Find research datasets worth reusing
Search datasets from major research repositories and use ShareScore to quickly assess how well each record supports discovery, access, and reuse.
467
datasets available to search
ShareScore release 0.9.0
Dataset results
467 results for “Trial Data”
Data from: A randomised trial comparing the clinical effectiveness of different emergency department healthcare professionals in soft tissue injury management
OBJECTIVE: To evaluate the clinical effectiveness of soft tissue injury management by emergency nurse practitioners (ENPs) and extended scope physiotherapists (ESPs) compared to the routine care provided by doctors in a UK emergency department (ED). DESIGN: Randomised, pragmatic trial of equivalence. SETTING: One adult ED in England. PARTICIPANTS: 372 patients were randomised; 126 to the ESP group, 123 to the ENP group and 123 to the doctor group. Participants were adults (older than 16 years) presenting to the ED with a peripheral soft tissue injury eligible for management by any of the three professional groups. Patients were excluded if they had any of the following: injury greater than 72 hours old; systemic disease; dislocated joints; recent surgery; unable to give informed consent (eg, dementia), open wounds; major deformities; opiate analgesia required; concurrent chest/rib injury; neurovascular deficits and associated fracture. INTERVENTIONS: Patients were randomised to treatment by ESPs, ENPs or routine care provided by doctors (of all grades). MAIN OUTCOME MEASURES: Upper-limb and lower-limb functional scores, quality of life, physical well-being, preference-based health measures and the number of days off work. RESULTS: The clinical outcomes of soft tissue injury treated by ESPs and ENPs in the ED were equivalent to routine care provided by doctors. CONCLUSIONS: As all groups were clinically equivalent it is other factors such as cost, workforce sustainability, service provision and skill mix that become important. This result validates the role of the ENP, which is becoming established as an integral part of minor injuries care, and demonstrates that the ESP should be considered as part of the clinical skill mix without detriment to outcomes. ISRCTN-ISRCTN trials register number 70891354.
Data from: Assessment of the quality of reporting in randomized controlled trials of acupuncture in the Korean literature using the CONSORT statement and the STRICTA guidelines
Objectives: This study aimed to assess the completeness of reporting of RCTs of acupuncture in the Korean literature. Design: Systematic review. Methods: We searched 12 Korean databases and 7 Korean journals to identify eligible RCTs of acupuncture published from 1996 to July 2011. We used the Consolidated Standards of Reporting Trials (CONSORT) checklist for parallel RCTs and the revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) to assess the quality of reporting in Korean RCTs. We compared the completeness of reporting of CONSORT and STRICTA items in RCTs published in two time periods (1996-2004 referred to as the early period and 2005-2011 referred to as the late period). Results: We analysed 146 eligible RCTs using the CONSORT statement concerning RCTs of both needling and non-needling acupuncture and the STRICTA guidelines for 90 trials of needling acupuncture. Among the 103 RCTs in the late period, the proportion of RCTs that completely reported the CONSORT items of outcome definition (15.5%), sample size calculation (2.9%), randomisation (56%), allocation concealment (5.8%), implementation of allocation (11.7%), outcome assessor blinding (20.3%), flow of participants (25.2%), number of participants analysed (19.4%), ancillary analyses (0.0%), adverse events (24.3%), generalisability of findings (1.9%) and overall evidence (32.0%) remained small. Among the 61 RCTs of needling acupuncture in the late period, the STRICTA items of setting/context (24.6%) and practitioner background (27.9%) showed incomplete reporting. The completeness of reporting improved over time in several CONSORT and STRICTA items. Conclusion: The completeness of reporting of Korean RCTs of acupuncture was suboptimal according to the CONSORT and revised STRICTA statements. Trial authors and journal editors should use the CONSORT statement and the STRICTA guidelines for transparent reporting in Korean RCTs of acupuncture. The endorsement of the CONSORT and revised STRICTA statements in author instructions is also required.
