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467 results for “Trial Data”
Data from: Integrated wildlife monitoring, a pilot trial in Spain
<p>This study aims to report the implementation of the first nationwide pilot trial of balanced IWM in Europe, using a network of 11 pilot monitoring sites in Spain. The insights obtained in this pilot IWM trial will help to further develop a comprehensive IWM and serve as a reference for implementing IWM systems in other regions. For this purpose, a grid of 20 camera traps (Browning Strike Force HD ProX, Browning Arms Company®, Morgan, Utah, USA) was deployed for two months at each study site (n=11). REM was applied to wild boar (<em>Sus scrofa</em>), red deer (<em>Cervus elaphus</em>), and red fox (<em>Vulpes vulpes</em>) as the most frequently detected species. Relative abundance indexes, namely trapping rate and relative occupancy index, were calculated for the remaining, less frequently detected species.</p> <p>Files include the data necessary for the estimation of the population density by REM (DataREMZenodo.xlsx), data on indirect interactions recorded by camera traps at the pilot monitoring site level (DataIntZenodo.xlsx), and the metadata of the images (Metadata_imagesbyPP.xlsx).</p> <p> </p>
Continuous Digital Monitoring of Walking Speed in Frail Elderly Patients: Noninterventional Validation Study and Longitudinal Clinical Trial (Data for interventional clinical trial)
<p>Digital technologies and advanced analytics have drastically improved our ability to capture and interpret health relevant data from patients. However, to date, limited data and results have been published detailing real-world patient compliance, demonstrating accuracy in target indications or examining what novel insights and clinical value can be derived. Here we present novel, digital mobility data from two studies: an independent, non-interventional validation study with elderly, naturally slow walking subjects, and a global, multi-site phase IIb clinical trial involving patients with age-related muscle loss and slow walking speed (sarcopenia). Based on these data, we validate the accuracy of a novel algorithm for capturing in-clinic and real-world gait speed in frail, slow-walking adults. We demonstrate the feasibility of continuous monitoring with a wearable inertial sensor in elderly adults in real-world settings, and propose minimum thresholds for compliance required for robust capture of gait behaviors in this population. We also show how simple, inferred contextual information, describing the length of a given walking bout, can explain some of the variation in real-world gait speed, and use this information to demonstrate for the first time a relationship between in-clinic performance and real-world gait speed behavior. This work lays a foundation for exploration of the clinical relevance and value of such measures and is a first step in building a more complete chain of evidence between standardized physical performance assessment, real-world behavior, and subjective perceptions of mobility, independence and health.</p> <p>This dataset contains data collected during the interventional clinical trial: derived data from raw accelerometry data, and summary performance data.</p> <p>The full dataset, including raw accelerometry data, is available here: <a href="https://mueller-et-al-2019.s3.amazonaws.com/index.html">https://mueller-et-al-2019.s3.amazonaws.com/index.html</a></p>
Data from: 8-way randomized controlled trial of doxylamine, pyridoxine and dicyclomine for nausea and vomiting during pregnancy: restoration of unpublished information
Objectives: We report information about an unpublished 1970s study ("8-way" Bendectin Study) that aimed to evaluate the relative therapeutic efficacy of doxylamine, pyridoxine, and dicyclomine in the management of nausea and vomiting during pregnancy. We are publishing the trial's findings according to the restoring invisible and abandoned trials (RIAT) initiative because the trial was never published. Design: Double blinded, multi-centred, randomized placebo-controlled study. Setting: 14 clinics in the United States. Participants: 2308 patients in the first 12 weeks of pregnancy with complaints of nausea or vomiting were enrolled. Interventions: Each patient was randomized to one of eight arms: placebo, doxylamine/pyridoxine/dicylcomine, doxylamine/pyridoxine, dicylomine/pyridoxine, doxylamine, dicyclomine/pyridoxine, pyridoxine and dicyclomine. Each patient was instructed to take 2 tablets at bedtime and 1 additional tablet in the afternoon or morning if needed, for 7 nights. Outcomes: Reported outcomes included the number of hours of nausea reported by patients, the frequency of vomiting reported