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1,189 results for “randomized clinical trial”
TomoBreast randomized clinical trial's lung-heart outcomes and mortality through the 2020 COVID-19 pandemic: data and software
<p>Dataset and R script to reproduce the analyses of the manuscript:</p> <p>Vinh-Hung V, Gorobets O, Adriaenssens N, Van Parijs H, Storme G, Verellen D, Nguyen NP, Magne N, De Ridder M.</p> <p><strong>Lung-heart outcomes and mortality through the 2020 COVID-19 pandemic in a prospective cohort of breast cancer radiotherapy patients.</strong></p> <p>Cancers 2022; 14(24):6241. https:// doi.org/10.3390/cancers14246241</p> <p>https://www.mdpi.com/2072-6694/14/24/6241</p> <p>PubMed: PMID: 36551726</p> <p>PMCID: PMC9777311</p> <p>Info on the variables in file "aelq6_public.R"</p> <p>reproduced in "aelq_2_3_readme.txt":</p> <p>"aelq2_base2.txt" = baseline characteristics.</p> <p>"aelq3.txt" = longitudinal maesurements.</p> <p>Variables in "aelq2_base2.txt":</p> <p>"<strong>aelq2_base2.txt</strong>" = baseline characteristics. <br># Age at randomization, years. <br># RTdose: cf TomoBreast papers. <br># 51 Gy = hypofractionated, simultaneous integrated boost<br># 42 Gy = hypofractionated, no boost, mastectomy cases only<br># 50 Gy = conventional, no boost, mastectomy cases only<br># 66 Gy = conventional, sequential boost<br># Weight kg, Height cm, <br># Detection 1=found by screening (senology follow-up/controle)<br># 2=found by symptoms (pain, palpable)<br># 9=unknown<br># Smoker 0= Not smoker<br># 1= Smoker<br># 2=ex-smoker<br># Mastectomy (and other binary coded) 1= yes<br># chemosched 0=none<br># 1= planned after RT (sequential)<br># 2= prior to RT and is finished (sequential)<br># 3= chemo is on-going or is planned to start with RT (concomitant)<br># hormonetherapy 0=no<br># 1=tamoxifen (nolvadex)<br># 2=Femara (Letrozole)<br># 3=zoladex<br># 4=tamoxifen + zoladex<br># Laterality 1,=Right, 2=Left, 3=Bilateral<br># LengthFU: length of follow-up, days from randomization</p> <p>"<strong>aelq3.txt</strong>" = longitudinal maesurements.<br># "Nr" = Case ID<br># "Time" in days from origin (origin =date of randomization), <br># if negative =before randomization<br># "KPS" "Weight" <br># "Died" "LocalRec" "Metast" "NewPrim" = binary code, 0=no, 1=yes<br># "fAEBreast" "fAEHeart" "fAELung" "fAEOther" <br># fAE = freedom from breast, heart, lung, other adverse event score<br># "LVEF2" = ejection fraction, %<br># "MacIver" = estimated cardiac strain</p> <p># the following are pulmonary function tests, untransformed units<br># "FVC", "FEV1", "PEF", "VC", "TLC", "RV", "FRC", "Raw", "sRaw", "DLCO",<br># "VA", "PF"</p> <p># "fDY", "fFA", "fPA" = freedom from dyspnea, from fatigue, from pain<br># range 0 to 100 (best)<br># see papers:</p> <p># Van Parijs, H.; Vinh-Hung, V.; Fontaine, C.; Storme, G.; Verschraegen, C.;<br># Nguyen, D.M.; Adriaenssens, N.; Nguyen, N.P.; Gorobets, O.; De Ridder, M.<br># Cardiopulmonary-related patient-reported outcomes in a randomized clinical<br># trial of radiation therapy for breast cancer. BMC Cancer 2021, 21, 1177,<br># doi:10.1186/s12885-021-08916-z.</p> <p># preprint:<br># Van Parijs, H.; Cecilia-Joseph, E.; Gorobets, O.; Storme, G.; <br># Adriaenssens, N.; Heyndrickx, B.; Verschraegen, C.; Nguyen, N.P.;<br># De Ridder, M.; Vinh-Hung, V. Lung-heart toxicity in a randomized <br># clinical trial of hypofractionated image guided radiation therapy for<br># breast cancer. Preprints 2022, 202212, 0214.<br># https://doi.org/10.20944/preprints202212.0214.v1</p> <p># <br># "Year" = year of the observation<br># example: randomized 1/1/2011, measurement done 1/31/2011, time = 30 days,<br># Year =2011<br>#<br> </p>
Dataset and codebook for the article by Gaume J, Bertholet N, McCambridge J, et al. Effect of a Novel Brief Motivational Intervention for Alcohol-Intoxicated Young Adults in the Emergency Department: A Randomized Clinical Trial. JAMA Netw Open. 2022;5(10):e2237563. doi: 10.1001/jamanetworkopen.2022.37563
<p>Dataset and codebook for the article Gaume J, Bertholet N, McCambridge J, et al. <strong>Effect of a Novel Brief Motivational Intervention for Alcohol-Intoxicated Young Adults in the Emergency Department: A Randomized Clinical Trial</strong>. JAMA Netw Open. 2022;5(10):e2237563. doi: <a href="http://jamanetwork.com/article.aspx?doi=10.1001/jamanetworkopen.2022.37563">10.1001/jamanetworkopen.2022.37563</a></p> <p>The dataset contains all data needed to reproduce the results in the above cited article.</p> <p>Variable description and labels can be found in the codebook.</p> <p>Please refer to the published article and supplemental online content for further information about the data and the study procedures.</p>
Geographic Scope of Randomized Clinical Trials from Africa