Data from: Risk factors for suicidality in Huntington's disease: an analysis of the 2CARE clinical trial
Most suicidality literature in HD is based on natural history studies or retrospective reviews, but reports on risk factors from clinical trials are limited. We analyzed 609 participants from 2CARE, a randomized, double-blind, placebo controlled clinical trial with up to 5 years of follow-up, for risk factors related to suicidality. The primary outcome variable was the time from randomization until the first occurrence of either suicidal ideation or attempt. We also considered time from randomization until the first suicide attempt as a secondary outcome variable. Depression, anxiety, bipolar disorder, antidepressant or anxiolytic use, and prior suicide attempt at baseline were associated with time to ideation or attempt. Baseline employment status, marital status, CAG repeat length, tetrabenazine use, and treatment assignment (coenzyme Q10 or placebo) were not associated with suicidality. Time-dependent variables from the UHDRS Behavioral Assessment were associated with time to suicidal ideation or attempt, driven mainly by items related to depressed mood, low self-esteem/guilt, anxiety, suicidal thoughts, irritability, and compulsions. Variables associated with time to suicide attempt alone were generally similar. These data suggest psychiatric co-morbidities in HD are predictive of suicidal behavior while participating in clinical trials, reinforcing the importance of clinical surveillance and treatment towards lessening risk during participation and perhaps beyond. Designing a composite algorithm for early prediction of suicide attempts in HD may be of value, particularly given anticipated trials aimed at disease modification are likely to be long-term.
Data from: Quality of descriptions of treatments: a review of published randomised controlled trials
OBJECTIVES: To be useable in clinical practice, treatments studied in trials must provide sufficient information to enable clinicians and researchers to replicate. We sought to assess the completeness of treatment descriptions in published randomised controlled trials using a checklist and to determine the extent to which peer reviewers and editors comment on the quality of reporting of treatments. DESIGN: Cross-sectional study. SETTING: Trials published in the BMJ, a general medical journal. PARTICIPANTS: 51 trials published in the BMJ were independently evaluated by two raters using the checklist. Reviewers' and editors' comments were also assessed for statements on treatment descriptions. PRIMARY AND SECONDARY OUTCOME MEASURES: Proportion of trials rated as replicable (primary outcome). RESULTS: For 57% (29/51) of the papers, published treatment descriptions were not considered sufficient to allow replication. Most poorly described aspects were the actual procedures involved including the sequencing of the technique (what happened and when) and the physical or informational materials used (e.g. training materials): 53% and 43% not clear, respectively. For a third of treatments, the dose/duration of individual sessions was not clear and for a quarter the schedule (interval, frequency, duration, or timing) was not clear. Although the majority of problems were not picked up by reviewers and editors, when they were detected only about two-thirds were fixed before publication. CONCLUSIONS: Journals wanting to publish research of use to practicing health care professionals need to pay more attention to descriptions of treatments. Our checklist, may be useful for reviewers, and editors and could help ensure important details of treatments are provided before papers are in the public domain.
Data from: Randomised controlled trial of an education and support package for stroke patients and their carers
Objective: Tailoring stroke information and providing reinforcement opportunities are two strategies proposed to enhance the effectiveness of education. This study aimed to evaluate the effects of an education package which utilised both strategies on the knowledge, health and psychosocial outcomes of stroke patients and carers. Design: Multisite, randomised trial comparing usual care with an education and support package. Setting: Two acute stroke units. Participants: Patients and their carers (N=138) were randomised (control n=67, intervention n=71) of which data for 119 participants (control n=59, intervention n=60) were analysed. Intervention: The package consisted of a computer-generated, tailored written information booklet and verbal reinforcement provided prior to, and for 3 months following, discharge. Outcome measures: Outcome measures were administered prior to hospital discharge and at 3-month follow-up by blinded assessors. The primary outcome was stroke knowledge (score range: 0–25). Secondary outcomes were: self-efficacy (1–10), anxiety and depression (0–21), ratings of importance of information (1–10), feelings of being informed (1–10), satisfaction with information (1–10), caregiver burden (carers) (0–13) and quality of life (patients) (1–5). Results: Intervention group participants reported better: self-efficacy for accessing stroke information (adjusted mean difference (MD) of 1.0, 95% CI 0.3 to 1.7, p=0.004); feeling informed (MD 0.9, 95% CI 0.2 to 1.6, p=0.008); and satisfaction with medical (MD 2.0, 95% CI 1.1 to 2.8, p<0.001); practical (MD 1.1, 95% CI 0.3 to 1.9, p=0.008), services and benefits (MD 0.9, 95% CI 0.1 to 1.8, p=0.036) and secondary prevention information (MD 1.7, 95% CI 0.9 to 2.5, p<0.001). There was no significant effect on other outcomes. Conclusions: Intervention group participants had improved self-efficacy for accessing stroke information and satisfaction with information, but other outcomes were not significantly affected. Evaluation of a more intensive intervention in a trial with a larger sample size is required to establish the value of an educational intervention that uses tailoring and reinforcement strategies.
