Gary Lichtenstein Editions has partnered with Urban Pathways to increase awareness and safety in the homeless community.

Introduction: Gastrin Releasing peptide receptors (GRPRs) are potential molecular imaging targets in a variety of tumors. Recently, a ⁶⁸Ga-labelled antagonist to GRPRs, NeoBOMB1, was developed for PET. We report on the outcome of a Phase I/IIa clinical trial (EudraCT 2016-002053-38) within the EU-FP7 project Closed-loop Molecular Environment for Minimally Invasive Treatment of Patients with Metastatic Gastrointestinal Stromal Tumours (‘MITIGATE’) (grant agreement number 602306) in patients with oligometastatic gastrointestinal stromal tumors (GIST). Materials and Methods: The main objectives were evaluation of safety, biodistribution, dosimetry and preliminary tumor targeting of ⁶⁸Ga-NeoBOMB1 in patients with advanced TKI-treated GIST using PET/CT. Six patients with histologically confirmed GIST and unresectable primary or metastases undergoing an extended protocol for detailed pharmacokinetic analysis were included. ⁶⁸Ga-NeoBOMB1 was prepared using a kit procedure with a licensed ⁶⁸Ge/⁶⁸Ga generator. 3 MBq/kg body-weight were injected intravenously and safety parameters were assessed. PET/CT included dynamic imaging at 5 min, 11 min and 19 min as well as static imaging at 1, 2 and 3-4 h p.i. for dosimetry calculations. Venous blood samples and urine were collected for pharmacokinetics. Tumor targeting was assessed on a per-lesion and per-patient basis. Results: ⁶⁸Ga-NeoBOMB1 (50 µg) was prepared with high radiochemical purity (yield >97%). Patients received 174 ± 28 MBq of the radiotracer, which was well tolerated in all patients over a follow-up period of 4 weeks. Dosimetry calculations revealed a mean adsorbed effective dose of 0.029 ± 0.06 mSv/MBq with highest organ dose to the pancreas (0.274 ± 0.099 mSv/MBq). Mean plasma half-life was 27.3 min with primarily renal clearance (mean 25.7 ± 5.4% of injected dose 4h p.i.). Plasma metabolite analyses revealed high stability, metabolites were only detected in the urine. In three patients a significant uptake with increasing maximum standard uptake values (SUV_max at 2h p.i.: 4.3 to 25.9) over time was found in tumor lesions. Conclusion: This Phase I/IIa study provides safety data for ⁶⁸Ga-NeoBOMB1, a promising radiopharmaceutical for targeting GRPR-expressing tumors. Safety profiles and pharmacokinetics are suitable for PET imaging and absorbed dose estimates are comparable to other ⁶⁸Ga-labelled radiopharmaceuticals used in clinical routine.

Robert R. Henry
Dec 1, 2015; 38:2258-2265
Special Article Collection: Insulin

Khalid A. Jadoon
Oct 1, 2016; 39:1777-1786
Emerging Technologies and Therapeutics

Vanita R. Aroda
Sep 1, 2019; 42:1724-1732
Emerging Therapies: Drugs and Regimens

W. Timothy Garvey
May 1, 2020; 43:1085-1093
Emerging Therapies: Drugs and Regimens

OBJECTIVE

To evaluate the efficacy and safety of fast-acting insulin aspart (faster aspart) compared with insulin aspart (IAsp), both with insulin degludec with or without metformin, in adults with type 2 diabetes not optimally controlled with a basal-bolus regimen.

OBJECTIVE

To assess the efficacy and safety of a 1:1 fixed-ratio combination of insulin glargine and lixisenatide (iGlarLixi) versus lixisenatide (Lixi) in insulin-naive Japanese patients with type 2 diabetes mellitus (T2DM) inadequately controlled on oral antidiabetic drugs (OADs).

OBJECTIVE

Data regarding the effects of sodium–glucose cotransporter 2 inhibitors in the elderly (age ≥65 years) and very elderly (age ≥75 years) are limited.

Technology has changed a number of aspects of our everyday lives and has led to increased efficiency. But when it comes to driving, has it helped or hindered the process? In this article, we will be looking into some of the ways that technology has improved safety on our roads in the last 10 years. […]

A federal appeals court rejected a multi-pronged challenge to a school district plan allowing transgender students to use restrooms and other facilities that match their gender identity.

