Recombinant ADAMTS13 in Congenital Thrombotic Thrombocytopenic Purpura.

BACKGROUND: Congenital thrombotic thrombocytopenic purpura (TTP) results from severe hereditary deficiency of ADAMTS13. The efficacy and safety of recombinant ADAMTS13 and standard therapy (plasma-derived products) administered as routine prophylaxis or on-demand treatment in patients with congenital TTP is not known. METHODS: In this phase 3, open-label, crossover trial, we randomly assigned patients in a 1:1 ratio to two 6-month periods of prophylaxis with recombinant ADAMTS13 (40 IU per kilogram of body weight, administered intravenously) or standard therapy, followed by the alternate treatment; thereafter, all the patients received recombinant ADAMTS13 for an additional 6 months. The trigger for this interim analysis was trial completion by at least 30 patients. The primary outcome was acute TTP events. Manifestations of TTP, safety, and pharmacokinetics were assessed. Patients who had an acute TTP event could receive on-demand treatment. RESULTS: A total of 48 patients underwent randomization; 32 completed the trial. No acute TTP event occurred during prophylaxis with recombinant ADAMTS13, whereas 1 patient had an acute TTP event during prophylaxis with standard therapy (mean annualized event rate, 0.05). Thrombocytopenia was the most frequent TTP manifestation (annualized event rate, 0.74 with recombinant ADAMTS13 and 1.73 with standard therapy). Adverse events occurred in 71% of the patients with recombinant ADAMTS13 and in 84% with standard therapy. Adverse events that were considered by investigators to be related to the trial drug occurred in 9% of the patients with recombinant ADAMTS13 and in 48% with standard therapy. Trial-drug interruption or discontinuation due to adverse events occurred in no patients with recombinant ADAMTS13 and in 8 patients with standard therapy. No neutralizing antibodies developed during recombinant ADAMTS13 treatment. The mean maximum ADAMTS13 activity after recombinant ADAMTS13 treatment was 101%, as compared with 19% after standard therapy. CONCLUSIONS: During prophylaxis with recombinant ADAMTS13 in patients with congenital TTP, ADAMTS13 activity reached approximately 100% of normal levels, adverse events were generally mild or moderate in severity, and TTP events and manifestations were rare. (Funded by Takeda Development Center Americas and Baxalta Innovations; ClinicalTrials.gov number, NCT03393975.).

Synthesis of α-sulfenylated carbonyl compounds under metal-free conditions.

An efficient synthesis of α-sulfenylated carbonyl compounds from propargylic alcohols and aryl thiols under heating conditions is described. The method is characterized by mild conditions, simple operation, metal-free catalysis and good functional group tolerance. Mechanistic studies suggest that the reaction involves a radical pathway and an isomerization process.

A balancing act: drifting away from the reflexive use of "ab"normal saline.

Maintenance intravenous fluids are the most frequently ordered medications for hospitalized children. Since the American Association of Pediatrics published national guidelines, there has been an increased reflexive use of isotonic solutions, especially 0.9% saline, as a prophylaxis against hyponatremia. In this educational review, we discuss the potential deleterious effects of using 0.9% saline, including the development of hyperchloremia, metabolic acidosis, acute kidney injury, hyperkalemia, and a proinflammatory state. Balanced solutions with anion buffers cause relatively minimal harm when used in most children. While the literature supporting one fluid choice over the other is variable, we highlight the benefits of balanced solutions over saline and the importance of prescribing fluid therapy that is individualized for each patient.

Association between cooking patterns and the prevalence of hyperlipidemia in Eastern China.

BACKGROUND: Hyperlipidemia is a major risk factor for many diseases. Previous studies have shown that diet is closely associated with hyperlipidemia. However, the relationship between cooking methods and hyperlipidemia remains unclear. The objective of this study was to identify the major cooking patterns existing in the Eastern Chinese population and evaluate their association with the prevalence of hyperlipidemia. METHODS: We interviewed 4,710 residents in Eastern China regarding the consumption frequency of each cooking method when they prepare food at home or when eating out and regarding the prevalence of hyperlipidemia. Factor analysis, Chi-square tests, analysis of variance, and binary logistic regression analysis were used to identify the cooking patterns and analyze the characteristics of participants' categories of cooking patterns and the relationship between different cooking patterns and prevalence of hyperlipidemia. RESULTS: Three major cooking patterns were identified: Traditional Chinese, Bland (little or no oil is used to process the food), and High-temperature cooking patterns. After controlling for potential confounders, participants in the highest quartile of the Bland cooking pattern had lower odds of hyperlipidemia than those in the lowest quartile. Nevertheless, no significant associations were observed between the Traditional Chinese and High-temperature cooking patterns and the prevalence of hyperlipidemia. CONCLUSIONS: This study confirms the association between cooking patterns and the prevalence of hyperlipidemia and indicates that the Bland cooking pattern is associated with a reduced prevalence of hyperlipidemia.

