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Purpose: To describe the design and rationale of a series of postmarketing studies to examine the safety of saxagliptin, an oral dipeptidyl peptidase-4 inhibitor for the treatment of type 2 diabetes mellitus, in real-world settings., Methods: We are conducting a series of retrospective cohort studies using two UK (General Practice Research Database, and The Health Improvement Network) and two US (Medicare, HealthCore Integrated Research Database(SM) ) data sources. The primary outcomes of interest will include (i) hospitalization with acute liver failure, (ii) hospitalization for acute kidney injury, (iii) hospitalization for severe hypersensitivity reactions, (iv) hospitalization for severe infections, (v) hospitalization with infections associated with T-lymphocyte dysfunction (i.e., herpes zoster, tuberculosis, or nontuberculous mycobacteria), and (vi) major cardiovascular events. Diagnosis codes for the outcomes of interest will be validated by medical record review within each data source. Projected use and estimated incidence rates of outcomes of interest suggest there will be at least 80% statistical power to detect a minimum hazard ratio of 1.5 for major cardiovascular events, 2.0 for acute kidney injury and severe infections, 2.4 for acute liver failure, and 4.0 for severe hypersensitivity reactions., Results: Forthcoming., Conclusions: This postmarketing safety assessment will provide important information regarding the safety of saxagliptin and could potentially identify important dipeptidyl peptidase-4 inhibitor class effects. The methods described may be useful to others planning similar evaluations., (Copyright © 2012 John Wiley & Sons, Ltd.)

Background: Fatigue is a chief complaint in cancer patients, and warrants effective treatment. Biofield therapies are complementary medicine approaches used by cancer populations. There is little information about their efficacy., Methods: This blinded, randomized controlled trial examined the effects of 4 weeks (eight 1-hour sessions) of biofield healing compared with mock healing and a waitlist control group on fatigue in 76 fatigued breast cancer survivors (stages I-IIIa). Secondary outcomes were diurnal cortisol variability (via estimates of cortisol slope), depression, and quality of life (QOL). Treatment belief was assessed to explore whether belief predicted outcomes. Data were analyzed via hierarchical linear modeling., Results: There were no significant differences between biofield healing and mock healing on belief; 75% thought they received biofield healing. Compared with controls, biofield healing significantly decreased total fatigue (P < .0005, Cohen's d = 1.04), as did mock healing (P = .02, Cohen's d = 0.68), with no significant differences between biofield healing and mock healing. Cortisol slope significantly decreased for biofield healing versus both mock healing and control (P < .04 in both cases; Cohen's d = 0.58). Belief predicted changes in QOL over and above group (P = .004, Cohen's d = 0.84). Belief did not impact fatigue or cortisol variability., Conclusions: Nonspecific factors are important in responses to biofield interventions for fatigue. Belief predicts QOL responses but not fatigue or cortisol variability. Biofield therapies increase cortisol variability independent of belief and other nonspecific factors. There is a need to further examine the effects of specific processes of biofield healing on outcomes for cancer populations., (Copyright © 2011 American Cancer Society.)

Measurement of the EEG during fMRI scanning can give rise to image distortions due to magnetic susceptibility, eddy currents or chemical shift artifacts caused by certain types of EEG electrodes, cream, leads, or amplifiers. Two different creams were tested using MRS and T2* measurements, and we found that the one with higher water content was superior. This study introduces an index that quantifies the influence of EEG equipment on the BOLD fMRI signal. This index can also be used more generally to measure the changes in the fMRI signal due to the presence of any type of device inside (or outside) of the field of view (e.g., with fMRI and diffuse optical tomography, infrared imaging, transcranial magnetic stimulation, ultrasound imaging, etc.). Quantitative noise measurements are hampered by the normal variability of functional activation within the same subject and by the different slice profiles obtained when inserting a subject multiple times inside a MR imaging system. Our measurements account for these problems by using a matched filtering of cortical surface maps of functional activations. The results demonstrate that the BOLD signal is not influenced by the presence of EEG electrodes when using a properly constructed MRI compatible recording cap., (Copyright 2001 Wiley-Liss, Inc.)

A quiet magnetic resonance (MR) imaging technique for detecting changes in cerebral activity functions is presented. This single-shot method, functional Burst imaging (FBI), combines elements of Burst imaging with an offset technique known as asymmetric spin echo (ASE). The FBI sequence has the unique feature of being nearly silent, because of the low number of gradient switching steps involved. Furthermore, this approach has the key advantage that it can be implemented on conventional MR systems. Established auditory and visual paradigms were used to evaluate whether FBI can detect changes in cerebral activity using a 1.5 Tesla MR system. In a second set of experiments, the FBI technique was used to evaluate cerebral activity changes during different sleep stages in humans. The results obtained demonstrate that the FBI sequence provides an alternative approach for functional imaging of brain activity in primary and secondary sensory areas of the human brain. Furthermore, in using this quiet MR technique, it was possible to scan continuously during different stages of human sleep without acoustic noise perturbation.

We previously observed tht low oral doses of melatonin given at noon increase blood melatonin concentrations to those normally occurring nocturnally and facilitate sleep onset, as assessed using and involuntary muscle relaxation test. In this study we examined the induction of polysomnographically recorded sleep by similar doses given later in the evening, close to the times of endogenous melatonin release and habitual sleep onset. Volunteers received the hormone (oral doses of 0.3 or 1.0 mg) or placebo at 6, 8, or 9 PM. Latencies to sleep onset, to stage 2 sleep, and to rapid eye movement (REM) sleep were measured polysomnographically. Either dose given at any of the three time points decreased sleep onset latency and latency to stage 2 sleep. Melatonin did not suppress REM sleep or delay its onset. Most volunteers could clearly distinguish between the effects of melatonin and those of placebo when the hormone was tested at 6 or 8 PM. Neither melatonin dose induced "hangover" effects, as assessed with mood and performance tests administered on the morning after treatment. These data provide new evidence that nocturnal melatonin secretion may be involved in physiologic sleep onset and that exogenous melatonin may be useful in treating insomnia.

Although ECT as the treatment of choice for psychotic depression has been in use for many years, little is known about the neocortical residual of such treatments inferred from behavioral measures. The major portion of the literature has been concerned with inferred or observed changes in affective state. The present study compared pre- and posttreatment performances on the Halstead-Reitan neuropsychological battery of 20 patients who were receiving ECT from two different machines. Most Ss gave indicators of cerebral impairment prior to treatment when performance of one side of the body was contrasted with performance of the other side. After treatment, there was an increased number of Ss who evidenced signs consistent with damage to the right cerebral hemisphere. Some concern was raised that a large number of patients who eventually are subject ot ECT because of depression behave in this way because of an undiagnosed neocortical dysfunction. There is some suggestion that the effect of the procedure is to either create or intensify a right hemisphere focus as inferred from behavioral measures.