to health, submitted to the United Nations General Assembly in August 2008. The "Human Rights Guidelines for Pharmaceutical Companies in relation to Access to Medicines" include responsibilities for transparency, management, monitoring and accountability, pricing, and ethical marketing, and against lobbying for more protection in intellectual property laws, applying for patents for trivial modifications of existing medicines, inappropriate drug promotion, and excessive pricing. Two years after the release of the Guidelines, the PLoS Medicine Debate asks whether drug companies are living up to their human rights responsibilities. Sofia Gruskin and Zyde Raad from the Harvard School of Public Health say more assessment is needed of such responsibilities; Geralyn Ritter, Vice President of Global Public Policy and Corporate Responsibility at Merck & Co. argues that multiple stakeholders could do more to help States deliver the right to health; and Paul Hunt and Rajat Khosla introduce Mr. Hunt's work as the UN Special Rapporteur on the right to the highest attainable standard of health, regarding the human rights responsibilities of pharmaceutical companies and access to medicines.

Rosiglitazone: a disappointing DREAM.

PubMed

Nissen, Steven

2007-09-01

Dr Steven Nissen is a heart specialist and currently holds the position of chairman of cardiovascular medicine at the Cleveland Clinic, OH, USA. His work has involved the development of miniaturised ultrasound imaging devices that can be threaded into a patient's heart that allow measurement of the size and composition of plaques, which indicate early artery damage. The ability to characterize and measure the size of plaques provided a novel, effective method to evaluate the efficacy of anticholesterol medications, and for the past two decades Dr Nissen has been using these and other techniques to examine the efficacy of drugs. He has also developed a strong interest in drug safety. His work linked COX-2 inhibitors such as Celebrex and Vioxx (Merck, NJ, USA) with heart attacks, and prevented Merck's similar product, Arcoxia, from being approved. He also highlighted the serious heart attack risk associated with the experimental drug Pargluva and the drug was subsequently not approved by the US FDA. More recently, Dr Nissen's work has focused on the drug rosiglitazone, which was shown to have high cardiovascular risks and has since been given a FDA warning. Here, Dr Nissen discusses the publication of the rosiglitazone meta-analysis and why he considers work in this area to be crucially important for patients.

Psychosocial development of full term singletons, born after preimplantation genetic diagnosis (PGD) at preschool age and family functioning: a prospective case-controlled study and multi-informant approach.

PubMed

Winter, C; Van Acker, F; Bonduelle, M; Desmyttere, S; Nekkebroeck, J

2015-05-01

Do full term singletons born after preimplantation genetic diagnosis (PGD) differ in their psychosocial functioning from children born after intracytoplasmic sperm injection (ICSI) and spontaneous conceived controls (SC)? The psychosocial maturation process of 5-6-year-old PGD children is comparable between the three conception groups (PGD, ICSI and SC). In general, a lot of research has been published regarding follow-up of children born after artificial reproductive technologies (ART), which mainly is reassuring. But the ART population itself is marked by broad diversity [IVF, ICSI, gamete donation, preimplantation genetic screening (PGS) or PGD] which complicates comparisons. Some literature concerning the socio-emotional development of PGD/PGS children is available and it suggests a normal maturation process. However, the complex reality of PGD families (e.g. safety of the technique and psychological burden of genetic histories) asks for an exclusive PGD sample with matched control groups and a multi-informant approach. Between April 2011 and May 2013, the psychosocial wellbeing of preschoolers and their families born after PGD was assessed in a prospective case-controlled, matched follow-up study, with a multi-informant approach. A group of 47 PGD, 50 ICSI and 55 SC 5-6-year-old children participated in a follow-up study performed at the Centre for Medical Genetics of the Universitair Ziekenhuis Brussel (UZ Brussel). Assessments took place in the hospital and in kindergartens. Children performed the Bene-Anthony family relations test (FRT), yielding their perceptions upon family relationships. Parents and teachers completed the child behaviour checklist (CBCL) and Caregiver Teacher Report Form (C-/TRF), respectively. Parental and family functioning were measured by the NEO-FFi, the parenting stress index (PSI), the Greenberger Work-Parenting Investment Questionnaire and the Marlowe-Crowne Social Desirability Scale (MCSDS). Statistical analysis was performed by using analysis of covariance (ANCOVA). No differences were detected between the psychosocial development of PGD children and the control groups. Parents did not differ in reporting problem behaviour and they were stricter than teachers. Concerning family functioning the ART parents scored comparable with each other. PGD and ICSI mothers were emotionally more stable [NEO-FFi Neuroticism/emotionality: P = 0.013, η(2) = 0.066; 95% confidence interval (CI) 95% (0.003;0.148)]. They experienced less parental stress in general [PSI, Total stress: P = 0.001, η(2) = 0.102, 95% CI (0.02;0.192)] and on different sublevels opposed to their SC counterparts. Yet ART mothers presented higher ratings on the NEO-FFi Conscientiousness [P = 0.011, η(2) = 0.064; 95% CI (0.003;0.144)] indicating a higher feeling of competence and goal directedness. Mediation analysis confirmed: PGD and ICSI mothers who experienced less family stress were emotionally more stable. A power analysis indicated that a sample with 152 children is sufficient to detect a medium size effect with 80% power using ANCOVA. The current sample comprised only Dutch speaking Caucasians, hence conclusions should be drawn cautiously. Future research should include larger groups, prematures, multiples and children from different cultural backgrounds. This current research is the first to compare PGD preschoolers with matched controls. Concerns about the behavioural effects on the offspring should not inhibit the use of PGD. Furthermore, our findings suggest that on the long run ART procedures might enhance personal resources of women to cope with family stress. These findings are reassuring for women who might feel insecure and anxious during their ART trajectory. This research project gained funding from the OZR (a grant by the Research group of the Vrije Universiteit Brussel), the FWO (Fonds Wetenschappelijk Onderzoek) and the Wetenschappelijk Fonds Willy Gepts. The UZ Brussel and the Centre of Medical Genetics received funding from pharmaceutical firms for data collection. UZ Brussel and the Centre for Medical Genetics have received many educational grants for organizing the data collection, from IBSA, Ferring, Organon, Shering-Plough, Merck and Merck Belgium. M.B. has received consultancy and speaker's fees from Organon, Serono Symposia and Merck. The other authors have no competing interests. not applicable. © The Author 2015. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Impact of gonadotropin type on progesterone elevation during ovarian stimulation in GnRH antagonist cycles.

PubMed

Lawrenz, B; Beligotti, F; Engelmann, N; Gates, D; Fatemi, H M

2016-11-01

Does hormonal stimulation with corifollitropin alpha (CFA) only, mimicking a step down protocol, result in lower incidence of progesterone elevation on the day of hCGtrigger as compared to sustained stimulation with recombinant FSH (rFSH)? The current findings support the concept that sustained FSH stimulus contributes to premature progesterone elevation in stimulated IVF cycles. Serum progesterone rise during the follicular phase of ovarian stimulation for IVF treatment seems to be related to a poorer reproductive outcome. However, the mechanism by which the rise in progesterone is caused is not yet fully understood. This study was a post hoc analysis of data from two multi-center, randomized, double-blind, double-dummy, active-controlled, non-inferiority trials, ENGAGE and PURSUE, conducted from June 2006 to January 2008 and from July 2010 to October 2012 respectively. In the ENGAGE-study, 1506 women, aged 18-36 years, were allocated to either a single injection of 150 mg CFA or daily injections of 200 IU rFSH in the first week of stimulation, using a standard GnRH antagonist protocol. In the PURSUE-study, a total of 1390 women, aged 35-42 years, were allocated to either a single injection of 150 mg of CFA or daily 300 IU of rFSH for the first week, again using a standard GnRH antagonist protocol. In both trials, daily rFSH was continued until three follicles reached >17 mm in size. All women had a body weight of between 50 and 90 kg, regular menstrual cycles and an indication for ovarian stimulation before IVF. The incidence of progesterone elevation on day of hCG-trigger in patients with CFA only or rFSH stimulation, and triggered on Day 8 of stimulation, was analyzed. Of patients with CFA only stimulation, 5.4% (13/239 patients) showed a progesterone elevation above 1.5 ng/ml on day of hCG-trigger, whereas patients with rFSH stimulation had a significant higher incidence of progesterone elevation (18.3%; 62/339 patients) (P < 0.001). Post hoc analysis of data from previously published trials could be considered as a reason for caution. Future studies should evaluate whether it would be possible to prevent a premature progesterone rise in cycles stimulated with daily FSH by using a step down protocol towards the end of the follicular phase. Financial/Material Support was provided by Merck & Co., Inc., Kenilworth, NJ, USA. Davis Gates is an employee of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA and may own stock and/or hold stock options in the company. Fabiola Beligotti is an employee of MSD, Italy, a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA and may own stock and/or hold stock options in the company. Barbara Lawrenz, Nils Engelmann and Human M. Fatemi have no conflict of interest. ENGAGE study: ClinicalTrials.gov identifier NTC00696800. PURSUE-study: NCT01144416. © The Author 2016. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Performance of the EUCAST Disk Diffusion Method, the CLSI Agar Screen Method, and the Vitek 2 Automated Antimicrobial Susceptibility Testing System for Detection of Clinical Isolates of Enterococci with Low- and Medium-Level VanB-Type Vancomycin Resistance: a Multicenter Study

PubMed Central

Giske, Christian G.; Haldorsen, Bjørg; Matuschek, Erika; Schønning, Kristian; Leegaard, Truls M.; Kahlmeter, Gunnar

2014-01-01

Different antimicrobial susceptibility testing methods to detect low-level vancomycin resistance in enterococci were evaluated in a Scandinavian multicenter study (n = 28). A phenotypically and genotypically well-characterized diverse collection of Enterococcus faecalis (n = 12) and Enterococcus faecium (n = 18) strains with and without nonsusceptibility to vancomycin was examined blindly in Danish (n = 5), Norwegian (n = 13), and Swedish (n = 10) laboratories using the EUCAST disk diffusion method (n = 28) and the CLSI agar screen (n = 18) or the Vitek 2 system (bioMérieux) (n = 5). The EUCAST disk diffusion method (very major error [VME] rate, 7.0%; sensitivity, 0.93; major error [ME] rate, 2.4%; specificity, 0.98) and CLSI agar screen (VME rate, 6.6%; sensitivity, 0.93; ME rate, 5.6%; specificity, 0.94) performed significantly better (P = 0.02) than the Vitek 2 system (VME rate, 13%; sensitivity, 0.87; ME rate, 0%; specificity, 1). The performance of the EUCAST disk diffusion method was challenged by differences in vancomycin inhibition zone sizes as well as the experience of the personnel in interpreting fuzzy zone edges as an indication of vancomycin resistance. Laboratories using Oxoid agar (P < 0.0001) or Merck Mueller-Hinton (MH) agar (P = 0.027) for the disk diffusion assay performed significantly better than did laboratories using BBL MH II medium. Laboratories using Difco brain heart infusion (BHI) agar for the CLSI agar screen performed significantly better (P = 0.017) than did those using Oxoid BHI agar. In conclusion, both the EUCAST disk diffusion and CLSI agar screening methods performed acceptably (sensitivity, 0.93; specificity, 0.94 to 0.98) in the detection of VanB-type vancomycin-resistant enterococci with low-level resistance. Importantly, use of the CLSI agar screen requires careful monitoring of the vancomycin concentration in the plates. Moreover, disk diffusion methodology requires that personnel be trained in interpreting zone edges. PMID:24599985

CDK5 A Novel Role in Prostate Cancer Immunotherapy

DTIC Science & Technology

2016-10-01

Distribution Unlimited The views, opinions and/or findings contained in this report are those of the author(s) and should not be construed as an official...We are now discussing our next steps in pursuing this finding; these may include treatment of TRAMP Cdk5 knockout mice to inhibit the putative...Merck and Bayer have terminated clinical development of these compounds. The compounds are still well suited as “tool compounds,” for the

Urticaria following varicella vaccine associated with gelatin allergy.

PubMed

Singer, S; Johnson, C E; Mohr, R; Holowecky, C

1999-01-28

An uncommon reaction to varicella vaccine has been urticaria. Based on two reports of urticaria believed to be due to gelatin in recipients of measles-mumps-rubella vaccine, we suspected gelatin as the cause of generalized urticaria in two children after varicella vaccination. Intradermal testing with gelatin yielded a wheal and flare reaction in both children. We conclude that children known to be allergic to gelatin should not receive Oka/Merck varicella vaccine (VARIVAX).

Reproductive hormones of ICSI-conceived young adult men: the first results.

PubMed

Belva, Florence; Roelants, Mathieu; De Schepper, Jean; Van Steirteghem, André; Tournaye, Herman; Bonduelle, Maryse

2017-02-01

Are reproductive hormone levels (FSH, LH, inhibin B and testosterone) in male offspring conceived by ICSI because of male infertility comparable with those from peers born after spontaneous conception? In this cohort of 54 young men conceived by ICSI because of male-factor infertility, mean and median reproductive hormone levels were found to be comparable with results from spontaneously conceived peers, but ICSI-conceived men were more likely to have low inhibin B (<10th percentile) and high FSH (>90th percentile) levels. Since the worldwide oldest ICSI offspring have recently reached young adulthood, their reproductive health can now be investigated. This typically involves semen analysis and a hormonal profiling including the measurement of FSH, LH, inhibin B and testosterone. Circulating levels of FSH and inhibin B are generally known as markers of the exocrine function of the testis, i.e. spermatogenesis, while LH and testosterone reflect its endocrine function. We have previously observed a normal pubertal development and comparable levels of inhibin B and testosterone among pubertal ICSI boys when compared to spontaneously conceived peers. However, at present, information on the gonadal function of ICSI offspring in adulthood is still lacking. This study, conducted between March 2013 and April 2016 at the UZ Brussel, is part of a larger follow-up project focusing on reproductive and metabolic health of young adults between 18 and 22 years and conceived after ICSI because of male infertility. The ICSI men are part of a longitudinally followed cohort while the spontaneously conceived controls were recruited cross-sectionally. Results of a single fasting blood sample from 54 young adult ICSI men were compared to that of 57 spontaneously conceived peers. Reproductive hormone analysis involved FSH, LH, testosterone and inhibin B measurement. Furthermore, the association between their reproductive hormones and their sperm parameters was examined. Data were analyzed by multiple linear and logistic regression adjusted for covariates. ICSI men had comparable mean levels of FSH, LH, testosterone and inhibin B in comparison to spontaneously conceived counterparts, even after adjustment for confounders, such as age, BMI and season. Young ICSI-conceived men were more likely to have inhibin B levels below the 10th percentile (<125.2 ng/l; Adjusted Odds Ratio (AOR) 4.0; 95% CI: 0.9-18.4; P = 0.07) compared with spontaneously conceived peers and were more likely to have FSH levels above the 90th percentile (>5.5 IU/L; AOR 3.3; 95% CI: 0.9-11.9; P = 0.06) compared with spontaneously conceived peers, but neither difference reached statistical significance. FSH, LH and inhibin B, but not testosterone, levels were significantly associated with sperm concentration and total sperm count. The main limitation is the small study population. Furthermore, the results of this study should be interpreted according to the background of the participants: all subjects in our study group were conceived by ICSI because of severe male infertility and hence the results cannot be generalized to all ICSI offspring because the indications for performing ICSI have since been widened. These first results in a small group of ICSI men show reassuring reproductive hormonal levels. However, larger studies are required to confirm our results. Since inhibin B and FSH are consistently correlated with semen characteristics, we would suggest that the reproductive status of young adults conceived by ICSI is explored with a hormonal assessment given its easier acceptance compared to semen sampling. This study was supported by Methusalem grants and by grants from Wetenschappelijk Fonds Willy Gepts, all issued by the Vrije Universiteit Brussel (VUB). A grant from the Belgian Society for Pediatric Endocrinology and Diabetology was received for this project. All co-authors, except M.B. and H.T., declare no conflict of interest. M.B. has received consultancy fees from MSD, Serono Symposia and Merck. The Universitair Ziekenhuis Brussel (UZ Brussel) and the Centre for Medical Genetics have received several educational grants from IBSA, Ferring, Organon, Shering-Plough, Merck for establishing the database for follow-up research and organizing the data collection. The institution of HT receives research grants from the 'Research Fund of Flanders' (FWO), an unconditional grant from Ferring for research on testicular stem cells and research grants from Ferring, Merck, MSD, Roche, Besins, Goodlife and Cook for several research projects in female infertility. H.T. has received consultancy fees from Finox, Abbott and ObsEva for research projects in female infertility. N/A. © The Author 2016. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Semen quality of young adult ICSI offspring: the first results.

PubMed

Belva, F; Bonduelle, M; Roelants, M; Michielsen, D; Van Steirteghem, A; Verheyen, G; Tournaye, H

2016-12-01

What is the semen quality of young adult men who were conceived 18-22 years ago by ICSI for male infertility? In this cohort of 54 young adult ICSI men, median sperm concentration, total sperm count and total motile sperm count were significantly lower than in spontaneously conceived peers. The oldest ICSI offspring cohort worldwide has recently reached adulthood. Hence, their reproductive health can now be investigated. Since these children were conceived by ICSI because of severe male-factor infertility, there is reasonable concern that male offspring have inherited the deficient spermatogenesis from their fathers. Previously normal pubertal development and adequate Sertoli and Leydig cell function have been described in pubertal ICSI boys; however, no information on their sperm quality is currently available. This study was conducted at UZ Brussel between March 2013 and April 2016 and is part of a large follow-up project focussing on reproductive and metabolic health of young adults, between 18 and 22 years and conceived after ICSI with ejaculated sperm. Results of both a physical examination and semen analysis were compared between young ICSI men being part of a longitudinally followed cohort and spontaneously conceived controls who were recruited cross-sectionally. Results of a single semen sample in 54 young adult ICSI men and 57 spontaneously conceived men are reported. All young adults were individually assessed, and the results of their physical examination were completed by questionnaires. Data were analysed by multiple linear and logistic regression, adjusted for covariates. In addition, semen parameters of the ICSI fathers dating back from their ICSI treatment application were analysed for correlations. Young ICSI adults had a lower median sperm concentration (17.7 million/ml), lower median total sperm count (31.9 million) and lower median total motile sperm count (12.7 million) in comparison to spontaneously conceived peers (37.0 million/ml; 86.8 million; 38.6 million, respectively). The median percentage progressive and total motility, median percentage normal morphology and median semen volume were not significantly different between these groups. After adjustment for confounders (age, BMI, genital malformations, time from ejaculation to analysis, abstinence period), the statistically significant differences between ICSI men and spontaneously conceived peers remained: an almost doubled sperm concentration in spontaneously conceived peers in comparison to ICSI men (ratio 1.9, 95% CI 1.1-3.2) and a two-fold lower total sperm count (ratio 2.3, 95% CI 1.3-4.1) and total motile count (ratio 2.1, 95% CI 1.2-3.6) in ICSI men compared to controls were found. Furthermore, compared to men born after spontaneous conception, ICSI men were nearly three times more likely to have sperm concentrations below the WHO reference value of 15 million/ml (adjusted odds ratio (AOR) 2.7; 95% CI 1.1-6.7) and four times more likely to have total sperm counts below 39 million (AOR 4.3; 95% CI 1.7-11.3). In this small group of 54 father-son pairs, a weak negative correlation between total sperm count in fathers and their sons was found. The main limitation is the small study population. Also, the results of this study where ICSI was performed with ejaculated sperm and for male-factor infertility cannot be generalized to all ICSI offspring because the indications for ICSI have nowadays been extended and ICSI is also being performed with non-ejaculated sperm and reported differences may thus either decrease or increase. These first results in a small group of ICSI men indicate a lower semen quantity and quality in young adults born after ICSI for male infertility in their fathers. This study was supported by Methusalem grants and by grants from Wetenschappelijk Fonds Willy Gepts, all issued by the Vrije Universiteit Brussel (VUB). All co-authors except M.B. and H.T. declared no conflict of interest. M.B. has received consultancy fees from MSD, Serono Symposia and Merck. The Universitair Ziekenhuis Brussel (UZ Brussel) and the Centre for Medical Genetics have received several educational grants from IBSA, Ferring, Organon, Shering-Plough and Merck for establishing the database for follow-up research and organizing the data collection. The institution of H.T. has received research grants from the Research Fund of Flanders (FWO), an unconditional grant from Ferring for research on testicular stem cells and research grants from Ferring, Merck, MSD, Roche, Besins, Goodlife and Cook for several research projects in female infertility. H.T. has received consultancy fees from Finox, Abbott and ObsEva for research projects in female infertility. © The Author 2016. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Use of Magnetic Bead Resin and Automated Liquid Handler Extraction Methods to Robotically Isolate Nucleic Acids of Biological Agent Simulates

DTIC Science & Technology

2003-09-01

concentration, and Bacillus subtilis var. niger spores were detectable at 10,000 CFU/ml. When combined with bead beating, these spores were consistently...Bioloeical Aaent Simulants. Cell suspensions of Bacillus subtilis var. niger spores (BG spores ) and Erwinia herbicola vegetative cells were prepared for...use as biological simulants. BG spores were prepared by inoculating 1 g spores of Bacillus subtilis var. niger (Merck & Co., Inc., Whitehouse Station

Partnerships in Pharma--An Economist Intelligence Unit Seminar--Building Innovation into Alliances and Business Models. 1 October 2010, London, UK.

PubMed

Kibble, Alexandra

2010-12-01

The Partnerships in Pharma seminar, held in London, included topics related to building innovation into alliances and business models within the pharmaceutical industry. This conference report highlights selected presentations on strategies for successful partnering, partnering alongside an evolving CRO industry, considering the pharma value chain, and partnerships between industry and academia. Approaches used by Ipsen, Merck Serono, Pfizer and ViiV Healthcare are also described.

The prevention and management of herpes zoster.

PubMed

Cunningham, Anthony L; Breuer, Judith; Dwyer, Dominic E; Gronow, David W; Helme, Robert D; Litt, John C; Levin, Myron J; Macintyre, C Raina

2008-02-04

The burden of illness from herpes zoster (HZ) and postherpetic neuralgia (PHN) in the Australian community is high. The incidence and severity of HZ and PHN increase with age in association with a progressive decline in cell-mediated immunity to varicella-zoster virus (VZV). Antiviral medications (valaciclovir, famciclovir, aciclovir) have been shown to be effective in reducing much but not all of the morbidity associated with HZ and PHN, but are consistently underprescribed in Australia. Zoster-associated pain should be treated early and aggressively, as it is more difficult to treat once established. Clinicians should be proactive in their follow-up of individuals at high risk of developing PHN, and refer patients to a specialist pain clinic earlier, rather than later. A live, attenuated VZV vaccine (Oka/Merck strain, Zostavax [Merck Sharp & Dohme]) has proven to be efficacious in reducing the incidence of and morbidity associated with HZ and PHN in older adults. The vaccine's efficacy has been shown to persist for at least 4 years, but is likely to last a lot longer. Ongoing surveillance will determine the duration of protection and whether a booster dose is required. Clinicians should consider recommending the vaccine, which can be safely administered at the same time as the inactivated influenza vaccine, to all immunocompetent patients aged 60 years or older. Clinicians should refer to the Australian immunisation handbook for advice on the use of the live vaccine in immunosuppressed individuals.

Individualized FSH dosing based on ovarian reserve testing in women starting IVF/ICSI: a multicentre trial and cost-effectiveness analysis.

PubMed

van Tilborg, Theodora C; Oudshoorn, Simone C; Eijkemans, Marinus J C; Mochtar, Monique H; van Golde, Ron J T; Hoek, Annemieke; Kuchenbecker, Walter K H; Fleischer, Kathrin; de Bruin, Jan Peter; Groen, Henk; van Wely, Madelon; Lambalk, Cornelis B; Laven, Joop S E; Mol, Ben Willem J; Broekmans, Frank J M; Torrance, Helen L

2017-12-01

Is there a difference in live birth rate and/or cost-effectiveness between antral follicle count (AFC)-based individualized FSH dosing or standard FSH dosing in women starting IVF or ICSI treatment? In women initiating IVF/ICSI, AFC-based individualized FSH dosing does not improve live birth rates or reduce costs as compared to a standard FSH dose. In IVF or ICSI, ovarian reserve testing is often used to adjust the FSH dose in order to normalize ovarian response and optimize live birth rates. However, no robust evidence for the (cost-)effectiveness of this practice exists. Between May 2011 and May 2014 we performed a multicentre prospective cohort study with two embedded RCTs in women scheduled for IVF/ICSI. Based on the AFC, women entered into one of the two RCTs (RCT1: AFC < 11; RCT2: AFC > 15) or the cohort (AFC 11-15). The primary outcome was ongoing pregnancy achieved within 18 months after randomization resulting in a live birth (delivery of at least one live foetus after 24 weeks of gestation). Data from the cohort with weight 0.5 were combined with both RCTs in order to conduct a strategy analysis. Potential half-integer numbers were rounded up. Differences in costs and effects between the two treatment strategies were compared by bootstrapping. In both RCTs women were randomized to an individualized (RCT1:450/225 IU, RCT2:100 IU) or standard FSH dose (150 IU). Women in the cohort all received the standard dose (150 IU). Anti-Müllerian hormone (AMH) was measured to assess AMH post-hoc as a biomarker to individualize treatment. For RCT1 dose adjustment was allowed in subsequent cycles based on pre-specified criteria in the standard group only. For RCT2 dose adjustment was allowed in subsequent cycles in both groups. Both effectiveness and cost-effectiveness of the strategies were evaluated from an intention-to-treat perspective. We included 1515 women, of whom 483 (31.9%) entered the cohort, 511 (33.7%) RCT1 and 521 (34.4%) RCT2. Live births occurred in 420/747 (56.3%) women in the individualized strategy and 447/769 (58.2%) women in the standard strategy (risk difference -0.019 (95% CI, -0.06 to 0.02), P = 0.39; a total of 1516 women due to rounding up the half integer numbers). The individualized strategy was more expensive (delta costs/woman = €275 (95% CI, 40 to 499)). Individualized dosing reduced the occurrence of mild and moderate ovarian hyperstimulation syndrome (OHSS) and subsequently the costs for management of these OHSS categories (costs saved/woman were €35). The analysis based on AMH as a tool for dose individualization suggested comparable results. Despite a training programme, the AFC might have suffered from inter-observer variation. In addition, although strict cancel criteria were provided, selective cancelling in the individualized dose group (for poor response in particular) cannot be excluded as observers were not blinded for the FSH dose and small dose adjustments were allowed in subsequent cycles. However, as both first cycle live birth rates and cumulative live birth rates show no difference between strategies, the open design probably did not mask a potential benefit for the individualized group. Despite increasing consensus on using GnRH antagonist co-treatment in women predicted for a hyper response in particular, GnRH agonists were used in almost 80% of the women in this study. Hence, in those women, the AFC and bloodsampling for the post-hoc AMH analysis were performed during pituitary suppression. As the correlation between AFC and ovarian response is not compromised during GnRH agonist use, this will probably not have influenced classification of response. Individualized FSH dosing for the IVF/ICSI population as a whole should not be pursued as it does not improve live birth rates and it increases costs. Women scheduled for IVF/ICSI with a regular menstrual cycle are therefore recommended a standard FSH starting dose of 150 IU per day. Still, safety management by individualized dosing in predicted hyper responders is open for further research. This study was funded by The Netherlands Organisation for Health Research and Development (ZonMW number 171102020). AMH measurements were performed free of charge by Roche Diagnostics. TCT, HLT and SCO received an unrestricted personal grant from Merck BV. AH declares that the department of Obstetrics and Gynecology, University Medical Centre Groningen receives an unrestricted research grant from Ferring pharmaceutics BV, The Netherlands. CBL receives grants from Merck, Ferring and Guerbet. BWJM is supported by a NHMRC Practitioner Fellowship (GNT1082548) and reports consultancy for OvsEva, Merck and Guerbet. FJMB receives monetary compensation as a member of the external advisory board for Ferring pharmaceutics BV (the Netherlands) and Merck Serono (the Netherlands) for consultancy work for Gedeon Richter (Belgium) and Roche Diagnostics on automated AMH assay development (Switzerland) and for a research cooperation with Ansh Labs (USA). All other autors have nothing to declare. Registered at the ICMJE-recognized Dutch Trial Registry (www.trialregister.nl). Registration number: NTR2657. © The Author 2017. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com

Efficacy and safety of follitropin alfa/lutropin alfa in ART: a randomized controlled trial in poor ovarian responders.

PubMed

Humaidan, P; Chin, W; Rogoff, D; D'Hooghe, T; Longobardi, S; Hubbard, J; Schertz, J

2017-03-01

How does the efficacy and safety of a fixed-ratio combination of recombinant human FSH plus recombinant human LH (follitropin alfa plus lutropin alfa; r-hFSH/r-hLH) compare with that of r-hFSH monotherapy for controlled ovarian stimulation (COS) in patients with poor ovarian response (POR)? The primary and secondary efficacy endpoints were comparable between treatment groups and the safety profile of both treatment regimens was favourable. Although meta-analyses of clinical trials have suggested some beneficial effect on reproductive outcomes with r-hLH supplementation in patients with POR, the definitions of POR were heterogeneous and limit the comparability across studies. Phase III, single-blind, active-comparator, randomized, parallel-group clinical trial. Patients were followed for a single ART cycle. A total of 939 women were randomized (1:1) to receive either r-hFSH/r-hLH or r-hFSH. Randomization, stratified by study site and participant age, was conducted via an interactive voice response system. Women classified as having POR, based on criteria incorporating the ESHRE Bologna criteria, were down-regulated with a long GnRH agonist protocol and following successful down-regulation were randomized (1:1) to COS with r-hFSH/r-hLH or r-hFSH alone. The primary efficacy endpoint was the number of oocytes retrieved following COS. Safety endpoints included the incidence of adverse events, including ovarian hyperstimulation syndrome (OHSS). Post hoc analyses investigated safety outcomes and correlations between live birth and baseline characteristics (age and number of oocytes retrieved in previous ART treatment cycles or serum anti-Müllerian hormone (AMH)). The significance of the treatment effect was tested by generalized linear models (Poisson regression for counts and logistic regression for binary endpoints) adjusting for age and country. Of 949 subjects achieving down-regulation, 939 were randomized to r-hFSH/r-hLH (n = 477) or r-hFSH (n = 462) and received treatment. Efficacy assessment: In the intention-to-treat (ITT) population, the mean (SD) number of oocytes retrieved (primary endpoint) was 3.3 (2.71) in the r-hFSH/r-hLH group compared with 3.6 (2.82) in the r-hFSH group (between-group difference not statistically significant). The observed difference between treatment groups (r-hFSH/r-hLH and r-hFSH, respectively) for efficacy outcomes decreased over the course of pregnancy (biochemical pregnancy rate: 17.3% versus 23.9%; clinical pregnancy rate: 14.1% versus 16.8%; ongoing pregnancy rate: 11.0% versus 12.4%; and live birth rate: 10.6% versus 11.7%). An interaction (identified post hoc) between baseline characteristics related to POR and treatment effect was noted for live birth, with r-hFSH/r-hLH associated with a higher live birth rate for patients with moderate or severe POR, whereas r-hFSH was associated with a higher live birth rate for those with mild POR. A post hoc logistic regression analysis indicated that the incidence of total pregnancy outcome failure was lower in the r-hFSH/r-hLH group (6.7%) compared with the r-hFSH group (12.4%) with an odds ratio of 0.52 (95% CI 0.33, 0.82; P = 0.005). Safety assessment: The overall proportion of patients with treatment-emergent adverse events (TEAEs) occurring during or after r-hFSH/r-hLH or r-hFSH use (stimulation or post-stimulation phase) was 19.9% and 26.8%, respectively. There was no consistent pattern of TEAEs associated with either treatment. Despite using inclusion criteria for POR incorporating the ESHRE Bologna criteria, further investigation is needed to determine the impact of the heterogeneity of POR in the Bologna patient population. The observed correlation between baseline clinical characteristics related to POR and live birth rate, as well as the observed differences between groups regarding total pregnancy outcome failure were from post hoc analyses, and the study was not powered for these endpoints. In addition, the attrition rate for pregnancy outcomes in this trial may not reflect general medical practice. Furthermore, as the patient population was predominantly White these results might not be applicable to other ethnicities. In the population of women with POR investigated in this study, although the number of oocytes retrieved was similar following stimulation with either a fixed-ratio combination of r-hFSH/r-hLH or r-hFSH monotherapy, post hoc analyses showed that there was a lower rate of total pregnancy outcome failure in patients receiving r-hFSH/r-hLH, in addition to a higher live birth rate in patients with moderate and severe POR. These findings are clinically relevant and require additional investigation. The benefit:risk balance of treatment with either r-hFSH/r-hLH or r-hFSH remains positive. This study was funded by Merck KGaA, Darmstadt, Germany. P.H. has received honoraria for lectures and unrestricted research grants from Ferring, Merck KGaA and MSD. D.R. is a former employee of EMD Serono, a business of Merck KGaA, Darmstadt, Germany. J.S., J.H. and W.C. are employees of EMD Serono Research and Development Institute, a business of Merck KGaA, Darmstadt, Germany. T.D.'H. and S.L. are employees of Merck KGaA, Darmstadt, Germany. ClinicalTrials.gov identifier: NCT02047227; EudraCT Number: 2013-003817-16. ClinicalTrials.gov: 24 January 2014; EudraCT: 19 December 2013. 30 January 2014. © The Author 2017. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology.

Vaccine manufacturing and technology: from biotechnological platforms to syntethic epitopes, current viepoint.

PubMed

Ignateva, G A

2016-01-01

The Purposes: the review take into account short history of vaccination practice and development of vaccine technology. In the review we include data from several monographs about manufacturing of vaccines published by authors from such companies as Merck & Co; Sanofi Pasteur; Dynavax Europe/Rhein Biotech GmbH; Latham Biopharm Group; Aridis Pharmaceuticals LLC; Genentech; Amgen; Shamir Biologics LLC; Biopharm Services US; Novartis Pharma AG, аnd several research centers: Laboratory of Bacterial Polysaccharides, Center for Biologics Evaluation and Research; Purdue University, West Lafayette, IN, US; Department of Pharmaceutical Chemistry, Univ. Of Kansas; Max Planck Institute for dynamics of Complex Technical Systems; Fraunhofer USA Center for Molecular Biotechnology; US Dep. of Agriculture Animal and Plant Health Inspection Service, etc. In historic literature there are data about inoculation practices in antique China, Persia, India, Byzantium, native Americans, some African population. In modern immunology since the end of XIX century the vaccines were produced at the in vivo platforms - in animals (rabbits, mice, cows). Since 1931 due to E. Goodpasture' elaboration most virus vaccines were and are produced at the in ovo platform. In 1949 J.F. Enders elaborated large-scale polio virus production in the primary culture of monkey kidney cells in vitro. Up to day primary culture of chiken embrio fibroblasts are used to large-scale production of vaccine viruses of measles, mumps, rabies. Since 2000-th in Western countries most part of virus vaccines were began to produced via a cultivation in continuous tumor cell lines. The last technology is the most low cost for large-scale production of vaccines. We review several new biotechnological platforms for the production of the recombinant protein or virus-like particles as subunit vaccines: plant system, algae, mushrooms, insect cells, etc. Beside of good purpose of vaccination - prophylactic of several infectious deseases, doctors must take into account possibility of inter-species transmission of unknown pathogens (retroviruses, prions, etc) from biotechnological platforms - animals, cell cultures - into human population, and don't ignore L.A. Zilber' theory of virus' etiology of cancer diseases.

A Curriculum for a Three Year High School Science Research Program

NASA Astrophysics Data System (ADS)

Darytichen, F.; Danch, J.

2003-12-01

A three-year high school science research program has been taught in Woodbridge Township School District - Woodbridge, New Jersey, since 1987. The program's focus is to foster originial science research projects for high school students that have shown an aptitude and an interest in science. Students are instructed in basic research skills, including developing and conducting original research projects, statistical analysis, scientific writing, and presentation of research at local and national symposia, and science fairs. Upon completion of the third year all students are required to submit a paper, suitable for journal publication, detailing their research. Participating students have gone on to win awards with Westinghouse, Intel, The National Junior Science and Humanities Symposium, the International Science and Engineering Fair, New Jersey Academy of Sciences, and local and regional science fairs and symposia. Participating teachers have been recoginized by the Sigma Xi Research Society of Rutgers University for excellence in science teaching. New Jersey awarded the curriulum a Best Practice Award for 2003. Goals and strategies of the curriculum are detailed in a guide written for the courses. Professional development for the courses and resources for mentoring programs are the responsibility of the District Science Supervisor, and have been fostered over the years with the assistance of local colleges and universities including Rutgers Univesity, Monmouth University, University of Medicine and Dentistry of New Jersey, Liberty Science Center of New Jersey's Partners in Science Program, as well as local industries including Hatco Corporation, Merck Corporation, Englehard Corporation, and Lucent Technologies. Science Research teachers have conducted developmental workshops for school districts interested in implementing similar curricula.

Interview: interview with P Jeffrey Conn. Interview by Hannah Coaker.

PubMed

Conn, P Jeffrey

2013-09-01

Dr Conn is the Lee E Limbird Professor of Pharmacology at Vanderbilt University and Director of the Vanderbilt Center for Neuroscience Drug Discovery (VCNDD). Dr Conn received a PhD in Pharmacology from Vanderbilt in 1986 and pursued postdoctoral studies at Yale University. He served as a professor of Pharmacology at Emory University from 1988 to 2000, before moving to Merck and Co. (PA, USA) as head of the Department of Neuroscience. Dr Conn moved to Vanderbilt University in 2003 where he is the founding director of the VCNDD, with a primary mission of facilitating translation of recent advances in basic science to novel therapeutics. The VCNDD consists of approximately 100 full-time scientists and has advanced novel molecules from four major programs as development candidates for clinical testing with industry partners. Dr Conn has served in editorial positions with multiple international journals and has served the scientific advisory boards of multiple foundations and companies. He has received numerous awards based on the impact of his basic and translational research. Dr Conn's current research is focused on development of novel treatment strategies for schizophrenia, Parkinson's disease and other serious brain disorders. Interview conducted by Hannah Coaker, Assistant Commissioning Editor.

Current approaches to exploit actinomycetes as a source of novel natural products.

PubMed

Genilloud, Olga; González, Ignacio; Salazar, Oscar; Martín, Jesus; Tormo, José Rubén; Vicente, Francisca

2011-03-01

For decades, microbial natural products have been one of the major sources of novel drugs for pharmaceutical companies, and today all evidence suggests that novel molecules with potential therapeutic applications are still waiting to be discovered from these natural sources, especially from actinomycetes. Any appropriate exploitation of the chemical diversity of these microbial sources relies on proper understanding of their biological diversity and other related key factors that maximize the possibility of successful identification of novel molecules. Without doubt, the discovery of platensimycin has shown that microbial natural products can continue to deliver novel scaffolds if appropriate tools are put in place to reveal them in a cost-effective manner. Whereas today innovative technologies involving exploitation of uncultivated environmental diversity, together with chemical biology and in silico approaches, are seeing rapid development in natural products research, maximization of the chances of exploiting chemical diversity from microbial collections is still essential for novel drug discovery. This work provides an overview of the integrated approaches developed at the former Basic Research Center of Merck Sharp and Dohme in Spain to exploit the diversity and biosynthetic potential of actinomycetes, and includes some examples of those that were successfully applied to the discovery of novel antibiotics.

Alterations in dorsal and ventral posterior cingulate connectivity in APOE ε4 carriers at risk of Alzheimer's disease.

PubMed

Kerestes, Rebecca; Phal, Pramit M; Steward, Chris; Moffat, Bradford A; Salinas, Simon; Cox, Kay L; Ellis, Kathryn A; Cyarto, Elizabeth V; Ames, David; Martins, Ralph N; Masters, Colin L; Rowe, Christopher C; Sharman, Matthew J; Salvado, Olivier; Szoeke, Cassandra; Lai, Michelle; Lautenschlager, Nicola T; Desmond, Patricia M

2015-10-01

Recent evidence suggests that exercise plays a role in cognition and that the posterior cingulate cortex (PCC) can be divided into dorsal and ventral subregions based on distinct connectivity patterns. To examine the effect of physical activity and division of the PCC on brain functional connectivity measures in subjective memory complainers (SMC) carrying the epsilon 4 allele of apolipoprotein E (APOE ε 4) allele. Participants were 22 SMC carrying the APOE ε 4 allele ( ε 4+; mean age 72.18 years) and 58 SMC non-carriers ( ε 4-; mean age 72.79 years). Connectivity of four dorsal and ventral seeds was examined. Relationships between PCC connectivity and physical activity measures were explored. ε 4+ individuals showed increased connectivity between the dorsal PCC and dorsolateral prefrontal cortex, and the ventral PCC and supplementary motor area (SMA). Greater levels of physical activity correlated with the magnitude of ventral PCC-SMA connectivity. The results provide the first evidence that ε 4+ individuals at increased risk of cognitive decline show distinct alterations in dorsal and ventral PCC functional connectivity. D.A. has served on scientific advisory boards for Novartis, Eli Lilly, Janssen, Prana and Pfizer, and as Editor-in-Chief for International Psychogeriatrics; received speaker honoraria from Pfizer and Lundbeck, and research support from Eli Lilly, GlaxoSmithKline, Forest Laboratories, Novartis, and CSIRO. C.L.M. has received consulting fees from Eli Lilly and Prana Biotechnology, and has stock ownership in Prana Biotechnology. C.C.R. has received consultancy payments from Roche and Piramal, and research support from Avid Radiopharmaceuticals, Eli Lilly, GE Healthcare, Piramal and Navidea for amyloid imaging. C.S. has provided clinical consultancy and been on scientific advisory committees for the Australian CSIRO, Alzheimer's Australia, University of Melbourne and other relationships, which are subject to confidentiality clauses; she has been a named Chief Investigator on investigator-driven collaborative research projects in partnership with Pfizer, Merck, Piramal, Bayer and GE Healthcare. Her research programme has received support from the National Health and Medical Research Council Alzheimer's Association, Collier Trust, Scobie and Claire McKinnon Foundation, JO and JR Wicking Trust, Shepherd Foundation, Brain Foundation, Mason Foundation, Ramaciotti Foundation, Alzheimer's Australia and the Royal Australian College of Physicians. © The Royal College of Psychiatrists 2015. This is an open access article distributed under the terms of the Creative Commons Non-Commercial, No Derivatives (CC BY-NC-ND) licence.

Alterations in dorsal and ventral posterior cingulate connectivity in APOE ε4 carriers at risk of Alzheimer's disease

PubMed Central

Phal, Pramit M.; Steward, Chris; Moffat, Bradford A.; Salinas, Simon; Cox, Kay L.; Ellis, Kathryn A.; Cyarto, Elizabeth V.; Ames, David; Martins, Ralph N.; Masters, Colin L.; Rowe, Christopher C.; Sharman, Matthew J.; Salvado, Olivier; Szoeke, Cassandra; Lai, Michelle; Lautenschlager, Nicola T.; Desmond, Patricia M.