<p><strong>Overview</strong></p> <p>This map reports the geographic scope of randomized controlled trials (RCTs) conducted in Africa, as found in PubMed. The map highlights a discrepancy between actual trial location and how trials are reported: although reports of research from Africa are often labeled as being "African" in scope, RCTs are rarely continent-wide and many countries are not represented in even a single study. The intent of the map is to visualize actual trial locations, hopefully leading to a more accurate portrayal of RCT study sites on the African continent.</p> <p><strong>Data Source and Tools</strong></p> <p>Data for the map was extracted from PubMed and the map was created in ArcGIS Online.</p> <p><strong>Audience</strong></p> <p>The map was created for an original research poster at the 2022 International Congress on Peer Review and Scientific Publication (see "Attribution" below). Its audience is researchers, clinicians, policy makers, librarians, scholarly communications stakeholders, and editors in chief interested in improving the accuracy of the reported scope of research in Africa to better inform health care research, policy, and resource distribution.</p> <p><strong>Design</strong></p> <p>A PubMed search using Medical Subject Headings and keywords representing Africa, African, and RCTs was run to identify citations published between 1968 and February 2022. The citation titles and abstracts were screened against established inclusion/exclusion criteria, with included studies continuing through a full text review and data extraction process. Total RCT representation per country was then mapped in ArcGIS with higher RCT counts represented by darker shading. The map highlights the variance in RCT representation across the continent, with some countries represented in up to 80 RCTs and many countries represented in none.</p> <p><strong>Attribution</strong></p> <p>Folafoluwa Olutobi Odetola and Marisa L. Conte conceived the research question, crafted the PubMed search, and analyzed the citation data; Tyler Nix created the map. Special thanks to Caroline Kayko (University of Michigan) for her input in the creation of the map. </p> <p>See the original research poster at:</p> <p>Odetola, FO; Conte, ML. Geographical Scope of Randomized Clinical Trials from Africa. [Poster]. 9th International Congress on Peer Review and Scientific Publication, September 8-10, 2022, Chicago, IL. Available from: <a href="https://peerreviewcongress.org/abstract/geographical-scope-of-randomized-clinical-trials-from-africa/">https://peerreviewcongress.org/abstract/geographical-scope-of-randomized-clinical-trials-from-africa/</a></p> <p>The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.</p>
Data of 14 participants in the RCT titled Acute effects of virtual reality exercise bike games on psychophysiological outcomes in college North-African adolescents with cerebral palsy: A randomized clinical trial
<p>It is an Excel file including the numerical data of the 14 participants included in the study titled: <a name="_Hlk151119211"></a><span>Acute effects of virtual reality exercise bike games on psychophysiological outcomes in college North-African adolescents with cerebral palsy: A randomized clinical trial</span></p>
Data and Code Supplement to: "Processes of change in a randomized clinical trial of Radically Open Dialectical Behavior Therapy (RO DBT) for adults with treatment refractory depression"
<p>Dataset to support secondary analyses reported in "Processes of change in a randomized clinical trial of Radically Open Dialectical Behavior Therapy (RO DBT) for adults with treatment refractory depression" in the Journal of Consulting and Clinical Psychology</p>
Dataset related to article "Harmonization of sensorimotor deficit assessment in a registered multicentre pre-clinical randomized controlled trial using two models of ischemic stroke"
<p>https://figshare.com/search?q=10.6084%2Fm9.figshare.21346731</p>
Loss of socioemotional and occupational roles in people with Long COVID according to sociodemographic and clinical factors: Secondary data from Randomized Clinical Trial.
<p>This is a cross-sectional study was carried out with the participation of 100 patients diagnosed with Long-COVID, over 18 years of age and attended by Primary Health Care in the Autonomous Community of Aragon. The purpose of this study is to analyse the loss of socioemotional and occupational roles that people with Long COVID have suffered in their lives as a consequence of the disease. As a secondary objective, it was proposed to analyze the sociodemographic and clinical factors associated with this loss of roles. The main study variable was the loss of significant socioemotional and occupational roles of the participants. Sociodemographic and clinical data were also collected through a structured interview.</p>
Air-Q® SP Versus Air-Q® and I-gel: A Randomized Clinical Trial
ClinicalTrials.gov study NCT01592760. IPD Sharing: NO. Countries: 1. Publications: 1.
Second-Line Uterotonics in Postpartum Hemorrhage: A Randomized Clinical Trial
ClinicalTrials.gov study NCT03584854. IPD Sharing: YES. Countries: 1. Publications: 2.
