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Data from: Comparison of self-perceived cardiovascular disease risk among smokers with Framingham and PROCAM scores: a cross-sectional analysis of baseline data from a randomised controlled trial
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Data from: Initiating Antiretroviral Therapy for HIV at a Patient’s First Clinic Visit: The RapIT Randomized Controlled Trial
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Synthetic Data Set for Uplift Modeling (One Trial)
<p>This dataset is designed and simulated for evaluating uplift modeling and feature selection methods.</p> <p>This dataset contains 10,000 samples and 36 features (one trial).</p> <p>The samples are equally split for control and treatment group.</p> <p>The generated data has three types of features: (1) uplift features influencing the treatment effect on the conversion probability; (2) classification features affecting the conversion probability but independent of the treatment effect; and (3) irrelevant features that are independent of both conversion probability and the treatment effect. To model the relationship between uplift features and the treatment effect and classification features and outcome probability, we implement six types of association patterns in the data generation process: linear, quadratic, cubic, ReLU (Rectified Linear Unit), trigonometric function sine, and cosine.</p> <p>In this data set, there are 36 features in total, including 10 classification features, 6 uplift features, and 20 irrelevant features.</p> <p>Column names:</p> <ul> <li>Experiment group label: 'treatment_group_key'</li> <li>Feature names: ['x1_informative',<br> 'x2_informative',<br> 'x3_informative',<br> 'x4_informative',<br> 'x5_informative',<br> 'x6_informative',<br> 'x7_informative',<br> 'x8_informative',<br> 'x9_informative',<br> 'x10_informative',<br> 'x11_irrelevant',<br> 'x12_irrelevant',<br> 'x13_irrelevant',<br> 'x14_irrelevant',<br> 'x15_irrelevant',<br> 'x16_irrelevant',<br> 'x17_irrelevant',<br> 'x18_irrelevant',<br> 'x19_irrelevant',<br> 'x20_irrelevant',<br> 'x21_irrelevant',<br> 'x22_irrelevant',<br> 'x23_irrelevant',<br> 'x24_irrelevant',<br> 'x25_irrelevant',<br> 'x26_irrelevant',<br> 'x27_irrelevant',<br> 'x28_irrelevant',<br> 'x29_irrelevant',<br> 'x30_irrelevant',<br> 'x31_uplift_increase',<br> 'x32_uplift_increase',<br> 'x33_uplift_increase',<br> 'x34_uplift_increase',<br> 'x35_uplift_increase',<br> 'x36_uplift_increase']</li> <li>Outcome variable: 'conversion'</li> <li>True underlying control conversion probability: 'control_conversion_prob'</li> <li>True underlying treatment conversion probability: 'treatment1_conversion_prob'</li> <li>True treatment effect: 'treatment1_true_effect'</li> <li>Note columns names with '_transformed' suffix are feature variables used in the intermediate steps during the data generation, that should be excluded for model training.</li> </ul>
Statistical methodologies applied to BCN02 clinical trial - Excel raw data
<p>The Excel files correspond to the raw ELISpot assay data regarding the BCN02 clinical trial.</p>
Data from: Impact of a pre-feeding oral stimulation program on first feed attempt in preterm infants: Double-blind controlled clinical trial
<p><b>Objective: </b>To evaluate the effect of an oral stimulation program in preterm on the performance in the first oral feeding, oral feeding skills and transition time from tube to total oral intake.</p> <p><b>Study Designer: </b>Double-blind randomized clinical trial including very preterm newborns. Congenital malformations, intracranial hemorrhage grade III or IV, bronchopulmonary dysplasia, and necrotizing enterocolitis were excluded. Intervention group (GI) received an oral stimulation program of tactile extra-, peri-, and intraoral tactile manipulation once a day for 15 minutes, during a 10-day period. Control group (GII) received sham procedure with same duration of time. Feeding ability was assessed by a speech-language pathologist blinded to group assignment. The classification of infants' oral performance was determined by Oral Feeding Skills (OFS). Neonates were monitored until hospital discharge.