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Trial Period (trial + period)
Selected AbstractsImproving glycaemic control in children and adolescents: which aspects of therapy really matter?DIABETIC MEDICINE, Issue 4 2010T. C. Skinner Diabet. Med. 27, 369,375 (2010) Abstract In paediatric diabetes, the concept of intensive therapy in the post-Diabetes Control and Complications Trial period has become subverted by a pharmaco-technological paradigm at the expense of other aspects of care such as goal-setting and psychosocial support. This review examines which patients benefit most from intensive therapy in terms of glycaemic control (HbA1c). It also reviews published controlled trial and observational data relating to the impact of various insulin types and delivery systems on glycaemic control and canvasses the literature dealing with the impact of patient support, philosophy of care, goal setting and treating team dynamic on HbA1c. Taking into account the characteristics of those patients who benefit most from intensive therapy, the quantum of HbA1c change and the persistence of changes that have been reported in selected and non-selected patient groups, it appears that there is a clear hierarchy in aspects of therapy that improve glycaemic control for children and adolescents with Type 1 diabetes. Prime issues appear to be patient support, team cohesion and goal setting. The reported glycaemic benefits achieved by an isolated emphasis upon a pharmaco-technological paradigm are limited in children and adolescents. It appears that only after the prime issues have been first considered will the potential benefits of the insulin types and regimens then be realized. [source] Ascorbic acid oral treatment modifies lipolytic response and behavioural activity but not glucocorticoid metabolism in cafeteria diet-fed ratsACTA PHYSIOLOGICA, Issue 4 2009D. F. Garcia-Diaz Abstract Aim:, To analyse the effects of vitamin C (VC), a potent dietary antioxidant, oral supplementation on body weight gain, behavioural activity, lipolytic response and glucocorticoid metabolism in the early stages of diet-induced overweight in rats. Methods:, Food intake, locomotive activity and faecal corticosterone were assessed during the 14 day trial period. After 2 weeks, the animals were sacrificed and the body composition, biochemical markers and lipolytic response from isolated adipocytes from retroperitoneal white adipose tissue were examined. Results:, The intake of a high-fat diet by rats induced a significant increase in body weight, adiposity and insulin resistance markers as well as a decrease in faecal corticosterone levels compared with standard diet-fed rats. Interestingly, the animals fed on the cafeteria diet showed a significant increase in the isoproterenol-induced lipolytic response in isolated adipocytes. Furthermore, this cafeteria-fed group showed a reduced locomotive behaviour than the control rats. On the other hand, oral VC supplementation in animals receiving the high-fat diet restored the cafeteria diet effect in some of the analysed variables such as final body weight and plasma insulin to control group levels. Remarkably, increases in locomotive behaviour and a significant decrease in the lipolytic response induced by isoproterenol on isolated adipocytes from animals treated with VC were observed. Conclusion:, This work demonstrates that an oral ascorbic acid supplementation has direct effects on behavioural activity and on adipocyte lipolysis in early obesity stages in rats, which could indicate a protective short-term role of this vitamin against adiposity induced by chronic high-fat diet consumption. [source] An economic evaluation of atenolol vs. captopril in patients with Type 2 diabetes (UKPDS 54)DIABETIC MEDICINE, Issue 6 2001A. Gray Abstract Aims To compare the net cost of a tight blood pressure control policy with an angiotensin converting enzyme inhibitor (captopril) or , blocker (atenolol) in patients with Type 2 diabetes. Design A cost-effectiveness analysis based on outcomes and resources used in a randomized controlled trial and assumptions regarding the use of these therapies in a general practice setting. Setting Twenty United Kingdom Prospective Diabetes Study Hospital-based clinics in England, Scotland and Northern Ireland. Subjects Hypertensive patients (n= 758) with Type 2 diabetes (mean age 56 years, mean blood pressure 159/94 mmHg), 400 of whom were allocated to the angiotensin converting enzyme inhibitor captopril and 358 to the , blocker atenolol. Main outcome measures Life expectancy and mean cost per patient. Results There was no statistically significant difference in life