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5,826 results for “Randomized trial”
Effectiveness of Facility-Based Personalized Maternal Nutrition Counseling in Improving Child Growth and Morbidity up to 18 Months: A Cluster-Randomized Controlled Trial in Rural Burkina Faso.
<p>"Baseline Characteristics.dta": give data on participants first sociodemographic caracteristics and outcome collected during the first follow_up visit.</p> <p>"Follow-up Data.dta": Provide data on all the follow-up visits"</p>
Anticoagulant and anti-inflammatory effects of fondaparinux sodium in anterior cruciate ligament reconstruction in patients at high risk of VTE: A Randomized Controlled Trial
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Tongue cleaning enhances the myoelectric activity of the suprahyoid muscles in older adults: A six-week randomized controlled trial
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To swim or not to swim after eating: a randomized controlled crossover feasibility trial
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Suplementary Files-Effect of Post-Extubation Inspiratory Muscle Training on Diaphragmatic Function in Mechanically Ventilated Patients: A Randomized Controlled Trial
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Integrated Pulmonary Index during procedural sedation and analgesia: a cluster-randomized trial
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Effect of Structured Diet with Exercise Education on Anthropometry and Lifestyle Modification in Patients with Type 2 Diabetes: A 12-Month Randomized Clinical Trial
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raw data - Effects of preemptive acupuncture on cognitive function of the elderly patients after hip replacement: a randomized controlled trial
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Data from: Risk of cancer with angiotensin-receptor blockers increases with increasing cumulative exposure: Meta-regression analysis of randomized trials
<p>Angiotensin-receptor blockers (ARBs) are a class of drugs approved for the treatment of several common conditions, such as hypertension and heart failure. Recently, regulatory agencies have started to identify possibly carcinogenic nitrosamines and azido compounds in a multitude of formulations of several ARBs, resulting in progressive recalls. Furthermore, data from several randomized controlled trials suggested that there is also a clinically increased risk of cancer and specifically lung cancer with ARBs; whereas other trials suggested no increased risk. The purpose of this analysis was to provide additional insight into the ARB-cancer link by examining whether there is a relationship between degree of cumulative exposure to ARBs and risk of cancer in randomized trials. Trial-level data from ARB Trialists Collaboration including 15 randomized controlled trials was extracted and entered into meta-regression analyses. The two co-primary outcomes were the relationship between cumulative exposure to ARBs and risk of all cancers combined and the relationship between cumulative exposure and risk of lung cancer. A total of 74,021 patients were randomized to an ARB resulting in a total cumulative exposure of 172,389 person-years of exposure to daily high dose (or equivalent). 61,197 patients were randomized to control. There was a highly significant correlation between the degree of cumulative exposure to ARBs and risk of all cancers combined (slope=0.07 [95% CI 0.03 to 0.11], p<0.001), and also lung cancer (slope=0.16 [95% CI 0.05 to 0.27], p=0.003). Accordingly, in trials where the cumulative exposure was greater than 3 years of exposure to daily high dose, there was a statistically significant increase in risk of all cancers combined (I<sup>2</sup>=31.4%, RR 1.11 [95% CI 1.03 to 1.19], p=0.006). There was a statistically significant increase in risk of lung cancers in trials where the cumulative exposure was greater than 2.5 years (I<sup>2</sup>=0%, RR 1.21 [95% CI 1.02 to 1.44], p=0.03). In trials with lower cumulative exposure to ARBs, there was no increased risk of all cancers combined or lung cancer. Cumulative exposure-risk relationship with ARBs was independent of background angiotensin-converting enzyme inhibitor treatment or the type of control (i.e. placebo or non-placebo control). Since this is a trial-level analysis. the effects of patient characteristics such as age and smoking status could not be examined due to lack of patient-level data. In conclusion, this analysis, for the first time, reveals that risk of cancer with ARBs (and specifically lung cancer) increases with increasing cumulative exposure to these drugs. The excess risk of cancer with long-term ARB use has public health implications.</p>
The impact of sleep hygiene education and lavender essential oil inhalation on the sleep quality and overall well-being of athletes who undergo late-evening training: a randomized controlled trial
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STRICTA Check list for Effects of Electroacupuncture on Cognitive Symptoms in Major Depressive Disorder: A Pilot Study and Randomized Controlled Trial
<p>STRICTA 2010 check list</p>
Feasibility of a Randomized Controlled Trial of Large Artificial Intelligence-Based Linguistic Models for Clinical Reasoning Training of Physical Therapy Students.
