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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Statistical considerations | PCOS | This study is conducted to compare two treatment groups with each other in respect to PCOS parameters. In the double-blind part, comparisons between the probiotic and the placebo arms will be performed to show that probiotics are superior to placebos. The comparison of the open-label metformin arm with the probiotic ar... | PMC10106320 | |
Sample size calculation | ®, PCOS | Prior to this RCT, we conducted a short pilot trial with 30 women with PCOS (EC number 30–205 ex 17/18), randomly assigning 10 women into three probiotic intervention arms respectively, both to test our methodology as well as to assess the feasibility of improving PCOS symptoms with probiotics (Borzan V., Sommer F., Ri... | PMC10106320 | |
Statistical analysis of outcomes | SECONDARY | The analysis of the collected data in the study will be performed with SAS v9.4. The primary analysis will be performed on the intention-to-treat population. Details regarding the defined populations and the statistical analysis will be provided in the statistical analysis plan (SAP). The SAP will be prepared before un... | PMC10106320 | |
Adherence to study procedures | CRF | CRF | Due to stringent exclusion criteria and the long duration of the intervention period, we expect many participants to not be able to fully adhere to study procedures as outlined in the study protocol due to for example requiring antibiotic treatment or an unscheduled pregnancy. The study was planned and submitted prior ... | PMC10106320 |
Responsibilities | PD | This is an investigator-initiated trial, with Barbara Obermayer-Pietsch, Prof. MD acting as the principal investigator as well as the sponsor in the name of the Medical University of Graz, thereby having all rights and responsibilities of both roles. Additional investigators are Valentin Borzan, MD, Stefan Pilz, MD, Ph... | PMC10106320 | |
Data collection and handling | MEDOCS, CRF | ADVERSE EVENTS, CRF | For data collection, the newest version of SPSS (currently Version 26) will be used.The results from the medical history and the physical examination are entered in the CRF. In addition, we will document the visit progress and whether every test and procedure was completed according to the protocol. This includes the l... | PMC10106320 |
Storage and data protection | ADVERSE EVENTS, RECRUITMENT | This study adheres to legal regulations for the storage, registration, transfer and evaluation of data according to the Austrian Act on Pharmaceutical Products and data protection law (AMG). By signing the consent form, potential participants are informed and agree to the following:Data obtained during the course of th... | PMC10106320 | |
Acknowledgements | PD | Roswitha Gumpold, study nurse, as well as Natascha Schweighofer, PhD contributed to the study protocol as well as other study materials such as writing instructions for the use of the isoflavone and gut permeability test utensils, while study coordinator Cornelia Missbrenner gave valuable input regarding the outcome as... | PMC10106320 | |
Author Contribution | The protocol as well as the manuscript were written by Valentin Borzan, MD and planned, edited and proofread by the principal investigator (and guarantor of this study) Barbara Obermayer-Pietsch, Prof. MD, with the exception of the statistical contributions, which were edited by Regina Riedl, PhD. All authors approved ... | PMC10106320 | ||
Funding | DISORDERS | This RCT is part of CBmed project 3.22: “Diagnostic and predictive biomarkers in disorders of fertility and metabolism”. Work done in “CBmed” was funded by the Austrian Federal Government within the COMET K1 Centre Program, Land Steiermark and Land Wien. Institut AllergoSan as well as Winclove Probiotics are company pa... | PMC10106320 | |
Data Availability | The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request. | PMC10106320 | ||
Declarations | PMC10106320 | |||
Ethics approval and consent to participate | CRF | CRF | This study including the protocol, consent forms, CRF and all study-related procedures has been approved by the Ethics committee at the Medical university of Graz (approval number: EK 32–230 ex 19/20). The Austrian authority for the conduct and safety of clinical trials (Bundesamt für Sicherheit im Gesundheitswesen, BA... | PMC10106320 |
Consent for publication | Not applicable. | PMC10106320 | ||
Competing interests | The authors and contributors declare no conflicts of interest regarding work related to this study and its published materials. | PMC10106320 | ||
References | PMC10106320 | |||