Data from: Handover training for medical students – a controlled educational trial of a pilot curriculum
Background: Handovers are a critical point of patient care and a significant source of adverse events. The WHO patient safety curriculum provides some structure for handover teaching; in Europe, there is no standardized curriculum for undergraduate handover training. To address this, the Aachen Interdisciplinary Training Centre for Medical Education, developed and established a pilot curriculum for handover training in the context of the EU-funded PATIENT-project Objective: To develop and implement a handover curriculum for medical students and to assess its effect on students' awareness, confidence and knowledge regarding patient safety and handover in multiple settings. Methods: The pilot handover training curriculum was designed following Kern´s principles of curriculum development and was integrated into a curricular course led by departments for anesthesiology and intensive care (AI) at the University Hospital. A controlled educational research study was conducted with 4th year medical students (n=147) who either received the standard existing curriculum (no teaching of handover, n=78) or the pilot handover training (n=69). Paper-based questionnaires regarding attitude, confidence and knowledge towards handover and patient safety were used for pre- and post-assessment. The pilot curriculum consisted of 3 units (1-2 hours each) integrated into a 4-week course of AI. Multiple types of handover (end-of-shift, operating room/post anesthesia recovery unit/ICU, telephone, discharge) were addressed. Results: Students showed a significant increase in knowledge (p<0.01) and self-confidence for the use of standardized handover tools (p<0.01) and accurate handover performance (p<0.01) among the pilot group. Discussion/Conclusion: We developed and implemented a pilot curriculum for undergraduate handover training. Students displayed a significant increase in knowledge and self-confidence for the use of standardized handover tools and accurate handover performance. An evaluation of the curriculum by other faculties is needed. Further studies should evaluate whether the observed effect of a specific handover strategy is associated with a patient benefit.
Data from: Terminated trials in the ClinicalTrials.gov results database: evaluation of availability of primary outcome data and reasons for termination
Background: Clinical trials that end prematurely (or "terminate") raise financial, ethical, and scientific concerns. The extent to which the results of such trials are disseminated and the reasons for termination have not been well characterized. Methods and Findings: A cross-sectional, descriptive study of terminated clinical trials posted on the ClinicalTrials.gov results database as of February 2013 was conducted. The main outcomes were to characterize the availability of primary outcome data on ClinicalTrials.gov and in the published literature and to identify the reasons for trial termination. Approximately 12% of trials with results posted on the ClinicalTrials.gov results database (905/7,646) were terminated. Most trials were terminated for reasons other than accumulated data from the trial (68%; 619/905), with an insufficient rate of accrual being the lead reason for termination among these trials (57%; 350/619). Of the remaining trials, 21% (193/905) were terminated based on data from the trial (findings of efficacy or toxicity) and 10% (93/905) did not specify a reason. Overall, data for a primary outcome measure were available on ClinicalTrials.gov and in the published literature for 72% (648/905) and 22% (198/905) of trials, respectively. Primary outcome data were reported on the ClinicalTrials.gov results database and in the published literature more frequently (91% and 46%, respectively) when the decision to terminate was based on data from the trial. Conclusions: Trials terminate for a variety of reasons, not all of which reflect failures in the process or an inability to achieve the intended goals. Primary outcome data were reported most often when termination was based on data from the trial. Further research is needed to identify best practices for disseminating the experience and data resulting from terminated trials in order to help ensure maximal societal benefit from the investments of trial participants and others involved with the study.
