baseline trial
Recently Published Documents


TOTAL DOCUMENTS

25
(FIVE YEARS 7)

H-INDEX

5
(FIVE YEARS 0)

2021 ◽  
Vol 13 (16) ◽  
pp. 9089
Author(s):  
Federico Orsini ◽  
Mariaelena Tagliabue ◽  
Giulia De Cet ◽  
Massimiliano Gastaldi ◽  
Riccardo Rossi

Real-time coaching programs are designed to give feedback on driving behavior to usage-based motor insurance users; they are often general purpose programs that aim to promote smooth driving. Here, we investigated the effect of different on-board real-time coaching programs on the driving behavior on highway deceleration lanes with a driving simulator experiment. The experiment was organized into two trials. The first was a baseline trial, in which participants drove without receiving any feedback; a cluster analysis was then performed to divide participants into two groups, based on their observed driving style. One month later, a second trial was carried out, with participants driving on the same path as the first trial, this time receiving contingent feedback related to their braking/acceleration behavior. Four feedback systems were tested; overall, there were eight experimental groups, depending on the clustered driving style (aggressive and defensive), feedback modality (visual and auditory), and feedback valence (positive and negative). Speed, deceleration, trajectory, and lateral control variables, collected before and onto the deceleration lane, were investigated with mixed ANOVAs, which showed that the real-time coaching programs significantly reduced speeds and maximum deceleration values, while improving lateral control. A change toward a safer exit strategy (i.e., entering the lane before starting to decelerate) was also observed in defensive drivers.


Author(s):  
Moriz Herzberg ◽  
Korbinian Scherling ◽  
Robert Stahl ◽  
Steffen Tiedt ◽  
Frank A. Wollenweber ◽  
...  

Abstract Background and Purpose To provide real-world data on outcome and procedural factors of late thrombectomy patients. Methods We retrospectively analyzed patients from the multicenter German Stroke Registry. The primary endpoint was clinical outcome on the modified Rankin scale (mRS) at 3 months. Trial-eligible patients and the subgroups were compared to the ineligible group. Secondary analyses included multivariate logistic regression to identify predictors of good outcome (mRS ≤ 2). Results Of 1917 patients who underwent thrombectomy, 208 (11%) were treated within a time window ≥ 6–24 h and met the baseline trial criteria. Of these, 27 patients (13%) were eligible for DAWN and 39 (19%) for DEFUSE3 and 156 patients were not eligible for DAWN or DEFUSE3 (75%), mainly because there was no perfusion imaging (62%; n = 129). Good outcome was not significantly higher in trial-ineligible (27%) than in trial-eligible (20%) patients (p = 0.343). Patients with large trial-ineligible CT perfusion imaging (CTP) lesions had significantly more hemorrhagic complications (33%) as well as unfavorable outcomes. Conclusion In clinical practice, the high number of patients with a good clinical outcome after endovascular therapy ≥ 6–24 h as in DAWN/DEFUSE3 could not be achieved. Similar outcomes are seen in patients selected for EVT ≥ 6 h based on factors other than CTP. Patients triaged without CTP showed trends for shorter arrival to reperfusion times and higher rates of independence.


Pain Medicine ◽  
2021 ◽  
Author(s):  
Tibor M Szikszay ◽  
Juliette L M Lévénez ◽  
Janne von Selle ◽  
Waclaw M Adamczyk ◽  
Kerstin Luedtke

