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3,361 results for “Randomized Controlled Trial”

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zenodo32/100

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>

opencc-by-nc-sa-4.0Jun 2016View details →
zenodo32/100

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

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opencc-by-4.0Nov 2023View details →
zenodo32/100

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&ndash;2 &micro;g/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>&nbsp; </span></span></p> <p><strong><span><span>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </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>&nbsp;</span></strong></p> <p><strong><span>&nbsp;</span></strong></p> <p><strong><span>&nbsp;</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>&nbsp;</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>&reg;</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&nbsp;mg of granisteron and 180 mg of ketorolac. The concentration of morphine was set to 0.2&nbsp;mg/ml, the loading dose was 1&nbsp;mg (5 ml), the lockout interval was 15&nbsp;min (bolus of 1ml/15 min), and a 1&nbsp;mg/h (5ml/hr) continuous infusion was maintained for 48&nbsp;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 &gt; 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 (&micro;g) means (<a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8908442/">https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8908442/</a>).<span>&nbsp; </span>The effect size for ANOVA is typically measured using <span>Cohen's<em><span>&nbsp;d</span></em>&nbsp;=&nbsp;<em><span>M</span></em><sub>1</sub>&nbsp;-&nbsp;<em><span>M</span></em><sub>2</sub>&nbsp;/&nbsp;s<sub>pooled</sub></span>, <span>where&nbsp;s<sub>pooled</sub>&nbsp;=&amp;radic; [(s&nbsp;<sub>1</sub><sup>2</sup>+&nbsp;s&nbsp;<sub>2</sub><sup>2</sup>) / 2]</span> and <strong><span>effect-size</span></strong><span>&nbsp;<em><span>r</span></em>= d /&nbsp;&radic; (d<sup>2</sup>&nbsp;+ 4)[</span><a href="https://lbecker.uccs.edu/#means%20and%20standard%20deviations">https://lbecker.uccs.edu/#means%20and%20standard%20deviations</a><span>].<span>&nbsp; </span></span></span></p> <p><span>Given the following values: </span></p> <p><span><span>&middot;<span>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></span></span><span>Mean 1: 820 SD1: 102</span></p> <p><span><span>&middot;<span>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></span></span><span>Mean2: 641 SD2: 140</span></p> <p><span><span>&middot;<span>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></span></span><span>&alpha;=0.05</span></p> <p><span><span>&middot;<span>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></span></span><span>&beta;=0.05 (implying a power of 0.95)</span></p> <p><strong><span>Then, Cohen's&nbsp;</span></strong><em><span>d: -1.46<span>&nbsp; </span>&amp;<span>&nbsp;&nbsp; </span></span></em><strong><span>effect-size</span></strong><span>&nbsp;<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&plusmn; 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 &gt; 0.05, significant if &lt; 0.05, and highly significant if &lt;0.001.</span></p>

opencc-by-4.0Dec 2023View details →
zenodo32/100

Data set from: Robot-Assisted Gait Training in Patients with Multiple Sclerosis: A Randomized Controlled Crossover Trial.

<p>Data set from the paper&nbsp;&quot;Robot-Assisted Gait Training in Patients with Multiple Sclerosis: A Randomized Controlled Crossover Trial&quot;&nbsp;&nbsp;doi:&nbsp;<a href="https://dx.doi.org/10.3390%2Fmedicina57070713">10.3390/medicina57070713</a></p>

opencc-by-4.0Dec 2021View details →
dryad32/100

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 &amp; (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>

opencc-zeroDec 2020View details →
dryad32/100

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>

opencc-zeroDec 2021View details →
zenodo32/100

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 &#39;<strong>Neuromodulation of premotor and posterior parietal cortices for enhancing explicit motor sequence learning in healthy individuals: a randomized, sham-controlled crossover trial&#39;,&nbsp;</strong>by Russo et al.&nbsp;PPCR. The Principles and Practice of Clinical Research, 2021</p>

opencc-by-4.0Feb 2021View details →
zenodo32/100

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>&nbsp;</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>

