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Distribution by Scientific Domains

Medical Sciences	78%
Life Sciences	10%
Humanities and Social Sciences	10%

Selected Abstracts

Atrioventricular Nodal Reentrant Tachycardia in Children: Effect of Slow Pathway Ablation on Fast Pathway Function

JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, Issue 3 2002
GEORGE F. VAN HARE M.D.
AV Nodal Reentry in Children.Introduction: Prior studies in adults have shown significant shortening of the fast pathway effective refractory period after successful slow pathway ablation. As differences between adults and children exist in other characteristics of AV nodal reentrant tachycardia (AVNRT), we sought to characterize the effect of slow pathway ablation or modification in a multicenter study of pediatric patients. Methods and Results: Data from procedures in pediatric patients were gathered retrospectively from five institutions. Entry criteria were age < 21 years, typical AVNRT inducible with/without isoproterenol infusion, and attempted slow pathway ablation or modification. Dual AV nodal pathways were defined as those with > 50 msec jump in A2-H2 with a 10-msec decrease in A1-A2. Successful ablation was defined as elimination of AVNRT inducibility. A total of 159 patients (age 4.4 to 21 years, mean 13.1) were studied and had attempted slow pathway ablation. AVNRT was inducible in the baseline state in 74 (47%) of 159 patients and with isoproterenol in the remainder. Dual AV nodal pathways were noted in 98 (62%) of 159 patients in the baseline state. Ablation was successful in 154 (97%) of 159 patients. In patients with dual AV nodal pathways and successful slow pathway ablation, the mean fast pathway effective refractory period was 343 ± 68 msec before ablation and 263 ± 64 msec after ablation. Mean decrease in the fast pathway effective refractory period was 81 ± 82 msec (P < 0.0001) and was not explained by changes in autonomic tone, as measured by changes in sinus cycle length during the ablation procedure. Electrophysiologic measurements were correlated with age. Fast pathway effective refractory period was related to age both before (P = 0.0044) and after ablation (P < 0.0001). AV block cycle length was related to age both before (P = 0.0005) and after ablation (P < 0.0001). However, in dual AV nodal pathway patients, the magnitude of change in the fast pathway effective refractory period after ablation was not related to age. Conclusion: Lack of clear dual AV node physiology is common in pediatric patients with inducible AVNRT (38%). Fast pathway effective refractory period shortens substantially in response to slow pathway ablation. The magnitude of change is large compared with adult reports and is not completely explained by changes in autonomic tone. Prospective studies in children using autonomic blockade are needed. [source]

Occipital Nerve Blocks: Effect of Symptomatic Medication

HEADACHE, Issue 10 2009
Headache Type on Failure Rate, Overuse
Objective., To explore the effect of symptomatic medication overuse (SMO) and headache type on occipital nerve block (ONB) efficacy. Methods., We conducted a chart review of all of the ONBs performed in our clinic over a 2-year period. Results., Of 108 ONBs with follow-up data, ONB failed in 22% of injections overall. Of the other 78%, the mean decrease in head pain was 83%, and the benefit lasted a mean of 6.6 weeks. Failure rate without SMO was 16% overall, and with SMO was 44% overall (P < .000). In those who did respond, overall magnitude and duration of response did not differ between those with and those without SMO. Without SMO, ONB failure rate was 0% for postconcussive syndrome, 14% for occipital neuralgia, 11% for non-intractable migraine, and 39% for intractable migraine. With SMO, failure rate increased by 24% (P = .14) in occipital neuralgia, by 36% (P = .08) for all migraine, and by 52% (P = .04) for non-intractable migraine. Conclusions., SMO tripled the risk of ONB failure, possibly because medication overuse headache does not respond to ONB. SMO increased ONB failure rate more in migraineurs than in those with occipital neuralgia, possibly because migraineurs are particularly susceptible to medication overuse headache. This effect was much more pronounced in non-intractable migraineurs than in intractable migraineurs. [source]

Treatment response to transcatheter arterial embolization and chemoembolization in primary and metastatic tumors of the liver

