Find research datasets worth reusing

opencc-zeroSep 2021View details →

The influence of the statistical significance of results and spin on readers' interpretation of the results in an abstract for a hypothetical clinical trial: A randomized trial

Objectives: To assess the impact on readers' interpretation of the results reported in an abstract for a hypothetical clinical trial with 1) a statistically significant result, 2) spin, 3) both a statistically significant result and spin compared to 4) no spin and no statistically significant result. Participants: Health students and professionals from universities and health institutions in France and the UK. Interventions: Participants completed an online questionnaire using Likert scales and free text, after reading one of the four versions of an abstract about a hypothetical randomized trial evaluating "Naranex" and "Bulofil" (two hypothetical drugs) for chronic low back pain. The abstracts differed in a) reported result of "mean difference of 1.31 points (95%CI 0.08 to 2.54; p= 0.04)" or "mean difference of 1.31 points (95%CI -0.08 to 2.70; p= 0.06)" and b) presence or absence of spin. The effect size for the trial's primary outcome (pain disability score) was the same in each abstract; slightly in favour of Naranex. Primary outcome: The reader's interpretation of the trial's results, based on their answer (1: disagree, 4: neutral, 7: agree) to the following statement: "About the main findings of the study, what is your opinion about the following statement: 'Naranex is better than Bulofil'?" Results: 297 of the 404 people randomized to receive one of the four abstracts completed the study. Respondents were more likely to favour Narenex when the abstract reported a statistically significant result without spin; a statistically significant result with spin, a non-statistically significant result with spin, compared to when it reported a non-statistically significant result without spin. Conclusions: Statistical significance appears to have influenced readers' perception whatever the level of spin, while spin influenced readers' perception when the results were not statistically significant but did not appear to have an impact when results were statistically significant

opencc-zeroNov 2022View details →

Adaptive, randomized, non-inferiority trial to evaluate the efficacy of monoclonal antibodies in outpatients with mild or moderate COVID-19

The dataset is based on the results of a trial called MANTICO (Clinical trial number NCT05205759). The study is a non-inferiority randomised controlled trial comparing the clinical efficacy of bamlanivimab/etesevimab, casirivimab/imdevimab, and sotrovimab in outpatients aged 50 or older with early COVID-19. The primary outcome was COVID-19 progression (hospitalisation, need of supplemental oxygen therapy, or death through day 14).

opencc-zeroFeb 2023View details →

DMID14-0100: A randomized, controlled Phase 1b trial of the Sm-TSP-2 vaccine for intestinal schistosomiasis ELISA results

Recombinant Schistosoma mansoni Tetraspanin-2 formulated on Alhydrogel (Sm-TSP-2/Alhydrogel) is being developed to prevent intestinal and hepatic disease caused by S. mansoni. The tegumentary Sm-TSP-2 antigen was selected based on its unique recognition by cytophilic antibodies in putatively immune individuals living in areas of ongoing S. mansoni transmission in Brazil, and preclinical studies in which vaccination with Sm-TSP-2 protected mice following infection challenge.

openother-closedFeb 2023View details →

Video supplement to "A randomized, controlled, crossover trial of median nerve stimulation for treatment of Tourette syndrome"

Video from the last 60 s of Block 5 (stimulation off) and the first 60 s of Block 6 (stimulation on) from the rhythmic \(\pm \) arrhythmic visits of three study participants who reported substantial improvement in tic severity on at least one visit.

opencc-zeroMar 2023View details →

The effectiveness and safety of intensive lipid-lowering with different Rosuvastatin-based regimens in patients at high risk: A nonblind, randomized, controlled trial

