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5,826 results for “Randomized trial”
EXTRACT-NOAC randomized clinical trial Dataset
<p>This database concerns a randomized clinical trial, called the EXTRACT-NOAC trial. The title of the trial is 'Tranexamic acid and bleeding after dental extraction in patients treated with non-vitamin K oral anticoagulants'. The aim of the trial was to evaluate the efficacy of tranexamic acid mouthwash to reduce bleeding after dental extraction in patients on non-vitamin K oral anticoagulants. </p>
A randomized clinical trial to compare P. falciparum gametocytaemia and infectivity following blood-stage or mosquito bite induced controlled malaria infection
<p>For malaria elimination efforts, it is important to better understand parasite transmission to mosquitoes and to develop models to allow early clinical evaluation of transmission-blocking interventions. We previously described a Controlled Human Malaria Infection protocol for induction of gametocytemia in malaria naïve volunteers by mosquito bite (CHMI-trans) (Reuling et al., 2018). Here, we compared gametocyte production and infectivity in the CHMI-trans model after bites of <em>Plasmodium falciparum (Pf)- </em>infected mosquitoes to that after intravenous administration of <em>Pf-</em>infected-erythrocytes. Volunteers received (sub) curative treatments with gametocyte-permissive piperaquine or sulfadoxine-pyrimethamine. Blood-stage inoculation induced considerably higher gametocyte densities compared to mosquito bitesthat was predicted by <em>Pf</em>AP2-G transcripts indicative of gametocyte commitment, and resulted in <em>Pf</em>-positive mosquito infections in 9/12 volunteers versus 0/12 volunteers after mosquito bite inoculation. Current findings firmly establish the CHMI-trans with intravenous administration of asexual parasites as a model for early clinical evaluation of interventions that aim to interrupt <em>Pf</em>-transmission.</p>
THREE-DIMENSIONAL VOLUMETRIC EVALUATION OF ROOT RESORPTION IN MAXILLARY ANTERIORS FOLLOWING EN-MASSE RETRACTION WITH VARYING FORCE VECTORS - A RANDOMIZED CONTROL TRIAL
<p>To assess the severity of root resorption (RR) during retraction of maxillary anteriors with and without skeletal anchorage (three different force systems); and analyze it comprehensively using cone-beam computed tomography (CBCT) superimpositions.</p>
Gastric Residual Volume, Safety and Effectiveness of Drinking 250ml Glucose Solution 2-3 Hours before Surgery in Gastric Cancer Patients: A Multicenter, Single-blind, Randomized Controlled Trial
<p><strong>Supplementary Figure 1</strong></p> <p> </p> <p>A. Change of QUICKI level after surgery</p> <p>Post-OP: right after operation; POD: post-operation day; Mixed linear model statistics showed that the effect of time ( p=0.004) was significant, but no significant differences were noted for group(P=0.600) or group*time(P=0.963).</p> <p>B. Change of Recovery Level of QUICKI after surgery</p> <p>Post-OP: right after operation; POD: post-operation day; Mixed linear model statistics showed that no significant differences were noted for group(P=0.600) ,time (P=0.235) or group×time(P=0.963).</p> <p>C. Change of WBC level after surgery</p> <p>Post-OP: right after operation; POD: post-operation day; Mixed linear model statistics showed that the effect of time ( p<0.001) was significant, and no significant differences were noted for group(P=0.392) or group×time(P=0.314).</p> <p>D. Change of CRP level after surgery</p> <p>Post-OP: right after operation; POD: post-operation day; Mixed linear model statistics showed that the effect of time ( p<0.001) was significant, but no significant differences were noted for group(P=0.312) or group × time(P=0.826).</p>
Dataset for "Definition and rationale for placebo composition: Cross-sectional analysis of randomized trials and protocols published in high-impact medical journals"
<p>Contains our data extraction sheets</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>
Effect Of Pulsed Electromagnetic Field And Microwave Therapy On Pain And Physical Function In Older Adults With Knee Osteoarthritis: A Randomized Clinical Trial.