HPB, Issue 6 2008
Avo Artinyan
Abstract Introduction. Transcatheter arterial embolization (TAE) and chemoembolization (TACE) are increasingly used to treat unresectable primary and metastatic liver tumors. The purpose of this study was to determine the objective response to TAE and TACE in unresectable hepatic malignancies and to identify clinicopathologic predictors of response. Materials and methods. Seventy-nine consecutive patients who underwent 119 TAE/TACE procedures between 1998 and 2006 were reviewed. The change in maximal diameter of 121 evaluable lesions in 56 patients was calculated from pre and post-procedure imaging. Response rates were determined using Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. The Kaplan-Meier method was used to compare survival in responders vs. non-responders and in primary vs. metastatic histologies. Results. TAE and TACE resulted in a mean decrease in lesion size of 10.3%±1.9% (p<0.001). TACE (vs. TAE) and carcinoid tumors were associated with a greater response (p<0.05). Lesion response was not predicted by pre-treatment size, vascularity, or histology. The RECIST partial response (PR) rate was 12.3% and all partial responders were in the TACE group. Neuroendocrine tumors, and specifically carcinoid lesions, had a significantly greater PR rate (p<0.05). Overall survival, however, was not associated with histology or radiologic response. Discussion. TAE and TACE produce a significant objective treatment response by RECIST criteria. Response is greatest in neuroendocrine tumors and is independent of vascularity and lesion size. TACE appears to be superior to TAE. Although an association of response with improved survival was not demonstrated, large cohort studies are necessary to further define this relationship. [source]

Safety and tolerability of duloxetine in the treatment of major depressive disorder: analysis of pooled data from eight placebo-controlled clinical trials

HUMAN PSYCHOPHARMACOLOGY: CLINICAL AND EXPERIMENTAL, Issue 5 2005
James I. Hudson
Abstract Objective To examine the safety and tolerability of the antidepressant duloxetine across multiple studies for major depressive disorder (MDD). Method Safety data were integrated from the acute phases of eight double-blind, placebo-controlled trials in which patients were randomized to duloxetine (40,120,mg/d; n,=,1139) or placebo (n,=,777) for up to 9 weeks. This data set included all acute-phase clinical trials that formed the basis of the New Drug Application (United States) or European Union submission package for duloxetine in the treatment of MDD. Two studies included continuation phases in which acute treatment responders received duloxetine or placebo for an additional 26 weeks. Safety assessments included serious adverse event reports, rates of discontinuation, spontaneously reported treatment-emergent adverse events, changes in vital signs and laboratory values, and electrocardiograms. Results The rates of serious adverse events for duloxetine- and placebo-treated patients were 0.3% and 0.6%, respectively (p,=,0.282). Adverse events led to discontinuation in 9.7% of duloxetine-treated patients, compared with 4.2% of patients receiving placebo (p,<,0.001). Treatment-emergent adverse events with an incidence for duloxetine ,,5.0% and significantly greater than placebo were nausea, dry mouth, constipation, insomnia, dizziness, fatigue, somnolence, increased sweating and decreased appetite. Mean changes in blood pressure and heart rate were small, and the incidence of increases above normal ranges was low. Duloxetine-treated patients had a mean decrease in weight of 0.5,kg compared with an increase of 0.2,kg for patients receiving placebo (p,<,0.001). No significant differences were found between duloxetine and placebo in the incidence of potentially clinically significant laboratory values at anytime while on treatment. Conclusion These results are consistent with those obtained previously from smaller pooled data sets, and suggest that duloxetine is safe and well tolerated in patients with MDD. Copyright © 2005 John Wiley & Sons, Ltd. [source]

Are niche-based species distribution models transferable in space?

JOURNAL OF BIOGEOGRAPHY, Issue 10 2006
Christophe F. Randin
Abstract Aim, To assess the geographical transferability of niche-based species distribution models fitted with two modelling techniques. Location, Two distinct geographical study areas in Switzerland and Austria, in the subalpine and alpine belts. Methods, Generalized linear and generalized additive models (GLM and GAM) with a binomial probability distribution and a logit link were fitted for 54 plant species, based on topoclimatic predictor variables. These models were then evaluated quantitatively and used for spatially explicit predictions within (internal evaluation and prediction) and between (external evaluation and prediction) the two regions. Comparisons of evaluations and spatial predictions between regions and models were conducted in order to test if species and methods meet the criteria of full transferability. By full transferability, we mean that: (1) the internal evaluation of models fitted in region A and B must be similar; (2) a model fitted in region A must at least retain a comparable external evaluation when projected into region B, and vice-versa; and (3) internal and external spatial predictions have to match within both regions. Results, The measures of model fit are, on average, 24% higher for GAMs than for GLMs in both regions. However, the differences between internal and external evaluations (AUC coefficient) are also higher for GAMs than for GLMs (a difference of 30% for models fitted in Switzerland and 54% for models fitted in Austria). Transferability, as measured with the AUC evaluation, fails for 68% of the species in Switzerland and 55% in Austria for GLMs (respectively for 67% and 53% of the species for GAMs). For both GAMs and GLMs, the agreement between internal and external predictions is rather weak on average (Kulczynski's coefficient in the range 0.3,0.4), but varies widely among individual species. The dominant pattern is an asymmetrical transferability between the two study regions (a mean decrease of 20% for the AUC coefficient when the models are transferred from Switzerland and 13% when they are transferred from Austria). Main conclusions, The large inter-specific variability observed among the 54 study species underlines the need to consider more than a few species to test properly the transferability of species distribution models. The pronounced asymmetry in transferability between the two study regions may be due to peculiarities of these regions, such as differences in the ranges of environmental predictors or the varied impact of land-use history, or to species-specific reasons like differential phenotypic plasticity, existence of ecotypes or varied dependence on biotic interactions that are not properly incorporated into niche-based models. The lower variation between internal and external evaluation of GLMs compared to GAMs further suggests that overfitting may reduce transferability. Overall, a limited geographical transferability calls for caution when projecting niche-based models for assessing the fate of species in future environments. [source]