by patients and the overall efficacy of medication as judged by physicians. Results: Data from 1599 (69% of those randomized) participants were analyzed. Based on the available summary data of physician evaluation of symptoms and ignoring missing data and data integrity issues, the proportion of participants who were "evaluated moderate or excellent" was greater in each of the seven active treatment groups when compared with placebo (57%): doxylamine/pyridoxine/dicylcomine (14% absolute difference versus placebo; 95% CI: 4 to 24), doxylamine/pyridoxine (21; 95% CI 11 to 30), dicylomine/pyridoxine (21; 95% CI 11 to 30), doxylamine (20; 95% CI 10 to 29), dicyclomine/pyridoxine (4; 95% CI -6 to 14), pyridoxine (9; 95% CI -1 to 19) and dicyclomine (4; 95% CI -6 to 14). Based on incomplete information, the most common adverse events were apparently drowsiness and fatigue. There is a high risk of bias in these previously unpublished results given the high attrition rate in a 7 day trial, the lack of prespecified outcomes or analyses, and the exclusion of some data because of questionable data integrity. Conclusion: The available information about this "8-way Bendectin" trial indicates it should not be used to support the efficacy of doxylamine, pyridoxine or dicyclomine for the treatment of nausea and vomiting during pregnancy because of a high risk of bias.
Data from: Conventional analysis of trial-by-trial adaptation is biased: empirical and theoretical support using a Bayesian estimator
Research on human motor adaptation has often focused on how people adapt to self-generated or externally-influenced errors. Trial-by-trial adaptation is a person's response to self-generated errors. Externally-influenced errors applied as catch-trial perturbations are used to calculate a person's perturbation adaptation rate. Although these adaptation rates are sometimes compared to one another, we show through simulation and empirical data that the two metrics are distinct. We demonstrate that the trial-by-trial adaptation rate, often calculated as a coefficient in a linear regression, is biased under typical conditions. We tested 12 able-bodied subjects moving a cursor on a screen using a computer mouse. Statistically different adaptation rates arise when sub-sets of trials from different phases of learning are analyzed from within a sequence of movement results. We propose a new approach to identify when a person's learning has stabilized in order to identify steady-state movement trials from which to calculate a more reliable trial-by-trial adaptation rate. Using a Bayesian model of human movement, we show that this analysis approach is more consistent and provides a more confident estimate than alternative approaches. Constraining analyses to steady-state conditions will allow researchers to better decouple the multiple concurrent learning processes that occur while a person makes goal-directed movements. Streamlining this analysis may help broaden the impact of motor adaptation studies, perhaps even enhancing their clinical usefulness.
Data from: Perioperative medication management: expanding the role of the preadmission clinic pharmacist in a single centre, randomised controlled trial of collaborative prescribing
Objectives: Current evidence to support non-medical prescribing is predominantly qualitative, with little evaluation of accuracy, safety and appropriateness. Our aim was to evaluate a new model of service for the Australia healthcare system, of inpatient medication prescribing by a pharmacist in an elective surgery pre admission clinic (PAC) against usual care, using an endorsed performance framework. Design: Single centre, randomised controlled, two arm trial Setting: Elective surgery pre admission clinic in Brisbane based tertiary hospital Participants: Four hundred adults scheduled for elective surgery were randomised to intervention or control. Intervention: A pharmacist generated the inpatient medication chart to reflect the patient's regular medication, made a plan for medication perioperatively and prescribed VTE prophylaxis. In the control arm, the medication chart was generated by the Resident Medical Officers (RMO). Outcome Measures: Primary outcome was frequency of omissions and prescribing errors when compared against the medication history. The clinical significance of omissions was also analysed. Secondary outcome was appropriateness of VTE prophylaxis prescribing. Results: There were significantly less unintended omissions of medications: 11 of 887 (1.2%) intervention orders compared with 383 of 1217 (31.5%) control (p<0.001). There were significantly less prescribing errors involving selection of drug, dose or frequency: 2 in 857 (0.2%) intervention orders compared with 51 in 807 (6.3%) control (p<0.001). Orders with at least one component of the prescription missing, incorrect or unclear occurred in 20826 of 904 (235%) intervention orders and 445667 of 1034 (4364.5%) control (p<0.001). VTE prophylaxis on admission to the ward was appropriate in 93% of intervention patients and 90% control (p=0.29). Conclusion: Medication charts in the intervention arm contained fewer clinically significant omissions, and prescribing errors, when compared to control. There was no difference in appropriateness of VTE prophylaxis on admission between the two groups. Trial Registration: Registered with ANZCTR – ACTR Number ACTRN12609000426280
