Dental fear and its determinants in 7-11-year-old children in Tehran, Iran.

AIM: To assess dental fear and its determinants in 7-11-year-old children. METHODS: In this cross-sectional (descriptive-analytical) study, the standard Persian version of the Children's Fear Survey Schedule-Dental Subscale (CFSS-DS) questionnaire was completed by 240 parent-child (children aged 7-11 years) pairs referred to dental clinics in Tehran city, Iran. Background characteristics were also inquired. RESULTS: An equal number of boys and girls participated in the study. The mean score of fear among the children was 21.66 ± 8.33. The causes of fear among the children were, first, injection, and then, seeing the dentist's drill, choking feeling, and finally, filling the tooth. There was a significant correlation between the scores of children's dental fear and their experience of meeting with the dentist (p = 0.001). The result of the regression test showed that the age of the children (p = 0.022) and high levels of dental fear among their fathers (p < 0.001) was related to high levels of dental fear among the children. CONCLUSIONS: The present children revealed a moderate level of dental fear. Taking children's age into account in behavioural management and challenging father's fear seemed to play a key role to reduce the child's fear and prevent its long-term consequences.

Starting the fight in the tumor: expert recommendations for the development of human intratumoral immunotherapy (HIT-IT).

A European Society for Medical Oncology (ESMO)-sponsored expert meeting was held in Paris on 8 March 2018 which comprised 11 experts from academia, 11 experts from the pharmaceutical industry and 2 clinicians who were representatives of ESMO. The focus of the meeting was exclusively on the intratumoral injection/delivery of immunostimulatory agents with the aim of harmonizing the standard terms and methodologies used in the reporting of human intratumoral immunotherapy (HIT-IT) clinical trials to ensure quality assurance and avoid a blurring of the data reported from different studies. The goal was to provide a reference document, endorsed by the panel members that could provide guidance to clinical investigators, pharmaceutical companies, ethics committees, independent review boards, patient advocates and the regulatory authorities and promote an increase in the number and quality of HIT-IT clinical trials in the future. Particular emphasis was placed not only on the development of precise definitions to facilitate a better understanding between investigators but also on the importance of systematic serial biopsies as a driver for translational research and the need for the recording and reporting of data, to facilitate a better understanding of the key processes involved.

Developmental capacity of Ascaridia galli eggs is preserved after anaerobic storage in faeces.

The reliability of the results of in vitro studies such as detection of anthelmintic resistance often depends on the ability of the parasite eggs to develop under laboratory conditions. The aim of this study was to assess the embryonation capability of the chicken roundworm Ascaridia galli eggs after storage under different conditions. Two storage media for parasite eggs were used; faeces or water. Eggs in petri dishes (90 dishes in total) containing faces or water media were first exposed either to aerobic or anaerobic conditions at different temperatures (4 °C /+O2, 4 °C /-O2, 25 °C/-O2) for a maximum of 72 days. Every second week, materials from petri dishes in triplicates were recovered and incubated aerobically for two weeks at 25 °C. After the incubation, 200-300 eggs from each petri shish (sampling unit) were counted and the number of embryonated eggs was determined. Data was analyzed in R (version 3.4.3) A logistic regression model with the probability of an egg to embryonate as dependent variable and conditions, storage medium and time points as fixed effects with quasibinomial distribution was run. Least-square means were calculated and pairwise comparisons were made with the fixed effect factors (condition, storage medium and time point). Eggs in faeces had a significantly (p ˂ 0.05) higher embryonation than those in water, irrespective of storage conditions. At 4 °C embryonation tended to decline over time under aerobic conditions irrespective of the storage medium, whereas it remained constant following storage at anaerobic conditions. In contrast, anaerobic storage at the 25 °C negatively affected egg development in both media, except for day 14 in faeces. Our major finding was that eggs in faeces under anaerobic conditions and at 4 °C retained the highest rate of development, with a minimum decline in their developmental capacity over time compared to cleaned eggs stored in water.

