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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Results | PMC10796506 | |||
Study participants characteristics | Between July 27Flow chart of study profile.The demographic characteristics of enrolled participants were similar between different lots or workshops either in SS or PPS, with no statistically significant difference in age, gender, ethnicity, height, and weight (Demographic characteristics of study participants (SS and ... | PMC10796506 | ||
Immunogenicity | -11 | The immunogenicity results in PPS are shown in Immunogenicity of neutralizing antibody before and 28 days after two-dose vaccination (PPS).Seropositive indicates the GMT level ≥1:8. Seroconversion indicates the GMT changes from <1:8 to ≥1:8 after vaccination, or at least 4-fold increase after vaccination if baseline GM... | PMC10796506 | |
Lot-to-lot consistency | For lot-to-lot consistency analyses, as shown in | PMC10796506 | ||
Safety | ADVERSE REACTIONS | A total of 171 out of 2,513 participants (6.80%) in SS reported adverse reactions after two-dose vaccination during Day 0-56, and the most common one was solicited adverse reactions (6.76%) (Incidence of adverse reactions (AR) after two-dose vaccination according to the grade of serivity (SS, 0-56 days).Incidence of ad... | PMC10796506 | |
Discussion | confusion, infections | ADVERSE REACTIONS, INFECTIONS | In this phase IV, randomized, double-blind clinical trial in healthy children and adolescents aged 3-17 years, we found equivalent immune responses after CoronaVac vaccination among all comparative groups of different lots or workshops, where the 95%CIs of GMT ratios were all within the equivalence criterion of [0.67, ... | PMC10796506 |
Data availability statement | The original contributions presented in the study are included in the article/ | PMC10796506 | ||
Ethics statement | DISEASE | The studies involving humans were approved by Shaanxi Provincial Center for Disease Control and Prevention, China. The studies were conducted in accordance with the local legislation and institutional requirements. Written informed consent for participation in this study was provided by the participants’ legal guardian... | PMC10796506 | |
Author contributions | WH: Investigation, Methodology, Supervision, Validation, Writing – review & editing. XLu: Investigation, Methodology, Supervision, Validation, Writing – review & editing. XL: Investigation, Methodology, Software, Supervision, Validation, Writing – review & editing. DZ: Investigation, Supervision, Writing – review & edi... | PMC10796506 | ||
Acknowledgments | DISEASE | The authors would like to express thanks to the staff of Shaanxi Provincial Centre for Disease Control and Prevention and to the local Yanliang District Center for Disease Control and Prevention for their efforts in leading the field work for this trial. We would like to express our sincere gratitude to all participant... | PMC10796506 | |
Conflict of interest | Authors XL, SL, XGL and YG are employed by Sinovac Biotech Co., Ltd. Authors JS, YZ and GC are employed by Sinovac Life Sciences Co., Ltd.The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.... | PMC10796506 | ||
Publisher’s note | All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or ... | PMC10796506 | ||
Supplementary material | The Supplementary Material for this article can be found online at: Click here for additional data file. | PMC10796506 | ||
References | PMC10796506 | |||
Abstract | PMC10651970 | |||
Aims | CSE, Status Epilepticus‐Diazepam Resistance‐Image, cerebral hypoxia | CEREBRAL HYPOXIA | The prediction of outcomes in convulsive status epilepticus (CSE) remains a constant challenge. The Encephalitis‐Nonconvulsive Status Epilepticus‐Diazepam Resistance‐Image Abnormalities‐Tracheal Intubation (END‐IT) score was a useful tool for predicting the functional outcomes of CSE patients, excluding cerebral hypoxi... | PMC10651970 |
Methods | REGRESSION | The prediction model was designed from a cohort of CSE patients from Xijing Hospital (China), between 2008 and 2020. The enrolled subjects were randomly divided into training cohort and validation cohort as a ratio of 2:1. The logistic regression analysis was performed to identify the predictors and construct the nomog... | PMC10651970 | |
Results | SE | The training cohort included 131 patients and validation cohort included 66 patients. Variables included in the nomogram were age, etiology of CSE, non‐convulsive SE, mechanical ventilation, abnormal albumin level at CSE onset. The concordance index of the nomogram in the training and validation cohorts was 0.853 (95% ... | PMC10651970 | |
Conclusions | convulsive status epilepticus | CONVULSIVE STATUS EPILEPTICUS | A nomogram for predicting the individualized risks of poor functional outcomes in CSE was constructed and validated, which has been an important modification of END‐IT score.A nomogram prediction of functional outcome in patients with convulsive status epilepticus.