<p>Data collected for students who participated in the study</p>
The effect of a 6-month tablet-based multimodal training for cognitive functioning in Alzheimer's disease in a randomized controlled trial
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Comparison of Transurethral Split of the Prostate versus Transurethral Resection of the Prostate for Treatment of Benign Prostate Hyperplasia in a Small Prostate Volume: A Prospective Randomized Trial.
<p>The endoscopic appearance before and after surgery</p>
Evaluation of Clinical application of sclerotherapy combined with oral sirolimus in the treatment of tongue microcystic lymphatic malformation in children:A Randomized Controlled Trial
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Data from: 8-way randomized controlled trial of doxylamine, pyridoxine and dicyclomine for nausea and vomiting during pregnancy: restoration of unpublished information
Objectives: We report information about an unpublished 1970s study ("8-way" Bendectin Study) that aimed to evaluate the relative therapeutic efficacy of doxylamine, pyridoxine, and dicyclomine in the management of nausea and vomiting during pregnancy. We are publishing the trial's findings according to the restoring invisible and abandoned trials (RIAT) initiative because the trial was never published. Design: Double blinded, multi-centred, randomized placebo-controlled study. Setting: 14 clinics in the United States. Participants: 2308 patients in the first 12 weeks of pregnancy with complaints of nausea or vomiting were enrolled. Interventions: Each patient was randomized to one of eight arms: placebo, doxylamine/pyridoxine/dicylcomine, doxylamine/pyridoxine, dicylomine/pyridoxine, doxylamine, dicyclomine/pyridoxine, pyridoxine and dicyclomine. Each patient was instructed to take 2 tablets at bedtime and 1 additional tablet in the afternoon or morning if needed, for 7 nights. Outcomes: Reported outcomes included the number of hours of nausea reported by patients, the frequency of vomiting reported by patients and the overall efficacy of medication as judged by physicians. Results: Data from 1599 (69% of those randomized) participants were analyzed. Based on the available summary data of physician evaluation of symptoms and ignoring missing data and data integrity issues, the proportion of participants who were "evaluated moderate or excellent" was greater in each of the seven active treatment groups when compared with placebo (57%): doxylamine/pyridoxine/dicylcomine (14% absolute difference versus placebo; 95% CI: 4 to 24), doxylamine/pyridoxine (21; 95% CI 11 to 30), dicylomine/pyridoxine (21; 95% CI 11 to 30), doxylamine (20; 95% CI 10 to 29), dicyclomine/pyridoxine (4; 95% CI -6 to 14), pyridoxine (9; 95% CI -1 to 19) and dicyclomine (4; 95% CI -6 to 14). Based on incomplete information, the most common adverse events were apparently drowsiness and fatigue. There is a high risk of bias in these previously unpublished results given the high attrition rate in a 7 day trial, the lack of prespecified outcomes or analyses, and the exclusion of some data because of questionable data integrity. Conclusion: The available information about this "8-way Bendectin" trial indicates it should not be used to support the efficacy of doxylamine, pyridoxine or dicyclomine for the treatment of nausea and vomiting during pregnancy because of a high risk of bias.
Effects of supervised exercise training during pregnancy on psychological well-being among overweight and obese women: Secondary analyses of the ETIP-trial, a randomized controlled trial.
