title stringlengths 1 1.19k | keywords stringlengths 0 668 | concept stringlengths 0 909 | paragraph stringlengths 0 61.8k | PMID stringlengths 10 11 |
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Adverse Events | ADVERSE EVENT, ADVERSE EVENT | Adverse events were experienced by 41 control participants (26.1%) and 56 intervention participants (35.2%). The most commonly reported adverse event was skin and subcutaneous tissue irritation from the 24-hour AMBP cuff (24 control participants and 31 intervention participants), which has been previously reported. | PMC9898821 | |
Discussion | PMC9898821 | |||
Summary of Findings | hypertension | SECONDARY, HYPERTENSION, RECRUITMENT | The MyHEART study represents successful recruitment, enrollment, and engagement of racially and geographically diverse young adults. The trial did not demonstrate a significant change between study groups in systolic or diastolic BP or the secondary outcome of hypertension control at 6 or 12 months. However, both study... | PMC9898821 |
BP Values at End Points | atherosclerotic cardiovascular disease, hypertension, chronic kidney disease, diabetes | ATHEROSCLEROTIC CARDIOVASCULAR DISEASE, HYPERTENSION, DIABETES | There was always a lower BP value in the intervention group compared with the control group during follow-up, with the exception of the 12-month clinic systolic BP. The fact that the control group only demonstrated a significant reduction in clinic BP results and systolic AMBP values may suggest that using only clinic ... | PMC9898821 |
Limitations | hypertension | HYPERTENSION | This study has limitations. The dropout rate was higher than expected but did not differ by study group. The latter part of the study overlapped with the COVID-19 pandemic; however, there was greater study dropout or loss to follow-up prior to the pandemic. It is possible that stay-at-home orders may have provided part... | PMC9898821 |
Conclusions | reduction in systolic and diastolic BP, hypertension | UNCONTROLLED HYPERTENSION, HYPERTENSION | The MyHEART intervention did not demonstrate a significant change in systolic and diastolic BP measurements or hypertension control at 6 or 12 months when compared with control participants. However, both groups had a reduction in systolic and diastolic BP and an increase in hypertension control. Intervention participa... | PMC9898821 |
Background | non-small cell lung cancer | NON-SMALL CELL LUNG CANCER | Lungsco01 is the first study assessing the real benefits and the medico-economic impact of video-thoracoscopy versus open thoracotomy for non-small cell lung cancer in the French context. | PMC10507914 |
Methods | SENSITIVITY | Two hundred and fifty nine adult patients from 10 French centres were randomised in this prospective multicentre randomised controlled trial, between July 29, 2016, and November 24, 2020. Survival from surgical intervention to day 30 and later was compared with the log-rank test. Total quality-adjusted-life-years (QALY... | PMC10507914 | |
Results | The average cumulative costs of thoracotomy were lower than those of video-thoracoscopy at 30 days (€9,730 (SD = 3,597) | PMC10507914 | ||
Conclusions | Given our results, the economic efficiency of video-thoracoscopy at 30 days remains fragile at a willingness-to-pay threshold of €25,000/QALY. The economic efficiency is not established beyond that time horizon. The acceptability curves given will allow decision-makers to judge the probability of efficiency of this tec... | PMC10507914 | ||
Trial registration | NCT02502318. | PMC10507914 | ||
Keywords | PMC10507914 | |||
Background | NSCLC, cancer death, Lung cancer, lung cancer, deaths, tumors | NON-SMALL CELL LUNG CANCER, POSTOPERATIVE COMPLICATIONS, LUNG CANCER, LUNG CANCER, SECONDARY, NSCLC, TUMORS, COMPLICATIONS | Lung cancer (LC) remains a major health problem with an estimated 130,180 deaths in 2022 in the US, which makes it the leading cause of cancer death in both sexes [During the last decade, the use of video-assisted thoracoscopic surgery (VATS) lobectomy for LC has grown considerably. In France, the use of VATS jumped fr... | PMC10507914 |
Material and methods | Lungsco01 is an open two-arm parallel RCT comparing lobectomy or segmentectomy performed by VATS with lobectomy or segmentectomy using thoracotomy for the treatment of LC. As specified in the published study protocol, the study involved French thoracic surgery departments that had already performed more than 50 VATS lo... | PMC10507914 | ||
