75 FR 38097 - Agency Information Collection Activities; Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-01

....jsp ), you may also file an electronic comment through that website. The Commission will consider all comments that regulations.gov forwards to it. You may also visit the FTC website at ( http://www.ftc.gov... will be available to the public on the FTC Website, to the extent practicable, at ( http://www.ftc.gov...

78 FR 79451 - Service Corporation International, and Stewart Enterprises, Inc.; Analysis of Agreement...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-30

....commentworks.com/ftc/scistewartconsent by following the instructions on the web-based form. If you prefer to... Wide Web, at http://www.ftc.gov/os/actions.shtm . A paper copy can be obtained from the FTC Public... extent practicable, on the public Commission Web site, at http://www.ftc.gov/os/publiccomments.shtm . As...

Solar industry advertising guidelines. Task III

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

Hostetler, J.S.

The purpose of these guidelines is to acquaint SEIA members with basic principles of Federal Trade Commission (FTC) law related to advertising and sales representations in order to assist SEIA members in insuring that their advertising is fair and accurate when assessed against FTC standards, thereby avoiding potentially costly FTC action. The following are discussed: the nature of advertising, when is an advertisement deceptive, advertising of product certification and testing results, substantiation for advertising claims, advertising of tax credits, warranty advertising, potential liabilities under the FTC Act, and recommendations for avoiding FTC action. (MHR)

A Novel Topology Control Approach to Maintain the Node Degree in Dynamic Wireless Sensor Networks

PubMed Central

Huang, Yuanjiang; Martínez, José-Fernán; Díaz, Vicente Hernández; Sendra, Juana

2014-01-01

Topology control is an important technique to improve the connectivity and the reliability of Wireless Sensor Networks (WSNs) by means of adjusting the communication range of wireless sensor nodes. In this paper, a novel Fuzzy-logic Topology Control (FTC) is proposed to achieve any desired average node degree by adaptively changing communication range, thus improving the network connectivity, which is the main target of FTC. FTC is a fully localized control algorithm, and does not rely on location information of neighbors. Instead of designing membership functions and if-then rules for fuzzy-logic controller, FTC is constructed from the training data set to facilitate the design process. FTC is proved to be accurate, stable and has short settling time. In order to compare it with other representative localized algorithms (NONE, FLSS, k-Neighbor and LTRT), FTC is evaluated through extensive simulations. The simulation results show that: firstly, similar to k-Neighbor algorithm, FTC is the best to achieve the desired average node degree as node density varies; secondly, FTC is comparable to FLSS and k-Neighbor in terms of energy-efficiency, but is better than LTRT and NONE; thirdly, FTC has the lowest average maximum communication range than other algorithms, which indicates that the most energy-consuming node in the network consumes the lowest power. PMID:24608008

A multicenter randomized controlled trial of two group education programs for fatigue in multiple sclerosis: Long-term (12-month) follow-up at one site.

PubMed

Hugos, Cinda L; Cameron, Michelle H; Chen, Zunqiu; Chen, Yiyi; Bourdette, Dennis

2018-05-01

A four-site RCT of Fatigue: Take Control (FTC), a multicomponent group program, found no significant differences from a control program, MS: Take Control (MSTC), in fatigue on the Modified Fatigue Impact Scale (MFIS) through 6 months. Assess FTC for a delayed effect on fatigue. Of 78 subjects at one site, 74 randomized to FTC or MSTC completed the MFIS at 12 months. Compared to baseline, FTC produced greater improvements in MFIS scores than MSTC (FTC -8.9 (confidence interval (CI): 32.2, 45), MSTC -2.5 (CI 39.6, 47.7), p = 0.03) at 12 months. The delayed effect of FTC on fatigue suggests the need for longer follow-up when assessing interventions for fatigue.

Front teeth-to-carina distance in children undergoing cardiac catheterization.

PubMed

Hunyady, Agnes I; Pieters, Benjamin; Johnston, Troy A; Jonmarker, Christer

2008-06-01

Knowledge of normal front teeth-to-carina distance (FT-C) might prevent accidental bronchial intubation. The aim of the current study was to measure FT-C and to examine whether the Morgan formula for oral intubation depth, i.e., endotracheal tube (ETT) position at front teeth (cm) = 0.10 x height (cm) + 5, gives appropriate guidance when intubating children of different ages. FT-C was measured in 170 infants and children, aged 1 day to 19 yr, undergoing cardiac catheterization. FT-C was obtained as the sum of the ETT length at the upper front teeth/dental ridge and the distance from the ETT tip to the carina. The latter measure was taken from an anterior-posterior chest x-ray. There was close linear correlation between FT-C and height: FT-C (cm) = 0.12 x height (cm) + 5.2, R = 0.98. The linear correlation coefficients (R) for FT-C versus weight and age were 0.78 and 0.91, respectively. If the Morgan formula had been used for intubation, the ETT tip would have been at 90 +/- 4% of FT-C. No patient would have been bronchially intubated, but the ETT tip would have been less than 0.5 cm from the carina in 13 infants. FT-C can be well predicted from the height/length of the child. The Morgan formula provides good guidance for intubation in children but can result in a distal ETT tip position in small infants. Careful auscultation is necessary to ensure correct tube position.

16 CFR 436.3 - Cover page.

Code of Federal Regulations, 2010 CFR

2010-01-01

... business address, telephone number, and, if applicable, email address and primary home page address. (c) A... Commission. You can contact the FTC at 1-877-FTC-HELP or by writing to the FTC at 600 Pennsylvania Avenue, NW...

Rilpivirine versus efavirenz with emtricitabine/tenofovir disoproxil fumarate in treatment-naïve HIV-1-infected patients with HIV-1 RNA ≤100,000 copies/mL: week 96 pooled ECHO/THRIVE subanalysis.

PubMed

Behrens, Georg; Rijnders, Bart; Nelson, Mark; Orkin, Chloe; Cohen, Calvin; Mills, Anthony; Elion, Richard A; Vanveggel, Simon; Stevens, Marita; Rimsky, Laurence; Thorpe, David; Bosse, Matthew; White, Kirsten; Zhong, Lijie; DeMorin, Jennifer; Chuck, Susan K

2014-04-01

The once daily, single-tablet regimen (STR) combining rilpivirine (RPV), emtricitabine (FTC), and tenofovir disoproxil fumarate (TDF) provides a simplified treatment option for antiretroviral therapy (ART)-naïve patients with baseline HIV-1 RNA (BLVL) of ≤100,000 copies/mL. The aim of this analysis is to compare long-term efficacy, safety, and tolerability of RPV+FTC/TDF vs. efavirenz (EFV)+FTC/TDF as individual components in subjects with BLVL ≤100,000 copies/mL. Week 96 efficacy and safety data from subjects with BLVL ≤100,000 copies/mL, who received daily RPV 25 mg or EFV 600 mg with FTC/TDF in the phase 3, randomized, double-blind, double-dummy, active-controlled, registrational trials ECHO and THRIVE, were analyzed. Virologic response was evaluated by intent-to-treat, time to loss of virological response (ITT-TLOVR), and Snapshot algorithms. Through Week 96, RPV+FTC/TDF demonstrated non-inferior efficacy to EFV+FTC/TDF (84% vs. 81%, respectively; ITT-TLOVR) in 543 subjects with BLVL ≤100,000 copies/mL, and overall rates of virologic failure (VF) were 5.9% vs. 2.4%, respectively. Resistance development was lower in Year 2 than Year 1. Subjects in both arms with suboptimal adherence (≤95%) had lower virologic responses (63% vs. 62%, respectively). Treatment with RPV+FTC/TDF was associated with significantly fewer treatment-related adverse events (AEs), grade 2-4 AEs, neurological and psychiatric AEs (including dizziness and abnormal dreams/nightmares), and rash. Additionally, grade 2-4 treatment-emergent laboratory abnormalities and grade 1-3 lipid abnormalities were significantly less common with RPV+FTC/TDF than EFV+FTC/TDF. RPV+FTC/TDF demonstrated non-inferior efficacy to EFV+FTC/TDF in ART-naïve subjects with BLVL ≤100,000 copies/mL and was associated with a higher rate of VF but a more favorable safety and tolerability profile through Week 96.

Reassuring Birth Outcomes With Tenofovir/Emtricitabine/Efavirenz Used for Prevention of Mother-to-Child Transmission of HIV in Botswana.

PubMed

Zash, Rebecca; Souda, Sajini; Chen, Jennifer Y; Binda, Kelebogile; Dryden-Peterson, Scott; Lockman, Shahin; Mmalane, Mompati; Makhema, Joseph; Essex, Max; Shapiro, Roger

2016-04-01

Before introduction of tenofovir/emtricitabine/efavirenz (TDF/FTC/EFV), 3-drug antiretroviral therapy (ART) was associated with increased adverse birth outcomes when used for prevention of mother-to-child HIV transmission (PMTCT) in Botswana. We extracted obstetric records from all women at the 2 largest maternities in Botswana from 2009-2011 when Botswana National Guidelines recommended zidovudine (ZDV) from 28 weeks gestational age (GA) for CD4 ≥350 and ART for CD4 <350, and again in 2013-2014 after implementation of TDF/FTC/EFV for prevention of mother-to-child HIV transmission regardless of CD4 or GA. We compared the use of TDF/FTC/EFV in pregnancy with other 3-drug ART regimens, and with initiation of ZDV, among women with similar CD4 cell counts. Outcomes included small for gestational age (SGA), preterm delivery (PTD) (<37 weeks GA), and stillbirths (SB). Among 9445 HIV-infected women delivering during the study period, 170 were on TDF/FTC/EFV at conception and 1468 initiated TDF/FTC/EFV during pregnancy. Adverse birth outcomes were high overall (3% SB, 21% PTD, and 18% SGA) and among women receiving TDF/FTC/EFV (3% SB, 22% PTD, and 12% SGA). There was no difference in PTD or SB among women initiating TDF/FTC/EFV compared with ZDV or other 3-drug ART, but initiating TDF/FTC/EFV was associated with fewer SGA infants than other 3-drug ART (adjusted odds ratio: 0.4, 95% confidence interval: 0.2 to 0.7). Adverse birth outcomes remain high among HIV-infected women. TDF/FTC/EFV was at least as safe as other ART and associated with fewer SGA infants when initiated during pregnancy. Larger studies are needed to evaluate birth outcomes and congenital abnormalities among women on TDF/FTC/EFV at conception.

Re-induction of cell differentiation and (131)I uptake in dedifferentiated FTC-133 cell line by TSHR gene transfection.

PubMed

Feng, Fang; Wang, Hui; Hou, Shasha; Fu, Hongliang

2012-11-01

Radioiodine therapy is commonly used to treat differentiated thyroid cancer (DTC), but a major challenge is dedifferentiation of DTC with the loss of radioiodine uptake. TSHR is a key molecule regulating thyrocyte proliferation and function. This study aimed to test the therapeutic potential of TSHR in dedifferentiated DTC by gene transfection in order to restore cell differentiation and radioiodine uptake. Dedifferentiated FTC-133 (dFTC-133) cells were obtained by monoclonal culture of FTC-133 cell line after (131)I radiation. Recombinant plasmid pcDNA3.1-hTSHR was transfected into dFTC-133 cells by using Lipofectamine 2000 reagent. Immunofluorescence analysis was carried out to confirm TSHR expression and its location. Radioiodine uptake assay was thereafter investigated. mRNAs and proteins of TSHR and other thyroid differentiated markers were detected by real-time PCR and western blot respectively. Among the thyroid specific genes in dFTC-133 cells with stable low radioiodine uptake, TSHR was down-regulated most significantly compared with FTC-133. Then, after TSHR gene transfection, augmented expression of TSHR was observed in dFTC-133 cell surface and cytoplasm by immunofluorescence analysis. It was found that (125)I uptake was 2.9 times higher (t=28.63, P<.01) in cells with TSHR transfection than control. The mRNAs of TSHR, NIS, TPO and Tg were also significantly increased by 1.7 times (t=13.8, P<.05), 4 times (t=28.52, P<.05), 1.5 times (t=14.43, P<.05) and 2.2 times (t=19.83, P<.05) respectively compared with control group. Decreased TSHR expression correlated with FTC-133 ongoing dedifferentiation. TSHR transfection contributed to the re-differentiation of dedifferentiated thyroid follicular carcinoma cells. Copyright © 2012 Elsevier Inc. All rights reserved.

Patient-Reported Symptoms on the Antiretroviral Regimen Efavirenz/Emtricitabine/Tenofovir

PubMed Central

Gordon, Kirsha; Rodriguez-Barradas, Maria C.; Justice, Amy C.

2012-01-01

Abstract Most patients (80–90%) newly diagnosed with HIV are started on the antiretroviral regimen efavirenz, emtricitabine, and tenofovir (EFV/FTC/TDF). Existing studies of patient tolerability, however, are limited. We compared symptom experiences of patients on EFV/FTC/TDF, and the subsequent impact on health-related quality of life, with those of patients on other combination antiretroviral therapy (cART). We conducted a cross-sectional analysis of the Veterans Aging Cohort Study from February 2008 to August 2009 to compare the symptom experiences of patients on EFV/FTC/TDF vs. other cART, unadjusted and then adjusted for treatment characteristics, and comorbid disease severity. We then assessed the association between EFV/FTC/TDF use and health-related quality of life. Among the 1,759 patients in our analytic sample, EFV/FTC/TDF use was associated with fewer symptoms than was other cART. The use of EFV/FTC/TDF was independently associated with health-related quality of life, and this association was at least partially explained by symptom burden. PMID:22612469

The effect of low light intensity on the maintenance of circadian synchrony in human subjects

NASA Technical Reports Server (NTRS)

Winget, C. M.; Lyman, J.; Beljan, J. R.

1976-01-01

Experiments were conducted on six healthy male subjects aged 20-23 yr and exposed for 21 days in a confined regulated environment to 16L:8D light:dark cycle with a view toward determining whether the light environment of 16L:8D at the relatively low light intensity of 15 ft.c. is adequate for the maintenance of circadian synchrony in man. The light intensity was 100 ft.c. during the first seven days, reduced to 15 ft.c. during the next seven days, and increased again to 100 ft.c. during the last seven days. Rectal temperature (RT) and heart rate (HR) were recorded throughout the three phases. In the 100 ft.c. regime, the RT and HR rhythms remained stable and circadian throughout. It is shown that 15 ft.c. light intensity is at or below threshold for maintaining circadian synchrony of human physiologic rhythms marked by instability and internal desynchronization with degradation of performance and well-being.

Sino-implant (II)® continuation and effect of concomitant tenofovir disoproxil fumarate-emtricitabine use on plasma levonorgestrel concentrations among women in Bondo, Kenya.

PubMed

Todd, Catherine S; Deese, Jennifer; Wang, Meng; Hubacher, David; Steiner, Markus J; Otunga, Sheila; Van Damme, Lut

2015-03-01

The objective was to assess associations between tenofovir disoproxil fumarate-emtricitabine (TDF-FTC) exposure and levonorgestrel (LNG) concentrations among Kenyan HIV prevention trial participants using Sino-implant (II) LNG implants for contraception. Women were offered implants among other contraceptive methods, were randomized to daily TDF-FTC or placebo, and followed monthly up to 56weeks. Associations between TDF-FTC exposure and mean LNG values were analyzed with linear mixed models. Of 739 women, 29 (3.9%) received implants with no incident pregnancies and one discontinuation. Mean LNG concentrations over 56weeks among 28 women contributing data ranged between 214.0 and 659.8pg/mL with no significant difference between TDF-FTC and placebo arms or between variable levels of TDF-FTC adherence. Concomitant TDF-FTC use was not associated with a significant change in plasma LNG concentrations among women using Sino-implant (II) in the first year of use. Copyright © 2015 Elsevier Inc. All rights reserved.

A Consumer's Guide to the Federal Trade Commission.

ERIC Educational Resources Information Center

Williams, Elizabeth

This publication presents consumer information designed to encourage and facilitate active citizen involvement in Federal Trade Commission (FTC) proceedings. Nine chapters are included, covering (1) the FTC and its impact on consumers (discusses the authority of FTC, the Bureau of Competition, the Bureau of Consumer Protection, and lists FTC…

A case study of chewed Truvada® for PrEP maintaining protective drug levels as measured by a novel urine tenofovir assay.

PubMed

Lalley-Chareczko, Linden; Clark, Devon; Zuppa, Athena F; Moorthy, Ganesh; Conyngham, Caitlin; Mounzer, Karam; Koenig, Helen

2017-01-01

Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF; Truvada ® ) given as pre-exposure prophylaxis (PrEP) successfully blocks HIV when taken once daily prior to potential HIV exposure. A 22-year-old male reported difficulty swallowing FTC/TDF for PrEP and subsequently began chewing the FTC/TDF tablets. Monthly urine samples assessed using liquid chromatography-tandem mass spectrometry (LC-MS/MS) indicated tenofovir levels >1,000 ng/ml, indicative of protection from HIV acquisition, over a 48-week period. Data from observational studies of HIV-positive patients details the successful treatment of HIV using crushed FTC/TDF delivered via feeding and gastronomy tubes while small, randomized trials of healthy volunteers demonstrate bioequivalence between whole and crushed FTC/TDF.

Prediction of secondary generalization from a focal onset seizure in intracerebral EEG.

PubMed

Karthick, P A; Tanaka, Hideaki; Khoo, Hui Ming; Gotman, Jean

2018-05-01

We propose a system based on the first five seconds of intracerebrally recorded focal seizures to predict their evolution from focal to bilateral tonic-clonic seizure (FTC), to spread outside the onset zone but without tonic-clonic component (FS), or to a seizure remaining focal (F). Nineteen time and frequency domain features were extracted from 39 seizures of 32 patients and were subjected to support vector machine based classification. Three prediction approaches regarding seizure evolution were (1) FTC vs FS vs F, (2) FTC vs FS or F and (3) FTC or FS vs F. We used 21 seizures for training. Most features had significantly different distributions in the three seizure types (p < 0.05). Eighteen seizures were used for testing. We predicted the evolution of 12 seizures in FTC vs FS vs F, 13 seizures in FTC vs FS or F and 14 seizures in FTC or FS vs F. The first five seconds of a focal seizure contains information regarding the eventual evolution of the seizure, which could be predicted in most seizures. The proposed system could alert the health care team when a patient is hospitalized for intracerebral EEG and improve safety and eventually result in an implantable device. Copyright © 2018 International Federation of Clinical Neurophysiology. Published by Elsevier B.V. All rights reserved.

SWIFT: Prospective 48-Week Study to Evaluate Efficacy and Safety of Switching to Emtricitabine/Tenofovir From Lamivudine/Abacavir in Virologically Suppressed HIV-1 Infected Patients on a Boosted Protease Inhibitor Containing Antiretroviral Regimen

PubMed Central

Campo, R.; DeJesus, E.; Bredeek, U. F.; Henry, K.; Khanlou, H.; Logue, K.; Brinson, C.; Benson, P.; Dau, L.; Wang, H.; White, K.; Flaherty, J.; Fralich, T.; Guyer, B.; Piontkowsky, D.

2013-01-01

Background. In the United States, emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) is a preferred nucleoside reverse transcriptase inhibitor (NRTI) backbone with lamivudine/abacavir (3TC/ABC) as a commonly used alternative. For patients infected with human immunodeficiency virus (HIV-1) virologically suppressed on a boosted protease inhibitor (PI) + 3TC/ABC regimen, the merits of switching to FTC/TDF as the NRTI backbone are unknown. Methods. SWIFT was a prospective, randomized, open-label 48-week study to evaluate efficacy and safety of switching to FTC/TDF. Subjects receiving 3TC/ABC + PI + ritonavir (RTV) with HIV-1 RNA < 200 c/mL ≥3 months were randomized to continue 3TC/ABC or switch to FTC/TDF. The primary endpoint was time to loss of virologic response (TLOVR) with noninferiority measured by delta of 12%. Virologic failure (VF) was defined as confirmed rebound or the last HIV-1 RNA measurement on study drug ≥200 c/mL. Results. In total, 311 subjects were treated in this study (155 to PI + RTV + FTC/TDF, 156 to PI + RTV + 3TC/ABC). Baseline characteristics were similar between the arms: 85% male, 28% black, median age, 46 years; and median CD4 532 cells/mm3. By TLOVR through week 48, switching to FTC/TDF was noninferior compared to continued 3TC/ABC (86.4% vs 83.3%, treatment difference 3.0% (95% confidence interval, −5.1% to 11.2%). Fewer subjects on FTC/TDF experienced VF (3 vs 11; P = .034). FTC/TDF showed greater declines in fasting low-density lipoproteins (LDL), total cholesterol (TC), and triglycerides (TG) with significant declines in LDL and TC beginning at week 12 with no TC/HDL ratio change. Switching to FTC/TDF showed improved NCEP thresholds for TC and TG and improved 10-year Framingham TC calculated scores. Decreased epidermal growth factor receptor (eGFR) was observed in both arms with a larger decrease in the FTC/TDF arm. Conclusions. Switching to FTC/TDF from 3TC/ABC maintained virologic suppression, had fewer VFs, improved lipid parameters and Framingham scores but decreased eGFR. ClinicalTrials.gov identifier. NCT00724711. PMID:23362296

Development of a Test Facility for Air Revitalization Technology Evaluation

NASA Technical Reports Server (NTRS)

Lu, Sao-Dung; Lin, Amy; Campbell, Melissa; Smith, Frederick

2006-01-01

An active fault tolerant control (FTC) law is generally sensitive to false identification since the control gain is reconfigured for fault occurrence. In the conventional FTC law design procedure, dynamic variations due to false identification are not considered. In this paper, an FTC synthesis method is developed in order to consider possible variations of closed-loop dynamics under false identification into the control design procedure. An active FTC synthesis problem is formulated into an LMI optimization problem to minimize the upper bound of the induced-L2 norm which can represent the worst-case performance degradation due to false identification. The developed synthesis method is applied for control of the longitudinal motions of FASER (Free-flying Airplane for Subscale Experimental Research). The designed FTC law of the airplane is simulated for pitch angle command tracking under a false identification case.

Gain-Scheduled Fault Tolerance Control Under False Identification

NASA Technical Reports Server (NTRS)

Shin, Jong-Yeob; Belcastro, Christine (Technical Monitor)

2006-01-01

An active fault tolerant control (FTC) law is generally sensitive to false identification since the control gain is reconfigured for fault occurrence. In the conventional FTC law design procedure, dynamic variations due to false identification are not considered. In this paper, an FTC synthesis method is developed in order to consider possible variations of closed-loop dynamics under false identification into the control design procedure. An active FTC synthesis problem is formulated into an LMI optimization problem to minimize the upper bound of the induced-L2 norm which can represent the worst-case performance degradation due to false identification. The developed synthesis method is applied for control of the longitudinal motions of FASER (Free-flying Airplane for Subscale Experimental Research). The designed FTC law of the airplane is simulated for pitch angle command tracking under a false identification case.

Effects of Emtricitabine/Tenofovir on Bone Mineral Density in HIV-Negative Persons in a Randomized, Double-Blind, Placebo-Controlled Trial

PubMed Central

Mulligan, Kathleen; Glidden, David V.; Anderson, Peter L.; Liu, Albert; McMahan, Vanessa; Gonzales, Pedro; Ramirez-Cardich, Maria Esther; Namwongprom, Sirianong; Chodacki, Piotr; de Mendonca, Laura Maria Carvalo; Wang, Furong; Lama, Javier R.; Chariyalertsak, Suwat; Guanira, Juan Vicente; Buchbinder, Susan; Bekker, Linda-Gail; Schechter, Mauro; Veloso, Valdilea G.; Grant, Robert M.; Vargas, Lorena; Sanchez, Jorge; Mai, Chiang; Saokhieo, Pongpun; Murphy, Kerry; Gilmore, Hailey; Holland, Sally; Faber, Elizabeth; Duda, John; Bewerunge, Linda; Batist, Elizabeth; Hoskin, Christine; Brown, Ben; de Janeiro, Rio; Beppu-Yoshida, Carina; da Costa, Marcellus Dias; Assis de Jesus, Sergio Carlos; Grangeiro da Silva, Jose Roberto; Millan, Roberta; de Siqueira Hoagland, Brenda Regina; Martinez Fernandes, Nilo; da Silva Freitas, Lucilene; Grinsztejn, Beatriz; Pilotto, Jose; Bushman, Lane; Zheng, Jia-Hua; Anthony Guida, Louis; Kline, Brandon; Goicochea, Pedro; Manzo, Jonathan; Hance, Robert; McConnell, Jeff; Defechereux, Patricia; Levy, Vivian; Robles, Malu; Postle, Brian; Burns, David; Rooney, James

2015-01-01

Background. Daily preexposure prophylaxis (PrEP) with oral emtricitabine and tenofovir disoproxil fumarate (FTC/TDF) decreases the risk of human immunodeficiency virus (HIV) acquisition. Initiation of TDF decreases bone mineral density (BMD) in HIV-infected people. We report the effect of FTC/TDF on BMD in HIV-seronegative men who have sex with men and in transgender women. Methods. Dual-energy X-ray absorptiometry was performed at baseline and 24-week intervals in a substudy of iPrEx, a randomized, double-blind, placebo-controlled trial of FTC/TDF PrEP. Plasma and intracellular tenofovir concentrations were measured in participants randomized to FTC/TDF. Results. In 498 participants (247 FTC/TDF, 251 placebo), BMD in those randomized to FTC/TDF decreased modestly but statistically significantly by 24 weeks in the spine (net difference, −0.91% [95% confidence interval {CI}, −1.44% to −.38%]; P = .001) and hip (−0.61% [95% CI, −.96% to −.27%], P = .001). Changes within each subsequent 24-week interval were not statistically significant. Changes in BMD by week 24 correlated inversely with intracellular tenofovir diphosphate (TFV-DP), which was detected in 53% of those randomized to FTC/TDF. Net BMD loss by week 24 in participants with TFV-DP levels indicative of consistent dosing averaged −1.42% ± 29% and −0.85% ± 19% in the spine and hip, respectively (P < .001 vs placebo). Spine BMD tended to rebound following discontinuation of FTC/TDF. There were no differences in fractures (P = .62) or incidence of low BMD. Conclusions. In HIV-uninfected persons, FTC/TDF PrEP was associated with small but statistically significant decreases in BMD by week 24 that inversely correlated with TFV-DP, with more stable BMD thereafter. Clinical Trials Registration. NCT00458393. PMID:25908682

Parameter Transient Behavior Analysis on Fault Tolerant Control System

NASA Technical Reports Server (NTRS)

Belcastro, Christine (Technical Monitor); Shin, Jong-Yeob

2003-01-01

In a fault tolerant control (FTC) system, a parameter varying FTC law is reconfigured based on fault parameters estimated by fault detection and isolation (FDI) modules. FDI modules require some time to detect fault occurrences in aero-vehicle dynamics. This paper illustrates analysis of a FTC system based on estimated fault parameter transient behavior which may include false fault detections during a short time interval. Using Lyapunov function analysis, the upper bound of an induced-L2 norm of the FTC system performance is calculated as a function of a fault detection time and the exponential decay rate of the Lyapunov function.

Farm-to-Consumer Retail Outlet Use, Fruit and Vegetable Intake, and Obesity Status among WIC Program Participants in Alabama.

PubMed

Singleton, Chelsea R; Baskin, Monica; Levitan, Emily B; Sen, Bisakha; Affuso, Ermanno; Affuso, Olivia

2016-07-01

We studied whether use of farm-to-consumer (FTC) retail outlets (eg, farmers market, farm/roadside stand) was associated with daily fruit and vegetable (F&V) intake or obesity status among women who participate in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) in Birmingham, AL. We used a cross-sectional study design and recruited a convenience sample of 312 women (mean age = 27.6; 67.0% non-Hispanic black; 45.6% obese) participating in Birmingham's WIC Program. Participants were recruited between October 2014 and January 2015. Participants who self-reported purchasing produce from a FTC outlet during the 2014 farmers' market season were classified as FTC outlet users. Multivariable-adjusted regression models were used to examine associations between FTC outlet use, daily F&V intake, and obesity status (ie, body mass index ≥ 30). Approximately 26.1% of participants were classified as FTC outlet users. After adjusting for socio-demographic factors and WIC Cash Value Voucher redemption, FTC outlet use was associated with increased odds of consuming ≥ 5 servings of F&Vs per day (OR: 2.01; 95%: 1.15 - 3.50), but not obesity status (OR: 0.68; 95% CI: 0.39 - 1.20). FTC retail outlet use was associated with F&V intake among program participants but not obesity status.

Farm-to-Consumer Retail Outlet Use, Fruit and Vegetable Intake, and Obesity Status among WIC Program Participants in Alabama

PubMed Central

Singleton, Chelsea R.; Baskin, Monica; Levitan, Emily B.; Sen, Bisakha; Affuso, Ermanno; Affuso, Olivia

2017-01-01

Objectives We studied whether use of farm-to-consumer (FTC) retail outlets (eg, farmers market, farm/roadside stand) was associated with daily fruit and vegetable (F&V) intake or obesity status among women who participate in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) in Birmingham, AL. Methods We used a cross-sectional study design and recruited a convenience sample of 312 women (mean age = 27.6; 67.0% non-Hispanic black; 45.6% obese) participating in Birmingham’s WIC Program. Participants were recruited between October 2014 and January 2015. Participants who self-reported purchasing produce from a FTC outlet during the 2014 farmers’ market season were classified as FTC outlet users. Multivariable-adjusted regression models were used to examine associations between FTC outlet use, daily F&V intake, and obesity status (ie, body mass index ≥ 30). Results Approximately 26.1% of participants were classified as FTC outlet users. After adjusting for socio-demographic factors and WIC Cash Value Voucher redemption, FTC outlet use was associated with increased odds of consuming ≥ 5 servings of F&Vs per day (OR: 2.01; 95%: 1.15 – 3.50), but not obesity status (OR: 0.68; 95% CI: 0.39 – 1.20). Conclusions FTC retail outlet use was associated with F&V intake among program participants but not obesity status. PMID:27338991

75 FR 53697 - Agency Information Collection Activities; Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-01

... research firm to identify consumers and conduct the survey. The results will assist the FTC in determining... comment. SUMMARY: The FTC intends to conduct a survey of consumers to advance its understanding of the prevalence of consumer fraud and to allow the FTC to better serve people who experience fraud. The survey is...

Efficacy and safety of three antiretroviral regimens for initial treatment of HIV-1: a randomized clinical trial in diverse multinational settings.

PubMed

Campbell, Thomas B; Smeaton, Laura M; Kumarasamy, N; Flanigan, Timothy; Klingman, Karin L; Firnhaber, Cynthia; Grinsztejn, Beatriz; Hosseinipour, Mina C; Kumwenda, Johnstone; Lalloo, Umesh; Riviere, Cynthia; Sanchez, Jorge; Melo, Marineide; Supparatpinyo, Khuanchai; Tripathy, Srikanth; Martinez, Ana I; Nair, Apsara; Walawander, Ann; Moran, Laura; Chen, Yun; Snowden, Wendy; Rooney, James F; Uy, Jonathan; Schooley, Robert T; De Gruttola, Victor; Hakim, James Gita

2012-01-01

Antiretroviral regimens with simplified dosing and better safety are needed to maximize the efficiency of antiretroviral delivery in resource-limited settings. We investigated the efficacy and safety of antiretroviral regimens with once-daily compared to twice-daily dosing in diverse areas of the world. 1,571 HIV-1-infected persons (47% women) from nine countries in four continents were assigned with equal probability to open-label antiretroviral therapy with efavirenz plus lamivudine-zidovudine (EFV+3TC-ZDV), atazanavir plus didanosine-EC plus emtricitabine (ATV+DDI+FTC), or efavirenz plus emtricitabine-tenofovir-disoproxil fumarate (DF) (EFV+FTC-TDF). ATV+DDI+FTC and EFV+FTC-TDF were hypothesized to be non-inferior to EFV+3TC-ZDV if the upper one-sided 95% confidence bound for the hazard ratio (HR) was ≤1.35 when 30% of participants had treatment failure. An independent monitoring board recommended stopping study follow-up prior to accumulation of 472 treatment failures. Comparing EFV+FTC-TDF to EFV+3TC-ZDV, during a median 184 wk of follow-up there were 95 treatment failures (18%) among 526 participants versus 98 failures among 519 participants (19%; HR 0.95, 95% CI 0.72-1.27; p = 0.74). Safety endpoints occurred in 243 (46%) participants assigned to EFV+FTC-TDF versus 313 (60%) assigned to EFV+3TC-ZDV (HR 0.64, CI 0.54-0.76; p<0.001) and there was a significant interaction between sex and regimen safety (HR 0.50, CI 0.39-0.64 for women; HR 0.79, CI 0.62-1.00 for men; p = 0.01). Comparing ATV+DDI+FTC to EFV+3TC-ZDV, during a median follow-up of 81 wk there were 108 failures (21%) among 526 participants assigned to ATV+DDI+FTC and 76 (15%) among 519 participants assigned to EFV+3TC-ZDV (HR 1.51, CI 1.12-2.04; p = 0.007). EFV+FTC-TDF had similar high efficacy compared to EFV+3TC-ZDV in this trial population, recruited in diverse multinational settings. Superior safety, especially in HIV-1-infected women, and once-daily dosing of EFV+FTC-TDF are advantageous for use of this regimen for initial treatment of HIV-1 infection in resource-limited countries. ATV+DDI+FTC had inferior efficacy and is not recommended as an initial antiretroviral regimen. www.ClinicalTrials.gov NCT00084136. Please see later in the article for the Editors' Summary.

Role of GPER1, EGFR and CXCR1 in differentiating between malignant follicular thyroid carcinoma and benign follicular thyroid adenoma

PubMed Central

Zhao, Le; Zhu, Xiao-Yun; Jiang, Rong; Xu, Man; Wang, Ni; Chen, George G; Liu, Zhi-Min

2015-01-01

It is extremely difficult to discriminate between follicular thyroid carcinoma (FTC) and follicular thyroid adenoma (FTA) before surgery, because the morphologies of carcinoma cells and adenoma cells obtained by fine needle aspiration biopsy (FNAB) are similar. Molecular markers may be helpful on this issue. The purpose of this study was to assess the role of GPER1, EGFR and CXCR1 in differential diagnosis between FTC and FTA. GPER1, EGFR and CXCR1 mRNA expression levels were examined in 15 FTCs and 10 FTAs using real-time RT-PCR. FTC showed to have significantly increased mRNA levels of the three molecules compared to FTA (P < 0.001 for all the three molecules). GPER1, EGFR and CXCR1 protein expression in 106 FTCs and 128 FTAs were analyzed using immunohistochemistry. The rates of GPER1, EGFR and CXCR1 high expression were 73.6%, 72.6% and 70.8% in FTC and 30.5%, 28.1% and 27.3% in FTA, respectively. Statistical analysis showed that GPER1, EGFR and CXCR1 protein expression were correlated with one another in FTC and concomitant high expression of the three molecules had stronger correlation with the occurrence of FTC than did each alone. The positive predictive values (PPV) for concomitant high expression of the three molecules for discriminating between FTC and FTA were 91.0% for GPER1/EGFR, 93.8% for GPER1/CXCR1, 92.3% for EGFR/CXCR1 and 98.2% for GPER1/EGFR/CXCR1, respectively. These results indicated that the evaluation of GPER1, EGFR and CXCR1 concomitant high expression may be helpful in differential diagnosis between FTC and FTA. PMID:26617848

Mutational burdens and evolutionary ages of thyroid follicular adenoma are comparable to those of follicular carcinoma

PubMed Central

Jung, Seung-Hyun; Kim, Min Sung; Jung, Chan Kwon; Park, Hyun-Chun; Kim, So Youn; Liu, Jieying; Bae, Ja-Seong; Lee, Sung Hak; Kim, Tae-Min; Lee, Sug Hyung; Chung, Yeun-Jun

2016-01-01

Follicular thyroid adenoma (FTA) precedes follicular thyroid carcinoma (FTC) by definition with a favorable prognosis compared to FTC. However, the genetic mechanism of FTA to FTC progression remains unknown. For this, it is required to disclose FTA and FTC genomes in mutational and evolutionary perspectives. We performed whole-exome sequencing and copy number profiling of 14 FTAs and 13 FTCs, which exhibited previously-known gene mutations (NRAS, HRAS, BRAF, TSHR and EIF1AX) and copy number alterations (CNAs) (22q loss and 1q gain) in follicular tumors. In addition, we found eleven potential cancer-related genes with mutations (EZH1, SPOP, NF1, TCF12, IGF2BP3, KMT2C, CNOT1, BRIP1, KDM5C, STAG2 and MAP4K3) that have not been reported in thyroid follicular tumors. Of note, FTA genomes showed comparable levels of mutations to FTC in terms of the number, sequence composition and functional consequences (potential driver mutations) of mutations. Analyses of evolutionary ages using somatic mutations as molecular clocks further identified that FTA genomes were as old as FTC genomes. Whole-transcriptome sequencing did not find any gene fusions with potential significance. Our data indicate that FTA genomes may be as old as FTC genomes, thus suggesting that follicular thyroid tumor genomes during the transition from FTA to FTC may stand stable at genomic levels in contrast to the discernable changes at pathologic and clinical levels. Also, the data suggest a possibility that the mutational profiles obtained from early biopsies may be useful for the molecular diagnosis and therapeutics of follicular tumor patients. PMID:27626165

Mutational burdens and evolutionary ages of thyroid follicular adenoma are comparable to those of follicular carcinoma.

PubMed

Jung, Seung-Hyun; Kim, Min Sung; Jung, Chan Kwon; Park, Hyun-Chun; Kim, So Youn; Liu, Jieying; Bae, Ja-Seong; Lee, Sung Hak; Kim, Tae-Min; Lee, Sug Hyung; Chung, Yeun-Jun

2016-10-25

Follicular thyroid adenoma (FTA) precedes follicular thyroid carcinoma (FTC) by definition with a favorable prognosis compared to FTC. However, the genetic mechanism of FTA to FTC progression remains unknown. For this, it is required to disclose FTA and FTC genomes in mutational and evolutionary perspectives. We performed whole-exome sequencing and copy number profiling of 14 FTAs and 13 FTCs, which exhibited previously-known gene mutations (NRAS, HRAS, BRAF, TSHR and EIF1AX) and copy number alterations (CNAs) (22q loss and 1q gain) in follicular tumors. In addition, we found eleven potential cancer-related genes with mutations (EZH1, SPOP, NF1, TCF12, IGF2BP3, KMT2C, CNOT1, BRIP1, KDM5C, STAG2 and MAP4K3) that have not been reported in thyroid follicular tumors. Of note, FTA genomes showed comparable levels of mutations to FTC in terms of the number, sequence composition and functional consequences (potential driver mutations) of mutations. Analyses of evolutionary ages using somatic mutations as molecular clocks further identified that FTA genomes were as old as FTC genomes. Whole-transcriptome sequencing did not find any gene fusions with potential significance. Our data indicate that FTA genomes may be as old as FTC genomes, thus suggesting that follicular thyroid tumor genomes during the transition from FTA to FTC may stand stable at genomic levels in contrast to the discernable changes at pathologic and clinical levels. Also, the data suggest a possibility that the mutational profiles obtained from early biopsies may be useful for the molecular diagnosis and therapeutics of follicular tumor patients.

Preexposure prophylaxis for HIV infection among African women.

PubMed

Van Damme, Lut; Corneli, Amy; Ahmed, Khatija; Agot, Kawango; Lombaard, Johan; Kapiga, Saidi; Malahleha, Mookho; Owino, Fredrick; Manongi, Rachel; Onyango, Jacob; Temu, Lucky; Monedi, Modie Constance; Mak'Oketch, Paul; Makanda, Mankalimeng; Reblin, Ilse; Makatu, Shumani Elsie; Saylor, Lisa; Kiernan, Haddie; Kirkendale, Stella; Wong, Christina; Grant, Robert; Kashuba, Angela; Nanda, Kavita; Mandala, Justin; Fransen, Katrien; Deese, Jennifer; Crucitti, Tania; Mastro, Timothy D; Taylor, Douglas

2012-08-02

Preexposure prophylaxis with antiretroviral drugs has been effective in the prevention of human immunodeficiency virus (HIV) infection in some trials but not in others. In this randomized, double-blind, placebo-controlled trial, we assigned 2120 HIV-negative women in Kenya, South Africa, and Tanzania to receive either a combination of tenofovir disoproxil fumarate and emtricitabine (TDF-FTC) or placebo once daily. The primary objective was to assess the effectiveness of TDF-FTC in preventing HIV acquisition and to evaluate safety. HIV infections occurred in 33 women in the TDF-FTC group (incidence rate, 4.7 per 100 person-years) and in 35 in the placebo group (incidence rate, 5.0 per 100 person-years), for an estimated hazard ratio in the TDF-FTC group of 0.94 (95% confidence interval, 0.59 to 1.52; P=0.81). The proportions of women with nausea, vomiting, or elevated alanine aminotransferase levels were significantly higher in the TDF-FTC group (P=0.04, P<0.001, and P=0.03, respectively). Rates of drug discontinuation because of hepatic or renal abnormalities were higher in the TDF-FTC group (4.7%) than in the placebo group (3.0%, P=0.051). Less than 40% of the HIV-uninfected women in the TDF-FTC group had evidence of recent pill use at visits that were matched to the HIV-infection window for women with seroconversion. The study was stopped early, on April 18, 2011, because of lack of efficacy. Prophylaxis with TDF-FTC did not significantly reduce the rate of HIV infection and was associated with increased rates of side effects, as compared with placebo. Despite substantial counseling efforts, drug adherence appeared to be low. (Supported by the U.S. Agency for International Development and others; FEM-PrEP ClinicalTrials.gov number, NCT00625404.).

Brief Report: Efficacy and Safety of Switching to Coformulated Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide (E/C/F/TAF) in Virologically Suppressed Women.

PubMed

Hodder, Sally; Squires, Kathleen; Kityo, Cissy; Hagins, Debbie; Avihingsanon, Anchalee; Kido, Anna; Jiang, Shuping; Kulkarni, Rima; Cheng, Andrew; Cao, Huyen

2018-06-01

The integrase inhibitor regimen [elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (TDF)] demonstrated superior efficacy when compared with a protease inhibitor regimen [ritonavir-boosted atazanavir (ATV + RTV) and FTC/TDF] in 575 treatment-naive women at week 48. We investigated the efficacy, safety, and tolerability of switching to a TAF-based, single-tablet regimen containing elvitegravir, cobicistat, FTC, and tenofovir alafenamide (E/C/F/TAF) versus remaining on ATV + RTV plus FTC/TDF. After completing the initial randomized, blinded phase, virologically suppressed (HIV-1 RNA <50 copies/mL) women on ATV + RTV plus FTC/TDF were rerandomized (3:1) to receive open-label E/C/F/TAF versus remaining on their current regimen. The primary end point was proportion of participants with plasma HIV-1 RNA <50 copies per milliliter at week 48 (U.S. FDA snapshot algorithm), with a prespecified noninferiority margin of 12%. Safety [adverse events (AEs)] and tolerability were also assessed. Of 575 women originally randomized and treated in the blinded phase, 159 were rerandomized to switch to E/C/F/TAF and 53 to remain on ATV + RTV plus FTC/TDF. At week 48, virologic suppression was maintained in 150 (94%) of women on E/C/F/TAF and 46 (87%) on ATV + RTV plus FTC/TDF [difference 7.5% (95% confidence interval -1.2% to 19.4%)], demonstrating noninferiority of E/C/F/TAF to ATV + RTV and FTC/TDF. Incidence of AEs was similar between groups; study drug-related AEs were more common with E/C/F/TAF (11% versus 4%). Switching to E/C/F/TAF was noninferior to continuing ATV + RTV plus FTC/TDF in maintaining virologic suppression and was well tolerated at 48 weeks.

Role of GPER1, EGFR and CXCR1 in differentiating between malignant follicular thyroid carcinoma and benign follicular thyroid adenoma.

PubMed

Zhao, Le; Zhu, Xiao-Yun; Jiang, Rong; Xu, Man; Wang, Ni; Chen, George G; Liu, Zhi-Min

2015-01-01

It is extremely difficult to discriminate between follicular thyroid carcinoma (FTC) and follicular thyroid adenoma (FTA) before surgery, because the morphologies of carcinoma cells and adenoma cells obtained by fine needle aspiration biopsy (FNAB) are similar. Molecular markers may be helpful on this issue. The purpose of this study was to assess the role of GPER1, EGFR and CXCR1 in differential diagnosis between FTC and FTA. GPER1, EGFR and CXCR1 mRNA expression levels were examined in 15 FTCs and 10 FTAs using real-time RT-PCR. FTC showed to have significantly increased mRNA levels of the three molecules compared to FTA (P < 0.001 for all the three molecules). GPER1, EGFR and CXCR1 protein expression in 106 FTCs and 128 FTAs were analyzed using immunohistochemistry. The rates of GPER1, EGFR and CXCR1 high expression were 73.6%, 72.6% and 70.8% in FTC and 30.5%, 28.1% and 27.3% in FTA, respectively. Statistical analysis showed that GPER1, EGFR and CXCR1 protein expression were correlated with one another in FTC and concomitant high expression of the three molecules had stronger correlation with the occurrence of FTC than did each alone. The positive predictive values (PPV) for concomitant high expression of the three molecules for discriminating between FTC and FTA were 91.0% for GPER1/EGFR, 93.8% for GPER1/CXCR1, 92.3% for EGFR/CXCR1 and 98.2% for GPER1/EGFR/CXCR1, respectively. These results indicated that the evaluation of GPER1, EGFR and CXCR1 concomitant high expression may be helpful in differential diagnosis between FTC and FTA.

Waving the Red Flag: FTC Regulation of Deceptive Weight-Loss Advertising 1951-2009.

PubMed

Lellis, Julie C

2016-01-01

This article documents the historical role of the Federal Trade Commission (FTC) in regulating deceptive weight-loss advertising, which the commission began to prioritize in the 1990s after a dramatic rise in complaints. It also includes the results of a content analysis of more than 150 FTC complaints filed between 1951 and 2009, which were used to analyze trends in advertising content, liability for deceptive practices, and outcomes. Regulatory efforts may not have curbed the use of bogus weight-loss claims, which have only increased over time. The FTC has made attempts to apply broad liability, but advertisers and corporate leaders continue to be named most frequently over other respondents, including advertising agencies, media outlets, and product endorsers. Although the number of complaints that result in financial penalties is increasing, the FTC lacks systematic and specific policies to adequately deter advertisers and address what continues to be a growing problem.

12 CFR Appendix B to Part 748 - Guidance on Response Programs for Unauthorized Access to Member Information and Member Notice

Code of Federal Regulations, 2011 CFR

2011-01-01

..., in conjunction with the member's social security number, driver's license number, account number... should provide the FTC's Web site address and toll-free telephone number that members may use to obtain... Web site for the ID Theft brochure and the FTC Hotline phone number are http://www.ftc.gov/idtheft and...

Investor Behavior and Flow-through Capability in the US Stock Market

PubMed Central

Cano, Carlos; Jareño, Francisco; Tolentino, Marta

2016-01-01

This paper analyzes investor behavior depending on the flow-through capability (FTC) in the US stock market, because investors seek protection from inflation rate changes, and the FTC (a firm's ability to transmit inflation shocks to the prices of its products and services) is a key factor in investment decisions. Our estimates of the FTC of firms listed on the US stock exchange at the sector level are significantly different among industries, and we demonstrate a direct relationship between changes in stock prices (at the sector level) and FTC. These results would be relevant because they have important implications on investor behavior. PMID:27242585

Investor Behavior and Flow-through Capability in the US Stock Market.

PubMed

Cano, Carlos; Jareño, Francisco; Tolentino, Marta

2016-01-01

This paper analyzes investor behavior depending on the flow-through capability (FTC) in the US stock market, because investors seek protection from inflation rate changes, and the FTC (a firm's ability to transmit inflation shocks to the prices of its products and services) is a key factor in investment decisions. Our estimates of the FTC of firms listed on the US stock exchange at the sector level are significantly different among industries, and we demonstrate a direct relationship between changes in stock prices (at the sector level) and FTC. These results would be relevant because they have important implications on investor behavior.

Follicular variant of papillary thyroid carcinoma: genome-wide appraisal of a controversial entity.

PubMed

Wreesmann, Volkert B; Ghossein, Ronald A; Hezel, Michael; Banerjee, Debenranrath; Shaha, Ashok R; Tuttle, R Michael; Shah, Jatin P; Rao, Pulivarthi H; Singh, Bhuvanesh

2004-08-01

The majority of thyroid tumors are classified as papillary (papillary thyroid carcinomas; PTCs) or follicular neoplasms (follicular thyroid adenomas and carcinomas; FTA/FTC) based on nuclear features and the cellular growth pattern. However, classification of the follicular variant of papillary thyroid carcinoma (FVPTC) remains an issue of debate. These tumors contain a predominantly follicular growth pattern but display nuclear features and overall clinical behavior consistent with PTC. In this study, we used comparative genomic hybridization (CGH) to compare the global chromosomal aberrations in FVPTC to the PTC of classical variant (classical PTC) and FTA/FTC. In addition, we assessed the presence of peroxisome proliferator-activated receptor-gamma (PPARG) alteration, a genetic event specific to FTA/FTC, using Southern blot and immunohistochemistry analyses. In sharp contrast to the findings in classical PTC (4% of cases), CGH analysis demonstrated that both FVPTC (59% of cases) and FTA/FTC (36% of cases) were commonly characterized by aneuploidy (P = 0.0002). Moreover, the pattern of chromosomal aberrations (gains at chromosome arms 2q, 4q, 5q, 6q, 8q, and 13q and deletions at 1p, 9q, 16q, 17q, 19q, and 22q) in the follicular variant of PTC closely resembled that of FTA/FTC. Aberrations in PPARG were uniquely detected in FVPTC and FTA/FTC. Our findings suggest a stronger relationship between the FVPTC and FTA/FTC than previously appreciated and support further consideration of the current classification of thyroid neoplasms. Copyright 2004 Wiley-Liss, Inc.

Tenofovir-based Pre-Exposure Prophylaxis for HIV Prevention: Evidence and evolving questions

PubMed Central

Celum, Connie; Baeten, Jared

2012-01-01

Purpose of review Topical tenofovir gel and oral tenofovir and emtricitabine/tenofovir (FTC/TDF) have been demonstrated to have efficacy in preventing HIV-1 in some populations. Pre-exposure prophylaxis (PrEP) trials and future directions are summarized. Recent findings Peri-coital use of 1% tenofovir gel in CAPRISA 004 reduced HIV-1 acquisition by 39% and HSV-2 acquisition by 51%. Daily oral FTC/TDF demonstrated 44% reduction in HIV-1 acquisition among men who have sex with men (MSM) in iPrEx. Both studies showed higher efficacy among those with higher adherence. Efficacy of daily oral TDF and FTC/TDF was 66% and 73%, respectively, among HIV-1 uninfected partners in an HIV-1 serodiscordant partnership in the Partners PrEP Study. Efficacy of daily oral FTC/TDF was 66% in young heterosexuals in Botswana in the TDF-2 trial. The FEM-PrEP and VOICE studies in African women found no efficacy with oral FTC/TDF and TDF, respectively. Safety and tolerability were excellent and limited resistance was observed in seroconverters. Summary Topical tenofovir gel showed efficacy in African women and daily oral TDF and FTC/TDF were efficacious in MSM, and African HIV-1 serodiscordant couples and young heterosexuals. The reasons for lack of efficacy of oral FTC/TDF and TDF in two studies in African women are being investigated. Longer-acting formulations, invtravaginal rings, and new candidate antiretrovirals are being evaluated. PMID:22156901

Probing the structural and molecular basis of nucleotide selectivity by human mitochondrial DNA polymerase γ

PubMed Central

Sohl, Christal D.; Szymanski, Michal R.; Mislak, Andrea C.; Shumate, Christie K.; Amiralaei, Sheida; Schinazi, Raymond F.; Anderson, Karen S.; Yin, Y. Whitney

2015-01-01

Nucleoside analog reverse transcriptase inhibitors (NRTIs) are the essential components of highly active antiretroviral (HAART) therapy targeting HIV reverse transcriptase (RT). NRTI triphosphates (NRTI-TP), the biologically active forms, act as chain terminators of viral DNA synthesis. Unfortunately, NRTIs also inhibit human mitochondrial DNA polymerase (Pol γ), causing unwanted mitochondrial toxicity. Understanding the structural and mechanistic differences between Pol γ and RT in response to NRTIs will provide invaluable insight to aid in designing more effective drugs with lower toxicity. The NRTIs emtricitabine [(-)-2,3′-dideoxy-5-fluoro-3′-thiacytidine, (-)-FTC] and lamivudine, [(-)-2,3′-dideoxy-3′-thiacytidine, (-)-3TC] are both potent RT inhibitors, but Pol γ discriminates against (-)-FTC-TP by two orders of magnitude better than (-)-3TC-TP. Furthermore, although (-)-FTC-TP is only slightly more potent against HIV RT than its enantiomer (+)-FTC-TP, it is discriminated by human Pol γ four orders of magnitude more efficiently than (+)-FTC-TP. As a result, (-)-FTC is a much less toxic NRTI. Here, we present the structural and kinetic basis for this striking difference by identifying the discriminator residues of drug selectivity in both viral and human enzymes responsible for substrate selection and inhibitor specificity. For the first time, to our knowledge, this work illuminates the mechanism of (-)-FTC-TP differential selectivity and provides a structural scaffold for development of novel NRTIs with lower toxicity. PMID:26124101

Efficacy and Safety of Three Antiretroviral Regimens for Initial Treatment of HIV-1: A Randomized Clinical Trial in Diverse Multinational Settings

PubMed Central

Campbell, Thomas B.; Smeaton, Laura M.; Kumarasamy, N.; Flanigan, Timothy; Klingman, Karin L.; Firnhaber, Cynthia; Grinsztejn, Beatriz; Hosseinipour, Mina C.; Kumwenda, Johnstone; Lalloo, Umesh; Riviere, Cynthia; Sanchez, Jorge; Melo, Marineide; Supparatpinyo, Khuanchai; Tripathy, Srikanth; Martinez, Ana I.; Nair, Apsara; Walawander, Ann; Moran, Laura; Chen, Yun; Snowden, Wendy; Rooney, James F.; Uy, Jonathan; Schooley, Robert T.; De Gruttola, Victor; Hakim, James Gita; Swann, Edith; Barnett, Ronald L.; Brizz, Barbara; Delph, Yvette; Gettinger, Nikki; Mitsuyasu, Ronald T.; Eshleman, Susan; Safren, Steven; Fiscus, Susan A.; Andrade, Adriana; Haas, David W.; Amod, Farida; Berthaud, Vladimir; Bollinger, Robert C.; Bryson, Yvonne; Celentano, David; Chilongozi, David; Cohen, Myron; Collier, Ann C.; Currier, Judith Silverstein; Cu-Uvin, Susan; Eron, Joseph; Flexner, Charles; Gallant, Joel E.; Gulick, Roy M.; Hammer, Scott M.; Hoffman, Irving; Kazembe, Peter; Kumwenda, Newton; Lama, Javier R.; Lawrence, Jody; Maponga, Chiedza; Martinson, Francis; Mayer, Kenneth; Nielsen, Karin; Pendame, Richard B.; Ramratnam, Bharat; Sanne, Ian; Severe, Patrice; Sirisanthana, Thira; Solomon, Suniti; Tabet, Steve; Taha, Taha; van der Horst, Charles; Wanke, Christine; Gormley, Joan; Marcus, Cheryl J.; Putnam, Beverly; Loeliger, Edde; Pappa, Keith A.; Webb, Nancy; Shugarts, David L.; Winters, Mark A.; Descallar, Renard S.; Steele, Joseph; Wulfsohn, Michael; Said, Farideh; Chen, Yue; Martin, John C; Bischofberger, Norbert; Cheng, Andrew; Jaffe, Howard; Sharma, Jabin; Poongulali, S.; Cardoso, Sandra Wagner; Faria, Deise Lucia; Berendes, Sima; Burke, Kelly; Mngqibisa, Rosie; Kanyama, Cecelia; Kayoyo, Virginia; Samaneka, Wadzanai P.; Chisada, Anthony; Faesen, Sharla; Chariyalertsak, Suwat; Santos, Breno; Lira, Rita Alves; Joglekar, Anjali A.; Rosa, Alberto La; Infante, Rosa; Jain, Mamta; Petersen, Tianna; Godbole, Sheela; Dhayarkar, Sampada; Feinberg, Judith; Baer, Jenifer; Pollard, Richard B.; Asmuth, David; Gangakhedkar, Raman R; Gaikwad, Asmita; Ray, M. Graham; Basler, Cathi; Para, Michael F.; Watson, Kathy J.; Taiwo, Babafemi; McGregor, Donna; Balfour, Henry H.; Mullan, Beth; Kim, Ge-Youl; Klebert, Michael K.; Cox, Gary Matthew; Silberman, Martha; Mildvan, Donna; Revuelta, Manuel; Tashima, Karen T.; Patterson, Helen; Geiseler, P. Jan; Santos, Bartolo; Daar, Eric S; Lopez, Ruben; Frarey, Laurie; Currin, David; Haas, David H.; Bailey, Vicki L.; Tebas, Pablo; Zifchak, Larisa; Noel-Connor, Jolene; Torres, Madeline; Sha, Beverly E.; Fritsche, Janice M.; Cespedes, Michelle; Forcht, Janet; O'Brien, William A.; Mogridge, Cheryl; Hurley, Christine; Corales, Roberto; Palmer, Maria; Adams, Mary; Luque, Amneris; Lopez-Detres, Luis; Stroberg, Todd

2012-01-01

Background Antiretroviral regimens with simplified dosing and better safety are needed to maximize the efficiency of antiretroviral delivery in resource-limited settings. We investigated the efficacy and safety of antiretroviral regimens with once-daily compared to twice-daily dosing in diverse areas of the world. Methods and Findings 1,571 HIV-1-infected persons (47% women) from nine countries in four continents were assigned with equal probability to open-label antiretroviral therapy with efavirenz plus lamivudine-zidovudine (EFV+3TC-ZDV), atazanavir plus didanosine-EC plus emtricitabine (ATV+DDI+FTC), or efavirenz plus emtricitabine-tenofovir-disoproxil fumarate (DF) (EFV+FTC-TDF). ATV+DDI+FTC and EFV+FTC-TDF were hypothesized to be non-inferior to EFV+3TC-ZDV if the upper one-sided 95% confidence bound for the hazard ratio (HR) was ≤1.35 when 30% of participants had treatment failure. An independent monitoring board recommended stopping study follow-up prior to accumulation of 472 treatment failures. Comparing EFV+FTC-TDF to EFV+3TC-ZDV, during a median 184 wk of follow-up there were 95 treatment failures (18%) among 526 participants versus 98 failures among 519 participants (19%; HR 0.95, 95% CI 0.72–1.27; p = 0.74). Safety endpoints occurred in 243 (46%) participants assigned to EFV+FTC-TDF versus 313 (60%) assigned to EFV+3TC-ZDV (HR 0.64, CI 0.54–0.76; p<0.001) and there was a significant interaction between sex and regimen safety (HR 0.50, CI 0.39–0.64 for women; HR 0.79, CI 0.62–1.00 for men; p = 0.01). Comparing ATV+DDI+FTC to EFV+3TC-ZDV, during a median follow-up of 81 wk there were 108 failures (21%) among 526 participants assigned to ATV+DDI+FTC and 76 (15%) among 519 participants assigned to EFV+3TC-ZDV (HR 1.51, CI 1.12–2.04; p = 0.007). Conclusion EFV+FTC-TDF had similar high efficacy compared to EFV+3TC-ZDV in this trial population, recruited in diverse multinational settings. Superior safety, especially in HIV-1-infected women, and once-daily dosing of EFV+FTC-TDF are advantageous for use of this regimen for initial treatment of HIV-1 infection in resource-limited countries. ATV+DDI+FTC had inferior efficacy and is not recommended as an initial antiretroviral regimen. Trial Registration www.ClinicalTrials.gov NCT00084136 Please see later in the article for the Editors' Summary. PMID:22936892

Combinatorial anticancer effects of curcumin and sorafenib towards thyroid cancer cells via PI3K/Akt and ERK pathways.

PubMed

Zhang, Junjia; Yu, Jichun; Xie, Rong; Chen, Wanzhi; Lv, Yunxia

2016-08-01

The objective of this study was to examine the in vitro combinatorial anticancer effects of curcumin and sorafenib towards thyroid cancer cells FTC133 using a MTT cytotoxicity assay, and to test whether the mechanism involves induction of apoptosis. The present results demonstrated that curcumin at 15-25 μM dose-dependently suppressed the proliferation of FTC133. Combined treatment (curcumin (25 μM) and sorafenib (2 μM)) resulted in a reduction in cell colony formation and significantly decreased the invasion and migration of FTC133 cells compared with that treated with individual drugs. Western blot showed that the levels of p-ERK and p-Akt proteins were significantly reduced (p < 0.01) in the medicine-treated FTC133 cells. The curcumin was found to dose-dependently inhibit the apoptosis of FTC133 cells possibly via PI3K/Akt and ERK pathways. There is a synergetic antitumour effect between curcumin and sorafenib.

75 FR 70921 - Simon Property Group, Inc.; Analysis of Proposed Agreement Containing Consent Orders To Aid...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-19

... site, at http:[sol][sol]www.ftc.gov[sol]os[sol]publiccomments.shtm. Because comments will be made.../simonproperty . If this Notice appears at http:[sol][sol]www.regulations.gov[sol]search[sol]index.jsp, you may... regulations.gov forwards to it. You may also visit the FTC Web site at http:[sol][sol]www.ftc.gov[sol] to read...

Lessons Learned From a Randomized Controlled Trial of a Family-Based Intervention to Promote School Functioning for School-Age Children With Sickle Cell Disease.

PubMed

Daniel, Lauren C; Li, Yimei; Smith, Kelsey; Tarazi, Reem; Robinson, M Renee; Patterson, Chavis A; Smith-Whitley, Kim; Stuart, Marie; Barakat, Lamia P

2015-01-01

Tested a family-based group problem-solving intervention, "Families Taking Control," (FTC) to improve school functioning and health-related quality of life (HRQL) for children with sickle cell disease. Children and caregivers completed questionnaires assessing HRQL and school functioning and children completed performance-based measures of IQ and achievement at baseline and 6 months later. Families were randomized to the intervention (FTC, n = 42) or delayed intervention control (DIC, n = 41) group. FTC involved a full-day workshop followed by 3 booster calls. There were no differences between FTC completers (n = 24) and noncompleters (n = 18). FTC group (n = 24) and DIC group (n = 38) did not differ significantly on primary outcomes at follow-up: number of formal academic and disease-related accommodations, individualized education plan/504 service plan, school absences, school HRQL, or academic skills. Although families found FTC to be acceptable, there were no intervention effects. Challenges of the trial and implications for future research are discussed. © The Author 2015. Published by Oxford University Press on behalf of the Society of Pediatric Psychology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Risk of Drug Resistance Among Persons Acquiring HIV Within a Randomized Clinical Trial of Single- or Dual-Agent Preexposure Prophylaxis

PubMed Central

Lehman, Dara A.; Baeten, Jared M.; McCoy, Connor O.; Weis, Julie F.; Peterson, Dylan; Mbara, Gerald; Donnell, Deborah; Thomas, Katherine K.; Hendrix, Craig W.; Marzinke, Mark A.; Frenkel, Lisa; Ndase, Patrick; Mugo, Nelly R.; Celum, Connie; Overbaugh, Julie; Matsen, Frederick A.; Celum, Connie; Baeten, Jared M.; Donnell, Deborah; Coombs, Robert W.; Frenkel, Lisa; Hendrix, Craig W.; Marzinke, Mark A.; Lingappa, Jairam; McElrath, M. Juliana; Fife, Kenneth; Were, Edwin; Tumwesigye, Elioda; Ndase, Patrick; Katabira, Elly; Katabira, Elly; Ronald, Allan; Bukusi, Elizabeth; Cohen, Craig; Wangisi, Jonathan; Campbell, James; Tappero, Jordan; Kiarie, James; Farquhar, Carey; John-Stewart, Grace; Mugo, Nelly Rwamba; Campbell, James; Tappero, Jordan; Wangisi, Jonathan

2015-01-01

Background. Preexposure prophylaxis (PrEP) with emtricitabine plus tenofovir disoproxil fumarate (FTC/TDF) or TDF alone reduces the risk of human immunodeficiency virus (HIV) acquisition. Understanding the risk of antiretroviral resistance selected by PrEP during breakthrough infections is important because of the risk of treatment failure during subsequent antiretroviral use. Methods. Within the largest randomized trial of FTC/TDF versus TDF as PrEP, plasma samples were tested for HIV with resistance mutations associated with FTC (K65R and M184IV) and TDF (K65R and K70E), using 454 sequencing. Results. Of 121 HIV seroconverters, 25 received FTC/TDF, 38 received TDF, and 58 received placebo. Plasma drug levels in 26 individuals indicated PrEP use during or after HIV acquisition, of which 5 had virus with resistance mutations associated with their PrEP regimen. Among those with PrEP drug detected during infection, resistance was more frequent in the FTC/TDF arm (4 of 7 [57%]), compared with the TDF arm (1 of 19 [5.3%]; P = .01), owing to the FTC-associated mutation M184IV. Of these cases, 3 had unrecognized acute infection at PrEP randomization, and 2 were HIV negative at enrollment. Conclusions. These results suggest that resistance selected by PrEP is rare but can occur both with PrEP initiation during acute seronegative HIV infection and in PrEP breakthrough infections and that FTC is associated with a greater frequency of resistance mutations than TDF. PMID:25587020

Evaluation of a Multidrug Assay for Monitoring Adherence to a Regimen for HIV Preexposure Prophylaxis in a Clinical Study, HIV Prevention Trials Network 073.