<p><strong><span>Background and purpose:</span></strong><span> </span><span>Pulsed electromagnetic field (PEMF) therapy and microwaves (MW) are two electrotherapy modalities that have shown to improve pain and function in patients with knee osteoarthritis (KOA). Nevertheless, the effectiveness of these therapies is controversial due to diversity in the application parameters and treatment protocols in these patients. The objective is to compare the effectiveness of active PEMF versus MW, as well as sham PEMF, in addressing pain and improving functionality for treating KOA.</span></p> <p><strong><span>Methods:</span></strong><span> </span><span>Double-blind, placebo-controlled, randomized clinical trial. Participants diagnosed with KOA were assigned to an intervention combining an exercise program with active PEMF, MW, or sham PEMF, delivered in three weekly sessions over four weeks. The main outcomes were pain, reported on a 0–10 cm visual analogue scale (VAS), and functionality, as evaluated with the Western Ontario and McMaster Universities Arthritis (WOMAC) questionnaire, and the Timed Up and Go test. The outcomes were measured at pre-intervention, immediately post-intervention, and one and four months after the intervention.</span></p>
Evaluation of comparative efficacy of Babool Vati versus Tablet Metformin in the Management of Type 2 Diabetes Mellitus (Prameha)- a randomized controlled trial protocol
Open the record for dataset details and reuse information.
Effect of Informative Cesarean Delivery Operative Steps Video to Maternal Anxiety Level: a Randomized Controlled Trial
<p>This is a SPSS data for analysis in "Effect of Informative Cesarean Delivery Operative Steps Video to Maternal Anxiety Level: a Randomized Controlled Trial" research, and video is used for intervention group.</p>
Data for the project 'Feasibility and Effectiveness of a Personalized Home-Based Motor-Cognitive Training Program in Community-Dwelling Older Adults: a Pragmatic Pilot Randomized Controlled Trial'
<p>Data for the project 'Feasibility and Effectiveness of a Personalized Home-Based Motor-Cognitive Training Program in Community-Dwelling Older Adults: a Pragmatic Pilot Randomized Controlled Trial' including four complete datasets with all variables collected in this project and a corresponding README file ('README-File_Data_Feasibility and Effectiveness of a Personalized Home-Based Motor-Cognitive Training Program in Community-Dwelling Older Adults: a Pragmatic Pilot Randomized Controlled Trial.txt'). The latter provides (1) general information, (2) sharing and access information, (3) data and file overview, (4) methodological information, and (5) data-specific information.</p>
Medical publications with information as to whether a publication reports a randomized controlled trial and/or if it covers an oncology topic
<p><strong>Background:</strong></p> <p>Most tools trying to automatically extract information from medical publications are domain agnostic and process publications from any field. However, only retrieving trials from dedicated fields could have advantages for further processing of the data.</p> <p><strong>Dataset collection:</strong></p> <p>A random sample of 900 publications from seven major journals (British Medical Journal, JAMA, JAMA Oncology, Journal of Clinical Oncology, Lancet, Lancet Oncology, New England Journal of Medicine) published between 2010 and 2022 were annotated. Publications that described randomized controlled trials (RCTs) received the label "RCT". Publications that covered oncological topics received the label "ONCOLGY". Trials that fulfilled both criteria were assigned both labels. Trials that were neither RCTs nor covered oncology topics were assigned no label. 100 randomly sampled trials from the New England Journal of Medicine were used as the unseen test set as the journal publishes both oncology and non-oncology articles. </p> <p><strong>Data properties:</strong></p> <p>Each trial is a row in the CSV file. For each trial, there is a doi, a publication date, a title, an abstract, the abstract sections (introduction, methods, results, conclusion), several tags associated with the annotation process (text, _input_hash, _task_hash, options, _view_id, config, accept, answer, _timestamp, _annotator_id,_session_id), and the assigned labels (answer).</p>
The Efficacy of Daily versus Weekly Ferrous Sulfate in Maintaining Normal Serum Ferritin Levels During Pregnancy: A Randomized Controlled Trial
