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1,219 results for “randomisation”

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dryad32/100

Data from: Economic evaluation of a general hospital unit for older people with delirium and dementia (TEAM randomised controlled trial)

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publicNov 2016View details →
dryad32/100

Data from: Sleep, major depressive disorder and Alzheimer’s disease: a Mendelian randomisation study

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publicOct 2020View details →
dryad32/100

Data from: Umbilical vein oxytocin for the treatment of retained placenta (Release Study): a double-blind, randomised controlled trial.

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publicMar 2015View details →
dryad32/100

Effect of engaging communities in decision-making and action through traditional and religious leaders on vaccination coverage in Cross River State, Nigeria: a cluster randomised-control trial

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publicMar 2021View details →
dryad32/100

Data from: Effect of methylcobalamin on capecitabine-induced hand-foot syndrome in patients with HER2-negative early breast cancer: A multicentre, double-blind, randomised, placebo-controlled, phase 3 trial

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publicAug 2025View details →
dryad32/100

Data from: Strategies for understanding and reducing the Plasmodium vivax and Plasmodium ovale hypnozoite reservoir in Papua New Guinean children: a randomised placebo-controlled trial and mathematical model

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publicSep 2016View details →
dryad32/100

Sick leave and return to work after surgery for type II SLAP lesions of the shoulder. A secondary analysis of a randomised sham - controlled study

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publicMar 2020View details →
dryad32/100

Data from: Comparison of self-perceived cardiovascular disease risk among smokers with Framingham and PROCAM scores: a cross-sectional analysis of baseline data from a randomised controlled trial

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publicNov 2016View details →
dryad32/100

Feasibility and acceptability of a tailored health coaching intervention to improve type 2 diabetes self-management in Saudi Arabia: A mixed-methods randomised feasibility trial

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publicMay 2024View details →
zenodo28/100

MiRoR14 - P3 - Effect of an editorial intervention to improve the completeness of reporting of randomised trials: a randomised controlled trial

<p>Protocol:</p> <ul> <li><strong><em>RCT Protocol Ammendment 2.pdf</em></strong>&nbsp;is the final version of the RCT protocol.&nbsp;</li> </ul> <p>R scripts used:</p> <ul> <li><strong><em>Power RCT_bootstrap_paper.R</em></strong>&nbsp;was the code used for the power analysis.&nbsp;</li> <li><strong><em>server.R</em></strong>&nbsp;and&nbsp;<strong><em>ui.R</em></strong>&nbsp;were part of the&nbsp;Shiny application used for the randomisation process.</li> <li><strong><em>Primary Outcome analysis.R</em></strong>&nbsp;was the code used for the primary outcome analysis.&nbsp;</li> </ul> <p>These files can be found below.</p>

opencc-by-4.0Feb 2020View details →
zenodo28/100

Randomised Trial of Block and Replace versus dose titration antithyroid drug treatment in children and adolescents with thyrotoxicosis.

<p><strong>This dataset contains the study regimens for the&nbsp;randomised controlled trial. </strong></p> <p><strong>Context</strong></p> <p>First line treatment of thyrotoxicosis in young people is thionamide antithyroid drug (ATD) in a blocking dose with levothyroxine replacement (block and replace, BR) or in a smaller dose tailored to render the patient euthyroid (dose titration, DT).&nbsp;</p> <p><strong>Objective</strong></p> <p>To determine which regimen provides more stable biochemical control.&nbsp;</p> <p><strong>Design and setting</strong></p> <p>A multi-centre phase III, open-label randomised trial comparing BR with DT in patients aged 2 to 16 years with newly diagnosed thyrotoxicosis at 15 UK centres. Patients were randomised shortly after diagnosis and treated for 3 years. The primary outcome was the percentage of serum thyroid stimulating hormone (TSH) levels in the reference range between 6 months and 3 years.&nbsp;&nbsp;Secondary outcomes included the proportion of Free thyroxine (FT4) levels in the reference range, adverse event frequency and 4y outcome (remission/relapse).</p> <p><strong>Results</strong></p> <p>Eighty-two patients were randomised, with details on clinical course in 81 (62 Female); 40 were allocated to BR (41 DT). Three withdrew with one ineligible. The mean percentage of serum TSH within reference range was 60&middot;2% in BR and 63&middot;8% in DT patients; adjusted difference 4&middot;3%, 95% CI (-7&middot;8 to 16&middot;4);p=0.48. Proportions for FT4 were 79&middot;2% in BR and 85&middot;7% in DT patients; adjusted difference 6&middot;8%, (-0&middot;2 to 15&middot;6);p=0&middot;13.&nbsp;&nbsp;Three patients developed neutropenia &ndash; all on BR. 6 BR and 10 DT patients were in remission at 4y.&nbsp;&nbsp;</p> <p><strong>Conclusion</strong></p> <p>This trial has shown no evidence to suggest that BR improves biochemical stability. DT, recommended by American Thyroid Association guidelines, remains the preferred approach in this age group.&nbsp;&nbsp;&nbsp;</p>