Data from: Can recombinant human thrombomodulin increase survival among patients with severe septic-induced disseminated intravascular coagulation: a single-centre, open-label, randomised controlled trial
Objective: To determine whether treatment with recombinant human thrombomodulin (rhTM) increases survival among severe septic patients with sepsis-induced disseminated intravascular coagulation (DIC) Design: Single-center, open-label, randomized controlled trial Setting: Single tertiary hospital Participant: 92 severe septic patients with sepsis-induced DIC Interventions: Patients with DIC scores ≥4, as defined by the Japanese Association of Acute Medicine, were diagnosed with DIC. Randomization was performed by the envelope method. The treatment group (rhTM group, n = 47) was intravenously treated with rhTM within 24 h of admission (day 0), and the control group (n = 45) did not receive any anti-coagulants, except in cases of deep venous thrombosis and pulmonary embolism. Primary and secondary measurements: Data were collected on days 0 (admission), 1, 2, 3, 5, 7, and 10. The primary outcome was survival at 28 and 90 days. The secondary endpoints comprised changes in DIC scores, platelet counts, D-dimer, antithrombin III (ATIII), and C-reactive protein (CRP) levels, and Sequential Organ Failure Assessment (SOFA) scores. All analyses were conducted on an intent-to-treat basis. Main Results: The 28-day survival rates were 84 and 83% in the control and rhTM groups, respectively (p = 0.745, log rank test). The 90-day survival rates were 73% and 72% in the control and rhTM groups, respectively (p = 0.94, log rank test). Meanwhile, the rates of recovery from DIC (<4) were significantly higher in the rhTM group than in the control group (p = 0.001, log rank test). Relative change from baseline of D-dimer levels were significantly lower in the rhTM group than in the control group, on day 3 and 5. Conclusion: rhTM treatment decreased D-dimer levels and facilitated DIC recovery in severe septic patients with sepsis-induced DIC. However, the treatment did not improve survival in this cohort.
Data from: Validation of the GARD™skin assay for assessment of chemical skin sensitizers – ring trial results of predictive performance and reproducibility
Proactive identification of chemicals with skin sensitizing properties is a key toxicological endpoint within chemical safety assessment. In order to meet recent legislations and increase animal welfare, considerable efforts have been made to develop non-animal approaches to replace current animal testing. Genomic Allergen Rapid Detection (GARD™) is a state-of-the-art technology platform, the most advanced application of which is the assay for assessment of skin sensitizing chemicals, GARD™skin. The methodology is based on a dendritic cell (DC)-like cell line, thus mimicking the mechanistic events leading to initiation and modulation of downstream immunological responses. Induced transcriptional changes are measured following exposure to test chemicals, providing a detailed evaluation of cell activation. These changes are associated with the immunological decision-making role of DCs in vivo and include among other phenotypic modifications, up-regulation of co-stimulatory molecules, induction of cellular and oxidative stress pathways and xenobiotic responses. Here, results from an inter-laboratory ring trial of GARD™skin, conducted in compliance with OECD guidance documents and comprising a blinded chemical test set of 28 chemicals, are summarized. The assay was found to be transferable to naïve laboratories, with an inter-laboratory reproducibility of 92.0%. The within-laboratory reproducibility ranged between 82.1-88.9%, while the cumulated predictive accuracy across the three laboratories was 93.8%. Based on these and previously published data, it is concluded that GARD™skin is a robust and reliable method for the identification of skin sensitizing chemicals and suitable for use as a stand-alone assay. These data form the basis for the regulatory validation of GARD™skin.
