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Tramadol effects on physical performance and sustained attention during a 20-min indoor cycling time-trial: A randomised controlled trial
<p>Objectives: To investigate the effect of tramadol on performance during a 20-min cycling time-trial (Exper- iment 1), and to test whether sustained attention would be impaired during cycling after tramadol intake (Experiment 2). Design: Randomized, double-blind, placebo controlled trial. Methods: In Experiment 1, participants completed a cycling time-trial, 120-min after they ingested either tramadol or placebo. In Experiment 2, participants performed a visual oddball task during the time-trial. Electroencephalography measures (EEG) were recorded throughout the session. Results: In Experiment 1, average time-trial power output was higher in the tramadol vs. placebo condition (tramadol: 220 W vs. placebo: 209 W; p < 0.01). In Experiment 2, no differences between conditions were observed in the average power output (tramadol: 234 W vs. placebo: 230 W; p > 0.05). No behavioural differences were found between conditions in the oddball task. Crucially, the time frequency analysis in Experiment 2 revealed an overall lower target-locked power in the beta-band (p < 0.01), and higher alpha suppression (p < 0.01) in the tramadol vs. placebo condition. At baseline, EEG power spectrum was higher under tramadol than under placebo in Experiment 1 while the reverse was true for Experiment 2. Conclusions: Tramadol improved cycling power output in Experiment 1, but not in Experiment 2, which may be due to the simultaneous performance of a cognitive task. Interestingly enough, the EEG data in Experiment 2 pointed to an impact of tramadol on stimulus processing related to sustained attention. Trial registration: EudraCT number: 2015-005056-96.</p>
Raw data related to: Randomised Clinical Trial: Calorie Restriction Regimen with Tomato Juice Supplementation Ameliorates Oxidative Stress and Preserves a Proper Immune Surveillance Modulating Mitochondrial Bioenergetics of T-Lymphocytes in Obese Children Affected by Non-Alcoholic Fatty Liver Disease (NAFLD)
<p><strong>Abstract</strong></p> <p>Fatty liver disease is a serious complication of childhood obesity. Calorie-restricted regimen (RCR) is one of the e ective therapy for this condition. Aim of the study was to evaluate the effect of lycopene-rich tomato sauce with oregano and basil extracts in obese children with fatty liver on RCR. 61 obese children with fatty liver were enrolled, 52 completed the study. A randomized cross over clinical trial was performed. Participants were assigned to RCR alone or with a supplement of lycopene-rich tomato juice for 60 days; subsequently, the groups were switched to the alternative regimen for the next 60 days. Reduction in BMI, HOMA-IR, cholesterol, triglycerides, liver size, and steatosis was more profound in tomato-supplemented group. Leptin decreased in both groups whereas adiponectin raised only after tomato supplementation. RCR is associated with the impaired engagement of T-cells glycolysis and proliferation, tomato-supplementation resulted in glycolytic metabolic activation of T-cells. Tomato juice ameliorates glucose and lipid metabolism in obese children, improve oxidative and inflammatory state and modulates the mitochondrial metabolism of T-cells contributing to a maintenance of a proper immune surveillance in children, impaired by RCR. The addition of tomato to RCR could be considered a protective and preventive support to obese child.</p> <p><strong>Progetto giovani ricercatori </strong>[GR-2016-02363725] dal titolo: "Immune Tolerance, Metabolism and Multiple Sclerosis: Novel Molecular Tools to Monitor Disease Pathogenesis and Progression"</p>
Comfort and wearability of orthodontic mouthguards during contact sports in adolescent patients undergoing fixed appliance orthodontic treatment: a randomised clincal trial
<p>Dataset for all analyses in the paper</p>
Pharmacodynamics parameters underlying the manuscript: The effect of morning versus evening administration of empagliflozin on its pharmacokinetics and pharmacodynamics characteristics in healthy adults: a two-way crossover, non-randomised trial
<p><b>Background</b>: Empagliflozin is an SGLT2 inhibitor approved for use in patients with Diabetes Mellitus type 2 (DMT2) with- or without other cardiovascular disease. Empagliflozin is taken once daily without rationale on the optimal timing for administration. This study aimed<b> </b>to determine the chronopharmacological effects of morning vs evening administration of empagliflozin 10 mg in Healthy Egyptian adults, by investigating the pharmacokinetics and pharmacodynamics parameters of empagliflozin depending on the intake time. </p> <p><b>Methods: </b>An open label, sequential, two‐way crossover trial comprised two periods with a washout period of 7 days. Pharmacokinetics parameters (t<sub>max</sub> (h), C<sub>max</sub> (ng/ml), AUC <sub>0-t</sub> (ng.h/ml)) as primary endpoints, and (AUC <sub>0 to ∞</sub>(ng.h/ml)) as secondary endpoint were assessed. Method validation was done prior to injection in LC/MS/MS and samples were processed by Liquid-Liquid extraction. The pharmacodynamic profile (UGE <sub>0-24</sub>) was determined after method validation (glucose hexokinase method).</p> <p><b>Results: </b>T<sub>max</sub> increased by (35%) in the evening phase compared to the morning phase, while C<sub>max</sub> decreased by (-6.5%)in the evening dose compared to the morning dose. Besides, AUC<sub>0 to ∞</sub> increased in the evening phase by (8.25%) compared to the morning phase. The mean cumulative amount of glucose excreted; UGE (<sub>0-24</sub>) increased by (43%) in the evening dose compared to the morning dose</p> <p><strong>Conclusion: </strong>Despite there was a significant difference between morning and evening doses, it didn't reach the significant level, thus, it can be concluded that there is no difference between the morning and evening doses.</p>