2015-01-01

Background Recent evidence suggests that exercise plays a role in cognition and that the posterior cingulate cortex (PCC) can be divided into dorsal and ventral subregions based on distinct connectivity patterns. Aims To examine the effect of physical activity and division of the PCC on brain functional connectivity measures in subjective memory complainers (SMC) carrying the epsilon 4 allele of apolipoprotein E (APOE ε4) allele. Method Participants were 22 SMC carrying the APOE ε4 allele (ε4+; mean age 72.18 years) and 58 SMC non-carriers (ε4–; mean age 72.79 years). Connectivity of four dorsal and ventral seeds was examined. Relationships between PCC connectivity and physical activity measures were explored. Results ε4+ individuals showed increased connectivity between the dorsal PCC and dorsolateral prefrontal cortex, and the ventral PCC and supplementary motor area (SMA). Greater levels of physical activity correlated with the magnitude of ventral PCC–SMA connectivity. Conclusions The results provide the first evidence that ε4+ individuals at increased risk of cognitive decline show distinct alterations in dorsal and ventral PCC functional connectivity. Declaration of interest D.A. has served on scientific advisory boards for Novartis, Eli Lilly, Janssen, Prana and Pfizer, and as Editor-in-Chief for International Psychogeriatrics; received speaker honoraria from Pfizer and Lundbeck, and research support from Eli Lilly, GlaxoSmithKline, Forest Laboratories, Novartis, and CSIRO. C.L.M. has received consulting fees from Eli Lilly and Prana Biotechnology, and has stock ownership in Prana Biotechnology. C.C.R. has received consultancy payments from Roche and Piramal, and research support from Avid Radiopharmaceuticals, Eli Lilly, GE Healthcare, Piramal and Navidea for amyloid imaging. C.S. has provided clinical consultancy and been on scientific advisory committees for the Australian CSIRO, Alzheimer's Australia, University of Melbourne and other relationships, which are subject to confidentiality clauses; she has been a named Chief Investigator on investigator-driven collaborative research projects in partnership with Pfizer, Merck, Piramal, Bayer and GE Healthcare. Her research programme has received support from the National Health and Medical Research Council Alzheimer's Association, Collier Trust, Scobie and Claire McKinnon Foundation, JO and JR Wicking Trust, Shepherd Foundation, Brain Foundation, Mason Foundation, Ramaciotti Foundation, Alzheimer's Australia and the Royal Australian College of Physicians. Copyright and usage © The Royal College of Psychiatrists 2015. This is an open access article distributed under the terms of the Creative Commons Non-Commercial, No Derivatives (CC BY-NC-ND) licence. PMID:27703739

Effects of HMG-COA Reductase Inhibitor Therapy on LDL Cholesterol Blood Levels in Hyperlipidemia: A Longitudinal Retrospective Anlaysis Using a Department of Defense Integrated Database.

DTIC Science & Technology

1998-05-21

United States. They are atorvastatin (Lipitor® by Bristol-Myers Squibb), fluvastatin (Lescol® by Sandoz), lovastatin (Mevacor® by Merck), pravastatin...34first- and-a-half40 generation statin (semi-synthetic), fluvastatin being a second generation statin (a racemic synthetic), and atorvastatin being a...third generation 27 statin (a pure enantiomer synthetic). Atorvastatin , fluvastatin, and pravastatin are taken in the active hydroxy-acid form114

Depression, pregnancy-related anxiety and parental-antenatal attachment in couples using preimplantation genetic diagnosis.

PubMed

Winter, C; Van Acker, F; Bonduelle, M; Van Berkel, K; Belva, F; Liebaers, I; Nekkebroeck, J

2016-06-01

Do preimplantation genetic diagnosis (PGD) couples experience higher levels of stress during pregnancy and the perinatal period compared with couples who conceive spontaneously (SC) or with ICSI? PGD couples did not experience more psychological stress during pregnancy and beyond than ICSI or SC couples. Previous studies have shown that assisted reproduction technology (ART) couples are more prone to pregnancy-related anxieties than SC couples, but display depressed feelings to an equal or lesser extent. However, only one study has focused on a female PGD sample, which may be a more vulnerable group than other ART groups, due to the potentially complex hereditary background, adverse childhood experiences and losses. In that study, PGD women experienced a reduction in state anxiety, and maternal-antenatal attachment did not differ from normative data. Unfortunately, no data exist on pregnancy-related anxiety, depression and parental-antenatal attachment. Valuable information from both parents (e.g.: couples) is also lacking. For this longitudinal prospective study questionnaire, data from 185 women and 157 men (157 couples) were collected between February 2012 until April 2014. Data were analysed using multilevel analysis. The couples conceiving after PGD, ICSI or SC were followed from the first trimester of the pregnancy until the third month post-partum. A total of 60 PGD, 58 ICSI and 69 SC couples were initially recruited by various departments of Universitair Ziekenhuis Brussel (UZ Brussel). At each trimester (T1: 12-14 weeks, T2: 20-22 weeks, T3: 30-32 weeks) of pregnancy, depression (EPDS), pregnancy-related anxieties (PRAQ) and parental-antenatal attachment (M/PAAS) were recorded. At T4 (3 months post-partum), depression (EPDS) was assessed again. In the first trimester (T1) broad socio-demographic data and at T4 perinatal health data of both mother and child were recorded. Differences between conception groups over time were analysed using multilevel analyses, taking into account covariation between measurements and within couples. Several perinatal covariates as well as social desirability, coping and adult attachment style were controlled for. All three conception groups had similar scores for depression during pregnancy and beyond. Also, pregnancy-related anxiety scales did not differ among the three groups. All groups also followed a similar trajectory in time regarding their scores for anxiety, depression and parental-antenatal attachment. ART groups did not give more socially desirable answers than SC controls. The subsequent moderators: coping and adult attachment style did not add any relevant information. No interaction effects occurred between gender and conception groups. The participants were Caucasian, Dutch-speaking couples, with medium to high socio-economic status, from a single centre. Our data should be replicated by multicultural and multicentre studies. Furthermore, the inclusion of an additional control group of couples who did not opt for PGD but for prenatal diagnosis may point to the most beneficial strategy for the couple. PGD parents invest a similar amount of time and emotion in their future children compared with controls. This implies that successful PGD treatment makes an important psychological contribution towards the well-being of couples given their complex hereditary and family backgrounds. This research project was funded by grants from the internal research council of the Vrije Universiteit Brussel (OZR), the Flemish Fonds Wetenschappelijk Onderzoek (FWO) and the Wetenschappelijk Fonds Willy Gepts (WGFG). UZ Brussel and the Centre for Medical Genetics have received several educational grants for organizing the data collection, from IBSA, Ferring, Organon, Shering-Plough, Merck and Merck Belgium. M.B. has received consultancy and speaker's fees from Organon, Serono Symposia and Merck. © The Author 2016. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Individualized versus standard FSH dosing in women starting IVF/ICSI: an RCT. Part 1: The predicted poor responder.

PubMed

van Tilborg, Theodora C; Torrance, Helen L; Oudshoorn, Simone C; Eijkemans, Marinus J C; Koks, Carolien A M; Verhoeve, Harold R; Nap, Annemiek W; Scheffer, Gabrielle J; Manger, A Petra; Schoot, Benedictus C; Sluijmer, Alexander V; Verhoeff, Arie; Groen, Henk; Laven, Joop S E; Mol, Ben Willem J; Broekmans, Frank J M

2017-12-01

Does an increased FSH dose result in higher cumulative live birth rates in women with a predicted poor ovarian response, apparent from a low antral follicle count (AFC), scheduled for IVF or ICSI? In women with a predicted poor ovarian response (AFC < 11) undergoing IVF/ICSI, an increased FSH dose (225/450 IU/day) does not improve cumulative live birth rates as compared to a standard dose (150 IU/day). In women scheduled for IVF/ICSI, an ovarian reserve test (ORT) can predict ovarian response to stimulation. The FSH starting dose is often adjusted based on the ORT from the belief that it will improve live birth rates. However, the existing RCTs on this topic, most of which show no benefit, are underpowered. Between May 2011 and May 2014, we performed an open-label multicentre RCT in women with an AFC < 11 (Dutch Trial Register NTR2657). The primary outcome was ongoing pregnancy achieved within 18 months after randomization and resulting in a live birth. We needed 300 women to assess whether an increased dose strategy would increase the cumulative live birth rate from 25 to 40% (two-sided alpha-error 0.05, power 80%). Women with an AFC ≤ 7 were randomized to an FSH dose of 450 IU/day or 150 IU/day, and women with an AFC 8-10 were randomized to 225 IU or 150 IU/day. In the standard group, dose adjustment was allowed in subsequent cycles based on pre-specified criteria. Both effectiveness and cost-effectiveness of the strategies were evaluated from an intention-to-treat perspective. In total, 511 women were randomized, 234 with an AFC ≤ 7 and 277 with an AFC 8-10. The cumulative live birth rate for increased versus standard dosing was 42.4% (106/250) versus 44.8% (117/261), respectively [relative risk (RR): 0.95 (95%CI, 0.78-1.15), P = 0.58]. As an increased dose strategy was more expensive [delta costs/woman: €1099 (95%CI, 562-1591)], standard FSH dosing was the dominant strategy in our economic analysis. Despite our training programme, the AFC might have suffered from inter-observer variation. As this open study permitted small dose adjustments between cycles, potential selective cancelling of cycles in women treated with 150 IU could have influenced the cumulative results. However, since first cycle live birth rates point in the same direction we consider it unlikely that the open design masked a potential benefit for the individualized strategy. Since an increased dose in women scheduled for IVF/ICSI with a predicted poor response (AFC < 11) does not improve live birth rates and is more expensive, we recommend using a standard dose of 150 IU/day in these women. This study was funded by The Netherlands Organisation for Health Research and Development (ZonMW number 171102020). T.C.T., H.L.T. and S.C.O. received an unrestricted personal grant from Merck BV. H.R.V. receives monetary compensation as a member on an external advisory board for Ferring pharmaceutical BV. B.W.J.M. is supported by a NHMRC Practitioner Fellowship (GNT1082548) and reports consultancy for OvsEva, Merck and Guerbet. F.J.M.B. receives monetary compensation as a member of the external advisory board for Ferring pharmaceutics BV (the Netherlands) and Merck Serono (the Netherlands) for consultancy work for Gedeon Richter (Belgium) and Roche Diagnostics on automated AMH assay development (Switzerland) and for a research cooperation with Ansh Labs (USA). All other authors have nothing to declare. Registered at the ICMJE-recognized Dutch Trial Registry (www.trialregister.nl). Registration number NTR2657. 20 December 2010. 12 May 2011. © The Author 2017. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com

Diurnal behaviour of some salivary parameters in patients with diabetes mellitus (flow rate, pH, thiocianat, LDH activity)--note II.

PubMed

Ionescu, S; Bădiţă, D; Artino, M; Dragomir, M; Huidovici, E; Niţă, V; Chiţoi, E

1998-01-01

The study was performed on 31 diabetic patients of both sexes, divided in 2 groups: group I--17 patients with insulin-dependent diabetes (IDDM) and group II--14 patients with noninsulin-dependent diabetes (NIDDM) and compared with a control group of 16 non-diabetic subjects. Mixed saliva was sampled without stimulation during 2 periods of the day: 07:30-08:00 before breakfast and 17:30-18:00 before dinner. We determined: salivary flow rate, pH with Merck indicator and, after homogenization, the thiocianat with the FeCl3 method and LDH activity (the Norbert method adapted in our laboratory for saliva). Our study showed the same diurnal changes in flow rate and salivary pH in both diabetic and control groups: minimal values in the morning and maximal ones in the afternoon. In non-smoking diabetic patients the salivary thiocianat had maximal values in the morning and minimal ones in the afternoon; similar behaviour, but less obvious was observed in smoking diabetic patients and in the control group regardless of the smoking habit. LDH activity showed unsignificant diurnal variations in the diabetic patients. In the control group we found a significant decrease of LDH activity in the afternoon. The discussion is about the implication of these salivary parameters in the pathology of oral cavity: gingivitis, periodontitis and caries in diabetic patients.

World Endometriosis Society consensus on the classification of endometriosis.

PubMed

Johnson, Neil P; Hummelshoj, Lone; Adamson, G David; Keckstein, Jörg; Taylor, Hugh S; Abrao, Mauricio S; Bush, Deborah; Kiesel, Ludwig; Tamimi, Rulla; Sharpe-Timms, Kathy L; Rombauts, Luk; Giudice, Linda C

2017-02-01

What is the global consensus on the classification of endometriosis that considers the views of women with endometriosis? We have produced an international consensus statement on the classification of endometriosis through systematic appraisal of evidence and a consensus process that included representatives of national and international, medical and non-medical societies, patient organizations, and companies with an interest in endometriosis. Classification systems of endometriosis, developed by several professional organizations, traditionally have been based on lesion appearance, pelvic adhesions, and anatomic location of disease. One system predicts fertility outcome and none predicts pelvic pain, response to medications, disease recurrence, risks for associated disorders, quality of life measures, and other endpoints important to women and health care providers for guiding appropriate therapeutic options and prognosis. A consensus meeting, in conjunction with pre- and post-meeting processes, was undertaken. A consensus meeting was held on 30 April 2014 in conjunction with the World Endometriosis Society's 12th World Congress on Endometriosis. Rigorous pre- and post-meeting processes, involving 55 representatives of 29 national and international, medical and non-medical organizations from a range of disciplines, led to this consensus statement. A total of 28 consensus statements were made. Of all, 10 statements had unanimous consensus, however none of the statements was made without expression of a caveat about the strength of the statement or the statement itself. Two statements did not achieve majority consensus. The statements covered women's priorities, aspects of classification, impact of low resources, as well as all the major classification systems for endometriosis. Until better classification systems are developed, we propose a classification toolbox (that includes the revised American Society for Reproductive Medicine and, where appropriate, the Enzian and Endometriosis Fertility Index staging systems), that may be used by all surgeons in each case of surgery undertaken for women with endometriosis. We also propose wider use of the World Endometriosis Research Foundation Endometriosis Phenome and Biobanking Harmonisation Project surgical and clinical data collection tools for research to improve classification of endometriosis in the future, of particular relevance when surgery is not undertaken. This consensus process differed from that of formal guideline development, although based on the same available evidence. A different group of international experts from those participating in this process may have yielded subtly different consensus statements. This is the first time that a large, global, consortium-representing 29 major stake-holding organizations, from 19 countries - has convened to systematically evaluate the best available evidence on the classification of endometriosis and reach consensus. In addition to 21 international medical organizations and companies, representatives from eight national endometriosis organizations were involved, including lay support groups, thus generating and including input from women who suffer from endometriosis in an endeavour to keep uppermost the goal of optimizing quality of life for women with endometriosis. The World Endometriosis Society convened and hosted the consensus meeting. Financial support for participants to attend the meeting was provided by the organizations that they represented. There was no other specific funding for this consensus process. Mauricio Abrao is an advisor to Bayer Pharma, and a consultant to AbbVie and AstraZeneca; G David Adamson is the Owner of Advanced Reproductive Care Inc and Ziva and a consultant to Bayer Pharma, Ferring, and AbbVie; Deborah Bush has received travel grants from Fisher & Paykel Healthcare and Bayer Pharmaceuticals; Linda Giudice is a consultant to AbbVie, Juniper Pharmaceutical, and NextGen Jane, holds research grant from the NIH, is site PI on a clinical trial sponsored by Bayer, and is a shareholder in Merck and Pfizer; Lone Hummelshoj is an unpaid consultant to AbbVie; Neil Johnson has received conference expenses from Bayer Pharma, Merck-Serono, and MSD, research funding from AbbVie, and is a consultant to Vifor Pharma and Guerbet; Jörg Keckstein has received a travel grant from AbbVie; Ludwig Kiesel is a consultant to Bayer Pharma, AbbVie, AstraZeneca, Gedeon Richter, and Shionogi, and holds a research grant from Bayer Pharma; Luk Rombauts is an advisor to MSD, Merck Serono, and Ferring, and a shareholder in Monash IVF. The following have declared that they have nothing to disclose: Kathy Sharpe Timms; Rulla Tamimi; Hugh Taylor. N/A. © The Author 2016. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Immediate versus delayed insertion of an etonogestrel releasing implant at medical abortion-a randomized controlled equivalence trial.

PubMed

Hognert, Helena; Kopp Kallner, Helena; Cameron, Sharon; Nyrelli, Christina; Jawad, Izabella; Heller, Rebecca; Aronsson, Annette; Lindh, Ingela; Benson, Lina; Gemzell-Danielsson, Kristina

2016-11-01

Does a progestin releasing subdermal contraceptive implant affect the efficacy of medical abortion if inserted at the same visit as the progesterone receptor modulator, mifepristone, at medical abortion? A etonogestrel releasing subdermal implant inserted on the day of mifepristone did not impair the efficacy of the medical abortion compared with routine insertion at 2-4 weeks after the abortion. The etonogestrel releasing subdermal implant is one of the most effective long acting reversible contraceptive methods. The effect of timing of placement on the efficacy of mifepristone and impact on prevention of subsequent unintended pregnancy is not known. This multicentre, randomized controlled, equivalence trial with recruitment between 13 October 2013 and 17 October 2015 included a total of 551 women with pregnancies below 64 days gestation opting for the etonogestrel releasing subdermal implant as postabortion contraception. Women were randomized to either insertion at 1 hour after mifepristone intake (immediate) or at follow-up 2-4 weeks later (delayed insertion). An equivalence design was used due to advantages for women such as fewer visits to the clinic with immediate insertion. The primary outcome was the percentage of women with complete abortion not requiring surgical intervention within 1 month. Secondary outcomes included insertion rates, pregnancy and repeat abortion rates during 6 months follow-up. Analysis was per protocol and by intention to treat. Women aged 18 years and older who had requested medical termination of a pregnancy up to 63 days of gestation and opted for an etonogestrel releasing contraceptive implant were recruited in outpatient family planning clinics in six hospitals in Sweden and Scotland. Efficacy of medical abortion was 259/275 (94.2%) in the immediate insertion group and 239/249 (96%) in the routine insertion group with a risk difference of 1.8% (95% CI -0.4 to 4.1%), which was within the ±5% margin of equivalence. The insertion rate was 275/277 (98.9%) in the immediate group compared to 187/261 (71.6%) women in the routine group (P < 0.001). At 6 months of follow-up significantly fewer women in the immediate group had become pregnant again (2/277, 0.8%) compared to the routine group (10/261, 3.8%) P = 0.018. For the main outcome loss to follow-up data was minimized through access to patient records. Efforts were made to reduce loss to follow-up also for secondary outcomes. The results of the sensitivity analysis did not differ from the intention to treat or per protocol analysis. Guidelines on postabortion contraception should be amended to include insertion of the etonogestrel releasing implant at the time of mifepristone intake for medical abortion up to and including a gestation of 63 days. This study was funded by the Swedish Research Council (2012-2844), Stockholm City County and Karolinska Institutet (ALF). The contraceptive implants were provided by Merck and supplied by MSD Sweden. HKK and KGD have received honorariums for giving lectures for MSD/Merck and have participated in the national (HKK and KGD) and international (KGD) medical advisory boards for MSD/Merck. The other authors have nothing to declare. ClinicalTrials number NCT01920022. 06 August 2013. 13 October 2013. © The Author 2016. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Comparative Assessment of Medical Resource Use and Costs Associated with Patients with Symptomatic Peripheral Artery Disease in the United States.

PubMed

Chase, Monica Reed; Friedman, Howard S; Navaratnam, Prakash; Heithoff, Kim; Simpson, Ross J

2016-06-01

There is growing concern about appropriate disease management for peripheral artery disease (PAD) because of the rapidly expanding population at risk for PAD and the high burden of illness associated with symptomatic PAD. A better understanding of the potential economic impact of symptomatic PAD relative to a matched control population may help improve care management for these patients. To compare the medical resource utilization, costs, and medication use for patients with symptomatic PAD relative to a matched control population. In this retrospective longitudinal analysis, the index date was the earliest date of a symptomatic PAD record (symptomatic PAD cohort) or any medical record (control cohort), and a period of 1 year pre-index and 3 years post-index was the study time frame. Symptomatic PAD patients and control patients (aged ≥ 18 years) enrolled in the MarketScan Commercial and Encounters database from January 1, 2006, to June 30, 2010, were identified. Symptomatic PAD was defined as having evidence of intermittent claudication (IC) and/or acute critical limb ischemia requiring medical intervention. Symptomatic PAD patients were selected using an algorithm comprising a combination of PAD-related ICD-9-CM diagnostic and diagnosis-related group codes, peripheral revascularization CPT-4 procedure codes, and IC medication National Drug Code numbers. Patients with stroke/transient ischemic attack, bleeding complications, or contraindications to antiplatelet therapy were excluded from the symptomatic PAD group but not the control group. A final 1:1 symptomatic PAD to control population with an exact match based on age, sex, index year, and Charlson Comorbidity Index (CCI) was identified. Descriptive statistics comparing patient demographics, comorbidities, medical resource utilization, cost, and medication use outcomes were generated. Generalized linear models were developed to compare the outcomes while controlling for residual difference in demographics, comorbidities, pre-index resource use, and pre-index costs. 3,965 symptomatic PAD and 3,965 control patients were matched. In both cohorts, 54.7% were male, with a mean age (SD) of 69.0 (12.9) years and a CCI score of 1.3 (0.9). Symptomatic PAD patients had more cardiovascular comorbidities than control patients (27.7% vs. 12.6% coronary artery disease, 27.1% vs. 15.9% hyperlipidemia, and 49.8% vs. 28.2% hypertension) in the pre-index period. Post-index rates of ischemic stroke, non-ST segment elevation myocardial infarction, unstable angina, and cardiovascular- or PAD-related procedures (limb amputations, endovascular procedures, open surgical procedures, percutaneous coronary intervention, and coronary artery bypass graft) were higher among symptomatic PAD patients versus control patients. All-cause annualized inpatient admissions (0.46 vs. 0.22 admissions), emergency department/urgent care days (0.27 vs. 0.22 days), and office visit days (12.5 vs. 10.2 days) were higher among symptomatic PAD versus control patients post-index. Annualized all-cause inpatient costs ($8,494 vs. $3,778); outpatient costs ($8,459 vs. $5,692); and total costs ($20,880 vs. $12,501) were higher among symptomatic PAD versus control patients post-index. Only 17.8% of symptomatic PAD patients versus 6.6% of control patients were on clopidogrel pre-index. In the post-index period, clopidogrel prescriptions in the symptomatic PAD population increased to 38.0%. Results were consistent in the regression models with the symptomatic PAD population having a higher number of all-cause post-index inpatient admissions, emergency department/urgent care days, office visit days, inpatient costs, outpatient costs, and total costs versus control patients (P ≤ 0.026). Symptomatic PAD patients have significantly higher medical resource use and costs when compared with a matched control population. As the prevalence of symptomatic PAD increases, there will be a significant impact on the population and health care system. The rates of use of evidence-based secondary prevention therapies, such as antiplatelet medication, were low. Therefore, greater effort must be made to increase utilization rates of appropriate treatments to determine if the negative economic and clinical impacts of symptomatic PAD can be minimized. This study was funded by Merck & Co., Kenilworth, New Jersey. Chase and Heithoff are employees of Merck & Co., Kenilworth, New Jersey, and Upper Gwynedd, Pennsylvania. Friedman and Navaratnam are paid consultants for Merck & Co. Simpson is a paid consultant for Merck, Pfizer, and Amgen and has received speaker's fees from Merck and Pfizer. Study concept and design were contributed by Chase, Navaratnam, and Heilhoff, along with Simpson and Friedman. Friedman collected the data, which was interpreted by Simpson and Navaratnam, along with Friedman. The manuscript was written by Navaratnam and Friedman, along with Chase, Heilhoff and Simpson, and revised by all of the authors.

Live birth rates after modified natural cycle compared with high-dose FSH stimulation using GnRH antagonists in poor responders.

PubMed

Lainas, Trifon G; Sfontouris, Ioannis A; Venetis, Christos A; Lainas, George T; Zorzovilis, Ioannis Z; Tarlatzis, Basil C; Kolibianakis, Efstratios M

2015-10-01

Do live birth rates differ between modified natural cycles (MNCs) and cycles using high-dose follicle stimulating hormone (HDFSH) with gonadotrophin-releasing hormone (GnRH) antagonist in poor responder patients? Live birth rates are significantly higher in MNC compared with HDFSH GnRH antagonist cycles in poor responder patients. Previous data on the efficiency of MNC in poor responders are very limited and suggest that MNC in vitro fertilization (IVF) does not offer a realistic solution for parenthood in these patients, since live birth rates are disappointingly low. To date, no studies exist comparing MNC with HDFSH stimulation protocols in poor responders. The present retrospective study included 161 MNCs (106 women in the MNC group) and 164 HDFSH antagonist cycles (136 women in the HDFSH group) performed between January 2008 and December 2013 at Eugonia Assisted Reproduction Unit. The patients included in the study had to fulfill the Bologna criteria for the definition of poor ovarian response. Irrespective of their age, poor responder patients should have a diminished ovarian reserve as shown by low antral follicle count (≤5) and increased basal FSH (>12 IU/l), and one or more previous failed IVF cycles in which ≤3 oocytes were retrieved using a high gonadotrophin dose. Analysis was performed by adjusting for the non-independence of the data. The probability of live birth was significantly higher in the MNC when compared with the HDFSH group (OR: 4.01, 95% CI: 1.14-14.09), after adjusting for basal FSH, female age and cause of infertility, variables which were shown to be associated with the probability of live birth in univariable analysis. MNCs were characterized by significantly lower total gonadotrophin dose (490.0 ± 35.2 IU versus 2826.1 ± 93.4 IU, P < 0.001), lower estradiol concentrations (237.5 ± 12.3 pg/ml versus 487.3 ± 29.8 pg/ml, P < 0.001), fewer follicles present on the day of hCG (1.9 ± 0.1 versus 3.2 ± 0.2, P < 0.001), fewer oocytes retrieved (1.1 ± 0.01 versus 2.4 ± 0.1, P < 0.001), fewer oocytes fertilized (0.7 ± 0.1 versus 1.4 ± 0.1, P < 0.001), fewer embryos transferred (0.7 ± 0.1 versus 1.4 ± 0.1, P < 0.001), fewer good-quality embryos available (0.5 ± 0.1 versus 0.8 ± 0.1, P < 0.001) and fewer good-quality embryos transferred (0.5 ± 0.05 versus 0.8 ± 0.1, P < 0.001) compared with the HDFSH group. However, the proportion of cycles with at least one good-quality embryo transferred per started cycle was similar between the two groups compared (62.5, 95% CI: 52.7-72.3 versus 62.7, 95% CI: 53.0-72.5, respectively). This is a retrospective comparison between MNC and HDFSH GnRH antagonist protocols in a large group of poor responder patients according to the Bologna criteria. Although the two groups compared were not imbalanced for all basic characteristics and multivariate analysis were performed to adjust for all known confounders, it cannot be excluded that non-apparent sources of bias might still be present. Future randomized controlled trials are necessary to verify the present findings. Both MNC and HDFSH antagonist protocols offer very low chances of live birth in poor responder patients who fulfill the Bologna criteria. However, MNC-IVF is a more patient-friendly approach, with a higher probability of live birth compared with the HDFSH antagonist protocol. In this respect, the current data might be of help in counseling such patients, who do not wish to undergo oocyte donation, prior to abandoning treatment altogether and/or proceeding to adoption. No funding was obtained. C.A.V. reports personal fees and non-financial support from Merck, Sharp and Dome, personal fees and non-financial support from Merck Serono, personal fees and non-financial support from IPSEN Hellas S.A. outside the submitted work. B.C.T. reports grants from Merck Serono, grants from Merck Sharp & Dohme, personal fees from IBSA, personal fees from Merck Sharp & Dohme and personal fees from Ovascience outside the submitted work . © The Author 2015. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Update on herpes zoster vaccine: licensure for persons aged 50 through 59 years.

PubMed

2011-11-11

Herpes zoster vaccine (Zostavax, Merck & Co., Inc.) was licensed and recommended in 2006 for prevention of herpes zoster among adults aged 60 years and older. In March 2011, the Food and Drug Administration (FDA) approved the use of Zostavax in adults aged 50 through 59 years. In June 2011, the Advisory Committee on Immunization Practices (ACIP) declined to recommend the vaccine for adults aged 50 through 59 years and reaffirmed its current recommendation that herpes zoster vaccine be routinely recommended for adults aged 60 years and older.

Safinamide for the treatment of Parkinson's disease, epilepsy and restless legs syndrome.

PubMed

Chazot, Paul L

2007-07-01

Merck Serono SA (formerly Serono), under license from Newron Pharmaceuticals SpA (following its acquisition of the rights from Pharmacia and Upjohn AB [now Pfizer Inc]), is developing the oral alpha-aminoamide derivative of milacemide, safinamide, a monoamine oxidase-B and glutamate release inhibitor, for the potential treatment of Parkinson's disease, epilepsy and restless legs syndrome. In March 2007, plans to develop the agent for the potential treatment of other cognitive disorders, such as Alzheimer's disease, were being finalized and testing was expected to begin before the end of that year.

Advertisements impact the physiological efficacy of a branded drug

PubMed Central

Kamenica, Emir; Naclerio, Robert; Malani, Anup

2013-01-01

We conducted randomized clinical trials to examine the impact of direct-to-consumer advertisements on the efficacy of a branded drug. We compared the objectively measured, physiological effect of Claritin (Merck & Co.), a leading antihistamine medication, across subjects randomized to watch a movie spliced with advertisements for Claritin or advertisements for Zyrtec (McNeil), a competitor antihistamine. Among subjects who test negative for common allergies, exposure to Claritin advertisements rather than Zyrtec advertisements increases the efficacy of Claritin. We conclude that branded drugs can interact with exposure to television advertisements. PMID:23878212

Advertisements impact the physiological efficacy of a branded drug.

PubMed

Kamenica, Emir; Naclerio, Robert; Malani, Anup

2013-08-06

We conducted randomized clinical trials to examine the impact of direct-to-consumer advertisements on the efficacy of a branded drug. We compared the objectively measured, physiological effect of Claritin (Merck & Co.), a leading antihistamine medication, across subjects randomized to watch a movie spliced with advertisements for Claritin or advertisements for Zyrtec (McNeil), a competitor antihistamine. Among subjects who test negative for common allergies, exposure to Claritin advertisements rather than Zyrtec advertisements increases the efficacy of Claritin. We conclude that branded drugs can interact with exposure to television advertisements.

Tildrakizumab: First Global Approval.

PubMed

Markham, Anthony

2018-05-11

Merck & Company Inc. have developed tildrakizumab (tildrakizumab-asmn; Ilumya™), a high-affinity, humanised IgG1 κ monoclonal antibody that specifically targets interleukin-23 p19, as a treatment for chronic plaque psoriasis. The drug was recently approved for marketing by the US FDA based on positive results from the phase III reSURFACE clinical trial programme in patients with chronic plaque psoriasis. This article summarizes the milestones in the development of tildrakizumab leading to this first approval for the treatment of adults with moderate-to-severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.

An interview with Margaret A Liu: the future of gene-based vaccines and immunotherapies, and other musings.

PubMed

Liu, Margaret A; Rees, Jenaid

2015-02-01

Interview by Jenaid Rees, commissioning editor. Margaret A Liu is best known for her pioneering work in the area of DNA vaccines. A world renowned scientist, Liu was named one of 'The 50 Most Important Women Scientists' by Discover magazine in 2002. Liu obtained her M.D. from Harvard Medical School, and has held positions at numerous institutions including Harvard Medical School, Massachusetts Institute of Technology, University of Pennsylvania, UCSF, and the Karolinska Institutet in Stockholm. In her career she has served as Senior Advisor in Vaccinology at the Bill & Melinda Gates Foundation and Executive Vice-Chair of the International Vaccine Institute in Seoul, Korea and worked for companies including Merck, Transgène and Chiron Corporation. Her research achievements have led to her receipt of honorary lectureships, and she has held many board positions throughout her career. Liu currently consults in the fields of vaccines and immunotherapy for companies, universities, and non-governmental and governmental scientific organizations, and is a Foreign Adjunct Professor at the Karolinska Institutet in Stockholm, and an Adjunct Professor at the University of California, San Francisco.

Application of HPLC with ELSD Detection for the Assessment of Azelaic Acid Impurities in Liposomal Formulation

PubMed Central

Han, Stanislaw; Karlowicz-Bodalska, Katarzyna; Ozimek, Lukasz

2013-01-01

In the course of research and development of a new pharmaceutical formulation of azelaic acid in the liposomal form, we developed a rapid and accurate method for the detection of impurities using high-performance liquid chromatography. A chromatographic column from Merck (Purospher Star RP C18, 250–4 mm (5 μm) was used in the assay, and the mobile phase gradient consisted of three phases: A—methanol : water (5 : 95) + 1.5% (v/v) acetic acid; B—water : methanol (5 : 95) + 1.5% (v/v) acetic acid; and C—chloroform. Detection of the impurities and the active substance was performed by an evaporative light-scattering detector. The method was validated for selectivity, system precision, method precision, limit of detection, and response rates. The proposed method can be used to detect impurities in the liposomal formulation of azelaic acid. The method enables separation of azelaic acid from the identified and unidentified impurities and from the excipients used in the drug form. PMID:24228008

Networks of innovation or networks of opportunity? The making of the Spanish antibiotics industry.

PubMed

Puig, Nuria

2004-07-01

The pharmaceutical industry is a typically research-intensive, first world-industry. This article seeks to explain why it has been so difficult for late industrialised nations to reproduce the networks of innovation on which the design and manufacturing of new drugs has historically based, and why alternative concepts are needed in order to understand the dynamics of science-based industries in emerging countries. The article analyses the development of the Spanish antibiotics industry, build after the World War II under the strong influence of the new international order and Spain's political framework, academic traditions and business groups. Focusing on the long-term relationships established between two Spanish companies (Antibióticos SA and Compañía Española de Penicilina y Antibióticos, CEPA), their American technological partners (Schenley and Merck), and their social and scientific environment, the article identifies networks of opportunity as the key institutional arrangement of this new industry in Spain. Opportunity (as opposed to innovation) networks are thus proposed to conceptualise the development of technologically complex industries in the European periphery.

Application of HPLC with ELSD detection for the assessment of azelaic acid impurities in liposomal formulation.

PubMed

Han, Stanislaw; Karlowicz-Bodalska, Katarzyna; Szura, Dorota; Ozimek, Lukasz; Musial, Witold

2013-01-01

In the course of research and development of a new pharmaceutical formulation of azelaic acid in the liposomal form, we developed a rapid and accurate method for the detection of impurities using high-performance liquid chromatography. A chromatographic column from Merck (Purospher Star RP C18, 250-4 mm (5 μm) was used in the assay, and the mobile phase gradient consisted of three phases: A--methanol : water (5 : 95) + 1.5% (v/v) acetic acid; B--water : methanol (5 : 95) + 1.5% (v/v) acetic acid; and C--chloroform. Detection of the impurities and the active substance was performed by an evaporative light-scattering detector. The method was validated for selectivity, system precision, method precision, limit of detection, and response rates. The proposed method can be used to detect impurities in the liposomal formulation of azelaic acid. The method enables separation of azelaic acid from the identified and unidentified impurities and from the excipients used in the drug form.

Impact of two different saponins on the organization of model lipid membranes.

PubMed

Korchowiec, Beata; Gorczyca, Marcelina; Wojszko, Kamila; Janikowska, Maria; Henry, Max; Rogalska, Ewa

2015-10-01

Saponins, naturally occurring plant compounds are known for their biological and pharmacological activity. This activity is strongly related to the amphiphilic character of saponins that allows them to aggregate in aqueous solution and interact with membrane components. In this work, Langmuir monolayer techniques combined with polarization modulation infrared reflection-absorption spectroscopy (PM-IRRAS) and Brewster angle microscopy were used to study the interaction of selected saponins with lipid model membranes. Two structurally different saponins were used: digitonin and a commercial Merck Saponin. Membranes of different composition, namely, cholesterol, 1,2-dipalmitoyl-sn-glycero-3-phosphocholine or 1,2-dipalmitoyl-sn-glycero-3-phospho-rac-(1-glycerol) were formed at the air/water and air/saponin solution interfaces. The saponin-lipid interaction was characterized by changes in surface pressure, surface potential, surface morphology and PM-IRRAS signal. Both saponins interact with model membranes and change the physical state of membranes by perturbing the lipid acyl chain orientation. The changes in membrane fluidity were more significant upon the interaction with Merck Saponin. A higher affinity of saponins for cholesterol than phosphatidylglycerols was observed. Moreover, our results indicate that digitonin interacts strongly with cholesterol and solubilize the cholesterol monolayer at higher surface pressures. It was shown, that digitonin easily penetrate to the cholesterol monolayer and forms a hydrogen bond with the hydroxyl groups. These findings might be useful in further understanding of the saponin action at the membrane interface and of the mechanism of membrane lysis. Copyright © 2015 Elsevier B.V. All rights reserved.

Fenofibrate-associated changes in renal function and relationship to clinical outcomes among individuals with type 2 diabetes: the Action to Control Cardiovascular Risk in Diabetes (ACCORD) experience.

PubMed

Bonds, D E; Craven, T E; Buse, J; Crouse, J R; Cuddihy, R; Elam, M; Ginsberg, H N; Kirchner, K; Marcovina, S; Mychaleckyj, J C; O'Connor, P J; Sperl-Hillen, J-A

2012-06-01

Fenofibrate has been noted to cause an elevation in serum creatinine in some individuals. Participants in the Action to Control Cardiovascular Risk in Diabetes Lipid Study were studied to better characterise who is at risk of an increase in creatinine level and to determine whether those with creatinine elevation have a differential risk of adverse renal or cardiovascular outcomes. A fenofibrate-associated creatinine increase (FACI) was defined as an increase in serum creatinine of at least 20% from baseline to month 4 in participants assigned to fenofibrate. Baseline patient characteristics, and baseline and 4-month drug, clinical, laboratory characteristics and study outcomes were examined by FACI status. Of the sample, 48% of those randomised to receive fenofibrate had at least a 20% increase in serum creatinine within 4 months. In multivariable analysis, participants who were older, male, used an ACE inhibitor at baseline, used a thiazolidinedione (TZD) at 4 months post-randomisation, had baseline CVD, and had lower baseline serum creatinine and LDL-cholesterol levels were all more likely to meet the criteria for FACI. Participants in the FACI group were also more likely to have a decrease in their serum triacylglycerol level from baseline to 4 months. No differences in study outcomes were seen by FACI criteria. Several characteristics predict a rapid rise in serum creatinine upon starting fenofibrate. Participants who met the criteria for FACI also had a greater change in triacylglycerol levels. In the setting of careful renal function surveillance and reduction of fenofibrate dose as indicated, no increase in renal disease or cardiovascular outcome was seen in those individuals demonstrating FACI. ClincalTrials.gov: NCT00000620. The ACCORD Trial was supported by grants (N01-HC-95178, N01-HC-95179, N01-HC-95180, N01-HC-95181, N01-HC-95182, N01-HC-95183, N01-HC-95184, IAA-Y1-HC-9035 and IAA-Y1-HC-1010) from the National Heart, Lung, and Blood Institute; by the National Institute of Diabetes and Digestive and Kidney Diseases, the National Institute on Aging, and the National Eye Institute; by the Centers for Disease Control and Prevention; by General Clinical Research Centers and by the Clinical and Translational Science Awards. Abbott Laboratories, Amylin Pharmaceutical, AstraZeneca Pharmaceuticals LP, Bayer HealthCare LLC, Closer Healthcare, GlaxoSmithKline Pharmaceuticals, King Pharmaceuticals, Merck, Novartis Pharmaceuticals, Novo Nordisk, Omron Healthcare, sanofi-aventis US and Takeda Pharmaceuticals provided study medications, equipment or supplies.

Temperature Dependence of Quasiparticle Spectral Weight and Coherence in High Tc Superconductors

NASA Astrophysics Data System (ADS)

He, Yang; Zhang, Jessie; Hoffman, Jennifer; Hoffman Lab Team

2014-03-01

Superconductivity arises from the Cooper pairing of quasiparticles on the Fermi surface. Understanding the formation of Cooper pairs is an essential step towards unveiling the mechanism of high Tc superconductivity. We compare scanning tunneling microscope investigations of the temperature dependence of quasiparticle spectral weight and quasiparticle interference in several families of high Tc materials. We calculate the coherent spectral weight related to superconductivity, despite the coexistence of competing orders. The relation between pairing temperature and coherent spectral weight is discussed. We acknowledge support by the New York Community Trust-George Merck Fund.

Update on montelukast and its role in the treatment of asthma, allergic rhinitis and exercise-induced bronchoconstriction.

PubMed

Storms, William

2007-09-01

Montelukast sodium (Singulair, Merck and Co., Inc., Whitehouse Station, NJ) is a selective and orally-active leukotriene receptor antagonist with demonstrated effectiveness for treating allergic asthma and allergic rhinitis in adults and children as young as 12 months of age for allergic asthma and 6 months of age for allergic rhinitis. It was recently approved in the US for prevention of exercise-induced bronchoconstriction in patients who are > or = 15 years of age. This paper updates a prior review of the data on the clinical efficacy of montelukast published in this journal.

Quantitative Component Analysis of Solid Mixtures by Analyzing Time Domain 1H and 19F T1 Saturation Recovery Curves (qSRC).

PubMed

Stueber, Dirk; Jehle, Stefan

2017-07-01

Prevalent polymorphism and complicated phase behavior of active pharmaceutical ingredients (APIs) often result in remarkable differences in the respective biochemical and physical API properties. Consequently, API form characterization and quantification play a central role in the pharmaceutical industry from early drug development to manufacturing. Here we present a novel and proficient quantification protocol for solid mixtures (qSRC) based on the measurement and mathematical fitting of T 1 nuclear magnetic resonance (NMR) saturation recovery curves collected on a bench top time-domain NMR instrument. The saturation recovery curves of the relevant pure components are used as fingerprints. Employing a bench top NMR instrument possesses clear benefits. These instruments exhibit a small footprint, do not present any special requirements on lab space, and required sample handling is simple and fast. The qSRC analysis can easily be conducted in a conventional laboratory setting as well as in an industrial production environment, making it a versatile tool with the potential for widespread application. The accuracy and efficiency of the qSRC method is illustrated using 1 H and 19 F T 1 data of selected pharmaceutical model compounds, as well as utilizing 1 H T 1 data of an actual binary API anhydrous polymorph system of a Merck & Co., Inc. compound formerly developed as a hepatitis C virus drug. Copyright © 2017 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

NIAID, NIEHS, NHLBI, and MCAN Workshop Report: The indoor environment and childhood asthma-implications for home environmental intervention in asthma prevention and management.

PubMed

Gold, Diane R; Adamkiewicz, Gary; Arshad, Syed Hasan; Celedón, Juan C; Chapman, Martin D; Chew, Ginger L; Cook, Donald N; Custovic, Adnan; Gehring, Ulrike; Gern, James E; Johnson, Christine C; Kennedy, Suzanne; Koutrakis, Petros; Leaderer, Brian; Mitchell, Herman; Litonjua, Augusto A; Mueller, Geoffrey A; O'Connor, George T; Ownby, Dennis; Phipatanakul, Wanda; Persky, Victoria; Perzanowski, Matthew S; Ramsey, Clare D; Salo, Päivi M; Schwaninger, Julie M; Sordillo, Joanne E; Spira, Avrum; Suglia, Shakira F; Togias, Alkis; Zeldin, Darryl C; Matsui, Elizabeth C

2017-10-01

Environmental exposures have been recognized as critical in the initiation and exacerbation of asthma, one of the most common chronic childhood diseases. The National Institute of Allergy and Infectious Diseases; National Institute of Environmental Health Sciences; National Heart, Lung, and Blood Institute; and Merck Childhood Asthma Network sponsored a joint workshop to discuss the current state of science with respect to the indoor environment and its effects on the development and morbidity of childhood asthma. The workshop included US and international experts with backgrounds in allergy/allergens, immunology, asthma, environmental health, environmental exposures and pollutants, epidemiology, public health, and bioinformatics. Workshop participants provided new insights into the biologic properties of indoor exposures, indoor exposure assessment, and exposure reduction techniques. This informed a primary focus of the workshop: to critically review trials and research relevant to the prevention or control of asthma through environmental intervention. The participants identified important limitations and gaps in scientific methodologies and knowledge and proposed and prioritized areas for future research. The group reviewed socioeconomic and structural challenges to changing environmental exposure and offered recommendations for creative study design to overcome these challenges in trials to improve asthma management. The recommendations of this workshop can serve as guidance for future research in the study of the indoor environment and on environmental interventions as they pertain to the prevention and management of asthma and airway allergies. Published by Elsevier Inc.

