safety studies
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Author(s):  
Pallavi Dan ◽  
Swetha Senthilkumar ◽  
Devanand Venkatsubbu Gopinath ◽  
Sahabudeen Sheik Mohideen

Author(s):  
Union of Concerned Scientists Earthjustice

More than 180 preventable incidents at hazardous chemicals facilities occur each year, resulting in deaths, injuries, evacuations, shelter in place orders, environmental contamination, and facility shutdowns with permanent job loss. As of June 17, 2021, the Chemical Safety Board (CSB) had nineteen open site investigations of incidents that in total killed thirty-two people, injured at least eighty-seven people, led to thousands of residents sheltering in place or evacuating, and resulted in many millions of dollars in property damage. This document outlines twenty-one practical and measurable actions that the CSB can take to rebuild its investigative and recommendations capacity; set clear priorities for agency action; reform its governance policies; and increase public transparency and engagement. The proposed actions address incident investigations, safety studies, safety recommendations, agency governance, and public transparency and engagement.


Medicina ◽  
2021 ◽  
Vol 58 (1) ◽  
pp. 30
Author(s):  
Kamil Adamczyk ◽  
Ewa Rusyan ◽  
Edward Franek

Autoimmune thyroid diseases are the most common organ-specific autoimmune diseases, affecting 2–5% of the world’s population. Due to the autoimmune background of thyroid diseases, we analyzed a wide range of cosmetic procedures, from minimally invasive cosmetic injections (mesotherapy) to highly invasive procedures, such as lifting threads. Out of the seven categories of treatments in aesthetic medicine analyzed by us—hyaluronic acid, botulinum toxin, autologous platelet-rich plasma, autologous fat grafting, lifting threads, IPL and laser treatment and mesotherapy—only two, mesotherapy and lifting threads, are not recommended. This is due to the lack of safety studies and the potential possibility of a higher frequency of side effects in patients with autoimmune thyroid diseases.


2021 ◽  
pp. 1098612X2110670
Author(s):  
Samuel J Keepman ◽  
MacKenzie A Pellin

Objectives Non-steroidal anti-inflammatory drugs (NSAIDs) are infrequently utilized in cats due to concern for renal compromise; however, recent studies demonstrate tolerability of low dose meloxicam. Toceranib phosphate is used to treat several feline cancers and is well tolerated. This study aimed to determine the tolerability and adverse event profile of combined toceranib and low dose meloxicam in cancer-bearing cats. Secondary goals involved assessing anticancer tumor efficacy and impact upon quality of life and analgesia. Methods Cats with any cancer not involving the kidneys were eligible. The study adopted a conventional 3 + 3 dose escalation design. Toceranib was administered every other day at a standard dose with meloxicam administered in an escalating fashion in subsequent cohorts, at a starting dose of 0.01 mg/kg on opposite days to toceranib, up to a maximum of 0.02 mg/kg daily, based upon previous safety studies. Laboratory work, blood pressure, tumor measurements, pain score and client-completed quality-of-life surveys were recorded every 2–4 weeks during the 12-week study period. Results Twenty-one cats were enrolled. When combined with toceranib, a meloxicam dose of 0.02 mg/kg q24h was safe and well tolerated, with no cats being withdrawn due to adverse events from the drug combination. The majority of cats demonstrated clinical benefit with stable to mildly improved tumor measurements, quality of life and pain scores. Conclusions and relevance Low dose meloxicam combined with toceranib is safe and well tolerated in cancer-bearing cats. Continued patient recruitment and data collection are needed to determine the maximum tolerated dose of meloxicam. The results of our study will guide further phase II/III trials.


Buildings ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. 643
Author(s):  
Hongqiang Fang ◽  
Siuming Lo ◽  
Jacqueline T. Y. Lo

Complex and tall buildings have been constructed in many cities recently. Fire safety should be a major concern of building designers, engineers, and governments. Previous fire experience has made us understand the importance of acquiring fire-ground information to facilitate firefighting operations, evacuation processes, rescues, etc. Recently, the rapid advancement in Information Technology, Data Analytics, and other detection and monitoring systems has provided the basis for fire safety researchers to re-think fire safety strategies in the built environment. Amongst all fire safety studies, evacuation in tall buildings, including elevator evacuations, has attracted much attention. IoT-aided building fire evacuation is a new concept of the building evacuation mode, which improves the building evacuation process by making decisions of escape based on the real-time fire-ground information, such as the fire environment and occupant situations. Focusing on IoT applications in building fire evacuation, this paper explores the advantages and insufficiencies of current smart building fire evacuation systems. A conceptual design of an IoT-aided building fire evacuation control system is described. The system is introduced in the sequence of information needs, information sources and data transmission, and potential services and applications. Finally, new insights into promising 5G technologies for future building fire evacuations are discussed.