opencc-by-4.0Aug 2021View details →
zenodo32/100

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 &quot;Determinants of Laypersons&rsquo; Trust in Medical Decision Aids: Randomized Controlled Trial&quot; (<a href="https://doi.org/10.2196/35219">https://doi.org/10.2196/35219</a>).</p> <p>This dataset contains 494 respondents&#39; appraisals of a fictitious case vignette. They received support from a&nbsp;decision aid (that always disagreed with participants&#39; first appraisal)&nbsp;showing a mock symptom checker logo, a decision aid framed as anthropomorphic or as an AI. Their second appraisal&nbsp;- taking into account the symptom checker advice -&nbsp;was collected again.&nbsp;</p> <p>Additionally, the data contains participants&#39;</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>

opencc-by-4.0Mar 2022View details →
zenodo32/100

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>&nbsp;</p>

opencc-by-4.0Mar 2022View details →
zenodo32/100

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>

opencc-by-4.0Apr 2022View details →
zenodo32/100

Efficacy of a multiple-component and multifactorial personalized fall prevention program in a mixed population of community-dwelling older adults with stroke, Parkinson's disease, or frailty compared to usual care: The PRE.C.I.S.A. Randomized Controlled Trial

<p>Raw data associated with the scientific publication &#39;Efficacy of a multiple-component and multifactorial personalized fall prevention program in a mixed population of community-dwelling older adults with stroke, Parkinson&rsquo;s disease, or frailty compared to usual care: The PRE.C.I.S.A. Randomized Controlled Trial&#39;.</p>

opencc-by-4.0Jul 2022View details →
zenodo32/100

Effects of upper thoracic Mulligan mobilization on pain, range of motion and function in patients with mechanical neck pain: a randomized placebo-controlled trial

<p><span><span>Bu &ccedil;alışmanın amacı mekanik boyun ağrısı olan bireylerde &uuml;st torasik b&ouml;lgeye uygulanan Mulligan Ters Doğal Apofizeal Kaydırmaların (RNAGS) ağrı, hareket kısıtlılığı ve fonksiyon &uuml;zerindeki etkisini değerlendirmektir. Ocak 2021 ile Mayıs 2021 arasında y&uuml;r&uuml;t&uuml;len &ccedil;alışmaya, sahte grup, fizyoterapi grubu ve Mulligan grubuna rastgele atanan 69 katılımcı dahil edildi. T&uuml;m gruplara, paylaşımlı fizyoterapi m&uuml;dahaleleri ve germe egzersizleri ile iki haftalık, 11 seanslık bir tedavi programı uygulandı. Mulligan grubuna Mulligan RNAGS tekniği ile ek mobilizasyon uygulandı. Sahte grup, standart altı Mulligan mobilizasyonu aldı. Sonu&ccedil; &ouml;l&ccedil;&uuml;mleri arasında Hareket Aralığı (ROM), G&ouml;rsel Analog Skala (VAS) ve Boyun Engellilik İndeksi (NDI) vardı. Gruplar arasında &ouml;l&ccedil;&uuml;mlerde hi&ccedil;bir temel fark bulunamadı. M&uuml;dahaleden sonra, t&uuml;m gruplarda ROM artmış ve VAS ve NDI skorlarında azalma g&ouml;r&uuml;ld&uuml; (p&lt;0,001). Mulligan grubu diğer gruplara kıyasla VAS, ROM ve NDI'da &ouml;nemli &ouml;l&ccedil;&uuml;de daha fazla iyileşme g&ouml;sterdi (p&lt;0,001). Sham grubu fizyoterapi grubuna kıyasla NDI ve ekstansiyon ROM'da daha fazla iyileşme g&ouml;sterdi (p&lt;0,001). &Uuml;st torasik b&ouml;lgedeki Mulligan RNAGS tekniği mekanik boyun ağrısında ağrı kesici, hareket aralığı ve işlevsellik a&ccedil;ısından faydalı olduğu kanıtlandı. Uzun vadeli etkiler pop&uuml;lasyon bazlı &ccedil;alışmalarla daha fazla araştırılmayı hak ediyor.</span></span></p>

opencc-by-4.0Aug 2024View details →
zenodo32/100

Transcutaneous spinal cord stimulation enhances motor score and gait recovery in incomplete spinal cord injury. A double-blind randomized controlled trial