</p> <p><b>Results: </b>Seventy-four (37 in each group) were randomized. Mean gestational ages and birth weights were 30±1.4 and 30±1.5 weeks, and 1,452±330g and 1,457±353g for intervention and control groups, respectively. Mean proficiency (PRO), transfer rate (RT), and overall transfer (OT) were 41.5%±18.3 and 19.9%±11.6 (p<0.001), 2.3 mL/min and 1.1 mL/min (p<0.001), 57.2%±19.7 and 35.0%±15.7 (p<0.001) in intervention and control groups, respectively. Median transition time from tube to oral feeding was 4 (3-11) and 8 days in intervention and control groups, respectively (p=0.003). Intake of breast milk was found to reduce transition time from tube feeds to exclusive oral feeding (p<0.001, HR 1.01, 95%CI 1.005-1.019), but the impact of the study intervention remained significant (p=0.007, HR 1.97, 95%CI 1.2-3.2).</p> <p><b>Conclusion: </b>Infants who were breast-fed and an oral stimulation program proved beneficial in reducing transition time from tube feeding to oral feeding.</p> <p>ClinicalTrials.gov number NCT03025815</p>
CARE-CF-1 Clinical trial data: An exploratory, randomized, double-blind, placebo-controlled 6-arm clinical trial examining cysteamine as an adjunct therapy for the treatment of pulmonary exacerbations of cystic fibrosis
<p><em>Background:</em> Emerging data suggests a possible role for cysteamine as an adjunct treatment for pulmonary exacerbations of cystic fibrosis (CF) that continue to be a major clinical challenge. There are no studies investigating the use of cysteamine in pulmonary exacerbations of CF. This exploratory randomized clinical trial was conducted to answer the question: In future pivotal trials of cysteamine as an adjunct treatment in pulmonary exacerbations of CF, which candidate cysteamine dosing regimens should be tested and which are the most appropriate, clinically meaningful outcome measures to employ as endpoints?</p> <p><em>Methods and findings: </em>Multicentre double-blind randomized clinical trial. Adults experiencing a pulmonary exacerbation of CF being treated with standard care that included aminoglycoside therapy were randomized equally to a concomitant 14-day course of placebo, or one of 5 dosing regimens of cysteamine. Outcomes were recorded on days 0, 7, 14 and 21 and included sputum bacterial load and the patient reported outcome measures (PROMs): Chronic Respiratory Infection Symptom Score (CRISS), the Cystic Fibrosis Questionnaire–Revised (CFQ-R); FEV1, blood leukocyte count, and inflammatory markers. Eighty nine participants in fifteen US and EU centres were randomized, 78 completed the 14-day treatment period. Cysteamine had no significant effect on sputum bacterial load, however technical difficulties limited interpretation. The most consistent findings were for cysteamine 450mg twice daily that had effects additional to that observed with placebo, with improved symptoms, CRISS additional 9.85 points (95% CI 0.02, 19.7) p=0.05, reduced blood leukocyte count by 2.46x109 /l (95% CI 0.11, 4.80), p=0.041 and reduced CRP by geometric mean 2.57 nmol/l (95% CI 0.15, 0.99), p=0.049.</p> <p><em>Conclusion:</em> In this exploratory study cysteamine appeared to be safe and well-tolerated. Future pivotal trials investigating the utility of cysteamine in pulmonary exacerbations of CF need to include the cysteamine 450mg doses and CRISS and blood leukocyte count as outcome measures.</p>
Data from: Cell therapy for chronic TBI: interim analysis of the randomized, controlled, double-blind STEMTRA trial
<p><b>Objective:</b> To determine if chronic motor deficits secondary to traumatic brain injury (TBI) can be improved by implantation of allogeneic modified bone marrow-derived mesenchymal stromal/stem cells (SB623).</p> <p><b>Methods:</b> This 6-month interim analysis of the 1-year double-blind, randomized, surgical sham-controlled, Phase 2 STEMTRA trial (NCT02416492) evaluated safety and efficacy of the stereotactic intracranial implantation of SB623 in patients with stable chronic motor deficits secondary to TBI. Patients in this multi-center trial (N=63) underwent randomization in a 1:1:1:1 ratio to 2.5x10<sup>6</sup>, 5.0x10<sup>6</sup>, 10x10<sup>6</sup> SB623 cells or control. Safety was assessed in patients who underwent surgery (N=61), and efficacy in the modified intent-to-treat population of randomized patients who underwent surgery (N=61; SB623=46, control=15).</p> <p><b>Results:</b> The primary efficacy endpoint of significant improvement from baseline of Fugl-Meyer Motor Scale score at 6 months for SB623-treated patients was achieved. SB623-treated patients improved by (LS mean [SE]) +8.3 (1.4) versus +2.3 (2.5) for control at 6 months, the LS mean difference was 6.0 (95% CI: 0.3-11.8); P=0.040. Secondary efficacy endpoints improved from baseline, but were not statistically significant versus control at 6 months. There were no dose-limiting toxicities or deaths, and 100% of SB623-treated patients experienced treatment-emergent adverse events versus 93.3% of control patients (P=0.25).</p> <p><b>Conclusions:</b> SB623 cell implantation appeared to be safe and well tolerated, and patients implanted with SB623 experienced significant improvement from baseline motor status at 6 months compared to controls.</p> <p><b>Classification of Evidence:</b> This study provides Class I evidence that implantation of SB623 was well tolerated and associated with improvement in motor status.</p>