Abstract Objective Endogenous pain modulation can be quantified through the use of various paradigms. Commonly used paradigms include conditioned pain modulation (CPM), offset analgesia (OA), spatial summation of pain (SSP), and temporal summation of pain (TSP), which reflect spatial and temporal aspects of pro- and antinociceptive processing. Although these paradigms are regularly used and are of high clinical relevance, the underlying physiological mechanisms are not fully understood. Design The aim of this study is therefore to assess the association between these paradigms by using comparable protocols and methodological approaches. Setting University campus. Subjects Healthy and pain-free volunteers (n = 48) underwent psychophysical assessment of CPM, OA, SSP, and TSP (random order) at the same body area (volar nondominant forearm) with individualized noxious stimuli. Methods CPM included heat stimuli before, during, and after a noxious cold-water bath, whereas for OA, three heat stimuli were applied: baseline trial, offset trial, and constant trial. For the SSP paradigm, two differently sized heat stimulation areas were evaluated, whereas for TSP, the first and last stimulus of 10 consecutive short heat stimuli were assessed. A computerized visual analog scale was used to continuously evaluate pain intensity. The magnitudes of all associations between all paradigm pairs were analyzed with Spearman’s correlation, and individual influencing factors were assessed with a multivariate linear regression model. Results Weak to moderate correlations among all four paradigms were found (P > 0.05), and no distinct influencing factors were identified. Conclusions A limited association between pain modulation paradigms suggests that CPM, OA, SSP, and TSP assess distinct aspects of endogenous analgesia with different underlying physiological mechanisms.


Author(s):  
Simone S. Fricke ◽  
Hilde J. G. Smits ◽  
Cristina Bayón ◽  
Jaap H. Buurke ◽  
Herman van der Kooij ◽  
...  

Abstract Background Recently developed controllers for robot-assisted gait training allow for the adjustment of assistance for specific subtasks (i.e. specific joints and intervals of the gait cycle that are related to common impairments after stroke). However, not much is known about possible interactions between subtasks and a better understanding of this can help to optimize (manual or automatic) assistance tuning in the future. In this study, we assessed the effect of separately assisting three commonly impaired subtasks after stroke: foot clearance (FC, knee flexion/extension during swing), stability during stance (SS, knee flexion/extension during stance) and weight shift (WS, lateral pelvis movement). For each of the assisted subtasks, we determined the influence on the performance of the respective subtask, and possible effects on other subtasks of walking and spatiotemporal gait parameters. Methods The robotic assistance for the FC, SS and WS subtasks was assessed in nine mildly impaired chronic stroke survivors while walking in the LOPES II gait trainer. Seven trials were performed for each participant in a randomized order: six trials in which either 20% or 80% of assistance was provided for each of the selected subtasks, and one baseline trial where the participant did not receive subtask-specific assistance. The influence of the assistance on performances (errors compared to reference trajectories) for the assisted subtasks and other subtasks of walking as well as spatiotemporal parameters (step length, width and height, swing and stance time) was analyzed. Results Performances for the impaired subtasks (FC, SS and WS) improved significantly when assistance was applied for the respective subtask. Although WS performance improved when assisting this subtask, participants were not shifting their weight well towards the paretic leg. On a group level, not many effects on other subtasks and spatiotemporal parameters were found. Still, performance for the leading limb angle subtask improved significantly resulting in a larger step length when applying FC assistance. Conclusion FC and SS assistance leads to clear improvements in performance for the respective subtask, while our WS assistance needs further improvement. As effects of the assistance were mainly confined to the assisted subtasks, tuning of FC, SS and WS can be done simultaneously. Our findings suggest that there may be no need for specific, time-intensive tuning protocols (e.g. tuning subtasks after each other) in mildly impaired stroke survivors.


2019 ◽  
Vol 21 (4) ◽  
pp. 14-16
Author(s):  
Sue Cowley

A Freedom of Information request to find out more about the baseline trial is raising questions about the test's validity, reliability and implications for workload. When will the DfE admit it is in trouble?