opencc-by-4.0Dec 2019View details →
zenodo28/100

DATASET OF "Intrathecal morphine and sleep apnoea severity in patients undergoing hip arthroplasty: a randomised, controlled, triple- blinded trial"

<p><strong>Background: </strong>Intrathecal morphine prolongs analgesia after surgery, but has been implicated in postoperative respiratory depression or apnoeic episodes. However, this has not been investigated in a prospective trial using respiratory polygraphy. This randomized controlled triple-blinded trial tested the hypothesis that intrathecal morphine increases sleep apnoea severity, measured using respiratory polygraphy.</p> <p><strong>Methods: </strong>Sixty patients undergoing hip arthroplasty under spinal anaesthesia received either 15 mg isobaric bupivacaine 0.5% with 0.5 mL normal saline 0.9% (control group) or 15 mg isobaric bupivacaine 0.5% with 0.5 mL intrathecal morphine 100 &micro;g (intrathecal morphine group). Respiratory polygraphy was performed before surgery and on the first and third postoperative nights. The primary outcome was the apnoea-hypopnoea index in the supine position (supine AHI) on the first postoperative night. Secondary outcomes included supine AHI on the third postoperative night, oxygen desaturation index (ODI) and respiratory rate in the first and third postoperative nights.</p> <p><strong>Results: </strong>On the first postoperative night, mean (95% confidence interval) values for supine AHI were 20.6 (13.9&ndash;27.3) and 21.2 (12.4&ndash;30.0) events/h in the control and intrathecal morphine groups, respectively (p=0.90). There were no significant between-group differences for any of the secondary outcomes, except for a significantly higher central and mixed apnoea index preoperatively and significantly lower mean SpO<sub>2</sub> on the third postoperative night in the control group.</p> <p><strong>Conclusions: </strong>Intrathecal morphine did not increase sleep apnoea severity, when measured using respiratory polygraphy. Of note, all patients had an increased number of apnoeic episodes on the third postoperative night.</p>

opencc-by-4.0Dec 2019View details →
dryad28/100

Probiotic-prebiotic therapy improved constipation and gut motility in Parkinson's disease: Randomised controlled trial

<p><b>Objective</b>: We determined the effectiveness of a multi-strain probiotic-prebiotic combination on constipation symptoms and gut motility in PD patients with constipation.</p> <p><b>Methods: </b>PD<b> </b>patients with constipation (ROME III criteria) were randomized to receive a multi-strain probiotic (<i>Lactobacillus sp</i> and <i>Bifidobacterium sp at </i>30 X 10<sup>9</sup> CFU) with fructo-oligosaccaride (prebiotic) or placebo (fermented milk) twice daily for 8 weeks. Primary outcomes were changes in the presence of constipation symptoms using 9 items of Garrigues Questionnaire (GQ), which included an item on bowel opening frequency. Secondary outcomes were whole gut transit time (WGTT), quality of life (PDQ39-SI), motor (MDS-UPDRS) and non-motor symptoms (NMSS).</p> <p><strong>Results:</strong> Of 55 recruited<b>, </b>48 patients completed the study: 22 received probiotic and 26 received placebo. At 8 weeks, the item on bowel opening frequency (BOF) of GQ showed  a higher mean weekly BOF in the probiotic group compared to placebo [4.18 (SD 1.44) vs 2.81(SD 1.06), (mean difference 1.37, 95% CI 0.68, 2.07, uncorrected <i>p</i>&lt;0.001). Patients in the probiotic group reported five times higher odds (odds ratio=5.48, 95% CI 1.57, 19.12, uncorrected <i>p</i>=0.008) for increasing BOF (&lt; 3 to 3-5 to &gt;5 times/week) compared to the placebo group. Between-group differences were observed in the WGTT [77.32 (SD 55.35) hours vs 113.54 (SD 61.54) hours], (mean difference -36.22, 95% CI -68.90, -3.54, uncorrected <i>p</i>=0.030) and the mean change in WGTT [58.05 (SD 59.30) vs 20.73 (60.48) hours], (mean difference 37.32, 95% CI 4.00, 70.63, uncorrected <i>p</i>=0.028). No between-groups differences were observed in the NMSS, PDQ39-SI, MDS-UPDRS II, III, scores. Four patients in the probiotics group experienced mild reversible side effects.</p> <p><b>Conclusion:</b> This study provides Class I evidence that consumption of multi-strain probiotics with prebiotic over 8 weeks improved bowel opening frequency and whole gut transit time.</p>

opencc-zeroOct 2020View details →
dryad28/100

Influence of videolaryngoscopy using McGrath Mac™ on the need for a helper to perform intubation during general anaesthesia: A multicentre randomised video - no-video trial