PubMed

Zhang, Yinfeng; Clarke, William; Marzinke, Mark A; Piwowar-Manning, Estelle; Beauchamp, Geetha; Breaud, Autumn; Hendrix, Craig W; Cloherty, Gavin A; Emel, Lynda; Rose, Scott; Hightow-Weidman, Lisa; Siegel, Marc; Shoptaw, Steven; Fields, Sheldon D; Wheeler, Darrell; Eshleman, Susan H

2017-07-01

Daily oral tenofovir disoproxil fumarate (TDF)-emtricitabine (FTC) is a safe and effective intervention for HIV preexposure prophylaxis (PrEP). We evaluated the performance of a qualitative assay that detects 20 antiretroviral (ARV) drugs (multidrug assay) in assessing recent PrEP exposure (detection limit, 2 to 20 ng/ml). Samples were obtained from 216 Black men who have sex with men (208 HIV-uninfected men and 8 seroconverters) who were enrolled in a study in the United States evaluating the acceptability of TDF-FTC PrEP (165 of the uninfected men and 5 of the seroconverters accepted PrEP). Samples from 163 of the 165 HIV-uninfected men who accepted PrEP and samples from all 8 seroconverters were also tested for tenofovir (TFV) and FTC using a quantitative assay (detection limit for both drugs, 0.31 ng/ml). HIV drug resistance was assessed in seroconverter samples. The multidrug assay detected TFV and/or FTC in 3 (1.4%) of the 208 uninfected men at enrollment, 84 (40.4%) of the 208 uninfected men at the last study visit, and 1 (12.5%) of the 8 seroconverters. No other ARV drugs were detected. The quantitative assay confirmed all positive results from the multidrug assay and detected TFV and/or FTC in 9 additional samples (TFV range, 0.65 to 16.5 ng/ml; FTC range, 0.33 to 14.6 ng/ml). Resistance mutations were detected in 4 of the 8 seroconverter samples. The multidrug assay had 100% sensitivity and specificity for detecting TFV and FTC at drug concentrations consistent with daily PrEP use. The quantitative assay detected TFV and FTC at lower levels, which also might have provided protection against HIV infection. Copyright © 2017 American Society for Microbiology.

Preexposure Prophylaxis for HIV Infection among African Women

PubMed Central

Van Damme, Lut; Corneli, Amy; Ahmed, Khatija; Agot, Kawango; Lombaard, Johan; Kapiga, Saidi; Malahleha, Mookho; Owino, Fredrick; Manongi, Rachel; Onyango, Jacob; Temu, Lucky; Monedi, Modie Constance; Mak’Oketch, Paul; Makanda, Mankalimeng; Reblin, Ilse; Makatu, Shumani Elsie; Saylor, Lisa; Kiernan, Haddie; Kirkendale, Stella; Wong, Christina; Grant, Robert; Kashuba, Angela; Nanda, Kavita; Mandala, Justin; Fransen, Katrien; Deese, Jennifer; Crucitti, Tania; Mastro, Timothy D.; Taylor, Douglas

2013-01-01

BACKGROUND Preexposure prophylaxis with antiretroviral drugs has been effective in the prevention of human immunodeficiency virus (HIV) infection in some trials but not in others. METHODS In this randomized, double-blind, placebo-controlled trial, we assigned 2120 HIV-negative women in Kenya, South Africa, and Tanzania to receive either a combination of tenofovir disoproxil fumarate and emtricitabine (TDF–FTC) or placebo once daily. The primary objective was to assess the effectiveness of TDF–FTC in preventing HIV acquisition and to evaluate safety. RESULTS HIV infections occurred in 33 women in the TDF–FTC group (incidence rate, 4.7 per 100 person-years) and in 35 in the placebo group (incidence rate, 5.0 per 100 person-years), for an estimated hazard ratio in the TDF-FTC group of 0.94 (95% confidence interval, 0.59 to 1.52; P = 0.81). The proportions of women with nausea, vomiting, or elevated alanine aminotransferase levels were significantly higher in the TDF–FTC group (P = 0.04, P<0.001, and P = 0.03, respectively). Rates of drug discontinuation because of hepatic or renal abnormalities were higher in the TDF–FTC group (4.7%) than in the placebo group (3.0%, P = 0.051). Less than 40% of the HIV-uninfected women in the TDF–FTC group had evidence of recent pill use at visits that were matched to the HIV-infection window for women with seroconversion. The study was stopped early, on April 18, 2011, because of lack of efficacy. CONCLUSIONS Prophylaxis with TDF–FTC did not significantly reduce the rate of HIV infection and was associated with increased rates of side effects, as compared with placebo. Despite substantial counseling efforts, drug adherence appeared to be low. (Supported by the U.S. Agency for International Development and others; FEM-PrEP ClinicalTrials.gov number, NCT00625404.) PMID:22784040

Discovery and Development of the Anti-Human Immunodeficiency Virus Drug, Emtricitabine (Emtriva, FTC).

PubMed

Liotta, Dennis C; Painter, George R

2016-01-01

The HIV/AIDS epidemic, which was first reported on in 1981, progressed in just 10 years to a disease afflicting 10 million people worldwide including 1 million in the US. In 1987, AZT was approved for treating HIV/AIDS. Unfortunately, its clinical usefullness was severly limited by associated toxicities and the emergence of resistance. Three other drugs that were approved in the early 1990s suffered from similar liabilities. In 1990, the Liotta group at Emory University developed a highly diastereoselective synthesis of racemic 3'-thia-2',3'-dideoxycytidine and 3'-thia-2',3'-5-fluorodideoxycytidine and demonstrated that these compounds exhibited excellent anti-HIV activity with no apparent cytotoxicity. Subsequently, the enantiomers of these compounds were separated using enzyme-mediated kinetic resolutions and their (-)-enantiomers (3TC and FTC, respectively) were found to have exceptionally attractive preclinical profiles. In addition to their anti-HIV activity, 3TC and FTC potently inhibit the replication of hepatitis B virus. The development of FTC, which was being carried out by Burroughs Wellcome, had many remarkable starts and stops. For example, passage studies indicated that the compound rapidly selected for a single resistant mutant, M184V, and that this strain was 500-1000-fold less sensitive to FTC than was wild-type virus. Fortunately, it was found that combinations of AZT with either 3TC or FTC were synergistic. The effectiveness of AZT-3TC combination therapy was subsequently demonstrated in four independent clinical trials, and in 1997, the FDA approved Combivir, a fixed dose combination of AZT and 3TC. In phase 1 clinical trials, FTC was well tolerated by all subjects with no adverse events observed. However, the development of FTC was halted by the aquistition of Wellcome PLC by Glaxo PLC in January 1995. In 1996, Triangle Pharmaceuticals licensed FTC from Emory and initiated a series of phase I/II clinical studies that demonstrated the safety and efficacy of the drug. In August 1998, FTC was granted "Fast Track" status, based primarily on its potential for once daily dosing. While the outcomes of two subsequent phase III trials were positive, a third phase III clinical trial involving combinations of 3TC or FTC with stavudine and neviripine had to be terminated due to serious liver-related adverse events. Although analysis of the data suggested that the liver toxicity was due to neviripine, the FDA decided that the study could not be used for drug registration. Ultimately, in January 2003, Gilead Sciences acquired Triangle Pharmaceuticals and completed the development of FTC (emtricitabine), which was approved for once a day, oral administration in July 2003. A year later, Truvada, a once a day, oral, fixed dose combination of emtricitabine and tenofovir disoproxyl fumarate received FDA approval and quickly became the accepted first line therapy when used with a third antiretroviral agent. In July 2006, the FDA approved Atripla, a once a day, oral, fixed dose combination of emtricitabine, tenofovir disoproxyl fumarate, and efavirenz, which represented the culmination of two decades of research that had transformed AIDS from a death sentence to a manageable chronic disease.

Cancer Treatment Scams

MedlinePlus

... Loss & Fitness Jobs & Making Money Privacy, Identity & Online Security Blog Video & ... The Federal Trade Commission (FTC) is the nation’s consumer protection agency. The FTC works to prevent fraudulent, deceptive ...

Friend Finder (Game)

MedlinePlus

... Health & Fitness Jobs & Making Money Privacy, Identity & Online Security Blog Video & ... The Federal Trade Commission (FTC) is the nation’s consumer protection agency. The FTC works to prevent fraudulent, deceptive ...

Types of Funerals

MedlinePlus

... Health & Fitness Jobs & Making Money Privacy, Identity & Online Security Blog Video ... The Federal Trade Commission (FTC) is the nation’s consumer protection agency. The FTC works to prevent fraudulent, deceptive ...

Planning Your Own Funeral

MedlinePlus

... Health & Fitness Jobs & Making Money Privacy, Identity & Online Security Blog Video ... The Federal Trade Commission (FTC) is the nation’s consumer protection agency. The FTC works to prevent fraudulent, deceptive ...

Research on frequency control strategy of interconnected region based on fuzzy PID

NASA Astrophysics Data System (ADS)

Zhang, Yan; Li, Chunlan

2018-05-01

In order to improve the frequency control performance of the interconnected power grid, overcome the problems of poor robustness and slow adjustment of traditional regulation, the paper puts forward a frequency control method based on fuzzy PID. The method takes the frequency deviation and tie-line deviation of each area as the control objective, takes the regional frequency deviation and its deviation as input, and uses fuzzy mathematics theory, adjusts PID control parameters online. By establishing the regional frequency control model of water-fire complementary power generation in MATLAB, the regional frequency control strategy is given, and three control modes (TBC-FTC, FTC-FTC, FFC-FTC) are simulated and analyzed. The simulation and experimental results show that, this method has better control performance compared with the traditional regional frequency regulation.

FDA-Approved HIV Medicines

MedlinePlus

... bictegravir sodium / emtricitabine / tenofovir alafenamide fumarate, BIC / FTC / TAF) Biktarvy February 7, 2018 darunavir and cobicistat (darunavir ... elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide, EVG / COBI / FTC / TAF) Genvoya November 5, 2015 elvitegravir, cobicistat, emtricitabine, and ...

Effect of Intra- and Extrauterine Growth on Long-Term Neurologic Outcomes of Very Preterm Infants.

PubMed

Guellec, Isabelle; Lapillonne, Alexandre; Marret, Stephane; Picaud, Jean-Charles; Mitanchez, Delphine; Charkaluk, Marie-Laure; Fresson, Jeanne; Arnaud, Catherine; Flamand, Cyril; Cambonie, Gilles; Kaminski, Monique; Roze, Jean-Christophe; Ancel, Pierre-Yves

2016-08-01

To determine whether extrauterine growth is associated with neurologic outcomes and if this association varies by prenatal growth profile. For 1493 preterms from the EPIPAGE (Étude Épidémiologique sur les Petits Âges Gestationnels [Epidemiological Study on Small Gestational Ages]) cohort, appropriate for gestational-age (AGA) was defined by birth weight >-2 SD and small for gestational-age (SGA) by birth weight ≤-2 SD. Extra-uterine growth was defined by weight gain or loss between birth and 6 months by z-score change. Growth following-the-curve (FTC) was defined as weight change -1 to +1 SD, catch-down-growth (CD) as weight loss ≥1 SD, and catch-up-growth (CU) as weight gain ≥1 SD. At 5 years, a complete medical examination (n = 1305) and cognitive evaluation with the Kauffman Assessment Battery for Children (n = 1130) were performed. Behavioral difficulties at 5 years and school performance at 8 years were assessed (n = 1095). Overall, 42.5% of preterms were AGA-FTC, 20.2% AGA-CD, 17.1% AGA-CU, 5.6% SGA-FTC, and 14.5% SGA-CU. Outcomes did not differ between CU and FTC preterm AGA infants. Risk of cerebral palsy was greater for AGA-CD compared with AGA-FTC (aOR 2.26 [95% CI 1.37-3.72]). As compared with children with SGA-CU, SGA-FTC children showed no significant increased risk of cognitive deficiency (aOR 1.41[0.94-2.12]) or school difficulties (aOR 1.60 [0.84-3.03]). Compared with AGA-FTC, SGA showed increased risk of cognitive deficiency (SGA-FTC aOR 2.19 [1.25-3.84]) and inattention-hyperactivity (SGA-CU aOR 1.65 [1.05-2.60]). Deficient postnatal growth was associated with poor neurologic outcome for AGA and SGA preterm infants. CU growth does not add additional benefits. Regardless of type of postnatal growth, SGA infants showed behavioral problems and cognitive deficiency. Copyright © 2016 Elsevier Inc. All rights reserved.

Balancing the health workforce: breaking down overall technical change into factor technical change for labour-an empirical application to the Dutch hospital industry.

PubMed

Blank, Jos L T; van Hulst, Bart L

2017-02-17

Well-trained, well-distributed and productive health workers are crucial for access to high-quality, cost-effective healthcare. Because neither a shortage nor a surplus of health workers is wanted, policymakers use workforce planning models to get information on future labour markets and adjust policies accordingly. A neglected topic of workforce planning models is productivity growth, which has an effect on future demand for labour. However, calculating productivity growth for specific types of input is not as straightforward as it seems. This study shows how to calculate factor technical change (FTC) for specific types of input. The paper first theoretically derives FTCs from technical change in a consistent manner. FTC differs from a ratio of output and input, in that it deals with the multi-input, multi-output character of the production process in the health sector. Furthermore, it takes into account substitution effects between different inputs. An application of the calculation of FTCs is given for the Dutch hospital industry for the period 2003-2011. A translog cost function is estimated and used to calculate technical change and FTC for individual inputs, especially specific labour inputs. The results show that technical change increased by 2.8% per year in Dutch hospitals during 2003-2011. FTC differs amongst the various inputs. The FTC of nursing personnel increased by 3.2% per year, implying that fewer nurses were needed to let demand meet supply on the labour market. Sensitivity analyses show consistent results for the FTC of nurses. Productivity growth, especially of individual outputs, is a neglected topic in workforce planning models. FTC is a productivity measure that is consistent with technical change and accounts for substitution effects. An application to the Dutch hospital industry shows that the FTC of nursing personnel outpaced technical change during 2003-2011. The optimal input mix changed, resulting in fewer nurses being needed to let demand meet supply on the labour market. Policymakers should consider using more detailed and specific data on the nature of technical change when forecasting the future demand for health workers.

The Putative PAX8/PPARγ Fusion Oncoprotein Exhibits Partial Tumor Suppressor Activity through Up-Regulation of Micro-RNA-122 and Dominant-Negative PPARγ Activity.

PubMed

Reddi, Honey V; Madde, Pranathi; Milosevic, Dragana; Hackbarth, Jennifer S; Algeciras-Schimnich, Alicia; McIver, Bryan; Grebe, Stefan K G; Eberhardt, Norman L

2011-01-01

In vitro studies have demonstrated that the PAX8/PPARγ fusion protein (PPFP), which occurs frequently in follicular thyroid carcinomas (FTC), exhibits oncogenic activity. However, paradoxically, a meta-analysis of extant tumor outcome studies indicates that 68% of FTC-expressing PPFP are minimally invasive compared to only 32% of those lacking PPFP (χ(2) = 6.86, P = 0.008), suggesting that PPFP favorably impacts FTC outcomes. In studies designed to distinguish benign thyroid neoplasms from thyroid carcinomas, the previously identified tumor suppressor miR-122, a major liver micro-RNA (miR) that is decreased in hepatocellular carcinoma, was increased 8.9-fold (P < 0.05) in all FTC versus normal, 9.2-fold in FTC versus FA (P < 0.05), and 16.8-fold (P < 0.001) in FTC + PPFP versus FTC - PPFP. Constitutive expression of PPFP in the FTC-derived cell line WRO (WRO-PPFP) caused a 5-fold increase of miR-122 expression (P < 0.05) and a striking 5.1-fold reduction (P < 0.0001) in tumor progression compared to WRO-vector cells in a mouse xenograft model. Constitutive expression of either miR-122 or a dominant-negative PPARγ mutant in WRO cells was less effective than PPFP at inhibiting xenograft tumor progression (1.8-fold [P < 0.001] and 1.7-fold [P < 0.03], respectively). PPFP-induced up-regulation of miR-122 expression was independent of its known dominant-negative PPARγ activity. Up-regulation of miR-122 negatively regulates ADAM-17, a known downstream target, in thyroid cells, suggesting an antiangiogenic mechanism in thyroid carcinoma. This latter inference is directly supported by reduced CD-31 expression in WRO xenografts expressing PPFP, miR-122, and DN-PPARγ. We conclude that, in addition to its apparent oncogenic potential in vitro, PPFP exhibits paradoxical tumor suppressor activity in vivo, mediated by multiple mechanisms including up-regulation of miR-122 and dominant-negative inhibition of PPARγ activity.

Stable Caloric Intake and Continued Virologic Suppression for HIV-Positive Antiretroviral Treatment-Experienced Women After Switching to a Single-Tablet Regimen of Emtricitabine, Rilpivirine, and Tenofovir Disoproxil Fumarate.

PubMed

Menezes, Prema; Mollan, Katie; Hoffman, Erin; Xie, Zimeng; Wills, Jennifer; Marcus, Cheryl; Rublein, John; Hudgens, Michael; Eron, Joseph J

2018-05-02

Benefits of switching to a single-tablet regimen (STR) of emtricitabine/rilpivirine/tenofovir (FTC/RPV/TDF) in virologically suppressed antiretroviral treatment (ART) experienced HIV-positive women include pregnancy category B rating and lack of clinically significant drug interactions between RPV and oral contraceptives. Unfortunately, studies involving switching to FTC/RPV/TDF enrolled fewer than 25% women. We undertook this 48-week study to assess the ability of virologically suppressed HIV-positive women switching to RPV STR to remain virologically suppressed and comply with the caloric intake requirement. HIV-positive women on ART with viral load <50 c/mL for 6 months before study entry and no known resistance to FTC, TDF, or RPV were enrolled and switched to STR RPV/FTC/TDF. Caloric intake (≥400 kcal) compliance and concurrency with oral STR RPV/FTC/TDF were evaluated with a 3-day food diary, which was validated by obtaining participant's caloric consumption through phone calls on randomly chosen dates. For each 3-day food diary, the daily median caloric intake and median value for each macronutrient consumed concurrent with FTC/RPV/TDF were computed. Medication adherence was measured using a visual analog scale. We enrolled 33 women, 73% of whom were African American. At week 48, virologic suppression (HIV RNA <40 c/mL) was maintained in 96% of women, including those (n = 4) who reported imperfect ART adherence. The daily median caloric intake concurrent with FTC/RPV/TDF was 820 kcal by food diary and 677 kcal by random phone call. Median kcal intake (food diary) did not change significantly from baseline (684 kcal) to week 48 (820 kcal); median change 102 kcal, p = .15. Women who reported noncompliance with a ≥400 kcal meal did not experience virologic failure. Significant concordance between caloric adherence and virologic suppression was not detected. Our study demonstrated that HIV-positive women who switched to STR FTC/RPV/TDF continued to experience virologic suppression and were readily able to comply with the recommended caloric intake requirement.

Brief Report: Long-Term (96-Week) Efficacy and Safety After Switching From Tenofovir Disoproxil Fumarate to Tenofovir Alafenamide in HIV-Infected, Virologically Suppressed Adults

PubMed Central

Raffi, François; Orkin, Chloe; Clarke, Amanda; Slama, Laurence; Gallant, Joel; Daar, Eric; Henry, Keith; Santana-Bagur, Jorge; Stein, David K.; Bellos, Nicholaos; Scarsella, Anthony; Yan, Mingjin; Abram, Michael E.; Cheng, Andrew

2017-01-01

Abstract: In a double-blind, phase 3 trial, 663 HIV-infected, virologically suppressed adults were randomized to switch to tenofovir alafenamide (TAF; n = 333) vs. remain on tenofovir disoproxil fumarate (TDF; n = 330), each coformulated with emtricitabine (FTC), while continuing their third agent (boosted protease inhibitor or unboosted third agent). At week 96, 88.6% on FTC/TAF and 89.1% on FTC/TDF had HIV-1 RNA <50 copies per milliliter [adjusted difference −0.5% (95% confidence interval: −5.3 to 4.4%)]. Proteinuria, albuminuria, proximal renal tubular function, and bone mineral density improved after switching to TAF- from TDF-containing regimens. These longer-term data support FTC/TAF as a safe, well-tolerated, and durable nucleotide reverse transcriptase inhibitor backbone. PMID:28272164

Response of N2O emissions to biochar amendment in a cultivated sandy loam soil during freeze-thaw cycles

PubMed Central

Liu, Xiang; Wang, Quan; Qi, Zhiming; Han, Jiangang; Li, Lanhai

2016-01-01

In the last decade, an increasing number of studies have reported that soil nitrous oxide (N2O) emissions can be reduced by adding biochar. However, the effect of biochar amendment on soil N2O emissions during freeze-thaw cycle (FTC) is still unknown. In this laboratory study, biochar (0%, 2% and 4%, w/w) was added into a cultivated sandy loam soil and then treated with 15 times of FTC (each FTC consisted of freeze at −5/−10 °C for 24 h and thaw at 5/10 °C for 24 h), to test whether biochar can mitigate soil N2O emissions during FTC, and estimate the relationships between N2O emissions and soil inorganic nitrogen contents/microbial biomass content/enzyme activities. The results showed that biochar amendment suppressed soil N2O emissions by 19.9–69.9% as compared to soils without biochar amendment during FTC. However, N2O emissions were only significantly correlated to soil nitrate nitrogen (NO3−-N) contents, which decreased after biochar amendment, indicating that the decreased soil nitrification by adding biochar played an important role in mitigating N2O emissions during FTC. Further studies are needed to estimate the effectiveness of biochar amendment on reducing freeze-thaw induced N2O emissions from different soils under field conditions. PMID:27748462

Tenofovir alafenamide, emtricitabine, elvitegravir, and cobicistat combination therapy for the treatment of HIV.

PubMed

Imaz, Arkaitz; Podzamczer, Daniel

2017-03-01

Tenofovir alafenamide (TAF) is a novel prodrug of the nucleotide analogue reverse-transcriptase inhibitor, tenofovir. TAF has been co-formulated with emtricitabine (FTC), elvitegravir (EVG) and the EVG metabolic enhancer, cobicistat (COBI) as a single-tablet regimen being the first TAF-containing antiretroviral combination available. Areas covered: This article summarizes the available information on the pharmacology of the novel compound TAF and overviews TAF/FTC/EVG/COBI use for HIV-1 infected patients, with specific focus on clinical efficacy and safety data. Information sources include peer-reviewed scientific literature, conference proceedings and publically available regulatory reports. Compared to tenofovir disoproxil fumarate, TAF results in higher concentrations of the active metabolite tenofovir diphosphate within lymphoid cells, whereas plasma tenofovir exposure is about 90% lower. The efficacy and safety of TAF/FTC/EVG/COBI in treatment-naïve HIV-infected patients has been assessed in phase-III randomized trials, showing non-inferior virological suppression in comparison with TDF/FTC/EVG/COBI, and significantly lower renal and bone toxicity. In addition, TAF/FTC/EVG/COBI has demonstrated efficacy and safety as a switching strategy in suppressed HIV-1 infected individuals, including those with mild or moderate renal impairment. Expert commentary: Approval of the single-tablet TAF/FTC/EVG/COBI regimen is an important advance in HIV therapy, as it is associated with very high efficacy and a better kidney and bone safety profile compared to TDF-containing regimens due to the incorporation of TAF.

The Effect of Fe-Ti-rich Cumulate Overturn on Evolution of the Lunar Interior

NASA Astrophysics Data System (ADS)

Mallik, A.; Ejaz, T.; Shcheka, S.; Garapic, G.; Petitgirard, S.; Blanchard, I.

2017-12-01

The last 5% of magma ocean crystallized Fe-Ti rich cumulates (FTC) emplaced below the anorthitic crust [1]. Due to gravitational instability, FTC underwent diapiric downwelling [2], associated with overturn of the lunar mantle. Petrological studies on Apollo basalts with variable TiO2 place their sources between 1.5-3 GPa. This indicates the presence of heterogeneous Ti-rich domains in the lunar interior which could either be produced by inefficient overturn and mixing [3], or due to post-overturn upwelling of FTC from the core-mantle boundary (CMB) [4]. Also, a seismically attenuating layer at the CMB ( 4.5 GPa) maybe associated with partial melt of overturned FTC [5]. Thus, it is important to investigate the phase equilibria of FTC with and without assimilation with the surrounding mantle, to understand better the effect of the overturn process on lunar evolution. We performed phase equilibria experiments at 2 and 4.5 GPa, 1230 to 1700 °C using a multi-anvil apparatus on FTC and a 1:1 mixture of FTC and mantle composition. FTC produced Fe-Ti rich (FeO 13-26 wt.%, TiO2 11-18 wt.%), Mg-poor (MgO 6-10 wt.%) basalts with residues of clinopyroxene+quartz+Fe-metal±spinel, while the mixture of FTC and mantle produced Fe-Ti-Mg rich (FeO 10-13 wt.%, TiO2 5-11 wt.% and MgO 20-30 wt.%) basalts with residues of orthopyroxene+olivine+Fe-metal±spinel±garnet. We find that partial melting of overturned cumulates within the lunar mantle can reproduce certain chemical attributes of Apollo high Ti basalts. Also, to test whether the partial melt of overturned cumulates can be stable at the CMB to produce the attenuating layer, we estimated the densities of these melt compositions using the published range of KT and K' of high Fe-Ti picrites. We find that the densities obtained from the published spread in K' and KT values yield inconclusive results about the stability of these partial melts at the CMB. This is being resolved by in-situ experimental determination of the densities of the high Fe-Ti melt compositions, currently underway. If these partial melts are indeed stable at the CMB, they bracket the present-day CMB temperature between 1300-1490 °C (5 to 30% partial melting [5]).[1] Snyder et al. (1992), GCA [2] Hess & Permentier (1995), EPSL [3] Brown & Grove (2015), GCA [4] Zhong et al. (2000), EPSL [5] Weber et al. (2011), Science

Thick tumor capsule is a valuable risk factor for distant metastasis in follicular thyroid carcinoma.

PubMed

Shimbashi, Wataru; Sugitani, Iwao; Kawabata, Kazuyoshi; Mitani, Hiroki; Toda, Kazuhisa; Yamada, Keiko; Sato, Yukiko

2018-02-01

While the biological behavior of follicular thyroid carcinoma (FTC) has been studied in great detail using clinical experience, few studies have investigated pre- or intraoperative factors related to the risk of distant metastasis (DM) among patients with FTC. The aim of this study was to analyze the characteristics of FTC with DM. This study retrospectively investigated 102 patients with FTC who underwent surgery between 1988 and 2013. We compared clinicopathological characteristics between FTC with and without DM. Univariate analysis revealed nodal metastasis (p=0.045), serum thyroglobulin (Tg) at initial operation (≥1000ng/ml; p<0.0001), widely invasive appearance according to macroscopic findings (p<0.0001), thick tumor capsule (≥1mm; p<0.0001), vascular invasion (p=0.0003), extrathyroidal invasion (p=0.047), and venous tumor embolism (p=0.045) as significant risk factors for DM. Multivariate analysis conducted using pre- and intraoperative factors identified thick tumor capsule (≥1mm), serum Tg at initial operation (≥1000ng/ml), and macroscopically widely invasive appearance as risk factors independently associated with development of DM. Patients with these risk factors should undergo total thyroidectomy and radioactive iodine ablation. Copyright © 2017 Elsevier B.V. All rights reserved.

[Usefulness of galectin-3 expression in the clinical behavior of differentiated thyroid carcinoma].

PubMed

López Mondéjar, Pedro; Picó, Antonio; Seguí, Javier; López Maciá, Alicia

2008-02-16

Our objective was to quantify the galectin-3 (gal-3) expression in differentiated thyroid carcinoma and study its relation with the clinical behavior of these tumors. We investigated the immunohistochemical reaction of gal-3 in patients with papillary thyroid carcinoma (PTC) and follicular thyroid carcinoma (FTC) and performed a retrospective study in order to find correlations with clinical features. Gal-3 expression was studied in 53 differentiated tyroid carcinomas (42 PTC and 11 FTC), and was related with clinical features: metastases, extrathyroid invasion and initial stage in the diagnosis and persistence disease and relapses in the follow up. Gal-3 expression positivity in PTC had a median of 60% (percentil 25 [p25], 17.5%; percentil 75 [p75], 100%), and was significantly higher (p < 0.0001) than in FTC (median, 0%; p25, 0%; p75, 15%). In PTC, gal-3 expression was significantly higher in advanced stages at the time of initial diagnosis (p = 0.014), persistent disease (p = 0.012) and relapses (p = 0.012) during the follow up. We did not find any significant association between gal-3 expression and clinical features of FTC. Gal-3 is a negative prognosis marker in PTC but not in FTC.

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Selected single-nucleotide polymorphisms in FOXE1, SERPINA5, FTO, EVPL, TICAM1 and SCARB1 are associated with papillary and follicular thyroid cancer risk: replication study in a German population

PubMed Central

Sigurdson, Alice J.; Brenner, Alina V.; Roach, James A.; Goudeva, Lilia; Müller, Jörg A.; Nerlich, Kai; Reiners, Christoph; Schwab, Robert; Pfeiffer, Liliane; Waldenberger, Melanie; Braganza, Melissa; Xu, Li; Sturgis, Erich M.; Yeager, Meredith; Chanock, Stephen J.; Pfeiffer, Ruth M.; Abend, Michael; Port, Matthias

2016-01-01

Several single-nucleotide polymorphisms (SNPs) have been associated with papillary and follicular thyroid cancer (PTC and FTC, respectively) risk, but few have replicated. After analyzing 17525 tag SNPs in 1129 candidate genes, we found associations with PTC risk in SERPINA5, FTO, HEMGN (near FOXE1) and other genes. Here, we report results from a replication effort in a large independent PTC/FTC case–control study conducted in Germany. We evaluated the best tagging SNPs from our previous PTC study and additionally included SNPs in or near FOXE1 and NKX2-1 genes, known susceptibility loci for thyroid cancer. We genotyped 422 PTC and 130 FTC cases and 752 controls recruited from three German clinical centers. We used polytomous logistic regression to simultaneously estimate PTC and FTC associations for 79 SNPs based on log-additive models. We assessed effect modification by body mass index (BMI), gender and age for all SNPs, and selected SNP by SNP interactions. We confirmed associations with PTC and SNPs in FOXE1/HEMGN, SERPINA5 (rs2069974), FTO (rs8047395), EVPL (rs2071194), TICAM1 (rs8120) and SCARB1 (rs11057820) genes. We found associations with SNPs in FOXE1, SERPINA5, FTO, TICAM1 and HSPA6 and FTC. We found two significant interactions between FTO (rs8047395) and BMI (P = 0.0321) and between TICAM1 (rs8120) and FOXE1 (rs10984377) (P = 0.0006). Besides the known associations with FOXE1 SNPs, we confirmed additional PTC SNP associations reported previously. We also found several new associations with FTC risk and noteworthy interactions. We conclude that multiple variants and host factors might interact in complex ways to increase risk of PTC and FTC. PMID:27207655

Selected single-nucleotide polymorphisms in FOXE1, SERPINA5, FTO, EVPL, TICAM1 and SCARB1 are associated with papillary and follicular thyroid cancer risk: replication study in a German population.

PubMed

Sigurdson, Alice J; Brenner, Alina V; Roach, James A; Goudeva, Lilia; Müller, Jörg A; Nerlich, Kai; Reiners, Christoph; Schwab, Robert; Pfeiffer, Liliane; Waldenberger, Melanie; Braganza, Melissa; Xu, Li; Sturgis, Erich M; Yeager, Meredith; Chanock, Stephen J; Pfeiffer, Ruth M; Abend, Michael; Port, Matthias

2016-07-01

Several single-nucleotide polymorphisms (SNPs) have been associated with papillary and follicular thyroid cancer (PTC and FTC, respectively) risk, but few have replicated. After analyzing 17525 tag SNPs in 1129 candidate genes, we found associations with PTC risk in SERPINA5, FTO, HEMGN (near FOXE1) and other genes. Here, we report results from a replication effort in a large independent PTC/FTC case-control study conducted in Germany. We evaluated the best tagging SNPs from our previous PTC study and additionally included SNPs in or near FOXE1 and NKX2-1 genes, known susceptibility loci for thyroid cancer. We genotyped 422 PTC and 130 FTC cases and 752 controls recruited from three German clinical centers. We used polytomous logistic regression to simultaneously estimate PTC and FTC associations for 79 SNPs based on log-additive models. We assessed effect modification by body mass index (BMI), gender and age for all SNPs, and selected SNP by SNP interactions. We confirmed associations with PTC and SNPs in FOXE1/HEMGN, SERPINA5 (rs2069974), FTO (rs8047395), EVPL (rs2071194), TICAM1 (rs8120) and SCARB1 (rs11057820) genes. We found associations with SNPs in FOXE1, SERPINA5, FTO, TICAM1 and HSPA6 and FTC. We found two significant interactions between FTO (rs8047395) and BMI (P = 0.0321) and between TICAM1 (rs8120) and FOXE1 (rs10984377) (P = 0.0006). Besides the known associations with FOXE1 SNPs, we confirmed additional PTC SNP associations reported previously. We also found several new associations with FTC risk and noteworthy interactions. We conclude that multiple variants and host factors might interact in complex ways to increase risk of PTC and FTC. Published by Oxford University Press 2016.

Costs and cost-efficacy analysis of the 2017 GESIDA/Spanish National AIDS Plan recommended guidelines for initial antiretroviral therapy in HIV-infected adults.

PubMed

Rivero, Antonio; Pérez-Molina, José Antonio; Blasco, Antonio Javier; Arribas, José Ramón; Asensi, Víctor; Crespo, Manuel; Domingo, Pere; Iribarren, José Antonio; Lázaro, Pablo; López-Aldeguer, José; Lozano, Fernando; Martínez, Esteban; Moreno, Santiago; Palacios, Rosario; Pineda, Juan Antonio; Pulido, Federico; Rubio, Rafael; Santos, Jesús; de la Torre, Javier; Tuset, Montserrat; Gatell, Josep M

2018-05-01

GESIDA and the Spanish National AIDS Plan panel of experts have recommended preferred (PR), alternative (AR) and other regimens (OR) for antiretroviral therapy (ART) as initial therapy in HIV-infected patients for 2017. The objective of this study was to evaluate the costs and the efficiency of initiating treatment with PR and AR. Economic assessment of costs and efficiency (cost-efficacy) based on decision tree analyses. Efficacy was defined as the probability of reporting a viral load <50copies/mL at week 48, in an intention-to-treat analysis. Cost of initiating treatment with an ART regimen was defined as the costs of ART and its consequences (adverse effects, changes of ART regimen and drug resistance studies) during the first 48 weeks. The payer perspective (National Health System) was applied considering only differential direct costs: ART (official prices), management of adverse effects, resistance studies and HLA B*5701 screening. The setting was Spain and the costs correspond to those of 2017. A deterministic sensitivity analysis was conducted, building three scenarios for each regimen: base case, most favourable and least favourable. In the base case scenario, the cost of initiating treatment ranged from 6882 euro for TFV/FTC/RPV (AR) to 10,904 euros for TFV/FTC+RAL (PR). The efficacy varied from 0.82 for TFV/FTC+DRV/p (AR) to 0.92 for TAF/FTC/EVG/COBI (PR). The efficiency, in terms of cost-efficacy, ranged from 7923 to 12,765 euros per responder at 48 weeks, for ABC/3TC/DTG (PR) and TFV/FTC+RAL (PR), respectively. Considering ART official prices, the most efficient regimen was ABC/3TC/DTG (PR), followed by TFV/FTC/RPV (AR) and TAF/FTC/EVG/COBI (PR). Copyright © 2017 Elsevier España, S.L.U. and Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica. All rights reserved.

Analysis of the costs and cost-effectiveness of the guidelines recommended by the 2018 GESIDA/Spanish National AIDS Plan for initial antiretroviral therapy in HIV-infected adults.

PubMed

Pérez-Molina, José Antonio; Martínez, Esteban; Blasco, Antonio Javier; Arribas, José Ramón; Domingo, Pere; Iribarren, José Antonio; Knobel, Hernando; Lázaro, Pablo; López-Aldeguer, José; Lozano, Fernando; Mariño, Ana; Miró, José M; Moreno, Santiago; Negredo, Eugenia; Pulido, Federico; Rubio, Rafael; Santos, Jesús; de la Torre, Javier; Tuset, Montserrat; von Wichmann, Miguel A; Gatell, Josep M

2018-06-05

The GESIDA/National AIDS Plan expert panel recommended preferred regimens (PR), alternative regimens (AR) and other regimens (OR) for antiretroviral treatment (ART) as initial therapy in HIV-infected patients for 2018. The objective of this study was to evaluate the costs and the efficiency of initiating treatment with PR and AR. Economic assessment of costs and efficiency (cost-effectiveness) based on decision tree analyses. Effectiveness was defined as the probability of reporting a viral load <50copies/mL at week 48, in an intention-to-treat analysis. Cost of initiating treatment with an ART regimen was defined as the costs of ART and its consequences (adverse effects, changes of ART regimen, and drug-resistance studies) over the first 48 weeks. The payer perspective (National Health System) was applied considering only differential direct costs: ART (official prices), management of adverse effects, studies of resistance, and HLA B*5701 testing. The setting was Spain and the costs correspond to those of 2018. A deterministic sensitivity analysis was conducted, building three scenarios for each regimen: base case, most favourable and least favourable. In the base-case scenario, the cost of initiating treatment ranges from 6788 euros for TAF/FTC/RPV (AR) to 10,649 euros for TAF/FTC+RAL (PR). The effectiveness varies from 0.82 for TAF/FTC+DRV/r (AR) to 0.91 for TAF/FTC+DTG (PR). The efficiency, in terms of cost-effectiveness, ranges from 7814 to 12,412 euros per responder at 48 weeks, for ABC/3TC/DTG (PR) and TAF/FTC+RAL (PR), respectively. Considering ART official prices, the most efficient regimen was ABC/3TC/DTG (PR), followed by TAF/FTC/RPV (AR) and TAF/FTC/EVG/COBI (AR). Copyright © 2018 Elsevier España, S.L.U. and Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica. All rights reserved.

Comparing the novel method of assessing PrEP adherence/exposure using hair samples to other pharmacologic and traditional measures.

PubMed

Baxi, Sanjiv M; Liu, Albert; Bacchetti, Peter; Mutua, Gaudensia; Sanders, Eduard J; Kibengo, Freddie M; Haberer, Jessica E; Rooney, James; Hendrix, Craig W; Anderson, Peter L; Huang, Yong; Priddy, Frances; Gandhi, Monica

2015-01-01

The efficacy of pre-exposure prophylaxis (PrEP) in HIV will diminish with poor adherence; pharmacologic measures of drug exposure have proven critical to PrEP trial interpretation. We assessed drug exposure in hair against other pharmacologic and more routinely used measures to assess pill-taking. Participants were randomized to placebo, daily PrEP, or intermittent PrEP to evaluate safety and tolerability of daily versus intermittent tenofovir/emtricitabine (TFV/FTC) in 2 phase II PrEP clinical trials conducted in Africa. Different measures of drug exposure, including self-report, medication event monitoring system (MEMS)-caps openings, and TFV/FTC levels in hair and other biomatrices were compared. At weeks 8 and 16, self-reported pill-taking, MEMS-caps openings, and TFV/FTC levels in hair, plasma, and peripheral blood mononuclear cells (PBMCs) were measured. Regression models evaluated predictors of TFV/FTC concentrations in the 3 biomatrices; correlation coefficients between pharmacologic and nonpharmacologic measures were calculated. Both trials were registered on ClinicalTrials.gov (NCT00931346/NCT00971230). Hair collection was highly feasible and acceptable (100% in week 8; 96% in week 16). In multivariate analysis, strong associations were seen between pharmacologic measures and MEMS-caps openings (all P < 0.001); self-report was only weakly associated with pharmacologic measures. TFV/FTC hair concentrations were significantly correlated with levels in plasma and PBMCs (correlation coefficients, 0.41-0.86, all P < 0.001). Measuring TFV/FTC exposure in small hair samples in African PrEP trials was feasible and acceptable. Hair levels correlated strongly with PBMC, plasma concentrations, and MEMS-caps openings. As in other PrEP trials, self-report was the weakest measure of exposure. Further study of hair TFV/FTC levels in PrEP trials and demonstration projects to assess adherence/exposure is warranted.

Comparing the Novel Method of Assessing PrEP Adherence/Exposure Using Hair Samples to Other Pharmacologic and Traditional Measures

PubMed Central

Baxi, Sanjiv M.; Liu, Albert; Bacchetti, Peter; Mutua, Gaudensia; Sanders, Eduard J.; Kibengo, Freddie M.; Haberer, Jessica E.; Rooney, James; Hendrix, Craig W.; Anderson, Peter L.; Huang, Yong; Priddy, Frances

2015-01-01

Objective: The efficacy of pre-exposure prophylaxis (PrEP) in HIV will diminish with poor adherence; pharmacologic measures of drug exposure have proven critical to PrEP trial interpretation. We assessed drug exposure in hair against other pharmacologic and more routinely used measures to assess pill-taking. Design: Participants were randomized to placebo, daily PrEP, or intermittent PrEP to evaluate safety and tolerability of daily versus intermittent tenofovir/emtricitabine (TFV/FTC) in 2 phase II PrEP clinical trials conducted in Africa. Different measures of drug exposure, including self-report, medication event monitoring system (MEMS)-caps openings, and TFV/FTC levels in hair and other biomatrices were compared. Methods: At weeks 8 and 16, self-reported pill-taking, MEMS-caps openings, and TFV/FTC levels in hair, plasma, and peripheral blood mononuclear cells (PBMCs) were measured. Regression models evaluated predictors of TFV/FTC concentrations in the 3 biomatrices; correlation coefficients between pharmacologic and nonpharmacologic measures were calculated. Both trials were registered on ClinicalTrials.gov (NCT00931346/NCT00971230). Results: Hair collection was highly feasible and acceptable (100% in week 8; 96% in week 16). In multivariate analysis, strong associations were seen between pharmacologic measures and MEMS-caps openings (all P < 0.001); self-report was only weakly associated with pharmacologic measures. TFV/FTC hair concentrations were significantly correlated with levels in plasma and PBMCs (correlation coefficients, 0.41–0.86, all P < 0.001). Conclusions: Measuring TFV/FTC exposure in small hair samples in African PrEP trials was feasible and acceptable. Hair levels correlated strongly with PBMC, plasma concentrations, and MEMS-caps openings. As in other PrEP trials, self-report was the weakest measure of exposure. Further study of hair TFV/FTC levels in PrEP trials and demonstration projects to assess adherence/exposure is warranted. PMID:25296098

Adaptive Neural Networks Decentralized FTC Design for Nonstrict-Feedback Nonlinear Interconnected Large-Scale Systems Against Actuator Faults.

PubMed

Li, Yongming; Tong, Shaocheng

The problem of active fault-tolerant control (FTC) is investigated for the large-scale nonlinear systems in nonstrict-feedback form. The nonstrict-feedback nonlinear systems considered in this paper consist of unstructured uncertainties, unmeasured states, unknown interconnected terms, and actuator faults (e.g., bias fault and gain fault). A state observer is designed to solve the unmeasurable state problem. Neural networks (NNs) are used to identify the unknown lumped nonlinear functions so that the problems of unstructured uncertainties and unknown interconnected terms can be solved. By combining the adaptive backstepping design principle with the combination Nussbaum gain function property, a novel NN adaptive output-feedback FTC approach is developed. The proposed FTC controller can guarantee that all signals in all subsystems are bounded, and the tracking errors for each subsystem converge to a small neighborhood of zero. Finally, numerical results of practical examples are presented to further demonstrate the effectiveness of the proposed control strategy.The problem of active fault-tolerant control (FTC) is investigated for the large-scale nonlinear systems in nonstrict-feedback form. The nonstrict-feedback nonlinear systems considered in this paper consist of unstructured uncertainties, unmeasured states, unknown interconnected terms, and actuator faults (e.g., bias fault and gain fault). A state observer is designed to solve the unmeasurable state problem. Neural networks (NNs) are used to identify the unknown lumped nonlinear functions so that the problems of unstructured uncertainties and unknown interconnected terms can be solved. By combining the adaptive backstepping design principle with the combination Nussbaum gain function property, a novel NN adaptive output-feedback FTC approach is developed. The proposed FTC controller can guarantee that all signals in all subsystems are bounded, and the tracking errors for each subsystem converge to a small neighborhood of zero. Finally, numerical results of practical examples are presented to further demonstrate the effectiveness of the proposed control strategy.

Effects on vitamin D, bone and the kidney of switching from fixed-dose tenofovir disoproxil fumarate/emtricitabine/efavirenz to darunavir/ritonavir monotherapy: a randomized, controlled trial (MIDAS).

PubMed

Hamzah, Lisa; Tiraboschi, Juan M; Iveson, Helen; Toby, Martina; Mant, Christine; Cason, John; Burling, Keith; Wandolo, Emily; Jendrulek, Isabelle; Taylor, Chris; Ibrahim, Fowzia; Kulasegaram, Ranjababu; Teague, Alastair; Post, Frank A; Fox, Julie

2016-01-01

Efavirenz (EFV) has been associated with reductions in vitamin D (25[OH]D) and tenofovir (TDF) with increased bone turnover, reductions in bone mineral density (BMD) and renal tubular dysfunction. We hypothesized that switching from fixed-dose TDF/emtricitabine (FTC)/EFV to darunavir/ritonavir monotherapy (DRV/r) might increase 25(OH)D and BMD, and improve renal tubular function. Subjects with HIV RNA <50 copies/ml on TDF/FTC/EFV for ≥6 months were randomized 1:1 to ongoing TDF/FTC/EFV or DRV/r (800/100 mg once daily) for 48 weeks. The primary end point was change from baseline in 25(OH)D at week 48. Secondary end points included changes in BMD, bone turnover markers and renal tubular function. A total of 64 subjects (86% male, 66% white, mean [sd] CD4(+) T-cell count 537.3 [191.5]/mm(3)) were analysed. After adjustment for baseline 25(OH)D and demographics, at week 48 DRV/r monotherapy was associated with a +3.6 (95% CI 0.6, 6.6) ng/ml increase in 25(OH)D compared to TDF/FTC/EFV (P=0.02). DRV/r monotherapy was associated with an increase in BMD (+2.9% versus -0.003% at the neck of femur and +2.6% versus +0.008% at the lumbar spine for DRV/r versus TDF/FTC/EFV; P<0.05 for all) and reductions in bone biomarkers compared with those remaining on TDF/FTC/EFV. No significant difference in renal tubular function was observed. Reasons for discontinuation in the DRV/r arm included side effects (n=4) and viral load rebound (n=3), all of which resolved with DRV/r discontinuation or regimen intensification. Switching from TDF/FTC/EFV to DRV/r in patients with suppressed HIV RNA resulted in significant improvements in 25(OH)D and bone biomarkers, and a 2-3% increase in BMD.

5 CFR 2423.26 - Stipulations of fact submissions.

Code of Federal Regulations, 2013 CFR

2013-01-01

... material issue of fact exists, the parties may jointly submit a motion to the Administrative Law Judge or... required and must be submitted within 30 days of the joint motion. Upon receipt of the briefs, such motions shall be ruled upon expeditiously. (b) Stipulations to the Administrative Law Judge. Where the...

5 CFR 2423.26 - Stipulations of fact submissions.

Code of Federal Regulations, 2012 CFR

2012-01-01

... material issue of fact exists, the parties may jointly submit a motion to the Administrative Law Judge or... required and must be submitted within 30 days of the joint motion. Upon receipt of the briefs, such motions shall be ruled upon expeditiously. (b) Stipulations to the Administrative Law Judge. Where the...

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2014-01-01

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5 CFR 2423.26 - Stipulations of fact submissions.

Code of Federal Regulations, 2011 CFR

2011-01-01

... material issue of fact exists, the parties may jointly submit a motion to the Administrative Law Judge or... required and must be submitted within 30 days of the joint motion. Upon receipt of the briefs, such motions shall be ruled upon expeditiously. (b) Stipulations to the Administrative Law Judge. Where the...

Molecular differential diagnosis of follicular thyroid carcinoma and adenoma based on gene expression profiling by using formalin-fixed paraffin-embedded tissues

PubMed Central

2013-01-01

Background Differential diagnosis between malignant follicular thyroid cancer (FTC) and benign follicular thyroid adenoma (FTA) is a great challenge for even an experienced pathologist and requires special effort. Molecular markers may potentially support a differential diagnosis between FTC and FTA in postoperative specimens. The purpose of this study was to derive molecular support for differential post-operative diagnosis, in the form of a simple multigene mRNA-based classifier that would differentiate between FTC and FTA tissue samples. Methods A molecular classifier was created based on a combined analysis of two microarray datasets (using 66 thyroid samples). The performance of the classifier was assessed using an independent dataset comprising 71 formalin-fixed paraffin-embedded (FFPE) samples (31 FTC and 40 FTA), which were analysed by quantitative real-time PCR (qPCR). In addition, three other microarray datasets (62 samples) were used to confirm the utility of the classifier. Results Five of 8 genes selected from training datasets (ELMO1, EMCN, ITIH5, KCNAB1, SLCO2A1) were amplified by qPCR in FFPE material from an independent sample set. Three other genes did not amplify in FFPE material, probably due to low abundance. All 5 analysed genes were downregulated in FTC compared to FTA. The sensitivity and specificity of the 5-gene classifier tested on the FFPE dataset were 71% and 72%, respectively. Conclusions The proposed approach could support histopathological examination: 5-gene classifier may aid in molecular discrimination between FTC and FTA in FFPE material. PMID:24099521

The role of prospero homeobox 1 (PROX1) expression in follicular thyroid carcinoma cells

PubMed Central

Rudzinska, Magdalena; Ledwon, Joanna K.; Gawel, Damian; Sikorska, Justyna; Czarnocka, Barbara

2017-01-01

The prospero homeobox 1 (Prox1) transcription factor is a key player during embryogenesis and lymphangiogenesis. Altered Prox1 expression has been found in a variety of human cancers, including papillary thyroid carcinoma (PTC). Interestingly, Prox1 may exert tumor suppressive or tumor promoting effect, depending on the tissue context. In this study, we have analyzed Prox1 expression in normal and malignant human thyroid carcinoma cell lines. Moreover, we determined the effect of Prox1 silencing and overexpression on the cellular processes associated with the metastatic potential of tumor cells: proliferation, migration, invasion, apoptosis and anchorage-independent growth, in the follicular thyroid carcinoma (FTC) FTC-133 cell line. We found that Prox1 expression was significantly higher in FTC-derived cells than in PTC-derived cells and normal thyroid, and it was associated with the PI3K/Akt signaling pathway. In the FTC-133 cells, it was associated with cell invasive potential, motility and wound closure capacities, but not with proliferation or apoptosis. Modifying Prox1 expression also induced substantial changes in the cytoskeleton structure and cell morphology. In conclusion, we have shown that Prox1 plays an important role in the development of FTC and that its suppression prevents, whereas its overexpression promotes, the malignant behavior of thyroid follicular cancer cells. PMID:29371975

Pre-exposure prophylaxis does not affect the fertility of HIV-1-uninfected men.

PubMed

Were, Edwin O; Heffron, Renee; Mugo, Nelly R; Celum, Connie; Mujugira, Andrew; Bukusi, Elizabeth A; Baeten, Jared M

2014-08-24

There is a paucity of data on the effect of antiretroviral medications on male fertility. Couples affected by HIV-1 often have fertility intentions, and antiretroviral medications, as both treatment of HIV-1-infected persons and pre-exposure prophylaxis (PrEP) for uninfected persons, are part of peri-conception risk reduction. Within a randomized, placebo-controlled trial of daily oral tenofovir disoproxil fumarate (TDF) and combination emtricitabine (FTC)/TDF PrEP for HIV-1 prevention conducted among heterosexual HIV-1-serodiscordant couples, we assessed the impact of TDF and FTC/TDF use on male fertility, measured as incident pregnancy in female partners of men assigned to PrEP vs. placebo. Of the 2962 HIV-1-uninfected men partners, 986 were randomized to TDF, 1013 to FTC/TDF, and 963 to placebo. The overall pregnancy incidence in their HIV-1-infected female partners was 12.9 per 100 person-years and did not differ significantly across the study arms (13.2 TDF, 12.4 FTC/TDF, 13.2 placebo). The frequency of live births, pregnancy losses, and gestational age at birth or loss was also statistically similar in the three randomization groups. TDF and FTC/TDF, when used as PrEP by HIV-1-uninfected men, did not adversely affect male fertility or pregnancy outcomes.

77 FR 36149 - Disclosure Requirements and Prohibitions Concerning Franchising

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2012-06-18

... FTC announces revised monetary thresholds for three exemptions from the Franchise Rule. FTC is... July 1, 2012. FOR FURTHER INFORMATION CONTACT: Craig Tregillus, Franchise Rule Coordinator, Division of... and Prohibitions Concerning Franchising'' (Franchise Rule or Rule) \\1\\ provides three exemptions based...

Protecting Your Child's Privacy Online

MedlinePlus

... Keeping Up With Kids' Apps infographic Kids and Computer Security Kids and Mobile Phones Kids and Socializing Online ... email Looking for business guidance on privacy and ... The Federal Trade Commission (FTC) is the nation’s consumer protection agency. The FTC works to prevent fraudulent, deceptive ...

Week 96 efficacy of lopinavir/ritonavir monotherapy in virologically suppressed patients with HIV: a randomized non-inferiority trial (ANRS 140 DREAM).

PubMed

Meynard, Jean-Luc; Moinot, Laetitia; Landman, Roland; Morand-Joubert, Laurence; Besseghir, Amel; Kolta, Sami; Spire, Bruno; Todesco, Eve; Bouchaud, Olivier; Fagard, Catherine; Chene, Geneviève; Girard, Pierre-Marie

2018-06-01

Sparing of antiretroviral drug classes could reduce the toxicity and cost of maintenance treatment for HIV infection. To evaluate the non-inferiority of efficacy and the safety of lopinavir/ritonavir (r) monotherapy versus a single-tablet regimen of efavirenz, emtricitabine and tenofovir (EFV/FTC/TDF) over 2 years. Adults on stable ART with plasma HIV-1 RNA viral load <50 copies/mL for the past 12 months and no documented treatment failure were randomized to receive either lopinavir/r or EFV/FTC/TDF for 2 years. The primary endpoint was the proportion of patients without treatment failure at week 96 (viral load <50 copies/mL at week 96, confirmed at week 98), without study treatment discontinuation, a new AIDS-defining illness, or death. In the ITT analysis, the primary endpoint was reached by, respectively, 64% and 71% of patients in the lopinavir/r (n = 98) and EFV/FTC/TDF arms (n = 97), yielding a difference of -6.8% (lower limit of the 95% two-sided CI: -19.9%). Sanger and UltraDeep sequencing showed the occurrence of PI mutations in the lopinavir/r arm (n = 4) and of NNRTI and/or NRTI mutations in the EFV/FTC/TDF arm (n = 2). No unexpected serious clinical events occurred. Lopinavir/r monotherapy cannot be considered non-inferior to EFV/FTC/TDF. PI resistance rarely emerged in the lopinavir/r arm and did not undermine future PI options. Two years of lopinavir/r monotherapy had no deleterious clinical impact when compared with EFV/FTC/TDF.

lncRNA CCAT1 promotes cell proliferation, migration, and invasion by down-regulation of miR-143 in FTC-133 thyroid carcinoma cell line.

PubMed

Yang, Tianzheng; Zhai, Hongyan; Yan, Ruihong; Zhou, Zhenhu; Gao, Lei; Wang, Luqing

2018-01-01

Thyroid cancer is a common malignant tumor. Long non-coding RNA colon cancer-associated transcript 1 (lncRNA CCAT1) is highly expressed in many cancers; however, the molecular mechanism of CCAT1 in thyroid cancer remains unclear. Hence, this study aimed to investigate the effect of CCAT1 on human thyroid cancer cell line FTC-133. FTC-133 cells were transfected with CCAT1 expressing vector, CCAT1 shRNA, miR-143 mimic, and miR-143 inhibitor, respectively. After different treatments, cell viability, proliferation, migration, invasion, and apoptosis were measured. Moreover, the regulatory relationship of CCAT1 and miR-143, as well as miR-143 and VEGF were tested using dual-luciferase reporter assay. The relative expressions of CCAT1, miR-143, and VEGF were tested by qRT-PCR. The expressions of apoptosis-related factors and corresponding proteins in PI3K/AKT and MAPK pathways were analyzed using western blot analysis. The results suggested that CCAT1 was up-regulated in the FTC-133 cells. CCAT1 suppression decreased FTC-133 cell viability, proliferation, migration, invasion, and miR-143 expression, while it increased apoptosis and VEGF expression. CCAT1 might act as a competing endogenous RNA (ceRNA) for miR-143. Moreover, CCAT1 activated PI3K/AKT and MAPK signaling pathways through inhibition of miR-143. This study demonstrated that CCAT1 exhibited pro-proliferative and pro-metastasis functions on FTC-133 cells and activated PI3K/AKT and MAPK signaling pathways via down-regulation of miR-143. These findings will provide a possible target for clinical treatment of thyroid cancer.

77 FR 13324 - Fresenius Medical Care AG & Co. KGaA; Analysis of Agreement Containing Consent Orders To Aid...

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2012-03-06

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2013-04-23

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In vivo antiviral activity and pharmacokinetics of (-)-cis-5-fluoro-1-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine in woodchuck hepatitis virus-infected woodchucks.

PubMed Central

Cullen, J M; Smith, S L; Davis, M G; Dunn, S E; Botteron, C; Cecchi, A; Linsey, D; Linzey, D; Frick, L; Paff, M T; Goulding, A; Biron, K

1997-01-01

The (-) enantiomer of cis-5-fluoro-1l-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine [(-)-FTC)], a substituted oxathiolane compound with anti-hepatitis B virus activity in vitro, was assessed for its efficacy in woodchucks with naturally acquired woodchuck hepatitis virus (WHV) infection. Pharmacokinetics and in vitro anabolism were also determined. (-)-FTC was anabolized to the 5'-triphosphate in a dose-related fashion, reaching a maximum concentration at about 24 h in cultured woodchuck hepatocytes. Following administration of a dose of 10 mg/kg of body weight intraperitoneally (i.p.), the clearance of (-)-FTC from plasma was monoexponential, the terminal half-life was 3.76 +/- 1.4 h, and the systemic clearance was 0.12 +/- 0.06 liters/h/kg. The antiviral efficacy of (-)-FTC in the woodchuck model was assessed by quantitation of serum WHV DNA levels and by WHV particle-associated DNA polymerase activity at two dosages, 30 and 20 mg/kg given i.p. twice daily (b.i.d.), respectively. The level of WHV DNA in serum was reduced 20- to 150-fold (average, 56-fold) in the 30-mg/kg-b.i.d. treatment group and 6- to 49-fold (average, 27-fold) in the 20-mg/kg-b.i.d. treatment group. Viral DNA polymerase levels diminished accordingly. One week after treatment was discontinued, WHV levels returned to pretreatment levels in both studies. These animals were biopsied before and following treatment with 30 mg of (-)-FTC per kg. Their livers were characterized by a mild increase in cytoplasmic lipid levels, but this change was not associated with altered liver enzyme levels. Serum chemistry and hematology results were within the normal ranges for all treated animals. We conclude that (-)-FTC is a potent antihepadnaviral agent and that it has no detectable toxic effects in woodchucks when given for up to 25 days. Further development of (-)-FTC as an anti-hepatitis B virus therapy for patients is warranted. PMID:9333028

A randomized comparative trial of continued abacavir/lamivudine plus efavirenz or replacement with efavirenz/emtricitabine/tenofovir DF in hypercholesterolemic HIV-1 infected individuals.

PubMed

Moyle, Graeme J; Orkin, Chloe; Fisher, Martin; Dhar, Jyoti; Anderson, Jane; Wilkins, Edmund; Ewan, Jacqueline; Ebrahimi, Ramin; Wang, Hui

2015-01-01

Drug choice and metabolic changes with antiretroviral therapy contribute to cardiovascular risk in persons with HIV-1 infection. A randomized, 12 week, open-label, comparative study of the impact on lipids of continuation of abacavir/lamivudine (ABC/3TC) plus efavirenz (EFV) or replacement with the single tablet regimen of EFV/emtricitabine/tenofovir DF (EFV/FTC/TDF) in hypercholesterolaemic subjects on successful antiretroviral therapy, with a 12-week extension with all subjects on EFV/FTC/TDF. 157 subjects received study drug, 79 switched to EFV/FTC/TDF and 78 subjects continued ABC/3TC+EFV. At Week 12, 73 subjects on ABC/3TC+EFV switched to EFV/FTC/TDF. The switch was well tolerated and no subject experienced viral rebound. Median baseline fasting total cholesterol was 6.32 mmol/L. 12 weeks following switch, the difference in the means (LSM) between treatment groups (EFV/FTC/TDF minus ABC/3TC+EFV) in total cholesterol change from baseline was -0.74 mmol/l (95% CI -1.00, -0.47, p < 0.001). The median change from baseline in total cholesterol following switch in the EFV/FTC/TDF arm was -0.86 mmol/l (p < 0.001) compared with +0.01 mmol/l (p = 0.45) in the continuation arm at Week 12. Significant (p < 0.001) differences between treatment groups following switch were seen for all lipid fractions from baseline to Week 12: LDL cholesterol (-0.47 mmol/L [-0.70, -0.25]), HDL cholesterol (-0.15 mmol/L [-0.21, -0.08]), triglycerides (-0.43 mmol/L [-0.75, -0.11]), and non HDL cholesterol (-0.56 mmol/L [-0.80, -0.31]). In the extension phase, similar declines in total cholesterol were observed with a median change from Week 12 to Week 24 of -0.73 mmol/L (p < 0.001). Switching from ABC/3TC+EFV to EFV/FTC/TDF in persons with hypercholesterolemia maintains virological control and significantly improves key lipid parameters. ClinicalTrials.gov NCT00615810.

On-Demand Preexposure Prophylaxis in Men at High Risk for HIV-1 Infection.

PubMed

Molina, Jean-Michel; Capitant, Catherine; Spire, Bruno; Pialoux, Gilles; Cotte, Laurent; Charreau, Isabelle; Tremblay, Cecile; Le Gall, Jean-Marie; Cua, Eric; Pasquet, Armelle; Raffi, François; Pintado, Claire; Chidiac, Christian; Chas, Julie; Charbonneau, Pierre; Delaugerre, Constance; Suzan-Monti, Marie; Loze, Benedicte; Fonsart, Julien; Peytavin, Gilles; Cheret, Antoine; Timsit, Julie; Girard, Gabriel; Lorente, Nicolas; Préau, Marie; Rooney, James F; Wainberg, Mark A; Thompson, David; Rozenbaum, Willy; Doré, Veronique; Marchand, Lucie; Simon, Marie-Christine; Etien, Nicolas; Aboulker, Jean-Pierre; Meyer, Laurence; Delfraissy, Jean-François

2015-12-03

Antiretroviral preexposure prophylaxis has been shown to reduce the risk of human immunodeficiency virus type 1 (HIV-1) infection in some studies, but conflicting results have been reported among studies, probably due to challenges of adherence to a daily regimen. We conducted a double-blind, randomized trial of antiretroviral therapy for preexposure HIV-1 prophylaxis among men who have unprotected anal sex with men. Participants were randomly assigned to take a combination of tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) or placebo before and after sexual activity. All participants received risk-reduction counseling and condoms and were regularly tested for HIV-1 and HIV-2 and other sexually transmitted infections. Of the 414 participants who underwent randomization, 400 who did not have HIV infection were enrolled (199 in the TDF-FTC group and 201 in the placebo group). All participants were followed for a median of 9.3 months (interquartile range, 4.9 to 20.6). A total of 16 HIV-1 infections occurred during follow-up, 2 in the TDF-FTC group (incidence, 0.91 per 100 person-years) and 14 in the placebo group (incidence, 6.60 per 100 person-years), a relative reduction in the TDF-FTC group of 86% (95% confidence interval, 40 to 98; P=0.002). Participants took a median of 15 pills of TDF-FTC or placebo per month (P=0.57). The rates of serious adverse events were similar in the two study groups. In the TDF-FTC group, as compared with the placebo group, there were higher rates of gastrointestinal adverse events (14% vs. 5%, P=0.002) and renal adverse events (18% vs. 10%, P=0.03). The use of TDF-FTC before and after sexual activity provided protection against HIV-1 infection in men who have sex with men. The treatment was associated with increased rates of gastrointestinal and renal adverse events. (Funded by the National Agency of Research on AIDS and Viral Hepatitis [ANRS] and others; ClinicalTrials.gov number, NCT01473472.).

