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54 results for “cluster-randomized trial”
Impact of Community Masking on COVID-19: A Cluster-Randomized Trial in Bangladesh
<p>We ran a randomized trial of mask promotion in Bangladesh; the intervention increased mask-use and reduced symptomatic SARS-CoV-2 infections.</p>
Recent HIV infections among newly diagnosed individuals living with HIV in rural Lesotho: Secondary data from the VIBRA cluster-randomized trial
<p>These are pseudo-anonymised data from a secondary analysis of the VIBRA randomised trial.</p> <p>HIV recency assays are used to distinguish recently acquired infection from long-term infection among individuals newly diagnosed with HIV. Since 2015, the World Health Organisation recommends the use of an algorithm to assess recency of infections which is based on an HIV recency assay and viral load (VL) quantification. We determined the proportion of recent HIV infections among participants of the VIBRA (Village-Based Refill of Antiretroviral therapy) cluster-randomized trial in Lesotho and assessed risk factors for these recent infections.</p> <p>The VIBRA trial recruited individuals living with HIV and not taking antiretroviral therapy during a door-to-door HIV testing campaign in two rural districts (Butha-Buthe and Mokhotlong). Samples were collected from participants newly diagnosed and tested for HIV recency using the Asanté HIV-1 Rapid Recency Assay and VL using the Roche Cobas System. Clinical and socio-demographic data were extracted from the trial database. Univariate analysis was conducted to determine factors associated with recent compared to long-term infection.</p> <p>There is one dataset containing all data presented in this dtuy. The data codebook explains the data available in the dataset.</p>
Data from: Evaluation of a community health worker home visit intervention to improve child development in South Africa: A cluster-randomized controlled trial
<p><span>This dataset was collected as part of a</span><span> cluster-randomized controlled trial that evaluated the impact of </span>a home visit intervention on child development<span> in Limpopo Province, South Africa. </span><span>Household survey data were collected at baseline and endline. In a subsample of children, neural function was assessed at a lab at endline and at two interim time points. Primary outcomes were: height-for-age z-scores (HAZ) and stunting; child development scores measured using the Malawi Developmental Assessment Tool (MDAT); absolute electroencephalography (EEG) gamma and total power; relative EEG gamma power; and saccadic reaction time (SRT)—</span>an eye-tracking measure of visual processing speed.</p>
IMPROVE AKI Cluster-Randomized Trial
ClinicalTrials.gov study NCT03556293. IPD Sharing: YES. Countries: 1. Publications: 2.
A Prospective Cluster-Randomized, Controlled Crossover Trial to Validate an Electronic "Resistance Calculator"
ClinicalTrials.gov study NCT05304221. IPD Sharing: NO. Countries: 1. Publications: 10.
Cluster-randomized Controlled Trial of Mindfulness-Based Cognitive Therapy Effects on Anxiety and Stress
ClinicalTrials.gov study NCT06019299. IPD Sharing: YES. Countries: 1. Publications: 1.
Self-Help Plus to Enhance Early Development: A Cluster-Randomized Controlled Trial of Maternal Mental Health, Child Cognitive Abilities, and Socio-Behavioral Skills Among South Sudanese Refugee Mother
ClinicalTrials.gov study NCT07062341. IPD Sharing: NO. Countries: 1. Publications: 1.
A Cluster-randomized Trial to Assess a Sexual Assault Prevention Intervention in Adolescents in Nairobi, Kenya
ClinicalTrials.gov study NCT02771132. IPD Sharing: NO. Countries: 1. Publications: 2.
Direct Gloving Strategy: A Cluster-randomized Trial
ClinicalTrials.gov study NCT03119389. IPD Sharing: NO. Countries: 1. Publications: 1.
Data from: Evaluation of a community health worker home visit intervention to improve child development in South Africa: A cluster-randomized controlled trial
Open the record for dataset details and reuse information.