<p>Serum ferritin is the most reliable indication of stored iron in pregnancy, offering a<br>noninvasive way to detect iron deficiency anemia before it occurs. Therefore, this study aimed to<br>determine serum ferritin levels among women receiving daily versus weekly iron supplementation,<br>with a secondary focus on comparing the proportion developing iron deficiency anemia and compli-<br>ance rates between the two groups.<br>Methods: This non-blinded randomized control trial involved non-anaemic pregnant women attend-<br>ing antenatal clinics at two Teaching Hospitals in Osun State. One hundred twenty-five subjects were<br>recruited to receive 65mg in the control group, while another 125 subjects in the active group re-<br>ceived three tablets (195mg) of ferrous sulfate (Fesulf) once weekly for 17 weeks from the 20th to<br>37th weeks of gestation. The primary outcome measure was comparing mean serum ferritin levels in<br>both groups at 37 weeks.<br>Results: Among the 240 subjects analyzed, the 37-week serum ferritin level was higher in the daily<br>group (73.26±26.67µg/L) compared to the weekly group (63.04±30.71 µg/L), p value=0.006. Four<br>(3.36%) and 10 (8.26%) of our subjects had Iron deficiency anaemia. Nine subjects (3.75%) reported<br>dyspepsia as a side effect. Daily 65 mg of Felsulf proved more effective than weekly 195mg in main-<br>taining normal blood ferritin levels during pregnancy.<br>Conclusions: Daily iron supplementation with 65mg ferrous sulfate was more effective at main-<br>taining adequate maternal iron concentration in this group of non-anaemic pregnant women. This<br>dosage is recommended for routine iron supplementation in our environment.</p>
Broccoli sprout beverage is safe for thyroid hormonal and autoimmune status: Results of a 12-week randomized trial.
<p>The .csv file contains all the primary data for publication: <br> Chartoumpekis DV, Ziros PG, Chen JG, Groopman JD, Kensler TW, Sykiotis GP.<br> Broccoli sprout beverage is safe for thyroid hormonal and autoimmune status: Results of a 12-week randomized trial.<br> Food Chem Toxicol. 2019 Feb 5;126:1-6.<br> [Epub ahead of print] PubMed PMID: 30735751<br> doi: 10.1016/j.fct.2019.02.004.</p> <p>These data are used in all figures of the paper (Figure 1 and Figure 2).</p> <p>The data are tabular. The headers are the following:</p> <p>sample ID: It comprises 4 digits. The first 3 digits are the unique identifier of the subject in the trial, e.g., "613".<br> The last digit indicates whether the sample was collected at the start of the trial "0", or at the end of the trial "1".<br> E.g., "6130" is the sample collected from participant 613 at the beginning of the trial,<br> and 6131 is the sample collected from the same participant at the end of the trial.</p> <p>Autoimmunity: "0" means that both anti-TG and anti-TPO antibodies were within the reference range.<br> "1" means that either anti-TG, or anti-TPO antibodies, or both, were above the reference range.</p> <p>anti-TG (IU/ml): antibodies against thyroglobuline. The units are given in the parenthesis.</p> <p>anti-TPO (IU/ml): antibodies against thyropreoxidase. The units are given in the parenthesis.</p> <p>Treatment: "1"=placebo and "2"=broccoli sprouts extract beverage.</p> <p>Gender: "F" for female and "M" for male. Data from males were not included in the analyses.</p> <p>Age: In years.</p> <p><br> For any questions, contact: gerasimos.sykiotis@chuv.ch</p>
What evidence exists for myofunctional therapy with prefabricated appliances? A systematic review with meta-analyses of randomized trials
<p>Dataset for all analysis in the review</p>
Dataset for Spence et al., "Availability of study protocols for randomized trials published in high-impact medical journals: cross-sectional analysis" (CITATION)
<p>Contains our extraction sheets (as SAS data files), code to calculate the values in the tables in our manuscript, and a supplemental file with additional notes on methods used in our study.</p>
Data for: To Tweet or Not to Tweet, That is the Question: A Randomized Trial of Twitter Effects in Medical Education