An alternative NMR method to determine nuclear shielding anisotropies for molecules in liquid-crystalline solutions with (13)C shielding anisotropy of methyl iodide as an example.

PubMed

Tallavaara, Pekka; Jokisaari, Jukka

2008-03-28

An alternative NMR method for determining nuclear shielding anisotropies in molecules is proposed. The method is quite simple, linear and particularly applicable for heteronuclear spin systems. In the technique, molecules of interest are dissolved in a thermotropic liquid crystal (LC) which is confined in a mesoporous material, such as controlled pore glass (CPG) used in this study. CPG materials consist of roughly spherical particles with a randomly oriented and connected pore network inside. LC Merck Phase 4 was confined in the pores of average diameter from 81 to 375 A and LC Merck ZLI 1115 in the pores of average diameter 81 A. In order to demonstrate the functionality of the method, the (13)C shielding anisotropy of (13)C-enriched methyl iodide, (13)CH(3)I, was determined as a function of temperature using one dimensional (13)C NMR spectroscopy. Methane gas, (13)CH(4), was used as an internal chemical shift reference. It appeared that methyl iodide molecules experience on average an isotropic environment in LCs inside the smallest pores within the whole temperature range studied, ranging from bulk solid to isotropic phase. In contrast, in the spaces in between the particles, whose diameter is approximately 150 microm, LCs behave as in the bulk. Consequently, isotropic values of the shielding tensor can be determined from spectra arising from molecules inside the pores at exactly the same temperature as the anisotropic ones from molecules outside the pores. Thus, for the first time in the solution state, shielding anisotropies can easily be determined as a function of temperature. The effects of pore size as well as of different LC media on the shielding anisotropy are examined and discussed.

Herpes zoster vaccine live: A 10 year review of post-marketing safety experience.

PubMed

Willis, English D; Woodward, Meredith; Brown, Elizabeth; Popmihajlov, Zoran; Saddier, Patricia; Annunziato, Paula W; Halsey, Neal A; Gershon, Anne A

2017-12-19

Zoster vaccine is a single dose live, attenuated vaccine (ZVL) indicated for individuals ≥50 years-old for the prevention of herpes zoster (HZ). Safety data from clinical trials and post-licensure studies provided reassurance that ZVL is generally safe and well tolerated. The objective of this review was to provide worldwide post-marketing safety information following 10 years of use and >34 million doses distributed. All post-marketing adverse experience (AE) reports received worldwide between 02-May-2006 and 01-May-2016 from healthcare professionals following vaccination with ZVL and submitted to the MSD AE global safety database, were analyzed. A total of 23,556 AE reports, 93% non-serious, were reported. Local injection site reactions (ISRs), with a median time-to-onset of 2 days, were the most frequently reported AEs followed by HZ. The majority of HZ reports were reported within 2 weeks of vaccination and considered, based on time-to-onset, pathogenesis of HZ, and data from clinical trials, to be caused by wild-type varicella-zoster virus (VZV). HZ confirmed by PCR analysis to be VZV Oka/Merck vaccine-strain was identified in an immunocompetent individual 8 months postvaccination and in 4 immunocompromised individuals. Disseminated HZ was reported very rarely (<1%) with 38% occurring in immunocompromised individuals. All reports of disseminated HZ confirmed by PCR as VZV Oka/Merck vaccine-strain were in individuals with immunosuppressive conditions and/or therapy at the time of vaccination. The safety profile of ZVL, following 10 years of post-marketing use, was favorable and consistent with that observed in clinical trials and post-licensure studies. Copyright © 2017 Elsevier Ltd. All rights reserved.

Unprecedented Therapeutic Potential with a Combination of A2A/NR2B Receptor Antagonists as Observed in the 6-OHDA Lesioned Rat Model of Parkinson's Disease

PubMed Central

Michel, Anne; Downey, Patrick; Nicolas, Jean-Marie; Scheller, Dieter

2014-01-01

In Parkinson's disease, the long-term use of dopamine replacing agents is associated with the development of motor complications; therefore, there is a need for non-dopaminergic drugs. This study evaluated the potential therapeutic impact of six different NR2B and A2A receptor antagonists given either alone or in combination in unilateral 6-OHDA-lesioned rats without (monotherapy) or with (add-on therapy) the co-administration of L-Dopa: Sch-58261+ Merck 22; Sch-58261+Co-101244; Preladenant + Merck 22; Preladenant + Radiprodil; Tozadenant + Radiprodil; Istradefylline + Co-101244. Animals given monotherapy were assessed on distance traveled and rearing, whereas those given add-on therapy were assessed on contralateral rotations. Three-way mixed ANOVA were conducted to assess the main effect of each drug separately and to determine whether any interaction between two drugs was additive or synergistic. Additional post hoc analyses were conducted to compare the effect of the combination with the effect of the drugs alone. Motor activity improved significantly and was sustained for longer when the drugs were given in combination than when administered separately at the same dose. Similarly, when tested as add-on treatment to L-Dopa, the combinations resulted in higher levels of contralateral rotation in comparison to the single drugs. Of special interest, the activity observed with some combinations could not be described by a simplistic additive effect and involved more subtle synergistic pharmacological interactions. The combined administration of A2A/NR2B-receptor antagonists improved motor behaviour in 6-OHDA rats. Given the proven translatability of this model such a combination may be expected to be effective in improving motor symptoms in patients. PMID:25513815

Simultaneous quantification of delta-9-THC, THC-acid A, CBN and CBD in seized drugs using HPLC-DAD.

PubMed

Ambach, Lars; Penitschka, Franziska; Broillet, Alain; König, Stefan; Weinmann, Wolfgang; Bernhard, Werner

2014-10-01

An HPLC-DAD method for the quantitative analysis of Δ(9)-tetrahydrocannabinol (THC), Δ(9)-tetrahydrocannabinolic acid-A (THCA-A), cannabidiol (CBD), and cannabinol (CBN) in confiscated cannabis products has been developed, fully validated and applied to analyse seized cannabis products. For determination of the THC content of plant material, this method combines quantitation of THCA-A, which is the inactive precursor of THC, and free THC. Plant material was dried, homogenized and extracted with methanol by ultrasonication. Chromatographic separation was achieved with a Waters Alliance 2695 HPLC equipped with a Merck LiChrospher 60 RP-Select B (5μm) precolumn and a Merck LiChroCart 125-4 LiChrospher 60 RP-Select B (5μm) analytical column. Analytes were detected and quantified using a Waters 2996 photo diode array detector. This method has been accepted by the public authorities of Switzerland (Bundesamt für Gesundheit, Federal Office of Public Health), and has been used to analyse 9092 samples since 2000. Since no thermal decarboxylation of THCA-A occurs, the method is highly reproducible for different cannabis materials. Two calibration ranges are used, a lower one for THC, CBN and CBD, and a higher one for THCA-A, due to its dominant presence in fresh plant material. As provider of the Swiss proficiency test, the robustness of this method has been tested over several years, and homogeneity tests even in the low calibration range (1%) show high precision (RSD≤4.3%, except CBD) and accuracy (bias≤4.1%, except CBN). Copyright © 2014. Published by Elsevier Ireland Ltd.

[Vaccines against varicella-zoster virus (VZV)].

PubMed

Salleras, Luis; Salleras, Montserrat; Soldevila, Nuria; Prat, Andreu; Garrido, Patricio; Domínguez, Ángela

2015-01-01

In Western countries, two attenuated varicella vaccines derived from the OKA strain are licensed: Varilrix® GlaxoSmithKline (OKA/RIT strain) and Varivax® Merck Sharp and Dohme (OKA/Merck strain). Currently, in Spain, varicella vaccination is only included in the Ministry of Health, Social Services and Equality official vaccination calendar for administration in adolescents who have not had the disease. Given the good results obtained in Navarra and Madrid with universal administration of the vaccine in children, it would be desirable to include the vaccine in the routine immunization schedule, with the administration of two doses at 15-18 months of age in the future. The protective efficacy of the attenuated herpes zoster vaccine was evaluated in the Shingles Prevention Study, which showed that in the short term (0-4 years) the vaccine reduced the incidence of herpes zoster by 53%, post-herpetic neuralgia by 66%, and the disease burden in immunocompetent persons aged ≥60 years by 61%. Another study demonstrated protective efficacy in persons aged 50-59 years. Over time, the protective efficacy decreases, but remains at acceptable levels, especially for post-herpetic neuralgia and the disease burden. Recently, the results of a controlled clinical trial (phase III) conducted in 18 countries to assess the protective efficacy of the inactivated subunit vaccine (glycoprotein E) adjuvanted with the adjuvant AS01B were published. The study inferred that the vaccine significantly reduced the incidence of herpes zoster in the short term (3.2 years) in people aged ≥50 years. Vaccine protection did not decrease with age at vaccination, ranging between 96.8% and 97.9% in all age groups. Copyright © 2015. Published by Elsevier España, S.L.U.

Herpes zoster vaccine live: A 10 year review of post-marketing safety experience

PubMed Central

Willis, English D.; Woodward, Meredith; Brown, Elizabeth; Popmihajlov, Zoran; Saddier, Patricia; Annunziato, Paula W.; Halsey, Neal A.; Gershon, Anne A.

2017-01-01

Background Zoster vaccine is a single dose live, attenuated vaccine (ZVL) indicated for individuals ≥50 years-old for the prevention of herpes zoster (HZ). Safety data from clinical trials and post-licensure studies provided reassurance that ZVL is generally safe and well tolerated. The objective of this review was to provide worldwide post-marketing safety information following 10 years of use and >34 million doses distributed. Methods All post-marketing adverse experience (AE) reports received worldwide between 02-May-2006 and 01-May-2016 from healthcare professionals following vaccination with ZVL and submitted to the MSD AE global safety database, were analyzed. Results A total of 23,556 AE reports, 93% non-serious, were reported. Local injection site reactions (ISRs), with a median time-to-onset of 2 days, were the most frequently reported AEs followed by HZ. The majority of HZ reports were reported within 2 weeks of vaccination and considered, based on time-to-onset, pathogenesis of HZ, and data from clinical trials, to be caused by wild-type varicella-zoster virus (VZV). HZ confirmed by PCR analysis to be VZV Oka/Merck vaccine-strain was identified in an immunocompetent individual 8 months postvaccination and in 4 immunocompromised individuals. Disseminated HZ was reported very rarely (<1%) with 38% occurring in immunocompromised individuals. All reports of disseminated HZ confirmed by PCR as VZV Oka/Merck vaccine-strain were in individuals with immunosuppressive conditions and/or therapy at the time of vaccination. Conclusions The safety profile of ZVL, following 10 years of post-marketing use, was favorable and consistent with that observed in clinical trials and post-licensure studies. PMID:29174682

A comparative evaluation of models to predict human intestinal metabolism from nonclinical data.

PubMed

Yau, Estelle; Petersson, Carl; Dolgos, Hugues; Peters, Sheila Annie

2017-04-01

Extensive gut metabolism is often associated with the risk of low and variable bioavailability. The prediction of the fraction of drug escaping gut wall metabolism as well as transporter-mediated secretion (F g ) has been challenged by the lack of appropriate preclinical models. The purpose of this study is to compare the performance of models that are widely employed in the pharmaceutical industry today to estimate F g and, based on the outcome, to provide recommendations for the prediction of human F g during drug discovery and early drug development. The use of in vitro intrinsic clearance from human liver microsomes (HLM) in three mechanistic models - the ADAM, Q gut and Competing Rates - was evaluated for drugs whose metabolism is dominated by CYP450s, assuming that the effect of transporters is negligible. The utility of rat as a model for human F g was also explored. The ADAM, Q gut and Competing Rates models had comparable prediction success (70%, 74%, 69%, respectively) and bias (AFE = 1.26, 0.74 and 0.81, respectively). However, the ADAM model showed better accuracy compared with the Q gut and Competing Rates models (RMSE =0.20 vs 0.30 and 0.25, respectively). Rat is not a good model (prediction success =32%, RMSE =0.48 and AFE = 0.44) as it seems systematically to under-predict human F g . Hence, we would recommend the use of rat to identify the need for F g assessment, followed by the use of HLM in simple models to predict human F g . © 2017 Merck KGaA. Biopharmaceutics & Drug Disposition Published by John Wiley & Sons, Ltd. © 2017 Merck KGaA. Biopharmaceutics & Drug Disposition Published by John Wiley & Sons, Ltd.

Report on the 5‘th scientific meeting of the “Verein zur Förderung des Wissenschaftlichen Nachwuchses in der Neurologie” (NEUROWIND e.V.) held in Motzen, Germany, Oct. 25th – Oct. 27th, 2013

PubMed Central

2013-01-01

From october 25th - 27th 2013, the 5th NEUROWIND e.V. meeting was held in Motzen, Brandenburg, Germany. This year more than 60 doctoral students and postdocs from over 25 different groups working in German university hospitals or research institutes attended the meeting to discuss their latest findings in the fields of neuroimmunology, neurodegeneration and neurovascular research. All participants appreciated the stimulating environment in Motzen, Brandenburg, and people took the opportunity for scientific exchange, discussion about ongoing projects and already started further collaborations. Like in the previous years, the symposium was regarded as a very well organized platform to support research of young investigators in Germany. According to the major aim of NEUROWIND e.V. to support younger researchers in Germany the 3rd NEUROWIND YOUNG SCIENTIST AWARD for experimental neurology was awarded to Ruth Stassart working in the group of Klaus Armin Nave and Wolfgang Brück (MPI Göttingen and Department of Neuropathology, Göttingen Germany). The successful work was published in Nature Neuroscience entitled “A role for Swann cell-derived neuregulin-1 in remyelination”. This outstanding paper deals with the function of Schwann cell neuregulin as an endogenous factor for myelin repair. The award is endowed with 20.000 Euro sponsored by Merck Serono GmbH, Darmstadt, Germany (unrestricted educational grant). This year’s keynote lecture was given by Albert Ludolph, Head of the Department of Neurology at the University Clinic of Ulm. Dr. Ludolph highlighted the particular role of individual scientists for the development of research concepts in Alzheimer´s disease (AD) and frontotemporal dementia (FTD). PMID:24330587

Design and Calibration of the US Army Research Laboratory (ARL) Closed Loop Laboratory Radio Frequency (RF) Propagation Section

DTIC Science & Technology

2016-10-01

ARL-TR-7860 ● OCT 2016 US Army Research Laboratory Design and Calibration of the US Army Research Laboratory (ARL) Closed Loop ...ARL-TR-7860 ● OCT 2016 US Army Research Laboratory Design and Calibration of the US Army Research Laboratory (ARL) Closed Loop Laboratory...Design and Calibration of the US Army Research Laboratory (ARL) Closed Loop Laboratory Radio Frequency (RF) Propagation Section 5a. CONTRACT NUMBER

[Lower is better: ENHANCE affair].

PubMed

Scardi, Sabino; Umari, Paolo; D'Agata, Bianca Maria

2008-06-01

Ezetimibe lowers the intestinal absorption of cholesterol, being complementary to the effects of statin. To check its efficacy in lowering the carotid intima-media thickness, in 2002 a multicenter international trial called ENHANCE was started, in order to assess by ultrasound the regression of atherosclerotic plaques. The protocol tested the use of simvastatin 80 mg + placebo versus simvastatin 80 mg + ezetimibe 10 mg in 720 randomized patients. Both drugs were well tolerated. Combination therapy was associated with a larger reduction in LDL cholesterol, but there were no differences in the intima-media thickness measured at three sites in the carotid arteries, nor differences in cardiovascular events between the two groups in the trial. These results provoked disappointment of sponsors (Merck, Schering Plough) who, although the results of the trial were available since march 2007, delayed official communication of about 18 months. This led to speculations and rumors among media, American Government, cardiologic scientific associations, and consequences in the Ezetimibe market and at Wall Street. In particular, the American College of Cardiology didn't accept the communication of ENHANCE results to the Late Breaking Trial Session of the Chicago congress, diverting it to another secondary forum. In conclusion, the experience of the ENHANCE trial suggests to pharmaceutical companies, researchers, clinicians, scientific companies and media a deep meditation in order to avoid in the future similar problems in the management of results of medical research.

Partnership between small biotech and big pharma.

PubMed

Wiederrecht, Gregory J; Hill, Raymond G; Beer, Margaret S

2006-08-01

The process involved in the identification and development of novel breakthrough medicines at big pharma has recently undergone significant changes, in part because of the extraordinary complexity that is associated with tackling diseases of high unmet need, and also because of the increasingly demanding requirements that have been placed on the pharmaceutical industry by investors and regulatory authorities. In addition, big pharma no longer have a monopoly on the tools and enabling technologies that are required to identify and discover new drugs, as many biotech companies now also have these capabilities. As a result, researchers at biotech companies are able to identify credible drug leads, as well as compounds that have the potential to become marketed medicinal products. This diversification of companies that are involved in drug discovery and development has in turn led to increased partnering interactions between the biotech sector and big pharma. This article examines how Merck and Co Inc, which has historically relied on a combination of internal scientific research and licensed products, has poised itself to become further engaged in partnering with biotech companies, as well as academic institutions, to increase the probability of success associated with identifying novel medicines to treat unmet medical needs--particularly in areas such as central nervous system disorders, obesity/metabolic diseases, atheroma and cancer, and also to cultivate its cardiovascular, respiratory, arthritis, bone, ophthalmology and infectious disease franchises.

A Recombinant 63-kDa Form of Bacillus anthracis Protective Antigen Produced in the Yeast Saccharomyces cerevisiae Provides Protection in Rabbit and Primate Inhalational Challenge Models of Anthrax Infection

DTIC Science & Technology

2005-10-21

provides protection in rabbit and primate inhalational challenge models of anthrax infection Robert W. Hepler a, 1 , Rosemarie Kelly b,∗, 1 , Tessie B. McNeely a...October 2005 A t t y i H k r e a © K 1 B 9 9 0 d Approved for public release. Distribution is unlimited.bstract Infection by Bacillus anthracis is...Corresponding author. Tel.: + 1 732 594 6385; fax: + 1 732 594 1399. E-mail address: rosemarie kelly@merck.com (R. Kelly). 1 Authors made an equal contribution to

Fixed-dose combination of sitagliptin and metformin for the treatment of type 2 diabetes

PubMed Central

Reynolds, Jonathan K

2009-01-01

JanumetTM, a fixed dose combination of sitagliptin/metformin HCL manufactured by Merck Pharmaceuticals, has received US Food and Drug Administration approval for treatment of patients with type 2 diabetes, that are inadequately controlled, either by sitagliptin or metformin alone or together in free-dose combination form. Sitagliptin, an inhibitor of the enzyme DDP-4, assists patients with type 2 diabetes mellitus to achieve glycemic control. It has been shown to be safe and effective at 100 mg daily doses. The effect of giving sitagliptin in combination with metformin is thought to have a complimentary and possibly additive effect on glycemic control. PMID:21437126

Detecting Infections Rapidly and Easily for Candidemia Trial (DIRECT1): A Prospective, Multicenter Study of the T2Candida Panel

PubMed Central

Clancy, Cornelius J; Pappas, Peter; Vazquez, Jose; Judson, Marc A; Tobin, Ellis; Kontoyiannis, Dimitrios P; Thompson, George R; Reboli, Annette; Garey, Kevin W; Greenberg, Richard N; Ostrosky-Zeichner, Luis; Wu, Alan; Lyon, G Marshall; Apewokin, Senu; Nguyen, M Hong; Caliendo, Angela

2017-01-01

Abstract Background Blood cultures (BC) are the diagnostic gold standard for candidemia, but sensitivity is <50%. T2 Candida (T2) is a novel, FDA-approved nanodiagnostic panel, which utilizes T2 magnetic resonance and a dedicated instrument to detect Candida within whole blood samples. Methods Candidemic adults were identified at 14 centers by diagnostic BC (dBC). Follow-up blood samples were collected from all patients (pts) for testing by T2 and companion BC (cBC). T2 was run-in batch at a central lab; results are reported qualitatively for three groups of spp. (Candida albicans/C. tropicalis (CA/CT), C. glabrata/C. krusei (CG/CK), or C. parapsilosis (CP)). T2 and cBC were defined as positive (+) if they detected a sp. identified in dBC. Results 152 patients were enrolled (median age: 54 yrs (18–93); 54% (82) men). Candidemia risk factors included indwelling catheters (82%, 125), abdominal surgery (24%, 36), transplant (22%, 33), cancer (22%, 33), hemodialysis (17%, 26), neutropenia (10%, 15). Mean times to Candida detection/spp. identification by dBC were 47/133 hours (2/5.5 d). dBC revealed CA (30%, 46), CG (29%, 45), CP (28%, 43), CT (11%, 17) and CK (3%, 4). Mean time to collection of T2/cBC was 62 hours (2.6 d). 74% (112) of patients received antifungal (AF) therapy prior to T2/cBC (mean: 55 hours (2.3 d)). Overall, T2 results were more likely than cBC to be + (P < 0.0001; Table), a result driven by performance in AF-treated patients (P < 0.0001). T2 was more likely to be + among patients originally infected with CA (61% (28) vs. 20% (9); P = 0.001); there were trends toward higher positivity in patients infected with CT (59% (17) vs. 23% (4; P = 0.08) and CP (42% (18) vs. 28% (12); P = 0.26). T2 was + in 89% (32/36) of patients with + cBC. Conclusion T2 was sensitive for diagnosing candidemia at the time of + cBC, and it was significantly more like to be + than cBC among AF-treated patients. T2 is an important advance in the diagnosis of candidemia, which is likely to be particularly useful in patients receiving prophylactic, pre-emptive or empiric AF therapy. Test results, n (%) Pt group (n) T2+ T2- cBC+ cBC- T2+/cBC+ T2+/cBC- T2-/cBC+ T2-/cBC- All (152) 69 
(45%) 83 
(55%) 36 
(24%) 116 
(76%) 32 
(21%) 37 
(24%) 4 
(3%) 79 
(52%) Prior AF (112) 55 
(49%) 57 
(51%) 23 
(20%) 89 
(80%) 20 
(18%) 35 
(31%) 3 
(3%) 54 
(48%) No AF (40) 14 
(35%) 26 
(65%) 13 
(32%) 27 
(68%) 12 
(30%) 2 
(5%) 1 
(2%) 25 
(62%) Disclosure D. P. Kontoyiannis, Pfizer: Research Contractor, Research support and Speaker honorarium; Astellas: Research Contractor, Research support and Speaker honorarium; Merck: Honorarium, Speaker honorarium; Cidara: Honorarium, Speaker honorarium; Amplyx: Honorarium, Speaker honorarium; F2G: Honorarium, Speaker honorarium; L. Ostrosky-Zeichner, Astellas: Consultant and Grant Investigator, Consulting fee and Research grant; Merck: Scientific Advisor and Speaker’s Bureau, Consulting fee and Speaker honorarium; Pfizer: Grant Investigator and Speaker’s Bureau, Grant recipient and Speaker honorarium; Scynexis: Grant Investigator and Scientific Advisor, Consulting fee and Grant recipient; Cidara: Grant Investigator and Scientific Advisor, Consulting fee and Research grant; S. Apewokin, T2 biosystems: Investigator, Research support; Astellas: Scientific Advisor, Consulting fee

Research and test facilities

NASA Technical Reports Server (NTRS)

1993-01-01

A description is given of each of the following Langley research and test facilities: 0.3-Meter Transonic Cryogenic Tunnel, 7-by 10-Foot High Speed Tunnel, 8-Foot Transonic Pressure Tunnel, 13-Inch Magnetic Suspension & Balance System, 14-by 22-Foot Subsonic Tunnel, 16-Foot Transonic Tunnel, 16-by 24-Inch Water Tunnel, 20-Foot Vertical Spin Tunnel, 30-by 60-Foot Wind Tunnel, Advanced Civil Transport Simulator (ACTS), Advanced Technology Research Laboratory, Aerospace Controls Research Laboratory (ACRL), Aerothermal Loads Complex, Aircraft Landing Dynamics Facility (ALDF), Avionics Integration Research Laboratory, Basic Aerodynamics Research Tunnel (BART), Compact Range Test Facility, Differential Maneuvering Simulator (DMS), Enhanced/Synthetic Vision & Spatial Displays Laboratory, Experimental Test Range (ETR) Flight Research Facility, General Aviation Simulator (GAS), High Intensity Radiated Fields Facility, Human Engineering Methods Laboratory, Hypersonic Facilities Complex, Impact Dynamics Research Facility, Jet Noise Laboratory & Anechoic Jet Facility, Light Alloy Laboratory, Low Frequency Antenna Test Facility, Low Turbulence Pressure Tunnel, Mechanics of Metals Laboratory, National Transonic Facility (NTF), NDE Research Laboratory, Polymers & Composites Laboratory, Pyrotechnic Test Facility, Quiet Flow Facility, Robotics Facilities, Scientific Visualization System, Scramjet Test Complex, Space Materials Research Laboratory, Space Simulation & Environmental Test Complex, Structural Dynamics Research Laboratory, Structural Dynamics Test Beds, Structures & Materials Research Laboratory, Supersonic Low Disturbance Pilot Tunnel, Thermal Acoustic Fatigue Apparatus (TAFA), Transonic Dynamics Tunnel (TDT), Transport Systems Research Vehicle, Unitary Plan Wind Tunnel, and the Visual Motion Simulator (VMS).

US Army Research Laboratory and University of Notre Dame Distributed Sensing: Hardware Overview

DTIC Science & Technology

2017-11-01

ARL-TR-8199 ● NOV 2017 US Army Research Laboratory US Army Research Laboratory and University of Notre Dame Distributed Sensing...US Army Research Laboratory US Army Research Laboratory and University of Notre Dame Distributed Sensing: Hardware Overview by Roger P...TITLE AND SUBTITLE US Army Research Laboratory and University of Notre Dame Distributed Sensing: Hardware Overview 5a. CONTRACT NUMBER 5b. GRANT

Oxytocin and Vasopressin Agonists and Antagonists as Research Tools and Potential Therapeutics

PubMed Central

Manning, M; Misicka, A; Olma, A; Bankowski, K; Stoev, S; Chini, B; Durroux, T; Mouillac, B; Corbani, M; Guillon, G

2012-01-01

We recently reviewed the status of peptide and nonpeptide agonists and antagonists for the V1a, V1b and V2 receptors for arginine vasopressin (AVP) and the oxytocin receptor for oxytocin (OT). In the present review, we update the status of peptides and nonpeptides as: (i) research tools and (ii) therapeutic agents. We also present our recent findings on the design of fluorescent ligands for V1b receptor localisation and for OT receptor dimerisation. We note the exciting discoveries regarding two novel naturally occurring analogues of OT. Recent reports of a selective VP V1a agonist and a selective OT agonist point to the continued therapeutic potential of peptides in this field. To date, only two nonpeptides, the V2/V1a antagonist, conivaptan and the V2 antagonist tolvaptan have received Food and Drug Administration approval for clinical use. The development of nonpeptide AVP V1a, V1b and V2 antagonists and OT agonists and antagonists has recently been abandoned by Merck, Sanofi and Pfizer. A promising OT antagonist, Retosiban, developed at Glaxo SmithKline is currently in a Phase II clinical trial for the prevention of premature labour. A number of the nonpeptide ligands that were not successful in clinical trials are proving to be valuable as research tools. Peptide agonists and antagonists continue to be very widely used as research tools in this field. In this regard, we present receptor data on some of the most widely used peptide and nonpeptide ligands, as a guide for their use, especially with regard to receptor selectivity and species differences. PMID:22375852

Discovery of novel biomarkers and phenotypes by semantic technologies

PubMed Central

2013-01-01

Background Biomarkers and target-specific phenotypes are important to targeted drug design and individualized medicine, thus constituting an important aspect of modern pharmaceutical research and development. More and more, the discovery of relevant biomarkers is aided by in silico techniques based on applying data mining and computational chemistry on large molecular databases. However, there is an even larger source of valuable information available that can potentially be tapped for such discoveries: repositories constituted by research documents. Results This paper reports on a pilot experiment to discover potential novel biomarkers and phenotypes for diabetes and obesity by self-organized text mining of about 120,000 PubMed abstracts, public clinical trial summaries, and internal Merck research documents. These documents were directly analyzed by the InfoCodex semantic engine, without prior human manipulations such as parsing. Recall and precision against established, but different benchmarks lie in ranges up to 30% and 50% respectively. Retrieval of known entities missed by other traditional approaches could be demonstrated. Finally, the InfoCodex semantic engine was shown to discover new diabetes and obesity biomarkers and phenotypes. Amongst these were many interesting candidates with a high potential, although noticeable noise (uninteresting or obvious terms) was generated. Conclusions The reported approach of employing autonomous self-organising semantic engines to aid biomarker discovery, supplemented by appropriate manual curation processes, shows promise and has potential to impact, conservatively, a faster alternative to vocabulary processes dependent on humans having to read and analyze all the texts. More optimistically, it could impact pharmaceutical research, for example to shorten time-to-market of novel drugs, or speed up early recognition of dead ends and adverse reactions. PMID:23402646

Goniochromatic and sparkle properties of effect pigmented samples in multidimensional configuration

NASA Astrophysics Data System (ADS)

Höpe, Andreas; Hauer, Kai-Olaf; Teichert, Sven; Hünerhoff, Dirk; Strothkämper, Christian

2015-03-01

The effects of goniochromatism and sparkle are gaining more and more interest for surface refinement applications driven by demanding requirements from such different branches as automotive, cosmetics, printing and packaging industry. The common background and intention in all of these implementations is improvement of the visual appearance of the related commercial products. Goniochromatic materials show strong angular-dependent reflection characteristics and hence a color impression depending on the effective spatial arrangement of illumination and observation relative to the surface of the artifact. Sparkle is a texture related effect giving a surface which is irradiated directionally, like direct sun light, a bright glittering effect, similar to twinkling stars at the night sky. The prototype for this new effect is the Xirallic® pigment of MERCK KGaA, Germany. The same pigment shows in diffuse irradiation, like on a cloudy day, a different visual effect called graininess (coarseness) which appears as a granular structure of the surface. Both effects were studied on especially manufactured samples of a dilution series in pigment concentration and a tonality series with carbon black. The experiments were carried out with the robot-based gonioreflectometer and integrating sphere facilities at Physikalisch-Technische Bundesanstalt (PTB) in multidimensional configurations of directional and diffuse irradiation. The research is part of the European Metrology Research Program (EMRP), which is a metrology-focused program of coordinated Research & Development (R&D) funded by the European Commission and participating countries within the European Association of National Metrology Institutes (EURAMET). More information and updated news concerning the project can be found on the xD-Reflect website http://www.xdreflect.eu/.

Perspectives from Former Executives of the DOD Corporate Research Laboratories

DTIC Science & Technology

2009-03-01

Research Laboratory (NRL) in Washington, DC; and the Air Force Research Laboratory ( AFRL ) in Dayton, Ohio respectively. These individuals are: John Lyons...13 Vincent Russo and the Air Force Research Laboratory The Air Force Research Laboratory ( AFRL ) was activated in 1997. Prior to the creation of... AFRL , the Air Force conducted its research at four major

Student research laboratory for optical engineering

NASA Astrophysics Data System (ADS)

Tolstoba, Nadezhda D.; Saitgalina, Azaliya; Abdula, Polina; Butova, Daria

2015-10-01

Student research laboratory for optical engineering is comfortable place for student's scientific and educational activity. The main ideas of laboratory, process of creation of laboratory and also activity of laboratory are described in this article. At ITMO University in 2013-2014 were formed a lot of research laboratories. SNLO is a student research (scientific) laboratory formed by the Department of Applied and computer optics of the University ITMO (Information Technologies of Mechanics and Optics). Activity of laboratory is career guidance of entrants and students in the field of optical engineering. Student research laboratory for optical engineering is a place where student can work in the interesting and entertaining scientific atmosphere.

2nd Annual Postdoc Research Day: US Army Research Laboratory PosterSymposia and Activities

DTIC Science & Technology

2018-04-12

ARL-SR-0394•APR 2018 US Army Research Laboratory 2nd Annual Postdoc Research Day: US Army Research Laboratory Poster Symposia and Activities by...Do not return it to the originator. ARL-SR-0394•APR 2018 US Army Research Laboratory 2nd Annual Postdoc Research Day: US Army Research Laboratory...Poster Symposia and Activities by Efraín Hernández–Rivera Weapons and Materials Research Directorate, ARL Julia Cline Oak Ridge Institute for Science and

41 CFR 101-25.109 - Laboratory and research equipment.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 41 Public Contracts and Property Management 2 2010-07-01 2010-07-01 true Laboratory and research...-General Policies § 101-25.109 Laboratory and research equipment. (a) This section prescribes controls for use by Federal agencies in managing laboratory and research equipment in Federal laboratories...

41 CFR 101-25.109 - Laboratory and research equipment.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 41 Public Contracts and Property Management 2 2014-07-01 2012-07-01 true Laboratory and research...-General Policies § 101-25.109 Laboratory and research equipment. (a) This section prescribes controls for use by Federal agencies in managing laboratory and research equipment in Federal laboratories...

41 CFR 101-25.109 - Laboratory and research equipment.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 41 Public Contracts and Property Management 2 2012-07-01 2012-07-01 false Laboratory and research...-General Policies § 101-25.109 Laboratory and research equipment. (a) This section prescribes controls for use by Federal agencies in managing laboratory and research equipment in Federal laboratories...

DOE Office of Scientific and Technical Information (OSTI.GOV)

Radman, Ali M

The Division of Natural Sciences and Mathematics is housed in the Wilson-Booker Science Building (WBSB) which previously consisted of six classrooms, a lecture room, three biology laboratories, one physics laboratory, one chemistry laboratory, one research laboratory, and three computer laboratories. However, due to rapid expansion in STEM majors, there was a dire need for more classroom and laboratory space to accommodate this expansion. Further, since the College started integrating research into the curriculum in 2004 in order to keep pace with the national trend in science education, it has become apparent that one small research laboratory that accommodates 10 studentsmore » will not keep pace with the growing needs of the new students interested in research. Therefore , it became imperative to add another research laboratory to augment the existing one. Thus, the new instrumentation/Research Laboratory will provide space for the new equipment and research space for an additional 8 - 10 students. In addition, the new WBSB wing also houses a Biochemisty/Molecular Biology Laboratory, an Organic Chemistry laboratory, an Animal Laboratory, a Seminar Room, two spacious classrooms, and 3 Faculty Offices. The impact of the new facility will be far-reaching.« less

▼ Bezlotoxumab for prevention of recurrence of Clostridium difficile infection.

PubMed

2018-05-01

Clostridium difficile infection is a significant cause of infectious diarrhoea and is associated with considerable morbidity and mortality. 1,2 Management of Clostridium difficile infection often requires treatment with antibiotics (metronidazole, vancomycin or fidaxomicin) alongside supportive care to manage hydration, electrolytes and nutrition. However, the risk of recurrence is approximately 20%. 2 Here, we review the evidence for bezlotoxumab (▼ Zinplava - Merck Sharp & Dohme Limited), a monoclonal antibody licensed for the prevention of recurrence of Clostridium difficile in adults who are at high risk of recurrence. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

TIPdb-3D: the three-dimensional structure database of phytochemicals from Taiwan indigenous plants

PubMed Central

Tung, Chun-Wei; Lin, Ying-Chi; Chang, Hsun-Shuo; Wang, Chia-Chi; Chen, Ih-Sheng; Jheng, Jhao-Liang; Li, Jih-Heng

2014-01-01

The rich indigenous and endemic plants in Taiwan serve as a resourceful bank for biologically active phytochemicals. Based on our TIPdb database curating bioactive phytochemicals from Taiwan indigenous plants, this study presents a three-dimensional (3D) chemical structure database named TIPdb-3D to support the discovery of novel pharmacologically active compounds. The Merck Molecular Force Field (MMFF94) was used to generate 3D structures of phytochemicals in TIPdb. The 3D structures could facilitate the analysis of 3D quantitative structure–activity relationship, the exploration of chemical space and the identification of potential pharmacologically active compounds using protein–ligand docking. Database URL: http://cwtung.kmu.edu.tw/tipdb. PMID:24930145

Resident research associateships. Postdoctoral and senior research awards

NASA Technical Reports Server (NTRS)

1984-01-01

Opportunities for research at Marshall Space Flight Center's Materials and Processes Laboratory, Space Sciences Laboratory, and Systems Dynamics Laboratory are described. Information is provided for applicants desiring designation as a research associate and a list of laboratory directors and research advisors is provided.

US Army Research Laboratory (ARL) Robotics Collaborative Technology Alliance 2014 Capstone Experiment

DTIC Science & Technology

2016-07-01

ARL-TR-7729 ● JULY 2016 US Army Research Laboratory US Army Research Laboratory (ARL) Robotics Collaborative Technology Alliance...TR-7729 ● JULY 2016 US Army Research Laboratory US Army Research Laboratory (ARL) Robotics Collaborative Technology Alliance 2014 Capstone...National Robotics Engineering Center, Pittsburgh, PA Robert Dean, Terence Keegan, and Chip Diberardino General Dynamics Land Systems, Westminster

MIT Lincoln Laboratory Annual Report 2010

DTIC Science & Technology

2010-01-01

Research and Development Center (FFRDC) and a DoD Research and Development Laboratory. The Laboratory conducts research and development pertinent to...year, the Laboratory restruc- tured three divisions to focus research and development in areas that are increasingly important to the nation...the Director 3 Collaborations with MIT campus continue to grow, leveraging the strengths of researchers at both the Laboratory and campus. The

Phillips Laboratory Geophysics Scholar Program

DTIC Science & Technology

1993-09-30

research at Phillips Laboratory . Research sponsored by Air Force Geophysics Laboratory ...Geophysics Laboratory (now the Phillips Laboratory , Geophysics Directorate), United States Air Force for its sponsorship of this research through the Air ...September 1993 Approved for public release; distribution unlimited PHILLIPS LABORATORY Directorate of Geophysics AIR FORCE MATERIEL COMMAND

Air Force Research Laboratory Preparation for Year 2000.

DTIC Science & Technology

1998-10-05

Air Force Research Laboratory , Phillips Research Site , Kirkland Air Force Base, New...Pentagon, Washington, D.C. 20301-1900. The identity of each writer and caller is fully protected. Acronym AFRL Air Force Research Laboratory INSPECTOR...completion of the implementation phase was May 31, 1999. Air Force Research Laboratory . The Air Force Research

Helical Explosive Flux Compression Generator Research at the Air Force Research Laboratory

DTIC Science & Technology

1999-06-01

Air Force Research Laboratory Kirtland AFB...ORGANIZATION NAME(S) AND ADDRESS(ES) Directed Energy Directorate, Air Force Research Laboratory Kirtland AFB, NM 8. PERFORMING ORGANIZATION REPORT...in support of the Air Force Research Laboratory ( AFRL ) explosive pulsed power program. These include circuit codes such as Microcap and

Adaptive Training and Education Research at the US Army Research Laboratory: Bibliography (2016-2017)

DTIC Science & Technology

2018-03-05

Validation suite. Synthetic training environments. Service orientated architecture. Citation: Robson, E., Ray, F., Sinatra, A. M., & Sinatra, A. M. (2017...ARL-SR-0393 ● MAR 2018 US Army Research Laboratory Adaptive Training and Education Research at the US Army Research Laboratory... Training and Education Research at the US Army Research Laboratory: Bibliography (2016–2017) by Robert A Sottilare Human Research and

About the Frederick National Laboratory for Cancer Research | Frederick National Laboratory for Cancer Research

Cancer.gov

The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and currently operated by Leidos Biomedical Research, Inc. The laboratory addresses some of the most urge

Phase I study of pegylated interferon-alpha-2b as an adjuvant therapy in Japanese patients with malignant melanoma.

PubMed

Yamazaki, Naoya; Uhara, Hisashi; Wada, Hidefumi; Matsuda, Kenji; Yamamoto, Keiko; Shimamoto, Takashi; Kiyohara, Yoshio

2016-10-01

In the adjuvant setting for malignant melanoma, interferon (IFN)-α-2b and pegylated (PEG) IFN-α-2b were approved in several countries including the USA before these were approved in Japan. To resolve the "drug-lag" issue, this phase I study was designed to evaluate the safety and tolerability in Japanese patients with stage II or III malignant melanoma who had undergone surgery, by treating with PEG IFN-α-2b. As with a previously reported phase III study, patients were to receive PEG IFN-α-2b 6 μg/kg per week s.c. during an 8-week induction phase, followed by a maintenance phase at a dose of 3 μg/kg per week up to 5 years. Dose-limiting toxicity and pharmacokinetics were assessed during the initial 8 weeks. Of the nine patients enrolled, two patients had dose-limiting toxicities that resolved after discontinuation of treatment. The most frequently reported drug-related adverse events (DRAE) included pyrexia, decreased neutrophil and white blood cell counts, and arthralgia. Grade 3 DRAE included decreased neutrophil count. No deaths, serious adverse events and grade 4 adverse events were reported. Distant metastasis occurred in one patient. No apparent differences in area under the concentration-time curve and maximum observed serum concentration were observed between Japanese and historical non-Japanese pharmacokinetic data, suggesting no marked racial differences. No neutralizing antibody was detected in these patient samples. PEG IFN-α-2b was tolerated in Japanese patients, and eventually approved in Japan in May 2015 for adjuvant therapy in patients with stage III malignant melanoma. Because the number of patients was limited, further investigation would be crucial. © 2016 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. The Journal of Dermatology published by John Wiley & Sons Australia, Ltd on behalf of Japanese Dermatological Association.

The Recipe for Corporate Longevity: From the Perspective of "Managing Innovation".

PubMed

Griesar, Klaus; Bessant, John; Bernschneider-Reif, Sabine

2018-04-09

The elephant is in the room-a metaphorical idiom for an obvious problem or risk that nobody wants to discuss. This abstract is not intended to be a summary, to reveal major findings, or unveil conclusions. On the contrary, it is aimed to provoke curiosity as to the question of corporate survival. Is there any recipe to be followed for companies to achieve this? The answer comes neither from the modest and traditional study rooms of philosophers nor the recent fact-based studies from the offices (and well-paid opinions) of business consultants. The Archimedean point from which we can objectively explore the subject of corporate survival does not exist. Instead we offer seven analogies (or metaphors) as intellectual platforms where new perspectives can be considered. Innovation obviously plays a major role in corporate survival-yet, by its nature all innovation is messy. In order to reduce entropy, this abstract reveals some keywords in alphabetical order starting from A, such as ambidexterity, architecture, and ant colonies, moving on to B, such as, (mental) boxes and biodiversity. For obvious reasons, C plays a major role-sufficiently that we have already revealed curiosity as one part of the answer-treading over to D (Darwin, DNA, and discontinuity), followed by E (earthquakes and evolution). As a final warning signal in order to manage the expectation: It is not the intention of this article to give a comprehensive overview about the rich and complex history of Merck KGaA, Darmstadt, Germany. Indeed, only the final chapter will provide reference to this company: Before the curtains will finally close, an epilogue will start in which one of the protagonists of the 350-year journey of the company-Emanuel Merck-will appear on the stage and "let history speak for itself". Still curious? © 2018 Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim.

Sequential Treatment Initiation with Timothy Grass and Ragweed Sublingual Immunotherapy Tablets Followed by Simultaneous Treatment Is Well Tolerated.

