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3,361 results for “Randomized controlled trials”
The BE WITH Project: A Partially Nested Randomized Control Trial (PN-RCT)
ClinicalTrials.gov study NCT07204444. IPD Sharing: NO. Countries: 1. Publications: 26.
Acupuncture for Hot Flashes in Hormone Receptor-Positive Breast Cancer, a Randomized Controlled Trial
ClinicalTrials.gov study NCT03783546. IPD Sharing: YES. Countries: 1. Publications: 1.
Randomized controlled clinical trials with tagged information regarding the number of participants
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Randomized controlled oncology trials with tumor stage inclusion criteria
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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>
Serial correlation of temporal pain intensities with beta-endorphin and meta-enkephalin concentrations, following Transcutaneous Electrical Nerve Stimulation among patients with chronic low back pain: a randomized controlled trial
<p>This is a dataset for the research that evaluate the responses of plasma beta-endorphin (βE), met-enkephalin (ME) and pain intensity (PI) among patients with chronic low back pain exposed to transcutaneous electrical nerve stimulation (TENS) = Group 1 or sham-TENS = Group 2.</p> <p>The dataset codes: TENS group = 1, Sham-TENS = 2, Sex: male = 1, female = 2, Baseline = before trial, Zero_Hr = immediately after trial, One_Hr = an hour after trial, TwentyFour_Hrs = 24 hrs after trial, FortyEight_Hrs = 48 hrs after trial.</p> <p>Variables labels: group, sex, age, pain duration, systolic blood pressure (SBP), diastolic blood pressure (DBP), resting heart rate (RHR), body temperature (Temp), beta-endorphin (BE), meta-enkephalin (ME), pain intensity (PI) measured with numeric pain scale.</p> <p>To describe time series, codes were combined with variable labels E.g. TwentyFour_Hrs_BE = bete endorphin concentration after 24 hrs of intervention.</p>
Switch to second-line versus continued first-line antiretroviral therapy for patients with low-level HIV-1 viremia: an open-label randomized controlled trial in Lesotho
<p>These are pseudo-anonymised data from the SESOTHO randomised trial: "Switch to second-line versus WHO-guided standard of care for unsuppressed patients on first-line ART with viremia below 1000 copies/mL – a multicenter, parallel-group, open-label, randomized clinical study in rural Lesotho". There are two datasets, one containing baseline data (one row per participant) and one containing longitudinal viral load data (one row per participant per visit). The data dictionary explains the data available in each dataset. Between August 2017 and August 2019, 80 eligible and consenting participants were enrolled from eight health facilities in four districts of Lesotho, and followed up for nine months. The protocol was published, DOI: 10.1186/s12879-018-2979-y</p>
Data from: A randomized controlled safety and feasibility trial of floatation-REST in anxious and depressed individuals
<div> <div> <div> <div> <p>Background: Reduced Environmental Stimulation Therapy via floatation (floatation- REST) is a behavioral intervention designed to attenuate exteroceptive sensory input to the nervous system. Prior studies in anxious and depressed individuals demonstrated that single sessions of floatation-REST are safe, well-tolerated, and associated with an acute anxiolytic and antidepressant effect that persists for over 48 hours. However, the feasibility of using floatation-REST as a repeated intervention in anxious and depressed populations has not been well-investigated.</p> <p>Methods: In this single-blind safety and feasibility trial, 75 individuals with anxiety and depression were randomized to complete six sessions of floatation-REST in different formats: pool-REST (weekly 1-hour float sessions), pool-REST preferred (float sessions with flexibility of duration and frequency), or an active comparator (chair- REST; weekly 1-hour sessions in a Zero Gravity chair). Feasibility (primary outcome) was assessed via an 80% rate of adherence to the assigned intervention; tolerability via study dropout and duration/frequency of REST utilization; and safety via incidence of adverse events and ratings about the effects of REST.</p> <p>Results: Of 1,715 individuals initially screened, 75 participants were ultimately randomized. Six-session adherence was 85% for pool-REST (mean, M=5.1 sessions; standard deviation, SD=1.8), 89% for pool-REST preferred (M=5.3 sessions; SD=1.6), and 74% for chair-REST (M=4.4 sessions; SD=2.5). Dropout rates at the end of the intervention did not differ significantly between the treatment conditions. Mean session durations were 53.0 minutes (SD=12.3) for pool-REST, 75.4 minutes (SD=29.4) for pool-REST preferred, and 58.4 minutes (SD=4.3) for chair-REST. There were no serious adverse events associated with any intervention. Positive experiences were endorsed more commonly than negative ones and were also rated at higher levels of intensity.</p> <p>Conclusions: Six sessions of floatation-REST appear feasible, well-tolerated, and safe in anxious and depressed individuals. Floatation-REST induces positively-valenced experiences with few negative effects. Larger randomized controlled trials evaluating markers of clinical efficacy are warranted.</p> <p>Clinical Trial Registration Identifier: NCT03899090</p> </div> </div> </div> </div>
Design and implementation of a brief digital mindfulness and compassion training app for health care professionals: cluster randomized controlled trial