<p>This is the raw data for the manuscript: To Tweet or Not to Tweet, That is the Question: A Randomized Trial of Twitter Effects in Medical Education. The abstract for the study is as follows: </p> <p>Introduction: Many medical education journals use Twitter to garner attention for their articles. The purpose of this study was to test the effects of tweeting on article page views and downloads.</p> <p>Methods: The authors conducted a randomized trial using <em>Academic Medicine</em> articles published in 2015. Beginning in February through May 2018, one article per day was randomly assigned to a Twitter (case) or control group. Daily, an individual tweet was generated for each article in the Twitter group that included the title, #MedEd, and a link to the article. The link delivered users to the article’s landing page, which included immediate access to the HTML full text and a PDF link. The authors extracted HTML page views and PDF downloads from the publisher. To assess differences in page views and downloads between cases and controls, a time-centered approach was used, with outcomes measured at 1, 7, and 30 days.</p> <p>Results: In total, 189 articles (94 cases, 95 controls) were analyzed. After days 1 and 7, there were no statistically significant differences between cases and controls on any metric. On day 30, HTML page views exhibited a 63% increase for cases (M=14.72, SD=63.68) when compared to controls (M=9.01, SD=14.34; incident rate ratio=1.63, p=0.01). There were no differences between cases and controls for PDF downloads on day 30.</p> <p>Discussion: Contrary to the authors’ hypothesis, only one statistically significant difference in page views between the Twitter and control groups was found. These findings provide preliminary evidence that after 30 days a tweet can have a small positive effect on article page views.</p>
Ivermectin as an adjuvant to anti-epileptic treatment in persons with onchocerciasis-associated epilepsy: a randomized proof-of-concept clinical trial
<p>Open dataset for a proof-of-concept randomized clinical trial with a four month follow-up period was conducted to investigate whether ivermectin had an added value in decreasing the frequency of seizures in onchocerciasis-infected persons with epilepsy (PWE). The 90 PWE with epilepsy were randomly allocated to the treatment arms: phenobarbital + ivermectin (n = 44) or phenobarbital alone (n = 46). Two weeks after randomization, a follow-up visit was scheduled to assess the early treatment outcomes and potential side effects of AED. After the second week visit, PWE had to report to the health center for further follow-up consultations by the project nurses and medical doctors, scheduled at 1, 2, 3 and 4 months. By March 2018, 89 (99%) participants in both arms attended the final follow-up visit. The trial was conducted in five onchocerciasis-endemic villages within the Logo health zone in the Ituri province, DRC: Draju, Kanga, Wala, Ulyeko and Thedeja. </p> <p>At baseline, information was collected on seizure semiology, seizure frequency, epilepsy risk factors, relevant medical history, previous AED and ivermectin use. Weight and height measurements were carried out on all participants, followed by a complete physical and neurological examination performed by one of the medical doctors who had been trained in epilepsy, or by the neurologist. Cognitive impairment was assessed by determining whether the participant was well oriented in time and place, whether he/she could remember his/her name, was coherent in speech, and was obedient to orders; abnormal behaviour such as unexplained aggressive attitudes and/or wandering episodes were also noted.</p> <p> </p> <p> </p>
Figure 2 in A new policy to implement CONSORT guidelines for surgical randomized controlled trials
Figure 2. - Distribution of Smilosicyopus species.
Raw data for the article: A Randomized Controlled Trial of Antithrombin Supplementation During Extracorporeal Membrane Oxygenation
<p><strong>Objectives: </strong>Supplementation of antithrombin might decrease the amount of heparin needed to achieve a given anticoagulation target during extracorporeal membrane oxygenation. However, exogenous antithrombin itself may increase the risk of bleeding. We conceived a study to evaluate the effect of antithrombin supplementation in adult patients requiring venovenous extracorporeal membrane oxygenation for respiratory failure on heparin dose, adequacy of anticoagulation, and safety.</p> <p><strong>Design: </strong>Prospective randomized controlled trial.</p> <p><strong>Setting: </strong>ICUs of two Italian referral extracorporeal membrane oxygenation centers.</p> <p><strong>Patients: </strong>Adult patients requiring venovenous extracorporeal membrane oxygenation for severe respiratory failure and unfractionated heparin for systemic anticoagulation.</p> <p><strong>Interventions: </strong>Before extracorporeal membrane oxygenation start, patients were randomized to either receive antithrombin concentrate to maintain a plasmatic level 80-120% (treatment) or not (control) during the extracorporeal membrane oxygenation course.