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opencc-zeroJul 2024View details →

Medical publications with information as to whether a publication reports a randomized controlled trial and/or if it covers an oncology topic

Background: Most tools trying to automatically extract information from medical publications are domain agnostic and process publications from any field. However, only retrieving trials from dedicated fields could have advantages for further processing of the data. Dataset collection: A random sample of 900 publications from seven major journals (British Medical Journal, JAMA, JAMA Oncology, Journal of Clinical Oncology, Lancet, Lancet Oncology, New England Journal of Medicine) published between 2010 and 2022 were annotated. Publications that described randomized controlled trials (RCTs) received the label "RCT". Publications that covered oncological topics received the label "ONCOLGY". Trials that fulfilled both criteria were assigned both labels. Trials that were neither RCTs nor covered oncology topics were assigned no label. 100 randomly sampled trials from the New England Journal of Medicine were used as the unseen test set as the journal publishes both oncology and non-oncology articles. Data properties: Each trial is a row in the CSV file. For each trial, there is a doi, a publication date, a title, an abstract, the abstract sections (introduction, methods, results, conclusion), several tags associated with the annotation process (text, _input_hash, _task_hash, options, _view_id, config, accept, answer, _timestamp, _annotator_id,_session_id), and the assigned labels (answer).

opencc-by-4.0Jul 2024View details →

The Efficacy of Daily versus Weekly Ferrous Sulfate in Maintaining Normal Serum Ferritin Levels During Pregnancy: A Randomized Controlled Trial

Serum ferritin is the most reliable indication of stored iron in pregnancy, offering a noninvasive way to detect iron deficiency anemia before it occurs. Therefore, this study aimed to determine serum ferritin levels among women receiving daily versus weekly iron supplementation, with a secondary focus on comparing the proportion developing iron deficiency anemia and compli- ance rates between the two groups. Methods: This non-blinded randomized control trial involved non-anaemic pregnant women attend- ing antenatal clinics at two Teaching Hospitals in Osun State. One hundred twenty-five subjects were recruited to receive 65mg in the control group, while another 125 subjects in the active group re- ceived three tablets (195mg) of ferrous sulfate (Fesulf) once weekly for 17 weeks from the 20th to 37th weeks of gestation. The primary outcome measure was comparing mean serum ferritin levels in both groups at 37 weeks. Results: Among the 240 subjects analyzed, the 37-week serum ferritin level was higher in the daily group (73.26±26.67µg/L) compared to the weekly group (63.04±30.71 µg/L), p value=0.006. Four (3.36%) and 10 (8.26%) of our subjects had Iron deficiency anaemia. Nine subjects (3.75%) reported dyspepsia as a side effect. Daily 65 mg of Felsulf proved more effective than weekly 195mg in main- taining normal blood ferritin levels during pregnancy. Conclusions: Daily iron supplementation with 65mg ferrous sulfate was more effective at main- taining adequate maternal iron concentration in this group of non-anaemic pregnant women. This dosage is recommended for routine iron supplementation in our environment.

opencc-by-4.0Dec 2014View details →

Figure 2 in A new policy to implement CONSORT guidelines for surgical randomized controlled trials

Figure 2. - Distribution of Smilosicyopus species.

opencc-by-4.0Aug 2021View details →

Raw data for the article: A Randomized Controlled Trial of Antithrombin Supplementation During Extracorporeal Membrane Oxygenation

Objectives: Supplementation of antithrombin might decrease the amount of heparin needed to achieve a given anticoagulation target during extracorporeal membrane oxygenation. However, exogenous antithrombin itself may increase the risk of bleeding. We conceived a study to evaluate the effect of antithrombin supplementation in adult patients requiring venovenous extracorporeal membrane oxygenation for respiratory failure on heparin dose, adequacy of anticoagulation, and safety. Design: Prospective randomized controlled trial. Setting: ICUs of two Italian referral extracorporeal membrane oxygenation centers. Patients: Adult patients requiring venovenous extracorporeal membrane oxygenation for severe respiratory failure and unfractionated heparin for systemic anticoagulation. Interventions: Before extracorporeal membrane oxygenation start, patients were randomized to either receive antithrombin concentrate to maintain a plasmatic level 80-120% (treatment) or not (control) during the extracorporeal membrane oxygenation course. Measurements and main results: The primary outcome was the total amount of heparin required to maintain activated partial thromboplastin time ratio 1.5-2. Secondary outcomes were anti-factor Xa, the incidence of hemorrhagic and thrombotic events, and the amount of blood products transfused. Twenty-four patients in the treatment group and 24 in the control group were included in the intention-to-treat analysis. Antithrombin was 109.5% (93.0-123.0%) in the treatment group and 84.0% (68.5-98.0%) in the control group (p = 0.001). Supplementation of antithrombin did not decrease heparin dose (13.5 international units/kg/hr [9.6-17.9 international units/kg/hr] vs 15.1 international units/kg/hr [10.7-18.3 international units/kg/hr] in the treatment and control group, respectively; p = 0.33) and anti-Factor Xa levels (0.4 international units/mL [0.3-0.5 international units/mL] vs 0.3 international units/mL [0.2-0.5 international units/mL] in the treatment group and control group respectively; p = 0.65). Bleeding, blood product transfusions, and thrombosis were not different in the two groups. Conclusions: Antithrombin supplementation may not decrease heparin requirement nor diminish the incidence of bleeding and/or thrombosis in adult patients on venovenous extracorporeal membrane oxygenation.

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-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-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.

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.