<p><b>Objective:</b> We hypothesized was that use of a videolaryngoscope modifies the practice of tracheal intubation.</p> <p><b>Design:</b> Randomized single-blinded study.</p> <p><b>Setting:</b> Three institutions: one academic, one non-profit and one profit.</p> <p><b>Participants</b><b>:</b> Inclusion criteria were patients aged 18 years minimum, requiring orotracheal intubation, without a predicted difficult intubation (Arne score &lt;11). Non-inclusion criteria was patients requiring a rapid-sequence intubation. 300 patients were included, 271 randomised, 256 analysed: 123 in the No-Video group and 133 in the Video group.</p> <p><b>Intervention</b>: Tracheal intubation uses a McGrath Mac™ videolaryngoscope. Patients were randomised into two groups: a Video group (screen activated) and a No-Video group (screen hidden).</p> <p><b>Primary and secondary outcome measures</b>: The main outcome was the need for help for the anaesthesiologist or the nurse anaesthetist in performing tracheal intubation, the sequence being video recorded. Secondary outcomes included the ease of intubation (intubation difficulty scale, Cormack and Lehane<b> </b>grade, percentage of glottic opening<b> </b>scale score, use of alternative techniques, duration, oxygen desaturation, especially). Other outcomes included the cooperation between members of the anaesthesiology team, the proportion of patients suffering from postoperative hoarseness or sore throat, and other adverse events.</p> <p><b>Results:</b>. Requirement for assistance was not decreased in the Video group: 36.1% <span>[95% CI</span> 27.9 to 44.9] versus 45.5% <span>[95% </span>36.5 to 54.7] in the No-Video group (p=0.124). Intubation difficulty scale was lower in the Video group (p=0.009); glottis visualization (Cormack and Lehane score and glottic opening score) was better in the Video group (p&lt;0.001). Duration of intubation was similar between groups. Oxygen desaturation or hypotension requiring treatment during the intubation period and postoperative complications (hoarseness or sore throat) were observed similarly in both groups. No other adverse event occurred.</p> <p><b>Conclusion:</b> In patients without risk of difficulty in airway management, videolaryngoscopy did not decrease the requirement for assistance to perform intubation.</p> <p><b>Trial registration:</b> <span><a href="http://clinicaltrials.gov/">Clinicaltrials.gov</a></span> identifier: NCT02926144<b> </b></p>

opencc-zeroJan 2021View details →
dryad28/100

Data from: Effectiveness of continence promotion for older women via community organisations: a cluster randomised trial

Objectives: The primary objective of this cluster randomised controlled trial was to compare the effectiveness of the three experimental continence promotion interventions against a control intervention on urinary symptom improvement in older women with untreated incontinence recruited from community organisations. Setting: 71 community organisations across the United Kingdom Participants: 259 women aged 60 years and older with untreated incontinence entered the trial; 88% completed the 3-month follow-up. Interventions: The three active interventions consisted of a single 60-minute group workshop on 1) continence education (20 clusters, 64 women); 2) evidence-based self-management (17 clusters, 70 women); or 3) combined education and self-management (17 clusters, 61 women). The control intervention was a single 60-minute educational group workshop on memory loss, polypharmacy and osteoporosis (17 clusters, 64 women). Primary and secondary outcome measures: The primary outcome was self-reported improvement in incontinence 3 months post-intervention at the level of the individual. The secondary outcome was change in the International Consultation on Incontinence Questionnaire (ICIQ). Changes in incontinence-related knowledge and behaviours were also assessed. Results: The highest rate of urinary symptom improvement occurred in the combined intervention group (66% vs 11% of the control group, prevalence difference 55%, 95% CI 43%-67%, intracluster correlation 0). Thirty percent versus 6% of participants reported significant improvement respectively (prevalence difference 23%, 95% CI 10%-36%, intracluster correlation 0). The number-needed-to-treat was 2 to achieve any improvement in incontinence symptoms, and 5 to attain significant improvement. Compared to controls, the combined group reported an adjusted mean 2.05 point (95% CI 0.87-3.24) greater improvement on the ICIQ. Changes in knowledge and self-reported risk-reduction behaviours paralleled rates of improvement in all intervention arms. Conclusion: Continence education combined with evidence-based self-management improves symptoms of incontinence among untreated older women. Community organisations represent an untapped vector for delivering effective continence promotion interventions.

