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Comparative study between Dexmedetomidine with Bupivacaine and Bupivacaine alone in erector spinae plane block for postoperative pain control of posterior lumbosacral spine fixation surgeries: A randomized controlled trial
<p><strong><span>2. </span></strong><strong><span>Materials and Methods</span></strong></p> <p><strong><span>2.1. Participants</span></strong></p> <p><span>Patients above 18 years old of either sex submitted for elective posterior lumbosacral spine fixation and fusion surgery were eligible to participate if they were classified as ASA I-III according to the American Society of Anesthesiologists (ASA) classification. The surgery was done on all the patients by the same neurosurgical team and using the same surgical techniques. The exclusion criteria included patient refusal, hypersensitivity to the drugs used in the study, patients with any contraindication to regional anesthesia, such as skin infections at the site of the block, and patients with a history of bleeding disorders or receiving anticoagulant medications. All patients were screened for eligibility criteria. Eligible patients were asked for voluntary informed consent to participate in the trial.</span></p> <p><strong><span>2.2 Study design</span></strong></p> <p><span>This double-blind, randomized controlled trial was carried out on 90 patients on October 6 University Hospitals. It was conducted from November 2022 to July 2023. The study was approved by the Clinical Research Ethical Committee of October 6 University Hospitals (approval number PRC-Me-2210035). It was registered online at ClinicalTrials.gov Identifier: NCT05590234. All patients who participated in this study had to sign a detailed, informed, written anesthesia and surgery consent. </span></p> <p><strong><span>2.3. Randomization and allocation </span></strong></p> <p><span>Patients were randomly allocated using a random allocation sequence by a web-based program. Participants were randomized to three groups in a 1:1:1 ratio. Each group consisted of 30 patients. Dexmedetomidine Bupivacaine ESPB group (<a name="_Hlk145148479"></a>DB group) receive <a name="_Hlk145148507"></a>0.5 ug/kg dexmedetomidine plus 20 mL of bupivacaine 0.25%, Bupivacaine ESPB group (<a name="_Hlk145148593"></a>B group) receive 20 mL of bupivacaine 0.25%, and Saline ESPB (S group) which is the Control group receive 20 ml of normal saline 0.9%. The block procedure was done bilaterally in the three groups. Neither patients nor investigators knew the group in which the patients were placed, and the type of intervention received.</span></p> <p><strong><span>2.4. Preoperative management</span></strong></p> <p><span>All patients were assessed clinically before surgery, including full history, thorough clinical examination, and laboratory investigations. On arrival at the operating suite, patients were fully monitored (5 leads ECG, noninvasive blood pressure, and pulse oximetry). Basal readings of vital data were recorded. Intravenous access was established.</span></p> <p><strong><span>2.5. Anesthetic management</span></strong></p> <p><span>Midazolam 3 mg IV was given for sedation. Induction of anesthesia was performed with IV propofol (2mg/kg), fentanyl (1.5–2 µg/kg), and rocuronium bromide (0.6 mg/kg). Maintenance of anesthesia was done by isoflurane. The prone position was established immediately after the intubation of anesthesia. Intraoperatively, the data of (peripheral oxygen saturation, heart rate, noninvasive arterial blood pressure, and end-tidal carbon dioxide level) were recorded every five minutes throughout the operation. </span></p> <p><span>Any decrease in heart rate below 50 beats per minute was treated with intravenous atropine, according to the response. A reduction in mean blood pressure below 20% of the basal reading or systolic BP below 90 mmHg was treated with 5 mg increments of intravenous ephedrine. After the induction of anesthesia and putting the patients in the prone position, the US-guided ESPB was performed in the three groups.</span></p> <p><span>The study was conducted in a double-blind fashion where the attending anesthetist who performed the ESPB and the neurosurgical team were blind entirely to the content of the injected solution composition. The responsible anesthetist in this study was the only one not blind to the injected solution composition but was not involved in the postoperative patient assessment.