The effect of lauryl capping group on protein release and degradation of poly(D,L-lactic-co-glycolic acid) particles.

The aim of this study was to investigate the effect of a specific and frequently used end group (lauryl alcohol) on the protein release and degradation kinetics of poly(DL-lactic-co-glycolic acid) particles of different sizes. Lauryl-capped PLGA and uncapped PLGA (referred to as PLGA-capped and PLGA-COOH, respectively) particles (0.3, 1 and 20 µm) were prepared by a double emulsion solvent evaporation technique. Bovine serum albumin (BSA) was used as a model protein for release studies. During degradation (PBS buffer, pH7.4 at 37°C), a slower dry mass loss was observed for 0.3 µm particles than for particles of 1 and 20 µm. It was further shown that PLGA-capped particles showed slower mass loss likely due to its more hydrophobic nature. It was found that the ester bond hydrolysis rate was substantially slower for PLGA-capped particles and that the rate increased with particle size. Particles showed enrichment in lactic acid content (and thus a decrease in glycolic acid content) in time, and interestingly PLGA-capped particles showed also an enrichment of the lauryl alcohol content. No difference was observed in degradation kinetics between BSA loaded and blank particles. Independent of size, PLGA-COOH based particles showed, after a small burst, a sustained and nearly complete release of BSA during 60-80 days. On the other hand, particles based on PLGA-capped showed a much slower release and exhibited incomplete release, accompanied by the presence of an insoluble residue remaining even after 180 days. FTIR analysis of this residue showed that it contained both polymer and protein. Considering the polymer enrichment in lauryl alcohol, the incomplete release observed for PLGA-capped is likely attributed to interactions between the protein and the lauryl end group. In conclusion, since PLGA-COOH, in contrast to the capped derivative, shows complete degradation as well as quantitative release of an entrapped protein, this polymer is preferred for the design of protein formulations.

Population pharmacokinetics of oral high-dose busulfan in adult patients undergoing hematopoietic stem cell transplantation.

BACKGROUND AND THE PURPOSE OF THE STUDY: Many factors have been reported that contribute to the wide intra- and inter-patient variability of Busulfan (Bu) disposition. The purpose of this study was to develop a population pharmacokinetic model and to determine the covariates affecting the pharmacokinetics (PK) of Bu in Iranian adult patients who received oral high-dose as a conditioning regimen before Hematopoietic Stem Cell Transplantation (HSCT). METHODS: A population PK analysis was performed in 30 patients who received an oral Bu and cyclophosphamide regimen before HSCT. Bu was given orally according to the protocol of the institution. In order to prevent seizures caused by Bu, phenytoin was administered orally one hour before each dose of Bu.A total of 180 blood samples were analyzed by HPLC and PK parameters were estimated by the non-linear mixed effect model by MONOLIX 3.1 program. A one-compartment model with an additive error model was used to describe the concentration-time profile of Bu. RESULTS: Patients' disease and weight was found to be the determinant factors for clearance (CL) and the volume of distribution (Vd) according to Monolix analysis. The covariate entered in final model followed by these equations:[Formula: see text][Formula: see text] In this limited study, the age (15-43 years) had no significant effect. For a patient weighting 60 kg, the typical CL and Vd were estimated to be 13.4 l/hr and 42.6 L, respectively. The interindividual variability of CL and Vd were 13.6 and 6.3%, respectively. There was no significant metabolic induction in these four days as is evident by comparing the trough levels of Bu. However it should be mentioned that, one tailed t-test p-values of the days of two and three, two and four and three and four were 0.083, 0.069 and 0.388, respectively. MAJOR CONCLUSIONS: Results of this study showed that the type of disease was a determinant of CL and the weight of patient was a determinant of Vd for Bu population PK parameters. A reliable PK parameters and Css, estimated from only one plasma concentrations (5 hrs after the first dose), were validated. Since these methods require few sampling and are easy to be used, the limited sampling methods might be advantageous in the routine clinical practice.