<p><strong><span>Background: </span></strong><span>Although transcutaneous spinal cord stimulation (tSCS) has been suggested as a safe and feasible intervention for gait rehabilitation, no studies have determined its effectiveness compared to sham stimulation.</span></p> <p><strong><span>Objective: </span></strong><span>To determine the effectiveness of tSCS combined with robotic-assisted gait training (RAGT) on lower limb muscle strength and walking function in incomplete spinal cord injury (iSCI) participants.</span></p> <p><strong><span>Methods: </span></strong><span>A randomized, double-blind, sham-controlled clinical trial was designed. Twenty-seven subacute iSCI participants were randomly allocated to tSCS or sham-tSCS group. The intervention consisted of 20 sessions of standard Lokomat walking training enhanced with tSCS. Primary outcomes were the lower extremity motor score (LEMS) and dynamometry. Secondary outcomes included the 10-Meter Walk Test (10MWT), the Timed Up and Go test (TUG), the 6-Minute Walk test (6MWT), the Spinal Cord Independence Measure III (SCIM III) and the Walking Index for Spinal Cord Injury II (WISCI-II). Assessments were performed before and after the intervention and at 1-month follow-up.</span></p> <p><strong><span>Results: </span></strong><span>Although no significant differences between groups were detected after the intervention, the tSCS group showed greater effects than the sham-tSCS group for LEMS (3.4 points; p=0.033), 10MWT (37.5s; p=0.030), TUG (47.7s; p=0.009), and WISCI-II (3.4 points; p=0.023) at the 1-month follow-up. Furthermore, the percentage of subjects who were able to walk at the follow-up was greater in the tSCS group (85.7%) compared to the sham group (43.1%; p=0.029).</span></p> <p><strong><span>Conclusions:</span></strong><span> The combination of standard RAGT with tSCS for 20 sessions was effective for LEMS and gait recovery in subacute iSCI participants after one month of follow-up.</span></p> <p><strong><span>Key words: </span></strong><span>Spinal cord injury; Transcutaneous spinal cord stimulation; Lokomat; Robotic-assisted gait training; Motor function; </span><span>Gait rehabilitation.</span></p>