12 CFR 391.14 - Enforcement of orders.

Code of Federal Regulations, 2012 CFR

2012-01-01

... credit commitment, of the borrower's overall financial condition and resources, the financial... deleted; d. An explanation of how the customer may obtain a credit report free of charge; and e... to the FTC, and should provide the FTC's Web site address and toll-free telephone number that...

Emboldened, the FTC Seems Ready to Fight More Mergers.

PubMed

Kirkner, Richard Mark

2016-11-01

Because hospital spending makes up the largest piece of U.S. health care spending-32%, according to data from CMS-any judicial rulings or legislative move to curb a hospital's market dominance are key to controlling overall health care costs. The FTC is stepping in.

Will Your Catalog Stand FTC Scrutiny?

ERIC Educational Resources Information Center

Bender, Louis W.

1976-01-01

In light of recent court rulings and Federal Trade Commission (FTC) hearings regarding unfair methods of competition and deceptive advertising, a content analysis was conducted of 20 randomly selected college catalogs from 2-year and 4-year, public and private institutions. Four types of misrepresentations were identified including institutional…

Spectroscopic analysis of normal and neoplastic (WI-FTC) thyroid tissue.

PubMed

Depciuch, Joanna; Stanek-Widera, Agata; Lange, Dariusz; Biskup-Frużyńska, Magdalena; Stanek-Tarkowska, Jadwiga; Czarny, Wojciech; Cebulski, Jozef

2018-06-07

Thyroid cancer holds the first place of the malignant tumors of the endocrine system. One of the less common thyroid cancers is follicular thyroid carcinoma (FTC), which is very difficult to diagnose because it gives the same image as adenoma, which is benign. Certainty of the diagnosis is gained only when FTC gives metastases. Therefore, it was decided to compare normal and neoplastic (FTC) thyroid tissues with Fourier Transform Infrared (FTIR) spectroscopy. The obtained FTIR spectra and Principal Component Analysis (PCA) allowed us to conclude that there are differences in the FTIR spectrum between normal tissues and those affected by cancer. In addition, the results indicate that there is a decrease in the number of functional groups that build cellular and tissue structures in tumoral tissues. The shifts of wave numbers corresponding to the protein and lipid function group vibrations, as well as the calculated second derivative of the FTIR spectra showed the structural changes in neoplastic tissues. Moreover, the deconvolution of the amide I massif indicates that in cancerous tissues the prevailing secondary structure is β-sheet structure, while in normal tissues it is α-helix. The obtained results allow us to conclude that infrared spectroscopy, in addition to providing information on the composition of tested samples, can be an excellent diagnostic tool contributing to understanding the FTC substrate. Copyright © 2018. Published by Elsevier B.V.

Deceptive Advertising: Unprotected and Unknown.

ERIC Educational Resources Information Center

Ducoffe, Robert Hal

The Supreme Court tentatively extended First Amendment protection to commercial speech, but left the issue of defining and regulating deceptive advertising to the Federal Trade Commission (FTC), which has employed tools such as the cease-and-desist order, affirmative disclosure, and corrective advertising. The FTC Act did not define deception, but…

16 CFR 4.13 - Privacy Act rules.

Code of Federal Regulations, 2013 CFR

2013-01-01

... Appeals—FTC Information Retrieval and Indexing System—FTC (3) Pursuant to 5 U.S.C. 552a(k)(5... containing personal information in systems of records for which notice has been published by the Commission... grouping of personal information about an individual that is maintained by the Commission, including, but...

16 CFR 4.13 - Privacy Act rules.

Code of Federal Regulations, 2011 CFR

2011-01-01

... Appeals—FTC Information Retrieval and Indexing System—FTC (3) Pursuant to 5 U.S.C. 552a(k)(5... containing personal information in systems of records for which notice has been published by the Commission... grouping of personal information about an individual that is maintained by the Commission, including, but...

16 CFR 4.13 - Privacy Act rules.

Code of Federal Regulations, 2010 CFR

2010-01-01

... Appeals—FTC Information Retrieval and Indexing System—FTC (3) Pursuant to 5 U.S.C. 552a(k)(5... containing personal information in systems of records for which notice has been published by the Commission... grouping of personal information about an individual that is maintained by the Commission, including, but...

16 CFR 4.13 - Privacy Act rules.

Code of Federal Regulations, 2014 CFR

2014-01-01

... Appeals—FTC Information Retrieval and Indexing System—FTC (3) Pursuant to 5 U.S.C. 552a(k)(5... containing personal information in systems of records for which notice has been published by the Commission... grouping of personal information about an individual that is maintained by the Commission, including, but...

16 CFR 4.13 - Privacy Act rules.

Code of Federal Regulations, 2012 CFR

2012-01-01

... Appeals—FTC Information Retrieval and Indexing System—FTC (3) Pursuant to 5 U.S.C. 552a(k)(5... containing personal information in systems of records for which notice has been published by the Commission... grouping of personal information about an individual that is maintained by the Commission, including, but...

75 FR 41696 - Appliance Labeling Rule

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-19

... (foreign language disclosures in advertising); 16 CFR 308.3(a)(1) (foreign language disclosures under Pay... advertising terms such as ``energy savings'' or ``energy efficient'' as suggested by CEE. The FTC declines to permanently fix the meanings of these terms. Under FTC law, advertising terms have the meaning that reasonable...

13 CFR 126.616 - What requirements must a joint venture satisfy to submit an offer on a HUBZone contract?

Code of Federal Regulations, 2010 CFR

2010-01-01

... procurement having a revenue-based size standard, the procurement exceeds half the size standard corresponding to the NAICS code assigned to the contract; and (ii) For a procurement having an employee-based size... for the purpose of submitting an offer for a HUBZone contract. The joint venture itself need not be...

24 CFR 943.128 - How does a consortium carry out planning and reporting functions?

Code of Federal Regulations, 2010 CFR

2010-04-01

... HOUSING, DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT PUBLIC HOUSING AGENCY CONSORTIA AND JOINT VENTURES... the consortium agreement, the consortium must submit joint five-year Plans and joint Annual Plans for... the joint PHA Plan. ...

Size of thyroid carcinoma by histotype and variants: A population-based study in a mildly iodine-deficient area.

PubMed

Marina, Michela; Ceda, Gian Paolo; Corcione, Luigi; Sgargi, Paolo; Michiara, Maria; Silini, Enrico Maria; Ceresini, Graziano

2017-10-01

Data relating the size of thyroid cancer with histological types and variants are scarce. All incident thyroid cancer diagnosed between 2003 and 2012 in a mildly iodine-deficient area were derived from a population-based tumor registry. Undifferentiated/anaplastic thyroid cancer and incidental cases were excluded. Major diameter of thyroid cancer, as assessed by pathological examination, was stratified in classes: ≤10 mm; 11-20 mm; 21-40 mm; and >40 mm. For each class, absolute and relative frequencies of histological types were calculated. Tumors >20 mm were more frequent among follicular thyroid carcinoma (FTC) and Hürthle cell carcinoma than in other histotypes, with median size of 22.50 mm (95% confidence interval [CI] 16.71-28.29) and 25.00 mm (95% CI 17.04-32.96) in FTC and Hürthle cell carcinoma, respectively. Odds ratio for tumors >20 mm was significant for FTC and Hürthle cell carcinoma only (P < .0001). Among the histotypes and variants of differentiated thyroid cancer, FTC and Hürthle cell carcinoma are characterized by the largest size. © 2017 Wiley Periodicals, Inc.

Emergent HIV-1 Drug Resistance Mutations Were Not Present at Low-Frequency at Baseline in Non-Nucleoside Reverse Transcriptase Inhibitor-Treated Subjects in the STaR Study

PubMed Central

Porter, Danielle P.; Daeumer, Martin; Thielen, Alexander; Chang, Silvia; Martin, Ross; Cohen, Cal; Miller, Michael D.; White, Kirsten L.

2015-01-01

At Week 96 of the Single-Tablet Regimen (STaR) study, more treatment-naïve subjects that received rilpivirine/emtricitabine/tenofovir DF (RPV/FTC/TDF) developed resistance mutations compared to those treated with efavirenz (EFV)/FTC/TDF by population sequencing. Furthermore, more RPV/FTC/TDF-treated subjects with baseline HIV-1 RNA >100,000 copies/mL developed resistance compared to subjects with baseline HIV-1 RNA ≤100,000 copies/mL. Here, deep sequencing was utilized to assess the presence of pre-existing low-frequency variants in subjects with and without resistance development in the STaR study. Deep sequencing (Illumina MiSeq) was performed on baseline and virologic failure samples for all subjects analyzed for resistance by population sequencing during the clinical study (n = 33), as well as baseline samples from control subjects with virologic response (n = 118). Primary NRTI or NNRTI drug resistance mutations present at low frequency (≥2% to 20%) were detected in 6.6% of baseline samples by deep sequencing, all of which occurred in control subjects. Deep sequencing results were generally consistent with population sequencing but detected additional primary NNRTI and NRTI resistance mutations at virologic failure in seven samples. HIV-1 drug resistance mutations emerging while on RPV/FTC/TDF or EFV/FTC/TDF treatment were not present at low frequency at baseline in the STaR study. PMID:26690199

Emergent HIV-1 Drug Resistance Mutations Were Not Present at Low-Frequency at Baseline in Non-Nucleoside Reverse Transcriptase Inhibitor-Treated Subjects in the STaR Study.

PubMed

Porter, Danielle P; Daeumer, Martin; Thielen, Alexander; Chang, Silvia; Martin, Ross; Cohen, Cal; Miller, Michael D; White, Kirsten L

2015-12-07

At Week 96 of the Single-Tablet Regimen (STaR) study, more treatment-naïve subjects that received rilpivirine/emtricitabine/tenofovir DF (RPV/FTC/TDF) developed resistance mutations compared to those treated with efavirenz (EFV)/FTC/TDF by population sequencing. Furthermore, more RPV/FTC/TDF-treated subjects with baseline HIV-1 RNA >100,000 copies/mL developed resistance compared to subjects with baseline HIV-1 RNA ≤100,000 copies/mL. Here, deep sequencing was utilized to assess the presence of pre-existing low-frequency variants in subjects with and without resistance development in the STaR study. Deep sequencing (Illumina MiSeq) was performed on baseline and virologic failure samples for all subjects analyzed for resistance by population sequencing during the clinical study (n = 33), as well as baseline samples from control subjects with virologic response (n = 118). Primary NRTI or NNRTI drug resistance mutations present at low frequency (≥2% to 20%) were detected in 6.6% of baseline samples by deep sequencing, all of which occurred in control subjects. Deep sequencing results were generally consistent with population sequencing but detected additional primary NNRTI and NRTI resistance mutations at virologic failure in seven samples. HIV-1 drug resistance mutations emerging while on RPV/FTC/TDF or EFV/FTC/TDF treatment were not present at low frequency at baseline in the STaR study.

Follicular thyroid carcinoma with metastases to the pituitary causing pituitary insufficiency.

PubMed

Vianello, Federica; Mazzarotto, Renzo; Taccaliti, Augusto; Lora, Ornella; Basso, Michela; Servodio, Oscar; Mian, Caterina; Sotti, Guido

2011-08-01

Pituitary metastases are found in about 1% of all pituitary resections. They often derive from breast, lung, and gastroenteric tract adenocarcinomas, very rarely from thyroid carcinoma. Presenting symptoms of thyroid carcinoma metastatic to the pituitary gland are usually chiasmatic with central neurological impairment due to space-occupying expansion in the parasellar region. Hypopituitarism is more often associated with papillary and medullary rather than follicular thyroid carcinoma (FTC). Here we describe a patient with pituitary metastasis from FTC who had hypopituitarism with thyrotropin (TSH) deficiency. A 61-year-old woman, who presented with visual deficits and pain to the right orbit, was found on magnetic resonance imaging to have a large mass involving the pituitary gland. She was found to have pituitary insufficiency based on corticotropin-releasing hormone and TSH-releasing hormone testing. Transnasopharyngeal biopsy of the mass revealed metastases from FTC. After total thyroidectomy, which confirmed widely invasive FTC, the patient underwent external beam radiation therapy of the metastases for progressive neurological symptoms and an increase in orbit pain. Since endogenous TSH production was insufficient, we used recombinant human TSH (rhTSH) as preparation for a series of radioiodine treatments. rhTSH administration, followed by 7.4 GBq of (131)I, was repeated seven times over a 10-year period. This was associated with a marked decrease in serum thyroglobulin levels accompanied by substantial clinical improvement, but after 7 years disease progression occurred. Seven patients with pituitary metastases from FTC have been reported. In all cases, some neurological signs and symptoms related to mass effect were reported, but no pituitary insufficiency was described. This may be the first case of FTC with metastases to the pituitary causing hypopituitarism. It seems likely that management of such cases could be limited to biopsy to confirm thyroid carcinoma, rather than more extensive surgery, and that this could be followed by multiple treatments with rhTSH followed by (131)I.

[Analysis of costs and cost-effectiveness of preferred GESIDA/National AIDS Plan regimens for initial antiretroviral therapy in human immunodeficiency virus infected adult patients in 2013].

PubMed

Blasco, Antonio Javier; Llibre, Josep M; Arribas, José Ramón; Boix, Vicente; Clotet, Bonaventura; Domingo, Pere; González-García, Juan; Knobel, Hernando; López, Juan Carlos; Lozano, Fernando; Miró, José M; Podzamczer, Daniel; Santamaría, Juan Miguel; Tuset, Montserrat; Zamora, Laura; Lázaro, Pablo; Gatell, Josep M

2013-11-01

The GESIDA and National AIDS Plan panel of experts have proposed "preferred regimens" of antiretroviral treatment (ART) as initial therapy in HIV infected patients for 2013. The objective of this study is to evaluate the costs and effectiveness of initiating treatment with these "preferred regimens". An economic assessment of costs and effectiveness (cost/effectiveness) was performed using decision tree analysis models. Effectiveness was defined as the probability of having viral load <50copies/mL at week48, in an intention-to-treat analysis. Cost of initiating treatment with an ART regime was defined as the costs of ART and its consequences (adverse effects, changes of ART regime and drug resistance analyses) during the first 48weeks. The perspective of the analysis is that of the National Health System was applied, only taking into account differential direct costs: ART (official prices), management of adverse effects, resistance studies, and determination of HLA B*5701. The setting is Spain and the costs are those of 2013. A sensitivity deterministic analysis was performed, constructing three scenarios for each regimen: baseline, most favourable, and most unfavourable cases. In the baseline case scenario, the cost of initiating treatment ranges from 6,747euros for TDF/FTC+NVP to 12,059euros for TDF/FTC+RAL. The effectiveness ranges between 0.66 for ABC/3TC+LPV/r and ABC/3TC+ATV/r, and 0.87 for TDF/FTC+RAL and ABC/3TC+RAL. Effectiveness, in terms of cost/effectiveness, varies between 8,396euros and 13,930euros per responder at 48weeks, for TDF/FTC/RPV and TDF/FTC+RAL, respectively. Taking ART at official prices, the most effective regimen was TDF/FTC/RPV, followed by the rest of non-nucleoside containing regimens. The sensitivity analysis confirms the robustness of these findings. Copyright © 2013 Elsevier España, S.L. All rights reserved.

Antiretroviral Prophylaxis for HIV-1 Prevention among Heterosexual Men and Women

PubMed Central

Baeten, Jared M.; Donnell, Deborah; Ndase, Patrick; Mugo, Nelly R.; Campbell, James D.; Wangisi, Jonathan; Tappero, Jordan W.; Bukusi, Elizabeth A.; Cohen, Craig R.; Katabira, Elly; Ronald, Allan; Tumwesigye, Elioda; Were, Edwin; Fife, Kenneth H.; Kiarie, James; Farquhar, Carey; John-Stewart, Grace; Kakia, Aloysious; Odoyo, Josephine; Mucunguzi, Akasiima; Nakku-Joloba, Edith; Twesigye, Rogers; Ngure, Kenneth; Apaka, Cosmas; Tamooh, Harrison; Gabona, Fridah; Mujugira, Andrew; Panteleeff, Dana; Thomas, Katherine K.; Kidoguchi, Lara; Krows, Meighan; Revall, Jennifer; Morrison, Susan; Haugen, Harald; Emmanuel-Ogier, Mira; Ondrejcek, Lisa; Coombs, Robert W.; Frenkel, Lisa; Hendrix, Craig; Bumpus, Namandjé N.; Bangsberg, David; Haberer, Jessica E.; Stevens, Wendy S.; Lingappa, Jairam R.; Celum, Connie

2013-01-01

Introduction Antiretroviral pre-exposure prophylaxis (PrEP) reduces the incidence of acquisition of human immunodeficiency virus type 1 (HIV-1) in men who have sex with men and is a promising approach for preventing HIV-1 in heterosexual populations. Methods We conducted a randomized, three-arm trial of oral antiretroviral PrEP among heterosexual couples from Kenya and Uganda in which one member was HIV-1 seronegative and the other HIV-1 seropositive. Seronegative partners were randomly assigned to once-daily tenofovir (TDF), combination emtricitabine/tenofovir (FTC/TDF), or matching placebo and followed monthly for up to 36 months. At enrollment, HIV-1 seropositive partners were not eligible for antiretroviral therapy under national guidelines. All couples received standard HIV-1 treatment and prevention services, including individual and couples risk-reduction counseling and condoms. Results 4758 couples were enrolled; for 62%, the HIV-1 seronegative partner was male. For HIV-1 seropositive participants, the median CD4 count was 495 cells/μL (interquartile range 375–662). Of 82 post-randomization HIV-1 infections, 17 were among those assigned TDF (incidence 0.65 per 100 person-years), 13 among those assigned FTC/TDF (incidence 0.50 per 100 person-years), and 52 among those assigned placebo (incidence 1.99 per 100 person-years), indicating a 67% relative reduction in HIV-1 incidence for TDF (95% CI 44 to 81, p<0.001) and 75% for FTC/TDF (95% CI 55 to 87, p<0.001). HIV-1 protective effects of FTC/TDF and TDF were not significantly different (p=0.23), and both study medications significantly reduced HIV-1 incidence in both men and women. The rate of serious medical events was similar across the study arms. Conclusions Oral TDF and FTC/TDF provided substantial protection against HIV-1 acquisition in heterosexual men and women, with comparable efficacy of TDF and FTC/TDF. (Funded by the Bill and Melinda Gates Foundation; ClinicalTrials.gov number NCT00557245) PMID:22784037

PHASE 2 SAFETY AND TOLERABILITY STUDY OF MARAVIROC-CONTAINING REGIMENS TO PREVENT HIV INFECTION IN WOMEN (HPTN 069/ACTG A5305): A RANDOMIZED TRIAL

PubMed Central

Gulick, Roy M.; Wilkin, Timothy J.; Chen, Ying Q.; Landovitz, Raphael J.; Amico, K. Rivet; Young, Alicia M.; Richardson, Paul; Marzinke, Mark A.; Hendrix, Craig W.; Eshleman, Susan H.; McGowan, Ian; Cottle, Leslie M.; Andrade, Adriana; Marcus, Cheryl; Klingman, Karin L.; Chege, Wairimu; Rinehart, Alex R.; Rooney, James F.; Andrew, Philip; Salata, Robert A.; Siegel, Marc; Manabe, Yukari C.; Frank, Ian; Ho, Ken; Santana, Jorge; Stekler, Joanne D.; Swaminathan, Shobha; McCauley, Marybeth; Hodder, Sally; Mayer, Kenneth H.

2017-01-01

BACKGROUND Maraviroc (MVC) is a candidate drug for HIV PrEP. OBJECTIVE To assess the safety/tolerability of MVC-containing PrEP in U.S. women at-risk for HIV over 48 weeks. DESIGN Phase 2 randomized, controlled, double-blinded study of four PrEP regimens (#NCT01505114). SETTING Twelve clinical research sites of the HIV Prevention Trials Network and AIDS Clinical Trials Group. PARTICIPANTS HIV-uninfected women reporting condomless vaginal or anal intercourse with ≥1 HIV-infected or unknown-serostatus man within 90 days. INTERVENTIONS MVC alone, MVC+emtricitabine (FTC), MVC+tenofovir disoproxil fumarate (TDF), and TDF+FTC (control). MEASUREMENTS At each visit, clinical and laboratory (including HIV) assessments were conducted. Primary outcomes were grade 3–4 adverse events and time to permanent regimen discontinuation. Analyses were conducted on all randomized participants, according to original regimen assignment. RESULTS Among 188 participants, 85% completed follow-up, 11% withdrew early, and 4% were lost-to-follow-up; 19% discontinued their regimen prematurely. Number discontinuing and time-to-discontinuation did not differ among regimens. Grade 3/4 adverse events occurred in 5 (MVC), 13 (MVC+FTC), 9 (MVC+TDF) and 8 (TDF+FTC) participants; rates did not differ among regimens. One death occurred (suicide; MVC+FTC), judged not regimen-related. Of available samples at week 48 (n=126), 60% demonstrated detectable drug concentrations. No new HIV infections occurred. LIMITATIONS Participants were not necessarily high-risk for HIV. Regimen was 3 pills daily. Study was not powered for efficacy. CONCLUSIONS MVC-containing PrEP regimens were safe and well-tolerated compared to the control regimen of TDF+FTC in U.S. women. No new HIV infections occurred, although whether this was due to low risk of the population or to protection from the study regimens is not certain. MVC-containing PrEP for women may warrant further study. FUNDING SOURCE U.S. National Institutes of Health PMID:28828489

Syphilis Predicts HIV Incidence Among Men and Transgender Women Who Have Sex With Men in a Preexposure Prophylaxis Trial

PubMed Central

Solomon, Marc M.; Mayer, Kenneth H.; Glidden, David V.; Liu, Albert Y.; McMahan, Vanessa M.; Guanira, Juan V.; Chariyalertsak, Suwat; Fernandez, Telmo; Grant, Robert M.; Bekker, Linda-Gail; Buchbinder, Susan; Casapia, Martin; Chariyalertsak, Suwat; Guanira, Juan; Kallas, Esper; Lama, Javier; Mayer, Kenneth; Montoya, Orlando; Schechter, Mauro; Veloso, Valdiléa

2014-01-01

Background. Syphilis infection may potentiate transmission of human immunodeficiency virus (HIV). We sought to determine the extent to which HIV acquisition was associated with syphilis infection within an HIV preexposure prophylaxis (PrEP) trial and whether emtricitabine/tenofovir (FTC/TDF) modified that association. Methods. The Preexposure Prophylaxis Initiative (iPrEx) study randomly assigned 2499 HIV-seronegative men and transgender women who have sex with men (MSM) to receive oral daily FTC/TDF or placebo. Syphilis prevalence at screening and incidence during follow-up were measured. Hazard ratios for the effect of incident syphilis on HIV acquisition were calculated. The effect of FTC/TDF on incident syphilis and HIV acquisition was assessed. Results. Of 2499 individuals, 360 (14.4%) had a positive rapid plasma reagin test at screening; 333 (92.5%) had a positive confirmatory test, which did not differ between the arms (FTC/TDF vs placebo, P = .81). The overall syphilis incidence during the trial was 7.3 cases per 100 person-years. There was no difference in syphilis incidence between the study arms (7.8 cases per 100 person-years for FTC/TDF vs 6.8 cases per 100 person-years for placebo, P = .304). HIV incidence varied by incident syphilis (2.8 cases per 100 person-years for no syphilis vs 8.0 cases per 100 person-years for incident syphilis), reflecting a hazard ratio of 2.6 (95% confidence interval, 1.6–4.4; P < .001). There was no evidence for interaction between randomization to the FTC/TDF arm and incident syphilis on HIV incidence. Conclusions. In HIV-seronegative MSM, syphilis infection was associated with HIV acquisition in this PrEP trial; a syphilis diagnosis should prompt providers to offer PrEP unless otherwise contraindicated. PMID:24928295

Associations between vitamin D metabolites, antiretroviral therapy and bone mineral density in people with HIV.

PubMed

Klassen, K M; Kimlin, M G; Fairley, C K; Emery, S; Anderson, P H; Ebeling, P R

2016-05-01

To see if vitamin D and antiretroviral therapy are associated with bone mineral density (BMD) in people with HIV. Lower hip BMD was associated with tenofovir (an antiretroviral medicine) in those with 25(OH)D ≥50 nmol/L. The relationship between antiretroviral therapy and hip BMD differs depending on vitamin D status. People with HIV have an increased risk of low BMD and fractures. Antiretroviral therapy contributes to this increased risk. The aim of this study was to evaluate associations between vitamin D metabolites and antiretroviral therapy on BMD. The simplification of antiretroviral therapy with tenofovir-emtricitabine or abacavir-lamivudine trial (STEAL) was an open-label, prospective randomised non-inferiority study that compared simplification of current nucleoside reverse transcriptase inhibitors (NRTIs) to fixed-dose combination tenofovir-emtricitabine (TDF-FTC) or abacavir-lamivudine. Serum 25(OH)D and 1,25(OH)2D were measured in 160 individuals (90 receiving TDF-FTC, 70 receiving other NRTIs) at baseline from this study. Multivariable linear regression models were constructed to evaluate the covariates of 1,25(OH)2D and BMD. Protease inhibitor use (p = 0.02) and higher body mass index (BMI) (p = 0.002) were associated with lower 1,25(OH)2D levels in those with 25(OH)D <50 nmol/L. However, TDF-FTC use (p = 0.01) was associated with higher 1,25(OH)2D levels, but only in those with 25(OH)D ≥50 nmol/L. White ethnicity (p = 0.02) and lower BMI (p < 0.001) in those with 25(OH)D <50 nmol/L and with TDF-FTC use (p = 0.008) in those with 25(OH)D ≥50 nmol/L were associated with lower hip BMD. TDF-FTC use, higher serum calcium and serum βCTX, winter, and lower bone-specific alkaline phosphatase (BALP) and BMI were associated with lower lumbar spine BMD. TDF-FTC use (versus non-TDF-FTC use) was associated with lower hip BMD, and this difference was more pronounced in those with 25(OH)D ≥50 nmol/L. Serum 25(OH)D <50 nmol/L was associated with lower hip BMD in all participants. Therefore, the associations between antiretroviral therapy and hip BMD differ depending on vitamin D status.

Relationship between foliar chemistry and insect performance: the forest tent caterpillar

Treesearch

Francois Lorenzetti; Yves Mauffette; Eric Bauce

1999-01-01

Forest tent caterpillar (FTC) feeds on several species of deciduous trees (Stehr and Cook 1968), in northeastern North America, quaking aspen is the preferred host of this spring-feeding insect. FTC commonly defoliates several thousands of hectares of aspen stands each year in Quebec (Bordeleau 1990), although its secondary hosts seldom are attacked.

7 CFR 3405.7 - Joint project proposals.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 15 2011-01-01 2011-01-01 false Joint project proposals. 3405.7 Section 3405.7... AGRICULTURE HIGHER EDUCATION CHALLENGE GRANTS PROGRAM Program Description § 3405.7 Joint project proposals. Applicants are encouraged to submit joint project proposals as defined in § 3405.2(m), which address regional...

Cost-effectiveness of memantine in moderate and severe Alzheimer's disease in Norway.

PubMed

Rive, B; Aarsland, D; Grishchenko, M; Cochran, J; Lamure, M; Toumi, M

2012-06-01

The cost-effectiveness of memantine for the treatment of moderate and severe Alzheimer's disease has been assessed in several European countries. Objective of the study was to assess it in Norwegian settings. This cost-utility analysis used a Markov modelling approach to simulate the evolution of patients until their need for full-time care (FTC) over a 5-year period. FTC was defined as a patient becoming either dependent or institutionalised. Transition probabilities were estimated using a newly developed predictive equation of time to FTC. Health resource use and utilities were obtained from the Scandinavian Study of Cost and Quality of Life in Alzheimer's Disease study, and mortality was obtained from the Oslo study. Memantine efficacy was based on a meta-analysis of six large trials. The model compared memantine with its alternative in this population, that is no pharmacological treatment or background therapy with acetylcholinesterase inhibitors. The model underwent extensive sensitivity analyses. In Norway, memantine was found to delay the need for FTC by 4.4 weeks compared with standard care and was associated with increased quality-adjusted life years. Memantine was the dominant strategy with cost savings of €3739 (30 041 NOK) per patient. The probability of being the dominant strategy was 98.8%. This result was confirmed across multiple sensitivity analyses. The model suggests that memantine prolongs time to FTC for no additional cost to the healthcare system and society. It can be regarded as a cost-effective choice in the management of moderate and severe Alzheimer's disease. Copyright © 2011 John Wiley & Sons, Ltd.

Alcohol facts labels on Four Loko: will the Federal Trade Commission's order be effective in reducing hazardous drinking among underage youth?

PubMed

Esser, Marissa B; Siegel, Michael

2014-11-01

Underage drinking accounts for 4400 alcohol-attributable deaths in the US each year. After several reports of the deaths of young people due to the consumption of the flavored-alcoholic beverage (FAB) Four Loko, the Federal Trade Commission (FTC) examined whether Phusion Projects violated federal law by using deceptive marketing. In 2013, the FTC responded by ordering alcohol facts labels on Four Loko disclosing the number of standard drinks contained in the product. This paper aims to discuss whether the FTC's order for alcohol facts labels on Four Loko cans will effectively reduce the hazardous consumption of FABs among youth. The authors discuss the existing research that relates to the FTC's order, including studies on the effectiveness of serving size labeling for reducing youth drinking, research on the brand-specific consumption of FABs among underage youth, and the associations between youth drinking and exposure to alcohol marketing. After synthesizing the evidence, the authors conclude that simply requiring the disclosure of the number of standard drinks on supersized Four Loko cans is not likely to adequately address the hazardous consumption of this beverage among underage drinkers. Instead, if the FTC addresses the marketing of these products and its potential to encourage the excessive use of alcohol, as the Attorneys General did recently in a settlement with the same company, it is possible that there would be a greater impact on reducing youth alcohol consumption. Additional research is needed to determine the impact of alcohol facts labels in changing underage drinking behaviors.

3D printed, controlled release, tritherapeutic tablet matrix for advanced anti-HIV-1 drug delivery.

PubMed

Siyawamwaya, Margaret; du Toit, Lisa C; Kumar, Pradeep; Choonara, Yahya E; Kondiah, Pierre P P D; Pillay, Viness

2018-04-12

A 3D-Bioplotter® was employed to 3D print (3DP) a humic acid-polyquaternium 10 (HA-PQ10) controlled release fixed dose combination (FDC) tablet comprising of the anti-HIV-1 drugs, efavirenz (EFV), tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC). Chemical interactions, surface morphology and mechanical strength of the FDC were ascertained. In vitro drug release studies were conducted in biorelevant media followed by in vivo study in the large white pigs, in comparison with a market formulation, Atripla®. In vitro-in vivo correlation of results was undertaken. EFV, TDF and FTC were successfully entrapped in the 24-layered rectangular prism-shaped 3DP FDC with a loading of ∼12.5 mg/6.3 mg/4 mg of EFV/TDF/FTC respectively per printed layer. Hydrogen bonding between the EFV/TDF/FTC and HA-PQ10 was detected which was indicative of possible drug solubility enhancement. The overall surface of the tablet exhibited a fibrilla structure and the 90° inner pattern was determined to be optimal for 3DP of the FDC. In vitro and in vivo drug release profiles from the 3DP FDC demonstrated that intestinal-targeted and controlled drug release was achieved. A 3DP FDC was successfully manufactured with the aid of a 3D-Bioplotter in a single step process. The versatile HA-PQ10 entrapped all drugs and achieved an enhanced relative bioavailability of EFV, TDF, and FTC compared to the market formulation for potentially enhanced HIV treatment. Copyright © 2018 Elsevier B.V. All rights reserved.

76 FR 33298 - Grifols, S.A. and Talecris Biotherapeutics Holdings Corp.; Analysis of Agreement Containing...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-08

... comment online or on paper, by following the instructions in the Request for Comment part of the... instructions on the web-based form. If you prefer to file your comment on paper, mail or deliver your comment..., at http://www.ftc.gov/os/actions.shtm . A paper copy can be obtained from the FTC Public Reference...

Regulation of Children's Advertising--A Three Party Discussion: The FTC, the First Amendment, and the Parents.

ERIC Educational Resources Information Center

Oliver, Lauren

Arguments for and against banning television commercials aimed at children under age 12, as well as the role of the Federal Trade Commission (FTC), the First Amendment, and parents in regulating such commercials, are explored in this paper. Following an introduction that describes the controversy, a second section of the paper details the…

A Forest Tent Caterpiller Outbreak in the Mississippi Delta: Host Preference and Growth Effects

Treesearch

Theodor D. Leininger; J.D. Solomon

1995-01-01

Abstract - An outbreak of forest tent caterpillars (FTC) began ln spring, 1989 and lasted three years.This is the first recorded epidemic of FTC in the Mississippi Delta. Species fed upon and defoliated, or nearly defoliated, include: willow oak, water oak, nuttall oak, overcup oak, green ash, and sweetgum.Water hickory, and sugarberry were not fed...

Military Sealift Command’s Combat Logistics Force in Contested Environments

DTIC Science & Technology

2017-05-12

submitted to the Naval War College faculty in partial satisfaction of the requirements of the Joint Military Operations Department. The contents of this...submitted to the Faculty of the Naval War College in partial satisfaction of the requirements of the Department of Joint Military Operations. The contents...the customer requirements the service is tailored to meet. CLF ships are the in-theater provider 4 to the fleet for force sustainment, solely

FTC - THE FAULT-TREE COMPILER (SUN VERSION)

NASA Technical Reports Server (NTRS)

Butler, R. W.

1994-01-01

FTC, the Fault-Tree Compiler program, is a tool used to calculate the top-event probability for a fault-tree. Five different gate types are allowed in the fault tree: AND, OR, EXCLUSIVE OR, INVERT, and M OF N. The high-level input language is easy to understand and use. In addition, the program supports a hierarchical fault tree definition feature which simplifies the tree-description process and reduces execution time. A rigorous error bound is derived for the solution technique. This bound enables the program to supply an answer precisely (within the limits of double precision floating point arithmetic) at a user-specified number of digits accuracy. The program also facilitates sensitivity analysis with respect to any specified parameter of the fault tree such as a component failure rate or a specific event probability by allowing the user to vary one failure rate or the failure probability over a range of values and plot the results. The mathematical approach chosen to solve a reliability problem may vary with the size and nature of the problem. Although different solution techniques are utilized on different programs, it is possible to have a common input language. The Systems Validation Methods group at NASA Langley Research Center has created a set of programs that form the basis for a reliability analysis workstation. The set of programs are: SURE reliability analysis program (COSMIC program LAR-13789, LAR-14921); the ASSIST specification interface program (LAR-14193, LAR-14923), PAWS/STEM reliability analysis programs (LAR-14165, LAR-14920); and the FTC fault tree tool (LAR-14586, LAR-14922). FTC is used to calculate the top-event probability for a fault tree. PAWS/STEM and SURE are programs which interpret the same SURE language, but utilize different solution methods. ASSIST is a preprocessor that generates SURE language from a more abstract definition. SURE, ASSIST, and PAWS/STEM are also offered as a bundle. Please see the abstract for COS-10039/COS-10041, SARA - SURE/ASSIST Reliability Analysis Workstation, for pricing details. FTC was originally developed for DEC VAX series computers running VMS and was later ported for use on Sun computers running SunOS. The program is written in PASCAL, ANSI compliant C-language, and FORTRAN 77. The TEMPLATE graphics library is required to obtain graphical output. The standard distribution medium for the VMS version of FTC (LAR-14586) is a 9-track 1600 BPI magnetic tape in VMSINSTAL format. It is also available on a TK50 tape cartridge in VMSINSTAL format. Executables are included. The standard distribution medium for the Sun version of FTC (LAR-14922) is a .25 inch streaming magnetic tape cartridge in UNIX tar format. Both Sun3 and Sun4 executables are included. FTC was developed in 1989 and last updated in 1992. DEC, VAX, VMS, and TK50 are trademarks of Digital Equipment Corporation. UNIX is a registered trademark of AT&T Bell Laboratories. SunOS is a trademark of Sun Microsystems, Inc.

FTC - THE FAULT-TREE COMPILER (VAX VMS VERSION)

NASA Technical Reports Server (NTRS)

Butler, R. W.

1994-01-01

FTC, the Fault-Tree Compiler program, is a tool used to calculate the top-event probability for a fault-tree. Five different gate types are allowed in the fault tree: AND, OR, EXCLUSIVE OR, INVERT, and M OF N. The high-level input language is easy to understand and use. In addition, the program supports a hierarchical fault tree definition feature which simplifies the tree-description process and reduces execution time. A rigorous error bound is derived for the solution technique. This bound enables the program to supply an answer precisely (within the limits of double precision floating point arithmetic) at a user-specified number of digits accuracy. The program also facilitates sensitivity analysis with respect to any specified parameter of the fault tree such as a component failure rate or a specific event probability by allowing the user to vary one failure rate or the failure probability over a range of values and plot the results. The mathematical approach chosen to solve a reliability problem may vary with the size and nature of the problem. Although different solution techniques are utilized on different programs, it is possible to have a common input language. The Systems Validation Methods group at NASA Langley Research Center has created a set of programs that form the basis for a reliability analysis workstation. The set of programs are: SURE reliability analysis program (COSMIC program LAR-13789, LAR-14921); the ASSIST specification interface program (LAR-14193, LAR-14923), PAWS/STEM reliability analysis programs (LAR-14165, LAR-14920); and the FTC fault tree tool (LAR-14586, LAR-14922). FTC is used to calculate the top-event probability for a fault tree. PAWS/STEM and SURE are programs which interpret the same SURE language, but utilize different solution methods. ASSIST is a preprocessor that generates SURE language from a more abstract definition. SURE, ASSIST, and PAWS/STEM are also offered as a bundle. Please see the abstract for COS-10039/COS-10041, SARA - SURE/ASSIST Reliability Analysis Workstation, for pricing details. FTC was originally developed for DEC VAX series computers running VMS and was later ported for use on Sun computers running SunOS. The program is written in PASCAL, ANSI compliant C-language, and FORTRAN 77. The TEMPLATE graphics library is required to obtain graphical output. The standard distribution medium for the VMS version of FTC (LAR-14586) is a 9-track 1600 BPI magnetic tape in VMSINSTAL format. It is also available on a TK50 tape cartridge in VMSINSTAL format. Executables are included. The standard distribution medium for the Sun version of FTC (LAR-14922) is a .25 inch streaming magnetic tape cartridge in UNIX tar format. Both Sun3 and Sun4 executables are included. FTC was developed in 1989 and last updated in 1992. DEC, VAX, VMS, and TK50 are trademarks of Digital Equipment Corporation. UNIX is a registered trademark of AT&T Bell Laboratories. SunOS is a trademark of Sun Microsystems, Inc.

Cost-utility analysis of the fixed-dose combination of dolutegravir/abacavir/lamivudine as initial treatment of HIV+ patients in Spain.

PubMed

Moreno Guillen, Santiago; Losa García, Juan Emilio; Berenguer Berenguer, Juan; Martínez Sesmero, José Manuel; Cenoz Gomis, Santiago; Graefenhain, Ruth; Lopez Sanchez-Cambronero, David; Parrondo Garcia, Francisco Javier

2017-09-01

Fixed-dose combinations of antiretroviral drugs have meant an important step forward in simplifying treatment and improving compliance and has led to an increased effectiveness of therapy, a viral load decrease and improving the quality of life of patients. The single-table formulation of dolutegravir with abacavir and lamivudine (DTG/ABC/3TC) is a highly efficacious and well-tolerated once-daily regimen for HIV-infected patients. The objective of the study was to assess the incremental cost-utility ratio of the fixed-dose combination of (DTG/ABC/3TC) versus the combinations emtricitabine/tenofovir/efavirenz (FTC/TDF/EFV), and darunavir/r (DRV/r) or raltegravir (RAL) with emtricitabine/tenofovir (FTC/TDF) or abacavir/lamivudine (ABC/3TC) as initial antiretroviral therapy in patients infected with HIV-1 from the perspective of the Spanish National Health System. The ARAMIS model, which uses a microsimulation approach to simulate the individual changes in each patient from the start of treatment to death through a Markov chain of descriptive health states of the disease, was adapted to Spain. The alternatives used for comparison were the fixed-dose combination of emtricitabine/tenofovir/efavirenz (FTC/TDF/EFV), and the fixed- dose combinations of emtricitabine/tenofovir (FTC/TDF) or abacavir/lamivudine (ABC/3TC) with darunavir/r (DRV/r) or raltegravir (RAL). The probability of achieving virological suppression by the treatments included in the model was obtained from clinical trials SINGLE, SPRING-2 and FLAMINGO and the costs were expressed in € (2015). The model use the perspective of the Spanish National Health System, with a lifetime horizon and a discount rate of 3% was applied to cost and effectiveness. Treatment initiation with DTG/ABC/3TC was dominant when it was compared with treatment initiation with all the comparators: vs. FTC/TDF/EFV (-67 210.71€/QALY), vs. DRV/r + FTC/TDF or ABC/3TC (-1 787 341.44€/QALY), and vs. RAL + FTC/TDF or ABC/3TC (-1 005 117.13€/QALY). All the sensitivity analyses performed showed the consistency of these findings. With the premises considered, treatment initiation with DTG/ABC/3TC STR appears to be the most cost-effective option in ARTnaïve HIV infected patients from the Spanish Health System perspective. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.

Advanced Organic Electro-Optic Materials for Integrated Device Applications

DTIC Science & Technology

2001-06-01

Electro - optic chromophores (FTC and CLD) were synthesized in bulk (kilogram) quantities and were distributed to the participants of this program...to stabilize electro - optic activity for operation at elevated temperatures and photon flux levels. Over 100 variants of these chromophores were...1.5-2.0 improvement over FTC and CLD chromophores in terms of electro - optic activity at telecommunication wavelengths. They also have proven more

Overt Skeletal Metastases in a Patient of Occult (Microscopic) Follicular Thyroid Carcinoma: a Rare Case.

PubMed

Jha, Chandan Kumar; Agrawal, Vinita; Mishra, Anjali; Pradhan, P K

2018-03-01

Occult follicular thyroid carcinoma (FTC) presenting as distant metastases is a rare occurrence. However, despite being occult in majority of these cases, primary tumor can be detected on thyroid imaging or during surgery. Here, we present an extremely rare case of an occult FTC with overt skeletal metastases in which primary tumor was discernible only on microscopic examination.

75 FR 35033 - U-Haul International, Inc. and AMERCO; Analysis of Agreement Containing Consent Order to Aid...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-21

... comments electronically or in paper form. Comments should refer to``U-Haul AMERCO, File No. 081 0157'' to... paper form, must be clearly labeled ``Confidential,'' and must comply with FTC Rule 4.9(c), 16 CFR 4.9(c...). Because paper mail addressed to the FTC is subject to delay due to heightened security screening, please...

Illegal, Unethical or Just Fattening? A Revisionist Look at the FTC Hearings on Electric Utility Public Relations and Franklin Roosevelt's 1932 Public Power Pledge.

ERIC Educational Resources Information Center

Jordan, Myron K.

Did President Franklin D. Roosevelt's condemnation of electric utility public relations represent a fair interpretation of the findings of the Federal Trade Commission (FTC) investigation into the electric utility industry as authorized by Senate Resolution 83 in February, 1928, or were Roosevelt's statements simply campaign hyperbole that met the…

Phosphatidylinositide 3-kinase (PI3K) and PI3K-related kinase (PIKK) activity contributes to radioresistance in thyroid carcinomas.

PubMed

Burrows, Natalie; Williams, Joseph; Telfer, Brian A; Resch, Julia; Valentine, Helen R; Fitzmaurice, Richard J; Eustace, Amanda; Irlam, Joely; Rowling, Emily J; Hoang-Vu, Cuong; West, Catharine M; Brabant, Georg; Williams, Kaye J

2016-09-27

Anaplastic (ATC) and certain follicular thyroid-carcinomas (FTCs) are radioresistant. The Phosphatidylinositide 3-kinase (PI3K) pathway is commonly hyperactivated in thyroid-carcinomas. PI3K can modify the PI3K-related kinases (PIKKs) in response to radiation: How PIKKs interact with PI3K and contribute to radioresistance in thyroid-carcinomas is unknown. Further uncertainties exist in how these interactions function under the radioresistant hypoxic microenvironment. Under normoxia/anoxia, ATC (8505c) and FTC (FTC-133) cells were irradiated, with PI3K-inhibition (via GDC-0941 and PTEN-reconstitution into PTEN-null FTC-133s) and effects on PIKK-activation, DNA-damage, clonogenic-survival and cell cycle, assessed. FTC-xenografts were treated with 5 × 2 Gy, ± 50 mg/kg GDC-0941 (twice-daily; orally) for 14 days and PIKK-activation and tumour-growth assessed. PIKK-expression was additionally assessed in 12 human papillary thyroid-carcinomas, 13 FTCs and 12 ATCs. GDC-0941 inhibited radiation-induced activation of Ataxia-telangiectasia mutated (ATM), ATM-and Rad3-related (ATR) and DNA-dependent protein kinase catalytic subunit (DNA-PKcs). Inhibition of ATM and DNA-PKcs was PI3K-dependent, since activation was reduced in PTEN-reconstituted FTC-133s. Inhibition of PIKK-activation was greater under anoxia: Consequently, whilst DNA-damage was increased and prolonged under both normoxia and anoxia, PI3K-inhibition only reduced clonogenic-survival under anoxia. GDC-0941 abrogated radiation-induced cell cycle arrest, an effect most likely linked to the marked inhibition of ATR-activation. Importantly, GDC-0941 inhibited radiation-induced PIKK-activation in FTC-xenografts leading to a significant increase in time taken for tumours to triple in size: 26.5 ± 5 days (radiation-alone) versus 31.5 ± 5 days (dual-treatment). PIKKs were highly expressed across human thyroid-carcinoma classifications, with ATM scoring consistently lower. Interestingly, some loss of ATM and DNA-PKcs was observed. These data provide new insight into the mechanisms of hypoxia-associated radioresistance in thyroid-carcinoma.

Phosphatidylinositide 3-kinase (PI3K) and PI3K-related kinase (PIKK) activity contributes to radioresistance in thyroid carcinomas

PubMed Central

Burrows, Natalie; Williams, Joseph; Telfer, Brian A; Resch, Julia; Valentine, Helen R; Fitzmaurice, Richard J; Eustace, Amanda; Irlam, Joely; Rowling, Emily J; Hoang-Vu, Cuong; West, Catharine M; Brabant, Georg; Williams, Kaye J

2016-01-01

Anaplastic (ATC) and certain follicular thyroid-carcinomas (FTCs) are radioresistant. The Phosphatidylinositide 3-kinase (PI3K) pathway is commonly hyperactivated in thyroid-carcinomas. PI3K can modify the PI3K-related kinases (PIKKs) in response to radiation: How PIKKs interact with PI3K and contribute to radioresistance in thyroid-carcinomas is unknown. Further uncertainties exist in how these interactions function under the radioresistant hypoxic microenvironment. Under normoxia/anoxia, ATC (8505c) and FTC (FTC-133) cells were irradiated, with PI3K-inhibition (via GDC-0941 and PTEN-reconstitution into PTEN-null FTC-133s) and effects on PIKK-activation, DNA-damage, clonogenic-survival and cell cycle, assessed. FTC-xenografts were treated with 5 × 2 Gy, ± 50 mg/kg GDC-0941 (twice-daily; orally) for 14 days and PIKK-activation and tumour-growth assessed. PIKK-expression was additionally assessed in 12 human papillary thyroid-carcinomas, 13 FTCs and 12 ATCs. GDC-0941 inhibited radiation-induced activation of Ataxia-telangiectasia mutated (ATM), ATM-and Rad3-related (ATR) and DNA-dependent protein kinase catalytic subunit (DNA-PKcs). Inhibition of ATM and DNA-PKcs was PI3K-dependent, since activation was reduced in PTEN-reconstituted FTC-133s. Inhibition of PIKK-activation was greater under anoxia: Consequently, whilst DNA-damage was increased and prolonged under both normoxia and anoxia, PI3K-inhibition only reduced clonogenic-survival under anoxia. GDC-0941 abrogated radiation-induced cell cycle arrest, an effect most likely linked to the marked inhibition of ATR-activation. Importantly, GDC-0941 inhibited radiation-induced PIKK-activation in FTC-xenografts leading to a significant increase in time taken for tumours to triple in size: 26.5 ± 5 days (radiation-alone) versus 31.5 ± 5 days (dual-treatment). PIKKs were highly expressed across human thyroid-carcinoma classifications, with ATM scoring consistently lower. Interestingly, some loss of ATM and DNA-PKcs was observed. These data provide new insight into the mechanisms of hypoxia-associated radioresistance in thyroid-carcinoma. PMID:27527858

Antiretroviral prophylaxis for HIV prevention in heterosexual men and women.

PubMed

Baeten, Jared M; Donnell, Deborah; Ndase, Patrick; Mugo, Nelly R; Campbell, James D; Wangisi, Jonathan; Tappero, Jordan W; Bukusi, Elizabeth A; Cohen, Craig R; Katabira, Elly; Ronald, Allan; Tumwesigye, Elioda; Were, Edwin; Fife, Kenneth H; Kiarie, James; Farquhar, Carey; John-Stewart, Grace; Kakia, Aloysious; Odoyo, Josephine; Mucunguzi, Akasiima; Nakku-Joloba, Edith; Twesigye, Rogers; Ngure, Kenneth; Apaka, Cosmas; Tamooh, Harrison; Gabona, Fridah; Mujugira, Andrew; Panteleeff, Dana; Thomas, Katherine K; Kidoguchi, Lara; Krows, Meighan; Revall, Jennifer; Morrison, Susan; Haugen, Harald; Emmanuel-Ogier, Mira; Ondrejcek, Lisa; Coombs, Robert W; Frenkel, Lisa; Hendrix, Craig; Bumpus, Namandjé N; Bangsberg, David; Haberer, Jessica E; Stevens, Wendy S; Lingappa, Jairam R; Celum, Connie

2012-08-02

Antiretroviral preexposure prophylaxis is a promising approach for preventing human immunodeficiency virus type 1 (HIV-1) infection in heterosexual populations. We conducted a randomized trial of oral antiretroviral therapy for use as preexposure prophylaxis among HIV-1-serodiscordant heterosexual couples from Kenya and Uganda. The HIV-1-seronegative partner in each couple was randomly assigned to one of three study regimens--once-daily tenofovir (TDF), combination tenofovir-emtricitabine (TDF-FTC), or matching placebo--and followed monthly for up to 36 months. At enrollment, the HIV-1-seropositive partners were not eligible for antiretroviral therapy, according to national guidelines. All couples received standard HIV-1 treatment and prevention services. We enrolled 4758 couples, of whom 4747 were followed: 1584 randomly assigned to TDF, 1579 to TDF-FTC, and 1584 to placebo. For 62% of the couples followed, the HIV-1-seronegative partner was male. Among HIV-1-seropositive participants, the median CD4 count was 495 cells per cubic millimeter (interquartile range, 375 to 662). A total of 82 HIV-1 infections occurred in seronegative participants during the study, 17 in the TDF group (incidence, 0.65 per 100 person-years), 13 in the TDF-FTC group (incidence, 0.50 per 100 person-years), and 52 in the placebo group (incidence, 1.99 per 100 person-years), indicating a relative reduction of 67% in the incidence of HIV-1 with TDF (95% confidence interval [CI], 44 to 81; P<0.001) and of 75% with TDF-FTC (95% CI, 55 to 87; P<0.001). Protective effects of TDF-FTC and TDF alone against HIV-1 were not significantly different (P=0.23), and both study medications significantly reduced the HIV-1 incidence among both men and women. The rate of serious adverse events was similar across the study groups. Eight participants receiving active treatment were found to have been infected with HIV-1 at baseline, and among these eight, antiretroviral resistance developed in two during the study. Oral TDF and TDF-FTC both protect against HIV-1 infection in heterosexual men and women. (Funded by the Bill and Melinda Gates Foundation; Partners PrEP ClinicalTrials.gov number, NCT00557245.).

Mutual regulation of TGF-β1, TβRII and ErbB receptors expression in human thyroid carcinomas

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

Mincione, Gabriella, E-mail: g.mincione@unich.it; Center of Excellence on Aging, Ce.S.I., ‘G. d'Annunzio’ University Foundation, Chieti; Tarantelli, Chiara

2014-09-10

The role of EGF and TGF-β1 in thyroid cancer is still not clearly defined. TGF-β1 inhibited the cellular growth and migration of follicular (FTC-133) and papillary (B-CPAP) thyroid carcinoma cell lines. Co-treatments of TGF-β1 and EGF inhibited proliferation in both cell lines, but displayed opposite effect on their migratory capability, leading to inhibition in B-CPAP and promotion in FTC-133 cells, by a MAPK-dependent mechanism. TGF-β1, TβRII and EGFR expressions were evaluated in benign and malignant thyroid tumors. Both positivity (51.7% and 60.0% and 80.0% in FA and PTC and FTC) and overexpression (60.0%, 77.7% and 75.0% in FA, PTC andmore » FTC) of EGFR mRNA correlates with the aggressive tumor behavior. The moderate overexpression of TGF-β1 and TβRII mRNA in PTC tissues (61.5% and 62.5%, respectively), counteracted their high overexpression in FTC tissues (100% and 100%, respectively), while EGFR overexpression was similar in both carcinomas. Papillary carcinomas were positive to E-cadherin expression, while the follicular carcinomas lose E-cadherin staining. Our findings of TGF-β1/TβRII and EGFR overexpressions together with a loss of E-cadherin observed in human follicular thyroid carcinomas, and of increased migration ability MAPK-dependent after EGF/TGF-β1 treatments in the follicular thyroid carcinoma cell line, reinforced the hypothesis of a cross-talk between EGF and TGF-β1 systems in follicular thyroid carcinomas phenotype. - Highlights: • We reinforce the hypothesis of a cross talk between EGF and TGF-β1 in follicular thyroid carcinoma. • Increased migration MAPK-dependent is observed after EGF+TGF-β1 treatment in follicular thyroid carcinoma cells. • EGF and TGF-β1 caused opposite effect on the migratory ability in B-CPAP and in FTC-133 cells. • TGF-β1, TβRII and EGFR are overexpressed in follicular thyroid carcinoma.« less

MTN-017: A Rectal Phase 2 Extended Safety and Acceptability Study of Tenofovir Reduced-Glycerin 1% Gel

PubMed Central

Lama, Javier R.; Richardson, Barbra A.; Carballo-Diéguez, Alex; Kunjara Na Ayudhya, Ratiya Pamela; Liu, Karen; Patterson, Karen B.; Leu, Cheng-Shiun; Galaska, Beth; Jacobson, Cindy E.; Parikh, Urvi M.; Marzinke, Mark A.; Hendrix, Craig W.; Johnson, Sherri; Piper, Jeanna M.; Grossman, Cynthia; Ho, Ken S.; Lucas, Jonathan; Pickett, Jim; Bekker, Linda-Gail; Chariyalertsak, Suwat; Chitwarakorn, Anupong; Gonzales, Pedro; Holtz, Timothy H.; Liu, Albert Y.; Mayer, Kenneth H.; Zorrilla, Carmen; Schwartz, Jill L.; Rooney, James; McGowan, Ian

2017-01-01

Abstract Background. Human immunodeficiency virus (HIV) disproportionately affects men who have sex with men (MSM) and transgender women (TGW). Safe and acceptable topical HIV prevention methods that target the rectum are needed. Methods. MTN-017 was a phase 2, 3-period, randomized sequence, open-label, expanded safety and acceptability crossover study comparing rectally applied reduced-glycerin (RG) 1% tenofovir (TFV) and oral emtricitabine/TFV disoproxil fumarate (FTC/TDF). In each 8-week study period participants were randomized to RG-TFV rectal gel daily, or RG-TFV rectal gel before and after receptive anal intercourse (RAI; or at least twice weekly in the event of no RAI), or daily oral FTC/TDF. Results. MSM and TGW (n = 195) were enrolled from 8 sites in the United States, Thailand, Peru, and South Africa with mean age of 31.1 years (range 18-64). There were no differences in ≥grade 2 adverse event rates between daily gel (incidence rate ratio [IRR], 1.09; P = .59) or RAI gel (IRR, 0.90; P = .51) compared to FTC/TDF. High adherence (≥80% of prescribed doses assessed by unused product return and Short Message System reports) was less likely in the daily gel regimen (odds ratio [OR], 0.35; P < .001), and participants reported less likelihood of future daily gel use for HIV protection compared to FTC/TDF (OR, 0.38; P < .001). Conclusions. Rectal application of RG TFV gel was safe in MSM and TGW. Adherence and product use likelihood were similar for the intermittent gel and daily oral FTC/TDF regimens, but lower for the daily gel regimen. Clinical Trials Registration: NCT01687218. PMID:27986684

Short-term in vivo modifications of platelet NADPH oxidase 2 (NOX2) and prostaglandin F2α in HIV-1 patients on abacavir-based therapies.

PubMed

Pastori, D; Esposito, A; Carnevale, R; Bartimoccia, S; Nocella, C; Fantauzzi, A; Pignatelli, P; Violi, F; Mezzaroma, I

2016-11-01

The aim of the study was to investigate the in vivo effect of abacavir (ABC) on platelet oxidative stress. We performed a randomized pilot study including 39 HIV-1-infected patients, 17 on zidovudine/lamivudine (ZDV/3TC) and 22 on tenofovir/emtricitabine (TDF/FTC). Ten patients on ZDV/3TC and eight patients on TDF/FTC were randomly allocated to switching the nucleoside backbone to ABC/3TC. At baseline and after 6 months, platelet oxidative stress was assessed by platelet NADPH oxidase 2 (NOX2)-derived peptide (sNOX2-dp), a marker of NOX2 activation, and platelet prostaglandin F 2α (8-iso-PGF 2α ). Platelet activation was measured by soluble CD40L (sCD40L). At baseline, no differences between ZDV/3TC or TDF/FTC recipients were found. After 6 months, patients switching from ZDV/3TC showed a decrease of sNOX2-dp (from 20.9±5.7 to 12.5±3.8 pg/ml, p=0.002) and 8-iso-PGF 2α (from 154.3±41.9 to 122.9±28.0 pmol/l, p=0.025). No effects on platelet oxidative stress biomarkers were observed in subjects from TDF/FTC, who showed a significant increase in blood glucose (p=0.043) and total cholesterol (p=0.027). ABC showed no effect on sCD40L levels in both groups. ABC reduced platelet sNOX2-dp and 8-iso-PGF 2α in HIV-1 subjects switching from ZDV/3TC but not in those from TDF/FTC after 6 months. No changes in platelet activation were found in both groups. © 2016 British HIV Association.

Development of a method to estimate organ doses for pediatric CT examinations

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

Papadakis, Antonios E., E-mail: apapadak@pagni.gr; Perisinakis, Kostas; Damilakis, John

Purpose: To develop a method for estimating doses to primarily exposed organs in pediatric CT by taking into account patient size and automatic tube current modulation (ATCM). Methods: A Monte Carlo CT dosimetry software package, which creates patient-specific voxelized phantoms, accurately simulates CT exposures, and generates dose images depicting the energy imparted on the exposed volume, was used. Routine head, thorax, and abdomen/pelvis CT examinations in 92 pediatric patients, ranging from 1-month to 14-yr-old (49 boys and 43 girls), were simulated on a 64-slice CT scanner. Two sets of simulations were performed in each patient using (i) a fixed tubemore » current (FTC) value over the entire examination length and (ii) the ATCM profile extracted from the DICOM header of the reconstructed images. Normalized to CTDI{sub vol} organ dose was derived for all primary irradiated radiosensitive organs. Normalized dose data were correlated to patient’s water equivalent diameter using log-transformed linear regression analysis. Results: The maximum percent difference in normalized organ dose between FTC and ATCM acquisitions was 10% for eyes in head, 26% for thymus in thorax, and 76% for kidneys in abdomen/pelvis. In most of the organs, the correlation between dose and water equivalent diameter was significantly improved in ATCM compared to FTC acquisitions (P < 0.001). Conclusions: The proposed method employs size specific CTDI{sub vol}-normalized organ dose coefficients for ATCM-activated and FTC acquisitions in pediatric CT. These coefficients are substantially different between ATCM and FTC modes of operation and enable a more accurate assessment of patient-specific organ dose in the clinical setting.« less

The Safety of Tenofovir-Emtricitabine for HIV Pre-Exposure Prophylaxis (PrEP) in Individuals With Active Hepatitis B.

PubMed

Solomon, Marc M; Schechter, Mauro; Liu, Albert Y; McMahan, Vanessa M; Guanira, Juan V; Hance, Robert J; Chariyalertsak, Suwat; Mayer, Kenneth H; Grant, Robert M

2016-03-01

Pre-exposure prophylaxis (PrEP) with daily oral emtricitabine and tenofovir disoproxil fumarate (FTC/TDF) prevents HIV infection. The safety and feasibility of HIV PrEP in the setting of hepatitis B virus (HBV) infection were evaluated. The Iniciativa Profilaxis Pre-Exposición study randomized 2499 HIV-negative men and transgender women who have sex with men to once-daily oral FTC/TDF versus placebo. Hepatitis serologies and transaminases were obtained at screening and at the time PrEP was discontinued. HBV DNA was assessed by polymerase chain reaction, and drug resistance was assessed by population sequencing. Vaccination was offered to individuals susceptible to HBV infection. Of the 2499 participants, 12 (0.5%; including 6 randomized to FTC/TDF) had chronic HBV infection. After stopping FTC/TDF, 5 of the 6 participants in the active arm had liver function tests performed at follow-up. Liver function tests remained within normal limits at post-stop visits except for a grade 1 elevation in 1 participant at post-stop week 12 (alanine aminotransferase = 90, aspartate aminotransferase = 61). There was no evidence of hepatic flares. Polymerase chain reaction of stored samples showed that 2 participants in the active arm had evidence of acute HBV infection at enrollment. Both had evidence of grade 4 transaminase elevations with subsequent resolution. Overall, there was no evidence of TDF or FTC resistance among tested genotypes. Of 1633 eligible for vaccination, 1587 (97.2%) received at least 1 vaccine; 1383 (84.7%) completed the series. PrEP can be safely provided to individuals with HBV infection if there is no evidence of cirrhosis or substantial transaminase elevation. HBV vaccination rates at screening were low globally, despite recommendations for its use, yet uptake and efficacy were high when offered.

Results of Annual Screening in Phase I of the United Kingdom Familial Ovarian Cancer Screening Study Highlight the Need for Strict Adherence to Screening Schedule

PubMed Central

Rosenthal, Adam N.; Fraser, Lindsay; Manchanda, Ranjit; Badman, Philip; Philpott, Susan; Mozersky, Jessica; Hadwin, Richard; Cafferty, Fay H.; Benjamin, Elizabeth; Singh, Naveena; Evans, D. Gareth; Eccles, Diana M.; Skates, Steven J.; Mackay, James; Menon, Usha; Jacobs, Ian J.

