Find research datasets worth reusing
Search datasets from major research repositories and use ShareScore to quickly assess how well each record supports discovery, access, and reuse.
5,826
datasets available to search
ShareScore release 0.9.0
Dataset results
5,826 results for “Randomized trial”
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: Single-dose oral ciprofloxacin prophylaxis as a response to a meningococcal meningitis epidemic in the African meningitis belt: a three-arm, open-label, cluster-randomized trial
Background: Antibiotic prophylaxis for contacts of meningitis cases is not recommended during outbreaks in the African meningitis belt. We assessed the effectiveness of single-dose oral ciprofloxacin administered to household contacts and in village-wide distributions on the overall attack rate (AR) in an outbreak of meningococcal meningitis. Methods and findings: In this 3-arm, open-label, cluster-randomized trial during a meningococcal meningitis outbreak in Madarounfa District, Niger, villages notifying a suspected case were randomly assigned (1:1:1) to standard care (the control arm), single-dose oral ciprofloxacin for household contacts within 24 hours of case notification, or village-wide distribution of ciprofloxacin within 72 hours of first case notification. The primary outcome was the overall AR of suspected meningitis after inclusion. A random sample of 20 participating villages was enrolled to document any changes in fecal carriage prevalence of ciprofloxacin-resistant and extended-spectrum beta-lactamase (ESBL)–producing Enterobacteriaceae before and after the intervention. Between April 22 and May 18, 2017, 49 villages were included: 17 to the control arm, 17 to household prophylaxis, and 15 to village-wide prophylaxis. A total of 248 cases were notified in the study after the index cases. The AR was 451 per 100,000 persons in the control arm, 386 per 100,000 persons in the household prophylaxis arm (t test versus control p = 0.68), and 190 per 100,000 persons in the village-wide prophylaxis arm (t test versus control p = 0.032). The adjusted AR ratio between the household prophylaxis arm and the control arm was 0.94 (95% CI 0.52–1.73, p = 0.85), and the adjusted AR ratio between the village-wide prophylaxis arm and the control arm was 0.40 (95% CI 0.19‒0.87, p = 0.022). No adverse events were notified. Baseline carriage prevalence of ciprofloxacin-resistant Enterobacteriaceae was 95% and of ESBL-producing Enterobacteriaceae was >90%, and did not change post-intervention. One limitation of the study was the small number of cerebrospinal fluid samples sent for confirmatory testing. Conclusions: Village-wide distribution of single-dose oral ciprofloxacin within 72 hours of case notification reduced overall meningitis AR. Distributions of ciprofloxacin could be an effective tool in future meningitis outbreak responses, but further studies investigating length of protection, effectiveness in urban settings, and potential impact on antimicrobial resistance patterns should be carried out.
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.
Data from: Ambulatory versus inpatient management of severe nausea and vomiting of pregnancy: a randomized control trial with patient preference arm
ABSTRACT Objective To determine whether ambulatory (outpatient, OP) treatment of severe nausea and vomiting of pregnancy (NVP) is as effective as inpatient (IP) care. Design Non-blinded randomized control trial (RCT) with patient preference arm Setting Multi-center Participants Women less than 20 weeks pregnant with severe NVP and associated ketonuria Methods Women participating in the RCT were randomized via web-based application to either ambulatory or IP treatment. Women declining randomisation entered the patient preference trial (PPT) arm. Protocols, data collection and follow-up were the same for all participants. Main Outcome Measures Primary outcome was reduction in Pregnancy Unique Quantification of Emesis (PUQE) score at 48 hours. Secondary outcomes were duration of treatment; improvement in symptom scores and ketonuria at 48 hours; re-attendances within 7 days of discharge; and comparison of symptoms at 7 days post discharge Results 152/174 eligible women agreed to participate with 77/152 (51%) recruited to the RCT and 79/152 (49%) to the PPT. Patients were initially compared in 4 groups (randomized IP, randomized OP, non-randomized IP and non-randomized OP). Comprehensive cohort analysis of participants in the (RCT) and (PPT) did not demonstrate any differences in patient demographics or baseline clinical characteristics. Pooled analysis of IP versus OP groups showed no difference in reduction in PUQE score at 48 hours (p=0.86). There was no difference in change in eating score (p=0.69), drinking score (p=0.77), wellbeing rating (p=0.64) or reduction in ketonuria (p=0.47) at 48 hours, with no difference in duration of index treatment episode (p=0.83) or re-attendances within 7 days (p=0.52). Conclusions Ambulatory management is an effective alternative to inpatient management of severe NVP. The trial also demonstrated that many women requiring treatment for HG have a strong preferences regarding treatment setting, which needs to be considered by care providers, especially given the psychological impact of HG.
