Background and Objectives: Three post-marketing clinical follow-up studies were performed in Europe to confirm the safety and performance of four nonprescription, nasal cleansing medical devices: Otrivin Sea Water (OS...Background and Objectives: Three post-marketing clinical follow-up studies were performed in Europe to confirm the safety and performance of four nonprescription, nasal cleansing medical devices: Otrivin Sea Water (OSW) pressurized spray, OSW with aloe vera (OSWAV), Otrisal 0.74% NaCl Metered-Dose Spray (MDS), and Prorhinel spray. Material and Methods: Observational, single-arm, retrospective studies consisting of a single online questionnaire were performed between July 2021 and December 2021. Eligible participants were adults who used the device or supervised use of the device in a participant under 18 years of age within 6 months of completing the questionnaire. Demographics, safety, and device performance were assessed. Results: Based on questionnaires submitted on OSW (n = 556), OSWAV (n = 555), Otrisal MDS (n = 555), and Prorhinel (n = 555), proportions of users who reported safety events were 1.8% for OSW, 2.3% for OSWAV, 1.4% for Otrisal MDS, and 2.0% for Prorhinel. Proportions of users who indicated they were satisfied or very satisfied with device performance ranged from 72.0% - 89.0% across all devices. Device performance for all products was also supported for additional preventative and symptomatic uses through exploratory analyses. Conclusions and Significance: These data confirm device safety and performance of OSW, OSWAV, Otrisal MDS, and Prorhinel for their intended uses.展开更多
The biological hydrogen generating from fermentation of low-cost lignocellulosic feedstocks by hydrogen-producing bacteria has attracted many attentions in recent years. In the present investigation, ten hydrogen-prod...The biological hydrogen generating from fermentation of low-cost lignocellulosic feedstocks by hydrogen-producing bacteria has attracted many attentions in recent years. In the present investigation, ten hydrogen-producing bacteria were newly isolated from the intestine of wild common carp (</span><span style="font-family:Verdana;"><i>Cyprinus carpio</i></span><span style="font-family:Verdana;"> L.), and identified belonging to the genera of </span><i><span style="font-family:Verdana;">Enterobacter</span></i><span style="font-family:Verdana;"> and </span><i><span style="font-family:Verdana;">Klebsiella</span></i><span style="font-family:Verdana;"> based on analysis of the 16S rDNA gene sequence and examination of the physiological and biochemical characteristics. All the isolates inherently owned the ability to metabolize xylose especially the cotton stalk hydrolysate for hydrogen production with hydrogen yield (HY) higher than 100 mL</span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;">·</span></span><span></span><span></span><span style="font-family:""><span style="font-family:Verdana;">L</span><sup><span style="font-family:Verdana;">-1</span></sup><span style="font-family:Verdana;">. In particular, two isolates, WL1306 and WL1305 obtained higher HY, hydrogen production rate (HPR), and hydrogen production potential (HPP) using cotton stalk hydrolysate as sugar substrate than the mixed sugar of glucose & xylose, which obtained the HY of 249.5 ± 29.0, 397.0 ± 36.7 mL</span></span><span style="font-family:Verdana;">·</span><span style="font-family:Verdana;">L</span><sup><span style="font-family:Verdana;">-</span></sup><sup><span style="font-family:Verdana;">1</span></sup><span style="font-family:Verdana;">, HPR of 10.4 ± 1.2, 16.5 ± 1.5 mL</span><span style="font-family:Verdana;">·</span><span style="font-family:Verdana;">L</span><sup><span style="font-family:Verdana;">-</span></sup><sup><span style="font-family:Verdana;">1</span></sup><span style="font-family:Verdana;">·</span><span style="font-family:Verdana;">h</span><sup><span style="font-family:Verdana;">-</span></sup><sup><span style="font-family:Verdana;">1</span></sup><span style="font-family:Verdana;">, HPP of 19.5 ± 2.3, 31.0 ± 2.8 mL</span><span style="font-family:Verdana;">·</span><span style="font-family:Verdana;">L</span><sup><span style="font-family:Verdana;">-</span></sup><sup><span style="font-family:Verdana;">1</span></sup><span style="font-family:Verdana;">·</span><span style="font-family:Verdana;">g</span><sup><span style="font-family:Verdana;">-</span></sup><sup><span style="font-family:Verdana;">1</span></sup><sub><span style="font-family:Verdana;">sugar</span></sub><span style="font-family:Verdana;">, separately. The generation of soluble metabolites, such as the lactate, formate, acetate, succinate and ethanol reflected the mixed acid fermentation properties of the hydrogen production pathway.展开更多
