We examined the relationship between moderate obesity and glucose metabolism, insulin sensitivity and suspected fatty liver in children. We measured body mass index (BMI), z-score BMI, caliper ...skinfold thickness, waist and hip circumference in 94 participants (mean age 9.7 +/-2.2 years). Fasting blood glucose, insulin, HOMA score, lipid profile and transaminases (ALT, AST) were measured. Fatty liver and skinfold thickness were evaluated by means of ultrasound. The z-score BMI was 2.01 +/-0.39 (mean +/- SD), and the duration of obesity was 4.3+/-3.03 years. A positive correlation was found between caliper and US skinfold thickness for tricipital (r= 0.33; p= 0.003) and sovrailiac skinfold (r= 0.34; p=0.003). Fatty liver was diagnosed in 64% of children and it was positively related to anthropometric measurements. The three sub-groups--group 0 (normal US liver and normal transaminases); group 1 (US fatty liver and normal transaminases); group 2 (US fatty liver and elevated transaminases)--showed a difference concerning z-score BMI, insulin and HOMA parameters (Tukey test: z score BMI group 1 vs group 0 and 2 vs group 0; serum insulin: group 2 vs group 1 and group 2 vs group 0; HOMA IR: group 2 vs group 1 and group 2 vs group 0). Moderately obese children with steatosis exhibited a clear increase of insulin and insulin resistance which represents indices of a future metabolic syndrome. In addition, it is important to perform a liver ultrasound since transaminases seems to be not adequate for the diagnosis of fatty liver.
The aim of this study was to evaluate the lean body mass variation in obese children and adolescents under Protein Sparing Modified Fast (PSMF) treatment through two indirect, not invasive, methods: ...The Slaughter-Lohman formal as an anthropometric method, and the urinary excretion of 3-Methylhistidine (3MHIS) as a biochemical method. Materials and methods. Thirty-five subjects, divided in two groups, participated in this study: Group A, 12 children (4 girls, 8 boys, age 9.5±1.9, OW% 73.8±20.1); Group B, 19 adolescents (14 girls, 5 boys, age 14.6±2.3, OW% 61.7±19.7). Diet: PSMF: Protein g 1.8±0.08 kg. IBW. day, total Kcalories 10.64±0.63 kg. IBW.day, prescribed for 9 weeks ± 1. Results. The 3MHIS final values were not significantly increased compared to the initial ones in both groups. In both groups the final value of lean body mass was significantly higher than the initial ones (p<0.03) in terms of percentage and Kg, while the fat mass was significantly reduced. Conclusion. With all the limitations using indirect methods to measure body composition, it seems that a PSMF, prescribed for 9 weeks ± 1, does not cause a significant lean body mass loss in obese children and adolescents.
Abstract Background Sex-determining region Y (Sry) is a transcription factor. Our research group has shown that there are multiple copies of Sry in Wistar-Kyoto (WKY) and spontaneous hypertensive ...(SHR) rats, and that they have novel functions separate from testes determination. Objective We hypothesized that exogenously delivered Sry3 to the normotensive WKY male kidney would activate the renin-angiotensin system (RAS) and raise blood pressure (BP), based on previous in vitro studies. Methods Sry3 or control vector was electroporated to the left kidney of male WKY rats and the following measurements were taken: BP by telemetry, renin-angiotensin measures by radioimmunoassay, plasma and tissue catecholamines by HPLC with electrochemical detection, sodium by flame photometry, and inulin by ELISA. Results Sry3 increased BP 10 to 20 mm Hg compared with controls ( P < 0.01) and produced a significant 40% decrease in urine sodium compared with controls ( P < 0.05). Sry3 increased renal angiotensin II and plasma renin activity by >100% compared with controls ( P < 0.01 and P < 0.05, respectively). Conclusion The findings presented here confirm and extend the argument for Sry3 as one of the genes responsible for the SHR hypertensive Y chromosome phenotype and are consistent with increased tissue RAS activity due to Sry3 and increased sodium reabsorption.
The Levelized Cost Of Energy (LCOE) of a Concentrated Solar Power (CSP) plant strongly depends on the costs and efficiency of the solar field. A three-fold configuration has to be considered to ...optimize the chosen technology: Thermal Energy Storage (TES), Heat Transfer Fluid (HTF) and the concentration system technology.