Efficacy and safety of topical minocycline foam (FMX101 4%) in treatment of Chinese subjects with moderate-to-severe facial acne vulgaris: A phase 3, multi-centre, randomized, double-blind, vehicle-controlled study.

BACKGROUND: FMX101 4%, as a topical foam formulation of minocycline, has been approved by US Food and Drug Administration for the treatment of moderate-to-severe acne vulgaris (AV). OBJECTIVE: To evaluate the efficacy and safety of FMX101 4% in treating Chinese subjects with moderate-to-severe facial AV. METHODS: This was a multi-centre, randomized, double-blind, vehicle-controlled phase 3 study in Chinese subjects with moderate-to-severe AV. Eligible subjects were randomized 2:1 to receive either FMX101 4% or vehicle foam treatment for 12 weeks. The primary efficacy endpoint was the change in inflammation lesion count (ILC) from baseline at week 12. The key secondary endpoint was the treatment success rate according to Investigator's Global Assessment (IGA) at week 12. RESULTS: In total, 372 subjects were randomized into two groups (FMX101 4% group, n = 248; vehicle group, n = 124). After 12 weeks treatment, the reduction in ILC from baseline was statistically significant in favour of FMX101 4%, compared with vehicle foam (-21.0 [0.08] vs. -12.3 [1.14]; LSM [SE] difference, -8.7 [1.34]; 95% CI [-11.3, -6.0]; p < 0.001). FMX101 4% treatment yielded significantly higher IGA treatment success rate at week 12 as compared to the control treatment (8.06% vs. 0%). Applying FMX101 4% also resulted in significant reduction in noninflammatory lesion count (nILC) versus vehicle foam at week 12 (-19.4 [1.03] vs. -14.9 [1.47]; LSM [SE] difference, -4.5 [1.74]; 95% CI [-8.0, -1.1]; p = 0.009). Most treatment-emergent adverse events (TEAEs) were mild-to-moderate in severity, and no treatment-related treatment-emergent serious adverse event (TESAE) occurred. Thus, FMX101 4% was considered to be a safe and well-tolerated product during the 12-week treatment period. CONCLUSION: FMX101 4% treatment for 12 weeks could lead to significantly reduced ILC and nILC, and improved IGA treatment success rate in Chinese subjects with moderate-to-severe facial AV. It also showed a well acceptable safe and tolerability profile.

Awake intraoperative mapping for the prevention of amusia.

The authors describe the awake surgical mapping of music skills for patients who require resection in brain areas that may support musical abilities. A 65-year-old man was diagnosed with an anterolateral right temporal nonenhancing lesion, likely a diffusely infiltrating glioma, after presenting with several episodes of altered taste and smell and one episode of loss of consciousness. The patient specializes in music and music technology and has composed scores for films. An awake surgery was planned in a semiseated position. Prerecorded melodies were designed preoperatively as a surrogate for a composition skill task. These consisted of 10- to 15-second musical clips played during bipolar electrical stimulation of the overlying cortex and were divided into three segments: listen, play, and accuracy check. During the "listen" phase, the patient listened to a musical prompt. During the "play" phase, he played a musical response on a keyboard. Stimulation at multiple temporal neocortical sites was negative for any alteration in task performance. The patient did well postoperatively with excellent clinical and radiographic results and returned to composing music without functional compromise. Musical composition tasks can be performed safely intraoperatively for patients with musical expertise. Whether stimulating more posterior nondominant temporal neocortex or other cortical or white matter locations can disrupt this task remains undetermined.

Practical training using BEWE aimed at improving the diagnosis ability of erosive tooth wear for dental students-A randomized trial.