Background | TB | Several appliances have been used for correction of developing skeletal Class II, including different myofunctional appliances as Twin block (TB)as well as the new pre-fabricated Myobrace (MB) appliance. However, the effects of these devices on the pharyngeal airways have not been compared in the literature. Thus, the ... | PMC10720117 | |
Methods | mandibular deficiency, TB, Skeletal Class II malocclusion | SECONDARY | This is a two parallel arms randomized comparative clinical trial. Twenty-six children of 9–12 years with Skeletal Class II malocclusion due to mandibular deficiency and normal maxillary growth as confirmed by lateral cephalometric X-ray readings (ANB angle > 4° and SNB angle < 78) and Cervical vertebral maturational i... | PMC10720117 |
Results | TB | By Comparing changes in airway measurements within each group, it was found that NPAA, OPAA, and LPAA increased significantly after treatment within each group of MB and TB. TB group showed significantly higher mean difference (T2-T1) in both NPAA and OPAA than MB group with 28.39 (± 56.75) and 40.46 (± 52.16) respecti... | PMC10720117 | |
Conclusions | TB, airway problems | POSTURING | TB was more effective than MB in improving the upper (NPAA) and middle (OPAA) airways, while no difference was found regarding the lower airway (LPAA). Both TB and MB reduced the severity of developing skeletal class II due to mandibular retrognathism by forward posturing of the mandible. Thus, patients with airway pro... | PMC10720117 |
Keywords | Open access funding provided by The Science, Technology & Innovation Funding Authority (STDF) in cooperation with The Egyptian Knowledge Bank (EKB). | PMC10720117 | ||
Introduction | TB, malocclusion, palate, dentofacial anomalies, Class II malocclusion, malocclusions | Skeletal Class II malocclusion is considered one of the most common dentofacial anomalies affecting almost one-third of the population [As a result of mandibular retrognathism, the space between the cervical column and the mandibular corpus is diminished, the tongue and soft palate are posteriorly postured; consequentl... | PMC10720117 | |
Materials and methods | PMC10720117 | |||
Study Design | This is a two parallel arms randomized comparative clinical trial, involving two groups, each evaluating one of the tested Myofunctional appliances. This study followed the CONSORT guidelines of reporting of randomized controlled trials [
| PMC10720117 | ||
Participants | Children were selected from the outpatient clinic of the Orthodontic Department, Faculty of Dentistry, Alexandria University. | PMC10720117 | ||
Inclusion criteria | mandibular deficiency |
Healthy children age ranged from 9 to 12 years.Skeletal Class II malocclusion with mandibular deficiency and normal maxillary growth depending on clinical diagnosis and confirmed with the lateral cephalometric X-ray readings (ANB angle > 4° and SNB angle < 78).Cervical vertebral maturational index (CVMI) 3 assessed by... | PMC10720117 | |
Exclusion criteria | ANTERIOR |
Previous orthodontic/orthopedic treatment.Previous extractions.Mandibular shifts.Severe crowding.Anterior open bite.Any peri-oral habits. | PMC10720117 | |
Sample size calculation | malocclusion | The sample size was planned based on 95% confidence level to detect differences in SNB angle between Twin block and Myobrace appliances in class II malocclusion patients. Johnson et al. [ | PMC10720117 | |
Ethical approval | This study was approved by the Institutional Review Board at the Faculty of Dentistry, Alexandria University, Alexandria, Egypt (IRB:00010556–IORG:0008839) Manuscript Ethics Committee number (0418-03/2022). The trial was registered on ClinicalTrials.gov, with the name of the registry being “CEPHALOMETRIC CHANGES IN PHA... | PMC10720117 | ||
Randomization and allocation concealment | Twenty-six children were randomly assigned in a 1:1 ratio using a computer-generated list of random numbers [
Research design flow chart | PMC10720117 | ||
Blinding | BLIND | Due to the nature of the intervention, it was not possible to blind the patients or the orthodontist. The researcher and the statistician who evaluated the data were blinded. | PMC10720117 | |
Methods | PMC10720117 | |||
Appliance fabrication | PMC10720117 | |||
Group I: Twin block group | incisors, malocclusion | Wax bite registration included advancing the mandible of each patient until the upper and lower central incisors were in an edge-to-edge relation and a gap of 2–3 mm beyond the freeway space. Depending on the degree of the malocclusion, the procedure included one or two stages of advancement. The appliance should be wo... | PMC10720117 | |
Group II: Myobrace group | crowding, upper incisors | The appropriate size of Myobrace is chosen by using a special ruler to measure the distance between the distal portion of the lateral upper right incisor and the left, regardless of any crowding or diastema. The measure is based on the mesial-distal dimensions of the upper incisors, and not on their position. In cases ... | PMC10720117 | |
