Trials
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Randomized Controlled Trial Multicenter Study
Efficacy of naloxone in reducing postictal central respiratory dysfunction in patients with epilepsy: study protocol for a double-blind, randomized, placebo-controlled trial.
Generalized tonic-clonic seizures (GTCSs) are the main risk factor for sudden unexpected death in epilepsy (SUDEP). Experimental and clinical data strongly suggest that the majority of SUDEP results from a postictal respiratory dysfunction progressing to terminal apnea. Postictal apnea could partly derive from a seizure-induced massive release of endogenous opioids. The main objective of this study is to evaluate the efficacy of an opioid antagonist, naloxone, administered in the immediate aftermath of a GTCS, in reducing the severity of the postictal central respiratory dysfunction. ⋯ The demonstration of naloxone's efficacy on the severity of postictal hypoxemia will have two primary consequences. First, naloxone would be the first and only therapeutic approach that could be delivered immediately to reverse postictal apnea. Second, demonstration that an opioid antagonist can effectively reduce postictal apnea would pave the way for an assessment of a preventive therapy for SUDEP targeting the same pathophysiological pathway using oral administration of naltrexone.
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Randomized Controlled Trial Multicenter Study
Evolving methods to combine cognitive and physical training for individuals with mild cognitive impairment: study protocol for a randomized controlled study.
Nonpharmacologic interventions, such as cognitive training or physical exercise, are effective in improving cognitive functions for older adults with mild cognitive impairment (MCI). Some researchers have proposed that combining physical exercise with cognitive training may augment the benefits of cognition. However, strong evidence is lacking regarding whether a combined therapy is superior to a single type of training for older adults with MCI. Moreover, which combination approach - combining physical exercise with cognitive training sequentially or simultaneously - is more advantageous for cognitive improvement is not yet clear. This proposed study is designed to clarify these questions. ⋯ The results of this proposed study will provide important information regarding the feasibility and intervention effects of combining physical exercise and cognitive training for older individuals with MCI.
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Randomized Controlled Trial
The effect of skin-to-skin contact at birth, early versus immediate, on the duration of exclusive human lactancy in full-term newborns treated at the Clínica Universidad de La Sabana: study protocol for a randomized clinical trial.
Human lactancy is a simple and cost-effective strategy that influences infant and maternal mortality rates. Skin-to-skin contact (SSC) is an immediate postpartum period strategy that has proven to benefit the initiation and continuation of human lactation and to decrease hospitalization during the first week of life. This study aims to determine the effect of SSC initiation at birth (immediate versus early) in healthy, full-term newborns treated at the Universidad de La Sabana Clinic on the duration of exclusive human lactation. ⋯ SSC at birth has shown benefits in the short and long term for both the mother and the full-term newborn. Although the meta-analysis that have been done have shown the benefits of this technique, multiple differences in the SSC interventions have been identified because criteria such as the initiation or duration of SSC (dose) have not been unified. Colombia has a malnutrition risk of 11,4 % in the total population for the period 2012-2014, so it is necessary to promote strategies that generate a positive impact on the duration of human lactation, providing support from the clinical setting of humanized delivery which is included in the IAMI strategy (Instituciones Amigas de la Mujer y la Infancia - Friends of Women and Children Institution). Therefore, we propose that the initiation time of SSC in full-term new-borns is related to the duration of exclusive human lactation.
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Randomized Controlled Trial Multicenter Study
Acupuncture for the treatment of phantom limb syndrome in lower limb amputees: a randomised controlled feasibility study.
Post amputation, the complication of phantom limb pain (PLP) is prevalent and difficult to manage. This study aimed to determine whether it was feasible and acceptable to undertake a definitive multicentred randomised controlled trial assessing the effectiveness of acupuncture for treating lower limb amputees with PLP. ⋯ A future definitive trial may be possible if the areas identified in this study are addressed. As acupuncture may be effective at treating PLP, and as this feasibility study suggests that a definitive trial may be possible, a multicentred trial with adequate sample size and blinding is now needed.
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Randomized Controlled Trial Multicenter Study
Measurement of HbA1c in multicentre diabetes trials - should blood samples be tested locally or sent to a central laboratory: an agreement analysis.
Glycated haemoglobin (HbA1c) is an important outcome measure in diabetes clinical trials. For multicentre designs, HbA1c can be measured locally at participating centres or by sending blood samples to a central laboratory. This study analyses the agreement between local and central measurements, using 1-year follow-up data collected in a multicentre randomised controlled trial (RCT) of newly diagnosed children with type I diabetes. ⋯ Variation in agreement between HbA1c measurements was greater than had been expected although no overall bias was detected and standard deviations were similar. Discrepancies were present across all participating centres. These findings have implications for the comparison of standards of clinical care between centres, the design of future multicentre RCTs and existing quality assurance processes for HbA1c measurements. We recommend that centralised HbA1c measurement is preferable in the multicentre clinical trial setting.