Data from: The impact of hotspot-targeted interventions on malaria transmission in Rachuonyo south district in the western Kenyan highlands: a cluster-randomized controlled trial
Background: Malaria transmission is highly heterogeneous, generating malaria hotspots that can fuel malaria transmission across a wider area. Targeting hotspots may represent an efficacious strategy for reducing malaria transmission. We determined the impact of interventions targeted to serologically defined malaria hotspots on malaria transmission both inside hotspots and in surrounding communities. Methods and Findings: Twenty-seven serologically defined malaria hotspots were detected in a survey conducted from 24 June to 31 July 2011 that included 17,503 individuals from 3,213 compounds in a 100-km2 area in Rachuonyo South District, Kenya. In a cluster-randomized trial from 22 March to 15 April 2012, we randomly allocated five clusters to hotspot-targeted interventions with larviciding, distribution of long-lasting insecticide-treated nets, indoor residual spraying, and focal mass drug administration (2,082 individuals in 432 compounds); five control clusters received malaria control following Kenyan national policy (2,468 individuals in 512 compounds). Our primary outcome measure was parasite prevalence in evaluation zones up to 500 m outside hotspots, determined by nested PCR (nPCR) at baseline and 8 wk (16 June–6 July 2012) and 16 wk (21 August–10 September 2012) post-intervention by technicians blinded to the intervention arm. Secondary outcome measures were parasite prevalence inside hotpots, parasite prevalence in the evaluation zone as a function of distance from the hotspot boundary, Anopheles mosquito density, mosquito breeding site productivity, malaria incidence by passive case detection, and the safety and acceptability of the interventions. Intervention coverage exceeded 87% for all interventions. Hotspot-targeted interventions did not result in a change in nPCR parasite prevalence outside hotspot boundaries (p ≥ 0.187). We observed an average reduction in nPCR parasite prevalence of 10.2% (95% CI −1.3 to 21.7%) inside hotspots 8 wk post-intervention that was statistically significant after adjustment for covariates (p = 0.024), but not 16 wk post-intervention (p = 0.265). We observed no statistically significant trend in the effect of the intervention on nPCR parasite prevalence in the evaluation zone in relation to distance from the hotspot boundary 8 wk (p = 0.27) or 16 wk post-intervention (p = 0.75). Thirty-six patients with clinical malaria confirmed by rapid diagnostic test could be located to intervention or control clusters, with no apparent difference between the study arms. In intervention clusters we caught an average of 1.14 female anophelines inside hotspots and 0.47 in evaluation zones; in control clusters we caught an average of 0.90 female anophelines inside hotspots and 0.50 in evaluation zones, with no apparent difference between study arms. Our trial was not powered to detect subtle effects of hotspot-targeted interventions nor designed to detect effects of interventions over multiple transmission seasons. Conclusions: Despite high coverage, the impact of interventions targeting malaria vectors and human infections on nPCR parasite prevalence was modest, transient, and restricted to the targeted hotspot areas. Our findings suggest that transmission may not primarily occur from hotspots to the surrounding areas and that areas with highly heterogeneous but widespread malaria transmission may currently benefit most from an untargeted community-wide approach. Hotspot-targeted approaches may have more validity in settings where human settlement is more nuclear. Trial registration: ClinicalTrials.gov NCT01575613.
Data from: Improving rational use of ACTs through diagnosis-dependent subsidies: evidence from a cluster-randomized controlled trial in western Kenya
Background: More than half of artemisinin combination therapies (ACTs) consumed globally are dispensed in the retail sector where diagnostic testing is uncommon, leading to overconsumption and poor targeting. In many malaria-endemic countries, ACTs sold over-the-counter are available at heavily subsidized prices, further contributing to their misuse. Inappropriate use of ACTs can have serious implications for the spread of drug resistance and leads to poor outcomes for non-malaria patients treated with incorrect drugs. We evaluated the public health impact of an innovative strategy that targets ACT subsidies to confirmed malaria cases by coupling free diagnostic testing with a diagnosis-dependent ACT subsidy. Methods and Findings: We conducted a cluster-randomized controlled trial in 32 community clusters in western Kenya (population ~160,000). Eligible clusters had retail outlets selling ACTs and existing community health worker (CHW) programs and were randomly assigned 1:1 to control and intervention arms. In intervention areas, CHWs were available in their villages to perform malaria rapid diagnostic tests on demand for any individual >1 year of age experiencing a malaria-like illness. Malaria RDT positive individuals received a voucher for a discount on a quality-assured ACT, redeemable at a participating retail