Digest of state alcohol-highway safety related legislation. Nineteenth edition. Current as of January 1, 2001.

Mode of access: Internet.

Digest of state alcohol-highway safety related legislation : current as of January 1, 2002 /

"April 2002."

Digest of state alcohol-highway safety related legislation. Current as of January 1, 1998. Sixteenth edition.

Mode of access: Internet.

Rules for inspection of safety appliances, adopted April 1, 1901 by the Interstate Commerce Commission.

"Revised and amended January 1, 1903, amended April 1, 1904, amended July 1, 1904."

Classification of safety appliance defects to be reported by federal inspectors : July 1, 1911 /

At head of title: Interstate Commerce Commission.

Workmen's Compensation, Insurance and Safety Act : chapter 176 of the Laws of 1913, effective January 1, 1914 /

Includes index.

Nominations of John Hammerschmidt to be a member of the National Transportation Safety Board, Jeffrey Runge to be Administrator of the National Highway Traffic Safety Administration, Nancy Victory to be Assistant Secretary of Commerce for Communications and Information, and Otto Wolff to be Assistant Secretary of Commerce and Chief Financial Officer : hearing before the Committee on Commerce, Science, and Transportation, United States Senate, One Hundred Seventh Congress, first session, Wednesday, August 1, 2001.

Distributed to some depository libraries in microfiche.

Safety appliances on railroads. State of equipment April 1, 1896-September 1, 1897 ...

Mode of access: Internet.

Live Attenuated Chimeric Yellow Fever Dengue Type 2 (Chimeri Vax -DEN2) Vaccine: Phase 1 clinical trial for safety and immunogenicity

A randomized double-blind Phase I Trial was conducted to evaluate safety, tolerability, and immunogenicity of a yellow fever (YF)-dengue 2 (DEN2) chimera (ChimeriVax™-DEN2) in comparison to that of YF vaccine (YF-VAX®). Forty-two healthy YF naïve adults randomly received a single dose of either ChimeriVax™-DEN2 (high dose, 5 log plaque forming units [PFU] or low dose, 3 log PFU) or YF-VAXâ by the subcutaneous route (SC). To determine the effect of YF pre-immunity on the ChimeriVaxTM-DEN2 vaccine, 14 subjects previously vaccinated against YF received a high dose of ChimeriVax™-DEN2 as an open-label vaccine. Most adverse events were similar to YF-VAX® and of mild to moderate intensity, with no serious side-effects. One hundred percent and 92.3% of YF naïve subjects inoculated with 5.0 and 3.0 log10 PFU of ChimeriVaxTM-DEN2, respectively, seroconverted to wt DEN2 (strain 16681); 92% of subjects inoculated with YF-VAX® seroconverted to YF 17D virus but none of YF naïve subjects inoculated with ChimeriVax-DEN2 seroconverted to YF 17D virus. Low seroconversion rates to heterologous DEN serotypes 1, 3, and 4 were observed in YF naïve subjects inoculated with either ChimeriVax™-DEN2 or YF-VAX®. In contrast, 100% of YF immune subjects inoculated with ChimeriVax™-DEN2 seroconverted to all 4 DEN serotypes. Surprisingly, levels of neutralizing antibodies to DEN 1, 2, and 3 viruses in YF immune subjects persisted after 1 year. These data demonstrated that 1) the safety and immunogenicity profile of the ChimeriVax™-DEN2 vaccine is consistent with that of YF-VAX®, and 2) pre-immunity to YF virus does not interfere with ChimeriVaxTM-DEN2 immunization, but induces a long lasting and cross neutralizing antibody response to all 4 DEN serotypes. The latter observation can have practical implications toward development of a dengue vaccine.

