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3,361 results for “Randomized Controlled Trial”
A Randomized, Double Blinded, Placebo-Controlled Clinical Trial Evaluating the Efficacy and Safety of anti-SARS-CoV-2 Convalescent Plasma in Hospitalized Patients (CONTAIN COVID-19)
<p>This dataset contains de-identified patient data of 941 patients from 21 centers across the United States who were enrolled in the CONTAIN COVID-19 randomized controlled trial that ran from 4/17/2020-3/15/2021. The information in this dataset was used to conduct the analysis reported in the CONTAIN COVID-19 manuscript published in JAMA Internal Medicine (doi: 10.1001/jamainternmed.2021.6850) and includes demographic information, baseline history, baseline medications, baseline laboratory values, clinical status based on the WHO 11-point scale at 14 and 28 days after randomization, antibody titers, randomization arms.</p>
The ACTonHEART Study: a Randomized Controlled Clinical Trial of a short intervention based on Acceptance and Commitment Therapy vs. usual care for cardiac rehabilitation patients with coronary heart disease.
<p>The ACTonHEART study evaluates the effectiveness of adding an ACT-based intervention to usual secondary prevention care of coronary heart disease, in order to promote healthy lifestyle changes and improve psychological wellbeing and quality of life among CR patients; psychological flexibility was a hypothesized mechanism of change.</p> <p>Ninety-two patients were enrolled and randomized, following an unbalanced randomization ratio of 2:1, to the ACT group (N= 59) and the control group (N= 33). The control group completed standard CR (Usual Care; UC) and the experimental subjects participated in the ACTonHEART group intervention in addition to standard CR. The ACTonHEART intervention consisted of three, two-hour, group sessions, focused on integrating acceptance and mindfulness skills into educational topics on heart-healthy behaviors. The primary study hypothesis is that the ACTonHEART group is superior to the UC group in the following primary outcome measures: LDL-cholesterol, resting systolic blood pressure, body mass index, and psychological wellbeing.</p> <p>Participants were assessed at baseline and at the end of the rehabilitation period. Linear mixed models analyses were used to detect the group x time interaction. Across all outcome variables, no time x treatment effect was found. The results of this study may inform the future implementations of ACT in the cardiac rehabilitation context.</p> <p>Corresponding author: Chiara Spatola (chiara.spatola@unime.it)</p>
Effects of Dualsite Anodic tDCS on Lower Limbs Function in Patients After Stroke: Randomized, Double-blind, Placebo-controlled, Crossover Trial
<p>https://docs.google.com/spreadsheets/d/1gyZvGAK0t3D83jHWWULAdhNmDYWvHa8nvzGJeLP4oVk/edit#gid=1006784133</p>
Dataset related to: "Home-based exercises with teleconsultation following hospitalization for COVID-19 pneumonia: a randomized controlled trial"
<p>We provide the raw data used for the following article:</p> <p>Paneroni M, Scalvini S, Perger E, Zampogna E, Govetto S, Oliva FM, Matrone A, Bernocchi P, Rosa D, Vitacca M. <strong>Home-based exercise program for people with residual disability following hospitalization for COVID-19: Randomized control trial. </strong>Ann Phys Rehabil Med. 2024 Mar;67(2):101815. doi: 10.1016/j.rehab.2023.101815. </p> <p><strong>ABSTRACT</strong></p> <p><em><span>Background</span></em><span>: In post-COVID-19 individuals with effort intolerance or hypoxia at rest and/ or during exercise, the best exercise program after in-hospital rehabilitation remains unknown.</span></p> <p><em><span>Objective:</span></em><span> We aimed to evaluate the efficacy of a Home-based Exercise Program with teleconsultation (Intervention group) to improve effort tolerance. </span></p> <p><em><span>Methods</span></em><span>: This is a multicenter randomized controlled trial. We included COVID-19 individuals after rehabilitation attempts with a) less than 70% of the predicted distance during the Six-Minute Walking test (6MWT) and/or b) oxygen desaturation all day long or during effort.