Trials
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Randomized Controlled Trial
The influence of surface EMG-triggered multichannel electrical stimulation on sensomotoric recovery in patients with lumbar disc herniation: study protocol for a randomized controlled trial (RECO).
Intervertebral disc degeneration is one of the most common reasons for chronic low back pain and sensomotoric deficits, often treated by lumbar sequestrectomy. Nevertheless, the prognostic factors relevant for time and quality of recovery, of the surgical procedure, relative to conservative treatment, remain controversial and require further investigation. Surface electrical stimulation (SES) may be an influential intervention, already showing positive impact on motor and sensory recovery in different patient groups. Since mechanisms of SES still remain unclear, further inquiry is needed. ⋯ The results of the RECO study will detect the effect of EMG-triggered multichannel SES on the improvement of mechanical and thermal sensitivity and the effect on motor recovery and pain, associated with clinical and laboratory parameters. Furthermore, data comparing surgical and conservative treatment can be collected. This will hopefully allow treatment recommendations for patients with LDH accompanied by a sensomotoric deficit.
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Randomized Controlled Trial Comparative Study
Herbst appliance with skeletal anchorage versus dental anchorage in adolescents with Class II malocclusion: study protocol for a randomised controlled trial.
The Herbst appliance is an orthodontic appliance that is used for the correction of class II malocclusion with skeletal discrepancies. Research has shown that this is effective. However, a potential harm is excessive protrusion of the lower front teeth. This is associated with gingival recession, loss of tooth support, and root resorption. This trial evaluates a method of reducing this problem. ⋯ If this new intervention is effective, the findings can change orthodontic practice and may also be relevant to other forms of treatment in which appliances are fixed to the bones of the jaws. However, if the bone anchoring is not effective, the trial will provide much needed information on the use of this comparatively new development.
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Randomized Controlled Trial Multicenter Study Comparative Study
Comparison of the effect of high versus low mean arterial pressure levels on clinical outcomes and complications in elderly patients during non-cardiothoracic surgery under general anesthesia: study protocol for a randomized controlled trial.
Intraoperative blood pressure (BP) is a concern in daily clinic anesthesia and contributes to the differences in clinical outcome. We conducted a randomized controlled trial (RCT) to compare the effect of high vs. low mean arterial pressure (MAP) levels on clinical outcomes and complications in elderly patients under general anesthesia (GA). ⋯ Results of this trial will help clarify whether BP management is beneficial for elderly patients under GA and will make clear whether the effect of high-level MAP can reduce the postoperative complication compared to low-level MAP.
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Randomized Controlled Trial Multicenter Study Comparative Study
The ICU-Diary study: prospective, multicenter comparative study of the impact of an ICU diary on the wellbeing of patients and families in French ICUs.
Post-intensive care syndrome includes the multiple consequences of an intensive care unit (ICU) stay for patients and families. It has become a new challenge for intensivists. Prevention programs have been disappointing, except for ICU diaries, which report the patient's story in the ICU. However, the effectiveness of ICU diaries for patients and families is still controversial, as the interpretation of the results of previous studies was open to criticism hampering an expanded use of the diary. The primary objective of the study is to evaluate the post-traumatic stress syndrome in patients. The secondary objectives are to evaluate the post-traumatic stress syndrome in families, anxiety and depression symptoms in patients and families, and the recollected memories of patients. Endpoints will be evaluated 3 months after ICU discharge or death. ⋯ This study will provide new insights on the impact of ICU diaries on post-traumatic stress disorders in patients and families after an ICU stay.
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Randomized Controlled Trial Comparative Study
Intramuscular oxytocin versus intravenous oxytocin to prevent postpartum haemorrhage at vaginal delivery (LabOR trial): study protocol for a randomised controlled trial.
Primary postpartum haemorrhage (PPH) is one of the leading causes of maternal morbidity and mortality worldwide. The most common cause of primary PPH is uterine atony. Atonic PPH rates are increasing in developed countries despite routine active management of the third stage of labour. In less-developed countries, primary PPH remains the leading cause of maternal death. Although the value of routine oxytocics in the third stage of labour has been well established, there is inconsistent practice in the choice of agent and route of administration. Oxytocin is the preferred agent because it has fewer side effects than other uterotonics with similar efficacy. It can be given intravenously or intramuscularly; however, to date, the most effective route of administering oxytocin has not been established. ⋯ Given the increasing trends of atonic PPH it is both important and timely that we evaluate the most effective route of oxytocin administration for the management of the third stage of labour. To date, there has been limited research comparing the efficacy of intramuscular oxytocin vs intravenous oxytocin for the third stage of labour.