Raloxifene, conjugated oestrogen and endothelial function in postmenopausal women

JOURNAL OF INTERNAL MEDICINE, Issue 1 2003
E. J. J. Duschek
Abstract., Duschek EJJ, Stehouwer CDA, de Valk-de Roo GW, Schalkwijk CG, Lambert J, Netelenbos C (VU University Medical Center, Amsterdam; Sophia Hospital, Zwolle; The Netherlands). Raloxifene, conjugated oestrogen and endothelial function in postmenopausal women. J Intern Med 2003; 254: 85,94. Objectives., To study the long-term effects of raloxifene, a potential designer oestrogen, and oestrogen monotherapy on endothelial function in healthy postmenopausal women. Design., A 2-year double-blind, randomized and placebo-controlled study in an Academic Medical Center. Fifty-six hysterectomized but otherwise healthy postmenopausal women randomly received raloxifene hydrochloride 60 mg day,1 (n = 15) or 150 mg day,1 (n = 13), conjugated equine oestrogen (CEE) 0.625 mg day,1 (n = 15), or placebo (n = 13). Main outcome measures., Endothelial function as estimated from brachial artery flow-mediated, endothelium-dependent vasodilation and nitroglycerine-induced endothelium-independent vasodilation, and plasma levels of the endothelium-derived regulatory proteins, von Willebrand factor (vWF) and endothelin (ET). Results., Raloxifene 60 mg did not significantly affect endothelial function. As compared with placebo, at 6 months of therapy, raloxifene 150 mg and CEE were associated with a mean increase in vWF of 25.5% point (95% CI 3.6,47.3) and 26.6% point (95% CI 6.9,46.3), respectively. At 24 months of therapy, raloxifene 150 mg was associated with a mean decrease in ET of 0.96 pg mL,1 (95% CI ,1.57 to ,0.36). Raloxifene nor CEE significantly affected endothelium-dependent and/or -independent vasodilation. Conclusions., Our results suggest that long-term therapy with raloxifene or oral CEE does not affect endothelium-dependent vasodilation in healthy postmenopausal women. Raloxifene 150 mg day,1 might have both positive and negative effects on endothelium. The clinical significance of these findings remains to be investigated. [source]

Zinc deficiency may be a cause of burning mouth syndrome as zinc replacement therapy has therapeutic effects

JOURNAL OF ORAL PATHOLOGY & MEDICINE, Issue 9 2010
Gye Song Cho
J Oral Pathol Med (2010) 39: 722,727 Background:, Zinc is known to play an important role for growth and development, the immune response, neurological function, and reproduction. Although the etiology of burning mouth syndrome (BMS) is unknown, zinc deficiency may be implicated in the pathogenesis of BMS. The aim of this study was to demonstrate a causal relationship between zinc deficiency and BMS and to assess whether zinc replacement is an effective therapy for BMS. Methods:, Serum zinc level was evaluated in 276 patients with BMS. To assess the therapeutic effect of zinc replacement, patients with zinc deficiency were administered a zinc supplement (14.1 mg/day). Pain intensity 6 months after zinc replacement was evaluated using an 11-point numerical scale. We also developed an animal model of zinc deficiency to assess the effects of zinc deficiency on the oral mucosa. Results:, Of the 276 patients with BMS, 74 (26.8%) had low serum zinc levels. Zinc replacement therapy lowered the mean numerical pain scale in these patients from 8.1 to 4.1, compared with a mean decrease from 7.7 to 6.7 in a control group (P = 0.004). In our animal model of zinc deficiency, the main pathologic findings were hyperkeratinization and increased mitosis on the dorsum of the tongue, although there were no gross oral mucosal lesions. Conclusions:, Zinc deficiency might play a role in some patients with BMS. In such patients, appropriate zinc replacement therapy is effective in relieving symptoms. [source]