</span><span> Effort tolerance was evaluated by 6MWT (primary outcome). Secondary outcomes were dyspnea, fatigue, spirometry, respiratory muscle evaluations, and oxygenation. The</span><span> Intervention group performed one month of a self-administered exercise program and bi-weekly physiotherapist video calls; the Control group was free to conduct physical activity as usual. Exercise intensity was set into 4 levels according to disability and oxygen desaturation, and progressively increased ranging from low (walking, free-body exercise, sit-to-stand, balance exercises), to higher (speed walking with a pedometer, cycle ergometer, strengthening exercises) intensity. </span></p> <p><em><span>Results</span></em><span>: We included 79 participants, 40 in the Intervention and 39 in the Control group [mean (SD) 67.1(10.3) years old, 72% male]. No difference in effort tolerance was found after the intervention between groups [Intervention 77.6 (75.4) vs Control 49.5 (73.3) m, p= 0.109]. Participants with 6MWT below the Lower Limit of Normality experienced a better improvement in effort tolerance [Intervention: mean (SD) 120.1 (75.8) vs Control 59.1 (75.6) m, p= 0.035]. After two months, the 6MWT distance in the two groups was similar (Intervention mean (SD) 475.9 (82.4) vs Control 469.2 (118.9) m, p= 0.807). </span></p> <p><em><span>Conclusions</span></em><span>: In post-COVID-19 individuals with a residual disability after a rehabilitation attempt, a home-based exercise program with teleconsultation</span><span> </span><span>leads to a significant benefit on effort tolerance only in participants with severe effort intolerance at baseline. </span></p> <p><span> </span><em><span>Database Registration</span></em><span>: ClinicalTrials.gov number, NCT04821934</span></p> <p><span> </span><em><span>Keywords</span></em><span>: COVID-19; exercise; teleconsultation, healthcare providers</span></p>
Short-term Ketogenic Diet as Compared With Conventional Long-term Trial in Refractory Infantile Spasms: A Randomized, Controlled Study
ClinicalTrials.gov study NCT00968136. IPD Sharing: Not stated. Countries: 0. Publications: 0.
Alanyl-glutamine in peritoneal dialysis fluids - a randomized controlled phase I/II trial
GEO Series GSE57070. Homo sapiens. 6 samples. Type: Expression profiling by array.
Dataset related to article "Cost-effectiveness of second-line diagnostic investigations in patients included in the DANTE trial: a randomized controlled trial of lung cancer screening with low-dose computed tomography."
<p>AIM:</p> <p>The aim of this study was to analyze the economic efficiency of second-line diagnostic investigations in patients with undetermined lung nodules.</p> <p>PARTICIPANTS AND METHODS:</p> <p>A retrospective review of all surgical cases included in the DANTE trial from 2001 to 2006 for lung cancer screening was performed. Overall, 217 patients and 261 lung nodules were analyzed. The cohort was divided into patients investigated with PET and/or computed tomography (CT)-guided biopsy (PET-CTB protocol; N=100), compared with those assessed with serial low-dose CT scans (standard protocol; N=161). Outpatient's and inpatient's costs were expressed in euros and derived from the Italian National Health Service. Ineffective costs were defined as the cost of procedures that lead to avoidable surgical intervention.</p> <p>RESULTS:</p> <p>The diagnostic accuracy of the two protocols was 91% for the standard (sensitivity 100%, specificity 91%, positive predictive value 26%, and negative predictive value 100%) and 90% for the PET-CTB protocol (sensitivity 98%, specificity 81%, positive predictive value 85%, and negative predictive value 97%). Average costs for outpatient's diagnostics were 694 and 1.462 euros, respectively, for the standard and PET-CTB protocol. Average inpatient's costs for both protocols were 12.121 euros. The two protocols showed comparable effectiveness in terms of outpatient's costs (94 and 90%, respectively; P=0.252). Inpatient's costs were effective in 36% of cases monitored according to the standard protocol compared with 85% of patients investigated with PET-CTB protocol. Ineffective costs corresponded to 64 and 15%, respectively (P<0.0001).</p> <p>CONCLUSION:</p> <p>Despite a higher average cost for outpatient's diagnostics, the implementation of PET imaging with or without CT-guided needle biopsy in the workup of suspicious lung nodules results in reduced unnecessary harm and costs related to inpatient's procedures.</p>
Loss to follow-up in a randomized controlled trial study for pediatric weight management (EPOC)
<p>This is the data set as supporting information, provided as .sav file.</p> <p>Further information is available on request.</p>
Variations of HRV and skin conductance reveal the influence of CV4 and Rib Raising techniques on autonomic balance: A randomized controlled clinical trial