Data from: Do urology journals enforce trial registration? A cross-sectional study of published trials
OBJECTIVES: Trial registration can increase scientific transparency, but its implementation in specialty fields such as urology is unclear. We aimed to assess the endorsement of trial registration in the author instructions of urology-related journals and to assess whether randomized controlled trials (RCTs) in the field were effectively registered. DESIGN: Cross-sectional study of published trials. SETTING: We first assessed the author instructions of urology-related journals indexed in 'Journal Citation Reports 2009' (12/2010). Second, we divided the results into two groups of five journals each, all with high impact factors either requiring or not mentioning trial registration as a precondition for publication. We then performed a MEDLINE search to identify RCTs published in these 10 journals in 2009 (01/2011) and searched the clinical trials meta-search interface of the World Health Organization (ICTRP) for RCTs without information about registration (01–03/2011). Two authors independently assessed information regarding editorial advice about trial registration and identified the RCTs. RESULTS: Of 55 journals included, 26 (47.3%) contained some editorial advice about trial registration. Journals with high impact factors were more likely to mention trial registration directly (p=0.015). Of 106 RCTs published in 2009, 63 were registered (59.4%) with a tendency to an increase after 2005 (83.3%, p=0.035). 71.4% (30/42) of the RCTs that were published in journals mentioning and requiring registration, and 51.6% (33/64) of the RCTs that were published in journals that did not mention trial registration directly were registered. This difference was statistically significant (p=0.04). CONCLUSION: A statement of trial registration in author instructions resulted in a higher proportion of registered RCTs. Journals with high impact factors were more likely to mention trial registration. We suggest, though, that ensuring trial registration is not the responsibility only of the editors. Medical scientists should realize that trial registration is necessary to contribute to transparency in research.
Data from: An investigation of the therapeutic effects of statins with metformin on polycystic ovary syndrome: a meta-analysis of randomized controlled trials
Objectives: To investigate the therapeutic effects of statins with metformin on polycystic ovary syndrome (PCOS). Settings: Endocrinology department. Participants: MEDLINE, EMBASE and Cochrane Central Register of Controlled Trials were searched until October 2014. Studies comparing statins and placebo, as well as the combination of statins and metformin and metformin alone, were included in the analysis. Interventions: Data were independently extracted by two researchers; any convergence was resolved by a third reviewer. Primary and secondary outcome measures: The following properties were extracted from the qualified trials to identify the effects of statins: clinical variables, metabolic characteristics, hormone outcomes, sign of inflammation, glucose parameters and insulin outcomes. Results: Data from four trials comparing statin and metformin with metformin alone were analysed. The combination of statins and metformin decreases the levels of C reactive protein (standardised mean difference (SMD) −0.91; 95% CI −1.81 to −0.02; p=0.046), triglyceride (SMD −1.37; 95% CI −2.46 to −0.28; p=0.014), total cholesterol (SMD −1.28; 95% CI −1.59 to −0.97; p=0.000) and low-density lipoprotein (LDL) cholesterol (SMD −0.74; 95% CI −1.03 to −0.44; p=0.000). However, the combined therapy fails to reduce fasting insulin (SMD −0.92; 95% CI −2.07 to 0.24; p=0.120), homeostasis model assessment of insulin resistance (SMD −1.15; 95% CI −3.36 to 1.06; p=0.309) and total testosterone (SMD −1.12; 95% CI −2.29 to 0.05; p=0.061). Analysis of the five trials comparing statin with placebo shows that statin monotherapy reduces LDL-cholesterol, triglyceride and total cholesterol. Conclusions: Combined statin and metformin therapy can improve lipid and inflammation parameters, but cannot effectively improve insulin sensitivity and reduce hyperandrogenism in women with PCOS. A large-scale randomised controlled study must be conducted to ascertain the long-term effects of the therapy.
