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5,826 results for “Randomized trial”
Transcriptomic Profile of Breast Tissue of Premenopausal Women Following Treatment with Progesterone Receptor Modulator: Secondary Outcomes of a Randomized Controlled Trial
GEO Series GSE252145. Homo sapiens. 32 samples. Type: Expression profiling by high throughput sequencing.
Which are the most sensitive search filters to identify randomized controlled trials in MEDLINE?
<p>The raw data is attached for the paper: </p> <p>Which are the most sensitive search filters to identify randomized controlled trials in MEDLINE?</p>
The Effectiveness of Strengthening primary health care teams with palliative care leaders: a Pragmatic cluster randomized clinical trial
<p>Full dataset of the clinical trial PI14/01336 Effectiveness of Strengthening primary health care teams with palliative care leaders</p>
High flow nasal oxygen during procedural sedation: A randomized controlled trial
<p>Data and code for publication</p>
Nasal ventilation and Rapid Maxillary Expansion (RME): a randomized trial
<p>Dataset for all analyses of the paper</p>
Acute sleep hygiene strategy improves objective sleep latency following a late-evening soccer-specific training session: A randomized controlled trial
<p>The aim of this study was to evaluate the effects of sleep hygiene (SH) education on sleep quality in soccer players after a late-evening small-sided-game (SSG) training session. Twenty-nine non-professional players were recruited and allocated to either an experimental group (EG, n=17) that received SH education, or a control group (CG, n=12). SSG consisted of 3´4 minutes in a 4vs4, with 3 minutes of recovery and was performed at 8.00 p.m. Sleep quality was monitored via actigraphy and sleep diary entries before (PRE) and two nights after (POST1, POST2) the SSG. Sleep latency (SL) differed between the two groups at POST1 (4.9±5.4 vs. 15.5±16.1 for EG and CG, respectively; p=0.017, effect size [ES]=2.0); SL values were lower at POST1 compared to PRE for the EG (-47%; p=0.021, ES=0.6). Subjective sleep quality was better in the EG than the CG at POST1 (8.6±1.0 vs. 7.1±2.0 for EG and CG, respectively; p=0.016, ES=0.9) with a significant improvement over PRE values (+11.0%, p=0.004, ES=0.8). Despite SL and subjective sleep quality were similar in PRE and POST2, no significant deterioration in such sleep indices over time was observed for EG. No other objective sleep indices were influenced by late-evening training or SH practices implemented by the EG. Soccer players may benefit from acute SH strategies to reduce the time to sleep onset after late-evening training sessions.</p>
The effect of piezocision vs no piezocision on maxillary extraction space closure: a split-mouth, randomized controlled clinical trial.
<p>This is a “2-arm-parallel”, split-mouth trial with the aim to investigate the effects of piezocision compared to no piezocision on maxillary canine distalization and to evaluate patients’ perceptions on the surgical procedure.</p>
Data from: Effect of aerobic exercise on cognition in younger adults: a randomized clinical trial
Objective: To determine efficacy of aerobic exercise for cognitive function in younger healthy adults. Methods: In a randomized, parallel-group, observer-masked, community-based clinical trial, 132 cognitively normal individuals aged 20-67 with below median aerobic capacity were randomly assigned to one of two 6-month, four-times-weekly conditions: aerobic exercise and stretching/toning. Efficacy measures included: aerobic capacity; cognitive function in six domains (executive function, episodic memory, processing speed, language, and attention), everyday function, BMI and cortical thickness. Results: Aerobic capacity increased significantly (β=2.718; p=0.003), and BMI decreased significantly (β=-0.596; p=0.013) in the aerobic exercise but not in the stretching/toning condition. Executive function improved significantly in the aerobic exercise condition; this effect was moderated by age (β=0.018 s.d. per year; p=0.028). At age 40 the executive function measure increased by 0.228 s.d. (95% CI: 0.007 - 0.448), and by 0.596 s.d. (95% CI: 0.219 - 0.973) at age 60. Cortical thickness increased significantly in the aerobic exercise group in a left frontal region and did not interact with age. Controlling for age and baseline performance, individuals with at least one APOE ε4 allele showed less improvement in executive function with aerobic exercise (β=0.5129, 95%CI 0.0381 to 0.988; p=0.0346). Conclusions: This randomized clinical trial demonstrates the efficacy of aerobic exercise for cognition in adults age 20 – 67. The effect of aerobic exercise on executive function was more pronounced as age increased, suggesting that it may mitigate age-related declines. Increased cortical thickness suggests that aerobic exercise contributes to brain health in individuals as young as age 20. Clinicaltrials.gov Identifier: NCT01179958 Classification of evidence: This study provides Class II evidence that for adults age 20-67 with below median aerobic capacity, aerobic exercise significantly improves executive function but not other measures of cognitive function.