<p><strong>Background: </strong>Several studies show that intense work schedules make health care professionals particularly vulnerable to emotional exhaustion and burnout.</p> <p><strong>Objective:</strong> In this scenario, promoting self-compassion and mindfulness may be beneficial for well-being. Notably, scalable, digital app–based methods may have the potential to enhance self-compassion and mindfulness in health care professionals.</p> <p><strong>Methods: </strong>In this study, we designed and implemented a scalable, digital app–based, brief mindfulness and compassion training program called "WellMind" for health care professionals. A total of 22 adult participants completed up to 60 sessions of WellMind training, 5-10 minutes in duration each, over 3 months. Participants completed behavioral assessments measuring self-compassion and mindfulness at baseline (preintervention), 3 months (postintervention), and 6 months (follow-up). In order to control for practice effects on the repeat assessments and calculate effect sizes, we also studied a no-contact control group of 21 health care professionals who only completed the repeated assessments but were not provided any training. Additionally, we evaluated preand postintervention neural activity in core brain networks using electroencephalography source imaging as an objective<br>neurophysiological training outcome.</p> <p><strong>Results:</strong> Findings showed a post- versus preintervention increase in self-compassion (Cohen d=0.57; P=.007) and state-mindfulness (d=0.52; P=.02) only in the WellMind training group, with improvements in self-compassion sustained at follow-up (d=0.8; P=.01). Additionally, WellMind training durations correlated with the magnitude of improvement in self-compassion across human participants (ρ=0.52; P=.01). Training-related neurophysiological results revealed plasticity specific to the default mode network (DMN) that is implicated in mind-wandering and rumination, with DMN network suppression selectively observed at the postintervention time point in the WellMind group (d=–0.87; P=.03). We also found that improvement in self-compassion was directly related to the extent of DMN suppression (ρ=–0.368; P=.04).</p> <p><strong>Conclusions:</strong> Overall, promising behavioral and neurophysiological findings from this first study demonstrate the benefits of brief digital mindfulness and compassion training for health care professionals and compel the scale-up of the digital intervention.</p>
Evaluation of comparative Efficacy of two routes of administration of Carathmus Tinctorius (Medicated Enema and Nasal Administration) as an Adjuvant Therapy with Standard Care With Physiotherapy in the Rehabilitation of Thrombolytic Stroke (Pakshaghat): A Randomized Controlled Trial Protocol
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Evaluation of comparative efficacy of Trayodashang Guggul versus Asitaka Churna Vati in the management of Katigraha (Stiffness in Lumbar Region): A randomized controlled trial protocol
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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>
Association between prenatal provision of lipid‐based nutrient supplements and cesarean delivery: Findings from a randomized controlled trial in Malawi
<p>Data set for a published manuscript on Maternal & Child Nutrition.</p> <p><strong>ABSTRACT:</strong> In populations with a high prevalence of childhood and adolescent undernutrition, supplementation during pregnancy aiming at improving maternal nutritional status and preventing fetal growth restriction might theoretically lead to cephalopelvic disproportion and delivery complications. We investigated whether the prenatal provision of small-quantity lipid-based nutrient supplements (SQ-LNS) was associated with an increased risk of caesarean section (CS) or other delivery complications. Pregnant Malawian women were randomised to receive daily i) iron–folic acid (IFA) capsule (control), ii) multiple micronutrient (MMN) capsule of 18 micronutrients (second control), or iii) SQ-LNS with similar micronutrients as MMN, plus four minerals and macronutrients contributing 118 kcal. We analysed the associations of SQ-LNS, CS, and other delivery complications using log-binomial regressions. Among 1391 women enrolled, 1255 had delivery information available. The incidence of CS and delivery complications was 6.3% and 8.2%, respectively. The incidence of CS was 4.0%, 6.0%, and 8.9% (p = 0.017) in the IFA, MMN, and LNS groups, respectively. Compared to the IFA group, the relative risk (95% confidence interval) of CS was 2.2 (1.3–3.8) (p = 0.006) in the LNS group and 1.5 (0.8–2.7) (p = 0.200) in the MMN group. We found no significant differences for other delivery complications. Provision of SQ-LNS to pregnant women may have increased the incidence of CS. The baseline rate was, however, lower than recommended. It is unclear if the higher CS incidence in the SQ-LNS group resulted from increased obstetric needs or more active health seeking and a better supply of services. Trial registered at clinicaltrials.gov, NCT01239693.</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>
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>
Evaluation of comparative efficacy of Babool Vati versus Tablet Metformin in the Management of Type 2 Diabetes Mellitus (Prameha)- a randomized controlled trial protocol
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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>
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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.