opencc-by-4.0Apr 2024View details →
zenodo32/100

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>- &nbsp; &nbsp;The first row of the dataset identifies the columns.<br>- &nbsp; &nbsp;Column A represents the participants&rsquo; iDs.<br>- &nbsp; &nbsp;Column B represents the participants&rsquo; assigned group [0: Control (ExpertFeedback) 1: Intervention (ChatGPTFeedback)].<br>- &nbsp; &nbsp;Column C represents the genders of the participants (1: Female, 2: Male).<br>- &nbsp; &nbsp;Column D represents the first-year repetition status of the participants. (0: No, 1: Yes)<br>- &nbsp; &nbsp;Column E to H represent the scores in four different uncomplicated urinary tract infection (UTI) Key-Features Questions Items separately.&nbsp;<br>- &nbsp; &nbsp;Column I represents the total scores in uncomplicated UTI Key-Features Questions Items.&nbsp;<br>- &nbsp; &nbsp;Column J to M represent the scores in four different complicated UTI Key-Features Questions Items separately.&nbsp;<br>- &nbsp; &nbsp;Column N represents the total scores in complicated UTI Key-Features Questions Items.&nbsp;<br>- &nbsp; &nbsp;Column O to R represent the scores in four different pyelonephritis Key-Features Questions Items separately.&nbsp;<br>- &nbsp; &nbsp;Column S represents the total scores in pyelonephritis Key-Features Questions Items.&nbsp;<br>- &nbsp; &nbsp;Column T represents the total scores in immediate test.&nbsp;</p> <p><strong>2) Delayed Test</strong><br>- &nbsp; &nbsp;The first row of the dataset identifies the columns.<br>- &nbsp; &nbsp;Column A represents the participants iDs.<br>- &nbsp; &nbsp;Column B represents the participants&rsquo; assigned group [0: Control (ExpertFeedback) 1: Intervention (ChatGPTFeedback)].<br>- &nbsp; &nbsp;Column C represents the genders of the participants (1: Female, 2: Male).<br>- &nbsp; &nbsp;Column D represents the first-year repetition status of the participants. (0: No, 1: Yes)<br>- &nbsp; &nbsp;Column E to H represent the scores in four different uncomplicated urinary tract infection (UTI) Key-Features Questions Items separately.&nbsp;<br>- &nbsp; &nbsp;Column I represents the total scores in uncomplicated UTI Key-Features Questions Items.&nbsp;<br>- &nbsp; &nbsp;Column J to M represent the scores in four different complicated UTI Key-Features Questions Items separately.&nbsp;<br>- &nbsp; &nbsp;Column N represents the total scores in complicated UTI Key-Features Questions Items.&nbsp;<br>- &nbsp; &nbsp;Column O to R represent the scores in four different pyelonephritis Key-Features Questions Items separately.&nbsp;<br>- &nbsp; &nbsp;Column S represents the total scores in pyelonephritis Key-Features Questions Items.&nbsp;<br>- &nbsp; &nbsp;Column T represents the total scores in delayed test.&nbsp;</p> <p><strong>3) Pre-Intervention Survey on Critical Approach to AI</strong><br>- &nbsp; &nbsp;The first row of the dataset identifies the columns.<br>- &nbsp; &nbsp;Column A represents the participants iDs.<br>- &nbsp; &nbsp;Column B represents the participants&rsquo; assigned group [0: Control (ExpertFeedback) 1: Intervention (ChatGPTFeedback)].<br>- &nbsp; &nbsp;Column C represents the genders of the participants (1: Female, 2: Male).<br>- &nbsp; &nbsp;Column D represents the first-year repetition status of the participants (0: No, 1: Yes).<br>- &nbsp; &nbsp;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>- &nbsp; &nbsp;The first row of the dataset identifies the columns.<br>- &nbsp; &nbsp;Column A represents the participants iDs.<br>- &nbsp; &nbsp;Column B represents the participants&rsquo; assigned group [0: Control (ExpertFeedback) 1: Intervention (ChatGPTFeedback)].<br>- &nbsp; &nbsp;Column C represents the genders of the participants (1: Female, 2: Male).<br>- &nbsp; &nbsp;Column D represents the first-year repetition status of the participants (0: No, 1: Yes).<br>- &nbsp; &nbsp;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. &nbsp;(1: No agreement at all, 7: completely agree)</p>

opencc-by-4.0Sep 2024View details →
dryad32/100

Telerehabilitation program for COVID-19 survivors (TERECO) - Randomized controlled trial

<p><b>Objectives</b></p> <p>To investigate superiority of a telerehabilitation program for Covid-19 (TERECO) over no rehabilitation with regard to exercise capacity, lower-limb muscle strength (LMS), pulmonary function, health-related quality of life (HRQOL), and dyspnoea.</p> <p><b>Design</b></p> <p>Parallel-group randomised controlled-trial with 1:1 block-randomisation.</p> <p><b>Setting</b></p> <p>Three major hospitals from Jiangsu and Hubei provinces, China.</p> <p><b>Participants</b></p> <p>120 formerly hospitalised Covid-19 survivors with remaining dyspnoea complaints were randomised with 61 allocated to control and 59 to TERECO.</p> <p><b>Intervention</b></p> <p>Unsupervised home-based 6-week exercise program comprising breathing control and thoracic expansion, aerobic exercise, and LMS exercise, delivered via smartphone, and remotely monitored with heart rate telemetry.</p> <p><b>Outcomes</b></p> <p>Primary outcome was 6-minute walking distance (6MWD) in metres. Secondary outcomes were squat time in seconds; pulmonary function assessed by spirometry; HRQOL measured with SF-12; and mMRC-dyspnoea. Outcomes were assessed at 6 weeks (post-treatment) and 28 weeks (follow-up).</p> <p><b>Results</b></p> <p>Adjusted between-group difference in change in 6MWD was 65.45 metres (95% CI 43.8, 87.1; p&lt;0.001) at post-treatment and 68.62 metres (95% CI 46.39, 90.85; p&lt;0.001) at follow-up. Treatment effects for LMS were 20.12 seconds (95% CI 12.34, 27.9; p&lt;0.001) post-treatment and 22.23 seconds (95% CI 14.24, 30.21; p&lt;0.001) at follow-up. No group differences were found for lung function except post-treatment MVV. Increase in SF-12 physical component was greater in the TERECO group with treatment effects estimated as 3.79 (95% CI 1.24, 6.35; p=0.004) at post-treatment and 2.69 (95% CI 0.06, 5.32; p=0.045) at follow-up.</p> <p><b>Conclusions</b></p> <p>This trial demonstrated superiority of TERECO over no rehabilitation for 6MWD, LMS, and physical HRQOL.</p> <p><b>Trial registration</b>: ChiCTR2000031834, URL: <a href="http://www.chictr.org.cn/showproj.aspx?proj=52216">http://www.chictr.org.cn/showproj.aspx?proj=52216</a></p>