INTRODUCTION: Erosive tooth wear (ETW) has been gaining attention due to its high prevalence. However, ETW clinical diagnosis is difficult and may go unnoticed by many professionals. The present study aimed to develop, implement and evaluate a theoretical-practical training using active methodologies in the development of undergraduate students' skills for the diagnosis of ETW compared to the traditional teaching method. MATERIALS AND METHODS: This randomized controlled study involved two parallel groups: control group (n = 22), with learning based only on theoretical content and test group (n = 24), learning by theoretical-practical activity mediated by monitors/tutors. The theoretical class covered the current concepts of ETW, aetiology, diagnosis, use of the BEWE index, prevention and treatment. The practical training included exercises and discussions based on the diagnosis using BEWE scores of a collection of images and extracted teeth. To evaluate the efficacy of the teaching-learning methods, a theoretical multiple-choice questionnaire and a practical test using images and extracted teeth were applied. The outcome was the number of correct answers. Groups were compared by Mann-Whitney (theoretical knowledge) and T tests (practical ability in diagnosis) (p < .05). RESULTS: There was no significant difference between groups in the theoretical evaluation (p = .866). The test group showed higher ability to diagnose ETW lesions compared to the control group in the practical tests (p = .001). The performance of ETW diagnosis was similar when images were used in comparison to extracted teeth (p = .570). CONCLUSION: The practical activity associated with theoretical classes can be a promising strategy to improve the development of undergraduate students' skills in the diagnosis of ETW.

Brazilian undergraduates' and dentists' knowledge on preventing, diagnosing and managing dentin hypersensitivity: A cross-sectional questionnaire study.

OBJECTIVES: To analyse the knowledge of dental undergraduates and dentists on the prevention, diagnosis and management of dentin hypersensitivity (DH); to compare their knowledge scores; and to understand the related variables using a regression model. METHODS: An original online questionnaire investigated the attitudes, self-reported knowledge ('how much they thought they knew') and real knowledge ('how much they really knew') of 132 students and 338 dentists. Data were analysed descriptively, both knowledge scores were compared using Mann-Whitney and Wilcoxon signed-rank tests and data were subjected to two multiple linear regression analyses considering real knowledge scores as the dependent variable (α < 0.05). RESULTS: The self-reported knowledge on DH was higher than the real knowledge for both students and dentists, but dentists presented the highest scores. Gingival recession and acidic diet were reported as the main predisposing factors for DH by undergraduates and dentists. Students normally managed DH with dietary and hygiene instructions followed by a desensitizing agent application, while dentists managed with occlusal adjustments. The mechanism of glutaraldehyde/HEMA and bioactive fillers on DH is widely unknown by students and dentists. The majority of the questioned individuals cannot differentiate DH from sensitivity of caries or molar-incisor hypomineralization. CONCLUSION: Both students and dentists overestimate their knowledge of DH, revealing deficiencies in prevention, diagnosis and management. Students' knowledge improves towards the end of the Dentistry course, while younger dentists and PhD holders are more knowledgeable. Institutions should implement ongoing DH education for undergraduates and conduct interventions for experienced professionals, especially older ones.

Real-world compliance with the 2020 U.S. Multi-Society Task Force on Colorectal Cancer polypectomy surveillance guidelines: an observational study.

BACKGROUND AND AIMS: Overuse of screening colonoscopy increases cost and procedural adverse events, but inadequate surveillance can miss the development of colorectal cancer. We measured compliance with the 2020 U.S. Multi-Society Task Force on Colorectal Cancer (USMSTF) polypectomy surveillance guidelines in clinical records and a survey. METHODS: We performed a retrospective study comparing surveillance intervals for first-time average-risk colonoscopies with the 2020 USMSTF guidelines. Cases were analyzed from 3 intervals (March 2021 to May 2021, November 2021 to January 2022, and April 2022 to May 2022), collectively termed the postguideline period, and a baseline period from November 2019 to January 2020. Real-world compliance rates were compared with results of a survey conducted between November 2020 and February 2021. RESULTS: Overall compliance was 48.9% among 532 colonoscopies, ranging from 8.3% for low-risk adenomas (LRAs), 88.3% for high-risk adenomas, 63.1% for sessile serrated polyps (SSPs), and 88.6% for hyperplastic polyps. Compliance for LRA increased from the baseline period (.8% vs 8.3%, P = .003), and 95.3% of nonadherent LRA cases followed the 2012 USMSTF guidelines. Compliance for LRAs was 18.6% among respondents who provided a compliant surveillance interval for LRAs in the survey. Noncompliance was associated with finishing training >10 years ago (odds ratio, 1.9; 95% confidence interval, 1.4-2.7) and performing over 800 colonoscopies annually (odds ratio, 2.0; 95% confidence interval, 1.5-2.6). CONCLUSIONS: Adoption of the 2020 USMSTF surveillance guidelines remains low at 2 years. Further research into outcomes for patients with LRAs and SSPs may increase guideline adoption.

