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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Randomisation and group allocation | Centres were randomly allocated to either the intervention (menu box delivery) or comparison (menu planning) group after baseline data collection was complete. Centres were stratified into two equal groups matched for centre size (based on child attendance numbers) and centre socio-economic status using Socio-Economic ... | PMC10755420 | ||
The menu box delivery intervention | Centres allocated to the intervention received a weekly menu box delivery service that included all ingredients and recipes required for morning snack, lunch and afternoon snack for the week, tailored to the number of children attending the centre. Intervention centres were provided with menu packs that included inform... | PMC10755420 | ||
Data collection and entry | Data were collected on two occasions: (i) at baseline, pre-intervention between July and October 2020 and (ii) at follow-up, in weeks 11 and 12 of the intervention implementation period (between November and December 2020). The primary outcomes were child food provision and child dietary intake. Secondary outcomes were... | PMC10755420 | ||
Centre, staff and child socio-demographic characteristics | At baseline, operational data for the centres were collected, including average attendance and nutrition policies. Baseline cook characteristics including age, experience, hours worked/week and relevant qualifications were collected. Age and gender were collected for all children involved in dietary data collection. | PMC10755420 | ||
Primary outcomes: food provision and child dietary intake | The primary outcomes assessed were child food provision (what children were served at mealtimes) and child dietary intake assessed against the Victorian Menu Planning Guidelines for five food groups (vegetables and legumes; fruit; cereals and breads; dairy and alternatives and meat and alternatives) and discretionary f... | PMC10755420 | ||
Secondary outcomes: menu compliance and intervention acceptability, fidelity and cost | Menu compliance was measured by assessing two consecutive weeks of centre menus against the Victorian Menu Planning GuidelinesCook and director feedback was obtained through structured interviewer-administered questionnaires to evaluate cooks’ acceptability of intervention components and to collect feedback on training... | PMC10755420 | ||
Statistical analysis | All statistical analyses were performed using SPSS 24.0 statistical software. Data were checked and cleaned prior to analyses and visually assessed for normality using frequency histograms, which were then compared with the results of Kolmogorov–Smirnov and Shapiro–Wilk tests of normality. As child food provision and i... | PMC10755420 | ||
Results | PMC10755420 | |||
Sample characteristics | Eight of 11 LDC centres approached to participate in the study agreed to participate (four intervention, four comparison: Fig.
CONSORT flow diagram of centres and children through the study.
Demographic characteristics of comparison and intervention; centres, centre cooks and children included in follow up data analys... | PMC10755420 | ||
Child food provision and dietary intake | At follow-up, median (IQR) child daily vegetable provision within intervention centres was 0·9 (0·7–1·2) serves/d, compared with 0·8 (0·5–1·3) serves/d in the comparison centres (Table
Daily food group provision and intake to 2–5-year-old children at follow-up as assessed by plate waste in serves (IQR, inter-quartile ... | PMC10755420 | ||
Menu compliance | At follow-up, half of the intervention centres (
Number of centres meeting or exceeding menu planning guidelines at baseline and follow-up (Targets using Victorian Menu planning guidelines for long day care | PMC10755420 | ||
Staff acceptability | Overall, all intervention centre directors (four out of four) agreed that they would continue to use the menu box delivery service if able to, whereas only half of the cooks (two out of four) agreed (Table | PMC10755420 | ||
Fidelity | All intervention centre cooks (4/4) reported using the menu box delivery service and recipes over the 8-week intervention period. Intervention centre cooks reported modifying recipes to speed up preparation times and serving meals to children in ways they believed to be more preferable to children. For example, pasta a... | PMC10755420 | ||
Cost | In total, 59/64 invoices were collected from centres over the 8-week intervention period. Five invoices (8 %) were missing across two comparison centres. Missing invoices were assumed to be non-biased and missing completely at random as missingness resulted from cooks misplacing invoices. Mean intervention centre menu ... | PMC10755420 | ||