PubMed

Maloney, Jennifer; Berman, Gary; Gagnon, Remi; Bernstein, David I; Nelson, Harold S; Kleine-Tebbe, Jörg; Kaur, Amarjot; Li, Qing; Nolte, Hendrik

2016-01-01

Dual treatment with grass and ragweed sublingual immunotherapy (SLIT) tablets has not been studied. To characterize the safety and tolerability of dual grass and ragweed SLIT-tablet administration. This open-label, multicenter trial (NCT02256553) enrolled North American adults (N = 102) allergic to grass and ragweed. The trial had 3 periods, each of 2 weeks duration. In period 1, subjects received once-daily timothy grass SLIT tablet (2800 bioequivalent allergen unit; Merck, Inc, Kenilworth, NJ/ALK, Hørsholm, Denmark). In period 2, subjects received a short ragweed SLIT tablet (12 Ambrosia artemisiifolia 1-U; Merck/ALK) every morning and a grass SLIT tablet every evening. In period 3, subjects received once-daily grass and ragweed SLIT tablets within 5 minutes (simultaneous intake). The primary end point was the proportion of subjects with 1 or more local swelling events in each period. Secondary end points were the proportion of subjects with 1 or more local adverse events (AEs), that discontinued the treatment because of AEs, and subjects with 1 or more local AEs requiring treatment. No severe swellings, systemic allergic reactions, asthma attacks, or reactions requiring epinephrine were reported. Most (99%) AEs were graded mild to moderate. The proportions of subjects with 1 or more local swelling events were 14%, 22%, and 15% for periods 1, 2, and 3, respectively. For periods 1, 2, and 3, the proportions of subjects with 1 or more local AEs were 71%, 69%, and 56%, respectively; the proportions discontinuing the treatment because of treatment-related AEs were 5%, 1%, and 2%, and the proportions with 1 or more local AEs requiring treatment were 4%, 4%, and 1%. In this trial, a 4-week sequential SLIT-tablet dosing schedule followed by simultaneous intake of timothy grass and ragweed tablets was well tolerated. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

USAF Summer Research Program - 1994 Graduate Student Research Program Final Reports, Volume 8, Phillips Laboratory

DTIC Science & Technology

1994-12-01

Research Group at the Phillips Laboratory at Kirtland Air Force Base...for Summer Graduate Student Research Program Phillips Laboratory Sponsored by: Air Force Office of Scientific Research Boiling Air Force Base, DC...2390 S. York Street Denver, CO 80208-0177 Final Report for: Summer Faculty Research Program Phillips Laboratory Sponsored by: Air Force

US Army Research Laboratory and University of Notre Dame Distributed Sensing: Software Overview

DTIC Science & Technology

2017-09-01

ARL-TN-0847 ● Sep 2017 US Army Research Laboratory US Army Research Laboratory and University of Notre Dame Distributed Sensing...Destroy this report when it is no longer needed. Do not return it to the originator. ARL-TN-0847 ● Sep 2017 US Army Research Laboratory...US Army Research Laboratory and University of Notre Dame Distributed Sensing: Software Overview by Neal Tesny Sensors and Electron Devices

Science and Technology: The Making of the Air Force Research Laboratory

DTIC Science & Technology

2000-01-01

AFRL . . . . . . . . . . . 187 11 Air Force Research Laboratory : Before and After...United States Air Force during my tenure as chief of staff—the crea - tion of the Air Force Research Laboratory ( AFRL ). As the “high technology” service...consolidate four existing laboratories into one Air Force Research Laboratory ( AFRL ) designed to lead to a more efficient and streamlined

Network Science Research Laboratory (NSRL) Discrete Event Toolkit

DTIC Science & Technology

2016-01-01

ARL-TR-7579 ● JAN 2016 US Army Research Laboratory Network Science Research Laboratory (NSRL) Discrete Event Toolkit by...Laboratory (NSRL) Discrete Event Toolkit by Theron Trout and Andrew J Toth Computational and Information Sciences Directorate, ARL...Research Laboratory (NSRL) Discrete Event Toolkit 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S) Theron Trout

Using the crowd as an innovation partner.

PubMed

Boudreau, Kevin J; Lakhani, Karim R

2013-04-01

From Apple to Merck to Wikipedia, more and more organizations are turning to crowds for help in solving their most vexing innovation and research questions, but managers remain understandably cautious. It seems risky and even unnatural to push problems out to vast groups of strangers distributed around the world, particularly for companies built on a history of internal innovation. How can intellectual property be protected? How can a crowd-sourced solution be integrated into corporate operations? What about the costs? These concerns are all reasonable, the authors write, but excluding crowdsourcing from the corporate innovation tool kit means losing an opportunity. After a decade of study, they have identified when crowds tend to outperform internal organizations (or not). They outline four ways to tap into crowd-powered problem solving--contests, collaborative communities, complementors, and labor markets--and offer a system for picking the best one in a given situation. Contests, for example, are suited to highly challenging technical, analytical, and scientific problems; design problems; and creative or aesthetic projects. They are akin to running a series of independent experiments that generate multiple solutions--and if those solutions cluster at some extreme, a company can gain insight into where a problem's "technical frontier" lies. (Internal R&D may generate far less information.)

Air Force Research Laboratory Sensors Directorate Leadership Legacy, 1960-2011

DTIC Science & Technology

2011-03-01

AFRL -RY-WP-TM-2011-1017 AIR FORCE RESEARCH LABORATORY SENSORS DIRECTORATE LEADERSHIP LEGACY, 1960-2011 Compiled by Raymond C. Rang...Structures Divi- sion, Space Vehicles Directorate, Air Force Research Laboratory , Kirtland AFB, N.M. 7. March 1998 - July 1999, Chief, Integration and... Research Laboratory ( AFRL ), and Deputy Director of the Sensors Direc- torate, Air Force Research

Summer Research Program (1992). Graduate Student Research Program (GSRP) Reports. Volume 8. Phillips Laboratory.

DTIC Science & Technology

1992-12-28

Research Program Starfire Optical Range, Phillips Laboratory /LITE Kirtland Air Force Base, Albuquerque, NM 87117 Sponsored by: Air ... Phillips Laboratory Sponsored by: Air Force Office of Scientific Research Kirtland Air Force Base, Albuquerque, New Mexico September, 1992 18-1 PROGRESS...Report for: Summer Research Program Phillips Laboratory Sponsored by: Air

United States Air Force Summer Research Program -- 1993. Volume 8. Phillips Laboratory

DTIC Science & Technology

1993-12-01

Research Program Phillips Laboratory Kirtland Air Force Base Albuquerque. New Mexico Sponsored by...Best Available Copy UNITED STATES AIR FORCE SUMMER RESEARCH PROGRAM -- 1993 SUMMER RESEARCH PROGRAM FINAL REPORTS VOLUME 8 PHILLIPS LABORATORY ...Alabama Box 870344 Tuscaloosa, AL 35487-0344 Final Report for: Graduate Student Research Program Phillips Laboratory , Hanscom AFB Sponsored by: Air

United States Air Force Summer Research Program -- 1992 High School Apprenticeship Program (HSAP) Reports. Volume 13. Phillips Laboratory

DTIC Science & Technology

1992-01-01

Research Program Phillips Laboratory I4oJ A*6Iv4 Sponsored by: Air Force Office of Scientific Research Kirtland Air ...UNITED STATES AIR FORCE SUMMER RESEARCH PROGki"A -- 1992 HIGH SCHOOL APPRENTICESHIP PROGRAM (HSAP) REPORTS VOLUME 13 (t PHILLIPS LABORATORY . RESEARCH ...Arlington High School Final Report for: Summer Research Program Geophysics Directorate Phillips Laboratory

Entrance to the NACA's Flight Propulsion Research Laboratory

NASA Image and Video Library

1948-08-21

The sign near the entrance of the National Advisory Committee for Aeronautics (NACA) Flight Propulsion Research Laboratory. The name was changed several weeks later to the Lewis Flight Propulsion Laboratory in honor of the NACA’s former Director of Aeronautical Research, George W. Lewis. The research laboratory has had five different names since its inception in 1941. The Cleveland laboratory was originally known as the NACA Aircraft Engine Research Laboratory. In 1947 it was renamed the NACA Flight Propulsion Research Laboratory to reflect the expansion of the research activities beyond just engines. Following the death of George Lewis, the name was changed to the NACA Lewis Flight Propulsion Laboratory in September 1948. On October 1, 1958, the lab was incorporated into the new NASA space agency, and it was renamed the NASA Lewis Research Center. Following John Glenn’s flight on the space shuttle, the name was changed again to the NASA Glenn Research Center on March 1, 1999. From his office in Washington DC, George Lewis managed the aeronautical research conducted at the NACA for over 20 years. His most important accomplishment, however, may have been an investigative tour of German research facilities in the fall of 1936. The visit resulted in the broadening of the scope of the NACA’s research and the physical expansion that included the new engine laboratory in Cleveland.

41 CFR 101-25.109 - Laboratory and research equipment.

Code of Federal Regulations, 2011 CFR

2011-07-01

... equipped and/or used for scientific research, testing, or analysis, except clinical laboratories operating... 41 Public Contracts and Property Management 2 2011-07-01 2007-07-01 true Laboratory and research...-General Policies § 101-25.109 Laboratory and research equipment. (a) This section prescribes controls for...

Air Force Research Laboratory’s Focused Long Term Challenges

DTIC Science & Technology

2008-04-01

Air Force Research Laboratory ( AFRL ) mission is to provide support to the Air Force (AF) and the warfighters with... Air Force Research Laboratory’s Focused Long Term Challenges Leo J Rose Munitions Directorate, Air Force Research Laboratory , 101 W Eglin Blvd...This technology vision, which was born in our Air Force Research Laboratory , builds on the Air Force’s traditional kill

Facilities | Argonne National Laboratory

Science.gov Websites

Skip to main content Argonne National Laboratory Toggle Navigation Toggle Search Research Facilities Advanced Powertrain Research Facility Center for Transportation Research Distributed Energy Research Center Engine Research Facility Heat Transfer Laboratory Materials Engineering Research Facility

HIV Salvage Therapy Does Not Require Nucleoside Reverse Transcriptase Inhibitors: A Randomized, Controlled Trial.

PubMed

Tashima, Karen T; Smeaton, Laura M; Fichtenbaum, Carl J; Andrade, Adriana; Eron, Joseph J; Gandhi, Rajesh T; Johnson, Victoria A; Klingman, Karin L; Ritz, Justin; Hodder, Sally; Santana, Jorge L; Wilkin, Timothy; Haubrich, Richard H

2015-12-15

Nucleoside reverse transcriptase inhibitors (NRTIs) are often included in antiretroviral regimens in treatment-experienced patients in the absence of data from randomized trials. To compare treatment success between participants who omit versus those who add NRTIs to an optimized antiretroviral regimen of 3 or more agents. Multicenter, randomized, controlled trial. (ClinicalTrials.gov: NCT00537394). Outpatient HIV clinics. Treatment-experienced patients with HIV infection and viral resistance. Open-label optimized regimens (not including NRTIs) were selected on the basis of treatment history and susceptibility testing. Participants were randomly assigned to omit or add NRTIs. The primary efficacy outcome was regimen failure through 48 weeks using a noninferiority margin of 15%. The primary safety outcome was time to initial episode of a severe sign, symptom, or laboratory abnormality before discontinuation of NRTI assignment. 360 participants were randomly assigned, and 93% completed a 48-week visit. The cumulative probability of regimen failure was 29.8% in the omit-NRTIs group versus 25.9% in the add-NRTIs group (difference, 3.2 percentage points [95% CI, -6.1 to 12.5 percentage points]). No significant between-group differences were found in the primary safety end points or the proportion of participants with HIV RNA level less than 50 copies/mL. No deaths occurred in the omit-NRTIs group compared with 7 deaths in the add-NRTIs group. Unblinded study design, and the study may not be applicable to resource-poor settings. Treatment-experienced patients with HIV infection starting a new optimized regimen can safely omit NRTIs without compromising virologic efficacy. Omitting NRTIs will reduce pill burden, cost, and toxicity in this patient population. National Institute of Allergy and Infectious Diseases, Boehringer Ingelheim, Janssen, Merck, ViiV Healthcare, Roche, and Monogram Biosciences (LabCorp).

In Vitro Activity of Oral Antimicrobial Agents against Pathogens Associated with Community-Acquired Upper Respiratory Tract and Urinary Tract Infections: A Five Country Surveillance Study.

PubMed

Biedenbach, Douglas J; Badal, Robert E; Huang, Ming-Yi; Motyl, Mary; Singhal, Puneet K; Kozlov, Roman S; Roman, Arthur Dessi; Marcella, Stephen

2016-06-01

Bacterial infections that cause community-acquired urinary tract infections (CA-UTI) and upper respiratory tract infections (CA-URTI) are most frequently treated empirically. However, an increase in antimicrobial resistance has become a problem when treating outpatients. This study determined the in vitro activities of oral antibiotics among 1501 pathogens from outpatients with CA-UTI and CA-URTI in medical centers during 2012 and 2013 from Argentina, Mexico, Venezuela, Russia, and the Philippines. Minimal inhibitory concentrations (MICs) were determined using broth microdilution and susceptibility defined by Clinical Laboratory Standards Institute (CLSI) and European Committee for Antimicrobial Susceptibility Testing (EUCAST) criteria. Ceftibuten (MIC50, ≤0.25 mg/L) was more potent in vitro compared to other β-lactams against Enterobacteriaceae from CA-UTI. Susceptibility to fluoroquinolones using CLSI criteria varied: Argentina and Mexico (50%), the Philippines (60%), Venezuela (70%), and Russia (80%). Fosfomycin susceptibility was >90% against Enterobacteriaceae in each country. Susceptibility among Enterobacteriaceae to trimethoprim-sulfamethoxazole was 30.6-75.6% and nitrofurantoin susceptibility also varied among the countries and was higher when EUCAST breakpoints were applied (65->90%) compared to CLSI (52-84%). All Haemophilus influenzae isolates from CA-URTI were susceptible to ceftibuten, cefixime, cefpodoxime, and cefuroxime using CLSI breakpoint criteria. EUCAST criteria produced intermediate and resistant MIC values for these oral cephalosporins. Country-specific susceptibility variation for fluoroquinolones, macrolides, and trimethoprim-sulfamethoxazole was observed among Streptococcus pneumoniae and Streptococcus pyogenes from CA-URTI. This study demonstrated that antimicrobial susceptibility patterns varied in the five countries investigated among pathogens from CA-UTI and CA-URTI. Merck & Co. Inc., Kenilworth, New Jersey, USA.

Relevance of studying T cell responses in SIV-infected rhesus macaques

PubMed Central

Valentine, Laura E.; Watkins, David I.

2010-01-01

HIV infection, once established, is never cleared. Rare individuals do, however, control viral replication to low levels. These successful immune responses are primarily linked to certain class I MHC alleles (MHC-I). Because of this association, many AIDS vaccines in development are designed to generate virus-specific CD8+ T cells. The Merck STEP phase 2b efficacy trial of one such vaccine was recently halted, and declared a failure. Thus, basic questions regarding what constitutes an effective T cell response and how such responses could be elicited by vaccination remain open. The best animal model available to explore such issues is simian immunodeficiency virus infection of rhesus macaques, which serves as the primary proving ground for AIDS vaccines. PMID:18964016

TIPdb-3D: the three-dimensional structure database of phytochemicals from Taiwan indigenous plants.

PubMed

Tung, Chun-Wei; Lin, Ying-Chi; Chang, Hsun-Shuo; Wang, Chia-Chi; Chen, Ih-Sheng; Jheng, Jhao-Liang; Li, Jih-Heng

2014-01-01

The rich indigenous and endemic plants in Taiwan serve as a resourceful bank for biologically active phytochemicals. Based on our TIPdb database curating bioactive phytochemicals from Taiwan indigenous plants, this study presents a three-dimensional (3D) chemical structure database named TIPdb-3D to support the discovery of novel pharmacologically active compounds. The Merck Molecular Force Field (MMFF94) was used to generate 3D structures of phytochemicals in TIPdb. The 3D structures could facilitate the analysis of 3D quantitative structure-activity relationship, the exploration of chemical space and the identification of potential pharmacologically active compounds using protein-ligand docking. Database URL: http://cwtung.kmu.edu.tw/tipdb. © The Author(s) 2014. Published by Oxford University Press.

United States Air Force Summer Research Program -- 1993. Volume 13. Phillips Laboratory

DTIC Science & Technology

1993-12-01

Research Kirtland Air Force Base, Albuquerque, NM August 1993 14-1 My Summer Apprenticeship At Kirtland Air Force Base, Phillips Laboratory Andrea Garcia...AFOSR Summer Research Program Phillips Laboratory Sponsored By: Air Force Office of Scientific Research Kirtland Air Force Base, Albuquerque, NM... Phillips Laboratory Sponsored by: Air

United States Air Force Summer Research Program -- 1993. Volume 3. Phillips Laboratory

DTIC Science & Technology

1993-12-01

PHILLIPS LABORATORY KIRTLAND AIR FORCE BASE, NEW MEXICO SPONSORED BY: AIR FORCE OFFICE OF SCIENTIFIC RESEARCH ROLLING AIR FORCE BASE, WASHINGTON ,D.C...Report for. Summer Faculty Research Program at Phillips Laboratory Kirtland Air Force Base Sponsored by: Air Force Offlce of Scientific Research ...Prcgram Phillips Laboratory Kirtland

41 CFR 109-25.109 - Laboratory and research equipment.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 41 Public Contracts and Property Management 3 2010-07-01 2010-07-01 false Laboratory and research... PROCUREMENT 25-GENERAL 25.1-General Policies § 109-25.109 Laboratory and research equipment. The provisions of 41 CFR 101-25.109 and this section apply to laboratory and research equipment in the possession of...

Nanoscience and Technology at the Air Force Research Laboratory (AFRL)

DTIC Science & Technology

2005-05-01

AIR FORCE RESEARCH LABORATORY ( AFRL ) Dr. Richard A. Vaia Dr. Daniel Miracle Dr. Thomas Cruse Air Force Research ...Technology At The Air Force Research Laboratory ( AFRL ) 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S) 5d. PROJECT...98) Prescribed by ANSI Std Z39-18 AFRL NST Overview 2 AIR FORCE RESEARCH LABORATORY VISION We defend

Nanoscience and Technology at the Air Force Research Laboratory (AFRL)

DTIC Science & Technology

2005-02-01

AIR FORCE RESEARCH LABORATORY ( AFRL ) Dr. Richard A. Vaia Dr. Daniel Miracle Dr. Thomas Cruse Air Force Research ...Technology At The Air Force Research Laboratory ( AFRL ) 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S) 5d. PROJECT...98) Prescribed by ANSI Std Z39-18 AFRL NST Overview 2 AIR FORCE RESEARCH LABORATORY VISION We defend

Laboratory Directed Research and Development Program FY2016 Annual Summary of Completed Projects

DOE Office of Scientific and Technical Information (OSTI.GOV)

None, None

ORNL FY 2016 Annual Summary of Laboratory Directed Research and Development Program (LDRD) Completed Projects. The Laboratory Directed Research and Development (LDRD) program at ORNL operates under the authority of DOE Order 413.2C, “Laboratory Directed Research and Development” (October 22, 2015), which establishes DOE’s requirements for the program while providing the Laboratory Director broad flexibility for program implementation. The LDRD program funds are obtained through a charge to all Laboratory programs. ORNL reports its status to DOE in March of each year.

Comparison of microbiological diagnosis of urinary tract infection in young children by routine health service laboratories and a research laboratory: Diagnostic cohort study.

PubMed

Birnie, Kate; Hay, Alastair D; Wootton, Mandy; Howe, Robin; MacGowan, Alasdair; Whiting, Penny; Lawton, Michael; Delaney, Brendan; Downing, Harriet; Dudley, Jan; Hollingworth, William; Lisles, Catherine; Little, Paul; O'Brien, Kathryn; Pickles, Timothy; Rumsby, Kate; Thomas-Jones, Emma; Van der Voort, Judith; Waldron, Cherry-Ann; Harman, Kim; Hood, Kerenza; Butler, Christopher C; Sterne, Jonathan A C

2017-01-01

To compare the validity of diagnosis of urinary tract infection (UTI) through urine culture between samples processed in routine health service laboratories and those processed in a research laboratory. We conducted a prospective diagnostic cohort study in 4808 acutely ill children aged <5 years attending UK primary health care. UTI, defined as pure/predominant growth ≥105 CFU/mL of a uropathogen (the reference standard), was diagnosed at routine health service laboratories and a central research laboratory by culture of urine samples. We calculated areas under the receiver-operator curve (AUC) for UTI predicted by pre-specified symptoms, signs and dipstick test results (the "index test"), separately according to whether samples were obtained by clean catch or nappy (diaper) pads. 251 (5.2%) and 88 (1.8%) children were classified as UTI positive by health service and research laboratories respectively. Agreement between laboratories was moderate (kappa = 0.36; 95% confidence interval [CI] 0.29, 0.43), and better for clean catch (0.54; 0.45, 0.63) than nappy pad samples (0.20; 0.12, 0.28). In clean catch samples, the AUC was lower for health service laboratories (AUC = 0.75; 95% CI 0.69, 0.80) than the research laboratory (0.86; 0.79, 0.92). Values of AUC were lower in nappy pad samples (0.65 [0.61, 0.70] and 0.79 [0.70, 0.88] for health service and research laboratory positivity, respectively) than clean catch samples. The agreement of microbiological diagnosis of UTI comparing routine health service laboratories with a research laboratory was moderate for clean catch samples and poor for nappy pad samples and reliability is lower for nappy pad than for clean catch samples. Positive results from the research laboratory appear more likely to reflect real UTIs than those from routine health service laboratories, many of which (particularly from nappy pad samples) could be due to contamination. Health service laboratories should consider adopting procedures used in the research laboratory for paediatric urine samples. Primary care clinicians should try to obtain clean catch samples, even in very young children.

The Air Force Research Laboratory’s In-Space Propulsion Program

DTIC Science & Technology

2015-02-01

Air Force Research Laboratory (AFMC) AFRL /RQRS 1 Ara...MONITOR’S ACRONYM(S) Air Force Research Laboratory (AFMC) AFRL /RQR 5 Pollux Drive 11. SPONSOR/MONITOR’S REPORT Edwards AFB CA 93524-7048 NUMBER(S) AFRL ...illustrate the rationale behind AFRL’s technology development strategy. INTRODUCTION The Air Force Research Laboratory ( AFRL ) is the technology

Summer Research Program (1992). Summer Faculty Research Program (SFRP) Reports. Volume 3. Phillips Laboratory.

DTIC Science & Technology

1992-12-28

Phillips Laboratory Kirtland Air Force Base NM 87117-6008 Sponsored by: Air Force Office of Scientific Research Bolling Air Force Base...Zindel, D.: 1963, Z. Astrophys. 57, 82. 29-13 FINAL REPORT SUMMER FACULTY RESEARCH PROGRAM AT PHILLIPS LABORATORY KIRTLAND AIR FORCE BASE...Program Phillips Laboratory Sponsored by: Air Force Office of Scientific

MO-DE-207B-11: Reliability of PET/CT Radiomics Features in Functional and Morphological Components of NSCLC Lesions: A Repeatability Analysis in a Prospective Multicenter Cohort

DOE Office of Scientific and Technical Information (OSTI.GOV)

Desseroit, M; EE DACTIM, CHU de Poitiers, Poitiers; Tixier, F

2016-06-15

Purpose: The goal of this study was to evaluate the repeatability of radiomics features (intensity, shape and heterogeneity) in both PET and low-dose CT components of test-retest FDG-PET/CT images in a prospective multicenter cohort of 74 NSCLC patients from ACRIN 6678 and a similar Merck trial. Methods: Seventy-four patients with stage III-IV NCSLC were prospectively included. The primary tumor and up to 3 additional lesions per patient were analyzed. The Fuzzy Locally Adaptive Bayesian algorithm was used to automatically delineate metabolically active volume (MAV) in PET. The 3D SlicerTM software was exploited to delineate anatomical volumes (AV) in CT. Tenmore » intensity first-order features, as well as 26 textural features and four 3D shape descriptors were calculated from tumour volumes in both modalities. The repeatability of each metric was assessed by Bland-Altman analysis. Results: One hundred and five lesions (primary tumors and nodal or distant metastases) were delineated and characterized. The MAV and AV determination had a repeatability of −1.4±11.0% and −1.2±18.7% respectively. Several shape and heterogeneity features were found to be highly or moderately repeatable (e.g., sphericity, co-occurrence entropy or intensity size-zone matrix zone percentage), whereas others were confirmed as unreliable with much higher variability (more than twice that of the corresponding volume determination). Conclusion: Our results in this large multicenter cohort with more than 100 measurements confirm the PET findings in previous studies (with <30 lesions). In addition, our study is the first to explore the repeatability of radiomics features in the low-dose CT component of PET/CT acquisitions (previous studies considered dosimetry CT, CE-CT or CBCT). Several features were identified as reliable in both PET and CT components and could be used to build prognostic models. This work has received a French government support granted to the CominLabs excellence laboratory and managed by the National Research Agency in the “Investing for the Future” program under reference ANR-10-LABX-07-01, and support from the city of Brest.« less

Summer Research Program (1992). Summer Faculty Research Program (SFRP) Reports. Volume 5A. Wright Laboratory

DTIC Science & Technology

1992-12-01

1992 6-~1 SOME RESULTS IN MACIIINE- LEARNING Mike Breen Assistant Professor Department of Mathematics Tennessee Technological Universitv Abstract The...Research Laboratory; Wilford Hall Medical Center 12 High School Apprenticeship Program Reports: Armstrong Laboratory 13 High School Apprenticeship ...Program Reports: Phillips Laboratory 14 High School Apprenticeship Program Reports: Rome Laboratory 15 High School Apprenticeship Program Reports

USAF Summer Research Program - 1993 Graduate Student Research Program Final Reports, Volume 8, Phillips Laboratory

DTIC Science & Technology

1994-12-01

Research Program Phillips Laboratory Kirtland Air Force Base Albuquerque, New Mexico Sponsored by: Air ...Summer Research Program Phillips Laboratory Sponsored by. Air Force Office of Scientific Research Kirtland Air Force Base, Albuquerque, New Mexico...UNITED STATES AIR FORCE SUMMER RESEARCH PROGRAM -- 1993 SUMMER RESEARCH PROGRAM FINAL REPORTS VOLUME 8

Environmental Assessment for Air Force Research Laboratory Space Vehicles Integrated Experiments Division Office Space at Kirtland Air Force Base, Albuquerque, New Mexico

DTIC Science & Technology

2005-06-01

AIR FORCE RESEARCH LABORATORY SPACE VEHICLES INTEGRATED EXPERMENTS DIVISION OFFICE SPACE AT KIRTLAND AIR FORCE ... Kirtland Air Force Base (KAFB). The office building would house the Air Force Research Laboratory Space Vehicles Integrated Experiments Division...ADDRESS(ES) Air Force Research Laboratory ,Space Vehicles Directorate,3550 Aberdeen Ave. SE, Kirtland

AFRL’s Demonstration and Science Experiments (DSX) Mission

DTIC Science & Technology

2009-09-01

Air Force Research Laboratory , Kirtland AFB, Albuquerque, NM...Technology, Lincoln Laboratory , Boston, MA ABSTRACT The Air Force Research Laboratory , Space Vehicles Directorate ( AFRL /RV) has developed the...PERFORMING ORGANIZATION NAME(S) AND ADDRESS(ES) Air Force Research Laboratory ,Space Vehicles Directorate, Kirtland AFB,NM,87117 8.

A 13-Week Research-Based Biochemistry Laboratory Curriculum

ERIC Educational Resources Information Center

Lefurgy, Scott T.; Mundorff, Emily C.

2017-01-01

Here, we present a 13-week research-based biochemistry laboratory curriculum designed to provide the students with the experience of engaging in original research while introducing foundational biochemistry laboratory techniques. The laboratory experience has been developed around the directed evolution of an enzyme chosen by the instructor, with…

Laboratory Animal Facilities. Laboratory Design Notes.

ERIC Educational Resources Information Center

Jonas, Albert M.

1965-01-01

Design of laboratory animal facilities must be functional. Accordingly, the designer should be aware of the complex nature of animal research and specifically the type of animal research which will be conducted in a new facility. The building of animal-care facilities in research institutions requires special knowledge in laboratory animal…

Frederick National Laboratory and Georgetown University Launch Research and Education Collaboration | Frederick National Laboratory for Cancer Research

Cancer.gov

FREDERICK, Md. -- A new collaboration established between Georgetown University and the Frederick National Laboratory for Cancer Research aims to expand both institutions’ research and training missions in the biomedical sciences. Representatives f

A Research-Based Laboratory Course Designed to Strengthen the Research-Teaching Nexus

ERIC Educational Resources Information Center

Parra, Karlett J.; Osgood, Marcy P.; Pappas, Donald L., Jr.

2010-01-01

We describe a 10-week laboratory course of guided research experiments thematically linked by topic, which had an ultimate goal of strengthening the undergraduate research-teaching nexus. This undergraduate laboratory course is a direct extension of faculty research interests. From DNA isolation, characterization, and mutagenesis, to protein…

Our Story | Materials Research Laboratory at UCSB: an NSF MRSEC

Science.gov Websites

this site Materials Research Laboratory at UCSB: an NSF MRSEC logo Materials Research Laboratory at & Workshops Visitor Info Research IRG-1: Magnetic Intermetallic Mesostructures IRG 2: Polymeric Seminars Publications MRL Calendar Facilities Computing Energy Research Facility Microscopy &

Financial Relationships With Industry of Editorial Board Members of the Three Journals of the American Society for Radiation Oncology.

PubMed

Verma, Vivek

2017-10-01

To quantitate financial conflicts of interest (FCOIs) among radiation oncology peer-reviewers, specifically editorial board members of the 3 American Society for Radiation Oncology journals. The public Centers for Medicare and Medicaid Services Open Payments database delineates payments in 3 categories (general payments, research funding, and company ownership). After excluding non-US and non-MDs, names of board members were searched. Values of each FCOI were extracted for 2013 to 2015 and compiled. Of 85 board members, 65 (76%) received any form of payment during the overall period. The majority of delivered payments were general payments: 59 (69%) received at least 1 general payment during these 3 years. In each year, 9 board members (11%) received research funding, and 3 board members (4%) reported company ownership. Over the studied period, all board members received a sum total of $5,387,985; this was composed of $665,801 (12%) in general payments, $3,758,968 (70%) in research funding, and $963,216 (18%) in company ownership. The mean general payment and research funding amounts (all members) were $2,621 and $14,741, respectively. Median (interquartile range) general payments and research funding only in board members receiving payments were $419 ($91-$5072) and $56,250 ($13,345-$200,000), respectively. When assessing general payments according to amount, the vast majority of editorial board members received lower-quantity or no such payments, along with a smaller proportion that received higher-volume payments. The most frequent sources of general payments were Varian, Elekta, and Bristol-Myers Squibb. Merck and Varian were the most frequent funding sources for research payments. In this population, the majority of FCOIs were general payments, but research funding comprised the highest monetary sums. Large-volume FCOIs do not apply to the vast majority of editorial board members, implying that the maintained integrity of academic peer-review is likely not influenced to a large extent by FCOIs. Copyright © 2017 Elsevier Inc. All rights reserved.

Definition of experiments and instruments for a communication/navigation research laboratory. Volume 3: Laboratory descriptions

NASA Technical Reports Server (NTRS)

1972-01-01

The following study objectives are covered: (1) identification of major laboratory equipment; (2) systems and operations analysis in support of the laboratory design; and (3) conceptual design of the comm/nav research laboratory.

Environmental Assessment, Balloon Launch and Landing Operations, Air Force Research Laboratory, Space Vehicles Directorate, Kirtland Air Force Base, New Mexico

DTIC Science & Technology

2012-06-01

Force Research Laboratory , Space Vehicles Directorate ( AFRL /RV) located at Kirtland Air Force Base is preparing an Environmental Assessment (EA) for...United States Air Force Research Laboratory , Space Vehicles Directorate ( AFRL /RV) located at Kirtland Air Force Base is preparing an Environmental...United States Air Force Research Laboratory , Space Vehicles Directorate ( AFRL

Comparison of microbiological diagnosis of urinary tract infection in young children by routine health service laboratories and a research laboratory: Diagnostic cohort study

PubMed Central

Birnie, Kate; Hay, Alastair D.; Wootton, Mandy; Howe, Robin; MacGowan, Alasdair; Whiting, Penny; Lawton, Michael; Delaney, Brendan; Downing, Harriet; Dudley, Jan; Hollingworth, William; Lisles, Catherine; Little, Paul; O’Brien, Kathryn; Pickles, Timothy; Rumsby, Kate; Thomas-Jones, Emma; Van der Voort, Judith; Waldron, Cherry-Ann; Harman, Kim; Hood, Kerenza; Butler, Christopher C.; Sterne, Jonathan A. C.

2017-01-01

Objectives To compare the validity of diagnosis of urinary tract infection (UTI) through urine culture between samples processed in routine health service laboratories and those processed in a research laboratory. Population and methods We conducted a prospective diagnostic cohort study in 4808 acutely ill children aged <5 years attending UK primary health care. UTI, defined as pure/predominant growth ≥105 CFU/mL of a uropathogen (the reference standard), was diagnosed at routine health service laboratories and a central research laboratory by culture of urine samples. We calculated areas under the receiver-operator curve (AUC) for UTI predicted by pre-specified symptoms, signs and dipstick test results (the “index test”), separately according to whether samples were obtained by clean catch or nappy (diaper) pads. Results 251 (5.2%) and 88 (1.8%) children were classified as UTI positive by health service and research laboratories respectively. Agreement between laboratories was moderate (kappa = 0.36; 95% confidence interval [CI] 0.29, 0.43), and better for clean catch (0.54; 0.45, 0.63) than nappy pad samples (0.20; 0.12, 0.28). In clean catch samples, the AUC was lower for health service laboratories (AUC = 0.75; 95% CI 0.69, 0.80) than the research laboratory (0.86; 0.79, 0.92). Values of AUC were lower in nappy pad samples (0.65 [0.61, 0.70] and 0.79 [0.70, 0.88] for health service and research laboratory positivity, respectively) than clean catch samples. Conclusions The agreement of microbiological diagnosis of UTI comparing routine health service laboratories with a research laboratory was moderate for clean catch samples and poor for nappy pad samples and reliability is lower for nappy pad than for clean catch samples. Positive results from the research laboratory appear more likely to reflect real UTIs than those from routine health service laboratories, many of which (particularly from nappy pad samples) could be due to contamination. Health service laboratories should consider adopting procedures used in the research laboratory for paediatric urine samples. Primary care clinicians should try to obtain clean catch samples, even in very young children. PMID:28199403

The role of veterinary research laboratories in the provision of veterinary services.

PubMed

Verwoerd, D W

1998-08-01

Veterinary research laboratories play an essential role in the provision of veterinary services in most countries. These laboratories are the source of new knowledge, innovative ideas and improved technology for the surveillance, prevention and control of animal diseases. In addition, many laboratories provide diagnostic and other services. To ensure the optimal integration of various veterinary activities, administrators must understand the functions and constraints of research laboratories. Therefore, a brief discussion is presented of the following: organisational structures methods for developing research programmes outputs of research scientists and how these are measured the management of quality assurance funding of research. Optimal collaboration can only be attained by understanding the environment in which a research scientist functions and the motivational issues at stake.

USAF Summer Research Program - 1993 Summer Research Extension Program Final Reports, Volume 2, Phillips Laboratory

DTIC Science & Technology

1994-11-01

Research Extension Program Phillips Laboratory Kirtland Air Force Base Sponsored by: Air Force Office of Scientific Research Boiling Air Force Base...Program Phillips Laboratory Sponsored by: Air Force Office of Scientific Research Bolling Air Force Base, Washington, D.C. and Arkansas Tech University...Summer Research Extension Program (SREP) Phillips

32 CFR 555.2 - Applicability.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Experiment Station (WES), the U.S. Army Construction Engineering Research Laboratory (CERL), the U.S. Army Engineer Topographic Laboratories (ETL), the U.S. Army Coastal Engineering Research Center (CERC), the U.S... CEMETERIES CORPS OF ENGINEERS, RESEARCH AND DEVELOPMENT, LABORATORY RESEARCH AND DEVELOPMENT AND TESTS, WORK...

The viability of establishing collaborative, reconfigurable research environments for the Human Performance Research Laboratory at NASA Ames

NASA Technical Reports Server (NTRS)

Clipson, Colin

1994-01-01

This paper will review and summarize research initiatives conducted between 1987 and 1992 at NASA Ames Research Center by a research team from the University of Michigan Architecture Research Laboratory. These research initiatives, funded by a NASA grant NAG2-635, examined the viability of establishing collaborative, reconfigurable research environments for the Human Performance Research Laboratory at NASA Ames in California. Collaborative Research Environments are envisioned as a way of enhancing the work of NASA research teams, optimizing the use of shared resources, and providing superior environments for housing research activities. The Integrated Simulation Project at NASA, Ames Human Performance Research Laboratory is one of the current realizations of this initiative.

Visitor's Guide | Frederick National Laboratory for Cancer Research

Cancer.gov

The Frederick National Laboratory for Cancer Research headquarters are located at the Advanced Technology and Research Facility (ATRF), located at 8560 Progress Drive, Frederick Maryland. Additional offices and laboratories are locatedon the NC

GENETIC INDICATORS IN ENVIRONMENTAL PROTECTION

EPA Science Inventory

University of California, Davis, Bodega Bay Marine Laboratory; US EPA National Exposure Research Laboratory, Molecular Ecology Research Division, Cincinnati, OH; US EPA National Health and Environmental Effects Research Laboratory (NHEERL), Gulf Ecology Division, Gulf Breeze, FL;...

75 FR 53863 - Amendment of Restricted Area R-5113; Socorro, NM

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-02

... using agency of Restricted Area R- 5113, Socorro, NM, to ``U.S. Air Force, Air Force Research Laboratory....S. Air Force, Air Force Research Laboratory.'' This change is required to reflect the change in the... words ``Using Agency. U.S. Air Force, Air Force Research Laboratory.'' Issued in Washington, DC, on...

FRC Compression Heating Experiment (FRCHX) at AFRL

DTIC Science & Technology

2007-06-01

Air Force Research Laboratory ( AFRL ) and Los Alamos National Laboratory (LANL) have been... Air Force Research Laboratory , Directed Energy Directorate, 3550 Aberdeen Avenue SE Kirtland AFB, NM 87117-5776 USA 8. PERFORMING ORGANIZATION REPORT...Matt Domonkos, Don Gale, Bernard Martinez, Jerry Parker, Dale Ralph, Ed Ruden, and Wayne Sommars Air Force Research Laboratory , Directed

United States Air Force Summer Research Program -- 1993. Volume 16. Arnold Engineering Development Center. Frank J. Seiler Research Laboratory. Wilford Hall Medical Center

DTIC Science & Technology

1993-12-01

A I 7f t UNITED STATE AIR FORCE SUMMER RESEARCH PROGRAM -- 1993 SUMMER RESEARCH PROGRAM FINAL REPORTS VOLUME 16 ARNOLD ENGINEERING DEVELOPMENT CENTER...FRANK J. SELLER RESEARCH LABORATORY WILFORD HALL MEDICAL CENTER RESEARCH & DEVELOPMENT LABORATORIES 5800 Uplander Way Culver City, CA 90230-6608...National Rd. Vol-Page No: 15-44 Dist Tecumseh High School 8.4 New Carlisle, OH 45344-0000 Barber, Jason Laboratory: AL/CF 1000 10th St. Vol-Page No

Laboratory Directed Research and Development FY-10 Annual Report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Dena Tomchak

2011-03-01

The FY 2010 Laboratory Directed Research and Development (LDRD) Annual Report is a compendium of the diverse research performed to develop and ensure the INL's technical capabilities can support the future DOE missions and national research priorities. LDRD is essential to the INL -- it provides a means for the laboratory to pursue novel scientific and engineering research in areas that are deemed too basic or risky for programmatic investments. This research enhances technical capabilities at the laboratory, providing scientific and engineering staff with opportunities for skill building and partnership development.

Outcomes of a Research-Driven Laboratory and Literature Course Designed to Enhance Undergraduate Contributions to Original Research

ERIC Educational Resources Information Center

Rasche, Madeline E.

2004-01-01

This work describes outcomes of a research-driven advanced microbiology laboratory and literature research course intended to enhance undergraduate preparation for and contributions to original research. The laboratory section was designed to teach fundamental biochemistry and molecular biology techniques in the context of an original research…

NATIONAL RISK MANAGEMENT RESEARCH LABORATORY - PROVIDING SOLUTIONS FOR A BETTER TOMORROW

EPA Science Inventory

As part of the U.S. Environmental Protection Agency's Office of Research and Development, the National Risk Management Research Laboratory (NRMRL) conducts research into ways to prevent and reduce pollution risks that threaten human health and the environment. The laboratory inve...

Manufacturing Laboratory | Energy Systems Integration Facility | NREL

Science.gov Websites

Manufacturing Laboratory Manufacturing Laboratory Researchers in the Energy Systems Integration Facility's Manufacturing Laboratory develop methods and technologies to scale up renewable energy technology manufacturing capabilities. Photo of researchers and equipment in the Manufacturing Laboratory. Capability Hubs

U.S. Army Aeromedical Research Laboratory Annual Progress Report: FY 84

DTIC Science & Technology

1984-10-01

OFFICE SYMBOL 7a. NAME OF MONITORING ORGANIZATION U.S. Army Aeromedical Research (if applicable) U.S. Army Medical Research and Developmmt Laboratory...Group for Aerospace Research and Develop- ment--Aerospace Medical Panel ......................... 105 American National Standards Institute (ANSI...aviation specialities. Assists other US Army Medical Research and Development Command (USAMRDC) laboratories and institutes in research on the

The case for vaccinating boys against human papillomavirus.

PubMed

Hull, Sarah C; Caplan, Arthur L

2009-01-01

Vaccination policy in the case of human papillomavirus (HPV) has remained a constant source of controversy ever since Gardasil, Merck's vaccine against HPV, received US Food and Drug Administration approval in the summer of 2006. This controversy has centered on the risks and benefits of vaccinating girls and women in rich and poor nations alike. However, despite all of the attention created by this important policy question, relatively little has been focused on another key public health question: should boys be vaccinated against HPV as well? If herd immunity against the most carcinogenic strains of HPV could be more rapidly and efficiently achieved by vaccinating everyone at risk for being a carrier, it logically follows that vaccine policy should expand to include boys and men. Copyright 2009 S. Karger AG, Basel.

[Septopal from E. Merck in the prevention and treatment of bone and soft tissue infections].

PubMed

Misterka, S

1992-01-01

On the basis of the many years usage of Gentamycin-Septopal in treatment of blood-derived and traumatic inflammation of bones we can say that in both forms of inflammation fully satisfying results were achieved. In chronic traumatic inflammations of bones with active stomias where the inflammatory process lasted many weeks, and from the purulent matter two or more tribes with various sensitiveness to antibiotics, associated treatment was also used with application of large doses cephalosporin antibiotics of Glaxo-Zinacef of Fortum firms. It should be stressed that in treatment of a patient with that disease correct radioisotopic diagnostic of the focus of inflammation and the evaluation of the immunity state of the organism of the patient, especially during long-lasting disease, is, among others, important.

HPV Vaccination's Second Act: Promotion, Competition, and Compulsion

PubMed Central

2010-01-01

Developments regarding human papillomavirus (HPV) vaccines will transform HPV vaccination in the United States while simultaneously raising several new policy and ethical concerns. Policymakers, vaccine manufacturers, and the public health community must now respond to the presence of competing vaccines that are similar but distinct, particularly with respect to genital wart prevention and the benefits of vaccinating males. This work arises in the shadow of the contentious introduction of the HPV vaccine Gardasil (Merck & Co, Inc, Whitehouse Station, NJ) in 2006, particularly the opposition to efforts in many states to require the vaccine for school attendance. I review the current status of HPV vaccine policy in the United States and examine issues of public health ethics and policy central to ongoing and future HPV vaccination programs. PMID:20724671

Continuous bioprocessing: The real thing this time?

