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467 results for “Trial Data”
Data from: Quality expectations and tolerance limits of trial master files (TMF) - Developing a risk-based approach for quality assessments of TMFs
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Data from: Optimal cardiac resynchronization therapy pacing rate in non-ischemic heart failure patients: a randomized crossover pilot trial
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Data from: Terminated trials in the ClinicalTrials.gov results database: evaluation of availability of primary outcome data and reasons for termination
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Data from: Conventional analysis of trial-by-trial adaptation is biased: empirical and theoretical support using a Bayesian estimator
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Data from: Cell therapy for chronic TBI: interim analysis of the randomized, controlled, double-blind STEMTRA trial
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Data from: Cross-species infection trials reveal cryptic parasite varieties and a putative polymorphism shared among host species.
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Individual trial data on path choice in response to risk in Linepithema humile
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Gene expression data of glioblastoma patients from GAPVAC trial (Glioma Actively Personalized Vaccine Consortium)
GEO Series GSE122498. Homo sapiens. 17 samples. Type: Expression profiling by array.
Next Generation Sequencing RNA Seq data from UKE Phase I rVSV ZEBOV vaccine clinical trial, from full blood samples on Days 0,1,3,7
GEO Series GSE97590. Homo sapiens. 56 samples. Type: Expression profiling by high throughput sequencing.
Array data from neoDDRD clinical trial
GEO Series GSE180295. Homo sapiens. 46 samples. Type: Expression profiling by array.
RNA-seq data from PBMC of M.tb-infected and M.tb-uninfected infants in MVA85A clinical trial
GEO Series GSE203395. Homo sapiens. 294 samples. Type: Expression profiling by high throughput sequencing.
I-SPY2 TRIAL RPPA data for ganitumab arm (and control arm)
GEO Series GSE298828. Homo sapiens. 221 samples. Type: Protein profiling by protein array.
Inter-trial phase coherence of visually evoked postural responses in virtual reality, ExpBrainRes (2020): Data
<p>Data set accompanying the publication:</p> <p>Engel, D., Schütz, A., Krala, M. <em>et al.</em> Inter-trial phase coherence of visually evoked postural responses in virtual reality. <em>Exp Brain Res</em> <strong>238, </strong>1177–1189 (2020).</p> <p>https://doi.org/10.1007/s00221-020-05782-2</p> <p> </p>
Data from: A structured training program for health workers in intravenous treatment with fluids and antibiotics in nursing homes: a modified stepped-wedge cluster-randomised trial to reduce hospital admissions
Objectives: Hospitalization is potentially detrimental to nursing home patients and resource demanding for the specialist health care. This study assessed if a brief training program in administrating intravenous fluids and antibiotics in nursing homes could reduce hospital transfers and ensure high quality care locally. Design: A pragmatic and modified cluster randomized stepped-wedge trial with randomization on nursing home level. Participants: 330 cases in 296 nursing home residents from 30 nursing homes were included. Cases were patients provided intravenous antibiotics or intravenous fluids, in nursing home or hospital. Primary outcome was localization of treatment, secondary outcomes were number of days treated, days of hospitalization among admitted patients, type of antibiotics used and 30-day mortality. Intervention: The nursing homes sequentially received a one-day educational program for the health workers including theory and practical training in intravenous treatment of dehydration and infection, run by two skilled nurses. After completing the training program, the nursing homes had competence to provide intravenous treatment locally. Results: The intervention had a highly significant effect on treatment in nursing homes (OR 8.35, 2.08 to 33.6; P<0.01, or RR 2.23, 1.48 to 2.56). The number treated in nursing homes was stable over time; the number treated in hospital gradually decreased (chi square for trend P< 0.001). Among patients receiving intravenous antibiotics in the nursing homes, 50 (46%) died within 30 days, compared to 30 (36%) treated in the hospital (P=0.19). Among patients receiving intravenous fluids locally, 21 (19%) died within 30 days, compared to 2 (8%) in the hospital group (P=0.34). Mortality was associated with reduced consciousness and elevated c-reactive protein. Conclusions: A brief educational program delivered to nursing home personnel was feasible and effective in reducing acute hospital admissions from nursing homes for treatment of dehydration and infections.