Study population | NSCLC | NSCLC | The study population included patients with proven or suspected NSCLC which could be treated by lobectomy or segmentectomy performed by VATS or lobectomy or segmentectomy using thoracotomy. Inclusion criteria and exclusion criteria were described in the published protocol [ | PMC10507914 |
Procedures | There were two potential approaches for lobectomy or segmentectomy using video-thoracoscopy (VATS) and two potential types of thoracotomy: posterolateral thoracotomy with muscle sparing or lateral thoracotomy [ | PMC10507914 | ||
Post-operative care | Thrombophlebitis | THROMBOPHLEBITIS | Postoperatively, whether after VATS or thoracotomy, analgesia (morphine) was delivered via the epidural catheter or paravertebral catheter or intravenously. All patients had respiratory and motor physiotherapy immediately after the surgery at least twice a day during the hospital stay. All patients had a nasal cannula.... | PMC10507914 |
Outcomes | death | As part of the cost-effectiveness analyses initially planned, incremental cost-effectiveness ratios (ICER) were to be calculated taking into account the cost differential and the survival differential between the two groups. The ratios would have been expressed as the additional cost per life-year gained using the inno... | PMC10507914 | |
Data collection | All the clinical data, resources consumed and responses to the EQ-5D-3L® questionnaire were collected prospectively via an electronic Case Report Form (e-CRF). | PMC10507914 | ||
Cost estimations | COMPLICATIONS | The costs of VATS and thoracotomy were estimated for each patient for the 30 first days and the 3 first months after surgery. Costs were estimated from the hospital perspective given the available data on resources consumed (hospital stays). They included: (i) the production costs of the initial stays (including surger... | PMC10507914 | |
Utility measure | QALYs were evaluated using collected responses to the EQ-5D-3L® generic questionnaire completed pre-operatively, 3 days after surgery, during the day-30 visit and during the 3-month visit after surgery [ | PMC10507914 | ||
Statistical analyses | Analyses were performed on an intention-to-treat basis. Qualitative variables were compared using the χThe cost-utility analyses at 30 days and at 3 months were performed on cases with complete QALYs (no missing data). Then, a non-parametric bootstrap method (10,000 replications) was used in order to study the uncertai... | PMC10507914 | ||
Discussion | NSCLC | NSCLC, COMPLICATIONS | Of the two strategies, VATS was found to be more expensive, and it did not result in cost reductions in the post-surgical period at 30 days or at 3 months. Like in other RCTs, we did not show significant benefits for VATS in terms of post-operative complications or mortality [This trial is the first prospective multice... | PMC10507914 |
Conclusions | Given our results, the economic efficiency of VATS at a willingness-to-pay threshold of €25,000/QALY remains fragile at 30 days (64% probability). The economic efficiency is not established beyond that time horizon. However, the acceptability curves given will allow decision-makers to judge the probability of efficienc... | PMC10507914 | ||
Acknowledgements | The authors thank the 10 centres that participated in the inclusion of patients and the collection of data for this study: CH Victor Dupouy (ARGENTEUIL), CH Henri Duffaut (AVIGNON), HCL—Louis Pradel (BRON), Centre Jean Perrin (CLERMONT-FERRAND), CHU Dijon – Hôpital du Bocage (DIJON), APHM—Hôpital Nord (MARSEILLE), CHU ... | PMC10507914 | ||
Authors’ contributions | A-LS realized medico-economic literature review, conducted the medico-economic analyses and wrote the manuscript (Abstract, Material and Methods, Results, Discussion, Conclusion, Tables and Figures). SA conducted the statistical analyses. AB was the chief investigator and led the project. P-BP realized clinical literat... | PMC10507914 | ||
Funding | This study was funded by the French Ministry of Health as part of the 2014 Medico-Economic Research Program. | PMC10507914 | ||
Availability of data and materials | The clinical datasets generated and/or analysed during the current study are not publicly available because the indirect nominative data cannot be shared publicly under French law, but they can be made available from the corresponding author on reasonable request. The hospital cost data per DRG used during the current ... | PMC10507914 | ||
Declarations | PMC10507914 | |||
Ethics approval and consent to participate | This study was performed in accordance with the Declaration of Helsinki. The protocol of this study was approved by an Ethics Committee ( | PMC10507914 | ||
Consent for publication | Not applicable. | PMC10507914 | ||