medicine outlet. In control areas, CHWs offered a standard package of health education, prevention and referral services. We conducted four population-based surveys, at baseline, 6 months, 12 months and 18 months, of a random sample of households with fever in the last 4 weeks to evaluate predefined, individual-level outcomes. The primary outcome was uptake of malaria diagnostic testing at 12 months. The main secondary outcome was rational ACT use, defined as the proportion of ACTs used by test-positive individuals. Analyses followed the intention-to-treat principle using generalized estimating equations to account for clustering with pre-specified adjustment for gender, age, education and wealth. All descriptive statistics and regressions were weighted to account for sampling design. Between July 2015 and May 2017, 32,404 participants were tested for malaria and 10,870 vouchers were issued. 7416 randomly-selected participants with recent fever from all 32 clusters were surveyed. The majority of recent fevers were in children under 18 years (62.9%, n=4653). The gender of enrolled participants was balanced in children (50.0%, n=2318 v 50.2%, n=2335), but more adult women were enrolled than men (78.0%, n=2139 v 22.0%, n=604). At baseline, 67.6% (n=1362) of participants took an ACT for their illness and 40.3% (n=810) of all participants took an ACT purchased from a retail outlet. At 12 months, 50.5% (n=454) in the intervention arm and 43.4% (n=389) in the control arm had a malaria diagnostic test for their recent fever (Adjusted Risk Difference=9 percentage points [pp], 95%CI: 2-15pp, p=0.015; Adjusted Risk Ratio=1.20, 95%CI:1.05-1.38, p=0.015). By 18-months, the ARR had increased to 1.25 (95%CI:1.09-1.44, p=0.005). Rational use of ACTs in the intervention area increased from 41.7% (n=279) at baseline to 59.6% (n=403) and was 40% higher in the intervention arm at 18 months (Adj RR 1.40, 95%CI: 1.19-1.64). While intervention effects increased between 12 and 18 months, we were not able to estimate longer-term impact of the intervention and could not independently evaluate the effects of the free testing and the voucher on uptake of testing. Conclusions: Diagnosis-dependent ACT subsidies and community-based interventions that include the private sector can have an important impact on diagnostic testing and population-wide rational use of ACTs. Targeting of the ACT subsidy itself to those with a positive malaria diagnostic test may also improve sustainability and reduce the cost of retail sector ACT subsidies.
Data from: Single-dose oral ciprofloxacin prophylaxis as a response to a meningococcal meningitis epidemic in the African meningitis belt: a three-arm, open-label, cluster-randomized trial
Background: Antibiotic prophylaxis for contacts of meningitis cases is not recommended during outbreaks in the African meningitis belt. We assessed the effectiveness of single-dose oral ciprofloxacin administered to household contacts and in village-wide distributions on the overall attack rate (AR) in an outbreak of meningococcal meningitis. Methods and findings: In this 3-arm, open-label, cluster-randomized trial during a meningococcal meningitis outbreak in Madarounfa District, Niger, villages notifying a suspected case were randomly assigned (1:1:1) to standard care (the control arm), single-dose oral ciprofloxacin for household contacts within 24 hours of case notification, or village-wide distribution of ciprofloxacin within 72 hours of first case notification. The primary outcome was the overall AR of suspected meningitis after inclusion. A random sample of 20 participating villages was enrolled to document any changes in fecal carriage prevalence of ciprofloxacin-resistant and extended-spectrum beta-lactamase (ESBL)–producing Enterobacteriaceae before and after the intervention. Between April 22 and May 18, 2017, 49 villages were included: 17 to the control arm, 17 to household prophylaxis, and 15 to village-wide prophylaxis. A total of 248 cases were notified in the study after the index cases. The AR was 451 per 100,000 persons in the control arm, 386 per 100,000 persons in the household prophylaxis arm (t test versus control p = 0.68), and 190 per 100,000 persons in the village-wide prophylaxis arm (t test versus control p = 0.032). The adjusted AR ratio between the household prophylaxis arm and the control arm was 0.94 (95% CI 0.52–1.73, p = 0.85), and the adjusted AR ratio between the village-wide prophylaxis arm and the control arm was 0.40 (95% CI 0.19‒0.87, p = 0.022). No adverse events were notified. Baseline carriage prevalence of ciprofloxacin-resistant Enterobacteriaceae was 95% and of ESBL-producing Enterobacteriaceae was >90%, and did not change post-intervention. One limitation of the study was the small number of cerebrospinal fluid samples sent for confirmatory testing. Conclusions: Village-wide distribution of single-dose oral ciprofloxacin within 72 hours of case notification reduced overall meningitis AR. Distributions of ciprofloxacin could be an effective tool in future meningitis outbreak responses, but further studies investigating length of protection, effectiveness in urban settings, and potential impact on antimicrobial resistance patterns should be carried out.