The first two authors contributed equally to this work... | PMC10651970 |
BACKGROUND | CSE, Status Epilepticus‐Diazepam Resistance‐Image | CONVULSIVE STATUS EPILEPTICUS | Convulsive status epilepticus (CSE) is a common neurological emergency and is characterized by significant mortality.The Encephalitis‐Nonconvulsive Status Epilepticus‐Diazepam Resistance‐Image Abnormalities‐Tracheal Intubation (END‐IT) score, which was proposed in our previous work, was the only clinical tool used to p... | PMC10651970 |
MATERIALS AND METHODS | PMC10651970 | |||
Study setting, patients, and treatments | Epilepsy | EPILEPSY | This study was carried out based on a prospective registry of consecutive patients with CSE in the neurological intensive care unit (neuro‐ICU), Department of Neurology, Xijing Hospital, from March 2008 to June 2020. Informed consent was obtained from the patients or their guardians. The procedures of this study were a... | PMC10651970 |
Data collection | Status Epilepticus’, Epilepsy | MAY, STATUS EPILEPTICUS, EPILEPSY, COMPLICATIONS | The demographic data and clinical parameters were collected from the electronic medical records system, including age, sex, CSE etiologies, neuroimaging findings, anti‐SE treatments, complications, and albumin (ALB) at CSE onset. The underlying etiology of CSE was categorized according to the ‘List of Etiologies That M... | PMC10651970 |
Statistical analysis | Based on our clinical experience and from a search of published studies,The subjects were randomly divided into training cohort and validation cohort as a ratio of 2:1 in order to construct and validate the nomogram. Univariate logistic analysis was carried out to identify the risk factors for the poor prognosis of CSE... | PMC10651970 | ||
RESULTS | A total of 197 patients with CSE were enrolled in the final analysis of this prognostic study. Among them, 131 patients were included in the training group and 66 patients were included in the validation group (Figure | PMC10651970 | ||
Characteristics and outcomes of patients | cerebralvascular disease, nonconvulsive status encephalitis, autoimmune encephalitis, SD, NCSE | CVD, STATUS EPILEPTICUS, AUTOIMMUNE ENCEPHALITIS, REFRACTORY STATUS EPILEPTICUS | The characteristics of patients with CSE were shown in Table Baseline characteristics of patients in the training and validation cohorts.Abbreviations: AE, autoimmune encephalitis; ALB, albumin; CNS, central nervous system; CVD, cerebralvascular disease; NCSE, nonconvulsive status encephalitis; RSE, refractory status e... | PMC10651970 |
Logistic analysis and the development of the nomogram | cerebralvascular disease, nonconvulsive status encephalitis, autoimmune encephalitis, convulsive status epilepticus, cerebral vascular disease, SE, NCSE | NONCONVULSIVE STATUS EPILEPTICUS, AUTOIMMUNE ENCEPHALITIS, CONVULSIVE STATUS EPILEPTICUS, CVD, REGRESSION | As shown in Table Univariate and multivariate logistic regression analysis of factors associated with poor outcome in patients with SE in training cohort.