Lateral cephalograms analysis | Lateral cephalograms were taken for all patients in both groups before treatment (T1) and after treatment (6 months later) (T2). Lateral cephalograms were taken using a standardized technique with the same machine; patients stood in the natural head position (NHP) [Digital tracing of the Lateral cephalograms was done u... | PMC10720117 | ||
Intra-examiner and inter-examiner reliability | After a wash-out period of 2 weeks, the same and another calibrated independent investigator remeasured the whole parameters of 14 randomly selected x-rays to test intra and inter-examiner reliability using Intraclass Correlation Coefficient (ICC) [
Intra- examiner and inter-examiner reliabilityICC: Intraclass Correlat... | PMC10720117 | ||
Statistical analysis | Normality was checked for all variables using descriptive statistics, plots (Q-Q plots and histogram), and normality tests. All variables showed normal distribution, so means and standard deviation (SD) were calculated, and parametric tests were used. Comparisons between the two study groups were done using independent... | PMC10720117 | ||
Results | TB | Over the course of the study, there were no subject dropouts in the pre-intervention period, nor throughout the rest of the study. All the twenty-six initially recruited subjects completed the entire study period (13 subjects per group). The patient flow throughout the trial is presented through a CONSORT Flow Diagram ... | PMC10720117 | |
Discussion | malocclusion, retrognathic mandible | According to literature, there is a reduction in pharyngeal airway dimensions in patients with skeletal Class II malocclusion and retrognathic mandible [Thus, in the current study Skeletal class II patients with ANB angle greater than 4° and SNB angle less than 78° were given functional appliances in an attempt to impr... | PMC10720117 | |
Twin block group | TB | The present study showed a statistically significant increase in the three airways (NPAA, OPAA, LPAA) between T1 and T2 after the use of TB appliance. This was in agreement with the results of previous researches [From the present results, it was evident that the sagittal jaw relationship was significantly improved fol... | PMC10720117 | |
Myobrace group | Unfortunately, there is a lack of evidence regarding the effect of MB on the airway dimensions. Therefore, this study was conducted regarding the use of MB for Class II patients to widen their airway passages. The current results agreed with AHN et al. [In this work, MB appliance postured the mandibular position forwar... | PMC10720117 | ||
Twin block versus myobrace | TB | There were no statistically significant differences between both groups regarding the sagittal skeletal relations with similar results obtained previously [Twin block was superior to MB because of the increased reciprocal force pushing backwards on the maxilla upon the practically full-time wear in combination with the... | PMC10720117 | |
Limitations of the study | Due to ethical concerns, this research did not include a control group that was not given any therapy in order to determine the skeletal treatment effects and airway modifications of both appliances compared to natural development. In addition, two-dimensional measurements on the lateral cephalometric radiographs canno... | PMC10720117 | ||
Conclusion | TB, airway problems | POSTURING | TB was more effective than MB in improving the upper (NPAA) and middle (OPAA) airways, while no difference was found regarding the lower airway (LPAA). Both TB and MB reduced the severity of developing skeletal class II due to mandibular retrognathism by forward posturing of the mandible. Thus, patients with airway pro... | PMC10720117 |
Acknowledgements | Not applicable. | PMC10720117 | ||
Authors’ contributions | A.M: Conceptualization, data curation, Performing the study measurements, analysis of the study results, drawing out the final study conclusions, writing and preparing the original manuscript, reviewing and editing. D.E: Conceptualization, data curation, Performing the study measurements, analysis of the study results,... | PMC10720117 | ||
Funding | There was no funding source for this study.Open access funding provided by The Science, Technology & Innovation Funding Authority (STDF) in cooperation with The Egyptian Knowledge Bank (EKB). | PMC10720117 | ||
Data Availability | The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request. | PMC10720117 | ||
Declarations | PMC10720117 | |||
Ethics approval and consent to participate | This study was approved by the Institutional Review Board at the Faculty of Dentistry, Alexandria University, Alexandria, Egypt (IRB:00010556–IORG:0008839) Manuscript Ethics Committee number (0418-03/2022). The trial was registered on ClinicalTrials.gov, with the name of the registry being “CEPHALOMETRIC CHANGES IN PHA... | PMC10720117 | ||
