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Methods | PMC10250373 | |||
Trial design | The study was conducted at the First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China, from March 1, 2020, to June 30, 2021. The study was a double-blind randomized controlled trial. The participants were allocated to one of two groups, A and B. In group A, the V1 areas that were functionall... | PMC10250373 | ||
Flow chart of study recruitment and the reasons for participant withdrawal. | CORTEX | DLPFC dorsolateral prefrontal cortex, ACC anterior cingulate cortex, A1, DLPFC active-sham rTMS Group, A2, DLPFC sham-active rTMS Group, B1, ACC active-sham rTMS Group, B2, ACC sham-active rTMS Group. | PMC10250373 | |
Sample size | The optimum size of the sample was determined using the difference in means between the baseline and post-treatment Symbol Check accuracy scores, which were 0.26 in group A1, 0.08 in group A2, 0.2 in group B1, and 0.05 in group B2, according to the preliminary experiment. Furthermore, it was also calculated based on th... | PMC10250373 | ||
Participants | REMISSION | Outpatients with BD at the Department of Psychiatry, First Affiliated Hospital, Zhejiang University School of Medicine, were recruited by advertisement from March 1, 2020, to June 30, 2021. The inclusion criteria included: (i) 16–65 years of age; (ii) diagnosis of BD established by two professional psychiatrists, in ac... | PMC10250373 | |
Assessments | cognitive impairments, depression, cognitive impairment | ADVERSE EVENTS | The PDQ-D was used to screen the cognitive impairment in the participants at baseline. The HDRS-17 and YMRS were used for assessing symptom severity at different time points. The researcher evaluators were trained for assessment consistency. The occurrence of adverse events was documented during the treatment process. ... | PMC10250373 |
Neuroimaging method and analysis | PMC10250373 | |||
Imaging acquisition | Imaging was performed on a 3.0 Telsa scanner (GE SIGNA) with a standard whole-head coil at the First Affiliated Hospital, Zhejiang University School of Medicine. The participants were asked to lie on the scanner with their eyes closed. Foam cushions were positioned on either side of the head to restrict head motion, an... | PMC10250373 | ||
Data preprocessing | Preprocessing of the fMRI data was done on the DAPBI platform ( | PMC10250373 | ||
Stimulating target and rTMS parameters | Several regions of interest (ROIs) were defined in DLPFC and ACC according to previously reported coordinates from earlier studies on BD (−32, 42, 32) (−4, 50, 4) [After positioning the TMS coil over the V1 coordinates calculated from the individual MRI images, a 3D curvilinear reconstruction of the brain was generated... | PMC10250373 | ||
Statistical analysis | All data were analyzed using SPSS version 24.0 (IBM Corp., Armonk, NY, USA). The data are expressed as mean ± standard deviation (SD). To compare the general demographic data, one-way ANOVA was used for comparing means between the four groups, and nonparametric data were compared using the Chi-square test.Repeated-meas... | PMC10250373 | ||
Results | PMC10250373 | |||
Mood symptoms | There were no significant differences observed in the YMRS and HDRS-17 scores at the various time points (see Supplementary Table | PMC10250373 | ||
FC changes after rTMS treatment | PMC10250373 | |||
DLPFC ROI-based FC | In the DLPFC active-sham group, we compared the whole-brain FC network with DLPFC (−32, 42, 32) seed between W0 and W2. This showed no significant change between the baseline and after active treatment (voxel-wise < 0.001, cluster-wise FWE-corrected, | PMC10250373 | ||
ACC ROI-based FC | In ACC active-sham group, we compared the whole-brain FC network with ACC (−4, 50, 4) seed between W0 and W2. No significant within-group change was observed between the baseline and after active treatment (voxel-wise < 0.001, cluster-wise FWE-corrected, | PMC10250373 | ||
Adverse effects | nausea, overdose, earache, mood instability, pain, dizziness, sleepiness, depression, Depression, irritability, DSM-5, cephalgia | ADVERSE EFFECTS, MAY, DISEASE PROGRESSION, ADVERSE EFFECTS | Adverse effects were mostly seen during and after active rTMS treatment. Of the 12 participants who experienced adverse effects, the effects were mild and temporary. These mainly included mild cephalgia, slight dizziness, nausea, sleepiness, transient earache, and pain at the site of stimulation. Only one participant i... | PMC10250373 |
Discussion | affective disorders, overdose, cognitive impairment, depressive symptoms, mania/hypomania, depression, MDD, depressive disorders | DISEASE PROGRESSION, CORTEX | It was found that rTMS targeting of the visual cortex functionally connected to the ACC led to a significant improvement in the accuracy of Symbol Check in the THINC-it tests, reflecting working memory, executive function, and attention. However, targeting of the VC functionally anti-correlated with the DLPFC did not h... | PMC10250373 |