This publication outlines the Commonwealth Child Safe Framework requirements and guidance for its implementation.The primary audience for this publication is Commonwealth entities. This publication has been developed to assist entities to understand and implement the requirements of the Commonwealth Child Safe Framework.

"Fixed safety cameras that detect red light running and speeding vehicles are known to be an effective method of controlling driver behaviour and producing road safety benefits. While no definitive best practice for choosing safety camera locations was found in the literature, there are a number of criteria that are frequently used and that make sense: locations with a high number of crashes (particularly injury crashes); locations with a high proportion of speeding vehicles; locations with high traffic volumes; locations with large numbers of unprotected road users (pedestrians and bicyclists); different camera types covering different areas of the road network; and deploying cameras widely throughout the road network. Evaluation of the effects of safety cameras on particular sites and as a whole can be attempted using a number of methodologies: changes in crash numbers before and after installation; changes in vehicle speeds before and after installation; and changes in offence detections from the time of installation onwards. There are limitations with each of these methodologies such that evaluating the effectiveness of an individual safety camera is often not possible. By tracking many safety camera sites for a long period of time, the effect of the safety cameras can be examined but there will always be other factors that may explain any observed changes. A true experiment could be conducted to determine safety camera effects but it would involve deliberate non-treatment of good candidate sites for many years. This study gives a reasonable set of principles for selecting safety camera sites and evaluating their effectiveness. However, the detailed processes for South Australia will depend on what data is available, the resources and funding that can be applied, and political and other considerations." -- page 3.

"Fixed safety cameras that detect speeding (and in some cases red light running) are known to be a generally effective method of controlling driver behaviour and producing road safety benefits. They were first introduced in South Australia in 1988 and are now in operation at more than 150 locations around the State. Data on the speeding and red light running offences recorded at each of the sites are now publicly available. If the number of offences declines over time, this is an indication that the safety cameras are becoming increasingly effective in preventing speeding or red light running behaviour. The offence rates of the five types of safety cameras in use in South Australia were examined on a site by site basis. Safety cameras located in South Australian 50-90 km/h speed limit zones in built-up areas showed a similar overall trend in offence rates: speeding offence rates decreased rapidly during the first two to three years of operation; continued declines in speeding offence rates occurred for many years after that; and red light running offences showed general declines over time but not as consistently or to the same extent as speeding offences. Making the cameras more conspicuous from the time of installation may accelerate their positive effects. Safety cameras may also prevent vehicle speeding on high speed rural roads upon installation (this could not be measured here) but there appears to be little change in offence rates after this time. This is possibly due to the more conspicuous nature of these cameras. The tolerances applied to point to point average speed measurements appear to be the same as applied to spot speed measurements and could reasonably be reduced." -- Summary.

The Florida supreme court has ordered a statewide grand jury with a broad mandate to investigate school safety.

Springfield, Virginia : National Technical Information Service, 1986.

The N.W.T. and Nunavut Workers’ Safety and Compensation Commission says it filed multiple charges in the Nunavut Court of Justice under the Nunavut Safety Act on May 1.

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Press release: CPMI and IOSCO share authorities´ experiences in cooperation to increase FMI safety and efficiency, 10 December 2019

The union that represents thousands of Manitoba workers is asking what safety protocols were in place when a construction worker was killed after a trench wall collapsed on him earlier this week.

As automakers look to restart the industry, union representatives are looking to ensure safety is the number one priority for workers.

In light of the regulations on hygiene and gatherings in connection with the global corona pandemic, a fire safety and evacuation exercise, which was scheduled to take place on 29 April in Terminal T1 and the BER railway station, has been postponed yest...

Amid public concerns about school safety fueled by high-profile school shootings, new federal data show reports of student fights, bullying, and other forms of victimization have continued a decades-long trend of decline. At the same time, schools have ramped up security measures, like the use of ca

Infants with hypoxic-ischemic encephalopathy suffer a high rate (>40%) of death or moderate to severe disability, even after therapeutic hypothermia. High-dose erythropoietin (Epo) reduces brain injury and improves neurologic function in animal models of neonatal hypoxic-ischemic brain injury.

Multiple doses of Epo (up to 2500 U/kg intravenously) given in conjunction with hypothermia are well tolerated in newborns with HIE. Epo doses of 1000 U/kg intravenously in cooled infants produce plasma concentrations that are neuroprotective in animal studies. (Read the full article)

The effect of substandard housing on children’s risk of diseases such as asthma has been studied; little is known about how it affects child injury risk. Pediatricians actively promote injury prevention but typically without regard to housing quality.