2021 ◽  
pp. 019262332110568
Author(s):  
Daniel Petkov ◽  
Daniel J. Patrick ◽  
Petrina Rogerson ◽  
David Rehagen ◽  
Gayle Hennig ◽  
...  

Aneurysms of the ascending aorta, unrelated to xenobiotic administration, are described in 5 rats and 2 mice in nonclinical safety studies conducted at Charles River Laboratories (CRL) sites over the past 10 years. The most prominent microscopic finding was focal dilation with disruption of the wall of the ascending aorta with chronic adventitial inflammation or fibroplasia. The pathogenesis of this finding is unknown. There were no associated macroscopic findings, clinical abnormalities, or vascular lesions elsewhere. The results of a search of historical control data from toxicology studies of 1 day to 72 weeks’ duration performed at CRL for aortic findings from 5900 mice and 23,662 rats are also reported. Aortic lesions are uncommon in mice and rats used in nonclinical safety studies, but toxicologic pathologists should be aware that aneurysms of the ascending aorta with fibroplasia and inflammation in the aortic wall and adventitia may occur spontaneously or iatrogenically, as they have the potential to impact interpretation in toxicology studies.


2021 ◽  
Vol 37 (S1) ◽  
pp. 27-27
Author(s):  
María del Mar Polo-deSantos ◽  
Setefilla Luengo-Matos ◽  
Ana Isabel Hijas-Gómez ◽  
Esther Elena García-Carpintero ◽  
Luis María Sánchez-Gómez

IntroductionRobotic surgery (RS) can offer benefits compared to freehand surgery (FS) in the treatment of patients with spinal diseases. The aim of this study was to assess efficacy and safety of RS versus FS in spinal fusion. The outcomes considered were accuracy in the placement of pedicle screws, surgical times, hospital stay, exposure to radiation, and complications.MethodsA systematic review and meta-analysis were performed by researchers at the Instituto de Salud Carlos III (ISCIII). Studies published until June 2019 in the English, Spanish, or French languages were retrieved. The data analyses and risk of bias assessments were undertaken using RevMan 5.3.ResultsEight randomized controlled trials including 610 patients (RS: 308, FS: 302) were found. The mean age of the patients ranged from 56 to 68 years in the FS group and from 55 to 68 years in the RS group. The percentage of women included ranged from 46 to 73 percent undergoing FS and from 33 to 70 percent undergoing RS. The main diagnosis was degenerative spine disease. The number of screws implanted ranged from 22 to 584 for FS and 23 to 532 for RS. The robots used were the SpineAssist and Renaissance Guidance System (Mazor Robotics, Ltd) and the TiRobot® Orthopaedic Robotic System (Beijing Tinavi Medical Technologies Co., Ltd). Pedicle screw placement within the safety zone (Grades A and B on the Gertzbein and Robbins scale) ranged from 93 to 100 percent in FS and from 85 to 100 percent in RS (relative risk 1.0, 95% confidence interval [CI] 0.99–1.03; p = 0.36) (I2=75%; p = 0.0005). Regarding intervention time, the meta-analysis showed a mean difference (MD) of 15.2 minutes (95% CI 5.35–25.05; p = 0.002) (I2 = 0%; p = 0.39) in favor of FS. The MD in hospital stay was 0.36 days (95% CI -1.03–0.31; p = 0.30) (I2 = 62%; p = 0.07), which was not statistically significant. Contradictory results were found for fluoroscopy time, although RS was associated with a lower radiation dose than FS (p < 0.05). In relation to safety, studies only reported on rates of surgical revision, which ranged from 0 to 2 after FS and from 0 to 10 after RS. The risk or bias was unclear in most studies.ConclusionsWe found no conclusive results suggesting benefits for spinal fusion using RS compared with FS. Further research with adequate selection of patients, type of robot, and comparator is needed.


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