Data from: ALS drug development guidances and trial guidelines: consensus and opportunities for alignment
The Food and Drug Administration (FDA) developed a draft guidance for drug development in Amyotrophic Lateral Sclerosis (ALS) that was issued in February 2018. The FDA draft guidance considered the recommendations developed by the ALS community which incorporated the views of a large group of clinical investigators, industry representatives, advocacy groups, patients, and caregivers. This external input from the ALS community reviewed the current state of clinical research in ALS and made suggestions over a wide range of drug development topics and served as an educational tool to provide the Agency with additional inputs about ALS, the state of the science and the community's views on key topics. In parallel to this effort, there was an independent effort to revise and update the ALS clinical trial guidelines. We discuss the areas of agreement of these three documents, and the areas that provide opportunities to improve the efficiency of drug development in ALS. It is likely that further research into biomarkers, efficacy endpoints, and predictive algorithms will provide greater alignment among community stakeholders and increase clarity on drug development efforts going forward. Continued patient engagement and inclusion of patient experience data in every aspect of the drug development process will further facilitate the approval of new treatments.
Data from: Ginkgo biloba extract for prevention of acute mountain sickness: a systematic review and meta-analysis of randomized controlled trials
Study objective: Trials of ginkgo biloba extract (GBE) for the prevention of acute mountain sickness (AMS) have been published since 1996. Because of their conflicting results, the efficacy of GBE remains unclear. We performed a systematic review and meta-analysis to assess whether GBE prevents acute mountain sickness. Methods: The Cochrane Library, EMBASE, Google Scholar, and PubMed databases were searched for articles published up to May 20, 2017. Only randomized controlled trials were included. AMS defined as acute mountain sickness–cerebral(AMS-C) score≧0.7 or Lake Louise Score (LLS)≧3 with headache. The main outcome measures were the relative risks of AMS in participants receiving GBE for prophylaxis. Meta-analyses were conducted using random-effects models. Sensitivity analyses, subgroup analyses and tests for publication bias were conducted. Results: Six published articles with a total of 451 participants met all eligibility criteria. In the primary meta-analysis of all 7 study groups, GBE showed trend of AMS prophylaxis, but it is not statistically significant (RR =0.68; 95% CI: 0.45 to 1.04; p-value=0.08) (Figure 2). The I2 statistic was 58.7% (p-value=0.02), indicating substantial heterogeneity. The results of subgroup analyses of studies with low risk of bias, low starting altitude (<2500 m), number of treatment days before ascending and dosage of GBE were similar. Conclusions: The currently available data suggest that although GBE may tend toward AMS prophylaxis, there are not enough data to show the statistically significant effect of GBE for preventing AMS. Further large randomized control studies are warranted.
Data from: Using matrix and tensor factorizations for the single-trial analysis of population spike trains
Advances in neuronal recording techniques are leading to ever larger numbers of simultaneously monitored neurons. This poses the important analytical challenge of how to capture compactly all sensory information that neural population codes carry in their spatial dimension (differences in stimulus tuning across neurons at different locations), in their temporal dimension (temporal neural response variations), or in their combination (temporally coordinated neural population firing). Here we investigate the utility of tensor factorizations of population spike trains along space and time. These factorizations decompose a dataset of single-trial population spike trains into spatial firing patterns (combinations of neurons firing together), temporal firing patterns (temporal activation of these groups of neurons) and trial-dependent activation coefficients (strength of recruitment of such neural patterns on each trial). We validated various factorization methods on simulated data and on populations of ganglion cells simultaneously recorded in the salamander retina. We found that single-trial tensor space-by-time decompositions provided low-dimensional data-robust representations of spike trains that capture efficiently both their spatial and temporal information about sensory stimuli. Tensor decompositions with orthogonality constraints were the most efficient in extracting sensory information, whereas non-negative tensor decompositions worked well even on non-independent and overlapping spike patterns, and retrieved informative firing patterns expressed by the same population in response to novel stimuli. Our method showed that populations of retinal ganglion cells carried information in their spike timing on the ten-milliseconds-scale about spatial details of natural images. This information could not be recovered from the spike counts of these cells. First-spike latencies carried the majority of information provided by the whole spike train about fine-scale image features, and supplied almost as much information about coarse natural image features as firing rates. Together, these results highlight the importance of spike timing, and particularly of first-spike latencies, in retinal coding.