expectancy between groups. The cost per patient over the trial period was £6485 in the captopril group, compared with £5550 in the atenolol group, an average cost difference of £935 (95% confidence interval £188, £1682). This 14% reduction arose partly because of lower drug prices, and also because of significantly fewer and shorter hospitalizations in the atenolol group, and despite higher antidiabetic drug costs in the atenolol group. Conclusions Treatment of hypertensive patients with Type 2 diabetes using atenolol or captopril was equally effective. However, total costs were significantly lower in the atenolol group. Diabet. Med. 18, 438,444 (2001) [source] A European methodology for sustainable development strategy reviewsENVIRONMENTAL POLICY AND GOVERNANCE, Issue 2 2010Joachim H. Spangenberg Abstract In 2005 the EU Environment Directorate initiated the production of a guidebook for peer reviews of national sustainable development strategies (NSDSs), which was published in 2006. Its objective is to support EU member states planning to evaluate their respective NSDS, supporting and stimulating all potential participants. It describes how to initiate, start, lead and conclude an evaluation process, and suggests, based on European experiences, a spectrum of methods available for this purpose. During a Commission-sponsored trial period, 2006/2007, the Netherlands was the only country to make use of this offer. However, the renewed EU Sustainable Development Strategy (EUSDS) calls for regular (peer) reviews of NSDS. Using this specific review instrument is recommended as part of a mutual learning exercise, which might stimulate a self-organized convergence of NSDSs, and better vertical integration, without establishing new competences and mechanisms on the EU level. Two new elements are suggested, a simple ,pressure,policy matrix' (PPM), supporting comprehensiveness control, and the possibility of patchwork evaluations, based on the systematique of the matrix. Copyright © 2010 John Wiley & Sons, Ltd and ERP Environment. [source] Botulinum Toxin Type-A (BOTOX®) in the Treatment of Occipital Neuralgia: A Pilot StudyHEADACHE, Issue 10 2008Martin Taylor DO Objective., To determine the efficacy of occipital nerve blocks using reconstituted botulinum toxin type-A (BTX-A) in providing significant and prolonged pain relief in chronic occipital neuralgia. Background., Occipital neuralgia is a unilateral or bilateral radiating pain with paresthesias commonly manifesting as paroxysmal episodes and involving the occipital and parietal regions. Common causes of occipital neuralgia include irritation or injury to the divisions of the occipital nerve, myofascial spasm, and focal entrapment of the occipital nerve. Treatment options include medication therapy, occipital nerve blocks, and surgical techniques. BTX-A, which has shown promise in relief of other headache types, may prove a viable therapeutic option for occipital neuralgia pain. Methods., Botulinum toxin type-A (reconstituted in 3 cc of saline) was injected into regions traversed by the greater and lesser occipital nerve in 6 subjects diagnosed with occipital neuralgia. Subjects were instructed to report their daily pain level (on a visual analog pain scale), their ability to perform daily activities (on several quality of life instruments) and their daily pain medication usage (based on a self-reported log), 2 weeks prior to the injection therapy and 12 weeks following injection therapy. Data were analyzed for significant variation from baseline values. Results., The dull/aching and pin/needles types of pain reported by the subjects did not show a statistically significant improvement during the trial period. The sharp/shooting type of pain, however, showed improvement during most of the trial period except weeks 3-4 and 5-6. The quality of life measures exhibited some improvement. The headache-specific quality of life measure showed significant improvement by 6 weeks which continued through week 12. The general health- and depression-related measures showed no statistical improvement. No significant reduction in pain medication usage was demonstrated. Conclusions., Our results indicate that BTX-A improved the sharp/shooting type of pain most commonly known to be associated with occipital neuralgia. Additionally, the quality of life measures assessing burden and long-term impact of the headaches, further corroborated improvement seen in daily head pain. [source] Oral colonization by Lactobacillus reuteri ATCC 55730 after exposure to probioticsINTERNATIONAL JOURNAL OF PAEDIATRIC DENTISTRY, Issue 5 2009ESBER ÇAGLAR Objective., The aim of this study was