opencc-zeroDec 2013View details →
dryad28/100

The impact of cardiopulmonary resuscitation on a cannot intubate, cannot oxygenate condition – a randomised crossover simulation research study of the interaction between two algorithms

<p>This is the original data file of the publication entiteled:</p> <p>The impact of cardiopulmonary resuscitation on a cannot intubate, cannot oxygenate condition – A randomised crossover simulation research study of the interaction between two algorithms</p> <p> </p>

opencc-zeroOct 2019View details →
dryad28/100

Data from: Characteristics of randomised trials on diseases in the digestive system registered in ClinicalTrials.gov - a retrospective analysis

Objectives: To evaluate the adequacy of reporting of protocols for randomised trials on diseases of the digestive system registered in ClinicalTrials.gov and the consistency between primary outcomes, secondary outcomes and sample size specified in ClinicalTrials.gov and published trials. Design: Randomised phase III trials on adult patients with gastrointestinal diseases registered before January 2009 in ClinicalTrials.gov were eligible for inclusion. From ClinicalTrials.gov all data elements in the database required by the International Committee of Medical Journal Editors (ICMJE) member journals were extracted. The subsequent publications for registered trials were identified. For published trials, data concerning publication date, primary and secondary endpoint, sample size, and whether the journal adhered to ICMJE principles were extracted. Differences between primary and secondary outcomes, sample size and sample size calculations data in ClinicalTrials.gov and in the published paper were registered. Results: 105 trials were evaluated. Sixty-six trials (63%) were published. Thirty-one percent of trials were registered incorrectly after their completion date. Several data elements of the required ICMJE data list were not filled in, with lacking data in 22% and 11% of cases concerning the primary outcome measure and sample size. In 26% of the published papers data of sample size calculations were missing and discrepancies between sample size reporting in ClinicalTrials.gov and published trials existed. Conclusion: The quality of registration of randomised controlled trials still needs improvement.

opencc-zeroDec 2010View details →
dryad28/100

Data from: EdAl-2 (Educació en Alimentació) programme: reproducibility of a cluster randomised, interventional, primary-school-based study to induce healthier lifestyle activities in children

Objectives: To assess the reproducibility of an educational intervention EdAl-2 (Educació en Alimentació) programme in 'Terres de l'Ebre' (Spain), over 22 months, to improve lifestyles, including diet and physical activity (PA). Design: Reproduction of a cluster randomised controlled trial. Setting: Two semi-rural town-group primary-school clusters were randomly assigned to the intervention or control group. Participants: Pupils (n=690) of whom 320 constituted the intervention group (1 cluster) and 370 constituted the control group (1 cluster). Ethnicity was 78% Western European. The mean age (±SD) was 8.04±0.6 years (47.7% females) at baseline. Inclusion criteria for clusters were towns from the southern part of Catalonia having a minimum of 500 children aged 7–8 year; complete data for participants, including name, gender, date and place of birth, and written informed consent from parents or guardians. Intervention: The intervention focused on eight lifestyle topics covered in 12 activities (1 h/activity/session) implemented by health promoting agents in the primary school over three academic years. Primary and secondary outcomes: The primary outcome was obesity (OB) prevalence and the secondary outcomes were body mass index (BMI) collected every year and dietary habits and lifestyles collected by questionnaires filled in by parents at baseline and end-of-study. Results: At 22 months, the OB prevalence and BMI values were similar in intervention and control groups. Relative to children in control schools, the percentage of boys in the intervention group who performed ≥4 after-school PA h/week was 15% higher (p=0.027), whereas the percentage of girls in both groups remained similar. Also, 16.6% more boys in the intervention group watched ≤2 television (TV) h/day (p=0.009), compared to controls; and no changes were observed in girls in both groups. Conclusions: Our school-based intervention is feasible and reproducible by increasing after-school PA (to ≥4 h/week) in boys. Despite this improvement, there was no change in BMI and prevalence of OB.

opencc-zeroDec 2013View details →
dryad28/100

Data from: Impact of numerical information on 'risk knowledge' regarding human papillomavirus (HPV) vaccination among schoolgirls: a randomised controlled trial