文摘Background and Objectives: Three post-marketing clinical follow-up studies were performed in Europe to confirm the safety and performance of four nonprescription, nasal cleansing medical devices: Otrivin Sea Water (OSW) pressurized spray, OSW with aloe vera (OSWAV), Otrisal 0.74% NaCl Metered-Dose Spray (MDS), and Prorhinel spray. Material and Methods: Observational, single-arm, retrospective studies consisting of a single online questionnaire were performed between July 2021 and December 2021. Eligible participants were adults who used the device or supervised use of the device in a participant under 18 years of age within 6 months of completing the questionnaire. Demographics, safety, and device performance were assessed. Results: Based on questionnaires submitted on OSW (n = 556), OSWAV (n = 555), Otrisal MDS (n = 555), and Prorhinel (n = 555), proportions of users who reported safety events were 1.8% for OSW, 2.3% for OSWAV, 1.4% for Otrisal MDS, and 2.0% for Prorhinel. Proportions of users who indicated they were satisfied or very satisfied with device performance ranged from 72.0% - 89.0% across all devices. Device performance for all products was also supported for additional preventative and symptomatic uses through exploratory analyses. Conclusions and Significance: These data confirm device safety and performance of OSW, OSWAV, Otrisal MDS, and Prorhinel for their intended uses.
文摘The biological hydrogen generating from fermentation of low-cost lignocellulosic feedstocks by hydrogen-producing bacteria has attracted many attentions in recent years. In the present investigation, ten hydrogen-producing bacteria were newly isolated from the intestine of wild common carp (</span><span style="font-family:Verdana;"><i>Cyprinus carpio</i></span><span style="font-family:Verdana;"> L.), and identified belonging to the genera of </span><i><span style="font-family:Verdana;">Enterobacter</span></i><span style="font-family:Verdana;"> and </span><i><span style="font-family:Verdana;">Klebsiella</span></i><span style="font-family:Verdana;"> based on analysis of the 16S rDNA gene sequence and examination of the physiological and biochemical characteristics. All the isolates inherently owned the ability to metabolize xylose especially the cotton stalk hydrolysate for hydrogen production with hydrogen yield (HY) higher than 100 mL</span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;">·</span></span><span></span><span></span><span style="font-family:""><span style="font-family:Verdana;">L</span><sup><span style="font-family:Verdana;">-1</span></sup><span style="font-family:Verdana;">. In particular, two isolates, WL1306 and WL1305 obtained higher HY, hydrogen production rate (HPR), and hydrogen production potential (HPP) using cotton stalk hydrolysate as sugar substrate than the mixed sugar of glucose & xylose, which obtained the HY of 249.5 ± 29.0, 397.0 ± 36.7 mL</span></span><span style="font-family:Verdana;">·</span><span style="font-family:Verdana;">L</span><sup><span style="font-family:Verdana;">-</span></sup><sup><span style="font-family:Verdana;">1</span></sup><span style="font-family:Verdana;">, HPR of 10.4 ± 1.2, 16.5 ± 1.5 mL</span><span style="font-family:Verdana;">·</span><span style="font-family:Verdana;">L</span><sup><span style="font-family:Verdana;">-</span></sup><sup><span style="font-family:Verdana;">1</span></sup><span style="font-family:Verdana;">·</span><span style="font-family:Verdana;">h</span><sup><span style="font-family:Verdana;">-</span></sup><sup><span style="font-family:Verdana;">1</span></sup><span style="font-family:Verdana;">, HPP of 19.5 ± 2.3, 31.0 ± 2.8 mL</span><span style="font-family:Verdana;">·</span><span style="font-family:Verdana;">L</span><sup><span style="font-family:Verdana;">-</span></sup><sup><span style="font-family:Verdana;">1</span></sup><span style="font-family:Verdana;">·</span><span style="font-family:Verdana;">g</span><sup><span style="font-family:Verdana;">-</span></sup><sup><span style="font-family:Verdana;">1</span></sup><sub><span style="font-family:Verdana;">sugar</span></sub><span style="font-family:Verdana;">, separately. The generation of soluble metabolites, such as the lactate, formate, acetate, succinate and ethanol reflected the mixed acid fermentation properties of the hydrogen production pathway.