PubMed Central

Farid, Suzanne S; Thompson, Bill; Davidson, Andrew

2014-01-01

The Annual bioProcessUK Conference has acted as the key networking event for bioprocess scientists and engineers in the UK for the past 10 years. The following article is a report from the sessions that focused on continuous bioprocessing during the 10th Annual bioProcessUK Conference (London, December 2013). These sessions were organized by the ‘EPSRC Centre for Innovative Manufacturing in Emergent Macromolecular Therapies’ hosted at University College London. A plenary lecture and workshop provided a forum for participants to debate topical issues in roundtable discussions with industry and academic experts from institutions such as Genzyme, Janssen, Novo Nordisk, Pfizer, Merck, GE Healthcare and University College London. The aim of these particular sessions was to understand better the challenges and opportunities for continuous bioprocessing in the bioprocessing sector. PMID:25484060

AFRL Solid Propellant Laboratory Explosive Siting and Renovation Lessons Learned

DTIC Science & Technology

2010-05-19

AFRL Solid Propellant Laboratory Explosive Siting and Renovation Lessons Learned Daniel F. Schwartz Air Force Research Laboratory ...9. SPONSORING / MONITORING AGENCY NAME(S) AND ADDRESS(ES) 10. SPONSOR/MONITOR’S ACRONYM(S) Air Force Research Laboratory (AFMC) AFRL /RZS...provide the United States Air Force with advanced rocket propulsion technologies, the Air Force Research

STEM Education: Introduction of Quantitative Math and Science Content into Elementary Education, STEM Enrichment Effort in Title One Elementary and Middle Schools in Bay County, Florida

DTIC Science & Technology

2013-06-01

inside pages STINFO COPY AIR FORCE RESEARCH LABORATORY MATERIALS AND MANUFACTURING DIRECTORATE WRIGHT PATTERSON AIR FORCE BASE, OH 45433-7750...Materials and Manufacturing Directorate Materials and Manufacturing Directorate Air Force Research Laboratory Air Force Research Laboratory This... Research Laboratory Materials and Manufacturing Directorate Wright Patterson Air Force Base, OH 45433-7750 Air Force Materiel Command United States

Air Force Research Laboratory, Edwards Air Force Base, CA

DTIC Science & Technology

2011-06-27

Air Force Research Laboratory (AFMC) AFRL /RZS 1 Ara Road Edwards AFB CA 93524-7013 AFRL -RZ-ED-VG-2011-269 9...SPONSORING / MONITORING AGENCY NAME(S) AND ADDRESS(ES) 10. SPONSOR/MONITOR’S ACRONYM(S) Air Force Research Laboratory (AFMC) AFRL /RZS 11. SPONSOR...Form 298 (Rev. 8-98) Prescribed by ANSI Std. 239.18 Air Force Research Laboratory Ed d Ai F B CA Col Mike Platt war s r orce

Artificial intelligence within AFSC

NASA Technical Reports Server (NTRS)

Gersh, Mark A.

1990-01-01

Information on artificial intelligence research in the Air Force Systems Command is given in viewgraph form. Specific research that is being conducted at the Rome Air Development Center, the Space Technology Center, the Human Resources Laboratory, the Armstrong Aerospace Medical Research Laboratory, the Armamant Laboratory, and the Wright Research and Development Center is noted.

Laboratory Directed Research and Development FY2001 Annual Report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Al-Ayat, R

2002-06-20

Established by Congress in 1991, the Laboratory Directed Research and Development (LDRD) Program provides the Department of Energy (DOE)/National Nuclear Security Administration (NNSA) laboratories, like Lawrence Livermore National Laboratory (LLNL or the Laboratory), with the flexibility to invest up to 6% of their budget in long-term, high-risk, and potentially high payoff research and development (R&D) activities to support the DOE/NNSA's national security missions. By funding innovative R&D, the LDRD Program at LLNL develops and extends the Laboratory's intellectual foundations and maintains its vitality as a premier research institution. As proof of the Program's success, many of the research thrusts thatmore » started many years ago under LDRD sponsorship are at the core of today's programs. The LDRD Program, which serves as a proving ground for innovative ideas, is the Laboratory's most important single resource for fostering excellent science and technology for today's needs and tomorrow's challenges. Basic and applied research activities funded by LDRD enhance the Laboratory's core strengths, driving its technical vitality to create new capabilities that enable LLNL to meet DOE/NNSA's national security missions. The Program also plays a key role in building a world-class multidisciplinary workforce by engaging the Laboratory's best researchers, recruiting its future scientists and engineers, and promoting collaborations with all sectors of the larger scientific community.« less

Boston City Hospital and the Thorndike Memorial Laboratory: the birth of modern haematology.

PubMed

Elrod, Jeffrey M; Karnad, Anand B

2003-05-01

Established in 1923, the Thorndike Memorial Laboratory at Boston City Hospital was the first clinical research laboratory in a municipal hospital in the United States of America. Minot and Castle, who were the second and third directors of the Laboratory, were pioneer haematologists and clinical investigators of the highest calibre who created an atmosphere at the Laboratory that would foster patient-centred research and attract the best physician-scientists to work and train there. The haematology research division of the Laboratory made important original contributions to the understanding of the pathophysiology of anaemia, the mechanisms of red cell and platelet destruction and the phagocytic role of the spleen, the nature of haemoglobin (normal and sickle cell), the nature of haemophilia and its therapy and the early classification of lymphoma. It contributed to the Thorndike Memorial Laboratory's worldwide reputation as a model research laboratory and established its reputation as the birthplace of modern haematology.

Open- and closed-formula laboratory animal diets and their importance to research.

PubMed

Barnard, Dennis E; Lewis, Sherry M; Teter, Beverly B; Thigpen, Julius E

2009-11-01

Almost 40 y ago the scientific community was taking actions to control environmental factors that contribute to variation in the responses of laboratory animals to scientific manipulation. Laboratory animal diet was recognized as an important variable. During the 1970s, the American Institute of Nutrition, National Academy of Science, Institute of Laboratory Animal Resources, and Laboratory Animals Centre Diets Advisory Committee supported the use of 'standard reference diets' in biomedical research as a means to improve the ability to replicate research. As a result the AIN76 purified diet was formulated. During this same time, the laboratory animal nutritionist at the NIH was formulating open-formula, natural-ingredient diets to meet the need for standardized laboratory animal diets. Since the development of open-formula diets, fixed-formula and constant-nutrient-concentration closed-formula laboratory animal natural ingredient diets have been introduced to help reduce the potential variation diet can cause in research.

Guidelines for Biosafety Training Programs for Workers Assigned to BSL-3 Research Laboratories.

PubMed

Homer, Lesley C; Alderman, T Scott; Blair, Heather Ann; Brocard, Anne-Sophie; Broussard, Elaine E; Ellis, Robert P; Frerotte, Jay; Low, Eleanor W; McCarthy, Travis R; McCormick, Jessica M; Newton, JeT'Aime M; Rogers, Francine C; Schlimgen, Ryan; Stabenow, Jennifer M; Stedman, Diann; Warfield, Cheryl; Ntiforo, Corrie A; Whetstone, Carol T; Zimmerman, Domenica; Barkley, Emmett

2013-03-01

The Guidelines for Biosafety Training Programs for Workers Assigned to BSL-3 Research Laboratories were developed by biosafety professionals who oversee training programs for the 2 national biocontainment laboratories (NBLs) and the 13 regional biocontainment laboratories (RBLs) that participate in the National Institute of Allergy and Infectious Diseases (NIAID) NBL/RBL Network. These guidelines provide a general training framework for biosafety level 3 (BSL-3) high-containment laboratories, identify key training concepts, and outline training methodologies designed to standardize base knowledge, understanding, and technical competence of laboratory personnel working in high-containment laboratories. Emphasis is placed on building a culture of risk assessment-based safety through competency training designed to enhance understanding and recognition of potential biological hazards as well as methods for controlling these hazards. These guidelines may be of value to other institutions and academic research laboratories that are developing biosafety training programs for BSL-3 research.

Open- and Closed-Formula Laboratory Animal Diets and Their Importance to Research

PubMed Central

Barnard, Dennis E; Lewis, Sherry M; Teter, Beverly B; Thigpen, Julius E

2009-01-01

Almost 40 y ago the scientific community was taking actions to control environmental factors that contribute to variation in the responses of laboratory animals to scientific manipulation. Laboratory animal diet was recognized as an important variable. During the 1970s, the American Institute of Nutrition, National Academy of Science, Institute of Laboratory Animal Resources, and Laboratory Animals Centre Diets Advisory Committee supported the use of ‘standard reference diets’ in biomedical research as a means to improve the ability to replicate research. As a result the AIN76 purified diet was formulated. During this same time, the laboratory animal nutritionist at the NIH was formulating open-formula, natural-ingredient diets to meet the need for standardized laboratory animal diets. Since the development of open-formula diets, fixed-formula and constant-nutrient–concentration closed-formula laboratory animal natural ingredient diets have been introduced to help reduce the potential variation diet can cause in research. PMID:19930817

Sandia National Laboratories: Research: Laboratory Directed Research &

Science.gov Websites

; Technology Defense Systems & Assessments About Defense Systems & Assessments Program Areas Robotics R&D 100 Awards Laboratory Directed Research & Development Technology Deployment Centers Audit Sandia's Economic Impact Licensing & Technology Transfer Browse Technology Portfolios

Laboratory Directed Research and Development FY-15 Annual Report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Pillai, Rekha Sukamar

The Laboratory Directed Research and Development (LDRD) Program at Idaho National Laboratory (INL) reports its status to the U.S. Department of Energy (DOE) by March of each year. The program operates under the authority of DOE Order 413.2B, “Laboratory Directed Research and Development” (April 19, 2006), which establishes DOE’s requirements for the program while providing the laboratory director broad flexibility for program implementation. LDRD funds are obtained through a charge to all INL programs. This report includes summaries of all INL LDRD research activities supported during Fiscal Year (FY) 2015.

Assessment of three medical and research laboratories using WHO AFRO_SLIPTA Quality Standards in Southwestern Uganda: a long way to go.

PubMed

Taremwa, Ivan Mugisha; Ampaire, Lucas; Iramiot, Jacob; Muhwezi, Obed; Matte, Aloysius; Itabangi, Herbert; Mbabazi, Hope; Atwebembeire, Jeninah; Kamwine, Monicah; Katawera, Victoria; Mbalibulha, Yona; Orikiriza, Patrick; Boum, Yap

2017-01-01

While the laboratory represents more than 70% of clinical diagnosis and patient management, access to reliable and quality laboratory diagnostics in sub-Saharan Africa remains a challenge. To gain knowledge and suggest evidence based interventions towards laboratory improvement in Southwestern Uganda, we assessed the baseline laboratory quality standards in three medical and research laboratories in Southwestern Uganda. We conducted a cross sectional survey from October, 2013 to April, 2014. Selected laboratories, including one private research, one private for profit and one public laboratory, were assessed using the WHO AFRO_SLIPTA checklist and baseline scores were determined. The three laboratories assessed met basic facility requirements, had trained personnel, and safety measures in place. Sample reception was properly designed and executed with a well designated chain of custody. All laboratories had sufficient equipment for the nature of work they were involved in. However, we found that standard operating procedures were incomplete in all three laboratories, lack of quality audit schemes by two laboratories and only one laboratory enrolled into external quality assurance schemes. The SLIPTA scores were one star for the research laboratory and no star for both the public and private-for-profit laboratories. While most of the laboratory systems were in place, the low scores obtained by the assessed laboratories reflect the need for improvement to reach standards of quality assured diagnostics in the region. Therefore, routine mentorship and regional supportive supervision are necessary to increase the quality of laboratory services.

Air Force Research Laboratory

DTIC Science & Technology

2009-06-08

Air Force Research Laboratory 8 June 2009 Mr. Leo Marple Ai F R h L b t r orce esearc a ora ory Leo.Marple@wpafb.af.mil DISTRIBUTION STATEMENT A...TITLE AND SUBTITLE Air Force Research Laboratory 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S) 5d. PROJECT NUMBER...5e. TASK NUMBER 5f. WORK UNIT NUMBER 7. PERFORMING ORGANIZATION NAME(S) AND ADDRESS(ES) Air Force Research Laboratory ,Wright

M2 .50-cal. Multishot Capabilities at the US Army Research Laboratory

DTIC Science & Technology

2015-09-01

a platform was designed to simulate the 2-round burst of the M2 .50-caliber Browning machine gun (BMG). The 2-round-burst cyclic rate was achieved...ARL-TN-0694 ● SEP 2015 US Army Research Laboratory M2 .50-cal. Multishot Capabilities at the US Army Research Laboratory by...longer needed. Do not return it to the originator. ARL-TN-0694 ● SEP 2015 US Army Research Laboratory M2 .50-cal. Multishot

Staff Scientist | Center for Cancer Research

Cancer.gov

The scientist will be tasked with independent research projects that support and/or further the scope of our laboratory goals as determined by the Principal Investigator. The scientist will be responsible for overseeing daily operations and coordination of projects in close conjunction with all laboratory personnel. The scientist will participate in teaching laboratory methods to first-time post-docs, research fellows, and students. The scientist will work closely with a full-time research biologist, both in collaboration of research projects and in the lab-critical administrative tasks of IRB-approval, animal protocols, budget, etc. Our laboratory has two post-doctoral researchers at any given time. This is a great opportunity for candidates who are interested in cancer biology and want to grow their research career by working in our program with outstanding support of other established laboratories and core facilities in the National Cancer Institute.

Redefining Authentic Research Experiences in Introductory Biology Laboratories and Barriers to Their Implementation

PubMed Central

Spell, Rachelle M.; Guinan, Judith A.; Miller, Kristen R.; Beck, Christopher W.

2014-01-01

Incorporating authentic research experiences in introductory biology laboratory classes would greatly expand the number of students exposed to the excitement of discovery and the rigor of the scientific process. However, the essential components of an authentic research experience and the barriers to their implementation in laboratory classes are poorly defined. To guide future reform efforts in this area, we conducted a national survey of biology faculty members to determine 1) their definitions of authentic research experiences in laboratory classes, 2) the extent of authentic research experiences currently experienced in their laboratory classes, and 3) the barriers that prevent incorporation of authentic research experiences into these classes. Strikingly, the definitions of authentic research experiences differ among faculty members and tend to emphasize either the scientific process or the discovery of previously unknown data. The low level of authentic research experiences in introductory biology labs suggests that more development and support is needed to increase undergraduate exposure to research experiences. Faculty members did not cite several barriers commonly assumed to impair pedagogical reform; however, their responses suggest that expanded support for development of research experiences in laboratory classes could address the most common barrier. PMID:24591509

Redefining authentic research experiences in introductory biology laboratories and barriers to their implementation.

PubMed

Spell, Rachelle M; Guinan, Judith A; Miller, Kristen R; Beck, Christopher W

2014-01-01

Incorporating authentic research experiences in introductory biology laboratory classes would greatly expand the number of students exposed to the excitement of discovery and the rigor of the scientific process. However, the essential components of an authentic research experience and the barriers to their implementation in laboratory classes are poorly defined. To guide future reform efforts in this area, we conducted a national survey of biology faculty members to determine 1) their definitions of authentic research experiences in laboratory classes, 2) the extent of authentic research experiences currently experienced in their laboratory classes, and 3) the barriers that prevent incorporation of authentic research experiences into these classes. Strikingly, the definitions of authentic research experiences differ among faculty members and tend to emphasize either the scientific process or the discovery of previously unknown data. The low level of authentic research experiences in introductory biology labs suggests that more development and support is needed to increase undergraduate exposure to research experiences. Faculty members did not cite several barriers commonly assumed to impair pedagogical reform; however, their responses suggest that expanded support for development of research experiences in laboratory classes could address the most common barrier.

Drug-like properties and the causes of poor solubility and poor permeability.

PubMed

Lipinski, C A

2000-01-01

There are currently about 10000 drug-like compounds. These are sparsely, rather than uniformly, distributed through chemistry space. True diversity does not exist in experimental combinatorial chemistry screening libraries. Absorption, distribution, metabolism, and excretion (ADME) and chemical reactivity-related toxicity is low, while biological receptor activity is higher dimensional in chemistry space, and this is partly explainable by evolutionary pressures on ADME to deal with endobiotics and exobiotics. ADME is hard to predict for large data sets because current ADME experimental screens are multi-mechanisms, and predictions get worse as more data accumulates. Currently, screening for biological receptor activity precedes or is concurrent with screening for properties related to "drugability." In the future, "drugability" screening may precede biological receptor activity screening. The level of permeability or solubility needed for oral absorption is related to potency. The relative importance of poor solubility and poor permeability towards the problem of poor oral absorption depends on the research approach used for lead generation. A "rational drug design" approach as exemplified by Merck advanced clinical candidates leads to time-dependent higher molecular weight, higher H-bonding properties, unchanged lipophilicity, and, hence, poorer permeability. A high throughput screening (HTS)-based approach as exemplified by unpublished data on Pfizer (Groton, CT) early candidates leads to higher molecular weight, unchanged H-bonding properties, higher lipophilicity, and, hence, poorer aqueous solubility.

USAF/SCEEE Graduate Student Summer Research Program (1984). Program Management Report. Volume 1.

DTIC Science & Technology

1984-10-01

AFRL -TN-87, Air Force . Weapons Laboratory , Kirtland Air Foce...Mexico Research Location: Air Force Weapons Laboratory , NTATT, Kirtland Air Force Base, Albuquerque, NM 87117 .. USAF Research Contact: Dr. Carl E. Baum...Albuquerque, NM 87131 ... Research Location: Air Force Weapons Laboratory Kirtland Air Force Base Albuquerque, New Mexico 87117 USAF

2001 NRL Review

DTIC Science & Technology

2001-01-01

Air Force Research Laboratory , Rome Research Site ( AFRL /RSS) in Rome, New York. The... AFRL ). The Kinetic Kill Vehicle Hardware in the Loop Simulator (KHILS) is managed by the Air Force Research Laboratory Mu- nitions Directorate ( AFRL ...Development Department 2Spacecraft Engineering Department 3Optical Sciences Division 4U.S. Air Force Research Laboratory 5SAIC Introduction:

24. PHOTOCOPY OF PLAN DRAWING. Quartermaster Research and Development Laboratory, ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

24. PHOTOCOPY OF PLAN DRAWING. Quartermaster Research and Development Laboratory, Natick, Mass, Climatic Building, First Floor Plan, Architectural. Drawing No. 35-07-01, Sheet 2 of 72, 1952, updated to 1985. (Source: NRDEC). - Natick Research & Development Laboratories, Climatic Chambers Building, U.S. Army Natick Research, Development & Engineering Center (NRDEC), Natick, Middlesex County, MA

The taming of the prairie: A century of agricultural research at the Northern Great Plains Research Laboratory

USDA-ARS?s Scientific Manuscript database

Nearly a century after Congress authorized the Northern Great Plains Research Laboratory, it had approximately 35 employees and an annual budget of 3.4 million dollars. The long history of research accomplishments from the Laboratory have been well accepted by the agricultural community and have ide...

25. PHOTOCOPY OF PLAN DRAWING. Quartermaster Research and Development Laboratory, ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

25. PHOTOCOPY OF PLAN DRAWING. Quartermaster Research and Development Laboratory, Natick, Mass. Climatic Building, First Floor Plan, Refrigeration and Engineering. Drawing No. 35-07-01, Sheet 52 of 72, 1952. (Source: NRDEC). - Natick Research & Development Laboratories, Climatic Chambers Building, U.S. Army Natick Research, Development & Engineering Center (NRDEC), Natick, Middlesex County, MA

George Lewis Addresses Staff during the Construction of the New Laboratory

NASA Image and Video Library

1942-05-21

Construction Manager Raymond Sharp and the National Advisory Committee for Aeronautics (NACA) Director of Research George Lewis speak to employees during the May 8, 1942, Initiation of Research ceremony at the Aircraft Engine Research Laboratory. The event marked the first operation of a test facility at the new laboratory. The overall laboratory was still under construction, however, and behind schedule. Lewis traveled from his office in Washington, DC every week to personally assess the progress. Drastic measures were undertaken to accelerate the lab’s construction schedule. The military provided special supplies, contractors were given new agreements and pressured to meet deadlines, and Congress approved additional funds. The effort paid off and much of the laboratory was operational in early 1943. George Lewis managed the NACA’s aeronautical research for over 20 years. Lewis joined the NACA as Executive Officer in 1919, and was named Director of Aeronautical Research in 1924. In this role Lewis served as the liaison between the Executive Committee and the research laboratories. His most important accomplishment may have been the investigative tours of the research facilities in Germany in 1936 and 1939. The visits resulted in the NACA’s physical expansion and the broadening of the scope of its research. Lewis did not take a day of leave between the Pearl Harbor attack and the Armistice. He began suffering health problems in 1945 and was forced to retire two years later. The Aircraft Engine Research Laboratory was renamed the NACA Lewis Flight Propulsion Laboratory in September 1948.

Bringing the excitement and motivation of research to students; Using inquiry and research-based learning in a year-long biochemistry laboratory : Part II-research-based laboratory-a semester-long research approach using malate dehydrogenase as a research model.

PubMed

Knutson, Kristopher; Smith, Jennifer; Nichols, Paul; Wallert, Mark A; Provost, Joseph J

2010-09-01

Research-based learning in a teaching environment is an effective way to help bring the excitement and experience of independent bench research to a large number of students. The program described here is the second of a two-semester biochemistry laboratory series. Here, students are empowered to design, execute and analyze their own experiments for the entire semester. This style of laboratory replaces a variety of shorter labs in favor of an in depth research-based learning experience. The concept is to allow students to function in independent research groups. The research projects are focused on a series of wild-type and mutant clones of malate dehydrogenase. A common research theme for the laboratory helps instructors administer the course and is key to delivering a research opportunity to a large number of students. The outcome of this research-based learning laboratory results in students who are much more confident and skilled in critical areas in biochemistry and molecular biology. Students with research experience have significantly higher confidence and motivation than those students without a previous research experience. We have also found that all students performed better in advanced courses and in the workplace. Copyright © 2010 International Union of Biochemistry and Molecular Biology, Inc.

NRCL-70, Review of the Activities of the Laboratories 1970.

ERIC Educational Resources Information Center

National Research Council of Canada, Ottawa (Ontario).

Included are descriptions of activities of each of the 12 laboratories in the National Research Council of Canada, including background information and a summary of the studies (research) and results. The 12 laboratories in the NRCL are the following: Atlantic Regional Laboratory, Biochemistry Laboratory, Division of Biology, Division of Building…

Teaching laboratory neuroscience at bowdoin: the laboratory instructor perspective.

PubMed

Hauptman, Stephen; Curtis, Nancy

2009-01-01

Bowdoin College is a small liberal arts college that offers a comprehensive Neuroscience major. The laboratory experience is an integral part of the major, and many students progress through three stages. A core course offers a survey of concepts and techniques. Four upper-level courses function to give students more intensive laboratory research experience in neurophysiology, molecular neurobiology, social behavior, and learning and memory. Finally, many majors choose to work in the individual research labs of the Neuroscience faculty. We, as laboratory instructors, are vital to the process, and are actively involved in all aspects of the lab-based courses. We provide student instruction in state of the art techniques in neuroscience research. By sharing laboratory teaching responsibilities with course professors, we help to prepare students for careers in laboratory neuroscience and also support and facilitate faculty research programs.

Salmon lice (Lepeophtheirus salmonis) showing varying emamectin benzoate susceptibilities differ in neuronal acetylcholine receptor and GABA-gated chloride channel mRNA expression

PubMed Central

2013-01-01

Background Caligid copepods, also called sea lice, are fish ectoparasites, some species of which cause significant problems in the mariculture of salmon, where the annual cost of infection is in excess of €300 million globally. At present, caligid control on farms is mainly achieved using medicinal treatments. However, the continued use of a restricted number of medicine actives potentially favours the development of drug resistance. Here, we report transcriptional changes in a laboratory strain of the caligid Lepeophtheirus salmonis (Krøyer, 1837) that is moderately (~7-fold) resistant to the avermectin compound emamectin benzoate (EMB), a component of the anti-salmon louse agent SLICE® (Merck Animal Health). Results Suppression subtractive hybridisation (SSH) was used to enrich transcripts differentially expressed between EMB-resistant (PT) and drug-susceptible (S) laboratory strains of L. salmonis. SSH libraries were subjected to 454 sequencing. Further L. salmonis transcript sequences were available as expressed sequence tags (EST) from GenBank. Contiguous sequences were generated from both SSH and EST sequences and annotated. Transcriptional responses in PT and S salmon lice were investigated using custom 15 K oligonucleotide microarrays designed using the above sequence resources. In the absence of EMB exposure, 359 targets differed in transcript abundance between the two strains, these genes being enriched for functions such as calcium ion binding, chitin metabolism and muscle structure. γ-aminobutyric acid (GABA)-gated chloride channel (GABA-Cl) and neuronal acetylcholine receptor (nAChR) subunits showed significantly lower transcript levels in PT lice compared to S lice. Using RT-qPCR, the decrease in mRNA levels was estimated at ~1.4-fold for GABA-Cl and ~2.8-fold for nAChR. Salmon lice from the PT strain showed few transcriptional responses following acute exposure (1 or 3 h) to 200 μg L-1 of EMB, a drug concentration tolerated by PT lice, but toxic for S lice. Conclusions Avermectins are believed to exert their toxicity to invertebrates through interaction with glutamate-gated and GABA-gated chloride channels. Further potential drug targets include other Cys-loop ion channels such as nAChR. The present study demonstrates decreased transcript abundances of GABA-Cl and nAChR subunits in EMB-resistant salmon lice, suggesting their involvement in avermectin toxicity in caligids. PMID:23773482

Salmon lice (Lepeophtheirus salmonis) showing varying emamectin benzoate susceptibilities differ in neuronal acetylcholine receptor and GABA-gated chloride channel mRNA expression.

PubMed

Carmichael, Stephen N; Bron, James E; Taggart, John B; Ireland, Jacqueline H; Bekaert, Michaël; Burgess, Stewart Tg; Skuce, Philip J; Nisbet, Alasdair J; Gharbi, Karim; Sturm, Armin

2013-06-18

Caligid copepods, also called sea lice, are fish ectoparasites, some species of which cause significant problems in the mariculture of salmon, where the annual cost of infection is in excess of €300 million globally. At present, caligid control on farms is mainly achieved using medicinal treatments. However, the continued use of a restricted number of medicine actives potentially favours the development of drug resistance. Here, we report transcriptional changes in a laboratory strain of the caligid Lepeophtheirus salmonis (Krøyer, 1837) that is moderately (~7-fold) resistant to the avermectin compound emamectin benzoate (EMB), a component of the anti-salmon louse agent SLICE® (Merck Animal Health). Suppression subtractive hybridisation (SSH) was used to enrich transcripts differentially expressed between EMB-resistant (PT) and drug-susceptible (S) laboratory strains of L. salmonis. SSH libraries were subjected to 454 sequencing. Further L. salmonis transcript sequences were available as expressed sequence tags (EST) from GenBank. Contiguous sequences were generated from both SSH and EST sequences and annotated. Transcriptional responses in PT and S salmon lice were investigated using custom 15 K oligonucleotide microarrays designed using the above sequence resources. In the absence of EMB exposure, 359 targets differed in transcript abundance between the two strains, these genes being enriched for functions such as calcium ion binding, chitin metabolism and muscle structure. γ-aminobutyric acid (GABA)-gated chloride channel (GABA-Cl) and neuronal acetylcholine receptor (nAChR) subunits showed significantly lower transcript levels in PT lice compared to S lice. Using RT-qPCR, the decrease in mRNA levels was estimated at ~1.4-fold for GABA-Cl and ~2.8-fold for nAChR. Salmon lice from the PT strain showed few transcriptional responses following acute exposure (1 or 3 h) to 200 μg L-1 of EMB, a drug concentration tolerated by PT lice, but toxic for S lice. Avermectins are believed to exert their toxicity to invertebrates through interaction with glutamate-gated and GABA-gated chloride channels. Further potential drug targets include other Cys-loop ion channels such as nAChR. The present study demonstrates decreased transcript abundances of GABA-Cl and nAChR subunits in EMB-resistant salmon lice, suggesting their involvement in avermectin toxicity in caligids.

ORNLs Laboratory Directed Research and Development Program FY 2009 Annual Report

DOE Office of Scientific and Technical Information (OSTI.GOV)

None, None

2010-03-01

The Laboratory Directed Research and Development (LDRD) program at Oak Ridge National Laboratory (ORNL) reports its status to the U.S. Department of Energy (DOE) in March of each year. The program operates under the authority of DOE Order 413.2B, “Laboratory Directed Research and Development” (April 19, 2006), which establishes DOE’s requirements for the program while providing the Laboratory Director broad flexibility for program implementation. LDRD funds are obtained through a charge to all Laboratory programs. This report includes summaries all ORNL LDRD research activities supported during FY 2009. The associated FY 2009 ORNL LDRD Self-Assessment (ORNL/PPA-2010/2) provides financial data andmore » an internal evaluation of the program’s management process.« less

ORNLs Laboratory Directed Research and Development Program FY 2013 Annual Report

DOE Office of Scientific and Technical Information (OSTI.GOV)

None, None

2014-03-01

The Laboratory Directed Research and Development (LDRD) program at Oak Ridge National Laboratory (ORNL) reports its status to the US Department of Energy (DOE) in March of each year. The program operates under the authority of DOE Order 413.2B, “Laboratory Directed Research and Development” (April 19, 2006), which establishes DOE’s requirements for the program while providing the Laboratory Director broad flexibility for program implementation. LDRD funds are obtained through a charge to all Laboratory programs. This report includes summaries of all ORNL LDRD research activities supported during FY 2013. The associated FY 2013 ORNL LDRD Self-Assessment (ORNL/PPA-2014/2) provides financial datamore » and an internal evaluation of the program’s management process.« less

Laboratory Directed Research and Development Program FY 2006 Annual Report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Sjoreen, Terrence P

2007-04-01

The Oak Ridge National Laboratory (ORNL) Laboratory Directed Research and Development (LDRD) Program reports its status to the US Departmental of Energy (DOE) in March of each year. The program operates under the authority of DOE Order 413.2B, 'Laboratory Directed Research and Development' (April 19, 2006), which establishes DOE's requirements for the program while providing the Laboratory Director broad flexibility for program implementation. LDRD funds are obtained through a charge to all Laboratory programs. This report includes summaries all ORNL LDRD research activities supported during FY 2006. The associated FY 2006 ORNL LDRD Self-Assessment (ORNL/PPA-2007/2) provides financial data about themore » FY 2006 projects and an internal evaluation of the program's management process.« less

ORNLs Laboratory Directed Research and Development Program FY 2008 Annual Report

DOE Office of Scientific and Technical Information (OSTI.GOV)

None, None

2009-03-01

The Oak Ridge National Laboratory (ORNL) Laboratory Directed Research and Development (LDRD) Program reports its status to the U.S. Department of Energy (DOE) in March of each year. The program operates under the authority of DOE Order 413.2B, “Laboratory Directed Research and Development” (April 19, 2006), which establishes DOE’s requirements for the program while providing the Laboratory Director broad flexibility for program implementation. LDRD funds are obtained through a charge to all Laboratory programs. This report includes summaries all ORNL LDRD research activities supported during FY 2008. The associated FY 2008 ORNL LDRD Self-Assessment (ORNL/PPA-2008/2) provides financial data and anmore » internal evaluation of the program’s management process.« less

ORNLs Laboratory Directed Research and Development Program FY 2012 Annual Report

DOE Office of Scientific and Technical Information (OSTI.GOV)

None, None

2013-03-01

The Laboratory Directed Research and Development (LDRD) program at Oak Ridge National Laboratory (ORNL) reports its status to the US Department of Energy (DOE) in March of each year. The program operates under the authority of DOE Order 413.2B, “Laboratory Directed Research and Development” (April 19, 2006), which establishes DOE’s requirements for the program while providing the Laboratory Director broad flexibility for program implementation. LDRD funds are obtained through a charge to all Laboratory programs. This report includes summaries of all ORNL LDRD research activities supported during FY 2012. The associated FY 2012 ORNL LDRD Self-Assessment (ORNL/PPA-2012/2) provides financial datamore » and an internal evaluation of the program’s management process.« less

A pocket guide to electronic laboratory notebooks in the academic life sciences

PubMed Central

Dirnagl, Ulrich; Przesdzing, Ingo

2016-01-01

Every professional doing active research in the life sciences is required to keep a laboratory notebook. However, while science has changed dramatically over the last centuries, laboratory notebooks have remained essentially unchanged since pre-modern science. We argue that the implementation of electronic laboratory notebooks (eLN) in academic research is overdue, and we provide researchers and their institutions with the background and practical knowledge to select and initiate the implementation of an eLN in their laboratories. In addition, we present data from surveying biomedical researchers and technicians regarding which hypothetical features and functionalities they hope to see implemented in an eLN, and which ones they regard as less important. We also present data on acceptance and satisfaction of those who have recently switched from paper laboratory notebook to an eLN.  We thus provide answers to the following questions: What does an electronic laboratory notebook afford a biomedical researcher, what does it require, and how should one go about implementing it? PMID:26835004

Blast Overpressure Studies.

DTIC Science & Technology

1998-05-01

Ribera U.S. Army Aeromedical Research Laboratory (205) 255-6913 By signing this form I hereby acknowledge I have fully read and understand the...Army Aeromedical Research Laboratory (334) 255-6821 MAJ John Ribera U.S. Army Aeromedical Research Laboratory (334) 255-6823 By signing this form I

NRMRL SCIENCE PUBLICATIONS (NATIONAL RISK MANAGEMENT RESEARCH LABORATORY, EPA, CINCINNATI, OH)

EPA Science Inventory

The National Risk Management Research Laboratory (NRMRL)is the U.S.EPA's center for investigating technological and management approaches for preventing and reducing risks from pollution that threaten human health and the environment. The focus of the Laboratory's research progra...

Research and Teaching: The Impact of a Four-Step Laboratory Pedagogical Framework on Biology Students' Perceptions of Laboratory Skills, Knowledge, and Interest in Research

ERIC Educational Resources Information Center

McLaughlin, Jacqueline Shea; Favre, David E.; Weinstein, Suzanne E.; Goedhart, Christine M.

2017-01-01

Authentic undergraduate research laboratory experiences are essential to aid in the implementation of science education reform mandates and to effectively train a new generation of biology students. Here we present assessment data on a unique four-step laboratory pedagogical framework that allows students to develop scientific thinking and…

Virtual Special Issue on Catalysis at the U.S. Department of Energy’s National Laboratories

DOE Office of Scientific and Technical Information (OSTI.GOV)

Pruski, Marek; Sadow, Aaron; Slowing, Igor

Catalysis research at the U.S. Department of Energy's (DOE's) National Laboratories covers a wide range of research topics in heterogeneous catalysis, homogeneous/ molecular catalysis, electrocatalysis, and surface science. Since much of the work at National Laboratories is funded by DOE, the research is largely focused on addressing DOE’s mission to ensure America’s security and prosperity by addressing its energy, environmental, and nuclear challenges through trans-formative science and technology solutions. The catalysis research carried out at the DOE National Laboratories ranges from very fundamental catalysis science, funded by DOE’s Office of Basic Energy Sciences (BES), to applied research and development (R&D)more » in areas such as biomass conversion to fuels and chemicals, fuel cells, and vehicle emission control with primary funding from DOE’s Office of Energy Efficiency and Renewable Energy. National Laboratories are home to many DOE Office of Science national scientific user facilities that provide researchers with the most advanced tools of modern science, including accelerators, colliders, supercomputers, light sources, and neutron sources, as well as facilities for studying the nanoworld and the terrestrial environment. National Laboratory research programs typically feature teams of researchers working closely together, often joining scientists from different disciplines to attack scientific and technical problems using a variety of tools and techniques available at the DOE national scientific user facilities. Along with collaboration between National Laboratory scientists, interactions with university colleagues are common in National Laboratory catalysis R&D. In some cases, scientists have joint appoint-ments at a university and a National Laboratory.« less

Virtual Special Issue on Catalysis at the U.S. Department of Energy’s National Laboratories

DOE Office of Scientific and Technical Information (OSTI.GOV)

Pruski, Marek; Sadow, Aaron D.; Slowing, Igor I.

Catalysis research at the U.S. Department of Energy’s (DOE’s) National Laboratories covers a wide range of research topics in heterogeneous catalysis, homogeneous/molecular catalysis, biocatalysis, electrocatalysis, and surface science. Since much of the work at National Laboratories is funded by DOE, the research is largely focused on addressing DOE’s mission to ensure America’s security and prosperity by addressing its energy, environmental, and nuclear challenges through transformative science and technology solutions. The catalysis research carried out at the DOE National Laboratories ranges from very fundamental catalysis science, funded by DOE’s Office of Basic Energy Sciences (BES), to applied research and development (R&D)more » in areas such as biomass conversion to fuels and chemicals, fuel cells, and vehicle emission control with primary funding from DOE’s Office of Energy Efficiency and Renewable Energy. National Laboratories are home to many DOE Office of Science national scientific user facilities that provide researchers with the most advanced tools of modern science, including accelerators, colliders, supercomputers, light sources, and neutron sources, as well as facilities for studying the nanoworld and the terrestrial environment. National Laboratory research programs typically feature teams of researchers working closely together, often joining scientists from different disciplines to tackle scientific and technical problems using a variety of tools and techniques available at the DOE national scientific user facilities. Along with collaboration between National Laboratory scientists, interactions with university colleagues are common in National Laboratory catalysis R&D. In some cases, scientists have joint appointments at a university and a National Laboratory.« less

Monitoring outcomes of pregnancy following drug exposure: a company-based pregnancy registry program.

PubMed

Shields, Kristine E; Wiholm, Bengt-Erik; Hostelley, Linda S; Striano, Linda F; Arena, Sam R; Sharrar, Robert G

2004-01-01

Women who discover they are pregnant after exposure to a drug and pregnant women who have a condition that requires continued treatment during pregnancy are told to balance the benefits and risks of the exposure to justify continuation of treatment, discontinuation of treatment or, possibly, pregnancy termination. However, there are limited data available to inform decision-making. The Merck Pregnancy Registry Program is a company-run pregnancy registry whose objective is to acquire and analyse information on drug exposures and pregnancy outcomes to better describe the safety profile of Merck products used during pregnancy. Information is collected from women and healthcare providers who call to report drug exposure during pregnancy. Prospective pregnancies are followed up to outcome and data are collected via questionnaires, telephone calls and a review of medical records. Reports are classified as prospective (information received prior to knowledge of pregnancy outcome) or retrospective (received after the outcome is known). Congenital anomaly reports are assessed for timing of exposure, maternal age and medical history, biological plausibility and concomitant medication exposures. Rates of pregnancy outcomes and birth defects in the prospective cohort are computed and confidence intervals are calculated to reflect the strength of the finding based on the sample size. Rates of pregnancy outcomes in the Pregnancy Registry are compared with the rates of pregnancy outcomes in the general US population and, if available, in subpopulations with the relevant disease states. The limitations of post-marketing surveillance are well known as voluntary reporting of individuals and healthcare professionals is known to be subject to various types of bias. Small sample size is another major limitation. However, the strength of the registry lies in its ability to gather pregnancy outcome reports early in the life of a product and to recognise and analyse unusual birth defects. Our data suggest that pregnancy registries can be used to review human exposure data in a systematic fashion so that useful information can be shared with women and their healthcare providers. The use of the pregnancy registry design has allowed for the collection and analysis of data on the effects of drug exposures on human pregnancies that have otherwise been difficult to obtain.

FDA Approval Summary: Pembrolizumab for the Treatment of Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma with Disease Progression on or After Platinum‐Containing Chemotherapy

PubMed Central

Blumenthal, Gideon M.; Yuan, Weishi; He, Kun; Sridhara, Rajeshwari; Subramaniam, Sriram; Zhao, Hong; Liu, Chao; Yu, Jingyu; Goldberg, Kirsten B.; McKee, Amy E.; Keegan, Patricia; Pazdur, Richard

2017-01-01

Abstract On August 5, 2016, the U.S. Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA injection, Merck Sharp & Dohme Corp., Kenilworth, NJ) for treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum‐containing chemotherapy. Approval was based on the objective response rate (ORR) and duration of response (DoR) in a cohort of patients in a nonrandomized multi‐cohort trial (KEYNOTE‐012) that included 174 patients with recurrent or metastatic HNSCC who had disease progression on or after platinum‐containing chemotherapy. Patients received either intravenous pembrolizumab 10 mg/kg every 2 weeks or 200 mg every 3 weeks. ORR was determined by independent review according to Response Evaluation Criteria in Solid Tumors 1.1. ORR was 16% (95% confidence interval 11, 22) with a complete response rate of 5%. DoR ranged from 2.4+ months to 27.7+ months. Twenty‐three of 28 responding patients (82%) had response durations of ≥6 months. Safety was evaluated in 192 patients with HNSCC receiving at least one dose of pembrolizumab. Frequent (≥2%) serious adverse reactions were pneumonia, dyspnea, confusional state, vomiting, pleural effusion, and respiratory failure. Clinically significant immune‐mediated adverse reactions included pneumonitis, colitis, hepatitis, adrenal insufficiency, diabetes mellitus, skin toxicity, myositis, and thyroid disorders. The benefit‐risk profile of pembrolizumab was considered acceptable in this patient population. As a condition of accelerated approval, Merck is required to conduct a confirmatory trial; this trial, KEYNOTE‐040, is ongoing. Implications for Practice. This accelerated approval expands the U.S. Food and Drug Administration‐approved indications for pembrolizumab, providing health care providers with new information regarding pembrolizumab for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum‐containing chemotherapy. Pembrolizumab is the first drug to receive approval for treatment of patients with HNSCC since cetuximab was approved for this indication in 2006. PMID:28533473

Bioequivalence study of two losartan tablet formulations with special emphasis on cardiac safety.

PubMed

Khandave, Suhas S; Sawant, Satish V; Sahane, Rakhi V; Murthi, Vivekanand; Dhanure, Shivanand S; Surve, Pradeep G

2012-05-01

To study the bioequivalence of Losartan Potassium Tablets 50 mg manufactured by Micro Labs Ltd. India to Cozaar® Tablets 50 mg, manufactured by Merck Sharp and Dohme Ltd., UK in normal healthy adult subjects under fasting condition along with the comparative safety evaluation of both treatments. The in vitro dissolution studies were carried out on 12 units each of test and reference products using the paddle method and dissolution media like water, 0.1 N hydrochloric acid with pH 1.2, pH 4.5 acetate buffer and pH 6.8 phosphate buffer. An open label, randomized, two-treatment, two-period, two-sequence, crossover bioequivalence study with a washout period of 7 days was conducted in 60 healthy Indian male subjects. Serial blood samples were collected after drug administration in each study period. Plasma concentrations of losartan and losartan acid were determined using a validated LC-MS-MS method. The pharmacokinetic parameters of losartan and losartan acid were determined using a non compartmental model. Occurrence of adverse events, change in systolic blood pressure, diastolic blood pressure, heart rate and QT interval from the baseline to 3.50 h post dose were studied and compared between the two treatments as safety parameters. The in vitro study proved the essential similarity of both the formulations as evident from the similarity factor of > 50% in all the dissolution media. The ratios for geometric least square means and 90% confidence intervals were within the acceptance criteria of 80% to 125% for log transformed C(max), AUC(0-t) and AUC(0-∞) for losartan. No statistically significant difference between the two treatments was observed for either of the safety parameters. The test product Losartan Potassium tablets 50 mg manufactured by Micro Labs Limited, India was bioequivalent to Cozaar® tablets 50 mg, manufactured by Merck Sharp and Dohme Ltd., UK in terms of rate and extent of absorption. Both treatments were well tolerated and had similar non significant effect on the safety parameters.