Competing interests | The authors declare no competing interests. | PMC10507914 | ||
References | PMC10507914 | |||
Background | T2D, GDM | GDM, TYPE 2 DIABETES, GESTATIONAL DIABETES MELLITUS | Many lifestyle interventions have demonstrated efficacy up to one-year follow-up, yet maintaining improvements at longer-term follow-up is a well-recognized worldwide challenge, especially in underserved areas. The purpose of this study is to compare the 18-month efficacy of an Intensive LifeStyle Modification Program ... | PMC9881320 |
Methods | GDM, T2D | GDM, SECONDARY | We conducted a two-arm, cluster randomized controlled trial among women with a history of GDM in China. A total of 16 towns (clusters) in two distinct rural areas in south-central China were randomly selected (8 towns per area) and assigned (1:1) to the intervention (Intensive LifeStyle Modification Program) or control... | PMC9881320 |
Results | T2D, fasting blood glucose | The sample included 320 women from 16 clusters (20 women per cluster). At 18 months, the intervention group demonstrated a significant improvement in T2D risk score, fasting blood glucose, body mass index (BMI), waist circumference, intention to eat low glycemic index food, perceived stress, quality of life in psycholo... | PMC9881320 | |
Conclusions | T2D, blood glucose intolerance, GDM, overweight, diabetes | GDM, ADIPOSITY, DIABETES | Over 18 months, the Intensive LifeStyle Modification Program reduced T2D risk among rural women with a history of GDM in China. Women who were overweight, had high abdominal adiposity, or had blood glucose intolerance benefited more from this intervention. This program serves as a potential diabetes prevention model fo... | PMC9881320 |
Trial registration | Registered on Chinese Clinical Trial Registry (ChiCTR1800015023) on 1st March 2018, | PMC9881320 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s12992-023-00910-3. | PMC9881320 | ||
Keywords | PMC9881320 | |||
Introduction | Type 2 diabetes, T2D, GDM, diabetes | GDM, TYPE 2 DIABETES, DIABETES | Type 2 diabetes (T2D) affects approximately 425 million people worldwide and is projected to rise to 629 million by 2045, posing major health and economic consequences [However, maintaining lifestyle change over time is a well-recognized worldwide challenge, and few studies investigated the sustainability of lifestyle ... | PMC9881320 |
Methods | PMC9881320 | |||
Study design | GDM | GDM | This study utilized a cluster randomized controlled trial design to investigate the 18-month health impact of ILSM among 320 women with a history of GDM in rural China. The study was approved by the local ethics committee and registered at the Chinese Clinical Trial Registry. The details of the rationale, study and res... | PMC9881320 |
Setting and randomization | The study was conducted in Yongding County and You County, Hunan Province in south-central China. Yongding County comprising 17 towns, has a large ethnic minority population (~ 50%, mainly Tujia and Miao population) in western Hunan Province; and You County comprising 14 towns, has a large ethnic Han population in east... | PMC9881320 | ||
Participants | GDM, cognitive disability, diabetes | GDM, DIABETES | Inclusion criteria were: 1) adult women with a history of GDM; 2) 6 weeks to 10 years postpartum; 3) living in the allocated towns and intending to live in these towns for at least 3 years; 4) having telephone access, and 5) able to read and speak in Mandarin Chinese. Exclusion criteria were: 1) women who were pregnant... | PMC9881320 |
Interventions | T2D | BLIND | The timeline of the intervention activities and measurements for ILSM group and control group is showed in Table The flowchart of the intervention activities and measurements(1) the T2D risk score;(2) glycemic outcomes: FBG, 2 h-OGTT;(3)weight-related outcomes: BMI, waist circumference;(4) behavior outcomes: physical a... | PMC9881320 |
Statistical analysis | glucose dysregulation, T2D | The analyses were done at the individual level in SPSS (Version 22.0; Armonk, NY, United States). The double-entry data method was adopted to ensure data accuracy via the EpiData 3.0 software (EpiData Association, Odense, Denmark). All randomly assigned participants (The data were presented as means with SDs or as coun... | PMC9881320 | |
Results | PMC9881320 | |||
Changes in glycemic and weight-related outcomes | Participants in the intervention group experienced a significant decline of 0.37 mmol/L in FBG compared with 0.09 mmol/L in the control group from baseline to 18-month follow-up (β = −.169 [95%CI −.252, −.087]; There was a significant decrease of 1.07 kg/m | PMC9881320 | ||