<span> </span></span></p> <p><strong><span><span> </span>2.6. ESPB technique</span></strong></p> <p><span>Under strict aseptic technique, the ESPB was done in the prone position for all patients of the three groups. A sterile ultrasound curved probe (Philips ultrasound machine HD7 XE C153160013, Philips and Neusoft Medical Systems Co., Ltd. China.) was used for the technique. The ultrasound probe was placed on the third lumbar vertebral body level in the parasagittal plane. When the spinous process was first seen, the probe was moved laterally from the midline, and then the transverse process of L3 and erector spinae muscle was observed at about 2 to 3 cm from the midline (Figure 1). </span></p> <p><span>A 22 gauge/ 8 cm ultrasound-visible needle (Stimuplex, Braun AG, Melsungen, Germany) was used to make a puncture using the in-plane technique. The direction of the needle was craniocaudal, and the proper position of the needle was confirmed by injecting 2 ml of saline solution. After ensuring the position of the needle, 20 ml of 0.25% bupivacaine plus 0.5 ug/kg dexmedetomidine was administered to the DB group. The same ESPB procedure was done on the other side with the same drugs and volume. In total, 40 ml of 0.25% bupivacaine plus 1 ug/kg dexmedetomidine was administered.</span></p> <p><span>The same block procedure was done in the B group with only 20 ml of 0.25% bupivacaine on both sides (with a total volume of 40 ml). In the S group (control group), the same block procedure was done with 20 ml of 0.9% normal saline on both sides (40 ml total volume).</span></p> <p><strong><span> </span></strong></p> <p><strong><span> </span></strong></p> <p><strong><span> </span></strong></p> <p><strong><span> </span></strong></p> <p><strong><span>Figure 1. </span></strong><strong><span>Ultrasound image of ESPB.</span></strong></p> <p><strong><span> </span></strong></p> <p><span>At the end of surgery, 1 gm of paracetamol IV and 30 mg of ketorolac IV infusion were given to all the patients of the three groups. The patients were extubated after efficient spontaneous breathing and transported to the post-anesthesia care unit (PACU). Patients were discharged from the PACU to the ward with a modified Aldrete score of 12.</span></p> <p><strong><span>2.7. Postoperative pain management</span></strong></p> <p><span>The postoperative analgesic management was done using the classical protocol of our department to all patients of the three groups, which included a PCA (patient-controlled analgesia) device, and an IV of one gm paracetamol was given every eight hours for the first 48 hours postoperatively. The PCA device (Accufuser Plus <sup>®</sup><sub>REF,</sub> manufactured by Woo Young Medical Co., Ltd. Korea) has a silicon balloon infuser with a total volume of 300 ml, basal rate of 5 ml per hour, bolus 1 ml, and lockout interval every 15 minutes. </span></p> <p><span>A PCA device with morphine was attached to all the patients. The PCA infusion (300ml) consisted of 60 mg of morphine with 2 mg of granisteron and 180 mg of ketorolac. The concentration of morphine was set to 0.2 mg/ml, the loading dose was 1 mg (5 ml), the lockout interval was 15 min (bolus of 1ml/15 min), and a 1 mg/h (5ml/hr) continuous infusion was maintained for 48 hrs. IV one gm paracetamol was given every eight hours postoperatively.</span></p> <p><span>A nurse blind to the study used the visual analog scale (VAS; zero, no pain, ten = the most severe pain) to evaluate and record the pain scores and recorded the opioid consumption of the patients. The nurse recorded passive (at rest) and active (while mobilization) VAS scores at intervals of every two hours in the first 24 hours and every 4 hours in the second 24 hours and total opioid consumption for the first 48 hours postoperatively. Rescue analgesic medication was done using pethidine 50 mg IM when passive VAS pain score > 6. </span></p> <p><span>Patients who experienced pruritis, nausea, vomiting, or respiratory depression (opioid-related adverse effects) were recorded. On the first day postoperative, all patients were encouraged to ambulate in the ward after wearing lumbosacral support. The subcutaneous closed suction drainage system was removed after 36 hours. All patients were discharged home after 48 hours.</span></p> <p><strong><span>2.8. Outcome measurements</span></strong></p> <p><span>The primary clinical outcome measures were active (while mobilization) and passive (at rest) visual analog scale (VAS) pain score at the first 48 hours, measured every 2 hours in the first 24 hours and every 4 hours in the second 24 hours. </span></p> <p><span>Other clinical outcomes included opioid consumption (the number of PCA presses), the need for rescue analgesia, postoperative opioid side effects, and intraoperative dexmedetomidine side effects such as bradycardia and hypotension.</span></p> <p><strong><span>2. 9. Sample size calculation </span></strong></p> <p><span>As we have three treatment groups (S, B, DB), we performed a one-way analysis of variance (ANOVA) to assess effect size and the required number of patients per group based on the overall difference of total Fentanyl consumption (µg) means (<a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8908442/">https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8908442/</a>).<span> </span>The effect size for ANOVA is typically measured using <span>Cohen's<em><span> d</span></em> = <em><span>M</span></em><sub>1</sub> - <em><span>M</span></em><sub>2</sub> / s<sub>pooled</sub></span>, <span>where s<sub>pooled</sub> =&radic; [(s <sub>1</sub><sup>2</sup>+ s <sub>2</sub><sup>2</sup>) / 2]</span> and <strong><span>effect-size</span></strong><span> <em><span>r</span></em>= d / √ (d<sup>2</sup> + 4)[</span><a href="https://lbecker.uccs.edu/#means%20and%20standard%20deviations">https://lbecker.uccs.edu/#means%20and%20standard%20deviations</a><span>].