Conclusion | cognitive impairment | In summary, neuro-navigated rTMS targeting the V1 functionally connected to the ACC was found to improve attention, working memory, and executive function in remitted BD patients with good tolerance. It is thus suggested that the V1 is a potentially effective stimulation target for neuro-navigated rTMS for the enhancem... | PMC10250373 | |
Supplementary information | The online version contains supplementary material available at 10.1038/s41398-023-02498-z. | PMC10250373 | ||
Acknowledgements | We thank all the funding that supported the present study, including grants from the Zhejiang Provincial Key Research and Development Program (grant No. 2021C03107), grants from the National Natural Science Foundation of China (grant No. 81971271 and 82201675), Leading Talent of Scientific and Technological Innovation—... | PMC10250373 | ||
Author contributions | Trial design: SH and FW. Data acquisition: DW, CX, DL, YL, QH, ZW, JC, XZ, and HZ; Manuscript draft: DW and LT. Statistical analysis: DW, LT, and CX. Funding: SH and DW. | PMC10250373 | ||
Data availability | The datasets used in the present study are not publicly available to protect the privacy of participants but are available from the corresponding author upon reasonable request. | PMC10250373 | ||
COMPETING INTERESTS | The authors declare no competing interests. | PMC10250373 | ||
References | PMC10250373 | |||
Keywords | CHOLERA, CHOLERA | These authors contributed equally to this work.The current global initiative to end Cholera by 2030 emphasizes the use of oral cholera vaccine (OCV) combined with feasible household Water-Sanitation-Hygiene (WASH) interventions. However, little is known about how improved WASH practices and behaviors and OCV interact t... | PMC10102718 | |
Introduction | deaths, death, diarrhea | CHOLERA, CHOLERA, EPIDEMIC CHOLERA | Both endemic and epidemic cholera remain major public health problems in many low and middle-income countries (LMICs), with an estimated death toll nearing 100,000 deaths annually The success of the stockpile, together with the persistently high burden of cholera globally, helped catalyze a major global initiative led ... | PMC10102718 |
Methods | PMC10102718 | |||
The cluster-randomized trial of OCV and WASH | CHOLERA | As described in detail elsewhere (9), the CRT was conducted in a densely populated urban slum in Mirpur, Dhaka. Participants were residents of households of the slum considered at higher risk of cholera by At baseline, the study area was demarcated into 90 geographical clusters with approximately the same population si... | PMC10102718 | |
Definitions | loose stools, diarrhea, cholera [, dehydration, diarrheal, diarrhoeal | DEHYDRATION, CHOLERA | A treatment center visit for diarrhea was considered to be any visit in which a patient reported having 3 or more loose stools or 1–2 or an indeterminate number of loose stools with evidence of dehydration in the 24 h before presentation. If the date of discharge from an earlier diarrheal visit and the date of symptom ... | PMC10102718 |
Analysis | death, diarrhea | REGRESSION, CHOLERA | To evaluate the interplay between preexisting household WASH and OCV in preventing all episodes of cholera as well as severe cholera, we included only the OCV-only and control clusters of the trial since the OCV-WASH clusters had received an external WASH intervention. We approached the problem in two ways, following o... | PMC10102718 |
Registration and approvals | The trial is registered at | PMC10102718 | ||
Results | PMC10102718 | |||
Protection against all cholera episodes and severe cholera episodes in the population evaluated for overall OCV protection | diarrhoea | CHOLERA | A total of 442 confirmed cholera episodes, 171 severe, were diagnosed in the study population assessed for overall OCV protection during the 2 years of the follow-up. Two hundred fifty-nine cholera cases (106 severe) occurred among the residents in control clusters, and 183 cases (65 severe) occurred in OCV clusters (P... | PMC10102718 |
Discussion | CHOLERA | Our analysis of the population considered for measurement of overall OCV protection revealed that a program of OCV vaccination, including both vaccinees and non-vaccinees in the population targeted for vaccination, and “Better WASH” preexisting in the households were independently associated with protection against all... | PMC10102718 | |
Declaration of Competing Interest | The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. | PMC10102718 | ||
References | PMC10102718 | |||
Supplementary data | The following are the Supplementary data to this article: | PMC10102718 | ||
Supplementary data 1 | PMC10102718 | |||
Data availability | Data will be made available on request. | PMC10102718 | ||
Acknowledgement | This study was funded by Grant INV-025386 from the Supplementary data to this article can be found online at | PMC10102718 | ||