</p> <p><strong>Measurements and main results: </strong>The primary outcome was the total amount of heparin required to maintain activated partial thromboplastin time ratio 1.5-2. Secondary outcomes were anti-factor Xa, the incidence of hemorrhagic and thrombotic events, and the amount of blood products transfused. Twenty-four patients in the treatment group and 24 in the control group were included in the intention-to-treat analysis. Antithrombin was 109.5% (93.0-123.0%) in the treatment group and 84.0% (68.5-98.0%) in the control group (p = 0.001). Supplementation of antithrombin did not decrease heparin dose (13.5 international units/kg/hr [9.6-17.9 international units/kg/hr] vs 15.1 international units/kg/hr [10.7-18.3 international units/kg/hr] in the treatment and control group, respectively; p = 0.33) and anti-Factor Xa levels (0.4 international units/mL [0.3-0.5 international units/mL] vs 0.3 international units/mL [0.2-0.5 international units/mL] in the treatment group and control group respectively; p = 0.65). Bleeding, blood product transfusions, and thrombosis were not different in the two groups.</p> <p><strong>Conclusions: </strong>Antithrombin supplementation may not decrease heparin requirement nor diminish the incidence of bleeding and/or thrombosis in adult patients on venovenous extracorporeal membrane oxygenation.</p>
Data from: Computer-aided X-ray screening for tuberculosis and HIV testing among adults with cough in Malawi (the PROSPECT study): a randomized trial and cost-effectiveness analysis
<p>Suboptimal tuberculosis (TB) diagnostics and HIV contribute to the high global burden of TB. We investigated costs and yield from systematic HIV-TB screening, including computer-aided digital chest X-ray (DCXR-CAD). Suboptimal tuberculosis (TB) diagnostics and HIV contribute to the high global burden of TB. We investigated costs and yield from systematic HIV-TB screening, including computer-aided digital chest X-ray (DCXR-CAD).</p> <p>In this open, three-arm randomised trial, adults (≥18 years) with cough attending acute primary services in Malawi were randomised (1:1:1) to standard-of-care (SOC); oral HIV testing (HIV screening) and linkage to care; or HIV testing and linkage to care plus DCXR-CAD with sputum Xpert for high CAD4TBv5 scores (HIV-TB screening). Participants and study staff were not blinded to intervention allocation, but investigator blinding was maintained until final analysis. The primary outcome was time to TB treatment. Secondary outcomes included proportion with same-day TB treatment; prevalence of undiagnosed/untreated bacteriologically-confirmed TB on day 56; and undiagnosed/untreated HIV. Analysis was done on an intention to treat basis. Cost-effectiveness analysis used a health-provider perspective. Between 15/11/2018-27/11/2019, 8236 were screened for eligibility, with 473, 492, and 497 randomly allocated to SOC, HIV, and HIV-TB screening arms; 53 (11%), 52 (9%), and 47 (9%) were lost to follow-up, respectively. At 56 days, TB treatment had been started in 5 (1.1%) SOC, 8 (1.6%) HIV-screening, and 15 (3.0%) HIV-TB screening participants. Median (IQR) time to TB treatment was 11 (6.5-38), 6 (1-22) and 1 (0-3) days (hazard ratio for HIV-TB vs. SOC: 2.86, 1.04-7.87), with same-day treatment of 0/5 (0%) SOC, 1/8 (12.5%) HIV, and 6/15 (40.0%) HIV-TB screening arm TB patients (p=0.03). At day 56, 2 SOC (0.5%), 4 HIV (1.0%), and 2 HIV-TB (0.5%) participants had undiagnosed microbiologically-confirmed TB. HIV screening reduced the proportion with undiagnosed or untreated HIV from 10 (2.7%) in the SOC arm to 2 (0.5%) in the HIV-screening arm (risk ratio [RR]: 0.18, 0.04-0.83), and 1 (0.2%) in the HIV-TB screening arm (RR: 0.09, 0.01-0.71). Incremental costs were US$3.58 and US$19.92 per participant screened for HIV and HIV-TB; the probability of cost-effectiveness at a US$1200/quality-adjusted life-year (QALY) threshold were 83.9% and 0%. Main limitations were the lower than anticipated prevalence of tuberculosis and short participant follow-up period; cost and quality of life benefits of this screening approach may accrue over a longer time horizon.</p> <p>DCXR-CAD with universal HIV screening significantly increased the timeliness and completeness of HIV and TB diagnosis. If implemented at scale this has potential to rapidly and efficiently improve TB and HIV diagnosis and treatment.</p>
ScienceDex guides
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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.