<span> </span></span></span></p> <p><span>Given the following values: </span></p> <p><span><span>·<span> </span></span></span><span>Mean 1: 820 SD1: 102</span></p> <p><span><span>·<span> </span></span></span><span>Mean2: 641 SD2: 140</span></p> <p><span><span>·<span> </span></span></span><span>α=0.05</span></p> <p><span><span>·<span> </span></span></span><span>β=0.05 (implying a power of 0.95)</span></p> <p><strong><span>Then, Cohen's </span></strong><em><span>d: -1.46<span> </span>&<span> </span></span></em><strong><span>effect-size</span></strong><span> <em><span>r: -0.58</span></em></span></p> <p><span>In addition,</span><span> the required sample size per group is <strong>17</strong> based on the following online tool [https://homepage.univie.ac.at/robin.ristl/samplesize.php?test=anova] for </span><span>s</span><span>ample size for one-way analysis of variance.</span><span> </span></p> <p><strong><span>2.10. Statistical analysis</span></strong></p> <p><span>Data were analyzed using the statistical package for social sciences, version 20.0 (SPSS Inc., Chicago, Illinois, USA). We conducted the Shapiro-Wilk test to assess whether the numeric data followed a normal distribution or not. Quantitative normal distributed data were expressed as mean± standard deviation (SD). Qualitative data were expressed as frequency and percentage. The following tests were used: A one-way analysis of variance (ANOVA) when comparing between more than two means, Post Hoc test: Least Significant Difference (LSD) was used for multiple comparisons between different variables, and Chi-square (X<sup>2</sup>) test of significance was used to compare proportions between two qualitative parameters.<a name="2et92p0"></a><a name="3znysh7"></a> Furthermore, we performed linear and binary regression analyses to elucidate the relationship between the primary outcomes and the intervention groups (S, D, DB).</span></p> <p><span>The confidence interval was set to 95%, and the margin of error accepted was set to 5%. So, the p-value was considered non-significant when the P-value > 0.05, significant if < 0.05, and highly significant if <0.001.</span></p>
Effectiveness of a multidisciplinary approach to prevent falls and gait impairment in patients with Parkinson's disease: A randomized, longitudinal clinical trial.
<p>This graph describes the <span>short and long-term effectiveness of a multidisciplinary telemedicine program in addition to in-office usual care in non-demented patients with PD at risk for falling.</span></p>
Random Asian Statue
This was surrounded by stuff so I'm shocked it came out this swell! And shiny too! 📍 [51.53109, -0.69799](https://scaniver.se/L51.53109,-0.69799) Source: Objaverse 1.0 / Sketchfab
Climate footprint of industry-sponsored clinical research: An analysis of a phase-1 randomized clinical study and discussion of opportunities to reduce its impact
<p>Objective: To calculate the global warming potential, in carbon dioxide (CO<sub>2</sub>) equivalent emissions, from a phase-1 clinical study Design: Retrospective analysis. Data source: Internal data held by Janssen Pharmaceuticals Studies included: Janssen-sponsored TMC114FD1HTX1002 study conducted between 2019-2021 Main outcome: measure CO<sub>2</sub> equivalents for trial activities calculated according to IPCC 2021 impact assessment methodology Results: The CO2-eq emissions generated by the trial was 17.65 tonnes. This is equivalent to the emissions generated by driving the average petrol-fueled family car 71,004km or roughly 1.8 times around the circumference of the Earth. Commuting to the clinical site by the study patients generated the most emissions (5,419kg, 31% of overall emissions), followed by trial site utilities (2,725kg, 16% of overall emissions), and Janssen site staff travel (2,560kg, 15% of overall emissions). In total, the movement of people (patient travel, Janssen site staff travel, and trial site staff travel) accounted for 8,914kg or 51% of overall trial emissions. Conclusions: Opportunities exist to reduce many of the largest contributors to the clinical trial's CO<sub>2</sub>-eq emissions. The largest contributor was patient travel (31%) and combined with sponsor (15%) and site staff (5%) travel, the movement of people was responsible for 51% of CO<sub>2</sub>-eq emissions. Decentralized trial models which seek to bring clinical trial operations closer to the patient offer opportunities to reduce patient travel. The electrification of sponsor vehicle fleets and society's transition towards electric vehicles may result in further reductions.</p>
Supplementary Materials of the article:The relationship between circulating inflammatory proteins mediating gut microbiota and postherpetic neuralgia: A Mendelian Randomization study
Open the record for dataset details and reuse information.
