Methods for epidemiological studies in competitive cycling:an extension of the IOC consensus statement on methods for recording and reporting of epidemiological data on injury and illness in sport 2020

In 2020, the IOC released a consensus statement that provides overall guidelines for the recording and reporting of epidemiological data on injury and illness in sport. Some aspects of this statement need to be further specified on a sport-by-sport basis. To extend the IOC consensus statement on methods for recording and reporting of epidemiological data on injury and illness in sports and to meet the sport-specific requirements of all cycling disciplines regulated by the Union Cycliste Internationale (UCI). A panel of 20 experts, all with experience in cycling or cycling medicine, participated in the drafting of this cycling-specific extension of the IOC consensus statement. In preparation, panel members were sent the IOC consensus statement, the first draft of this manuscript and a list of topics to be discussed. The expert panel met in July 2020 for a 1-day video conference to discuss the manuscript and specific topics. The final manuscript was developed in an iterative process involving all panel members. This paper extends the IOC consensus statement to provide cycling-specific recommendations on health problem definitions, mode of onset, injury mechanisms and circumstances, diagnosis classifications, exposure, study population characteristics and data collection methods. Recommendations apply to all UCI cycling disciplines, for both able-bodied cyclists and para-cyclists. The recommendations presented in this consensus statement will improve the consistency and accuracy of future epidemiological studies of injury and illness in cycling

A phase III placebo-controlled study in advanced head and neck cancer using intratumoural cisplatin/epinephrine gel

Patients with recurrent or refractory head and neck squamous cell carcinoma received cisplatin/epinephrine injectable gel or placebo gel injected directly into the clinically dominant tumour. The double-blind phase III trial comprised of up to 6 weekly treatments over 8 weeks, 4 weekly evaluation visits, and then monthly follow-up; open-label dosing began as needed after three blinded treatments. Tumour response was defined as complete (100% regression) or partial (50–99% regression) sustained for ⩾28 day, and patient benefit as attainment of palliative or preventive goals prospectively selected by investigators and patients. With cisplatin/epinephrine gel, 25% (14 out of 57) of tumours responded (16% complete regression, 9% partial regression), vs 3% (one out of 35, complete regression) with placebo (P=0.007). Patient benefit was positively associated with target tumour response in the blinded period among cisplatin/epinephrine gel recipients (P=0.024): 43% (six out of 14) of responders benefited, vs 12% (five out of 43) of non-responders. The most frequent adverse event was pain during injection and the next most frequent was local cytotoxic effects consistent with the gel's mode of action. Systemic adverse events typical of intravenous cisplatin were uncommon. Intratumoural therapy with cisplatin/epinephrine gel provided safe, well-tolerated, effective palliative treatment for patients with locally advanced head and neck squamous cell carcinoma, who lack other satisfactory treatment options

Low Levels of Human HIP14 Are Sufficient to Rescue Neuropathological, Behavioural, and Enzymatic Defects Due to Loss of Murine HIP14 in Hip14−/− Mice

Huntingtin Interacting Protein 14 (HIP14) is a palmitoyl acyl transferase (PAT) that was first identified due to altered interaction with mutant huntingtin, the protein responsible for Huntington Disease (HD). HIP14 palmitoylates a specific set of neuronal substrates critical at the synapse, and downregulation of HIP14 by siRNA in vitro results in increased cell death in neurons. We previously reported that mice lacking murine Hip14 (Hip14−/−) share features of HD. In the current study, we have generated human HIP14 BAC transgenic mice and crossed them to the Hip14−/− model in order to confirm that the defects seen in Hip14−/− mice are in fact due to loss of Hip14. In addition, we sought to determine whether human HIP14 can provide functional compensation for loss of murine Hip14. We demonstrate that despite a relative low level of expression, as assessed via Western blot, BAC-derived human HIP14 compensates for deficits in neuropathology, behavior, and PAT enzyme function seen in the Hip14−/− model. Our findings yield important insights into HIP14 function in vivo

Evaluation of the Puritan Bennett™ 980 Ventilator System Safety and Performance in the Real-World Setting