Discussion | This study evaluated the impact of a menu box delivery service to support menu compliance and improve food provision and children’s dietary intakes in the ECEC setting. While intervention centre menus showed greater compliance with food group guidelines at follow-up, the impact observed was similar between the interven... | PMC10755420 | ||
Acknowledgements | MANSON | The authors acknowledge the contributions of Nutrition Australia (Victoria) for providing the menu box delivery service menus and Paul Capobianco and Luca Caristo for their input into the menu box delivery service design. The authors would also like to acknowledge the contributions of Robyn Dustchke and Alexandra Manso... | PMC10755420 | |
Financial support | SK is supported by the Flinders University Research Scholarship and Healthy Development Adelaide PhD Excellence Award. This study was conducted as part of the VegKIT project ( | PMC10755420 | ||
Conflicts of interest | There are no conflicts of interest. | PMC10755420 | ||
Authorship | R.K.G. is a principal investigator of this study. D.N.C. and R.K.G. conceived the study and obtained funding. R.K.G., D.Z. and S.K. led the design of the study. V.B. developed the cost analysis and design. J.C.A. contributed to the design and preparation of the intervention components. S.K., D.Z. and R.K.G. led impleme... | PMC10755420 | ||
Ethics of human subject participation | This study was conducted according to the guidelines laid down in the Declaration of Helsinki, and all procedures involving research study participants were approved by the Flinders University Human Research Ethics Committee (HREC project number 8566). Written informed consent was obtained from all subjects. | PMC10755420 | ||
References | PMC10755420 | |||
Background | Intimate partner violence and abuse (IPVA) is a pervasive societal issue that impacts many women globally. Web-based help options are becoming increasingly available and have the ability to eliminate certain barriers in help seeking for IPVA, especially in improving accessibility. | PMC10337397 | ||
Objective | This study focused on the quantitative evaluation of the SAFE eHealth intervention for women IPVA survivors. | PMC10337397 | ||
Methods | depression, anxiety | A total of 198 women who experienced IPVA participated in a randomized controlled trial and quantitative process evaluation. Participants were largely recruited on the internet and signed up through self-referral. They were allocated (blinded for the participants) to (1) the intervention group (N=99) with access to a c... | PMC10337397 | |
Results | depression, anxiety | We found no significant difference over time between groups for self-efficacy, depression, anxiety, fear of partner, awareness, and perceived support. However, both study arms showed significantly decreased scores for anxiety and fear of partner. Most participants in both groups were satisfied, but the intervention gro... | PMC10337397 | |
Conclusions | Our findings did not show a significant difference in outcomes between the extensive SAFE intervention and the limited-intervention control group. It is, however, difficult to quantify the real contribution of the interactive components, as the control group also had access to a limited version of the intervention for ... | PMC10337397 | ||
Trial Registration | Netherlands Trial Register NL7108 NTR7313; https://trialsearch.who.int/Trial2.aspx?TrialID=NTR7313 | PMC10337397 | ||
Introduction | Intimate partner violence and abuse (IPVA) is a type of domestic violence and abuse (DVA) that affects many women. It consists of various types of violence between current or former partners: physical, sexual, psychological, and economic [While Van Rosmalen-Nooijens and colleagues [All the aforementioned outcomes for e... | PMC10337397 | ||
Methods | PMC10337397 | |||
Ethics Approval | Nijmegen | All research components, including 2 amendments, covering a clarification of the inclusion criteria for fear of partner scores and the introduction of the OFS, were approved by the Medical Ethics Committee from Arnhem and Nijmegen (NL68268.091.18; dossier 2018-5009) and the RCT was registered at the Netherlands Trial R... | PMC10337397 | |
Framework of RCT | The RCT is a parallel-group design with 2 arms and stratified (block size of 4) automated randomization in 2 age groups (18-30 years and 31-50 years). The eHealth developer and a statistician generated the random allocation sequence. The randomization was single-blinded for the participants. The researchers could track... | PMC10337397 | ||
SAFE modules and functionalities during randomized controlled trial (boldfaced: available to the control and intervention group; not boldfaced: only available to the intervention group) and open feasibility study (in italics: not available or applicable during OFS). OFS: open feasibility study. | stress reduction |
Information on physical health (issues).Information on mental health (issues).Information on coping strategies and stress reduction.
Information on social support.Information on disclosing IPVA.Information on contact options.