Abbreviations: AE, autoimmune encephalitis; ALB, albumin; CNS, central nervous system; CVD, cerebralvascular disease; NCSE, nonconvulsive status encephalitis.The nom... | PMC10651970 |
Assessment of the nomogram | The C‐index of the nomogram in the training and validation cohorts was 0.853 (95% CI, 0.787–0.920) and 0.806 (95% CI, 0.683–0.923), respectively, which revealed good predictive discrimination. The ROC curves were presented in Figure Receiver operating characteristic curves for estimating the risk of poor functional out... | PMC10651970 | ||
Website of the nomogram | The nomogram was converted to a web‐based user‐friendly calculator ( | PMC10651970 | ||
DISCUSSION | SE, inflammation, epileptic | NONCONVULSIVE STATUS EPILEPTICUS, DISEASE COURSE, INFLAMMATION, RECRUITMENT, EPILEPTIC | On the basis of our previous study on the END‐IT score,In this prognostic study, the consecutive recruitment lasted for 12 years, which made it a larger database to explore the CSE predictors, compared with our previous study. The age distribution of patients in this prognostic study was closer to that in other study s... | PMC10651970 |
CONCLUSIONS | In this prognostic study, as a modification of END‐IT, a nomogram model was developed and converted to a clinically useful tool to estimate the individualized risk for poor functional outcomes after discharge in CSE patients. Further multicenter external validation will be performed in the future. | PMC10651970 | ||
AUTHOR CONTRIBUTIONS | Xuan Wang, Fang Yang, and Wen Jiang designed the study. Xuan Wang, Yuan‐Yuan Wang, Qiong Gao, Yao‐Yao Zhang, Chang‐Geng Song, and Jing‐Ya Wei, collected the data. Xuan Wang, Yuan‐Yuan Wang, Jian Wan and Wen Jiang analyzed the data. Chang‐Geng Song and Xiao‐Gang Kang revised the statistical analyses. Xuan Wang wrote the... | PMC10651970 | ||
FUNDING INFORMATION | This study was supported by National Natural Science Foundation of China (No. 81771406). | PMC10651970 | ||
CONFLICT OF INTEREST STATEMENT | The authors declare that they have no conflict of interest. | PMC10651970 | ||
PATIENT CONSENT STATEMENT | Informed consent was obtained from the patients or their guardians. | PMC10651970 | ||
Supporting information |
Figure S1:
Click here for additional data file. | PMC10651970 | ||
ACKNOWLEDGMENTS | We thank all the staffs and patients who contributed to the study. | PMC10651970 | ||
DATA AVAILABILITY STATEMENT | The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request. | PMC10651970 | ||
REFERENCES | PMC10651970 | |||
Background | INFLUENZA | The UK is rolling out a national childhood influenza immunisation programme for children, delivered through primary care and schools. Behaviourally-informed letters and reminders have been successful at increasing uptake of other public health interventions. Therefore, we investigated the effects of a behaviourally-inf... | PMC9854224 | |
Methods and results | FLU | Study 1 was a cluster-randomised parallel trial of 21,786 two- and three-year olds in 250 GP practices, conducted during flu season (September to January inclusive) 2016/7. The intervention was a centrally-sent behaviourally-informed invitation letter, control was usual care. The proportion of two- and three-year olds ... | PMC9854224 | |
Conclusion | INFLUENZA | Sending a behaviourally informed invitation letter can increase uptake of childhood influenza vaccines at the GP surgery compared to usual practice. A reminder SMS or email can increase uptake of the influenza vaccine in schools, but the effect size was minimal. | PMC9854224 | |
Trial registration | Study 1: Trial registration: Study 2: Trial registration: | PMC9854224 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s12889-022-14439-4. | PMC9854224 | ||
Keywords | PMC9854224 | |||
Introduction | FLU, FLU, INFLUENZA | In 2012, the UK Joint Committee on Vaccination and Immunisation recommended a national childhood influenza immunisation programme be rolled out to 2- to 16-year olds, using a live attenuated influenza vaccine [In 2015/16 nationally, uptake in school years 1 and 2 was 53.6% [National template letters are published on th... | PMC9854224 | |
Study 1: cluster-randomized controlled parallel trial of the effect of a behaviourally-informed letter on childhood flu vaccination uptake in general practice | PMC9854224 | |||
Aim | FLU | To test whether a behaviourally-informed invitation letter will increase uptake of childhood flu vaccine in general practice (compared to standard practice). | PMC9854224 | |
Methods | The trial was registered at | PMC9854224 | ||