Data from: INTREPAD: a randomized trial of naproxen to slow progress of presymptomatic Alzheimer disease
Objective: Evaluate the safety and efficacy of low-dose naproxen for prevention of progression in pre-symptomatic AD among cognitively intact persons at-risk. Methods: INTREPAD, a two-year double-masked pharmaco-prevention trial, enrolled 195 AD family history-positive elderly (mean age 63 years) screened carefully to exclude cognitive disorder. These were randomized 1:1 to naproxen sodium 220mg twice-daily or placebo. Multimodal imaging, neurosensory, cognitive and (in ~50%) CSF biomarker evaluations were performed at Baseline, 3, 12, and 24 months. A modified intent-to-treat analysis considered 160 participants who remained on-treatment through their first follow-up examination. The primary outcome was rate of change in a multimodal composite pre-symptomatic Alzheimer Progression Score (APS). Results: Safety: Naproxen-treated individuals showed a clear excess of adverse events. Efficacy: Among treatment groups combined, the APS increased by 0.101 points/year (S.E = 0.014; P < 10-5), but rate of change showed little difference by treatment assignment (0.017 points/year). The treatment-related slope ratio of 1.10 (95% Confidence Interval 0.588–2.04) suggested that naproxen does not reduce the rate of APS progression by more than 41%. Secondary analyses revealed no notable treatment effects on individual CSF, cognitive, or neurosensory biomarker indicators of progressive pre-symptomatic AD. Conclusions: In cognitively intact individuals at-risk, sustained treatment with naproxen sodium 220 mg twice-daily increases frequency of adverse health effects but does not reduce apparent progression of pre-symptomatic AD. Classification of Evidence: This study provides Class I evidence that, for people who are cognitively intact, low-dose naproxen does not significantly reduce progression of a composite indicator of pre-symptomatic AD.
Data from: Mobile phone reminders and peer counseling improve adherence and treatment outcomes of patients on ART in Malaysia: a randomized clinical trial
Background: Adherence to treatment remains the cornerstone of long term viral suppression and successful treatment outcomes among patients receiving Antiretroviral Therapy (ART). Objective(s): Evaluate the effectiveness of mobile phone reminders and peer counseling in improving adherence and treatment outcomes among HIV positive patients on ART in Malaysia. Methods: A single-blind, parallel group RCT conducted in Hospital Sungai Buloh, Malaysia in which 242 adult Malaysian patients were randomized to intervention or control groups. Intervention consisted of a reminder module delivered through SMS and telephone call reminders by trained research assistants for 24 consecutive weeks (starting from date of ART initiation), in addition to adherence counseling at every clinic visit. The length of intended follow up for each patient was 6 months. Data on adherence behavior of patients was collected using specialized, pre-validated Adult AIDS Clinical Trial Group (AACTG) adherence questionnaires. Data on weight, clinical symptoms, CD4 count and viral load tests were also collected. Data was analyzed using SPSS version 22 and R software. Repeated measures ANOVA, Friedman's ANOVA and Multivariate regression models were used to evaluate efficacy of the intervention. Results: The response rate after 6 months follow up was 93%. There were no significant differences at baseline in gender, employment status, income distribution and residential location of respondents between the intervention and control group. After 6 months follow up, the mean adherence was significantly higher in the intervention group (95.7; 95% CI: 94.39–96.97) as compared to the control group (87.5; 95% CI: 86.14–88.81). The proportion of respondents who had Good (>95%) adherence was significantly higher in the intervention group (92.2%) compared to the control group (54.6%). A significantly lower frequency in missed appointments (14.0% vs 35.5%) (p = 0.001), lower viral load (p = 0.001), higher rise in CD4 count (p = 0.017), lower incidence of tuberculosis (p = 0.001) and OIs (p = 0.001) at 6 months follow up, was observed among patients in the intervention group. Conclusion: Mobile phone reminders (SMS and telephone call reminders) and peer counseling are effective in improving adherence and treatment outcomes among HIV positive patients on ART in Malaysia. These findings may be of potential benefit for collaborative adherence planning between patients and health care providers at ART commencement.