Data from: Effect of aerobic exercise on cognition in younger adults: a randomized clinical trial
Objective: To determine efficacy of aerobic exercise for cognitive function in younger healthy adults. Methods: In a randomized, parallel-group, observer-masked, community-based clinical trial, 132 cognitively normal individuals aged 20-67 with below median aerobic capacity were randomly assigned to one of two 6-month, four-times-weekly conditions: aerobic exercise and stretching/toning. Efficacy measures included: aerobic capacity; cognitive function in six domains (executive function, episodic memory, processing speed, language, and attention), everyday function, BMI and cortical thickness. Results: Aerobic capacity increased significantly (β=2.718; p=0.003), and BMI decreased significantly (β=-0.596; p=0.013) in the aerobic exercise but not in the stretching/toning condition. Executive function improved significantly in the aerobic exercise condition; this effect was moderated by age (β=0.018 s.d. per year; p=0.028). At age 40 the executive function measure increased by 0.228 s.d. (95% CI: 0.007 - 0.448), and by 0.596 s.d. (95% CI: 0.219 - 0.973) at age 60. Cortical thickness increased significantly in the aerobic exercise group in a left frontal region and did not interact with age. Controlling for age and baseline performance, individuals with at least one APOE ε4 allele showed less improvement in executive function with aerobic exercise (β=0.5129, 95%CI 0.0381 to 0.988; p=0.0346). Conclusions: This randomized clinical trial demonstrates the efficacy of aerobic exercise for cognition in adults age 20 – 67. The effect of aerobic exercise on executive function was more pronounced as age increased, suggesting that it may mitigate age-related declines. Increased cortical thickness suggests that aerobic exercise contributes to brain health in individuals as young as age 20. Clinicaltrials.gov Identifier: NCT01179958 Classification of evidence: This study provides Class II evidence that for adults age 20-67 with below median aerobic capacity, aerobic exercise significantly improves executive function but not other measures of cognitive function.
Data from: The effect of funding sources on donepezil randomised controlled trial outcome: a meta-analysis
Objective: To investigate whether there is a difference in the treatment effect of donepezil on cognition in Alzheimer disease between industry-funded and independent randomised controlled trials. Design: Fixed effects meta-analysis of standardised effects of donepezil on cognition as measured by the Mini Mental State Examination and the Alzheimer's Disease Assessment Scale-cognitive subscale. Data sources: Studies included in the meta-analyses reported in the National Institute for Health and Care Excellence (NICE) technical appraisal 217 updated with new studies through a PubMed search. Eligibility criteria: Inclusion criteria were double-blind, placebo-controlled trials of any length comparing patients diagnosed with probable Alzheimer disease (according to the NINCDS-ADRDA/DSM-III/IV criteria) taking any dosage of donepezil. Studies of combination therapies (eg, donepezil and memantine) were excluded, as were studies that enrolled patients with a diagnosis of Alzheimer disease associated with other disorders (eg, Parkinson's disease and Down's syndrome). Results: Our search strategy identified 14 relevant trials (4 independent) with suitable data. Trials sponsored by pharmaceutical companies reported a larger effect of donepezil on standardised cognitive tests than trials published by independent research groups (standardised mean difference (SMD)=0.46, 95% CI 0.37 to 0.55 vs SMD=0.33, 95% CI 0.18 to 0.48, respectively). This difference remained when only data representing change up to 12 weeks from baseline were analysed (industry SMD=0.44, 95% CI 0.34 to 0.53 vs independent SMD=0.35, 95% CI 0.18 to 0.52). Analysis revealed that the effect of funding as a moderator variable of study heterogeneity was not statistically significant at either time point. Conclusions: The effect size of donepezil on cognition is larger in industry-funded than independent trials and this is not explained by the longer duration of industry-funded trials. The lack of a statistically significant moderator effect may indicate that the differences are due to chance, but may also result from lack of power.
Data from: INTREPAD: a randomized trial of naproxen to slow progress of presymptomatic Alzheimer disease
Objective: Evaluate the safety and efficacy of low-dose naproxen for prevention of progression in pre-symptomatic AD among cognitively intact persons at-risk. Methods: INTREPAD, a two-year double-masked pharmaco-prevention trial, enrolled 195 AD family history-positive elderly (mean age 63 years) screened carefully to exclude cognitive disorder. These were randomized 1:1 to naproxen sodium 220mg twice-daily or placebo. Multimodal imaging, neurosensory, cognitive and (in ~50%) CSF biomarker evaluations were performed at Baseline, 3, 12, and 24 months. A modified intent-to-treat analysis considered 160 participants who remained on-treatment through their first follow-up examination. The primary outcome was rate of change in a multimodal composite pre-symptomatic Alzheimer Progression Score (APS). Results: Safety: Naproxen-treated individuals showed a clear excess of adverse events. Efficacy: Among treatment groups combined, the APS increased by 0.101 points/year (S.E = 0.014; P < 10-5), but rate of change showed little difference by treatment assignment (0.017 points/year). The treatment-related slope ratio of 1.10 (95% Confidence Interval 0.588–2.04) suggested that naproxen does not reduce the rate of APS progression by more than 41%. Secondary analyses revealed no notable treatment effects on individual CSF, cognitive, or neurosensory biomarker indicators of progressive pre-symptomatic AD. Conclusions: In cognitively intact individuals at-risk, sustained treatment with naproxen sodium 220 mg twice-daily increases frequency of adverse health effects but does not reduce apparent progression of pre-symptomatic AD. Classification of Evidence: This study provides Class I evidence that, for people who are cognitively intact, low-dose naproxen does not significantly reduce progression of a composite indicator of pre-symptomatic AD.