Michael Roshon,1 Paras B Khandhar,2 Manoj Biniwale,3 Rangasamy Ramanathan,3 T Patrick Frazier,4 Feng Xu,5 Linlin Zhang,6 Xiangdong Guan,7 Dai Wenling,8 Bernard Lambermont9 1Department of Emergency Medicine, Penrose-St. Francis Health Services, Colorado, Springs, CO, USA; 2Pediatric Critical Care Medicine, Beaumont Children’s Hospital, Royal Oak, MI, USA; 3Division of Neonatology, University of Southern California Keck School of Medicine, Los Angeles, CA, USA; 4Department of Medicine, University of Alabama at Birmingham, Heersink School of Medicine, Birmingham, AL, USA; 5Department of Intensive Care, Children’s Hospital of Chongqing Medical University, Chongqing, People’s Republic of China; 6Department of Critical Care Medicine, Beijing Tiantan Hospital, Capital Medical University, Beijing, People’s Republic of China; 7Department of Critical Care Medicine, the First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, People’s Republic of China; 8Department of Critical Care Medicine, Yancheng First People’s Hospital, Yancheng, People’s Republic of China; 9Department of Intensive Care, University Hospital of Liege, Liege, BelgiumCorrespondence: Michael Roshon, Email [email protected]: Mechanical ventilation is a life-supporting intervention but is associated with known risks and complications. To improve the efficacy and safety profile of mechanical ventilation, manufacturers have developed advanced ventilator settings, modes, and alarm strategies to optimize ventilation for patient needs while avoiding complications. However, there is little real-world data published on the deployment of ventilator technology. The main objective of this study was to assess the clinical safety and performance of the Puritan Bennett™ 980 Ventilator System (PB980) using real-world clinical data collected from a diverse, global patient population.Methods: This was a multi-center, post-market registry study that included nine sites: four in the United States of America, one in Europe, and four in China. Patients were enrolled into the registry if they were intended to be treated with a PB980. Data collection began at the start of ventilation and continued until extubation off the ventilator or up to seven days of ventilation, whichever occurred first. Subjects were divided by age into three categories: infants (0– 365 days), pediatric (1– 17 years), and adult (18 years and older). The primary outcome was device-related complication rate.Results: Two-hundred-and-eleven subjects were enrolled (41 infants, 48 pediatric, and 122 adults). Sixteen deaths, unrelated to device deficiency, occurred during the data collection timeframe (relative frequency: 7.58, 95% CI: 4.40, 12.0). Only one device-related adverse event was reported (relative frequency: 0.47% 95% CI: 0.01%, 2.61%).Conclusion: Ventilation by the PB980 was delivered safely in this multi-center observational study, which included a diverse sample of patients with broad ventilatory needs.Plain Language Summary: Mechanical ventilation is a life supporting intervention. Much progress has been made in this field thanks to a better knowledge of respiratory physiopathology and improved ventilation delivered by modern ventilators.In this global, post-market registry study, ventilation by the Puritan Bennett™ 980 Ventilator was delivered safely to a diverse sample of patients.Keywords: ventilation, PB980, safety, complications, respiratory distress, critical car

Testing the Use of the Water Milfoil ( Myriophyllum spicatum L.) in Laboratory Toxicity Assays

Abstract Tests aiming to determine the toxic properties of compounds discharged into aquatic systems have relied more on fish or invertebrates than on primary producers and among a number of producers; algae are the most popular test organisms. Macrophytes are important ecological elements in freshwaters and are therefore potentially key organisms for use in toxicity testing of compounds suspected of acting in primary producers. The most common macrophyte used in toxicity testing is Lemna sp., but as a floating plant, it has the limitation of being exposed to toxic compounds only through its lower leaf surface, including roots and rhizoids. Therefore, it is questionable whether tests with Lemna may accurately predict potential effects on submersed and exposed plant species, which have different routs of exposure and morphology. Few other submersed macrophytes have been tested, notably Myriophyllum. In the Iberian peninsula M. spicatum is the most common species within its genus and has been presented as a good bioaccumulator of heavy metals (Wang et al. 1996) and as being sensitive to several toxicants (e.g. Hanson et al. 2003). The aim of this study was to assess the potential of M. spicatum as a testing organism in laboratory assays, by obtaining axenic cultures of this plant and exposing them to several reference compounds to determine the sensitive endpoints