Tobacco exposure in adults and children with proteinuric glomerulopathies: a NEPTUNE cohort study.

BACKGROUND: Tobacco exposure has been recognized as a risk factor for cardiovascular disease (CVD) and progression of kidney disease. Patients with proteinuric glomerulopathies are at increased risk for cardiovascular morbidity and mortality. Multiple studies have linked tobacco exposure to CVD and chronic kidney disease, but the relationships between smoking and proteinuric glomerulopathies in adults and children have not been previously explored. METHODS: Data from the Nephrotic Syndrome Study Network (NEPTUNE), a multi-center prospective observational study of participants with proteinuric glomerulopathies, was analyzed. 371 adults and 192 children enrolled in NEPTUNE were included in the analysis. Self-reported tobacco exposure was classified as non-smoker, active smoker, former smoker, or exclusive passive smoker. Baseline serum cotinine levels were measured in a sub-cohort of 178 participants. RESULTS: The prevalence of active smokers, former smokers and exclusive passive smoking among adults at baseline was 14.6%, 29.1% and 4.9%, respectively. Passive smoke exposure was 16.7% among children. Active smoking (reference non-smoking) was significantly associated with greater total cholesterol among adults (ß 17.91 95% CI 0.06, 35.76, p = 0.049) while passive smoking (reference non-smoking) was significantly associated with greater proteinuria over time among children (ß 1.23 95% CI 0.13, 2.33, p = 0.03). Higher cotinine levels were associated with higher baseline eGFR (r = 0.17, p = 0.03). CONCLUSION: Tobacco exposure is associated with greater risk for CVD and worse kidney disease outcomes in adults and children with proteinuric glomerulopathies. Preventive strategies to reduce tobacco exposure may help protect against future cardiovascular and kidney morbidity and mortality in patients with proteinuric glomerulopathies.

Malignant Glioma.

This chapter provides a comprehensive overview of malignant gliomas, the most common primary brain tumor in adults. These tumors are varied in their cellular origin, genetic profile, and morphology under the microscope, but together they share some of the most dismal prognoses of all neoplasms in the body. Although there is currently no cure for malignant glioma, persistent efforts to improve outcomes in patients with these tumors have led to modest increases in survival, and researchers worldwide continue to strive toward a deeper understanding of the factors that influence glioma development and response to treatment. In addition to well-established epidemiology, clinical manifestations, and common histopathologic and radiologic features of malignant gliomas, this section considers recent advances in molecular biology that have led to a more nuanced understanding of the genetic changes that characterize the different types of malignant glioma, as well as their implications for treatment. Beyond the traditional classification of malignant gliomas based on histopathological features, this chapter incorporates the World Health Organization's 2016 criteria for the classification of brain tumors, with special focus on disease-defining genetic alterations and newly established subcategories of malignant glioma that were previously unidentifiable based on microscopic examination alone. Traditional therapeutic modalities that form the cornerstone of treatment for malignant glioma, such as aggressive surgical resection followed by adjuvant chemotherapy and radiation therapy, and the studies that support their efficacy are reviewed in detail. This provides a foundation for additional discussion of novel therapeutic methods such as immunotherapy and convection-enhanced delivery, as well as new techniques for enhancing extent of resection such as fluorescence-guided surgery.

Job burnout is associated with poorer hand-washing behaviors among restaurant kitchen chefs: evidence from Jiangsu Province, China.