to investigate whether Lactobacillus reuteri ATCC 55730 can be detected in the oral cavity after discontinuation of administration of a product prepared with this bacterium. Materials and Methods., The study consisted of three 2-week periods: clearance period, intervention period, and post-treatment period. Twenty-five volunteers consumed a chewable tablet of L. reuteri ATCC 55730 (108 cfu/tablet) during a 14-day trial period. Saliva samples were collected and cultured onto MRS agar after a clearance period of 2 weeks and then daily after a 2-week intervention period for as long as L. reuteri was found. Lactobacillus reuteri colonies were analysed in saliva samples. The analysis was performed using selective media for L. reuteri followed by confirmation using the specific detection of reuterin produced by L. reuteri. Results., The number of L. reuteri carriers decreased gradually, and after 1 week only 8% of the subjects harboured the bacterium. After 5 weeks, L. reuteri was not detected in any of the subjects. Conclusion., Consuming L. reuteri for 2 weeks does not seem to be sufficient for permanent colonization of L. reuteri in the oral cavity. [source] Reduction in Fear of Falling Through Intense Tai Chi Exercise Training in Older, Transitionally Frail AdultsJOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 7 2005Richard W. Sattin MD Objectives: To determine whether an intense tai chi exercise program could reduce fear of falling better than a wellness education (WE) program in older adults who had fallen previously and meet criteria for transitioning to frailty. Design: Cluster-randomized, controlled trial of 48 weeks' duration. Setting: Ten matched pairs of congregate living facilities in the greater Atlanta area. Participants: Sample of 291 women and 20 men, aged 70 to 97. Measurements: Activity-related fear of falling using the Activities-Specific Balance Confidence Scale (ABC) and the Fall Efficacy Scale at baseline and every 4 months for 1 year. Demographics, time to first fall and all subsequent falls, functional measures, Centers for Epidemiologic Studies Depression Scale, medication use, level of physical activity, comorbidities, and adherence to interventions. Results: Mean ABC was similar in both cohort groups at the time of randomization but became significantly higher (decreased fear) in the tai chi cohort at 8 months (57.9 vs 49.0, P<.001) and at study end (59.2 vs 47.9, P<.001). After adjusting for covariates, the mean ABC after 12 months of intervention was significantly greater in the tai chi group than in the WE group, with the differences increasing with time (mean difference at 12 months=9.5 points, 95% confidence interval=4.8,14.2, P<.001). Conclusion: Tai chi led to a significantly greater reduction in fear of falling than a WE program in transitionally frail older adults. The mean percentage change in ABC scores widened between tai chi and WE participants over the trial period. Tai chi should be considered in any program designed to reduce falling and fear of falling in transitionally frail older adults. [source] Assessment of anaerobic wastewater treatment failure using terminal restriction fragment length polymorphism analysisJOURNAL OF APPLIED MICROBIOLOGY, Issue 6 2005C. Scully Abstract Aims:, The suitability of genetic fingerprinting to study the microbiological basis of anaerobic bioreactor failure is investigated. Methods and Results:, Two laboratory-scale anaerobic expanded granular sludge bed bioreactors, R1 and R2, were used for the mesophilic (37°C) treatment of high-strength [10 g chemical oxygen demand (COD) l,1] synthetic industrial-like wastewater over a 100-day trial period. A successful start up was achieved by both bioreactors with COD removal over 90%. Both reactors were operated under identical parameters; however, increased organic loading during the trial induced a reduction in the COD removal of R1, while R2 maintained satisfactory performance (COD removal >90%) throughout the experiment. Specific methanogenic activity measurements of biomass from both reactors indicated that the main route of methane production was hydrogenotrophic methanogenesis. Terminal restriction fragment length polymorphism (TRFLP) analysis was applied to the characterization of microbial community dynamics within the system during the trial. The principal differences between the two consortia analysed included an increased abundance of Thiovulum - and Methanococcus -like organisms and uncultured Crenarchaeota in R1. Conclusions:, The results indicated that there was a microbiological basis for the deviation, in terms of operational performance, of R1 and R2. Significance