<p>Variations of HRV and skin conductance reveal the influence of CV4 and Rib Raising techniques on autonomic balance: A randomized controlled clinical trial</p> <p> </p> <p>Introduction: The aim of the present study was to evaluate whether Fourth Ventricle Compression</p> <p>Technique (CV4) and Rib Raising (RR) osteopathic techniques influence Autonomic Nervous System (ANS) activity, as measured by Heart Rate Variability (HRV) and Skin Conductance (SC).</p> <p>Method: A randomized-controlled clinical trial has been performed from June 2010 to January 2011. 32 healthy adults (33.9 ± 14 years, and 72% female) were selected. Subjects were randomized in three groups: CV4 group, RR group and Placebo group. Each subject of each group underwent respective technique only once. HRV and SC were continuously recorded during the session. All data analysis was performed using SPSS statistical software (version 21.0) and the significance level was considered at p 0.05.</p> <p>Results: RR technique intra-group subject analysis showed a significant decrease in LF/HF ratio (F ¼ 25.18; p < 0.001), a statistically significant decrease of LF (F ¼ 27.09; p < 0.001), and increase of HF, both at the end of treatment (F ¼ 27.09; p < 0.001). CV4 technique intra-group subject analysis showed a significant reduction of the LF/HF ratio (F ¼ 81.15; p < 0.001), a significant decrease in LF (F ¼ 38.29; p < 0.001) and a significant increase of HF, at the end of treatment (F ¼ 38.28; p < 0.001). Between-group analysis showed only a significant difference in LF/HF ratio between CV4 and PL groups (F ¼ 3.44; p ¼ 0.042).</p> <p>Discussion: Our results suggest that the application of CV4 and RR techniques favors a shift in the autonomic balance towards a parasympathetic predominant state. Thus, their use within OMT protocol, as holistic approach, might improve the outcome of the treatment of clinical neuro-vegetative conditions.</p>
Anodal transcranial direct current stimulation in chronic migraine and medication overuse headache: A pilot double-blind randomized sham-controlled trial
<p>This dataset includes raw data from the article “Anodal transcranial direct current stimulation in chronic migraine and medication overuse headache: A pilot double-blind randomized sham-controlled trial”.</p> <p>In this study, we enrolled 20 patients with chronic migraine (CM) and medication overuse headache (MOH). They were hospitalized for a 7-day detoxification treatment and were randomly assigned to anodal tDCS or sham stimulation delivered over the primary motor cortex contralateral to the prevalent migraine pain side every day for 5 days. Clinical data were recorded at baseline (T0), after 1 month (T2) and 6 months (T3). EEG recording was performed at T0, at the end of the tDCS/Sham treatment, and at T2.</p> <p>At T2 and T3, we found a significant reduction in monthly migraine days (p = 0.001), which were more pronounced in the tDCS group when compared to the sham group (p = 0.016). At T2, we found a significant increase of alpha rhythm in occipital leads, which was significantly higher in tDCS group when compared to sham group. In conclusion, tDCS showed adjuvant effects to detoxification in the management of patients with CM and MOH. The EEG recording showed a significant potentiation of alpha rhythm, which may represent a correlate of the underlying changes in cortico-thalamic connections.</p>
Preliminary Results from The ACTyourCHANGE in Teens Protocol: A Randomized Controlled Trial Evaluating Acceptance and Commitment Therapy for Adolescents with Obesity
<p>The study shows preliminary results of “The ACTyourCHANGE in Teens” project, a Randomized Controlled Trial aimed at evaluating the efficacy of an Acceptance and Commitment Therapy-based intervention combined with treatment as usual (ACT+TAU) compared to TAU only, for improving psychological well-being, psychological distress, experiential avoidance and fusion, emotion dysregulation, and emotional eating in a sample of 34 in-patient adolescents with obesity (Body Mass Index > 97th centile). Mixed between-within 2 × 2 repeated-measures analyses of variances (ANOVAs) were carried out to examine the changes in psychological conditions of participants over time. Moderation analyses were also conducted to test whether pre-test anxiety, depression, stress, and experiential avoidance and fusion predicted emotional eating at post-test with groups (ACT+TAU vs. TAU only) as moderators. Only a significant interaction effect (time × group) from pre- to post-test (<em>p </em>= 0.031) and a significant main effect of time on anxiety (<em>p </em>< 0.001) and emotional eating (<em>p</em> = 0.010) were found. Only in the TAU only group were higher levels of depression (<em>p</em> = 0.0011), stress (<em>p</em> = 0.0012), and experiential avoidance and fusion (<em>p</em> = 0.0282) at pre-test significantly associated with higher emotional eating at post-test. Although future replication and improvements of the study may allow us to obtain more consistent results, this preliminary evidence is actually promising.</p>
Effect of Alpha Soundwave Auditory Stimulation on anxiety level on patients undergoing endodontic treatment: A Randomized Controlled Trial.
Open the record for dataset details and reuse information.