Data from: First-in-human randomized controlled trial of an oral, replicating Adenovirus 26 vector vaccine for HIV-1
Background: Live, attenuated viral vectors that express HIV-1 antigens are being investigated as an approach to generating durable immune responses against HIV-1 in humans. We recently developed a replication-competent, highly attenuated Ad26 vector that expresses mosaic HIV-1 Env (rcAd26.MOS1.HIV-Env, "rcAd26"). Here we present the results of a first-in-human, placebo-controlled clinical trial to test the safety, immunogenicity and mucosal shedding of rcAd26 given orally. Methods: Healthy adults were randomly assigned to receive a single oral dose of vaccine or placebo at 5:1 ratio in a dosage escalation of 10^8 to 10^11 rcAd26 VP (nominal doses) at University of Rochester Medical Center, Rochester, NY, USA. Participants were isolated and monitored for reactogenicity for 10 days post-vaccination, and adverse events were recorded up to day 112. Rectal and oropharyngeal secretions were evaluated for shedding of the vaccine. Humoral and cellular immune responses were measured. Household contacts were monitored for secondary vaccine transmission. Results: We enrolled 22 participants and 11 household contacts between February 7 and June 24, 2015. 18 participants received one dose of HIV-1 vaccine and 4 participants received placebo. The vaccine caused only mild to moderate adverse events. No vaccine-related SAEs were observed. No infectious rcAd26 viral particles were detected in rectal or oropharyngeal secretions from any participant. Env-specific ELISA and ELISPOT responses were undetectable. No household contacts developed vaccine-induced HIV-1 seropositivity or vaccine-associated illness. Conclusions: The highly attenuated rcAd26.MOS1.HIV-Env vaccine was well tolerated up to 10^11 VP in healthy, HIV-1-uninfected adults, though the single dose was poorly immunogenic suggesting the replicative capacity of the vector was too attenuated. There was no evidence of shedding of infectious virus or secondary vaccine transmission following the isolation period. These data suggest the use of less attenuated viral vectors in future studies of live, oral HIV-1 vaccines. Clinical Trials Registration: NCT02366013
A novel thermal compression device for perioperative warming: A randomized trial for safety and efficacy - dataset
<p>Data set for <strong>A novel thermal compression device for perioperative warming: A randomized trial for safety and efficacy </strong></p>
Behavioural Weight Loss Treatment Plus Motivational Interviewing versus Attention Control: A Randomized Controlled Trial
<p>Studies evaluating the benefit of adding motivational interviewing (MI) to behavioural weight loss programs (BWLPs) have yielded mixed findings. The aims of this randomized controlled trial were to: (1) assess the efficacy of adding MI to a BWLP on weight loss and adherence among 135 overweight and obese individuals (77.8% female; mean BMI = 33.6 kg/m<sup>2</sup>) enrolled in a 12-week BWLP, and (2) explore levels of importance, confidence, and readiness for change ratings. Participants, who were randomized to receive 2 MI sessions or 2 attention control sessions, were assessed at baseline, end of BWLP, and 6 months post-BWLP. Both groups decreased their weight from baseline to end of the BWLP; however, there was no weight change from baseline to 6 months post-BWLP in either group. We observed no group differences in importance, confidence, and readiness for change after each session. Participants may not have benefited from MI because they were already highly motivated to change. These findings suggest that pre-treatment assessment and treatment monitoring may help enhance MI+BWLP efficacy by guiding a stepped-care approach that identifies individuals for whom additional MI sessions are needed, and when. A focus on refining elements of treatment remains an important direction for effective obesity treatment.</p>
Dataset and additional info for "Serious adverse events of special interest following mRNA vaccination in randomized trials" (Fraiman et al. 2022)
<p>Dataset for:</p> <p>Fraiman J, Erviti J, Jones M, Greenland S, Whelan P, Kaplan RM, Doshi P. Serious adverse events of special interest following mRNA COVID-19 vaccination in randomized trials in adults. Vaccine. 2022 Aug 30;40(40):5798–805. doi: 10.1016/j.vaccine.2022.08.036. Epub ahead of print. PMID: 36055877; PMCID: PMC9428332. <a href="https://doi.org/10.1016/j.vaccine.2022.08.036">https://doi.org/10.1016/j.vaccine.2022.08.036</a> </p>
Therapeutic Evaluation of Bifidobacterium animalis subsp. lac-tis MH-02, as an Adjunctive Treatment in Patients with Reflux Esophagitis: A Randomized, Double-Blind, Placebo-Controlled Trial
Open the record for dataset details and reuse information.