Single-center, double-blind, randomized, placebo-controlled, single andmultiple dose escalation study to assess safety and tolerability and pharmacokinetics of HRX215 in healthy male volunteers under food and fasting conditions
<p><a name="_Hlk123284665"></a><a name="_Hlk135557103"></a><span><span>Diminished hepatocyte regeneration is a key feature of acute and chronic liver diseases and after extended liver resections, resulting in the inability to maintain or restore a sufficient functional liver mass. </span></span><span><span>Therapies to restore hepatocyte regeneration are lacking, making liver transplantation the only curative option for end stage liver disease. We here report on the structure-based development and characterization (NMR-spectroscopy) of first-in-class small molecule inhibitors of the dual specific kinase MKK4 (MKK4i). MKK4i increased liver regeneration upon hepatectomy in murine and porcine models, allowed for survival of pigs in a lethal 85% hepatectomy model and showed antisteatotic and antifibrotic effects in liver disease mouse models. A first-in-human phase I trial (EudraCT 2021-000193-28) with the clinical candidate HRX215 was conducted and revealed excellent safety and pharmacokinetics. Clinical trials to probe HRX215 for prevention/treatment of liver failure after extensive oncological liver resections or after transplantation of small grafts are warranted.</span></span></p>
A combination technique for optimal control problems constrained by random PDEs - numerical tests
<p>This dataset contains the codes used and data analyzed in the manuscript ``A combination technique for optimal control problems under uncertainty".</p> <p> </p>
Implementation and Results of a Randomized Local Search on the 2D Rectangular Bin Packing Problem with Item Rotation using Different Objective Functions
<p><strong><em>1. Introduction</em></strong></p> <p>In this archive, we provide the implementation and experimental results of a Randomized Local Search (RLS) applied to the two-dimensional bin packing problem without orientation (where items can be rotated by 90 degrees). As benchmark dataset, we use the <code>beng</code>, <code>A</code>, and <code>class</code> instances from <a href="https://site.unibo.it/operations-research/en/research/2dpacklib">2DPackLib</a> as well as the four non-trivial Almost Squares in Almost Squares (<a href="https://math.vu.nl/~sbhulai/publications/data_analytics2016b.pdf"><code>Asqas</code></a>) instances</p> <p>These are the data used in the paper below, which contains the exact specification of all algorithms, objective functions, and the encoding we applied.</p> <p>Rui Zhao, Tianyu Liang, Zhize Wu, Daan van den Berg, Matthias Thürer, and Thomas Weise. 2024. Randomized Local Search on the 2D Rectangular Bin Packing Problem with Item Rotation. In <em>Genetic and Evolutionary Computation Conference (GECCO'24 Companion),</em> July 14–18, 2024, Melbourne, VIC, Australia. ACM, New York, NY, USA, 4 pages. doi:<a href="https://doi.org/10.1145/3638530.3654139">10.1145/3638530.3654139</a>.</p> <p>To run the experiments, you need <a href="https://thomasweise.github.io/moptipyapps">moptipyapps</a> version 0.8.34 and <a href="https://thomasweise.github.io/moptipy">moptipy</a> version 0.9.98, which contain the actual algorithm implementations. Both packages are available on GitHub and on PyPI. However, we include several versions of them in the folder <code>source/packages</code>, just in case.</p> <p><strong><em>2. Directory Structure</em></strong></p> <p>This archive contains the following directories:</p> <ul> <li><code>source</code> contains the Python source codes needed to run the experiment.</li> <li><code>source/packages</code> contains the source codes of the Python packages with the actual algorithm implementations.</li> <li><code>data</code> is the directory with the results and their evaluation.</li> <li><code>data/results</code> is the directory with the log files generated by the experiment. In this folder, there are two sub-folders, <code>ibf1</code> and <code>ibf2</code>. We tested two different encodings, but found that the second one (<code>ibf2</code>) is too slow to do meaningful experiments. Thus, the experiments with it were abandoned and only one objective function was tested. We include <code>ibf2</code> for the sake of completeness, whereas <code>ibf1</code> was used in our paper. Either way, both <code>ibfX</code> folders contain one directory for each objective function applied to them. In each such directory, there is one folder (for the single algorithm applied) and this folder, in return, contains one folder per benchmark instance. The benchmark instance folders contain the three log files of the three runs that we applied to each instance/algorithm/objective combination.