2013-01-01

Purpose To establish the performance characteristics of annual transvaginal ultrasound and serum CA125 screening for women at high risk of ovarian/fallopian tube cancer (OC/FTC) and to investigate the impact of delayed screening interval and surgical intervention. Patients and Methods Between May 6, 2002, and January 5, 2008, 3,563 women at an estimated ≥ 10% lifetime risk of OC/FTC were recruited and screened by 37 centers in the United Kingdom. Participants were observed prospectively by centers, questionnaire, and national cancer registries. Results Sensitivity for detection of incident OC/FTC at 1 year after last annual screen was 81.3% (95% CI, 54.3% to 96.0%) if occult cancers were classified as false negatives and 87.5% (95% CI, 61.7% to 98.5%) if they were classified as true positives. Positive and negative predictive values of incident screening were 25.5% (95% CI, 14.3 to 40.0) and 99.9% (95% CI, 99.8 to 100) respectively. Four (30.8%) of 13 incident screen-detected OC/FTCs were stage I or II. Compared with women screened in the year before diagnosis, those not screened in the year before diagnosis were more likely to have ≥ stage IIIc disease (85.7% v 26.1%; P = .009). Screening interval was delayed by a median of 88 days before detection of incident OC/FTC. Median interval from detection screen to surgical intervention was 79 days in prevalent and incident OC/FTC. Conclusion These results in the high-risk population highlight the need for strict adherence to screening schedule. Screening more frequently than annually with prompt surgical intervention seems to offer a better chance of early-stage detection. PMID:23213100

Visualizing Nerve Injury in a Neuropathic Pain Model with [18F]FTC-146 PET/MRI.

PubMed

Shen, Bin; Behera, Deepak; James, Michelle L; Reyes, Samantha T; Andrews, Lauren; Cipriano, Peter W; Klukinov, Michael; Lutz, Amanda Brosius; Mavlyutov, Timur; Rosenberg, Jarrett; Ruoho, Arnold E; McCurdy, Christopher R; Gambhir, Sanjiv S; Yeomans, David C; Biswal, Sandip; Chin, Frederick T

2017-01-01

The ability to locate nerve injury and ensuing neuroinflammation would have tremendous clinical value for improving both the diagnosis and subsequent management of patients suffering from pain, weakness, and other neurologic phenomena associated with peripheral nerve injury. Although several non-invasive techniques exist for assessing the clinical manifestations and morphological aspects of nerve injury, they often fail to provide accurate diagnoses due to limited specificity and/or sensitivity. Herein, we describe a new imaging strategy for visualizing a molecular biomarker of nerve injury/neuroinflammation, i.e. , the sigma-1 receptor (S1R), in a rat model of nerve injury and neuropathic pain. The two-fold higher increase of S1Rs was shown in the injured compared to the uninjured nerve by Western blotting analyses. With our novel S1R-selective radioligand, [ 18 F]FTC-146 (6-(3-[ 18 F]fluoropropyl)-3-(2-(azepan-1-yl)ethyl)benzo[ d ]thiazol-2(3H)-one), and positron emission tomography-magnetic resonance imaging (PET/MRI), we could accurately locate the site of nerve injury created in the rat model. We verified the accuracy of this technique by ex vivo autoradiography and immunostaining, which demonstrated a strong correlation between accumulation of [ 18 F]FTC-146 and S1R staining. Finally, pain relief could also be achieved by blocking S1Rs in the neuroma with local administration of non-radioactive [ 19 F]FTC-146. In summary, [ 18 F]FTC-146 S1R PET/MR imaging has the potential to impact how we diagnose, manage and treat patients with nerve injury, and thus warrants further investigation.

Effects of Pump Pulsation on Hydrodynamic Properties and Dissolution Profiles in Flow-Through Dissolution Systems (USP 4).

PubMed

Yoshida, Hiroyuki; Kuwana, Akemi; Shibata, Hiroko; Izutsu, Ken-Ichi; Goda, Yukihiro

2016-06-01

To clarify the effects of pump pulsation and flow-through cell (FTC) dissolution system settings on the hydrodynamic properties and dissolution profiles of model formulations. Two FTC systems with different cell temperature control mechanisms were used. Particle image velocimetry (PIV) was used to analyze the hydrodynamic properties of test solutions in the flow-through dissolution test cell. Two pulsation pumps (semi-sine, full-sine) and a non-pulsatile pump were used to study the effects of varied flows on the dissolution profiles of United States Pharmacopeia standard tablets. PIV analysis showed periodic changes in the aligned upward fluid flow throughout the dissolution cell that was designed to reduce the temperature gradient during pump pulsation (0.5 s/pulse). The maximum instantaneous flow from the semi-sine pump was higher than that of the full-sine pump under all conditions. The flow from the semi-sine wave pump showed faster dissolution of salicylic acid and prednisone tablets than those from other pumps. The semi-sine wave pump flow showed similar dissolution profiles in the two FTC systems. Variations in instantaneous fluid flow caused by pump pulsation that meets the requirements of pharmacopoeias are a factor that affects the dissolution profiles of tablets in FTC systems.

28 CFR 34.4 - Additional competitive application requirements and procedures.

Code of Federal Regulations, 2010 CFR

2010-07-01

... other eligible parties, including those in another State, and submit joint applications for assistance. (2) A joint application made by two or more applicants for assistance may have separate budgets... combined budget. If joint applications present separate budgets, the Administrator may make separate awards...

AdChoices? Compliance with Online Behavioral Advertising Notice and Choice Requirements. Revised Version

DTIC Science & Technology

2011-10-07

further information and a means of opting out. Revised October 7, 2011. Keywords: Online behavioral advertising ; privacy; consumer choice; notice... consumers ’ activities online to target advertising .”1 The FTC has been examining ways to reduce the privacy concerns associated with OBA for over a decade...behavioral advertising practices that would foster transparency, knowledge and choice for consumers . As the FTC determines what to do next, it is

Premerger notification: reporting and waiting period requirements--FTC. Notice of adoption of formal interpretation and request for comments.

PubMed

Clark, D S

1998-10-13

The Premerger Notification Office ("PNO") of the Federal Trade Commission ("FTC"), with the concurrence of the Assistant Attorney General in charge of the Antitrust Division of the Department of Justice ("DOJ"), is adopting a Formal Interpretation of the Hart-Scott-Rodino Act, which requires certain persons planning certain mergers, consolidations, or other acquisitions to report information about the proposed transactions to the FTC and DOJ. The Interpretation concerns the reportability of certain transactions involving a Limited Liability Company ("LLC"), a relatively new form of entity authorized by state statutes. Under the Interpretation, the formation of an LLC will be reportable if it will unite two or more pre-existing businesses under common control. Similarly, acquisitions of existing LLC membership interests will be reportable if they would have the effect of uniting two or more pre-existing businesses under common control.

Prescribed-performance fault-tolerant control for feedback linearisable systems with an aircraft application

NASA Astrophysics Data System (ADS)

Gao, Gang; Wang, Jinzhi; Wang, Xianghua

2017-05-01

This paper investigates fault-tolerant control (FTC) for feedback linearisable systems (FLSs) and its application to an aircraft. To ensure desired transient and steady-state behaviours of the tracking error under actuator faults, the dynamic effect caused by the actuator failures on the error dynamics of a transformed model is analysed, and three control strategies are designed. The first FTC strategy is proposed as a robust controller, which relies on the explicit information about several parameters of the actuator faults. To eliminate the need for these parameters and the input chattering phenomenon, the robust control law is later combined with the adaptive technique to generate the adaptive FTC law. Next, the adaptive control law is further improved to achieve the prescribed performance under more severe input disturbance. Finally, the proposed control laws are applied to an air-breathing hypersonic vehicle (AHV) subject to actuator failures, which confirms the effectiveness of the proposed strategies.

Prevention of the Post-traumatic Fibrotic Response in Joints

DTIC Science & Technology

2014-10-01

The American journal of forensic medicine and pathology . 1988; 9(4):310-2. 14 APPENDICES: An abstract submitted for the ORS conference...clinical problem of posttraumatic joint stiffness, a pathology that reduces the range of motion (ROM) of injured joints and contributes to the...development of osteoarthritis. The fundamental hypothesis that drives the current study is that pathological fibrotic response of injured joint tissues

24 CFR 943.118 - What is a consortium?

Code of Federal Regulations, 2010 CFR

2010-04-01

... DEVELOPMENT PUBLIC HOUSING AGENCY CONSORTIA AND JOINT VENTURES Consortia § 943.118 What is a consortium? A... consortium also submits a joint PHA Plan. The lead agency collects the assistance funds from HUD that would... same fiscal year so that the applicable periods for submission and review of the joint PHA Plan are the...

75 FR 47900 - Joint Report: Differences in Accounting and Capital Standards Among the Federal Banking Agencies...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-09

... OTS-supervised savings association to file the Thrift Financial Report (TFR). The reporting standards...-for-line basis for financial reporting purposes, joint ventures, and associated companies, the parent... jointly submit an annual report to the Committee on Financial Services of the United States House of...

Gene Expression (mRNA) Markers for Differentiating between Malignant and Benign Follicular Thyroid Tumours

PubMed Central

Wojtas, Bartosz; Pfeifer, Aleksandra; Oczko-Wojciechowska, Malgorzata; Krajewska, Jolanta; Czarniecka, Agnieszka; Kukulska, Aleksandra; Eszlinger, Markus; Musholt, Thomas; Stokowy, Tomasz; Swierniak, Michal; Stobiecka, Ewa; Chmielik, Ewa; Rusinek, Dagmara; Tyszkiewicz, Tomasz; Halczok, Monika; Hauptmann, Steffen; Lange, Dariusz; Jarzab, Michal; Paschke, Ralf; Jarzab, Barbara

2017-01-01

Distinguishing between follicular thyroid cancer (FTC) and follicular thyroid adenoma (FTA) constitutes a long-standing diagnostic problem resulting in equivocal histopathological diagnoses. There is therefore a need for additional molecular markers. To identify molecular differences between FTC and FTA, we analyzed the gene expression microarray data of 52 follicular neoplasms. We also performed a meta-analysis involving 14 studies employing high throughput methods (365 follicular neoplasms analyzed). Based on these two analyses, we selected 18 genes differentially expressed between FTA and FTC. We validated them by quantitative real-time polymerase chain reaction (qRT-PCR) in an independent set of 71 follicular neoplasms from formaldehyde-fixed paraffin embedded (FFPE) tissue material. We confirmed differential expression for 7 genes (CPQ, PLVAP, TFF3, ACVRL1, ZFYVE21, FAM189A2, and CLEC3B). Finally, we created a classifier that distinguished between FTC and FTA with an accuracy of 78%, sensitivity of 76%, and specificity of 80%, based on the expression of 4 genes (CPQ, PLVAP, TFF3, ACVRL1). In our study, we have demonstrated that meta-analysis is a valuable method for selecting possible molecular markers. Based on our results, we conclude that there might exist a plausible limit of gene classifier accuracy of approximately 80%, when follicular tumors are discriminated based on formalin-fixed postoperative material. PMID:28574441

Gene Expression (mRNA) Markers for Differentiating between Malignant and Benign Follicular Thyroid Tumours.

PubMed

Wojtas, Bartosz; Pfeifer, Aleksandra; Oczko-Wojciechowska, Malgorzata; Krajewska, Jolanta; Czarniecka, Agnieszka; Kukulska, Aleksandra; Eszlinger, Markus; Musholt, Thomas; Stokowy, Tomasz; Swierniak, Michal; Stobiecka, Ewa; Chmielik, Ewa; Rusinek, Dagmara; Tyszkiewicz, Tomasz; Halczok, Monika; Hauptmann, Steffen; Lange, Dariusz; Jarzab, Michal; Paschke, Ralf; Jarzab, Barbara

2017-06-02

Distinguishing between follicular thyroid cancer (FTC) and follicular thyroid adenoma (FTA) constitutes a long-standing diagnostic problem resulting in equivocal histopathological diagnoses. There is therefore a need for additional molecular markers. To identify molecular differences between FTC and FTA, we analyzed the gene expression microarray data of 52 follicular neoplasms. We also performed a meta-analysis involving 14 studies employing high throughput methods (365 follicular neoplasms analyzed). Based on these two analyses, we selected 18 genes differentially expressed between FTA and FTC. We validated them by quantitative real-time polymerase chain reaction (qRT-PCR) in an independent set of 71 follicular neoplasms from formaldehyde-fixed paraffin embedded (FFPE) tissue material. We confirmed differential expression for 7 genes ( CPQ , PLVAP , TFF3 , ACVRL1 , ZFYVE21 , FAM189A2 , and CLEC3B ). Finally, we created a classifier that distinguished between FTC and FTA with an accuracy of 78%, sensitivity of 76%, and specificity of 80%, based on the expression of 4 genes ( CPQ , PLVAP , TFF3 , ACVRL1 ). In our study, we have demonstrated that meta-analysis is a valuable method for selecting possible molecular markers. Based on our results, we conclude that there might exist a plausible limit of gene classifier accuracy of approximately 80%, when follicular tumors are discriminated based on formalin-fixed postoperative material.

Estimating tar and nicotine exposure: human smoking versus machine generated smoke yields.

PubMed

St Charles, F K; Kabbani, A A; Borgerding, M F

2010-02-01

Determine human smoked (HS) cigarette yields of tar and nicotine for smokers using their own brand in their everyday environment. A robust, filter analysis method was used to estimate the tar and nicotine yields for 784 subjects. Seventeen brands were chosen to represent a wide range of styles: 85 and 100 mm lengths; menthol and non-menthol; 17, 23, and 25 mm circumference; with tar yields [Federal Trade Commission (FTC) method] ranging from 1 to 18 mg. Tar bands chosen corresponded to yields of 1-3 mg, 4-6 mg, 7-12 mg, and 13+ mg. A significant difference (p<0.0001) in HS yields of tar and nicotine between tar bands was found. Machine-smoked yields were reasonable predictors of the HS yields for groups of subjects, but the relationship was neither exact nor linear. Neither the FTC, the Massachusetts (MA) nor the Canadian Intensive (CI) machine-smoking methods accurately reflect the HS yields across all brands. The FTC method was closest for the 7-12 mg and 13+ mg products and the MA method was closest for the 1-3mg products. The HS yields for the 4-6 mg products were approximately midway between the FTC and the MA yields. HS nicotine yields corresponded well with published urinary and plasma nicotine biomarker studies. 2009 Elsevier Inc. All rights reserved.

Comparative release studies on suppositories using the basket, paddle, dialysis tubing and flow-through cell methods I. Acetaminophen in a lipophilic base suppository.

PubMed

Hori, Seiichi; Kawada, Tsubasa; Kogure, Sanae; Yabu, Shinako; Mori, Kenji; Akimoto, Masayuki

2017-02-01

The release characteristics of lipophilic suppositories containing acetaminophen (AAP) were examined using four types of dissolution methods: the basket, paddle, dialysis tubing (DT) and flow-through cell (FTC) methods. The suitability of each apparatus for quality control in AAP compounded suppositories was evaluated using statistical procedures. More than 80% of the drug was released over 60 min in all the release methods studied, with the exception of the basket method. Reproducible and faster release was achieved using the paddle method at 100 and 200 rpm, whereas poor release occurred with the basket method. The mean dissolution time (MDT), maximum dissolved quantity of AAP at the end of the sampling time (Q) and dissolution efficiency (DE) were calculated by model-independent methods. The FTC method with a single chamber used in this study was also appreciable for AAP suppositories (Q of 100%, MDT of 71-91 min and DE of 75-80%). The DT apparatus is considered similar to the FTC apparatus from a quality control perspective for judging the release properties of lipophilic base suppositories containing AAP. However, even the single chamber FTC used in this study has potential as an in vitro drug release test for suppositories. The comparative dissolution method is expected to become one of the valuable tools for selecting an adequate dissolution test.

96 weeks combination of adefovir dipivoxil plus emtricitabine vs. adefovir dipivoxil monotherapy in the treatment of chronic hepatitis B.

PubMed

Hui, Chee-Kin; Zhang, Hai-Ying; Bowden, Scott; Locarnini, Stephen; Luk, John M; Leung, Kar-Wai; Yueng, Yui-Hung; Wong, April; Rousseau, Frank; Yuen, Kwok-Yung; Naoumov, Nikolai N; Lau, George K K

2008-05-01

In order to prevent the occurrence of drug-resistant mutants associated with treatment for chronic hepatitis B virus (HBV) infection, combination therapy is being developed. To determine the efficacy of adefovir dipivoxil (ADV) plus emtricitabine (FTC) combination therapy in chronic HBV infection. Thirty treatment-nai ve, HBeAg-positive patients were randomized to combination ADV plus FTC (n=14) or ADV plus placebo monotherapy (n=16) for 96 weeks. HBV DNA was measured by polymerase chain reaction. Treatment was stopped in those with HBeAg seroconversion. The median decrease in HBV DNA at week 96 was higher in the combination group (-5.30 vs. -3.98 log(10)copies/ml, p=0.05). More patients in the combination group had normalization of alanine aminotransaminase and HBV DNA<300 copies/ml at week 96 when compared with the monotherapy group [11 of the 14 patients (78.6%) vs. 6 of the 16 patients (37.5%), p=0.03]. However, HBeAg seroconversion at week 96 was similar in the 2 groups [2/14 (14.3%) vs. 4/16 (25.0%), p=NS]. No ADV or FTC resistance was detected at week 96. In those with HBeAg seroconversion, 50.0% had post-treatment relapse. Combination ADV plus FTC resulted in more potent suppression of HBV DNA over 96 weeks of therapy.

Assessment of oral bioavailability enhancing approaches for SB-247083 using flow-through cell dissolution testing as one of the screens.

PubMed

Perng, Cherng-Yih; Kearney, Albert S; Palepu, Nagesh R; Smith, Brian R; Azzarano, Leonard M

2003-01-02

SB-247083 is a potent, nonpeptidic, orally active, ETA-selective, endothelin receptor antagonist. The diacid form and three salts (monoarginine, diarginine and disodium) of SB-247083 were evaluated during the pre-clinical phase of development. The developability attributes (i.e. hygroscopicity, thermal behavior, aqueous solubility, and drug-excipient compatibility) of these compounds were evaluated. In addition to these attributes, the flow-through cell (FTC) dissolution testing (using USP Apparatus 4) was used as a screening technique to evaluate several SB-247083 formulations of the diacid and its salts. FTC dissolution testing offers two distinct advantages over the more traditional static-condition dissolution testing: (1) maintenance of sink conditions; and (2) the ability to change the dissolution medium during a dissolution run. The former advantage is especially important for poorly aqueous soluble drugs having associated dissolution-rate-limitations, and the latter advantage allows one to more closely simulate the pH gradient associated with transit through the GI tract. Based on the comparative dissolution data, three formulations were chosen for oral dosing in dogs. The reasonable correlation found between the FTC dissolution results and the oral bioavailability data demonstrate that FTC dissolution testing can be a valuable tool for aiding in salt (solid-state form) and formulation selection in the early stages of development of drug candidates.

24 CFR 943.122 - How is a consortium organized?

Code of Federal Regulations, 2010 CFR

2010-04-01

... URBAN DEVELOPMENT PUBLIC HOUSING AGENCY CONSORTIA AND JOINT VENTURES Consortia § 943.122 How is a... participating PHAs, specifying a lead agency (see § 943.124), and submit a joint PHA Plan (§ 943.118). HUD...

No Evidence of Sexual Risk Compensation in the iPrEx Trial of Daily Oral HIV Preexposure Prophylaxis

PubMed Central

Marcus, Julia L.; Glidden, David V.; Mayer, Kenneth H.; Liu, Albert Y.; Buchbinder, Susan P.; Amico, K. Rivet; McMahan, Vanessa; Kallas, Esper Georges; Montoya-Herrera, Orlando; Pilotto, Jose; Grant, Robert M.

2013-01-01

Objective Preexposure prophylaxis (PrEP) with emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) reduced HIV acquisition in the iPrEx trial among men who have sex with men and transgender women. Self-reported sexual risk behavior decreased overall, but may be affected by reporting bias. We evaluated potential risk compensation using biomarkers of sexual risk behavior. Design and methods Sexual practices were assessed at baseline and quarterly thereafter; perceived treatment assignment and PrEP efficacy beliefs were assessed at 12 weeks. Among participants with ≥1 follow-up behavioral assessment, sexual behavior, syphilis, and HIV infection were compared by perceived treatment assignment, actual treatment assignment, and perceived PrEP efficacy. Results Overall, acute HIV infection and syphilis decreased during follow-up. Compared with participants believing they were receiving placebo, participants believing they were receiving FTC/TDF reported more receptive anal intercourse partners prior to initiating drug (12.8 vs. 7.7, P = 0.04). Belief in receiving FTC/TDF was not associated with an increase in receptive anal intercourse with no condom (ncRAI) from baseline through follow-up (risk ratio [RR] 0.9, 95% confidence interval [CI]: 0.6–1.4; P = 0.75), nor with a decrease after stopping study drug (RR 0.8, 95% CI: 0.5–1.3; P = 0.46). In the placebo arm, there were trends toward lower HIV incidence among participants believing they were receiving FTC/TDF (incidence rate ratio [IRR] 0.8, 95% CI: 0.4–1.8; P = 0.26) and also believing it was highly effective (IRR 0.5, 95% CI: 0.1–1.7; P = 0.12). Conclusions There was no evidence of sexual risk compensation in iPrEx. Participants believing they were receiving FTC/TDF had more partners prior to initiating drug, suggesting that risk behavior was not a consequence of PrEP use. PMID:24367497

Urine assay for tenofovir to monitor adherence in real time to tenofovir disoproxil fumarate/emtricitabine as pre-exposure prophylaxis.

PubMed

Koenig, H C; Mounzer, K; Daughtridge, G W; Sloan, C E; Lalley-Chareczko, L; Moorthy, G S; Conyngham, S C; Zuppa, A F; Montaner, L J; Tebas, P

2017-07-01

Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) is approved for pre-exposure prophylaxis (PrEP) against HIV infection. Adherence is critical for the success of PrEP, but current adherence measurements are inadequate for real-time adherence monitoring. We developed and validated a urine assay to measure tenofovir (TFV) to objectively monitor adherence to PrEP. We developed a urine assay using high-performance liquid chromatography coupled to tandem mass spectrometry with high sensitivity/specificity for TFV that allowed us to determine TFV concentrations in log 10 categories between 0 and 10 000 ng/mL. We validated the assay in three cohorts: (1) HIV-positive subjects with undetectable viral loads on a TDF/FTC-based regimen, (2) healthy HIV-negative subjects who received a single dose of TDF/FTC, and (3) HIV-negative subjects receiving daily TDF/FTC as PrEP for 24 weeks. The urine assay detected TFV with greater sensitivity than plasma-based measures and with a window of measurements within 7 days of the last TDF/FTC dose. Based on the urine log-linear clearance after the last dose and its concordance with all detectable plasma levels, a urine TFV concentration > 1000 ng/mL was identified as highly predictive of the presence of TFV in plasma at > 10 ng/mL. The urine assay was able to distinguish high and low adherence patterns within the last 48 h (> 1000 ng/mL versus 10-1000 ng/mL), as well as nonadherence (< 10 ng/mL) extended over at least 1 week prior to measurement. We provide proof of concept that a semiquantitative urine assay measuring levels of TFV could be further developed into a point-of-care test and be a useful tool to monitor adherence to PrEP. © 2017 British HIV Association.

The Safety of Tenofovir–Emtricitabine for HIV Pre-Exposure Prophylaxis (PrEP) in Individuals With Active Hepatitis B

PubMed Central

Schechter, Mauro; Liu, Albert Y.; McManhan, Vanessa M.; Guanira, Juan V.; Hance, Robert J.; Chariyalertsak, Suwat; Mayer, Kenneth H.; Grant, Robert M.

2016-01-01

Background: Pre-exposure prophylaxis (PrEP) with daily oral emtricitabine and tenofovir disoproxil fumarate (FTC/TDF) prevents HIV infection. The safety and feasibility of HIV PrEP in the setting of hepatitis B virus (HBV) infection were evaluated. Methods: The Iniciativa Profilaxis Pre-Exposición study randomized 2499 HIV-negative men and transgender women who have sex with men to once-daily oral FTC/TDF versus placebo. Hepatitis serologies and transaminases were obtained at screening and at the time PrEP was discontinued. HBV DNA was assessed by polymerase chain reaction, and drug resistance was assessed by population sequencing. Vaccination was offered to individuals susceptible to HBV infection. Results: Of the 2499 participants, 12 (0.5%; including 6 randomized to FTC/TDF) had chronic HBV infection. After stopping FTC/TDF, 5 of the 6 participants in the active arm had liver function tests performed at follow-up. Liver function tests remained within normal limits at post-stop visits except for a grade 1 elevation in 1 participant at post-stop week 12 (alanine aminotransferase = 90, aspartate aminotransferase = 61). There was no evidence of hepatic flares. Polymerase chain reaction of stored samples showed that 2 participants in the active arm had evidence of acute HBV infection at enrollment. Both had evidence of grade 4 transaminase elevations with subsequent resolution. Overall, there was no evidence of TDF or FTC resistance among tested genotypes. Of 1633 eligible for vaccination, 1587 (97.2%) received at least 1 vaccine; 1383 (84.7%) completed the series. Conclusions: PrEP can be safely provided to individuals with HBV infection if there is no evidence of cirrhosis or substantial transaminase elevation. HBV vaccination rates at screening were low globally, despite recommendations for its use, yet uptake and efficacy were high when offered. PMID:26413853

Ethical issues in professional advertising.

PubMed

Peters, C R

1989-07-01

Physician advertising has received considerable attention since the courts decided in favor of the Federal Trade Commission (FTC) in its initial complaint against the American Medical Association in the 1970s. Continued investigations by the FTC into AMA opinions on advertising and publicity have promulgated a new freedom in advertising by physicians. False and deceptive advertising though is the grounds for court action as well as license revocation. This is an attempt to analyze where physician advertising is most prevalent, which physicians are doing it and why.

Fault-Tree Compiler Program

NASA Technical Reports Server (NTRS)

Butler, Ricky W.; Martensen, Anna L.

1992-01-01

FTC, Fault-Tree Compiler program, is reliability-analysis software tool used to calculate probability of top event of fault tree. Five different types of gates allowed in fault tree: AND, OR, EXCLUSIVE OR, INVERT, and M OF N. High-level input language of FTC easy to understand and use. Program supports hierarchical fault-tree-definition feature simplifying process of description of tree and reduces execution time. Solution technique implemented in FORTRAN, and user interface in Pascal. Written to run on DEC VAX computer operating under VMS operating system.

Minimum Energy of Multicomponent Distillation Systems Using Minimum Additional Heat and Mass Integration Sections

DOE PAGES

Jiang, Zheyu; Ramapriya, Gautham Madenoor; Tawarmalani, Mohit; ...

2018-04-20

Heat and mass integration to consolidate distillation columns in a multicomponent distillation configuration can lead to a number of new energy efficient and cost effective configurations. In this paper, we identify a powerful and simple-to-use fact about heat and mass integration. The newly developed heat and mass integrated configurations, which we call as HMP configurations, involve first introducing thermal couplings to all intermediate transfer streams, followed by consolidating columns associated with a lighter pure product reboiler and a heavier pure product condenser. A systematic method of enumerating all HMP configurations is introduced. We compare the energy savings of HMP configurationsmore » with the well-known fully thermally coupled (FTC) configurations. We demonstrate that HMP configurations can have very similar and sometimes even the same minimum total vapor duty requirement as the FTC configuration, while using far less number of column sections, intermediate transfer streams, and thermal couplings than the FTC configurations.« less

Minimum Energy of Multicomponent Distillation Systems Using Minimum Additional Heat and Mass Integration Sections

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

Jiang, Zheyu; Ramapriya, Gautham Madenoor; Tawarmalani, Mohit

Heat and mass integration to consolidate distillation columns in a multicomponent distillation configuration can lead to a number of new energy efficient and cost effective configurations. In this paper, we identify a powerful and simple-to-use fact about heat and mass integration. The newly developed heat and mass integrated configurations, which we call as HMP configurations, involve first introducing thermal couplings to all intermediate transfer streams, followed by consolidating columns associated with a lighter pure product reboiler and a heavier pure product condenser. A systematic method of enumerating all HMP configurations is introduced. We compare the energy savings of HMP configurationsmore » with the well-known fully thermally coupled (FTC) configurations. We demonstrate that HMP configurations can have very similar and sometimes even the same minimum total vapor duty requirement as the FTC configuration, while using far less number of column sections, intermediate transfer streams, and thermal couplings than the FTC configurations.« less

A review of fault tolerant control strategies applied to proton exchange membrane fuel cell systems

NASA Astrophysics Data System (ADS)

Dijoux, Etienne; Steiner, Nadia Yousfi; Benne, Michel; Péra, Marie-Cécile; Pérez, Brigitte Grondin

2017-08-01

Fuel cells are powerful systems for power generation. They have a good efficiency and do not generate greenhouse gases. This technology involves a lot of scientific fields, which leads to the appearance of strongly inter-dependent parameters. This makes the system particularly hard to control and increases fault's occurrence frequency. These two issues call for the necessity to maintain the system performance at the expected level, even in faulty operating conditions. It is called "fault tolerant control" (FTC). The present paper aims to give the state of the art of FTC applied to the proton exchange membrane fuel cell (PEMFC). The FTC approach is composed of two parts. First, a diagnosis part allows the identification and the isolation of a fault; it requires a good a priori knowledge of all the possible faults. Then, a control part allows an optimal control strategy to find the best operating point to recover/mitigate the fault; it requires the knowledge of the degradation phenomena and their mitigation strategies.

The future of tobacco product regulation and labelling in Europe: implications for the forthcoming European Union directive.

PubMed

Bates, C; McNeill, A; Jarvis, M; Gray, N

1999-01-01

The European Commission has announced that it is considering legislation concerning further restrictions on cigarette tar and nicotine yields, as well as new provisions to regulate additives and the labelling of tobacco products. This report considers these issues and their relation to public health. In particular, we argue that further reductions in tar and nicotine yields as measured by the International Standards Organisation/Federal Trade Commission (ISO/FTC) method will be largely cosmetic and certainly misleading to consumers. If a new directive uses the ISO/FTC methodology as a basis for regulation, it risks lending further official support to the concept of "low tar" cigarettes, which may be used by smokers as an alternative to smoking cessation. Although new regulations based on the ISO/FTC methodology may appear to offer health gains, these will be illusory and there may even be negative health consequences, as has been the case with these tests up to the present. We therefore make the following recommendations for the way forward.

Effects of Milk or Apple Juice Ingestion on the Pharmacokinetics of Elvitegravir and Cobicistat in Healthy Japanese Male Volunteers: A Randomized, Single-Dose, Three-Way Crossover Study.

PubMed

Yonemura, Takuma; Okada, Nozomi; Sagane, Koichi; Okamiya, Kazuhiro; Ozaki, Hideki; Iida, Toshiaki; Yamada, Hiroyuki; Yagura, Hiroki

2018-01-24

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (EVG/COBI/FTC/TAF) is specified in its package insert to be taken with food to obtain sufficient exposure of EVG. It has been reported that a nutritional protein-rich drink shows comparable pharmacokinetics (PK) of EVG to those with a standard breakfast. In this study, the PK profiles of EVG and COBI were evaluated by administration of a single dose of EVG/COBI/FTC/TAF, after ingestion of either a nutritional protein-rich drink, milk, or apple juice. The geometric means for C max and AUC inf of EVG following milk ingestion slightly decreased by 21% and 14%, respectively, and those following apple juice ingestion decreased by 67% and 61%, respectively, compared with a nutritional protein-rich drink. There were no differences in any PK parameters of COBI. Therefore, taking EVG/COBI/FTC/TAF after milk or apple juice ingestion appeared to be not appropriate. However, for plasma trough concentrations (C tau ), it is known that C tau is best correlated with the efficacy of EVG. The mean C 24 of EVG after milk ingestion was 620.6 ng/mL, which was more than 10-fold the protein binding-adjusted 95% inhibitory concentration. With all the above considerations, it was concluded that taking EVG/COBI/FTC/TAF with milk could be an option to maintain sufficient plasma concentrations of EVG. © 2018, The American College of Clinical Pharmacology.

The impact of an unconditional tax credit for families on self-rated health in adults: further evidence from the cohort study of 6900 New Zealanders.

PubMed

Pega, Frank; Carter, Kristie; Kawachi, Ichiro; Davis, Peter; Blakely, Tony

2014-05-01

It is hypothesized that unconditional (given without obligation) publicly funded financial credits more effectively improve health than conditional financial credits in high-income countries. We previously reported no discernible short-term impact of an employment-conditional tax credit for families on self-rated health (SRH) in adults in New Zealand. This study estimates the effect of an unconditional tax credit for families, called Family Tax Credit (FTC), on SRH in the same study population and setting. A balanced panel of 6900 adults in families was extracted from seven waves (2002-2009) of the Survey of Family, Income and Employment. The exposures, eligibility for and amount of FTC, were derived by applying government eligibility and entitlement criteria. The outcome, SRH, was collected annually. Fixed effects regression analyses eliminated all time-invariant confounding and adjusted for measured time-varying confounders. Becoming eligible for FTC was associated with a small and statistically insignificant change in SRH over the past year [effect estimate: 0.013; 95% confidence interval (CI) -0.011 to 0.037], as was an increase in the estimated amount of FTC by $1000 (effect estimate: -0.001; 95% CI -0.006 to 0.004). The unconditional tax credit for families had no discernible short-term impact on SRH in adults in New Zealand. It did not more effectively improve health status than an employment-conditional tax credit for families. Copyright © 2014 Elsevier Ltd. All rights reserved.

Perceived Barriers and Facilitators of Farm-to-Consumer Retail Outlet Use Among Participants of the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) in Alabama

PubMed Central

Singleton, Chelsea R.; Baskin, Monica; Levitan, Emily B.; Sen, Bisakha; Affuso, Ermanno; Affuso, Olivia

2018-01-01

This research aimed to identify perceived barriers and facilitators of farm-to-consumer (FTC) retail outlet (eg, farmers’ markets, farm/roadside stands) usage among Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) participants residing in Birmingham, Alabama. Additionally, associations between barriers and facilitators reported and daily fruit and vegetable (F&V) intake were examined. A sample of 312 lower income women (mean age = 27.6; 67.0% non-Hispanic black; 45.3% obese) who participate in the Birmingham WIC program were surveyed between October 2014 and January 2015. Fischer’s exact test was used to assess associations between barriers (eg, outlet location, price, transportation), facilitators (eg, produce quality, produce variety), and high F&V intake (ie, consuming ≥ 5 servings per day). Approximately 81 (26.1%) participants reported using an FTC outlet to purchase produce in 2014. Lack of awareness (39.3%), outlet location (32.8%), and lack of interest (28.4%) were the barriers most often reported. Produce quality (69.1%), produce variety (49.4%), and price (39.5%) were the facilitators most often reported. Barriers and facilitators mentioned were not associated with high F&V intake. Lack of awareness and lack of interest are key barriers to FTC outlet usage among Birmingham WIC recipients. Interventions aiming to promote use of FTC outlets should consider the perceived barriers and facilitators to usage. PMID:29430270

Dolutegravir plus abacavir-lamivudine for the treatment of HIV-1 infection.

PubMed

Walmsley, Sharon L; Antela, Antonio; Clumeck, Nathan; Duiculescu, Dan; Eberhard, Andrea; Gutiérrez, Felix; Hocqueloux, Laurent; Maggiolo, Franco; Sandkovsky, Uriel; Granier, Catherine; Pappa, Keith; Wynne, Brian; Min, Sherene; Nichols, Garrett

2013-11-07

Dolutegravir (S/GSK1349572), a once-daily, unboosted integrase inhibitor, was recently approved in the United States for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in combination with other antiretroviral agents. Dolutegravir, in combination with abacavir-lamivudine, may provide a simplified regimen. We conducted a randomized, double-blind, phase 3 study involving adult participants who had not received previous therapy for HIV-1 infection and who had an HIV-1 RNA level of 1000 copies per milliliter or more. Participants were randomly assigned to dolutegravir at a dose of 50 mg plus abacavir-lamivudine once daily (DTG-ABC-3TC group) or combination therapy with efavirenz-tenofovir disoproxil fumarate (DF)-emtricitabine once daily (EFV-TDF-FTC group). The primary end point was the proportion of participants with an HIV-1 RNA level of less than 50 copies per milliliter at week 48. Secondary end points included the time to viral suppression, the change from baseline in CD4+ T-cell count, safety, and viral resistance. A total of 833 participants received at least one dose of study drug. At week 48, the proportion of participants with an HIV-1 RNA level of less than 50 copies per milliliter was significantly higher in the DTG-ABC-3TC group than in the EFV-TDF-FTC group (88% vs. 81%, P=0.003), thus meeting the criterion for superiority. The DTG-ABC-3TC group had a shorter median time to viral suppression than did the EFV-TDF-FTC group (28 vs. 84 days, P<0.001), as well as greater increases in CD4+ T-cell count (267 vs. 208 per cubic millimeter, P<0.001). The proportion of participants who discontinued therapy owing to adverse events was lower in the DTG-ABC-3TC group than in the EFV-TDF-FTC group (2% vs. 10%); rash and neuropsychiatric events (including abnormal dreams, anxiety, dizziness, and somnolence) were significantly more common in the EFV-TDF-FTC group, whereas insomnia was reported more frequently in the DTG-ABC-3TC group. No participants in the DTG-ABC-3TC group had detectable antiviral resistance; one tenofovir DF-associated mutation and four efavirenz-associated mutations were detected in participants with virologic failure in the EFV-TDF-FTC group. Dolutegravir plus abacavir-lamivudine had a better safety profile and was more effective through 48 weeks than the regimen with efavirenz-tenofovir DF-emtricitabine. (Funded by ViiV Healthcare; SINGLE ClinicalTrials.gov number, NCT01263015 .).

Fault-Tree Compiler

NASA Technical Reports Server (NTRS)

Butler, Ricky W.; Boerschlein, David P.

1993-01-01

Fault-Tree Compiler (FTC) program, is software tool used to calculate probability of top event in fault tree. Gates of five different types allowed in fault tree: AND, OR, EXCLUSIVE OR, INVERT, and M OF N. High-level input language easy to understand and use. In addition, program supports hierarchical fault-tree definition feature, which simplifies tree-description process and reduces execution time. Set of programs created forming basis for reliability-analysis workstation: SURE, ASSIST, PAWS/STEM, and FTC fault-tree tool (LAR-14586). Written in PASCAL, ANSI-compliant C language, and FORTRAN 77. Other versions available upon request.

76 FR 10009 - Privacy Act of 1974; System of Records

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-23

... received which result in a contrary determination. ADDRESSES: You may submit comments, identified by docket... Joint Manpower Automation System Files, (February 22, 1993, 58 FR 10557). Reason: The Joint Staff... responsible for maintaining data on training completion. Deletion: JS003SMB Manpower, Personnel and Security...

Costs and cost-efficacy analysis of the 2014 GESIDA/Spanish National AIDS Plan recommended guidelines for initial antiretroviral therapy in HIV-infected adults.

PubMed

Blasco, Antonio Javier; Llibre, Josep M; Berenguer, Juan; González-García, Juan; Knobel, Hernando; Lozano, Fernando; Podzamczer, Daniel; Pulido, Federico; Rivero, Antonio; Tuset, Montserrat; Lázaro, Pablo; Gatell, Josep M

2015-03-01

GESIDA and the National AIDS Plan panel of experts suggest preferred (PR) and alternative (AR) regimens of antiretroviral treatment (ART) as initial therapy in HIV-infected patients for 2014. The objective of this study is to evaluate the costs and the efficiency of initiating treatment with these regimens. An economic assessment was made of costs and efficiency (cost/efficacy) based on decision tree analyses. Efficacy was defined as the probability of reporting a viral load <50 copies/mL at week 48, in an intention-to-treat analysis. Cost of initiating treatment with an ART regimen was defined as the costs of ART and its consequences (adverse effects, changes of ART regimen, and drug resistance studies) during the first 48 weeks. The payer perspective (National Health System) was applied by considering only differential direct costs: ART (official prices), management of adverse effects, studies of resistance, and HLA B*5701 testing. The setting is Spain and costs correspond to those of 2014. A sensitivity deterministic analysis was conducted, building three scenarios for each regimen: base case, most favourable and least favourable. In the base case scenario, the cost of initiating treatment ranges from 5133 Euros for ABC/3TC+EFV to 11,949 Euros for TDF/FTC+RAL. The efficacy varies between 0.66 for ABC/3TC+LPV/r and ABC/3TC+ATV/r, and 0.89 for TDF/FTC/EVG/COBI. Efficiency, in terms of cost/efficacy, ranges from 7546 to 13,802 Euros per responder at 48 weeks, for ABC/3TC+EFV and TDF/FTC+RAL respectively. Considering ART official prices, the most efficient regimen was ABC/3TC+EFV (AR), followed by the non-nucleoside containing PR (TDF/FTC/RPV and TDF/FTC/EFV). The sensitivity analysis confirms the robustness of these findings. Copyright © 2014 Elsevier España, S.L.U. y Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica. All rights reserved.

Strength in Amalgamation: Newer Combination Agents for HIV and Implications for Practice.

PubMed

McCoy, Christopher; Badowski, Melissa; Sherman, Elizabeth; Crutchley, Rustin; Smith, Ethan; Chastain, Daniel B

2018-01-01

Antiretroviral (ART) therapy for the treatment of human immunodeficiency virus (HIV) infection has undergone significant changes over the past 30 years. Many single-tablet regimens (STRs), including newer fixed-dose combination (FDC) tablets, are available, offering patients several options for choosing a treatment regimen that works best for them. Given these changes, patients are more likely to adhere to treatment, achieve better clinical outcomes, and experience both fewer side effects and drug-drug interactions. Newer STRs include dolutegravir (DTG)/lamivudine (3TC)/abacavir (ABC) (Triumeq; Viiv Healthcare, Research Triangle Park, NC), rilpivirine (RPV)/emtricitabine (FTC)/tenofovir alafenamide (TAF) (Odefsey; Gilead, Foster City, CA), RPV/FTC/tenofovir disoproxil fumarate (TDF) (Complera; Gilead), elvitegravir (EVG)/cobicistat (COBI)/FTC/TDF (Stribild; Gilead), and EVG/COBI/FTC/TAF (Genvoya; Gilead). Recently approved FDCs, such as atazanavir (ATV)/COBI (Evotaz; Bristol-Myers Squibb, Princeton, NJ), darunavir (DRV)/COBI (Prezcobix; Janssen Products, Titusville NJ), and FTC/TAF (Descovy; Gilead), are also now available. The Department of Health and Human Services treatment guidelines for HIV recommend many of these integrase strand transfer inhibitor (INSTI) STRs as a preferred choice for initiation of treatment in both ART-naive and -experienced patients because they offer comparably faster rates of virologic suppression, reduced rates of resistance development (especially with DTG), and overall better adherence than protease inhibitors or NNRTIs. Numerous phase 3 clinical trials support these recommendations including several switch or simplification clinical trials. Notably, the novel pharmacokinetic booster COBI, with its water soluble properties, has enabled the development and coformulation of a few of these STRs and FDCs. Also, a newer tenofovir salt formulation, TAF, has an advantageous pharmacokinetic profile, contributing to better overall renal and bone tolerability compared with TDF. Further simplification regimens comprising dual ART therapies are currently being explored. This review provides an overview of the clinical efficacy and safety data for these coformulated agents, highlighting the relative impact on comparative adverse events, assessing the potential for experiencing fewer drug-drug interactions, and discussing the clinical implications regarding adherence to treatment. © 2017 Pharmacotherapy Publications, Inc.

Phenotypic and Genotypic Characterization and Treatment of a Cohort with Familial Tumoral Calcinosis/Hyperostosis-Hyperphosphatemia Syndrome

PubMed Central

Ramnitz, Mary Scott; Gourh, Pravitt; Goldbach-Mansky, Raphaela; Wodajo, Felasfa; Ichikawa, Shoji; Econs, Michael J.; White, Kenneth; Molinolo, Alfredo; Chen, Marcus Y.; Heller, Theo; Del Rivero, Jaydira; Seo-Mayer, Patricia; Arabshahi, Bita; Jackson, Malaka B.; Hatab, Sarah; McCarthy, Edward; Guthrie, Lori C.; Brillante, Beth A.; Gafni, Rachel I.; Collins, Michael T.

2016-01-01

Familial tumoral calcinosis (FTC)/hyperostosis-hyperphosphatemia syndrome (HHS) is a rare disorder caused by mutations in the genes encoding fibroblast growth factor-23 (FGF23), N-acetylgalactosaminyltransferase 3 (GALNT3), or KLOTHO. The result is functional deficiency of, or resistance to, intact FGF23 (iFGF23), causing hyperphosphatemia, increased renal tubular reabsorption of phosphorus (TRP), elevated or inappropriately normal 1,25-dihydroxyvitamin D3 (1,25D), ectopic calcifications and/or diaphyseal hyperostosis. Eight subjects with FTC/HHS were studied and treated. Clinical manifestations varied, even within families, ranging from asymptomatic to large, disabling calcifications. All subjects had hyperphosphatemia, increased TRP, and elevated or inappropriately normal 1,25D. C-terminal FGF23 was markedly elevated while iFGF23 was comparatively low, consistent with increased FGF23 cleavage. Radiographs ranged from diaphyseal hyperostosis to massive calcification. Two subjects with severe calcifications also had overwhelming systemic inflammation and elevated C-reactive protein (CRP). GALNT3 mutations were identified in 7 subjects; no causative mutation was found in the eighth. Biopsies from 4 subjects showed ectopic calcification and chronic inflammation, with areas of heterotopic ossification observed in 1 subject. Treatment with low phosphate diet, phosphate binders, and phosphaturia-inducing therapies was prescribed with variable response. One subject experienced complete resolution of a calcific mass after 13 months of medical treatment. In the 2 subjects with systemic inflammation, interleukin-1 (IL-1) antagonists significantly decreased CRP levels with resolution of calcinosis cutis and peri-lesional inflammation in one subject and improvement of overall well-being in both subjects. This cohort expands the phenotype and genotype of FTC/HHS and demonstrates the range of clinical manifestations despite similar biochemical profiles and genetic mutations. Overwhelming systemic inflammation has not been described previously in FTC/HHS; the response to IL-1 antagonists suggests that anti-inflammatory drugs may be useful adjuvants. In addition, this is the first description of heterotopic ossification reported in FTC/HHS, possibly mediated by the adjacent inflammation. PMID:27164190

Development, validation and clinical application of a method for the simultaneous quantification of lamivudine, emtricitabine and tenofovir in dried blood and dried breast milk spots using LC-MS/MS.

PubMed

Waitt, Catriona; Diliiy Penchala, Sujan; Olagunju, Adeniyi; Amara, Alieu; Else, Laura; Lamorde, Mohammed; Khoo, Saye

2017-08-15

To present the validation and clinical application of a LC-MS/MS method for the quantification of lamivudine (3TC), emtricitabine (FTC) and tenofovir (TFV) in dried blood spots (DBS) and dried breast milk spots (DBMS). DBS and DBMS were prepared from 50 and 30μL of drug-spiked whole blood and human breast milk, respectively. Following extraction with acetonitrile and water, chromatographic separation utilised a Synergi polar column with a gradient mobile phase program consisting of 0.1% formic acid in water and 0.1% formic acid in acetonitrile. Detection and quantification was performed using a TSQ Quantum Ultra triple quadrupole mass spectrometer. The analytical method was used to evaluate NRTI drug levels in HIV-positive nursing mothers-infant pairs. The assay was validated over the concentration range of 16.6-5000ng/mL for 3TC, FTC and TFV in DBS and DBMS except for TFV in DBMS where linearity was established from 4.2-1250ng/mL. Intra and inter-day precision (%CV) ranged from 3.5-8.7 and accuracy was within 15% for all analytes in both matrices. The mean recovery in DBS was >61% and in DBMS >43% for all three analytes. Matrix effect was insignificant. Median AUC 0-8 values in maternal DBS and DBMS, respectively, were 4683 (4165-6057) and 6050 (5217-6417)ngh/mL for 3TC, 3312 (2259-4312) and 4853 (4124-6691)ngh/mL for FTC and 1559 (930-1915) and 56 (45-80)ngh/mL for TFV. 3TC and FTC were quantifiable (>16.6ng/mL) in DBS from 2/6 and 1/6 infants respectively whereas TFV was undetectable in all infants. DBS and DBMS sampling for bioanalysis of 3TC, FTC and TFV is straightforward, robust, accurate and precise, and ideal for use in low-resource settings. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

Fluoride-containing nanoporous calcium-silicate MTA cements for endodontics and oral surgery: early fluorapatite formation in a phosphate-containing solution.

PubMed

Gandolfi, M G; Taddei, P; Siboni, F; Modena, E; Ginebra, M P; Prati, C

2011-10-01

To test the chemical-physical properties and apatite-forming ability of experimental fluoride-doped calcium silicate cements designed to create novel bioactive materials for use in endodontics and oral surgery. A thermally treated calcium silicate cement (wTC) containing CaCl(2) 5%wt was modified by adding NaF 1%wt (FTC) or 10%wt (F10TC). Cements were analysed by environmental scanning electron microscopy with energy-dispersive X-ray analysis, IR and micro-Raman spectroscopy in wet conditions immediately after preparation or after ageing in a phosphate-containing solution (Dulbecco's phosphate-buffered saline). Calcium and fluoride release and pH of the storage solution were measured. The results obtained were analysed statistically (Tukey's HSD test and two-way anova). The formation of calcium phosphate precipitates (spherulites) was observed on the surface of 24 h-aged cements and the formation of a thick bone-like B-type carbonated apatite layer (biocoating) on 28 day-aged cements. The rate of apatite formation was FTC>F10TC>wTC. Fluorapatite was detected on FTC and F10TC after 1 day of ageing, with a higher fluoride content on F10TC. All the cements released calcium ions. At 5 and 24 h, the wTC had the significantly highest calcium release (P<0.001) that decreased significantly over the storage time. At 3-28 days, FTC and F10TC had significantly higher calcium release than wTC (P<0.05). The F10TC had the significantly highest fluoride release at all times (P<0.01) that decreased significantly over storage time. No significant differences were observed between FTC and wTC. All the cements had a strong alkalinizing activity (OH(-) release) that remained after 28 days of storage. The addition of sodium fluoride accelerated apatite formation on calcium silicate cements. Fluoride-doped calcium silicate cements had higher bioactivity and earlier formation of fluorapatite. Sodium fluoride may be introduced in the formulation of mineral trioxide aggregate cements to enhance their biological behaviour. F-doped calcium silicate cements are promising bone cements for clinical endodontic use. © 2011 International Endodontic Journal.

Bone Mineral Density and Vitamin D Levels in HIV Treatment-Naïve African American Individuals Randomized to Receive HIV Drug Regimens.

PubMed

Cook, Paul P; Stang, Alexandra Te; Walker, Lia R; Akula, Shaw M; Cook, Fiona J

2016-11-01

Treatment of human immunodeficiency virus (HIV)-infected patients with tenofovir disoproxil fumarate is associated with a decrease in bone mineral density (BMD). Treatment with efavirenz is associated with vitamin D deficiency. We compared the effects of efavirenz, emtricitabine, and tenofovir disoproxil fumarate (EFV/FTC/TDF) with the effects of raltegravir, darunavir, and ritonavir (RAL/DRV/r) on BMD and 25-hydroxyvitamin D (25[OH]D) levels in HIV-infected, antiretroviral treatment-naïve African American subjects. This was a pilot study at a single HIV clinic. Forty HIV treatment-naïve African American subjects were screened, 35 of whom were randomized to receive either EFV/FTC/TDF or RAL/DRV/r. All of the subjects received supplemental vitamin D 3 and calcium. CD4 counts, HIV RNA, parathyroid hormone, osteocalcin, N-telopeptide, and 25(OH)D levels were obtained at baseline and at 8, 24, 36, and 48 weeks. Dual-energy x-ray absorptiometry of the spine and hip was performed at baseline and at week 48. Of the 35 subjects enrolled, 10 patients receiving each regimen completed the study. Median baseline 25(OH)D levels were decreased and similar in both groups. All of the patients had plasma HIV RNA <50 copies per milliliter by week 24. By week 48, there was a sustained increase in 25(OH)D in the RAL/DRV/r group ( P = 0.0004) but not in the EFV/FTC/TDF group ( P = 0.78). There were reductions in BMD of the mean total hip ( P = 0.002) and the mean femoral neck ( P = 0.004) in the EFV/FTC/TDF group but not in the RAL/DRV/r group. Treatment of African American patients with HIV using EFV/FTC/TDF is associated with a reduction in BMD of the hip and sustained reductions of 25(OH)D not seen in the group that received RAL/DRV/r. This phenomenon may have long-term consequences on bone integrity in this population.

75 FR 29750 - Combined Notice of Filings #1

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-27

.... submits joint application for approval under section 203 of the Federal Power Act. Filed Date: 05/18/2010.... Eastern Time on Monday, June 7, 2010. Docket Numbers: ER09-1397-002. Applicants: Southwest Power Pool, Inc. Description: Southwest Power Pool, Inc submits clean copy of the Revised Agreements and redlined copies of the...

Low Risk of Proximal Tubular Dysfunction Associated With Emtricitabine-Tenofovir Disoproxil Fumarate Preexposure Prophylaxis in Men and Women

PubMed Central

Mugwanya, Kenneth; Baeten, Jared; Celum, Connie; Donnell, Deborah; Nickolas, Thomas; Mugo, Nelly; Branch, Andrea; Tappero, Jordan; Kiarie, James; Ronald, Allan; Yin, Michael; Wyatt, Christina

2016-01-01

Objective. Tenofovir disoproxil fumarate (TDF) is associated with proximal tubular dysfunction (tubulopathy) when used in the treatment of human immunodeficiency virus (HIV) infection. We evaluated whether TDF causes tubulopathy when used as HIV preexposure prophylaxis (PrEP) and whether tubulopathy predicts clinically relevant decline (≥25%) in the estimated glomerular filtration rate (eGFR). Methods. A subgroup analysis of the Partners PrEP Study, a randomized, placebo-controlled trial of daily oral TDF, alone or with emtricitabine (FTC), in HIV-uninfected African men and women (Clinicaltrials.gov NCT00557245). Tubulopathy was assessed in concurrently obtained urine and serum samples at the 24-month or last on-treatment visit, predefined as ≥2 of the following: tubular proteinuria, euglycemic glycosuria, increased urinary phosphate, and uric acid excretion. Results. Of 1549 persons studied (776 receiving FTC-TDF, 773 receiving placebo), 64% were male, and the median age was 37 years. Over a median 24 months of study-drug exposure, the frequency of tubulopathy was 1.7% for FTC-TDF versus 1.3% for placebo (odds ratio, 1.30; 95% confidence interval, .52–3.33; P = .68); Tubulopathy occurred in 2 of 52 persons (3.8%) with versus 3 of 208 (1.4%) without ≥25% eGFR decline (adjusted odds ratio, 1.39; .10–14.0; P > .99). Conclusions. Daily oral FTC-TDF PrEP was not significantly associated with tubulopathy over the course of 24 months, nor did tubulopathy predict clinically relevant eGFR decline. PMID:27029778

Effectiveness and safety of generic fixed-dose combination of tenofovir/emtricitabine/efavirenz in HIV-1-infected patients in Western India.

PubMed

Pujari, Sanjay; Dravid, Ameet; Gupte, Nikhil; Joshi, Kedar; Bele, Vivek

2008-01-01

To assess effectiveness and safety of a generic fixed-dose combination of tenofovir (TDF)/emtricitabine (FTC)/efavirenz (EFV) among HIV-1-infected patients in Western India. Antiretroviral (ARV)-naive and experienced (thymidine analog nucleoside reverse transcriptase inhibitor [tNRTI] replaced by TDF) patients were started on a regimen of 1 TDF/FTC/EFV pill once a day. They were followed clinically on a periodic basis, and viral loads and CD4 counts were measured at 6 and 12 months. Creatinine clearance was calculated at baseline and at 6 months and/or as clinically indicated. Effectiveness was defined as not having to discontinue the regimen due to failure or toxicity. One hundred forty-one patients who started TDF/FTC/EFV before 1 June 2007 were eligible. Of these, 130 (92.2%) and 44 (31.2%) had 6- and 12-months follow-up, respectively. Thirty-five percent of the patients were ARV-naive. Eleven patients discontinued treatment (4 for virologic failure, 1 for grade 3-4 central nervous system disturbances, 4 for grade 3-4 renal toxicity, and 2 for cost). Ninety-six percent of patients were virologically suppressed at 6 months. Frequency of TDF-associated grade 3-4 renal toxicity was 2.8%; however, 3 of these patients had comorbid conditions associated with renal dysfunction. A fixed-dose combination of generic TDF/FTC/EFV is effective in ARV-naive and experienced patients. Although frequency of severe renal toxicity was higher than has been reported in the literature, it was safe in patients with no comorbid renal conditions.

Effectiveness and Safety of Generic Fixed-Dose Combination of Tenofovir/Emtricitabine/Efavirenz in HIV-1-Infected Patients in Western India.

PubMed

Pujari, Sanjay; Dravid, Ameet; Gupte, Nikhil; Joshix, Kedar; Bele, Vivek

2008-08-20

To assess effectiveness and safety of a generic fixed-dose combination of tenofovir (TDF)/emtricitabine (FTC)/efavirenz (EFV) among HIV-1-infected patients in Western India. Antiretroviral (ARV)-naive and experienced (thymidine analog nucleoside reverse transcriptase inhibitor [tNRTI] replaced by TDF) patients were started on a regimen of 1 TDF/FTC/EFV pill once a day. They were followed clinically on a periodic basis, and viral loads and CD4 counts were measured at 6 and 12 months. Creatinine clearance was calculated at baseline and at 6 months and/or as clinically indicated. Effectiveness was defined as not having to discontinue the regimen due to failure or toxicity. One hundred forty-one patients who started TDF/FTC/EFV before 1 June 2007 were eligible. Of these, 130 (92.2%) and 44 (31.2%) had 6- and 12-months follow-up, respectively. Thirty-five percent of the patients were ARV-naive. Eleven patients discontinued treatment (4 for virologic failure, 1 for grade 3-4 central nervous system disturbances, 4 for grade 3-4 renal toxicity, and 2 for cost). Ninety-six percent of patients were virologically suppressed at 6 months. Frequency of TDF-associated grade 3-4 renal toxicity was 2.8%; however, 3 of these patients had comorbid conditions associated with renal dysfunction. A fixed-dose combination of generic TDF/FTC/EFV is effective in ARV-naive and experienced patients. Although frequency of severe renal toxicity was higher than has been reported in the literature, it was safe in patients with no comorbid renal conditions.

Efferent control of temporal response properties of the Limulus lateral eye

PubMed Central

1990-01-01

The sensitivity of the Limulus lateral eye exhibits a pronounced circadian rhythm. At night a circadian oscillator in the brain activates efferent fibers in the optic nerve, inducing multiple changes in the physiological and anatomical characteristics of retinal cells. These changes increase the sensitivity of the retina by about five orders of magnitude. We investigated whether this increase in retinal sensitivity is accompanied by changes in the ability of the retina to process temporal information. We measured the frequency transfer characteristic (FTC) of single receptors (ommatidia) by recording the response of their optic nerve fibers to sinusoidally modulated light. We first measured the FTC in the less sensitive daytime state and then after converting the retina to the more sensitive nighttime state by electrical stimulation of the efferent fibers. The activation of these fibers shifted the peak of the FTC to lower frequencies and reduced the slope of the low-frequency limb. These changes reduce the eye's ability to detect rapid changes in light intensity but enhance its ability to detect dim flashes of light. Apparently Limulus sacrifices temporal resolution for increased visual sensitivity at night. PMID:2307958

A novel Met-to-Thr mutation in the YMDD motif of reverse transcriptase from feline immunodeficiency virus confers resistance to oxathiolane nucleosides.

PubMed Central

Smith, R A; Remington, K M; Lloyd, R M; Schinazi, R F; North, T W

1997-01-01

Variants of feline immunodeficiency virus (FIV) that possess a unique methionine-to-threonine mutation within the YMDD motif of reverse transcriptase (RT) were selected by culturing virus in the presence of inhibitory concentrations of (-)-beta-L-2',3'-dideoxy-5-fluoro-3'-thiacytidine [(-)-FTC]. The mutants were resistant to (-)-FTC and (-)-beta-L-2',3'-dideoxy-3'-thiacytidine (3TC) and additionally exhibited low-level resistance to 2',3'-dideoxycytidine (ddC). DNA sequence analysis of the RT-encoding region of the pol gene amplified from resistant viruses consistently identified a Met-to-Thr mutation in the YMDD motif. Purified RT from the mutants was also resistant to the 5'-triphosphate forms of 3TC, (-)-FTC, and ddC. Site-directed mutants of FIV were engineered which contain either the novel Met-to-Thr mutation or the Met-to-Val mutation seen in oxathiolane nucleoside-resistant HIV-1. Both site-directed mutants displayed resistance to 3TC, thus confirming the role of these mutations in the resistance of FIV to beta-L-3'-thianucleosides. PMID:9032372

Working Together for Student Achievement. 6th Biennial Joint Report

ERIC Educational Resources Information Center

Washington State Board of Education, 2016

2016-01-01

The Washington State Board of Education (SBE) and the Professional Educator Standards Board (PESB) submitted this 6th biennial joint report to the Governor, Legislative Education Committees, and Superintendent of Public Instruction. The report outlines the collaborative work of the Boards, highlights accomplishments, and provides goals and…

20 CFR 416.1208 - How funds held in financial institution accounts are counted.

Code of Federal Regulations, 2010 CFR

2010-04-01

... accounts are counted. 416.1208 Section 416.1208 Employees' Benefits SOCIAL SECURITY ADMINISTRATION... joint account, why there is a joint account, who has made deposits to and withdrawals from the account, and how withdrawals have been spent; (ii) Submit account records showing deposits, withdrawals, and...

A Model for a Single Unmanned Aircraft Systems (UAS) Program Office Managing Joint ISR Capabilities

DTIC Science & Technology

2017-10-01

reduction in manning from the multiple program office structure to the new single program management model. Additional information regarding this...OFFICE MANAGING JOINT ISR CAPABILITIES by Angela E. Burris A Research Report Submitted to the Faculty In Partial Fulfillment of...research paper is to answer how a single management office could provide greater agility for unmanned aircraft systems (UAS); supporting Joint concepts

Whatever Happened to Joint Vision 2010

DTIC Science & Technology

2010-04-02

submitted to the Faculty of the Joint Advanced Warfighting School in partial satisfaction of the requirements of a Master of Science Degree in Joint...Service efforts and evolve “jointness” beyond the dictates of the 1986 Goldwater-Nichols Act. JV2010 delineated a common set of environmental ...towards something that is fresh, new and important. In this sense, the term vision may have been the wrong term. Warren Bennis and Burt Nanus, noted

Evidence of Stage Shift in Women Diagnosed With Ovarian Cancer During Phase II of the United Kingdom Familial Ovarian Cancer Screening Study.

PubMed

Rosenthal, Adam N; Fraser, Lindsay S M; Philpott, Susan; Manchanda, Ranjit; Burnell, Matthew; Badman, Philip; Hadwin, Richard; Rizzuto, Ivana; Benjamin, Elizabeth; Singh, Naveena; Evans, D Gareth; Eccles, Diana M; Ryan, Andy; Liston, Robert; Dawnay, Anne; Ford, Jeremy; Gunu, Richard; Mackay, James; Skates, Steven J; Menon, Usha; Jacobs, Ian J

2017-05-01

Purpose To establish the performance of screening with serum cancer antigen 125 (CA-125), interpreted using the risk of ovarian cancer algorithm (ROCA), and transvaginal sonography (TVS) for women at high risk of ovarian cancer (OC) or fallopian tube cancer (FTC). Patients and Methods Women whose estimated lifetime risk of OC/FTC was ≥ 10% were recruited at 42 centers in the United Kingdom and underwent ROCA screening every 4 months. TVS occurred annually if ROCA results were normal or within 2 months of an abnormal ROCA result. Risk-reducing salpingo-oophorectomy (RRSO) was encouraged throughout the study. Participants were observed via cancer registries, questionnaires, and notification by centers. Performance was calculated after censoring 365 days after prior screen, with modeling of occult cancers detected at RRSO. Results Between June 14, 2007, and May 15, 2012, 4,348 women underwent 13,728 women-years of screening. The median follow-up time was 4.8 years. Nineteen patients were diagnosed with invasive OC/FTC within 1 year of prior screening (13 diagnoses were screen-detected and six were occult at RRSO). No symptomatic interval cancers occurred. Ten (52.6%) of the total 19 diagnoses were stage I to II OC/FTC (CI, 28.9% to 75.6%). Of the 13 screen-detected cancers, five (38.5%) were stage I to II (CI, 13.9% to 68.4%). Of the six occult cancers, five (83.3%) were stage I to II (CI, 35.9% to 99.6%). Modeled sensitivity, positive predictive value, and negative predictive value for OC/FTC detection within 1 year were 94.7% (CI, 74.0% to 99.9%), 10.8% (6.5% to 16.5%), and 100% (CI, 100% to 100%), respectively. Seven (36.8%) of the 19 cancers diagnosed < 1 year after prior screen were stage IIIb to IV (CI, 16.3% to 61.6%) compared with 17 (94.4%) of 18 cancers diagnosed > 1 year after screening ended (CI, 72.7% to 99.9%; P < .001). Eighteen (94.8%) of 19 cancers diagnosed < 1 year after prior screen had zero residual disease (with lower surgical complexity, P = .16) (CI, 74.0% to 99.9%) compared with 13 (72.2%) of 18 cancers subsequently diagnosed (CI, 46.5% to 90.3%; P = .09). Conclusion ROCA-based screening is an option for women at high risk of OC/FTC who defer or decline RRSO, given its high sensitivity and significant stage shift. However, it remains unknown whether this strategy would improve survival in screened high-risk women.

