Monoclonal antibody therapies for COVID-19: lessons learned and implications for the development of future products.

Several companies were authorized to treat COVID-19 patients with monoclonal antibodies within 1-2 years of the start of the pandemic. These products were discovered, developed, manufactured, clinically tested, and approved under emergency-use authorization at unprecedented speed. Pandemic urgency led to novel development approaches that reduced the time to clinical trials by 75% or more without creating unacceptable patient or product-safety risks. Hundreds of thousands of patients now benefit from these therapeutics that have reduced the rates of hospitalization and death. The chemistry, manufacturing, and control development strategies set a new precedent of speed, safety, and demonstrated clinical benefit and will likely have a lasting impact on the development of future monoclonal antibody therapies for not only infectious diseases but also for oncology, inflammation, and rare diseases.

Effectiveness of and Dental Student Satisfaction with Three Teaching Methods for Behavior Guidance Techniques in Pediatric Dentistry.

The aim of this study was to compare the effect of different types of instructional styles-traditional lecture with and without video examples and contemporary format that simulated a flipped classroom-on dental students' learning of behavior guidance techniques (BGTs) in pediatric dentistry. The study also sought to determine if students had an improved comfort level with BGTs with these instructional methods, if videos improved learning and comfort with BGTs, and if there were differences in outcomes by gender. All 96 second-year dental students at one U.S. dental school were recruited to participate in the study in 2017. Students were randomly divided into three groups: contemporary instruction (CI), traditional instruction with video (TIV), and traditional instruction with no video (TI). CI students watched a 20-minute mini-lecture and were divided into discussion groups led by calibrated faculty members. TIV students received 50 minutes of traditional lecture with video examples. TI students received a traditional lecture with no video examples. All groups completed a questionnaire prior to and on completion of the course. The questionnaire assessed students' learning and perceptions of the learning experience. All students participated in the course and the assessments, for a 100% response rate. The students' post-course scores improved for all teaching methods (TI>CI>TIV) with no significant differences among them. CI students rated comfort with BGTs and usefulness of videos higher than the other groups, but the difference was not statistically significant. Students rated their satisfaction with and usefulness of the course high for all groups (>3 on a four-point scale). Learning style and comfort treating children were not statistically significant by gender. Overall, the students reported high satisfaction with all the teaching methods. Although the differences were not statistically significant, discussion groups were ranked highest in satisfaction and usefulness.

Detection of prostate cancer-specific transcripts in extracellular vesicles isolated from post-DRE urine.

BACKGROUND: The measurement of gene expression in post-digital rectal examination (DRE) urine specimens provides a non-invasive method to determine a patient's risk of prostate cancer. Many currently available assays use whole urine or cell pellets for the analysis of prostate cancer-associated genes, although the use of extracellular vesicles (EVs) has also recently been of interest. We investigated the expression of prostate-, kidney-, and bladder-specific transcripts and known prostate cancer biomarkers in urine EVs. METHODS: Cell pellets and EVs were recovered from post-DRE urine specimens, with the total RNA yield and quality determined by Bioanalyzer. The levels of prostate, kidney, and bladder-associated transcripts in EVs were assessed by TaqMan qPCR and targeted sequencing. RESULTS: RNA was more consistently recovered from the urine EV specimens, with over 80% of the patients demonstrating higher RNA yields in the EV fraction as compared to urine cell pellets. The median EV RNA yield of 36.4 ng was significantly higher than the median urine cell pellet RNA yield of 4.8 ng. Analysis of the post-DRE urine EVs indicated that prostate-specific transcripts were more abundant than kidney- or bladder-specific transcripts. Additionally, patients with prostate cancer had significantly higher levels of the prostate cancer-associated genes PCA3 and ERG. CONCLUSIONS: Post-DRE urine EVs are a viable source of prostate-derived RNAs for biomarker discovery and prostate cancer status can be distinguished from analysis of these specimens. Continued analysis of urine EVs offers the potential discovery of novel biomarkers for pre-biopsy prostate cancer detection.

Telecoaching plus a portion control plate for weight care management: a randomized trial.

BACKGROUND: Obesity is a leading preventable cause of death and disability and is associated with a lower health-related quality of life. We evaluated the impact of telecoaching conducted by a counselor trained in motivational interviewing paired with a portion control plate for obese patients in a primary care setting. METHODS: We conducted a randomized, clinical trial among patients in a primary care practice in the midwestern United States. Patients were randomized to either usual care or an intervention including telecoaching with a portion control plate. The intervention was provided during a 3-month period with follow-up of all patients through 6 months after randomization. The primary outcomes were weight, body mass index (BMI),waist circumference, and waist to hip ratio measured at baseline, 6, 12, 18, and 24 weeks. Secondary outcomes included measures assessing eating behaviors, self-efficacy, and physical activity at baseline and at 12 and 24 weeks. RESULTS: A total of 1,101 subjects were pre-screened, and 90 were randomly assigned to telecoaching plus portion control plate (n = 45) or usual care (n = 45). Using last-value carried forward without adjustment for baseline demographics, significant reductions in BMI (estimated treatment effect -0.4 kg/m(2), P = .038) and waist to hip ratio (estimated treatment effect -.02, P = .037) at 3 months were observed in the telecoaching plus portion control plate group compared to usual care. These differences were not statistically significant at 6 months. In females, the telecoaching plus portion control plate intervention was associated with significant reductions in weight and BMI at both 3 months (estimated treatment effect -1.6 kg, P = .016 and -0.6 kg/m(2), P = .020) and 6 months (estimated treatment effect -2.3 kg, P = .013 and -0.8 kg/m(2), P = .025). In males, the telecoaching plus portion control intervention was associated with a significant reduction in waist to hip ratio at 3 months (estimated treatment effect -0.04, P = .017), but failed to show a significant difference in weight and BMI. CONCLUSION: Telecoaching with a portion control plate can produce positive change in body habitus among obese primary care patients; however, changes depend upon sex. TRIAL REGISTRATION: ClinicalTrials.gov NCT02373878, 13 February 2015. https://clinicaltrials.gov/ct2/show/NCT02373878.