Comparative study between Dexmedetomidine with Bupivacaine and Bupivacaine alone in erector spinae plane block for postoperative pain control of posterior lumbosacral spine fixation surgeries: A randomized controlled trial
<p><strong><span>2. </span></strong><strong><span>Materials and Methods</span></strong></p> <p><strong><span>2.1. Participants</span></strong></p> <p><span>Patients above 18 years old of either sex submitted for elective posterior lumbosacral spine fixation and fusion surgery were eligible to participate if they were classified as ASA I-III according to the American Society of Anesthesiologists (ASA) classification. The surgery was done on all the patients by the same neurosurgical team and using the same surgical techniques. The exclusion criteria included patient refusal, hypersensitivity to the drugs used in the study, patients with any contraindication to regional anesthesia, such as skin infections at the site of the block, and patients with a history of bleeding disorders or receiving anticoagulant medications. All patients were screened for eligibility criteria. Eligible patients were asked for voluntary informed consent to participate in the trial.</span></p> <p><strong><span>2.2 Study design</span></strong></p> <p><span>This double-blind, randomized controlled trial was carried out on 90 patients on October 6 University Hospitals. It was conducted from November 2022 to July 2023. The study was approved by the Clinical Research Ethical Committee of October 6 University Hospitals (approval number PRC-Me-2210035). It was registered online at ClinicalTrials.gov Identifier: NCT05590234. All patients who participated in this study had to sign a detailed, informed, written anesthesia and surgery consent. </span></p> <p><strong><span>2.3. Randomization and allocation </span></strong></p> <p><span>Patients were randomly allocated using a random allocation sequence by a web-based program. Participants were randomized to three groups in a 1:1:1 ratio. Each group consisted of 30 patients. Dexmedetomidine Bupivacaine ESPB group (<a name="_Hlk145148479"></a>DB group) receive <a name="_Hlk145148507"></a>0.5 ug/kg dexmedetomidine plus 20 mL of bupivacaine 0.25%, Bupivacaine ESPB group (<a name="_Hlk145148593"></a>B group) receive 20 mL of bupivacaine 0.25%, and Saline ESPB (S group) which is the Control group receive 20 ml of normal saline 0.9%. The block procedure was done bilaterally in the three groups. Neither patients nor investigators knew the group in which the patients were placed, and the type of intervention received.</span></p> <p><strong><span>2.4. Preoperative management</span></strong></p> <p><span>All patients were assessed clinically before surgery, including full history, thorough clinical examination, and laboratory investigations. On arrival at the operating suite, patients were fully monitored (5 leads ECG, noninvasive blood pressure, and pulse oximetry). Basal readings of vital data were recorded. Intravenous access was established.</span></p> <p><strong><span>2.5. Anesthetic management</span></strong></p> <p><span>Midazolam 3 mg IV was given for sedation. Induction of anesthesia was performed with IV propofol (2mg/kg), fentanyl (1.5–2 µg/kg), and rocuronium bromide (0.6 mg/kg). Maintenance of anesthesia was done by isoflurane. The prone position was established immediately after the intubation of anesthesia. Intraoperatively, the data of (peripheral oxygen saturation, heart rate, noninvasive arterial blood pressure, and end-tidal carbon dioxide level) were recorded every five minutes throughout the operation. </span></p> <p><span>Any decrease in heart rate below 50 beats per minute was treated with intravenous atropine, according to the response. A reduction in mean blood pressure below 20% of the basal reading or systolic BP below 90 mmHg was treated with 5 mg increments of intravenous ephedrine. After the induction of anesthesia and putting the patients in the prone position, the US-guided ESPB was performed in the three groups.