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.

Background and Purpose-The NeuroThera Effectiveness and Safety Trial-1 (NEST-1) study evaluated the safety and preliminary effectiveness of the NeuroThera Laser System in the ability to improve 90-day outcomes in ischemic stroke patients treated within 24 hours from stroke onset. The NeuroThera Laser System therapeutic approach involves use of infrared laser technology and has shown significant and sustained beneficial effects in animal models of ischemic stroke. Methods-This was a prospective, intention-to-treat, multicenter, international, double-blind, trial involving 120 ischemic stroke patients treated, randomized 2:1 ratio, with 79 patients in the active treatment group and 41 in the sham (placebo) control group. Only patients with baseline stroke severity measured by National Institutes of Health Stroke Scale (NIHSS) scores of 7 to 22 were included. Patients who received tissue plasminogen activator were excluded. Outcome measures were the patients' scores on the NIHSS, modified Rankin Scale (mRS), Barthel Index, and Glasgow Outcome Scale at 90 days after treatment. The primary outcome measure, prospectively identified, was successful treatment, documented by NIHSS. This was defined as a complete recovery at day 90 (NIHSS 0 to 1), or a decrease in NIHSS score of at least 9 points (day 90 versus baseline), and was tested as a binary measure (bNIH). Secondary outcome measures included mRS, Barthel Index, and Glasgow Outcome Scale. Primary statistical analyses were performed with the Cochran-Mantel-Haenszel rank test, stratified by baseline NIHSS score or by time to treatment for the bNIH and mRS. Logistic regression analyses were conducted to confirm the results. Results-Mean time to treatment was Ͼ16 hours (median time to treatment 18 hours for active and 17 hours for control).Time to treatment ranged from 2 to 24 hours. More patients (70%) in the active treatment group had successful outcomes than did controls (51%), as measured prospectively on the bNIH (Pϭ0.035 stratified by severity and time to treatment; Pϭ0.048 stratified only by severity). Similarly, more patients (59%) had successful outcomes than did controls (44%) as measured at 90 days as a binary mRS score of 0 to 2 (Pϭ0.034 stratified by severity and time to treatment; Pϭ0.043 stratified only by severity). Also, more patients in the active treatment group had successful outcomes than controls as measured by the change in mean NIHSS score from baseline to 90 days (Pϭ0.021 stratified by time to treatment) and the full mRS ("shift in Rankin") score (Pϭ0.020 stratified by severity and time to treatment; Pϭ0.026 stratified only by severity). The prevalence odds ratio for bNIH was 1.40 (95% CI, 1.01 to 1.93) and for binary mRS was 1.38 (95% CI, 1.03 to 1.83), controlling for baseline severity. Similar results held for the Barthel Index and Glasgow Outcome Scale. Mortality rates and serious adverse events (SAEs) did not differ significantly (8.9% and 25.3% for active 9.8% and 36.6% for control, respectively, for mortality and SAEs). Conclusion-The NE...

Insulin lispro may be considered a treatment option for women with gestational diabetes.

Background and Objectives: Low-level laser therapy (LLLT) has been shown to have beneficial effects on ischemic skeletal and heart muscles tissues. The aim of the present study was to approve the effectiveness of LLLT treatment at different locations on the brain in acute stroked rats. Study Design/Materials and Methods: Stroke was induced in 169 rats that were divided into four groups: control non-laser and three laser-treated groups where laser was employed ipsilateral, contralateral, and both to the side of the induced stroke. Rats were tested for neurological function. Results: In all three laser-treated groups, a marked and significant improvement in neurological deficits was evident at 14, 21, and 28 days post stroke relative to the nontreated group. Conclusions: These observations suggest that LLLT applied at different locations in the skull and in a rather delayed-phase post stroke effectively improves neurological function after acute stroke in rats.

Laser application to NHNP cells significantly increases ATP production in these cells. These findings may explain the beneficial effects of low-level laser therapy (LLLT) in stroked rats. Tissue culture of NHNP cells might offer a good model to study the mechanisms associated with promotion of ATP production in the nervous system by LLLT.

Long-term safety tests lasting 30 and 70 days at optimal 10x and 100x doses, as well as at multiple doses at the same power densities, indicate that the tested laser energy doses are safe under this treatment regime. Neurological deficits and histopathological damage to 750 mW/cm2 CW laser irradiation are attributed to thermal damage and not due to tissue-photon interactions.

To evaluate phasic function and deformation of the left atrium (LA) and right atrium (RA) in subjects with prediabetes and type 2 diabetes mellitus. This cross-sectional study included 50 untreated normotensive subjects with prediabetes, 60 recently diagnosed normotensive diabetic patients and 60 healthy controls of similar sex and age. All the subjects underwent laboratory analyses and complete echocardiographic examination including strain analysis. LA and RA reservoir and conduit function gradually decreased, while booster pump increased, from the healthy controls, throughout the prediabetics, to the diabetics. The strain analysis of atrial phasic function showed more regular pattern of progressive atrial function deterioration than conventional evaluation with total, active and passive atrial function. In the whole study population HbA1c correlated with LA passive emptying fraction (r = -0.38, p < 0.01), LA active emptying fraction (r = 0.36, p < 0.01), LA longitudinal strain during systole (r = -0.35, p < 0.01), RA passive emptying fraction (r = -0.42, p < 0.01), RA active emptying fraction (r = 0.38, p < 0.01), and RA longitudinal strain during systole (r = -0.32, p < 0.01). However, only LA passive emptying fraction (β = -0.32, p < 0.01) and LA longitudinal strain during systole (β = -0.28, p = 0.02) were independently associated with HbA1c among the LA parameters; whereas solely RA passive emptying fraction (β = -0.37, p < 0.01) and RA active emptying fraction (β = 0.31, p = 0.01) were independently associated with HbA1c among the RA parameters. LA and RA phasic functions are significantly impaired in the prediabetics and the diabetics. The parameter of glucose control correlated with LA and RA reservoir, conduit and pump atrial function.

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