Inadequate hand-washing among chefs is a major contributor to outbreaks of foodborne illnesses originating in restaurants. Previous studies have found that mental health influences hygiene behaviors among food handlers, who have a high rate of job burnout. However, it is still unclear whether job burnout leads to restaurant kitchen chefs' poor hand washing behaviors (HWBs). In this study, we interviewed 453 restaurant kitchen chefs in Jiangsu Province, China regarding job burnout and HWBs during the summer (July-August) of 2020. The aims were to investigate job burnout (an individual internal motivation factor), identify determinants of job burnout, and examine the association between job burnout and HWBs. Variance analysis, post hoc multiple comparisons, linear regression models, and structural equation modeling were used to analyze the response data. This study revealed that chef age and the scale of the restaurant were significantly and negatively associated with reduced professional efficacy. Combined cuisine and pastry chefs had a more positive perception of their own professional efficacy than the other kitchen chefs, whereas the incidence of exhaustion was significantly higher in pastry chefs than in cuisine chefs and kitchen hands. Reduced professional efficacy was significantly and negatively associated with HWBs for all chefs. To improve the level of hand hygiene among chefs, measures should be taken to enhance chefs' professional efficacy. Furthermore, close attention should be paid to chefs in small-scale restaurants, younger chefs, cuisine chefs, pastry chefs, and kitchen hands.

Irx3 promotes gap junction communication between uterine stromal cells to regulate vascularization during embryo implantation†.

Appropriate embryo-uterine interactions are essential for implantation. Besides oocyte abnormalities, implantation failure is a major contributor to early pregnancy loss. Previously, we demonstrated that two members of the Iroquois homeobox transcription factor family, IRX3 and IRX5, exhibited distinct and dynamic expression profiles in the developing ovary to promote oocyte and follicle survival. Elimination of each gene independently caused subfertility, but with different breeding pattern outcomes. Irx3 KO (Irx3LacZ/LacZ) females produced fewer pups throughout their reproductive lifespan which could only be partially explained by poor oocyte quality. Thus, we hypothesized that IRX3 is also expressed in the uterus where it acts to support pregnancy. To test this hypothesis, we harvested pregnant uteri from control and Irx3 KO females to evaluate IRX3 expression profiles and the integrity of embryo implantation sites. Our results indicate that IRX3 is expressed in the endometrial stromal cells at day 4 of pregnancy (D4) with peak expression at D5-D6, and then greatly diminishes by D7. Further, studies showed that while embryos were able to attach to the uterus, implantation sites in Irx3 KO pregnant mice exhibited impaired vascularization and abnormal expression of decidualization markers. Finally, we also observed an impaired response of the Irx3 KO uteri to an artificial deciduogenic stimulus, indicating a critical role of this factor in regulating the decidualization program. Together, these data established that IRX3 promotes female fertility via at least two different mechanisms: (1) promoting competent oocytes and (2) facilitating functional embryo-uterine interactions during implantation.

In-situ bypass is associated with superior infection-free survival compared with extra-anatomic bypass for the management of secondary aortic graft infections without enteric involvement.

OBJECTIVE: The optimal revascularization modality following complete resection of aortic graft infection (AGI) without enteric involvement remains unclear. The purpose of this investigation is to determine the revascularization approach associated with the lowest morbidity and mortality using real-world data in patients undergoing complete excision of AGI. METHODS: A retrospective, multi-institutional study of AGI from 2002 to 2014 was performed using a standardized database. Baseline demographics, comorbidities, and perioperative variables were recorded. The primary outcome was infection-free survival. Descriptive statistics, Kaplan-Meier survival analysis, and univariate and multivariable analyses were performed. RESULTS: A total of 241 patients at 34 institutions from seven countries presented with AGI during the study period (median age, 68 years; 75% male). The initial aortic procedures that resulted in AGI were 172 surgical grafts (71%), 66 endografts (27%), and three unknown (2%). Of the patients, 172 (71%) underwent complete excision of infected aortic graft material followed by in situ (in-line) bypass (ISB), including antibiotic-treated prosthetic graft (35%), autogenous femoral vein (neo-aortoiliac surgery) (24%), and cryopreserved allograft (41%). Sixty-nine patients (29%) underwent extra-anatomic bypass (EAB). Overall median Kaplan-Meier estimated survival was 5.8 years. Perioperative mortality was 16%. When stratified by ISB vs EAB, there was a significant difference in Kaplan-Meier estimated infection-free survival (2910 days; interquartile range, 391-3771 days vs 180 days; interquartile range, 27-3750 days; P < .001). There were otherwise no significant differences in presentation, comorbidities, or perioperative variables. Multivariable Cox regression showed lower infection-free survival among patients with EAB (hazard ratio [HR], 2.4; 95% confidence interval [CI], 1.6-3.6; P < .001), polymicrobial infection (HR, 2.2; 95% CI, 1.4-3.5; P = .001), methicillin-resistant Staphylococcus aureus infection (HR, 1.7; 95% CI, 1.1-2.7; P = .02), as well as the protective effect of omental/muscle flap coverage (HR, 0.59; 95% CI, 0.37-0.92; P = .02). CONCLUSIONS: After complete resection of AGI, perioperative mortality is 16% and median overall survival is 5.8 years. EAB is associated with nearly a two and one-half-fold higher reinfection/mortality compared with ISB. Omental and/or muscle flap coverage of the repair appear protective.