Effects of Alcohol Withdrawal on 24 Hour Ambulatory Blood Pressure Among Alcohol-Dependent Patients

ALCOHOLISM, Issue 12 2003
Ramón Estruch
Background: Although epidemiologic studies have reported an association between alcohol intake and high blood pressure (BP), the results of intervention studies have shown inconsistent results. We embarked on a study to determine whether different subgroups of alcohol-dependent patients may be identified in relation to the effect of alcohol on BP. Methods: Fifty alcohol-dependent men (mean age, 41.4 years) received 0.4 g of ethanol per kilogram of body weight every 4 hr in 200 ml of orange juice during 24 hr and the same amount of orange juice without ethanol during another 24 hr. Twenty-four hour ambulatory BP monitoring was performed during ethanol and orange juice intakes, as was hormonal and biochemical analysis. Results: Thirty-five (75%) alcohol-dependent men were normotensive and 15 (30%) hypertensive. Eighteen (51%) normotensive and 12 (80%) hypertensive subjects showed a significant decrease in 24 hr mean BP after ethanol withdrawal (mean decrease of 8.4 mm Hg [95% confidence interval, ,11.2 to ,5.7] and 12.5 mm Hg [confidence interval, ,16.2 to ,8.8], respectively) and were considered as sensitive to alcohol. The remaining alcohol-dependent subjects were considered as resistant to alcohol. Normotensive subjects sensitive to ethanol showed a significantly greater left ventricular mass and a significantly lower ejection fraction than those normotensive patients whose BP did not change after ethanol withdrawal (both p < 0.01). Conclusions: More than three fourths of the hypertensive and more than half of the normotensive alcohol-dependent patients showed sensitivity to the pressor effects of ethanol. Impairment also was observed in heart function in normotensive patients sensitive to the pressor effects of ethanol. [source]

Sacral nerve stimulation for voiding dysfunction: One institution's 11-year experience,

NEUROUROLOGY AND URODYNAMICS, Issue 1 2007
Suzette E. Sutherland
Abstract Aim The purpose of this study was to review our institution's 11-year experience with SNS for the treatment of refractory voiding dysfunction. Dating back to 1993, it covers a span of time which describes the evolution of SNS as it includes PNE trials, non-tined (bone-anchored or fascial-anchored) leads, percutaneous tined leads with two-staged procedures, and even percutaneous pudendal trials. Methods A retrospective review was performed on SNS patients who received an implantable pulse generator (IPG) in our practice from 12/1993 to 12/2004. After Institutional Review Board approval, consents for chart review were obtained from 104 patients, representing 44% of this neuromodulatory patient population. Results Of our population, 87% were female and 13% were male. Average age at implant was 50 years,±,13.4 years. Duration of symptoms before implantation was 116 months (range 9,600 months). Eighty percent were implanted for a predominant complaint of urinary urgency and frequency (U/F). Overall, 22% had U/F only, 38% had concomitant urge incontinence (UI), and 20% had concomitant mixed incontinence (MI). Twenty percent were treated for non-obstructive urinary retention (UR), with half of these associated with a neurogenic etiology. Additionally, 46.2% had pelvic pain, 58.6% had bowel complaints, and 51% reported sexual dysfunction. In patients with U/F, mean voiding parameters as described by pre-implant voiding diaries revealed the following: 12.4 (±5.1) voids per 24 hr; 2.3 (±1.8) voids per night; 5.0 (±4.7) leaks per 24 hr; and 2.3 (±2.6) pads per 24 hr. Statistically significant improvements post-implantation were noted with mean decreases in the following: 4.3 voids per 24 hr; 1.0 void per night; 4.4 leaks per 24 hr; and 2.3 pads per 24 hr (all P,<,0.05). In the UR group a statistically significant improvement post-implantation was noted only in voids per night, with a mean decrease of 0.8 (P,<,0.05). With a mean follow up of 22 months (range 3,162 months), sustained subjective improvement was >50%, >80%, and >90% in 69%, 50%, and 35% of patients, respectively. By quality of life survey, 60.5% of patients were satisfied and 16.1% were dissatisfied with current urinary symptoms. Only 13% (14 patients) abandoned therapy, making up a significant portion of those dissatisfied with current urinary symptoms. Good overall lead durability was seen (mean 22 months, range 1,121 months), with the first successful lead proving to be the most durable (mean 28 months, range 1.4,120 months). Lead durability decreased progressively with subsequent trials. Overall, 53% of patients experienced at least one reportable event (RE) attributable to either lead or IPG. A total of 126 REs were noted, with 97% mild-to-moderate in severity. REs included lack of efficacy, loss of efficacy, infection, hematoma/seroma, migration, pain, undesirable change in sensation, and device malfunction. In this population, 47.1% of leads were tined while 52.9% were non-tined. Tined leads had an overall lower RE rate as compared to non-tined leads: 28% and 73%, respectively. Conclusions SNS is an effective method for treating certain types of voiding dysfunction. Although 53% of patients experienced at least one RE, 97% were mild-to-moderate and did not appear to affect the continued use of this therapy. With improved technology, such as percutaneous tined leads, the RE rate is decreasing. Further analyses of subsets of this population are currently underway. Neurourol. Urodynam. © 2006 Wiley-Liss, Inc. [source]