Exercises for creating awareness and to stimulate reflecting on their situati... | PMC10337397 | |
Framework of PE and OFS | PE consists of surveys at several time points. We also conducted a qualitative PE (interviews), described in a separate article (van Gelder NE, et al, unpublished data, 2023). The OFS tests the intervention in a real-world setting while gathering feasibility data that are combined with additional data from the RCT on s... | PMC10337397 | ||
Results | PMC10337397 | |||
Feasibility: Level of Need and Use | This intervention scored high on demand, implementation, and practicality. We saw an increase in registrations during the OFS (N=170; RCT and OFS means per month are 13.2 and 56.7, respectively; Furthermore, the costs of this intervention have been higher in the development phase than in the implementation phase, and i... | PMC10337397 | ||
Discussion | PMC10337397 | |||
Principal Findings | SECONDARY | This study quantitatively evaluated the effectiveness and feasibility of the first Dutch self-support eHealth intervention (SAFE) for women exposed to IPVA. This study did not provide statistically significant evidence that the extensive SAFE intervention was more effective than the minimal intervention in increasing s... | PMC10337397 | |
Comparison to Previous Work | depression, anxiety | In line with the findings of Hegarty and colleagues [Both groups showed significant improvements for anxiety and fear of partner but no significant effect for depression. Since anxiety was not included as an outcome in other studies, a comparison was not possible. Other studies have not found a significant impact on fe... | PMC10337397 | |
Strengths and Limitations | First, a strength of this study is the extensive study design, using 3 evaluation methods to assess the intervention’s effectiveness on multiple levels. Second, the IPVA experiences within the study sample represent all 4 types of IPVA (psychological, physical, economic, and sexual) that survivors can endure. Third, fo... | PMC10337397 | ||
Implications | SECONDARY, RECRUITMENT | With regard to improving self-efficacy and mental health in women IPVA survivors, we could conclude that while some studies found significant improvements for both groups [Overall, the feasibility of this intervention is high, with survivors expressing a demand for web-based options and professionals expressing interes... | PMC10337397 | |
Abbreviations | analysis of covarianceAbused Women’s Active Response EmergencyChecklist for Reporting Results of Internet E-surveysConsolidated Standards of Reporting Trials of Electronic and Mobile HEalth Applications and onLine TeleHealthdomestic violence and abuseGeneral Data Protection RegulationGeneral Self-Efficacy Scaleintimate... | PMC10337397 | ||
Data Availability | The data sets generated and analyzed during this study are available on reasonable request from the DANS repository [ | PMC10337397 | ||
1. Introduction | LEMS, cognitive deficits | FEMINIZATION | This study aims to investigate the effects of dual-task physical–cognitive the training on body balance (BB), gait performance (GP), lower limb muscle strength (LEMS), and cognitive performance (CP) in a group of cognitively normal older adult women (Aging brings a series of biological, psychological, and functional ch... | PMC10139030 |
2. Materials and Methods | This is a randomized experimental study with a double-blind design. Those responsible for the evaluations in all phases of the study were blinded. After assessments of all participants at baseline (T1), study members were randomly assigned (1:1) into a dual-task (DT) or control (CG) group. Single-sequence randomization... | PMC10139030 | ||
2.1. Sample Size | Sample size and power calculations were performed with G* Power3, based on a previous study. Thus, a priori repeated measure ANOVA suggested that a total sample size of 44 was needed to reach 0.80% power to detect the interaction effect size of 0.20 at the 0.05 level of significance. Considering possible sample loss, 5... | PMC10139030 | ||
2.2. Participants and Eligibility | FEMINIZATION | Participants were recruited through dissemination in WhatsApp, Facebook, radio, and older adult groups in the city. Initially, the intention was to include individuals of both sexes, however, 98% of those interested were women. Thus, the investigation was composed exclusively of older women. It is worth noting that in ... | PMC10139030 | |
2.3. Intervention | PMC10139030 | |||
2.3.1. Dual-Task Training | DT physical–cognitive training was structured based on the principle of variable priority, when the focus of attention is divided between two or more tasks [The training load was implemented by the progression of tasks, more specifically, through the variation in motor exercises and increased difficulty of cognitive ta... | PMC10139030 | ||