Changes in behavioral outcomes | We found a significant improvement of the intention to eat low-glycemic index food in the intervention group, whereas it declined in the control group over 18 months (+ 6.64 points vs. -2.28 points; β = 2.879 [95%CI −.776, .224]; | PMC9881320 | ||
Changes in psychosocial outcomes | The intervention group participants reported a significant decrease in perceived negative stress, while the control group reported an increase in perceived negative stress over time (β = −.444 [95%CI −.858, −.029]; | PMC9881320 | ||
Changes in T2D risk scores by subgroups | T2D | INTERACTION | In the subgroup analysis, the intervention was more effective for women with BMI > 24 kg/ m2 (95% CI − 4.42 to − 1.98, Forest plot of intervention effect at 18 months on T2D risk scores and BMI by subgroup. Interaction between intervention group and subgroup | PMC9881320 |
Discussion | T2D, GDM, overweight, T2DM, dysglycemia, diabetes | GDM, OBESE, DIABETES | In this study, we demonstrated that ILSM significantly reduced T2D risk scores and obtained statistically significant benefits for FBG, BMI, and intention to eat low-index glycemic food at an 18-month follow-up based on the intention-to-treat analysis. This is encouraging as previous studies reported that the benefit o... | PMC9881320 |
Conclusion | T2D, abdominal adiposity, GDM, diabetes | GDM, GLUCOSE INTOLERANCE, DIABETES | In conclusion, the ILSM provided robust evidence to support lifestyle interventions in preventing T2D wasn’t weakened by time, but can preserve and strengten it over 18 months in women with a history of GDM in low-resource rural settings in China. Women with a history of GDM who are currently overweight, have abdominal... | PMC9881320 |
Acknowledgements | RECRUITMENT | The authors thank Mrs. Shuangyan Yang, the chair of People’s Hospital of Youxian for her support and valuable input to recruitment and implementation. The authors also thank all the local healthcare providers and the participants involved in this work. | PMC9881320 | |
Authors’ contributions | The study was initially designed and conceptualized by JG, RW, JC, SX and QL but all authors contributed to the final concept. QZ, YC, ML and JT collected the data. JW, QZ, and YC analyzed the data. All authors interpreted the data. QZ and YC drafted the manuscript. All authors critically revised the manuscript and hav... | PMC9881320 | ||
Funding | This work was supported by the China Medical Board (grant number:16–256) and the Natural Science Fund of Changsha City (grant number: kq2202120). The study sponsors were not involved in the design of the study, the collection, analysis, and interpretation of data, writing the report or the decision to submit the report... | PMC9881320 | ||
Availability of data and materials | The datasets used during the current study are available from the corresponding author on reasonable request. | PMC9881320 | ||
Declarations | PMC9881320 | |||
Ethics approval and consent to participate | The trial was approved by the local ethics committee (IRB #2016034) and registered at the Chinese Clinical Trial Registry (No. ChiCTR1800015023). At the start of the study, local nurses explained the program to interested women, confirmed their eligibility, and obtained consent. | PMC9881320 | ||
Consent for publication | Not applicable. | PMC9881320 | ||
Competing interests | The authors declare that they have no competing interests. | PMC9881320 | ||
References | PMC9881320 | |||
Key Points | PMC10603500 | |||
Question | infection | INFECTION | Does a strategy of direct gloving compared with performing hand hygiene before donning nonsterile gloves influence adherence to infection prevention practices among health care personnel? | PMC10603500 |
Findings | This mixed-method, multicenter, cluster randomized trial including 3790 health care personnel across 13 hospital units of 4 academic centers demonstrated a statistically significant 46% increase in adherence to a direct-gloving strategy vs usual care of hand hygiene before donning gloves (87% vs 41% adherence). | PMC10603500 | ||
Meaning | infection | INFECTION | These results suggest that a policy endorsing direct gloving may increase adherence to expected infection prevention practices and overall glove use in many hospital settings. | PMC10603500 |
Importance | Current guidelines require hand hygiene before donning nonsterile gloves, but evidence to support this requirement is lacking. | PMC10603500 | ||
Objective | infection | INFECTION | To evaluate the effectiveness of a direct-gloving policy on adherence to infection prevention practices in a hospital setting. | PMC10603500 |