2019 ◽  
Vol 104 (6) ◽  
pp. e21.2-e22
Author(s):  
B Aurich ◽  
V Elie ◽  
E Jacqz-Aigrain

BackgroundProtocol development for neonatal or paediatric clinical trials needs to take into account the age group specifics of the study population (e.g. pharmacokinetics, reference values for laboratory data and vital signs). Drug safety and risk management for neonatal/paediatric trials require an understanding of how these change throughout childhood. We were interested in reviewing and summarising the literature to identify publications which provide researchers with practical information of how the neonatal/paediatric drug safety profile informs age group specific safety data collection and risk management in the protocol.MethodsPubmed, Embase and regulatory authority (RA) websites were searched for publications up to 31/12/2018 for children (0–18 years). In addition, the bibliography of included publications was reviewed to identify additional publications.ResultsRA websites provided general and disease specific guidance on neonatal/paediatric clinical trials with sections relating to drug safety. No publication was identified describing the practicalities of how the neonatal/paediatric drug safety profile can be included throughout the various sections of a clinical trial protocol. The existing literature was summarised providing an overview of how the neonatal/paediatric drug safety profile supports the development of the various protocol sections. For example laboratory values in the exclusion criteria and safety monitoring sections need to be adjusted for age. Vital sign and psychomotor assessment should be done at least at baseline, trial completion and follow-up. Monitoring of adverse events of interest requires consideration of how these may present in neonatal/paediatric patients.ConclusionsIn order to support the protocol development with regards to neonatal/paediatric drug safety a dual competence in both paediatrics and drug safety is required. This review provides an overview of the practical aspects related to neonatal/paediatric drug safety during protocol development.Disclosure(s)Nothing to disclose


2018 ◽  
Vol 13 (8) ◽  
pp. 1097-1099 ◽  
Author(s):  
Jan Kodejška ◽  
Jiří Baláš ◽  
Nick Draper

Purpose: To determine the effect of 2 cold-water-immersion (CWI) temperatures (15°C and 8°C) on repeat handgrip performance to failure. Methods: A total of 32 participants completed 3 intermittent trials to failure on a climbing-specific handgrip dynamometer on 3 laboratory visits. For each visit, a different recovery strategy was employed: passive (PAS) recovery, CWI at 8°C (CW8), or CWI at 15°C (CW15). The force time integral (FTI: time of contraction multiplied by the force of contraction) was determined to assess handgrip performance. Results: There was no significant difference between recovery strategies at the end of trial 1. In response to the PAS recovery strategy, there were 10% and 22% decreases in FTI in the second and third trials, respectively. The PAS recovery-strategy FTI values were lower than both CWI strategies for trials 2 and 3 (P < .05). FTI increased in the second trial (↑32% and ↑38%; P < .05) for both immersion strategies (CW8 and CW15, respectively) compared with trial 1. During the third trial, FTI was significantly higher for CW15 than CW8 (↑27% and ↓4% with respect to baseline trial; P < .05). Conclusions: The results suggest that CWI has potential performance advantages over PAS recovery for rock climbing. The data show that in events where multiple recoveries are required, 15°C CWI may be more beneficial for climbers than 8°C CWI. Future research should focus on the optimization of protocols for sport performance.


2017 ◽  
Author(s):  
Eric Giesberg

The relevant issue with monitoring and measuring ship performance is the measurement of speed through the water. In 2016 an ADCP was mounted on a US Navy ship for the purposes of a hull monitoring program. At the onset of the program a baseline trial was completed to both determine the clean hull performance of the ship and the performance of the ADCP on a surface ship. The trial included completing reciprocals using standard calculations and ’triangles’ using more advanced calculations to calculate speed through the water. The results from the ADCP, maneuvers, EMLog, and surface based HFRadar corrections are compared in this report and examined for agreement and repeatability. The ADCP performed successfully showing strong agreement and repeatability though strong concerns still exist for long term viability. The EMLog was found to have issues beyond calibration offsets. The surface based HFRadar appears to be a passable correction method that may be of more benefit for measurement of ship maneuvers. The new method for analyzing GPS/INS speed over the ground data presented in this report is shown to have good agreement with the ADCP with the added advantage over the classic calculation by generating an associated uncertainty with the speed.


Sign in / Sign up

Export Citation Format

Share Document