<p><b>Objectives: </b>Women with high body mass index (BMI) have increased risk for symptoms of anxiety and depression during pregnancy and postpartum. In this pre-specified secondary analysis from the ETIP trial, our aim was to examine effects of supervised exercise during pregnancy on psychological well-being in late pregnancy and postpartum among women with a pre-pregnancy BMI ≥ 28 kg/m<sup>2</sup>.</p> <p><b>Design: </b>Single-centre, parallel group, randomized controlled trial.</p> <p><b>Setting: </b>University Hospital, Norway</p> <p><b>Participants: </b><a name="_Hlk10799837">Ninety-one women (age 31.2±4.1 years, BMI 34.5±4.2 kg/m<sup>2</sup>), 46 in the exercise group, 45 in the control group, were included in the trial. </a></p> <p><b>Intervention:</b> The exercise group was offered three weekly supervised exercise sessions (35 minutes of moderate intensity walking/running and 25 minutes of resistance training), until delivery.</p> <p><b>Primary and secondary outcomes measures:</b> Primary analyses were based on intention to treat, with secondary per-protocol analyses. To assess psychological well-being, we used the «Psychological General Well-Being Index» (PGWBI) at inclusion (gestational week 12-18), late pregnancy (gestational week 34-37), and three months postpartum. We assessed postpartum depression using the «Edinburgh Postnatal Depression Scale» (EDPS).</p> <p><b>Results:</b> Numbers completed data collection: Late pregnancy 72 (exercise 38, control 36), postpartum 70 (exercise 36, control 34). In the exercise group, 50% adhered to the exercise protocol. Baseline PGWBI for all women was 76.4±12.6. Late pregnancy PGWBI; exercise 76.6 (95% CI 72.2, 81.0), control 74.0 (95% CI 69.4, 78.5) (<i>p</i> = 0.42). Postpartum PGWBI; exercise 85.4 (95% CI 81.9, 88.8), control 84.6 (95% CI 80.8, 88.4) (with no between-group difference, <i>p</i> = 0.77). There was no between-group difference in EDPS; exercise 2.96 (95% CI 1.7, 4.2), control 3.48 (95% CI 2.3, 4.7) (<i>p</i> = 0.55).</p> <p><b>Conclusions: </b>We found no effect of supervised exercise during pregnancy on psychological well-being among women with high BMI. Our findings may be hampered by low adherence to the exercise protocol.</p>
Data from: An investigation of the therapeutic effects of statins with metformin on polycystic ovary syndrome: a meta-analysis of randomized controlled trials
Objectives: To investigate the therapeutic effects of statins with metformin on polycystic ovary syndrome (PCOS). Settings: Endocrinology department. Participants: MEDLINE, EMBASE and Cochrane Central Register of Controlled Trials were searched until October 2014. Studies comparing statins and placebo, as well as the combination of statins and metformin and metformin alone, were included in the analysis. Interventions: Data were independently extracted by two researchers; any convergence was resolved by a third reviewer. Primary and secondary outcome measures: The following properties were extracted from the qualified trials to identify the effects of statins: clinical variables, metabolic characteristics, hormone outcomes, sign of inflammation, glucose parameters and insulin outcomes. Results: Data from four trials comparing statin and metformin with metformin alone were analysed. The combination of statins and metformin decreases the levels of C reactive protein (standardised mean difference (SMD) −0.91; 95% CI −1.81 to −0.02; p=0.046), triglyceride (SMD −1.37; 95% CI −2.46 to −0.28; p=0.014), total cholesterol (SMD −1.28; 95% CI −1.59 to −0.97; p=0.000) and low-density lipoprotein (LDL) cholesterol (SMD −0.74; 95% CI −1.03 to −0.44; p=0.000). However, the combined therapy fails to reduce fasting insulin (SMD −0.92; 95% CI −2.07 to 0.24; p=0.120), homeostasis model assessment of insulin resistance (SMD −1.15; 95% CI −3.36 to 1.06; p=0.309) and total testosterone (SMD −1.12; 95% CI −2.29 to 0.05; p=0.061). Analysis of the five trials comparing statin with placebo shows that statin monotherapy reduces LDL-cholesterol, triglyceride and total cholesterol. Conclusions: Combined statin and metformin therapy can improve lipid and inflammation parameters, but cannot effectively improve insulin sensitivity and reduce hyperandrogenism in women with PCOS. A large-scale randomised controlled study must be conducted to ascertain the long-term effects of the therapy.
Supplementary material 1 from: Abu-Samak MS, Hasoun LZ, Barham A, Mohammad BA, Mosleh I, Aljaberi A, Awwad SH (2021) The supplementary effects of omega-3 fatty acid alone and in a combination with vitamin D3 on serum leptin levels: A randomized clinical trial on men and women with vitamin D deficiency. Pharmacia 68(3): 517-525. https://doi.org/10.3897/pharmacia.68.e64422
Supplemental tables
Figure 1 from: Abu-Samak MS, Hasoun LZ, Barham A, Mohammad BA, Mosleh I, Aljaberi A, Awwad SH (2021) The supplementary effects of omega-3 fatty acid alone and in a combination with vitamin D3 on serum leptin levels: A randomized clinical trial on men and women with vitamin D deficiency. Pharmacia 68(3): 517-525. https://doi.org/10.3897/pharmacia.68.e64422
Figure 1 CONSORT flow diagram for the study, indicating the number of subjects screened, recruited, and randomly assigned to the different intervention groups.
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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.