Data from: Placebo effects in trials evaluating 12 selected minimally invasive interventions: a systematic review and meta-analysis
Objectives: To analyse the impact of placebo effects on outcome in trials of selected minimally invasive procedures and to assess reported adverse events in both trial arms. Design: A systematic review and meta-analysis. Data sources and study selection: We searched MEDLINE and Cochrane library to identify systematic reviews of musculoskeletal, neurological and cardiac conditions published between January 2009 and January 2014 comparing selected minimally invasive with placebo (sham) procedures. We searched MEDLINE for additional randomised controlled trials published between January 2000 and January 2014. Data synthesis: Effect sizes (ES) in the active and placebo arms in the trials' primary and pooled secondary end points were calculated. Linear regression was used to analyse the association between end points in the active and sham groups. Reported adverse events in both trial arms were registered. Results: We included 21 trials involving 2519 adult participants. For primary end points, there was a large clinical effect (ES≥0.8) after active treatment in 12 trials and after sham procedures in 11 trials. For secondary end points, 7 and 5 trials showed a large clinical effect. Three trials showed a moderate difference in ES between active treatment and sham on primary end points (ES ≥0.5) but no trials reported a large difference. No trials showed large or moderate differences in ES on pooled secondary end points. Regression analysis of end points in active treatment and sham arms estimated an R2 of 0.78 for primary and 0.84 for secondary end points. Adverse events after sham were in most cases minor and of short duration. Conclusions: The generally small differences in ES between active treatment and sham suggest that non-specific mechanisms, including placebo, are major predictors of the observed effects. Adverse events related to sham procedures were mainly minor and short-lived. Ethical arguments frequently raised against sham-controlled trials were generally not substantiated.
Data from: Efficacy and safety of four weeks' treatment with combined fluticasone furoate/vilanterol in a single inhaler given once daily in COPD: a placebo-controlled randomised trial
BACKGROUND: Fluticasone furoate/vilanterol (FF/VI) is a novel once-daily (OD) inhaled corticosteroid/long-acting β2 agonist combination in development for chronic obstructive pulmonary disease (COPD) and asthma. TRIAL DESIGN: A multicentre, randomised, double-blind, parallel-group, placebo-controlled study. METHODS: Participants were patients with moderate-to-severe COPD treated with placebo or FF/VI 400/25 μg OD for 4 weeks. Study objectives were to assess the safety and efficacy of FF/VI 400/25 μg OD administered for 4 weeks via a novel dry powder inhaler. Co-primary end points were change from baseline in weighted mean (wm) heart rate 0–4 h postdose at day 28 and the incidence of adverse events (AEs). Secondary end points included change from baseline in trough forced expiratory volume in one second (FEV1) (23–24 h postdose; day 29) and wm FEV1 (0–4 h postdose; day 28). Patients were randomised to receive FF/VI 400/25 μg or placebo in a 2:1 ratio; all patients and investigators were blinded to active or placebo treatment. RESULTS: 60 patients (mean age 64 years) were randomised (FF/VI: n=40; placebo: n=20), and all contributed data to the analysis. Mean screening post-bronchodilator FEV1 per cent predicted was comparable between groups (FF/VI: 58.5%; placebo: 60.1%). The wm heart rate 0–4 h postdose was similar between groups (difference: 0.6 beats per minute; 95% CI −3.9 to 5.1). More on-treatment AEs were reported in the FF/VI group (68%) compared with the placebo group (50%). The most common drug-related AEs in the FF/VI group were oral candidiasis (8%) and dysphonia (5%). There were no clinically relevant effects on laboratory values, including glucose and potassium, or on vital signs or ECGs/Holters. The FF/VI group had statistically greater improvements compared with placebo in trough FEV1 (mean difference 183 ml) and 0–4 h postdose wm FEV1 (mean difference 236 ml). CONCLUSION: FF/VI has a good safety and tolerability profile and improves lung function compared with placebo in patients with COPD.