Electrical Characteristics of an Electronic Control Device Under a Physiologic Load: A Brief Report

PACING AND CLINICAL ELECTROPHYSIOLOGY, Issue 3 2010
DONALD M. DAWES M.D.
Background:,Law enforcement officers use electronic control devices (ECDs), such as the TASER X26 (TASER International, Inc., Scottsdale, AZ, USA), to control resisting subjects. Some of the debate on the safety of the devices has centered on the electrical characteristics of the devices. The electrical characteristics published by TASER International have historically based on discharges into a 400 , resistor. There are no studies that the authors are aware of that report the electrical characteristics under a physiologic load. In this study, we make an initial attempt to determine the electrical characteristics of the TASER X26 during a 5-second exposure in human volunteers. Methods:,Subjects received an exposure to the dry, bare chest (top probe), and abdomen (bottom probe) with a standard TASER X26 in the probe deployment mode for 5 seconds. There were 10,11 pulse captures during the 5 seconds. Resistance was calculated using the sum of the absolute values of the instantaneous voltage measurements divided by the sum of the absolute values of the instantaneous current measurements (Ohm's Law). Results:,For the eight subjects, the mean spread between top and bottom probes was 12.1 inches (30.7 cm). The mean resistance was 602.3 ,, with a range of 470.5,691.4 ,. The resistance decreased slightly over the 5-second discharge with a mean decrease of 8.0%. The mean rectified charge per pulse was 123.0 ,C. The mean main phase charge per pulse was 110.5 ,C. The mean pulse width was 126.9 ,s. The mean voltage per pulse was 580.1 V. The mean current per pulse was 0.97 A. The average peak main phase voltage was 1899.2 V and the average peak main phase current was 3.10 A. Conclusions:,The mean tissue resistance was 602.3 , in this study. There was a decrease in resistance of 8% over the 5-second exposure. This physiologic load is different than the 400 , laboratory load used historically by the manufacturer. We recommend future characterization of these devices use a physiologic load for reporting electrical characteristics. We also recommend that all the electrical characteristics be reported. (PACE 2010; 33:330,336) [source]

Toward quantifying the usage costs of human immunity: Altered metabolic rates and hormone levels during acute immune activation in men

AMERICAN JOURNAL OF HUMAN BIOLOGY, Issue 4 2010
Michael P. Muehlenbein
There is a paucity of data on the energetic demands of human immune functions, despite the fact that both clinical medicine and evolutionary biology would benefit from further clarification of these costs. To better understand the energetic requirements of mounting a mild immune response, as well as some of the major hormonal changes underlying these metabolic changes, we examined changes in resting metabolic rate (RMR) and hormones during and after respiratory tract infection in young adult men. An epidemiologic passive detection design was used to recruit 25 nonfebrile subjects naturally infected with respiratory tract pathogens. Symptomology, percent body fat, RMR, salivary testosterone and cortisol, and other information were collected at a minimum of three time points during and after convalescence. Comparisons of the differences in RMR, testosterone, and cortisol between sampling days within individual cases were made using paired t -tests. Participants experienced 8% higher RMR during illness, and a subset of these men experienced a mean increase greater than 14%. The participants also experienced 10% lower testosterone levels during illness, and a subset of these participants experienced a mean decrease of 30%, although cortisol levels did not change significantly. These results document elevated RMR following natural pathogen exposure in adult humans, demonstrating that even mild immune reactions can elicit significant increases in energy expenditure. Understanding the costs of immunity and the immunomodulatory actions of hormones are central to understanding the role of immunity in human life history evolution. Am. J. Hum. Biol. 2010. © 2010 Wiley-Liss, Inc. [source]

