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1,189 results for “randomized clinical trial”
Remodeling dental anatomy vs sham therapy for chronic temporomandibular disorders: A placebo-controlled randomized clinical trial
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Single versus multiple dose ivermectin regimen in onchocerciasis-infected persons with epilepsy treated with phenobarbital: a randomized clinical trial in the Democratic Republic of Congo
<p>Open data for a randomized clinical trial performed in onchocerciasis-endemic villages of the Logo health zone in Ituri province in the Democratic Republic of Congo where mass ivermectin administration had never been implemented. Ivermectin naïve, persons with epilepsy with <em>Onchocerca volvulus</em> infection were randomly allocated to receive ivermectin once, twice or thrice over a one year period of follow up. At the same time they were treated with the anti-epileptic drug phenobarbital. At baseline, information was collected on seizure semiology, seizure frequency, epilepsy risk factors, relevant medical history, previous AED and ivermectin use. The primary outcome was seizure freedom during the last four months of the 12-month follow up period.</p>
The Effects of Tramadol and Paracetamol on Physical Performance, Brain Dynamics and Sustained Attention During Cycling Exercise: A Double Blind Randomized Placebo-Controlled Clinical Trial
<p>The purposes of the current project are: 1) to investigate further the effect of Tramadol on cycling (at the physical, cognitive and brain levels) on the basis of the preliminary results of the TRAWADA2015 study (<a href="https://zenodo.org/deposit/1308615">https://zenodo.org/deposit/1308615</a>); 2) to study the effect of paracetamol at the physical, cognitive and brain levels during an aerobic and anaerobic exercise on cycle-ergometer, and compare it to that of tramadol</p>
Data from: Initiating Antiretroviral Therapy for HIV at a Patient's First Clinic Visit: The RapIT Randomized Controlled Trial
<p><strong>Background:</strong> High rates of patient attrition from care between HIV testing and antiretroviral therapy (ART) initiation have been documented in sub-Saharan Africa, contributing to persistently low CD4 cell counts at treatment initiation. One reason for this is that starting ART in many countries is a lengthy and burdensome process, imposing long waits and multiple clinic visits on patients. We estimated the effect on uptake of ART and viral suppression of an accelerated initiation algorithm that allowed treatment-eligible patients to be dispensed their first supply of antiretroviral medications on the day of their first HIV-related clinic visit.</p> <p><strong>Methods and Findings: </strong>RapIT was an unblinded randomized controlled trial of single-visit ART initiation in two public sector clinics in South Africa (a primary health clinic (PHC) and a hospital-based HIV clinic). Adult (≥18), non-pregnant patients receiving a positive HIV test or first treatment-eligible CD4 count were randomized to standard or rapid initiation. Rapid arm patients received a point-of-care (POC) CD4 count if needed; those ART-eligible received a POC TB test if symptomatic, POC blood tests, physical exam, education, counseling, and ARV dispensing. Standard arm patients followed standard clinic procedures (3-5 additional clinic visits over 2-4 weeks prior to ARV dispensing). Follow up was by record review only. The primary outcome was viral suppression, defined as initiated, retained in care, and suppressed (<=400 copies/ml) ≤ 10 months of study enrollment. Secondary outcomes included initiation of ART ≤ 90 days of study enrollment; retention in care; time to ART initiation; patient-level predictors of primary outcomes; prevalence of TB symptoms; and the feasibility and acceptability of the intervention. A survival analysis was conducted comparing attrition from care after ART initiation between the groups among those who initiated within 90 days. 377 patients were enrolled in the study between May 8, 2013 and August 29, 2014 (median CD4 count 210 cells/mm<sup>3</sup>). In the rapid arm, 119/187 patients (64%) initiated and were suppressed at 10 months, compared to 96/190 (51%) in the standard arm (RR 1.26 [1.05-1.50]. In the rapid arm 182/187 (97%) initiated ART ≤ 90 days, compared to 136/190 (72%) in the standard arm (relative risk [95% CI] 1.36 [1.24-1.49]. Among 318 patients who did initiate ART within 90 days, the hazard of attrition within the first 10 months did not differ between the treatment arms (HR 1.06; 95% CI 0.61-1.84). The study was limited by the small number of sites and small sample size and the generalizability of the results to other settings and to non-research conditions is uncertain.</p> <p><strong>Conclusions: </strong>Offering single-visit ART initiation to adult patients in South Africa increased uptake of ART by 36% and viral suppression by 26%. It should be considered for adoption in the public sector in Africa.</p>