Improved Criteria for Estimating Calibration Factors for Highway Safety Manual (HSM) Applications

The Highway Safety Manual (HSM) estimates roadway safety performance based on predictive models that were calibrated using national data. Calibration factors are then used to adjust these predictive models to local conditions for local applications. The HSM recommends that local calibration factors be estimated using 30 to 50 randomly selected sites that experienced at least a total of 100 crashes per year. It also recommends that the factors be updated every two to three years, preferably on an annual basis. However, these recommendations are primarily based on expert opinions rather than data-driven research findings. Furthermore, most agencies do not have data for many of the input variables recommended in the HSM. This dissertation is aimed at determining the best way to meet three major data needs affecting the estimation of calibration factors: (1) the required minimum sample sizes for different roadway facilities, (2) the required frequency for calibration factor updates, and (3) the influential variables affecting calibration factors. In this dissertation, statewide segment and intersection data were first collected for most of the HSM recommended calibration variables using a Google Maps application. In addition, eight years (2005-2012) of traffic and crash data were retrieved from existing databases from the Florida Department of Transportation. With these data, the effect of sample size criterion on calibration factor estimates was first studied using a sensitivity analysis. The results showed that the minimum sample sizes not only vary across different roadway facilities, but they are also significantly higher than those recommended in the HSM. In addition, results from paired sample t-tests showed that calibration factors in Florida need to be updated annually. To identify influential variables affecting the calibration factors for roadway segments, the variables were prioritized by combining the results from three different methods: negative binomial regression, random forests, and boosted regression trees. Only a few variables were found to explain most of the variation in the crash data. Traffic volume was consistently found to be the most influential. In addition, roadside object density, major and minor commercial driveway densities, and minor residential driveway density were also identified as influential variables.

Iowa Department of Public Health, Occupational Health & Safety Surveillance Program Annual Report, July 1, 2013- June 30, 2014, August 1, 2014

The mission of the Iowa OHSSP is to promote and protect the health and safety of Iowans in the workplace. The fundamental or core program provides administrative coordination and continuity across all IDPH OHSSP projects, explores options to improve the surveillance and data translation capacity of the entire program, and provides outreach, dissemination, and evaluation functions to support each project. The core program is also responsible for the Occupational Health Indicators project and Adult Blood Lead Epidemiology and Surveillance (ABLES), as well as working with external partner projects and reports.

Predictive Value Of Phase I Trials For Safety In Later Trials And Final Approved Dose: Analysis Of 61 Approved Cancer Drugs.

Phase I trials use a small number of patients to define a maximum tolerated dose (MTD) and the safety of new agents. We compared data from phase I and registration trials to determine whether early trials predicted later safety and final dose. We searched the U.S. Food and Drug Administration (FDA) website for drugs approved in nonpediatric cancers (January 1990-October 2012). The recommended phase II dose (R2PD) and toxicities from phase I were compared with doses and safety in later trials. In 62 of 85 (73%) matched trials, the dose from the later trial was within 20% of the RP2D. In a multivariable analysis, phase I trials of targeted agents were less predictive of the final approved dose (OR, 0.2 for adopting ± 20% of the RP2D for targeted vs. other classes; P = 0.025). Of the 530 clinically relevant toxicities in later trials, 70% (n = 374) were described in phase I. A significant relationship (P = 0.0032) between increasing the number of patients in phase I (up to 60) and the ability to describe future clinically relevant toxicities was observed. Among 28,505 patients in later trials, the death rate that was related to drug was 1.41%. In conclusion, dosing based on phase I trials was associated with a low toxicity-related death rate in later trials. The ability to predict relevant toxicities correlates with the number of patients on the initial phase I trial. The final dose approved was within 20% of the RP2D in 73% of assessed trials.

Efficacy And Safety Of Intravitreal Bevacizumab In Eyes With Neovascular Glaucoma Undergoing Ahmed Glaucoma Valve Implantation: 2-year Follow-up.