Study protocol and data dictionary: Effectiveness of a GP delivered medication review in reducing polypharmacy and potentially inappropriate prescribing in older patients with multimorbidity in Irish primary care: a cluster randomised controlled trial (SPPiRE study)
<p><strong>Methods</strong></p> <p><strong>Study design and participants</strong></p> <p>The methods for the SPPiRE cluster RCT have been described in the trial protocol (21). This study is reported in line with the CONSORT 2010 cluster RCT checklist (22), see Appendix 1, and was approved by the Irish College of General Practitioners Research Ethics Committee. In brief, SPPiRE was a pragmatic two arm cluster RCT, with the intervention delivered to GP clusters and analysis of outcomes at the patient level. Information about the trial was publicised through a variety of GP research, teaching and training networks throughout Ireland. Eligible practices expressing an interest were formally invited. Practices were eligible to participate if they had at least 300 registered patients aged ≥65 years (based on the need to identify a sufficient number of eligible participants) and used either of the two Irish GP practice management systems (PMS) with over 80% national cover; this enabled use of a SPPiRE patient finder tool which was developed and embedded into these systems. Practices were excluded if they were currently involved in a medication management or prescribing trial or if they were unable to recruit at least five participants.</p> <p>Eligible patients were aged ≥65 years and prescribed ≥15 repeat medicines. A repeat medicine was defined as any unique item with a World Health Organisation Anatomical Therapeutic Chemical code on the patient’s current repeat prescription. Patients were excluded if they had been recruited into a practice that was unable to recruit at least four other participants, they were judged by their GP as unable to give informed consent or they were unable to attend the practice for a face to face medication review, (e.g. nursing home residents and house bound patients). Recruited GPs ran the SPPiRE patient finder tool and screened the generated list to ensure only eligible patients were invited. Practices who identified more than 40 eligible patients were supported in selecting a random sample of 30 patients to invite. All recruited practices and patients gave fully informed consent and baseline data was collected prior to practice allocation, to reduce the likelihood of selection bias.</p> <p><strong>Randomisation and masking</strong></p> <p>Recruited practices were allocated to intervention or control groups by minimisation using Minimpy software (23) by the trial statistician (FB) who had no knowledge of participating practices. Minimisation variables included practice size (number of GP sessions per week, 0-14, 14-28 and 28 or more) and location (urban, rural or mixed). Considering the nature of the intervention, it was not possible to blind GPs or patients to the intervention, however to reduce the risk of detection bias the two primary outcome measures; the number of repeat medicines and whether a PIP was present were assessed by an independent blinded pharmacist (MF).</p> <p><strong>Procedures</strong></p> <p>Intervention GPs received unique login details to the SPPiRE website where they had access to five training videos and a template for performing the SPPiRE medication review. The training videos provided background information on multimorbidity and polypharmacy, PIP, eliciting patient treatment priorities and conducting a brown bag medication review. GPs were instructed to book a double appointment and to ask their patients to bring all their medicines in to the medication review visit with them. The SPPiRE medication review process had two main components; gather and record information and then to discuss and agree changes with their patient based on the recorded information, with a focus on deprescribing medicines that were potentially inappropriate, figure 1. The website provided suggested treatment alternatives for identified PIP but all treatment decisions were ultimately at the discretion of the individual GP, based on their clinical judgement and their patients’ individual priorities.</p> <p>Control GPs delivered usual care during the six to twelve month study period. At the time of intervention delivery there was no structured chronic disease management programme in Irish primary care and many patients with multimorbidity attended multiple hospital specialists. In Ireland, the majority of people aged ≥70 years of age have access to free GP visits and medicines with some prescription charge co-payments. In the 65 – 69 year old age category a lower proportion have access to both free GP visits and prescription medicines. Access to specialists and diagnostics in secondary care is free for the entire population.