Data from: A single session of hyperbaric oxygen therapy demonstrates acute and long-lasting neuroplasticity effects in humans: a replicated, randomized controlled clinical trial
Purpose: Animal studies have demonstrated anti-inflammatory, and anti-nociceptive properties of hyperbaric oxygen therapy (HBOT). However, physiological data are scarce in humans. In a recent experimental study, the authors used the burn injury (BI) model observing a decrease in secondary hyperalgesia area (SHA) in the HBOT-group compared to a control-group.Surprisingly, a long-lasting neuroplasticity effect mitigating the BI-induced SHA-response was seen in the HBOT-preconditioned group. The objective of the present study, therefore, was to confirm our previous findings using an examiner-blinded, block-randomized, controlled, crossover study design. Patients and methods: Nineteen healthy subjects attended two BI-sessions with an inter-session interval of ≥28 days. The BIs were induced on the lower legs by a contact thermode (12.5 cm2, 47C°, 420 s). The subjects were block-randomized to receive HBOT (2.4 ATA, 100% O2, 90 min) or ambient conditions ([AC]; 1 ATA, 21% O2), dividing cohorts equally into two sequence allocations: HBOT-AC or AC-HBOT. All sensory assessments performed during baseline, BI, and post-intervention phases were at homologous time points irrespective of sequence allocation. The primary outcome was SHA, comparing interventions and sequence allocations. Data are mean (95% CI). Results: During HBOT-sessions a mitigating effect on SHAs was demonstrated compared to AC-sessions, ie, 18.8 (10.5–27.0) cm2 vs 32.0 (20.1–43.9) cm2 (P=0.021), respectively. In subjects allocated to the sequence AC-HBOT a significantly larger mean difference in SHA in the AC-session vs the HBOT-session was seen 25.0 (5.4–44.7) cm2 (P=0.019). In subjects allocated to the reverse sequence, HBOT-AC, no difference in SHA between sessions was observed (P=0.55), confirming a preconditioning, long-lasting (≥28 days) effect of HBOT. Conclusion: Our data demonstrate that a single HBOT-session compared to control is associated with both acute and long-lasting mitigating effects on BI-induced SHA, confirming central anti-inflammatory, neuroplasticity effects of hyperbaric oxygen therapy.
Data from: Agreements between industry and academia on publication rights: a retrospective study of protocols and publications of randomized clinical trials
Background: Little is known about publication agreements between industry and academic investigators in trial protocols and the consistency of these agreements with corresponding statements in publications. We aimed to investigate (i) the existence and types of publication agreements in trial protocols, (ii) the completeness and consistency of the reporting of these agreements in subsequent publications, and (iii) the frequency of co-authorship by industry employees. Methods and Findings: We used a retrospective cohort of randomized clinical trials (RCTs) based on archived protocols approved by six research ethics committees between 13 January 2000 and 25 November 2003. Only RCTs with industry involvement were eligible. We investigated the documentation of publication agreements in RCT protocols and statements in corresponding journal publications. Of 647 eligible RCT protocols, 456 (70.5%) mentioned an agreement regarding publication of results. Of these 456, 393 (86.2%) documented an industry partner's right to disapprove or at least review proposed manuscripts; 39 (8.6%) agreements were without constraints of publication. The remaining 24 (5.3%) protocols referred to separate agreement documents not accessible to us. Of those 432 protocols with an accessible publication agreement, 268 (62.0%) trials were published. Most agreements documented in the protocol were not reported in the subsequent publication (197/268 [73.5%]). Of 71 agreements reported in publications, 52 (73.2%) were concordant with those documented in the protocol. In 14 of 37 (37.8%) publications in which statements suggested unrestricted publication rights, at least one co-author was an industry employee. In 25 protocol-publication pairs, author statements in publications suggested no constraints, but 18 corresponding protocols documented restricting agreements. Conclusions: Publication agreements constraining academic authors' independence are common. Journal articles seldom report on publication agreements, and, if they do, statements can be discrepant with the trial protocol.