<br>Each log file contains information of one run, i.e., one execution of one algorithm on one problem instance. All improving moves of a run as well as the final solution are stored in the log file.</li> <li><code>data/evaluator</code> is the folder containing Python scripts that were used to evaluate these results. Two scripts are provided: <code>evaluator_short.py</code> was used for generating the tables used in the final paper version. <code>evaluator_full.py</code> provides larger tables, which could not be included in the final paper due to space reasons.</li> <li>Folder <code>evaluation_full</code> was generated using <code>evaluator_full.py</code> and contains tables and figures and a result summary in CSV format.</li> <li>Folder <code>evaluation_short</code> was generated using <code>evaluator_short.py</code> and contains both the tables used in the paper as well as a result summary in CSV format.</li> </ul> <p><strong><em>3. License</em></strong></p> <p>The files in this repository are under the <a href="https://creativecommons.org/licenses/by/4.0/legalcode">Creative Commons Attribution 4.0 International</a>, with the exception of the files of <a href="https://site.unibo.it/operations-research/en/research/2dpacklib">2DPackLib</a> and other benchmark datasets included, which are under copyright of their respective owner (we believe that they are in the public domain, as they are provided by many sources, included in many software packages under various open source licenses, and on many websites). The license is contained as file <code>LICENSE.txt</code> in this archive.</p> <p><strong><em>4. Contact</em></strong></p> <p>If you have any questions or suggestions, please contact</p> <p>Mr. Rui ZHAO (赵睿) of the Institute of Applied Optimization (应用优化研究所, <a href="http://iao.hfuu.edu.cn">IAO</a>) of the School of Artificial Intelligence and Big Data (<a href="http://www.hfuu.edu.cn/aibd/">人工智能与大数据学院</a>) at <a href="http://www.hfuu.edu.cn/english/">Hefei University</a> (<a href="http://www.hfuu.edu.cn/">合肥大学</a>) in Hefei, Anhui, China (中国安徽省合肥市) via email to <a href="mailto:zr1329142665@163.com">zr1329142665@163.com</a>.</p>
Five thousand randomly generated modular biosynthetic pathways visualised by RAIChU
<p>We randomly generated 5000 modular biosynthetic pathways to test our visualisation software RAIChU: Reaction Analysis through Illustration of Chemical Units.</p>
Datasets and relevant code in the Manuscript "Estimation of fire counts and fire radiative power using satellite optical and microwave vegetation indices with random forest method"
<p>1. multiyears_season_fire_ndvi_fwi_edvi_0.25.mat<br>Multiyear averages of ln (FC), ln (FRP), DMC, ISI, EDVI10-18, EDVI18-36, and NDVI over East Asia in 2003–2010</p> <p>2. RF_edvi_data.mat<br>Estimated FC and FRP based on RF model with EDVIs and NDVI </p> <p>3.RF_fwis_data.mat<br>Estimated FC and FRP based on RF model without EDVIs and NDVI </p> <p>4. temporal_variations.mat<br>East Asia Regional Time Series Dataset</p> <p>5.rf_train_cv_forest_review.py<br>Random forest model python code</p>
Normative feedback on performance in a closed motor skill task: A randomized controlled study
<p><span>Augmented feedback can alter motor performance. This study examines whether, in the short term, positive normative feedback influences the execution of a closed motor task differently compared to negative normative feedback and exact augmented feedback. Using a double-blind experimental design, 68 students (73.5% female, <span><em>M<sub>age</sub></em><sub> </sub></span><span></span><span>= </span><span>21.63</span>, <span><em>SD</em> = 2.88) </span>were randomized into three groups: G1 - Exact Augmented Feedback Group (</span><span>𝑛</span><span> = 21), G2 - Positive Normative Feedback Group (</span><span>𝑛</span><span> </span><span>= 24), and G3 - Negative Normative Feedback Group (</span><span>𝑛</span><span> </span><span>= 23). The dependent variable was the score obtained in a dart-throwing task. Results showed that participants receiving positive normative feedback achieved higher scores than those receiving negative normative feedback or exact augmented feedback. These differences persisted in retention and transfer tests conducted 24 hours after the practice phase but only between the positive NF group and the exact AF group. Meanwhile, the exact augmented feedback group performed similarly to the negative normative feedback group. These findings have practical implications for training and execution in motor tasks, potentially contributing to enhanced athletic performance.</span></p>
Wing with Root Holes - Hierarchical, random and bifurcation tiling with heterogeneity in micro-structures construction via functional composition.