Report on Research at AFGL July 1976 - December 1978

DTIC Science & Technology

1980-11-01

Research at the Air Force Geophysics Laboratory . This report covers a two-and-one-half... Laboratories (AFCRL). The Air Force redesignated AFCRL to AFGL on January 15, 1976, in order to focus attention and effort into geophysics research and...USAF Commander Contents Th» Air Foro* GMphyalc« Laboratory C rganization and People . . . Annual Budgets . . . Field Sites . . . Research

A Place for Materials Science: Laboratory Buildings and Interdisciplinary Research at the University of Pennsylvania

ERIC Educational Resources Information Center

Choi, Hyungsub; Shields, Brit

2015-01-01

The Laboratory for Research on the Structure of Matter (LRSM), University of Pennsylvania, was built in 1965 as part of the Advanced Research Projects Agency's (ARPA) Interdisciplinary Laboratories (IDL) program intended to foster interdisciplinary research and training in materials science. The process that led to the construction of the…

42 CFR 93.213 - Institution.

Code of Federal Regulations, 2011 CFR

2011-10-01

... STUDIES OF HAZARDOUS SUBSTANCES RELEASES AND FACILITIES PUBLIC HEALTH SERVICE POLICIES ON RESEARCH... research, biomedical or behavioral research training, or activities related to that research or training... research laboratories, research and development centers, national user facilities, industrial laboratories...

Laboratory Tests

MedlinePlus

... PI CONNECT Research Network USIDNET Patient Registry IDF Survey Research IDF Surveys National Health Insurance Surveys Clinical Trials ... and Fellows Research USIDNET IDF Research Fund IDF Survey Research IDF Surveys Contact Us Search form Search Laboratory ...

Frederick National Laboratory, National Cancer Institute of Mexico to Offer Training Fellowships | Frederick National Laboratory for Cancer Research

Cancer.gov

FREDERICK, Md. -- The Frederick National Laboratory for Cancer Research will extend its scientific mentoring across international borders for the first time by offering postdoctoral research fellowships to scientists under an agreement with the Nati

Guided-inquiry based laboratory instruction: Investigation of critical thinking skills, problem solving skills, and implementing student roles in chemistry

NASA Astrophysics Data System (ADS)

Gupta, Tanya

Recent initiatives in the laboratory curriculum have encouraged an inquiry-based approach to learning and teaching in the laboratory. It has been argued that laboratory instruction should not just be hands-on, but it should portray the essence of inquiry through the process of experiential learning and reflective engagement in collaboration with peers and in facilitation by the instructor. A student-centered active learning approach may be an effective way to enhance student understanding of concepts in the laboratory. The dissertation research work explores the impact of laboratory instruction and its relevance for college-level chemistry. Each chapter is different from the preceding chapter in terms of the purpose of the study and the research questions asked. However, the overarching idea is to address the importance of guided-inquiry based laboratory instruction in chemistry and its relevance in helping students to make connections with the chemistry content and in imparting skills to students. Such skills include problem solving, collaborative group work and critical thinking. The first research study (Chapter 2) concerns the impact of first year co-requisite general chemistry laboratory instruction on the problem-solving skills of students. The second research study (Chapter 3) examines the impact of implementing student roles also known as Student-Led Instructor Facilitated Guided-Inquiry based Laboratories, SLIFGIL) by modifying the Science Writing Heuristic approach of laboratory instruction. In the third research study (Chapter 4), critical thinking skills of first semester general chemistry laboratory students were compared to advanced (third or fourth year) chemistry laboratory students based on the analysis of their laboratory reports.

Catalog of Research Abstracts, 1993: Partnership opportunities at Lawrence Berkeley Laboratory

DOE Office of Scientific and Technical Information (OSTI.GOV)

Not Available

1993-09-01

The 1993 edition of Lawrence Berkeley Laboratory`s Catalog of Research Abstracts is a comprehensive listing of ongoing research projects in LBL`s ten research divisions. Lawrence Berkeley Laboratory (LBL) is a major multi-program national laboratory managed by the University of California for the US Department of Energy (DOE). LBL has more than 3000 employees, including over 1000 scientists and engineers. With an annual budget of approximately $250 million, LBL conducts a wide range of research activities, many that address the long-term needs of American industry and have the potential for a positive impact on US competitiveness. LBL actively seeks to sharemore » its expertise with the private sector to increase US competitiveness in world markets. LBL has transferable expertise in conservation and renewable energy, environmental remediation, materials sciences, computing sciences, and biotechnology, which includes fundamental genetic research and nuclear medicine. This catalog gives an excellent overview of LBL`s expertise, and is a good resource for those seeking partnerships with national laboratories. Such partnerships allow private enterprise access to the exceptional scientific and engineering capabilities of the federal laboratory systems. Such arrangements also leverage the research and development resources of the private partner. Most importantly, they are a means of accessing the cutting-edge technologies and innovations being discovered every day in our federal laboratories.« less

Life Sciences Laboratories for the Shuttle/Spacelab

NASA Technical Reports Server (NTRS)

Schulte, L. O.; Kelly, H. B.; Secord, T. C.

1976-01-01

Space Shuttle and Spacelab missions will provide scientists with their first opportunity to participate directly in research in space for all scientific disciplines, particularly the Life Sciences. Preparations are already underway to ensure the success of these missions. The paper summarizes the results of the 1975 NASA-funded Life Sciences Laboratories definition study which defined several long-range life sciences research options and the laboratory designs necessary to accomplish high-priority life sciences research. The implications and impacts of Spacelab design and development on the life sciences missions are discussed. An approach is presented based upon the development of a general-purposs laboratory capability and an inventory of common operational research equipment for conducting life sciences research. Several life sciences laboratories and their capabilities are described to demonstrate the systems potentially available to the experimenter for conducting biological and medical research.

Life science payload definition and integration study, task C and D. Volume 3: Appendices

NASA Technical Reports Server (NTRS)

1973-01-01

Research equipment requirements were based on the Mini-7 and Mini-30 laboratory concepts defined in Tasks A and B of the intial LSPD contract. Modified versions of these laboratories and the research equipment within them were to be used in three missions of Shuttle/Sortie Module. These were designated (1) the shared 7-day laboratory (a mission with the life sciences laboratory sharing the sortie module with another scientific laboratory), (2) the dedicated 7-day laboratory (full use of the sortie module), and (3) the dedicated 30-day laboratory (full sortie module use with a 30-day mission duration). In defining the research equipment requirements of these laboratories, the equipment was grouped according to its function, and equipment unit data packages were prepared.

Laboratory Directed Research and Development annual report, fiscal year 1997

DOE Office of Scientific and Technical Information (OSTI.GOV)

NONE

1998-03-01

The Department of Energy Order 413.2(a) establishes DOE`s policy and guidelines regarding Laboratory Directed Research and Development (LDRD) at its multiprogram laboratories. As described in 413.2, LDRD is research and development of a creative and innovative nature which is selected by the Laboratory Director or his or her designee, for the purpose of maintaining the scientific and technological vitality of the Laboratory and to respond to scientific and technological opportunities in conformance with the guidelines in this Order. DOE Order 413.2 requires that each laboratory submit an annual report on its LDRD activities to the cognizant Secretarial Officer through themore » appropriate Operations Office Manager. The report provided in this document represents Pacific Northwest National Laboratory`s LDRD report for FY 1997.« less

Bringing the Excitement and Motivation of Research to Students; Using Inquiry and Research-Based Learning in a Year-Long Biochemistry Laboratory: Part II--Research-Based Laboratory--A Semester-Long Research Approach Using Malate Dehydrogenase as a Research Model

ERIC Educational Resources Information Center

Knutson, Kristopher; Smith, Jennifer; Nichols, Paul; Wallert, Mark A.; Provost, Joseph J.

2010-01-01

Research-based learning in a teaching environment is an effective way to help bring the excitement and experience of independent bench research to a large number of students. The program described here is the second of a two-semester biochemistry laboratory series. Here, students are empowered to design, execute and analyze their own experiments…

Using Pulsed Power for Hydrodynamic Code Validation

DTIC Science & Technology

2001-06-01

Air Force Research Laboratory ( AFRL ). A...bank at the Air Force Research Laboratory ( AFRL ). A cylindrical aluminum liner that is magnetically imploded onto a central target by self-induced...James Degnan, George Kiuttu Air Force Research Laboratory Albuquerque, NM 87117 Abstract As part of ongoing hydrodynamic code

Frederick National Laboratory Scientists to Present Advanced Technologies in Cancer Research | Frederick National Laboratory for Cancer Research

Cancer.gov

FREDERICK, Md. -- Hundreds of science and business professionals are expected to attend the second annual Technology Showcase at the Frederick National Laboratory for Cancer Research, scheduled for June 13.  The event will feature technologies bei

Metformin in non-diabetic hyperglycaemia: the GLINT feasibility RCT.

PubMed

Griffin, Simon J; Bethel, M Angelyn; Holman, Rury R; Khunti, Kamlesh; Wareham, Nicholas; Brierley, Gwen; Davies, Melanie; Dymond, Andrew; Eichenberger, Rose; Evans, Philip; Gray, Alastair; Greaves, Colin; Harrington, Kyla; Hitman, Graham; Irving, Greg; Lessels, Sarah; Millward, Ann; Petrie, John R; Rutter, Martin; Sampson, Mike; Sattar, Naveed; Sharp, Stephen

2018-04-01

The treatment of people with diabetes with metformin can reduce cardiovascular disease (CVD) and may reduce the risk of cancer. However, it is unknown whether or not metformin can reduce the risk of these outcomes in people with elevated blood glucose levels below the threshold for diabetes [i.e. non-diabetic hyperglycaemia (NDH)]. To assess the feasibility of the Glucose Lowering In Non-diabetic hyperglycaemia Trial (GLINT) and to estimate the key parameters to inform the design of the full trial. These parameters include the recruitment strategy, randomisation, electronic data capture, postal drug distribution, retention, study medication adherence, safety monitoring and remote collection of outcome data. A multicentre, individually randomised, double-blind, parallel-group, pragmatic, primary prevention trial. Participants were individually randomised on a 1 : 1 basis, blocked within each site. General practices and clinical research facilities in Cambridgeshire, Norfolk and Leicestershire. Males and females aged ≥ 40 years with NDH who had a high risk of CVD. Prolonged-release metformin (500 mg) (Glucophage ® SR, Merck KGaA, Bedfont Cross, Middlesex, UK) or the matched placebo, up to three tablets per day, distributed by post. Recruitment rates; adherence to study medication; laboratory results at baseline and 3 and 6 months; reliability and acceptability of study drug delivery; questionnaire return rates; and quality of life. We sent 5251 invitations, with 511 individuals consenting to participate. Of these, 249 were eligible and were randomised between March and November 2015 (125 to the metformin group and 124 to the placebo group). Participants were followed up for 0.99 years [standard deviation (SD) 0.30 years]. The use of electronic medical records to identify potentially eligible individuals in individual practices was resource intensive. Participants were generally elderly [mean age 70 years (SD 6.7 years)], overweight [mean body mass index 30.1 kg/m 2 (SD 4.5 kg/m 2 )] and male (88%), and the mean modelled 10-year CVD risk was 28.8% (SD 8.5%). Randomisation, postal delivery of the study drug and outcome assessment using registers/medical records were feasible and acceptable to participants. Most participants were able to take three tablets per day, but premature discontinuation of the study drug was common (≈30% of participants by 6 months), although there were no differences between the groups. All randomised participants returned questionnaires at baseline and 67% of participants returned questionnaires by the end of the study. There was no between-group difference in Short Form questionnaire-8 items or EuroQol-5 Dimensions scores. Compared with placebo, metformin was associated with small improvements in the mean glycated haemoglobin level [-0.82 mmol/mol, 95% confidence interval (CI) -1.39 to -0.24 mmol/mol], mean estimated glomerular filtration rate (2.31 ml/minute/1.73 m 2 , 95% CI -0.2 to 4.81 ml/minute/1.73 m 2 ) and mean low-density lipoprotein cholesterol level (-0.11 mmol/l, 95% CI -0.25 to 0.02 mmol/l) and a reduction in mean plasma vitamin B 12 level (-16.4 ng/l, 95% CI -32.9 to -0.01 ng/l). There were 35 serious adverse events (13 in the placebo group, 22 in the metformin group), with none deemed to be treatment related. Changes to sponsorship reduced the study duration, the limited availability of information in medical records reduced recruitment efficiency and discontinuation of study medication exceeded forecasts. A large, pragmatic trial comparing the effects of prolonged-release metformin and placebo on the risk of CVD events is potentially feasible. However, changes to the study design and conduct are recommended to enable an efficient scaling up of the trial. Recommendations include changing the inclusion criteria to recruit people with pre-existing CVD to increase the recruitment and event rates, using large primary/secondary care databases to increase recruitment rates, conducting follow-up remotely to improve efficiency and including a run-in period prior to randomisation to optimise trial adherence. Current Controlled Trials ISRCTN34875079. The project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 22, No. 18. See the NIHR Journals Library website for further project information. Merck KGaA provided metformin and matching placebo.

The virtual laboratory: a new on-line resource for the history of psychology.

PubMed

Schmidgen, Henning; Evans, Rand B

2003-05-01

The authors provide a description of the Virtual Laboratory at Department III of the Max Planck Institute for the History of Science in Berlin. The Virtual Laboratory currently provides Internet links to rooms that present texts, instruments, model organisms, research sites, and biographies. Existing links provide access to a library of journals, handbooks, monographs, and trade catalogues; research institutes and laboratories; biographies and bibliographic essays; and essays by contemporary researchers. Historians of psychology are encouraged to submit photographic material and essays to the Virtual Laboratory.

Undergraduate Biology Lab Courses: Comparing the Impact of Traditionally Based "Cookbook" and Authentic Research-Based Courses on Student Lab Experiences

ERIC Educational Resources Information Center

Brownell, Sara E.; Kloser, Matthew J.; Fukami, Tadishi; Shavelson, Rich

2012-01-01

Over the past decade, several reports have recommended a shift in undergraduate biology laboratory courses from traditionally structured, often described as "cookbook," to authentic research-based experiences. This study compares a cookbook-type laboratory course to a research-based undergraduate biology laboratory course at a Research 1…

Micropropulsion Research at AFRL (Postprint)

DTIC Science & Technology

2000-07-01

Air Force Research Laboratory (AFMC) AFRL /PRS 11. SPONSOR/MONITOR’S 5 Pollux Drive...be enabling for a new fleet of 25-kg class spacecraft supporting these missions. In response to this need, the Air Force Research Laboratory is... Research Laboratory (AFMC) AFRL /PRSS 1 Ara Road. Edwards AFB CA 93524-7013 AFRL -PR-ED-TP-2000-101 9. SPONSORING / MONITORING AGENCY NAME(S)

Cathode Research and the Threshold Cathode Test Facility

DTIC Science & Technology

2002-09-01

SYSTEM (LEFT) AND PULSED POWER TANK (RIGHT ) AS ASSEMBLED AT THE AIR FORCE RESEARCH LABORATORY , DIRECTED ENERGY DIRECTORATE AT KIRTLAND AFB, NM...Final Report APPROVED FOR PUBLIC RELEASE; DISTRIBUTION IS UNLIMITED. AIR FORCE RESEARCH LABORATORY Directed Energy Directorate 3550 Aberdeen Ave SE... Research Laboratory ( AFRL ), Directed Energy Directorate at Kirtland AFB, NM. In addition, simulations were performed that shed new light on the

21 CFR 312.160 - Drugs for investigational use in laboratory research animals or in vitro tests.

Code of Federal Regulations, 2010 CFR

2010-04-01

... research animals or in vitro tests. 312.160 Section 312.160 Food and Drugs FOOD AND DRUG ADMINISTRATION... Drugs for Investigational Use in Laboratory Research Animals or In Vitro Tests § 312.160 Drugs for investigational use in laboratory research animals or in vitro tests. (a) Authorization to ship. (1)(i) A person...

21 CFR 312.160 - Drugs for investigational use in laboratory research animals or in vitro tests.

Code of Federal Regulations, 2013 CFR

2013-04-01

... research animals or in vitro tests. 312.160 Section 312.160 Food and Drugs FOOD AND DRUG ADMINISTRATION... Drugs for Investigational Use in Laboratory Research Animals or In Vitro Tests § 312.160 Drugs for investigational use in laboratory research animals or in vitro tests. (a) Authorization to ship. (1)(i) A person...

21 CFR 312.160 - Drugs for investigational use in laboratory research animals or in vitro tests.

Code of Federal Regulations, 2014 CFR

2014-04-01

... research animals or in vitro tests. 312.160 Section 312.160 Food and Drugs FOOD AND DRUG ADMINISTRATION... Drugs for Investigational Use in Laboratory Research Animals or In Vitro Tests § 312.160 Drugs for investigational use in laboratory research animals or in vitro tests. (a) Authorization to ship. (1)(i) A person...

21 CFR 312.160 - Drugs for investigational use in laboratory research animals or in vitro tests.

Code of Federal Regulations, 2012 CFR

2012-04-01

... research animals or in vitro tests. 312.160 Section 312.160 Food and Drugs FOOD AND DRUG ADMINISTRATION... Drugs for Investigational Use in Laboratory Research Animals or In Vitro Tests § 312.160 Drugs for investigational use in laboratory research animals or in vitro tests. (a) Authorization to ship. (1)(i) A person...

21 CFR 312.160 - Drugs for investigational use in laboratory research animals or in vitro tests.

Code of Federal Regulations, 2011 CFR

2011-04-01

... research animals or in vitro tests. 312.160 Section 312.160 Food and Drugs FOOD AND DRUG ADMINISTRATION... Drugs for Investigational Use in Laboratory Research Animals or In Vitro Tests § 312.160 Drugs for investigational use in laboratory research animals or in vitro tests. (a) Authorization to ship. (1)(i) A person...

New Visiting Scholars Program at Frederick National Laboratory | Office of Cancer Clinical Proteomics Research

Cancer.gov

The Frederick National Laboratory for Cancer Research is now accepting Expressions of Interest to its new Visiting Scholars Program (VSP). VSP is a unique opportunity for researchers to work on important cancer and AIDS projects with teams of scientists at the only federal national laboratory in the United States devoted exclusively to biomedical research.

Laboratory directed research and development program, FY 1996

DOE Office of Scientific and Technical Information (OSTI.GOV)

NONE

1997-02-01

The Ernest Orlando Lawrence Berkeley National Laboratory (Berkeley Lab) Laboratory Directed Research and Development Program FY 1996 report is compiled from annual reports submitted by principal investigators following the close of the fiscal year. This report describes the projects supported and summarizes their accomplishments. It constitutes a part of the Laboratory Directed Research and Development (LDRD) program planning and documentation process that includes an annual planning cycle, projection selection, implementation, and review. The Berkeley Lab LDRD program is a critical tool for directing the Laboratory`s forefront scientific research capabilities toward vital, excellent, and emerging scientific challenges. The program provides themore » resources for Berkeley Lab scientists to make rapid and significant contributions to critical national science and technology problems. The LDRD program also advances the Laboratory`s core competencies, foundations, and scientific capability, and permits exploration of exciting new opportunities. Areas eligible for support include: (1) Work in forefront areas of science and technology that enrich Laboratory research and development capability; (2) Advanced study of new hypotheses, new experiments, and innovative approaches to develop new concepts or knowledge; (3) Experiments directed toward proof of principle for initial hypothesis testing or verification; and (4) Conception and preliminary technical analysis to explore possible instrumentation, experimental facilities, or new devices.« less

Laboratory Directed Research and Development Annual Report FY 2017

DOE Office of Scientific and Technical Information (OSTI.GOV)

Sullivan, Kelly O.

A national laboratory must establish and maintain an environment in which creativity and innovation are encouraged and supported in order to fulfill its missions and remain viable in the long term. As such, multiprogram laboratories are given discretion to allocate a percentage of their operating budgets to support research and development projects that align to PNNL’s and DOE’s missions and support the missions of other federal agencies, including DHS, DOD, and others. DOE Order 413.2C sets forth DOE’s Laboratory Directed Research and Development (LDRD) policy and guidelines for DOE multiprogram laboratories, and it authorizes the national laboratories to allocate upmore » to 6 percent of their operating budgets to fund the program. LDRD is innovative research and development, selected by the Laboratory Director or his/her designee, for the purpose of maintaining the scientific and technological vitality of the Laboratory. The projects supported by LDRD funding all have demonstrable ties to DOE/DHS missions and may also be relevant to the missions of other federal agencies that sponsor work at the Laboratory. The program plays a key role in attracting the best and brightest scientific staff, which is needed to serve the highest priority DOE mission objectives. Individual project reports comprise the bulk of this LDRD report. The Laboratory focuses its LDRD research on scientific assets that often address more than one scientific discipline.« less

Laboratory Directed Research and Development Annual Report FY 2016

DOE Office of Scientific and Technical Information (OSTI.GOV)

Sullivan, Kelly O.

A national laboratory must establish and maintain an environment in which creativity and innovation are encouraged and supported in order to fulfill its missions and remain viable in the long term. As such, multiprogram laboratories are given discretion to allocate a percentage of their operating budgets to support research and development projects that align to PNNL’s and DOE’s missions and support the missions of other federal agencies, including DHS, DOD, and others. DOE Order 413.2C sets forth DOE’s Laboratory Directed Research and Development (LDRD) policy and guidelines for DOE multiprogram laboratories, and it authorizes the national laboratories to allocate upmore » to 6 percent of their operating budgets to fund the program. LDRD is innovative research and development, selected by the Laboratory Director or his/her designee, for the purpose of maintaining the scientific and technological vitality of the Laboratory. The projects supported by LDRD funding all have demonstrable ties to DOE/DHS missions and may also be relevant to the missions of other federal agencies that sponsor work at the Laboratory. The program plays a key role in attracting the best and brightest scientific staff, which is needed to serve the highest priority DOE mission objectives. Individual project reports comprise the bulk of this LDRD report. The Laboratory focuses its LDRD research on scientific assets that often address more than one scientific discipline.« less

Review of Army Research Laboratory Programs for Historically Black Colleges and Universities and Minority Institutions

ERIC Educational Resources Information Center

National Academies Press, 2014

2014-01-01

"Review of Army Research Laboratory Programs for Historically Black Colleges and Universities and Minority Institutions" examines the ways in which historically black colleges and universities and minority institutions have used the Army Research Laboratory (ARL) funds to enhance the science, technology, engineering, and mathematics…

VERIFI | Virtual Engine Research Institute and Fuels Initiative

Science.gov Websites

VERIFI Virtual Engine Research Institute and Fuels Initiative Argonne National Laboratory Skip to Virtual Engine Research Institute and Fuels Initiative (VERIFI) at Argonne National Laboratory is the Argonne National Laboratory in which to answer your complex engine questions, verify the uncertainties

Frontiers: Research highlights 1946-1996 [50th Anniversary Edition. Argonne National Laboratory

DOE Office of Scientific and Technical Information (OSTI.GOV)

NONE

1996-12-31

This special edition of 'Frontiers' commemorates Argonne National Laboratory's 50th anniversary of service to science and society. America's first national laboratory, Argonne has been in the forefront of U.S. scientific and technological research from its beginning. Past accomplishments, current research, and future plans are highlighted.

Merging of Research and Teaching in Developmental Biology: Adaptation of Current Scientific Research Papers for Use in Undergraduate Laboratory Exercises

ERIC Educational Resources Information Center

Lee, H. H.; and others

1970-01-01

Describes two laboratory exercises adopted from current research papers for use in an undergraduate developmental biology course. Gives methods, summary of student results, and student comments. Lists lecture topics, text and reprint assignments, and laboratory exercises for course. (EB)

Frontiers: Research Highlights 1946-1996 [50th Anniversary Edition. Argonne National Laboratory

DOE R&D Accomplishments Database

1996-01-01

This special edition of 'Frontiers' commemorates Argonne National Laboratory's 50th anniversary of service to science and society. America's first national laboratory, Argonne has been in the forefront of U.S. scientific and technological research from its beginning. Past accomplishments, current research, and future plans are highlighted.

Revealing all: misleading self-disclosure rates in laboratory-based online research.

PubMed

Callaghan, Diana E; Graff, Martin G; Davies, Joanne

2013-09-01

Laboratory-based experiments in online self-disclosure research may be inadvertently compromising the accuracy of research findings by influencing some of the factors known to affect self-disclosure behavior. Disclosure-orientated interviews conducted with 42 participants in the laboratory and in nonlaboratory settings revealed significantly greater breadth of self-disclosure in laboratory interviews, with message length and intimacy of content also strongly related. These findings suggest that a contrived online setting with a researcher presence may stimulate motivation for greater self-disclosure than would occur naturally in an online environment of an individual's choice. The implications of these findings are that researchers should consider the importance of experimental context and motivation in self-disclosure research.

LABORATORY DIRECTED RESEARCH AND DEVELOPMENT ANNUAL REPORT TO THE DEPARTMENT OF ENERGY - DECEMBER 2006

DOE Office of Scientific and Technical Information (OSTI.GOV)

FOX, K.J.

Brookhaven National Laboratory (BNL) is a multidisciplinary laboratory that carries out basic and applied research in the physical, biomedical, and environmental sciences, and in selected energy technologies. It is managed by Brookhaven Science Associates, LLC, (BSA) under contract with the U. S. Department of Energy (DOE). BNL's total annual budget has averaged about $460 million. There are about 2,500 employees, and another 4,500 guest scientists and students who come each year to use the Laboratory's facilities and work with the staff. The BNL Laboratory Directed Research and Development (LDRD) Program reports its status to the U.S. Department of Energy (DOE)more » annually in March, as required by DOE Order 413.2B, ''Laboratory Directed Research and Development,'' April 19, 2006, and the Roles, Responsibilities, and Guidelines for Laboratory Directed Research and Development at the Department of Energy National Nuclear Security Administration Laboratories dated June 13, 2006. In accordance this is our Annual Report in which we describe the Purpose, Approach, Technical Progress and Results, and Specific Accomplishments of all LDRD projects that received funding during Fiscal Year 2006.« less

Strand transfer inhibitors of HIV-1 integrase: bringing IN a new era of antiretroviral therapy.

PubMed

McColl, Damian J; Chen, Xiaowu

2010-01-01

HIV-1 integrase (IN) is one of three essential enzymes (along with reverse transcriptase and protease) encoded by the viral pol gene. IN mediates two critical reactions during viral replication; firstly 3'-end processing (3'EP) of the double-stranded viral DNA ends and then strand transfer (STF) which joins the viral DNA to the host chromosomal DNA forming a functional integrated proviral DNA. IN is a 288 amino acid protein containing three functional domains, the N-terminal domain (NTD), catalytic core domain (CCD) and the C-terminal domain (CTD). The CCD contains three conserved catalytic residues, Asp64, Asp116 and Glu152, which coordinate divalent metal ions essential for the STF reaction. Intensive research over the last two decades has led to the discovery and development of small molecule inhibitors of the IN STF reaction (INSTIs). INSTIs are catalytic inhibitors of IN, and act to chelate the divalent metal ions in the CCD. One INSTI, raltegravir (RAL, Merck Inc.) was approved in late 2007 for the treatment of HIV-1 infection in patients with prior antiretroviral (ARV) treatment experience and was recently approved also for first line therapy. A second INSTI, elvitegravir (EVG, Gilead Sciences, Inc.) is currently undergoing phase 3 studies in ARV treatment-experienced patients and phase 2 studies in ARV naïve patients as part of a novel fixed dose combination. Several additional INSTIs are in early stage clinical development. This review will discuss the discovery and development of this novel class of antiretrovirals. This article forms part of a special issue of Antiviral Research marking the 25th anniversary of antiretroviral drug discovery and development, Vol 85, issue 1, 2010. Copyright 2009. Published by Elsevier B.V.

Effect of oral cladribine on time to conversion to clinically definite multiple sclerosis in patients with a first demyelinating event (ORACLE MS): a phase 3 randomised trial.

PubMed

Leist, Thomas P; Comi, Giancarlo; Cree, Bruce A C; Coyle, Patricia K; Freedman, Mark S; Hartung, Hans-Peter; Vermersch, Patrick; Casset-Semanaz, Florence; Scaramozza, Matthew

2014-03-01

Patients who develop relapsing-remitting multiple sclerosis (MS) present with a first clinical demyelinating event. In this double-blind, multicentre, randomised, phase 3 study we investigated the effect of oral cladribine on conversion to clinically definite MS in patients with a first clinical demyelinating event, when given at the same doses shown to be effective in relapsing-remitting MS. Between Oct 21, 2008, and Oct 11, 2010, we recruited patients aged 18-55 years, inclusive, from 160 hospitals, private clinics, or treatment centres in 34 countries. Eligible patients had a first clinical demyelinating event within 75 days before screening, at least two clinically silent lesions of at least 3 mm on a T2-weighted brain MRI scan, and an Expanded Disability Status Scale score of 5.0 or lower. Patients with a first clinical demyelinating event ≤75 days before screening were randomly assigned (1:1:1) to receive cladribine tablets at cumulative doses of 5.25 mg/kg or 3.5 mg/kg or placebo. Randomisation was done with a central web-based randomisation system and was stratified by geographic region. Masking was maintained using a two-physician model. The primary endpoint of this 96-week study was time to conversion to clinically definite MS according to the Poser criteria. This study is registered with ClinicalTrials.gov, number NCT00725985. Of 903 participants assessed for eligibility, 616 patients received cladribine 5.25 mg/kg (n=204), cladribine 3.5 mg/kg (n=206), or placebo (n=206). At trial termination on Oct 25, 2011, cladribine was associated with a risk reduction versus placebo for time to conversion to clinically definite MS (hazard ratio [HR] for 5.25 mg/kg=0.38, 95% CI 0.25-0.58, p<0.0001; HR for 3.5 mg/kg=0.33, 0.21-0.51, p<0.0001). Adverse events were reported in 165 (81%) patients in the cladribine 5.25 mg/kg group, 168 (82%) patients in the cladribine 3.5 mg/kg group, and 162 (79%) patients in the placebo group. We noted no increase in risk of adverse events with active treatment versus placebo apart from lymphopenia, which was a severe event in 10 (5%) patients in the 5.25 mg/kg group and four (2%) patients in the 3.5 mg/kg group. Both doses of cladribine significantly delayed MS diagnosis compared with placebo. The safety profile of cladribine was similar to that noted in a trial in patients with relapsing-remitting MS. Further research could clarify the potential effects of oral cladribine treatment in the early stages of MS. Merck Serono SA Geneva, a subsidiary of Merck KGaA, Darmstadt, Germany. Copyright © 2014 Elsevier Ltd. All rights reserved.

Historic Properties Report: Harry Diamond Laboratories, Maryland and Satellite Installations Woodbridge Research Facility, Virginia and Blossom Point Field Test Facility, Maryland

DTIC Science & Technology

1984-07-01

HISTORIC PROPERTIES REPORT HARRY DIAMOND LABORATORIES, MARYLAND ,’ / .’- AND SATELLITE INSTALLATIONS ~WOODBRIDGE RESEARCH FACILITY, VIRGINIA AND ,00... report . METHODOLOGY 1. Documentary Research Harry Diamond Laboratories (HDL) and its two satellite facilities at Woodbridge and Blossom Point are...drawings, and written history. Interagency Archeological Services and U.S. Army, Harry Diamond Laboratories. 106 Case Report and Mitigation Plan: Ballast

Known Structure, Unknown Function: An Inquiry-Based Undergraduate Biochemistry Laboratory Course

ERIC Educational Resources Information Center

Gray, Cynthia; Price, Carol W.; Lee, Christopher T.; Dewald, Alison H.; Cline, Matthew A.; McAnany, Charles E.; Columbus, Linda; Mura, Cameron

2015-01-01

Undergraduate biochemistry laboratory courses often do not provide students with an authentic research experience, particularly when the express purpose of the laboratory is purely instructional. However, an instructional laboratory course that is inquiry- and research-based could simultaneously impart scientific knowledge and foster a student's…

The Most Proficient Enzyme as the Central Theme in an Integrated, Research-based Biochemistry Laboratory Course

ERIC Educational Resources Information Center

Smiley, Jeffrey A.

2002-01-01

The enzyme orotidine-5'-monophosphate decarboxylase is an attractive choice for the central theme of an integrated, research-based biochemistry laboratory course. A series of laboratory exercises common to most instructional laboratories, including enzyme assays, protein purification, enzymatic characterization, elementary kinetics, and…

National Exposure Research Laboratory

EPA Pesticide Factsheets

The Ecosystems Research Division of EPA’s National Exposure Research Laboratory, conducts research on organic and inorganic chemicals, greenhouse gas biogeochemical cycles, and land use perturbations that create stressor exposures and potentia risk

Compulsory licenses: a tool to improve global access to the HPV vaccine?

PubMed

Maybarduk, Peter; Rimmington, Sarah

2009-01-01

Cervical cancer disproportionately affects women in lower- and middle-income countries. But the new vaccines developed to prevent infection with some strains of the human papillomavirus (HPV) that cause cervical cancer are priced beyond the reach of most women and health agencies in these regions, due in part to the monopoly pricing power of brand-name companies that hold the patents on the vaccines. Compulsory licenses, which authorize generic competition with patented products, could expand access to HPV vaccines under certain circumstances. If high-quality biogeneric HPV vaccines can be produced at low cost and be broadly and efficiently registered, and if Merck and GSK are unwilling to grant licenses on a voluntary basis, compulsory licensing could play a pivotal role in ensuring vaccinations against HPVare available to all, around the world, regardless of ability to pay.

The use of interlocking prostheses for both temporary and definitive management of infected periprosthetic femoral fractures.

PubMed

Konan, Sujith; Rayan, Faizal; Manketelow, Andrew R J; Haddad, Fares S

2011-12-01

Infected periprosthetic fractures around total hip arthroplasties are an extremely challenging problem. We describe our experience of managing infected periprosthetic femoral fractures using interlocking long-stem femoral prostheses either as temporary functional spacers or as definitive implants. The Cannulock (Orthodesign, Christchurch, United Kingdom) uncoated stem was used in 12 cases, and the Kent hip prosthesis (Biomet Merck, Bridgend, United Kingdom), in 5 cases. Satisfactory outcome was noted in all cases, and in 11 cases, revision to a definitive stem has been undertaken after successful control of infection and fracture union. The use of interlocking stems offers a relatively appealing solution for a complex problem and avoids the complications that would be associated with resection of the entire femur or the use of large quantities of bone cement. Copyright © 2011 Elsevier Inc. All rights reserved.

Avelumab: First Global Approval.

PubMed

Kim, Esther S

2017-05-01

Avelumab (Bavencio ® ) is an intravenously administered programmed cell death ligand-1-blocking human antibody initially developed by EMD Serono Inc. (the biopharmaceutical division of Merck KGaA, Darmstadt, Germany) [now jointly developed and commercialized by EMD Serono Inc. and Pfizer] for the treatment of various tumours. It has received accelerated approval in the USA for the treatment of metastatic Merkel cell carcinoma (mMCC) in adults and paediatric patients aged ≥12 years. The marketing authorization application for avelumab in the treatment of mMCC is undergoing regulatory review in the EU, the biologics license application for avelumab in the treatment of urothelial carcinoma is undergoing priority review by the FDA, and avelumab is in various stages of development internationally for a variety of cancers. This article summarizes the milestones in the development of avelumab leading to this first approval for mMCC.

Vision 2020 - the right to sight.

PubMed

Resnikoff, S; Kocur, I; Etya'ale, D E; Ukety, T O

2008-09-01

The unprecedented partnership for onchocerciasis control that followed Merck's decision to donate Mectizan has inspired the formation of a global initiative for the elimination of all avoidable blindness by the year 2020. 'Vision 2020, the Right to Sight', jointly co-ordinated by the World Health Organization's Programme for the Prevention of Blindness and Deafness and the International Agency for the Prevention of Blindness, was launched in 1999. This initiative's three pillars are disease control, human resource development, and infrastructure development. Vision 2020's achievements to date include the growth of the partnership, to include more than 60 member organizations, the revitalization of prevention activities, the completion of Vision-2020 plans in 40% of all countries and a reduction not only of blindness caused by onchocerciasis but also of blindness caused by trachoma. Cataract remains the leading cause of avoidable blindness.

Continuous bioprocessing: the real thing this time? 10(th) Annual bioProcessUK Conference, December 3-4, 2013, London, UK.

PubMed

Farid, Suzanne S; Thompson, Bill; Davidson, Andrew

2014-01-01

The Annual bioProcessUK Conference has acted as the key networking event for bioprocess scientists and engineers in the UK for the past 10 years. The following article is a report from the sessions that focused on continuous bioprocessing during the 10(th) Annual bioProcessUK Conference (London, December 2013). These sessions were organized by the 'EPSRC Centre for Innovative Manufacturing in Emergent Macromolecular Therapies' hosted at University College London. A plenary lecture and workshop provided a forum for participants to debate topical issues in roundtable discussions with industry and academic experts from institutions such as Genzyme, Janssen, Novo Nordisk, Pfizer, Merck, GE Healthcare and University College London. The aim of these particular sessions was to understand better the challenges and opportunities for continuous bioprocessing in the bioprocessing sector.

Design Considerations and Research Needs for Expanding the Current Perceptual Model of Spatial Orientation into an In-Cockpit Spatial Disorientation Warning System

DTIC Science & Technology

2016-11-30

USAARL Report No. 2017-07 Design Considerations and Research Needs for Expanding the Current Perceptual Model of Spatial Orientation into an In...Brill5, Angus H. Rupert1 1U.S. Army Aeromedical Research Laboratory 2Laulima Government Solutions, LLC 3National AeroSpace Training and Research ...Center 4Embry-Riddle Aeronautical University 5U.S. Air Force Research Laboratory United States Army Aeromedical Research Laboratory Auditory

Draftsmen at Work during Construction of the Aircraft Engine Research Laboratory

NASA Image and Video Library

1942-09-21

The National Advisory Committee for Aeronautics (NACA) Aircraft Engine Research Laboratory was designed by a group of engineers at the Langley Memorial Aeronautical Laboratory in late 1940 and 1941. Under the guidance of Ernest Whitney, the men worked on drawings and calculations in a room above Langley’s Structural Research Laboratory. The main Aircraft Engine Research Laboratory design group originally consisted of approximately 30 engineers and draftsmen, but there were smaller groups working separately on specific facilities. The new engine lab would have six principal buildings: the Engine Research Building, hangar, Fuels and Lubricants Building, Administration Building, Propeller Test Stand, and Altitude Wind Tunnel. In December 1941 most of those working on the project transferred to Cleveland from Langley. Harrison Underwood and Charles Egan led 18 architectural, 26 machine equipment, 3 structural and 10 mechanical draftsmen. Initially these staff members were housed in temporary offices in the hangar. As sections of the four-acre Engine Research Building were completed in the summer of 1942, the design team began relocating there. The Engine Research Building contained a variety of test cells and laboratories to address virtually every aspect of piston engine research. It also contained a two-story office wing, seen in this photograph that would later house many of the powerplant research engineers.

Proper laboratory notebook practices: protecting your intellectual property.

PubMed

Nickla, Jason T; Boehm, Matthew B

2011-03-01

A laboratory notebook contains a wealth of knowledge that can be critical for establishing evidence in support of intellectual property rights and for refuting claims of research misconduct. The proper type, organization, use, maintenance, and storage of laboratory notebooks should be a priority for everyone at research institutions. Failure to properly document research activities can lead to serious problems, including the loss of valuable patent rights. Consequences of improper laboratory notebook practices can be harsh; numerous examples are described in court cases and journal articles, indicating a need for research institutions to develop strict policies on the proper use and storage of research documentation.

Center-level variability in broad-spectrum antibiotic prescribing for children undergoing hematopoietic cell transplantion for acute leukemia.

PubMed Central

Elgarten, Caitlin; Arnold, Staci; Li, Yimei; Huang, Y Vera; Gerber, Jeffrey S; Saber, Wael; Aplenc, Richard; Fisher, Brian T

2017-01-01

Abstract Background Antibiotic exposure after allogeneic hematopoietic cell transplant (HCT) is common. Exposure to specific classes of antibiotics after HCT has been associated with mortality, relapse and graft-vs.-host disease. Exploring differences in antibiotic utilization across hospitals could provide opportunities for comparative effectiveness studies and quality improvement interventions. Methods We conducted a retrospective cohort study of patients undergoing HCT for acute leukemia using a dataset merged from two sources: the Pediatric Health Information System and the Center for International Blood and Marrow Transplant Research. Medication use data were obtained from the day of transplant through engraftment. Hospital antibiotic utilization rates were reported as antibiotic days/1000 neutropenic days. Adjusted rates were calculated using a poisson regression controlling for age, sex, race, graft characteristics and days of ICU-level care. Results After adjustment, hospital rates of anti-pseudomonal antibiotic use varied from 410 to 1037 antibiotic days/1000 neutropenic days (Figure 1A) and for Gram-positive antibiotic use from 109 to 771 antibiotic days/1000 neutropenic days (Figure 1B). As shown in Figure 1, within anti-pseudomonal antibiotics, there was variation by hospital in the use of Fourth and 5th generation cephalosporins, anti-pseudomonal penicillins and carbapenems; variation in Gram-positive exposure was driven by vancomycin. Gram-positive antibiotic use was moderately associated with days of ICU-level of care (spearman correlation coefficient = .55) but anti-pseudomonal antibiotic use was not (Figure 2). There was no association between days of antibiotic exposure and 30-day mortality. Conclusion Among a homogenous population of children undergoing transplantation for acute leukemia, both the volume and spectrum of antibiotic exposure in the immediate post-transplant period varied widely. These data present an opportunity for hospitals to benchmark their antibiotic utilization practices and can be further leveraged to assess the clinical impact of differential antibiotic exposure. Disclosures B. T. Fisher, Pfizer, Inc.: Grant Investigator, Research support. Merck, Inc.: Investigator, Research support. T2 Biosystems, Inc.: Investigator, Research support. Ansun Biopharma: Investigator, Research support

A laboratory medicine residency training program that includes clinical consultation and research.

PubMed

Spitzer, E D; Pierce, G F; McDonald, J M

1990-04-01

We describe a laboratory medicine residency training program that includes ongoing interaction with both clinical laboratories and clinical services as well as significant research experience. Laboratory medicine residents serve as on-call consultants in the interpretation of test results, design of testing strategies, and assurance of test quality. The consultative on-call beeper system was evaluated and is presented as an effective method of clinical pathology training that is well accepted by the clinical staff. The research component of the residency program is also described. Together, these components provide training in real-time clinical problem solving and prepare residents for the changing technological environment of the clinical laboratory. At the completion of the residency, the majority of the residents are qualified laboratory subspecialists and are also capable of running an independent research program.

Survey of Advanced Technologies in Japan, Vol. 3: Database Reports

DTIC Science & Technology

1990-05-01

INDUSTRIAL CO. LTD. Y NEC CORPORATION, CSC INFORMATION TECHNOLOGY RESEARCH LABORATORIES Y THE UNIVERSITY OF ELECTRO-COMMUNICATIONS Y TOKYO INSTITUTE...77 by the National *"eau of Standards, and is an outgrowth of research performed by IBM. which was based on information theory, using computer...Y COMMUNICATION RESEARCH LABORATORY, MINISTRY OF POSTS AND TELECOMMUNICATIONS Y MATSUSHITA ELECTRONICS CORP., ELECTRONICS RESEARCH LABORATORY Y

Michigan/Air Force Research Laboratory (AFRL) Collaborative Center in Control Science (MACCCS)

DTIC Science & Technology

2016-09-01

AFRL-RQ-WP-TR-2016-0139 MICHIGAN/AIR FORCE RESEARCH LABORATORY (AFRL) COLLABORATIVE CENTER IN CONTROL SCIENCE (MACCCS) Anouck Girard...Final 18 April 2007 – 30 September 2016 4. TITLE AND SUBTITLE MICHIGAN/AIR FORCE RESEARCH LABORATORY (AFRL) COLLABORATIVE CENTER IN CONTROL SCIENCE...and amplify an internationally recognized center of excellence in control science research and education, through interaction between the faculty and

Lumber drying and heat sterilization research at the U.S. Forest Products Laboratory

Treesearch

William T. Simpson

2002-01-01

The Forest Products Laboratory (FPL) has a long history of research and technology transfer in lumber drying. Many of the dry kiln schedules used in industry today were developed by the staff of the Laboratory, and for many years the Laboratory conducted a kiln drying short course for training dry kiln operators. The purpose of this report is to describe the Laboratory...