Effectiveness of community-based health education and home support program to reduce blood pressure among patients with uncontrolled hypertension in Nepal: A cluster-randomized trial
<p><b>Background: </b>Hypertension is a major global public health problem. Elevated blood pressure can cause cardiovascular and kidney diseases. We assessed the effectiveness of health education sessions and home support programs in reducing blood pressure among patients with uncontrolled hypertension in a suburban community of Nepal.</p> <p><b>Methods</b>: We conducted a community-based, open-level, parallel-group, cluster randomized controlled trial in Birendranagar municipality of Surkhet, Nepal. We randomly assigned four clusters (wards) into intervention and control arms. We provided four health education sessions, frequent home and usual care for intervention groups over six months. The participants of the control arm received only usual care from health facilities. The primary outcome of this study was the proportion of controlled systolic blood pressure (SBP). The analysis included all participants who completed follow-up at six months.</p> <p><b>Results</b>: 125 participants were assigned to either the intervention (n=63) or the control (n=62) group. Of them, 60 participants in each group completed six months follow-up. The proportion of controlled SBP was significantly higher among the intervention participants compared to the control (58.3% vs. 40%). Odds ratio of this was 2.1 with 95% CI: 1.01-4.35 (p=0.046) and that of controlled diastolic blood pressure (DBP) was 1.31 (0.63-2.72) (p=0.600). The mean change (follow-up minus baseline) in SBP was significantly higher in the intervention than in the usual care (-18.7 mmHg vs. -11.2 mmHg, p=0.041). Such mean change of DBP was also higher in the intervention (-10.95 mmHg vs. -5.53 mmHg, p=0.065). The knowledge score on hypertension improved by 2.38 (SD 2.4) in the intervention arm, which was significantly different from that of the control group, 0.13 (1.8) (p<0.001).</p> <p><b>Conclusions</b>: Multiple health education sessions complemented by frequent household visits by health volunteers can effectively improve knowledge on hypertension and reduce blood pressure among uncontrolled hypertensive patients at the community level in Nepal. </p> <p><b>Keywords:</b> Hypertension; Blood pressure; Systolic Blood Pressure; Diastolic Blood Pressure; Cardiovascular disease; Health Education; Home Support</p> <p><b>Trial Registration: </b>ClinicalTrial.gov: <span>NCT02981251</span></p>
Active Smarter Kids: A Cluster-randomized Controlled Trial
ClinicalTrials.gov study NCT02132494. IPD Sharing: Not stated. Countries: 1. Publications: 15.
Generation Healthy Kids: A Cluster-randomized Trial of a Multi-component, Multi-setting Intervention
ClinicalTrials.gov study NCT05940675. IPD Sharing: YES. Countries: 1. Publications: 1.
Efficacy of a Multi-faceted Intervention to Deprescribe Proton Pump Inhibitors (PPI) in Primary Care: a Population-based, Pragmatic, Cluster-randomized Controlled Trial.
ClinicalTrials.gov study NCT04255823. IPD Sharing: NO. Countries: 1. Publications: 1.
Effectiveness and Safety of a Flexible Family Visitation Model for Delirium Prevention in Adult Intensive Care Units: a Cluster-randomized, Crossover Trial (The ICU Visits Study)
ClinicalTrials.gov study NCT02932358. IPD Sharing: UNDECIDED. Countries: 1. Publications: 5.
Checking Smoking Status as a Routine Vital Sign: A Cluster-Randomized Trial of Its Effect on Cessation Counseling
ClinicalTrials.gov study NCT00245323. IPD Sharing: Not stated. Countries: 1. Publications: 1.
A Cluster-Randomized Intervention Trial to Improve Quality of Life for HIV-Infected Individuals in Anhui, China
ClinicalTrials.gov study NCT00479141. IPD Sharing: Not stated. Countries: 1. Publications: 1.
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DANDI Archive for NWB datasets
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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.