MD; for the NEST-2 InvestigatorsBackground and Purpose-We hypothesized that transcranial laser therapy (TLT) can use near-infrared laser technology to treat acute ischemic stroke. The NeuroThera Effectiveness and Safety Trial-2 (NEST-2) tested the safety and efficacy of TLT in acute ischemic stroke. Methods-This double-blind, randomized study compared TLT treatment to sham control. Patients receiving tissue plasminogen activator and patients with evidence of hemorrhagic infarct were excluded. The primary efficacy end point was a favorable 90-day score of 0 to 2 assessed by the modified Rankin Scale. Other 90-day end points included the overall shift in modified Rankin Scale and assessments of change in the National Institutes of Health Stroke Scale score. Results-We randomized 660 patients: 331 received TLT and 327 received sham; 120 (36.3%) in the TLT group achieved favorable outcome versus 101 (30.9%), in the sham group (Pϭ0.094), odds ratio 1.38 (95% CI, 0.95 to 2.00).Comparable results were seen for the other outcome measures. Although no prespecified test achieved significance, a post hoc analysis of patients with a baseline National Institutes of Health Stroke Scale score of Ͻ16 showed a favorable outcome at 90 days on the primary end point (PϽ0.044). Mortality rates and serious adverse events did not differ between groups with 17.5% and 17.4% mortality, 37.8% and 41.8% serious adverse events for TLT and sham, respectively. Conclusions-TLT within 24 hours from stroke onset demonstrated safety but did not meet formal statistical significance for efficacy. However, all predefined analyses showed a favorable trend, consistent with the previous clinical trial (NEST-1). Both studies indicate that mortality and adverse event rates were not adversely affected by TLT. A definitive trial with refined baseline National Institutes of Health Stroke Scale exclusion criteria is planned.
Current management of neuromyelitis optica (NMO) is noncurative and only partially effective. Immunosuppressive or immunomodulatory agents are the mainstays of maintenance treatment. Safer, better-tolerated, and proven effective treatments are needed. The perceived rarity of NMO has impeded clinical trials for this disease. However, a diagnostic biomarker and recognition of a wider spectrum of NMO presentations has expanded the patient population from which study candidates might be recruited. Emerging insights into the pathogenesis of NMO have provided rationale for exploring new therapeutic targets. Academic, pharmaceutical, and regulatory communities are increasingly interested in meeting the unmet needs of patients with NMO. Clinical trials powered to yield unambiguous outcomes and designed to facilitate rapid evaluation of an expanding pipeline of experimental agents are needed. NMO-related disability occurs incrementally as a result of attacks; thus, limiting attack frequency and severity are critical treatment goals. Yet, the severity of NMO and perception that currently available agents are effective pose challenges to study design. We propose strategies for NMO clinical trials to evaluate agents targeting recovery from acute attacks and prevention of relapses, the 2 primary goals of NMO treatment. Aligning the interests of all stakeholders is an essential step to this end.
Laboratory measurements of coefficients of friction of soft rubber compounds were made by towing specimens on horizontal tracks and by allowing them to slide down inclined tracks. The specimens were prepared by attaching the rubber to a metal backing and molding it against glass surfaces having different degrees of roughness. The coefficients increase markedly with speed, ranging from about 1 at 10-' cm/sec to more than 4 at 5 cm/ sec. The occurrence of vibrations prevented observations at higher speeds. Static friction is greater than dynamic friction for speeds appreciably less than 10-3 cm/sec and less than dynamic friction for greater speeds. The coefficients decrease slightly with increasing pressures and are independent of the size of the specimen. Except at very low speeds the smoother surfaces yield the higher coefficients. Materials such as talc or bloom on the sliding surfaces cause large decreases in the coefficients.Attention is called to the dependence of the coefficients of friction on the speed, which is shown in several previous investigations on rubber and other materials. CONTENTS Page
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