</span></p> <p><span>The study was conducted in a double-blind fashion where the attending anesthetist who performed the ESPB and the neurosurgical team were blind entirely to the content of the injected solution composition. The responsible anesthetist in this study was the only one not blind to the injected solution composition but was not involved in the postoperative patient assessment.<span> </span></span></p> <p><strong><span><span> </span>2.6. ESPB technique</span></strong></p> <p><span>Under strict aseptic technique, the ESPB was done in the prone position for all patients of the three groups. A sterile ultrasound curved probe (Philips ultrasound machine HD7 XE C153160013, Philips and Neusoft Medical Systems Co., Ltd. China.) was used for the technique. The ultrasound probe was placed on the third lumbar vertebral body level in the parasagittal plane. When the spinous process was first seen, the probe was moved laterally from the midline, and then the transverse process of L3 and erector spinae muscle was observed at about 2 to 3 cm from the midline (Figure 1). </span></p> <p><span>A 22 gauge/ 8 cm ultrasound-visible needle (Stimuplex, Braun AG, Melsungen, Germany) was used to make a puncture using the in-plane technique. The direction of the needle was craniocaudal, and the proper position of the needle was confirmed by injecting 2 ml of saline solution. After ensuring the position of the needle, 20 ml of 0.25% bupivacaine plus 0.5 ug/kg dexmedetomidine was administered to the DB group. The same ESPB procedure was done on the other side with the same drugs and volume. In total, 40 ml of 0.25% bupivacaine plus 1 ug/kg dexmedetomidine was administered.</span></p> <p><span>The same block procedure was done in the B group with only 20 ml of 0.25% bupivacaine on both sides (with a total volume of 40 ml). In the S group (control group), the same block procedure was done with 20 ml of 0.9% normal saline on both sides (40 ml total volume).</span></p> <p><strong><span> </span></strong></p> <p><strong><span> </span></strong></p> <p><strong><span> </span></strong></p> <p><strong><span> </span></strong></p> <p><strong><span>Figure 1. </span></strong><strong><span>Ultrasound image of ESPB.</span></strong></p> <p><strong><span> </span></strong></p> <p><span>At the end of surgery, 1 gm of paracetamol IV and 30 mg of ketorolac IV infusion were given to all the patients of the three groups. The patients were extubated after efficient spontaneous breathing and transported to the post-anesthesia care unit (PACU). Patients were discharged from the PACU to the ward with a modified Aldrete score of 12.</span></p> <p><strong><span>2.7. Postoperative pain management</span></strong></p> <p><span>The postoperative analgesic management was done using the classical protocol of our department to all patients of the three groups, which included a PCA (patient-controlled analgesia) device, and an IV of one gm paracetamol was given every eight hours for the first 48 hours postoperatively. The PCA device (Accufuser Plus <sup>®</sup><sub>REF,</sub> manufactured by Woo Young Medical Co., Ltd. Korea) has a silicon balloon infuser with a total volume of 300 ml, basal rate of 5 ml per hour, bolus 1 ml, and lockout interval every 15 minutes. </span></p> <p><span>A PCA device with morphine was attached to all the patients. The PCA infusion (300ml) consisted of 60 mg of morphine with 2 mg of granisteron and 180 mg of ketorolac. The concentration of morphine was set to 0.2 mg/ml, the loading dose was 1 mg (5 ml), the lockout interval was 15 min (bolus of 1ml/15 min), and a 1 mg/h (5ml/hr) continuous infusion was maintained for 48 hrs. IV one gm paracetamol was given every eight hours postoperatively.</span></p> <p><span>A nurse blind to the study used the visual analog scale (VAS; zero, no pain, ten = the most severe pain) to evaluate and record the pain scores and recorded the opioid consumption of the patients. The nurse recorded passive (at rest) and active (while mobilization) VAS scores at intervals of every two hours in the first 24 hours and every 4 hours in the second 24 hours and total opioid consumption for the first 48 hours postoperatively. Rescue analgesic medication was done using pethidine 50 mg IM when passive VAS pain score > 6. </span></p> <p><span>Patients who experienced pruritis, nausea, vomiting, or respiratory depression (opioid-related adverse effects) were recorded. On the first day postoperative, all patients were encouraged to ambulate in the ward after wearing lumbosacral support. The subcutaneous closed suction drainage system was removed after 36 hours. All patients were discharged home after 48 hours.