for the ROFECOXIB PHASE III PROTOCOL 035 STUDY GROUP Objective. To compare the clinical efficacy of rofecoxib, a specific inhibitor of cyclooxygenase 2 (COX-2), with that of diclofenac in patients with osteoarthritis (OA) and to evaluate the safety and tolerability of rofecoxib.Methods. We performed a randomized, doubleblind, active comparator-controlled trial in 784 adults with OA of the knee or hip. Patients were randomized to 1 of 3 treatment groups: 12.5 mg of rofecoxib once daily, 25 mg of rofecoxib once daily, and 50 mg of diclofenac 3 times daily. Clinical efficacy and safety were evaluated over a 1-year continuous treatment period.Results. Rofecoxib at dosages of 12.5 and 25 mg demonstrated efficacy that was clinically comparable to that of diclofenac, as assessed by all 3 primary end points according to predefined comparability criteria. Results from secondary end points were consistent with those of the primary end points. There were small statistical differences favoring diclofenac for 2 of the end points. All treatments were well tolerated.Conclusion. Rofecoxib was well tolerated and provided efficacy that was clinically comparable, according to predefined statistical criteria, to that of 150 mg of diclofenac per day in this 1-year study. Specific inhibition of COX-2 provided therapeutic efficacy in OA.
Wireless neural stimulators are being developed to address problems associated with traditional lead-based implants. However, designing wireless stimulators on the sub-millimeter scale (<1 mm3) is challenging. As device size shrinks, it becomes difficult to deliver sufficient wireless power to operate the device. Here, we present a sub-millimeter, inductively powered neural stimulator consisting only of a coil to receive power, a capacitor to tune the resonant frequency of the receiver, and a diode to rectify the radio-frequency signal to produce neural excitation. By replacing any complex receiver circuitry with a simple rectifier, we have reduced the required voltage levels that are needed to operate the device from 0.5 to 1 V (e.g., for CMOS) to ~0.25–0.5 V. This reduced voltage allows the use of smaller receive antennas for power, resulting in a device volume of 0.3–0.5 mm3. The device was encapsulated in epoxy, and successfully passed accelerated lifetime tests in 80°C saline for 2 weeks. We demonstrate a basic proof-of-concept using stimulation with tens of microamps of current delivered to the sciatic nerve in rat to produce a motor response.
Although there is much research to support the effectiveness of classwide interventions aimed at improving student engagement, there is also a great deal of variability in terms of how response to group-level intervention has been measured. The unfortunate consequence of this procedural variability is that it is difficult to determine whether differences in obtained results across studies are attributable to the way in which behavior was measured or actual intervention effectiveness. The purpose of this study was to comparatively evaluate the most commonly used observational methods for monitoring the effects of classwide interventions in terms of the degree to which obtained data represented actual behavior. The 5 most common sampling methods were identified and evaluated against a criterion generated by averaging across observations conducted on 14 students in one seventh-grade classroom. Results suggested that the best approximation of mean student engagement was obtained by observing a different student during each consecutive 15-s interval whereas observing an entire group of students during each interval underestimated the mean level of behavior within a phase and the degree of behavior change across phases. In contrast, when observations were restricted to the 3 students with the lowest levels of engagement, data revealed greater variability in engagement across baseline sessions and suggested a more notable change in student behavior subsequent to intervention implementation.
Rofecoxib is effective in treating OA with once-daily dosing for 6 weeks and 1 year. Rofecoxib was generally safe and well-tolerated in OA patients for 6 weeks and 1 year. Arch Fam Med. 2000;9:1124-1134
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