Interventions | FLU | Parents of eligible children at practices in the intervention arm were sent the behaviourally-informed invitation letter by post with minimal local adjustments (e.g. reflecting the sender and flu clinic booking arrangements). A number of behavioural techniques were used, several of which were coded according to the Beh... | PMC9854224 | |
Outcomes | FLU | The pre-registered primary outcome for this study was immunisation uptake by eligible children (i.e. those aged 2 and 3 years on 31st August 2016) at primary care. Anonymised individual-level data was extracted from the CHIS on 28th March 2017. This included flu vaccine history in 2016/17 and 2015/16 flu seasons, age, ... | PMC9854224 | |
Sample size | The sample was fixed as all practices in the participating areas. Power calculations indicated that, with 120 general practices, we would have 90% power to detect a 5% absolute increase in uptake, from 34 to 39% in children aged 2–3 years. | PMC9854224 | ||
Randomisation | FLU | A stratified randomisation strategy was used. In total 14 strata were created (all of the possible combinations of the seven CCGs and whether or not they were SystmOne users: SystmOne is a software system used in some practices; the databases of practices with SystmOne were automatically updated with a copy of the lett... | PMC9854224 | |
Statistical methods | REGRESSION | Classical linear logistic regression models were run, with a binary outcome variable equal to 1 if an eligible child was vaccinated, and 0 otherwise. The models included previous vaccination and demographic variables (age and sex) as fixed effects, in addition to the intervention. It also included GP practice as a rand... | PMC9854224 | |
Study 2: randomized controlled trial of the effect of a behaviourally-informed letter and a reminder on childhood flu vaccination uptake schools (factorial design) | PMC9854224 | |||
Aim | FLU | The aim of this study was to determine whether applying behaviourally-informed interventions to the invitation process will improve uptake of childhood flu immunisation in school-based programmes.Our specific hypotheses were:Behaviourally-informed changes to the invitation letter will increase uptake of childhood flu v... | PMC9854224 | |
Methods | The trial was registered at | PMC9854224 | ||
Interventions | PMC9854224 | |||
Intervention 1: Behaviourally-informed letter | FLU | A behaviourally-informed letter was sent via post by providers of childhood flu school vaccination to parents at those schools randomised to Intervention 1, with minimal local adjustments. The behavioural techniques used were the same as the ones used in the general practice trial except there was no personalisation (t... | PMC9854224 | |
Outcomes | SECONDARY, INFLUENZA | The pre-registered primary outcome for this study was the proportion of eligible children in the school years for each of years 1–3 (i.e. those aged 5 to 7 years on 31st August 2016) who received influenza immunisation as part of the national childhood immunisation programme. We focused only on children in years 1–3 du... | PMC9854224 | |
Data collection | FLU | Immunisation programme data were collected by providers of childhood flu school vaccination on a PHE template spreadsheet. Providers submitted school-level data throughout the 2016/17 flu season and the data used was submitted as part of usual practice. No individual-level data or personal identifiable information were... | PMC9854224 | |
Sample size | The sample was fixed by the number of schools in participating areas. Power calculations indicated that with the original number of schools available (~ 1700 schools and six providers) and assuming no variation between local authorities and an average of 100 children in years 1–3 in each school, we would have 90% power... | PMC9854224 | ||
Randomisation | A stratified method of randomisation was used with each local authority representing a separate strata. Randomisation was at school level. The intervention was a 2 × 2 factorial design, with schools within each strata randomly assigned to one of four interventions arms, one for each combination of interventions. For ev... | PMC9854224 | ||
Statistical methods | REGRESSION | We used multi-level Generalised Linear Model (GLM) regression models to predict the proportion of eligible children in the school year receiving a vaccine, with school year and school as random effects, and demographic variables as fixed effects. As random effects are included in the model there is no need to cluster s... | PMC9854224 | |