Background: Statin alone or nonstatins as add-ons have been introduced to intensive low-density lipoprotein cholesterol (LDL-C) lowering therapy in patients at high cardiovascular disease (CVD) risk. The purpose of this study was to evaluate the effectiveness and safety of different statin-based regimens for patients at high risk. Methods: Three hundred patients at high CVD risk were randomly assigned to the statin group (Rosuvastatin 20mg/d), statin_EZ group (Rosuvastatin 10mg/d + ezetimibe 10mg/d), statin_pcsk group (Rosuvastatin 10mg/d + alirocumab 75mg/2weeks) or combine3 group (Rosuvastatin 10mg/d + ezetimibe 10mg/d + alirocumab 75mg/2weeks). The primary outcome measure was cholesterol levels (LDL-C, total cholesterol (TC) triglycerides (TGs), and high-density lipoprotein cholesterol (HDL-C)) after 24 weeks of follow-up. The secondary outcome measures were safety markers and the proportion of patients who achieved the < 70 mg/dL (1.8 mmol/L) LDL-C target. A logistic regression model was performed to explore the factors affecting lipid target achievement. Results: The TC and LDL-C levels after treatment were significantly different among the four groups (p < 0.05). The levels in both the combine3 group and the statin_pcsk9 group were significantly lower than those in the statin group and the statin_EZ group (p < 0.05), but there was no significant difference between the combine3 group and the statin_pcsk9 group. The incidence of adverse events in the four groups was low. Body mass index (BMI) and hypertensive status were related to target achievement. Conclusion: The combination of a statin and a PCSK9 inhibitor was safe and more effective for the treatment of high-risk CVD patients, while the addition of ezetimibe was unable to significantly lower lipid levels any further. The rate of achieving the target was higher in patients with hypertension and a low BMI.

opencc-zeroMar 2023View details →

Automated, medication-targeted alerts for Acute Kidney Injury – A randomized trial

Acute kidney injury is common among hospitalized individuals, particularly those exposed to certain medications, and is associated with substantial morbidity and mortality. In a pragmatic, open-label, parallel group randomized controlled trial (clinicaltrials.gov NCT02771977), we investigate whether an automated clinical decision support system affects discontinuation rates of potentially nephrotoxic medications and improves outcomes in patients with AKI. Participants included 5,060 hospitalized adults with AKI and an active order for any of three classes of medications of interest: non-steroidal anti-inflammatory drugs, renin-angiotensin-aldosterone system inhibitors, or proton pump inhibitors. Within 24 hours of randomization, a medication of interest was discontinued in 61.1% of the alert group versus 55.9% of the usual care group (relative risk 1.08, 1.04–1.14, p=0.0003). The primary outcome – a composite of progression of acute kidney injury, dialysis, or death – occurred in 585 (23.1%) individuals in the alert group and 639 (25.3%) patients in the usual care group (RR 0.92, 0.83–1.01, p=0.09). The pre-specified subgroup analysis found a significant benefit of alerting among those exposed to proton pump inhibitors but not non-steroidal anti-inflammatory drug or renin-angiotensin system inhibitor.

opencc-zeroApr 2023View details →

Data from: Evaluation of a community health worker home visit intervention to improve child development in South Africa: A cluster-randomized controlled trial

This dataset was collected as part of a cluster-randomized controlled trial that evaluated the impact of a home visit intervention on child development in Limpopo Province, South Africa. Household survey data were collected at baseline and endline. In a subsample of children, neural function was assessed at a lab at endline and at two interim time points. Primary outcomes were: height-for-age z-scores (HAZ) and stunting; child development scores measured using the Malawi Developmental Assessment Tool (MDAT); absolute electroencephalography (EEG) gamma and total power; relative EEG gamma power; and saccadic reaction time (SRT)—an eye-tracking measure of visual processing speed.

opencc-by-4.0May 2023View details →

Underlying qualitative data for: "What went wrong? A qualitative exploration of the determinants of poor antiretroviral therapy adherence and retention in care among pregnant and postpartum women in the Uganda WiseMama randomized controlled trial"

This dataset is the underlying qualitative data for the paper entitled: "What went wrong? A qualitative exploration of the determinants of poor antiretroviral therapy adherence and retention in care among pregnant and postpartum women in the Uganda WiseMama randomized controlled trial"

opencc-by-4.0Jun 2023View details →

Pharmacokinetic dataset of a randomized controlled trial investigating the efficacy and safety of intravenous imatinib mesylate (Impentri®) in subjects with acute respiratory distress syndrome induced by COVID-19

