Gustavsenhuang8732

Background Mobile medical devices for self-patient use are a rapidly evolving section of telehealth. We examined the INSTINCT® ultrasound system, a portable, self-operated ultrasound device attached to a commercial smartphone for remote fetal assessment. We aimed to evaluate whether it is feasible to use remote fetal assessment during pregnancy. Materials and Methods This is an observational noninterventional trial. We included women with a singleton fetus at 14 + 0 to 39 + 6 gestational weeks. Each participant received the device for a self-use period of 7-14 days and was instructed to perform one to three scans a day. Participants completed a self-assessment questionnaire to evaluate safety and usability (i.e., user experience and satisfaction). Each scan was evaluated for fetal heart activity, amniotic fluid volume, fetal tone, fetal body, and breathing movements. Results One hundred women, completing 1,360 self scans, used the device for 8.1 ± 1.5 days, performing an average of 13.6 ± 6.2 scans each. There were no device-related serious adverse events. Success in detection was 95.3% for fetal heart activity, 88.3% for body movements, 69.4% for tone, 92.2% for normal amniotic fluid volume, and 23.8% for breathing movements. Interobserver agreement was 94.4% for fetal heart rate activity, 85.9% for body movements, 69.5% for fetal tone, 86.9% for amniotic fluid volume, and 94.0% for breathing movements. Self-assessed user experience was rated at 4.4/5, whereas device satisfaction was rated at 3.9/5. Conclusion The INSTINCT ultrasound system is a feasible solution for remote sonographic fetal assessment. Further studies are needed to assess its role and impact in telehealth antenatal care and fetal surveillance.The COVID-19 (coronavirus disease 2019) pandemic is an emerging, rapidly evolving situation. This study aims to investigate Chinese people's perceptions of COVID-19 and its effects on varied responses to take public health precautions and self-reported protective measures. The survey data were collected from 565 Chinese respondents online from January 25, 2020, to February 4, 2020. Respondents reported a highly perceived risk, knowledge, and self-efficacy associated with the spread of pandemic, and a strong agreement on public health precaution. The more possibilities pneumonia caused by COVID-19 was perceived as severe disease, the more chances public health precautions were taken, but intentions to take self-reported protective measures decreased. Neither infection risk of family member nor full awareness of increasing number of cases had any significant effect on respondents' decision to take personal health responses, suggesting urgent needs to offer health advice to those who deliberately ignore infection risk.Immunogenicity assays are required to evaluate anti-drug antibody (ADA) responses that can be generated against biotherapeutic modalities. Regulatory guidelines focus on clinical requirements, yet it has become apparent that industry has applied these clinical recommendations for immunogenicity assessment to nonclinical studies in varying degrees. ADAs are an anticipated outcome of dosing a humanized or fully human biotherapeutic into an animal. click here However, a nonclinical ADA response is rarely predictive of the immunogenic potential in humans. The addendum to ICH S6 recommends that immunogenicity should be explicitly examined where there is evidence of altered pharmacodynamic activity; unexpected changes in exposure in the absence of a pharmacodynamic marker or evidence of immuno-mediated reactions. The European Bioanalytical Forum has extensively discussed and reached a consensus on a minimal strategic approach of when and what to include for nonclinical immunogenicity assessments. Additionally, this paper recommends a strategy for ADA assay validation and sample analysis for those cases when it is considered necessary to include an immunogenicity assessment in nonclinical toxicology studies.Sarcopenia worsens survival in patients with advanced liver disease including cirrhosis. In this study, we aimed to characterize skeletal muscle status by dual-energy X-ray absorptiometry (DXA) in patients with cirrhosis and examine the association between different skeletal muscle compartments and mortality. We included 231 men and 84 women (Child A, B, and C) with cirrhosis and 315 healthy matched controls (231 men and 84 women). Body composition was assessed with DXA. Appendicular skeletal muscle index (ASMI), arms index (AI), and legs index (LI) were calculated by normalizing lean mass to height squared. Low ASMI was defined as ASMI  less then  7.0 kg/m2 in men and  less then 5.5 kg/m2 in women. Biochemical and hemodynamic data were recorded for cirrhotic patients and mortality data retrieved from registers. Low ASMI was more prevalent in both men (49%) and women (43%) with cirrhosis compared with healthy men (8%) and women (5%) (P less then 0.001). ASMI and LI were lowest in Child B, whereas AI decreasaking.Calorie restriction is a primary dietary intervention demonstrated over many decades in cellular and animal models to modulate aging pathways, positively affect age-associated diseases and, in clinical studies, to promote beneficial health outcomes. Because long-term compliance with daily calorie restriction has proven problematic in humans several intermittent fasting regimens, including alternate day fasting and time-restricted feeding, have evolved revealing similar clinical benefits as calorie restriction. Despite significant research on the cellular and physiological mechanisms contributing to, and responsible for, these observed benefits, relatively little research has investigated the impact of these various fasting protocols on the gut microbiome (GM). Reduced external nutrient supply to the gut may beneficially alter the composition and function of a "fed" gut microflora. Indeed, the prevalent, obesogenic Western diet can promote deleterious changes in the GM, signaling intermediates involved in lipid and glucose metabolism, and immune responses in the gastrointestinal tract. This review describes recent preclinical and clinical effects of varying fasting regimens on GM composition and associated physiology. Although the number of preclinical and clinical interventions are limited, significant data thus far suggest fasting interventions impact GM composition and physiology. However, there are considerable heterogeneities of study design, methodological considerations, and practical implications. Ongoing research on the health impact of fasting regimens on GM modulation is warranted.