Low-income children are likely living in substandard homes, which is significantly associated with not having working smoke alarms and safe hot water temperatures. Pediatricians can use these results to inform anticipatory guidance. (Read the full article)

Previous studies suggest that hospitals under the greatest financial strain may be more prone to adverse events because they have limited resources to invest in quality and safety.

The patient population served, rather than hospital category, best predicts measured quality, underscoring the need for robust risk adjustment when incentivizing quality or comparing hospitals. Thus, problems of quality may not be systemic across hospital categories. (Read the full article)

Quality urban playgrounds that are accessible and safe support physical activity and decrease injury rates. Little is known about the quality and accessibility of playgrounds in Chicago public parks.

Most playgrounds in Chicago are in fair condition, yet access to quality playgrounds varies by neighborhood. Public/private collaboration can lead to improved playgrounds, and failing playgrounds can be improved with modest investment. (Read the full article)

Yearly influenza immunization is recommended in patients with inflammatory bowel disease (IBD). However, concern regarding vaccine-related adverse events may limit uptake, and case reports in the literature detail disease flares after immunization.

Influenza immunization rates in children with IBD are low but immunization did not result in increased outpatient visits, hospitalizations or emergency visits. Immunization was associated with fewer IBD-related visits in the post-vaccine period, which may indicate protection against IBD symptoms. (Read the full article)

Brief periods of low oxygen saturation are common in infants while restrained in car safety seats. There is some evidence that an insert that allows the infant head to rest in a neutral position in sleep may reduce hypoxic episodes.

This randomized controlled study shows that the insert reduced numbers of obstructive apneas and the severity of desaturation events but did not significantly reduce the overall rate of moderate desaturations. (Read the full article)

Drug use in pediatrics is often based on adult efficacy data. Clinically significant discrepancies between adults and children may exist. To our knowledge, there is no large-scale evaluation of evidence comparing rates of adverse events between adults and children.

Available evidence on the comparative safety of pharmacologic interventions in adults versus children is inconclusive. In a third of meta-analyses, twofold or greater differences were identified between adults and children, and some clinically important discrepancies were also found. (Read the full article)

Individuals with DiGeorge syndrome (DGS) have varying degrees of immunodeficiency. All are susceptible to vaccine-preventable infections with serious complications. Although live vaccines are generally contraindicated in this population, limited evidence suggests that they may be effective and safe for select individuals.

Many individuals with DGS received live vaccines despite having a known diagnosis. Adverse events following live immunizations were typically minor and self-limited, suggesting that live vaccines may be considered for patients with DGS who exhibit mild-to-moderate immunosuppression. (Read the full article)

Rotavirus vaccination is discouraged during hospitalization, given concerns regarding live-attenuated virus transmission; vaccination is recommended upon NICU discharge for eligible infants, however. Vaccination must be initiated before 104 days of age or infants become age-ineligible.

RotaTeq vaccine administered with routine 2-month vaccinations within the NICU was tolerated in recipients, with no suggestion of symptomatic nosocomial transmission to neighboring unvaccinated infants. (Read the full article)

Phototherapy effectively treats unconjugated hyperbilirubinemia. However, in resource-poor settings, functional phototherapy devices are often unavailable due to financial constraints or erratic electrical power availability.

Filtered-sunlight phototherapy could be a cost-effective option in resource-poor settings with abundant sunlight. (Read the full article)

Influenza leads to respiratory deteriorations in cystic fibrosis (CF) patients. In children, live attenuated influenza virus vaccine (LAIV) is more efficacious than inactivated influenza vaccines, which could be beneficial for CF. Data on the safety of LAIV in this population are scarce.

This study assesses LAIV’s safety in patients with CF and is necessary to determine whether the anticipated benefits associated with LAIV will outweigh potential risks. This can potentially lead to a recommendation for preferential LAIV use in this population. (Read the full article)

Continuously aerosolized albuterol been shown to be safe and effective for the treatment of severe status asthmaticus in the emergency department and ICU. Little evidence supports its use in the non–intensive care setting.

With the appropriate resources and support, continuous albuterol may be administered in the non–ICU setting with a low incidence of clinical deterioration and adverse effects. Certain clinical factors may help identify which patients may benefit from higher acuity care. (Read the full article)