After-effects of near-threshold stimulation in single human motor axons

THE JOURNAL OF PHYSIOLOGY, Issue 3 2005
Hugh Bostock
Subthreshold electrical stimuli can generate a long-lasting increase in axonal excitability, superficially resembling the phase of superexcitability that follows a conditioning nerve impulse. This phenomenon of ,subthreshold superexcitability' has been investigated in single motor axons in six healthy human subjects, by tracking the excitability changes produced by conditioning stimuli of different amplitudes and waveforms. Near-threshold 1 ms stimuli caused a mean decrease in threshold at 5 ms of 22.1 ± 6.0% (mean ±s.d.) if excitation occurred, or 6.9 ± 2.6% if excitation did not occur. The subthreshold superexcitability was maximal at an interval of about 5 ms, and fell to zero at 30 ms. It appeared to be made up of two components: a passive component linearly related to conditioning stimulus amplitude, and a non-linear active component. The active component appeared when conditioning stimuli exceeded 60% of threshold, and accounted for a maximal threshold decrease of 2.6 ± 1.3%. The passive component was directly proportional to stimulus charge, when conditioning stimulus duration was varied between 0.2 and 2 ms, and could be eliminated by using triphasic stimuli with zero net charge. This change in stimulus waveform had little effect on the active component of subthreshold superexcitability or on the ,suprathreshold superexcitability' that followed excitation. It is concluded that subthreshold superexcitability in human motor axons is mainly due to the passive electrotonic effects of the stimulating current, but this is supplemented by an active component (about 12% of suprathreshold superexcitability), due to a local response of voltage-dependent sodium channels. [source]

Phase 1 Dose-Escalation Study of CP-690 550 in Stable Renal Allograft Recipients: Preliminary Findings of Safety, Tolerability, Effects on Lymphocyte Subsets and Pharmacokinetics

AMERICAN JOURNAL OF TRANSPLANTATION, Issue 8 2008
E. Van Gurp
CP-690 550 inhibits Janus kinase 3 with nanomolar potency. In this dose-escalation study, we assessed the safety, tolerability, effects on lymphocyte subsets, and pharmacokinetics of CP-690 550 when coadministered with mycophenolate mofetil in stable renal allograft recipients for 28 days. Twenty-eight patients were enrolled. Six patients received CP-690 550 5 mg twice daily (BID), 6 patients received 15 mg BID, 10 patients received 30 mg BID, and 6 patients received placebo. The most frequent adverse events were infections and gastrointestinal (abdominal pain, diarrhea, dyspepsia, and vomiting). CP-690 550 15 mg BID and 30 mg BID were associated with a mean decrease in hemoglobin from baseline of 11% and a mean decrease in absolute natural killer cell counts of 50%. CP-690 550 30 mg BID was also associated with a mean increase in absolute CD19+ B-lymphocytes of 130%. There were no changes in the number of neutrophils, total lymphocytes, platelets, or CD4+ or CD8+ T cells; clinical chemistry; vital signs; or electrocardiograms from the pretreatment baseline. Administration of CP-690 550 without a concomitant calcineurin inhibitor resulted in CP-690 550 exposures consistent with previous studies in nontransplant subjects. Additional dose-ranging studies are warranted to evaluate the safety and efficacy of CP-690 550 in renal transplant recipients over longer treatment duration. [source]

Correlation Relationship Assessment between Left Ventricular Hypertrophy Voltage Criteria and Body Mass Index in 41,806 Swiss Conscripts

ANNALS OF NONINVASIVE ELECTROCARDIOLOGY, Issue 4 2009
Roger Abächerli Ph.D.
Introduction: Electrocardiographic criteria for left ventricular hypertrophy (LVH) have been limited by low sensitivity at acceptable levels of specificity. A number of studies have demonstrated that body mass index (BMI) is associated with decreased sensitivity of ECG LVH classification in hypertensive patients. The objective of this study is to investigate the correlation relationship between LVH voltage criteria and BMI in Swiss conscripts. Methods: A database of 41,806 young Swiss people, who underwent compulsory conscription for the Swiss Army, was compiled. Along with other medical data, an ECG was taken. Statistical analyses, such as linear regression and calculation of correlation coefficient, were carried out between LVH voltage criteria and BMI. Results: The mean age in the studied population was 19.2 ± 1.1 years with a median age of 19 years (range from 17 to 38 years). We found an overweight prevalence of 25.1%. The results showed that body habitus had significant association with Sokolow-Lyon voltages. A mean decrease of 13%, 5%, 19%, 14%, and 12% for the five studied Sokolow-Lyon indexes were found between normal range subjects (18.5 , BMI < 25) and obese subjects (25, BMI). Conclusions: Our study confirms the hypothesis that people with higher BMI, a growing section of the population, have lower ECG amplitudes. Therefore, the Sokolow-Lyon voltage criteria may underestimate the presence of LVH for subjects with higher BMI, which is not the case for the Cornell voltage. Our analysis suggests that computerized electrocardiography for the diagnosis of left ventricular hypertrophy based on Sokolow-Lyon voltages should incorporate the BMI factor. [source]

