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3,361 results for “Randomized Controlled Trial”
Data from: Ambulatory versus inpatient management of severe nausea and vomiting of pregnancy: a randomized control trial with patient preference arm
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Data from: Internet-delivered therapist-guided physical activity for mild to moderate depression: a randomized controlled trial
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Effect of acupuncture and metformin on insulin sensitivity in women with polycystic ovary syndrome and insulin resistance: a three-armed randomized controlled trial
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Data from: A randomized, placebo-controlled phase 2 trial of laquinimod in primary progressive multiple sclerosis
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The STARS phase 2 study: a randomized controlled trial of gaboxadol in Angelman syndrome
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Data from: Effect of ecological momentary assessment, goal-setting and personalized phone-calls on adherence to interval walking training using the InterWalk application among patients with type 2 diabetes – a pilot randomized controlled trial
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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
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Data from: Adjunctive use of modified Yunu-Jian in the non-surgical treatment of male smokers with chronic periodontitis: a randomized double-blind, placebo-controlled clinical trial
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Data from: Identifying and overcoming breastfeeding challenges using two-way short message service, a randomized controlled trial
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Evaluating the educational effectiveness of a structured, simulator-assisted, peer-led training on cardiovascular physical examination in third-year medical students: A randomized, controlled trial
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Data from: Patterned frequency-modulated oral stimulation in preterm infants: a multicenter randomized controlled trial
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Data from: Scrambler therapy improves pain in neuromyelitis optica: a randomized 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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The Kanyakla Study: Randomized controlled trial of a microclinic social network intervention for promoting engagement and retention in HIV care in rural western Kenya
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The effects of LED-mediated photobiomodulation vs no photobiomodulation on extraction space closure in adolescents and young adult patients: A split-mouth, randomized controlled trial.
<p>The aim of this split-mouth trial was is to examine the effects of light emitting diode (LED)-mediated photobiomodulation (PBM) compared to no photobiomodulation on maxillary canine distalization.</p> <p>The dataset is openly provided upon acceptance for publication.</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>
Ivermectin as a potential treatment for mild to moderate COVID-19 – A double blind randomized placebo-controlled trial
<p><b>Objective:</b> Ivermectin has been suggested as a treatment for COVID-19.This randomised control trial was conducted to test the efficacy of Ivermectin in the treatment of mild and moderate COVID-19.</p> <p><b>Design:</b> Parallel, double blind, randomised, placebo controlled trial</p> <p><b>Setting:</b> A tertiary care dedicated COVID-19 hospital in Bihar, India</p> <p><b>Participants:</b> Adult patients (> 18 years) admitted with mild to moderate COVID 19 disease (saturation > 90% on room air, respiratory rate < 30 and no features of shock) with no contraindications to ivermectin and willing to participate in the study</p> <p><b>Intervention:</b> Patients in the intervention arm were given ivermectin 12 mg on day 1 and day 2 of admission. Patients in the placebo arm were given identical looking placebo tablets. Rest of the treatment was continued as per the existing protocol and the clinical judgment of the treating teams.</p> <p><b>Outcome Measures:</b> The primary outcome measure was a negative RT-PCR test for SARS-CoV-2 on day 6 of admission. The secondary outcome measures were symptom status on day 6, discharge status on day 10, admission to ICU, need for invasive mechanical ventilation and in-hospital mortality.</p> <p><b>Results:</b> A total of 115 patients were enrolled for the study of which 112 were included in the final analysis. Of them, 55 were randomised to the intervention arm while 57 were randomised to the placebo arm. There was no significant difference in the baseline characteristics of the two arms. There was no significant difference in the primary outcome, i.e. negative RT-PCR status on day 6 between the two groups. Similarly, there was no significant difference between the two groups in most of the secondary outcome measures, viz. symptom status on day 6, discharge status on day 10, admission to ICU, and need for invasive mechanical ventilation. However, while there was no in-hospital mortality in the intervention arm, there were 4 deaths in the placebo arm. As a result, all patients in the intervention arm (n=56) were successfully discharged as compared to 93.1% (n=54/58) in the placebo arm (RR 1.1, 95% CI 1.0 to 1.2, p=0.019).</p> <p><b>Conclusion:</b> There was no difference in the primary outcome i.e. negative RT-PCR status on day 6 of admission with the use of ivermectin. However, a significantly higher proportion of patients were discharged alive from the hospital when they received ivermectin.</p>
Staggering Sugammadex for Reduction of Postoperative Complications: A Randomized Controlled Trial
<p><strong>Background:</strong> We investigated if staggering sugammadex would reduce postoperative complications(with special regards to cough), compared to single dose of sugammadex or standard neostigmine in patients undergoing thyroidectomy surgery.</p> <p><strong>Methods</strong>: A 36 adult patients aged 21-60 years old, ASA I and II undergoing thyroidectomy surgery, were randomized into 3 groups; (S group) that received 2 mg/kg sugammadex as single bolus, (SS group) that received sugammadex 2 mg/kg in a staggered dose of 1 mg/kg prior to extubation and another 1 mg/kg immediately after extubation and (N group) that received 0.05 mg/kg neostigmine combined with 0.02 mg/kg atropine.</p> <p><strong>Results</strong>: Cough was absent in (SS) group. The percent of cough was 33% in S group and about 67 % in N group.Patients of (SS) and (S) groups had significant shorter recovery time and extubation time. Patients of (N) group showed significant increase in HR and SBP at 5 min after reversal compared to both (SS) and (S) groups, but no significant difference in DBP between all groups. There was no significant difference between all groups regarding postoperative complications other than cough.</p> <p><strong>Conclusion: </strong>Staggered sugammadex reduces significantly risks for cough on emergence when compared to 2mg single bolus sugammadex .In addition, staggered sugammadex-as well as bolus sugammadex-has better recovery and more stable hemodynamics when compared to neostigmine.</p>
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.
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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.