<p>This microstructure has been created using tools and algorithms developed at the Technion, and are part of the IRIT geometric modeling kernel (<a href="https://www.cs.technion.ac.il/~irit/">https://www.cs.technion.ac.il/~irit/</a>).</p> <p>This specific wing is a functional composition of trivariate spline tiles inside a macro trivariate shape of a wing. The root tiles have through vertical holes in them.</p> <p>Model is provided in STL format.</p>
Random numbers
This is a collection of ten datasets, each containing ten iid zero-mean, unit-variance random numbers. These are used in an example of the showyourwork open source scientific article workflow.<br><br>Created using <a href="https://github.com/rodluger/showyourwork">showyourwork</a> from <a href="https://github.com/rodluger/showyourwork-template/tree/d24bc06388bd4be5038b2eef6dbc681d9d786ecf">this GitHub repo</a> using the following command:<br><br><pre><code class="language-bash">cd src/figures && python src/analysis/run_simulation.py</code></pre><br>
Data set from: Robot-Assisted Gait Training in Patients with Multiple Sclerosis: A Randomized Controlled Crossover Trial.
<p>Data set from the paper "Robot-Assisted Gait Training in Patients with Multiple Sclerosis: A Randomized Controlled Crossover Trial" doi: <a href="https://dx.doi.org/10.3390%2Fmedicina57070713">10.3390/medicina57070713</a></p>
A comparative study between Vitamin K1 and K2 on vascular calcification in hemodialysis patients: a randomized controlled trial
<p><span><span><strong>Background: </strong>Vascular calcification is a common complication of end stage renal disease patients, an important cause of cardiovascular disease and all-cause mortality. Vitamin K is essential for the activation of matrix Gla protein (MGP), a powerful inhibitor of tissue calcification. Different forms of vitamin K have been proposed to have a good impact on vascular calcification. However, clinical data are still limited on efficacy and safety of different forms of vitamin K.</span></span></p> <p><span><span><strong>Methods : </strong>A prospective, randomized, placebo-controlled study that included 120 eligible hemodialysis patients who were randomly assigned to either vitamin k1 group (10 mg phytomenadione thrice weekly) or vitamin k2 group (90 ug daily) or placebo group for 3 months. Serum MGP, calcium, phosphorus, their product, and intact parathyroid hormone (iPTH) levels, were all assessed at baseline and at the end of the study.</span></span></p> <p><span><span><b>Results:</b> There were significant increase in percentages of change in MGP levels in Vitamin k2 group (700%) compared to (78%) in Vitamin k1 & (40%) in placebo groups. No correlations observed between calcium, phosphorous and PTH and MGP levels at baseline or after treatment. None of the treatment group patients experienced any adverse effects.</span></span></p> <p><span><span><strong>Conclusion: </strong>Vitamin k supplementation was tolerable and effective with k2 form showing superiority over k1 in their impact on MGP levels among hemodialysis patients.</span></span></p> <p><span><span><b>ClinicalTrials.gov registration number:</b><b> NCT04477811</b><b>.</b></span></span></p> <p><span><span> </span></span></p>
Effect of acupuncture and metformin on insulin sensitivity in women with polycystic ovary syndrome and insulin resistance: a three-armed randomized controlled trial
<p>STUDY QUESTION</p> <p>Does acupuncture improve insulin sensitivity more effectively than metformin or sham acupuncture in women with polycystic ovary syndrome (PCOS) and insulin resistance (IR)?</p> <p>SUMMARY ANSWER</p> <p>Among women with PCOS and IR, acupuncture was not more effective than metformin or sham acupuncture in improving insulin sensitivity.</p> <p>WHAT IS KNOWN ALREADY</p> <p>Uncontrolled trials have shown that acupuncture improved insulin sensitivity with fewer side effects compared with metformin in women with PCOS and IR. However, data from randomized trials between acupuncture and metformin or sham acupuncture are lacking.