</p> <p><strong>Outcomes</strong></p> <p>The two primary outcomes were the number of repeat medicines and the proportion of patients with any PIP, from a list of 34 pre-specified indicators (see Appendix 2). A series of secondary prescribing related outcome measure were pre-specified to allow a more in depth analysis of the effect of the intervention on prescribing. These were:</p> <ul> <li>The number of medicines stopped and started</li> <li>The proportion of patients with a reduction in significant polypharmacy (defined as ≥15 repeat medicines)</li> <li>The number of PIP</li> <li>The proportion of patients with a high risk PIP (see Appendix 2)</li> <li>The proportion of patients with any reduction in PIP</li> </ul> <p>Secondary patient reported outcomes measures were included to capture the effectiveness of the intervention from the patients’ perspective. These were:</p> <ul> <li>Health related Quality of life (EQ5D-5L)(24)</li> <li>Revised Patients' attitudes towards deprescribing (rPATD) (25)</li> <li>Multimorbidity Treatment Burden Questionnaire (MTBQ) (26)</li> </ul> <p>Health care utilisation data was collected to assess the effect of the intervention on health care usage and for the trial’s economic evaluation.</p> <p>Outcomes were collected at baseline and at six months after intervention delivery. Patient reported measures were collected by postal questionnaires. Data for all other measures including prescribed medicines, medical and investigations history and healthcare utilisation were collected by participating GPs and submitted to the study manager (CMC). This was a deviation from the original protocol, which indicated this data would be collected by the research team. This deviation related to changes in data protection and national health research regulations during the study period, which precluded research team access to the patients’ full clinical record.</p> <p><strong>Adverse events</strong></p> <p>Information on adverse events such as mortality, ED presentations and hospital admissions was collected at follow up. Given the deprescribing approach of the intervention a safety protocol for identifying and reporting any suspected adverse drug withdrawal events (ADWEs) was developed. An ADWE is defined as either recurrence of the condition for which the drug was prescribed (e.g. recurrence of angina after stopping a beta blocker) or a physiologic reaction to drug withdrawal (e.g. SSRI withdrawal syndrome) (27, 28). Although discontinuing medicines in older people has been demonstrated to be safe (29), given the paramount importance of the principle of “do no harm” in research ethics a vigorous and detailed method was established to ensure that any potential ADWEs precipitated by deprescribing in a SPPiRE medication review were captured. Intervention GPs were asked to report any possible ADWE following the SPPiRE medication review. The Naranjo ADR probability scale (30) has been adapted in other studies to assess the likelihood a reaction is related to drug withdrawal (27, 28). This tool was further adapted for SPPiRE and used to make an assessment on the causality of the ADWE. To ensure the patient perspective was included, self-reported possible ADWEs were also collected from patient follow up questionnaires. </p> <p> </p> <p><strong>Sample size</strong></p> <p>As outlined in the trial protocol (21), the study was designed with 90% power to detect a 20% reduction in the proportion with PIP and a mean difference of one medicine between intervention and control groups (based on a mean of 17.4 medicines SD (2.6)) and the sample size inflated to incorporate the effects of clustering (using an ICC of 0.025). The sample size was recalculated when it became apparent during early recruitment that it would not be possible to recruit clusters with an average of 15 participants, as was initially planned in the protocol. An average cluster size of eight was anticipated which inflated the original sample size from 30 practices (450 patients) to 50 practices (400 patients).</p> <p><strong>Statistical analysis</strong></p> <p>Descriptive statistics were used to describe baseline characteristics of recruited practices and participants. All analyses were conducted under the intention-to-treat principle and those lost to follow up had their baseline data carried forward. The primary analysis was carried out using multi-level modelling. The first primary outcome measure, number of repeat medications, was assessed using mixed effects Poisson regression with the individual as the unit of analysis and the practice included as the random effect to control for the effects of clustering and results presented using incidence rate ratios (IRR) and 95% confidence intervals (CI). The baseline number of medicines, GP size (number of GP sessions per week) and GP location (urban/rural) were included in the analysis as fixed effects. The second outcome measure, proportion of patients with a PIP, was analysed in a similar manner using mixed effects logistic regression, including PIP at baseline, GP size and location, and results presented using odd ratios (OR) and 95% CIs. A number of pre-specified sensitivity analyses were conducted; complete case analysis, per protocol analysis and including “presence of a repeat prescribing policy” as a covariate. All secondary outcomes were analysed in a similar manner to the primary outcomes, using appropriate mixed effects regression methods (i.e. linear, logistic, Poisson).</p> <p> </p> <p>Note: Version 3 (published 28 April 2025) updates Version 2 by removing Participant GP1P4 following consent withdrawal. This version should be used for all future analyses.</p> <p> </p>