Consent for publication | Not applicable. | PMC10720117 | ||
Competing interests | The authors declare no competing interests. | PMC10720117 | ||
References | PMC10720117 | |||
Background | Physical activity participation among preschoolers in childcare settings are low, and interventions to increase physical activity levels have produced mixed results. The Physical Literacy in the Early Years (PLEY) project implemented a six-month childcare-based outdoor loose parts play intervention in childcare centres... | PMC10262461 | ||
Methods | Preschoolers (3–5 years) were recruited from 19 childcare centres in Nova Scotia and centres were randomized (parallel design) to the outdoor loose parts play intervention group ( | PMC10262461 | ||
Results | Two hundred and nine preschoolers participated in the study (intervention group: | PMC10262461 | ||
Conclusions | Participation in the PLEY project was associated with increased development of various domains of physical literacy and perceived physical literacy among preschoolers, and outdoor loose parts play may be encouraged as an effective strategy to increase physical literacy in early learning settings. | PMC10262461 | ||
Trial registration | Biomed Central (ISRCTN14058106), 20/10/2017. | PMC10262461 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s12889-023-16030-x. | PMC10262461 | ||
Keywords | PMC10262461 | |||
Introduction | Participation in regular physical activity in the early years (0–4 years) is associated with numerous physical, mental and social health benefits such as favourable motor skill and cognitive development, cardiometabolic health, fitness and psychosocial health [The majority of Canadian toddlers and preschoolers are in s... | PMC10262461 | ||
Methods | PMC10262461 | |||
Study design | This mixed-methods study used a convergent parallel design [Flow diagram of participants (preschoolers) through the study | PMC10262461 | ||
Recruitment | The study and associated protocols were approved by the Dalhousie University Research Ethics Board (REB #2016–3924) and registered as a randomized controlled trial with Biomed Central (ISRCTN14058106; 20/10/2017). Informed consent forms were received from parents/ legal guardians of participating children, and from all... | PMC10262461 | ||
Intervention | The PLEY project used a socio-ecological approach to address preschoolers’ physical activity, physical literacy, and outdoor play at multiple levels of influence, including intrapersonal, interpersonal, organizational, community, and physical environment [ | PMC10262461 | ||
Assessment of physical literacy | At the time of data collection for the PLEY project, assessment tools to specifically measure preschoolers’ physical literacy were not available. As a result, the PLEY project conceptualized the assessment of physical literacy based on the term’s definition [ | PMC10262461 | ||
Accelerometry (physical activity domain) | Physical activity data collection and analysis methods have been described previously [ | PMC10262461 | ||
Test of Gross-Motor Development-3 (physical competence domain) | FMS | Data collection for FMS data has been described previously [ | PMC10262461 | |
Educator focus groups (all physical literacy domains) | Fifteen focus groups took place (9 at 3-months and 6 at 6-months), with 3–5 participants in each group. The focus groups included educators from multiple sites and took place in public locations. Educators from all intervention sites were represented in the focus groups. The focus groups included a series of questions ... | PMC10262461 | ||
Data analysis | PMC10262461 | |||
Quantitative | TGMD-3, balance assessment and accelerometry data were analysed and described in detail previously [ | PMC10262461 | ||
Qualitative | Analysis of focus group data has been described previously [Theoretical model for the assessment of physical literacy in the Physical Literacy in the Early Years project (physical literacy domains adapted from Canadian Physical Literacy Consensus Statement, 2015) | PMC10262461 | ||
Physical activity domain | PMC10262461 | |||
Quantitative | Valid accelerometry data were available for 130 preschoolers at baseline (67% adherence), 71 at 3 months, and 62 at 6 months. MVPA and TPA had curvilinear relationships over time, with MVPA and TPA increasing from baseline to 3 months and decreasing from 3 to 6 months (Table | PMC10262461 | ||
Qualitative | PMC10262461 | |||
Theme 1: OLPP contributed to increased physical activity | In focus groups, educators reported that they observed that OLPP contributed to increased physical activity levels during outdoor play sessions; for example, one educator commented “ | PMC10262461 | ||
Physical competence domain | PMC10262461 | |||