</p> <p>STUDY DESIGN, SIZE, DURATION</p> <p>This was a three-armed randomized controlled trial enrolling a total of 342 women with PCOS and IR from three hospitals between November 2015 and February 2018, with a 3-month follow-up until October 2018.</p> <p>PARTICIPANTS/MATERIALS, SETTING, METHODS</p> <p>Women aged from 18 to 40 years with PCOS and homeostasis model assessment of insulin resistance (HOMA-IR) ≥2.14 were randomly assigned (n = 114 per group) to receive true acupuncture plus placebo (true acupuncture), metformin plus sham acupuncture (metformin, 0.5 g three times daily) or sham acupuncture plus placebo (sham acupuncture) for 4 months, with an additional 3-month follow-up. True or sham acupuncture was given three times per week, and 0.5 g metformin or placebo was given three times daily. The primary outcome was change in HOMA-IR from baseline to 4 months after baseline visit. Secondary outcomes included changes in the glucose AUC during an oral glucose tolerance test, BMI and side effects at 4 months after baseline visit.</p> <p>MAIN RESULTS AND THE ROLE OF CHANCE</p> <p>After 4 months of treatment, the changes of HOMA-IR were –0.5 (decreased 14.7%) in the true acupuncture group, –1.0 (decreased 25.0%) in the metformin group and –0.3 (decreased 8.6%) in the sham acupuncture group, when compared with baseline. True acupuncture is not as effective as metformin in improving HOMA-IR at 4 months after baseline visit (difference, 0.6; 95% CI, 0.1–1.1). No significant difference was found in change in HOMA-IR between true and sham acupuncture groups at 4 months after baseline visit (difference, –0.2; 95% CI, –0.7 to 0.3). During the 4 months of treatment, gastrointestinal side effects were more frequent in the metformin group, including diarrhea, nausea, loss of appetite, fatigue, vomiting and stomach discomfort (31.6%, 13.2%, 11.4%, 8.8%, 14.0% and 8.8%, respectively). Bruising was more common in the true acupuncture group (14.9%).</p> <p>LIMITATIONS, REASONS FOR CAUTION</p> <p>This study might have underestimated the sample size in the true acupuncture group with 4 months of treatment to enable detection of statistically significant changes in HOMA-IR with fixed acupuncture (i.e. a non-personalized protocol). Participants who withdrew because of pregnancy did not have further blood tests and this can introduce bias.</p> <p>WIDER IMPLICATIONS OF THE FINDINGS</p> <p>True acupuncture did not improve insulin sensitivity as effectively as metformin in women with PCOS and IR, but it is better than metformin in improving glucose metabolism (which might reduce the risk of type 2 diabetes) and has less side effects. Metformin had a higher incidence of gastrointestinal adverse effects than acupuncture groups, and thus acupuncture might be a non-pharmacological treatment with low risk for women with PCOS. Further studies are needed to evaluate the effect of acupuncture combined with metformin on insulin sensitivity in these women.</p> <p>STUDY FUNDING/COMPETING INTEREST(S)</p> <p>This work was supported by grants 2017A020213004 and 2014A020221060 from the Science and Technology Planning Project of Guangdong Province. The authors have no conflicts of interest.</p> <p>TRIAL REGISTRATION NUMBER</p> <p>Clinicaltrials.gov number: NCT02491333.</p> <p>TRIAL REGISTRATION DATE</p> <p>8 July 2015.</p> <p>DATE OF FIRST PATIENT'S ENROLLMENT</p> <p>11 November 2015.</p>
Neuromodulation of premotor and posterior parietal cortices for enhancing explicit motor sequence learning in healthy individuals: a randomized, sham-controlled crossover trial
<p>Data collected and analysed in the manuscript '<strong>Neuromodulation of premotor and posterior parietal cortices for enhancing explicit motor sequence learning in healthy individuals: a randomized, sham-controlled crossover trial', </strong>by Russo et al. PPCR. The Principles and Practice of Clinical Research, 2021</p>
Effectiveness of a multicomponent intervention consisting of education and feedback on reducing benzodiazepine prescriptions by general practitioners: BENZORED hybrid type I cluster randomized controlled trial.