Extended data for behavioural change for Parkinson's disease: A randomised controlled feasibility study to promote physical activity and exercise adherence among people with Parkinson's, study protocol
<p><strong>Background: </strong>Parkinson's is a common progressive neurological condition characterized by motor and non-motor deficits. Physical activity and exercise can improve health, but many people with Parkinson's have trouble reaching the recommended dosage. Our recent literature review found improvements in exercise adherence with behavioural change interventions, but it remains unclear which are most effective. Further qualitative research and patient and public involvement has informed a novel behavioural change support intervention to be tested alongside an existing exercise program.<strong> </strong></p> <p><strong>Objective: </strong>To examine the feasibility of behavioural change support techniques delivered alongside an exercise programme to improve physical activity, function, and self-efficacy in PwP (and study procedures) to inform a future pilot RCT trial.<strong> </strong></p> <p><strong>Methods: </strong>A parallel-arm single blinded randomised feasibility study. Twenty participants with Parkinson's (Hoehn and Yahr stage 1-3) will be recruited from a physiotherapy primary-care waiting list. Following written consent, and baseline assessment, the participants will be randomly allocated to the intervention (n=10) or the control group (n=10). Both groups will receive usual care, which includes a weekly program of a multidisciplinary education, a supervised exercise class and a prescribed home exercise program. The intervention group will receive additional behavioural change techniques, targeting behaviour regulation, belief about capabilities and social influences. Class and home exercise adherence, behavioural component uptake and adherence, and negative events will be recorded. Outcomes will include enrolment and maintenance rates, physical function, falls, physical activity, and exercise self-efficacy measured pre- and post- the 12- week program (in-person). Surveys will be used to compare experiences and satisfaction between groups. Exit interviews will be completed with the intervention group only, exploring their experience of the behavioural change techniques. </p> <p><strong>Discussion: </strong>The results will help inform a future pilot RCT, based on the intervention acceptability, consent rate, maintenance, and protocol integrity.</p>
Intervention effect of person profiles for people with advanced dementia: Stepped-wedge cluster randomised trial
<p>Dataset related to study <a href="https://kofam.ch/en/snctp-portal/searching-for-a-clinical-trial/study/53440">SNCTP000003941</a></p> <div><strong># Project title</strong></div> <div>Intervention effect of person profiles for people with advanced dementia: Stepped-Wedge Cluster Randomised Trial.</div> <div> </div> <div><strong># Brief project overview</strong></div> <div>This is Data coming out of the IPOS-Dem project, a Stepped-wedge Cluster Randomised Trial (SW-CRT). Please make shure to check out the SW-CRT protocol for more details at <a href="https://www.doi.org/10.1111/jan.14953">https://www.doi.org/10.1111/jan.14953</a>. </div> <div> </div> <div>We are currently working on our main study (SW-CRT) analysis. While we remain dedicated to open science, our priority is to ensure the utmost integrity of our ongoing research.</div> <div> </div> <div><strong># Contributors</strong></div> <div>Frank Spichiger, Andrea Koppitz, André Meichtry</div> <div> </div> <div><strong>## Repository overview</strong></div> <div>|-- readme.md</div> <div>|-- documentation</div> <div> |--readme.md</div> <div> |--Datadictionary.html</div> <div>|-- data</div> <div> |--readme.md</div> <div> |--IPOS-Dem_CH-SW-CRT_PLD_IPOS-Dem.feather</div> <div> |--IPOS-Dem_CH-SW-CRT_PLD_locf_IPOS-Dem.feather</div> <div> |--IPOS-Dem_CH-SW-CRT_PLD_Qualidem.feather</div> <div> |--IPOS-Dem_CH-SW-CRT_PLD_locf_Qualidem.feather</div> <div> |--csv</div> <div> |--IPOS-Dem_CH-SW-CRT_PLD_IPOS-Dem.csv</div> <div> |--IPOS-Dem_CH-SW-CRT_PLD_locf_IPOS-Dem.csv</div> <div> |--IPOS-Dem_CH-SW-CRT_PLD_Qualidem.csv</div> <div> |--IPOS-Dem_CH-SW-CRT_PLD_locf_Qualidem.csv</div> <div>|-- analysis</div> <div> |--readme.md</div> <div> |--240229_Analysis_Main.html</div> <div> |--240229_Analysis_Main.qmd</div> <div> |--grateful-refs.bib</div> <div> |--output</div> <div> |--models-REML.csv</div> <div> |--models.csv</div> <div> |--subscale_estimates.csv</div> <div> |--figures</div> <div> |--Datashowcasing-1.png</div> <div> |--DEBI-Predictions-Plot-1.png</div> <div> |--DPII-Plot-1.png</div> <div> |--Model_1-Plots-1.png</div> <div> |--Model_1-Plots-2.png</div> <div> |--Model_2-Plots-1.png</div> <div> |--Model_2-Plots-2.png</div> <div> |--Model_3-Plot-1.png</div> <div> |--Model_4-Plot-1.png</div> <div> |--Model_5-Plot-1.png</div> <div> </div> <div> </div> <div><strong># Applicable instructions</strong></div> <div>The R markdown files were generated using <a href="https://www.r-project.org">R 4.2.2</a> in <a href="https://posit.co/downloads/">RStudio 2023.12.1</a> for MacOS X you can run them using free software but will need to install R, Rstudio and the packages cited at the end of the quarto or the rendered html we used.</div> <div> </div> <div><strong># Additional resources</strong></div> <div>- Main study protocol: <a href="https://www.doi.org/10.1111/jan.14953">https://www.doi.org/10.1111/jan.14953</a></div> <div>- QUALIDEM measure used: <a href="https://doi.org/10.1186/1477-7525-11-91">https://doi.org/10.1186/1477-7525-11-91</a> </div> <div>- Pos-Pal consortium with more information on the measure: <a href="https://www.pos-pal.org">https://www.pos-pal.org</a></div> <div>- IPOS-Dem translation and adaption: <a href="https://www.doi.org/10.1186/s41687-022-00420-7">https://www.doi.org/10.1186/s41687-022-00420-7</a></div> <div>- IPOS-Dem inter-rating reliability: <a href="https://doi.org/10.1371/journal.pone.0286557">https://doi.org/10.1371/journal.pone.0286557</a> </div>