Antiretroviral pre-exposure prophylaxis (PrEP) for preventing HIV in high-risk individuals.

PubMed

Okwundu, Charles I; Uthman, Olalekan A; Okoromah, Christy An

2012-07-11

More than 30 years into the global HIV/AIDS epidemic, infection rates remain alarmingly high, with over 2.7 million people becoming infected every year. There is a need for HIV prevention strategies that are more effective. Oral antiretroviral pre-exposure prophylaxis (PrEP) in high-risk individuals may be a reliable tool in preventing the transmission of HIV. To evaluate the effects of oral antiretroviral chemoprophylaxis in preventing HIV infection in HIV-uninfected high-risk individuals. We revised the search strategy from the previous version of the review and conducted an updated search of MEDLINE, the Cochrane Central Register of Controlled Trials and EMBASE in April 2012. We also searched the WHO International Clinical Trials Registry Platform and ClinicalTrials.gov for ongoing trials. Randomised controlled trials that evaluated the effects of any antiretroviral agent or combination of antiretroviral agents in preventing HIV infection in high-risk individuals Data concerning outcomes, details of the interventions, and other study characteristics were extracted by two independent authors using a standardized data extraction form. Relative risk with a 95% confidence interval (CI) was used as the measure of effect. We identified 12 randomised controlled trials that meet the criteria for the review. Six were ongoing trials, four had been completed and two had been terminated early. Six studies with a total of 9849 participants provided data for this review. The trials evaluated the following: daily oral tenofovir disoproxil fumarate (TDF) plus emtricitabine (FTC) versus placebo; TDF versus placebo and daily TDF-FTC versus intermittent TDF-FTC. One of the trials had three study arms: TDF, TDF-FTC and placebo arm. The studies were carried out amongst different risk groups, including HIV-uninfected men who have sex with men, serodiscordant couples and other high risk men and women.Overall results from the four trials that compared TDF-FTC versus placebo showed a reduction in the risk of acquiring HIV infection (RR 0.51; 95% CI 0.30 to 0.86; 8918 participants). Similarly, the overall results of the studies that compared TDF only versus placebo showed a significant reduction in the risk of acquiring HIV infection (RR 0.38; 95% CI 0.23 to 0.63, 4027 participants). There were no significant differences in the risk of adverse events across all the studies that reported on adverse events. Also, adherence and sexual behaviours were similar in both the intervention and control groups. Finding from this review suggests that pre-exposure prophylaxis with TDF alone or TDF-FTC reduces the risk of acquiring HIV in high-risk individuals including people in serodiscordant relationships, men who have sex with men and other high risk men and women.

Evidence of Stage Shift in Women Diagnosed With Ovarian Cancer During Phase II of the United Kingdom Familial Ovarian Cancer Screening Study

PubMed Central

Rosenthal, Adam N.; Fraser, Lindsay S.M.; Philpott, Susan; Manchanda, Ranjit; Burnell, Matthew; Badman, Philip; Hadwin, Richard; Rizzuto, Ivana; Benjamin, Elizabeth; Singh, Naveena; Evans, D. Gareth; Eccles, Diana M.; Ryan, Andy; Liston, Robert; Dawnay, Anne; Ford, Jeremy; Gunu, Richard; Mackay, James; Skates, Steven J.; Menon, Usha; Jacobs, Ian J.

2017-01-01

Purpose To establish the performance of screening with serum cancer antigen 125 (CA-125), interpreted using the risk of ovarian cancer algorithm (ROCA), and transvaginal sonography (TVS) for women at high risk of ovarian cancer (OC) or fallopian tube cancer (FTC). Patients and Methods Women whose estimated lifetime risk of OC/FTC was ≥ 10% were recruited at 42 centers in the United Kingdom and underwent ROCA screening every 4 months. TVS occurred annually if ROCA results were normal or within 2 months of an abnormal ROCA result. Risk-reducing salpingo-oophorectomy (RRSO) was encouraged throughout the study. Participants were observed via cancer registries, questionnaires, and notification by centers. Performance was calculated after censoring 365 days after prior screen, with modeling of occult cancers detected at RRSO. Results Between June 14, 2007, and May 15, 2012, 4,348 women underwent 13,728 women-years of screening. The median follow-up time was 4.8 years. Nineteen patients were diagnosed with invasive OC/FTC within 1 year of prior screening (13 diagnoses were screen-detected and six were occult at RRSO). No symptomatic interval cancers occurred. Ten (52.6%) of the total 19 diagnoses were stage I to II OC/FTC (CI, 28.9% to 75.6%). Of the 13 screen-detected cancers, five (38.5%) were stage I to II (CI, 13.9% to 68.4%). Of the six occult cancers, five (83.3%) were stage I to II (CI, 35.9% to 99.6%). Modeled sensitivity, positive predictive value, and negative predictive value for OC/FTC detection within 1 year were 94.7% (CI, 74.0% to 99.9%), 10.8% (6.5% to 16.5%), and 100% (CI, 100% to 100%), respectively. Seven (36.8%) of the 19 cancers diagnosed < 1 year after prior screen were stage IIIb to IV (CI, 16.3% to 61.6%) compared with 17 (94.4%) of 18 cancers diagnosed > 1 year after screening ended (CI, 72.7% to 99.9%; P < .001). Eighteen (94.8%) of 19 cancers diagnosed < 1 year after prior screen had zero residual disease (with lower surgical complexity, P = .16) (CI, 74.0% to 99.9%) compared with 13 (72.2%) of 18 cancers subsequently diagnosed (CI, 46.5% to 90.3%; P = .09). Conclusion ROCA-based screening is an option for women at high risk of OC/FTC who defer or decline RRSO, given its high sensitivity and significant stage shift. However, it remains unknown whether this strategy would improve survival in screened high-risk women. PMID:28240969

77 FR 75259 - Joint Report: Differences in Accounting and Capital Standards Among the Federal Banking Agencies...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-19

... consistent with U.S. generally accepted accounting principles. There were no significant differences in...] FEDERAL RESERVE SYSTEM FEDERAL DEPOSIT INSURANCE CORPORATION Joint Report: Differences in Accounting and... submit an annual report to the Committee on Financial Services of the U.S. House of Representatives and...

47 CFR 53.213 - Audit analysis and evaluation.

Code of Federal Regulations, 2010 CFR

2010-10-01

... auditor shall submit a draft of the audit report to the Federal/State joint audit team. (1) The Federal... auditor. Exceptions of the Federal/State joint audit team to the finding and conclusions of the independent auditor that remain unresolved shall be included in the final audit report. (2) Within 15 days...

A resolution providing for members on the part of the Senate of the Joint Committee on Printing and the Joint Committee of Congress on the Library.

THOMAS, 112th Congress

Sen. Schumer, Charles E. [D-NY

2011-03-16

Senate - 03/16/2011 Submitted in the Senate, considered, and agreed to without amendment by Unanimous Consent. (All Actions) Tracker: This bill has the status Agreed to in SenateHere are the steps for Status of Legislation:

A resolution providing for members on the part of the Senate of the Joint Committee on Printing and the Joint Committee of Congress on the Library.

THOMAS, 113th Congress

Sen. Schumer, Charles E. [D-NY

2013-03-21

Senate - 03/21/2013 Submitted in the Senate, considered, and agreed to without amendment by Unanimous Consent. (All Actions) Tracker: This bill has the status Agreed to in SenateHere are the steps for Status of Legislation:

A resolution providing for members on the part of the Senate of the Joint Committee on Printing and the Joint Committee of Congress on the Library.

THOMAS, 111th Congress

Sen. Schumer, Charles E. [D-NY

2009-04-03

Senate - 04/03/2009 Submitted in the Senate, considered, and agreed to without amendment by Unanimous Consent. (All Actions) Tracker: This bill has the status Agreed to in SenateHere are the steps for Status of Legislation:

47 CFR 53.213 - Audit analysis and evaluation.

Code of Federal Regulations, 2011 CFR

2011-10-01

... auditor shall submit a draft of the audit report to the Federal/State joint audit team. (1) The Federal... auditor. Exceptions of the Federal/State joint audit team to the finding and conclusions of the independent auditor that remain unresolved shall be included in the final audit report. (2) Within 15 days...

Fatigue performance of joints executed in pure titanium structures with several diameters.

PubMed

Nuñez-Pantoja, Juliana Maria Costa; Vaz, Luis Geraldo; Nóbilo, Mauro Antônio de Arruda; Mesquita, Marcelo Ferraz

2011-01-01

This study evaluated fatigue strength of CP-Ti laser-welded joints. Sixty (20/diameter) CP-Ti casted dumbbell rods with diameters of 1.5, 2.0, and 3.5 mm were sectioned and welded using two joint openings (0.0 (00) and 0.6 mm (06)). Six groups were formed, amounting to a total of 9 (n=10) with inclusion of intact groups. Welding was executed using 360 V/8 ms (1.5 and 2.0 mm) and 380 V/9 ms (3.5 mm). Joints were finished, polished, and submitted to radiographic examination to visually analyze presence of porosity (PP). Specimens were submitted to cyclic tests, and the number of cycles until failure (NC) was recorded. Fractured surfaces were examined by SEM. Kruskal-Wallis and Dunn (α=0.05) tests demonstrated that NC was lower for all diameters with 06, and for 3.5 mm/00. NC and PP were found to have a negative correlation (Spearman Coefficient). For CP-Ti frameworks with thin diameters, laser welding is better when structures are juxtaposed.

Pharmacokinetic and Safety Analyses of Tenofovir and Tenofovir-Emtricitabine Vaginal Tablets in Pigtailed Macaques

PubMed Central

Pereira, Lara E.; Friend, David R.; Garber, David A.; McNicholl, Janet M.; Hendry, R. Michael; Doncel, Gustavo F.

2014-01-01

Vaginal rapidly disintegrating tablets (RDTs) containing tenofovir (TFV) or TFV and emtricitabine (FTC) were evaluated for safety and pharmacokinetics in pigtailed macaques. Two separate animal groups (n = 4) received TFV (10 mg) or TFV-FTC (10 mg each) RDTs, administered near the cervix. A third group (n = 4) received 1 ml TFV gel. Blood plasma, vaginal tissue biopsy specimens, and vaginal fluids were collected before and after product application at 0, 0.5, 1, 4, and 24 h. A disintegration time of <30 min following vaginal application of the RDTs was noted, with negligible effects on local inflammatory cytokines, vaginal pH, and microflora. TFV pharmacokinetics were generally similar for both RDTs and gel, with peak median concentrations in vaginal tissues and vaginal secretions being on the order of 104 to 105 ng/g (147 to 571 μM) and 106 ng/g (12 to 34 mM), respectively, at 1 to 4 h postdose. At 24 h, however, TFV vaginal tissue levels were more sustained after RDT dosing, with median TFV concentrations being approximately 1 log higher than those with gel dosing. FTC pharmacokinetics after combination RDT dosing were similar to those of TFV, with peak median vaginal tissue and fluid levels being on the order of 104 ng/g (374 μM) and 106 ng/g (32 mM), respectively, at 1 h postdose with levels in fluid remaining high at 24 h. RDTs are a promising alternative vaginal dosage form, delivering TFV and/or FTC at levels that would be considered inhibitory to simian-human immunodeficiency virus in the macaque vaginal microenvironment over a 24-h period. PMID:24566178

Agent-based computational model of the prevalence of gonococcal infections after the implementation of HIV pre-exposure prophylaxis guidelines.

PubMed

Escobar, Erik; Durgham, Ryan; Dammann, Olaf; Stopka, Thomas J

2015-01-01

Recently, the first comprehensive guidelines were published for pre-exposure prophylaxis (PrEP) for the prevention of HIV infection in populations with substantial risk of infection. Guidelines include a daily regimen of emtricitabine/tenofovir disoproxil fumarate (TDF/FTC) as well as condom usage during sexual activity. The relationship between the TDF/FTC intake regimen and condom usage is not yet fully understood. If men who have sex with men (MSM,) engage in high-risk sexual activities without using condoms when prescribed TDF/FTC they might be at an increased risk for other sexually transmitted diseases (STD). Our study focuses on the possible occurrence of behavioral changes among MSM in the United States over time with regard to condom usage. In particular, we were interested in creating a model of how increased uptake of TDF/FTC might cause a decline in condom usage, causing significant increases in non-HIV STD incidence, using gonococcal infection incidence as a biological endpoint. We used the agent-based modeling software NetLogo, building upon an existing model of HIV infection. We found no significant evidence for increased gonorrhea prevalence due to increased PrEP usage at any level of sample-wide usage, with a range of 0-90% PrEP usage. However, we did find significant evidence for decreased prevalence of HIV, with a maximal effect being reached when 5% to 10% of the MSM population used PrEP. Our findings appear to indicate that attitudes of aversion, within the medical community, toward the promotion of PrEP due to the potential risk of increased STD transmission are unfounded.

Low Risk of Proximal Tubular Dysfunction Associated With Emtricitabine-Tenofovir Disoproxil Fumarate Preexposure Prophylaxis in Men and Women.

PubMed

Mugwanya, Kenneth; Baeten, Jared; Celum, Connie; Donnell, Deborah; Nickolas, Thomas; Mugo, Nelly; Branch, Andrea; Tappero, Jordan; Kiarie, James; Ronald, Allan; Yin, Michael; Wyatt, Christina

2016-10-01

Tenofovir disoproxil fumarate (TDF) is associated with proximal tubular dysfunction (tubulopathy) when used in the treatment of human immunodeficiency virus (HIV) infection. We evaluated whether TDF causes tubulopathy when used as HIV preexposure prophylaxis (PrEP) and whether tubulopathy predicts clinically relevant decline (≥25%) in the estimated glomerular filtration rate (eGFR). A subgroup analysis of the Partners PrEP Study, a randomized, placebo-controlled trial of daily oral TDF, alone or with emtricitabine (FTC), in HIV-uninfected African men and women (Clinicaltrials.gov NCT00557245). Tubulopathy was assessed in concurrently obtained urine and serum samples at the 24-month or last on-treatment visit, predefined as ≥2 of the following: tubular proteinuria, euglycemic glycosuria, increased urinary phosphate, and uric acid excretion. Of 1549 persons studied (776 receiving FTC-TDF, 773 receiving placebo), 64% were male, and the median age was 37 years. Over a median 24 months of study-drug exposure, the frequency of tubulopathy was 1.7% for FTC-TDF versus 1.3% for placebo (odds ratio, 1.30; 95% confidence interval, .52-3.33; P = .68); Tubulopathy occurred in 2 of 52 persons (3.8%) with versus 3 of 208 (1.4%) without ≥25% eGFR decline (adjusted odds ratio, 1.39; .10-14.0; P > .99). Daily oral FTC-TDF PrEP was not significantly associated with tubulopathy over the course of 24 months, nor did tubulopathy predict clinically relevant eGFR decline. © The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissions@oup.com.

Treatment of Severe Aortic Bleeding Using Hemopatch in Swine on Dual Antiplatelet Therapy.

PubMed

Baumgartner, Bernhard; Draxler, Wolfgang; Lewis, Kevin M

2016-12-01

The perioperative management of patients on antithrombotic therapy is currently an unresolved problem as these therapies pose a considerable risk for perioperative hemorrhagic complications. The presented studies investigated the efficacy of a new collagen technology to achieve hemostasis. A polyethylene glycol-coated collagen pad (PCC) was compared to a marketed fibrinogen-thrombin coated collagen pad (FTC) for the treatment of an aortotomy incision in heparinized swine on dual antiplatelet therapy. Twenty-eight 3-mm aortotomy incisions were created in nine heparinized pigs without antiplatelet therapy and treated with PCC. Sixty-eight aortotomy incisions were created in ten heparinized pigs that received clopidogrel (10-11 mg/kg) and acetylsalicylic acid (8-11 mg/kg) orally for 5 days, and treated with either PCC or FTC (N = 34/group). Dual antiplatelet therapy resulted in significantly reduced platelet function. Aortotomy incisions resulted in life-threatening bleeding of 35-292 ml/min. In animals without antiplatelet treatment, PCC provided 96% immediate hemostatic success. In animals with antiplatelet treatment, FTC provided 18% immediate hemostatic success increasing to 74% after 10 min. Strikingly, PCC provided 94% immediate success increasing to 100% after 10 min. Controlling for differences in pretreatment bleeding rates, statistical model-estimated time to hemostasis was 12 times shorter in PCC-treated lesions (p < .02). The combination of a procoagulant collagen pad with a synthetic sealing component provides excellent hemostatic properties under a worst-case scenario. PCC rapidly and firmly adheres to tissue, thereby controlling severe arterial bleeding, even when platelet function is significantly reduced. Treatment with PCC provided superior time to hemostasis compared to FTC.

Zidovudine/Lamivudine vs. Abacavir/Lamivudine vs. Tenofovir/Emtricitabine in fixed-dose combinations as initial treatment for HIV patients: a systematic review and network meta-analysis

PubMed Central

Duque Molina, Marcela María; García García, Héctor Iván

2017-01-01

Abstract Introduction: Initial treatment of the HIV is based on the use of three drugs, two of which are nucleoside analog reverse-transcriptase inhibitors. There are three combinations of these drugs which have been approved by different guidelines, each with divergent results in terms of efficacy and safety. Objective: To compare the efficacy and safety of these three combinations. Methods: Systematic review and network meta-analysis of randomized clinical trials comparing fixed doses of Tenofovir Disoproxil Fumarate / Emtricitabine (TDF/FTC), Abacavir / Lamivudine (ABC/3TC) and Zidovudine / Lamivudine (ZDV/3TC). Results: Seven clinical trials met the eligibility criteria. The results suggested higher efficacy with TDF/FTC vs. ABC/3TC at 96 weeks and vs. ZDV/3TC at 48 weeks. However, there is clinical and statistical heterogeneity. Subgroup analysis were performed by third drug and by level of viral load prior to treatment, and found no differences in virological control. Network meta-analysis could only be carried out with TDF/FTC vs. ZDV/3TC, and the proportion of patients with virological response, with no differences at 48 weeks nor at 96 weeks. Direct comparisons showed an increased risk of bone marrow suppression of ZDV/3TC vs. TDF/FTC and of ABC/3TC hypersensitivity reactions vs. ZDV/3TC Conclusions: The results did not show differences in effectiveness among the interventions. However, due to the heterogeneity of the third drug and the follow-up time between the included studies, this result is not definitive. The results raise the need for further studies to help improve treatment recommendations in patients infected with HIV. PMID:29021641

Cancer risk and clinicopathological characteristics of thyroid nodules harboring thyroid-stimulating hormone receptor gene mutations.

PubMed

Mon, Sann Y; Riedlinger, Gregory; Abbott, Collette E; Seethala, Raja; Ohori, N Paul; Nikiforova, Marina N; Nikiforov, Yuri E; Hodak, Steven P

2018-05-01

Thyroid-stimulating hormone receptor (TSHR) gene mutations play a critical role in thyroid cell proliferation and function. They are found in 20%-82% of hyperfunctioning nodules, hyperfunctioning follicular thyroid cancers (FTC), and papillary thyroid cancers (PTC). The diagnostic importance of TSHR mutation testing in fine needle aspiration (FNA) specimens remains unstudied. To examine the association of TSHR mutations with the functional status and surgical outcomes of thyroid nodules, we evaluated 703 consecutive thyroid FNA samples with indeterminate cytology for TSHR mutations using next-generation sequencing. Testing for EZH1 mutations was performed in selected cases. The molecular diagnostic testing was done as part of standard of care treatment, and did not require informed consent. TSHR mutations were detected in 31 (4.4%) nodules and were located in exons 281-640, with codon 486 being the most common. Allelic frequency ranged from 3% to 45%. Of 16 cases (12 benign, 3 FTC, 1 PTC) with surgical correlation, 15 had solitary TSHR mutations and 1 PTC had comutation with BRAF V600E. Hyperthyroidism was confirmed in all 3 FTC (2 overt, 1 subclinical). Of 5 nodules with solitary TSHR mutations detected at high allelic frequency, 3 (60%) were FTC. Those at low allelic frequency (3%-22%) were benign. EZH1 mutations were detected in 2 of 4 TSHR-mutant malignant nodules and neither of 2 benign nodules. We report that TSHR mutations occur in ∼5% thyroid nodules in a large consecutive series with indeterminate cytology. TSHR mutations may be associated with an increased cancer risk when present at high allelic frequency, even when the nodule is hyperfunctioning. Benign nodules were however most strongly correlated with TSHR mutations at low allelic frequency. © 2018 Wiley Periodicals, Inc.

Pregnancy and contraceptive use among women participating in the FEM-PrEP trial.

PubMed

Callahan, Rebecca; Nanda, Kavita; Kapiga, Saidi; Malahleha, Mookho; Mandala, Justin; Ogada, Teresa; Van Damme, Lut; Taylor, Douglas

2015-02-01

Pregnancy among study participants remains a challenge for trials of new HIV prevention agents despite promotion and provision of contraception. We evaluated contraceptive use, pregnancy incidence, and study drug adherence by contraceptive method among women enrolled in the FEM-PrEP trial of once-daily oral tenofovir disoproxil fumarate and emtricitabine (TDF-FTC) for HIV prevention. We required women to be using effective non-barrier contraception at enrollment. At each monthly follow-up visit, women were counseled on contraceptive use and tested for pregnancy. TDF-FTC adherence was determined by measuring plasma drug concentrations at 4-week intervals. We used Cox proportional hazards models to assess factors associated with incident pregnancy and multivariate logistic regression to examine the relationship between contraceptive method used at enrollment and TDF-FTC adherence. More than half of women were not using effective contraception before enrollment. Ninety-eight percent of these women adopted either injectable (55%) or oral (43%) contraceptives. The overall pregnancy rate was 9.6 per 100 woman-years. Among injectable users and new users of combined oral contraceptives (COCs), the rates were 1.6 and 35.1, respectively. New users of injectables had significantly greater odds of adhering to TDF-FTC than new COC users [odds ratio (95% confidence interval): 4.4 (1.7 to 11.6), P = 0.002], existing COC users [3.1 (1.3 to 7.3), P = 0.01], and existing injectable users [2.4 (1.1 to 5.6), P = 0.04]. Women using COCs during FEM-PrEP, particularly new adopters, were more likely to become pregnant and less likely to adhere to study product than injectable users. HIV prevention trials should consider requiring long-acting methods, including injectables, for study participation.

Effectiveness and Safety of Generic Fixed-Dose Combination of Tenofovir/Emtricitabine/Efavirenz in HIV-1-Infected Patients in Western India

PubMed Central

2008-01-01

Objective To assess effectiveness and safety of a generic fixed-dose combination of tenofovir (TDF)/emtricitabine (FTC)/efavirenz (EFV) among HIV-1-infected patients in Western India. Methods Antiretroviral (ARV)-naive and experienced (thymidine analog nucleoside reverse transcriptase inhibitor [tNRTI] replaced by TDF) patients were started on a regimen of 1 TDF/FTC/EFV pill once a day. They were followed clinically on a periodic basis, and viral loads and CD4 counts were measured at 6 and 12 months. Creatinine clearance was calculated at baseline and at 6 months and/or as clinically indicated. Effectiveness was defined as not having to discontinue the regimen due to failure or toxicity. Results One hundred forty-one patients who started TDF/FTC/EFV before 1 June 2007 were eligible. Of these, 130 (92.2%) and 44 (31.2%) had 6- and 12-months follow-up, respectively. Thirty-five percent of the patients were ARV-naive. Eleven patients discontinued treatment (4 for virologic failure, 1 for grade 3–4 central nervous system disturbances, 4 for grade 3–4 renal toxicity, and 2 for cost). Ninety-six percent of patients were virologically suppressed at 6 months. Frequency of TDF-associated grade 3–4 renal toxicity was 2.8%; however, 3 of these patients had comorbid conditions associated with renal dysfunction. Conclusion A fixed-dose combination of generic TDF/FTC/EFV is effective in ARV-naive and experienced patients. Although frequency of severe renal toxicity was higher than has been reported in the literature, it was safe in patients with no comorbid renal conditions. PMID:19825144

Effectiveness and Safety of Generic Fixed-Dose Combination of Tenofovir/Emtricitabine/Efavirenz in HIV-1-Infected Patients in Western India

PubMed Central

Pujari, Sanjay; Dravid, Ameet; Gupte, Nikhil; Joshi, Kedar; Bele, Vivek

2008-01-01

Objective To assess effectiveness and safety of a generic fixed-dose combination of tenofovir (TDF)/emtricitabine (FTC)/efavirenz (EFV) among HIV-1-infected patients in Western India. Methods Antiretroviral (ARV)-naive and experienced (thymidine analog nucleoside reverse transcriptase inhibitor [tNRTI] replaced by TDF) patients were started on a regimen of 1 TDF/FTC/EFV pill once a day. They were followed clinically on a periodic basis, and viral loads and CD4 counts were measured at 6 and 12 months. Creatinine clearance was calculated at baseline and at 6 months and/or as clinically indicated. Effectiveness was defined as not having to discontinue the regimen due to failure or toxicity. Results One hundred forty-one patients who started TDF/FTC/EFV before 1 June 2007 were eligible. Of these, 130 (92.2%) and 44 (31.2%) had 6- and 12-months follow-up, respectively. Thirty-five percent of the patients were ARV-naive. Eleven patients discontinued treatment (4 for virologic failure, 1 for grade 3-4 central nervous system disturbances, 4 for grade 3-4 renal toxicity, and 2 for cost). Ninety-six percent of patients were virologically suppressed at 6 months. Frequency of TDF-associated grade 3-4 renal toxicity was 2.8%; however, 3 of these patients had comorbid conditions associated with renal dysfunction. Conclusion A fixed-dose combination of generic TDF/FTC/EFV is effective in ARV-naive and experienced patients. Although frequency of severe renal toxicity was higher than has been reported in the literature, it was safe in patients with no comorbid renal conditions. PMID:18924648

Impact of free tumor clusters on prognosis after resection of pulmonary adenocarcinoma.

PubMed

Morimoto, Junichi; Nakajima, Takahiro; Suzuki, Hidemi; Nagato, Kaoru; Iwata, Takekazu; Yoshida, Shigetoshi; Fukuyo, Masaki; Ota, Satoshi; Nakatani, Yukio; Yoshino, Ichiro

2016-07-01

Pulmonary adenocarcinoma with a micropapillary component (MPC) has aggressive malignant behavior even if resectable. The aim of this study was to determine clinicopathologic features of patients who underwent surgery for pulmonary adenocarcinoma harboring MPCs, with particular focus on coexistent free tumor clusters (FTCs). We retrospectively reviewed 444 patients with pulmonary adenocarcinoma who underwent surgery from March 2007 to July 2013. An MPC was defined as a >5% micropapillary pattern. We also defined FTCs to be a group of more than 3 small clusters containing <20 nonintegrated micropapillary tumor cells that were spreading within air spaces, >3 mm apart from the main tumor. The clinicopathologic characteristics of patients with and without FTCs were retrospectively investigated in MPC-positive patients. MPCs were identified in 67 patients (15.1%), 31 of whom (46.3%) were positive for FTCs. The distance between the furthest edge of FTCs and main tumors did not exceed the diameter of the main tumor in each case (average, 7.3 mm). Locoregional recurrences were frequently observed in FTC-positive patients. FTC-positive patients experienced a significantly lower 5-year recurrence-free survival rate compared with FTC-negative/MPC-positive patients (20.4% vs 52.2%, P < .001). Recurrence-free survival of FTC-negative and -positive patients was equivalent to that of patients with p-T2 and p-T3 MPC-negative adenocarcinoma, respectively. Coexistence of FTCs resulted in a further negative impact on postoperative prognosis among MPC-positive adenocarcinomas and should be considered for upstaging the p-T factor and during evaluation of surgical margins. Copyright © 2016. Published by Elsevier Inc.

Dance training intensity at 11-14 years is associated with femoral torsion in classical ballet dancers.

PubMed

Hamilton, D; Aronsen, P; Løken, J H; Berg, I M; Skotheim, R; Hopper, D; Clarke, A; Briffa, N K

2006-04-01

To examine in a cross sectional study the influence of femoral torsion (FT) and passive hip external rotation (PER) on turnout (TO). Starting age, years of classical ballet training, and current and past dance training intensity were assessed to determine their influence on FT, PER, and TO in pre-professional female dancers. Sixty four dancers (mean (SD) age 18.16 (1.80) years) were recruited from four different dance training programmes. They completed a dance history questionnaire. FT was measured using a clinical method. PER was measured with the subjects prone, and TO was measured with the subjects standing. Mean TO was 136 degrees, mean unilateral PER was 49.4 degrees, and mean FT was 18.4 degrees. A positive correlation was observed between PER combined (PERC) and TO (r = 0.443, p < 0.001). A negative association was found between FT combined (FTC) and PERC (r = -0.402, p = 0.001). No association was found between starting age or years of classical ballet training and FTC, PERC, or TO. Dancers who trained for six hours a week or more during the 11-14 year age range had less FT than those who trained less (mean difference 6 degrees, 95% confidence interval 1.4 to 10.3). Students currently training for longer had higher levels of TO (p < 0.001) but comparable PERC and FTC. FT is significantly associated with PERC. Dancers who trained for six hours a week or more at 11-14 years of age had significantly less FT. FTC had a significant influence on PERC, but no influence on the execution of TO.

Abacavir/Lamivudine Versus Tenofovir DF/Emtricitabine as Part of Combination Regimens for Initial Treatment of HIV: Final Results

PubMed Central

Tierney, Camlin; Collier, Ann C.; Daar, Eric S.; Mollan, Katie; Budhathoki, Chakra; Godfrey, Catherine; Jahed, Nasreen C.; Myers, Laurie; Katzenstein, David; Farajallah, Awny; Rooney, James F.; Ha, Belinda; Woodward, William C.; Feinberg, Judith; Tashima, Karen; Murphy, Robert L.; Fischl, Margaret A.

2011-01-01

(See the editorial commentary by Hull and Montaner, on pages 1154–6.) Background. AIDS Clinical Trials Group A5202 compared blinded abacavir/lamivudine (ABC/3TC) to tenofovir DF/emtricitabine (TDF/FTC) with efavirenz (EFV) or atazanavir/ritonavir (ATV/r) in human immunodeficiency virus (HIV)-infected treatment-naive patients, stratified by screening HIV RNA (< or ≥105 copies/mL). Due to higher virologic failure with ABC/3TC in the high HIV RNA stratum, blinded treatment was stopped in this group, but study follow-up continued for all patients. Methods. Primary endpoints were times to virologic failure, regimen modification, and safety event. Results. In the low HIV RNA stratum, time to virologic failure was similar for ABC/3TC vs TDF/FTC with ATV/r (hazard ratio [HR] 1.25, 95% confidence interval [CI] 0.76, 2.05) or EFV (HR 1.23, 95% CI 0.77, 1.96), with significantly shorter times to regimen modification for ABC/3TC with EFV or ATV/r and to safety events with EFV. Prior to stopping blinded treatment in the high stratum, higher virologic failure rates were seen with ABC/3TC with EFV (HR 2.46, 95% CI 1.20, 5.05) or ATV/r (HR 2.22, 95% CI 1.19, 4.14). Conclusions. In the low HIV RNA stratum, times to virologic failure for ABC/3TC or TDF/FTC were not different with EFV or ATV/r. In the high stratum, virologic failure rate was significantly higher for ABC/3TC than for TDF/FTC when given with either EFV or ATV/r. PMID:21917892

Dance training intensity at 11–14 years is associated with femoral torsion in classical ballet dancers

PubMed Central

Hamilton, D; Aronsen, P; Løken, J H; Berg, I M; Skotheim, R; Hopper, D; Clarke, A; Briffa, N K

2006-01-01

Objective To examine in a cross sectional study the influence of femoral torsion (FT) and passive hip external rotation (PER) on turnout (TO). Starting age, years of classical ballet training, and current and past dance training intensity were assessed to determine their influence on FT, PER, and TO in pre‐professional female dancers. Methods Sixty four dancers (mean (SD) age 18.16 (1.80) years) were recruited from four different dance training programmes. They completed a dance history questionnaire. FT was measured using a clinical method. PER was measured with the subjects prone, and TO was measured with the subjects standing. Results Mean TO was 136°, mean unilateral PER was 49.4°, and mean FT was 18.4°. A positive correlation was observed between PER combined (PERC) and TO (r  =  0.443, p<0.001). A negative association was found between FT combined (FTC) and PERC (r  =  −0.402, p  =  0.001). No association was found between starting age or years of classical ballet training and FTC, PERC, or TO. Dancers who trained for six hours a week or more during the 11–14 year age range had less FT than those who trained less (mean difference 6°, 95% confidence interval 1.4 to 10.3). Students currently training for longer had higher levels of TO (p<0.001) but comparable PERC and FTC. Conclusion FT is significantly associated with PERC. Dancers who trained for six hours a week or more at 11–14 years of age had significantly less FT. FTC had a significant influence on PERC, but no influence on the execution of TO. PMID:16556782

Using Marginal Structural Modeling to Estimate the Cumulative Impact of an Unconditional Tax Credit on Self-Rated Health.

PubMed

Pega, Frank; Blakely, Tony; Glymour, M Maria; Carter, Kristie N; Kawachi, Ichiro

2016-02-15

In previous studies, researchers estimated short-term relationships between financial credits and health outcomes using conventional regression analyses, but they did not account for time-varying confounders affected by prior treatment (CAPTs) or the credits' cumulative impacts over time. In this study, we examined the association between total number of years of receiving New Zealand's Family Tax Credit (FTC) and self-rated health (SRH) in 6,900 working-age parents using 7 waves of New Zealand longitudinal data (2002-2009). We conducted conventional linear regression analyses, both unadjusted and adjusted for time-invariant and time-varying confounders measured at baseline, and fitted marginal structural models (MSMs) that more fully adjusted for confounders, including CAPTs. Of all participants, 5.1%-6.8% received the FTC for 1-3 years and 1.8%-3.6% for 4-7 years. In unadjusted and adjusted conventional regression analyses, each additional year of receiving the FTC was associated with 0.033 (95% confidence interval (CI): -0.047, -0.019) and 0.026 (95% CI: -0.041, -0.010) units worse SRH (on a 5-unit scale). In the MSMs, the average causal treatment effect also reflected a small decrease in SRH (unstabilized weights: β = -0.039 unit, 95% CI: -0.058, -0.020; stabilized weights: β = -0.031 unit, 95% CI: -0.050, -0.007). Cumulatively receiving the FTC marginally reduced SRH. Conventional regression analyses and MSMs produced similar estimates, suggesting little bias from CAPTs. © The Author 2016. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Analysis of drug-drug interactions among patients receiving antiretroviral regimens using data from a large open-source prescription database.

PubMed

Patel, Nimish; Borg, Peter; Haubrich, Richard; McNicholl, Ian

2018-06-14

Results of a study of contraindicated concomitant medication use among recipients of preferred antiretroviral therapy (ART) regimens are reported. A retrospective study was conducted to evaluate concomitant medication use in a cohort of previously treatment-naive, human immunodeficiency virus (HIV)-infected U.S. patients prescribed preferred ART regimens during the period April 2014-March 2015. Data were obtained from a proprietary longitudinal prescription database; elements retrieved included age, sex, and prescription data. The outcome of interest was the frequency of drug-drug interactions (DDIs) associated with concomitant use of contraindicated medications. Data on 25,919 unique treatment-naive patients who used a preferred ART regimen were collected. Overall, there were 384 instances in which a contraindicated medication was dispensed for concurrent use with a recommended ART regimen. Rates of contraindicated concomitant medication use differed significantly by ART regimen; the highest rate (3.2%) was for darunavir plus ritonavir plus emtricitabine-tenofovir disoproxil fumarate (DRV plus RTV plus FTC/TDF), followed by elvitegravir-cobicistat-emtricitabine-tenofovir disoproxil fumarate (EVG/c/FTC/TDF)(2.8%). The highest frequencies of DDIs were associated with ART regimens that included a pharmacoenhancing agent: DRV plus RTV plus FTC/TDF (3.2%) and EVG/c/FTC/TDF (2.8%). In a large population of treatment-naive HIV-infected patients, ART regimens that contained a pharmacoenhancing agent were involved most frequently in contraindicated medication-related DDIs. All of the DDIs could have been avoided by using therapeutic alternatives within the same class not associated with a DDI. Copyright © 2018 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

History of the Joint Chiefs of Staff: The Joint Chiefs of Staff and the War in Vietnam, 1971-1973

DTIC Science & Technology

2007-01-01

34Let’s take a crack at it." The President then approved the Chup opera- tion but called for further study of Tchepone. 7 On 4 January 1971, Admiral...of the Department of Defense.", Kissinger’s tasking included several studies on political and economic matters in Vietnam and Southeast Asia...answer these questions.1 The study was prepared by the Joint Staff and submitted to the Senior Review Group for a meeting on 24 May 1971. The Joint

78 FR 6849 - Agency Information Collection (eBenefits Portal) Activity under OMB Review

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-31

... for a single sign-on credential that will ultimately be shared by other VA and DoD portals. The e...: Comments must be submitted on or before March 4, 2013. ADDRESSES: Submit written comments on the collection..., a joint project between the VA and DoD, is intended to serve as a single point of entry for benefits...

Regional Security in the Gulf of Guinea; A Vital Interest of the United States

DTIC Science & Technology

2010-03-18

Davis Highway, Suite 1204, Arlington VA 22202-4302. Respondents should be aware that notwithstanding any other provision of law , no person shall be...A paper submitted to the Faculty of the Joint Advanced Warfighting School in partial satisfaction of the requirements of a Master of Science...Degree in Joint Campaign Planning and Strategy. The contents of this paper reflect my personal views and are not necessarily endorsed by the Joint

Managing Non-Standard Force Demands: Risk Implications of the Global Force Management System

DTIC Science & Technology

2012-04-26

GLOBAL FORCE MANAGEMENT SYSTEM by James C. Wright GS-14, Department of Defense A paper submitted to the Faculty of the Joint Advanced Warfighting...School in partial satisfaction of the requirements of a Master of Science Degree in Joint Campaign Planning and Strategy. The contents of this paper ...reflect my own personal views and are not necessarily endorsed by the Joint Forces Staff College or the Department of Defense. This paper is entirely

Compartmental modelling of the pharmacokinetics of a breast cancer resistance protein.

PubMed

Grandjean, Thomas R B; Chappell, Mike J; Yates, James T W; Jones, Kevin; Wood, Gemma; Coleman, Tanya

2011-11-01

A mathematical model for the pharmacokinetics of Hoechst 33342 following administration into a culture medium containing a population of transfected cells (HEK293 hBCRP) with a potent breast cancer resistance protein inhibitor, Fumitremorgin C (FTC), present is described. FTC is reported to almost completely annul resistance mediated by BCRP in vitro. This non-linear compartmental model has seven macroscopic sub-units, with 14 rate parameters. It describes the relationship between the concentration of Hoechst 33342 and FTC, initially spiked in the medium, and the observed change in fluorescence due to Hoechst 33342 binding to DNA. Structural identifiability analysis has been performed using two methods, one based on the similarity transformation/exhaustive modelling approach and the other based on the differential algebra approach. The analyses demonstrated that all models derived are uniquely identifiable for the experiments/observations available. A kinetic modelling software package, namely FACSIMILE (MPCA Software, UK), was used for parameter fitting and to obtain numerical solutions for the system equations. Model fits gave very good agreement with in vitro data provided by AstraZeneca across a variety of experimental scenarios. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

This Article Makes You Smarter! (Or, Regulating Health and Wellness Claims).

PubMed

Duranske, Sarah

2017-03-01

Information has power - to inspire, to transform, and to harm. Recent technological advancements have enabled the creation of products that offer consumers direct access to a level of personal health information unprecedented in history. But how are we to balance the promise of health and wellness information with its risks? Two agencies are tasked with protecting consumers from false claims of health products: the FDA and the FTC. This Article investigates if they are up to the task. In part a study of agency policymaking choices, and in part a prescription for more thoughtful and focused regulation, this Article compares both intra-agency and inter-agency regulation of informational health and wellness products. Certain procedural and substantive characteristics of FDA regulation are unsuited to informational health and wellness products, rendering comprehensive regulation by the FDA unrealistic. This gap creates an opportunity for the FTC to use its distinct and well-tailored enforcement tools to police harmful product claims that escape the FDA's purview. I posit that by tailoring the FDA's responsibility and sustaining the FTC's engagement with health claims, the agencies can dovetail into a cohesive and comprehensive regulatory regime.

Quantitation of Tenofovir and Emtricitabine in Dried Blood Spots (DBS) with LC-MS/MS

PubMed Central

Zheng, Jia-Hua; Guida, Louis A; Rower, Caitlin; Castillo-Mancilla, Jose; Meditz, Amie; Klein, Brandon; Kerr, Becky Jo; Langness, Jacob; Bushman, Lane; Kiser, Jennifer; Anderson, Peter L.

2013-01-01

A reversed-phase high performance liquid chromatographic (LC), tandem mass spectrometry (MS/MS) assay for the determination of tenofovir (TFV) and emtricitabine (FTC) in dried blood spots (DBS) from human whole blood was developed and validated. Whole blood samples were spotted, dried, and a 3mm punch was extracted with methanol for analysis by LC-MS/MS utilizing stable isotope labeled internal standards. The assay was validated over the range of 2.5ng/mL to 1,000ng/mL for TFV and 2.5ng/mL to 5,000ng/mL for FTC. The method was accurate (within ± 15% of control) and precise (coefficient of variation ≤ 15%) for hematocrit concentrations ranging from 25% to 76%; using edge punches versus center punches; and spot volumes of 10µL to 50µL. Analytes were stable for five freeze/thaw cycles and up to 6 days at room temperature, whereas long-term storage required −20°C or −80°C. Comparison of TFV and FTC in DBS versus plasma yielded r2 ≥ 0.96, indicating that DBS can be used as a plasma alternative for pharmacokinetic analyses in vivo. PMID:24055850

Optimal Fault-Tolerant Control for Discrete-Time Nonlinear Strict-Feedback Systems Based on Adaptive Critic Design.

PubMed

Wang, Zhanshan; Liu, Lei; Wu, Yanming; Zhang, Huaguang

2018-06-01

This paper investigates the problem of optimal fault-tolerant control (FTC) for a class of unknown nonlinear discrete-time systems with actuator fault in the framework of adaptive critic design (ACD). A pivotal highlight is the adaptive auxiliary signal of the actuator fault, which is designed to offset the effect of the fault. The considered systems are in strict-feedback forms and involve unknown nonlinear functions, which will result in the causal problem. To solve this problem, the original nonlinear systems are transformed into a novel system by employing the diffeomorphism theory. Besides, the action neural networks (ANNs) are utilized to approximate a predefined unknown function in the backstepping design procedure. Combined the strategic utility function and the ACD technique, a reinforcement learning algorithm is proposed to set up an optimal FTC, in which the critic neural networks (CNNs) provide an approximate structure of the cost function. In this case, it not only guarantees the stability of the systems, but also achieves the optimal control performance as well. In the end, two simulation examples are used to show the effectiveness of the proposed optimal FTC strategy.

Elvitegravir concentrations in seminal plasma in HIV-1-infected men.

PubMed

Imaz, A; Niubó, J; Kashuba, A D; Ferrer, E; Sykes, C; Rozas, N; Acerete, L; Vila, A; Podzamczer, D

2017-03-01

The aim of the study was to quantify elvitegravir (EVG) concentrations in the semen of HIV-1-infected men receiving antiretroviral therapy (ART) consisting of an elvitegravir/cobicistat/emtricitabine/tenofovir (EVG/COBI/FTC/TDF) single-tablet regimen. A phase IV, cross-sectional study was carried out including HIV-1-infected male adults with suppressed plasma HIV-1 RNA who switched ART to EVG/COBI/FTC/TDF. Total EVG concentrations at the end of the dosing interval (C 24 h ) and HIV-1 RNA were measured in paired seminal plasma (SP) and blood plasma (BP) samples 4 weeks after switching to EVG/COBI/FTC/TDF. Validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) was used to quantify EVG concentrations, and HIV-1 RNA was determined by real-time polymerase chain reaction (PCR). Ten men were included. Their median age was 40 years (range 24-47 years), the median time on ART was 50 months (range 10-186 months), the median time with plasma HIV-1 RNA < 40 copies/mL was 37 months (range 7-113 months), and the median CD4 count was 737 cells/μL (range 190-1122 cells/μL). Four weeks after switching to EVG/COBI/FTC/TDF, all subjects had HIV-1 RNA < 40 copies/mL in both BP and SP. Median EVG C 24 h was 277 ng/mL (range 64.8-1790 ng/mL) in BP and 169 ng/mL (range 12.8-792 ng/mL) in SP. A significant correlation was observed between BP and SP EVG concentrations (Spearman rho 0.952; P < 0.001). The median SP:BP EVG concentration ratio was 0.39 (range 0.20-0.92). EVG C 24 h in SP was at least 23-fold the in vitro protein-unbound 50% effective response (EC 50 ) of HIV-1 clinical isolates (0.04-0.55 ng/mL). In all but one individual, EVG C 24 h in SP was also higher than the blood plasma protein binding-adjusted 95% inhibitory concentration (IC 95 ) of wild-type HIV-1 (45 ng/mL). Seminal EVG concentrations in HIV-infected men treated with EVG/COBI/FTC/TDF sufficed to contribute to maintaining HIV-1 RNA suppression in this compartment. © 2016 British HIV Association.

75 FR 27010 - Joint Industry Plan; Notice of Filing of Amendment No. 21 to the Joint Self-Regulatory...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-13

... processor to create and make available depth-of-book displays; the incorporation into the Plan of the... Elizabeth Murphy, Secretary, Commission, dated February 26, 2010. \\6\\ The complete text of the Plan, as... to submit its projected capacity needs directly to the Plan's Processor. The process avoids any need...

The Early Impact of an Administrative Processing Fee on Manuscript Submissions at The Journal of Bone & Joint Surgery.

PubMed

Nwachukwu, Benedict U; Schairer, William W; So, Conan; Bernstein, Jaime L; Herndon, James; Dodwell, Emily R

2016-10-05

There was a dramatic increase in the volume of manuscripts submitted to The Journal of Bone & Joint Surgery (JBJS) between 2009 and 2012. This resulted in increased journal administrative costs. To offset this financial burden, in May 2013, JBJS started charging authors an administrative processing fee at the time of submission. The purpose of this study was to assess the impact of the administrative fee on the volume and characteristics of manuscripts submitted to JBJS. Our analysis included 866 manuscripts submitted to JBJS between November 2012 and November 2013. We compared manuscripts submitted 6 months prior to fee implementation and prior to the announcement (denoted as the baseline group), in the several months prior to fee implementation but after the fee implementation announcement (denoted as the fee announcement group), and in the 6 months after fee implementation (denoted as the fee implementation group). Manuscripts were reviewed for institutional and author demographic characteristics, as well as for general study characteristics. In the first full calendar year (2014) after the implementation of the fee, the annual volume of submissions to JBJS declined by 33.5% compared with the annual submission volume in 2010 to 2012. In a comparative analysis, the geographical region of origin (p = 0.003), level of evidence (p < 0.0001), funding, and specialty differed between the 3 submission periods. However, subgroup analyses demonstrated that differences were attributable to the fee announcement group and that there were few important differences between the baseline and fee implementation groups. Reporting of funding information improved significantly between the baseline and fee implementation groups; in the post-fee implementation period, studies were more likely to have declared no external funding source (p = 0.001). The administrative processing fee at JBJS has been associated with a decrease in submission volume, but, overall, there has not been a change in the characteristics of studies submitted. However, decreased overall volume implies a decrease in the absolute number of high-level studies submitted to the journal. Administrative processing fees at high-volume journals may be a financially viable way to offset high administrative costs without substantially changing the characteristics of submitted articles. Copyright © 2016 by The Journal of Bone and Joint Surgery, Incorporated.

Joint Training In Combined Entry Operations

DTIC Science & Technology

2014-02-13

AIR WAR COLLEGE AIR UNIVERSITY JOINT TRAINING IN COMBINED ENTRY OPERATIONS by Ethan Mitchell, CDR, USN A Research Report Submitted...government. DISTRIBUTION A . Approved for public release: distribution unlimited. 2 Biography CDR Ethan Mitchell is assigned to the Air War College...Areas of Responsibility. Ashore, her served in the requirements directorate on the Commander, Second Fleet staff and earned a Master’s of Science

75 FR 60846 - Bureau of Consular Affairs; Registration for the Diversity Immigrant (DV-2012) Visa Program

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-01

... need to submit a photo for a child who is already a U.S. citizen or a Legal Permanent Resident. Group... Joint Photographic Experts Group (JPEG) format; it must have a maximum image file size of two hundred... (dpi); the image file format in Joint Photographic Experts Group (JPEG) format; the maximum image file...

U. S.-Thailand Combatant Commander Considerations for the Asia-Pacific Rebalance

DTIC Science & Technology

2015-05-01

ADDRESS(ES) 8. PERFORMING ORGANIZATION REPORT NUMBER Joint Military Operations Department Naval War ...paper submitted to the Naval War College faculty in partial satisfaction of the requirements of the Joint Military Operations Department. The contents...Standard Form 298 (Rev. 8-98) NAVAL WAR COLLEGE Newport, R.I. U.S. – Thailand: Combatant Commander Considerations for the Asia

An overview of herb and dietary supplement efficacy, safety and government regulations in the United States with suggested improvements. Part 1 of 5 series.

PubMed

Brown, Amy Christine

2017-09-01

This is the first of five review articles investigating dietary supplements (DS; includes herbs) that now exceed over 50,000 in the Office of Dietary Supplement's "Dietary Supplement Label Database." Four review articles follow summarizing published medical case reports of DS related to liver toxicity, kidney toxicity, heart toxicity, and cancer. The most popular DS were vitamin or mineral supplements (43%) followed by specialty supplements (20%), botanicals (20%; herbs), and sports supplements (16%). The 2013 Annual Report of the American Association of Poison Control Centers revealed 1692 fatalities due to drugs, and zero deaths due to DS. Less than 1 percent of Americans experience adverse events related to DS, and the majority was classified as minor, with many of these related to caffeine, yohimbe, or other stimulant ingredients. The number one adulterant in DS is drugs, followed by New Dietary Ingredients (NDI) not submitted to the FDA - both are illegal and not DS, but rather "tainted products marketed as dietary supplements." The three main categories of DS prone to medical problems are those for sexual enhancement, weight loss, and sports performance/body building. DS are regulated in the U.S. by several federal agencies with overlapping jurisdiction - the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC); enforced by the State Attorneys General Offices (AGO) and Department of Justice (DOJ); and monitored (not regulated) by the Centers for Disease Control and Prevention (CDC). The FDA can remove a DS from the market for phase IV post-marketing surveillance adverse event reports, adulteration (drugs, NDI, synthetic substances), contamination, misidentification, mislabeling or false claims, and not meeting good manufacturing practices (GMP). The FTC and state AGO can also enforce laws against deceptive marketing practices. Suggested improvements to current regulatory requirements are included along with online DS Toxic Tables in the series to forewarn consumers, clinicians, corporations, and governments of possible serious adverse events. They may also quicken the response rate during Phase IV post-marketing surveillance, in which governments could then exercise their regulatory powers. Copyright © 2017 Elsevier Ltd. All rights reserved.

Six weeks of continuous joint distraction appears sufficient for clinical benefit and cartilaginous tissue repair in the treatment of knee osteoarthritis.

PubMed

van der Woude, J A D; van Heerwaarden, R J; Spruijt, S; Eckstein, F; Maschek, S; van Roermund, P M; Custers, R J H; van Spil, W E; Mastbergen, S C; Lafeber, F P J G

2016-10-01

Knee joint distraction (KJD) is a surgical joint-preserving treatment in which the knee joint is temporarily distracted by an external frame. It is associated with joint tissue repair and clinical improvement. Initially, patients were submitted to an eight-week distraction period, and currently patients are submitted to a six-week distraction period. This study evaluates whether a shorter distraction period influences the outcome. Both groups consisted of 20 patients. Clinical outcome was assessed by WOMAC questionnaires and VAS-pain. Cartilaginous tissue repair was assessed by radiographic joint space width (JSW) and MRI-observed cartilage thickness. Baseline data between both groups were comparable. Both groups showed an increase in total WOMAC score; 24±4 in the six-week group and 32±5 in the eight-week group (both p<0.001). Mean JSW increased 0.9±0.3mm in the six-week group and 1.1±0.3mm in the eight-week group (p=0.729 between groups). The increase in mean cartilage thickness on MRI was 0.6±0.2mm in the eight-week group and 0.4±0.1mm in the six-week group (p=0.277). A shorter distraction period does not influence short-term clinical and structural outcomes statistically significantly, although effect sizes tend to be smaller in six week KJD as compared to eight week KJD. Copyright © 2016 Elsevier B.V. All rights reserved.

77 FR 74745 - Used Motor Vehicle Trade Regulation Rule

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-17

...Except as specifically described below, the FTC has completed its regulatory review of its Used Motor Vehicle Trade Regulation Rule (``Used Car Rule'' or ``Rule'') as part of the FTC's systematic review of all current Commission regulations and guides. The Commission has decided to retain the Rule and, in a separate Federal Register document, to amend it by changing the Spanish translation of the Buyers Guide. In addition, the Commission also has decided to issue a notice of proposed rulemaking (``NPR'') soliciting comments on proposed changes to the Rule. In this NPR, the Commission addresses the comments received during its review and invites public comment on the following four proposed changes to the Buyers Guide: adding boxes to the back of the Buyers Guide where dealers would have the option to indicate manufacturers' and other third-party warranties; adding a statement to the Buyers Guide encouraging consumers to seek vehicle history information and directing consumers to an FTC Web site for more information about vehicle histories; adding catalytic converters and airbags to the List of Systems on the back of the Buyers Guide; and adding a statement in Spanish to the English Buyers Guide directing consumers who cannot read the Buyers Guide in English to ask for a copy of it in Spanish.

A 68-year old male presenting with rhabdomyolysis-associated acute kidney injury following concomitant use of elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate and pravastatin/fenofibrate: a case report.

PubMed

Suttels, Veronique; Florence, Eric; Leys, John; Vekemans, Marc; Van den Ende, Jef; Vlieghe, Erika; Kenyon, Chris

2015-09-08

We present what we believe to be the first case in the literature of rhabdomyolysis-induced renal failure caused by a probable drug interaction between elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF) and pravastatin/fenofibrate. A 68-year old Caucasian man presented with progressive pain in both legs two weeks after commencing treatment with EVG/COBI/FTC/TDF. He was found to have biochemical evidence of rhabdomyolysis and acute renal failure. We emphasize the need for post marketing surveillance of adverse effects of new products. Pharmacokinetic studies are necessary to investigate the levels of pravastatin in patients taking COBI and fenofibrate with and without other comorbidities. Meanwhile, we suggest that creatine kinase levels should be monitored and patients advised to report myalgias when using concomitant EVG/COBI/FTC/TDF and pravastatin/fenofibrate. This case serves as an important reminder to use estimated glomerular filtration rates rather than serum creatinine levels when choosing new medications. If potentially nephrotoxic combinations are started in patients with borderline estimated glomerular filtration rates, it may be prudent to check these filtration rates more frequently than usual. In patients with reduced estimated glomerular filtration rates, potentially nephrotoxic combinations should be avoided wherever possible.

A high-fidelity Monte Carlo evaluation of CANDU-6 safety parameters

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

Kim, Y.; Hartanto, D.

2012-07-01

Important safety parameters such as the fuel temperature coefficient (FTC) and the power coefficient of reactivity (PCR) of the CANDU-6 (CANada Deuterium Uranium) reactor have been evaluated by using a modified MCNPX code. For accurate analysis of the parameters, the DBRC (Doppler Broadening Rejection Correction) scheme was implemented in MCNPX in order to account for the thermal motion of the heavy uranium nucleus in the neutron-U scattering reactions. In this work, a standard fuel lattice has been modeled and the fuel is depleted by using the MCNPX and the FTC value is evaluated for several burnup points including the mid-burnupmore » representing a near-equilibrium core. The Doppler effect has been evaluated by using several cross section libraries such as ENDF/B-VI, ENDF/B-VII, JEFF, JENDLE. The PCR value is also evaluated at mid-burnup conditions to characterize safety features of equilibrium CANDU-6 reactor. To improve the reliability of the Monte Carlo calculations, huge number of neutron histories are considered in this work and the standard deviation of the k-inf values is only 0.5{approx}1 pcm. It has been found that the FTC is significantly enhanced by accounting for the Doppler broadening of scattering resonance and the PCR are clearly improved. (authors)« less

Mobil plans methanol plant in Nigeria

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

Alperowicz, N.

1992-08-12

Mobil Chemical (Houston) is in discussions with Nigerian National Petroleum Corp. (NNPC; Lagos) on a joint venture methanol plant at Port Harcourt, Nigeria. The U.S. firm has invited process owners to submit proposals for a 1-million m.t./year unit and hopes to select the technology by the end of this year. Three proposals have been submitted: Lurgi, offering its own low-pressure process; John Brown/Davy, with the ICI process; and M.W. Kellogg, proposing its own technology. Shareholding in the joint venture is yet to be decided, but it is likely to be a 50/50 tie-up. Marketing of Mobil's share or of themore » entire tonnage would be handled by Mobil Petrochemical International (Brussels). The plant could be onstream in late 1996.« less

Validation of the flow-through chamber (FTC) and steady-state (SS) methods for clearance rate measurements in bivalves

PubMed Central

Larsen, Poul S.; Riisgård, Hans Ulrik

2012-01-01

Summary To obtain precise and reliable laboratory clearance rate (filtration rate) measurements with the ‘flow-through chamber method’ (FTC) the design must ensure that only inflow water reaches the bivalve's inhalant aperture and that exit flow is fully mixed. As earlier recommended these prerequisites can be checked by a plot of clearance rate (CR) versus increasing through-flow (Fl) to reach a plateau, which is the true CR, but we also recommend to plot percent particles cleared versus reciprocal through-flow where the plateau becomes the straight line CR/Fl, and we emphasize that the percent of particles cleared is in itself neither a criterion for valid CR measurement, nor an indicator of appropriate ‘chamber geometry’ as hitherto adapted in many studies. For the ‘steady-state method’ (SS), the design must ensure that inflow water becomes fully mixed with the bivalve's excurrent flow to establish a uniform chamber concentration prevailing at its incurrent flow and at the chamber outlet. These prerequisites can be checked by a plot of CR versus increasing Fl, which should give the true CR at all through-flows. Theoretically, the experimental uncertainty of CR for a given accuracy of concentration measurements depends on the percent reduction in particle concentration (100×P) from inlet to outlet of the ideal ‘chamber geomety’. For FTC, it decreases with increasing values of P while for SS it first decreases but then increases again, suggesting the use of an intermediate value of P. In practice, the optimal value of P may depend on the given ‘chamber geometry’. The fundamental differences between the FTC and the SS methods and practical guidelines for their use are pointed out, and new data on CR for the blue mussel, Mytilus edulis, illustrate a design and use of the SS method which may be employed in e.g. long-term growth experiments at constant algal concentrations. PMID:23213362

Clinical Outcomes of Virologically-Suppressed Patients with Pre-existing HIV-1 Drug Resistance Mutations Switching to Rilpivirine/Emtricitabine/Tenofovir Disoproxil Fumarate in the SPIRIT Study.

PubMed

Porter, Danielle P; Toma, Jonathan; Tan, Yuping; Solberg, Owen; Cai, Suqin; Kulkarni, Rima; Andreatta, Kristen; Lie, Yolanda; Chuck, Susan K; Palella, Frank; Miller, Michael D; White, Kirsten L

2016-02-01

Antiretroviral regimen switching may be considered for HIV-1-infected, virologically-suppressed patients to enable treatment simplification or improve tolerability, but should be guided by knowledge of pre-existing drug resistance. The current study examined the impact of pre-existing drug resistance mutations on virologic outcomes among virologically-suppressed patients switching to Rilpivirine (RPV)/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF). SPIRIT was a phase 3b study evaluating the safety and efficacy of switching to RPV/FTC/TDF in virologically-suppressed HIV-1-infected patients. Pre-existing drug resistance at baseline was determined by proviral DNA genotyping for 51 RPV/FTC/TDF-treated patients with known mutations by historical RNA genotype and matched controls and compared with clinical outcome at Week 48. Drug resistance mutations in protease or reverse transcriptase were detected in 62.7% of patients by historical RNA genotype and in 68.6% by proviral DNA genotyping at baseline. Proviral DNA sequencing detected 89% of occurrences of NRTI and NNRTI resistance-associated mutations reported by historical genotype. Mutations potentially affecting RPV activity, including E138A/G/K/Q, Y181C, and H221Y, were detected in isolates from 11 patients by one or both assays. None of the patients with single mutants had virologic failure through Week 48. One patient with pre-existing Y181Y/C and M184I by proviral DNA genotyping experienced virologic failure. Nineteen patients with K103N present by historical genotype were confirmed by proviral DNA sequencing and 18/19 remained virologically-suppressed. Virologic success rates were high among virologically-suppressed patients with pre-existing NRTI and NNRTI resistance-associated mutations who switched to RPV/FTC/TDF in the SPIRIT study. While plasma RNA genotyping remains preferred, proviral DNA genotyping may provide additional value in virologically-suppressed patients for whom historical resistance data are unavailable.

Pre-exposure Prophylaxis With Tenofovir Disoproxil Fumarate/Emtricitabine and Kidney Tubular Dysfunction in HIV-Uninfected Individuals.

PubMed

Jotwani, Vasantha; Scherzer, Rebecca; Glidden, David V; Mehrotra, Megha; Defechereux, Patricia; Liu, Albert; Gandhi, Monica; Bennett, Michael; Coca, Steven G; Parikh, Chirag R; Grant, Robert M; Shlipak, Michael G

2018-06-01

Pre-exposure prophylaxis (PrEP) with tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) is becoming increasingly adopted for HIV prevention. Tenofovir can cause proximal tubular damage and chronic kidney disease in HIV-infected persons, but little is known regarding its nephrotoxic potential among HIV-uninfected persons. In this study, we evaluated the effects of PrEP on urine levels of the following: α1-microglobulin (α1m), a marker of impaired tubular reabsorption; albuminuria, a measure of glomerular injury; and total proteinuria. The Iniciativa Profilaxis Pre-Exposicion (iPrEx) study randomized HIV-seronegative men and transgender women who have sex with men to oral TDF/FTC or placebo. The iPrEx open-label extension (iPrEx-OLE) study enrolled former PrEP trial participants to receive open-label TDF/FTC. A cross-sectional analysis compared urine biomarker levels by study arm in iPrEx (N = 100 treatment arm, N = 100 placebo arm). Then, urine biomarker levels were compared before and after PrEP initiation in 109 participants of iPrEx-OLE. In iPrEx, there were no significant differences in urine α1m, albuminuria, or proteinuria by treatment arm. In iPrEx-OLE, after 24 weeks on PrEP, urine α1m and proteinuria increased by 21% [95% confidence interval (CI): 10 to 33] and 18% (95% CI: 8 to 28), respectively. The prevalence of detectable α1m increased from 44% to 65% (P < 0.001) and estimated glomerular filtration rate declined by 4 mL/min/1.73 m (P < 0.001). There was no significant change in albuminuria (6%; 95% CI: -7% to 20%). PrEP with TDF/FTC was associated with a statistically significant rise in urine α1m and proteinuria after 6 months, suggesting that PrEP may result in subclinical tubule dysfunction.

Cumulative receipt of an anti-poverty tax credit for families did not impact tobacco smoking among parents.