Data from: Prospective randomized trial comparing hepatic venous outflow and renal function after conventional versus piggyback liver transplantation
Background: This randomized prospective clinical trial compared the hepatic venous outflow drainage and renal function after conventional with venovenous bypass (n = 15) or piggyback (n = 17) liver transplantation. Methods: Free hepatic vein pressure (FHVP) and central venous pressure (CVP) measurements were performed after graft reperfusion. Postoperative serum creatinine (Cr) was measured daily on the first week and on the 14th, 21st and 28th postoperative days (PO). The prevalence of acute renal failure (ARF) up to the 28th PO was analyzed by RIFLE-AKIN criteria. A Generalized Estimating Equation (GEE) approach was used for comparison of longitudinal measurements of renal function. Results: FHVP-CVP gradient > 3 mm Hg was observed in 26.7% (4/15) of the patients in the conventional group and in 17.6% (3/17) in the piggyback group (p = 0.68). Median FHVP-CVP gradient was 2 mm Hg (0–8 mmHg) vs. 3 mm Hg (0–7 mm Hg) in conventional and piggyback groups, respectively (p = 0.73). There is no statistically significant difference between the conventional (1/15) and the piggyback (2/17) groups regarding massive ascites development (p = 1.00). GEE estimated marginal mean for Cr was significantly higher in conventional than in piggyback group (2.14 ± 0.26 vs. 1.47 ± 0.15 mg/dL; p = 0.02). The conventional method presented a higher prevalence of severe ARF during the first 28 PO days (OR = 3.207; 95% CI, 1.010 to 10.179; p = 0.048). Conclusion: Patients submitted to liver transplantation using conventional or piggyback methods present similar results regarding venous outflow drainage of the graft. Conventional with venovenous bypass technique significantly increases the harm of postoperative renal dysfunction.
Data from: Trial-and-error copying of demonstrated actions reveals how fledglings learn to 'imitate' their mothers
Understanding how humans and other animals learn to perform an act from seeing it done has been a major challenge in the study of social learning. To determine whether this ability is based on 'true imitation', many studies have applied the two-action experimental paradigm, examining whether subjects learn to perform the specific action demonstrated to them. Here, we show that the insights gained from animals' success in two-action experiments may be limited, and that a better understanding is achieved by monitoring subjects' entire behavioural repertoire. Hand-reared house sparrows that followed a model of a mother demonstrator were successful in learning to find seeds hidden under a leaf, using the action demonstrated by the mother (either pushing the leaf or pecking it). However, they also produced behaviours that had not been demonstrated but were nevertheless related to the demonstrated act. This finding suggests that while the learners were clearly influenced by the demonstrator, they did not accurately imitate her. Rather, they used their own behavioural repertoire, gradually fitting it to the demonstrated task solution through trial and error. This process is consistent with recent views on how animals learn to imitate, and may contribute to a unified process-level analysis of social learning mechanisms.