To evaluate the efficacy and safety of intravitreal bevacizumab (IVB) in eyes with neovascular glaucoma (NVG) undergoing Ahmed glaucoma valve (AGV) implantation. This was a multicentre, prospective, randomized clinical trial that enrolled 40 patients with uncontrolled neovascular glaucoma that had undergone panretinal photocoagulation and required glaucoma drainage device implantation. Patients were randomized to receive IVB (1.25 mg) or not during Ahmed valve implant surgery. Injections were administered intra-operatively, and 4 and 8 weeks after surgery. After a mean follow-up of 2.25 ± 0.67 years (range 1.5-3 years), both groups showed a significant decrease in IOP (p < 0.05). There was no difference in IOP between groups except at the 18-month interval, when IOP in IVB group was significantly lower (14.57 ± 1.72 mmHg vs. 18.37 ± 1.06 mmHg - p = 0.0002). There was no difference in survival success rates between groups. At 24 months, there was a trend to patients treated with IVB using less antiglaucoma medications than the control group (p = 0.0648). Complete regression of rubeosis iridis was significantly more frequent in the IVB group (80%) than in the control group (25%) (p = 0.0015). Intravitreal bevacizumab may lead to regression of new vessels both in the iris and in the anterior chamber angle in patients with neovascular glaucoma undergoing Ahmed glaucoma valve implantation. There is a trend to slightly lower IOPs and number of medications with IVB use during AGV implantation for neovascular glaucoma.

Impact Of Severe Haemophilia A On Patients' Health Status: Results From The Guardian(™) 1 Clinical Trial Of Turoctocog Alfa (novoeight(®) ).

Haemophilia and its treatment interfere with patients' life and may affect adherence to treatment. This study explored the impact of severe haemophilia A on patients' health status, especially in young adults (YA), using data from guardian(™) 1, a multinational, open-label, non-controlled phase 3 trial investigating safety and efficacy of turoctocog alfa (NovoEight(®) ) in previously treated patients aged 12 years and older with severe haemophilia A (FVIII ≤ 1%). Health status was assessed using the EuroQoL-5 dimensions (EQ-5D-3L), covering 5 dimensions of health (mobility, self-care, usual activities, pain/discomfort and anxiety/depression), and a visual analogue scale (VAS) measuring self-rated overall health status. EQ-5D was administered pretreatment (screening/baseline) and posttreatment (end-of-trial). Baseline responses to the EQ-5D dimensions and VAS were described overall and by age and compared to reference values from UK general population. Guardian(™) 1 included 150 patients (16 adolescents, 83 YA aged 16-29 and 51 adults aged 30+). All five dimensions of patients' health status were impacted at baseline. The percentage of haemophilia patients reporting problems was consistently significantly greater than age-matched general population reference values. Likewise, for all age groups mean baseline EQ-5D VAS score was significantly lower for haemophilia patients (YA: 78.0) than for the general population (YA aged 18-29: 87.3). The health status of patients with severe haemophilia A entering guardian(™) 1 was markedly poorer than that of the general population, particularly regarding mobility and pain. YA patients reported better health status than older patients, but considerably lower than that of the general YA population.

Impact Of Drug Formulation And Free Platinum/cisplatin Ratio On Hypersensitivity Reactions To Cisplatin: Formulation Matters.

Use of cisplatin can induce type I hypersensitivity reactions that may also be linked to the quality of the drug utilized. We observed cases of hypersensitivity that appeared to be associated with the brand of cisplatin used. The aim of this study was to compare two different brands of cisplatin in relation to type I hypersensitivity reactions. Brand A was used in a tertiary care teaching hospital until 2012, and use of brand B started from January 2013, when the first hypersensitivity cases were observed. Patients were categorized based on symptom. Cisplatin of both brands was analysed by high-performance liquid chromatography (HPLC) and high-resolution electrospray ionization mass spectrometry (ESI-(+)-MS) and characterized according to US Pharmacopeia. There were no cases of hypersensitivity associated with the use of cisplatin brand A, whereas four of 127 outpatients that used cisplatin brand B were affected. The two brands were in accordance with the US Pharmacopeia parameters, and there was no significant difference in the total platinum levels between the two brands when analysed by HPLC. However, high-resolution ESI-(+)-MS analyses show that brand B contains approximately 2.7 times more hydrolysed cisplatin than brand A. The increase in the hydrolysed form of cisplatin found in brand B may be the cause of the hypersensitivity reaction observed in a subset of patients. We present the first study of the quality of drugs by high-resolution ESI-(+)-MS. Drug regulatory agencies and manufacturers should consider including measurement of hydrolysed cisplatin as a quality criterion for cisplatin formulations.