PubMed

Pega, Frank; Gilsanz, Paola; Kawachi, Ichiro; Wilson, Nick; Blakely, Tony

2017-04-01

The effect of anti-poverty tax credit interventions on tobacco consumption is unclear. Previous studies have estimated short-term effects, did not isolate the effects of cumulative dose of tax credits, produced conflicting results, and used methods with limited control for some time-varying confounders (e.g., those affected by prior treatment) and treatment regimen (i.e., study participants' tax credit receipt pattern over time). We estimated the longer-term, cumulative effect of New Zealand's Family Tax Credit (FTC) on tobacco consumption, using a natural experiment (administrative errors leading to exogenous variation in FTC receipt) and methods specifically for controlling confounding, reverse causation, and treatment regimen. We extracted seven waves (2002-2009) of the nationally representative Survey of Family, Income and Employment including 4404 working-age (18-65 years) parents in families. The exposure was the total numbers of years of receiving FTC. The outcomes were regular smoking and the average daily number of cigarettes usually smoked at wave 7. We estimated average treatment effects using inverse probability of treatment weighting and marginal structural modelling. Each additional year of receiving FTC affected neither the odds of regular tobacco smoking among all parents (odds ratio 1.02, 95% confidence interval 0.94-1.11), nor the number of cigarettes smoked among parents who smoked regularly (rate ratio 1.01, 95% confidence interval 0.99-1.03). We found no evidence for an association between the cumulative number of years of receiving an anti-poverty tax credit and tobacco smoking or consumption among parents. The assumptions of marginal structural modelling are quite demanding, and we therefore cannot rule out residual confounding. Nonetheless, our results suggest that tax credit programme participation will not increase tobacco consumption among poor parents, at least in this high-income country. Copyright © 2017 Elsevier Ltd. All rights reserved.

Prevention of Posttraumatic Contractures with Ketotifen (PERK)

DTIC Science & Technology

2017-10-01

opportunity to design a Phase III RCT on the use of ketotifen in post -traumatic joint contractures. The goal is to design and develop the infrastructure to...Research (CIHR) for the Phase III RCT. 2. KEYWORDS Post -traumatic contractures, elbow fractures, randomized clinical trial, multicenter, ketotifen...application to use ketotifen in post -traumatic joint contracture prevention was submitted to the Division of Pulmonary, Allergy, and Rheumatology

GDC-0941 inhibits metastatic characteristics of thyroid carcinomas by targeting both the phosphoinositide-3 kinase (PI3K) and hypoxia-inducible factor-1α (HIF-1α) pathways.

PubMed

Burrows, Natalie; Babur, Muhammad; Resch, Julia; Ridsdale, Sophie; Mejin, Melissa; Rowling, Emily J; Brabant, Georg; Williams, Kaye J

2011-12-01

Phosphoinositide 3-kinase (PI3K) regulates the transcription factor hypoxia-inducible factor-1 (HIF-1) in thyroid carcinoma cells. Both pathways are associated with aggressive phenotype in thyroid carcinomas. Our objective was to assess the effects of the clinical PI3K inhibitor GDC-0941 and genetic inhibition of PI3K and HIF on metastatic behavior of thyroid carcinoma cells in vitro and in vivo. Vascular endothelial growth factor ELISA, HIF activity assays, proliferation studies, and scratch-wound migration and cell spreading assays were performed under various O(2) tensions [normoxia, hypoxia (1 and 0.1% O(2)), and anoxia] with or without GDC-0941 in a panel of four thyroid carcinoma cell lines (BcPAP, WRO, FTC133, and 8505c). Genetic inhibition was achieved by overexpressing phosphatase and tensin homolog (PTEN) into PTEN-null cells and by using a dominant-negative variant of HIF-1α (dnHIF). In vivo, human enhanced green fluorescence protein-expressing follicular thyroid carcinomas (FTC) were treated with GDC-0941 (orally). Spontaneous lung metastasis was confirmed by viewing enhanced green fluorescence protein-positive colonies cultured from lung tissue. GDC-0941 inhibited hypoxia/anoxia-induced HIF-1α and HIF-2α expression and HIF activity in thyroid carcinoma cells. Basal (three of four cell lines) and/or hypoxia-induced (four of four) secreted vascular endothelial growth factor was inhibited by GDC-0941, whereas selective HIF targeting predominantly affected hypoxia/anoxia-mediated secretion (P < 0.05-0.0001). Antiproliferative effects of GDC-0941 were more pronounced in PTEN mutant compared with PTEN-restored cells (P < 0.05). Hypoxia increased migration in papillary cells and cell spreading/migration in FTC cells (P < 0.01). GDC-0941 reduced spreading and migration in all O(2) conditions, whereas dnHIF had an impact only on hypoxia-induced migration (P < 0.001). In vivo, GDC-0941 reduced expression of HIF-1α, phospho-AKT, GLUT-1, and lactate dehydrogenase A in FTC xenografts. DnHIF expression and GDC-0941 reduced FTC tumor growth and metastatic lung colonization (P < 0.05). PI3K plays a prominent role in the metastatic behavior of thyroid carcinoma cells irrespective of O(2) tension and appears upstream of HIF activation. GDC-0941 significantly inhibited the metastatic phenotype, supporting the clinical development of PI3K inhibition in thyroid carcinomas.

Burma in Transition: On the Path to Democracy

DTIC Science & Technology

2014-10-30

SUPPLEMENTARY NOTES A paper submitted to the Naval War College faculty in partial satisfaction of the requirements of the Joint Military Operations Department...War College in partial satisfaction of the requirements of the Department of Joint Military Operations. The contents of this paper reflect my own...protest to be held in the country since 1962.28 Other topics addressed in legislation during 2013 include the national budget, customer protection

75 FR 51061 - Joint and Several Liability Reallocation Agreement

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-18

... comments as submitted, but for technical reasons we may omit items such as logos and special characters... methodology. However, we are asking commenters to specifically comment on the comparisons and differences of...

Alerts and Advisories

MedlinePlus

... Elimidrol ‘Opiate Withdrawal’ Product (FTC 09/28/17 ) Physic Candy – Define contains hidden drug ingredients ( FDA 09/11/17 ) Physic Candy – Curve contains hidden drug ingredients ( FDA 08/ ...

An Analysis of Operational Availability of Brazilian Navy and Argentine Air Force A-4 Fleets Using Simulation Modeling

DTIC Science & Technology

1999-12-01

Escuela de Ingenieria Aeronäutica, 1982 Submitted in partial fulfillment of the requirements for the degree of MASTER OF SCD2NCE IN MANAGEMENT...defense industry , including joint production, technical data sharing, and reciprocal subcontracting in the joint development and production of a...34Foundations of Manufacturing Management". 15. Barton, Russell R., Simulation Metamodels, Department of Industrial and Manufacturing Engineering, The

Making Temporal Logic Calculational: A Tool for Unification and Discovery

NASA Astrophysics Data System (ADS)

Boute, Raymond

In temporal logic, calculational proofs beyond simple cases are often seen as challenging. The situation is reversed by making temporal logic calculational, yielding shorter and clearer proofs than traditional ones, and serving as a (mental) tool for unification and discovery. A side-effect of unifying theories is easier access by practicians. The starting point is a simple generic (software tool independent) Functional Temporal Calculus (FTC). Specific temporal logics are then captured via endosemantic functions. This concept reflects tacit conventions throughout mathematics and, once identified, is general and useful. FTC also yields a reasoning style that helps discovering theorems by calculation rather than just proving given facts. This is illustrated by deriving various theorems, most related to liveness issues in TLA+, and finding strengthenings of known results. Educational issues are addressed in passing.

Neural-Network-Based Adaptive Decentralized Fault-Tolerant Control for a Class of Interconnected Nonlinear Systems.

PubMed

Li, Xiao-Jian; Yang, Guang-Hong

2018-01-01

This paper is concerned with the adaptive decentralized fault-tolerant tracking control problem for a class of uncertain interconnected nonlinear systems with unknown strong interconnections. An algebraic graph theory result is introduced to address the considered interconnections. In addition, to achieve the desirable tracking performance, a neural-network-based robust adaptive decentralized fault-tolerant control (FTC) scheme is given to compensate the actuator faults and system uncertainties. Furthermore, via the Lyapunov analysis method, it is proven that all the signals of the resulting closed-loop system are semiglobally bounded, and the tracking errors of each subsystem exponentially converge to a compact set, whose radius is adjustable by choosing different controller design parameters. Finally, the effectiveness and advantages of the proposed FTC approach are illustrated with two simulated examples.

STOPPING DECEPTIVE HEALTH CLAIMS: THE NEED FOR A PRIVATE RIGHT OF ACTION UNDER FEDERAL LAW.

PubMed

Hoffmann, Diane; Schwartz, Jack

2016-01-01

This Article offers a thorough analysis of an important public health issue, namely how to confront the growing problem of deceptive claims regarding foods and dietary supplements, including increasingly prevalent but unverifiable claims. The authors call for the creation of a limited private right of action under the Federal Trade Commission (FTC) Act for deceptive health-related claims for these products. The proposal responds to the growing market for these products and the inadequacy of current laws and enforcement actions to prevent such claims. In crafting the limited private right of action, the authors attempt to enhance consumer protection without undermining federal agency primacy in enforcement. The Article ends with an appendix setting forth proposed language for a statutory amendment to the FTC Act incorporating the authors' proposal.

Validation of a Monte Carlo model used for simulating tube current modulation in computed tomography over a wide range of phantom conditions/challenges

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

Bostani, Maryam, E-mail: mbostani@mednet.ucla.edu; McMillan, Kyle; Cagnon, Chris H.

2014-11-01

Purpose: Monte Carlo (MC) simulation methods have been widely used in patient dosimetry in computed tomography (CT), including estimating patient organ doses. However, most simulation methods have undergone a limited set of validations, often using homogeneous phantoms with simple geometries. As clinical scanning has become more complex and the use of tube current modulation (TCM) has become pervasive in the clinic, MC simulations should include these techniques in their methodologies and therefore should also be validated using a variety of phantoms with different shapes and material compositions to result in a variety of differently modulated tube current profiles. The purposemore » of this work is to perform the measurements and simulations to validate a Monte Carlo model under a variety of test conditions where fixed tube current (FTC) and TCM were used. Methods: A previously developed MC model for estimating dose from CT scans that models TCM, built using the platform of MCNPX, was used for CT dose quantification. In order to validate the suitability of this model to accurately simulate patient dose from FTC and TCM CT scan, measurements and simulations were compared over a wide range of conditions. Phantoms used for testing range from simple geometries with homogeneous composition (16 and 32 cm computed tomography dose index phantoms) to more complex phantoms including a rectangular homogeneous water equivalent phantom, an elliptical shaped phantom with three sections (where each section was a homogeneous, but different material), and a heterogeneous, complex geometry anthropomorphic phantom. Each phantom requires varying levels of x-, y- and z-modulation. Each phantom was scanned on a multidetector row CT (Sensation 64) scanner under the conditions of both FTC and TCM. Dose measurements were made at various surface and depth positions within each phantom. Simulations using each phantom were performed for FTC, detailed x–y–z TCM, and z-axis-only TCM to obtain dose estimates. This allowed direct comparisons between measured and simulated dose values under each condition of phantom, location, and scan to be made. Results: For FTC scans, the percent root mean square (RMS) difference between measurements and simulations was within 5% across all phantoms. For TCM scans, the percent RMS of the difference between measured and simulated values when using detailed TCM and z-axis-only TCM simulations was 4.5% and 13.2%, respectively. For the anthropomorphic phantom, the difference between TCM measurements and detailed TCM and z-axis-only TCM simulations was 1.2% and 8.9%, respectively. For FTC measurements and simulations, the percent RMS of the difference was 5.0%. Conclusions: This work demonstrated that the Monte Carlo model developed provided good agreement between measured and simulated values under both simple and complex geometries including an anthropomorphic phantom. This work also showed the increased dose differences for z-axis-only TCM simulations, where considerable modulation in the x–y plane was present due to the shape of the rectangular water phantom. Results from this investigation highlight details that need to be included in Monte Carlo simulations of TCM CT scans in order to yield accurate, clinically viable assessments of patient dosimetry.« less

Cost analysis of initial highly active antiretroviral therapy regimens for managing human immunodeficiency virus-infected patients according to clinical practice in a hospital setting.

PubMed

Colombo, Giorgio L; Castagna, Antonella; Di Matteo, Sergio; Galli, Laura; Bruno, Giacomo; Poli, Andrea; Salpietro, Stefania; Carbone, Alessia; Lazzarin, Adriano

2014-01-01

In the study reported here, single-tablet regimen (STR) versus (vs) multi-tablet regimen (MTR) strategies were evaluated through a cost analysis in a large cohort of patients starting their first highly active antiretroviral therapy (HAART). Adult human immunodeficiency virus (HIV) 1-naïve patients, followed at the San Raffaele Hospital, Milan, Italy, starting their first-line regimen from June 2008 to April 2012 were included in the analysis. The most frequently used first-line HAART regimens (>10%) were grouped into two classes: 1) STR of tenofovir disoproxil fumarate (TDF) + emtricitabine (FTC) + efavirenz (EFV) and 2) MTR including TDF + FTC + EFV, TDF + FTC + atazanavir/ritonavir (ATV/r), TDF + FTC + darunavir/ritonavir (DRV/r), and TDF + FTC + lopinavir/ritoavir (LPV/r). Data were analyzed from the point of view of the Lombardy Regional Health Service. HAART, hospitalizations, visits, medical examinations, and other concomitant non-HAART drug costs were evaluated and price variations included. Descriptive statistics were calculated for baseline demographic, clinical, and laboratory characteristics; associations between categorical variables and type of antiretroviral strategy (STR vs MTR) were examined using chi-square or Fisher's exact tests. At multivariate analysis, the generalized linear model was used to identify the predictive factors of the overall costs of the first-line HAART regimens. A total of 474 naïve patients (90% male, mean age 42.2 years, mean baseline HIV-RNA 4.50 log 10 copies/mL, and cluster of differentiation 4 [CD4+] count of 310 cells/μL, with a mean follow-up of 28 months) were included. Patients starting an STR treatment were less frequently antibody-hepatitis C virus positive (4% vs 11%, P=0.040), and had higher mean CD4+ values (351 vs 297 cells/μL, P=0.004) than MTR patients. The mean annual cost per patient in the STR group was €9,213.00 (range: €6,574.71-€33,570.00) and €14,277.00 (range: €5,908.89-€82,310.30) among MTR patients. At multivariate analysis, after adjustment for age, sex, antibody-hepatitis C virus status, HIV risk factors, baseline CD4+, and HIV-RNA, the cost analysis was significantly lower among patients starting an STR treatment than those starting an MTR (adjusted mean: €12,096.00 vs €16,106.00, P=0.0001). STR was associated with a lower annual cost per patient than MTR, thus can be considered a cost-saving strategy in the treatment of HIV patients. This analysis is an important tool for policy makers and health care professionals to make short- and long-term cost projections and thus assess the impact of these on available budgets.

77 FR 64802 - Robocall Challenge

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2012-10-23

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...., Washington, DC 20549-1090. Comments mailed to this address should be submitted in triplicate and should refer... Trading and Markets, Securities and Exchange Commission, 100 F St., NE., Washington, DC 20549-1090; or...

Direct-to-Consumer Genetic Tests

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... sell their tests online and through multi-level marketing networks. The Federal Trade Commission (FTC) wants you to know the facts about the DTC marketing of genetic tests. Genes and Genetic Tests Interpreting ...

Costs and cost-effectiveness analysis of 2015 GESIDA/Spanish AIDS National Plan recommended guidelines for initial antiretroviral therapy in HIV-infected adults.

PubMed

Berenguer, Juan; Rivero, Antonio; Blasco, Antonio Javier; Arribas, José Ramón; Boix, Vicente; Clotet, Bonaventura; Domingo, Pere; González-García, Juan; Knobel, Hernando; Lázaro, Pablo; López, Juan Carlos; Llibre, Josep M; Lozano, Fernando; Miró, José M; Podzamczer, Daniel; Tuset, Montserrat; Gatell, Josep M

2016-01-01

GESIDA and the AIDS National Plan panel of experts suggest a preferred (PR), alternative (AR) and other regimens (OR) for antiretroviral treatment (ART) as initial therapy in HIV-infected patients for 2015. The objective of this study is to evaluate the costs and the effectiveness of initiating treatment with these regimens. Economic assessment of costs and effectiveness (cost/effectiveness) based on decision tree analyses. Effectiveness was defined as the probability of reporting a viral load <50 copies/mL at week 48, in an intention-to-treat analysis. Cost of initiating treatment with an ART regimen was defined as the costs of ART and its consequences (adverse effects, changes of ART regimen, and drug resistance studies) during the first 48 weeks. The payer perspective (National Health System) was applied, only taking into account differential direct costs: ART (official prices), management of adverse effects, studies of resistance, and HLA B*5701 testing. The setting is Spain and the costs correspond to those of 2015. A deterministic sensitivity analysis was conducted, building three scenarios for each regimen: base case, most favourable and least favourable. In the base case scenario, the cost of initiating treatment ranges from 4663 Euros for 3TC+LPV/r (OR) to 10,902 Euros for TDF/FTC+RAL (PR). The effectiveness varies from 0.66 for ABC/3TC+ATV/r (AR) and ABC/3TC+LPV/r (OR), to 0.89 for TDF/FTC+DTG (PR) and TDF/FTC/EVG/COBI (AR). The efficiency, in terms of cost/effectiveness, ranges from 5280 to 12,836 Euros per responder at 48 weeks, for 3TC+LPV/r (OR) and RAL+DRV/r (OR), respectively. The most efficient regimen was 3TC+LPV/r (OR). Among the PR and AR, the most efficient regimen was TDF/FTC/RPV (AR). Among the PR regimes, the most efficient was ABC/3TC+DTG. Copyright © 2015 Elsevier España, S.L.U. and Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica. All rights reserved.

Costs and cost-efficacy analysis of the 2016 GESIDA/Spanish AIDS National Plan recommended guidelines for initial antiretroviral therapy in HIV-infected adults.

PubMed

Rivero, Antonio; Pérez-Molina, José Antonio; Blasco, Antonio Javier; Arribas, José Ramón; Crespo, Manuel; Domingo, Pere; Estrada, Vicente; Iribarren, José Antonio; Knobel, Hernando; Lázaro, Pablo; López-Aldeguer, José; Lozano, Fernando; Moreno, Santiago; Palacios, Rosario; Pineda, Juan Antonio; Pulido, Federico; Rubio, Rafael; de la Torre, Javier; Tuset, Montserrat; Gatell, Josep M

2017-02-01

GESIDA and the AIDS National Plan panel of experts suggest preferred (PR), alternative (AR), and other regimens (OR) for antiretroviral treatment (ART) as initial therapy in HIV-infected patients for the year 2016. The objective of this study is to evaluate the costs and the efficacy of initiating treatment with these regimens. Economic assessment of costs and efficiency (cost/efficacy) based on decision tree analyses. Efficacy was defined as the probability of reporting a viral load <50copies/mL at week 48 in an intention-to-treat analysis. Cost of initiating treatment with an ART regimen was defined as the costs of ART and its consequences (adverse effects, changes of ART regimen, and drug resistance studies) during the first 48 weeks. The payer perspective (National Health System) was applied, only taking into account differential direct costs: ART (official prices), management of adverse effects, studies of resistance, and HLA B*5701 testing. The setting is Spain and the costs correspond to those of 2016. A sensitivity deterministic analysis was conducted, building three scenarios for each regimen: base case, most favourable, and least favourable. In the base case scenario, the cost of initiating treatment ranges from 4663 Euros for 3TC+LPV/r (OR) to 10,894 Euros for TDF/FTC+RAL (PR). The efficacy varies from 0.66 for ABC/3TC+ATV/r (AR) and ABC/3TC+LPV/r (OR), to 0.89 for TDF/FTC+DTG (PR) and TDF/FTC/EVG/COBI (AR). The efficiency, in terms of cost/efficacy, ranges from 5280 to 12,836 Euros per responder at 48 weeks, for 3TC+LPV/r (OR), and RAL+DRV/r (OR), respectively. Despite the overall most efficient regimen being 3TC+LPV/r (OR), among the PR and AR, the most efficient regimen was ABC/3TC/DTG (PR). Among the AR regimes, the most efficient was TDF/FTC/RPV. Copyright © 2016 Elsevier España, S.L.U. and Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica. All rights reserved.

Daily oral tenofovir and emtricitabine-tenofovir preexposure prophylaxis reduces herpes simplex virus type 2 acquisition among heterosexual HIV-1-uninfected men and women: a subgroup analysis of a randomized trial.

PubMed

Celum, Connie; Morrow, Rhoda A; Donnell, Deborah; Hong, Ting; Hendrix, Craig W; Thomas, Katherine K; Fife, Kenneth H; Nakku-Joloba, Edith; Mujugira, Andrew; Baeten, Jared M

2014-07-01

Daily oral preexposure prophylaxis (PrEP) using the antiretroviral tenofovir disoproxil fumarate (TDF) alone or in combination with emtricitabine (FTC-TDF) reduces the risk for HIV-1 acquisition. Tenofovir has in vitro activity against herpes simplex virus type 2 (HSV-2). To assess the efficacy of daily oral PrEP with tenofovir and FTC-TDF in the prevention of HSV-2 acquisition. Subgroup analysis of data from a randomized, placebo-controlled trial with concealed allocation. (ClinicalTrials.gov: NCT00557245). Multiple sites in Kenya and Uganda. Heterosexual men and women who were seronegative for HIV-1 and HSV-2 and at high risk for HIV-1 acquisition due to having an HIV-1-infected partner. Once-daily oral tenofovir disoproxil fumarate (TDF), alone or combined with emtricitabine (FTC-TDF), compared with placebo. HSV-2 seroconversion. A total of 131 participants seroconverted to HSV-2 (79 of 1041 assigned to tenofovir or FTC-TDF PrEP [HSV-2 incidence, 5.6 per 100 person-years] and 52 of 481 assigned to placebo [HSV-2 incidence, 7.7 per 100 person-years]). The hazard ratio (HR) for HSV-2 acquisition with daily oral PrEP was 0.70 (95% CI, 0.49 to 0.99; P = 0.047) compared with placebo, and the absolute risk reduction was 2.1 per 100 person-years. Among the 1044 participants with HSV-2-infected partners, the HR for PrEP was 0.67 (CI, 0.46 to 0.98; P = 0.038) compared with placebo, and the absolute risk reduction was 3.1 per 100 person-years. Randomization was not stratified by HSV-2 status, and diagnostic tests to exclude participants with acute HSV-2 at baseline are not available. Daily oral tenofovir-based PrEP significantly reduced the risk for HSV-2 acquisition among heterosexual men and women. Modest protection against HSV-2 is an added benefit of HIV-1 prevention with oral tenofovir-based PrEP. Bill & Melinda Gates Foundation.

Switching regimens in virologically suppressed HIV-1-infected patients: evidence base and rationale for integrase strand transfer inhibitor (INSTI)-containing regimens.

PubMed

Raffi, F; Esser, S; Nunnari, G; Pérez-Valero, I; Waters, L

2016-10-01

In an era when most individuals with treated HIV infection can expect to live into old age, clinicians should proactively review their patients' current and future treatment needs and challenges. Clinical guidelines acknowledge that, in the setting of virological suppression, treatment switch may yield benefits in terms of tolerability, regimen simplification, adherence, convenience and long-term health considerations, particularly in the context of ageing. In this paper, we review evidence from six key clinical studies on switching virologically suppressed patients to regimens based on integrase strand transfer inhibitors (INSTIs), the antiretroviral class increasingly preferred as initial therapy in clinical guidelines. We review these studies and focus on the virological efficacy, safety, and tolerability of switching to INSTI-based regimens in suppressed HIV-positive individuals. We review the early switch studies SWITCHMRK and SPIRAL [assessing a switch from a ritonavir-boosted protease inhibitor (PI/r) to raltegravir (RAL)-containing regimens], together with data from STRATEGY-PI [assessing a switch to elvitegravir (EVG)-containing regimens; EVG/cobicistat (COBI)/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) vs. remaining on a PI/r-containing regimen], STRATEGY-NNRTI [assessing a switch to EVG/COBI/FTC/TDF vs. continuation of a nonnucleoside reverse transcriptase inhibitor (NNRTI) and two nucleoside reverse transcriptase inhibitors (NRTIs)], STRIIVING [assessing a switch to a dolutegravir (DTG)-containing regimen (abacavir (ABC)/lamivudine (3TC)/DTG) vs. staying on the background regimen], and GS study 109 [assessing a switch to EVG/COBI/FTC/tenofovir alafenamide fumarate (TAF) vs. continuation of FTC/TDF-based regimens]. Switching to INSTI-containing regimens has been shown to support good virological efficacy, with evidence from two studies demonstrating superior virological efficacy for a switch to EVG-containing regimens. In addition, switching to INSTI regimens was associated with improved tolerability and greater reported patient satisfaction and outcomes in some studies. INSTI-based regimens offer an important contemporary switch option that may be tailored to meet and optimize the needs of many patients. © 2016 British HIV Association.

U.S. Joint Special Operations Forces: Two Few, Overworked, Young, Homogenous & Macho to Fulfill the Unconventional Demands of the Long War?

DTIC Science & Technology

2008-05-28

OVERWORKED , YOUNG, HOMOGENOUS, & MACHO TO FULFILL THE UNCONVENTIONAL DEMANDS OF THE LONG WAR? SUBMITTED IN PARTIAL FULFILLMENT OF THE REQUIREMENTS FOR...U.S. Joint Special Operations Forces: Two Few, Overworked , Young, Homogenous & Macho to Fulfill the Unconventional Demands of the Long War? 5a...to be the targets of nearly daily mortar, improvised explosive devices (IEDs), and occasional suicide vehicle-borne IED (SVBIED) attacks. It

Navy Nuclear-Powered Surface Ships: Background, Issues, and Options for Congress

DTIC Science & Technology

2010-03-29

246 of H.R. 2647 would require DOD to submit to the congressional defense committees a study on the use of thorium -liquid fueled nuclear reactors ...Congressional Research Service 19 SEC. 246. STUDY ON THORIUM -LIQUID FUELED REACTORS FOR NAVAL FORCES. (a) Study Required- The Secretary of Defense and...the Chairman of the Joint Chiefs of Staff shall jointly carry out a study on the use of thorium -liquid fueled nuclear reactors for naval power

Federal Trade Commission

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... a Consumer Complaint Report Identity Theft Get Your Free Credit Report Register for Do Not Call Get Scam Alerts ... File a claim if you were scammed via money transfer Ed tech, Privacy Workshop FTC, Department of ...

16 CFR 260.1 - Statement of purpose.

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2010-01-01

... of Section 5 of the FTC Act to environmental advertising and marketing practices. They provide the... ENVIRONMENTAL MARKETING CLAIMS § 260.1 Statement of purpose. The guides in this part represent administrative...

The Chicago-Iowa City passenger rail program : fact sheet.

DOT National Transportation Integrated Search

2011-02-23

Project costs : Overall cost: $310 million : Costs allocated between Iowa and Illinois : Iowa and Illinois submitted a joint application for $248 : million (up to 80 percent of the project cost) from the : High-Speed Intercity Passenger R...

13 CFR 127.506 - May a joint venture submit an offer on an EDWOSB or WOSB requirement?

Code of Federal Regulations, 2011 CFR

2011-01-01

... BUSINESS ADMINISTRATION WOMEN-OWNED SMALL BUSINESS FEDERAL CONTRACT ASSISTANCE PROCEDURES (Eff. until 2-4... must perform the applicable percentage of work required of the EDWOSB or WOSB offerors in accordance...

Anatomy of a Cancer Treatment Scam

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... and Office Directors Budgets Financial Documents Other Financial Information Performance Office of Inspector General FTC Imposter Scams ... Reading Rooms FOIA Request Fee Regulations Freedom of Information Act Contacts Frequently Asked Questions (FAQ) Links Table ...

Human Growth Hormone (HGH): Does It Slow Aging?

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... Pediatric. 7th ed. Philadelphia, Pa.; Saunders Elsevier; 2016. http://www.clinicalkey.com. Accessed Sept. 4, 2016. Anti-aging products. Federal Trade Commission. https://www.consumer.ftc.gov/articles/0118-anti-aging- ...

Robust Gain-Scheduled Fault Tolerant Control for a Transport Aircraft

NASA Technical Reports Server (NTRS)

Shin, Jong-Yeob; Gregory, Irene

2007-01-01

This paper presents an application of robust gain-scheduled control concepts using a linear parameter-varying (LPV) control synthesis method to design fault tolerant controllers for a civil transport aircraft. To apply the robust LPV control synthesis method, the nonlinear dynamics must be represented by an LPV model, which is developed using the function substitution method over the entire flight envelope. The developed LPV model associated with the aerodynamic coefficient uncertainties represents nonlinear dynamics including those outside the equilibrium manifold. Passive and active fault tolerant controllers (FTC) are designed for the longitudinal dynamics of the Boeing 747-100/200 aircraft in the presence of elevator failure. Both FTC laws are evaluated in the full nonlinear aircraft simulation in the presence of the elevator fault and the results are compared to show pros and cons of each control law.

The Regulation of Energy Medicine

NASA Astrophysics Data System (ADS)

Kosovich, Judy; Esq

This paper describes the laws and regulations that affect the practice of energy medicine. State law often has more impact on a health care practice than federal law, but federal law provides a common denominator among states. Device law is emphasized here because practitioners of energy medicine are more likely to use devices than drugs. For purposes of this paper, energy medicine is defined as practices that measure or benefit energy flow and overall energy in the body. This broad definition encompasses things as diverse as certain forms of exercise, measurement of meridian resistance, the use of electrical current or magnetic pulses to relieve pain, and the use of light, sound, scent, touch, position, or movement to stimulate the body's own electrical systems. What is of greatest importance in determining legal implications of a practice is whether there are any health-related claims. Two federal entities are pivotal. The Food and Drug Administration ("FDA") is authorized to protect health and safety and the Federal Trade Commission ("FTC") is authorized to protect consumers from false or misleading advertising. There are 5 things that FDA looks at: 1) intended use, 2) claims made in advertising and in labeling, 3) substantial equivalence to a predicate, 4) safety, and 5) effectiveness. A concern regarding any one of these can be the basis for denying clearance to market a device. The FTC looks at whether statements are true and substantiated and whether they might be misleading. The FTC often consults with the FDA on the interpretation of technical information.

Oxidative stress and apoptosis induction in human thyroid carcinoma cells exposed to the essential oil from Pistacia lentiscus aerial parts.

PubMed

Catalani, Simona; Palma, Francesco; Battistelli, Serafina; Benedetti, Serena

2017-01-01

Essential oils from the aerial parts (leaves, twigs and berries) of Pistacia lentiscus (PLEO) have been well characterized for their antibacterial and anti-inflammatory properties; however, poor information exists on their potential anticancer activity. Increasing concentrations of PLEO (0.01-0.1% v/v, 80-800 μg/ml) were administered to a wide variety of cultured cancer cells from breast, cervix, colon, liver, lung, prostate, and thyroid carcinomas. Fibroblasts were also included as healthy control cells. Cell viability was monitored by WST-8 assay up to 72 hours after PLEO administration. The intracellular formation of reactive oxygen species (ROS), the induction of apoptosis, and the enhancement of chemotherapeutic drug cytotoxicity by PLEO were further investigated in the most responsive cancer cell line. A dose-dependent reduction of tumor cell viability was observed upon PLEO exposure; while no cytotoxic effect was revealed in healthy fibroblasts. FTC-133 thyroid cancer cells were found to be the most sensitive cells to PLEO treatment; accordingly, an intracellular accumulation of ROS and an activation of both the extrinsic and intrinsic apoptotic pathways were evidenced in FTC-133 cells after PLEO administration. Furthermore, the cytotoxic effect of the antineoplastic drugs cisplatin, 5-fluorouracil and etoposide was enhanced in PLEO-exposed FTC-133 cells. Taking into account its mode of action, PLEO might be considered as a promising source of natural antitumor agents which might have therapeutic potential in integrated oncology.

Oxidative stress and apoptosis induction in human thyroid carcinoma cells exposed to the essential oil from Pistacia lentiscus aerial parts

PubMed Central

Catalani, Simona; Palma, Francesco; Battistelli, Serafina; Benedetti, Serena

2017-01-01

Background Essential oils from the aerial parts (leaves, twigs and berries) of Pistacia lentiscus (PLEO) have been well characterized for their antibacterial and anti-inflammatory properties; however, poor information exists on their potential anticancer activity. Methods Increasing concentrations of PLEO (0.01–0.1% v/v, 80–800 μg/ml) were administered to a wide variety of cultured cancer cells from breast, cervix, colon, liver, lung, prostate, and thyroid carcinomas. Fibroblasts were also included as healthy control cells. Cell viability was monitored by WST-8 assay up to 72 hours after PLEO administration. The intracellular formation of reactive oxygen species (ROS), the induction of apoptosis, and the enhancement of chemotherapeutic drug cytotoxicity by PLEO were further investigated in the most responsive cancer cell line. Results A dose-dependent reduction of tumor cell viability was observed upon PLEO exposure; while no cytotoxic effect was revealed in healthy fibroblasts. FTC-133 thyroid cancer cells were found to be the most sensitive cells to PLEO treatment; accordingly, an intracellular accumulation of ROS and an activation of both the extrinsic and intrinsic apoptotic pathways were evidenced in FTC-133 cells after PLEO administration. Furthermore, the cytotoxic effect of the antineoplastic drugs cisplatin, 5-fluorouracil and etoposide was enhanced in PLEO-exposed FTC-133 cells. Conclusion Taking into account its mode of action, PLEO might be considered as a promising source of natural antitumor agents which might have therapeutic potential in integrated oncology. PMID:28196126

13 CFR 127.506 - May a joint venture submit an offer on an EDWOSB or WOSB requirement?

Code of Federal Regulations, 2010 CFR

2010-01-01

... BUSINESS ADMINISTRATION WOMEN-OWNED SMALL BUSINESS FEDERAL CONTRACT ASSISTANCE PROCEDURES Federal Contract... applicable percentage of work required of the EDWOSB or WOSB offerors in accordance with § 125.6 of this...

32 CFR Appendix B to Part 310 - Sample Notification Letter

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2010-07-01

..., social security number, residential address, date of birth, office and home email address, office and... its Web site at http://www.consumer.gov/idtheft/con_steps.htm. The FTC urges that you immediately...

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..., social security number, residential address, date of birth, office and home email address, office and... its Web site at http://www.consumer.gov/idtheft/con_steps.htm. The FTC urges that you immediately...

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2011-01-01

... effected to the server maintained by the FTC for the purpose of receiving electronic filings. (iii) For... server or the date on which delivery of the attachments is effected to the designated offices as provided...

77 FR 13127 - Agency Information Collection Activities; Proposed Collection; Comment Request; Extension

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... electronics, small appliances, furniture, and other transactions. (Only consumer leases for more than four... transactions reflect a net decrease from prior FTC estimates, given current market conditions and the new PRA...

Campaign for Tobacco Free Kids

MedlinePlus

... about a “smoke-free world,” company should stop marketing cigarettes, fighting efforts to reduce smoking U.S. Tobacco ... 31, 2017 FTC Reports Cigarette and Smokeless Tobacco Marketing Rose to $8.9 Billion in 2015 – $1 ...

Acute HIV infection (AHI) in a specialized clinical setting: case-finding, description of virological, epidemiological and clinical characteristics.

PubMed

Ammassari, Adriana; Abbate, Isabella; Orchi, Nicoletta; Pinnetti, Carmela; Rozera, Gabriella; Libertone, Raffaella; Pierro, Paola; Martini, Federico; Puro, Vincenzo; Girardi, Enrico; Antinori, Andrea; Capobianchi, Maria Rosaria

2014-01-01

Diagnosis of HIV infection during early stages is mandatory to catch up with the challenge of limiting HIV viral replication and reservoirs formation, as well as decreasing HIV transmissions by immediate cART initiation. Aims were to describe (a) virological characteristics of AHI identified, (b) epidemiological and clinical factors associated with being diagnosed with AHI. Cross-sectional, retrospective study. All individuals diagnosed with AHI according to Fiebig's staging between Jan 2013 and Mar 2014 at the INMI "L. Spallanzani" were included. Serum samples reactive to a fourth generation HIV-1/2 assay (Architect HIV Ag/Ab Combo, Abbott) were retested with another fourth generation assay (VIDAS DUO HIV Ultra, Biomérieux) and underwent confirmation with HIV-1 WB (New Lav I Bio-Rad) and/or with Geenius confirmatory assay (Bio-Rad). WHO criteria (two env products reactivity) were used to establish positivity of confirmatory assays. In case of clinically suspected AHI, HIV-1 RNA (Real time, Abbott) and p24 assay (VIDAS HIV P24 Bio-Rad) were also performed. Avidity test was carried out, on confirmed positive samples lacking p31 reactivity, to discriminate between recent (true Fiebig V phase) and late infections; to avoid possible misclassifications, clinical data were also used. Demographic, epidemiological, clinical and laboratory data are routinely, and anonymously recorded in the SENDIH and SIREA studies. During the study period, we observed 483 newly HIV diagnosed individuals, of whom 40 were identified as AHI (8.3%). Fiebig classification showed: 7 stage II/III, 13 stage IV, 20 stage V. Demographic, epidemiological, and clinical characteristics of patients are shown in the Table. Overall, the study population had a median S/Co ratio at fourth generation EIA (Architect) of 49.50 (IQR, 23.54-98.05): values were significantly lower in Fiebig II-IV than in Fiebig V (38.68 [IQR, 20.08-54.84] vs 75.72 [IQR, 42.66-249.80], p=0.01). Overall, median HIV-1 RNA was 5.44 log copies/mL (IQR, 4.29-6.18) and the value observed in Fiebig phase II-IV was higher than that found in Fiebig stage V (6.10 [IQR, 5.49-7.00] vs 4.69 [3.71-5.44], p<0.001). Median CD4+ cell count was 596/mmc (IQR, 410-737). cART was started in 26 patients: TDF/FTC/DRV/r/RAL=18; TDF/FTC/DRV/r=2; TDF/FTC/ATV/r=2; TDF+FTC+EFV=2; TDF/FTC/RAL=1; DRV/r+RAL=1. Integration of careful epidemiological investigation, partner notification, and technical advances in virological testing are key elements in AHI case-finding. Significant differences were found between Fiebig stages II-IV and Fiebig V with regard to virological exams.

Changes in glomerular kidney function among HIV-1-uninfected men and women receiving emtricitabine-tenofovir disoproxil fumarate preexposure prophylaxis: a randomized clinical trial.

PubMed

Mugwanya, Kenneth K; Wyatt, Christina; Celum, Connie; Donnell, Deborah; Mugo, Nelly R; Tappero, Jordan; Kiarie, James; Ronald, Allan; Baeten, Jared M

2015-02-01

Tenofovir disoproxil fumarate (TDF) use has been associated with declines in the estimated glomerular filtration rate (eGFR) when used as part of antiretroviral treatment by persons with human immunodeficiency virus (HIV) type 1, but limited data are available for risk when used as preexposure prophylaxis (PrEP) for HIV-1 prevention. To determine whether TDF-based PrEP causes eGFR decline in HIV-1-uninfected adults. A per-protocol safety analysis of changes in eGFR in the Partners PrEP Study, a randomized, placebo-controlled trial of daily oral TDF and emtricitabine (FTC)-TDF PrEP among heterosexual HIV-1-uninfected members of serodiscordant couples in Kenya and Uganda. The trial was conducted from 2008 to 2012. Predefined outcomes of this analysis were mean eGFR change and a 25% or greater eGFR decline from baseline. The eGFR was calculated using the Chronic Kidney Disease Epidemiology Collaboration equation. Of 4640 participants in the once-daily TDF (n = 1548), FTC-TDF (n = 1545), or placebo (n = 1547) groups, 63% were men. At enrollment, median age was 35 years (range, 18-64 years), and mean eGFR was 130 mL/min/1.73 m². During a median follow-up of 18 months (interquartile range 12-27 months), mean within-group eGFR change from baseline was +0.14 mL/min/1.73 m² for TDF, -0.22 mL/min/1.73 m² for FTC-TDF, and +1.37 mL/min/1.73 m² for placebo, translating into average declines in eGFR attributable to PrEP vs placebo of -1.23 mL/min/1.73 m² (95% CI, -2.06 to -0.40; P = .004) for TDF and -1.59 mL/min/1.73 m² (95% CI, -2.44 to -0.74; P < .001) for FTC-TDF. The difference in mean eGFR between PrEP and placebo appeared by 1 month after randomization, was stable through 12 months, and then appeared to wane thereafter. The respective proportions of persons who developed a confirmed 25% or greater eGFR decline from baseline by 12 and 24 months was 1.3% and 1.8% for TDF and 1.2% and 2.5% for FTC-TDF, and these frequencies were not statistically different from the confirmed decline in the placebo group (0.9% and 1.3% by 12 and 24 months, respectively). In this large randomized, placebo-controlled trial among heterosexual persons, with median follow-up of 18 months and maximum follow-up of 36 months, daily oral TDF-based PrEP resulted in a small but nonprogressive decline in eGFR that was not accompanied by a substantial increase in the risk of clinically relevant (≥25%) eGFR decline. clinicaltrials.gov Identifier: NCT00557245.

Cost analysis of initial highly active antiretroviral therapy regimens for managing human immunodeficiency virus-infected patients according to clinical practice in a hospital setting

PubMed Central

Colombo, Giorgio L; Castagna, Antonella; Di Matteo, Sergio; Galli, Laura; Bruno, Giacomo; Poli, Andrea; Salpietro, Stefania; Carbone, Alessia; Lazzarin, Adriano

2014-01-01

Objective In the study reported here, single-tablet regimen (STR) versus (vs) multi-tablet regimen (MTR) strategies were evaluated through a cost analysis in a large cohort of patients starting their first highly active antiretroviral therapy (HAART). Adult human immunodeficiency virus (HIV) 1-naïve patients, followed at the San Raffaele Hospital, Milan, Italy, starting their first-line regimen from June 2008 to April 2012 were included in the analysis. Methods The most frequently used first-line HAART regimens (>10%) were grouped into two classes: 1) STR of tenofovir disoproxil fumarate (TDF) + emtricitabine (FTC) + efavirenz (EFV) and 2) MTR including TDF + FTC + EFV, TDF + FTC + atazanavir/ritonavir (ATV/r), TDF + FTC + darunavir/ritonavir (DRV/r), and TDF + FTC + lopinavir/ritoavir (LPV/r). Data were analyzed from the point of view of the Lombardy Regional Health Service. HAART, hospitalizations, visits, medical examinations, and other concomitant non-HAART drug costs were evaluated and price variations included. Descriptive statistics were calculated for baseline demographic, clinical, and laboratory characteristics; associations between categorical variables and type of antiretroviral strategy (STR vs MTR) were examined using chi-square or Fisher’s exact tests. At multivariate analysis, the generalized linear model was used to identify the predictive factors of the overall costs of the first-line HAART regimens. Results A total of 474 naïve patients (90% male, mean age 42.2 years, mean baseline HIV-RNA 4.50 log 10 copies/mL, and cluster of differentiation 4 [CD4+] count of 310 cells/μL, with a mean follow-up of 28 months) were included. Patients starting an STR treatment were less frequently antibody-hepatitis C virus positive (4% vs 11%, P=0.040), and had higher mean CD4+ values (351 vs 297 cells/μL, P=0.004) than MTR patients. The mean annual cost per patient in the STR group was €9,213.00 (range: €6,574.71–€33,570.00) and €14,277.00 (range: €5,908.89–€82,310.30) among MTR patients. At multivariate analysis, after adjustment for age, sex, antibody-hepatitis C virus status, HIV risk factors, baseline CD4+, and HIV-RNA, the cost analysis was significantly lower among patients starting an STR treatment than those starting an MTR (adjusted mean: €12,096.00 vs €16,106.00, P=0.0001). Conclusion STR was associated with a lower annual cost per patient than MTR, thus can be considered a cost-saving strategy in the treatment of HIV patients. This analysis is an important tool for policy makers and health care professionals to make short- and long-term cost projections and thus assess the impact of these on available budgets. PMID:24379676

7 CFR 1778.10 - Restrictions.

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Ethics, advertising and the definition of a profession.

PubMed Central

Dyer, A R

1985-01-01

In the climate of concern about high medical costs, the relationship between the trade and professional aspects of medical practice is receiving close scrutiny. In the United Kingdom there is talk of increasing privatisation of health services, and in the United States the Federal Trade Commission (FTC) has attempted to define medicine as a trade for the purposes of commercial regulation. The Supreme Court recently upheld the FTC charge that the American Medical Association (AMA) has been in restraint of trade because of ethical strictures against advertising. The concept of profession, as it has been analyzed in sociological, legal, philosophical, and historical perspectives, reveals the importance of an ethic of service as well as technical expertise as defining characteristics of professions. It is suggested that the medical profession should pay more attention to its service ideal at this time when doctors are widely perceived to be technically preoccupied. PMID:4009637

Pathogenesis-Related Proteins of Tomato 1

PubMed Central

Vera, Pablo; Conejero, Vicente

1988-01-01

An endoproteinase induced by citrus exocortis viroid has been purified from tomato (Lycopersicon esculentum Mill, cv “Rutgers”) leaves. The proteinase corresponds to one of the major pathogenesis-related proteins of tomato plants and was designated proteinase P-69 as it has a molecular weight of 69,000 to 70,000. The proteinase was purified in four steps: (NH4)2SO4 fractionation, chromatography on Bio-Gel P-60, DEAE-Sepharose chromatography, and casein-Sepharose affinity chromatography. The proteinase had a pH optimum of 8.5 to 9.0 when assayed with either fluorescein thiocarbamoyl derivative (FTC)-casein or FTC-ribulose 1,5-bisphosphate carboxylase/oxygenase as substrates. The proteinase activity was inhibited by pCMB and strongly activated by calcium and magnesium ions as well as by DTT. When analyzed by electrofocusing, the activity showed a pI around 9.0. Images Fig. 4 Fig. 8 PMID:16666127

Data-based fault-tolerant control for affine nonlinear systems with actuator faults.

PubMed

Xie, Chun-Hua; Yang, Guang-Hong

2016-09-01

This paper investigates the fault-tolerant control (FTC) problem for unknown nonlinear systems with actuator faults including stuck, outage, bias and loss of effectiveness. The upper bounds of stuck faults, bias faults and loss of effectiveness faults are unknown. A new data-based FTC scheme is proposed. It consists of the online estimations of the bounds and a state-dependent function. The estimations are adjusted online to compensate automatically the actuator faults. The state-dependent function solved by using real system data helps to stabilize the system. Furthermore, all signals in the resulting closed-loop system are uniformly bounded and the states converge asymptotically to zero. Compared with the existing results, the proposed approach is data-based. Finally, two simulation examples are provided to show the effectiveness of the proposed approach. Copyright © 2016 ISA. Published by Elsevier Ltd. All rights reserved.

The Developmental Process of the Growing Motile Ciliary Tip Region.

PubMed

Reynolds, Matthew J; Phetruen, Tanaporn; Fisher, Rebecca L; Chen, Ke; Pentecost, Brian T; Gomez, George; Ounjai, Puey; Sui, Haixin

2018-05-22

Eukaryotic motile cilia/flagella play vital roles in various physiological processes in mammals and some protists. Defects in cilia formation underlie multiple human disorders, known as ciliopathies. The detailed processes of cilia growth and development are still far from clear despite extensive studies. In this study, we characterized the process of cilium formation (ciliogenesis) by investigating the newly developed motile cilia of deciliated protists using complementary techniques in electron microscopy and image analysis. Our results demonstrated that the distal tip region of motile cilia exhibit progressive morphological changes as cilia develop. This developmental process is time-dependent and continues after growing cilia reach their full lengths. The structural analysis of growing ciliary tips revealed that B-tubules of axonemal microtubule doublets terminate far away from the tip end, which is led by the flagellar tip complex (FTC), demonstrating that the FTC might not directly mediate the fast turnover of intraflagellar transport (IFT).

Ethics, advertising and the definition of a profession.

PubMed

Dyer, A R

1985-06-01

In the climate of concern about high medical costs, the relationship between the trade and professional aspects of medical practice is receiving close scrutiny. In the United Kingdom there is talk of increasing privatisation of health services, and in the United States the Federal Trade Commission (FTC) has attempted to define medicine as a trade for the purposes of commercial regulation. The Supreme Court recently upheld the FTC charge that the American Medical Association (AMA) has been in restraint of trade because of ethical strictures against advertising. The concept of profession, as it has been analyzed in sociological, legal, philosophical, and historical perspectives, reveals the importance of an ethic of service as well as technical expertise as defining characteristics of professions. It is suggested that the medical profession should pay more attention to its service ideal at this time when doctors are widely perceived to be technically preoccupied.

Adaptive Fuzzy Output-Constrained Fault-Tolerant Control of Nonlinear Stochastic Large-Scale Systems With Actuator Faults.

PubMed

Li, Yongming; Ma, Zhiyao; Tong, Shaocheng

2017-09-01

The problem of adaptive fuzzy output-constrained tracking fault-tolerant control (FTC) is investigated for the large-scale stochastic nonlinear systems of pure-feedback form. The nonlinear systems considered in this paper possess the unstructured uncertainties, unknown interconnected terms and unknown nonaffine nonlinear faults. The fuzzy logic systems are employed to identify the unknown lumped nonlinear functions so that the problems of structured uncertainties can be solved. An adaptive fuzzy state observer is designed to solve the nonmeasurable state problem. By combining the barrier Lyapunov function theory, adaptive decentralized and stochastic control principles, a novel fuzzy adaptive output-constrained FTC approach is constructed. All the signals in the closed-loop system are proved to be bounded in probability and the system outputs are constrained in a given compact set. Finally, the applicability of the proposed controller is well carried out by a simulation example.

75 FR 27028 - Joint CFTC-SEC Advisory Committee on Emerging Regulatory Issues

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2010-05-13

... SECURITIES AND EXCHANGE COMMISSION [Release No. 33-9123; File No. 265-26] COMMODITY FUTURES... Exchange Commission (``SEC'') and Commodity Futures Trading Commission (``CFTC'') (each, an ``Agency,'' and... submit only information that you wish to make available publicly. Commodity Futures Trading Commission...

Comparison of clinical characteristics of patients with follicular thyroid carcinoma and Hürthle cell carcinoma.

PubMed

Ernaga Lorea, Ander; Migueliz Bermejo, Iranzu; Anda Apiñániz, Emma; Pineda Arribas, Javier; Toni García, Marta; Martínez de Esteban, Juan Pablo; Insausti Serrano, Ana María

2018-03-01

Hürthle cell carcinoma (HCC) is an uncommon thyroid cancer historically considered to be a variant of follicular thyroid carcinoma (FTC). The aim of this study was to assess the differences between these groups in terms of clinical factors and prognoses. A total of 230 patients (153 with FTC and 77 with HCC) with a median follow-up of 13.4 years were studied. The different characteristics were compared using SPSS version 20 statistical software. Patients with HCC were older (57.3±13.8 years vs. 44.6±15.2 years; P<.001). More advanced TNM stages were also seen in patients with HCC and a greater trend to distant metastases were also seen in patients with HCC (7.8% vs. 2.7%, P=.078). The persistence/recurrence rate at the end of follow-up was higher in patients with HCC (13% vs. 3.9%, P=.011). However, in a multivariate analysis, only age (hazard ratio [HR] 1.10, confidence interval [CI] 1.04-1.17; P=.001), size (HR 1.43, CI 1.05-1.94; P=.021), and histological subtype (HR 9.79, CI 2.35-40.81; P=.002), but not presence of HCC, were significantly associated to prognosis. HCC is diagnosed in older patients and in more advanced stages as compared to FTC. However, when age, size, and histological subtype are similar, disease-free survival is also similar in both groups. Copyright © 2018 SEEN y SED. Publicado por Elsevier España, S.L.U. All rights reserved.

Limited SHIV env diversification in macaques failing oral antiretroviral pre-exposure prophylaxis.

PubMed

Zheng, Qi; Ruone, Susan; Switzer, William M; Heneine, Walid; García-Lerma, J Gerardo

2012-05-09

Pre-exposure prophylaxis (PrEP) with daily Truvada [a combination of emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF)] is a novel HIV prevention strategy recently found to prevent HIV transmission among men who have sex with men and heterosexual couples. Acute infection in adherent persons who fail PrEP will inevitably occur under concurrent antiretroviral therapy, thus raising questions regarding the potential impact of PrEP on early viral dynamics. We investigated viral evolution dynamics in a macaque model of PrEP consisting of repeated rectal exposures to SHIV162P3 in the presence of PrEP. Four macaques were infected during daily or intermittent PrEP with FTC or FTC/TDF, and five were untreated controls. SHIV env sequence evolution was monitored by single genome amplification with phylogenetic and sequence analysis. Mean nucleotide divergence from transmitted founder viruses calculated 17 weeks (range = 12-20) post peak viremia was significantly lower in PrEP failures than in control animals (7.2 × 10-3 compared to 1.6 × 10-2 nucleotide substitutions per site per year, respectively, p < 0.0001). Mean virus diversity was also lower in PrEP failures after 17 weeks (0.13% vs. 0.53% in controls, p < 0.0001). Our results in a macaque model of acute HIV infection suggest that infection during PrEP limits early virus evolution likely because of a direct antiviral effect of PrEP and/or reduced target cell availability. Reduced virus diversification during early infection might enhance immune control by slowing the selection of escape mutants.

Inhibiting the phosphatidylinositide 3-kinase pathway blocks radiation-induced metastasis associated with Rho-GTPase and Hypoxia-inducible factor-1 activity.

PubMed

Burrows, Natalie; Telfer, Brian; Brabant, Georg; Williams, Kaye J

2013-09-01

Undifferentiated follicular and anaplastic thyroid tumours often respond poorly to radiotherapy and show increased metastatic potential. We evaluated radiation-induced effects on metastasis in thyroid carcinoma cells and tumours, mechanistically focusing on phosphatidylinositide 3-kinase (PI3K) and associated pathways. Migration was analysed in follicular (FTC133) and anaplastic (8505c) cells following radiotherapy (0-6 Gray) with concomitant pharmacological (GDC-0941) or genetic inhibition of PI3K. Hypoxia-inducible factor-1 (HIF-1)-activity was measured using luciferase reporter assays and was inhibited using a dominant-negative variant. Activation and subcellular localisation of target proteins were assessed via Western blot and immunofluorescence. In vivo studies used FTC133 xenografts with metastatic lung dissemination assessed ex vivo. Radiation induced migration in a HIF-dependent manner in FTC133 cells but decreased migration in 8505c's. Post-radiation HIF-activity correlated with migratory phenotype. PI3K-targeting inhibited migration under basal and irradiated conditions through inhibition of HIF-1α, Rho-GTPase expression/activity and localisation whilst having little effect on src/FAK. In vivo, radiation induced PI3K, HIF, Rho-GTPases and src but only PI3K, HIF and Rho-GTPases were inhibited by GDC-0941. Co-treatment with GDC-0941 and radiation significantly reduced metastatic dissemination versus radiotherapy alone. Radiation modifies metastatic characteristics of thyroid carcinoma cells, which can be successfully inhibited by targeting PI3K using GDC-0941 in vitro and in vivo. Copyright © 2013 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

Gelsolin: a novel thyroid hormone receptor-beta interacting protein that modulates tumor progression in a mouse model of follicular thyroid cancer.

PubMed

Kim, Caroline S; Furuya, Fumihiko; Ying, Hao; Kato, Yasuhito; Hanover, John A; Cheng, Sheue-yann

2007-03-01

Follicular thyroid cancer (FTC) is known to metastasize to distant sites via hematogenous spread; however, the underlying pathways that contribute to metastasis remain unknown. Recent creation of a knockin mutant mouse that expresses a mutant thyroid hormone receptor-beta (TRbeta(PV/PV) mouse) that spontaneously develops thyroid cancer with metastasis similar to humans has provided new opportunities to study contributors to FTC metastasis. This study evaluates the role of gelsolin, an actin-regulatory protein, in modulating the metastatic potential of FTC. Gelsolin was previously found by cDNA microarray analysis to be down-regulated in TRbeta(PV/PV) mice as compared with wild-type mice. This study found an age-dependent reduction of gelsolin protein abundance in TRbeta(PV/PV) mice as tumorigenesis progressed. Knockdown of gelsolin by small interfering RNA resulted in increased tumor cell motility and increased gelsolin expression by histone deacetylase inhibitor (trichostatin A) led to decreased cell motility. Additional biochemical analyses demonstrated that gelsolin physically interacted with TRbeta1 or PV in vivo and in vitro. The interaction regions were mapped to the C terminus of gelsolin and the DNA binding domain of TR. The physical interaction of gelsolin with PV reduced its binding to actin, leading to disarrayed cytoskeletal architectures. These results suggest that PV-induced alteration of the actin/gelsolin cytoskeleton contributes to increased cell motility. Thus, the present study uncovered a novel PV-mediated oncogenic pathway that could contribute to the local tumor progression and metastatic potential of thyroid carcinogenesis.

Effects of alkyl spacer group length on Vis-NIR absorption behavior in FTC-like guest-host EO polymers

NASA Astrophysics Data System (ADS)

Barto, Richard R., Jr.; Bedworth, Peter V.; Epstein, Joseph A.; Ermer, Susan P.; Taylor, Rebecca E.; Frank, Curtis W.

2003-07-01

Spectral absorption behavior of a series of FTC-like dyes of varying shape incorporated into amorphous polycarbonate (APC) is characterized by photothermal deflection spectroscopy. Previous Monte Carlo calculations by Dalton and Robinson predict a strong dependence of the macroscopic nonlinear optical susceptibility on the chromophore waist:length aspect ratio in electric field-poled films. This dependence arises from London interactions between chromophores, which are expected to influence the absorption characteristics of the composite both by changing the local polarity of the medium and through dipole interactions. It is expected that these interactions will play a role in the absorption characteristics of unpoled films as well. Of particular interest are the spectral characteristics of the red edge of the main dye electronic absorption peak, and the fine structure in the near-IR, dominated by overtones of fundamental C-H stretching and bending modes. The spectral structure in these key regions can be influenced by inter- and intramolecular interactions and conformational changes in the dye. The near-IR structure, in turn, will dictate absorption loss in optical devices prepared from these materials at key transmission wavelengths (1.3 and 1.55 um). In this study, a homologous series of spacer lengths, ranging from ethyl to hexyl, attached to an FTC-like NLO chromophore, LMCO-46M, is characterized by a combination of photothermal deflection spectroscopy (PDS) and UV-Vis spectroscopy to examine the effects of the molecular environment on near-IR loss at 1090 nm, 1300 nm and 1550 nm.

Genetic alterations in the phosphatidylinositol-3 kinase/Akt pathway in thyroid cancer.

PubMed

Xing, Mingzhao

2010-07-01

Aberrant activation of the phosphatidylinositol-3 kinase (PI3K)/Akt pathway plays a fundamental role in thyroid tumorigenesis, particularly in follicular thyroid cancer (FTC) and aggressive thyroid cancer, such as anaplastic thyroid cancer (ATC). As the drivers of this process, many genetic alterations activating the PI3K/Akt pathway have been identified in thyroid cancer in recent years. This review summarizes the current knowledge on major genetic alterations in the PI3K/Akt pathway. These include PIK3CA mutations and genomic amplification/copy gain, Ras mutations, PTEN mutations, RET/PTC and PPARgamma/Pax8 rearrangements, as well as amplification/copy gain of PIK3CB, PDK1, Akt, and various receptor tyrosine kinase genes. Most of these genetic alterations are particularly common in FTC and many of them are even more common in ATC; they are generally less common in papillary thyroid cancer (PTC), in which the MAP kinase (MAPK) pathway activated by the BRAF mutation instead plays a major role. Methylation and, thus, epigenetic silencing of PTEN, a major negative regulator of the PI3K/Akt pathway, occurs in close association with activating genetic alterations of the PI3K/Akt pathway, constituting a unique self-enhancement mechanism for this pathway. Many of these genetic alterations are mutually exclusive in differentiated thyroid tumors, but with increasing concurrence from benign tumors to FTC to ATC. RET/PTC, Ras, and receptor tyrosine kinase could dually activate the PI3K/Akt and MAPK pathways. Most cases of ATC harbor genetic alterations in these genes or other genetic combinations that can activate both pathways. It is proposed that genetic alterations in the PI3K/Akt pathway promote thyroid cell transformation to FTC and that genetic alterations in the MAPK pathway promote cell transformation to PTC; accumulation of multiple genetic alterations that can activate both pathways promotes thyroid cancer aggressiveness and progression to ATC. Genetic alterations are common in the PI3K/Akt pathway in thyroid cancer and play a fundamental role in the tumorigenesis and progression of this cancer. This provides a strong basis for the emerging development of novel genetic-based diagnostic, prognostic, and therapeutic strategies for thyroid cancer.

75 FR 7464 - Energy Efficient Building Systems Regional Innovation Cluster Initiative-Joint Federal Funding...

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... DEPARTMENT OF ENERGY Energy Efficient Building Systems Regional Innovation Cluster Initiative... Energy Efficient Building Systems Regional Innovation Cluster Initiative. A single proposal submitted by... systems design. The DOE funded Energy Efficient Building Systems Design Hub (the ``Hub'') will serve as a...

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76 FR 8713 - Pacific Fishery Management Council; Public Meeting

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2011-02-15

... purpose of the joint conference call is to consider any CPS-related fisheries research proposals that will... consider adopting for public review any proposals that are submitted. The CPSMT and CPSAS will discuss any EFP proposals, and will develop statements to be included in the March Council meeting record. Special...

78 FR 41609 - Energy Conservation Program for Consumer Products: Test Procedures for Refrigerators...

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.... Incomplete Cycling 6. Mechanical Temperature Controls 7. Ambient Temperature Gradient 8. Definitions.... at 29846-29847. A broad group of stakeholders \\1\\ submitted a joint comment supporting DOE's proposal... for variable defrost control (a control type in which the time interval between successive defrost...

5 CFR 2423.26 - Stipulations of fact submissions.

Code of Federal Regulations, 2010 CFR

2010-01-01

... required and must be submitted within 30 days of the joint motion. Upon receipt of the briefs, such motions... motion and decide the case through stipulation. (c) Stipulations to the Authority. Where the stipulation provides an adequate basis for application of established precedent and a decision by the Administrative...

40 CFR 304.33 - Arbitral decision and public comment.

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20 CFR 901.48 - Proposed findings and conclusions.

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2010-04-01

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... WREP. Arkansas Lower White-Bayou Des 08020301 CCPI and/or WREP. Arc. Arkansas Lower Arkansas... partners will help producers to voluntarily implement conservation practices that avoid, control, and trap... there groups of producers who may submit joint applications to address resource issues of common...

Mycoplasma columbinum Isolated From a Racing Pigeon ( Columba livia ) With Arthritis.

PubMed

Hellebuyck, Tom; Garmyn, An; De Cooman, Lien; Boyen, Filip; Pasmans, Frank; Martel, An

2014-09-01

A juvenile racing pigeon ( Columba livia ) was presented with drooping of the wing and inability to fly. On physical examination, the right shoulder joint was swollen. The pigeon was euthanatized and submitted for necropsy. An excessive amount of fibrin was present in the canalis triosseus with severe arthritis of the affected shoulder joint. A pure growth of Mycoplasma-like colonies was obtained on microbiological culture of the shoulder joint. A 16S ribosomal RNA gene-specific polymerase chain reaction assay was performed on the isolate and revealed 100% similarity with Mycoplasma columbinum . Although infectious arthritis in homing pigeons is primarily associated with paratyphoid and Streptococcus gallolyticus infection, clinical practitioners should consider the potential role of Mycoplasma columbinum in arthritis in pigeons.

77 FR 33460 - SES Performance Review Board

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75 FR 13471 - Telephone Consumer Protection

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2010-03-22

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Net Cetera: Chatting with Kids about Being Online

MedlinePlus

... smartwatches September 22, 2017 The price of free software? July 18, 2017 Ransomware re-do? Back up your files. June 27, 2017 New FTC website helps small businesses May 9, 2017 3 videos to help you be #CyberAware September 28, 2016 ...

DNA Mismatch Repair Deficiency Promotes Genomic Instability in a Subset of Papillary Thyroid Cancers.

