Trials
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Randomized Controlled Trial Multicenter Study Comparative Study
VITamin D supplementation in renAL transplant recipients (VITALE): a prospective, multicentre, double-blind, randomized trial of vitamin D estimating the benefit and safety of vitamin D3 treatment at a dose of 100,000 UI compared with a dose of 12,000 UI in renal transplant recipients: study protocol for a double-blind, randomized, controlled trial.
In addition to their effects on bone health, high doses of cholecalciferol may have beneficial non-classic effects including the reduction of incidence of type 2 diabetes mellitus, cardiovascular disease, and cancer. These pleiotropic effects have been documented in observational and experimental studies or in small intervention trials. Vitamin D insufficiency is a frequent finding in renal transplant recipients (RTRs), and this population is at risk of the previously cited complications. ⋯ We previously reported that the intensive cholecalciferol treatment (100 000 IU every 2 weeks for 2 months) was safe in RTR. Using a pharmacokinetic approach, we showed that cholecalciferol 100,000 IU monthly should maintain serum 25-hydroxyvitamin D at above 30 ng/ml but below 80 ng/ml after renal transplantation. Taken together, these results are reassuring regarding the safety of the cholecalciferol doses that will be used in the VITALE study. Analysis of data collected during the VITALE study will demonstrate whether high or low-dose cholecalciferol is beneficial in RTRs with vitamin D insufficiency.
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Randomized Controlled Trial Multicenter Study
Implementation of observational pain management protocol to improve pain management for long-term institutionalized older care residents with dementia: study protocol for a cluster-randomized controlled trial.
Systematic use of observational pain tools has been advocated as a means to improve pain management for care home residents with dementia. Pain experts suggest that any observational tool should be used as part of a comprehensive pain management protocol, which should include score interpretation and verification with appropriately suggested treatments. The Observational Pain Management Protocol (Protocol) was therefore developed. This study aims to investigate the extent to which the implementation of this Protocol can improve pain management in care home residents with dementia. ⋯ Although similar pain protocols have been suggested previously, the recommendations were based on experts' opinions rather than evaluation of research studies. The feasibility and effectiveness of this kind of pain management protocol, tailored to older people with dementia, remains unknown. The findings of this trial will offer strong evidence that better strategies for pain management should be used in the care home daily routine.
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Randomized Controlled Trial Comparative Study
Transversus abdominis plane block versus perioperative intravenous lidocaine versus patient-controlled intravenous morphine for postoperative pain control after laparoscopic colorectal surgery: study protocol for a prospective, randomized, double-blind controlled clinical trial.
Despite the laparoscopic approach becoming the standard in colorectal surgery, postoperative pain management for minimally invasive surgery is still mainly based on strategies that have been established for open surgical procedures. Patient-controlled epidural and intravenous analgesia are considered standard postoperative analgesia regimens in colorectal surgery. Epidural analgesia provides excellent analgesia, but is increasingly scrutinized in laparoscopic surgery since postoperative pain after the laparoscopic approach is significantly reduced. Moreover, epidural analgesia can be associated with numerous complications. Therefore, epidural analgesia is no longer recommended for the management of postoperative pain in laparoscopic colorectal surgery. Likewise, patient-controlled intravenous analgesia is subject to significant side effects. Given these important limitations of the traditional strategies for postoperative analgesia, effective and efficient alternatives in patients undergoing laparoscopic colorectal surgery are needed. Both the transversus abdominis plane block and systemically administered lidocaine have already been reported to effectively reduce pain after laparoscopic colorectal surgery. We hypothesize that the transversus abdominis plane block is superior to perioperative intravenous lidocaine. ⋯ Recognizing the importance of a multimodal approach for perioperative pain management, we aim to investigate whether a transversus abdominis plane block delivers superior pain control in comparison to perioperative intravenous lidocaine and patient-controlled intravenous analgesia with morphine alone.
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Randomized Controlled Trial Multicenter Study
An efficacy and mechanism evaluation study of Levosimendan for the Prevention of Acute oRgan Dysfunction in Sepsis (LeoPARDS): protocol for a randomized controlled trial.
Organ dysfunction consequent to infection ('severe sepsis') is the leading cause of admission to an intensive care unit (ICU). In both animal models and early clinical studies the calcium channel sensitizer levosimendan has been demonstrated to have potentially beneficial effects on organ function. The aims of the Levosimendan for the Prevention of Acute oRgan Dysfunction in Sepsis (LeoPARDS) trial are to identify whether a 24-hour infusion of levosimendan will improve organ dysfunction in adults who have septic shock and to establish the safety profile of levosimendan in this group of patients. ⋯ This trial will test the efficacy of levosimendan to reduce acute organ dysfunction in adult patients who have septic shock and evaluate its biological mechanisms of action.
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Randomized Controlled Trial Multicenter Study Comparative Study
A comparison of cognitive-behavioral couple therapy and lidocaine in the treatment of provoked vestibulodynia: study protocol for a randomized clinical trial.
Provoked vestibulodynia (PVD), a frequent form of chronic genital pain, is associated with decreased sexual function for afflicted women, as well as impoverished sexual satisfaction for women and their partners. Pain and sexuality outcomes for couples with PVD are influenced by interpersonal factors, such as pain catastrophizing, partner responses to pain, ambivalence over emotional expression, attachment style and perceived relationship and sexual intimacy. Despite recommendations in the literature to include the partner in cognitive-behavioral therapy targeted at improving pain and sexuality outcomes, no randomized clinical trial has tested the efficacy of this type of intervention and compared it to a first-line medical intervention. ⋯ The randomized clinical trial design is the most appropriate to examine the efficacy of cognitive-behavioral couple therapy, a recently developed and pilot-tested psychosocial intervention for couples coping with PVD, in comparison to a frequent first-line treatment option, topical lidocaine. Findings from this study will provide important information about empirically supported treatment options for PVD, and inform future treatment development and research for this patient population.