Randomised trials in maternal and perinatal health in low- and middle-income countries from 2010 to 2019: A systematic scoping review
<p><strong>Objectives: </strong>To identify and map all trials in maternal health conducted in low- and middle-income countries (LMIC) over the 10-year period 2010-2019, to identify geographical and thematic trends, as well as compare to global causes of maternal death and pre-identified priority areas.</p> <p><strong>Design: </strong>Systematic scoping review.</p> <p><strong>Primary and secondary outcome measures: </strong>Extracted data included location, study characteristics and whether trials corresponded to causes of mortality and identified research priority topics.</p> <p><strong>Results: </strong>Our search identified 7,269 articles, 874 of which were included for analysis. Between 2010 and 2019, maternal health trials conducted in LMICs more than doubled (50 to 114). Trials were conducted in 61 countries – 231 trials (26.4%) were conducted in Iran. Only 225 trials (25.7%) were aligned with a cause of maternal mortality. Within these trials, pre-existing medical conditions, embolism, obstructed labour, and sepsis were all under-represented when compared with number of maternal deaths globally. Large numbers of studies were conducted on priority topics such as labour and delivery, obstetric haemorrhage, and antenatal care. Hypertensive disorders of pregnancy, diabetes, and health systems and policy – despite being high-priority topics – had relatively few trials.</p> <p><strong>Conclusion: </strong>Despite trials conducted in LMICs increasing from 2010 to 2019, there were significant gaps in geographical distribution, alignment with causes of maternal mortality, and known research priority topics. The research gaps identified provide guidance and insight for future research conducted in low-resource settings.</p>
: Enzobiotics –A Novel Therapy For Elimination Of Uremic Toxins In Ckd Patients (EETOX Study)–Multicentric Double-Blinded Randomised Controlled Trial
<p>Supplementary file for <strong>: </strong><strong>Enzobiotics –A Novel Therapy For </strong><strong>Elimination Of Uremic Toxins In Ckd Patients (EETOX Study)–Multicentric Double-Blinded Randomised Controlled Trial</strong></p>
Data from: Effect of information about the benefits and harms of mammography on women's decision making: the InforMa randomised controlled trial
<p>Background:</p> <p>In Spain, women invited to breast screening are not usually informed about potential harms of screening. The objective of the InforMa study is to assess the effect of receiving information about the benefits and harms of breast screening on informed choice and other decision making outcomes, in women approaching the age of invitation to mammography screening.</p> <p>Methods:</p> <p>Two-stage randomised controlled trial. In the first stage, 40 elementary territorial units of the public healthcare system were selected and randomised to intervention or control. In the second stage, women aged 49-50 years were randomly obtained. The target sample size was 400 women. Women in the intervention arm received a decision aid (DA) with detailed information on the benefits and harms of screening. Women in the control arm received a standard leaflet that did not mention harms and recommended accepting the invitation to participate in the Breast Cancer Screening Program (BCSP). The primary outcome was informed choice, defined as adequate knowledge and intentions consistent with attitudes. Secondary outcomes included decisional conflict, worry about breast cancer, time perspective, opinions about the DA, and participation in the BCSP.</p> <p>Results:</p> <p>In the intervention group, 23.2% of 203 women made an informed choice compared to only 0.5% of 197 women in the control group (p < 0.001). Attitudes and intentions were similar in both study groups with a high frequency of women intending to be screened, 82.8% vs 82.2% (p=0.893). Decisional conflict was significantly lower in the intervention group. No differences were observed in confidence in the decision, anxiety, and participation in BCSP.</p> <p>Conclusions:</p> <p>Women in Spain lack knowledge on the benefits and harms of breast screening. Providing quantitative information on benefits and harms has produced a considerable increase on knowledge and informed choice, with a high acceptance of the informative materials.</p>
Randomised material parameter piezoelectric impedance dataset with structured electrodes (RaPIDstruc)