opencc-zeroJul 2021View details →
dryad32/100

Evaluating the educational effectiveness of a structured, simulator-assisted, peer-led training on cardiovascular physical examination in third-year medical students: A randomized, controlled trial

<p class="AbstractCxSpFirst"><span><span><span><span><span><span><span><span><span><span><span><b>Background:</b> Previous research suggests that cardiac examination skills in undergraduate medical students frequently need improvement. There are different ways to enhance physical examination (PE) skills such as simulator-based training or peer-assisted learning (PAL). </span></span></span></span></span></span></span></span></span></span></span></p> <p class="AbstractCxSpMiddle"><span><span><span><span><span><span><span><span><span><span><span><b>Aim:</b> The aim of this study was to evaluate the effectiveness of a structured, simulator-assisted, peer-led training on cardiovascular PE.</span></span></span></span></span></span></span></span></span></span></span></p> <p class="AbstractCxSpMiddle"><span><span><span><span><span><span><span><span><span><span><span><b>Methods:</b> Participants were third-year medical students at Leipzig University Faculty of Medicine. Students were randomly assigned to an intervention group (IG) and a control group (CG). In addition to standard curricular training, IG received a peer-led, simulator-based training in cardiac PE. Participant performance in cardiac PE was assessed using a standardized checklist with a maximum of 25 points. Primary outcome was assessed via checklist point distribution.</span></span></span></span></span></span></span></span></span></span></span></p> <p class="AbstractCxSpMiddle"><span><span><span><span><span><span><span><span><span><span><span><b>Results:</b> 89 students were randomised to either CG (<i>n</i> = 43) or IG (<i>n</i> = 46) with 70 completing the study. Overall, IG students performed significantly better than CG students did (max. points: 25, IG M ± SD in IG was 17 ± 3, in CG 12 ± 4, p &lt; .0001). Simple mistakes such as not using the stethoscope correctly were more frequent in CG students. Prior experience did not lead to a significant difference in performance. </span></span></span></span></span></span></span></span></span></span></span></p> <p class="Abstract"><span><span><span><span><span><span><span><span><span><span><span><b>Conclusions:</b> Structured, peer-led and simulator-assisted teaching sessions improve cardiac PE skills in this setting compared to control students that did not receive this training.</span></span></span></span></span></span></span></span></span></span></span></p>

opencc-zeroSep 2021View details →
dryad32/100

The STARS phase 2 study: a randomized controlled trial of gaboxadol in Angelman syndrome

<p><b>Objective</b>: To evaluate safety and tolerability and exploratory efficacy endpoints for gaboxadol (OV101) compared with placebo in individuals with Angelman syndrome (AS).</p> <p><b>Methods</b>: Gaboxadol is a highly selective orthosteric agonist that activates γ-subunit–containing extrasynaptic γ-aminobutyric acid type A (GABA<sub>A</sub>) receptors. In a multicenter, double-blind, placebo-controlled, parallel-group trial, adolescent and adult individuals with a molecular diagnosis of AS were randomized (1:1:1) to 1 of 3 dosing regimens for a duration of 12 weeks: placebo morning dose and gaboxadol 15 mg evening dose (qd); gaboxadol 10 mg morning dose and 15 mg evening dose (bid); or placebo morning and evening dose. Safety and tolerability were monitored throughout the study. Prespecified exploratory efficacy endpoints included adapted Clinical Global Impression–Severity (CGI-S) and Clinical Global Impression–Improvement (CGI-I) scales which documented the clinical severity at baseline and change after treatment, respectively.</p> <p><b>Results</b>: Eighty-eight individuals were randomized. Of 87 individuals (aged 13–45 years) who received at least 1 dose of study drug, 78 (90%) completed the study. Most adverse events (AEs) were mild to moderate, and no life-threatening AEs were reported. Efficacy of gaboxadol, as measured by CGI-I improvement in an exploratory analysis, was observed in gaboxadol qd vs placebo (p = 0.0006).</p> <p><b>Conclusion</b>: After 12 weeks of treatment, gaboxadol was found to be generally well tolerated with a favorable safety profile. The efficacy as measured by the AS-adapted CGI-I scale warrants further studies.</p>