<p>Complete dataset variables:</p> <p> </p> <p>GP_ID<br> Health_District<br> Health_District_name<br> PHC_ID<br> PHC_ID_name<br> Arm<br> DHD_Baseline<br> DHD_12m<br> PercentageBZD_baseline<br> PercentageBZD_12m<br> PercentageBZD_baseline_age65<br> PercentageBZD_12m_age65</p>
Appendix: Association between hemostatic profile and migraine: a Mendelian randomization analysis
<p><b>Objective: </b><span>To assess support for a causal relationship between </span>hemostatic measures and migraine susceptibility using genetic instrumental analysis.</p> <p><b>Methods: </b>Two-sample Mendelian randomization (MR) instrumental leveraging available genome-wide association study (GWAS) summary statistics was applied to hemostatic measures as potential causal for migraine and its subtypes, migraine with aura (MA) and migraine without aura (MO). Twelve blood-based measures of hemostasis were examined, including plasma level or activity of eight hemostatic factors and two <span>fibrinopeptides together with </span>two hemostasis clinical tests<span>.</span></p> <p><b>Results: </b>There were significant instrumental effects between increased coagulation factor VIII activity (FVIII, odds ratio[95% confidence interval]=1.05[1.03, 1.08]/standard deviation (SD), <i>P</i>=6.08×10<sup>-05</sup>), von Willebrand factor level (VWF, 1.05[1.03, 1.08]/SD, <i>P</i>=2.25×10<sup>-06</sup>), and phosphorylated <span>fibrinopeptide A level</span> (1.13[1.07, 1.19]/SD, <i>P</i>=5.44×10<sup>-06</sup>) with migraine susceptibility. When extended to migraine subtypes, FVIII, VWF, and phosphorylated <span>fibrinopeptide A</span> showed slightly stronger effects with MA than overall migraine. Fibrinogen level was inversely linked with MA (0.76[0.64, 0.91]/SD, <i>P</i>=2.32×10<sup>-03</sup>) but not overall migraine. None of the hemostatic factors was linked with MO. In sensitivity analysis, effects for fibrinogen and phosphorylated <span>fibrinopeptide A</span> were robust, while independent effects of FVIII and VWF could not be distinguished, and FVIIII associations were potentially affected by pleiotropy at the <i>ABO</i> locus. Causal effects from migraine to the hemostatic measures were not supported in reverse MR. However, MA was not included due to lack of instruments.</p> <p><b>Conclusions:</b> The current study supports potential causality of increased FVIII, VWF, and phosphorylated <span>fibrinopeptide A,</span> and decreased fibrinogen in migraine susceptibility, especially for MA, and may provide insights into the etiology underlying the relationship between <span>hemostasis</span> and migraine.</p>
Data set supplementing "Determinants of Laypersons' Trust in Medical Decision Aids: Randomized Controlled Trial"
<p>This is the de-identified data set used to conduct the analyses in the preprint submitted to JMIR Human Factors under the title "Determinants of Laypersons’ Trust in Medical Decision Aids: Randomized Controlled Trial" (<a href="https://doi.org/10.2196/35219">https://doi.org/10.2196/35219</a>).</p> <p>This dataset contains 494 respondents' appraisals of a fictitious case vignette. They received support from a decision aid (that always disagreed with participants' first appraisal) showing a mock symptom checker logo, a decision aid framed as anthropomorphic or as an AI. Their second appraisal - taking into account the symptom checker advice - was collected again. </p> <p>Additionally, the data contains participants'</p> <ul> <li>age</li> <li>gender</li> <li>education</li> <li>medical training</li> <li>propensity to trust</li> <li>eHealth Literacy</li> <li>certainty in their appraisals</li> <li>trust in the decision aid</li> </ul>
ScienceDex guides
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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.