1. Introduction | SB, Sedentary behavior | SECONDARY, DISEASES | Sedentary behavior (SB) is a risk factor for chronic non-communicable diseases. This study aimed to assess the effects of an extracurricular physical exercise program and health advice on SB in adolescents. This was a non-randomized experimental study involving 19 adolescents divided into an intervention group (IG) and... | PMC9859598 |
2. Materials and Methods | PMC9859598 | |||
2.1. Study Design and Sample | This was a non-randomized experimental study. The sample was selected in a non-probabilistic way, composed of 19 adolescents from elementary and high school at a public state school in the municipality of We included adolescents who were enrolled in classes from the 7th to the 9th grade of elementary school and the 1st... | PMC9859598 | ||
2.2. Procedures | SECONDARY | The study was divided into three stages: “pre-intervention”, where the primary (SB) and secondary variables (socioeconomic status, anthropometry, body composition, cardiorespiratory fitness, blood pressure, and biochemical markers) were evaluated; “intervention”; and “post-intervention”, where the primary and secondary... | PMC9859598 | |
2.2.1. Socioeconomic Status | In order to evaluate economic conditions, we used a questionnaire from the Brazilian Association of Research Companies [ | PMC9859598 | ||
2.2.2. Anthropometry | The height of each participant was measured using a personal caprice portable stadiometer (Sanny | PMC9859598 | ||
2.2.3. Body Composition | Body composition was estimated using a tetrapolar electrical bioimpedance test with the Biodynamics | PMC9859598 | ||
2.2.4. Cardiorespiratory Fitness | Cardiorespiratory fitness was evaluated using the 12-min running/walking test proposed by Cooper [ | PMC9859598 | ||
2.2.5. Blood Pressure | BLOOD | Blood pressure was measured using an automatic blood pressure monitor (OMRON | PMC9859598 | |
2.2.6. Biochemical Markers | After a 12-h fast, we collected blood samples from the adolescents (7.5 mL) in vacuum tubes (VACUETTE | PMC9859598 | ||
2.2.7. Sedentary Behavior | SB was evaluated using the COMPAC and Tecno-Q questionnaires and accelerometry. COMPAC [In addition, we used ActiGraph | PMC9859598 | ||
2.2.8. Intervention | The intervention lasted 12 weeks and was based on the “Social Cognitive Theory” [Health advice took place as follows: a WhatsApp group was established among adolescents, their parents, or legal guardians, and the research team. Every three days, short messages were sent by a team member about the importance of reducing... | PMC9859598 | ||
2.3. Statistical Analysis | We applied the Shapiro–Wilk test of normality. After checking the distribution of the data, we applied analysis of variance (ANOVA) of repeated measures, with the Bonferroni adjustment. Moreover, we used descriptive measures (mean and standard deviation) and the significance level adopted to be α = 5%. The data from th... | PMC9859598 | ||
3. Results | Of the 19 adolescents in the present study, 10 adolescents were assigned to the intervention group (IG), and 9 to the control group (CG). The mean frequency in the program = 70.93% (SD = 16.34). Due to the low frequency in the extracurricular program on physical exercise (31.25%), one participant in the intervention gr... | PMC9859598 | ||
4. Discussion | weight gain | This study examined the effects of a physical exercise program and health advice on SB and anthropometric measures, body composition, cardiorespiratory fitness, blood pressure, and biochemical markers of adolescents. The major results showed that there was a statistically significant difference between the groups in we... | PMC9859598 | |
5. Conclusions | CARDIOVASCULAR DISEASES | We can conclude that an extracurricular physical exercise program and health advice lasting 12 weeks helped reduce the time of exposure to SB in the adolescents of this study. Moreover, we obtained important results related to the reduction of the tricipital, subscapular, and suprailiac skinfolds and in the improvement... | PMC9859598 | |
Author Contributions | Conceptualization, R.C.d.S.S.F. and A.C.R.A.; methodology, R.C.d.S.S.F. and A.C.R.A.; project administration, R.C.d.S.S.F.; writing—original draft, R.C.d.S.S.F. and A.C.R.A.; writing—review and editing, R.C.d.S.S.F., J.E.S., A.P.G. and A.C.R.A. All authors have read and agreed to the published version of the manuscript... | PMC9859598 | ||
Institutional Review Board Statement | The study was conducted in accordance with the Declaration of Helsinki and approved by the local Human Research Ethics Committee of the Federal University of Triângulo Mineiro (protocol code 2.915.141, 25 September 2018). This study was prospectively registered in the Brazilian Registry of Clinical Trials (register nº ... | PMC9859598 | ||
Informed Consent Statement | Informed consent was obtained from all subjects involved in the study. | PMC9859598 | ||