Quantitative | FMS | As we previously reported, there was no intervention effect on any of the FMS variables. All FMS variables increased across the three time points in children attending intervention or control sites [ | PMC10262461 | |
Qualitative | PMC10262461 | |||
Theme 2: OLPP contributed to increased physical competence | SAID | Several educators commented in the interviews how they observed that children’s physical competence was developing and improving over the course of the intervention; for example, they said: “The increased physical competence that educators observed was primarily developed through multiple attempts or trial-and-error. A... | PMC10262461 | |
Confidence and motivation domain | PMC10262461 | |||
Qualitative | PMC10262461 | |||
Theme 4: OLPP increased confidence in physical abilities and desire to try new or challenging activities | In the focus groups, educators repeatedly shared how the loose parts helped increase children’s confidence in their physical abilities. For example, one educator shared: “Coupled with the increased confidence in physical abilities, educators shared that children had increased confidence and motivation to try something ... | PMC10262461 | ||
Theme 5: OLPP increased enjoyment of physical activity | The second theme related to confidence and motivation highlighted the children’s enjoyment to engage in OLPP over the course of the intervention. One educator shared how they also enjoyed the loose parts, | PMC10262461 | ||
Knowledge and understanding domain | PMC10262461 | |||
Qualitative | PMC10262461 | |||
Theme 6: OLPP increased knowledge/learning about physical activity | Educators perceived that much of the children’s learning with OLPP happened through mimicry, modelling, and peer leadership, as children observed other children do something and would then proceed to try it themselves, or with guidance from their peers. This quote displays that educators perceived children were learnin... | PMC10262461 | ||
Theme 7: OLPP contributed to cognitive and social development | cognitive and social development | In addition to increased knowledge and learning about PA through OLPP, educators observed that the OLPP helped with children’s cognitive and social development, including teamwork, collaboration, problem solving skills, and independence. One of the educators shared what they believed children developed through OLPP: “ | PMC10262461 | |
Discussion | ’ increased cognitive and social development | FMS | This study described the role of the PLEY project’s OLPP intervention on domains of physical literacy in preschoolers attending childcare centres in Nova Scotia. Previous results from this study suggested that the OLPP intervention had a positive impact on some measures of physical activity and no impact on physical co... | PMC10262461 |
Conclusion | ’ FMS | We observed that participation in the PLEY project was positively associated with the development of domains of physical literacy (physical activity, physical competence, confidence and motivation, knowledge and understanding) among a sample of preschoolers. Using a mixed-methods design, we reported that OLPP contribut... | PMC10262461 | |
Acknowledgements | The authors would like to thank all childcare centres, parents and children who participated in the PLEY project. The authors also acknowledge the support provided by the Healthy Populations Institute at Dalhousie University and thank all research assistants and volunteers who supported the project. | PMC10262461 | ||
Authors’ contributions | MS and SFLK conceived the study and submitted the successful funding application for the PLEY Study. MS, NJ, KB, and JC contributed to data collection. HH and DS led the quantitative statistical analyses; HATC, RAS, NJ and KB completed the qualitative analyses, and all authors assisted with the interpretation of result... | PMC10262461 | ||
Funding | This research was generously supported by the Lawson Foundation’s Outdoor Play Strategy (GRT 2015–67). | PMC10262461 | ||
Availability of data and materials | The datasets analysed during the current study are available from the corresponding author on reasonable request. | PMC10262461 | ||
Declarations | PMC10262461 | |||
Ethics approval and consent to participate | The study was approved by the Dalhousie University Research Ethics Board (REB #2016–3924). Informed consent forms were received from parents/ guardians of participating children, and from all participating educators. All methods were carried out with relevant guidelines and regulation, with REB approved protocols. | PMC10262461 | ||
Consent for publication | Not applicable. | PMC10262461 | ||
Competing interests | The authors declare that they have no competing interests. | PMC10262461 | ||
References | PMC10262461 |
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