opencc-zeroOct 2021View details →
zenodo32/100

Rethinking mental health care for migrants and refugees; a randomized controlled trial on the effectiveness of Value Based Counseling, a culturally-sensitive, strength-based psychological intervention

<p>The study&rsquo;s minimal data set&nbsp;</p>

opencc-by-4.0Nov 2022View details →
zenodo32/100

Efficacy of Kinesiotaping on functional outcomes, pain and edema in the early rehabilitation after total knee arthroplasty surgery: a randomized controlled trial

<p><strong>Objective </strong>The aim of our study was to verify whether the application of Kinesiotaping in addition to usual treatment was superior to usual treatment alone regarding functional outcome, pain and edema in the first 13 days after total knee arthroplasty (TKA) surgery.</p> <p><strong>Design</strong> Open-label, parallel two-groups, Randomized controlled trial.</p> <p><strong>Setting </strong>Galeazzi hospital, Milan.</p> <p><strong>Participants </strong>Inpatients, aged between 50 and 85 years old, waiting TKA were invited to voluntarily participate to the trial. The study sample (n=71) was 42.3% men and the mean age was 68.1 (&plusmn;9) years. A 1:1 ratio randomization list, to allocate the patient either to a Kinesiotaping Group (KT) or to a control (CON) group.</p> <p><strong>Interventions </strong>KT and CON groups received the same volume of standard post-TKA rehabilitation. KT was additionally treated with lymphatic correction applications of Kinesiotaping (Kinesio&reg; Tex Classic, Mogliano Veneto, IT) on day 3rd (&plusmn; 1) and 7th (&plusmn; 1) post-surgery (2 applications during the rehabilitation period). Each application lasted 4-5 days before removal. KT was removed before patients discharge</p> <p><strong>Main Outcome Measure(s)</strong> 1) Circumference at knee level; 2) VAS for pain; 3) 10 Meter Walking Test; 4) Timed Up and Go Test; 5) passive knee range of motion; 6) body composition; 7) Functional Independence Measure; 8) Modified Barthel Index. Data were collected at T0 (before surgery), T1 (3&plusmn;1 days after surgery), T2 (7&plusmn;1 days after surgery), T3 (13&plusmn;1 days after surgery)</p> <p><strong>Results </strong>No inter-group differences were found between KT and CON at T0, T1, T2 and T3. An effect of time was observed for all outcome measures.</p> <p><strong>Conclusions </strong>No superiority of Kinesiotaping was observed compared to usual rehabilitation treatment. Based on these results, the use of Kinesiotaping applied in the early stages of rehabilitation after TKA is not recommended.</p>

opencc-by-4.0Sep 2022View details →

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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.

allen-brain-atlas
neuroscienceopenDocumentation, web resources, and API references are available online.
Last verified 2026-04-30Open record

Annotated Behaviour and Observability Dataset (ABODe)

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behavioral-neuroscienceopenThe DataShare record exposes download links for annotations, documentation, license text, and the zipped per-snippet data directory.
Last verified 2026-04-30Open record

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.

dandi-nwb
electrophysiologyopenPublished Dandiset metadata and archive endpoints are available through the production DANDI API.
Last verified 2026-04-30Open record

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.

ibl
behavioral-neuroscienceopenPublic sessions can be searched and loaded from the IBL public data server through ONE.
Last verified 2026-04-29Open record

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.

openneuro
neuroscienceopenPublished datasets are available on demand over the internet.
Last verified 2026-04-29Open record