</span></p> <p><strong><span>2.8. Outcome measurements</span></strong></p> <p><span>The primary clinical outcome measures were active (while mobilization) and passive (at rest) visual analog scale (VAS) pain score at the first 48 hours, measured every 2 hours in the first 24 hours and every 4 hours in the second 24 hours. </span></p> <p><span>Other clinical outcomes included opioid consumption (the number of PCA presses), the need for rescue analgesia, postoperative opioid side effects, and intraoperative dexmedetomidine side effects such as bradycardia and hypotension.</span></p> <p><strong><span>2. 9. Sample size calculation </span></strong></p> <p><span>As we have three treatment groups (S, B, DB), we performed a one-way analysis of variance (ANOVA) to assess effect size and the required number of patients per group based on the overall difference of total Fentanyl consumption (µg) means (<a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8908442/">https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8908442/</a>).<span> </span>The effect size for ANOVA is typically measured using <span>Cohen's<em><span> d</span></em> = <em><span>M</span></em><sub>1</sub> - <em><span>M</span></em><sub>2</sub> / s<sub>pooled</sub></span>, <span>where s<sub>pooled</sub> =&radic; [(s <sub>1</sub><sup>2</sup>+ s <sub>2</sub><sup>2</sup>) / 2]</span> and <strong><span>effect-size</span></strong><span> <em><span>r</span></em>= d / √ (d<sup>2</sup> + 4)[</span><a href="https://lbecker.uccs.edu/#means%20and%20standard%20deviations">https://lbecker.uccs.edu/#means%20and%20standard%20deviations</a><span>].<span> </span></span></span></p> <p><span>Given the following values: </span></p> <p><span><span>·<span> </span></span></span><span>Mean 1: 820 SD1: 102</span></p> <p><span><span>·<span> </span></span></span><span>Mean2: 641 SD2: 140</span></p> <p><span><span>·<span> </span></span></span><span>α=0.05</span></p> <p><span><span>·<span> </span></span></span><span>β=0.05 (implying a power of 0.95)</span></p> <p><strong><span>Then, Cohen's </span></strong><em><span>d: -1.46<span> </span>&<span> </span></span></em><strong><span>effect-size</span></strong><span> <em><span>r: -0.58</span></em></span></p> <p><span>In addition,</span><span> the required sample size per group is <strong>17</strong> based on the following online tool [https://homepage.univie.ac.at/robin.ristl/samplesize.php?test=anova] for </span><span>s</span><span>ample size for one-way analysis of variance.</span><span> </span></p> <p><strong><span>2.10. Statistical analysis</span></strong></p> <p><span>Data were analyzed using the statistical package for social sciences, version 20.0 (SPSS Inc., Chicago, Illinois, USA). We conducted the Shapiro-Wilk test to assess whether the numeric data followed a normal distribution or not. Quantitative normal distributed data were expressed as mean± standard deviation (SD). Qualitative data were expressed as frequency and percentage. The following tests were used: A one-way analysis of variance (ANOVA) when comparing between more than two means, Post Hoc test: Least Significant Difference (LSD) was used for multiple comparisons between different variables, and Chi-square (X<sup>2</sup>) test of significance was used to compare proportions between two qualitative parameters.<a name="2et92p0"></a><a name="3znysh7"></a> Furthermore, we performed linear and binary regression analyses to elucidate the relationship between the primary outcomes and the intervention groups (S, D, DB).</span></p> <p><span>The confidence interval was set to 95%, and the margin of error accepted was set to 5%. So, the p-value was considered non-significant when the P-value > 0.05, significant if < 0.05, and highly significant if <0.001.</span></p>
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 set from: Robot-Assisted Gait Training in Patients with Multiple Sclerosis: A Randomized Controlled Crossover Trial.