2.3.2. Education Control Group | The CG activities consisted of a set of thematic workshops developed by the interdisciplinary team of the University of Third Age. The activities were under the responsibility of professionals from different areas (Physical Education, Medicine, Pharmacy, Nursing, Physiotherapy, History, Literature, English, Politics, S... | PMC10139030 | ||
2.4. Control of Procedures and Adherence | Members of both groups attended at least 75% of training sessions [ | PMC10139030 | ||
2.5. Outcome Measures | Before randomization, participants answered a standardized questionnaire to collect sociodemographic data (e.g., age, education), history of falls, medications, and comorbidities. Secondly, anthropometric data (weight, height) were collected, and the Body Mass Index (BMI) was determined. Finally, we used the Mini-Menta... | PMC10139030 | ||
2.5.1. Primary Outcomes | VF | The instruments used in this study are part of the list of tests commonly applied to assess mobility [In the TUGm, participants were asked to travel the 3 m-round trip carrying a paper tray (25 cm in diameter) with a dominant hand. On the tray, there was a glass (6.9 cm in diameter and 8.4 cm high) containing 200 mL of... | PMC10139030 | |
2.5.2. Secondary Outcomes | LEMS | STS | LEMS was performed using the sit-to-stand (STS) test [ | PMC10139030 |
2.6. Covariates | Considering possible confounding factors, the analyses were controlled by a set of variables recognized as a potential for falls among the older adult population, namely: sex and age [ | PMC10139030 | ||
2.7. Statistical Analysis | Normality was tested with the Shapiro–Wilk test. Categorical variables (medications, education, and comorbidities) were presented by several cases, and the frequency was analyzed using the chi-square test. Considering that all scalar variables (age, BMI, falls, MMSE, BB, GP, VF) presented a normal distribution, they we... | PMC10139030 | ||
3. Results | Seventy-five people were selected for the study ( | PMC10139030 | ||
3.1. Sample Characteristic | Forty-four women participated in the study (66.20 ± 4.05 years). No significant difference between the groups was found in the baseline assessments ( | PMC10139030 | ||
3.2. Descriptive Statistics | PMC10139030 | |||
3.2.1. Gait, Body Balance, and Lower Extremity Muscle Strength | The comparative results obtained by both groups in the motor assessments at baseline, post-tests, and follow-up are presented in | PMC10139030 | ||
3.2.2. Cognition | Concerning the result of the VF-total, there were significant time–effect differences [F(2.96) = 6.301, | PMC10139030 | ||
4. Discussion | VF, lower extremity muscle strength, age-related deterioration, LEMS, visual, auditory, and somatosensory systems, cognitive and motor tests | This study investigated the effects of a 12-week dual-task physical–cognitive training on gait performance, balance, lower extremity muscle strength, and cognitive performance in a group of cognitively normal older adult women compared to a control group, who participated only in educational activities. Our two assumpt... | PMC10139030 | |
5. Conclusions | The findings provided evidence for the effectiveness of 12 weeks of dual-task physical–cognitive training in counteracting age-related changes in gait performance (single- and dual-task conditions), also improving static and dynamic balance performance, and increasing lower limb strength. A strong point of our study wa... | PMC10139030 | ||
Author Contributions | Conceptualization, M.d.M.N.; methodology, M.d.M.N., P.A.M. and A.I.; software, M.d.M.N.; validation P.M.B.R., P.A.M., L.d.S.N., C.N.S. and A.I.; data curation, M.d.M.N. and P.A.M.; writing—original draft preparation, M.d.M.N., M.K. and A.I.; writing—review and editing, P.M.B.R., P.A.M., L.d.S.N. and C.N.S.; visualizati... | PMC10139030 | ||
Institutional Review Board Statement | The study was conducted according to the guidelines of the Declaration of Helsinki and had been approved by the local ethics committee before the start of the data collection. The actions were approved by the Human Research Ethics Committee of the Federal University of Vale do São Francisco in Brazil (number 2,866,845,... | PMC10139030 | ||
Informed Consent Statement | Informed consent was obtained from all subjects involved in the study before participation. | PMC10139030 | ||
Data Availability Statement | The data presented in this study are available upon request from the corresponding author. | PMC10139030 | ||