Solvent use in private research laboratories in Japan: comparison with the use in public research laboratories and on production floors in industries.

PubMed

Hanada, Takaaki; Zaitsu, Ai; Kojima, Satoshi; Ukai, Hirohiko; Nagasawa, Yasuhiro; Takada, Shiro; Kawakami, Takuya; Ohashi, Fumiko; Ikeda, Masayuki

2014-01-01

Solvents used in production facility-affiliated private laboratories have been seldomly reported. This study was initiated to specify solvent use characteristics in private laboratories in comparison with the use in public research laboratories and on production floors. Elucidation of the applicability of conclusions from a public laboratory survey to private institutions is not only of scientific interest but also of practical importance. A survey on use of 47 legally stipulated organic solvents was conducted. The results were compiled for April 2011 to March 2013. Through sorting, data were available for 479 unit workplaces in private laboratories. Similar sorting for April 2012 to March 2013 was conducted for public research laboratories (e.g., national universities) and production floors (in private enterprises) to obtain 621 and 937 cases, respectively. Sampling of workroom air followed by capillary gas-chromatographic analyses for solvents was conducted in accordance with regulatory requirements. More than one solvent was usually detected in the air of private laboratories. With regard to solvent types, acetone, methyl alcohol, chloroform and hexane were prevalently used in private laboratories, and this was similar to the case of public laboratories. Prevalent use of ethyl acetate was unique to private laboratories. Toluene use was less common both in private and public laboratories. The prevalence of administrative control class 1 (i.e., an adequately controlled environment) was higher in laboratories (both private and public) than production floors. Solvent use patterns are similar in private and public laboratories, except that the use of mixtures of solvents is substantially more popular in private laboratories than in public laboratories.

Discourse, Power, and Knowledge in the Management of "Big Science": The Production of Consensus in a Nuclear Fusion Research Laboratory.

ERIC Educational Resources Information Center

Kinsella, William J.

1999-01-01

Extends a Foucauldian view of power/knowledge to the archetypical knowledge-intensive organization, the scientific research laboratory. Describes the discursive production of power/knowledge at the "big science" laboratory conducting nuclear fusion research and illuminates a critical incident in which the fusion research…

Laboratory Animal Technician | Center for Cancer Research

Cancer.gov

PROGRAM DESCRIPTION The Laboratory Animal Sciences Program (LASP) provides exceptional quality animal care and technical support services for animal research performed at the National Cancer Institute at the Frederick National Laboratory for Cancer Research. LASP executes this mission by providing a broad spectrum of state-of-the-art technologies and services that are focused

Senior Laboratory Animal Technician | Center for Cancer Research

Cancer.gov

PROGRAM DESCRIPTION The Laboratory Animal Sciences Program (LASP) provides exceptional quality animal care and technical support services for animal research performed at the National Cancer Institute at the Frederick National Laboratory for Cancer Research. LASP executes this mission by providing a broad spectrum of state-of-the-art technologies and services that are focused

Redefining Authentic Research Experiences in Introductory Biology Laboratories and Barriers to Their Implementation

ERIC Educational Resources Information Center

Spell, Rachelle M.; Guinan, Judith A.; Miller, Kristen R.; Beck, Christopher W.

2014-01-01

Incorporating authentic research experiences in introductory biology laboratory classes would greatly expand the number of students exposed to the excitement of discovery and the rigor of the scientific process. However, the essential components of an authentic research experience and the barriers to their implementation in laboratory classes are…

Synthesis and Biological Testing of Penicillins: An Investigative Approach to the Undergraduate Teaching Laboratory

ERIC Educational Resources Information Center

Whitaker, Ragnhild D.; Truhlar, Laura M.; Yksel, Deniz; Walt, David R.; Williams, Mark D.

2010-01-01

The development and implementation of a research-based organic chemistry laboratory experiment is presented. The experiment was designed to simulate a scientific research environment, involve students in critical thinking, and develop the student's ability to analyze and present research-based data. In this experiment, a laboratory class…

Sandia, California Tritium Research Laboratory transition and reutilization project

DOE Office of Scientific and Technical Information (OSTI.GOV)

Garcia, T.B.

1997-02-01

This paper describes a project within Sandia National Laboratory to convert the shut down Tritium Research Laboratory into a facility which could be reused within the laboratory complex. In the process of decommissioning and decontaminating the facility, the laboratory was able to save substantial financial resources by transferring much existing equipment to other DOE facilities, and then expeditiously implementing a decontamination program which has resulted in the building being converted into laboratory space for new lab programs. This project of facility reuse has been a significant financial benefit to the laboratory.

Community Noise Exposure Resulting from Aircraft Operations. Volume 3. Acoustic Data on Military Aircraft: Air Force Attack/Fighter Aircraft

DTIC Science & Technology

1978-02-01

i< AEROSPACE MEDICAL RESEARCH LABORATORY AEROSPACE MEDICAL DIVISION AIR FORCE SYSTEMS COMMAND WRIGHT-PATTERSON AIR FORCE BASE, OHIO 45433...in any way be related thereto. Please do not request copies of this report from Aerospace Medical Research Laboratory. Additional copies may be...34Guide for the Care and Use of Laboratory Animals," Institute of Laboratory Animal Resources, National Research Council. The voluntary informed

Reflections on searching for a postdoctoral position: three points to ponder.

PubMed

Jeang, Kuan-Teh

2011-09-01

Choosing the right laboratory in which to do postdoctoral training is perhaps one of the most important decisions that a scientist makes in his or her career. Does one choose a laboratory based on the research topic or the research style of the mentor? Does one choose a large laboratory or a small one? How does one fit the selection of a postdoctoral laboratory into the context of one's long-range career goals? Here, I briefly discuss three points worth considering in seeking a research laboratory for postdoctoral training after the completion of a graduate degree. Copyright © 2011.

Development and implications of technology in reform-based physics laboratories

NASA Astrophysics Data System (ADS)

Chen, Sufen; Lo, Hao-Chang; Lin, Jing-Wen; Liang, Jyh-Chong; Chang, Hsin-Yi; Hwang, Fu-Kwun; Chiou, Guo-Li; Wu, Ying-Tien; Lee, Silvia Wen-Yu; Wu, Hsin-Kai; Wang, Chia-Yu; Tsai, Chin-Chung

2012-12-01

Technology has been widely involved in science research. Researchers are now applying it to science education in an attempt to bring students’ science activities closer to authentic science activities. The present study synthesizes the research to discuss the development of technology-enhanced laboratories and how technology may contribute to fulfilling the instructional objectives of laboratories in physics. To be more specific, this paper discusses the engagement of technology to innovate physics laboratories and the potential of technology to promote inquiry, instructor and peer interaction, and learning outcomes. We then construct a framework for teachers, scientists, and programmers to guide and evaluate technology-integrated laboratories. The framework includes inquiry learning and openness supported by technology, ways of conducting laboratories, and the diverse learning objectives on which a technology-integrated laboratory may be focused.

Biological and Physical Space Research Laboratory 2002 Science Review

NASA Technical Reports Server (NTRS)

Curreri, P. A. (Editor); Robinson, M. B. (Editor); Murphy, K. L. (Editor)

2003-01-01

With the International Space Station Program approaching core complete, our NASA Headquarters sponsor, the new Code U Enterprise, Biological and Physical Research, is shifting its research emphasis from purely fundamental microgravity and biological sciences to strategic research aimed at enabling human missions beyond Earth orbit. Although we anticipate supporting microgravity research on the ISS for some time to come, our laboratory has been vigorously engaged in developing these new strategic research areas.This Technical Memorandum documents the internal science research at our laboratory as presented in a review to Dr. Ann Whitaker, MSFC Science Director, in July 2002. These presentations have been revised and updated as appropriate for this report. It provides a snapshot of the internal science capability of our laboratory as an aid to other NASA organizations and the external scientific community.

Tour of Research Laboratories at the Ford Company

NASA Astrophysics Data System (ADS)

Reitz, J. R.

1981-01-01

A brief description of the physics programs encountered on the tour of the Ford Motor Company Research Laboratories is provided. A visit to the Research Laboratories of the Ford Motor Company is part of the Conference on Physics in the Automotive Industry. The visit will show a cross-section of the programs in Research Staff which are clearly identified as physics research as well as other areas where physicists have established themselves as dominant or team members in what might traditionally be regarded as the province of engineering R&D. After a brief orientation, the Conference visitors will be divided into tour groups and will visit laboratories involved in combustion research, arc-discharge physics, various spectroscopic applications, metal gauging, energy management, optical display systems and solar energy research. Synopses of the specific tour visits follow.

Laboratory Directed Research and Development Program Assessment for FY 2008

DOE Office of Scientific and Technical Information (OSTI.GOV)

Looney, J P; Fox, K J

2008-03-31

Brookhaven National Laboratory (BNL) is a multidisciplinary Laboratory that carries out basic and applied research in the physical, biomedical, and environmental sciences, and in selected energy technologies. It is managed by Brookhaven Science Associates, LLC, (BSA) under contract with the U. S. Department of Energy (DOE). BNL's Fiscal Year 2008 spending was $531.6 million. There are approximately 2,800 employees, and another 4,300 guest scientists and students who come each year to use the Laboratory's facilities and work with the staff. The BNL Laboratory Directed Research and Development (LDRD) Program reports its status to the U.S. Department of Energy (DOE) annuallymore » in March, as required by DOE Order 413.2B, 'Laboratory Directed Research and Development,' April 19, 2006, and the Roles, Responsibilities, and Guidelines for Laboratory Directed Research and Development at the Department of Energy/National Nuclear Security Administration Laboratories dated June 13, 2006. The goals and objectives of BNL's LDRD Program can be inferred from the Program's stated purposes. These are to (1) encourage and support the development of new ideas and technology, (2) promote the early exploration and exploitation of creative and innovative concepts, and (3) develop new 'fundable' R&D projects and programs. The emphasis is clearly articulated by BNL to be on supporting exploratory research 'which could lead to new programs, projects, and directions' for the Laboratory. To be a premier scientific Laboratory, BNL must continuously foster groundbreaking scientific research and renew its research agenda. The competition for LDRD funds stimulates Laboratory scientists to think in new and creative ways, which becomes a major factor in achieving and maintaining research excellence and a means to address National needs within the overall mission of the DOE and BNL. By fostering high-risk, exploratory research, the LDRD program helps BNL to respond new scientific opportunities within existing mission areas, as well as to develop new research mission areas in response to DOE and National needs. As the largest expense in BNL's LDRD program is the support graduate students, post-docs, and young scientists, LDRD provides base for continually refreshing the research staff as well as the education and training of the next generation of scientists. The LDRD Program Assessment Report contains a review of the program. The report includes a summary of the management processes, project peer review, and the portfolio's relatedness to BNL's mission, initiatives and strategic plans. Also included are a metric of success indicators and Self Assessment.« less

Quality Assessment and Accessibility Applications of Crowdsourced Geospatial Data: A Report on the Development and Extension of the George Mason University Geocrowdsourcing Testbed

DTIC Science & Technology

2014-09-01

Approved for public release; distribution is unlimited. Prepared for Geospatial Research Laboratory U.S. Army Engineer Research and Development...Center U.S. Army Corps of Engineers Under Data Level Enterprise Tools Monitored by Geospatial Research Laboratory 7701 Telegraph Road...Engineer Research and Development Center (ERDC) ERDC Geospatial Research Laboratory 7701 Telegraph Road 11. SPONSOR/MONITOR’S REPORT Alexandria, VA 22135

An overview of Quality Management System implementation in a research laboratory

NASA Astrophysics Data System (ADS)

Molinéro-Demilly, Valérie; Charki, Abdérafi; Jeoffrion, Christine; Lyonnet, Barbara; O'Brien, Steve; Martin, Luc

2018-02-01

The aim of this paper is to show the advantages of implementing a Quality Management System (QMS) in a research laboratory in order to improve the management of risks specific to research programmes and to increase the reliability of results. This paper also presents experience gained from feedback following the implementation of the Quality process in a research laboratory at INRA, the French National Institute for Agronomic Research and details the various challenges encountered and solutions proposed to help achieve smoother adoption of a QMS process. The 7Ms (Management, Measurement, Manpower, Methods, Materials, Machinery, Mother-nature) methodology based on the Ishikawa `Fishbone' diagram is used to show the effectiveness of the actions considered by a QMS, which involve both the organization and the activities of the laboratory. Practical examples illustrate the benefits and improvements observed in the laboratory.

EPA LABORATORIES IMPLEMENT EMS PROGRAM

EPA Science Inventory

This paper highlights the breadth and magnitude of carrying out an effective Environmental Management System (EMS) program at the U.S. EPA's research and development laboratories. Federal research laboratories have unique operating challenges compared to more centralized industr...

Energy Systems High-Pressure Test Laboratory | Energy Systems Integration

Science.gov Websites

Facility | NREL Energy Systems High-Pressure Test Laboratory Energy Systems High-Pressure Test Laboratory In the Energy Systems Integration Facility's High-Pressure Test Laboratory, researchers can safely test high-pressure hydrogen components. Photo of researchers running an experiment with a hydrogen fuel

The Virtual Robotics Laboratory

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kress, R.L.; Love, L.J.

The growth of the Internet has provided a unique opportunity to expand research collaborations between industry, universities, and the national laboratories. The Virtual Robotics Laboratory (VRL) is an innovative program at Oak Ridge National Laboratory (ORNL) that is focusing on the issues related to collaborative research through controlled access of laboratory equipment using the World Wide Web. The VRL will provide different levels of access to selected ORNL laboratory secondary education programs. In the past, the ORNL Robotics and Process Systems Division has developed state-of-the-art robotic systems for the Army, NASA, Department of Energy, Department of Defense, as well asmore » many other clients. After proof of concept, many of these systems sit dormant in the laboratories. This is not out of completion of all possible research topics. but from completion of contracts and generation of new programs. In the past, a number of visiting professors have used this equipment for their own research. However, this requires that the professor, and possibly his/her students, spend extended periods at the laboratory facility. In addition, only a very exclusive group of faculty can gain access to the laboratory and hardware. The VRL is a tool that enables extended collaborative efforts without regard to geographic limitations.« less

Brookhaven National Laboratory Institutional Plan FY2001--FY2005

DOE Office of Scientific and Technical Information (OSTI.GOV)

Davis, S.

Brookhaven National Laboratory is a multidisciplinary laboratory in the Department of Energy National Laboratory system and plays a lead role in the DOE Science and Technology mission. The Laboratory also contributes to the DOE missions in Energy Resources, Environmental Quality, and National Security. Brookhaven strives for excellence in its science research and in facility operations and manages its activities with particular sensitivity to environmental and community issues. The Laboratory's programs are aligned continuously with the goals and objectives of the DOE through an Integrated Planning Process. This Institutional Plan summarizes the portfolio of research and capabilities that will assure successmore » in the Laboratory's mission in the future. It also sets forth BNL strategies for our programs and for management of the Laboratory. The Department of Energy national laboratory system provides extensive capabilities in both world class research expertise and unique facilities that cannot exist without federal support. Through these national resources, which are available to researchers from industry, universities, other government agencies and other nations, the Department advances the energy, environmental, economic and national security well being of the US, provides for the international advancement of science, and educates future scientists and engineers.« less

Developing Therapies for Brain Tumors: The Impact of the Johns Hopkins Hunterian Neurosurgical Research Laboratory.

PubMed

Brem, Henry; Sankey, Eric W; Liu, Ann; Mangraviti, Antonella; Tyler, Betty M

2017-01-01

The Johns Hopkins Hunterian Neurosurgical Laboratory at the Johns Hopkins University School of Medicine was created in 1904 by Harvey Cushing and William Halsted and has had a long history of fostering surgical training, encouraging basis science research, and facilitating translational application. Over the past 30 years, the laboratory has addressed the paucity of brain tumor therapies. Pre-clinical work from the laboratory led to the development of carmustine wafers with initial US Food and Drug Administration (FDA) approval in 1996. Combining carmustine wafers, radiation, and temozolomide led to a significant increase in the median survival of patients with glioblastoma. The laboratory has also developed microchips and immunotherapy to further extend survival in this heretofore underserved population. These achievements were made possible by the dedication, commitment, and creativity of more than 300 trainees of the Hunterian Neurosurgical Laboratory. The laboratory demonstrates the beneficial influence of research experience as well its substantial impact on the field of biomedical research.

Microwave remote sensing laboratory design

NASA Technical Reports Server (NTRS)

Friedman, E.

1979-01-01

Application of active and passive microwave remote sensing to the study of ocean pollution is discussed. Previous research efforts, both in the field and in the laboratory were surveyed to derive guidance for the design of a laboratory program of research. The essential issues include: choice of radar or radiometry as the observational technique; choice of laboratory or field as the research site; choice of operating frequency; tank sizes and material; techniques for wave generation and appropriate wavelength spectrum; methods for controlling and disposing of pollutants used in the research; and pollutants other than oil which could or should be studied.

Development of performance assessment instrument based contextual learning for measuring students laboratory skills

NASA Astrophysics Data System (ADS)

Susilaningsih, E.; Khotimah, K.; Nurhayati, S.

2018-04-01

The assessment of laboratory skill in general hasn’t specific guideline in assessment, while the individual assessment of students during a performance and skill in performing laboratory is still not been observed and measured properly. Alternative assessment that can be used to measure student laboratory skill is use performance assessment. The purpose of this study was to determine whether the performance assessment instrument that the result of research can be used to assess basic skills student laboratory. This research was conducted by the Research and Development. The result of the data analysis performance assessment instruments developed feasible to implement and validation result 62.5 with very good categories for observation sheets laboratory skills and all of the components with the very good category. The procedure is the preliminary stages of research and development stages. Preliminary stages are divided in two, namely the field studies and literature studies. The development stages are divided into several parts, namely 1) development of the type instrument, 2) validation by an expert, 3) a limited scale trial, 4) large-scale trials and 5) implementation of the product. The instrument included in the category of effective because 26 from 29 students have very high laboratory skill and high laboratory skill. The research of performance assessment instrument is standard and can be used to assess basic skill student laboratory.

Department of Defense In-House RDT&E Activities

DTIC Science & Technology

1986-10-30

Research Management, Air Force IResearch, Army Research . Navy Researche Research 19 ABSTRACT (Continue on reverse if necessary and identify by block...Aeromedical Research Laboratory ........................ 1 Air Defense Artillery Board ............................ 2 Airborne & Special Operations...NAVY Aerospace Medical Research Laboratory .................. 55 Air Development Center ................................. 56 Air Propulsion

USAF/SCEEE Graduate Student Summer Research Program (1984). Program Management Report.

DTIC Science & Technology

1984-10-01

adjunct effort to the SFRP. Its purpose is to provide funds for selected graduate students to do research at an appropriate Air Force laboratory or...under the Summer Faculty Research Program or an Air Force laboratory designated *- colleague. The students were U.S. citizens, working toward . an...faculty member; excellent laboratory experience. Good opportunity to become acquainted with Air Force research . Good concept. Good stipend

Initiation of Research at the Aircraft Engine Research Laboratory

NASA Image and Video Library

1942-05-21

A group of National Advisory Committee for Aeronautics (NACA) officials and local dignitaries were on hand on May 8, 1942, to witness the Initiation of Research at the NACA's new Aircraft Engine Research Laboratory in Cleveland, Ohio. The group in this photograph was in the control room of the laboratory's first test facility, the Engine Propeller Research Building. The NACA press release that day noted, "First actual research activities in what is to be the largest aircraft engine research laboratory in the world was begun today at the National Advisory Committee for Aeronautics laboratory at the Cleveland Municipal Airport.” The ceremony, however, was largely symbolic since most of the laboratory was still under construction. Dr. George W. Lewis, the NACA's Director of Aeronautical Research, and John F. Victory, NACA Secretary, are at the controls in this photograph. Airport Manager John Berry, former City Manager William Hopkins, NACA Assistant Secretary Ed Chamberlain, Langley Engineer-in-Charge Henry Reid, Executive Engineer Carlton Kemper, and Construction Manager Raymond Sharp are also present. The propeller building contained two torque stands to test complete engines at ambient conditions. The facility was primarily used at the time to study engine lubrication and cooling systems for World War II aircraft, which were required to perform at higher altitudes and longer ranges than previous generations.

Visiting Scholars Program | Frederick National Laboratory for Cancer Research

Cancer.gov

The Visiting Scholars Program (VSP) provides a unique opportunity for scientists to collaborate with the Frederick National Laboratory for Cancer Research (FNLCR), the only federal national laboratory in the United States devoted exclusively to b

Attributes of a research environment that contribute to excellent research and development

DOE Office of Scientific and Technical Information (OSTI.GOV)

G. B. Jordan; L. D. Streit; J. S. Binkley

1999-04-01

This paper presents initial work at two U. S. Department of Energy (DOE) national laboratories to identify attributes of DOE Laboratory research environments that are most important for fostering excellent research.

Reproducibility of preclinical animal research improves with heterogeneity of study samples

PubMed Central

Vogt, Lucile; Sena, Emily S.; Würbel, Hanno

2018-01-01

Single-laboratory studies conducted under highly standardized conditions are the gold standard in preclinical animal research. Using simulations based on 440 preclinical studies across 13 different interventions in animal models of stroke, myocardial infarction, and breast cancer, we compared the accuracy of effect size estimates between single-laboratory and multi-laboratory study designs. Single-laboratory studies generally failed to predict effect size accurately, and larger sample sizes rendered effect size estimates even less accurate. By contrast, multi-laboratory designs including as few as 2 to 4 laboratories increased coverage probability by up to 42 percentage points without a need for larger sample sizes. These findings demonstrate that within-study standardization is a major cause of poor reproducibility. More representative study samples are required to improve the external validity and reproducibility of preclinical animal research and to prevent wasting animals and resources for inconclusive research. PMID:29470495

A Numerical Method for Computing the Transonic Fan Duct Flow over a Centerbody into an Exterior Free Stream - Program Tea-343,

DTIC Science & Technology

1974-09-24

Transonic Flows with Imbedded Shock Waves", Boeing Scientific Research Laboratories Document D1-82-1053 (1971); also as invited lecture series for AGARD...Past Thin Lifting Airfoils", Boeing Scientific Research Laboratories Document D180-2298-1, June 1971. 5. Krupp, J. A. and Ia-man, 9. M., "Computation...Aerodynamics and Marine Sciences Laboratory, Boeing Scientific Research Laboratories, June 1971. 7. Krupp, J. A., "Documentation for Program TSONIC", Technical

1995 Laboratory-Directed Research and Development Annual report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Cauffman, D.P.; Shoaf, D.L.; Hill, D.A.

1995-12-31

The Laboratory-Directed Research and Development Program (LDRD) is a key component of the discretionary research conducted by Lockheed Idaho Technologies Company (Lockheed Idaho) at the Idaho National Engineering Laboratory (INEL). The threefold purpose and goal of the LDRD program is to maintain the scientific and technical vitality of the INEL, respond to and support new technical opportunities, and enhance the agility and flexibility of the national laboratory and Lockheed Idaho to address the current and future missions of the Department of Energy.

Redox Liquid Phase Exfoliation of Layered Transition Metal Dichalcogenides (Postprint)

DTIC Science & Technology

2016-12-29

RESEARCH LABORATORY MATERIALS AND MANUFACTURING DIRECTORATE WRIGHT-PATTERSON AIR FORCE BASE, OH 45433-7750 AIR FORCE MATERIEL COMMAND UNITED...ADDRESS(ES) 10. SPONSORING/MONITORING AGENCY ACRONYM(S) Air Force Research Laboratory Materials and Manufacturing Directorate Wright...Bultman, Adam Waite, Ming-Siao Hsiao, Richard A. Vaia* Materials and Manufacturing Directorate, Air Force Research Laboratory, Wright-Patterson AFB, Ohio

21 CFR 570.17 - Exemption for investigational use and procedure for obtaining authorization to market edible...

Code of Federal Regulations, 2013 CFR

2013-04-01

...) If intended for investigational use in vitro or in laboratory research animals, it bears a label.... Contains a new food additive for investigational use only in laboratory research animals or for tests in vitro. Not for use in humans. (b) If intended for use in animals other than laboratory research animals...

Human-Machine Teams: The Social Frontier

DTIC Science & Technology

2015-12-01

Trust & Interaction Branch December 2015 Interim Report Distribution A. Approved for public release AIR FORCE RESEARCH LABORATORY 711TH HUMAN...711th Human Performance Wing Air Force Research Laboratory This report is published in the interest of scientific and technical information exchange... Research Laboratory 711th Human Performance Wing Human Effectiveness Directorate Human Centered ISR Division Human Trust & Interaction Branch Wright

The SWRL Audio Laboratory System (ALS): An Integrated Configuration for Psychomusicology Research. Technical Report 51.

ERIC Educational Resources Information Center

Williams, David Brian; Hoskin, Richard K.

This report describes features of the Audio Laboratory System (ALS), a device which supports research activities of the Southwest Regional Laboratory's Music Program. The ALS is used primarily to generate recorded audio tapes for psychomusicology research related to children's perception and learning of music concepts such as pitch, loudness,…

FY 2014 LDRD Annual Report Project Summaries

DOE Office of Scientific and Technical Information (OSTI.GOV)

Tomchak, Dena

The FY 2014 Laboratory Directed Research and Development (LDRD) Annual Report is a compendium of the diverse research performed to develop and ensure the INL's technical capabilities can support future DOE missions and national research priorities. LDRD is essential to INL - it provides a means for the laboratory to pursue novel scientific and engineering research in areas that are deemed too basic or risky for programmatic investments. This research enahnces technical capabilities at the laboratory, providing scientific and engineering staff with opportunities for skill building and partnership development.

Research and the planned Space Experiment Research and Processing Laboratory

NASA Technical Reports Server (NTRS)

2000-01-01

Researchers perform tests at Kennedy Space Center. New facilities for such research will be provided at the Space Experiment Research Procession Laboratory (SERPL). The SERPL is a planned 100,000-square-foot laboratory that will provide expanded and upgraded facilities for hosting International Space Station experiment processing. In addition, it will provide better support for other biological and life sciences payload processing at KSC. It will serve as a magnet facility for a planned 400-acre Space Station Commerce Park.

National University Consortium on Microwave Research (NUCOMR)

DOE Office of Scientific and Technical Information (OSTI.GOV)

Barker, R.J.; Agee, F.J.

1995-11-01

This paper introduces a new cooperative research program of national scale that is focused on crucial research issues in the development of high energy microwave sources. These have many applications in the DOD and industry. The Air Force Office of Scientific Research (AFOSR), in cooperation with the Phillips Laboratory, the Naval Research Laboratory, and the Army Research Laboratory, has established a tri-service research consortium to investigate novel high energy microwave sources. To facilitate the rapid transition of research results into the industrial community, formal collaborative subcontracts are already in-place with James Benford at Physics International, Carter Armstrong at Northrop, andmore » Glen Huffman at Varian Associates. Although this new program officially only came into existence in mid-March of this year, it builds on over a decade of microwave research efforts funded by the plasma physics office at AFOSR. It also is synergistic with the ongoing Tri-Service Vacuum Electronics Initiative led by Robert Parker of NRL as well as with the AFOSR`s and Rome Laboratory`s long-standing Advanced Thermionic Research Initiative (ATRI). An overview will be given of the broad spectrum of research objectives encompassed by NUCOMR. Areas of collaboration and technology transfer will be highlighted. The areas in which the three university consortia will conduct research are described, and the connectivity to industry and to the DOD laboratories are discussed. There are a number of critical technical barriers to reaching the desired goals for high power and high energy sources. These are discussed and the planned focus of research to resolve them is also presented.« less

The role and importance of veterinary laboratories in the prevention and control of infectious diseases of animals.

PubMed

Truszczyński, M J

1998-08-01

Veterinary laboratories which deal with infectious diseases form three groups according to the tasks for which they are responsible. The first group includes central or national veterinary laboratories, national or international reference laboratories, high-security laboratories, district regional or state veterinary diagnostic laboratories. The major role of these laboratories is to assist national Veterinary Services in diagnosing infectious animal diseases. The second group comprises laboratories that produce veterinary diagnostic kits and those that produce veterinary vaccines. The third group is composed of veterinary research laboratories, which generally concentrate on basic research and do not contribute directly to the diagnosis and control of infectious animal diseases. The author describes the objectives of each of the three groups of laboratories.

National Biocontainment Training Center

DTIC Science & Technology

2014-08-01

and Dr. Christopher Kasanga, Virologist, SACIDS, SUA. Pictured bottom right: Martha Betson, an instructor at Sokoine from the Royal Veterinary ...laboratories in the Pendik Veterinary Control Institute, which is a national research laboratory under the Turkish Ministry of Food, Agriculture and Livestock...Gargili (first row, center) for laboratory staff of the Pendik Veterinary Control Institute, a national research laboratory under the Turkish

HUMAN HEALTH RESEARCH IMPLEMENTATION PLAN, NATIONAL HEALTH AND ENVIRONMENTAL EFFECTS RESEARCH LABORATORY

EPA Science Inventory

The National Health and Environmental Effects Research Laboratory (NHEERL), as part of the Environmental Protection Agency's (EPA's) Office of Research and Development (ORD), is responsible for conducting research to improve the risk assessment of chemicals for potential effects ...

USDA-ARS update

USDA-ARS?s Scientific Manuscript database

Potato research at the Red River Valley Agricultural Research Center is conducted by the Sugarbeet & Potato Research Unit at two locations: the Northern Crop Science Laboratory in Fargo, ND and the Potato Research Worksite located in East Grand Forks, MN. Research in Fargo is laboratory oriented an...

Laboratory Directed Research and Development FY 2000 Annual Report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Al-Ayat, R

This Annual Report provides an overview of the FY2000 Laboratory Directed Research and Development (LDRD) Program at Lawrence Livermore National Laboratory (LLNL) and presents a summary of the results achieved by each project during the year.

Earth Resources Laboratory research and technology

NASA Technical Reports Server (NTRS)

1983-01-01

The accomplishments of the Earth Resources Laboratory's research and technology program are reported. Sensors and data systems, the AGRISTARS project, applied research and data analysis, joint research projects, test and evaluation studies, and space station support activities are addressed.

Fuels and Lubrication Researcher at the Aircraft Engine Research Laboratory

NASA Image and Video Library

1943-08-21

A researcher at the National Advisory Committee for Aeronautics (NACA) Aircraft Engine Research Laboratory studies the fuel ignition process. Improved fuels and lubrication was an area of particular emphasis at the laboratory during World War II. The military sought to use existing types of piston engines in order to get large numbers of aircraft into the air as quickly as possible. To accomplish its goals, however, the military needed to increase the performance of these engines without having to wait for new models or extensive redesigns. The Aircraft Engine Research Laboratory was called on to lead this effort. The use of superchargers successfully enhanced engine performance, but the resulting heat increased engine knock [fuel detonation] and structural wear. These effects could be offset with improved cooling, lubrication, and fuel mixtures. The NACA researchers in the Fuels and Lubrication Division concentrated on new synthetic fuels, higher octane fuels, and fuel-injection systems. The laboratory studied 16 different types of fuel blends during the war, including extensive investigations of triptane and xylidine.

Empirical grounding of the nature of scientific inquiry: A study of developing researchers

NASA Astrophysics Data System (ADS)

Stucky, Amy Preece

This work uses grounded theory methodology for developing theory about the nature of authentic scientific inquiry that occurs on a day-to-day basis in an academic research laboratory. Symbolic interaction and situated learning provide a theoretical framework. Data were collected from field notes, over 100 hours of videotape of researchers working in a chemical research laboratory, and interviews with participants. The phenomena of a research laboratory suggest that authentic daily work stretches scientists in three learning modalities: cognitive, affective and motivational beliefs and goals, which influence action to promote learning. A laboratory's line of research is divided into individual, thematic projects. Researchers are enabled in a specialized laboratory environment with sets of unique artifacts, substances, people and theoretical concepts to facilitate production of significant research goals. The work itself consists of chemical and mechanical processes facilitated by human actions, appropriate mental states, and theoretical explanations. The cognitive, affective (emotional), and conative (motivational) stretching then leads to explicit learning as well as implicit learning in the gain of experience and tacit knowledge. Implications of these findings about the nature of authentic scientific research on a day-to-day basis are applied to inquiry in science education in undergraduate and graduate education.

Research Staff | Buildings | NREL

Science.gov Websites

Research Staff Research Staff Photo of Roderick Jackson Roderick Jackson Laboratory Program Manager -related research at NREL. He works closely with senior laboratory management to set the strategic agenda for NREL's buildings portfolio, including all research, development, and market implementation

Growth and maintenance of Escherichia coli laboratory strains.

PubMed

Son, Mike S; Taylor, Ronald K

2012-11-01

Escherichia coli is a Gram-negative bacterium, commonly used in both teaching and research laboratories. This unit includes protocols for the growth and maintenance of E. coli in any teaching- or research-associated laboratory. © 2012 by John Wiley & Sons, Inc.

Scientific and Technological Achievements, 1946-2011, of the AFRL Electromagnetics Technology Division (AFRL/RYH) and Its Progenitors

DTIC Science & Technology

2012-07-01

AFRL /RYH) Sensors Directorate Air Force Research Laboratory Wright-Patterson Air Force ...Lossless Acoustic Monopoles, Electric Dipoles, and Magnetodielectric Spheres, Air Force Research Laboratory in-house report AFRL -SN-HS-TR-2006-0039... FORCE RESEARCH LABORATORY SENSORS DIRECTORATE WRIGHT-PATTERSON AIR FORCE BASE, OH 45433-7320 AIR FORCE MATERIEL COMMAND UNITED

Environmental Enrichment Protects against Functional Deficits caused by Traumatic Brain Injury

DTIC Science & Technology

2012-11-01

Herman University of Cincinnati November 2012 Interim Report AIR FORCE RESEARCH LABORATORY 711 HUMAN PERFORMANCE WING, HUMAN EFFECTIVENESS DIRECTORATE...Chief, Warfighter Interface Division Human Effectiveness Directorate 711 Human Performance Wing Air Force Research Laboratory This report is published...MONITOR’S ACRONYM(S) Air Force Materiel Command Air Force Research Laboratory 711th Human Performance Wing Human Effectiveness Directorate Warfighter

A Molecular Genetics Laboratory Course Applying Bioinformatics and Cell Biology in the Context of Original Research

ERIC Educational Resources Information Center

Brame, Cynthia J.; Pruitt, Wendy M.; Robinson, Lucy C.

2008-01-01

Research based laboratory courses have been shown to stimulate student interest in science and to improve scientific skills. We describe here a project developed for a semester-long research-based laboratory course that accompanies a genetics lecture course. The project was designed to allow students to become familiar with the use of…

Theory of Near-Field Scanning with a Probe Array

DTIC Science & Technology

2014-01-01

AIR FORCE RESEARCH LABORATORY SENSORS DIRECTORATE WRIGHT-PATTERSON AIR FORCE BASE, OH 45433-7320 AIR FORCE MATERIEL COMMAND...AFRL/RYMH) Sensors Directorate, Air Force Research Laboratory Wright-Patterson Air Force Base, OH 45433-7320 Air Force Materiel Command, United...S) AND ADDRESS(ES) 10. SPONSORING/MONITORING AGENCY ACRONYM(S) Air Force Research Laboratory Sensors Directorate Wright-Patterson Air Force Base

Precipitation in Powder Metallurgy, Nickel Base Superalloys: Review of Modeling Approach and Formulation of Engineering (Postprint)

DTIC Science & Technology

2016-12-01

MATERIALS SOCIETY (STINFO COPY) AIR FORCE RESEARCH LABORATORY MATERIALS AND MANUFACTURING DIRECTORATE WRIGHT-PATTERSON AIR FORCE BASE, OH 45433-7750...S) AND ADDRESS(ES) 10. SPONSORING/MONITORING AGENCY ACRONYM(S) Air Force Research Laboratory Materials and Manufacturing Directorate...Pratt & Whitney 7. PERFORMING ORGANIZATION NAME(S) AND ADDRESS(ES) 3) Thermophysical Properties Research Laboratory, Inc., 3080

NATIONAL HEALTH AND ENVIRONMENTAL EFFECTS RESEARCH LABORATORY - ACCOMPLISHMENTS FOR FY 2001

EPA Science Inventory

This Annual Report showcases some of the scientific activities of the National Health and Environmental Effects Research Laboratory (NHEERL) in various health and environmental effects research areas. Where appropriate, the contributions of other collaborating research organizat...

Current safety practices in nano-research laboratories in China.

PubMed

Zhang, Can; Zhang, Jing; Wang, Guoyu

2014-06-01

China has become a key player in the global nanotechnology field, however, no surveys have specifically examined safety practices in the Chinese nano-laboratories in depth. This study reports results of a survey of 300 professionals who work in research laboratories that handle nanomaterials in China. We recruited participants at three major nano-research laboratories (which carry out research in diverse fields such as chemistry, material science, and biology) and the nano-chemistry session of the national meeting of the Chinese Chemical Society. Results show that almost all nano-research laboratories surveyed had general safety regulations, whereas less than one third of respondents reported having nanospecific safety rules. General safety measures were in place in most surveyed nano-research laboratories, while nanospecific protective measures existed or were implemented less frequently. Several factors reported from the scientific literature including nanotoxicology knowledge gaps, technical limitations on estimating nano-exposure, and the lack of nano-occupational safety legislation may contribute to the current state of affairs. With these factors in mind and embracing the precautionary principle, we suggest strengthening or providing nanosafety training (including raising risk awareness) and establishing nanosafety guidelines in China, to better protect personnel in the nano-workplace.

Evaluation of the implementation of a quality system in a basic research laboratory: viability and impacts.

PubMed

Fraga, Hilda Carolina de Jesus Rios; Fukutani, Kiyoshi Ferreira; Celes, Fabiana Santana; Barral, Aldina Maria Prado; Oliveira, Camila Indiani de

2012-01-01

To evaluate the process of implementing a quality management system in a basic research laboratory of a public institution, particularly considering the feasibility and impacts of this improvement. This was a prospective and qualitative study. We employed the norm "NIT DICLA 035--Princípios das Boas Práticas de Laboratório (BPL)" and auxiliary documents of Organisation for Economic Co-operation and Development to complement the planning and implementation of a Quality System, in a basic research laboratory. In parallel, we used the PDCA tool to define the goals of each phase of the implementation process. This study enabled the laboratory to comply with the NIT DICLA 035 norm and to implement this norm during execution of a research study. Accordingly, documents were prepared and routines were established such as the registration of non-conformities, traceability of research data and equipment calibration. The implementation of a quality system, the setting of a laboratory focused on basic research is feasible once certain structural changes are made. Importantly, impacts were noticed during the process, which could be related to several improvements in the laboratory routine.

Lawrence Berkeley Laboratory, Institutional Plan FY 1994--1999

DOE Office of Scientific and Technical Information (OSTI.GOV)

Not Available

1993-09-01

The Institutional Plan provides an overview of the Lawrence Berkeley Laboratory mission, strategic plan, scientific initiatives, research programs, environment and safety program plans, educational and technology transfer efforts, human resources, and facilities needs. For FY 1994-1999 the Institutional Plan reflects significant revisions based on the Laboratory`s strategic planning process. The Strategic Plan section identifies long-range conditions that will influence the Laboratory, as well as potential research trends and management implications. The Initiatives section identifies potential new research programs that represent major long-term opportunities for the Laboratory, and the resources required for their implementation. The Scientific and Technical Programs section summarizesmore » current programs and potential changes in research program activity. The Environment, Safety, and Health section describes the management systems and programs underway at the Laboratory to protect the environment, the public, and the employees. The Technology Transfer and Education programs section describes current and planned programs to enhance the nation`s scientific literacy and human infrastructure and to improve economic competitiveness. The Human Resources section identifies LBL staff diversity and development program. The section on Site and Facilities discusses resources required to sustain and improve the physical plant and its equipment. The new section on Information Resources reflects the importance of computing and communication resources to the Laboratory. The Resource Projections are estimates of required budgetary authority for the Laboratory`s ongoing research programs. The Institutional Plan is a management report for integration with the Department of Energy`s strategic planning activities, developed through an annual planning process.« less

Ernest Orlando Lawrence Berkeley National Laboratory institutional plan, FY 1996--2001

DOE Office of Scientific and Technical Information (OSTI.GOV)

NONE

1995-11-01

The FY 1996--2001 Institutional Plan provides an overview of the Ernest Orlando Lawrence Berkeley National Laboratory mission, strategic plan, core business areas, critical success factors, and the resource requirements to fulfill its mission in support of national needs in fundamental science and technology, energy resources, and environmental quality. The Laboratory Strategic Plan section identifies long-range conditions that will influence the Laboratory, as well as potential research trends and management implications. The Core Business Areas section identifies those initiatives that are potential new research programs representing major long-term opportunities for the Laboratory, and the resources required for their implementation. It alsomore » summarizes current programs and potential changes in research program activity, science and technology partnerships, and university and science education. The Critical Success Factors section reviews human resources; work force diversity; environment, safety, and health programs; management practices; site and facility needs; and communications and trust. The Resource Projections are estimates of required budgetary authority for the Laboratory`s ongoing research programs. The Institutional Plan is a management report for integration with the Department of Energy`s strategic planning activities, developed through an annual planning process. The plan identifies technical and administrative directions in the context of the national energy policy and research needs and the Department of Energy`s program planning initiatives. Preparation of the plan is coordinated by the Office of Planning and Communications from information contributed by the Laboratory`s scientific and support divisions.« less

Known structure, unknown function: An inquiry-based undergraduate biochemistry laboratory course.

PubMed

Gray, Cynthia; Price, Carol W; Lee, Christopher T; Dewald, Alison H; Cline, Matthew A; McAnany, Charles E; Columbus, Linda; Mura, Cameron

2015-01-01

Undergraduate biochemistry laboratory courses often do not provide students with an authentic research experience, particularly when the express purpose of the laboratory is purely instructional. However, an instructional laboratory course that is inquiry- and research-based could simultaneously impart scientific knowledge and foster a student's research expertise and confidence. We have developed a year-long undergraduate biochemistry laboratory curriculum wherein students determine, via experiment and computation, the function of a protein of known three-dimensional structure. The first half of the course is inquiry-based and modular in design; students learn general biochemical techniques while gaining preparation for research experiments in the second semester. Having learned standard biochemical methods in the first semester, students independently pursue their own (original) research projects in the second semester. This new curriculum has yielded an improvement in student performance and confidence as assessed by various metrics. To disseminate teaching resources to students and instructors alike, a freely accessible Biochemistry Laboratory Education resource is available at http://biochemlab.org. © 2015 The Authors Biochemistry and Molecular Biology Education published by Wiley Periodicals, Inc. on behalf of International Union of Biochemistry and Molecular Biology.

Tables of Calculated Transition Probabilities for the A-X System of OH

DTIC Science & Technology

1981-06-01

June 1981 US ARMY ARMAMENT RESEARCH AND DEVELOPMENT COMMAND BALLISTIC RESEARCH LABORATORY ABERDEEN PROVING GROUND , MARYLAND Approved for public release...Laboratory ATTN: DRDAR-BLP Aberdeen Proving Ground , MD 21005 1L16112AH43 II. CONTROLLING OFFICE NAME AND ADDRESS 12. REPORT DATE USA Armament Research and...Development Command /I JUNE. 1981 USA Ballistic Research Laboratory 4 ATTN: DRDAR-BL 1/1) S 2P’GE Aberden Provine Ground . MD 21001 56 Pazes 14

Potato-related research at USDA-ARS laboratories in Washington and Idaho

USDA-ARS?s Scientific Manuscript database

Potato-related research currently being conducted at three USDA-ARS laboratories in Idaho and Washington is reviewed. Objectives of research programs at the Temperate Tree Fruit & Vegetable Research Unit (Wapato, WA), the Irrigated Agriculture Research and Extension Center (Prosser, WA), and the Sm...