Data from: Video education versus face-to-face education on inhaler technique for patients with well-controlled or partly-controlled asthma: a phase IV, open-label, non-inferiority, multicenter, randomized, controlled trial
Background: Education on inhaler technique is critical for effective asthma treatment. However, traditionally used face-to-face education is a time-consuming, costly, and often laborious. The current study evaluated the efficacy of a newly developed video-based inhaler technique education method. Methods: A total of 184 subjects with well-controlled or partly-controlled asthma were enrolled from 12 hospitals in South Korea from 30 November 2015 to 01 June 2016. Subjects were randomly divided into two groups in a 1:1 ratio; a control group that received face-to-face education, and an study group that received video education. All subjects received fluticasone propionate plus salmeterol xinafoate (Fluterol® 250/50 inhalation capsules) for 12 weeks. The primary outcome measure was forced expiratory volume in the 1st second (FEV1) at 12 weeks. The secondary outcome measures were change in FEV1 at 4 weeks, change in asthma control test (ACT) score, and changes in various inhaler technique parameters. These measures were assessed with a non-inferiority margin of 10% between the control group and the study group. Results: FEV1 was significantly improved at 12 weeks in the control group and the study group. After adjustment, FEV1 improvement was not significantly inferior in the study group compared to the control group. The secondary outcome measures, including change in FEV1 at 4 weeks, ACT score, and various parameters pertaining to inhaler technique and satisfaction at 4 and 12 weeks did differ not significantly in the two groups. In subgroup analysis of elderly subjects and subjects with well-controlled asthma, FEV1 was significantly improved at 12 weeks in the study group but not the control group. Conclusion: The newly developed video education technique investigated functioned as a suitable substitute for face-to-face education on inhaler technique (dry powder inhalation capsule) in patients with stable asthma, particularly in elderly patients and patients with well-controlled asthma.
Clinical usability study of a transcranial direct current stimulation for primary dysmenorrhea: a randomized controlled trial
Open the record for dataset details and reuse information.
Datasets - "Telerehabilitation for visual field defects with a multisensory training: a randomized clinical trial" by Diana et al.
<p>Datasets of this research (Main experiment and Study 2).</p> <p><span>These data cannot be made publicly available because they include sensitive information, but can be made available to interested researchers upon reasonable request. Please, forward your request to Prof. Nadia Bolognini (n.bolognini@auxologico.it).</span></p>
Data from: Influence of needle-insertion depth on epidural spread and clinical outcomes in caudal epidural injections: a randomized clinical trial
Background: A caudal epidural steroid injection (CESI) is a commonly used method to improve symptoms of lumbosacral pain. We compared the achievement of successful epidurograms and patient-reported clinical outcomes following different needle-insertion depths during CESI. Methods: For the conventional method group, the needle was advanced into the sacral canal. For the alternative method group, the needle was positioned immediately after penetration of the sacrococcygeal ligament. Epidural filling patterns and vascular uptake during fluoroscopy were determined to verify successful epidural injection. Procedural pain scores were investigated immediately after the procedure. Pain scores and patient global impression of symptom change were evaluated at 1-month follow-up. Results: Assessments were completed by 127 patients (conventional method, n=64; alternative method, n=63). The incidence of intravascular injection was significantly lower in the alternative method group than in the conventional method group (3.2% vs 20.3%, P=0.005). Procedural pain during needle insertion was significantly lower in the alternative method group (3.7±1.3 vs 5.3±1.2, P<0.001). Epidural contrast filling patterns were similar in both groups. One-month follow-up pain scores and patient global impression of symptom change were comparable in both groups. Conclusion: Compared with the conventional method, the alternative method for CESI could achieve similar epidural spread and symptom improvement. The alternative technique exhibited clinical benefits of a lower rate of intravascular injection and less procedural pain.
EFFECT OF FRENCH MARITIME PINE BARK EXTRACT ON ATTENTION-DEFICIT HYPERACTIVITY DISORDER: A RANDOMIZED CLINICAL TRIAL.