Direct Steam Generation (DSG) represents a realistic alternative to the existing HTF solutions (molten salt or diathermic oil) as it uses water to feed the plant and get steam to be potentially directly injected in the steam turbine.
When applied to parabolic trough, the whole plant is undergoing a sequence of technological new problems 1 presently under further investigation within the CSP community, as for instance dedicated innovative thermal energy storage systems 2; the equilibrium between costs and efficiency is yet to have been exhaustively defined and leaves therefore large room for investigation and research.
This paper will be dealing with the dedicated efforts provided by Archimede Solar Energy to its DSG solar receiver (HCEDSG-12), presenting the solution chosen to get rid of the extremely hard operating conditions. Results obtained from half a year-long real plant investigation will be discussed, demonstrating the technical feasibility of this intriguing technology.
Streptococcus pneumoniae causes pneumococcal disease, and older adults are at an increased risk. Sequential vaccination of 13-valent pneumococcal conjugate vaccine (PCV13) followed by 23-valent ...pneumococcal polysaccharide vaccine (PPSV23) is recommended for broad protection against pneumococcal disease in some countries.
This phase III trial evaluated the safety, tolerability, and immunogenicity of sequential administration of either V114 (a 15-valent PCV containing serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F) or PCV13, followed 12 months later by PPSV23, in healthy adults aged ≥50 years (NCT03480763). A total of 652 participants were randomized 1:1 to receive either V114 or PCV13, followed by PPSV23.
The most common solicited adverse events (AEs) following PCV vaccination included injection-site pain and fatigue. Higher proportions of participants with these events were observed in the V114 group following PCV; however, these differences were not clinically significant. Following PPSV23 vaccination, the most common solicited AEs were injection-site pain and injection-site swelling; the proportions of participants with these events were comparable between both groups. Incidence of serious AEs was low in both groups following PCV and PPSV23, and none were related to study vaccines. No deaths occurred during the study. Serum opsonophagocytic activity geometric mean titers and immunoglobulin G geometric mean concentrations were comparable between both groups for all 15 serotypes in V114 following PPSV23. Immune responses elicited by V114 persisted for at least 12 months. Immune responses at 30 days and 12 months post-vaccination with PCV were comparable between both groups for the 13 shared serotypes and higher in the V114 group for the V114-unique serotypes (22F and 33F).
Administration of V114 followed by PPSV23 was well tolerated and induced comparable antibody levels to PCV13 followed by PPSV23 in healthy adults aged ≥50 years.
This paper introduces a method which conditions on the number of events that occur in the control group to determine rejection regions and power for comparative Poisson trials with multiple ...experimental treatment arms that are each compared to one control arm. This leads to the negative multinomial as the statistical distribution used for testing. For one experimental treatment and one control with curtailed sampling, this is equivalent to Gail's (1974) approach. We provide formulas to calculate exact one‐sided overall Type I error and pointwise power for tests of treatment superiority and inferiority (vs the control). Tables of trial design parameters for combinations of one‐sided overall Type I error = 0.05, 0.01 and pointwise power = 0.90, 0.80 are provided. Curtailment approaches are presented to stop follow‐up of experimental treatment arms or to stop the study entirely once the final outcomes for each arm are known.
Comparative Poisson trials of an experimental treatment versus a control typically condition on the total number of events that occur across both arms (Design A). Inference is based on the binomial ...distribution. Recently, an approach termed Design C to compare K experimental treatments to the same control was introduced. Under Design C without curtailment, the trial continues until a prespecified number of events occur in the control arm, leading to inference based on the negative multinomial distribution. The question remains of how advantageous it is to conduct one Design C trial comparing K experimental treatment arms to the same control arm as opposed to conducting K separate Design A trials each comparing one experimental treatment arm to a different control arm. This paper, therefore, compares the expected number of subjects to enroll for the two designs under uncurtailed and curtailed settings. The designs are evaluated when the null hypothesis and various assumptions for the alternative hypothesis hold. We simulate a variety of combinations for the Type 1 error, power, and ratio of the incidence rate of events in the experimental treatment to control arms. Design C frequently offers significant savings in terms of sample size relative to Design A.