Prospective evaluation of cell kinetics, yields and donor experiences during a single large-volume apheresis versus two smaller volume consecutive day collections of allogeneic peripheral blood stem cells

BRITISH JOURNAL OF HAEMATOLOGY, Issue 5 2003
Charles D. Bolan
Summary. We report cell kinetics, yields and donation experiences of 20 demographically matched allogeneic peripheral blood stem cell (PBSC) donors who were prospectively assigned to undergo either a single 25 l or two consecutive daily 15 l (15 l × 2) apheresis procedures. Procedures were performed using prophylactic intravenous calcium administration after standard granulocyte colony-stimulating factor (GCSF) mobilization (10 ,g/kg/d). Central line placements (two each), initial CD34 cell counts (0·077 vs 0·078 × 109/l) and yields (7·9 vs 8·1 × 108 CD34 cells) were similar in the two groups; however, 25 l donors spent significantly less time both in the clinic (7·5 vs 10·8 h) and with central venous catheters in place (8·5 vs 29·5 h) than 15 l × 2 donors. End-procedure platelet counts were below 100 × 109/l in one out of 10 25 l donors versus five out of 10 in 15 l × 2 donors (41%vs 53% mean decrease in platelet counts, P = 0·02). PBSC collection efficiency increased by 37% after 15 l of the 25-l volume had been processed, compared with no significant change during 15 l × 2 procedures. Results similar to these prospective findings were also observed in CD34 yields, symptoms and platelet counts in additional 25 l and 15 l procedures performed during the same period and evaluated retrospectively. This study indicates that a single 25-l apheresis procedure results in similar yields and symptoms, but less donor thrombocytopenia and inconvenience than two consecutive daily 15-l procedures. [source]

Risperidone in the treatment of disruptive behavioural symptoms in children with autistic and other pervasive developmental disorders

CHILD: CARE, HEALTH AND DEVELOPMENT, Issue 2 2005
Richard ReadingArticle first published online: 16 FEB 200
Risperidone in the treatment of disruptive behavioural symptoms in children with autistic and other pervasive developmental disorders . SheaS, TurgayA, CarrollA, SchulzM, OrlikH, SmithI & DunbarF. ( 2004 ) Pediatrics , 114 , e634 , e641 . Objective To investigate the efficacy and safety of risperidone for the treatment of disruptive behavioural symptoms in children with autism and other pervasive developmental disorders (PDD). Methods In this 8-week, randomized, double-blinded, placebo-controlled trial, risperidone/placebo solution (0.01,0.06 mg/kg/day) was administered to 79 children who were aged 5,12 years and had PDD. Behavioural symptoms were assessed using the Aberrant Behaviour Checklist (ABC), Nisonger Child Behaviour Rating Form and Clinical Global Impression-Change. Safety assessments included vital signs, electrocardiogram, extrapyramidal symptoms, adverse events and laboratory tests. Results Subjects who were taking risperidone (mean dosage: 0.04 mg/kg/day; 1.17 mg/day) experienced a significantly greater mean decrease on the irritability subscale of the ABC (primary endpoint) compared with those who were taking placebo. By study endpoint, risperidone-treated subjects exhibited a 64% improvement over baseline in the irritability score almost double that of placebo-treated subjects (31%). Risperidone-treated subjects also exhibited significantly greater decreases on the other four subscales of the ABC; on the conduct problem, insecure/anxious, hyperactive and overly sensitive subscales of the Nisonger Child Behaviour Rating Form (parent version); and on the Visual Analog Scale of the most troublesome symptom. More risperidone-treated subjects (87%) showed global improvement in their condition compared with the placebo group (40%). Somnolence, the most frequently reported adverse event, was noted in 72.5% vs. 7.7% of subjects (risperidone vs. placebo) and seemed manageable with dose/dose-schedule modification. Risperidone-treated subjects experienced statistically significantly greater increases in weight (2.7 vs. 1.0 kg), pulse rate and systolic blood pressure. Extrapyramidal symptoms scores were comparable between groups. Conclusions Risperidone was well-tolerated and efficacious in treating behavioural symptoms associated with PDD in children. [source]