Data from: Daridorexant, a new dual orexin receptor antagonist in elderly subjects with insomnia disorder: a randomized clinical trial
<p><b>Objective:</b> To assess the dose-response of daridorexant, a new dual orexin receptor antagonist, on wake after sleep onset (WASO).</p> <p><b>Methods:</b> Elderly (≥65 years) subjects (n = 58) with insomnia were randomly allocated (Latin square design) to receive five treatments (5, 10, 25, and 50 mg daridorexant and placebo) during five treatment periods, each consisting of two treatment nights followed by a 5–12-day washout period. Main efficacy endpoints were the absolute change from baseline in WASO (primary) and latency to persistent sleep (LPS; secondary) to Days 1&2 (mean of two treatment nights assessed by polysomnography) in each period. Safety and tolerability were also assessed.</p> <p><b>Results:</b> Of 58 subjects included, 67% were female and median age was 69 years [range 65–85]). WASO and LPS were dose-dependently reduced from baseline to Days 1&2 following daridorexant administration (multiple comparison procedure-modeling, p<0.0001 and p=0.004, respectively); reductions were statistically significant for doses 10 mg and above compared with placebo (WASO: –32.0, –45.1, –61.4 min; LPS: –44.9, –43.8, –45.4 min; for 10, 25, and 50 mg, respectively, p≤0.025). Treatment-emergent adverse events were similar for daridorexant and placebo; the most frequent were fatigue, nasopharyngitis, gait disturbance, and headache (≤7% in any group).</p> <p><b>Conclusions:</b> Daridorexant was well tolerated. Dose-dependent improvements in WASO and LPS were statistically significant (dose range 10–50 mg) in elderly subjects with insomnia disorder. ClinicalTrials.gov (NCT02841709).</p> <p><b>Classification of Evidence:</b> This study provides Class III evidence that for elderly subjects with insomnia, daridorexant reduced wake after sleep onset time.</p>
Data from: Quantifying genotype x environment effects in long-term common wheat yield trials from an agroecologically diverse production region
Multienvironment trials (METs) are used to investigate the performance of crop genotypes. To efficiently generate reliable performance estimates, the magnitude and patterns of genotype × environment interaction (G×E) in MET data must be known. We quantified G×E in fall-planted common wheat (Triticum aestivum L.) in California, with the goal of increasing the reliability and efficiency of statewide variety testing activities. Linear mixed models and the genotype main effects plus G×E interaction effects (GGE) biplot method were used to analyze MET data for 211 common wheat genotypes, the MET consisted of 9 locations and 14 seasons. The representativeness and discriminating power of the MET locations were tested, and estimates of the optimum number of test locations were made. The analyses did not find evidence for significant, repeatable, crossover G×E. The genotype and G×E effects were of a similar magnitude, and the G×E effects were relatively strong compared with other sources of variance but were dominated by seasonal effects, with potentially repeatable genotype-by-location (G×L) effects being relatively weak. The GGE analyses did not detect repeatable G×L patterns across seasons. As a result, we conclude that the cereal production regions of California consist of a single, but unstable, mega-environment for common wheat grain yield. The test location evaluation found few significant differences between test locations in terms of how well they represent the target production environment. We estimate that the number of test locations could be reduced while maintaining trial accuracy, which would improve the resource use efficiency of statewide trial activities without sacrificing information about variety-specific common wheat yield performance.