Conflicts of Interest | The authors declare no conflict of interest. | PMC10139030 | ||
References | lower extremity muscle strength | Study design and flow of participants.Results of the time × group interaction analysis, according to the groups. (Description of training components and task specificity.Strategies to increase DT training load during gait and balance tasks.Main characteristics of participants in the baseline.Note: Data are expressed as... | PMC10139030 | |
Introduction | ANTIBODY-MEDIATED REJECTION | The presence of donor-specific antibody (DSA) and antibody-mediated rejections are poor prognostic factors for graft survival and a major cause of graft failure in kidney transplant (KT) patientsThe allograft survival rate was poorer in patients with de novo (dnDSA) than in those with preexisting DSA, although antibody... | PMC10175554 | |
Methods | PMC10175554 | |||
Trial design | This study was an open-label, randomized, controlled clinical trial conducted at two large tertiary academic medical centers (Severance Hospital and Seoul National University Hospital) in Korea between January 2019 and October 2021. This study was approved by the Institutional Review Board (IRB) of Yonsei University He... | PMC10175554 | ||
Participants, randomization, and intervention | KT patients with subclinical class II dnDSA were screened. Participants who met the following criteria were included: (i) age ≥ 19 years; (ii) estimated glomerular filtration rate (eGFR) > 20 ml/min/1.73 mEligible participants who offered consent were randomly assigned to receive rituximab (IVIG–) or rituximab combined... | PMC10175554 | ||
Data collection and follow-up | ADVERSE EVENTS | The clinical and laboratory findings of the patients were assessed at baseline and 3 and 12 months. Assessment of general health status, medication use, and the occurrence of adverse events were performed at every visit. Laboratory measurements were performed at every visit, including DSA, serum creatinine, complete bl... | PMC10175554 | |
Study outcome | CHRONIC KIDNEY DISEASE, SECONDARY | The primary endpoint was the change in dnDSA titer at 3 and 12 months after preemptive treatment. The dnDSA titer was determined using either strength of immune-dominant class II dnDSA (MFI) or sum of class II dnDSA (MFI). Immune-dominant dnDSA was defined as DSA with the highest MFI at baseline. The sum of class II dn... | PMC10175554 | |
Statistical analyses | Continuous variables were presented as means with standard deviations (SD) for normally distributed data and medians with interquartile ranges (IQRs) for non-normally distributed data. Categorical variables were expressed as numbers with percentages. Between-group comparisons were tested for statistical significance us... | PMC10175554 | ||
Results | PMC10175554 | |||
Change in the sum of dnDSA titer | The sum of dnDSA also decreased at 3 and 12 months after treatment in the IVIG + and IVIG − groups (Fig. Generalized estimating equation analysis for comparing the treatment effect of IVIG/rituximab with that of rituximab alone on class II dnDSA sum.
Visit was treated as a categorical variable. The MFI values were log-... | PMC10175554 | ||
Change in kidney function | proteinuria | There was no significant difference in eGFR or proteinuria change between the IVIG + and IVIG– groups at either 3 or 12 months compared to baseline (Table | PMC10175554 | |
Adverse events and antibody-mediated rejection | ADVERSE EVENTS | During the study period, 36 and 41 adverse events occurred in the IVIG + and IVIG − groups, respectively, and there was no difference between the two groups ( | PMC10175554 | |
Comparison between treatment group and no treatment group | To verify the effect of treatment on dnDSA, patients who had subclinical dnDSA but did not receive any treatment (rituximab or IVIG) were retrospectively enrolled as a control group and compared with patients participating in the present study. The two treatment groups' demographic and baseline laboratory findings were... | PMC10175554 | ||
Discussion | microangiopathy | GRAFT LOSS, ANTIBODY-MEDIATED REJECTION, VASCULAR INFLAMMATION, MICROANGIOPATHY | In this open-label randomized controlled trial, we found that preemptive treatment in patients with dnDSA was associated with a reduction in dnDSA MFI. However, compared with the use of rituximab alone, combination of IVIG to rituximab did not provide additional benefit for dnDSA reduction. dnDSA-induced vascular infla... | PMC10175554 |
Supplementary Information |
Supplementary Information. | PMC10175554 | ||
Supplementary Information | The online version contains supplementary material available at 10.1038/s41598-023-34804-6. | PMC10175554 | ||