Introduction: In Germany the implementation of HPV vaccination for women 12-17 years of age was accompanied by various campaigns. Evidence based information including numerical data was not provided. However, standard information leads to overestimation of cancer risk and effects of HPV vaccination. Confidence in children's ability to deal with numerical data is low, especially in disadvantaged pupils. The aim of the present study was to compare the effects of a standard leaflet with an information leaflet supplemented with numerical data on 'risk knowledge' regarding HPV vaccination among schoolgirls. Methods: Randomised-controlled short-term trial. All 108 schoolgirls of seven school classes were asked to participate and 105 agreed. Participants were vocational schoolgirls who were preparing for grade 10 graduation and who were members of the target group for HPV vaccination. The control group was asked to read a standard leaflet on HPV vaccination of the German Women's Health Network. The intervention group received the same leaflet, but it was supplemented with numerical information on cancer risk and assumed effects of the HPV vaccination on cancer prevention. As baseline characteristics we surveyed: age, vaccination status, attitude towards HPV vaccination and aspects regarding migration background. The primary end point was 'risk knowledge'. Questionnaire surveys were performed under experimental conditions. Individual randomisation, participants, and intention-to-treat data analyses were blinded. The study was approved by the Ministry of Education and Culture of Schleswig-Holstein and the ethics committee of the Hamburg Chamber of Physicians. Results: We analysed 'risk knowledge' for all 105 randomised participants. Baseline characteristics of the two groups were comparable. Numerical risk information recipients were more likely to give correct answers compared to standard information recipients: Mean value of risk knowledge score (0-5 points): 4.6 ± 1.0 vs. 2.6 ± 1.2 (mean difference 2.0 (95% CI 1.6-2.4)); (P&lt;0.001). Post hoc distractor analysis of single items was performed. Incorrect answers of control participants indicated that cervical cancer risk was highly overestimated whereas total cancer risk was mostly underestimated, and possible impact of HPV vaccination on cancer prevention was overestimated. Conclusion: Supplementing health information on HPV vaccination with numerical data improves 'risk knowledge' among schoolgirls.

opencc-zeroDec 2012View details →
dryad28/100

Data from: Long-term use benefits of personal frequency-modulated systems for speech in noise perception in patients with stroke with auditory processing deficits: a non-randomised controlled trial study

Objectives: Approximately one in five stroke survivors suffer from difficulties with speech reception in noise, despite normal audiometry. These deficits are treatable with personal Frequency Modulated systems (FMs). This study aimed to evaluate long term benefits in speech reception in noise, after daily 10 week use of personal FMs, in non-aphasic stroke patients with auditory processing deficits. Design: This was a prospective non randomised controlled trial study. Patients were allocated to an intervention care group or standard care subjects group according to their willingness to use the intervention or not. Setting: Tertiary care setting. Participants: Nine non-aphasic subjects with ischemic stroke, normal/near normal audiometry, and auditory processing deficits and with reported difficulties understanding speech in background noise were recruited in the subacute stroke stage (3-12 months after stroke). Interventions: Four patients (intervention care subjects) used the FMs in their daily life over 10 weeks. Five patients (standard care subjects) received standard care. Primary outcome measures: All subjects were tested at baseline (visit 1) and 10 weeks later (visit 2) on a sentences in noise test with the FMs (aided) and without the FMs (unaided). Results: Speech reception thresholds showed clinically and statistically significant improvements in intervention but not in standard care subjects at 10 weeks in both aided and unaided conditions. Conclusions: 10 week use of FM systems by adult stroke patients may lead to benefits in unaided speech in noise perception. Our findings may indicate auditory plasticity type changes and require further investigation.

opencc-zeroDec 2016View details →

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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.

allen-brain-atlas
neuroscienceopenDocumentation, web resources, and API references are available online.
Last verified 2026-04-30Open record

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.

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behavioral-neuroscienceopenThe DataShare record exposes download links for annotations, documentation, license text, and the zipped per-snippet data directory.
Last verified 2026-04-30Open record

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.

dandi-nwb
electrophysiologyopenPublished Dandiset metadata and archive endpoints are available through the production DANDI API.
Last verified 2026-04-30Open record

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.

ibl
behavioral-neuroscienceopenPublic sessions can be searched and loaded from the IBL public data server through ONE.
Last verified 2026-04-29Open record

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.

openneuro
neuroscienceopenPublished datasets are available on demand over the internet.
Last verified 2026-04-29Open record

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