Effectiveness and Safety of Tofacitinib for Ulcerative Colitis: Systematic Review and Meta-analysis.

BACKGROUND: The objective of our systematic review and meta-analysis was to evaluate the effectiveness and safety of tofacitinib in the treatment of moderate-severe ulcerative colitis (UC). METHODS: We searched Medline, Embase, Web of Science, and Cochrane Central to identify articles and abstracts reporting efficacy or safety data on tofacitinib use in UC. Primary outcome assessed was remission. Secondary outcomes included clinical response, steroid free remission, and adverse events (AEs). RESULTS: A total of 26 studies were included. The rates of remission were 29.81% [95% confidence interval (CI): 22.37%-37.25%, I2 : 90%] at week 8, 32.27% (95% CI: 27.67%-36.88%, I2 : 42%) at 6 months and 38.03% (95% CI: 33.59%-42.48%, I2 : 0%) at 1-year. Clinical response rates were 59.41% (95% CI: 55.03%-63.94%, I2 : 61%) at week 8, 48.99% (95% CI: 36.92%-61.06%, I2 : 91%) at 6 months and 50.87% (95% CI: 42.16%-59.58%, I2 : 67%) at 1-year. Odds ratio of clinical response at week 8 in biologic naive versus biologic experienced patients was 1.59 (95% CI: 0.54-4.63). Pooled incidence rate for serious infections, major adverse cardiovascular events, and nonmelanotic squamous cell malignancies across all doses was 4.41 per 100-patient years (PYs) (95% CI: 2.32-8.38 per 100-PY, I2 : 78%), 0.91 per 100-PY (95% CI: 0.43-1.93 per 100-PY, I2 : 37%) and 0.91 per 100-PY (95% CI: 0.61-1.34 per 100-PY, I2 : 0%), respectively. Higher dose was associated with an increased frequency of AEs. CONCLUSIONS: While the overall efficacy and safety of tofacitinib in moderate-severe UC is consistent with clinical trial data, the dose dependent increase in AEs highlights the significance of early dose de-escalation. Rate of clinical response after tofacitinb induction was similar in biologic naive and biologic experienced patients.

A medical student-led model for telephone-based opioid overdose education and naloxone distribution during the COVID-19 pandemic.

Background: The co-occurrence of the COVID-19 pandemic and opioid epidemic has increased the risk of overdose and death for patients with opioid use disorder (OUD). COVID-19 has also exacerbated already limited access to opioid overdose education and naloxone distribution (OEND). In this context, we aim to increase access to OEND for patients at risk for opioid overdose. Methods: Medical student volunteers were trained to conduct telephone-based OEND, and subsequently contacted all patients at a NYC primary care clinic for people who use drugs as well as those presenting to the hospital with OUD or a history of opioid overdose. Interested patients who completed the training received naloxone kits via mail or at hospital discharge. Results: OEND provision was converted to a remote-only model from May to June 2020. During this time, eight pre-clinical medical students called a total of 503 high-risk patients. Of these patients, 165 were reached, with 90 (55%) accepting telephone-based OEND. Comparing across populations, 51% of primary care patients versus 76% of ED/hospitalized patients accepted opioid overdose education. Eighty-four total patients received naloxone. Conclusions: We have outlined a scalable, adaptable model by which clinics and hospitals with affiliated medical schools can provide OEND by telephone. Medical student-driven, telephone-based OEND efforts can effectively reach at-risk patients and increase naloxone access.

Using digital photographs as a tool to assess the clinical color stability of lithium disilicate veneers: A clinical trial.