and Impact of the Study:, High-throughput fingerprinting techniques, such as TRFLP, have been demonstrated as practically relevant for biomonitoring of anaerobic reactor communities. [source] Evaluation of marking European silver eels with visible implant elastomer tags and alcian blueJOURNAL OF FISH BIOLOGY, Issue 1 2007J. Simon After 183 days, the retention of the visible implant elastomer marks implanted on the belly and along the basis of the ventral fin margin of the European silver eel Anguilla anguilla was 100%. The retention of the alcian blue spots on the belly was 84% after 1 day, but decreased to 68% by the end of the experiment (after 183 days). Marking-induced mortality was 0% for both marking types over the complete trial period. [source] Comparison of Three Culture Methods for the Intensive Culture of Northern Quahog Seed, Mercenaria mercenariaJOURNAL OF THE WORLD AQUACULTURE SOCIETY, Issue 1 2001Timothy J. Pfeiffer A number of approaches have been utilized for growing bivalve hatchery seed (1 mm) to a size suitable for field planting (< 8 mm) but few have been directly compared. This study evaluated the growth and survival of northern quahog seed in three different culture systems and two different stocking densities. The three systems were: 1) a stacked-tray unit with downward water flow; 2) traditional upweller culture units with water flowing upward without seed bed expansion; and 3) upweller culture units with water flowing upward at fluidization velocities to provide seed bed expansion. The two stocking densities were 1.0 and 3.0 g whole wet weight clam/cm2 respectively. During each trial period the seed clams were fed a 1% daily ration (% dry weight algae per wet weight clam per day) of the cultured diatom Chaetoceros muelleri. After 14 d of culture at the 1.0 g whole wet weight/cm2 stocking density, seed clams (4.4 ± 0.6 mm initial shell length) under fluidized-flow condition exhibited better growth (0.54/d), and a greater final shell length (5.9 ± 1.0 mm). At the high density stocking conditions, after 28 d of culture, seed clams (4.2 ± 0.6 mm initial shell length) in the fluidized-flow culture conditions again exhibited better growth rate (0.031/d) and a greater final shell length (6.0 ± 1.0 mm). The preliminary evaluation of fluidized-flow for seed clam culture in land-based nurseries indicates its potential as a suitable alternative to raceway, downwelling, or traditional forced-flow culture methods. [source] Unilateral versus bilateral stage I neuromodulator lead placement for the treatment of refractory voiding dysfunctionNEUROUROLOGY AND URODYNAMICS, Issue 8 2008Khanh Pham Abstract Aims To determine if bilateral S3 lead placement during the stage I trial period improves the "success" rate for advancing to stage II (permanent) sacral neuromodulator placement. Methods A retrospective chart review of 124 (20 male and 104 female) patients undergoing stage I sacral neuromodulation (InterStim®, Medtronic, Minneapolis, Minnesota) implantation for the treatment of refractory voiding dysfunction was performed. Patients were divided into two cohorts based on unilateral versus bilateral stage I lead placement in the S3 foramina. Both groups were then evaluated and compared with regards to overall "success", defined as progression from stage I to stage II placement. Results Fifty-five (44%) patients underwent unilateral stage I lead placement and 69 (56%) received bilateral S3 leads. Successful stage I trials were reported in 32/55 (58%) and 53/69 (76%) of unilateral and bilateral cohorts, respectively (P,=,0.03). Five wound infections were reported,2 (3.6%) following unilateral and 3 (4.3%) after bilateral stage I lead placement. No other complications were encountered. Conclusions Bilateral stage I neuromodulation trial provides a significantly higher rate of improvement in refractory voiding symptoms to allow for the progress to stage II implantation. Neurourol. Urodynam. 27:779,781, 2008, © 2008 Wiley-Liss, Inc. [source] Hyperthermic, Supersaturated Humidification in the Treatment of Xerostomia,THE LARYNGOSCOPE, Issue 6 2001Mark A. Criswell MD Abstract Objectives To investigate the role of hyperthermic, supersaturated humidification in the treatment of radiation-induced xerostomia. Study Design A randomized, controlled, crossover pilot study of patients with symptomatic xerostomia following radiotherapy for head and neck cancer. Patients compared a standard bedside humidifier with a new device delivering hyperthermic, supersaturated humidification through a nasal cannula. Methods The patients were randomized to a 2-week course of standard, cool air bedside humidification