Raw Data for the article: Donor Simvastatin Treatment Is Safe and Might Improve Outcomes After Liver Transplantation: A Randomized Clinical Trial
<p><strong>Background: </strong>The current curative approaches for ischemia/reperfusion injury on liver transplantation are still under debate for their safety and efficacy in patients with end-stage liver disease. We present the SIMVA statin donor treatment before Liver Transplants study.</p> <p><strong>Methods: </strong>SIMVA statin donor treatment before Liver Transplants is a monocentric, double-blind, randomized, prospective tial aiming to compare the safety and efficacy of preoperative brain-dead donors' treatment with the intragastric administration of 80 mg of simvastatin on liver transplant recipient outcomes in a real-life setting. Primary aim was incidence of patient and graft survival at 90 and 180 d posttransplant; secondary end-points were severe complications.</p> <p><strong>Results: </strong>The trial enrolled 58 adult patients (18-65 y old). The minimum follow-up was 6 mo. No patient or graft was lost at 90 or 180 d in the experimental group (n = 28), whereas patient/graft survival were 93.1% ( P = 0.016) and 89.66% ( P = 0.080) at 90 d and 86.21% ( P = 0.041) and 86.2% ( P = 0.041) at 180 d in the control group (n = 29). The percentage of patients with severe complications (Clavien-Dindo ≥IIIb) was higher in the control group, 55.2% versus 25.0% in the experimental group ( P = 0.0307). The only significant difference in liver tests was a significantly higher gamma-glutamyl transferase and alkaline phosphatase at 15 d ( P = 0.017), ( P = 0.015) in the simvastatin group.</p> <p><strong>Conclusions: </strong>Donor simvastatin treatment is safe, and may significantly improve early graft and patient survival after liver transplantation, although further research is mandatory.</p>
my data trials for bci with different name
<p>Changing the names of the files to try changing less of the original code.</p>
Diabetes Data-Assisted Remission Trial (DDART)
ClinicalTrials.gov study NCT04663061. IPD Sharing: YES. Countries: 1. Publications: 0.
Data Analysis of a Managed Care Weight Reduction Trial
ClinicalTrials.gov study NCT00674180. IPD Sharing: Not stated. Countries: 0. Publications: 2.
Trial to Collect Safety Data and Sera for Immunogenicity Testing
ClinicalTrials.gov study NCT00389857. IPD Sharing: Not stated. Countries: 1. Publications: 0.
Phase IV Trial to Collect Safety Data and Sera for Immunogenicity Testing in Healthy Children Given Fluzone® Vaccine
ClinicalTrials.gov study NCT00561002. IPD Sharing: Not stated. Countries: 1. Publications: 0.
The Step Home Trial: Utilising Physical Activity Data in the Acute Post-operative Setting
ClinicalTrials.gov study NCT02583711. IPD Sharing: Not stated. Countries: 1. Publications: 0.
Statistical Analysis Plan for an Individual Patient Data Meta-analysis of Three, International Trials Comparing Protocolised With Usual Resuscitation in Patients Presenting to the Emergency Department
ClinicalTrials.gov study NCT02030158. IPD Sharing: Not stated. Countries: 0. Publications: 6.
Phase IV Trial to Collect Safety Data and Sera in Healthy Children Given Fluzone Vaccine
ClinicalTrials.gov study NCT00258817. IPD Sharing: Not stated. Countries: 1. Publications: 0.
Data from: Placebo effects in trials evaluating 12 selected minimally invasive interventions: a systematic review and meta-analysis
Open the record for dataset details and reuse information.
Data from: Impact of the modality of mechanical ventilation on bleeding during pituitary surgery: A single blinded randomized trial
Open the record for dataset details and reuse information.
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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.