Data from: Adjunctive use of modified Yunu-Jian in the non-surgical treatment of male smokers with chronic periodontitis: a randomized double-blind, placebo-controlled clinical trial
Background: Yunu-Jian (YJ) is a Chinese medicine (CM) heat purging formula, which is used to reduce wei huo (stomach-heat, SH) and enrich shen yin (kidney-yin, KY). This formula is also commonly used to manage diabetes mellitus and gum/oral inflammation. The activity of YJ can be modified or refined by the addition of other CM herbs and/or minor changes to one of its five key ingredients. The aim of this study was to evaluate the adjunctive use of modified YJ (mYJ) or YJ containing additional osteoblast-stimulating and inflammation-modulating CM herbs in the non-surgical periodontal treatment of smokers with chronic periodontitis in a randomized, double-blind, prospective, placebo-controlled study. Methods: Healthy adult male smokers with untreated chronic periodontitis who showed CM syndrome of SH and KY deficiency (KYD) whilst attending a dental teaching hospital from October to December, 2005, were invited to participate in a randomized double-blind, placebo-controlled clinical trial. The trial itself involved the once-daily oral administration of a placebo or mYJ for 3 months as an adjunct to non-surgical periodontal therapy. Several periodontal parameters, including radiographic alveolar bone density, were measured by computer-assisted densitometric image analysis (CADIA) on selected sites, and CM signs of SH and KYD were followed from their baseline values to various time points up to 12 months or the end of study. Results: Twenty-five smokers (consumed 25.0 ± 15.3 smoking-pack years, ranged 7.5–80; aged 46.3 ± 6.8 years) with periodontitis and SH and KYD were recruited (Placebo, n = 14; mYJ, n = 11). All of the participants showed good tolerance towards the CM recipe. All of the periodontal parameters had improved after 12-month follow-up, and no statistically significant differences were detected between the control group and test group, except for the higher CADIA values observed compared with the baseline at 12 months for test sites (P = 0.025). 4/3/3 test vs 14/13/13 control participants had persisting SH and KYD at 6, 9 and 12 months (P < 0.001), respectively. Conclusions: The adjunctive use of mYJ preserved the post-treatment increases in the radiographic alveolar bone density at the study sites and led to an overall improvement in SH and KYD compared with the controls.
Effectiveness of a multidisciplinary approach to prevent falls and gait impairment in patients with Parkinson's disease: A randomized, longitudinal clinical trial.
<p>This graph describes the <span>short and long-term effectiveness of a multidisciplinary telemedicine program in addition to in-office usual care in non-demented patients with PD at risk for falling.</span></p>
Data From: ChatGPT versus expert feedback on clinical reasoning questions and their effect on learning: a randomized controlled trial
<p>Dataset Info</p> <p><strong>1) Immediate Test</strong><br>- The first row of the dataset identifies the columns.<br>- Column A represents the participants’ iDs.<br>- Column B represents the participants’ assigned group [0: Control (ExpertFeedback) 1: Intervention (ChatGPTFeedback)].<br>- Column C represents the genders of the participants (1: Female, 2: Male).<br>- Column D represents the first-year repetition status of the participants. (0: No, 1: Yes)<br>- Column E to H represent the scores in four different uncomplicated urinary tract infection (UTI) Key-Features Questions Items separately. <br>- Column I represents the total scores in uncomplicated UTI Key-Features Questions Items. <br>- Column J to M represent the scores in four different complicated UTI Key-Features Questions Items separately. <br>- Column N represents the total scores in complicated UTI Key-Features Questions Items. <br>- Column O to R represent the scores in four different pyelonephritis Key-Features Questions Items separately. <br>- Column S represents the total scores in pyelonephritis Key-Features Questions Items. <br>- Column T represents the total scores in immediate test. </p> <p><strong>2) Delayed Test</strong><br>- The first row of the dataset identifies the columns.<br>- Column A represents the participants iDs.<br>- Column B represents the participants’ assigned group [0: Control (ExpertFeedback) 1: Intervention (ChatGPTFeedback)].<br>- Column C represents the genders of the participants (1: Female, 2: Male).