Data from: Effectiveness of continence promotion for older women via community organisations: a cluster randomised trial
Objectives: The primary objective of this cluster randomised controlled trial was to compare the effectiveness of the three experimental continence promotion interventions against a control intervention on urinary symptom improvement in older women with untreated incontinence recruited from community organisations. Setting: 71 community organisations across the United Kingdom Participants: 259 women aged 60 years and older with untreated incontinence entered the trial; 88% completed the 3-month follow-up. Interventions: The three active interventions consisted of a single 60-minute group workshop on 1) continence education (20 clusters, 64 women); 2) evidence-based self-management (17 clusters, 70 women); or 3) combined education and self-management (17 clusters, 61 women). The control intervention was a single 60-minute educational group workshop on memory loss, polypharmacy and osteoporosis (17 clusters, 64 women). Primary and secondary outcome measures: The primary outcome was self-reported improvement in incontinence 3 months post-intervention at the level of the individual. The secondary outcome was change in the International Consultation on Incontinence Questionnaire (ICIQ). Changes in incontinence-related knowledge and behaviours were also assessed. Results: The highest rate of urinary symptom improvement occurred in the combined intervention group (66% vs 11% of the control group, prevalence difference 55%, 95% CI 43%-67%, intracluster correlation 0). Thirty percent versus 6% of participants reported significant improvement respectively (prevalence difference 23%, 95% CI 10%-36%, intracluster correlation 0). The number-needed-to-treat was 2 to achieve any improvement in incontinence symptoms, and 5 to attain significant improvement. Compared to controls, the combined group reported an adjusted mean 2.05 point (95% CI 0.87-3.24) greater improvement on the ICIQ. Changes in knowledge and self-reported risk-reduction behaviours paralleled rates of improvement in all intervention arms. Conclusion: Continence education combined with evidence-based self-management improves symptoms of incontinence among untreated older women. Community organisations represent an untapped vector for delivering effective continence promotion interventions.
Data from: Early sitting in ischemic stroke patients (SEVEL): a randomized controlled trial
Background: Extended immobility has been associated with medical complications during hospitalization. However no clear recommendations are available for mobilization of ischemic stroke patients. Objective: As early mobilization has been shown to be feasible and safe, we tested the hypothesis that early sitting could be beneficial to stroke patient outcome. Methods: This prospective multicenter study tested two sitting procedures at the acute phase of ischemic stroke, in a randomized controlled fashion (clinicaltrials.org registration number NCT01573299). Patients were eligible if they were above 18 years of age and showed no sign of massive infarction or any contra-indication for sitting. In the early-sitting group, patients were seated out of bed at the earliest possible time but no later than one calendar day after stroke onset, whereas the progressively-sitting group was first seated out of bed on the third calendar day after stroke onset. Primary outcome measure was the proportion of patients with a modified Rankin score [0–2] at 3 months post stroke. Secondary outcome measures were a.) prevalence of medical complications, b.) length of hospital stay, and c.) tolerance to the procedure. Results: One hundred sixty seven patients were included in the study, of which 29 were excluded after randomization. Data from 138 patients, 63 in the early-sitting group and 75 in the progressively-sitting group were analyzed. There was no difference regarding outcome of people with stroke, with a proportion of Rankin [0–2] score at 3 months of 76.2% and 77.3% of patients in the early- and progressive-sitting groups, respectively (p = 0.52). There was also no difference between groups for secondary outcome measures, and the procedure was well tolerated in both arms. Conclusion: Due to a slow enrollment, fewer patients than anticipated were available for analysis. As a result, we can only detect beneficial/detrimental effects of +/- 15% of the early sitting procedure on stroke outcome with a realized 37% power. However, enrollment was sufficient to rule out effect sizes greater than 25% with 80% power, indicating that early sitting is unlikely to have an extreme effect in either direction on stroke outcome. Additionally, we were not able to provide a blinded assessment of the primary outcome. Taking these limitations into account, our results may help guide the development of more effective acute stroke rehabilitation strategies, and the design of future acute stroke trials involving out of bed activities and other mobilization regimens.