Data Availability Statement | The data presented in this study are available on request from the corresponding author. | PMC9859598 | ||
Conflicts of Interest | The authors declare no conflict of interest. | PMC9859598 | ||
References | SB | Distribution of portable technologies possession by groups in the pre and post-intervention stages.* Omitted value (n = 1).Anthropometric characteristics, body composition, cardiorespiratory fitness, blood pressure, and biochemical assessment by groups in the pre- and post-intervention stages.WC, waist circumference; S... | PMC9859598 | |
Background | Medication management has a key role in the daily tasks of home care professionals delivered to older clients in home care. The aim of this study was to examine the effect of using a robot for medication management on home care professionals´ use of working time. | PMC10693699 | ||
Methods | A pragmatic non-randomized controlled clinical trial was conducted. The participants were home care professionals who carried out home care clients’ medication management. Home care clients were allocated into intervention groups (IG) and control groups (CG) (n = 64 and 46, respectively) based on whether or not they re... | PMC10693699 | ||
Results | With robot use, the total amount of home visits decreased by 89.4% and 92.4% after 1 and 2 months of intervention use, respectively, compared to pre-intervention (p < 0.001). The total working time used for medication management considering the number of visits per day decreased from 54.2 min (95% CI 49.6–58.8) to 34.9... | PMC10693699 | ||
Conclusion | Using a robot for medication management had a notable effect on decreasing the use of working time of home care professionals. For health services, decreased use of working time for medication management means that the time saved can be assigned to services that cannot be replaced otherwise. More digital solutions shou... | PMC10693699 | ||
Trial registration | ClinicalTrials.gov Identifier: NCT05908604 retrospectively registered (18/06/2023). | PMC10693699 | ||
Keywords | PMC10693699 | |||
Background | ADVERSE EFFECTS | In older clients’ home care, medication management has a key role in the daily tasks of home care professionals [In home care, medication management is a process referring to the ordering, dispensing, reconstitution, administration, and monitoring of the effects of medications and medication education [During daily hom... | PMC10693699 | |
Methods | PMC10693699 | |||
Study design | A pragmatic non-randomized controlled clinical trial with three data collection points (at baseline, 1 month and 2 months) design [
The CONSORT diagram of the study | PMC10693699 | ||
Research environment | This study was conducted in home care in Eastern Finland. Home care there is organized with different service providers, such as municipal home care services [In this study, the collaboration organization operating in a rural region has 800 home care professionals with 1,500 older home care clients. In Finland, home ca... | PMC10693699 | ||
Study participants | The study participants were home care professionals including public health nurses, registered nurses, and practical nurses. Inclusion criteria for participation in this study were as follows: (1) voluntary participation in the study, (2) currently working in older people’s home care and (3) able to communicate in Finn... | PMC10693699 | ||
Study conduct | memory disorders | The study was conducted in 2021. Home care professionals assessed clients’ ability to use the robot for medication management. They proposed the robot for the clients who: (1) had regular tablet-form medication in use, (2) were able to use the robot independently, and (3) chose to use the robot voluntarily. Home care p... | PMC10693699 | |
Measures | SECONDARY | The primary outcome measures were the total amount of home visits (frequency) during the entire intervention period and total working time of home care professionals used for medication management (in minutes) during the entire intervention period. The secondary outcome was the home care professionals’ working time use... | PMC10693699 | |
Data collection | Data were collected from the groups using the Working Time Tracking Form at three data collection points (baseline, months 1 and 2). In addition, home care clients’ gender and age were asked as background data. The researcher (RT) delivered the paper Time Tracking Forms to the home care contact person who gave to the h... | PMC10693699 | ||
Data analysis | The SPSS v.26 software was used for data analysis by an expert statistician. The characteristics of the sample were reported using descriptive statistics including frequencies, percentages, mean values, and standard deviation.A summation variable based on the items of the medication management process was developed to ... | PMC10693699 | ||
