Trials
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Randomized Controlled Trial Multicenter Study Comparative Study
Intensive exercise program after spinal cord injury ("Full-On"): study protocol for a randomized controlled trial.
Rehabilitation after spinal cord injury (SCI) has traditionally involved teaching compensatory strategies for identified impairments and deficits in order to improve functional independence. There is some evidence that regular and intensive activity-based therapies, directed at activation of the paralyzed extremities, promotes neurological improvement. The aim of this study is to compare the effects of a 12-week intensive activity-based therapy program for the whole body with a program of upper body exercise. ⋯ The results of this trial will determine the effectiveness of a 12-week program of intensive exercise for the whole body in improving neurological recovery after spinal cord injury.
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Randomized Controlled Trial Multicenter Study Comparative Study
Guided Application of Ventricular Catheters (GAVCA)--multicentre study to compare the ventricular catheter position after use of a catheter guide versus freehand application: study protocol for a randomised trail.
The standard technique for the placement of ventricular catheters (VC) comprises a high proportion of malpositioning of the catheter (12.5 to 40%). Technical advances such as neuronavigation or ultrasound have been shown to increase the accuracy of the procedure. Since these means result in significant technical and time consuming efforts, they are used for selected cases only. In order to simplify the controlled placement of ventricular catheters a newly developed smartphone assisted guiding tool has been introduced. In this study the efficacy and safety of this guiding tool is determined. ⋯ The Guided Application of Ventricular Catheters (GAVCA) trial compares the guided catheter positioning with the standard freehand technique of catheter placement in hydrocephalic patients. If superiority is shown, the standard technique may be changed with the advantage of a more reliable and safer positioning of the ventricular catheter with just a slight effort in time and pre-operative planning.
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Randomized Controlled Trial
Use of dexmedetomidine for prophylactic analgesia and sedation in delayed extubation patients after craniotomy: a study protocol and statistical analysis plan for a randomized controlled trial.
Pain and agitation are common in patients after craniotomy. They can result in tachycardia, hypertension, immunosuppression, increased catecholamine production and increased oxygen consumption. Dexmedetomidine, an alpha-2 agonist, provides adequate sedation without respiratory depression, while facilitating frequent neurological evaluation. ⋯ The study has been initiated as planned in July 2012. One interim analysis advised continuation of the trial. The study will be completed in July 2013.
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Randomized Controlled Trial Comparative Study
P6 acupoint stimulation for prevention of postoperative nausea and vomiting in patients undergoing craniotomy: study protocol for a randomized controlled trial.
The incidence of postoperative nausea and vomiting (PONV) is 50 to 79% after neurosurgery. Our study is designed to evaluate the efficacy of pericardium 6 (P6; also known as Neiguan) acupoint stimulation versus placebo, and versus routine antiemetic for the prevention of PONV after craniotomy, as well as to compare the efficacy of invasive acupuncture with non-invasive transcutaneous electrical nerve stimulation (TENS) on P6. ⋯ The results from this study could potentially confirm that P6 acupoint stimulation is an effective adjunct to standard antiemetic drug therapy for the prevention of PONV in patients undergoing craniotomy. Our study may also confirm that conventional acupuncture is more effective than TENS.
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Randomized Controlled Trial Multicenter Study
Effectiveness of medicines review with web-based pharmaceutical treatment algorithms in reducing potentially inappropriate prescribing in older people in primary care: a cluster randomized trial (OPTI-SCRIPT study protocol).
Potentially inappropriate prescribing in older people is common in primary care and can result in increased morbidity, adverse drug events, hospitalizations and mortality. In Ireland, 36% of those aged 70 years or over received at least one potentially inappropriate medication, with an associated expenditure of over €45 million.The main objective of this study is to determine the effectiveness and acceptability of a complex, multifaceted intervention in reducing the level of potentially inappropriate prescribing in primary care. ⋯ This study will establish the effectiveness of a multifaceted intervention in reducing potentially inappropriate prescribing in older people in Irish primary care that is generalizable to countries with similar prescribing challenges.