ABSTRACT
Background: The conduct of clinical trials during COVID-19 created challenges to ensuring access to clinical trials, healthy clinical teams, and patients. Innovative methods such as remote patient follow-up and monitoring visits can lead to successful completion of device trials. Objective(s): The INGEVITY+ Active Fixation Pace/Sense Lead Study examined the safety/ efficacy of the INGEVITY+ Lead in a prospective, non-randomized, multicenter, post-approval study. Method(s): Subjects met indications for a pacing device with INGEVITY+ leads implanted in the RA and RV. The primary safety endpoint was the 3-month lead-related complication-free (LRC-free) rate. The primary efficacy endpoint evaluated the 3-month pacing capture threshold with the secondary efficacy endpoint evaluating the other lead-related electrical parameters. Implanter experience was assessed. Telephone visits with LATITUDE remote transmission of lead measurement data and remote monitoring visits were allowed. Result(s): A total of 201 leads were evaluated in 101 subjects, 46.8% female with a mean age of 73.2 years, at 13 centers in the United States. The study took 6.8 months, with a median follow-up of 3.4 months. The 3-month follow-up was completed by 98% of subjects, of which 36% were remote. A total of 98% of monitoring visits were done remotely. The study met all primary and secondary endpoints. The LRC-free rate through 3-months was 98.5% (lower CL 95.4%). Three leads were repositioned and reimplanted;two were RA dislodgements, and one was a RA perforation and hemothorax requiring thoracentesis. The pacing capture threshold was <= 2V in 98.9% of subjects with a mean of 0.77 V at 0.4-ms pulse width, mean pacing impedance of 712 ohms, and a median P-wave amplitude of 4.3 mV, and median R-wave amplitude of 15.9 mV at 3- months. No helix performance issues were reported. The mean turn count for helix extension was 6.7 and retraction was 7.6. More than 85% of physicians rated the lead as 'very good' or higher on all aspects of lead handling. Conclusion(s): The INGEVITY+ Lead was found to be safe and effective with a very favorable implant experience. This study was entirely conducted successfully during COVID-19 with remote follow-up and monitoring visits, and nearly half of the subjects were females.
ABSTRACT
The aim of this study is to clarify the impact of the change in the elements of the cash flow statement on the capital structure. However, this study was conducted on six pharmaceutical companies listed on the Amman Stock Exchange during the period between 2018 and 2021. Meanwhile, the descriptive analysis of the study variables was used, besides each of the correlation tests, simple regression, and analysis of changes in financial ratios. Thus, for the purpose of showing the impact of cash flows elements on the capital structure of pharmaceutical companies and the extent to which it is affected by the Coronavirus (COVID-19) pandemic. Whereas, the current study concluded that there is a statistically significant impact (reject the null hypothesis) of cash flows on the capital structure as well as having an impact of cash flows on indebtedness and that there is no statistically significant impact (rejection of the null hypothesis) of cash flows on the shareholders’ contribution to property rights. One of the most important conclusions of the current study is that the change in cash flows negatively affects the indebtedness rate, and this is a good thing, as the increase in cash flows leads to a decrease in the indebtedness ratio and this is desirable by the companies’ management, owners and creditors, but the decrease in these flows leads to an increase in the indebtedness rate. Meanwhile, the current study recommended the possibility of studying the company’s ability to sustain in light of the high indebtedness’ circumstances and ways to survive from insolvency and bankruptcy. © 2023, The Author(s), under exclusive license to Springer Nature Switzerland AG.
ABSTRACT
The current crisis has overwhelmed current debates about the need for an immediate response on the part of governments to act or take extreme measures to reduce human costs and economic losses. At the same time, governmental measures largely disprove the laissez-faire ideology that favors a "minimum state", or government limited scope. Which puts us in front of important questions that build on the early liberal discussions about the importance of the government role at the political, economic and social levels that emerged generally in the face of the challenges of the Covid-19 pandemic. The research aims to reach reasonable conclusions about government intervention in times of crisis. Crises are exceptional cases;require a comprehensive mobilization of social effort at the governmental and popular levels to avoid expected losses and damages because of crises. Libertarian inclinations oppose governmental intervention in the activities of public life. Which exposes for discussion the problem related to the importance of the government role in solving public problems that need capabilities that overtop the capabilities of the private sector. In addition to that;the government having an important role in providing social benefits to the poor classes who are unable to work in Healthy urban conditions.