<h1>Description of the dataset</h1> <p>This dataset contains the results of 652517 finite-element simulations of the complex, frequency-dependent electrical impedance of a piezoelectric disc with structured electrodes and randomised material parameters. Each impedance consists of 1500 samples in the frequency domain up to 9.37 MHz. The electrode structure is the result of a topology optimisation process with the aim to enhance the sensitivity of the impedance with respect to all material parameters (DOI: <a href="https://jsss.copernicus.org/articles/12/163/2023/">10.5194/jsss-12-163-2023</a>). The piezoelectric disc has a radius of 5 mm and a thickness of 1 mm. The transverse isotropic material parameters are sampled from independent uniform distributions with ranges that are intended to represent the behaviour of hard as well as soft piezoceramic materials. The parameters of the Rayleigh damping model (alpha_M and alpha_K) are sampled from a logarithmic distribution to account for the larger parameter range.</p> <table> <tbody> <tr> <td><strong>Parameter</strong></td> <td><strong>Min</strong></td> <td><strong>Max</strong></td> <td><strong>Unit</strong></td> <td><strong>Description</strong></td> </tr> <tr> <td>c11</td> <td>115</td> <td>150</td> <td>GPa</td> <td>Elastic stiffness </td> </tr> <tr> <td>c12</td> <td>70</td> <td>110</td> <td>GPa</td> <td>Elastic stiffness </td> </tr> <tr> <td>c13</td> <td>65</td> <td>95</td> <td>GPa</td> <td>Elastic stiffness </td> </tr> <tr> <td>c33</td> <td>95</td> <td>125</td> <td>GPa</td> <td>Elastic stiffness </td> </tr> <tr> <td>c44</td> <td>18</td> <td>25</td> <td>GPa</td> <td>Elastic stiffness </td> </tr> <tr> <td>eps11</td> <td>5</td> <td>18</td> <td>nF/m</td> <td>Dielectric permittivity</td> </tr> <tr> <td>eps33</td> <td>6</td> <td>12</td> <td>nF/m</td> <td>Dielectric permittivity</td> </tr> <tr> <td>e15</td> <td>7</td> <td>19</td> <td>C/m^2</td> <td>Piezoelectric coupling</td> </tr> <tr> <td>e31</td> <td>1</td> <td>7.5</td> <td>C/m^2</td> <td>Piezoelectric coupling</td> </tr> <tr> <td>e33</td> <td>13</td> <td>23</td> <td>C/m^2</td> <td>Piezoelectric coupling</td> </tr> <tr> <td>alpha_M</td> <td>2</td> <td>150</td> <td>1/ms</td> <td>Mass-proportional damping</td> </tr> <tr> <td>alpha_K</td> <td>0.1</td> <td>0.65</td> <td>ns</td> <td>Stiffness-proportional damping</td> </tr> <tr> <td>density</td> <td>7600</td> <td>7850</td> <td>kg/m^3</td> <td>Density</td> </tr> </tbody> </table> <h1>Files</h1> <p>The dataset contains the following files:</p> <ul> <li><strong>dataset.hdf5</strong>: The main dataset file in HDF5 format. Refer to the next section on how to load the dataset.</li> <li><strong>simulation.xml</strong>: The file describing the parameters of the finite element simulation. This file can be used with <a href="https://www.opencfs.org/">openCFS</a> along with the mesh and material file to simulate the behaviour of the piezoelectric ceramic in the frequency domain. This simulation file was used with randomised material parameters to generate the dataset.</li> <li><strong>material.xml</strong>: The material file used for the simulation with exemplary material parameters values.</li> <li><strong>piezo.geo</strong>: The gmsh geometry file with the axisymmetric representation of the piezoelectric disc and the electrode structure.</li> <li><strong>piezo.msh</strong>: The mesh file generated with gmsh using the piezo.geo file.</li> </ul> <h1>Loading the dataset</h1> <p>The dataset is stored as a HDF5 file, which can be opened with all libraries that support that format, e.g. in Python using the h5py library:</p> <pre><code>import h5py # Open the dataset in read mode. file = h5py.File("dataset.hdf5", "r") # Impedances as a 652517 x 1500 array of complex numbers. impedances = file["impedances"] # Material parameter values as a 652517 x 13 array of real numbers. parameters = file["parameters"] # Frequency vector of the impedance with length 1500. frequencies = file["meta"]["frequencies"] # 13 strings with the identifiers of the material parameters. parameter_labels = file["meta"]["parameter_labels"]</code></pre> <h1>Simulating impedances</h1> <p>To generate a result for the electrical impedance using the supplied simulation files, download and install openCFS and call the executable with the simulation.xml, but omit the file extension, e.g.:</p> <pre><code>cfsbin.exe simulation</code></pre> <p>The path to the executable of openCFS will depend on your operating system and installation. Running the simulation will result in the creation of several files and folders. Among those files will be the result for the electric charge on one of the electrodes of the sample, which will be placed in the 'history' subfolder. We can determine the current by taking the time derivative of the charge and already know the voltage because we excited the piezoceramic with an electric potential of 1 V in the simulation. Because the simulation is conducted in the frequency regime, all we have to do is to divide voltage by current to get the frequency dependent electrical impedance. The loading of the result and calculation of the impedance is implemented in the following Python script as an example:</p> <pre><code>import numpy as np # Load result file for electric charge result_path = 'history/simulation-elecCharge-surfRegion-ground.hist' data = np.loadtxt(result_path) frequency = data[:, 0] # Convert polar representation from file to complex numbers. charge = data[:, 1] * np.exp(1j * 2 * np. pi / 360 * data[:, 2]) # Excitation potential is 1 V in simulation. potential = 1 # Determine impedance by applying Z = V / I = V / (j omega Q). impedance = potential / (1j * 2 * np.pi * frequency * charge)</code></pre>
The impact of weekly fever-screening and treatment and monthly RDT testing and treatment on the infectious reservoir of malaria in Burkina Faso: results from a cluster-randomised trial
