scholarly journals DURABLE STRONG EFFICACY AND FAVORABLE LONG-TERM RENAL SAFETY OF THE ANATOMICALLY OPTIMIZED DISTAL RENAL DENERVATION ACCORDING TO THE 3 YEAR FOLLOW-UP EXTENSION OF THE DOUBLE-BLIND RANDOMIZED CONTROLLED TRIAL

Heliyon ◽  
2022 ◽  
pp. e08747
Author(s):  
Stanislav Pekarskiy ◽  
Andrei Baev ◽  
Alla Falkovskaya ◽  
Valeria Lichikaki ◽  
Ekaterina Sitkova ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Renal Denervation ◽  
Controlled Trial ◽  
Double Blind ◽  
Randomized Controlled ◽  
Renal Safety

The SNAP Trial: 2-Year Results of a Double-Blind Multicenter Randomized Controlled Trial of a Silicon Nitride Versus a PEEK Cage in Patients After Lumbar Fusion Surgery

2021 ◽  
pp. 219256822098547
Author(s):  
R. F. M. R. Kersten ◽  
F. C. Öner ◽  
M. P. Arts ◽  
M. Mitroiu ◽  
K. C. B. Roes ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Silicon Nitride ◽  
Interbody Fusion ◽  
Controlled Trial ◽  
Segmental Motion ◽  
Lumbar Interbody Fusion ◽  
Double Blind ◽  
Randomized Controlled ◽  
Disability Questionnaire

Study Design: Randomized controlled trial. Objectives: Lumbar interbody fusion with cages is performed to provide vertebral stability, restore alignment, and maintain disc and foraminal height. Polyetheretherketone (PEEK) is commonly used. Silicon nitride (Si3N4) is an alternative material with good osteointegrative properties. This study was designed to assess if Si3N4 cages perform similar to PEEK. Methods: A non-inferiority double-blind multicenter RCT was designed. Patients presenting with chronic low-back pain with or without leg pain were included. Single- or double-level instrumented transforaminal lumbar interbody fusion (TLIF) using an oblique PEEK or Si3N4 cage was performed. The primary outcome was the Roland-Morris Disability Questionnaire (RMDQ). The non-inferiority margin for the RMDQ was 2.6 points on a scale of 24. Secondary outcomes included the Oswestry Disability Questionnaire (ODI), Visual Analogue Scales (VAS), SF-36 Physical Function, patient and surgeon Likert scores, radiographic evaluations for subsidence, segmental motion, and fusion. Follow-up was planned at 3, 6, 12, and 24-months. Results: Ninety-two patients were randomized ( i.e. 48 to PEEK and 44 to Si3N4). Both groups showed good clinical improvements on the RMDQ scores of up to 5-8 points during follow-up. No statistically significant differences were observed in clinical and radiographic outcomes. Mean operative time and blood loss were statistically significantly higher for the Si3N4 cohort. Although not statistically significant, there was a higher incidence of complications and revisions associated with the Si3N4 cage. Conclusions: There was insufficient evidence to conclude that Si3N4 was non-inferior to PEEK.

scholarly journals Endothelial Dysfunction, Atherosclerosis, and Increase of von Willebrand Factor and Factor VIII: A Randomized Controlled Trial in Swine

2021 ◽  
Author(s):  
Ferdows Atiq ◽  
Jens van de Wouw ◽  
Oana Sorop ◽  
Ilkka Heinonen ◽  
Moniek P. M. de Maat ◽  
...  
Keyword(s):  
Cardiovascular Disease ◽  
Randomized Controlled Trial ◽  
Endothelial Dysfunction ◽  
Controlled Trial ◽  
Short Term ◽  
Randomized Controlled ◽  
Von Willebrand ◽  
Willebrand Factor

AbstractIt is well known that high von Willebrand factor (VWF) and factor VIII (FVIII) levels are associated with an increased risk of cardiovascular disease. It is still debated whether VWF and FVIII are biomarkers of endothelial dysfunction and atherosclerosis or whether they have a direct causative role. Therefore, we aimed to unravel the pathophysiological pathways of increased VWF and FVIII levels associated with cardiovascular risk factors. First, we performed a randomized controlled trial in 34 Göttingen miniswine. Diabetes mellitus (DM) was induced with streptozotocin and hypercholesterolemia (HC) via a high-fat diet in 18 swine (DM + HC), while 16 healthy swine served as controls. After 5 months of follow-up, FVIII activity (FVIII:C) was significantly higher in DM + HC swine (5.85 IU/mL [5.00–6.81]) compared with controls (4.57 [3.76–5.40], p = 0.010), whereas VWF antigen (VWF:Ag) was similar (respectively 0.34 IU/mL [0.28–0.39] vs. 0.34 [0.31–0.38], p = 0.644). DM + HC swine had no endothelial dysfunction or atherosclerosis during this short-term follow-up. Subsequently, we performed a long-term (15 months) longitudinal cohort study in 10 Landrace–Yorkshire swine, in five of which HC and in five combined DM + HC were induced. VWF:Ag was higher at 15 months compared with 9 months in HC (0.37 [0.32–0.42] vs. 0.27 [0.23–0.40], p = 0.042) and DM + HC (0.33 [0.32–0.37] vs. 0.25 [0.24–0.33], p = 0.042). Both long-term groups had endothelial dysfunction compared with controls and atherosclerosis after 15 months. In conclusion, short-term hyperglycemia and dyslipidemia increase FVIII, independent of VWF. Long-term DM and HC increase VWF via endothelial dysfunction and atherosclerosis. Therefore, VWF seems to be a biomarker for advanced cardiovascular disease.

scholarly journals Long-Term Effects of Resistance Exercise Training on Cognition and Brain Volume in Older Women: Results from a Randomized Controlled Trial

2015 ◽  
Vol 21 (10) ◽  
pp. 745-756 ◽  
Author(s):  
John R. Best ◽  
Bryan K. Chiu ◽  
Chun Liang Hsu ◽  
Lindsay S. Nagamatsu ◽  
Teresa Liu-Ambrose
Keyword(s):  
Randomized Controlled Trial ◽  
White Matter ◽  
Resistance Training ◽  
Exercise Training ◽  
Older Women ◽  
Controlled Trial ◽  
Resistance Exercise Training ◽  
Randomized Controlled

AbstractAerobic exercise training has been shown to attenuate cognitive decline and reduce brain atrophy with advancing age. The extent to which resistance exercise training improves cognition and prevents brain atrophy is less known, and few studies include long-term follow-up cognitive and neuroimaging assessments. We report data from a randomized controlled trial of 155 older women, who engaged in 52 weeks of resistance training (either once- or twice-weekly) or balance-and-toning (twice-weekly). Executive functioning and memory were assessed at baseline, 1-year follow-up (i.e., immediately post-intervention), and 2-year follow-up. A subset underwent structural magnetic resonance imaging scans at those time points. At 2-year follow-up, both frequencies of resistance training promoted executive function compared to balance-and-toning (standardized difference [d]=.31–.48). Additionally, twice-weekly resistance training promoted memory (d=.45), reduced cortical white matter atrophy (d=.45), and increased peak muscle power (d=.27) at 2-year follow-up relative to balance-and-toning. These effects were independent of one another. These findings suggest resistance training may have a long-term impact on cognition and white matter volume in older women. (JINS, 2015,21, 745–756)

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