Abstract Background The coronavirus disease 2019 (COVID-19) pandemic has led to a disruptive increase in the number of intensive care unit (ICU) admissions with acute respiratory distress syndrome (ARDS). ARDS is a severe, life-threatening medical condition characterized by widespread inflammation and vascular leak in the lungs. Although there is no proven therapy to reduce pulmonary vascular leak in ARDS, recent studies demonstrated that the tyrosine kinase inhibitor imatinib reinforces the endothelial barrier and prevents vascular leak in inflammatory conditions, while leaving the immune response intact. Methods This is a randomized, double-blind, parallel-group, placebo-controlled, multicenter clinical trial of intravenous (IV) imatinib mesylate in 90 mechanically ventilated subjects with COVID-19-induced ARDS. Subjects are 18 years or older, admitted to the ICU for mechanical ventilation, meeting the Berlin criteria for moderate-severe ARDS with a positive polymerase chain reaction test for SARS-CoV2. Participants will be randomized in a 1:1 ratio to either imatinib (as mesylate) 200 mg bis in die (b.i.d.) or placebo IV infusion for 7 days, or until ICU discharge or death. The primary study outcome is the change in Extravascular Lung Water Index (EVLWi) between day 1 and day 4. Secondary outcome parameters include changes in oxygenation and ventilation parameters, duration of invasive mechanical ventilation, number of ventilator-free days during the 28-day study period, length of ICU stay, and mortality during 28 days after randomization. Additional secondary parameters include safety, tolerability, and pharmacokinetics. Discussion The current study aims to investigate the efficacy and safety of IV imatinib in mechanically ventilated subjects with COVID-19-related ARDS. We hypothesize that imatinib decreases pulmonary edema, as measured by extravascular lung water using a PiCCO catheter. The reduction in pulmonary edema may reverse hypoxemic respiratory failure and hasten recovery. As pulmonary edema is an important contributor to ARDS, we further hypothesize that imatinib reduces disease severity, reflected by a reduction in 28-day mortality, duration of mechanical ventilation, and ICU length of stay.

opencc-by-4.0Jun 2023View details →

A Pilot Randomized Controlled Trial of Distance Laughter Therapy for Mothers' Level of Depression, Anxiety, and Parental Stress during the COVID-19 Pandemic

Presented here are both quantitative and qualitative datasets from a study titled 'A Pilot Randomized Controlled Trial of Distance Laughter Therapy for Mothers’ Level of Depression, Anxiety, and Parental Stress during the COVID-19 Pandemic.' The COVID-19 pandemic has necessitated significant lifestyle modifications globally, leading to heightened psychological stressors, notably depression and anxiety. Concurrently, the exigencies of parental care have escalated, thereby amplifying the risk of caregiver exhaustion and potential child maltreatment. This study sought to assess the efficacy and feasibility of utilizing distance laughter therapy for mothers who are looking after young children during these challenging times. The primary objective was to alleviate symptoms of depression, anxiety, and parental stress.

opencc-zeroJul 2023View details →

A feasibility randomized controlled superiority trial of fluticasone-vilanterol once daily use for the treatment of mild asthma in adults