Design, Setting, and Participants | This mixed-method, multicenter, cluster randomized clinical trial was conducted at 4 academic centers in Baltimore, Maryland, or Iowa City, Iowa, from January 1, 2016, to November 30, 2017. Data analysis was completed April 25, 2019. Participants were 3790 health care personnel (HCP) across 13 hospital units. | PMC10603500 | ||
Intervention | Hospital units were randomly assigned to direct gloving, with hand hygiene not required before donning gloves (intervention), or to usual care (hand hygiene before donning nonsterile gloves). | PMC10603500 | ||
Main Outcomes and Measures | SECONDARY | The primary outcome was adherence to the expected practice at room entry and exit. A random sample of HCPs’ gloved hands were imprinted on agar plates at entry to contact precautions rooms. The intention-to-treat approach was followed, and all analyses were conducted at the level of the participating unit. Primary and ... | PMC10603500 | |
Results | In total, 13 hospital units participated in the trial, and 3790 HCP were observed. Adherence to expected practice was greater in the 6 units with the direct-gloving intervention than in the 7 usual care units (1297 of 1491 [87%] vs 954 of 2299 [41%]; | PMC10603500 | ||
Conclusions and Relevance | Current guidelines require hand hygiene before donning nonsterile gloves, but evidence to support this requirement is lacking. The findings from this cluster randomized clinical trial indicate that a direct-gloving strategy without prior hand hygiene should be considered by health care facilities. | PMC10603500 | ||
Trial Registration | infection | INFECTION | ClinicalTrials.gov Identifier: This cluster randomized clinical trial compares the effectiveness of a direct-gloving policy with the usual practice of hand hygiene before donning nonsterile gloves on adherence of health care personnel to infection prevention practices across several hospital units. | PMC10603500 |
Introduction | infection | INFECTION | Hand hygiene is the cornerstone of infection prevention, but a prior comprehensive review found that typical adherence in health care settings is only 40%. | PMC10603500 |
Methods | PMC10603500 | |||
Study Setting and Participants | Shock | SHOCK | This cluster randomized clinical trial was performed from January 1, 2016, to November 30, 2017, in multiple clinical settings (ie, adult intensive care units [ICUs], general pediatrics wards, emergency departments (EDs), and inpatient hemodialysis units at 4 academic health care centers: University of Maryland Medical... | PMC10603500 |
Study Design | infection | INFECTION | We performed a mixed-method study including a cluster randomized trial to evaluate the effectiveness of a direct-gloving strategy in which each participating unit was assigned to either usual care (following the hospital’s policy to perform hand hygiene before donning nonsterile gloves) or the direct-gloving interventi... | PMC10603500 |
Intervention | We randomly assigned participating units to either usual care or direct gloving. Randomization was stratified by unit type by the study statistician (S.L.). Immediately before the intervention period, we delivered identical education regarding hand hygiene and glove use to HCP in all participating units via face-to-fac... | PMC10603500 | ||
Outcomes | The primary outcome was a composite of adherence to the expected practices of hand hygiene and glove use on entry to contact precautions rooms | PMC10603500 | ||
Data Collection | Study staff at each site used a standardized hand hygiene data collection tool to capture hand hygiene and glove use on room entry and exit. Study staff used this form when observing HCP adherence to expected hand hygiene and glove use practice in each of the potentially eligible units (baseline period) and participati... | PMC10603500 | ||
Sample Size and Effect Size | We estimated an effect size of approximately 30% based on prior studies that reported mean hand hygiene compliance rates of 40% (and lower when glove use is indicated | PMC10603500 | ||
Validation of Safety and Efficacy | The safety and efficacy of a direct-gloving strategy has been previously demonstrated. | PMC10603500 | ||
Qualitative Assessment | To assess potential facilitators and barriers to a direct-gloving strategy, we conducted a qualitative evaluation of HCP perceptions in eligible units. The qualitative data collection and analysis for this study are described in detail elsewhere. | PMC10603500 | ||