Ethical considerations | The Ethics Committee of the University of Eastern Finland provided ethical approval (24/2017) and the participating healthcare organization granted the required research permission. The study followed ethical principles and all methods were performed in accordance with Ethical principles and the Declaration of Helsinki... | PMC10693699 | ||
Results | PMC10693699 | |||
Demographic characteristics | The clients were mostly female in both groups (IG: n = 46, 71.9%; CG: n = 35, 76.1%, p = 0.621). Their mean age was 79.3 years, SD 6.4 (IG: 79.1 y, SD 6.6; CG: 79.6 y, SD 6.0, p = 0.718). There were no statistically significant differences between the groups. There was no attrition of samples and all recruited particip... | PMC10693699 | ||
Discussion | ’ loneliness | CHRONIC DISEASES | This study aimed to examine the effect of using a robot for medication management on home care professionals’ use of working time. The study produced new knowledge about the effect of a digital solution on home care professionals’ use of working time for medication management. The total number of home visits decreased ... | PMC10693699 |
Limitations and strengths of the study | Due to pragmatic reasons, we were unable to perform random allocation in our study. While random allocation is considered the gold standard for clinical trial design, we had to balance the need for rigorous scientific methodology with the practical realities of conducting a study in a real-world clinical setting. As a ... | PMC10693699 | ||
Acknowledgements | The authors would like to sincerely thank all home care professionals who participated in this study. | PMC10693699 | ||
Author Contributions | S.K.-U., M.V., M.K. and R.T. designed the study and collected the data. S.K.-U., M.V., J.K., M.K. and R.T. analyzed the data and wrote the manuscript. | PMC10693699 | ||
Funding | This study was financially supported by the Finnish Work Environment Fund. | PMC10693699 | ||
Data Availability | The datasets used and analyzed during the current study are available from the corresponding author on reasonable request. | PMC10693699 | ||
Declarations | PMC10693699 | |||
Ethics approval and consent to participate | The study followed the ethical principles, and all methods were performed in accordance with Ethical principles and Declaration of Helsinki [ | PMC10693699 | ||
Consent for publication | Not applicable. | PMC10693699 | ||
Competing interests | The authors declare no competing interests. | PMC10693699 | ||
List of abbreviations | Control groupConfidence IntervalConsolidated Standards of Reporting TrialsThe European Credit Transfer and Accumulation Systemthe European Qualifications FrameworkFrequencyIntervention groupStandard deviationStatistical Package for the Social Sciences | PMC10693699 | ||
References | PMC10693699 | |||
1. Introduction | obese, anxiety, psychoemotional sequelae, infection, overweight, post-traumatic stress disorder, PTSD, insomnia, depression | INFECTION, OBESE | The present study aimed to investigate the effects of a multi-professional intervention model on the mental health of middle-aged, overweight survivors of COVID-19. A clinical trial study with parallel groups and repeated measures was conducted. For eight weeks, multi-professional interventions were conducted (psychoed... | PMC10002443 |
2. Materials and Methods | PMC10002443 | |||
2.1. Study Design | This study presents an experimental design (controlled trial) of repeated measures and four parallel groups: three intervention groups (mild, moderate, and severe), and a control group (without a positive diagnosis of COVID-19). This study followed the guidelines of the Consolidated Standards of Reporting Trials (CONSO... | PMC10002443 | ||
2.2. Participants | overweight or obese | Participants were recruited via the Municipal Secretary of Health of Maringa and the Municipal Hospital of Maringa. Thus, 141 participants of both sexes were eligible for the study. It was accepted by people with the following characteristics: (i) male and female aged between 19 and 65 years old; (ii) present a positiv... | PMC10002443 | |
2.3. Procedures | Participants went to the university laboratory for medical clearance, with the following measurements being taken: measurement of body weight and height (subsequent calculation of BMI [ | PMC10002443 | ||
2.3.1. Mental Health Continuum–Short Form (MHC-SF) | To assess the well-being of the participants, the MHC-SF questionnaire was used, consisting of a Likert scale (1 to 6) with questions that measure the following components of well-being: Emotional well-being (EWB), social well-being (SWB), and psychological well-being (PWB), in the experiences the last two weeks [ | PMC10002443 | ||
2.3.2. Impact of Event Scale-Revised (IES-R) | post-traumatic symptoms | EVENT | The Event Impact Scale (IES-R) is a validated questionnaire for tracking post-traumatic symptoms. [ | PMC10002443 |
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