or to hyperthermic, supersaturated humidification through a nasal cannula (Vapotherm Inc., Annapolis, MD). After a 1-week washout period, patients were crossed over to the opposite device for another 2 weeks. The patients underwent physical examination initially and after each trial period using an objective xerostomia scale, and then completed a questionnaire quantifying their symptoms. Patients additionally rated their symptoms at home, twice daily, using a visual analogue scale. Results Using the Oral Assessment Guide, lip scores went from 1.67 initially to 1.67 after control and 1.67 after Vapotherm. Tongue scores were 1.67, 1.5, and 1.83, respectively. Saliva scores were 1.67, 1.5, and 1.5, respectively. Mucous membranes scores were 1.5, 1.67, and 1.5, respectively. The physical examination scores at these four sites were not significantly different between control and Vapotherm (P = .78, .78, .72, and .37, respectively). The patient symptom questionnaire and visual analogue scores also revealed no significant difference between the two devices. Conclusion The Vapotherm MT-3000 device appears to provide minimal or no additional relief from radiation xerostomia over standard bedside humidifiers. Further investigation may be warranted with newer models of the device and with disorders of mucociliary clearance. [source] Pilot trial of low-dose naltrexone and quality of life in multiple sclerosis,ANNALS OF NEUROLOGY, Issue 2 2010Bruce A. C. Cree MD Objective To evaluate the efficacy of 4.5mg nightly naltrexone on the quality of life of multiple sclerosis (MS) patients. Methods This single-center, double-masked, placebo-controlled, crossover study evaluated the efficacy of 8 weeks of treatment with 4.5mg nightly naltrexone (low-dose naltrexone, LDN) on self-reported quality of life of MS patients. Results Eighty subjects with clinically definite MS were enrolled, and 60 subjects completed the trial. Ten withdrew before completing the first trial period: 8 for personal reasons, 1 for a non,MS-related adverse event, and 1 for perceived benefit. Database management errors occurred in 4 other subjects, and quality of life surveys were incomplete in 6 subjects for unknown reasons. The high rate of subject dropout and data management errors substantially reduced the trial's statistical power. LDN was well tolerated, and serious adverse events did not occur. LDN was associated with significant improvement on the following mental health quality of life measures: a 3.3-point improvement on the Mental Component Summary score of the Short Form-36 General Health Survey (p = 0.04), a 6-point improvement on the Mental Health Inventory (p < 0.01), a 1.6-point improvement on the Pain Effects Scale (p =.04), and a 2.4-point improvement on the Perceived Deficits Questionnaire (p = 0.05). Interpretation LDN significantly improved mental health quality of life indices. Further studies with LDN in MS are warranted. ANN NEUROL 2010 [source] Sling distress: A subanalysis of the IVS tapes from the SUSPEND trialAUSTRALIAN AND NEW ZEALAND JOURNAL OF OBSTETRICS AND GYNAECOLOGY, Issue 6 2007Siva BALAKRISHNAN Abstract Aim:, To study the incidence of erosions and tape infections following the use of intravaginal slingplasty (IVS) treatment for stress urinary incontinence after the SUSPEND trial period of 30 months. This subanalysis was carried out because of concerns regarding high percentage of delayed sling erosions and infections during follow up of the patients who participated in the trial. Materials and methods:, The subanalysis patient group consisted of all IVS patients drawn from the SUSPEND randomised control trial that compared the safety and efficacy of three types of suburethral slings, TVT, SPARC and IVS, for the treatment of urodynamic stress incontinence. Results:, A total of 62 patients were reviewed during this study conducted from April 2002 to May 2003. Continence was achieved in 88% the patients. A total of eight (13%) sling erosions were found requiring sling removal. Forty-eight (77.4%) patients were followed up at 12 months with one case of erosion (1.7%). Twenty-nine (46.8%) of the 62 patients were followed up between 12 and 34 months, and seven cases of sling erosions were diagnosed. One patient had purulent suprapubic sinus, five patients had foul-smelling discharge, and one had recurrent urinary tract infection associated with pain and discharge. After the slings were removed the patients had no further symptoms. However, three of them had recurrent stress urinary incontinence. Discussion/conclusion:, The delayed presentation of the sling erosion from this subanalysis is a concern, and pelvic reconstructive surgeons using IVS need to be aware of the delayed presentations we found in our cohort of patients. [source] Effects of mild aerobic physical exercise on membrane fluidity of erythrocytes in essential hypertensionCLINICAL AND EXPERIMENTAL PHARMACOLOGY AND PHYSIOLOGY, Issue 5-6 2003Kazushi Tsuda Summary 1.,The present study was undertaken to investigate the effects of aerobic physical exercise on membrane function in mild essential hypertension. 