Purpose: In 2013, we reported the results of a third‐generation oral moisture‐checking device in a multicentre clinical study involving patients with dry mouth and healthy volunteers. Subsequently, several improvements have been made to the third‐generation device, and a fourth‐generation device is now commercially available. This study aimed to confirm the usefulness of this improved fourth‐generation device in the diagnosis of dry mouth and to assess the physiological wetness of lingual mucosa by using this device.
Materials and Method: This multicentre study comprised subjects with dry mouth (dry mouth group) and those without dry mouth (healthy group).
Results: In this study, the degree of moisture was considerably different between the two groups. Receiver operating characteristic analysis revealed an area under the curve value of 0.831. Sensitivity and specificity values were close to 80% in cases where the degree of moisture ≥29.6 was defined as normal, ≤27.9 was defined as dry mouth, and 28.0–29.5 was defined as borderline dry mouth.
Conclusions: These results suggest that the improved fourth‐generation moisture‐checking device can be used for the diagnosis of oral dryness.
Although cardiosphere-derived cells (CDCs) improve cardiac function and outcomes in patients with single ventricle physiology, little is known about their safety and therapeutic benefit in children with dilated cardiomyopathy (DCM). We aimed to determine the safety and efficacy of CDCs in a porcine model of DCM and translate the preclinical results into this patient population. A swine model of DCM using intracoronary injection of microspheres created cardiac dysfunction. Forty pigs were randomized as preclinical validation of the delivery method and CDC doses, and CDC-secreted exosome (CDCex)–mediated cardiac repair was analyzed. A phase 1 safety cohort enrolled five pediatric patients with DCM and reduced ejection fraction to receive CDC infusion. The primary endpoint was to assess safety, and the secondary outcome measure was change in cardiac function. Improved cardiac function and reduced myocardial fibrosis were noted in animals treated with CDCs compared with placebo. These functional benefits were mediated via CDCex that were highly enriched with proangiogenic and cardioprotective microRNAs (miRNAs), whereas isolated CDCex did not recapitulate these reparative effects. One-year follow-up of safety lead-in stage was completed with favorable profile and preliminary efficacy outcomes. Increased CDCex-derived miR-146a-5p expression was associated with the reduction in myocardial fibrosis via suppression of proinflammatory cytokines and transcripts. Collectively, intracoronary CDC administration is safe and improves cardiac function through CDCex in a porcine model of DCM. The safety lead-in results in patients provide a translational framework for further studies of randomized trials and CDCex-derived miRNAs as potential paracrine mediators underlying this therapeutic strategy.
Laparoscopic surgery following CRT was safe and feasible. A shorter anal verge was associated with a longer operation time. Blood loss increased in cases with high CTV, but this can likely be mitigated by experience.
Objective: This multicenter clinical study was to assess the clinical usability of an oral moisturechecking device in detecting the dry mouth patients and evaluating the optimal measurement site. Materials and Methods: The study group comprised 250 patients with dry mouth and 241 healthy volunteer subjects at 13 medical centers. This device was used to measure the moisture degrees of the lingual mucosa and the buccal mucosa. Subjective oral dryness, objective oral dryness, and saliva flow rates were also compared between the two groups. For statistical analysis, receiver-operating characteristic analysis was performed to calculate the area under the curve (AUC). Results: The moisture degree of the lingual mucosa was significantly lower in the dry mouth group (27.2 ± 4.9) than that in the healthy group (29.5 ± 3.1, AUC = 0.653). When a lingual mucosa moisture degree of 31.0 or higher was defined as normal, less than 27.0 as dry mouth, and 27.0 to less than 31.0 as borderline zone of dry mouth, both the sensitivity and the specificity for the diagnosis of dry mouth were close to 80%. Conclusion: These results suggest that the oral moisture-checking device is a usable screening device for dry mouth.
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