Virtual Instruction: A Qualitative Research Laboratory Course

ERIC Educational Resources Information Center

Stadtlander, Lee M.; Giles, Martha J.

2010-01-01

Online graduate programs in psychology are becoming common; however, a concern has been whether instructors in the programs provide adequate research mentoring. One issue surrounding research mentoring is the absence of research laboratories in the virtual university. Students attending online universities often do research without peer or lab…

The Effect of Viewing Television Violence on Aggression.

ERIC Educational Resources Information Center

Primavera, Louis H.; Herron, William G.; Jauier, Rafael A.

1996-01-01

Discusses research on the negative impact of television and movies, scientific research on television violence and aggression, laboratory research, criticisms of laboratory research, field research, correlation studies. Concludes there is no evidence that viewing television violence increases aggression in children or adults but viewing it can…

Safety and tolerability of extended-release niacin-laropiprant: Pooled analyses for 11,310 patients in 12 controlled clinical trials.

PubMed

McKenney, James; Bays, Harold; Gleim, Gilbert; Mitchel, Yale; Kuznetsova, Olga; Sapre, Aditi; Sirah, Waheeda; Maccubbin, Darbie

2015-01-01

The Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events (HPS2-THRIVE) showed that adding extended-release niacin-laropiprant (ERN-LRPT) to statin provided no incremental cardiovascular benefit vs placebo (PBO). ERN-LRPT was also associated with an excess of serious adverse experiences (AEs), some of which were unexpected (infections and bleeding). These findings led to the withdrawal of ERN-LRPT from all markets. We examined the safety profile of ERN-LRPT vs the comparators ERN alone and statins in the ERN-LRPT development program to assess whether similar safety signals were observed to those seen in HPS-THRIVE and whether these might be attributed to ERN or LRPT. Postrandomization safety data from 12 clinical studies, 12 to 52 weeks in duration and involving 11,310 patients, were analyzed across 3 treatments: (1) ERN-LRPT; (2) ERN-NSP (ERN, Merck & Co, Inc or Niaspan [NSP], Abbott Laboratories); and (3) statin-PBO (statin or PBO). The safety profiles of ERN-LRPT and ERN-NSP were similar, except for less flushing with ERN-LRPT. Nonflushing AEs reported more frequently with ERN-LRPT or ERN-NSP than with statin-PBO were mostly nonserious and typical of niacin (nausea, diarrhea, and increased blood glucose). There was no evidence for an increased risk of serious AEs related to diabetes, muscle, infection, or bleeding. Pooled data from 11,310 patients revealed that, except for reduced flushing, the safety profile of ERN-LRPT was similar to that of ERN-NSP; LRPT did not appear to adversely affect the side-effect profile of ERN. The inability to replicate the unexpected AE findings in HPS2-THRIVE could be because of the smaller sample size and substantially shorter duration of these studies. Copyright © 2015 National Lipid Association. Published by Elsevier Inc. All rights reserved.

Long Term Persistence of IgE Anti-Varicella Zoster Virus in Pediatric and Adult Serum Post Chicken Pox Infection and after Vaccination with Varicella Virus Vaccine.

PubMed

Smith-Norowitz, Tamar A; Josekutty, Joby; Silverberg, Jonathan I; Lev-Tov, Hadar; Norowitz, Yitzchok M; Kohlhoff, Stephan; Nowakowski, Maja; Durkin, Helen G; Bluth, Martin H

2009-12-01

The production of IgE specific to different viruses (HIV-1, Parvovirus B19, RSV), and the ability for IgE anti-HIV-1 to suppress HIV-1 production in vitro, strongly suggest an important role for IgE and/or anti viral specific IgE in viral pathogenesis. Previous studies in our laboratory were the first to report the presence of IgE anti-varicella zoster virus (VZV) in an adolescent patient with shingles. However, the presence and long term persistence of IgE anti VZV antibodies has not been studied in adults. The presence of serum IgE in addition to IgE and IgG anti-VZV antibody in sera were studied in children (N=12) (0-16 y/o) and adults (N=9) (32-76 y/o) with either a past history of (wild type) chicken pox (N=7 children, 9 adults) or 5 years after vaccination with varicella zoster (N=2 children) (Varicella virus vaccine live, Oka/Merck), as well as in non-infected subjects (N=3 children). Of the patients who had a positive history of chicken pox 13 of 16 (81%) contained IgE anti-VZV antibodies; they were both serum IgEHi (>100 IU/ml) and IgELo (<100 IU/ml). Of the patients who were vaccinated, IgE anti-VZV antibodies were undetected. In contrast, serum from the patients without a history of chicken pox or vaccination did not make either IgE or IgG anti-VZV antibodies. This is the first demonstration of the existence of IgE anti-VZV antibodies, and its long-term persistence in serum of previously infected subjects. Future studies regarding the functional role of anti-viral IgE and its relationship to VZV are warranted.

Expert Panel Recommendations for the Identification and Management of Hyperkalemia and Role of Patiromer in Patients with Chronic Kidney Disease and Heart Failure.

PubMed

Rafique, Zubaid; Weir, Matthew R; Onuigbo, Macaulay; Pitt, Bertram; Lafayette, Richard; Butler, Javed; Lopes, Maria; Farnum, Carolyn; Peacock, W Frank

2017-04-01

Virtual panel meetings were conducted among 7 physicians, all of whom are independent experts, including 3 nephrologists, 2 cardiologists, and 2 emergency medicine physicians (the panel). The panel met with the purpose of discussing the current treatment landscape, treatment challenges, economic impact, and gaps in care for patients with hyperkalemia that is associated with heart failure and chronic kidney disease. The stated goal of the panel discussion was to develop practical solutions in the identification and management of hyperkalemia in this patient population. The panel noted that hyperkalemia is a serious condition that can lead to life-threatening complications, yet the treatment paradigm for hyperkalemia has remained without major advances for approximately 50 years, until the approval of patiromer. A number of issues still exist in the management of this patient population, including the lack of uniform treatment guidelines and consensus regarding the approach to treatment. As part of its effort, the panel developed an algorithm, the Proposed Diagnostic Algorithm for Hyperkalemia Treatment in the Acute Care Setting/Chronic Care. The panel agreed that patiromer appears to be a viable option for the management of hyperkalemia in patients with chronic kidney disease and/or heart failure and in patients who experience chronic hyperkalemia. This panel discussion was funded by Relypsa and facilitated by Magellan Rx Management. Rafique is a principal investigator for Relypsa and serves as a consultant for Instrumentation Laboratory, Magellan Health, Relypsa, and ZS-Pharma. Butler serves as consultant for Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, CardioCell, Janssen, Merck, Novartis, Relypsa, and ZS-Pharma. Lopes and Farnum are employed by Magellan Rx Management. Rafique designed the management protocol for this panel discussion and contributed to the writing and editing of this report document. The other authors report no conflicting interests. Relypsa is the manufacturer of Veltassa (patiromer).

DOE Office of Scientific and Technical Information (OSTI.GOV)

Looney,J.P.; Fox, K.

Brookhaven National Laboratory (BNL) is a multidisciplinary laboratory that maintains a primary mission focus the physical sciences, energy sciences, and life sciences, with additional expertise in environmental sciences, energy technologies, and national security. It is managed by Brookhaven Science Associates, LLC, (BSA) under contract with the U. S. Department of Energy (DOE). BNL's Fiscal year 2008 budget was $531.6 million. There are about 2,800 employees, and another 4,300 guest scientists and students who come each year to use the Laboratory's facilities and work with the staff. The BNL Laboratory Directed Research and Development (LDRD) Program reports its status to themore » U.S. Department of Energy (DOE) annually in March, as required by DOE Order 413.2B, 'Laboratory Directed Research and Development,' April 19, 2006, and the Roles, Responsibilities, and Guidelines for Laboratory Directed Research and Developlnent at the Department of Energy/National Nuclear Security Administration Laboratories dated June 13, 2006. Accordingly, this is our Annual Report in which we describe the Purpose, Approach, Technical Progress and Results, and Specific Accomplishments of all LDRD projects that received funding during Fiscal Year 2008. BNL expended $12 million during Fiscal Year 2008 in support of 69 projects. The program has two categories, the annual Open Call LDRDs and Strategic LDRDs, which combine to meet the overall objectives of the LDRD Program. Proposals are solicited annually for review and approval concurrent with the next fiscal year, October 1. For the open call for proposals, an LDRD Selection Committee, comprised of the Associate Laboratory Directors (ALDs) for the Scientific Directorates, an equal number of scientists recommended by the Brookhaven Council, plus the Assistant Laboratory Director for Policy and Strategic Planning, review the proposals submitted in response to the solicitation. The Open Can LDRD category emphasizes innovative research concepts with limited management filtering to encourage the creativity of individual researchers. The competition is open to all BNL staff in programmatic, scientific, engineering, and technical support areas. Researchers submit their project proposals to the Assistant Laboratory Director for Policy and Strategic Planning. A portion of the LDRD budget is held for the Strategic LDRD (S-LDRD) category. Projects in this category focus on innovative R&D activities that support the strategic agenda of the Laboratory. The Laboratory Director entertains requests or articulates the need for S-LDRD funds at any time. Strategic LDRD Proposals also undergo rigorous peer review; the approach to review is tailored to the size and scope of the proposal. These Projects are driven by special opportunities, including: (1) Research project(s) in support of Laboratory strategic initiatives as defined and articulated by the Director; (2) Research project(s) in support of a Laboratory strategic hire; (3) Evolution of Program Development activities into research and development activities; and (4) ALD proposal(s) to the Director to support unique research opportunities. The goals and objectives of BNL's LDRD Program can be inferred fronl the Program's stated purposes. These are to (1) encourage and support the development of new ideas and technology, (2) promote the early exploration and exploitation of creative and innovative concepts, and (3) develop new 'fundable' R&D projects and programs. The emphasis is clearly articulated by BNL to be on supporting exploratory research 'which could lead to new programs, projects, and directions' for the Laboratory. We explicitly indicate that research conducted under the LDRD Program should be highly innovative, and an element of high risk as to success is acceptable. To be one of the premier DOE National Laboratories, BNL must continuously foster groundbreaking scientific research. At Brookhaven National Laboratory one such method is through its LDRD Program. This discretionary research and development tool is critical in maintaining the scientific excellence and long-term vitality of the Laboratory. Additionally, it is a means to stimulate the scientific community and foster new science and technology ideas, which becomes a major factor in achieving and maintaining staff excellence and a means to address National needs within the overall mission of the DOE and BNL.« less

Nanotechnology Laboratory Collaborates with Army to Develop Botulism Vaccine | Frederick National Laboratory for Cancer Research

Cancer.gov

The Nanotechnology Characterization Laboratory (NCL) is collaborating with the Army to develop a candidate vaccine against botulism. Under a collaboration agreement between the National Cancer Institute and the U.S. Army Medical Research Institute of

75 FR 15675 - Professional Research Experience Program in Chemical Science and Technology Laboratory...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-30

... in physics, chemistry, mathematics, computer science, or engineering. Institutions should have a 4..., mathematics, computer science, or engineering with work experiences in laboratories or other settings...-0141-01] Professional Research Experience Program in Chemical Science and Technology Laboratory...

32 CFR 555.6 - Authority.

Code of Federal Regulations, 2010 CFR

2010-07-01

... OF ENGINEERS, RESEARCH AND DEVELOPMENT, LABORATORY RESEARCH AND DEVELOPMENT AND TESTS, WORK FOR OTHERS § 555.6 Authority. The following delegations of authority to perform research and development and tests apply. (a) Major Corps of Engineers Research and Development Laboratories. The major Corps of...

Research Laboratories and Centers Fact Sheet

EPA Pesticide Factsheets

The Office of Research and Development is the research arm of the U.S. Environmental Protection Agency. It has three national laboratories and four national centers located in 14 facilities across the country.

Model of the NACA's Aircraft Engine Research Laboratory during its Construction

NASA Image and Video Library

1942-08-21

Zella Morewitz poses with a model of the National Advisory Committee for Aeronautics (NACA) Aircraft Engine Research Laboratory, currently the NASA Glenn Research Center. The model was displayed in the Administration Building during the construction of the laboratory in the early 1940s. Detailed models of the individual test facilities were also fabricated and displayed in the facilities. The laboratory was built on a wedge of land between the Cleveland Municipal Airport on the far side and the deep curving valley etched by the Rocky River on the near end. Roughly only a third of the laboratory's semicircle footprint was initially utilized. Additional facilities were added to the remaining areas in the years after World War II. In the late 1950s the site was supplemented by the acquisition of additional adjacent land. Morewitz joined the NACA in 1935 as a secretary in the main office at the Langley Memorial Aeronautical Laboratory. In September 1940 she took on the task of setting up and guiding an office dedicated to the design of the NACA’s new engine research laboratory. Morewitz and the others in the design office transferred to Cleveland in December 1941 to expedite the construction. Morewitz served as Manager Ray Sharp’s secretary for six years and was a popular figure at the new laboratory. In December 1947 Morewitz announced her engagement to Langley researcher Sidney Batterson and moved back to Virginia.

Between land and sea: divergent data stewardship practices in deep-sea biosphere research

NASA Astrophysics Data System (ADS)

Cummings, R.; Darch, P.

2013-12-01

Data in deep-sea biosphere research often live a double life. While the original data generated on IODP expeditions are highly structured, professionally curated, and widely shared, the downstream data practices of deep-sea biosphere laboratories are far more localized and ad hoc. These divergent data practices make it difficult to track the provenance of datasets from the cruise ships to the laboratory or to integrate IODP data with laboratory data. An in-depth study of the divergent data practices in deep-sea biosphere research allows us to: - Better understand the social and technical forces that shape data stewardship throughout the data lifecycle; - Develop policy, infrastructure, and best practices to improve data stewardship in small labs; - Track provenance of datasets from IODP cruises to labs and publications; - Create linkages between laboratory findings, cruise data, and IODP samples. In this paper, we present findings from the first year of a case study of the Center for Dark Energy Biosphere Investigations (C-DEBI), an NSF Science and Technology Center that studies life beneath the seafloor. Our methods include observation in laboratories, interviews, document analysis, and participation in scientific meetings. Our research uncovers the data stewardship norms of geologists, biologists, chemists, and hydrologists conducting multi-disciplinary research. Our research team found that data stewardship on cruises is a clearly defined task performed by an IODP curator, while downstream it is a distributed task that develops in response to local need and to the extent necessary for the immediate research team. IODP data are expensive to collect and challenging to obtain, often costing $50,000/day and requiring researchers to work twelve hours a day onboard the ships. To maximize this research investment, a highly trained IODP data curator controls data stewardship on the cruise and applies best practices such as standardized formats, proper labeling, and centralized storage. In the laboratory, a scientist is his or her own curator. In contrast to the IODP research parties, laboratory research teams analyze diverse datasets, share them internally, implement ad hoc data management practices, optimize methods for their specific research questions, and release data on request through personal transactions. We discovered that while these workflows help small research teams retain flexibility and local control - crucial in exploratory deep-sea biosphere research - they also hinder data interoperability, discoverability, and consistency of methods from one research team to the next. Additional consequences of this contrast between IODP and lab practices are that it is difficult to track the provenance of data and to create linkages between laboratory findings, cruise data, and archived IODP samples. The ability to track provenance would add value to datasets and provide a clearer picture of the decisions made throughout the data lifecycle. Better linkages between the original data, laboratory data, and samples would allow secondary researchers to locate IODP data that may be useful to their research after laboratory findings are published. Our case study is funded by the Sloan Foundation and NSF.

Directory of AFRL/HEA Technical Publications Submitted to DTIC from 1969 to 2007

DTIC Science & Technology

2007-09-01

Research Division ( AFRL /HEA) 2004 to 30 September 1007 – Air Force Research Laboratory , Warfighter Readiness Research Division ( AFRL /HEA...NUMBER 2003 AIR FORCE RESEARCH LABORATORY WARFIGHTER TRAINING RESEARCH DIVISION ( AFRL /HEA) TECHNICAL DOCUMENTS AUTHOR(S) AFRL -HE-AZ-TP-2003...NUMBER WORK UNIT NUMBER 2002 AIR FORCE RESEARCH

Solar Radiation Research Laboratory | Energy Systems Integration Facility |

Science.gov Websites

radiation components, and has expanded its expertise to include integrated metrology, optics, electronics Acquisition Laboratory, Metrology Laboratory, Optics Laboratory, and Electronics Laboratory. Photo of a

EPA ETV Program for Vapor Intrusion

EPA Science Inventory

TITLE: EPA Environmental Technology Verification (ETV) Program Douglas W. Grosse Senior Environmental Engineer U.S. EPA, Office of Research and Development National Risk Management Research Laboratory National Risk Management Research Laboratory Environmental Technology A...

ORNL Fuels, Engines, and Emissions Research Center (FEERC)

ScienceCinema

None

2018-02-13

This video highlights the Vehicle Research Laboratory's capabilities at the Fuels, Engines, and Emissions Research Center (FEERC). FEERC is a Department of Energy user facility located at the Oak Ridge National Laboratory.

Material Transfer Agreement (MTA) | Frederick National Laboratory for Cancer Research

Cancer.gov

Material Transfer Agreements are appropriate for exchange of materials into or out of the Frederick National Laboratory for research or testing purposes, with no collaborative research by parties involving the materials.

EPIDEMIOLOGY AND EXPOSURE ASSESSMENT

EPA Science Inventory

Research collaborations between the National Health and Environmental Effects Research Laboratory (NHEERL) and the National Exposure Research Laboratory (NERL) centered on the development and application of exposure analysis tools in environmental epidemiology include the El Paso...

Profile of central research and application laboratory of Aǧrı İbrahim Çeçen University

NASA Astrophysics Data System (ADS)

Türkoǧlu, Emir Alper; Kurt, Murat; Tabay, Dilruba

2016-04-01

Aǧrı İbrahim Çeçen University built a central research and application laboratory (CRAL) in the east of Turkey. The CRAL possesses 7 research and analysis laboratories, 12 experts and researchers, 8 standard rooms for guest researchers, a restaurant, a conference hall, a meeting room, a prey room and a computer laboratory. The CRAL aims certain collaborations between researchers, experts, clinicians and educators in the areas of biotechnology, bioimagining, food safety & quality, omic sciences such as genomics, proteomics and metallomics. It also intends to develop sustainable solutions in agriculture and animal husbandry, promote public health quality, collect scientific knowledge and keep it for future generations, contribute scientific awareness of all stratums of society, provide consulting for small initiatives and industries. It has been collaborated several scientific foundations since 2011.

Regional Educational Laboratory Researcher-Practitioner Partnerships: Documenting the Research Alliance Experience. REL 2018-291

ERIC Educational Resources Information Center

Scher, Lauren; McCowan, Ronald; Castaldo-Walsh, Cynthia

2018-01-01

This report provides a detailed account of the Regional Educational Laboratory (REL) Program's experience establishing and supporting research-practice partnerships (called "research alliances") during its 2012-17 contract cycle. The report adds to the growing literature base on researcher-practitioner partnerships by sharing how the…

Thirty-Two Years of Forest Service Research at the Southern Forest Fire Laboratory in Macon, GA

Treesearch

USDA Forest Service

1991-01-01

When completed in 1959, the Southern Forest Fire Laboratory was the world?s first devoted entirely to the study of forest fires, Since then the scientists at the Laboratory have: 1) performed basic and applied research on critical fire problems of national interest, 2) conducted special regional research on fire problems peculiar to the 13 Southern States, and 3)...

PSE Aysis of Crossflow Instability on HifIre-5B Flight Test

DTIC Science & Technology

2017-06-05

AIR FORCE RESEARCH LABORATORY AEROSPACE SYSTEMS DIRECTORATE WRIGHT-PATTERSON AIR FORCE BASE, OH 45433-7542 AIR FORCE MATERIEL COMMAND UNITED...Air Force Research Laboratory, Aerospace Systems Directorate Wright-Patterson Air Force Base, OH 45433-7542 Air Force Materiel Command, United...States Air Force 9. SPONSORING/MONITORING AGENCY NAME(S) AND ADDRESS(ES) 10. SPONSORING/MONITORING Air Force Research Laboratory Aerospace Systems

Circumscribing Circumscription. A Guide to Relevance and Incompleteness,

DTIC Science & Technology

1985-10-01

other rules of conjecture, to account for resource limitations. P "- h’ MASSACHUSETTS INSTITUTE OF TECHNOLOGY ARTIFICIAL INTELLIGENCE LABORATORY A.I. Memo...of conjecture, to account for resource limitations. This report describes research done at the Artificial Intelligence Laboratory of the Massachusetts...Institute of Technology. Support for the laboratory’s artificial intelligence research is provided in part by the Advanced Research Projects Agency

A Hybrid Integrated Laboratory and Inquiry-Based Research Experience: Replacing Traditional Laboratory Instruction with a Sustainable Student-Led Research Project

ERIC Educational Resources Information Center

Hartings, Matthew R.; Fox, Douglas M.; Miller, Abigail E.; Muratore, Kathryn E.

2015-01-01

The Department of Chemistry at American University has replaced its junior- and senior-level laboratory curriculum with two, two-semester long, student-led research projects as part of the department's American Chemical Society-accredited program. In the first semester of each sequence, a faculty instructor leads the students through a set of…

33 CFR 334.170 - Chesapeake Bay, in the vicinity of Chesapeake Beach, Md.; firing range, Naval Research Laboratory.

Code of Federal Regulations, 2010 CFR

2010-07-01

... of Chesapeake Beach, Md.; firing range, Naval Research Laboratory. 334.170 Section 334.170 Navigation..., Naval Research Laboratory. (a) The danger zone—(1) Area A. A roughly rectangular area bounded on the... enter or remain in Area B or Area C between the hours of 1:00 p.m. and 5:00 p.m. daily except Sundays...

33 CFR 334.170 - Chesapeake Bay, in the vicinity of Chesapeake Beach, Md.; firing range, Naval Research Laboratory.

Code of Federal Regulations, 2011 CFR

2011-07-01

... of Chesapeake Beach, Md.; firing range, Naval Research Laboratory. 334.170 Section 334.170 Navigation..., Naval Research Laboratory. (a) The danger zone—(1) Area A. A roughly rectangular area bounded on the... enter or remain in Area B or Area C between the hours of 1:00 p.m. and 5:00 p.m. daily except Sundays...

HPV vaccine: immersed in controversy.

PubMed

Ohri, Linda K

2007-11-01

There has been substantial media coverage of the quadrivalent human papillomavirus (HPV) vaccine since the Food and Drug Administration approved Gardasil (Merck & Co., Inc.) on June 8, 2006. The most vocal complaints maintain that its use will promote promiscuity among teenagers, and condemn proposed mandated use for school entry. Some also question evidence for the vaccine's safety. There have been concerns raised by both providers and patients regarding financial barriers to access. Still others argue that additional populations could benefit who have not been included in current recommendations. Clarification of these issues is essential to advance optimal use of this important new vaccine. There is strong evidence to support HPV vaccine as an effective, safe, and efficient public health measure. School mandates are valuable tools to reduce disparities in availability of immunizations. The time has come to consider universal funding as a means to improve access to all recommended vaccines.

Does direct-to-consumer advertising affect patients' choice of pain medications?

PubMed

Liu, Yifei; Doucette, William R

2008-04-01

In the United States, direct-to-consumer advertising (DTCA) has grown rapidly to promote prescription medications, including analgesics. Few studies in the literature directly examine the association between DTCA and patients' choice of pain medications. This article discusses how DTCA affects such choice from a behavioral perspective, because DTCA-prompted behaviors are important indicators of DTCA's influence. After DTCA exposure, patients may request prescriptions, seek further medication information, and ask about advertised conditions. Patients who suffer from pain may seek more communication with their health care providers because they are cautious about the information quality of DTCA, mainly because of the recall of rofecoxib (Vioxx; Merck, Whitehouse Station, NJ). However, the availability and DTCA of over-the-counter analgesics complicate their treatment choice. Patients could use DTCA as a tool to launch health communication and make an informed treatment choice with the guidance of their health care providers.

Efficacy of live zoster vaccine in preventing zoster and postherpetic neuralgia

PubMed Central

Gilden, D.

2011-01-01

Declining cell-mediated immunity to varicella zoster virus (VZV) in elderly individuals results in virus reactivation manifest by zoster (shingles) and postherpetic neuralgia (PHN). To prevent virus reactivation, a new VZV vaccine (Zostavax, Merck) that boosts cell-mediated immunity to VZV was developed. The 3-year Shingles Prevention Study showed that Zostavax significantly reduced burden of disease due to zoster and PHN. Despite its cost-effectiveness for adults ages 65 to 75 years, as determined in the US, Canada and UK, less than 2% of immunocompetent adults over age 60 years in the US were immunized in 2007. This was due to a combination of lack of patient awareness of the vaccine, physicians’ uncertainty about the duration of protection, and different cost-sharing plans for immunization. Nevertheless, zoster vaccine is safe, effective, and highly recommended for immunization of immunocompetent individuals over age 60 years with no history of recent zoster. PMID:21294791

Inhibition mechanism of SAHA in HDAC: a revisit.

PubMed

Zhou, Jingwei; Wu, Ruibo; Luo, Hai-Bin

2015-11-28

SAHA (vorinostat, Merck) is a famous clinical drug for zinc-containing histone deacetylase (HDAC) targets against cancer and several other human disorders, whose inhibition mechanism (namely the protonation mechanism) upon binding to HDAC has been debated for more than ten years. It is very challenging to verify experimentally and is still controversial theoretically. The popular "Class-dependent" (namely "Tyr-dependent") hypothesis is that the deprotonation of SAHA is mostly regulated by the conserved Tyr308 in class I HDAC while it is replaced by the His843 in class IIa HDAC. Herein, by elaborate QM(DFT)/MM MD simulations, we exclude the prevalent "Class-dependent" mechanism and advance a novel "Metal-dependent" mechanism, where the remote second metal site (K(+) in most HDAC and Ca(2+) in HDAC2) determines the protonation of SAHA. This proof-of-principle "Metal-dependent" mechanism opens up a new avenue to utilize the second metal site for isoform-selective inhibitor design.

Institute for scientific computing research;fiscal year 1999 annual report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Keyes, D

2000-03-28

Large-scale scientific computation, and all of the disciplines that support it and help to validate it, have been placed at the focus of Lawrence Livermore National Laboratory by the Accelerated Strategic Computing Initiative (ASCI). The Laboratory operates the computer with the highest peak performance in the world and has undertaken some of the largest and most compute-intensive simulations ever performed. Computers at the architectural extremes, however, are notoriously difficult to use efficiently. Even such successes as the Laboratory's two Bell Prizes awarded in November 1999 only emphasize the need for much better ways of interacting with the results of large-scalemore » simulations. Advances in scientific computing research have, therefore, never been more vital to the core missions of the Laboratory than at present. Computational science is evolving so rapidly along every one of its research fronts that to remain on the leading edge, the Laboratory must engage researchers at many academic centers of excellence. In FY 1999, the Institute for Scientific Computing Research (ISCR) has expanded the Laboratory's bridge to the academic community in the form of collaborative subcontracts, visiting faculty, student internships, a workshop, and a very active seminar series. ISCR research participants are integrated almost seamlessly with the Laboratory's Center for Applied Scientific Computing (CASC), which, in turn, addresses computational challenges arising throughout the Laboratory. Administratively, the ISCR flourishes under the Laboratory's University Relations Program (URP). Together with the other four Institutes of the URP, it must navigate a course that allows the Laboratory to benefit from academic exchanges while preserving national security. Although FY 1999 brought more than its share of challenges to the operation of an academic-like research enterprise within the context of a national security laboratory, the results declare the challenges well met and well worth the continued effort. A change of administration for the ISCR occurred during FY 1999. Acting Director John Fitzgerald retired from LLNL in August after 35 years of service, including the last two at helm of the ISCR. David Keyes, who has been a regular visitor in conjunction with ASCI scalable algorithms research since October 1997, overlapped with John for three months and serves half-time as the new Acting Director.« less

DOE Office of Scientific and Technical Information (OSTI.GOV)

None, None

The Laboratory Directed Research and Development (LDRD) program at Oak Ridge National Laboratory (ORNL) reports its status to the U.S. Department of Energy (DOE) in March of each year. The program operates under the authority of DOE Order 413.2B, “Laboratory Directed Research and Development” (April 19, 2006), which establishes DOE’s requirements for the program while providing the Laboratory Director broad flexibility for program implementation. LDRD funds are obtained through a charge to all Laboratory programs. This report includes summaries of all ORNL LDRD research activities supported during FY 2011. The associated FY 2011 ORNL LDRD Self-Assessment (ORNL/PPA-2012/2) provides financial datamore » and an internal evaluation of the program’s management process.« less

DOE Office of Scientific and Technical Information (OSTI.GOV)

None, None

The Laboratory Directed Research and Development (LDRD) program at Oak Ridge National Laboratory (ORNL) reports its status to the U.S. Department of Energy (DOE) in March of each year. The program operates under the authority of DOE Order 413.2B, “Laboratory Directed Research and Development” (April 19, 2006), which establishes DOE’s requirements for the program while providing the Laboratory Director broad flexibility for program implementation. LDRD funds are obtained through a charge to all Laboratory programs. This report includes summaries of all ORNL LDRD research activities supported during FY 2010. The associated FY 2010 ORNL LDRD Self-Assessment (ORNL/PPA-2011/2) provides financial datamore » and an internal evaluation of the program’s management process.« less

46 CFR 35.30-30 - Portable electric equipment-TB/ALL.

Code of Federal Regulations, 2011 CFR

2011-10-01

..., explosion-proof lamps approved by Underwriters Laboratories Inc., Factory Mutual Research Corporation, or... Underwriters Laboratories Inc., Factory Mutual Research Corporation, or other independent laboratory recognized...; (iv) Filled with Grade E liquid; or (v) Spaces where flammable gases are not expected to accumulate...

46 CFR 35.30-30 - Portable electric equipment-TB/ALL.

Code of Federal Regulations, 2010 CFR

2010-10-01

..., explosion-proof lamps approved by Underwriters Laboratories Inc., Factory Mutual Research Corporation, or... Underwriters Laboratories Inc., Factory Mutual Research Corporation, or other independent laboratory recognized...; (iv) Filled with Grade E liquid; or (v) Spaces where flammable gases are not expected to accumulate...

46 CFR 35.30-30 - Portable electric equipment-TB/ALL.

Code of Federal Regulations, 2012 CFR

2012-10-01

..., explosion-proof lamps approved by Underwriters Laboratories Inc., Factory Mutual Research Corporation, or... Underwriters Laboratories Inc., Factory Mutual Research Corporation, or other independent laboratory recognized...; (iv) Filled with Grade E liquid; or (v) Spaces where flammable gases are not expected to accumulate...

46 CFR 35.30-30 - Portable electric equipment-TB/ALL.

Code of Federal Regulations, 2014 CFR

2014-10-01

..., explosion-proof lamps approved by Underwriters Laboratories Inc., Factory Mutual Research Corporation, or... Underwriters Laboratories Inc., Factory Mutual Research Corporation, or other independent laboratory recognized...; (iv) Filled with Grade E liquid; or (v) Spaces where flammable gases are not expected to accumulate...

46 CFR 35.30-30 - Portable electric equipment-TB/ALL.

Code of Federal Regulations, 2013 CFR

2013-10-01

..., explosion-proof lamps approved by Underwriters Laboratories Inc., Factory Mutual Research Corporation, or... Underwriters Laboratories Inc., Factory Mutual Research Corporation, or other independent laboratory recognized...; (iv) Filled with Grade E liquid; or (v) Spaces where flammable gases are not expected to accumulate...

Laboratory Directed Research and Development Program Assessment for FY 2016

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hatton, Diane; Flynn, Liz

2017-03-31

Each year, Brookhaven National Laboratory (BNL) is required to provide a program description and overview of its Laboratory Directed Research and Development Program (LDRD) to the Department of Energy in accordance with DOE Order 413.2C, and this report fulfills that requirement.

Nanotechnology Characterization Laboratory Unveils New Technical Services for Drug Developers | Frederick National Laboratory for Cancer Research

Cancer.gov

FREDERICK, Md. -- Drug developers now have access to a shared analytical technology, developed and provided by the Frederick National Laboratory for Cancer Research, that helps fine-tune nanomedicine formulations and overcomes a key hurdle on the pat

Laboratory Directed Research and Development Program Assessment for FY 2017

DOE Office of Scientific and Technical Information (OSTI.GOV)

Anderson, Jack; Flynn, Liz

Each year, Brookhaven National Laboratory (BNL) is required to provide a program description and overview of its Laboratory Directed Research and Development Program (LDRD) to the Department of Energy in accordance with DOE Order 413.2C. This report fulfills that requirement.

Sandia National Laboratories: Hydrogen Risk Assessment Models toolkit now

Science.gov Websites

Energy Stationary Power Earth Science Transportation Energy Energy Research Global Security WMD Cyber & Infrastructure Security Global Security Remote Sensing & Verification Research Research Robotics R&D 100 Awards Laboratory Directed Research & Development Technology Deployment Centers

Sandia National Laboratories: 100 Resilient Cities: Sandia Challenge:

Science.gov Websites

Accomplishments Energy Stationary Power Earth Science Transportation Energy Energy Research Global Security WMD Cyber & Infrastructure Security Global Security Remote Sensing & Verification Research Research Robotics R&D 100 Awards Laboratory Directed Research & Development Technology Deployment Centers

NATIONAL RISK MANAGEMENT RESEARCH LABORATORY: PROVIDING SOLUTIONS FOR A BETTER TOMORROW

EPA Science Inventory

This small, two-fold flyer contains general information introducing EPA's National Risk Management Research Laboratory and its research program. The key overarching areas of research described are: Protection of drinking water; control of air pollution; pollution prevention and e...

Sandia National Laboratories: National Security Missions: Defense Systems

Science.gov Websites

Accomplishments Energy Stationary Power Earth Science Transportation Energy Energy Research Global Security WMD Cyber & Infrastructure Security Global Security Remote Sensing & Verification Research Research Robotics R&D 100 Awards Laboratory Directed Research & Development Technology Deployment Centers

ECOSYSTEM RESTORATION RESEARCH THROUGH THE NATIONAL RISK MANAGEMENT RESEARCH LABORATORY (NRMRL)

EPA Science Inventory

The Ecosystem Restoration Research Program underway through ORD's National Risk Management Research Laboratory (NRMRL) has the long-term goal of providing watershed managers with "..state-of-the-science field-evaluated tools, technical guidance, and decision-support systems for s...

QUALITY ASSURANCE IN RESEARCH LABORATORIES: RULES AND REASON

EPA Science Inventory

Quality Assurance in Research Laboratories: Rules and Reason

Ron Rogers, Quality Assurance and Records Manager, Environmental Carcinogenesis Division, NHEERL/ORD/US EPA, Research Triangle Park, NC, 27709

To anyone who has actively participated in research, as I have...

The NASA Lewis Research Center High Temperature Fatigue and Structures Laboratory

NASA Technical Reports Server (NTRS)

Mcgaw, M. A.; Bartolotta, P. A.

1987-01-01

The physical organization of the NASA Lewis Research Center High Temperature Fatigue and Structures Laboratory is described. Particular attention is given to uniaxial test systems, high cycle/low cycle testing systems, axial torsional test systems, computer system capabilities, and a laboratory addition. The proposed addition will double the floor area of the present laboratory and will be equipped with its own control room.

DOE Office of Scientific and Technical Information (OSTI.GOV)

SLAC,

The Department of Energy (DOE) and the SLAC National Accelerator Laboratory (SLAC) encourage innovation, creativity, originality and quality to maintain the Laboratory’s research activities and staff at the forefront of science and technology. To further advance its scientific research capabilities, the Laboratory allocates a portion of its funds for the Laboratory Directed Research and Development (LDRD) program. With DOE guidance, the LDRD program enables SLAC scientists to make rapid and significant contributions that seed new strategies for solving important national science and technology problems. The LDRD program is conducted using existing research facilities.

Bibliography on Biomass Feedstock Research: 1978-2002

DOE Office of Scientific and Technical Information (OSTI.GOV)

Cushman, J.H.

2003-05-01

This report provides bibliographic citations for more than 1400 reports on biomass feedstock development published by Oak Ridge National Laboratory and its collaborators from 1978 through 2002. Oak Ridge National Laboratory is engaged in analysis of biomass resource supplies, research on the sustainability of feedstock resources, and research on feedstock engineering and infrastructure. From 1978 until 2002, Oak Ridge National Laboratory also provided technical leadership for the U.S. Department of Energy's Bioenergy Feedstock Development Program (BFDP), which supported research to identify and develop promising energy crops. This bibliography lists reports published by Oak Ridge National Laboratory and by its collaboratorsmore » in the BFDP, including graduate student theses and dissertations.« less

Kathleen Igo | Frederick National Laboratory for Cancer Research

Cancer.gov

Directorate: Clinical Research Program Department or lab: Clinical Monitoring Research Program (CMRP) How many years have you worked at the Frederick National Laboratory? I am in my 7th year of employment.

About the Director of EPA's National Health and Environmental Effects Research Laboratory (NHEERL)

EPA Pesticide Factsheets

Dr. Wayne Cascio serves as Acting Director for the National Health and Environmental Effects Research Laboratory (NHEERL) within the U.S. Environmental Protection Agency's Office of Research and Development (ORD).

Hood College, Frederick National Laboratory Will Renew Popular Scientific Symposium | Frederick National Laboratory for Cancer Research

Cancer.gov

FREDERICK, Md. -- Hood College and the Frederick National Laboratory for Cancer Research have partnered to cohost an annual scientific symposium in the tradition of the landmark Oncogene Meeting, a national fixture in Frederick for more than 20 year

History and Accomplishments of USDA-ARS Avian Disease and Oncology Laboratory

USDA-ARS?s Scientific Manuscript database

The USDA-Agricultural Research Service Avian Disease and Oncology Laboratory (ADOL) in East Lansing, Michigan, formerly known as Regional Poultry Research Laboratory, was dedicated on August 8, 1939. Its establishment was the result of joint efforts by the Agricultural Experiment Stations of the Nor...

IBBR and Frederick National Laboratory Collaborate to Study Vaccine-Boosting Compounds | Frederick National Laboratory for Cancer Research

Cancer.gov

The Frederick National Laboratory and the University of Maryland’s Institute for Bioscience and Biotechnology Research (IBBR) will work under a formal collaboration to evaluate the effectiveness of new compounds that might be used to enhance the im

Crime Laboratory Proficiency Testing Research Program.

ERIC Educational Resources Information Center

Peterson, Joseph L.; And Others

A three-year research effort was conducted to design a crime laboratory proficiency testing program encompassing the United States. The objectives were to: (1) determine the feasibility of preparation and distribution of different classes of physical evidence; (2) assess the accuracy of criminalistics laboratories in the processing of selected…

A laboratory animal science pioneer.

PubMed

Kostomitsopoulos, Nikolaos

2014-11-01

Nikolaos Kostomitsopoulos, DVM, PhD, is Head of Laboratory Animal Facilities and Designated Veterinarian, Center of Clinical, Experimental Surgery and Translational Research, Biomedical Research Foundation of the Academy of Athens, Athens, Greece. Dr. Kostomitsopoulos discusses his successes in implementing laboratory animal science legislation and fostering collaboration among scientists in Greece.

Through Microgravity and Towards the Stars: Microgravity and Strategic Research at Marshall's Biological and Physical Space Research Laboratory

NASA Technical Reports Server (NTRS)

Curreri, Peter A.

2003-01-01

The Microgravity and Strategic research at Marshall s Biological and Physical Space Research Laboratory will be reviewed. The environment in orbit provides a unique opportunity to study Materials Science and Biotechnology in the absence of sedimentation and convection. There are a number of peer-selected investigations that have been selected to fly on the Space Station that have been conceived and are led by Marshall s Biological and Physical Research Laboratory s scientists. In addition to Microgravity research the Station will enable research in "Strategic" Research Areas that focus on enabling humans to live, work, and explore the solar system safely. New research in Radiation Protection, Strategic Molecular Biology, and In-Space Fabrication will be introduced.

FRESHWATER FINDINGS, 1979-1982: RESEARCH PUBLICATIONS OF THE ENVIRONMENTAL RESEARCH LABORATORY, DULUTH, MINNESOTA

EPA Science Inventory

This report contains citations of publications for the years 1979-1982 on research conducted or supported by the Environmental Research Laboratory-Duluth. All published material has been organized into two major categories: (1) Journal Articles, Book Chapters, Proceedings, etc., ...

Guidance for Human Subjects Research in the National Exposure Research Laboratory

EPA Science Inventory

This document provides guidance to investigators and managers associated with the U.S. Environmental Protection Agency (EPA) Office of Research and Development (ORD)’s National Exposure Research Laboratory (NERL) on the ethical conduct, regulatory review, and approval of all huma...

Manufacturing information system

NASA Astrophysics Data System (ADS)

Allen, D. K.; Smith, P. R.; Smart, M. J.

1983-12-01

The size and cost of manufacturing equipment has made it extremely difficult to perform realistic modeling and simulation of the manufacturing process in university research laboratories. Likewise the size and cost factors, coupled with many uncontrolled variables of the production situation has even made it difficult to perform adequate manufacturing research in the industrial setting. Only the largest companies can afford manufacturing research laboratories; research results are often held proprietary and seldom find their way into the university classroom to aid in education and training of new manufacturing engineers. It is the purpose for this research to continue the development of miniature prototype equipment suitable for use in an integrated CAD/CAM Laboratory. The equipment being developed is capable of actually performing production operations (e.g. drilling, milling, turning, punching, etc.) on metallic and non-metallic workpieces. The integrated CAD/CAM Mini-Lab is integrating high resolution, computer graphics, parametric design, parametric N/C parts programmings, CNC machine control, automated storage and retrieval, with robotics materials handling. The availability of miniature CAD/CAM laboratory equipment will provide the basis for intensive laboratory research on manufacturing information systems.

A woman like you: Women scientists and engineers at Brookhaven National Laboratory

DOE Office of Scientific and Technical Information (OSTI.GOV)

Benkovitz, Carmen; Bernholc, Nicole; Cohen, Anita

1991-01-01

This publication by the women in Science and Engineering introduces career possibilities in science and engineering. It introduces what work and home life are like for women who have already entered these fields. Women at Brookhaven National Laboratory work in a variety of challenging research roles -- from biologist and environmental scientist to safety engineer, from patent lawyer to technician. Brookhaven National Laboratory is a multi-program laboratory which carries out basic and applied research in the physical, biomedical and environmental sciences and in selected energy technologies. The Laboratory is managed by Associated University, Inc., under contract with the US Departmentmore » of Energy. Brookhaven and the other national laboratories, because of their enormous research resources, can play a critical role in a education and training of the workforce.« less

A woman like you: Women scientists and engineers at Brookhaven National Laboratory. Careers in action

DOE Office of Scientific and Technical Information (OSTI.GOV)

Not Available

1991-12-31

This publication by the women in Science and Engineering introduces career possibilities in science and engineering. It introduces what work and home life are like for women who have already entered these fields. Women at Brookhaven National Laboratory work in a variety of challenging research roles -- from biologist and environmental scientist to safety engineer, from patent lawyer to technician. Brookhaven National Laboratory is a multi-program laboratory which carries out basic and applied research in the physical, biomedical and environmental sciences and in selected energy technologies. The Laboratory is managed by Associated University, Inc., under contract with the US Departmentmore » of Energy. Brookhaven and the other national laboratories, because of their enormous research resources, can play a critical role in a education and training of the workforce.« less