Data from: Characteristics of randomised trials on diseases in the digestive system registered in ClinicalTrials.gov - a retrospective analysis
Objectives: To evaluate the adequacy of reporting of protocols for randomised trials on diseases of the digestive system registered in ClinicalTrials.gov and the consistency between primary outcomes, secondary outcomes and sample size specified in ClinicalTrials.gov and published trials. Design: Randomised phase III trials on adult patients with gastrointestinal diseases registered before January 2009 in ClinicalTrials.gov were eligible for inclusion. From ClinicalTrials.gov all data elements in the database required by the International Committee of Medical Journal Editors (ICMJE) member journals were extracted. The subsequent publications for registered trials were identified. For published trials, data concerning publication date, primary and secondary endpoint, sample size, and whether the journal adhered to ICMJE principles were extracted. Differences between primary and secondary outcomes, sample size and sample size calculations data in ClinicalTrials.gov and in the published paper were registered. Results: 105 trials were evaluated. Sixty-six trials (63%) were published. Thirty-one percent of trials were registered incorrectly after their completion date. Several data elements of the required ICMJE data list were not filled in, with lacking data in 22% and 11% of cases concerning the primary outcome measure and sample size. In 26% of the published papers data of sample size calculations were missing and discrepancies between sample size reporting in ClinicalTrials.gov and published trials existed. Conclusion: The quality of registration of randomised controlled trials still needs improvement.
Data from: Impact of numerical information on 'risk knowledge' regarding human papillomavirus (HPV) vaccination among schoolgirls: a randomised controlled trial
Introduction: In Germany the implementation of HPV vaccination for women 12-17 years of age was accompanied by various campaigns. Evidence based information including numerical data was not provided. However, standard information leads to overestimation of cancer risk and effects of HPV vaccination. Confidence in children's ability to deal with numerical data is low, especially in disadvantaged pupils. The aim of the present study was to compare the effects of a standard leaflet with an information leaflet supplemented with numerical data on 'risk knowledge' regarding HPV vaccination among schoolgirls. Methods: Randomised-controlled short-term trial. All 108 schoolgirls of seven school classes were asked to participate and 105 agreed. Participants were vocational schoolgirls who were preparing for grade 10 graduation and who were members of the target group for HPV vaccination. The control group was asked to read a standard leaflet on HPV vaccination of the German Women's Health Network. The intervention group received the same leaflet, but it was supplemented with numerical information on cancer risk and assumed effects of the HPV vaccination on cancer prevention. As baseline characteristics we surveyed: age, vaccination status, attitude towards HPV vaccination and aspects regarding migration background. The primary end point was 'risk knowledge'. Questionnaire surveys were performed under experimental conditions. Individual randomisation, participants, and intention-to-treat data analyses were blinded. The study was approved by the Ministry of Education and Culture of Schleswig-Holstein and the ethics committee of the Hamburg Chamber of Physicians. Results: We analysed 'risk knowledge' for all 105 randomised participants. Baseline characteristics of the two groups were comparable. Numerical risk information recipients were more likely to give correct answers compared to standard information recipients: Mean value of risk knowledge score (0-5 points): 4.6 ± 1.0 vs. 2.6 ± 1.2 (mean difference 2.0 (95% CI 1.6-2.4)); (P<0.001). Post hoc distractor analysis of single items was performed. Incorrect answers of control participants indicated that cervical cancer risk was highly overestimated whereas total cancer risk was mostly underestimated, and possible impact of HPV vaccination on cancer prevention was overestimated. Conclusion: Supplementing health information on HPV vaccination with numerical data improves 'risk knowledge' among schoolgirls.
Data from: NMDA receptor antagonists and pain relief: a meta-analysis of experimental trials
OBJECTIVES: We conducted a meta-analysis of controlled trials that used experimental models of acute pain and hyperalgesia to examine the analgesic effects of N-methyl-D-aspartate receptor (NMDAR) antagonists. METHODS: Six major databases were systematically searched (to 03/2018) for studies using human evoked pain models to compare NMDAR antagonists with no-intervention controls. Pain outcome data were analyzed with random-effects meta-analysis. RESULTS: Searches identified 70 eligible trials (N=1069). Meta-analysis found that low-dose ketamine (<1 mg/kg) produced a decrease in the size of hyperalgesic area (Standardized Mean Difference=0.54, CI95[0.34, 0.74], p<.001), and a 1.2-point decrease (CI95[0.88, 1.44], p<.001) in pain ratings from 4.6 to 3.4 on a 0-10 scale (a 26% reduction). Similar analgesia was observed for acute and hyperalgesic models and was constant across the dosing range (0.03-1.00 mg/kg). Moderate-high variability in effect size was observed and mild side effects (e.g. sedation, sensory disturbance) were common. No effects of dextromethorphan were found. CONCLUSIONS: Findings provide robust evidence for analgesic and anti-hyperalgesic effects of ketamine, supporting its utility for acute and chronic pain management. However, pain relief was modest, suggesting ketamine may potentially be most useful when opioids are contraindicated, rapid analgesia is required or for pain resistant to conventional medication.
