Trials
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Idiopathic normal-pressure hydrocephalus (iNPH) is a distinct form of dementia, characterized by gait ataxia, cognitive impairment and urinary incontinence. In contrast to all other causes of dementia (e.g., Alzheimer-type and others), ventriculoperitoneal (VP) shunt surgery may offer a curative treatment option to patients. While being a rather low-risk type of surgery, it may cause significant over- or underdrainage complications (e.g., headaches, dizziness, vomiting, intracerebral bleeding, etc.) during posture change. Anti-siphon devices (ASDs) are a group of technically different additional valves used in shunt surgery. They are designed to maintain intraventricular pressure within a normal physiological range regardless of patient position. Fixed ASDs proved to substantially lower the rate of overdrainage complications. No significant differences, however, were noted regarding underdrainage complications. Technical successors of fixed ASDs are programmable ASDs. The aim of this study is to evaluate whether programmable ASDs compared to fixed ASDs are able to avoid both over- and underdrainage complications. ⋯ SYGRAVA is the first randomized trial to determine whether programmable ASDs reduce complications of drainage compared to fixed ASDs in patients with iNPH. The results of this study may contribute to health-technology assessment of different valve systems used for VP-shunt surgery, and determination of the future standard of care.
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Site performance is key to the success of large multicentre randomised trials. A standardised set of clear and accessible summaries of site performance could facilitate the timely identification and resolution of potential problems, minimising their impact. The aim of this study was to identify and agree a core set of key performance metrics for managing multicentre randomised trials. ⋯ We have established a core set of metrics for measuring the performance of sites in multicentre randomised trials. These metrics could improve trial conduct by enabling researchers to identify and address problems before trials are adversely affected. Future work could evaluate the effectiveness of using the metrics and reporting tool.
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Acupuncture has been widely applied in the clinic to treat irritable bowel syndrome (IBS), but the underlying mechanism remains unknown. Diffuse noxious inhibitory control (DNIC) is deficient in patients with IBS, which attenuates the systemic analgesic effect elicited by noxious stimulation that is remote from pain areas. Therefore, the aim of this study is to investigate the analgesic effect of electroacupuncture (EA) at homotopic or heterotopic acupoints on abdominal pain in patients with IBS. ⋯ The aim of this study is to assess the analgesic effect of EA at homotopic (abdomen) acupoints and heterotopic (lower limb) acupoints on abdominal pain in patients with IBS, as well as the difference in analgesic effects between noxious and innocuous stimulation.
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Recent data suggest that 10-20% of injury patients will suffer for several months after the event from diverse symptoms, generally referred to as post-concussion-like symptoms (PCLS), which will lead to a decline in quality of life. A preliminary randomized control trial suggested that this condition may be induced by the stress experienced during the event or emergency room (ER) stay and can be prevented in up to 75% of patients with a single, early, short eye movement desensitization and reprocessing (EMDR) psychotherapeutic session delivered in the ER. The protocol of the SOFTER 3 study was designed to compare the impact on 3-month PCLS of early EMDR intervention and usual care in patients presenting at the ER. Secondary outcomes included 3-month post-traumatic stress disorder, 12-month PCLS, self-reported stress at the ER, self-assessed recovery expectation at discharge and 3 months, and self-reported chronic pain at discharge and 3 months. ⋯ In 2012, the year of the last national survey in France, 10.6 million people attended the ER, some of whom did so several times since 18 million visits were recorded in the same year. The SOFTER 3 study therefore addresses a major public health challenge.
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Tinnitus is a highly prevalent symptom affecting 10-15% of the adult population. It often affects patient quality of life and frequently causes distress. When subjective tinnitus can be elicited by the somatosensory system of the cervical spine or temporomandibular area it is termed somatic tinnitus. The first aim of the current study is to investigate the effect of the best evidence conservative temporomandibular disorder (TMD) treatment on tinnitus in patients with co-existence of tinnitus and TMD or oral parafunctions compared to no treatment. The second aim is to identify a subgroup of patients with tinnitus that benefits from the conservative temporomandibular joint treatment. ⋯ Herein, we aim to improve the quality of care for patients with tinnitus attributed to TMD or oral parafunctions. By evaluating the effect of state-of-the-art TMD treatment on tinnitus complaints, we can investigate the usefulness of TMD treatment in patients with somatic tinnitus.