Data from: Using partial genotyping to estimate the genetic and maternal determinants of adaptive traits in a progeny trial of Fagus sylvatica
Understanding the determinants of phenotypic variation is critical to evaluate the ability of traits to evolve in a changing environment. In trees, the genetic component of the phenotypic variance is most often estimated based on maternal progeny tests. However, the lack of knowledge about the paternal relatedness hampers the accurate estimation of additive genetic and maternal effects. Here, we investigate how different methods accounting for paternal relatedness allow the estimation of heritability and maternal determinants of adaptive traits in a natural population of Fagus sylvatica L., presenting non-random mating. Twelve potentially adaptive functional traits were measured in 60 maternal families in a nursery. We genotyped a subset of offspring and of all the potentially reproductive adults in the population at 13 microsatellite markers to infer paternal relationships and to estimate average relatedness within and between maternal families. This relatedness information was then used in family and animal models to estimate the components of phenotypic variance. All the studied traits displayed significant genetic variance and moderate heritability. Maternal effects were detected for the diameter increment, stem volume and bud burst. Comparison of family and animal models showed that unbalanced mating system led to only slight departures from maternal family assumptions in the progeny trial. However, neglecting the significant maternal effects led to an overestimation of the heritability. Overall, we highlighted the usefulness of relatedness pattern analyses using polymorphic molecular markers to accurately analyse tree sibling designs.
Data from: Improving accuracies of genomic predictions for drought tolerance in maize by joint modeling of additive and dominance effects in multi-environment trials
Breeding for drought tolerance is a challenging task that requires costly, extensive and precise phenotyping. Genomic selection (GS) can be used to maximize selection efficiency and the genetic gains in maize (Zea mays L.) breeding programs for drought tolerance. Here we evaluated the accuracy of genomic selection of additive (A) against additive+dominance (AD) models to predict the performance of untested maize single-cross hybrids for drought tolerance in multi-environment trials. Phenotypic data of five drought-tolerance traits were measured in 308 hybrids in eight trials under water-stressed (WS) and well-watered (WW) conditions over two years and two locations in Brazil. Hybrids' genotypes were inferred based on their parents' genotypes (inbred lines) using single nucleotide polymorphism data obtained via genotyping-by-sequencing. GS analyses were performed using genomic best linear unbiased prediction by fitting a factor analytic (FA) multiplicative mixed model. Results showed differences in the predictive accuracy between A and AD models for the five traits under consideration in both water conditions. For grain yield (GY), the AD model doubled the predictive accuracy in comparison to the A model. FA framework allowed for investigating the stability of additive and dominance effects across environments, as well as the additive- and dominance-by-environment interactions, with interesting applications for parental and hybrid selection. Prediction performance of untested hybrids using GS that benefit from borrowing information from correlated trials increased 40% and 9% for A and AD models, respectively. These results highlighted the importance of multi-environment trial analysis with GS that incorporate dominance effects into genomic predictions of GY in maize single-cross hybrids.
Data from: Mobile phone reminders and peer counseling improve adherence and treatment outcomes of patients on ART in Malaysia: a randomized clinical trial
Background: Adherence to treatment remains the cornerstone of long term viral suppression and successful treatment outcomes among patients receiving Antiretroviral Therapy (ART). Objective(s): Evaluate the effectiveness of mobile phone reminders and peer counseling in improving adherence and treatment outcomes among HIV positive patients on ART in Malaysia. Methods: A single-blind, parallel group RCT conducted in Hospital Sungai Buloh, Malaysia in which 242 adult Malaysian patients were randomized to intervention or control groups. Intervention consisted of a reminder module delivered through SMS and telephone call reminders by trained research assistants for 24 consecutive weeks (starting from date of ART initiation), in addition to adherence counseling at every clinic visit. The length of intended follow up for each patient was 6 months. Data on adherence behavior of patients was collected using specialized, pre-validated Adult AIDS Clinical Trial Group (AACTG) adherence questionnaires. Data on weight, clinical symptoms, CD4 count and viral load tests were also collected. Data was analyzed using SPSS version 22 and R software. Repeated measures ANOVA, Friedman's ANOVA and Multivariate regression models were used to evaluate efficacy of the intervention. Results: The response rate after 6 months follow up was 93%. There were no significant differences at baseline in gender, employment status, income distribution and residential location of respondents between the intervention and control group. After 6 months follow up, the mean adherence was significantly higher in the intervention group (95.7; 95% CI: 94.39–96.97) as compared to the control group (87.5; 95% CI: 86.14–88.81). The proportion of respondents who had Good (>95%) adherence was significantly higher in the intervention group (92.2%) compared to the control group (54.6%). A significantly lower frequency in missed appointments (14.0% vs 35.5%) (p = 0.001), lower viral load (p = 0.001), higher rise in CD4 count (p = 0.017), lower incidence of tuberculosis (p = 0.001) and OIs (p = 0.001) at 6 months follow up, was observed among patients in the intervention group. Conclusion: Mobile phone reminders (SMS and telephone call reminders) and peer counseling are effective in improving adherence and treatment outcomes among HIV positive patients on ART in Malaysia. These findings may be of potential benefit for collaborative adherence planning between patients and health care providers at ART commencement.
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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.