<br>- Column D represents the first-year repetition status of the participants. (0: No, 1: Yes)<br>- Column E to H represent the scores in four different uncomplicated urinary tract infection (UTI) Key-Features Questions Items separately. <br>- Column I represents the total scores in uncomplicated UTI Key-Features Questions Items. <br>- Column J to M represent the scores in four different complicated UTI Key-Features Questions Items separately. <br>- Column N represents the total scores in complicated UTI Key-Features Questions Items. <br>- Column O to R represent the scores in four different pyelonephritis Key-Features Questions Items separately. <br>- Column S represents the total scores in pyelonephritis Key-Features Questions Items. <br>- Column T represents the total scores in delayed test. </p> <p><strong>3) Pre-Intervention Survey on Critical Approach to AI</strong><br>- The first row of the dataset identifies the columns.<br>- Column A represents the participants iDs.<br>- Column B represents the participants’ assigned group [0: Control (ExpertFeedback) 1: Intervention (ChatGPTFeedback)].<br>- Column C represents the genders of the participants (1: Female, 2: Male).<br>- Column D represents the first-year repetition status of the participants (0: No, 1: Yes).<br>- Column E to J represent the responses of the participants to survey questions before the intervention. Each column is evaluated on a scale from 1 to 7. As it progresses from 1 to 7, the agreement status of participants to survey questions increases. (1: No agreement at all, 7: completely agree)</p> <p><strong>4) Post-Intervention Survey on Critical Approach to AI</strong><br>- The first row of the dataset identifies the columns.<br>- Column A represents the participants iDs.<br>- Column B represents the participants’ assigned group [0: Control (ExpertFeedback) 1: Intervention (ChatGPTFeedback)].<br>- Column C represents the genders of the participants (1: Female, 2: Male).<br>- Column D represents the first-year repetition status of the participants (0: No, 1: Yes).<br>- Column E to J represent the evaluation of the participants to survey questions after intervention. Each column is evaluated on a scale from 1 to 7. As it progresses from 1 to 7, the agreement status of participants to survey questions increases. (1: No agreement at all, 7: completely agree)</p>
CONSORT Checklist for The assessment of educational and supportive care to the infertile females undergoes In Vitro Fertilization procedure by clinical pharmacist: A Randomized Clinical Trial
<p>CONSORT Checklist for The assessment of educational and supportive care to the infertile females undergoes In Vitro Fertilization procedure by clinical pharmacist: A Randomized Clinical Trial</p>
The assessment of educational and supportive care to the infertile females undergoes In Vitro Fertilization procedure by clinical pharmacist: A Randomized Clinical Trial
<p>The assessment of educational and supportive care to the infertile females undergoes In Vitro Fertilization procedure by clinical pharmacist: A Randomized Clinical Trial</p>
Efficacy of Sealing Molars: Split-mouth Randomized Clinical Trial
ClinicalTrials.gov study NCT03819868. IPD Sharing: UNDECIDED. Countries: 1. Publications: 5.
Tunnel Technique With Emdogain® in Addition to Connective Tissue Graft Compared With Connective Tissue Graft Alone for the Treatment of Gingival Recessions: a Randomized Clinical Trial.
ClinicalTrials.gov study NCT03354104. IPD Sharing: Not stated. Countries: 1. Publications: 1.
A Pilot Clinical Trial of Sympathetic Blockade With Botulinum Toxin Type A to Treat Complex Regional Pain Syndrome (CRPS): a Randomized, Double-Blind, Controlled, Crossover Trial.
ClinicalTrials.gov study NCT00637533. IPD Sharing: Not stated. Countries: 1. Publications: 1.
The Health Log: A Randomized Clinical Trial
ClinicalTrials.gov study NCT01913080. IPD Sharing: Not stated. Countries: 1. Publications: 10.
A Randomized, Placebo-controlled, Double-blind Clinical Trial of Curcuminoids in Oral Lichen Planus
ClinicalTrials.gov study NCT00226174. IPD Sharing: Not stated. Countries: 1. Publications: 2.
Preventing Fetal Body and Brain Size Reduction in Low-income Smoking Mothers: A Randomized Clinical Trial
ClinicalTrials.gov study NCT01248260. IPD Sharing: Not stated. Countries: 1. Publications: 1.
A Randomized Clinical Trial Assessing Smoking Cessation Interventions In Dental Clinic Smokers
ClinicalTrials.gov study NCT00591175. IPD Sharing: Not stated. Countries: 1. Publications: 1.
Efficacy Comparison of Vonoprazan Combined With Different Antibiotics in Dual Therapy for Helicobacter Pylori Eradication: A Prospective, Randomized Controlled Clinical Trial
ClinicalTrials.gov study NCT07068607. IPD Sharing: NO. Countries: 1. Publications: 0.
Tooth Discoloration and Chairside Handling Time (Bonding-Debonding) in Flowable Versus Packable Composites for Clear Aligner Bonded Attachments: A Randomized Clinical Trial
ClinicalTrials.gov study NCT07234149. IPD Sharing: NO. Countries: 1. Publications: 1.
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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.