Because of its high biocompatibility, bio-degradability, low-cost and easy availability, cellulose finds application in disparate areas of research. Here we focus our attention on the most recent and ...attractive potential applications of cellulose in the biomedical field. We first describe the chemical/structural composition of cellulose fibers, the cellulose sources/features and cellulose chemical modifications employed to improve its properties. We then move to the description of cellulose potential applications in biomedicine. In this field, cellulose is most considered in recent research in the form of nano-sized particle, i.e., nanofiber cellulose (NFC) or cellulose nanocrystal (CNC). NFC is obtained from cellulose via chemical and mechanical methods. CNC can be obtained from macroscopic or microscopic forms of cellulose following strong acid hydrolysis. NFC and CNC are used for several reasons including the mechanical properties, the extended surface area and the low toxicity. Here we present some potential applications of nano-sized cellulose in the fields of wound healing, bone-cartilage regeneration, dental application and different human diseases including cancer. To witness the close proximity of nano-sized cellulose to the practical biomedical use, examples of recent clinical trials are also reported. Altogether, the described examples strongly support the enormous application potential of nano-sized cellulose in the biomedical field.
Summary
What is known and objective
The application of biologics to treat inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis, is well established. Our aim was to ...characterize the most recent five years of data on rates of adherence, persistence, switching and dose escalations with biologics used to treat IBD in the United States.
Methods
We systematically reviewed electronic databases MEDLINE, MEDLINE In‐Process, EMBASE and Cochrane Library for 2012‐2017 as well as conference proceedings for 2016‐2017 published in English.
Results and discussion
Of 449 records identified, 41 met all screening criteria. Published studies varied greatly in methodology, data sources, population studied, follow‐up time and endpoint definitions, preventing meaningful comparisons across studies. Based on studies using a medication possession rate threshold of <80% or <86%, 38%‐77% of patients were found non‐adherent to biologics. Discontinuation within the first 3 months occurred in 0%‐25% of patients in six studies; 7%‐65% discontinued by 12 months in 13 studies. Among all patients who initiated an index biologic, the switch rate to another biologic ranged from 4.5% to 20% in 6 studies. Dose escalations were reported in only four studies; 8%‐35% of patients had their dose escalated within the first year of therapy.
What is new and conclusion
This study demonstrates variability in study design and methodology to assess adherence, persistence, switching and dose escalation with biologics among adults with IBD in the United States. Our findings suggest that real‐world biologic use may be suboptimal and indicate new therapies and/or additional patient support may be needed.
In a systematic literature review, a considerable proportion of patients with inflammatory bowel disease were found to discontinue biologic therapy (0%‐25% of patients discontinued within the first 3 months of starting of an index biologic, which increased to 7%‐65% at 12 months). Variability in studies prevents direct comparison by prior exposure to biologics and by indication.
Objectives:
To evaluate the safety and immunogenicity of V114 15-valent pneumococcal conjugate vaccine (PCV) containing serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9 V, 14, 18C, 19A, 19F, 22F, 23F, 33F, ...followed by 23-valent pneumococcal polysaccharide vaccine (PPSV23) 8 weeks later, in children with HIV.
Design:
This phase 3 study (NCT03921424) randomized participants 6–17 years of age with HIV (CD4
+
T-cell count ≥200 cells/μl, plasma HIV RNA <50 000 copies/ml) to receive V114 or 13-valent PCV (PCV13) in a double-blind manner on Day 1, followed by PPSV23 at Week 8.
Methods:
Adverse events (AEs), pneumococcal serotype-specific immunoglobulin G (IgG), and opsonophagocytic activity (OPA) were evaluated 30 days after each vaccination.
Results:
The proportion of participants experiencing at least one AE post-PCV was 78.8% in the V114 group (
n
= 203) and 69.6% in the PCV13 group (
n
= 204); respective proportions post-PPSV23 were 75.4% (
n
= 203) and 77.2% (
n
= 202). There were no vaccine-related serious AEs. IgG geometric mean concentrations (GMCs) and OPA geometric mean titers (GMTs) were generally comparable between V114 and PCV13 for shared serotypes at Day 30, and were higher for V114 compared with PCV13 for the additional V114 serotypes 22F and 33F. Approximately 30 days after PPSV23, IgG GMCs and OPA GMTs were generally comparable between the V114 and PCV13 groups for all 15 serotypes in V114.
Conclusions:
In children with HIV, a sequential administration of V114 followed 8 weeks later with PPSV23 is well tolerated and induces immune responses for all 15 pneumococcal serotypes included in V114.
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