Statistical Analysis | SECONDARY | We followed the intention-to-treat approach and conducted all analyses at the level of the participating unit. We compared primary and secondary outcomes between treatment groups using a generalized estimating equations approach with an unstructured working correlation matrix to adjust for clustering. We performed mult... | PMC10603500 | |
Results | PMC10603500 | |||
Baseline Hand Hygiene and Qualitative Assessment | Study staff collected data from all 33 available units—20 ICUs, 7 general pediatrics wards, 3 hemodialysis units, and 3 EDs—at the 4 participating centers during the 6-month baseline period ( | PMC10603500 | ||
Trial Flow Diagram | skin irritation | ED indicates emergency department; ICU, intensive care unit.We conducted semistructured interviews with 25 HCP (5 physicians, 1 physician assistant, 3 nurse practitioners, 8 nurses, and 8 nursing assistants) across 9 of the 13 randomized units. When asked about the perceived benefits of a direct-gloving strategy, 17 of... | PMC10603500 | |
Intervention | Thirteen units were randomly assigned to either usual care (7) or direct gloving (6); 1 ED declined to participate. | PMC10603500 | ||
Baseline Characteristics of 13 Participating Units | HOSPITAL INFECTION | Abbreviation: NA, not applicable.Three participating units (2 usual care and 1 direct-gloving unit) required universal gloving for entry into any patient room during the study period as part of hospital infection prevention practices.Health care personnel were considered adherent in the baseline period if they were com... | PMC10603500 | |
Multivariable Regression Models of Adherence to Hand Hygiene and Glove Use | Abbreviation: ND, not determined.Primary outcome; health care personnel were considered adherent in the baseline period if they were compliant with expected practice of hand hygiene followed by glove use before entry into a contact precautions room among 13 participating units.Secondary outcome.Exposure variable.Covari... | PMC10603500 | ||
Safety and Efficacy Validation | We observed 2383 HCP at random on entry to contact precautions rooms, 1194 in direct-gloving units and 1189 in usual care units, and we sampled their gloves for bacteria before room entry. Pathogens were identified in 49 of 1194 (4%) samples obtained from the direct-gloving units, with a mean (SD) total bacterial colon... | PMC10603500 | ||
Detection of Bacteria on Gloves at Entry to Contact Precautions Rooms | Abbreviation: CFUs, colony-forming units. | PMC10603500 | ||
Discussion | infection, care-associated infection | INFECTION, EVENT | This cluster randomized clinical trial demonstrated that a policy endorsing a direct-gloving strategy compared with the current strategy requiring hand hygiene before glove use led to improved adherence with expected practices and increased overall glove use, was accepted by HCP, and did not increase bacterial contamin... | PMC10603500 |
Limitations | This study has limitations. The study was completed before the COVID-19 pandemic, and practices may be different during vs after the pandemic. Our study did not have clinical outcomes; however, such a study would be expensive and difficult to adequately power. | PMC10603500 | ||
Conclusions | This cluster randomized clinical trial demonstrated that a policy endorsing a direct-gloving strategy led to improved adherence with expected practices and increased overall glove use, was accepted by HCP, and was as safe as the current strategy requiring hand hygiene before donning gloves in areas in which hand hygien... | PMC10603500 | ||
Background | autism spectrum disorder, ASD, disability | Intranasal administration of oxytocin is increasingly explored as a new approach to facilitate social development and reduce disability associated with a diagnosis of autism spectrum disorder (ASD). The efficacy of multiple-dose oxytocin administration in children with ASD is, however, not well established. | PMC10117268 | |
Methods | repetitive behaviors, anxiety | A double-blind, randomized, placebo-controlled trial with parallel design explored the effects of a 4-week intranasal oxytocin administration (12 IU, twice daily) on parent-rated social responsiveness (Social Responsiveness Scale: SRS-2) in pre-pubertal school-aged children (aged 8–12 years, 61 boys, 16 girls). Seconda... | PMC10117268 | |
Results | SECONDARY | In the double-blind phase, both the oxytocin and placebo group displayed significant pre-to-post-improvements in social responsiveness and secondary questionnaires, but improvements were not specific to the intranasal oxytocin. Notably, in the single-blind phase, participants who were first allocated to intranasal plac... | PMC10117268 |
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