Data from: Evolution of ischemic damage and behavioural deficit over 6 months after MCAo in the rat: selecting the optimal outcomes and statistical power for multi-centre preclinical trials
Key disparities between the timing and methods of assessment in animal stroke studies and clinical trial may be part of the reason for the failure to translate promising findings. This study investigates the development of ischemic damage after thread occlusion MCAo in the rat, using histological and behavioural outcomes. Using the adhesive removal test we investigate the longevity of behavioural deficit after ischemic stroke in rats, and examine the practicality of using such measures as the primary outcome for future studies. Ischemic stroke was induced in 132 Spontaneously Hypertensive Rats which were assessed for behavioural and histological deficits at 1, 3, 7, 14, 21, 28 days, 12 and 24 weeks (n>11 per timepoint). The basic behavioural score confirmed induction of stroke, with deficits specific to stroke animals. Within 7 days, these deficits resolved in 50% of animals. The adhesive removal test revealed contralateral neglect for up to 6 months following stroke. Sample size calculations to facilitate the use of this test as the primary experimental outcome resulted in cohort sizes much larger than are the norm for experimental studies. Histological damage progressed from a necrotic infarct to a hypercellular area that cleared to leave a fluid filled cavity. Whilst absolute volume of damage changed over time, when corrected for changes in hemispheric volume, an equivalent area of damage was lost at all timepoints. Using behavioural measures at chronic timepoints presents significant challenges to the basic science community in terms of the large number of animals required and the practicalities associated with this. Multicentre preclinical randomised controlled trials as advocated by the MultiPART consortium may be the only practical way to deal with this issue.
Data from: Preclinical toxicity and pharmacokinetics of a new orally bioavailable flubendazole formulation and the impact for clinical trials and risk/benefit to patients.
Background: Flubendazole, originally developed to treat infections with intestinal nematodes, has been shown to be efficacious in animal models of filarial infections. For treatment of filarial nematodes, systemic exposure is needed. For this purpose, an orally bioavailable amorphous solid dispersion (ASD) formulation was developed. As this formulation results in improved systemic absorption, the pharmacokinetic and toxicological profile of flubendazole administered with this formulation have been assessed to ensure human safety before clinical trials could be initiated. Methods & Findings: Safety pharmacology, toxicity and genotoxicity studies have been conducted with the flubendazole ASD formulation. In animals, flubendazole has good oral bioavailability from an ASD formulation ranging from 15 % in dogs, 276 % in rats to more than 100% in jirds. In in vivo toxicity studies with the ASD formulation, high systemic exposure to flubendazole and its main metabolites was reached. Flubendazole, up to high peak plasma concentrations, does not induce Cmax related effects in the CNS or cardiovascular system. In repeated dose toxicity studies in rats and dogs, flubendazole-induced changes were observed in haematological, lymphoid and gastrointestinal systems and in testes. In dog, the liver was an additional target organ. Upon treatment cessation, at least partial recovery was observed for these changes in the dog. In rat, the low dose was the No Observed Adverse Effect Level (NOAEL) was , i.e. 5 mg (as base)/kg body weight/day (mg eq./kg/day)mg eq./kg/day in males and 2.5 mg eq./kg/day in females. In dog, the NOAEL was lower than the low dose, 20 mg eq./kg/day. Regarding genotoxicity, flubendazole was negative in the Ames test but positive in the in vivo micronucleus test. Conclusions: Based on these results, in combination with previously described genotoxicity and reproductive toxicity data and the outcome of the preclinical efficacy studies, it was concluded that no flubendazole treatment regimen can be selected that would provide efficacy in humans at safe exposure.
raw data - Effects of preemptive acupuncture on cognitive function of the elderly patients after hip replacement: a randomized controlled trial
Open the record for dataset details and reuse information.