Discussion | FLU, INFLUENZA | We explored the effects of a behaviourally-informed letter on uptake of childhood influenza vaccination in general practices, and of a letter and a reminder (SMS/email) on uptake at schools. The behaviourally-informed, centrally sent invitation letter increased the proportion of children who received a vaccination at t... | PMC9854224 | |
Limitations | Process evaluations for each study, which would have enhanced our contextual understanding of the study outcomes, were not conducted. Future research investigating the effectiveness of behaviourally-informed letters should therefore undertake process evaluation to better understand how and why the interventions may be ... | PMC9854224 | ||
Conclusion | INFLUENZA | Sending a behaviourally-informed invitation letter can increase uptake of childhood influenza vaccines at the GP surgery compared to usual practice. A reminder SMS or email, which follows on from an invitation letter, can lead to a small increase in uptake of the influenza vaccine in schools. | PMC9854224 | |
Authors’ contributions | R H-J, AB, SJ, PM, KT and TC conceived of the studies, R H-J implemented the studies and wrote the first draft of the paper, NG managed the data analysis and wrote up Study 1 and revised the manuscript, KT reviewed drafts of the letters and did data cleaning and preliminary statistical analysis, AS performed the random... | PMC9854224 | ||
Funding | The study was funded by Public Health England. | PMC9854224 | ||
Availability of data and materials | The datasets generated and analysed during the current study are available from the corresponding author on reasonable request. | PMC9854224 | ||
Declarations | PMC9854224 | |||
Ethics approval and consent to participate | FLU | Study 1: Ethical approval: Health Research Authority, REC reference16/WS/0181.Study 2: Ethical approval: PHE Research Ethics and Governance Group, Reference number R&D 281.All methods were carried out in accordance with relevant guidelines and regulations. CONSORT reporting guidelines were followed (see the Supplementa... | PMC9854224 | |
Consent for publication | Not Applicable. | PMC9854224 | ||
Competing interests | There are no conflicts of interest to report. | PMC9854224 | ||
References | PMC9854224 | |||
Abstract | PMC10715839 | |||
Background | cancers, ’ behavioral meditation | CANCERS | Cigarette smoking is the leading cause of preventable cancers. A majority of the 34 million people who currently smoke report wanting to quit. Mindfulness training apps offer a guided telehealth intervention to foster individuals’ behavioral meditation practice. We present the main outcomes of a parallel-group randomiz... | PMC10715839 |
Methods | We enrolled adult residents from across California who smoked daily and were willing to make a quit attempt (N = 213). Participants completed daily sessions in 10-minute segments for 14 consecutive days. Participants then started a quit attempt and reported daily smoking for 28 days following the quit date using the ti... | PMC10715839 | ||
Results | Seven-day point-prevalence abstinence for each week during the 4-week quit period ranged from 21.8% to 27.7% for app-based mindfulness training and 17.9% to 19.6% for controls. The intention-to-treat sample revealed that app-based mindfulness training outperformed controls on the proportion of abstinence days during th... | PMC10715839 | ||
Conclusion | A mindfulness training app prescribed for 2 weeks leading up to a quit date showed an advantage over controls for total abstinence days and fewer cigarettes smoked in a diverse sample consisting of urban and rural residents. These findings yield implications for the use of apps to reduce exposure to the carcinogenic pr... | PMC10715839 | ||
cancers, cognitive behavior, itchiness, pain | CANCERS, LUNG, DISEASES | Cigarette smoking is connected to a multitude of diseases and is the foremost contributor to preventable cancers. It exacts a toll of nearly 500 000 lives each year and imposes an annual health-care expenditure in excess of $300 billion (Mindfulness training encompasses intervention packages that provide individuals wi... | PMC10715839 | |
Study objective | SECONDARY | Our study objective was to test the effect of a commercially established mobile app–based mindfulness training telehealth intervention focused on guided mindfulness meditation but not specific to smoking cessation relative to a time-matched mobile attention control on smoking among people who currently smoke and are wi... | PMC10715839 | |
Methods | PMC10715839 | |||