<p>This is a dataset from a phase III, randomised, double-blind, placebo and active product controlled, multicentre clinical trial with three parallel treatment arms to compare effects on ADHD and ADD behaviour between Pycnogenol®, MPH (Medikinet® Retard) and placebo, using the ADHDRating Scale (ADHD-RS/ARS) as a primary outcome measure.</p> <p>Evaluations were performed in weeks 5 and 10, as compared to baseline. Two visits with similar evaluations were conducted: at baseline and after 10 weeks. Next to baseline and final evaluations, an extra evaluation of behaviour and physical symptoms was conducted in week 5 by means of questionnaires. The trial population will consists of ADHD and ADD patients recruited at the University Hospitals of Antwerp (UZA) and Ghent (UZ Ghent) and the Hospital Network Antwerp (ZNA), Belgium. Participants were randomised, stratified by trial centre, to one of the three treatment arms (placebo, Pycnogenol®, or Medikinet® Retard) by randomization.com randomisation software. Published protocol: Verlaet AAJ, Ceulemans B, Verhelst H, Van West D, De Bruyne T, Pieters L, Savelkoul HFJ, Hermans N. Effect of Pycnogenol® on attention-deficit hyperactivity disorder (ADHD): study protocol for a randomised controlled trial. Trials (2017), 18(1).</p> <p>As the primary objective is to assess the efficacy of Pycnogenol® for improving ADHD and ADD behaviour as rated by teachers compared to placebo and Medikinet® Retard, the primary outcome is the summed ADHD score of the ADHD-RS as rated by teachers. Teachers filled out this questionnaire before the start of the intervention and after 5 and 10 weeks. Secondary outcomes ADHD/ADD behaviour Secondary outcomes related to ADHD/ADD behaviour are:</p> <p>Summed ADHD score of the ADHD-RS, rated by parents</p> <p>Summed ADHD score of the Social-emotional Questionnaire (SEQ), rated by parents and teachers</p> <p>Scores on ADHD subscales of the ADHD-RS and SEQ, rated by parents and teachers (hyperactivity, impulsivity and inattention)</p> <p>Percentage of responders rated by parents and teachers, defined as participants with a reduction of at least 20% of their baseline summed ADHD-RS s</p> <p>Social behaviour problems subscale of the SEQ, rated by parents and teachers, to evaluate to what extent symptoms of ODD and CD are displayed</p> <p>Anxiety subscale of the SEQ, rated by parents and teachers, to evaluate symptoms of general anxiety, social anxiety and anxiety-depression</p> <p>Physical and sleep complaints, including various potential side effects, measured by the Physical Complaints Questionnaire (PCQ)</p> <p>Dietary habits of participants were assessed by a Food Frequency Questionnaire (FFQ).</p> <p>The ADHD-RS (ARS) is a validated, internationally accepted questionnaire. Its 9 inattention (IA) and 9 hyperactivity and impulsivity (HI) items, rated on a four-point rating scale (never/seldom 0, sometimes 1, often 2, or very often 3), are based on the DSM. The ADHD-RS was used in previous trials as well. </p> <p>Besides ADHD, the Social-Emotional Questionnaire (SEQ) assesses core symptoms of other social-emotional problems (social behaviour problems, anxiety and autism). Its 72 questions are based on the DSM and rated on a five-point scale (never 0, less than once a month 1, every month 2, every week 3, or (almost) every day 4). The ADHD score can be subdivided into an hyperactivity (H) score, impulsivity (I) score and inattention (IA) score, each based on 6 questions.</p> <p>The PCQ enquires physical and sleep complaints, for instance related to pain, unusual thirst/perspiration, asthma or rhinitis, skin problems, tiredness, gastrointestinal problems and sleep problems. Questions include potential adverse effects and are rated on a five-point scale. In addition to several stand-alone questions, various questions can be combined (e.g. total pain: headache, stomach ache and growing pains). Each item is rated on a five-point scale (never 0, less than once a month 1, every month 2, every week 3, or (almost) every day 4). </p> <p>The FFQ consisted of 50 questions on different food groups to be rated on a nine-point scale (never 0, less than once a month 1, 1-3 times a month 2, once a week 3, 2-4 times a week 4, 5-6 times a week 5, once a day 6, 2-3 times a day 7, more than 3 times a day 8) to assess global dietary habits (e.g. how often a participant consumes fresh fruits or vegetables).</p> <p>Researchers involved in digitalizing questionnaire answers and statistics were blind for the participant groups. In case of >2 missing answers regarding a (sub)score within a patient, this (sub)score was set to missing. Participants were excluded from analyses only for those outcomes without any data available. Several teacher questionnaires were missing due to teachers never responding/not responding anymore, starting/ending the study during the summer holiday, covid-19 (homeschooling), or a combination of these.</p> <p>Data in SPSS were directly used for statistics. Data in excel are raw data.</p>