Orlistat 120 mg improves glycaemic control in type 2 diabetic patients with or without concurrent weight loss

DIABETES OBESITY & METABOLISM, Issue 4 2009
S. Jacob
Background:, Both obesity and type 2 diabetes are associated with increased morbidity and mortality. Published data suggest that orlistat 120 mg, a lipase inhibitor used to treat obesity, may improve glycaemic parameters through weight loss,independent effects. Aim:, To investigate the effect of orlistat 120 mg on weight loss, and assess whether changes in glycaemic parameters [fasting plasma glucose (FPG) and haemoglobin A1c (HbA1c)] are independent of weight loss. Methods:, This retrospective analysis of pooled data from seven multicentre, double-blind, placebo-controlled studies involved overweight or obese patients with type 2 diabetes (aged 18,70 years). Patients were required to have a body mass index of 27,43 kg/m2, HbA1c of 6.5 to <13%, and stable weight for ,3 months. Subjects received orlistat 120 mg tid or placebo for 6 or 12 months. Results:, A total of 2550 overweight or obese patients with type 2 diabetes were enrolled and randomized to treatment with orlistat 120 mg tid (n = 1279) or placebo (n = 1271). For the whole population, patients treated with orlistat 120 mg had significantly greater mean decreases in FPG compared with placebo-treated patients (,1.39 mmol/l vs. ,0.47 mmol/l; p < 0.0001). In addition, orlistat 120 mg provided significantly larger mean decreases in HbA1c compared with placebo (,0.74% vs. ,0.31%; p < 0.0001). For patients with minimal weight loss (,1% of baseline body weight), orlistat 120 mg still provided a significantly greater decrease in the least squares mean value for both FPG (,0.83 mmol/l vs. ±0.02 mmol/l; p = 0.0052) and HbA1c,0.29% vs. ±0.14%; p = 0.0008). This suggested that the improvement of glycaemic control with orlistat 120 mg was independent of weight loss. Using linear regression analysis, improvement in glycaemic control (FPG and HbA1c) with orlistat 120 mg was less strongly correlated with weight loss than for placebo. Conclusion:, Orlistat 120 mg appears to improve glycaemic control more than would be predicted by weight loss alone in overweight or obese patients with type 2 diabetes. Postulated mechanisms underlying this effect include an improvement of insulin sensitivity, a slower and incomplete digestion of dietary fat, reduction of postprandial plasma non-esterified fatty acids, decreased visceral adipose tissue, and stimulation of glucagon-like peptide-1 secretion in the lower small intestine. [source]

Sacral nerve stimulation for voiding dysfunction: One institution's 11-year experience,

The effect of carbamazepine on the steady-state pharmacokinetics of ziprasidone in healthy volunteers

BRITISH JOURNAL OF CLINICAL PHARMACOLOGY, Issue S1 2000
J. J. Miceli
Aims, To evaluate the effect of steady-state carbamazepine administration on the steady-state pharmacokinetics of ziprasidone in healthy young adults, in an open, randomised, parallel-group study. Methods, Twenty-five subjects were randomized to one of two treatment groups. Group 1 received 20 mg ziprasidone twice daily on days 1 and 2, and a single dose on day 3. A single 100 mg dose of carbamazepine was given once daily on days 5 and 6 and twice daily on days 7 and 8, followed by 200 mg twice daily until day 28 and on the morning only on day 29. Ziprasidone 20 mg was also administered twice daily on days 26 and 27 and in the morning only on day 28. Group 2 received the same treatment regimen with carbamazepine replaced by placebo. Pharmacokinetic data were obtained on days 3 and 28. Results, Nine subjects in group 1 and 10 in group 2 completed all three treatment periods (ziprasidone, carbamazepine or placebo; and ziprasidone plus carbamazepine or placebo). Carbamazepine administration to group 1 was associated with modest reductions in ziprasidone exposure, with mean decreases in ziprasidone AUC(0,12 h) and Cmax values of 36% and 27%, respectively, on day 28 compared with day 3 (P<0.03). The mean differences between day 28 and day 3 ziprasidone AUC(0,12 h) and Cmax values were also statistically significantly greater in the carbamazepine group than in the placebo group. The mean half-life of ziprasidone decreased by 1 h from day 3 to day 28 in the subjects receiving carbamazepine, compared with virtually no change in the placebo group. All adverse events were mild or moderate in severity and there were no serious adverse events, or clinically significant changes in ECGs and vital signs throughout the study. Conclusions, Induction of CYP3A4 with carbamazepine led to a modest reduction (<36%) in steady-state exposure to ziprasidone that is believed to be clinically insignificant. [source]