Data from: The effect of promoting current local research activities on large monitors on the population's interest in health-related research – a randomized controlled trial
OBJECTIVE: The objectives of this study were threefold: to estimate people's interest in health-related research, to understand to what extent people appreciate being actively informed about current local health-related research and to investigate whether their interest can be influenced by advertising local current health-related research using large TV monitors. DESIGN: Randomized controlled trial using a stepped wedge design. SETTING: The emergency department waiting room at two public hospitals in northern Queensland, Australia. PARTICIPANTS: Waiting patients and their accompanying friends and relatives in the emergency department waiting room not requiring immediate medical attention. INTERVENTIONS: A TV monitor advertising local current health-related research. MAIN OUTCOME MEASURES: Odds ratio for the effect of intervention on changing the interest in health-related research compared to a control group while adjusting for gender, age and socioeconomic standard. RESULTS: The intervention significantly increased the short-term interest in health-related research with an odds ratio of 1.3 (1.1-1.7, p=0.0063). We also noted that being female and being older was correlated to a higher interest in health-related research CONCLUSIONS: This study found that proactive information significantly increased the general populations' interest in health-related research. There are reasonable set up costs involved but the costs for maintaining the system were very low. Hence, it seems reasonable that research-active organizations should give much higher priority to this type of activity. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR) with the registration number ACTRN12617001085369
Data from: Reducing therapeutic misconception: a randomized intervention trial in hypothetical clinical trials
Background: Participants in clinical trials frequently fail to appreciate key differences between research and clinical care. This phenomenon, known as therapeutic misconception, undermines informed consent to clinical research, but to date there have been no effective interventions to reduce it and concerns have been expressed that to do so might impede recruitment. We determined whether a scientific reframing intervention reduces therapeutic misconception without significantly reducing willingness to participate in hypothetical clinical trials. Methods: This prospective randomized trial was conducted from 2015 to 2016 to test the efficacy of an informed consent intervention based on scientific reframing compared to a traditional informed consent procedure (control) in reducing therapeutic misconception among patients considering enrollment in hypothetical clinical trials modeled on real-world studies for one of five disease categories. Patients with diabetes mellitus, hypertension, coronary artery disease, head/neck cancer, breast cancer, and major depression were recruited from medical clinics and a clinical research volunteer database. The primary outcomes were therapeutic misconception, as measured by a validated, ten-item Therapeutic Misconception Scale (range=10-50), and willingness to participate in the clinical trial. Results: 154 participants completed the study (age range, 23-87 years; 92.3% white, 56.5% female); 74 (48.1%) had been randomized to receive the experimental intervention. Therapeutic misconception was significantly lower (p=0.004) in the scientific reframing group (26.4, 95% CI [23.7 to 29.1] compared to the control group (30.9, 95% CI [28.4 to 33.5], and remained so after controlling for education (p=0.017). Willingness to participate in the hypothetical trial was not significantly different (p=0.603) between intervention (52.1%, 95% CI [40.2 to 62.4]) and control (56.3%, 95% CI [45.3 to 66.6] groups. Conclusions: An enhanced educational intervention augmenting traditional informed consent led to a meaningful reduction in therapeutic misconception without a statistically significant change in willingness to enroll in hypothetical clinical trials. Additional study of this intervention is required in real-world clinical trials.
Data from: Long-term use benefits of personal frequency-modulated systems for speech in noise perception in patients with stroke with auditory processing deficits: a non-randomised controlled trial study
Objectives: Approximately one in five stroke survivors suffer from difficulties with speech reception in noise, despite normal audiometry. These deficits are treatable with personal Frequency Modulated systems (FMs). This study aimed to evaluate long term benefits in speech reception in noise, after daily 10 week use of personal FMs, in non-aphasic stroke patients with auditory processing deficits. Design: This was a prospective non randomised controlled trial study. Patients were allocated to an intervention care group or standard care subjects group according to their willingness to use the intervention or not. Setting: Tertiary care setting. Participants: Nine non-aphasic subjects with ischemic stroke, normal/near normal audiometry, and auditory processing deficits and with reported difficulties understanding speech in background noise were recruited in the subacute stroke stage (3-12 months after stroke). Interventions: Four patients (intervention care subjects) used the FMs in their daily life over 10 weeks. Five patients (standard care subjects) received standard care. Primary outcome measures: All subjects were tested at baseline (visit 1) and 10 weeks later (visit 2) on a sentences in noise test with the FMs (aided) and without the FMs (unaided). Results: Speech reception thresholds showed clinically and statistically significant improvements in intervention but not in standard care subjects at 10 weeks in both aided and unaided conditions. Conclusions: 10 week use of FM systems by adult stroke patients may lead to benefits in unaided speech in noise perception. Our findings may indicate auditory plasticity type changes and require further investigation.