Study design | BLIND | This parallel-group, outcomes assessor–blind, randomized controlled trial involved participants recruited from both urban and rural regions across all 58 counties of California. The trial aimed to assess the efficacy of daily, app-based behavior interventions in helping people who smoke daily quit or reduce smoking. Th... | PMC10715839 | |
Participants and procedures | verbal initiation of the voluntary, Cancer | RECRUITMENT, CANCER | Individual adults were recruited online through Craigslist advertisements, and participants completed all study protocols and interviews remotely from their preferred location using a secure online videoconferencing platform. This method extended our reach of recruitment and addressed the in-person limitations caused b... | PMC10715839 |
Eligibility requirements | AIDS | To be eligible for the study, individuals had to be 18 years of age or older, have smoked daily (at least 5 cigarettes per day) for the past 2 years, be willing to make a self-directed and voluntary cigarette smoking quit attempt during the study period, and be a current resident of California (verified by a state-issu... | PMC10715839 | |
Randomization and blinding | Author M.K. used a computer-generated random selection of block permutations, with a range of 4 to 20 assignments per block, including strata to have sex equivalent, which allowed random assignment of 1 study intervention to each participant. This block method reduced potential selection bias, as with simple randomizat... | PMC10715839 | ||
Interventions | PMC10715839 | |||
App-based mindfulness training | PMC10715839 | |||
Attention control (app-control) | PMC10715839 | |||
Measures | PMC10715839 | |||
Cigarette smoking | The primary trial outcome was cigarette smoking abstinence, which was the target behavior captured in the timeline follow-back calendar, collected through Research Electronic Data Capture, and completed on day 28 following the quit date [which differs by 2 days due to a shortened measure to capture increments of 1 week... | PMC10715839 | ||
Sample characteristics | We collected descriptive information about each participant on the study baseline survey to understand the characteristics of the sample obtained and to verify that randomization assigned characteristics to study groups in a similar manner. Baseline measures included demographic information, smoking history, the Fagers... | PMC10715839 | ||
Statistical analysis | PMC10715839 | |||
Sample size calculation and data analysis | SECONDARY, BLIND | The primary trial outcome in the intent-to-treat (ITT) sample analysis was the between-group proportional difference in smoking abstinence (7-day point-prevalence abstinence and proportion of days abstinent). To guide our original decision on the size of the sample for the trial, we conducted an a priori power analysis... | PMC10715839 | |
Results | PMC10715839 | |||
Participant flow-through trial and sample characteristics |
CONSORT diagram showing the flow of participants in the trial comparing app-based mindfulness training with controls. A total of 549 individuals completed an online study screener form and an e-signature consent form to be contacted by the study staff. Of those assessed by initial survey, 276 people did not finish the... | PMC10715839 | ||
Study group effect on total abstinence days and complete 7-day point-prevalence abstinence |
Estimated group effect on total abstinence days and 7-day point-prevalence abstinence for week 4 of the 28-day quit periodModel adjusts for sex as the stratum variable used for randomization and for cigarette dependence. CI = confidence interval; ITT = intent to treat; OR = odds ratio; PPA = complete 7-day point-preva... | PMC10715839 | ||
Study group effect on the number of cigarettes smoked per day |
Estimated group effect on mean number of cigarettes smoked per day during the 28-day quit periodFor the ITT single-dose sample, a 50% reduction in cigarettes smoked was observed in 67.1% of the Mindfulness Training app group, as opposed to 57.3% in the control group. CI = confidence interval; ITT = intent to treat.Mod... | PMC10715839 | ||
Group effect on time to first cigarette smoked after a quit attempt | In a supplementary descriptive analysis to determine whether smoking abstinence contained a time element that was a function of study group, we produced a Kaplan-Meier curve to assess days from quit date to first cigarette smoked. The overall median abstinence days for the total sample was 24. The median abstinence day... | PMC10715839 |
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