Dataset concerning A double-blind randomized controlled trial combining cognitive training (CoRe) and neurostimulation (tDCS) in the early stages of cognitive impairment
<p>This is the processed data for the manuscript " Rodella C, Bernini S, Panzarasa S, Sinforiani E, Picascia M, Quaglini S, Cavallini E, Vecchi T, Tassorelli C, Bottiroli S. A double-blind randomized controlled trial combining cognitive training (CoRe) and neurostimulation (tDCS) in the early stages of cognitive impairment. Aging Clin Exp Res. 2021 Jun 22. Epub ahead of print".</p> <p>Dataset refers to a Randomized Controlled Trial aimed to evaluate the effectiveness of a combined treatment protocol associating a computerized cognitive training (CoRe) with anodal transcranial direct current stimulation (tDCS) in early phases of cognitive impairment. The dataset contains cognitive performances in neuropsychological tests (raw scores) at baseline (T0), post-intervention (T1) and 6-months later (T2). Data highlights the efficacy of combining cognitive training and neurostimulation.</p>
Dataset related to article "Endoscopic ultrasound-guided fine-needle biopsy with or without macroscopic on-site evaluation: a randomized controlled noninferiority trial "
<p>This record contains raw data related to article “Endoscopic ultrasound-guided fine-needle biopsy with or without macroscopic on-site evaluation: a randomized controlled noninferiority trial"</p> <p>Abstract</p> <p>BACKGROUND : The advantage of using the macroscopic on-site evaluation (MOSE) technique during endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) performed with 22G Franseen needles has not been investigated. We aimed to compare EUS-FNB with MOSE vs. EUS-FNB performed with three needle passes. METHODS : This randomized trial involved 10 Italian referral centers. Consecutive patients referred for EUS-FNB of pancreatic or nonpancreatic solid lesions were included in the study and randomized to the two groups. MOSE was performed by gross visualization of the collected material by the endoscopists and considered adequate when a white/yellowish aggregate core longer than 10 mm was retrieved. The primary outcome was diagnostic accuracy. Secondary outcomes were specimen adequacy, number of needle passes, and safety. RESULTS : 370 patients with 234 pancreatic lesions (63.2 %) and 136 nonpancreatic lesions (36.8 %) were randomized (190 EUS-FNB with MOSE and 180 with standard EUS-FNB). No statistically significant differences were found between EUS-FNB with MOSE and conventional EUS-FNB in terms of diagnostic accuracy (90.0 % [95 %CI 84.8 %-93.9 %] vs. 87.8 % [95 %CI 82.1 %-92.2 %]; <em>P</em> = 0.49), sample adequacy (93.1 % [95 %CI 88.6 %-96.3 %] vs. 95.5 % [95 %CI 91.4 %-98 %]; <em>P</em> = 0.31), and rate of adverse events (2.6 % vs. 1.1 %; <em>P</em> = 0.28). The median number of passes was significantly lower in the EUS-FNB with MOSE group (1 vs. 3; <em>P</em> < 0.001). CONCLUSIONS : The accuracy of EUS-FNB with MOSE is noninferior to that of EUS-FNB with three needle passes. MOSE reliably assesses sample adequacy and reduces the number of needle passes required to obtain the diagnosis with a 22G Franseen needle.</p>
dataset Is positive communication sufficient to modulate procedural pain and anxiety in the emergency room? A randomized controlled trial.
<p>Our study aimed to modulate contents and delivery vector of a message regarding peripheral intravenous catheter (PIC) placement in the emergency room (ER), to test if therapeutic communication could enhance patients' comfort during minor medical procedures. This study was a 2+2 randomized controlled trial. A positive versus standard message was delivered through audio tape (double blind) in the first phase (N= 131) and through the nurse in charge of the catheter placement (single blind) in the second phase (N= 120).</p>
Data related to article EFFICACY OF MINDFULNESS ADDED TO TREATMENT AS USUAL IN PATIENTS WITH CHRONIC MIGRAINE AND MEDICATION OVERUSE HEADACHE: A PHASE-III SINGLE-BLIND RANDOMIZED-CONTROLLED TRIAL (THE MIND-CM STUDY) - submitted
<p>DATA ON PATIENTS INCLUDED IN THE MIND-CM STUDY. TWO ARMS (TAU AND TAU+MIND), AND FOUR EVALUATIONS: BASELINE, 3-MONTHS, 6-MONTHS AND 12-MONTS FOLLOW-UP.</p>
Comparing Effects of Ultra Low Dose (Ethinyl Estradiol 20µg or 15µg) with Low Dose (Ethinyl Estradiol 30µg) Hormonal Pills on Lipid Discordance in Non-Obese PCOS Women: A Randomized Control Trial