PubMed

Javid, Mahsa; Sasanakietkul, Thanyawat; Nicolson, Norman G; Gibson, Courtney E; Callender, Glenda G; Korah, Reju; Carling, Tobias

2018-02-01

Efficient DNA damage repair by MutL-homolog DNA mismatch repair (MMR) enzymes, MLH1, MLH3, PMS1 and PMS2, are required to maintain thyrocyte genomic integrity. We hypothesized that persistent oxidative stress and consequent transcriptional dysregulation observed in thyroid follicles will lead to MMR deficiency and potentiate papillary thyroid tumorigenesis. MMR gene expression was analyzed by targeted microarray in 18 papillary thyroid cancer (PTC), 9 paracarcinoma normal thyroid (PCNT) and 10 normal thyroid (NT) samples. The findings were validated by qRT-PCR, and in follicular thyroid cancers (FTC) and follicular thyroid adenomas (FTA) for comparison. FOXO transcription factor expression was also analyzed. Protein expression was assessed by immunohistochemistry. Genomic integrity was evaluated by whole-exome sequencing-derived read-depth analysis and Mann-Whitney U test. Clinical correlations were assessed using Fisher's exact and t tests. Microarray and qRT-PCR revealed reduced expression of all four MMR genes in PTC compared with PCNT and of PMS2 compared with NT. FTC and FTA showed upregulation in MLH1, MLH3 and PMS2. PMS2 protein expression correlated with the mRNA expression pattern. FOXO1 showed lower expression in PMS2-deficient PTCs (log2-fold change -1.72 vs. -0.55, U = 11, p < 0.05 two-tailed). Rate of LOH, a measure of genomic instability, was higher in PMS2-deficient PTCs (median 3 and 1, respectively; U = 26, p < 0.05 two-tailed). No correlation was noted between MMR deficiency and clinical characteristics. MMR deficiency, potentially promoted by FOXO1 suppression, may explain the etiology for PTC development in some patients. FTC and FTA retain MMR activity and are likely caused by a different tumorigenic pathway.

Population-based study of survival for women with serous cancer of the ovary, fallopian tube, peritoneum or undesignated origin - on behalf of the Swedish gynecological cancer group (SweGCG).

PubMed

Dahm-Kähler, Pernilla; Borgfeldt, Christer; Holmberg, Erik; Staf, Christian; Falconer, Henrik; Bjurberg, Maria; Kjölhede, Preben; Rosenberg, Per; Stålberg, Karin; Högberg, Thomas; Åvall-Lundqvist, Elisabeth

2017-01-01

The aim of the study was to determine survival outcome in patients with serous cancer in the ovary, fallopian tube, peritoneum and of undesignated origin. Nation-wide population-based study of women≥18years with histologically verified non-uterine serous cancer, included in the Swedish Quality Registry for primary cancer of the ovary, fallopian tube and peritoneum diagnosed 2009-2013. Relative survival (RS) was estimated using the Ederer II method. Simple and multivariable analyses were estimated by Poisson regression models. Of 5627 women identified, 1246 (22%) had borderline tumors and 4381 had malignant tumors. In total, 2359 women had serous cancer; 71% originated in the ovary (OC), 9% in the fallopian tube (FTC), 9% in the peritoneum (PPC) and 11% at an undesignated primary site (UPS). Estimated RS at 5-years was 37%; for FTC 54%, 40% for OC, 34% for PPC and 13% for UPS. In multivariable regression analyses restricted to women who had undergone primary or interval debulking surgery for OC, FTC and PPC, site of origin was not independently associated with survival. Significant associations with worse survival were found for advanced stages (RR 2.63, P<0.001), moderate (RR 1.90, P<0.047) and poor differentiation (RR 2.20, P<0.009), neoadjuvant chemotherapy (RR1.33, P<0.022), residual tumor (RR 2.65, P<0.001) and platinum single (2.34, P<0.001) compared to platinum combination chemotherapy. Survival was poorer for serous cancer at UPS than for ovarian, fallopian tube and peritoneal cancer. Serous cancer at UPS needs to be addressed when reporting and comparing survival rates of ovarian cancer. Copyright © 2016 Elsevier Inc. All rights reserved.

Ultrasonic prediction of carcass merit in beef cattle: evaluation of technician effects on ultrasonic estimates of carcass fat thickness and longissimus muscle area.

PubMed

Perkins, T L; Green, R D; Hamlin, K E; Shepard, H H; Miller, M F

1992-09-01

The objective of this study was to determine technician effects of live animal ultrasonic estimates of fat thickness (FTU) and longissimus muscle area (LMAU). Steers (n = 36) representing four breed-types (Brown Swiss, Average Zebu-cross Mexican, Corriente Mexican, and typical British crossbred) of commercial slaughter cattle were isonified to estimate accuracy and repeatability of fat thickness (FT) and longissimus muscle area (LMA) measurements by two experienced technicians. Repeated measures of FTU and LMAU were taken by technicians on two consecutive days with an Aloka 500V ultrasound unit equipped with a 3.5-MHz, 172-mm scanning width, linear-array transducer. Ultrasonic estimates of fat thickness and LMAU were taken at the 12th and 13th rib interface 48 h before slaughter; carcass fat thickness (FTC) and longissimus muscle area (LMAC) were measured 48 h postmortem. Means for FTU, FTC, LMAU, and LMAC were .91 +/- .36 cm, .82 +/- .40 cm, 70.7 +/- 9.43 cm2, and 72.4 +/- 8.9 cm2, respectively. Ultrasound and carcass measures of FT and LMA were different (P less than .01) among breed-types but were not different (P greater than .10) between technicians or for technician x breed-type interactions. Pooled simple correlation coefficients (P less than .01) were .87 and .86 between FTU and FTC and .76 and .82 between LMAU and LMAC for Technicians 1 and 2, respectively. Repeatabilities estimated by intraclass correlation methods were .91 +/- .03 and .81 +/- .06 for images repeated over 2 d and .95 +/- .02 and .83 +/- .05 for images repeated by two technicians for FT and LMA, respectively.(ABSTRACT TRUNCATED AT 250 WORDS)

Weight and lean body mass change with antiretroviral initiation and impact on bone mineral density.

PubMed

Erlandson, Kristine M; Kitch, Douglas; Tierney, Camlin; Sax, Paul E; Daar, Eric S; Tebas, Pablo; Melbourne, Kathleen; Ha, Belinda; Jahed, Nasreen C; McComsey, Grace A

2013-08-24

To compare the effect that initiating different antiretroviral therapy (ART) regimens has on weight, BMI, and lean body mass (LBM) and explore how changes in body composition are associated with bone mineral density (BMD). A5224s was a sub-study of A5202, a prospective trial of 1857 ART-naive participants randomized to blinded abacavir-lamivudine (ABC/3TC) or tenofovir DF-emtricitabine (TDF/FTC) with open-label efavirenz (EFV) or atazanavir-ritonavir (ATV/r). All participants underwent dual-energy absorptiometry (DXA) and abdominal computed tomography for body composition. Analyses used two-sample t-tests and linear regression. A5224s included 269 participants: 85% men, 47% white non-Hispanic, median age 38 years, HIV-1 RNA 4.6 log10 copies/ml, and CD4 cell count 233 cells/μl. Overall, significant gains occurred in weight, BMI, and LBM at 96 weeks post-randomization (all P<0.001). Assignment to ATV/r (vs. EFV) resulted in significantly greater weight (mean difference 3.35 kg) and BMI gain (0.88 kg/m; both P=0.02), but not LBM (0.67 kg; P=0.15), whereas ABC/3TC and TDF/FTC were not significantly different (P≥0.10). In multivariable analysis, only lower baseline CD4 cell count and higher HIV-1 RNA were associated with greater increase in weight, BMI, or LBM. In multivariable analyses, increased LBM was associated with an increased hip BMD. ABC/3TC vs. TDF/FTC did not differ in change in weight, BMI, or LBM; ATV/r vs. EFV resulted in greater weight and BMI gain but not LBM. A positive association between increased LBM and increased hip BMD should be further investigated through prospective interventional studies to verify the impact of increased LBM on hip BMD.

Randomized Controlled Trial of Daily Text Messages to Support Adherence to Preexposure Prophylaxis in Individuals at Risk for Human Immunodeficiency Virus: The TAPIR Study.

PubMed

Moore, David J; Jain, Sonia; Dubé, Michael P; Daar, Eric S; Sun, Xiaoying; Young, Jason; Corado, Katya; Ellorin, Eric; Milam, Joel; Collins, Deborah; Blumenthal, Jill; Best, Brookie M; Anderson, Peter; Haubrich, Richard; Morris, Sheldon R

2018-05-02

Adherence is critical for efficacy of tenofovir disoproxil fumarate/emtricitabine (FTC) as preexposure prophylaxis (PrEP). Between February 2013 and February 2016, 398 men who have sex with men and transgender women were randomized 1:1 to receive individualized texting for adherence building (iTAB) or standard care (SoC) for 48 weeks. The primary endpoint was dried blood spot (DBS) tenofovir diphosphate (TFV-DP) concentrations at both week 12 and the last on-drug visit of >719 fmol/punch (ie, adequate adherence). Secondary outcomes included DBS TFV-DP concentrations of >1246 fmol/punch (ie, near-perfect adherence) and plasma FTC >350 ng/mL (consistent with dosing within the past 24 hours). Concentrations >719 fmol/punch of TFV-DP were found in 88.6% of participants at week 12 and 82.5% at week 48. For the primary endpoint, the study arms did not differ (72.0% in iTAB and 69.2% in SoC; P > .05). For the secondary composite endpoint of >1246 fmol/punch the iTAB arm was superior to SoC (33.5% vs 24.8%; P = .06), reaching statistical significance when adjusting for age (odds ratio, 1.56 [95% confidence interval, 1.00-2.42]; P < .05). At week 48, iTAB was superior to SoC for near-perfect adherence (51.0% vs 37.4%; P = .02). At week 12, iTAB was superior to SoC for dosing in past 24 hours by plasma FTC (47.5% vs 33.3%; P = .007), but not at weeks 24, 36, and 48 (all P > .05). Automated text messaging is a low-burden tool that improves durability of near-perfect PrEP adherence. NCT01761643.

Marketing nutrition & health-related benefits of food & beverage products: enforcement, litigation & liability issues.

PubMed

Roller, Sarah; Pippins, Raqiyyah

2010-01-01

Over the past decade, the liability risks associated with food and beverage product marketing have increased significantly, particularly with respect to nutrition and health-related product benefit claims. FDA and FTC enforcement priorities appear to have contributed to the increasing liability trends that are associated with these nutrition and health-related claims. This article examines key enforcement and litigation developments involving conventional food and beverage product marketing claims during the first 18 months of President Obama's administration: Part I considers FDA enforcement priorities and recent warning letters; Part II considers FTC enforcement priorities, warning letters, and consent orders; and Part III considers the relationship between FDA and FTC enforcement priorities and recent false advertising cases brought by private parties challenging nutrition and health-related marketing claims for food and beverage products. The article makes recommendations concerning ways in which food and beverage companies can help minimize liability risks associated with health-related marketing claims. In addition, the article suggests that federal policy reforms may be required to counter the perverse chilling effects current food liability trends appear to be having on health-related marketing claims for food and beverage products, and proposes a number of specific reforms that would help encourage the responsible use of well-substantiated marketing claims that can help foster healthy dietary practices. In view of the obesity prevention and other diet-related public health priorities of the Obama administration, the article suggests that this is an opportune time to address the apparent chilling effects increasing food liability risks are having on nutrition and health-related marketing claims for healthy food and beverage products, and potential adverse consequences for public health.

Non-daily pre-exposure prophylaxis for HIV prevention

PubMed Central

Anderson, Peter L.; García-Lerma, J. Gerardo; Heneine, Walid

2015-01-01

Purpose of review To discuss non-daily pre-exposure prophylaxis (PrEP) modalities that may provide advantages compared with daily PrEP in cost and cumulative toxicity, but may have lower adherence forgiveness. Recent Findings Animal models have informed our understanding of early viral transmission events, which help guide event-driven PrEP dosing strategies. These models indicate early establishment of viral replication in rectal or cervicovaginal tissues, so event-driven PrEP should rapidly deliver high mucosal drug concentrations within hours of the potential exposure event. Macaque models have demonstrated the high biological efficacy for event-driven dosing of oral tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) against both vaginal and rectal virus transmission. In humans, the IPERGAY study demonstrated 86% efficacy for event-driven oral TDF/FTC dosing among men who have sex with men (MSM), while no similar efficacy data are available on women or heterosexual men. The HPTN 067 study showed that certain MSM populations adhere well to non-daily PrEP while other populations of women adhere more poorly to non-daily versus daily regimens. Pharmacokinetic studies following oral TDF/FTC dosing in humans, indicate that TFV-diphosphate (the active form of TFV) accumulates to higher concentrations in rectal versus cervicovaginal tissue but non-adherence in trials complicates the interpretation of differential mucosal drug concentrations. Summary Event-driven dosing for TFV-based PrEP has promise for HIV prevention in MSM. Future research of event-driven PrEP in women and heterosexual men should be guided by a better understanding of the importance of mucosal drug concentrations for PrEP efficacy and its sensitivity to adherence. PMID:26633641

Cost-effectiveness analysis of dolutegravir plus backbone compared with raltegravir plus backbone, darunavir+ritonavir plus backbone and efavirenz/tenofovir/emtricitabine in treatment naïve and experienced HIV-positive patients.

PubMed

Restelli, Umberto; Rizzardini, Giuliano; Antinori, Andrea; Lazzarin, Adriano; Bonfanti, Marzia; Bonfanti, Paolo; Croce, Davide

2017-01-01

In January 2014, the European Medicines Agency issued a marketing authorization for dolutegravir (DTG), a second-generation integrase strand transfer inhibitor for HIV treatment. The study aimed at determining the incremental cost-effectiveness ratio (ICER) of the use of DTG+backbone compared with raltegravir (RAL)+backbone, darunavir (DRV)+ritonavir(r)+backbone and efavirenz/tenofovir/emtricitabine (EFV/TDF/FTC) in HIV-positive treatment-naïve patients and compared with RAL+backbone in treatment-experienced patients, from the Italian National Health Service's point of view. A published Monte Carlo Individual Simulation Model (ARAMIS-DTG model) was used to perform the analysis. Patients pass through mutually exclusive health states (defined in terms of diagnosis of HIV with or without opportunistic infections [OIs] and cardiovascular disease [CVD]) and successive lines of therapy. The model considers costs (2014) and quality of life per monthly cycle in a lifetime horizon. Costs and quality-adjusted life years (QALYs) are dependent on OI, CVD, AIDS events, adverse events and antiretroviral therapies. In treatment-naïve patients, DTG dominates RAL; compared with DRV/r, the ICER obtained is of 38,586 €/QALY (6,170 €/QALY in patients with high viral load) and over EFV/TDF/FTC, DTG generates an ICER of 33,664 €/QALY. In treatment-experienced patients, DTG compared to RAL leads to an ICER of 12,074 €/QALY. The use of DTG+backbone may be cost effective in treatment-naïve and treatment-experienced patients compared with RAL+backbone and in treatment-naïve patients compared with DRV/r+backbone and EFV/TDF/FTC considering a threshold of 40,000 €/QALY.

Early virologic response to abacavir/lamivudine and tenofovir/emtricitabine during ACTG A5202

PubMed Central

Grant, Philip M.; Tierney, Camlin; Budhathoki, Chakra; Daar, Eric S.; Sax, Paul E.; Collier, Ann C.; Fischl, Margaret A.; Zolopa, Andrew R.; Balamane, Maya; Katzenstein, David

2014-01-01

Background ACTG A5202 randomized treatment-naive individuals to tenofovir-emtricitabine (TDF/FTC) or abacavir-lamivudine (ABC/3TC) combined with efavirenz (EFV) or atazanavir/ritonavir (ATV/r). Individuals in the high screening viral load (VL) stratum (≥100,000 copies/mL) had increased rates of virologic failure with ABC/3TC. Objective Compare regimen-specific early virologic response. Methods Using Wilcoxon rank-sum tests, we compared regimen-specific VL changes from entry to week 4 in A5202 subjects (n=1813) and from entry to week 1, 2 and 4 in a 179-patient substudy. We evaluated associations between week 4 VL change and time to virologic failure with Cox proportional-hazards models. Results TDF/FTC- and ABC/3TC produced similar Week 4 viral load declines in the entire study population and in the high VL stratum. EFV produced greater VL declines from baseline at week 4 than ATV/r (median −2.1 vs. −1.9 log10 copies/mL; p<0.001). In the substudy of subjects with week 1, 2 and 4 VL data, there was no difference in viral load decline in those randomized to TDF/FTC versus ABC/3TC, but EFV resulted in greater VL decline from entry at each of these timepoints than ATV/r. Smaller Week 4 viral load decline was associated with increased risk of virologic failure. Conclusions Within all treatment arms, a less robust week 4 virologic response was associated with higher risk for subsequent virologic failure. However, between-regimen differences in week 4 VL declines did not parallel the previously reported differences in longer term virologic efficacy in A5202, suggesting that between-regimen differences in responses were not due to intrinsic differences in antiviral activity. PMID:24334181

Population pharmacokinetic analysis of carboxyhaemoglobin concentrations in adult cigarette smokers.

PubMed

Cronenberger, Carol; Mould, Diane R; Roethig, Hans-Juergen; Sarkar, Mohamadi

2008-01-01

To develop a population-based model to describe and predict the pharmacokinetics of carboxyhaemoglobin (COHb) in adult smokers. Data from smokers of different conventional cigarettes (CC) in three open-label, randomized studies were analysed using NONMEM (version V, Level 1.1). COHb concentrations were determined at baseline for two cigarettes [Federal Trade Commission (FTC) tar 11 mg; CC1, or FTC tar 6 mg; CC2]. On day 1, subjects were randomized to continue smoking their original cigarettes, switch to a different cigarette (FTC tar 1 mg; CC3), or stop smoking. COHb concentrations were measured at baseline and on days 3 and 8 after randomization. Each cigarette was treated as a unit dose assuming a linear relationship between the number of cigarettes smoked and measured COHb percent saturation. Model building used standard methods. Model performance was evaluated using nonparametric bootstrapping and predictive checks. The data were described by a two-compartment model with zero-order input and first-order elimination with endogenous COHb. Model parameters included elimination rate constant (k(10)), central volume of distribution (Vc/F), rate constants between central and peripheral compartments (k(12) and k(21)), baseline COHb concentrations (c0), and relative fraction of carbon monoxide absorbed (F1). The median (range) COHb half-lives were 1.6 h (0.680-2.76) and 30.9 h (7.13-367) (alpha and beta phases, respectively). F1 increased with increasing cigarette tar content and age, whereas k(12) increased with ideal body weight. A robust model was developed to predict COHb concentrations in adult smokers and to determine optimum COHb sampling times in future studies.

Changes in renal function associated with oral emtricitabine/tenofovir disoproxil fumarate use for HIV pre-exposure prophylaxis

PubMed Central

Solomon, Marc M.; Lama, Javier R.; Glidden, David V.; Mulligan, Kathleen; McMahan, Vanessa; Liu, Albert Y.; Guanira, Juan Vicente; Veloso, Valdilea G.; Mayer, Kenneth H.; Chariyalertsak, Suwat; Schechter, Mauro; Bekker, Linda-Gail; Kallás, Esper Georges; Burns, David N.; Grant, Robert M.

2014-01-01

Objective: Tenofovir disoproxil fumarate (TDF) pre-exposure prophylaxis decreases sexual acquisition of HIV infection. We sought to evaluate the renal safety of TDF in HIV-uninfected persons. Design and methods: The Iniciativa Profilaxis Pre-Exposición (iPrEx) study randomly assigned 2499 HIV-seronegative men and transgender women who have sex with men (MSM) to receive oral daily TDF coformulated with emtricitabine (FTC/TDF) or placebo. Serum creatinine and phosphorus during randomized treatment and after discontinuation were measured, and creatinine clearance (CrCl) was estimated by the Cockcroft–Gault equation. Indicators of proximal renal tubulopathy (fractional excretion of phosphorus and uric acid, urine protein, and glucose) were measured in a substudy. Results: There was a small but statistically significant decrease in CrCl from baseline in the active arm, compared to placebo, which was first observed at week 4 (mean change: −2.4 vs. −1.1 ml/min; P = 0.02), persisted through the last on-treatment visit (mean change: +0.3 vs. +1.8 ml/min; P = 0.02), and resolved after stopping pre-exposure prophylaxis (mean change: −0.1 vs. 0.0 ml/min; P = 0.83). The effect was confirmed when stratifying by drug detection. The effect of FTC/TDF on CrCl did not vary by race, age, or history of hypertension. There was no difference in serum phosphate trends between the treatment arms. In the substudy, two participants receiving placebo had indicators of tubulopathy. Conclusions: In HIV-seronegative MSM, randomization to FTC/TDF was associated with a very mild nonprogressive decrease in CrCl that was reversible and managed with routine serum creatinine monitoring. PMID:24499951

Comparison of image quality and radiation dose between fixed tube current and combined automatic tube current modulation in craniocervical CT angiography.

PubMed

Lee, E J; Lee, S K; Agid, R; Howard, P; Bae, J M; terBrugge, K

2009-10-01

The combined automatic tube current modulation (ATCM) technique adapts and modulates the x-ray tube current in the x-y-z axis according to the patient's individual anatomy. We compared image quality and radiation dose of the combined ATCM technique with those of a fixed tube current (FTC) technique in craniocervical CT angiography performed with a 64-section multidetector row CT (MDCT) system. A retrospective review of craniocervical CT angiograms (CTAs) by using combined ATCM (n = 25) and FTC techniques (n = 25) was performed. Other CTA parameters, such as kilovolt (peak), matrix size, FOV, section thickness, pitch, contrast agent, and contrast injection techniques, were held constant. We recorded objective image noise in the muscles at 2 anatomic levels: radiation exposure doses (CT dose index volume and dose-length product); and subjective image quality parameters, such as vascular delineation of various arterial vessels, visibility of small arterial detail, image artifacts, and certainty of diagnosis. The Mann-Whitney U test was used for statistical analysis. No significant difference was detected in subjective image quality parameters between the FTC and combined ATCM techniques. Most subjects in both study groups (49/50, 98%) had acceptable subjective artifacts. The objective image noise values at shoulder level did not show a significant difference, but the noise value at the upper neck was higher with the combined ATCM (P < .05) technique. Significant reduction in radiation dose (18% reduction) was noted with the combined ATCM technique (P < .05). The combined ATCM technique for craniocervical CTA performed at 64-section MDCT substantially reduced radiation exposure dose but maintained diagnostic image quality.

Climate Change Across Seasons Experiment (CCASE): A new method for simulating future climate in seasonally snow-covered ecosystems.

PubMed

Templer, Pamela H; Reinmann, Andrew B; Sanders-DeMott, Rebecca; Sorensen, Patrick O; Juice, Stephanie M; Bowles, Francis; Sofen, Laura E; Harrison, Jamie L; Halm, Ian; Rustad, Lindsey; Martin, Mary E; Grant, Nicholas

2017-01-01

Climate models project an increase in mean annual air temperatures and a reduction in the depth and duration of winter snowpack for many mid and high latitude and high elevation seasonally snow-covered ecosystems over the next century. The combined effects of these changes in climate will lead to warmer soils in the growing season and increased frequency of soil freeze-thaw cycles (FTCs) in winter due to the loss of a continuous, insulating snowpack. Previous experiments have warmed soils or removed snow via shoveling or with shelters to mimic projected declines in the winter snowpack. To our knowledge, no experiment has examined the interactive effects of declining snowpack and increased frequency of soil FTCs, combined with soil warming in the snow-free season on terrestrial ecosystems. In addition, none have mimicked directly the projected increase in soil FTC frequency in tall statured forests that is expected as a result of a loss of insulating snow in winter. We established the Climate Change Across Seasons Experiment (CCASE) at Hubbard Brook Experimental Forest in the White Mountains of New Hampshire in 2012 to assess the combined effects of these changes in climate on a variety of pedoclimate conditions, biogeochemical processes, and ecology of northern hardwood forests. This paper demonstrates the feasibility of creating soil FTC events in a tall statured ecosystem in winter to simulate the projected increase in soil FTC frequency over the next century and combines this projected change in winter climate with ecosystem warming throughout the snow-free season. Together, this experiment provides a new and more comprehensive approach for climate change experiments that can be adopted in other seasonally snow-covered ecosystems to simulate expected changes resulting from global air temperature rise.

Food marketing expenditures aimed at youth: putting the numbers in context.

PubMed

Powell, Lisa M; Harris, Jennifer L; Fox, Tracy

2013-10-01

In response to concerns about childhood obesity, the Federal Trade Commission (FTC) released two reports documenting food and beverage marketing expenditures to children and adolescents. The recently released 2012 report found an inflation-adjusted 19.5% reduction in marketing expenditures targeted to youth from $2.1 billion in 2006 to $1.8 billion in 2009. The current article highlights features of the FTC's analysis, examines how expenditures relate to youth exposure to food marketing, and assesses changes in the nutritional content of marketed products. Of the $304.0 million decline in expenditures, $117.8 million (38.7%) was from a decline in premium (i.e., restaurant children's meal toys) expenditures rather than direct marketing. Although inflation-adjusted TV expenditures fell by 19.4%, children and teens still see 12-16 TV advertisements (ads)/day for products generally high in saturated fat, sugar, or sodium. In addition, newer digital forms of unhealthy food and beverage marketing to youths are increasing; the FTC reported an inflation-adjusted 50.7% increase in new media marketing expenditures. The self-regulatory Children's Food and Beverage Advertising Initiative (CFBAI) is limited in scope and effectiveness: expenditures increased for many noncovered marketing techniques (i.e., product placement, movie/video, cross-promotion licenses, athletic sponsorship, celebrity fees, events, philanthropy, and other); only two restaurants are members of CFBAI, and nonpremium restaurant marketing expenditures were up by $86.0 million (22.5% inflation-adjusted increase); industry pledges do not protect children aged >11 years, and some marketing appears to have shifted to older children; and, nutritional content remains poor. Continued monitoring of and improvements to food marketing to youth are needed. © 2013 American Journal of Preventive Medicine.

Determination of nucleoside analog mono-, di-, and tri-phosphates in cellular matrix by solid phase extraction and ultra-sensitive LC-MS/MS detection.

PubMed

Bushman, Lane R; Kiser, Jennifer J; Rower, Joseph E; Klein, Brandon; Zheng, Jia-Hua; Ray, Michelle L; Anderson, Peter L

2011-09-10

An ultra-sensitive liquid chromatography tandem mass spectrometry (LC-MS/MS) assay was developed and validated to facilitate the assessment of clinical pharmacokinetics of nucleotide analogs from lysed intracellular matrix. The method utilized a strong anion exchange isolation of mono-(MP), di-(DP), and tri-phosphates (TP) from intracellular matrix. Each fraction was then dephosphorylated to the parent moiety yielding a molar equivalent to the original nucleotide analog intracellular concentration. The analytical portion of the methodology was optimized in specific nucleoside analog centric modes (i.e. tenofovir (TFV) centric, zidovudine (ZDV) centric), which included desalting/concentration by solid phase extraction and detection by LC-MS/MS. Nucleotide analog MP-, DP-, and TP-determined on the TFV centric mode of analysis include TFV, lamivudine (3TC), and emtricitibine (FTC). The quantifiable linear range for TFV was 2.5-2000 fmol/sample, and that for 3TC/FTC was 0.1 200 pmol/sample. Nucleoside analog MP-, DP-, and TP-determined on the ZDV centric mode of analysis included 3TC and ZDV. The quantifiable linear range for 3TC was 0.1 100 pmol/sample, and 5-2000 fmol/sample for ZDV. Stable labeled isotopic internal standards facilitated accuracy and precision in alternative cell matrices, which supported the intended use of the method for MP, DP, and TP determinations in various cell types. The method was successfully applied to clinical research samples generating novel intracellular information for TFV, FTC, ZDV, and 3TC nucleotides. This document outlines method development, validation, and application to clinical research. Copyright © 2011 Elsevier B.V. All rights reserved.

Changes in renal function associated with oral emtricitabine/tenofovir disoproxil fumarate use for HIV pre-exposure prophylaxis.

PubMed

Solomon, Marc M; Lama, Javier R; Glidden, David V; Mulligan, Kathleen; McMahan, Vanessa; Liu, Albert Y; Guanira, Juan Vicente; Veloso, Valdilea G; Mayer, Kenneth H; Chariyalertsak, Suwat; Schechter, Mauro; Bekker, Linda-Gail; Kallás, Esper Georges; Burns, David N; Grant, Robert M

2014-03-27

Tenofovir disoproxil fumarate (TDF) pre-exposure prophylaxis decreases sexual acquisition of HIV infection. We sought to evaluate the renal safety of TDF in HIV-uninfected persons. The Iniciativa Profilaxis Pre-Exposición (iPrEx) study randomly assigned 2499 HIV-seronegative men and transgender women who have sex with men (MSM) to receive oral daily TDF coformulated with emtricitabine (FTC/TDF) or placebo. Serum creatinine and phosphorus during randomized treatment and after discontinuation were measured, and creatinine clearance (CrCl) was estimated by the Cockcroft-Gault equation. Indicators of proximal renal tubulopathy (fractional excretion of phosphorus and uric acid, urine protein, and glucose) were measured in a substudy. There was a small but statistically significant decrease in CrCl from baseline in the active arm, compared to placebo, which was first observed at week 4 (mean change: -2.4 vs. -1.1 ml/min; P=0.02), persisted through the last on-treatment visit (mean change: +0.3 vs. +1.8 ml/min; P=0.02), and resolved after stopping pre-exposure prophylaxis (mean change: -0.1 vs. 0.0 ml/min; P=0.83). The effect was confirmed when stratifying by drug detection. The effect of FTC/TDF on CrCl did not vary by race, age, or history of hypertension. There was no difference in serum phosphate trends between the treatment arms. In the substudy, two participants receiving placebo had indicators of tubulopathy. In HIV-seronegative MSM, randomization to FTC/TDF was associated with a very mild nonprogressive decrease in CrCl that was reversible and managed with routine serum creatinine monitoring.

Climate Change Across Seasons Experiment (CCASE): A new method for simulating future climate in seasonally snow-covered ecosystems

PubMed Central

Templer, Pamela H.; Reinmann, Andrew B.; Sanders-DeMott, Rebecca; Sorensen, Patrick O.; Juice, Stephanie M.; Bowles, Francis; Sofen, Laura E.; Harrison, Jamie L.; Halm, Ian; Rustad, Lindsey; Martin, Mary E.; Grant, Nicholas

2017-01-01

Climate models project an increase in mean annual air temperatures and a reduction in the depth and duration of winter snowpack for many mid and high latitude and high elevation seasonally snow-covered ecosystems over the next century. The combined effects of these changes in climate will lead to warmer soils in the growing season and increased frequency of soil freeze-thaw cycles (FTCs) in winter due to the loss of a continuous, insulating snowpack. Previous experiments have warmed soils or removed snow via shoveling or with shelters to mimic projected declines in the winter snowpack. To our knowledge, no experiment has examined the interactive effects of declining snowpack and increased frequency of soil FTCs, combined with soil warming in the snow-free season on terrestrial ecosystems. In addition, none have mimicked directly the projected increase in soil FTC frequency in tall statured forests that is expected as a result of a loss of insulating snow in winter. We established the Climate Change Across Seasons Experiment (CCASE) at Hubbard Brook Experimental Forest in the White Mountains of New Hampshire in 2012 to assess the combined effects of these changes in climate on a variety of pedoclimate conditions, biogeochemical processes, and ecology of northern hardwood forests. This paper demonstrates the feasibility of creating soil FTC events in a tall statured ecosystem in winter to simulate the projected increase in soil FTC frequency over the next century and combines this projected change in winter climate with ecosystem warming throughout the snow-free season. Together, this experiment provides a new and more comprehensive approach for climate change experiments that can be adopted in other seasonally snow-covered ecosystems to simulate expected changes resulting from global air temperature rise. PMID:28207766

It Pays to Advertise...Truthfully

ERIC Educational Resources Information Center

Bender, Louis W.

1975-01-01

Many colleges are using commercial advertising techniques as an aid to recruitment. Federal Trade Commission safeguards against false or misleading advertising currently apply to proprietary schools, and may soon be applied to private non-profit and public schools as well. Administrators should apprise themselves of FTC standards. (NHM)

75 FR 55269 - Telemarketing Sales Rule Fees

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-10

... FEDERAL TRADE COMMISSION 16 CFR Part 310 RIN 3084-AA98 Telemarketing Sales Rule Fees AGENCY: Federal Trade Commission. ACTION: Policy statement. SUMMARY: The Federal Trade Commission (the ``Commission'' or ``FTC'') is giving notice that there will be no increase in the fees charged to entities...

76 FR 49479 - Franchise Rule Information Collection Activities; Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-10

... FEDERAL TRADE COMMISSION Franchise Rule Information Collection Activities; Proposed Collection... Concerning Franchising (``Franchise Rule''). That clearance expires on December 31, 2011. DATES: Comments... INFORMATION section below. Write ``Franchise Rule, PRA Comment, FTC File No. P094400'' on your comment, and...

Modeling and prediction of relaxation of polar order in high-activity nonlinear optical polymers

NASA Astrophysics Data System (ADS)

Guenthner, Andrew J.; Lindsay, Geoffrey A.; Wright, Michael E.; Fallis, Stephen; Ashley, Paul R.; Sanghadasa, Mohan

2007-09-01

Mach-Zehnder optical modulators were fabricated using the CLD and FTC chromophores in polymer-on-silicon optical waveguides. Up to 17 months of oven-ageing stability are reported for the poled polymer films. Modulators containing an FTC-polyimide had the best over all aging performance. To model and extrapolate the ageing data, a relaxation correlation function attributed to A. K. Jonscher was compared to the well-established stretched exponential correlation function. Both models gave a good fit to the data. The Jonscher model predicted a slower relaxation rate in the out years. Analysis showed that collecting data for a longer period relative to the relaxation time was more important for generating useful predictions than the precision with which individual model parameters could be estimated. Thus from a practical standpoint, time-temperature superposition must be assumed in order to generate meaningful predictions. For this purpose, Arrhenius-type expressions were found to relate the model time constants to the ageing temperatures.

The future of pre-exposure prophylaxis (PrEP) for human immunodeficiency virus (HIV) infection.

PubMed

Özdener, Ayşe Elif; Park, Tae Eun; Kalabalik, Julie; Gupta, Rachna

2017-05-01

People at high risk for HIV acquisition should be offered pre-exposure prophylaxis (PrEP). Tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) is currently the only medication recommended for pre-exposure prophylaxis (PrEP) by the Centers for Disease Control and Prevention (CDC) in people at high risk for HIV acquisition. This article will review medications currently under investigation and the future landscape of PrEP therapy. Areas covered: This article will review clinical trials that have investigated nontraditional regimens of TDF/FTC, antiretroviral agents from different drug classes such as integrase strand transfer inhibitors (INSTI), nucleoside reverse transcriptase inhibitors (NRTI), and non-nucleoside reverse transcriptase inhibitors (NNRTI) as potential PrEP therapies. Expert commentary: Currently, there are several investigational drugs in the pipeline for PrEP against HIV infection. Increased utilization of PrEP therapy depends on provider identification of people at high risk for HIV transmission. Advances in PrEP development will expand options and access for people and reduce the risk of HIV acquisition.

75 FR 25869 - The National Institutes of Health and the Food and Drug Administration Joint Leadership Council...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-10

... comments to the Division of Dockets Management (HFA- 305), Food and Drug Administration, 5630 Fishers Lane..., an ever-changing economic landscape resulting from globalization, and the prospect for fundamental... Dockets Management (see ADDRESSES) written or electronic comments. Submit a single copy of electronic...

21 CFR 807.20 - Who must register and submit a device list?

Code of Federal Regulations, 2013 CFR

2013-04-01

..., Drug, and Cosmetic Act or subpart D of this part who is engaged in the manufacture, preparation... establishments under the control of one of these organizations when operations are conducted at more than one establishment and there exists joint ownership and control among all the establishments. The term “device...

21 CFR 807.20 - Who must register and submit a device list?

Code of Federal Regulations, 2014 CFR

2014-04-01

..., Drug, and Cosmetic Act or subpart D of this part who is engaged in the manufacture, preparation... establishments under the control of one of these organizations when operations are conducted at more than one establishment and there exists joint ownership and control among all the establishments. The term “device...

76 FR 38642 - Meeting of the Defense Business Board

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-01

... Downsizing Applications for DoD'' Task Groups. The Board will also receive updates from the ``New Ways to... --Corporate Downsizing Applications for DoD 11:45-12 Task Group Updates --New Ways to Execute the Joint... organizations may submit written comments to the Board about its mission and topics pertaining to this public...

Joint Services Electronics Program

DTIC Science & Technology

1990-07-31

Raghunath , Mandayam M.S. 88 Raman, Shankar M.S. 88 Scheckler, Ed M.S. 88 Song. Joon Ph. D. 88 Tsay, Jcnngang M.S. 89 Tsay, Rcn-Song Ph.D. 89 Vakhshoori...from Planar Resonators," submitted for publication to IEEE Trans. on Microwave Theory and Techniques, on April 17, 1990. Ranade M.T. Raghunath and A.G

75 FR 42377 - Foreign-Trade Zone 244-Riverside County, CA; Application for Reorganization Under Alternative...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-21

... application and case record and to report findings and recommendations to the Board. Public comment is invited...--Riverside County, CA; Application for Reorganization Under Alternative Site Framework An application has been submitted to the Foreign-Trade Zones (FTZ) Board (the Board) by the March Joint Powers Authority...

14 CFR 151.25 - Procedures: Application; information as to property interests.

Code of Federal Regulations, 2010 CFR

2010-01-01

... time it submits the application. In the case of a joint project, any one or more of the sponsors may... 14 Aeronautics and Space 3 2010-01-01 2010-01-01 false Procedures: Application; information as to... Development Projects § 151.25 Procedures: Application; information as to property interests. (a) Each sponsor...

A joint resolution disapproving the rule submitted by the Federal Communications Commission with respect to regulating the Internet and broadband industry practices.

THOMAS, 112th Congress

Sen. Hutchison, Kay Bailey [R-TX

2011-02-16

Senate - 11/10/2011 Motion to proceed to consideration of measure rejected in Senate by Yea-Nay Vote. 46 - 52. Record Vote Number: 200. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

Update on the Common Core State Standards Initiative

ERIC Educational Resources Information Center

Ritter, Bill, Jr.

2009-01-01

In this update the National Governors Association presents the testimony of Honorable Bill Ritter, Jr., as submitted to the U.S. House Education and Labor Committee. Ritter speaks about the Common Core State Standards Initiative, a joint project by the National Governors Association (NGA) and Council of Chief State School Officers (CCSSO) to…

Children's Television Advertising: An Ethical Morass for Business and Government.

ERIC Educational Resources Information Center

Turk, Peter B.

Differing ethical approaches increase the confusion of the controversy over children's television advertising between the Federal Trade Commission (FTC) and representatives of marketing and broadcasting. Marketers and broadcasters base the argument for the status quo on teleologic (situational accommodation) grounds; namely, the competitive nature…

Deceptive Business Practices: Federal Regulations.

ERIC Educational Resources Information Center

Rohrer, Daniel Morgan

Federal regulations to prevent deceptive advertising seek to balance the advertiser's freedom of speech with protection of the consumer. This paper discusses what the Federal Trade Commission (FTC) has done to regulate advertising and evaluates the adequacy of its controls. The commission uses cease-and-desist orders, affirmative disclosure,…

16 CFR 305.20 - Paper catalogs and websites.

Code of Federal Regulations, 2011 CFR

2011-01-01

... estimated operating cost is based on a [Year] national average [electricity, natural gas, propane, or oil... natural gas. For more information, visit www.ftc.gov/appliances. (4) The energy efficiency or thermal efficiency ratings for pool heaters, central air conditioners, heat pumps, and furnaces (including boilers...

16 CFR 305.20 - Paper catalogs and websites.

Code of Federal Regulations, 2010 CFR

2010-01-01

... estimated operating cost is based on a [Year] national average [electricity, natural gas, propane, or oil... natural gas. For more information, visit www.ftc.gov/appliances. (4) The energy efficiency or thermal efficiency ratings for pool heaters, central air conditioners, heat pumps, and furnaces (including boilers...

77 FR 46643 - Children's Online Privacy Protection Rule

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-06

... the FTC's review of public comments and its enforcement experience, are intended to clarify the scope... proposed changes to these two definitions.\\2\\ After reviewing these comments, and based upon its experience.... Definition of Operator Public comments \\3\\ and the Commission's own enforcement experience \\4\\ highlight the...

16 CFR 0.2 - Official address.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 16 Commercial Practices 1 2011-01-01 2011-01-01 false Official address. 0.2 Section 0.2 Commercial Practices FEDERAL TRADE COMMISSION ORGANIZATION, PROCEDURES AND RULES OF PRACTICE ORGANIZATION § 0.2... 20580, unless otherwise specifically directed. The Commission's Web site address is www.ftc.gov. [63 FR...

16 CFR 0.2 - Official address.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 16 Commercial Practices 1 2010-01-01 2010-01-01 false Official address. 0.2 Section 0.2 Commercial Practices FEDERAL TRADE COMMISSION ORGANIZATION, PROCEDURES AND RULES OF PRACTICE ORGANIZATION § 0.2... 20580, unless otherwise specifically directed. The Commission's Web site address is www.ftc.gov. [63 FR...

78 FR 46583 - Agency Information Collection Activities; Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-01

... ask the Office of Management and Budget (OMB) to extend through November 30, 2016, the current Paperwork Reduction Act (PRA) clearance for the FTC's shared enforcement with the Consumer Financial Protection Bureau (CFPB) of the information collection requirements in Regulation N (Mortgage Acts and...

78 FR 72057 - Rules and Regulations Under the Wool Products Labeling Act

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-02

... FEDERAL TRADE COMMISSION 16 CFR Part 300 Rules and Regulations Under the Wool Products Labeling Act AGENCY: Federal Trade Commission (``FTC'' or ``Commission''). ACTION: Extension of the deadline..., mail or deliver your comment to the following address: Federal Trade Commission, Office of the...

Fatigue strength: effect of welding type and joint design executed in Ti-6Al-4V structures.

PubMed

Pantoja, Juliana M C Nuñez; Farina, Ana P; Vaz, Luis G; Consani, Rafael L X; Nóbilo, Mauro A de Arruda; Mesquita, Marcelo F

2012-06-01

This study evaluated the fatigue strength of Ti-6Al-4V-machined structures submitted to laser (L)-welding and TIG (TIG)-welding procedures, varying the joint designs. Seventy dumbbell rods were machined in Ti-6Al-4V alloy with central diameters of 3.5 mm. The specimens were sectioned and welded using TIG or L and three joint designs {'I' design, varying welding distances [0.0 mm (I00) or 0.6 mm (I06)], or 'X' [X] design}. The combinations of variables created six groups, which, when added to the intact group, made a total of seven groups (n = 10). L was executed as follows: 360 V/8 ms (X) and 390 V/9 ms (I00 and I06), with focus and frequency regulated to zero. TIG was executed using 2:2 (X) and 3:2 (I00 and I06) as welding parameters. Joints were finished, polished and submitted to radiographic examination to be analysed visually for the presence of porosity. The specimens were then subjected to mechanical cyclic tests, and the number of cycles completed until failure was recorded. The fracture surface was examined using a scanning electron microscope. The Kruskal-Wallis and Dunn test (α = 0.05) indicated that the number of cycles resisted for fracture was higher to X for both welding procedures. To L, I06 was as resistant as X. The Mann-Whitney U-test (α = 0.05) indicated that L joints were more resistant than TIG to I00 and I06. Spearman's correlation coefficient (α = 0.05) indicated a negative correlation between the number of cycles and presence of porosity. Thus, to weld Ti-6Al-4V structures, the best condition is X, independent of the welding method employed. © 2011 The Gerodontology Society and John Wiley & Sons A/S.

The Eleventh Commandment: Thou Shalt Not Covet My Child's Purse.

ERIC Educational Resources Information Center

Choate, Robert B.

In an appeal before the Federal Trade Commission (FTC), the author pleaded for governmental action to restrain national advertisers from "unscrupulous and erroneous advertising pitches aimed at children." Citing the principal media for child-targeted advertising, (comic books, youth magazines, school displays and radio and television), the speaker…

75 FR 60125 - SES Performance Review Board

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-29

... FEDERAL TRADE COMMISSION SES Performance Review Board AGENCY: Federal Trade Commission. ACTION: Notice. SUMMARY: Notice is hereby given of the appointment of members to the FTC Performance Review Board... the Performance Review Board (PRB) membership is required by 5 U.S.C. 4314(c)(4). The PRB reviews and...

16 CFR 698.2 - Legal effect.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 16 Commercial Practices 1 2013-01-01 2013-01-01 false Legal effect. 698.2 Section 698.2 Commercial Practices FEDERAL TRADE COMMISSION THE FAIR CREDIT REPORTING ACT MODEL FORMS AND DISCLOSURES § 698.2 Legal effect. These model forms and disclosures prescribed by the FTC do not constitute a trade regulation rule...

16 CFR 698.2 - Legal effect.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 16 Commercial Practices 1 2011-01-01 2011-01-01 false Legal effect. 698.2 Section 698.2 Commercial Practices FEDERAL TRADE COMMISSION THE FAIR CREDIT REPORTING ACT MODEL FORMS AND DISCLOSURES § 698.2 Legal effect. These model forms and disclosures prescribed by the FTC do not constitute a trade regulation rule...

16 CFR 698.2 - Legal effect.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 16 Commercial Practices 1 2012-01-01 2012-01-01 false Legal effect. 698.2 Section 698.2 Commercial Practices FEDERAL TRADE COMMISSION THE FAIR CREDIT REPORTING ACT MODEL FORMS AND DISCLOSURES § 698.2 Legal effect. These model forms and disclosures prescribed by the FTC do not constitute a trade regulation rule...

16 CFR 698.2 - Legal effect.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 16 Commercial Practices 1 2010-01-01 2010-01-01 false Legal effect. 698.2 Section 698.2 Commercial Practices FEDERAL TRADE COMMISSION THE FAIR CREDIT REPORTING ACT MODEL FORMS AND DISCLOSURES § 698.2 Legal effect. These model forms and disclosures prescribed by the FTC do not constitute a trade regulation rule...

16 CFR 698.2 - Legal effect.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 16 Commercial Practices 1 2014-01-01 2014-01-01 false Legal effect. 698.2 Section 698.2 Commercial Practices FEDERAL TRADE COMMISSION THE FAIR CREDIT REPORTING ACT MODEL FORMS AND DISCLOSURES § 698.2 Legal effect. These model forms and disclosures prescribed by the FTC do not constitute a trade regulation rule...

Rock 'Em, Sock 'Em!

ERIC Educational Resources Information Center

Waters, John K.

2011-01-01

K-12-level competitive robotics is growing in popularity around the country and worldwide. According to one of the leading organizers of these events, FIRST--For Inspiration and Recognition of Science and Technology--250,000 students from 56 countries take part in its competitions. FIRST Tech Challenge (FTC) is a yearly event the organization puts…

76 FR 31513 - Labeling Requirements for Alternative Fuels and Alternative Fueled Vehicles

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-01

... systematic review of all FTC rules and guides, the Commission requests public comment on the overall costs... Act, such labels should provide ``appropriate information with respect to costs and benefits [of... problems associated with developing and publishing useful and timely cost and benefit information, taking...

76 FR 40196 - Semiannual Agenda of Regulations

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-07

... Reporting Agencies (AD40) The OCC, Board, FDIC, OTS, NCUA, and FTC (collectively referred to as the... Transactions Act of 2003 (FACT Act) that amended section 623 of the Fair Credit Reporting Act (FCRA). This... opening date to a consumer reporting agency to promote the integrity of the information. In addition, the...

Hospital Consolidation: FTC May be a Stick in the Spokes of Hospital Mergers.

PubMed

Kirkner, Richard Mark

2017-12-01

For instance, in the case of Sanford Health's acquisition of Mid Dakota Clinic in North Dakota, the agency challenged the deal, claiming that the merged entity would control 75% or more of primary care and other health services in the Bismarck-Mandan metropolitan area.

76 FR 50218 - Agency Information Collection Activities; Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-12

... about the thermal performance characteristics of home insulation products. The R-value of an insulation signifies the insulation's degree of resistance to the flow of heat. This information tells consumers how... the FTC rule on ``Labeling and Advertising of Home Insulation'' (R-value Rule or Rule). That clearance...

16 CFR 1.20 - Alternative procedures.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 16 Commercial Practices 1 2010-01-01 2010-01-01 false Alternative procedures. 1.20 Section 1.20 Commercial Practices FEDERAL TRADE COMMISSION ORGANIZATION, PROCEDURES AND RULES OF PRACTICE GENERAL PROCEDURES Rules and Rulemaking Under Section 18(a)(1)(B) of the FTC Act § 1.20 Alternative procedures. If...

FTC advertising substantiation program. Household products manufacturers. Documentation of Hakuhodo Advertising America, Inc

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

Not Available

The report contains documentation in support of claims that the Toshiba Microwave Oven can cook any and all types of food satisfactorily with a 75% savings in energy usage and cost, regardless of the size of a household. (Portions of this document are not fully legible)

76 FR 67191 - Agency Information Collection Activities; Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-31

... Concerning Franchising (``Franchise Rule'' or ``Rule''). That clearance expires on December 31, 2011. DATES... INFORMATION section below. Write ``Franchise Rule, PRA Comment, FTC File No. P094400'' on your comment, and..., DC 20580, (202) 326-2970. SUPPLEMENTARY INFORMATION: Title: Franchise Rule, 16 CFR part 436. OMB...

16 CFR 460.23 - Other laws, rules, and orders.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 16 Commercial Practices 1 2010-01-01 2010-01-01 false Other laws, rules, and orders. 460.23 Section 460.23 Commercial Practices FEDERAL TRADE COMMISSION TRADE REGULATION RULES LABELING AND ADVERTISING OF HOME INSULATION § 460.23 Other laws, rules, and orders. (a) If an outstanding FTC Cease and...

77 FR 73467 - Agency Information Collection Activities; Proposed Collection; Comment Request; Extension

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-10

... parties may file a comment online or on paper, by following the instructions in the Request for Comment...'' on your comment, and file your comment online at https://ftcpublic.commentworks.com/ftc/altfuelspra... Alternative Fuels Rule should be addressed to Hampton Newsome, Attorney, Division of Marketing Practices...

Can Your Catalogue Stand the Test of FTC Guidelines?

ERIC Educational Resources Information Center

Bender, Louis W.

1975-01-01

College and university officials would be wise to observe attentively the outcome of public hearing and subsequent actions by the Federal Trade Commission concerning advertising, disclosure, cooling off, and refund requirements related to proprietary vocational and homestudy schools. Nonprofit schools may become subject to the same scrutiny.…

16 CFR 305.20 - Paper catalogs and websites.

Code of Federal Regulations, 2012 CFR

2012-01-01

...] national average electricity cost of [ ___ cents per kWh]. For more information, visit www.ftc.gov... estimated operating cost is based on a [Year] national average [electricity, natural gas, propane, or oil... washers] and a [Year] national average cost of ___ cents per kWh for electricity and $ ___ per therm for...

16 CFR 305.20 - Paper catalogs and websites.

Code of Federal Regulations, 2013 CFR

2013-01-01

...] national average electricity cost of [ ___ cents per kWh]. For more information, visit www.ftc.gov... estimated operating cost is based on a [Year] national average [electricity, natural gas, propane, or oil... washers] and a [Year] national average cost of ___ cents per kWh for electricity and $ ___ per therm for...

Identity Theft: Trends and Issues

DTIC Science & Technology

2010-01-05

mitigate the effects of identity theft, one option Congress may consider is whether to strengthen data breach notification requirements. Such requirements...identity theft complaints to the FTC as well as in the number of reported data breaches placing personally identifiable information at risk. This report...23 Effects of Data Breaches ..................................................................................................... 24

48 CFR 819.7108 - Application process.

Code of Federal Regulations, 2010 CFR

2010-10-01

... SOCIOECONOMIC PROGRAMS SMALL BUSINESS PROGRAMS VA Mentor-Protégé Program 819.7108 Application process. (a) Firms interested in becoming approved mentor-protégé participants must submit a joint written VA Mentor-Protégé Agreement to the VA OSDBU for review and approval. The proposed Mentor-Protégé Agreement will be...

Carbon Dioxide Emissions from the Generation of Electric Power in the United States 1998

EIA Publications

1999-01-01

The President issued a directive on April 15, 1999, requiring an annual report summarizing carbon dioxide (CO2) emissions produced by electricity generation in the United States, including both utilities and nonutilities. In response, this report is jointly submitted by the U.S. Department of Energy and the U.S. Environmental Protection Agency.

75 FR 70258 - Review of the Secondary National Ambient Air Quality Standards for Oxides of Nitrogen and Oxides...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-17

... you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for..., remember to: Identify the rulemaking by docket number and other identifying information (subject heading... the scientific basis for the NAAQS, EPA has decided to jointly assess the science, risks, and policies...

5 CFR Appendix A to Part 2634 - Certificate of Independence (Form Approved: OMB Control No. 3209-0007)

Code of Federal Regulations, 2010 CFR

2010-01-01

... GOVERNMENT ETHICS GOVERNMENT ETHICS EXECUTIVE BRANCH FINANCIAL DISCLOSURE, QUALIFIED TRUSTS, AND CERTIFICATES... submitted to the Office of Government Ethics for certification pursuant to the Ethics in Government Act of... interested party, and is not a partner of, or involved in any joint venture or other investment or business...

78 FR 77787 - Notice of Joint Application for Approval of Discontinuance or Modification of a Railroad Signal...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-24

... written communications concerning the petition, is available for review online at www.regulations.gov and... proceedings by submitting written views, data, or comments. FRA does not anticipate scheduling a public... interested party desires an opportunity for oral comment, they should notify FRA, in writing, before the end...

8 CFR 1216.4 - Joint petition to remove conditional basis of lawful permanent resident status for alien spouse.

Code of Federal Regulations, 2010 CFR

2010-01-01

... with the interview requirements contained in the Act. Furthermore, if the documentation submitted in... marital relationship, the petitioner must arrange for the affiants to be present at the interview, at no..., provided the alien and the petitioning spouse comply with the interview requirements described in § 1216.4...

Joint Services Electronics Program.

DTIC Science & Technology

1993-03-05

Mary- land, June 1992. Interconnection Network Design Based on Packaging Considerations Professor Abhiram Ranade with M. T. Raghunath A central...characterized by our abstract models of packaging technology. JSEP Publications [1] M.T. Raghunath and Abhiram Ranade, "Customizing Interconnection...94720, January 1993. [21 M.T. Raghunath and Abhiram Ranade, "Fault-Tolerant Routing in Partitioned Butterfly Networks," submitted to the 1993

15 CFR Supplement No. 3 to Part 754 - Statutory Provisions Dealing With Exports of Crude Oil

Code of Federal Regulations, 2011 CFR

2011-01-01

... Administration Act of 1979: Provided, That the President shall submit reports to the Congress containing findings made under this section, and after the date of receipt of such report Congress shall have a period of... of 1969. (c) Report of findings by President to Congress; joint resolution of disagreement with...

15 CFR Supplement No. 3 to Part 754 - Statutory Provisions Dealing With Exports of Crude Oil

Code of Federal Regulations, 2014 CFR

2014-01-01

... Administration Act of 1979: Provided, That the President shall submit reports to the Congress containing findings made under this section, and after the date of receipt of such report Congress shall have a period of... of 1969. (c) Report of findings by President to Congress; joint resolution of disagreement with...

15 CFR Supplement No. 3 to Part 754 - Statutory Provisions Dealing With Exports of Crude Oil

Code of Federal Regulations, 2013 CFR

2013-01-01

... Administration Act of 1979: Provided, That the President shall submit reports to the Congress containing findings made under this section, and after the date of receipt of such report Congress shall have a period of... of 1969. (c) Report of findings by President to Congress; joint resolution of disagreement with...

15 CFR Supplement No. 3 to Part 754 - Statutory Provisions Dealing With Exports of Crude Oil

Code of Federal Regulations, 2012 CFR

2012-01-01

... Administration Act of 1979: Provided, That the President shall submit reports to the Congress containing findings made under this section, and after the date of receipt of such report Congress shall have a period of... of 1969. (c) Report of findings by President to Congress; joint resolution of disagreement with...

76 FR 2293 - Approval and Promulgation of Air Quality Implementation Plans; Minnesota; Gopher Resource, LLC

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-13

... the Minnesota Pollution Control Agency (MPCA) on July 29, 2010, to revise the Minnesota State Implementation Plan (SIP) for lead (Pb) under the Clean Air Act (CAA). The State has submitted a joint Title I... that the conditions laid out with the citation ``Title I Condition: SIP for Lead NAAQS'' replace an...

78 FR 26357 - Alaska Electric Light & Power Company; Notice of Intent To File License Application, Filing of...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-06

... Light & Power Company; Notice of Intent To File License Application, Filing of Pre-Application Document.... Date Filed: March 29, 2013. d. Submitted By: Alaska Electric Light & Power Company (AEL&P). e. Name of... Act and the joint agency regulations thereunder at 50 CFR, Part 402; (b) NOAA Fisheries under section...

32 CFR Appendix A to Part 152 - Guidance to the Joint Service Committee (JSCA)

Code of Federal Regulations, 2010 CFR

2010-07-01

... to the Code Committee established by Article 146 of the UCMJ, with an invitation to submit comments. (4) The draft of the annual review shall set forth any specific recommendations for changes to the... Committee for its consideration under Article 146, UCMJ. (d) Public Notice and Meeting. (1) Proposals to...

Defense.gov Special Report: Pearl Harbor Anniversary

Science.gov Websites

Department of Defense Submit Search 71th Anniversary of the Attack on Pearl Harbor - World War II News Joint Chiefs of Staff, saluted veterans at the National World War II Memorial in Washington, D.C Attack Video Return To Pearl Harbor Return To Pearl Harbor World War II Timeline The attack on Pearl

The role of muscular co-contraction of the hip during movement.

PubMed

Catani, F; Hodge, A; Mann, R W; Ensini, A; Giannini, S

1995-01-01

The joint biomechanics of the hip was studied analyzing the kinematic, kinetic, electromyographic and in vivo pressure parameters during walking, going up stairs, and getting up from a chair. The most significant clinical and biomechanical data emerged when the temporal correlation between intra-articular pressure variations and electric activity of the bi-articular muscles was studied. The presence of co-contraction of the bi-articular muscles during the support and oscillation phases was evident. The maximum joint pressure values were measured while getting up from a chair when the hip was flexed more than 100 degrees. The posterior region of the acetabulum was that most submitted to loading. This data is useful in gaining an understanding of joint physiology, in correctly setting up physio-kinesitherapeutic protocols, and in setting up pre-clinical prosthetic mechanical tests.

[Endoprosthesis Infections - Guidelines for Antibiotic Therapy Common Guidelines of the Czech Society for Orthopaedics and Traumatology and the Society for Infectious Diseases of the Czech Medical Association of J. E. Purkyně].

PubMed

Musil, D; Balejová, M; Horníková, M; Chrdle, A; Mallátová, N; Nyč, O; Chmelík, V; Gallo, J; Jahoda, D; Stehlík, J

2017-01-01

PURPOSE OF THE STUDY This study aims to articulate regional guidelines for curative and suppressive antibiotic therapy of total joint replacement infections. MATERIAL AND METHODS When developing the standard, used as source materials were the published foreign guidelines for antibiotic therapy of prosthetic joint infections, the analysis of resistance of bacterial strains conducted in the Hospital in České Budějovice, a.s. and the assessment of strain resistance for the Czech Republic published by the European Antimicrobial Resistance Surveillance Network (EARS-Net). Considered was also the availability of individual antibiotics in the Czech Republic and restricted prescription according to the Summary of Product Characteristics as specified in the State Institute for Drug Control marketing authorisation. The expert group composed of orthopaedists, microbiologists and infectious disease specialists elaborated the basic antibiotic guideline for choosing an appropriate antibiotic/antifungal drug based on the usual susceptibility, its dose and dosage interval for initial and continuation therapy. The comments of individual specialists were gradually incorporated therein and in case of doubts majority rule was applied. The drafted document was sent for peer reviews to clinical orthopaedic, infectious disease and microbiological centres, whose comments were also incorporated and the finalised document was submitted for evaluation to specialised medical societies. RESULTS The outcome is the submitted guideline for antibiotic curative and suppressive therapy suitable for managing the prosthetic joint infections, which was approved by the committee of the Czech Society for Orthopaedics and Traumatology andthe Society for Infectious Diseases of the Czech Medical Association of J. E. Purkyně. DISCUSION Curative therapy of total joint replacement infections consists primarily in surgical treatment and has to be accompanied by adequate antibiotic therapy administered initially intravenously and later orally over a sufficient period of time. Bearing in mind the wide spectrum of pathogens that can cause infections of a joint replacement and their capacity to form a biofilm on foreign materials, the correct choice of an antibiotic, its dose and dosage interval are essential for successful treatment. Such standard should respect regional availability of antibiotics, regional pathogen resistance/susceptibility and ensure the achievement of sufficiently high concentrations at the requested location including anti-biofilm activity. CONCLUSIONS The submitted guideline is not the only treatment option for joint total replacement infections, but it makes the decisionmaking easier when treating these complications in the form of infections. The final choice of an antibiotic, its dose and duration of therapy shall be based on a critical assessment of results of microbiological (blood culture and molecular genetic) tests and reflect the patient s clinical condition. Since these are multidisciplinary issues, we consider useful for this guideline to be commented upon and approved by the committee of both the Society for Orthopaedics and Infectious Diseases so that it can become the starting point for treatment. Key words: total joint replacement infection, TEP, ATB, antibiotic therapy, consensus meeting, guideline.

FTC Staff Report on Television Advertising to Children.

ERIC Educational Resources Information Center

Federal Trade Commission, New York, NY. Bureau of Consumer Protection.

This report addresses the problems created by the large volume of current television advertising being directed to children, many of whom naively accept the messages and cannot perceive the selling purpose of television advertising or otherwise comprehend or evaluate it; and recommends that law-making proceedings begin to (1) ban all television…

75 FR 75091 - Mortgage Assistance Relief Services

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-01

... ; Stephanie Armour, Home Foreclosure Rates Posts First Annual Decline in Five Years, USA Today (May 13, 2010... (ANX), Mem. Supp. Pls. Ex Parte App. at 3 (Aug. 3, 2009) (alleging that defendants engaged in... companies. \\67\\ See FTC v. Fed. Loan Modification Law Ctr., LLP, No. SACV09-401 CJC (MLGx), Mem. Supp. Ex...

78 FR 73192 - Agency Information Collection Activities; Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-05

... PRA burden of the Rule's disclosure requirements is difficult given the highly diverse group of... December 21, 2010, OMB granted three-year clearance for the Rule through December 31, 2013 under Control No. 3084-0131. On February 3, 2012, OMB additionally approved under that control number FTC adjustments...

75 FR 11483 - Rule Concerning Disclosures Regarding Energy Consumption and Water Use of Certain Home Appliances...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-11

... article which consumes, or is designed to consume energy and which, to any significant extent, is...) and has discretion to require comparative information on the label. V. FTC's Advance Notice of... appear on a newly designed EnergyGuide label affixed to the product itself. Finally, the proposed...

76 FR 51308 - Retail Food Store Advertising and Marketing Practices Rule

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-18

... FTC rules and guides, the Commission requests public comment on the overall costs, benefits, necessity..., after a comment period and public hearings, the Commission concluded that the costs of complying with... about the costs and benefits of the rules and guides as well as their regulatory and economic impact...

75 FR 37806 - Twitter, Inc.; Analysis of Proposed Consent Order to Aid Public Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-30

... FEDERAL TRADE COMMISSION [File No. 092 3093] Twitter, Inc.; Analysis of Proposed Consent Order to... in paper form. Comments should refer to``Twitter, Inc., File No. 092 3093'' to facilitate the... weblink: ( http://public.commentworks.com/ftc/twitter ) and following the instructions on the web-based...

40 CFR 610.14 - Payment of program costs.

Code of Federal Regulations, 2012 CFR

2012-07-01

... from the costs of testing a device, EPA shall be responsible for costs of formulating its engineering... 40 Protection of Environment 31 2012-07-01 2012-07-01 false Payment of program costs. 610.14... program costs. (a) All costs incurred in an evaluation program initiated at the request of the FTC or at...

40 CFR 610.14 - Payment of program costs.

Code of Federal Regulations, 2011 CFR

2011-07-01

... from the costs of testing a device, EPA shall be responsible for costs of formulating its engineering... 40 Protection of Environment 30 2011-07-01 2011-07-01 false Payment of program costs. 610.14... program costs. (a) All costs incurred in an evaluation program initiated at the request of the FTC or at...

40 CFR 610.14 - Payment of program costs.

Code of Federal Regulations, 2013 CFR

2013-07-01

... from the costs of testing a device, EPA shall be responsible for costs of formulating its engineering... 40 Protection of Environment 31 2013-07-01 2013-07-01 false Payment of program costs. 610.14... program costs. (a) All costs incurred in an evaluation program initiated at the request of the FTC or at...