<p>The majority of malaria infections in endemic countries are asymptomatic and a source of onward transmission to mosquitoes. Malaria transmission and disease burden could be reduced by improving early detection and treatment of these infections with active screening approaches. In an 18-month cluster-randomized study in Sapone, Burkina Faso, households were enrolled and randomised to 1 of 3 arms: arm 1 - control; arm 2 - active weekly screening for febrile individuals and treatment if rapid diagnostic test (RDT) positive; or arm 3 – active weekly fever-screening (as arm 2) plus monthly RDT-testing regardless of symptoms. The primary outcome was parasite prevalence by qPCR in the end-of-study cross-sectional survey. Secondary outcomes included parasite and gametocyte prevalence and density in all three end-of-season cross-sectional surveys, incidence of infection, and the transmissibility of infections to mosquitoes. A total of<strong> </strong>906 individuals were enrolled during 2 phases. In Phase 1, 412 individuals were enrolled between August 9 and 17, 2018, and in Phase 2, 494 individuals were enrolled between January 10 and 31, 2019. In the end-of-study cross-sectional survey, malaria parasite prevalence by qPCR was statistically significantly lower in arm 3 (29·26% 79/270), but not in arm 2 (45·66% 121/265), when compared to arm 1 (48·72% 133/273) (RR = 0·65, 95%CI = 0·52 to 0·81, P=0·0001). Total parasite and gametocyte prevalence and density were also significantly lower in arm 3 in all surveys. The largest differences were seen at the end of the dry season, with gametocyte prevalence 78·38 % and transmission potential 98·20% lower in arm 3 vs arm 1. Active monthly RDT testing and treatment can reduce parasite carriage and the infectious reservoir of malaria to <2% when used during the dry season. This insight may inform approaches for malaria control and elimination.</p>
The effects of primary or secondary prevention with vitamin A supplementation on clinically important outcomes. A systematic review of randomised clinical trials with meta-analysis and Trial Sequential Analysis
<p>Meta data for the review entitled "The effects of primary or secondary prevention with vitamin A supplementation on clinically important outcomes. A systematic review of randomised clinical trials with meta-analysis and Trial Sequential Analysis<strong>"</strong></p>
Replication data for: "Effectiveness of iso-inertial resistance training on eccentric and concentric power, physical performance, and risk of falls in physically active middle-older adults: a randomised controlled trial"
<p>Replication data for: "Effectiveness of iso-inertial resistance training on eccentric and concentric power, physical performance, and risk of falls in physically active middle-older adults: a randomised controlled trial"</p> <p>This folder contains 4 files:</p> <p>1) Database that contains the values for concentric and eccentric power measured with both iso-inertial and gravitational systems (Dataset_power.xlsx)</p> <p>2) Database that contains the values for the Short Physical Performance Battery (SPPB) and Get Up and Go (GUG) test (Dataset_SPPB_GUG.xlsx)</p> <p>3) R Software script used to analyse file 1 (Iso-inertial analysis_power.R)<br> <br>4) R Software script used to analyse file 2 (Iso-inertial analysis_SPPB_GUG.R)</p>
Data from: Safety and efficacy of BCG re-vaccination in relation to COVID-19 morbidity in healthcare workers: A double-blind, randomised, controlled, phase 3 trial
<p>Morbidity and mortality attributable to COVID-19 is devastating global health systems and economies. Bacillus Calmette Guérin (BCG) vaccination has been in use for many decades to prevent severe forms of tuberculosis in children. Studies have also shown a combination of improved long-term innate or trained immunity (through epigenetic reprogramming of myeloid cells) and adaptive responses after BCG vaccination, which leads to non-specific protective effects in adults. Observational studies have shown that countries with routine BCG vaccination programs have significantly less reported cases and deaths of COVID-19, but such studies are prone to significant bias and need confirmation. To date, in the absence of direct evidence, WHO does not recommend BCG for the prevention of COVID-19. This project aims to investigate in a timely manner whether and why BCG-revaccination can reduce infection rate and/or disease severity in health care workers during the SARS-CoV-2 outbreak in South Africa. </p> <p>These objectives will be achieved with a blinded, randomised controlled trial of BCG revaccination versus placebo in exposed front-line staff in hospitals in Cape Town. Observations will include the rate of infection with COVID-19 as well as the occurrence of mild, moderate or severe ambulatory respiratory tract infections, hospitalisation, need for oxygen, mechanical ventilation or death. HIV-positive individuals will be excluded. Safety of the vaccines will be monitored. A secondary endpoint is the occurrence of latent or active tuberculosis. Initial sample size and follow-up duration is at least 500 workers and 52 weeks. Statistical analysis will be model-based and ongoing in real time with frequent interim analyses and optional increases of both sample size or observation time, based on the unforeseeable trajectory of the South African COVID-19 epidemic, available funds and recommendations of an independent data and safety monitoring board. The study will be supported by a novel 3D lung organoid model of SARS-CoV-2 infection system that can mimic the cascade of immunological events after SARS-CoV-2 infection to determine and analyse the contribution of cellular components to the impact of BCG revaccination in this study.</p> <p>Given the immediate threat of the SARS-CoV-2 epidemic the trial has been designed as a pragmatic study with highly feasible endpoints that can be continuously measured. This allows for the most rapid identification of a beneficial outcome that would lead to immediate dissemination of the results, vaccination of the control group and outreach to the health authorities to consider BCG vaccination for all qualifying health care workers.</p>