Author contributions | J.Y. and K.H.H. designed the study. H.W.K. and J.L. wrote the manuscript. H.W.K. and S.-J.H. analyzed the data. J.Y. reviewed and edited the manuscript. H.W.K., J.L., B.S.K., K.H.H., and J.Y. analyzed the data and contributed to the discussion. J.Y. is the guarantor of this work and takes responsibility for the integri... | PMC10175554 | ||
Funding | This study was supported by a grant from GC Biopharma, which was not involved in the study design or analysis. | PMC10175554 | ||
Data availability | The datasets generated and/or analyzed during the current study are not publicly available due privacy but are available from the corresponding author on reasonable request. | PMC10175554 | ||
Competing interests | The authors declare no competing interests. | PMC10175554 | ||
References | PMC10175554 | |||
Background | BREAST CANCER | Diphereline is a Gonadotropin-Releasing Hormone agonist commonly used in patients with breast cancer. This study aimed to compare the efficacy and safety of one-month and three-month Microrelin injections produced by Homa Pharmed Company with three-month Diphereline injections manufactured by IPSEN, France. | PMC10638790 | |
Methods | ’ menopausal symptoms | The study was a non-inferiority randomized clinical trial conducted between 2019 and 2023 on premenopausal women candidates for endocrine therapy. The participants were randomly assigned in blocks of six to one of three groups named A (Diphereline 11.25 mg), B (Microrelin 11.25 mg), and C (Microrelin 3.75 mg). The part... | PMC10638790 | |
Results | BREAST CANCER | The study included 133 patients with breast cancer. A decreasing trend in the serum levels of FSH and estradiol and an increasing trend of menopausal symptoms were recorded during the study. No specific side effects leading to drug disruption, hospitalization, or exclusion from the study were observed. Adjusting the ef... | PMC10638790 | |
Conclusions | It can be concluded that injections of both Microrelin 11.25 mg and 3.75 mg, produced by Homa Pharmed, Iran, are non-inferior in terms of effectiveness and incidence of menopausal symptoms compared to Diphereline, manufactured by IPSEN, France. | PMC10638790 | ||
Trial registration | IRCT.ir, IRCT20201227049847N1; Registered on 09/01/2021. | PMC10638790 | ||
Keywords | PMC10638790 | |||
Background | Breast cancer, cancers, breast cancer | BREAST CANCER, RECURRENCE, CANCERS, BREAST CANCER | Breast cancer ranks among the most frequently detected cancers in women globally, with an approximate occurrence of 2.3 million new cases [Estrogen is an important factor in breast cancer development and prognosis. In primary treatments of breast cancer, luteinizing hormone-releasing hormone agonist (LHRHa) can be used... | PMC10638790 |
Methods | MCI, Cancer | CANCER | This study is a non-inferiority RCT conducted at Motamed Cancer Research Institute (MCI) between 2019 and 2023. The primary objective was to examine the effectiveness, benefits, and side effects of a domestically produced medication called Microrelin, available in one-month and three-month formulations by Homa Pharmed ... | PMC10638790 |
Eligibility criteria | non-metastatic breast cancer | The study included premenopausal patients over the age of 18 with non-metastatic breast cancer and positive hormone receptor status who met the criteria for endocrine therapy All of the patients received chemotherapy regimen of AC4T4 (Adriamycin 60 mg/m2, Cyclophosphamide 600 mg/m2 – Docetaxel 75 mg/m2), and Tamoxifen ... | PMC10638790 | |
Method | Cancer | DRUG SIDE EFFECTS, CANCER | Throughout the treatment, all patients were monitored for their menstrual status. Patients with inclusion criteria who did not experience cessation of menstruation were recruited in the study. Menopausal status in the three groups was evaluated by examining the trends in serum estradiol and FSH levels as well as the ch... | PMC10638790 |
Instruments | menopause-related complaints | MRS |
Demographic and clinical characteristics of the participants were registered in a checklist.Serum estradiol and FSH titers were obtained from laboratory reports and recorded.The severity of menopause-related complaints was assessed using the Menopause Rating Scale (MRS) designed by Heinemann et al. in 2003 [ | PMC10638790 |
Randomization | RECRUITMENT | Recruited patients were randomly assigned to one of the three treatment groups using a block randomization with a block size of six. A statistician created the blocks in sets of six using Excel software, resulting in 35 sets of different states (e.g., BBCAAC, BCAACB, CCAABB). The letters A, B, and C represented each of... | PMC10638790 |
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