Data Supplements - N-of-1 trials in neurological disorders: Personalizing treatment
<p><strong>Supplemental data including</strong>: Study details of each included N-of-1 trial that reported individual responses (on a pre-defined primary outcome measure) and post-trial treatment decisions (eTable 1); PubMed and Medline primary search strategy for N-of-1 trials in neurological disorders (eAppendix 1); More specified inclusion and exclusion criteria (eAppendix 2); eReferences (eReferences).</p>
Data from: The COVID-19 trial finder
<p>Clinical trials are the gold standard for generating reliable medical evidence, but patient search of relevant trials often suffers from information overload. With nearly 700 COVID-19 trials conducted in the United States as of August 2020, it is imperative that trial seekers can search for COVID-related clinical trials efficiently to enable rapid recruitment to these studies. We developed a web application called COVID-19 Trial Finder, which facilitates COVID-19 trial search in the United States, first by location and radius distance from trial sites, then by brief, dynamically-generated medical questions to allow users to pre-screen their eligibility for nearby COVID-19 trials with minimum human computer interaction. A simulation study using 20 patient case reports demonstrates the accuracy and effectiveness of the COVID-19 Trial Finder. </p>
Data from: Risk of cancer with angiotensin-receptor blockers increases with increasing cumulative exposure: Meta-regression analysis of randomized trials
<p>Angiotensin-receptor blockers (ARBs) are a class of drugs approved for the treatment of several common conditions, such as hypertension and heart failure. Recently, regulatory agencies have started to identify possibly carcinogenic nitrosamines and azido compounds in a multitude of formulations of several ARBs, resulting in progressive recalls. Furthermore, data from several randomized controlled trials suggested that there is also a clinically increased risk of cancer and specifically lung cancer with ARBs; whereas other trials suggested no increased risk. The purpose of this analysis was to provide additional insight into the ARB-cancer link by examining whether there is a relationship between degree of cumulative exposure to ARBs and risk of cancer in randomized trials. Trial-level data from ARB Trialists Collaboration including 15 randomized controlled trials was extracted and entered into meta-regression analyses. The two co-primary outcomes were the relationship between cumulative exposure to ARBs and risk of all cancers combined and the relationship between cumulative exposure and risk of lung cancer. A total of 74,021 patients were randomized to an ARB resulting in a total cumulative exposure of 172,389 person-years of exposure to daily high dose (or equivalent). 61,197 patients were randomized to control. There was a highly significant correlation between the degree of cumulative exposure to ARBs and risk of all cancers combined (slope=0.07 [95% CI 0.03 to 0.11], p<0.001), and also lung cancer (slope=0.16 [95% CI 0.05 to 0.27], p=0.003). Accordingly, in trials where the cumulative exposure was greater than 3 years of exposure to daily high dose, there was a statistically significant increase in risk of all cancers combined (I<sup>2</sup>=31.4%, RR 1.11 [95% CI 1.03 to 1.19], p=0.006). There was a statistically significant increase in risk of lung cancers in trials where the cumulative exposure was greater than 2.5 years (I<sup>2</sup>=0%, RR 1.21 [95% CI 1.02 to 1.44], p=0.03). In trials with lower cumulative exposure to ARBs, there was no increased risk of all cancers combined or lung cancer. Cumulative exposure-risk relationship with ARBs was independent of background angiotensin-converting enzyme inhibitor treatment or the type of control (i.e. placebo or non-placebo control). Since this is a trial-level analysis. the effects of patient characteristics such as age and smoking status could not be examined due to lack of patient-level data. In conclusion, this analysis, for the first time, reveals that risk of cancer with ARBs (and specifically lung cancer) increases with increasing cumulative exposure to these drugs. The excess risk of cancer with long-term ARB use has public health implications.</p>
ScienceDex guides
Understand access before you commit
These curated guides explain access requirements, typical timelines, costs, and reuse considerations for widely used research datasets.
Allen Brain Atlas
Allen Brain Atlas is an Allen Institute collection of brain map atlases, datasets, APIs, and analysis tools covering mouse, human, and non-human primate brain resources.
Annotated Behaviour and Observability Dataset (ABODe)
ABODe is a University of Edinburgh DataShare dataset for behavior classification in group-housed mice using home-cage video, identities, bounding boxes, ground-plate positions, and annotator labels.
DANDI Archive for NWB datasets
DANDI is a BRAIN Initiative archive for publishing and sharing neurophysiology data, including electrophysiology, optophysiology, and behavioral data packaged as NWB and related standards.
International Brain Laboratory public data
The International Brain Laboratory public data releases expose standardized mouse decision-making experiments, including Neuropixels recordings, widefield calcium imaging, behavior, and session metadata accessed through the ONE API.
OpenNeuro
OpenNeuro is a free, open platform for sharing neuroimaging datasets, with public search, dataset pages, and download paths for web, S3, DataLad, and the OpenNeuro CLI.