Supplementary file 15 in Methylphenidate for attention deficit hyperactivity disorder (ADHD) in children and adolescents - assessment of possible adverse events in non-randomised studies
<p>Supplementary file 15: Proportion of participants withdrawn from methylphenidate treatment due to hallucinations</p>
Supplementary file 45 in Methylphenidate for attention deficit hyperactivity disorder (ADHD) in children and adolescents - assessment of possible adverse events in non-randomised studies
<p>Supplementary file 45: Proportion of participants on methylphenidate with somnolence </p>
Supplementary file 53 in Methylphenidate for attention deficit hyperactivity disorder (ADHD) in children and adolescents - assessment of possible adverse events in non-randomised studies
<p>Supplementary file 53: Proportion of participants on methylphenidate with cough</p>
Training, executive, attention and motor skills (TEAMS) training versus standard treatment for preschool children with attention deficit hyperactivity disorder: a randomised clinical trial
<p>This is the dataset used in the trial entitled Training, executive, attention and motor skills (TEAMS) training versus standard treatment for preschool children with attention deficit hyperactivity disorder, published in BMC Research Notes.</p>
Comparative Study of Intravenous Esmolol & Magnesium Sulphate in Attenuating Hemodynamic Response during Laryngoscopy & Endotracheal Intubation in Patients Undergoing Valvular Heart Surgery: a Randomised Clinical Trial
<p>The present study aimed to compare the effectiveness of esmolol & magnesium sulphate in attenuating the hemodynamic response<br> to endotracheal intubation and to note any signifi cant side effects caused by these drugs.<br> Background: Induction with endotracheal intubation in patients undergoing valvular heart replacement pose lot of hemodynamic<br> variations. Obtunding hemodynamic response which can be deleterious in such patients pose a challenge to the cardiac anaesthetist. We<br> hypothesized that using esmolol as compared to magnesium sulphate will attenuate the hemodynamic response during laryngoscopy &<br> endotracheal intubation in patients undergoing valvular heart replacement.<br> Methods: This was a double blind, randomised, single centre, interventional, prospective study. In this study 96 patients were divided<br> into two groups with 48 patients each (n = 48) by sealed enveloped method of randomisation. Group E received esmolol 1.5 mg/ kg i.v<br> and Group M received magnesium sulphate 50 mg/ kg i.v each diluted in normal saline to make up a volume of 50 ml & given via infusion<br> slowly over 5 minutes by a burette set. Hemodynamic parameters like Heart Rate (HR), Mean Arterial Pressure (MAP), Systolic Blood<br> Pressure (SBP), Diastolic Blood Pressure (DBP) at baseline, 5 minutes after premedication, just before intubation 3, 5, 10 & 15 minutes<br> post intubation were recorded. The last observation at the end of 15 minutes post intubation was considered as the end of study.<br> Results: All the enrolled patients were analyzed. The esmolol group showed a decrease in the H.R from baseline (86.13 ± 15.87)<br> as compared to magnesium sulphate (98.51 ± 16.81 with a 95% CI, 4.62-4.69, p value < 0.001) 5 minute after premedication. There was<br> statistically signifi cant difference in H.R between both groups 5 minutes after drug administration.<br> Conclusion: Administration of esmolol before intubation in valvular heart patients undergoing valve replacement surgery controls the<br> hemodynamic response much better as compared to magnesium sulphate.</p>
ScienceDex guides
Understand access before you commit
These curated guides explain access requirements, typical timelines, costs, and reuse considerations for widely used research datasets.
Allen Brain Atlas
Allen Brain Atlas is an Allen Institute collection of brain map atlases, datasets, APIs, and analysis tools covering mouse, human, and non-human primate brain resources.
Annotated Behaviour and Observability Dataset (ABODe)
ABODe is a University of Edinburgh DataShare dataset for behavior classification in group-housed mice using home-cage video, identities, bounding boxes, ground-plate positions, and annotator labels.
DANDI Archive for NWB datasets
DANDI is a BRAIN Initiative archive for publishing and sharing neurophysiology data, including electrophysiology, optophysiology, and behavioral data packaged as NWB and related standards.
International Brain Laboratory public data
The International Brain Laboratory public data releases expose standardized mouse decision-making experiments, including Neuropixels recordings, widefield calcium imaging, behavior, and session metadata accessed through the ONE API.
OpenNeuro
OpenNeuro is a free, open platform for sharing neuroimaging datasets, with public search, dataset pages, and download paths for web, S3, DataLad, and the OpenNeuro CLI.