<p>Data set from the paper "Robot-Assisted Gait Training in Patients with Multiple Sclerosis: A Randomized Controlled Crossover Trial" doi: <a href="https://dx.doi.org/10.3390%2Fmedicina57070713">10.3390/medicina57070713</a></p>
A comparative study between Vitamin K1 and K2 on vascular calcification in hemodialysis patients: a randomized controlled trial
<p><span><span><strong>Background: </strong>Vascular calcification is a common complication of end stage renal disease patients, an important cause of cardiovascular disease and all-cause mortality. Vitamin K is essential for the activation of matrix Gla protein (MGP), a powerful inhibitor of tissue calcification. Different forms of vitamin K have been proposed to have a good impact on vascular calcification. However, clinical data are still limited on efficacy and safety of different forms of vitamin K.</span></span></p> <p><span><span><strong>Methods : </strong>A prospective, randomized, placebo-controlled study that included 120 eligible hemodialysis patients who were randomly assigned to either vitamin k1 group (10 mg phytomenadione thrice weekly) or vitamin k2 group (90 ug daily) or placebo group for 3 months. Serum MGP, calcium, phosphorus, their product, and intact parathyroid hormone (iPTH) levels, were all assessed at baseline and at the end of the study.</span></span></p> <p><span><span><b>Results:</b> There were significant increase in percentages of change in MGP levels in Vitamin k2 group (700%) compared to (78%) in Vitamin k1 & (40%) in placebo groups. No correlations observed between calcium, phosphorous and PTH and MGP levels at baseline or after treatment. None of the treatment group patients experienced any adverse effects.</span></span></p> <p><span><span><strong>Conclusion: </strong>Vitamin k supplementation was tolerable and effective with k2 form showing superiority over k1 in their impact on MGP levels among hemodialysis patients.</span></span></p> <p><span><span><b>ClinicalTrials.gov registration number:</b><b> NCT04477811</b><b>.</b></span></span></p> <p><span><span> </span></span></p>
Effect of acupuncture and metformin on insulin sensitivity in women with polycystic ovary syndrome and insulin resistance: a three-armed randomized controlled trial
<p>STUDY QUESTION</p> <p>Does acupuncture improve insulin sensitivity more effectively than metformin or sham acupuncture in women with polycystic ovary syndrome (PCOS) and insulin resistance (IR)?</p> <p>SUMMARY ANSWER</p> <p>Among women with PCOS and IR, acupuncture was not more effective than metformin or sham acupuncture in improving insulin sensitivity.</p> <p>WHAT IS KNOWN ALREADY</p> <p>Uncontrolled trials have shown that acupuncture improved insulin sensitivity with fewer side effects compared with metformin in women with PCOS and IR. However, data from randomized trials between acupuncture and metformin or sham acupuncture are lacking.</p> <p>STUDY DESIGN, SIZE, DURATION</p> <p>This was a three-armed randomized controlled trial enrolling a total of 342 women with PCOS and IR from three hospitals between November 2015 and February 2018, with a 3-month follow-up until October 2018.</p> <p>PARTICIPANTS/MATERIALS, SETTING, METHODS</p> <p>Women aged from 18 to 40 years with PCOS and homeostasis model assessment of insulin resistance (HOMA-IR) ≥2.14 were randomly assigned (n = 114 per group) to receive true acupuncture plus placebo (true acupuncture), metformin plus sham acupuncture (metformin, 0.5 g three times daily) or sham acupuncture plus placebo (sham acupuncture) for 4 months, with an additional 3-month follow-up. True or sham acupuncture was given three times per week, and 0.5 g metformin or placebo was given three times daily. The primary outcome was change in HOMA-IR from baseline to 4 months after baseline visit. Secondary outcomes included changes in the glucose AUC during an oral glucose tolerance test, BMI and side effects at 4 months after baseline visit.</p> <p>MAIN RESULTS AND THE ROLE OF CHANCE</p> <p>After 4 months of treatment, the changes of HOMA-IR were –0.5 (decreased 14.7%) in the true acupuncture group, –1.0 (decreased 25.0%) in the metformin group and –0.3 (decreased 8.6%) in the sham acupuncture group, when compared with baseline. True acupuncture is not as effective as metformin in improving HOMA-IR at 4 months after baseline visit (difference, 0.6; 95% CI, 0.1–1.1). No significant difference was found in change in HOMA-IR between true and sham acupuncture groups at 4 months after baseline visit (difference, –0.2; 95% CI, –0.7 to 0.3). During the 4 months of treatment, gastrointestinal side effects were more frequent in the metformin group, including diarrhea, nausea, loss of appetite, fatigue, vomiting and stomach discomfort (31.6%, 13.2%, 11.4%, 8.8%, 14.0% and 8.8%, respectively). Bruising was more common in the true acupuncture group (14.9%).