Systematic comparison of Mendelian randomization studies and randomized controlled trials using electronic databases
<p>Supplementary Dataset 1. Select ClinicalTrials.Gov data fields for the RCT studies identified as the main dataset.<br> Supplementary Dataset 2. Select ClinicalTrials.Gov data fields for the RCT studies identified as the literature dataset.<br> Supplementary Dataset 3. Comparison of frequency of RCT general features between the Main dataset and background of all RCTs available in ClinicalTrials.Gov.<br> Supplementary Dataset 4. Case series of MR and RCT studies with matching exposures (interventions) and outcomes (conditions).</p>
[DATABASE] Comparing the Effectiveness, Tolerability, and Acceptability of Heated Tobacco Products and Refillable Electronic Cigarettes for Cigarette Substitution (CEASEFIRE): Randomized Controlled Trial
<p><strong>Background: </strong>People who smoke and who face challenges trying to quit or wish to continue to smoke may benefit by switching from traditional cigarettes to noncombustible nicotine delivery alternatives, such as heated tobacco products (HTPs) and electronic cigarettes (ECs). HTPs and ECs are being increasingly used to quit smoking, but there are limited data about their effectiveness.</p> <p><strong>Objective: </strong>We conducted the first randomized controlled trial comparing quit rates between HTPs and ECs among people who smoke and do not intend to quit.</p> <p><strong>Methods: </strong>We conducted a 12-week randomized noninferiority switching trial to compare effectiveness, tolerability, and product satisfaction between HTPs (IQOS 2.4 Plus) and refillable ECs (JustFog Q16) among people who do not intend to quit. The cessation intervention included motivational counseling. The primary endpoint of the study was the carbon monoxide-confirmed continuous abstinence rate from week 4 to week 12 (CAR weeks 4-12). The secondary endpoints included the continuous self-reported ≥50% reduction in cigarette consumption rate (continuous reduction rate) from week 4 to week 12 (CRR weeks 4-12) and 7-day point prevalence of smoking abstinence.</p> <p><strong>Results: </strong>A total of 211 participants completed the study. High quit rates (CAR weeks 4-12) of 39.1% (43/110) and 30.8% (33/107) were observed for IQOS-HTP and JustFog-EC, respectively. The between-group difference for the CAR weeks 4-12 was not significant (P=.20). The CRR weeks 4-12 values for IQOS-HTP and JustFog-EC were 46.4% (51/110) and 39.3% (42/107), respectively, and the between-group difference was not significant (P=.24). At week 12, the 7-day point prevalence of smoking abstinence values for IQOS-HTP and JustFog-EC were 54.5% (60/110) and 41.1% (44/107), respectively. The most frequent adverse events were cough and reduced physical fitness. Both study products elicited a moderately pleasant user experience, and the between-group difference was not significant. A clinically relevant improvement in exercise tolerance was observed after switching to the combustion-free products under investigation. Risk perception for conventional cigarettes was consistently higher than that for the combustion-free study products under investigation.</p> <p><strong>Conclusions: </strong>Switching to HTPs elicited a marked reduction in cigarette consumption among people who smoke and do not intend to quit, which was comparable to refillable ECs. User experience and risk perception were similar between the HTPs and ECs under investigation. HTPs may be a useful addition to the arsenal of reduced-risk alternatives for tobacco cigarettes and may contribute to smoking cessation. However, longer follow-up studies are required to confirm significant and prolonged abstinence from smoking and to determine whether our results can be generalized outside smoking cessation services offering high levels of support.</p>
A Prospective, Randomized Clinical Trial of PRP Concepts Fibrin Bio-Matrix in Non-Healing Diabetic Foot Ulcers
ClinicalTrials.gov study NCT02312596. IPD Sharing: NO. Countries: 1. Publications: 0.
Endothelial Cell Loss in Pseudophakic Patients Receiving a Paul Glaucoma Drainage Device With Its Tube Inserted in the Anterior Versus Posterior Chamber: a Randomized Controlled Trial
ClinicalTrials.gov study NCT05500469. IPD Sharing: NO. Countries: 1. Publications: 0.
HUMAN CHORIONIC GONADOTROPIN (HcG) VS MAGNESIUM SULPHATE (MgSo4) AS A TOCOLYTIC AGENT- A RANDOMIZED CONTROLLED TRIAL
ClinicalTrials.gov study NCT05828966. IPD Sharing: UNDECIDED. Countries: 1. Publications: 0.
ScienceDex guides
Understand access before you commit
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.