Trials
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Irritable bowel syndrome (IBS) is one of the most common functional gastrointestinal disorders characterized by recurrent abdominal pain associated with defecation or a change in bowel habits. Leading to significant negative effect on patients' quality of life and huge financial burden to health system, the management of IBS is a great challenge. Probiotics are considered as an effective therapy; however, in a lack of high-quality evidence of efficacy, no strain- and dose-specific probiotics were recommended in clinical guidelines. This study aims to evaluate the efficacy of the Bifidobacterium quadruple viable tablet in the treatment of IBS-D. ⋯ This multicenter randomized controlled trial may provide high-quality evidence on the efficacy of the Bifidobacterium quadruple viable tablet for IBS-D on both physical and mental dimensions in China. To fill the gap of previous probiotic intervention studies, in addition, this study will also present safety assessment which will be a significant emphasis.
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Patients with diabetes mellitus are at a high risk of developing postoperative acute kidney injury. For patients receiving laparoscopic surgery, standard-pressure pneumoperitoneum (SPP) currently applied in clinical practice also undermines renal perfusion. Several studies have shown that low-pressure pneumoperitoneum (LPP) might reduce pressure-related ischemic renal injury. However, LPP may compromise the view of the surgical field. Previous studies have indicated that deep neuromuscular blockade (NMB) can ameliorate this issue. However, the conclusion is still uncertain. The hypothesis of this study is that the joint use of LPP and deep NMB can reduce perioperative renal injury in diabetic patients undergoing laparoscopic pelvic surgery without impeding the view of the surgical field. ⋯ This study will provide evidence for the effect of LPP on renal function protection in patients with diabetes undergoing laparoscopic pelvic surgery. The trial can also help us to understand whether deep NMB can improve surgical conditions.
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Plantar fasciopathy is a common cause of plantar heel pain, with a reported prevalence of up to 10%. The choice of best practice in these patients is debated. Two randomised studies reported that radial extracorporeal shock wave therapy is effective, but a meta-analysis concluded that due to methodological limitations, the evidence is questionable. There are few studies reporting the effect of exercise programs with high-load strength training, despite widespread use. The objective of this placebo-controlled, observer-blinded and partly patient blinded trial is to compare rESWT, sham-rESWT, standardised exercise programme and usual care for alleviating heel pain at 6 and 12 months follow-up. ⋯ This trial is designed in order to provide results important for future clinical practice.
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In December 2019, 27 cases of pneumonia, of unknown cause, were identified in the province of Hubei (China). The WHO declared the situation as a Public Health Emergency of International Concern, and it was finally declared a global pandemic on March 11, 2020. The Spanish Government obliges the entire population to remain confined to their homes, with the exception of essential basic services, to stop the spread of COVID-19. Home isolation implies a notable physical deconditioning. Telerehabilitation methods have reported positive experiences, and we propose to study in affected patients of COVID-19, due to the general house confinement of the entire Spanish population. ⋯ We will analyze the results, in terms of the level of fatigue and perceived exertion, physical health, and maintenance of respiratory activity of two types of exercise programs, toning and respiratory, applied in patients affected by COVID-19 during the period of home confinement. We intend to investigate a field not previously studied, such as the repercussion of carrying out a toning and respiratory exercise program in these patients, in historical circumstances that no one had previously observed in Spain, since the general population has never been forced to remain confined in their homes, due to a pandemic infection, by a coronavirus (COVID-19). Observing the effects that these two home exercise programs could produce in patients infected with COVID-19, we will try to better analyze and understand the mechanisms that are associated with the worsening of breathing in this type of patient.
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Letter Multicenter Study
CytoResc - "CytoSorb" Rescue for critically ill patients undergoing the COVID-19 Cytokine Storm: A structured summary of a study protocol for a randomized controlled trial.
Approximately 8 - 10 % of COVID-19 patients present with a serious clinical course and need for hospitalization, 8% of hospitalized patients need ICU-treatment. Currently, no causal therapy is available and treatment is purely supportive. The main reason for death in critically ill patients is acute respiratory failure. However, in a number of patients a severe hyperinflammatory response with excessively elevated proinflammatory cytokines causes vasoplegic shock resistant to vasopressor therapy. A new polystyrene-based hemoadsorber (CytoSorb®, Cytosorbents Inc., New Jersey, USA) has been shown to adsorb effectively cytokines and other middle molecular weight toxins this way reducing their blood concentrations. This has been routinely used in clinical practice in the EU for other conditions where a cytokine storm occurs and an observational study has just been completed on COVID-19 patients. We hypothesized that the extracorporeal elimination of cytokines in critically ill COVID-19 patients with suspected hyperinflammation and shock may stabilize hemodynamics and improve outcome. The primary endpoint is time until resolution of vasoplegic shock, which is a well implemented, clinically relevant endpoint in critical care studies.