Data from: Equivalence analysis to support environmental safety assessment: using nontarget organism count data from field trials with cisgenically modified potato
This paper considers the statistical analysis of entomological count data from field experiments with genetically modified (GM) plants. Such trials are carried out to assess environmental safety. Potential effects on nontarget organisms (NTOs), as indicators of biodiversity, are investigated. The European Food Safety Authority (EFSA) gives broad guidance on the environmental risk assessment (ERA) of GM plants. Field experiments must contain suitable comparator crops as a benchmark for the assessment of designated endpoints. In this paper, a detailed protocol is proposed to perform data analysis for the purpose of assessing environmental safety. The protocol includes the specification of a list of endpoints and their hierarchical relations, the specification of intended levels of data analysis, and the specification of provisional limits of concern to decide on the need for further investigation. The protocol emphasizes a graphical representation of estimates and confidence intervals for the ratio of mean abundances for the GM plant and its comparator crop. Interpretation relies mainly on equivalence testing in which confidence intervals are compared with the limits of concern. The proposed methodology is illustrated with entomological count data resulting from multiyear, multilocation field trials. A cisgenically modified potato line (with enhanced resistance to late blight disease) was compared to the original conventional potato variety in the Netherlands and Ireland in two successive years (2013, 2014). It is shown that the protocol encompasses alternative schemes for safety assessment resulting from different research questions and/or expert choices. Graphical displays of equivalence testing at several hierarchical levels and their interpretation are presented for one of these schemes. The proposed approaches should be of help in the ERA of GM or other novel plants.
Data from: Are multiple views superior to a single view when teaching hip surgery? a single-blinded randomized controlled trial of technical skill acquisition
Purpose: Surgical education videos currently all use a single point of view (POV) with the trainee locked onto a fixed viewpoint, which may not deliver sufficient information for complex procedures. We developed a novel multiple POV video system and evaluated its training outcome compared with traditional single POV. Methods: We filmed a hip resurfacing procedure performed by an expert attending using 8 cameras in theatre. 30 medical students were randomly and equally allocated to learn the procedure using the multiple POV (experiment group [EG]) versus single POV system (control group [CG]). Participants advanced a pin into the femoral head as demonstrated in the video. We measured the drilling trajectories and compared it with pre-operative plan to evaluate distance of the pin insertion and angular deviations. Two orthopedic attendings expertly evaluated the participants' performance using a modified global rating scale (GRS). There was a pre-video knowledge test that was repeated post-simulation alongside a Likert-scale questionnaire. Results: The angular deviation of the pin in EG was significantly less by 29% compared to CG (p=0.037), with no significant difference in the entry point's distance between groups (p=0.204). The GRS scores for EG were higher than CG (p=0.046). There was a 32% higher overall knowledge test score (p<0.001) and 21% improved Likert-scale questionnaire score (p=0.002) after video-learning in EG than CG, albeit no significant difference in the knowledge test score before video-learning (p=0.721). Conclusion: The novel multiple POV provided significant objective and subjective advantages over single POV for acquisition of technical skills in hip surgery.
Data from: Dynamics of pre-choice and post-choice behaviour: rats approximate optimal strategy in a discrete-trial decision task
We simulate two types of environments to investigate how closely rats approximate optimal foraging. Rats initiated a trial where they chose between two spouts for sucrose, which was delivered at distinct probabilities. The discrete trial procedure used allowed us to observe the relationship between choice proportions, response latencies and obtained rewards. Our results show that rats approximate the optimal strategy across a range of environments that differ in the average probability of reward as well as the dynamics of the depletion-renewal cycle. We found that the constituent components of a single choice differentially reflect environmental contingencies. Post-choice behaviour, measured as the duration of time rats spent licking at the spouts on unrewarded trials, was the most sensitive index of environmental variables, adjusting most rapidly to changes in the environment. These findings have implications for the role of confidence in choice outcomes for guiding future choices.
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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.