40 CFR 610.14 - Payment of program costs.

Code of Federal Regulations, 2014 CFR

2014-07-01

... from the costs of testing a device, EPA shall be responsible for costs of formulating its engineering... 40 Protection of Environment 30 2014-07-01 2014-07-01 false Payment of program costs. 610.14... program costs. (a) All costs incurred in an evaluation program initiated at the request of the FTC or at...

78 FR 10574 - Premerger Notification; Reporting and Waiting Period Requirements

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-14

..., patterns, devices, manufacturing processes, or customer names. If you would like the Commission to give... service. Visit the Commission Web site at http://www.ftc.gov to read this Notice and the news release... of a tender offer under Sec. 801.30, that the intention to make the tender offer has been publicly...

76 FR 76162 - Agency Information Collection Activities; Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-06

... Franchise Rule, and it mirrors the requirements and prohibitions of the original Franchise Rule. The FTC... Franchise Rule. Staff estimates that 250 or so new business opportunity sellers will enter the market each... x 3 hours per seller)). \\3\\ Based upon staff's informal discussions with several franchises in...

76 FR 78259 - Valeant Pharmaceuticals International, Inc.; Analysis of Agreement Containing Consent Order to...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-16

... online or on paper, by following the instructions in the Request for Comment part of the SUPPLEMENTARY... online at https://ftcpublic.commentworks.com/ftc/valeantsanoficonsent , by following the instructions on... calling (202) 326-2222. You can file a comment online or on paper. For the Commission to consider your...

78 FR 46952 - Relief-Mart, Inc.; Analysis of Proposed Consent Order To Aid Public Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-02

... information, like anyone's Social Security number, date of birth, driver's license number or other state... involves respondent's marketing and sale of memory foam mattresses. According to the FTC's complaint... marketing of VOC-free mattresses. It prohibits respondent from making zero-VOC claims unless the VOC...

Countering Children's Sugared Food Commercials: Do Rebuttals Help?

ERIC Educational Resources Information Center

Kaufman, Lois; Sandman, Peter M.

To assist the Federal Trade Commission (FTC) in policy making decisions concerning sugared food advertisements on television, a study was conducted to assess the effects on children of counter advertisements and disclaimers as a means of lessening the undesirable impact of sugared food ads. Approximately 1,200 children, aged 5 to 10 years,…

An evaluation of the following too closely monitor system on a four-lane undivided highway : interim report.

DOT National Transportation Integrated Search

1976-01-01

The FOLLOWING TOO CLOSELY (FTC) MONITOR system is an experimental device designed to measure vehicle gaps at a point along the highway and to advise the motorist, by means of a flashing message on a sign, that he is following the car in front of him ...

77 FR 58838 - ABCSP, Inc.; Analysis of Proposed Consent Order to Aid Public Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-24

... FEDERAL TRADE COMMISSION [File No. 112 3168] ABCSP, Inc.; Analysis of Proposed Consent Order to... or before October 17, 2012. ADDRESSES: Interested parties may file a comment online or on paper, by.... Write ``AABCSP, Inc.,-- consent, FTC File No. 112 3168'' on your comment, and file your comment online...

Multivariate Approaches for Exploring the Evaluation of Deception in Television Advertising.

ERIC Educational Resources Information Center

Permut, Steven Eli

The objective of this study was to explore the semantic structure used by subjects in assessing (evaluating) a series of eight television commercials previously (but unofficially) rated for deceptiveness by FTC attorneys. Five local respondent groups were used: 158 undergraduate students enrolled in an introductory advertising course, 175…

16 CFR 3.45 - In camera orders.

Code of Federal Regulations, 2010 CFR

2010-01-01

... in a clearly defined, serious injury to the person, partnership, or corporation requesting in camera..., serious injury shall be based on the standard articulated in H.P. Hood & Sons, Inc., 58 F.T.C. 1184, 1188... to respond to a document shall run from the date the party is served with the complete version of the...

Evaluation of in vitro antioxidant properties of methanol and aqueous extracts of Parkinsonia aculeata L. leaves.

PubMed

Sharma, Sonia; Vig, Adarsh Pal

2013-01-01

In the present study, methanol and aqueous extracts of Parkinsonia aculeata L. leaves were prepared and analyzed for phytochemical analysis and antioxidant potential in different in vitro assays. Antioxidant activity was studied using DPPH, CUPRAC, reducing power assay, deoxyribose degradation (site and nonsite specific), ferric reducing antioxidant potential (FRAP), ferric thiocyanate (FTC), thiobarbituric acid (TBA), and molybdate ion reduction, respectively. The total phenolic contents of the methanol and aqueous leaf extract were 39 mg GAE/g and 38 mg GAE/g, whereas flavonoid contents of these extracts were found to be 0.013 mg RE/g and 0.006 mg RE/g, respectively. From the two extracts, the methanol extract shows maximum inhibition (%) of 57.82%, 71.23%, 48.26%, 69.85%, and 52.78% in DPPH, nonsite- and site-specific, FTC, and TBA assays and absorbance of 0.669 and 0.241 in reducing power and CUPRAC assays at the highest concentration tested. UPLC analysis was done to determine the presence of various types of polyphenols present in plant extracts.

Evaluation of In Vitro Antioxidant Properties of Methanol and Aqueous Extracts of Parkinsonia aculeata L. Leaves

PubMed Central

Vig, Adarsh Pal

2013-01-01

In the present study, methanol and aqueous extracts of Parkinsonia aculeata L. leaves were prepared and analyzed for phytochemical analysis and antioxidant potential in different in vitro assays. Antioxidant activity was studied using DPPH, CUPRAC, reducing power assay, deoxyribose degradation (site and nonsite specific), ferric reducing antioxidant potential (FRAP), ferric thiocyanate (FTC), thiobarbituric acid (TBA), and molybdate ion reduction, respectively. The total phenolic contents of the methanol and aqueous leaf extract were 39 mg GAE/g and 38 mg GAE/g, whereas flavonoid contents of these extracts were found to be 0.013 mg RE/g and 0.006 mg RE/g, respectively. From the two extracts, the methanol extract shows maximum inhibition (%) of 57.82%, 71.23%, 48.26%, 69.85%, and 52.78% in DPPH, nonsite- and site-specific, FTC, and TBA assays and absorbance of 0.669 and 0.241 in reducing power and CUPRAC assays at the highest concentration tested. UPLC analysis was done to determine the presence of various types of polyphenols present in plant extracts. PMID:24348173

A joint resolution disapproving a rule submitted by the Environmental Protection Agency relating to the mitigation by States of cross-border air pollution under the Clean Air Act.

THOMAS, 112th Congress

Sen. Paul, Rand [R-KY

2011-09-08

Senate - 11/10/2011 Motion to proceed to consideration of measure rejected in Senate by Yea-Nay Vote. 41 - 56. Record Vote Number: 201. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

A joint resolution providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the National Mediation Board relating to representation election procedures.

THOMAS, 111th Congress

Sen. Isakson, Johnny [R-GA

2010-05-11

Senate - 09/23/2010 Motion to proceed to consideration of measure rejected in Senate by Yea-Nay Vote. 43 - 56. Record Vote Number: 239. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

76 FR 24486 - Agency Information Collection Activities; Submission for OMB Review; Joint Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-02

...) on business days between 7 a.m. and 5 p.m. Public Inspection: All comments received will be posted... Fairfax Drive, Arlington, VA 22226, between 9 a.m. and 5 p.m. on business days. OTS: You may submit....m. to 4 p.m. on business days, Attention: Information Collection Comments, Chief Counsel's Office...

The Great Lakes fisheries: A review of the report of the International Board of Inquiry for the Great Lakes Fisheries

USGS Publications Warehouse

Van Oosten, John

1942-01-01

In August, 1942, the International Board of Inquiry for the Great Lakes Fisheries submitted its report to the governments of the United States and States and Canada. The report, which culminated a two-year investigation, recommended a common or joint agency of control for the fisheries through an international treaty.

75 FR 16716 - Fisheries of the Northeastern United States; Proposed 2010 Specifications for the Spiny Dogfish...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-02

... Information (for example, name, address, etc.) voluntarily submitted by the commenter may be publicly... 3, 1998, and added to the list of overfished stocks in the Report on the Status of the Fisheries of... measures to end overfishing and to rebuild the spiny dogfish stock. A joint FMP was developed by the MAFMC...

A joint resolution providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the Department of Labor relating to financial disclosure and transparency by labor union management.

THOMAS, 111th Congress

Sen. Cornyn, John [R-TX

2009-12-18

Senate - 12/18/2009 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

Environmental Design

DTIC Science & Technology

2015-04-13

Emphasis within planning needs to shift away from reductionism and towards a holistic understanding of the operational environment. This paper addresses...the author (INTENTION..4UY BLANK) Environmental Design By Christopher D. Gardiner Lieutenant Colonel, Australian Army A paper submitted to the...and Strategy. The contents of this paper reOect my own personal views and are not necessarily endorsed by the Joint Forces Staff College or the

Day-On, Day-Off emtricitabine, tenofovir disoproxil fumarate and efavirenz single tablet regimen (DODO) as maintenance therapy in HIV-infected patients.

PubMed

Costantini, Andrea; Tontini, Chiara; Rocchi, Monia; Martini, Matteo; Butini, Luca

2018-06-01

Reduced dose schedules may be feasible options to simplify antiretroviral therapy (ART) in selected HIV-1-infected individuals. Efficacy and safety of a Day-on, Day-off (DODO) schedule of tenofovir disoproxil fumarate, emtricitabine and efavirenz (FTC/TDF/EFV) single tablet regimen (STR) was assessed. Twenty-seven patients were prescribed the DODO schedule and were monitored for 48 weeks. Switching criteria were: no previous ART failure, no AIDS-defining illnesses, T CD4 cell nadir >200/mmc, and HIV-RNA below detection limit (40 copies/mL) for at least six months. Clinical and laboratory data, including plasma HIV-RNA levels, T CD4 and CD8 counts, liver and kidney function, lipid levels and ultrasensitive C-reactive protein (us-CRP) were assessed at baseline, week 4, 12, 24, and 48. Statistical analysis was performed by paired Student's T-test for comparison between baseline and each time point and Chi square test for CD4/CD8 ratio comparison. In all, 26 out of 27 patients maintained plasma HIV-RNA levels below the detection limit through the entire follow-up. One patient experienced low level plasma HIV-RNA rebound at week 36 (47 copies/ml) and immediately reverted to the conventional dose schedule of FTC/TDF/EFV; plasma HIV-RNA was undetectable after four weeks. No major changes on liver and kidney function tests, lipid levels and us-CRP were observed. Although no profound modifications of T CD4 count were observed during follow-up, the CD4/CD8 ratio increased significantly at week 48 compared to the baseline (p<0.05). In conclusion, 48-week DODO administration of the fixed dose FTC/TDF/EFV STR combination was safe and effective in maintaining HIV viral replication below the detection limit in a selected group of HIV-1-infected individuals.

Pre-exposure prophylaxis of HIV

PubMed Central

Naswa, Smriti; Marfatia, Y. S.

2011-01-01

Pre-exposure prophylaxis (PrEP) is an experimental approach to HIV prevention and consists of antiretroviral drugs to be taken before potential HIV exposure in order to reduce the risk of HIV infection and continued during periods of risk. An effective PrEP could provide an additional safety net to sexually active persons at risk, when combined with other prevention strategies. Women represent nearly 60% of adults infected with HIV and PrEP can be a female-controlled prevention method for women who are unable to negotiate condom use. Two antiretroviral nucleoside analog HIV-1 reverse transcriptase inhibitor drugs are currently under trial as PrEP drugs, namely tenofovirdisoproxilfumarate (TDF) alone and TDF in combination with emricitabine (FTC), to be taken as daily single dose oral drugs. There are 11 ongoing trials of ARV-based prevention in different at risk populations across the world. The iPrex trial showed that daily use of oral TDF/FTC by MSM resulted in 44% reduction in the incidence of HIV. This led to publication of interim guidance by CDC to use of PrEP by health providers for MSM. Few other trials are Bangkok Tenofovir Study, Partners PrEP Study, FEM-PrEP study, and VOICE (MTN-003) study. Future trials are being formulated for intermittent PrEP (iPrEP) where drugs are taken before and after sex, “stand-in dose” iPrEP, vaginal or rectal PrEP, etc. There are various issues/concerns with PrEP such as ADRs and resistance to TDF/FTC, adherence to drugs, acceptability, sexual disinhibition, use of PrEP as first line of defense for HIV without other prevention strategies, and cost. The PrEP has a potential to address unmet need in public health if delivered as a part of comprehensive toolkit of prevention services, including risk-reduction, correct and consistent use of condoms, and diagnosis and treatment of sexually transmitted infections. PMID:21799568

Combination Antiretroviral Treatment for Women Previously Treated Only in Pregnancy: Week 24 Results of AIDS Clinical Trials Group Protocol A5227

PubMed Central

Vogler, Mary A; Smeaton, Laura M; Wright, Rodney L; Cardoso, Sandra Wagner; Sanchez, Jorge; Infante, Rosa; Moran, Laura E; Godfrey, Catherine; Demeter, Lisa M; Johnson, Victoria A

2014-01-01

Background Women with HIV and prior exposure to combination antiretroviral therapy (cART) solely for prevention of Mother to Child Transmission (pMTCT) need to know whether they can later be treated successfully with a commonly used regimen of efavirenz (EFV) and co-formulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) Methods Non-pregnant women with plasma HIV-1 RNA of ≥ 500 copies/mL, previously cART- exposed for pMTCT only, were eligible if they were off ART for ≥ 24 weeks prior to entry, were without evidence of drug resistance on standard genotyping, and were ready to start EFV plus FTC/TDF. The primary endpoint was virologic response (defined as plasma HIV RNA <400 copies/mL) at 24 weeks. Results 54 women were enrolled between 10/07 and 12/09; 52/54 completed 24 weeks of follow- up. Median baseline CD4+ T-cell count was 265/mm3 and baseline plasma HIV-1 RNA was 4.6 log10 copies/mL. Median prior cART duration was 14 weeks, and median time elapsed from the last pMTCT dose to entry was 22 months. Virologic response at 24 weeks was observed in 42/52 women or 81% (exact 95% CI: 68%–90%). There were no differences in response by country, by number or class of prior pMTCT exposures. While confirmed virologic failure occurred in 8 women, no virologic failures were observed in women reporting perfect early adherence. Conclusions In this first prospective clinical trial studying combination antiretroviral re- treatment in women with a history of pregnancy-limited cART, the observed virologic response to TDF/FTC and EFV at 24 weeks was 81%. Virologic failures occurred and correlated with self-reported non-adherence. PMID:24759064

Cost-effectiveness analysis of dolutegravir plus backbone compared with raltegravir plus backbone, darunavir+ritonavir plus backbone and efavirenz/tenofovir/emtricitabine in treatment naïve and experienced HIV-positive patients

PubMed Central

Restelli, Umberto; Rizzardini, Giuliano; Antinori, Andrea; Lazzarin, Adriano; Bonfanti, Marzia; Bonfanti, Paolo; Croce, Davide

2017-01-01

Background In January 2014, the European Medicines Agency issued a marketing authorization for dolutegravir (DTG), a second-generation integrase strand transfer inhibitor for HIV treatment. The study aimed at determining the incremental cost-effectiveness ratio (ICER) of the use of DTG+backbone compared with raltegravir (RAL)+backbone, darunavir (DRV)+ritonavir(r)+backbone and efavirenz/tenofovir/emtricitabine (EFV/TDF/FTC) in HIV-positive treatment-naïve patients and compared with RAL+backbone in treatment-experienced patients, from the Italian National Health Service’s point of view. Materials and methods A published Monte Carlo Individual Simulation Model (ARAMIS-DTG model) was used to perform the analysis. Patients pass through mutually exclusive health states (defined in terms of diagnosis of HIV with or without opportunistic infections [OIs] and cardiovascular disease [CVD]) and successive lines of therapy. The model considers costs (2014) and quality of life per monthly cycle in a lifetime horizon. Costs and quality-adjusted life years (QALYs) are dependent on OI, CVD, AIDS events, adverse events and antiretroviral therapies. Results In treatment-naïve patients, DTG dominates RAL; compared with DRV/r, the ICER obtained is of 38,586 €/QALY (6,170 €/QALY in patients with high viral load) and over EFV/TDF/FTC, DTG generates an ICER of 33,664 €/QALY. In treatment-experienced patients, DTG compared to RAL leads to an ICER of 12,074 €/QALY. Conclusion The use of DTG+backbone may be cost effective in treatment-naïve and treatment-experienced patients compared with RAL+backbone and in treatment-naïve patients compared with DRV/r+backbone and EFV/TDF/FTC considering a threshold of 40,000 €/QALY. PMID:28721059

HIV pre-exposure prophylaxis in transgender women: A subgroup analysis of the iPrEx trial

PubMed Central

Deutsch, Madeline B.; Glidden, David V.; Sevelius, Jae; Keatley, Joanne; McMahan, Vanessa; Guanira, Juan; Kallas, Esper G.; Chariyalertsak, Suwat; Grant, Robert M.

2015-01-01

Summary Background Oral emtricitabine-tenofovir disoproxil fumarate (FTC/TDF) pre-exposure prophylaxis (PrEP) is used to prevent the sexual acquisition of HIV. Transgender women (TGW) have unique characteristics that may relate to PrEP use, effectiveness, and safety. Methods The iPrEx trial was a randomized controlled trial (RCT) of oral FTC/TDF PrEP versus placebo among men who have sex with men (MSM) and TGW, followed by an open label extension (OLE). Drug concentrations were measured in blood by liquid chromatography and tandem mass spectroscopy. Findings Of the 2499 participants enrolled in the RCT, 29 (1%) identified as women, 296 (12%) identified as “trans”, 14 (1%) identified as men but reported use of feminizing hormones, such that 339 (14%) reported one or more of these characteristics (TGW). Compared with MSM, TGW more frequently reported transactional sex, receptive anal intercourse without a condom, or more than 5 partners in the past 3 months. Among TGW, there were 11 HIV infections in the active arm and 10 in the placebo arm, representing a hazard ratio of 1.1 (95% CI: 0.5 to 2.7). Among active arm participants, drug was detected in none of the TGW at the seroconversion visit, 18% (6/37) of seronegative TGW (P=0.31), and 52% (58/111) of seronegative MSM (P < 0.0001). PrEP use was not linked to behavioral indicators of HIV risk among TGW, while MSM at highest risk were more adherent. Interpretation There were no HIV infections among TGW having drug concentrations commensurate with use of 4 or more FTC/TDF tablets per week. TGW receiving PrEP had low drug concentrations, especially at times of potential HIV exposure, leading to no PrEP effectiveness among this subgroup. Funding U.S. National Institutes of Health and the Bill and Melinda Gates Foundation; study medication was donated by Gilead Sciences. PMID:26614965

Coracoclavicular joint: osteologic study of 1020 human clavicles

PubMed Central

Gumina, S; Salvatore, M; De Santis, P; Orsina, L; Postacchini, F

2002-01-01

We examined 1020 dry clavicles from cadavers of Italian origin to determine the prevalence of the coracoclavicular joint (ccj), a diarthrotic synovial joint occasionally present between the conoid tubercle of the clavicle and the superior surface of the horizontal part of the coracoid process. Five hundred and nine clavicles from individuals of different ages were submitted to X-ray examination. Using radiography, we measured the entire length and the index of sinuosity of the anterior lateral curve, on which the distance between the conoid tubercle and the coracoid process depends. We also used radiography to record the differences in prevalence of arthritis in two neighbouring joints, the acromioclavicular and sternoclavicular joints. Of the 1020 clavicles, eight (0.8%) displayed the articular facet of the ccj. No statistical correlation was found between clavicular length and the index of sinuosity of the anterior lateral curve. The prevalence of arthritis in clavicles with ccj was higher than that revealed in clavicles without ccj. The prevalence of ccj in the studied clavicles is lower than that observed in Asian cohorts. Furthermore, ccj is not conditioned by either length or sinuosity of the anterior lateral curve of the clavicle. Finally, the assumption that ccj is a predisposing factor for degenerative changes of neighbouring joints is statistically justified. PMID:12489763

The role of sacroiliac joint dysfunction in the genesis of low back pain: the obvious is not always right.

PubMed

Weksler, Natan; Velan, Gad J; Semionov, Michael; Gurevitch, Boris; Klein, Moti; Rozentsveig, Vsevolod; Rudich, Tzvia

2007-12-01

It is a common practice to the link low back pain with protruding disc even when neurological signs are absent. Because pain caused by sacroiliac joint dysfunction can mimic discogenic or radicular low back pain, we assumed that the diagnosis of sacroiliac joint dysfunction is frequently overlooked. To assess the incidence of sacroiliac joint dysfunction in patients with low back pain and positive disc findings on CT scan or MRI, but without claudication or objective neurological deficits. Fifty patients with low back pain and disc herniation, without claudication or neurological abnormalities such as decreased motor strength, sensory alterations or sphincter incontinence and with positive pain provocation tests for sacroiliac joint dysfunction were submitted to fluoroscopic diagnostic sacroiliac joint infiltration. The mean baseline VAS pain score was 7.8 +/- 1.77 (range 5-10). Thirty minutes after infiltration, the mean VAS score was 1.3 +/- 1.76 (median 0.000E+00 with an average deviation from median = 1.30) (P = 0.0002). Forty-six patients had a VAS score ranging from 0 to 3, 8 weeks after the fluoroscopic guided infiltration. There were no serious complications after treatment. An unanticipated motor block that required hospitalization was seen in four patients, lasting from 12 to 36 h. Sacroiliac joint dysfunction should be considered strongly in the differential diagnosis of low back pain in this group of patients.

78 FR 77106 - U.S. Air Force Reminder Re: United Launch Alliance (ULA) Consent Order and Recent Change in...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-20

...: Headquarters Air Force, Deputy Under Secretary of the Air Force (Space). ACTION: Publicize Consent Order... Force (Space), as the Compliance Officer under the Federal Trade Commission (FTC) Decision and Order... Under Secretary of the Air Force (Space). This position is now held by Dr. Troy Meink. [[Page 77107...

Reference Aid Abbreviations in the Latin American Press

DTIC Science & Technology

1977-08-30

FTC Frente de Trabajadores de la Cultura Frente de Trabajadores Copeyanos FTCCP Federacion de Trabajadores en Construccion Civil del Peru...Naciones Unidas ACOLSURE Asociacion Colombiana de Suboficiales de las Fuerzas Militares en Retiro ACOMINAS Aco Minas Gerais S.A. ACOPECAFE...28 CAMACOL Camara Colombiana de la Construccion CAMAS Coordinador del Area Maritima del Atlantico Sur CAME Colombian Chamber of

76 FR 26297 - Agency Information Collection Activities; Proposed Collection; Comment Request; Extension

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-06

... statements per year x 3 minutes per statement)]. \\4\\ The compliance guide is available at http://business.ftc... paper, by following the instructions in the Request for Comment part of the SUPPLEMENTARY INFORMATION...-based form. If you prefer to file your comment on paper, mail or deliver your comment to the following...

76 FR 78258 - Valeant Pharmaceuticals International, Inc.; Analysis of Agreement Containing Consent Order to...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-16

....S.C. Sec. 18, and Section 5 of the FTC Act, as amended, 15 U.S.C. 45, in the market for tretinoin... rights to two pharmaceutical products, Refissa, a branded tretinoin emollient cream, and a generic tretinoin emollient cream, to Spear Pharmaceuticals (``Spear''), the company that owns both products. II...

76 FR 31985 - Irving Oil Limited and Irving Oil Terminals Inc.; Analysis of Proposed Agreement Containing...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-02

... violations of Federal law prohibiting unfair or deceptive acts or practices or unfair methods of competition... sole discretion, grants your request in accordance with the law and the public interest. \\1\\ In... release describing it. The FTC Act and other laws that the Commission administers permit the collection of...

Advertising and the Public Interest. A Staff Report to the Federal Trade Commission.

ERIC Educational Resources Information Center

Howard, John A.; Hulbert, James

The advertising industry in the United States is thoroughly analyzed in this comprehensive report. The report was prepared mostly from the transcripts of the Federal Trade Commission's (FTC) hearings on Modern Advertising Practices. The basic structure of the industry as well as its role in marketing strategy is reviewed and some interesting…

Forest Tent Caterpillar in the Upper Midwest

Treesearch

Steven Katovich; Jim Hanson

2001-01-01

The forest tent caterpillar (FTC), Malacosoma disstria, is a native species found throughout hardwood forests of North America. It feeds on the leaves of many trees, but in Michigan, Minnesota and Wisconsin, outbreaks occur in aspen, birch, basswood and oak stands. Sugar maple is a favorite host in Michigan's Lower Peninsula, but is not highly preferred in other...

A Comparative Evaluation of Minimal Therapist Contact and 15-Session Treatment for Female Orgasmic Dysfunction.

ERIC Educational Resources Information Center

Morokoff, Patricia J.; LoPiccolo, Joseph

1986-01-01

Compared a four-session minimal therapist contact (MTC) program for treatment of lifelong global orgasmic dysfunction in women to a 15-session full therapist contact (FTC) program. Both programs were effective in producing female orgasm and in improving satisfaction with the sexual relationship and, for women in MTC treatment, happiness in…

16 CFR 700.4 - Parties “actually making” a written warranty.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 16 Commercial Practices 1 2010-01-01 2010-01-01 false Parties âactually makingâ a written warranty... “actually making” a written warranty. Section 110(f) of the Act provides that only the supplier “actually making” a written warranty is liable for purposes of FTC and private enforcement of the Act. A supplier...

78 FR 64885 - Freedom of Information Act (FOIA); Miscellaneous Rules Redelegation of Authority To Determine...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-30

... present novel policy issues, the General Counsel, in his/her discretion, may make the determination... will not have a significant economic impact on a substantial number of small entities. See 5 U.S.C. 605(b). Most requests for access to FTC records are filed by individuals, who are not ``small entities...

78 FR 46949 - Essentia Natural Memory Foam Company, Inc.; Analysis of Proposed Consent Order to Aid Public Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-02

... information, like anyone's Social Security number, date of birth, driver's license number or other state.... This matter involves respondent's marketing and sale of memory foam mattresses. According to the FTC's... marketing of VOC-free mattresses. It prohibits respondent from making zero-VOC claims unless the VOC...

16 CFR 460.23 - Other laws, rules, and orders.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 16 Commercial Practices 1 2012-01-01 2012-01-01 false Other laws, rules, and orders. 460.23... ADVERTISING OF HOME INSULATION § 460.23 Other laws, rules, and orders. (a) If an outstanding FTC Cease and Desist Order applies to you but differs from the rules given here, you can petition to amend to order. (b...

16 CFR 460.23 - Other laws, rules, and orders.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 16 Commercial Practices 1 2013-01-01 2013-01-01 false Other laws, rules, and orders. 460.23... ADVERTISING OF HOME INSULATION § 460.23 Other laws, rules, and orders. (a) If an outstanding FTC Cease and Desist Order applies to you but differs from the rules given here, you can petition to amend to order. (b...

16 CFR 460.23 - Other laws, rules, and orders.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 16 Commercial Practices 1 2014-01-01 2014-01-01 false Other laws, rules, and orders. 460.23... ADVERTISING OF HOME INSULATION § 460.23 Other laws, rules, and orders. (a) If an outstanding FTC Cease and Desist Order applies to you but differs from the rules given here, you can petition to amend to order. (b...

16 CFR 460.23 - Other laws, rules, and orders.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 16 Commercial Practices 1 2011-01-01 2011-01-01 false Other laws, rules, and orders. 460.23... ADVERTISING OF HOME INSULATION § 460.23 Other laws, rules, and orders. (a) If an outstanding FTC Cease and Desist Order applies to you but differs from the rules given here, you can petition to amend to order. (b...

77 FR 17364 - Inadmissibility of Consumer Products and Industrial Equipment Noncompliant With Applicable Energy...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-26

... upon written or electronic notice by DOE or FTC, CBP may conditionally release under bond to the... furnishing of a bond) that ensure that the merchandise will not violate 42 U.S.C. 6302. Proposed Regulation... importer under a CBP basic importation and entry bond for purposes of bringing the merchandise into...

76 FR 47183 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Extension

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-04

... parties may file a comment online or on paper, by following the instructions in the Request for Comment... No. P084401'' on your comment, and file your comment online at https://ftcpublic.commentworks.com/ftc... Funeral Rule should be addressed to Craig Tregillus, Attorney, Division of Marketing Practices, Bureau of...

76 FR 56455 - DaVita, Inc.; Analysis of Agreement Containing Consent Orders To Aid Public Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-13

... agreement package can be obtained from the FTC Home Page (for September 2, 2011), on the World Wide Web, at... to ongoing dialysis treatments. The relevant geographic markets for the provision of dialysis... case in many of the geographic markets identified in the Commission's complaint. Each of the geographic...

78 FR 55077 - Timonium Chrysler, Inc. d/b/a Don White's Timonium Chrysler Jeep Dodge; Analysis of Proposed...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-09

... comment at https://ftcpublic.commentworks.com/ftc/timoniumchryslerincconsent online or on paper, by.... Write ``Timonium Chrysler, File No. 132 3014'' on your comment and file your comment online at https... comment online or on paper. For the Commission to consider your comment, we must receive it on or before...

A joint resolution relating to the disapproval of the President's exercise of authority to suspend the debt limit, as submitted under section 1002(b) of the Continuing Appropriations Act, 2014 on October 17, 2013.

THOMAS, 113th Congress

Sen. McConnell, Mitch [R-KY

2013-10-28

Senate - 10/29/2013 Motion to proceed to consideration of measure rejected in Senate by Yea-Nay Vote. 45 - 54. Record Vote Number: 220. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

A joint resolution providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the National Labor Relations Board relating to representation election procedures.

THOMAS, 112th Congress

Sen. Enzi, Michael B. [R-WY

2012-02-16

Senate - 04/24/2012 Motion to proceed to consideration of measure rejected in Senate by Yea-Nay Vote. 45 - 54. Record Vote Number: 68. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

A joint resolution relating to the disapproval of the President's exercise of authority to increase the debt limit, as submitted under section 3101A of title 31, United States Code, on August 2, 2011.

THOMAS, 112th Congress

Sen. McConnell, Mitch [R-KY

2011-09-06

Senate - 09/08/2011 Motion to proceed to consideration of measure rejected in Senate by Yea-Nay Vote. 45 - 52. Record Vote Number: 130. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

Joint Planning and Development Office Work Plan FY10

DTIC Science & Technology

2010-01-01

IPSA ) Division will make refinements to the NextGen Portfolio Analysis. In addition, IPSA will work with the Department of Defense (DoD) to define and...Submitted Interagency Portfolio and Systems Analysis ( IPSA ) DRAFT DoD Portfolio Analysis Criteria BASELINE DoD Portfolio Analysis Criteria DRAFT...WG Work Plan Review Prototype Capability Selected and Defined CHAs Complete Safety Metrics for IPSA Complete FINAL Prototype Report FINAL

76 FR 4399 - Joint Industry Plan; Order Approving Amendment To Add the BATS Y-Exchange, Inc. as Participant to...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-25

...; Order Approving Amendment To Add the BATS Y- Exchange, Inc. as Participant to National Market System... September 9, 2010, the BATS Y-Exchange, Inc. (``BYX'' or ``Exchange'') submitted to the Securities and... their monthly reports available to the public under Rule 11Ac1-5 under the Act (n/ k/a Rule 605 of...

Wnt10b and Dkk-1 gene therapy differentially influenced trabecular bone architecture, soft tissue integrity, and osteophytosis in a skeletally mature rat model of osteoarthritis.

PubMed

Mason, Jeffrey B; Gurda, Brittney L; Hankenson, Kurt D; Harper, Lindsey R; Carlson, Cathy S; Wilson, James M; Richardson, Dean W

2017-11-01

Our goals in the current experiments were to determine if (a) upregulation of Wnt signaling would induce osteoarthritis changes in stable stifle joints and (b) if downregulation of Wnt signaling in destabilized joints would influence the progression of OA. At 37 weeks of age, rats were injected in the stifle joint with a recombinant adeno-associated viral vector containing the Wnt-inhibitor Dkk-1 or a Wnt10b transgene. At 40 weeks of age, rats underwent surgical destabilization of the joint. At 50 weeks of age, stifle joints were submitted for micro-computed tomography and histopathological analysis. Injection of either Wnt10b or Dkk-1 transgenes in stable joints improved bone architectural parameters, but worsened soft tissue integrity. Osteophytosis was decreased by Dkk-1, but unchanged by Wnt10b. Destabilization negatively influenced bone architecture, increased osteophytosis, and decreased soft tissue integrity. Dkk-1 exacerbated the negative effects of destabilization, whereas Wnt10b had little effect on these parameters. Osteophytosis was improved, whereas soft tissue integrity was worsened by both transgenes in destabilized joints. The Wnt-inhibitor Dkk-1 does not appear to completely inhibit the effects of Wnt signaling on bone remodeling. In vivo upregulation of Wnt10b and its inhibitor, Dkk-1, can produce both parallel or contrasting phenotypic responses depending on the specific parameter measured and the fidelity of the examined joint. These observations elucidate different roles for Wnt signaling in stable versus destabilized joints and may help to explain the conflicting results previously reported for the role of Dkk-1 in joint disease.

78 FR 2398 - Motorola Mobility LLC and Google Inc.; Analysis of Proposed Consent Order to Aid Public Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-11

... responsible for making sure that your comment does not include any sensitive health information, like medical records or other individually identifiable health information. In addition, do not include any ``[t]rade... overnight service. Visit the Commission Web site at http://www.ftc.gov to read this Notice and the news...

77 FR 51535 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Extension

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-24

... following the instructions on the web- based form. If you prefer to file your comment on paper, mail or... the Web site of a vendor of personal health records; (2) offers products or services through the Web... Web site, at http://www.ftc.gov/os/publiccomments.shtm . As a matter of discretion, the Commission...

The Trading Post System on the Navajo Reservation. Staff Report to the Federal Trade Commission.

ERIC Educational Resources Information Center

Federal Trade Commission, Los Angeles, CA.

Since the late 19th century, trading posts have been a prominant feature in Navajo economic life. Today, due to geographic isolation and an absence of economic alternatives, many Navajos are still dependent upon trading posts. This report of a Federal Trade Commission (FTC) investigation details the system on the Navajo Reservation, including the…

To the Federal Trade Commission in the Matter of a Trade Regulation Rule on Food/Nutrition Advertising.

ERIC Educational Resources Information Center

Choate, Robert B.

Food advertising and its effects on children are discussed in this document petitioning the Federal Trade Commission (FTC) to amend a proposed rule on food promotion for the benefit of children under twelve. Extensive information is presented on television food commercials and their influence on children's nutritional beliefs and eating habits.…

Overview of EO polymers and polymer modulator stability

NASA Astrophysics Data System (ADS)

Lindsay, Geoffrey A.; Ashley, Paul R.; Guenther, Andrew P.; Sanghadasa, Mohan

2005-09-01

This is a brief overview of the technology of nonlinear optical polymers (NLOP) and their use in electro-optic (EO) modulators. This paper also covers preliminary results from the authors' laboratories on highly active CLD- and FTC-type chromophores in guest-host films of APC amorphous polycarbonate. Emphasis will be given to thermal stability and long-term EO modulator aging.

Using Form+Theme+Context (FTC) for Rebalancing 21st-Century Art Education

ERIC Educational Resources Information Center

Sandell, Renee

2009-01-01

This article addresses the need to rebalance 21st-century art education for inclusion and integration leading to fuller art engagement in an increasingly visual world. I expand upon the form versus content canon in art and offset the typically predominant use of sensory, formal, or technical qualities in comprehending meaning from, as well as in…

76 FR 41148 - Care Labeling of Textile Wearing Apparel and Certain Piece Goods as Amended

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-13

... the overall costs, benefits, necessity, and regulatory and economic impact of the FTC's Rule on Care... periodically. These reviews seek information about the costs and benefits of the rules and guides as well as... modifications, if any, should the Commission make to the Rule to increase its benefits or reduce its costs to...

77 FR 64515 - Watson Pharmaceuticals, Inc., Actavis Inc., Actavis Pharma Holding 4 ehf., and Actavis S.a.r.l...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-22

... comment must include the factual and legal basis for the request, and must identify the specific portions... comments to consider and use in this proceeding as appropriate. The Commission will consider all timely and..., including routine uses permitted by the Privacy Act, in the Commission's privacy policy, at http://www.ftc...

Local Media Concentration: Ad Hoc Challenges to Media Cross-Owners After "FCC v. NCCB."

ERIC Educational Resources Information Center

Firestone, Charles M.

This paper explores some of the implications of cross-ownership of newspapers and other media in a single market and the role of the Federal Communications Commission (FCC), the Department of Justice, and the Federal Trade Commission (FTC) in enforcing national policy favoring a deconcentration of local mass media. It describes the history of FCC…

The functional therapeutic chemical classification system.

PubMed

Croset, Samuel; Overington, John P; Rebholz-Schuhmann, Dietrich

2014-03-15

Drug repositioning is the discovery of new indications for compounds that have already been approved and used in a clinical setting. Recently, some computational approaches have been suggested to unveil new opportunities in a systematic fashion, by taking into consideration gene expression signatures or chemical features for instance. We present here a novel method based on knowledge integration using semantic technologies, to capture the functional role of approved chemical compounds. In order to computationally generate repositioning hypotheses, we used the Web Ontology Language to formally define the semantics of over 20 000 terms with axioms to correctly denote various modes of action (MoA). Based on an integration of public data, we have automatically assigned over a thousand of approved drugs into these MoA categories. The resulting new resource is called the Functional Therapeutic Chemical Classification System and was further evaluated against the content of the traditional Anatomical Therapeutic Chemical Classification System. We illustrate how the new classification can be used to generate drug repurposing hypotheses, using Alzheimers disease as a use-case. https://www.ebi.ac.uk/chembl/ftc; https://github.com/loopasam/ftc. croset@ebi.ac.uk Supplementary data are available at Bioinformatics online.

Knowledge, Attitudes, and Experiences of HIV Pre-Exposure Prophylaxis (PrEP) Trial Participants in Botswana.

PubMed

Toledo, Lauren; McLellan-Lemal, Eleanor; Henderson, Faith L; Kebaabetswe, Poloko M

2015-03-01

Recent clinical trials have shown that a daily dose of oral TDF/FTC pre-exposure prophylaxis (PrEP) is effective in reducing human immunodeficiency (HIV) risk. Understanding trial participants' perspectives about retention and PrEP adherence is critical to inform future PrEP trials and the scale-up and implementation of PrEP programs. We analyzed 53 in-depth interviews conducted in April 2010 with participants in the TDF2 study, a Phase 3, randomized, double-blind, placebo-controlled clinical trial of daily oral TDF/FTC with heterosexual men and women in Francistown and Gaborone, Botswana. We examined participants' knowledge, attitudes, and experiences of the trial, identified facilitators and barriers to enrollment and retention, and compared participant responses by study site, sex, and study drug adherence. Our findings point to several factors to consider for participant retention and adherence in PrEP trials and programs, including conducting pre-enrollment education and myth reduction counseling, providing accurate estimates of participant obligations and side effect symptoms, ensuring participant understanding of the effects of non-adherence, gauging personal commitment and interest in study outcomes, and developing a strong external social support network for participants.

The authorship and fate of international health papers submitted to the American Journal of Public Health in 1989.

PubMed Central

Koch-Weser, D; Yankauer, A

1993-01-01

We reviewed the authorship characteristics, editorial processing, and final fate of 126 papers dealing with data from countries other than the United States and Canada and submitted to the American Journal of Public Health in 1989. The acceptance rate of these international health papers was 22%, similar to that of all papers (25%). Authors from developed countries had higher acceptance rates than authors from developing countries, but the highest acceptance rate (36%) was for international health papers with joint authorship from both developed and developing countries. Of 83 rejected papers, 72% were published in other journals. Of these, 45% were published in journals covered by Index Medicus, a figure similar to that for all papers rejected by the Journal. PMID:8238689

78 FR 33394 - Notice To Extend Submittal Date for Scoping Comments for United States Air Force Main Operating...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-04

...The U.S. Air Force is issuing this notice to advise the public of an extension to submit scoping comments. The initial Notice of Availability published in the Federal Register on May 17, 2013 (Vol. 78, No. 96/Notices/29120), requested public scoping comments no later than June 10, 2013. The Air Force has extended the deadline for submitting public comments to July 5, 2013. All substantive scoping comments received during the public scoping period will be considered in the preparation of the Draft EIS. Point of Contact: Please direct any written comments or requests for information to KC-46A EIS Project Manager, National Guard Bureau, NGB/A7AM, 3501 Fetchet Avenue, Joint Base Andrews, Maryland, 20762- 5157.

China under the Four Modernizations: Part 2. Selected Papers Submitted to the Joint Economic Committee. Congress of the United States, Ninety-Seventh Congress, Second Session.

ERIC Educational Resources Information Center

Joint Economic Committee, Washington, DC.

The politics and performance of the post-Mao Chinese government (1976 to the present) in the areas of foreign economic relations and Sino-American normalization are examined. Realizing that the four modernizations program for bringing up to date agriculture, industry, science and technology, and defense, initiated by Mao's successors in 1977, was…

Demonstrating Innovations in Vocational Education: Initial Application Submitted to the Office of Education, Department of Health, Education and Welfare: Plan and Operation Grant.

ERIC Educational Resources Information Center

EHOVE Board of Education, Milan, OH.

The purpose of this proposed project is to demonstrate innovations in a joint vocational school which would serve public and non-public schools in Erie, Huron, and the eastern portion of Ottawa counties. The objectives of the proposed activities were to (1) emphasize a correlated curriculum developed around the "world of work" between…

Improving Public Diplomacy, the Frontline of Soft Power

DTIC Science & Technology

2009-05-01

State A paper submitted to the Faculty of the Joint Advanced Warfighting School in partial satisfaction of the requirements of a Master of Science...3 U.S. Department of State, Dictionary of International Relations Terms, Washington D.C., 1987, p. 85. 4...education, wine , public order, irrigation, roads, a fresh water system and public health,” Reg demands, “what have the Romans ever done for us?” 13 For Reg

Generating Extractive Summaries of Scientific Paradigms (Open Access, Publisher’s Version)

DTIC Science & Technology

2013-02-01

international joint conference on Artifical intelligence , IJCAI’07, pp. 2060–2065. Bassett, D. S., & Bullmore, E. (2006). Small-world brain networks. The...Journal of Artificial Intelligence Research 46 (2013) 165-201 Submitted 7/12; published 2/13 Generating Extractive Summaries of Scientific Paradigms...Whidby and Taesun Moon were supported, in part, by the Intelligence Advanced Research Projects Activity (IARPA) via Department of Interior Na- tional

A joint resolution disapproving a rule submitted by the Environmental Protection Agency relating to the endangerment finding and the cause or contribute findings for greenhouse gases under section 202(a) of the Clean Air Act.

THOMAS, 111th Congress

Sen. Murkowski, Lisa [R-AK

2010-01-21

Senate - 06/10/2010 Motion to proceed to consideration of measure rejected in Senate by Yea-Nay Vote. 47 - 53. Record Vote Number: 184. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

Omnibus Appropriations Act, 2009

THOMAS, 111th Congress

Rep. Obey, David R. [D-WI-7

2009-02-23

03/11/2009 Became Public Law No: 111-8. (TXT | PDF) (All Actions) Notes: An explanatory statement was submitted by Mr. Obey, Chairman of the House Committee on Appropriations "as if it were a joint explanatory statement of a committee of conference." See the statement in the 2/23/2009 Congressional Record or in the House Appropriations committee print. Tracker: This bill has the status Became LawHere are the steps for Status of Legislation:

Introduction of Information Science into Library Training in Eastern Africa. Expert Meeting (Dar es Salaam, Tanzania, February 26-29, 1980).

ERIC Educational Resources Information Center

Abidi, S. A. H.; Moeller, T.

In 1978 a team of three people was formed to survey the existing library training facilities in East Africa and to suggest possibilities as to how the elements of information science could be introduced either into existing programs or into special courses organized for the purpose. The team submitted its report to a joint meeting of the…

Hole of Government: Sealing the Gap in U.S. Stability Operations

DTIC Science & Technology

2010-06-15

including suggestions for reducing this burden, to Washington Headquarters Services, Directorate for Information Operations and Reports, 1215... Gap in U.S. Stability Operations” 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR (S) Commander Patrick J...THE GAP IN U.S. STABILITY OPERATIONS by Patrick J. Hannifin CDR, USN A paper submitted to the Faculty of the Joint Advanced

McNamara and Rumsfeld: Control and Imbalance in Civil-Military Relations

DTIC Science & Technology

2008-03-24

Approved for public release; distribution unlimited 13. SUPPLEMENTARY NOTES 14. ABSTRACT See attached 15. SUBJECT TERMS 16. SECURITY CLASSIFICATION OF...for the Joint Staff came after an interview in which Keys reportedly gave the wrong answer to the question of whether he would give unconditional ...United States Army DISTRIBUTION STATEMENT A: Approved for Public Release. Distribution is Unlimited. USAWC CLASS OF 2008 This SRP is submitted

The Joint Convention - Its Structure, the Articles and its Administration

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

Metcalf, P.; Louvat, D.

The objective of the Joint Convention on the Safety of Spent Fuel Management and on the Safety of Radioactive Waste Management (The Joint Convention) is to achieve a high level of safety worldwide in the management of spent nuclear and fuel and radioactive waste. [1] It is an incentive convention designed to encourage and assist countries to achieve the objective. Contracting Parties to the Joint Convention are required to compile and submit a national report on how they meet the articles of the Joint Convention. The reports are peer reviewed by other Contracting Parties to the Joint Convention and thenmore » countries have to defend the report at a review meeting of all the Contracting Parties. The process entails both a self appraisal in compiling the report and independent international peer review. Summaries are compiled of the various reviews and these are presented in plenary, with a view to identifying generic issues and areas in which countries are improving safety or have identified for further development. The process also presents an opportunity for countries involved to benchmark their national spent fuel and radioactive waste safety programmes against prevailing international practice. The paper elaborates the detailed elements involved and discusses the experience from the first review meeting of Contracting Parties, and issues envisaged for consideration at the second review meeting scheduled for May 2006. (authors)« less

Killer tans: state, feds crack down on indoor tanning.

PubMed

Conde, Crystal

2010-05-01

The American Cancer Society says that using a tanning bed before age 35 increases a person's risk of developing melanoma by 75 percent. Physicians hope that recent actions by the FTC, along with TMA-supported state legislation placing age restrictions on minors' use of tanning beds, will spur the tanning industry to operate more responsibly and stop spreading false information to the public.

Oral preexposure prophylaxis to prevent HIV infection: clinical and public health implications.

PubMed

Baker, Jonathan; OʼHara, Kevin Michael

2014-12-01

This article reviews the use of combination emtricitabine (FTC)/tenofovir as preexposure prophylaxis (PrEP) for HIV-negative patients at high risk of acquiring HIV, including heterosexual men and women, men who have sex with men, and IV drug users. When used with classic prevention strategies such as condoms, PrEP has been found effective in reducing the risk of HIV transmission.

76 FR 7211 - Agency Information Collection Activities; Proposed Collection; Comment Request; Extension

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-09

... exceptions. Request for Comments Under the PRA, 44 U.S.C. 3501-3521, Federal agencies must obtain approval... provide information to a third party. 44 U.S.C. 3502(3), 5 CFR 1320.3(c). As required by section 3506(c)(2... * * * privileged or confidential.'' See Section 6(f) of the Federal Trade Commission Act (``FTC Act''), 15 U.S.C...

America Reads-Mississippi Future Teacher Corps: A Study of Program Completers' Perception of Factors Influencing the Decision to Become and Remain Classroom Teachers

ERIC Educational Resources Information Center

Moore, Deborah Green

2012-01-01

Despite the number of programs in Mississippi that focus on developing and training teachers, the State continues to face a critical teacher shortage. This non-experimental, ex-post facto, quantitative study investigated the America Reads-Mississippi (ARM) Future Teacher Corps (FTC) program, an AmeriCorps program in Mississippi with a mission to…

To the Federal Trade Commission in the Matter of a Trade Regulation Rule on Over-the-Counter Drug Advertising.

ERIC Educational Resources Information Center

Council on Children, Media, and Merchandising, Washington, DC.

This report supports amending the proposed Federal Trade Commission (FTC) Rule on Over-the Counter (OTC) Drug Advertising to insure better protection for children, illiterate populations, the deaf and the blind, from advertising on the air-waves. Several points are addressed: (1) the difficulties of combining the rule making schedules of the Food…

Prevention of Rectal SHIV Transmission in Macaques by Daily or Intermittent Prophylaxis with Emtricitabine and Tenofovir

PubMed Central

García-Lerma, J. Gerardo; Otten, Ron A; Qari, Shoukat H; Jackson, Eddie; Cong, Mian-er; Masciotra, Silvina; Luo, Wei; Kim, Caryn; Adams, Debra R; Monsour, Michael; Lipscomb, Jonathan; Johnson, Jeffrey A; Delinsky, David; Schinazi, Raymond F; Janssen, Robert; Folks, Thomas M; Heneine, Walid

2008-01-01

Background In the absence of an effective vaccine, HIV continues to spread globally, emphasizing the need for novel strategies to limit its transmission. Pre-exposure prophylaxis (PrEP) with antiretroviral drugs could prove to be an effective intervention strategy if highly efficacious and cost-effective PrEP modalities are identified. We evaluated daily and intermittent PrEP regimens of increasing antiviral activity in a macaque model that closely resembles human transmission. Methods and Findings We used a repeat-exposure macaque model with 14 weekly rectal virus challenges. Three drug treatments were given once daily, each to a different group of six rhesus macaques. Group 1 was treated subcutaneously with a human-equivalent dose of emtricitabine (FTC), group 2 received orally the human-equivalent dosing of both FTC and tenofovir-disoproxil fumarate (TDF), and group 3 received subcutaneously a similar dosing of FTC and a higher dose of tenofovir. A fourth group of six rhesus macaques (group 4) received intermittently a PrEP regimen similar to group 3 only 2 h before and 24 h after each weekly virus challenge. Results were compared to 18 control macaques that did not receive any drug treatment. The risk of infection in macaques treated in groups 1 and 2 was 3.8- and 7.8-fold lower than in untreated macaques (p = 0.02 and p = 0.008, respectively). All six macaques in group 3 were protected. Breakthrough infections had blunted acute viremias; drug resistance was seen in two of six animals. All six animals in group 4 that received intermittent PrEP were protected. Conclusions This model suggests that single drugs for daily PrEP can be protective but a combination of antiretroviral drugs may be required to increase the level of protection. Short but potent intermittent PrEP can provide protection comparable to that of daily PrEP in this SHIV/macaque model. These findings support PrEP trials for HIV prevention in humans and identify promising PrEP modalities. PMID:18254653

Switch from unboosted protease inhibitor to a single-tablet regimen containing rilpivirine improves cholesterol and triglycerides.

PubMed

Di Biagio, Antonio; Riccardi, Niccolò; Taramasso, Lucia; Capetti, Amedeo; Cenderello, Giovanni; Signori, Alessio; Vitiello, Paola; Guerra, Michele; de Socio, Giuseppe Vittorio; Cassola, Giovanni; Quirino, Tiziano; Viscoli, Claudio

2016-11-01

This study aimed to evaluate the efficacy, tolerability and potential savings of combined antiretroviral therapy (cART) simplification from an unboosted protease inhibitor (PI) regimen with atazanavir or fosamprenavir to a single-tablet regimen (STR) based on rilpivirine/emtricitabine/tenofovir disoproxil fumarate (RPV/FTC/TDF) among HIV-1-infected patients with HIV-1 RNA <50 copies/mL. This was a retrospective, multicentre, open-label, 12-week trial. Plasma HIV-1-RNA levels, CD4+ cell counts, cholesterol, triglycerides, bilirubin, glycaemia, creatinine and physical examination were performed at baseline and at scheduled follow-up. All patient costs were calculated and were estimated for 52 weeks of therapy. Fifty-one patients were enrolled [28 male (54.9%)]. At baseline, 30 patients (58.8%) were treated with FTC/TDF, 20 (39.2%) with abacavir/lamivudine and 1 (2.0%) with lamivudine/zidovudine. Thirty-three patients (64.7%) received atazanavir. All patients maintained HIV-RNA <50 copies/mL; the median CD4+ cell count remained stable. Mean triglycerides decreased from 124 mg/dL (range, 39-625) at enrolment to 108.7 mg/dL (range, 39-561) at study end (P = 0.25). At baseline, mean cholesterol was 172.8 ± 38.1 mg/dL and decreased to 161.9 ± 38.6 mg/dL (P = 0.038); likewise, median total bilirubin decreased from 1.07 mg/dL (range, 0.2-4.7) to 0.6 mg/dL (range, 0.13-3.1) (P <0.001). cART-related annual cost reduction with a STR was €3155.47 per patient (-24%). Non-cART patient management expenses were €402.68 vs. €299.10 for atazanavir or fosamprenavir and STR regimens, respectively. Switching to RPV/FTC/TDF from an unboosted PI in virologically suppressed HIV-infected patients is safe and is associated with a reduction in triglycerides, cholesterol and cART-related costs. Copyright © 2016 Elsevier B.V. and International Society of Chemotherapy. All rights reserved.

Population pharmacokinetic analysis of carboxyhaemoglobin concentrations in adult cigarette smokers

PubMed Central

Cronenberger, Carol; Mould, Diane R; Roethig, Hans-Juergen; Sarkar, Mohamadi

2008-01-01

AIMS To develop a population-based model to describe and predict the pharmacokinetics of carboxyhaemoglobin (COHb) in adult smokers. METHODS Data from smokers of different conventional cigarettes (CC) in three open-label, randomized studies were analysed using NONMEM (version V, Level 1.1). COHb concentrations were determined at baseline for two cigarettes [Federal Trade Commission (FTC) tar 11 mg; CC1, or FTC tar 6 mg; CC2]. On day 1, subjects were randomized to continue smoking their original cigarettes, switch to a different cigarette (FTC tar 1 mg; CC3), or stop smoking. COHb concentrations were measured at baseline and on days 3 and 8 after randomization. Each cigarette was treated as a unit dose assuming a linear relationship between the number of cigarettes smoked and measured COHb percent saturation. Model building used standard methods. Model performance was evaluated using nonparametric bootstrapping and predictive checks. RESULTS The data were described by a two-compartment model with zero-order input and first-order elimination with endogenous COHb. Model parameters included elimination rate constant (k10), central volume of distribution (Vc/F), rate constants between central and peripheral compartments (k12 and k21), baseline COHb concentrations (c0), and relative fraction of carbon monoxide absorbed (F1). The median (range) COHb half-lives were 1.6 h (0.680–2.76) and 30.9 h (7.13–367) (α and β phases, respectively). F1 increased with increasing cigarette tar content and age, whereas k12 increased with ideal body weight. CONCLUSION A robust model was developed to predict COHb concentrations in adult smokers and to determine optimum COHb sampling times in future studies. WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT The pharmacokinetics of carboxyhaemoglobin have been reported previously, primarily with regard to poisoning and toxicity. Most of these reports have involved noncompartmental analysis of data obtained where the actual dose of carbon monoxide was not known. WHAT THIS STUDY ADDS This study presents a comprehensive population pharmacokinetic model for carboxyhaemoglobin in adult cigarette smokers. Since carboxyhaemoglobin is a marker of cigarette smoke exposure, model-based evaluations can be used for simulation and other evaluations of the kinetics of this agent. PMID:17764477

Safety, Adherence and Acceptability of Intermittent Tenofovir/Emtricitabine as HIV Pre-Exposure Prophylaxis (PrEP) among HIV-Uninfected Ugandan Volunteers Living in HIV-Serodiscordant Relationships: A Randomized, Clinical Trial

PubMed Central

Kibengo, Freddie M.; Ruzagira, Eugene; Katende, David; Bwanika, Agnes N.; Bahemuka, Ubaldo; Haberer, Jessica E.; Bangsberg, David R.; Barin, Burc; Rooney, James F.; Mark, David; Chetty, Paramesh; Fast, Patricia; Kamali, Anatoli; Priddy, Frances H.

2013-01-01

Background Efficacy of oral pre-exposure prophylaxis (PrEP) in prevention of HIV acquisition has been evaluated using a daily regimen. However, adherence to long term daily medication is rarely perfect. Intermittent regimen may be a feasible alternative. Preclinical studies have demonstrated effectiveness of intermittent PrEP in SHIV prevention among animals. However, little is known about intermittent PrEP regimens. Design Seventy two HIV-uninfected volunteers in HIV serodiscordant couple relationships in Uganda were randomly assigned to receive daily oral Tenofovir/Emtricitabine (TDF/FTC-Truvada) or placebo, or intermittent (Monday, Friday and within 2 hours after sex, not to exceed one dose per day) oral TDF/FTC or placebo in a 2:1:2:1 ratio. Volunteers and study staff were blinded to drug assignment, but not to regimen assignment. Methods Volunteers were followed for 4 months after randomization, with monthly clinical and laboratory safety assessments and comprehensive HIV risk reduction services. Adherence was monitored using medication event monitoring system (MEMS) and self-report. Sexual activity data were collected via daily short text message (SMS) and self-report. HIV-specific immune responses were assessed by IFN-γ ELISPOT. Results Both daily and intermittent oral TDF/FTC regimens were well tolerated. Median MEMS adherence rates were 98% (IQR: 93-100) for daily PrEP regimen, 91% (IQR: 73-97) for fixed intermittent dosing and 45% (IQR: 20-63) for post-coital dosing. SMS response rate was 74%, but increased to 80% after excluding server outages; results may have been affected by the novelty of this measure. The majority of volunteers expressed willingness with no particular preference for either regimen. Conclusions Both daily and intermittent oral PrEP dosing regimens were safe. Adherence was high for daily and fixed intermittent dosing; post-coital dosing was associated with poor adherence. Fixed intermittent PrEP regimens may be feasible especially if a minimum effective drug concentration correlating with HIV prevention can be achieved with this dosing. Registration Clinicaltrials.gov number NCT00931346 PMID:24086333

Practitioner Perceptions of Patients Wearing Decorative Contact Lenses Purchased Through Unauthorized Sellers.

PubMed

Gaiser, Hilary; Ho, Connie; Janier, Nicole; Wee, Amy; Johnson, Catherine; Watanabe, Ronald

2017-03-01

To describe practitioner experiences regarding ocular complications in patients wearing decorative contact lenses, and to investigate the compliance of unauthorized distributors of decorative contact lenses to current Food and Drug Administration (FDA) and Federal Trade Commission (FTC) regulations. Also, to provide data to support a more targeted public health approach to reducing the incidence of illegal contact lens sales and associated ocular complications. An institutional review board-approved online survey was distributed through mass email to a list of 98 optometrists in the Boston, MA area. Concurrently, an empirical evaluation of independent, online decorative contact lens sellers who were not associated with FDA-approved contact lens manufacturers was performed to determine their adherence to FDA and FTC guidelines. The first 18 noncoincidental websites that resulted from a Google search for "costume contact lens sellers" and "cosmetic contact lens sellers" were examined as to the brands and parameters of lenses being sold, whether or not a valid prescription was required or verified, and if consumer education was provided. Twenty-two optometrists completed the online survey. Seventy-seven percent of respondents reported having patients with complications from decorative contact lenses that were purchased both legally and illegally. The most common age group for complications was 18 to 25 years (61%). One third of complications were seen in first-time lens wearers, half of whom never received proper care instructions or were unaware that care instructions existed. One quarter of the lenses were purchased illegally with unlicensed stores being the most common place of purchase. Of the 18 online sites examined, 72% of sellers failed to adhere to FTC and FDA regulations. A significant number of individuals who obtain contact lenses illegally from unauthorized sources are young adults. Most unauthorized sellers reviewed did not adhere to the proper protocol for selling contact lenses or instruct their customers on proper lens wear and care. A significant percentage of optometrists responding to the survey reported complications associated with contact lenses purchased through unauthorized sources, suggesting that the risk of contact lens-related complications increases when the lenses are purchased from one of these sources.

Characteristics of differentiated thyroid carcinoma in children and adolescents with respect to age, gender, and histology.

PubMed

Farahati, J; Bucsky, P; Parlowsky, T; Mäder, U; Reiners, C

1997-12-01

Because of its rarity there have been only a few detailed studies on differentiated thyroid carcinoma (DTC) in children. The current investigation was undertaken to assess the characteristics of DTC with respect to age, gender, and histology in children and adolescents. In a questionnaire-based survey, data from 114 children and adolescents with DTC (age range, 3-18 years) was collected from 65 clinical institutions in Germany. Characteristics of 80 females and 34 males were evaluated and the influence of age, gender, histology, multicentric growth, tumor stage, and lymph node involvement on distant metastases was tested using multivariate discriminant analysis. Comparison between groups was performed using the Student's t test and chi-square test. Correlation between incidence and age was assessed by linear regression analysis. The overall incidence of thyroid carcinoma in females was higher than in males, with a peak of female/male ratio occurring at puberty. The incidence of DTC correlated with age in females < 16 years (correlation coefficient [r] = 0.84; P = 0.0006), which was more pronounced in children with papillary thyroid carcinoma (PTC) (r = 0.83; P = 0.006) but not in those with follicular thyroid carcinoma (FTC) (r = 0.20; P = 0.16). FTC was associated with less advanced disease (P = 0.009), fewer lymph nodes involved (P = 0.007), and fewer metastases (P = 0.02) compared with PTC. Males tended to have a higher risk for distant metastases. However, statistical analysis failed to reach a level of significance (P = 0.08). Multivariate analysis revealed tumor stage as the only powerful factor (P = 0.02) correlated with distant metastasis. The incidence of PTC shows a marked increase in females with the highest female/male ratio occurring at puberty. Childhood thyroid carcinoma frequently is associated with lymph node involvement, distant metastases, and extrathyroidal tumor infiltration. In children FTC appears to be less aggressive than PTC. Advanced local-regional extension stage appears to be the most powerful factor influencing the risk for distant metastases in children.

Landpower 2020: Enabling Regionally Aligned US Army Forces with Threat-Based Planning

DTIC Science & Technology

2013-03-01

situation, EUCOM has prioritized BPC as a tenet of its theater strategy, and it is the only command to have submitted the requirement for additional...Army forces to enable BPC as part of the annual GCC’s submission of integrated priorities to the joint staff.27 In fact, EUCOM has requested...perform BPC tasks in the AOR. However, United States Central Command (CENTCOM) indicated a vulnerability to effectively respond to emerging

Joint Light Tactical Vehicle (JLTV): Background and Issues for Congress

DTIC Science & Technology

2017-01-10

Development (TD) Phase to three industry teams: (1) BAE Systems, (2) the team of Lockheed Martin and General Tactical Vehicle, and (3) AM General and...Lockheed Martin Corporation (Grand Prairie, TX); and Oshkosh Corporation (Oshkosh, WI). On September 3, 2013, the Army began JLTV testing at Aberdeen...who were picked in 2012 to build prototypes—Oshkosh, Lockheed Martin , and AM General—submitted their bids for the LRIP contract by the February 10

The Afghan Tribe is a Critical Capability: Leveraging the Center of Gravity

DTIC Science & Technology

2010-05-03

other provision of law , no person shall be subject to any penalty for failing to comply with a collection of information if it does not display a...AVAILABILITY STATEMENT Distribution Statement A: Approved for public release; distribution is unlimited. 13. SUPPLEMENTARY NOTES A paper submitted to...the Naval War College faculty in partial satisfaction of the requirements of the Joint Military Operations Department. The contents of this paper

A joint resolution relating to the disapproval of the President's exercise of authority to increase the debt limit, as submitted under section 3101A of title 31, United States Code, on January 12, 2012

THOMAS, 112th Congress

Sen. McConnell, Mitch [R-KY

2012-01-23

Senate - 01/23/2012 Introduced in the Senate. Read twice. Placed on Senate Legislative Calendar under General Orders. Calendar No. 295 pursuant to P.L. 112-25, sec. 301(a)(2). (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

Good Governance Matters: Optimizing U.S. PRTs in Afghanistan to Advance Good Governance

DTIC Science & Technology

2009-04-01

a new school. Partnering is critical to ensure the synchronized application of aid. In this case ensuring that teachers ...traces the origins of the U.S. Afghanistan PRT Model from its inception in 2002 to today. The paper will take a critical look at all the three lines...Captain, U.S. Navy A paper submitted to the Faculty of the Joint Advanced Warfighting School in partial satisfaction of the