Objectives Current international guidelines recommend using a combination of Long-Acting Beta-Agonists and Inhaled Corticosteroids (LABA+ICS) therapy for symptomatic mild asthma. However, this change has yet to be widely implemented in the Middle East. The objective of this pilot study is to assess the feasibility (recruitment and retention rates) of conducting a future definitive RCT to investigate the effectiveness of fluticasone-vilanterol (LABA+ICS) in the management of mild asthma in adults, compared with usual care. Design This 8-month parallel two-arm pilot trial took place in the Kingdom of Bahrain. We randomly assigned 18 patients with mild asthma in a 1:1 ratio to the treatment (n=10) or usual care (n=8) arms. The treatment group received daily LABA+ICS therapy while the usual care group continued as required SABA or SABA+ICS combination. The main outcome measures were descriptors of study feasibility (recruitment and retention rates). We also compared unblinded outcome assessment of asthma control score, quality of life, and the number of asthma exacerbations experienced by patients in both arms. Results A total of 18 patients were recruited from a single primary healthcare center and randomized by remote web-based allocation into intervention (n=10) and usual care (n=8) groups. The baseline characteristics of participants did not differ significantly across the two arms at the start of the trial. Because of slow recruitment and limited funding, the study didn't meet our recruitment target but did successfully meet our retention criteria. At 32 weeks, the analysis indicated significant improvement in asthma control scores in the intervention arm (1.31 vs 2.91; 95% CI [0.72, 2.44]; P-value=0.003), but no significant differences were noted in quality-of-life scores (P-value=0.197) compared to the baseline levels. There were no significant differences in post-intervention asthma control mean score (P-value=0.361) or QoL mean score (P-value=0.337) between the two arms after adjustment for pre-intervention scores. Conclusions This pilot RCT indicates that a definitive RCT is feasible in a primary healthcare setting in Bahrain. In a definitive trial, we recommend increasing the recruitment rate by relaxing eligibility criteria, extending the timeline, and increasing the number of sites for recruitment. Additionally, outcomes of this pilot trial suggest that LABA+ICS is a feasible, acceptable, safe, and effective intervention for the management of mild asthma in a Middle Eastern context.

opencc-zeroAug 2023View details →

Establishing a new standard of care for calculus using trials with randomized student allocation

Calculus, the study of change in processes and systems, serves as the foundation of many STEM disciplines. Traditional, lecture-based calculus instruction presents a persistent barrier for students seeking STEM degrees, limits access to STEM professions, and blocks their potential to address society's challenges. A large-scale pragmatic trial with randomized student allocation was conducted to compare two calculus instruction styles: active student engagement (treatment condition) versus traditional, lecture-based instruction (control condition). A sample of 811 U.S. university students was studied across 32 sections taught by 19 instructors over three semesters at a large U.S. Hispanic-Serving Institution. Large effect sizes were consistently measured for student learning outcomes in the treatment condition, which demonstrated a new standard for calculus instruction and increased opportunities for completion of STEM degrees.

opencc-by-4.0Sep 2023View details →

Effectiveness of self-management of medication and self-monitoring of blood pressure, diet, and physical exercise on blood pressure in patients with poorly controlled hypertension (MEDICHY study): randomized and controlled trial

Dataset study medichy ISRCTN144433778

controlledIPD-YESFeb 2026View details →

TIME™ at Home Randomized Controlled Trial

ClinicalTrials.gov study NCT06245135. IPD Sharing: YES. Countries: 1. Publications: 1.

Believing People Can Change: A Randomized Controlled Trial of an Incremental Theory Intervention in Adolescence

ClinicalTrials.gov study NCT04133389. IPD Sharing: NO. Countries: 1. Publications: 8.

Randomized Controlled Trial of Talc Instillation In Addition To Daily Drainage Through a Tunneled Pleural Catheter to Improve Rates of Outpatient Pleurodesis in Patients With Malignant Pleural Effusio

ClinicalTrials.gov study NCT04792970. IPD Sharing: NO. Countries: 1. Publications: 2.

controlledIPD-YESFeb 2026View details →

IMPROVE AKI Cluster-Randomized Trial

ClinicalTrials.gov study NCT03556293. IPD Sharing: YES. Countries: 1. Publications: 2.

The Randomized Controlled Trial of Inferior Vena Cava Ultrasound-guided Fluid Management in Septic Shock Resuscitation

ClinicalTrials.gov study NCT03020407. IPD Sharing: NO. Countries: 1. Publications: 1.

restrictedIPD-UNDECIDEDFeb 2026View details →

Randomized Controlled Trial of Subcuticular Skin Closure Versus Steri-strip S Closure

ClinicalTrials.gov study NCT00727025. IPD Sharing: Not stated. Countries: 1. Publications: 1.

Evaluation of Bioflex and Zirconia Crowns Versus Stainless Steel Crowns on Primary Molars: Randomized Controlled Clinical Trial

ClinicalTrials.gov study NCT07156838. IPD Sharing: NO. Countries: 1. Publications: 3.