Randomized Clinical Trial on Clinical Management of ASCUS and LSIL (ALTS)
ClinicalTrials.gov study NCT01131312. IPD Sharing: YES. Countries: 1. Publications: 3.
Etomidate Versus Ketamine for Emergency Endotracheal Intubation: a Prospective Randomized Clinical Trial
ClinicalTrials.gov study NCT02643381. IPD Sharing: NO. Countries: 1. Publications: 2.
Randomized controlled clinical trials with tagged information regarding the number of participants
Open the record for dataset details and reuse information.
The effects of a clinically feasible application of low-level laser therapy on the rate of orthodontic tooth movement: A triple-blinded split-mouth randomized controlled clinical trial.
<p>Dataset for all study's analyses.</p>
CONSORT flow diagram for The assessment of educational and supportive care to the infertile females undergoes In Vitro Fertilization procedure by clinical pharmacist: a randomized clinical trial
<p><strong>The assessment of educational and supportive care to the infertile females undergoes In Vitro Fertilization procedure by </strong>a <strong>clinical pharmacist: a randomized clinical trial</strong>.</p>
Capacitive resistive monopolar radiofrequency at 448 kHz plus exercise versus exercise alone for subacromial pain: Randomized sham-controlled clinical trial.
<p>Objective: To investigate the effectiveness of thermal and sub-thermal capacitive resistive 448kHz monopolar radiofrequency (CRMRF) plus exercise compared to Sham CRMRF plus exercise on pain, functionality, and quality of life in patients with subacromial pain.</p> <p>Material and methods: A randomized sham-controlled double blind clinical trial was designed. Eighty-one participants with subacromial pain were enrolled and randomly assigned to three intervention groups (Thermal CRMRF, Sub-thermal CRMRF, and Sham CRMRF). The main outcomes variables were for pain: visual analogic scale (VAS) and pressure pain threshold, for functionality: shoulder pain and disability index (SPADI) and Quick- Disabilities of the Arm, Shoulder and Hand (Quick-DASH) and for quality of life: European Quality of Live Five Dimensions (EQ-5D). Variables were measured at baseline, post-intervention, and at one-month and three months follow-ups. An intention-to-treat analysis was realized.</p> <p>Results: All three groups statistically (p<0.01) and clinically significantly improved pain (VAS) and functionality (SPADI) respect to baseline at post-intervention and follow-up periods. The improvement in Quick-DASH outcome respect to baseline at one month follow-up was clinically relevant only in the thermal CRMRF group (-16.8 points; CI95% -27.3 to -6.3). Thermal-CRMRF group showed a greater effect on Quick-DASH at one month follow-up (-14.1 points, CI95% -28.1 to -0.1) compared with Sham-CRMRF group. EQ-5D measure at one month follow-up only improved in thermal-CRMRF group (0.12 points; CI95% 0.01 to 0.23). Only thermal-CRMRF group improved the pressure pain threshold outcome (0.42 kg/cm<sup>2 </sup>CI95% 0.05 to 0.79) at post-treatment.</p>
Remodeling dental anatomy vs sham therapy for chronic temporomandibular disorders: A placebo-controlled randomized clinical trial
<div><em>Background</em></div> <div>Evidence regarding the etiology or effective treatments for chronic orofacial pain, the majority diagnosed as temporomandibular disorder (TMD), is limited.</div> <div> </div> <div><em>Purpose</em></div> <div>To investigate whether occlusal equilibration therapy (ET) and decreasing the (higher) angle of the lateral guidance on the nonworking-side leads to a reduction in chronic TMDs intensity.</div> <div> </div> <div><em>Methods</em></div> <div>It was conducted a randomized, explanatory, single blind with blinded assessment, placebo-controlled trial with strong protection against bias involving patients with chronic TMDs. Participants were randomly assigned to receive equilibration therapy or sham therapy. ET in this study consisted of minimal invasive occlusal remodeling to obtain balanced occlusion with reduction of the steeper angle of lateral mandibular movement with respect to the Frankfort plane. The primary outcome was a change in the pain intensity score (on a 0–10 point scale, with 0 indicating no pain and 10 the worst possible pain) at month 6. Secondary outcomes include maximum unassisted mouth opening and psychological distress.</div> <div> </div> <div><em>Results</em></div> <div>A total of 77 participants underwent randomization, 39 of whom received ET and 38 sham therapy. The trial was stopped early for efficacy, according to preestablished rules when 67 participants (n = 34, n = 33, respectively) had completed the analysis. At month 6, the mean unadjusted pain intensity score was 2.1 in the ET and 3.6 in the sham therapy group (adjusted mean difference, −1.54; 95% confidence interval [CI] −0.5 to −2.6; P = 0.004; ANCOVA model). The mean increase in maximum unassisted mouth opening (main secondary outcome) was significantly higher in the real therapy group (adjusted mean difference 3.1 mm, 95% CI 0.5–5.7, p = 0.02).</div> <div> </div> <div><em>Conclusion</em></div> <div>ET significantly reduced the intensity of facial pain associated with chronic TMDs and increased maximum unassisted mouth opening, as compared with sham therapy, over the course of 6 months. There were no serious adverse events.</div>
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>
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>
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>
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.