METHODS: A double-blind, multicenter randomized clinical trial was undertaken in four teaching hospitals in the North of Iraq and Al-Azhar University Hospital in Egypt, from March 2016 to May 2019. Group I (274 women) received 400 μg misoprostol and group II (249 women) received 800 μg misoprostol. Data regarding the time of placental separation and amount of vaginal blood loss were analyzed and proportions were compared between groups using Chi-squared test. Mean values were compared using the Student's t-test. The Mann-Whitney test was used to determine the median of vaginal blood loss.
RESULTS: The proportion of placental separation was 84.3% among women in group I and 86.7% of women in group II. The mean time of placental separation was 18.86 ± 234.2 and 17.86 ± 213.09 min in groups I and II, respectively (P
MATERIALS AND METHODS: An experimental GIC (ex-GIC) was prepared by mixing CHX-D powder with the powder of type II GIC to obtain 1% (w/w) concentration of CHX-D in the GIC. Antibacterial activity of this ex-GIC was tested against L. casei and A. viscosus using the agar diffusion method. The ex-GIC specimens were tested in their unset and set forms for each bacterium. For the unset group, specimens were placed in each agar plate immediately after manipulation and for the set group, specimens were placed in each agar plate, 1 hour after manipulation. The inhibition zones on the agar plate were recorded in millimeters immediately on placement of the specimen in the agar plate and after 48 hours. The reading was recorded and statistically analyzed for significant difference.
RESULTS: Mann-Whitney U test showed statistically significant difference in the inhibition zones produced by ex-GIC against L. casei and A. viscosus when both were compared in unset (p-value = 0.002) and set (p-value = 0.031) groups. For both the groups, the zone of inhibition against L. casei was greater. Though the unset group recorded wider zone of inhibition, the difference was not significant when compared with the respective set group. This was true for both the bacterial groups.
CONCLUSION: The 1% CHX-D-modified type II GIC showed antibacterial property against L. casei and A. viscosus and significantly higher activity against L. casei.
CLINICAL SIGNIFICANCE: Addition of 1% CHX-D to type II GIC showed evidence of antibacterial activity against organisms found in deep carious lesion and therefore may exhibit superior antimicrobial efficiency when used as an intermediate therapeutic restoration in deep cavities.
METHODS: Patients who were 10 to less than 17 years of age were randomly assigned, in a 1:1 ratio, to receive subcutaneous liraglutide (up to 1.8 mg per day) or placebo for a 26-week double-blind period, followed by a 26-week open-label extension period. Inclusion criteria were a body-mass index greater than the 85th percentile and a glycated hemoglobin level between 7.0 and 11.0% if the patients were being treated with diet and exercise alone or between 6.5 and 11.0% if they were being treated with metformin (with or without insulin). All the patients received metformin during the trial. The primary end point was the change from baseline in the glycated hemoglobin level after 26 weeks. Secondary end points included the change in fasting plasma glucose level. Safety was assessed throughout the course of the trial.
RESULTS: Of 135 patients who underwent randomization, 134 received at least one dose of liraglutide (66 patients) or placebo (68 patients). Demographic characteristics were similar in the two groups (mean age, 14.6 years). At the 26-week analysis of the primary efficacy end point, the mean glycated hemoglobin level had decreased by 0.64 percentage points with liraglutide and increased by 0.42 percentage points with placebo, for an estimated treatment difference of -1.06 percentage points (P<0.001); the difference increased to -1.30 percentage points by 52 weeks. The fasting plasma glucose level had decreased at both time points in the liraglutide group but had increased in the placebo group. The number of patients who reported adverse events was similar in the two groups (56 [84.8%] with liraglutide and 55 [80.9%] with placebo), but the overall rates of adverse events and gastrointestinal adverse events were higher with liraglutide.
CONCLUSIONS: In children and adolescents with type 2 diabetes, liraglutide, at a dose of up to 1.8 mg per day (added to metformin, with or without basal insulin), was efficacious in improving glycemic control over 52 weeks. This efficacy came at the cost of an increased frequency of gastrointestinal adverse events. (Funded by Novo Nordisk; Ellipse ClinicalTrials.gov number, NCT01541215.).