2.,Hypertensive patients were divided into an exercise group (n = 8) and a non-exercise (control) group (n = 8). Physical exercise within the intensity of the anaerobic threshold level was performed twice a week for 6 months. Membrane fluidity of erythrocytes was examined by means of electron paramagnetic resonance (EPR) and spin-labelling methods before and after the trial period in both groups. 3.,After physical exercise, blood pressure decreased significantly. 4.,Compared with the non-exercise group, in the exercise group both the order parameter (S) and the peak height ratio (ho/h -1) in the EPR spectra of erythrocytes were significantly reduced (S, 0.717 ± 0.004 vs 0.691 ± 0.008, respectively (n = 8), P < 0.05; ho/h -1, 5.38 ± 0.06 vs 4.89 ± 0.06, respectively (n = 8), P < 0.05). These findings indicated that exercise increased membrane fluidity and improved the membrane microviscosity of erythrocytes. 5.,There was no direct correlation between blood pressure reduction and the exercise-induced increase in membrane fluidity of erythrocytes. 6.,In the non-exercise (control) group, blood pressure and membrane fluidity were not changed after a 6 month follow-up period. 7., The results show that aerobic physical exercise increased erythrocyte membrane fluidity and improved the rigidity of cell membranes in hypertensive patients. The improvement of rheological properties of erythrocytes may explain, in part, the cellular mechanisms for the beneficial effects of physical exercise in hypertension. [source] Randomised controlled trial of the effects of two rigid gas permeable (RGP) contact lens materials and two surface cleaners on straylight valuesOPHTHALMIC AND PHYSIOLOGICAL OPTICS, Issue 5 2009Marten F. Fortuin Abstract Purpose:, In a double-masked randomized controlled crossover study we investigated both the retinal responses to straylight, and the effects of lens cleaners on straylight values, in two different RGP contact lens materials. Methods:, Thirty patients (20,59 years) wearing RGP lenses were refitted with new lenses made of Boston XO material in one eye and made of Comfort O2 (ONSI-56) material in the other eye. Reported wetting angles for the Boston XO material (103°) and for the ONSI-56 material (7.2°) were obtained by sessile drop measurements. After refitting, the study comprised three 5-week trial periods. In Period 1 half of the participants (Group A) wore Boston XO lenses in their right eye and Comfort O2 (ONSI-56) lenses in their left eye, and the other half (Group B) vice versa. In Period 2 Group A wore Comfort O2 (ONSI-56) lenses in their right eye and Boston XO lenses in their left, and Group B vice versa. All participants used Miraflow cleaner during periods 1 and 2. In Period 3, during which all participants used Boston cleaner, Group A wore Boston XO lenses in their right eye and Comfort O2 (ONSI-56) lenses in their left eye and Group B vice versa. Straylight data (log S) were obtained with and without contact lenses using the Oculus C-Quant straylight meter in all three periods. Central corneal thickness (CCT) was measured in the second and third periods. Results:, When not wearing lenses (n = 60 eyes) at the end of the second 5 week trial period straylight was measured twice with averages of 1.07 log S, and the corrected CCT measurements averaged 546 ,m. Straylight values with Comfort O2 (ONSI-56) reached 1.15 log S at the end of both the second (n = 25 eyes) and third periods (n = 23 eyes). Straylight values with Boston XO were 1.17 log S (n = 26 eyes) at the end of the second period, and 1.16 log S (n = 25 eyes) at the end of the third period. Conclusions:, Existing RGP lens wearers refitted with new lenses with different contact angles, made of Boston XO and Comfort O2 (ONSI-56) showed, over three 5 week periods, relatively small increases in straylight, which were functionally comparable, irrespective of the type of lens material or lens cleaner used. At every visit, straylight values and CCTs returned to baseline levels after RGP lens removal, confirming that the straylight fluctuations were mainly due to scattering from the RGP lenses; or tear film interaction; or a combination of both. [source] | ||||||||||||||||