STATEMENT OF PROBLEM: Clinical information regarding the color stability of lithium disilicate veneers by using different methods of evaluation is scarce. PURPOSE: This clinical trial aimed to evaluate whether digital photographs are a reliable method of clinically assessing the color stability of lithium disilicate veneers. Standardized digital photographs (ELAB) were compared with the VITA Easyshade spectrophotometer (ES) at baseline and at a 6-month follow-up. MATERIAL AND METHODS: A split-mouth model was used in this randomized clinical trial to assess the performance of ceramic veneers (N=162), which were produced by either the CAD (IPS e.max CAD; n=81) or PRESS technique by heat pressing (IPS e.max PRESS; n=81), including the color dimension assessment. The ELAB evaluation was performed by making digital photographs with polarized light and a white balance (WhiBal) card. These data were transferred to the Adobe Lightroom CC2015 software program in RAW extension. The Digital Color Meter App (Apple) was used to measure L∗, a∗, and b∗ coordinates in this method. The ES color evaluation was performed with a spectrophotometer (Easy Shade) (control group) in the CIELab system. Measurements were performed 1 week after cementation (baseline) and at a 6-month follow-up. Data collected by the ELAB and ES methods were analyzed by a blinded calibrated operator to calculate ΔE by using the Mann-Whitney-Wilcoxon test (α=.05). RESULTS: For all periods, the comparison among ELAB and ES methods (P=.331), CAD×PRESS by ELAB (P=.658), and CAD×PRESS by ES (P=.833) showed no statistically significant differences. CONCLUSIONS: Standardized digital photographs (ELAB) were shown to be a straightforward and available resource for evaluating the color stability of lithium disilicate veneers, manufactured by CAD or PRESS.

Impact of rehabilitation with removable complete or partial dentures on masticatory efficiency and quality of life: A cross-sectional mapping study.

STATEMENT OF PROBLEM: Tooth loss directly affects mastication, cognitive function, and oral health-related quality of life (OHRQoL). Complete dentures (CDs) and removable partial dentures (RPDs) represent a common oral rehabilitation approach. However, studies addressing the impact of removable dentures on replacing missing teeth are lacking. PURPOSE: The purpose of this clinical study was to evaluate whether the OHRQoL, the jaw function limitation (JFL), and the masticatory efficiency of CD and RPD wearers are similar to those of patients with natural teeth and to evaluate whether wearing removable dentures can predict an effect on the OHRQoL, JFL, and masticatory efficiency of their wearers. MATERIAL AND METHODS: The Oral Health Impact Profile (OHIP-14) questionnaire and the JFL scale were used to measure OHRQoL and JFL. Masticatory efficiency was analyzed by using a subjective color-mixing index for the chewing gum bolus and shape index and an objective colorimetric analysis by using a software program ViewGum. Data were analyzed with Kruskal-Wallis and post hoc Dunn tests, followed by multiple linear regression (α=.05). RESULTS: The results from OHIP-14 evidenced that both denture groups presented a low impact on OHRQoL. JFL was higher for all denture wearers. For the subjective color-mixing analysis, the control and RPD groups presented better masticatory efficiency than CD wearers. Colorimetric analysis evidenced better masticatory efficiency for the control group, who differed from the CD and RPD groups. Wearing RPDs was a predictor of impaired JFL and OHRQoL, and the use of CDs was a predictor of impaired JFL and masticatory efficiency. CONCLUSIONS: Despite being rehabilitated, CD and RPD wearers still had impaired OHRQoL, JFL, and masticatory efficiency. Also, the use of these prostheses can predict a negative effect on these 3 variables.

Efficacy and safety of omalizumab in patients with moderate-to-severe asthma: An analytic comparison of data from randomized controlled trials between Chinese and Caucasians.