<p>Ultra-low dose hormonal pills have become the favoured treatment option over low dose pills in PCOS. Existing literature shows marked heterogeneity in metabolic effects of pills with different compositions. This might have been due to improper choice of outcome variable for comparison. Total cholesterol - high density lipoprotein ratio (TC/HDL) discordance with Low Density Lipoprotein cholesterol (LDL-C) was a better marker of future risk of atherosclerotic cardio-vascular disease and stable to variations. Present study was a randomised controlled trial conducted to compare prevalence of TC/HDL and LDL discordance among non-obese PCOS women treated with hormonal pills of different compositions. Role of baseline participant features and pill composition on discordance after treatment was determined. Women were randomised into three arms, two arms receiving ultra-low dose pills (either Ethinyl Estradiol 20µg with drosperinone 3mg or Ethinyl Estradiol 15µg with gestodene 60µg) and one arm receiving low dose pill (Ethinyl Estradiol 30µg with desogestrel 150 µg). Discordance was observed in more than 1/4<sup>th</sup> participants prior to intervention. After one year of treatment less than 1/5<sup>th</sup> of participants were discordant. Ultra-low dose pill users had lower discordance, LDL and TC compared to low dose pill users after one year of treatment. Random Forest a non-linear classifier showed the highest accuracy in predicting discordance. Baseline Parameters having maximal impact on occurrence of discordance were triglyceride (TG), HOMA-IR, BMI and HDL.Ultra-low dose hormonal pills have become the favoured treatment option over low dose pills in PCOS. Existing literature shows marked heterogeneity in metabolic effects of pills with different compositions. This might have been due to improper choice of outcome variable for comparison. Total cholesterol - high density lipoprotein ratio (TC/HDL) discordance with Low Density Lipoprotein cholesterol (LDL-C) was a better marker of future risk of atherosclerotic cardio-vascular disease and stable to variations. Present study was a randomised controlled trial conducted to compare prevalence of TC/HDL and LDL discordance among non-obese PCOS women treated with hormonal pills of different compositions. Role of baseline participant features and pill composition on discordance after treatment was determined. Women were randomised into three arms, two arms receiving ultra-low dose pills (either Ethinyl Estradiol 20µg with drosperinone 3mg or Ethinyl Estradiol 15µg with gestodene 60µg) and one arm receiving low dose pill (Ethinyl Estradiol 30µg with desogestrel 150 µg). Discordance was observed in more than 1/4<sup>th</sup> participants prior to intervention. After one year of treatment less than 1/5<sup>th</sup> of participants were discordant. Ultra-low dose pill users had lower discordance, LDL and TC compared to low dose pill users after one year of treatment. Random Forest a non-linear classifier showed the highest accuracy in predicting discordance. Baseline Parameters having maximal impact on occurrence of discordance were triglyceride (TG), HOMA-IR, BMI and HDL.</p>
A Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial to Evaluate the Safety and Immunogenicity of an HIV-1 Pseudovirion Vaccine
ClinicalTrials.gov study NCT00000835. IPD Sharing: Not stated. Countries: 0. Publications: 0.
A randomized controlled trial of hand/foot-cooling by hilotherapy to prevent oxaliplatin-related peripheral neuropathy in patients with malignancies of the digestive system
<p>This dataset reports data from a randomized controlled trial of hand/foot-cooling by hilotherapy to prevent oxaliplatin-related peripheral neuropathy in patients with malignancies of the digestive system.</p>
Data from; Concentration-Dependent Impact of Green Tea Catechin Gargling on Acute Upper Respiratory Tract Infections: An Exploratory Randomized Controlled Trial
<p>We conducted an open-label randomized study (UMIN000045060). The target population consisted of 209 students from the University of Shizuoka and Meiji University, who were randomly assigned to high-catechin (70 participants, approximate catechin concentration: 76.4 mg/dL), low-catechin (69 participants, approximate catechin concentration: 30.8 mg/dL), and a control water gargling (70 participants, catechin concentration: 0 mg/dL) groups. All participants gargled water or GT thrice daily for 12 weeks between December 2021 and February 2022. The symptoms experienced by participants who developed URTI during the study period were recorded on a survey form. The primary endpoint of URTI occurred in 6 (9.1%), 7 (10.8%), and 11 (15.7%) participants in the high-catechin, low-catechin, and water groups, respectively (Fisher's exact test for the overall group: <em>p</em>=0.482). Cox proportional hazards analysis, using background factors and prevention status as covariates, revealed a hazard ratio of 0.57 (95% CI: 0.21–1.55, <em>p</em>=0.261) for the high-catechin vs. water group and 0.54 (95% CI: 0.20–1.50, <em>p</em>=0.341) for the low-catechin vs. water group.</p>
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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.
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.