</p> <p>LIMITATIONS, REASONS FOR CAUTION</p> <p>This study might have underestimated the sample size in the true acupuncture group with 4 months of treatment to enable detection of statistically significant changes in HOMA-IR with fixed acupuncture (i.e. a non-personalized protocol). Participants who withdrew because of pregnancy did not have further blood tests and this can introduce bias.</p> <p>WIDER IMPLICATIONS OF THE FINDINGS</p> <p>True acupuncture did not improve insulin sensitivity as effectively as metformin in women with PCOS and IR, but it is better than metformin in improving glucose metabolism (which might reduce the risk of type 2 diabetes) and has less side effects. Metformin had a higher incidence of gastrointestinal adverse effects than acupuncture groups, and thus acupuncture might be a non-pharmacological treatment with low risk for women with PCOS. Further studies are needed to evaluate the effect of acupuncture combined with metformin on insulin sensitivity in these women.</p> <p>STUDY FUNDING/COMPETING INTEREST(S)</p> <p>This work was supported by grants 2017A020213004 and 2014A020221060 from the Science and Technology Planning Project of Guangdong Province. The authors have no conflicts of interest.</p> <p>TRIAL REGISTRATION NUMBER</p> <p>Clinicaltrials.gov number: NCT02491333.</p> <p>TRIAL REGISTRATION DATE</p> <p>8 July 2015.</p> <p>DATE OF FIRST PATIENT'S ENROLLMENT</p> <p>11 November 2015.</p>
Neuromodulation of premotor and posterior parietal cortices for enhancing explicit motor sequence learning in healthy individuals: a randomized, sham-controlled crossover trial
<p>Data collected and analysed in the manuscript '<strong>Neuromodulation of premotor and posterior parietal cortices for enhancing explicit motor sequence learning in healthy individuals: a randomized, sham-controlled crossover trial', </strong>by Russo et al. PPCR. The Principles and Practice of Clinical Research, 2021</p>
Effectiveness of a multicomponent intervention consisting of education and feedback on reducing benzodiazepine prescriptions by general practitioners: BENZORED hybrid type I cluster randomized controlled trial.
<p>Complete dataset variables:</p> <p> </p> <p>GP_ID<br> Health_District<br> Health_District_name<br> PHC_ID<br> PHC_ID_name<br> Arm<br> DHD_Baseline<br> DHD_12m<br> PercentageBZD_baseline<br> PercentageBZD_12m<br> PercentageBZD_baseline_age65<br> PercentageBZD_12m_age65</p>
Data set supplementing "Determinants of Laypersons' Trust in Medical Decision Aids: Randomized Controlled Trial"
<p>This is the de-identified data set used to conduct the analyses in the preprint submitted to JMIR Human Factors under the title "Determinants of Laypersons’ Trust in Medical Decision Aids: Randomized Controlled Trial" (<a href="https://doi.org/10.2196/35219">https://doi.org/10.2196/35219</a>).</p> <p>This dataset contains 494 respondents' appraisals of a fictitious case vignette. They received support from a decision aid (that always disagreed with participants' first appraisal) showing a mock symptom checker logo, a decision aid framed as anthropomorphic or as an AI. Their second appraisal - taking into account the symptom checker advice - was collected again. </p> <p>Additionally, the data contains participants'</p> <ul> <li>age</li> <li>gender</li> <li>education</li> <li>medical training</li> <li>propensity to trust</li> <li>eHealth Literacy</li> <li>certainty in their appraisals</li> <li>trust in the decision aid</li> </ul>
Research integrity assessment for randomized controlled trials in systematic reviews
<p>A tool to assess the integrity of research reported in randomized controlled trials (RCTs) of investigational medicinal products. The assessment uses signalling questions to identify problematic RCTs and is used when studies are being considered for inclusion into systematic reviews.</p> <p>RCTs with red flags regarding research integrity should be excluded and RCTs with open questions should be held in awaiting classification until clarified.</p> <p>The results of the research integrity assessment should be transparently reported and published together with the systematic review.</p> <p> </p>
Single-incision laparoscopic cholecystectomy versus conventional multi-port laparoscopic cholecystectomy: A systematic review, meta-analysis, and meta-regression of randomized controlled trials
<p>Single-incision laparoscopic cholecystectomy versus conventional multi-port laparoscopic cholecystectomy: A systematic review, meta-analysis, and meta-regression of randomized controlled trials</p>
''Eight-year efficacy update of the HOBOE randomized phase 3 trial in premenopausal patients with hormone-receptor positive early breast cancer comparing triptorelin plus either Tamoxifen or Letrozole or Zoledronic acid + Letrozole'' - dataset
<p>Dataset for analysis of the manuscript ''Eight-year efficacy update of the HOBOE randomized phase 3 trial in premenopausal patients with hormone-receptor positive early breast cancer comparing triptorelin plus either Tamoxifen or Letrozole or Zoledronic acid + Letrozole''</p>
ScienceDex guides
Understand access before you commit
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.