BACKGROUND: Omalizumab has > 15 years of real-world evidence of effectiveness in Caucasian patients. In August 2017, it was approved as an add-on therapy for the management of moderate-to-severe asthma in China. OBJECTIVE: To compare the efficacy and safety of omalizumab in Chinese and Caucasian patients. METHODS: This analysis included clinical trial data from a Chinese study (NCT01202903) and four studies with predominantly Caucasian patients (008, 009, EXTRA and INNOVATE). The following outcomes were analyzed: change from baseline in morning peak expiratory flow (mPEF), percentage predicted forced expiratory volume in one second (FEV1), patient-reported outcomes (PROs), asthma exacerbation and safety. Further, a population pharmacokinetic/pharmacodynamic (PK/PD) was also assessed. RESULTS: In the Chinese study, omalizumab significantly improved the mPEF from baseline vs placebo at Weeks > 4-8 through > 16-20; however, the change in mPEF did not reach statistical significance at Week 24. A similar trend towards improvement in mPEF was observed in the studies with Caucasians (INNOVATE, 008 and 009). In all studies, omalizumab showed greater improvement in %predicted FEV1, AQLQ score, and GETE score vs placebo. In addition, asthma symptom scores and seasonal exacerbations were lower, especially during winter, in the Chinese study, and was comparable to studies in Caucasians. PK/PD analyses showed that steady-state PK of omalizumab; free or total immunoglobulin E levels were similar in all studies. CONCLUSIONS: The clinical efficacy and safety of omalizumab was comparable among Chinese and Caucasian patients with moderate-to-severe asthma supporting therapeutic effectiveness, irrespective of race, ethnicity and geographical factors.

Perioperative outcomes for carotid revascularization on asymptomatic dialysis-dependent patients meet Society for Vascular Society guidelines.

OBJECTIVE: The current Society for Vascular Surgery practice guidelines recommend carotid revascularization for asymptomatic disease in patients with at least a 3-year life expectancy and stenosis >60% when the expected perioperative stroke and death rate is <3%. Based on this recommendation, it was previously determined that asymptomatic patients who require dialysis would not meet the perioperative stroke and death thresholds nor the long-term survival benchmarks to justify carotid surgery. To determine whether carotid surgery for patients requiring dialysis is appropriate, the present study compared the perioperative outcomes after carotid revascularization for dialysis-dependent patients relative to nondialysis patients in a contemporary, national cohort. METHODS: The targeted vascular module from the American College of Surgeons National Surgical Quality Improvement Program was queried to identify patients who undergone carotid endarterectomy or carotid artery stenting for asymptomatic carotid disease from 2011 to 2018. The cohort was categorized as requiring or not requiring dialysis. The primary 30-day outcomes included mortality and the composite of stroke/death and stroke/death/myocardial infarction (MI). Univariate analyses were performed using the Fisher exact test and Wilcoxon rank sum test. Multivariable analyses were used to assess the independent associations of the estimated glomerular filtration rate and dialysis dependence with the stroke/death rate. RESULTS: A total of 17,579 patients met the inclusion criteria. Of these patients, 226 (1.3%) required dialysis at revascularization. No difference was found in the degree of severe stenosis (80%-99%) demonstrated by 69% of the dialysis cohort and 72% of the nondialysis cohort (P = .9). Of the dialysis and nondialysis cohorts, 5% and 3.6% underwent carotid artery stenting (P = .3). The dialysis-dependent patients were younger (68 vs 71 years; P < .001) and were more likely to have insulin-dependent diabetes (47% vs 12%; P < .001), congestive heart failure (8.4% vs 1.4%; P < .001), and severe chronic obstructive pulmonary disease (15% vs 10%; P = .03). In the dialysis and nondialysis cohort, 2 (0.9%) and 88 (0.5%) patients died (P = .3); 4 (1.8%) and 247 (1.4%) experienced strokes (P = .6); and 3 (1.3%) and 185 (1.1%) patients experienced MI (P = .5), respectively. The composite outcomes of stroke/death and stroke/death/MI was 2.2% (n = 5) and 1.8% (n = 319; P = .6) and 3.5% (n = 8) and 2.8% (n = 479; P = .4) in the dialysis and nondialysis cohorts, respectively. After multivariable analysis, neither the estimated glomerular filtration rate (adjusted odds ratio, 1.0; 95% confidence interval, 1.00-1.01; P = .26) nor dialysis dependence (adjusted odds ratio, 0.21; 95% confidence interval, 0.03-1.57; P = .13) was independently associated with the composite outcome of stroke/death. CONCLUSIONS: The 30-day carotid revascularization outcomes for asymptomatic disease in dialysis-dependent patients met the Society for Vascular Surgery guidelines in this national cohort and might be better than previously surmised. Hence, vascular surgeons could consider carotid revascularization for select dialysis-dependent patients with the appropriate expected longevity and perioperative risk.