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Randomized Study (randomized + study)
Kinds of Randomized Study Selected AbstractsHelicobacter pylori Eradication Therapy May Facilitate Gastric Ulcer Healing After Endoscopic Mucosal Resection: A Prospective Randomized StudyHELICOBACTER, Issue 6 2008Jae Hee Cheon Abstract Background and Aim:, It remains unclear whether Helicobacter pylori eradication therapy affects the healing rate of iatrogenic ulcers following endoscopic mucosal resection (EMR) for gastric tumors. The aim of our study was to prospectively evaluate the effect of H. pylori eradication therapy on gastric ulcer healing after EMR. Methods:, After EMR, patients were randomly assigned to either the H. pylori eradication group (Hp group) (lansoprazole 30 mg, amoxicillin 1000 mg, and clarithromycin 500 mg, twice a day for 7 days) or the noneradication group (proton pump inhibitor, PPI group) (lansoprazole 30 mg, twice a day for 7 days). Four weeks after EMR, the ulcer stages and size were compared between the two groups. Moreover, ulcer-related symptoms, bleeding rates, adverse effects, and drug compliance were compared. Results:, A total of 64 patients were enrolled. Of these, 17 patients were excluded from the study. The two groups were comparable in terms of baseline clinicopathologic characteristics. Four weeks after EMR, the two groups did not differ with respect to ulcer stage (p = .475) or ulcer-related symptoms (p = .399). However, the ulcer reduction ratio was significantly higher in the Hp group (0.028 ± 0.024 vs. 0.065 ± 0.055, p < .05). No differences were observed between the two groups with regard to drug compliance, adverse drug event rates, or bleeding rates. Conclusions:, Our results suggest that H. pylori eradication therapy might improve the ulcer healing rate after EMR. [source] Impact of Systematic Isolation of Superior Vena Cava in Addition to Pulmonary Vein Antrum Isolation on the Outcome of Paroxysmal, Persistent, and Permanent Atrial Fibrillation Ablation: Results from a Randomized StudyJOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, Issue 1 2010ANDREA CORRADO M.D. Impact of the Systematic Isolation of the Superior Vena Cava.,Background: Pulmonary veins (PVs) have been shown to represent the most frequent sites of ectopic beats initiating paroxysmal atrial fibrillation (AF). However, additional non-PV triggers, arising from different areas, have been reported as well. One of the most common non-PV sites described is the superior vena cava. Aims: The purpose of the study was to investigate the impact resulting from the systematic isolation of the superior vena cava (SVCI) in addition to pulmonary vein antrum isolation (PVAI) on the outcome of paroxysmal, persistent, and permanent AF ablation. Methods: A total of 320 consecutive patients who had been referred to our center in order to undergo a first attempt of AF ablation were randomized into 2 groups. Group I (160 patients) underwent PVAI only; Group II (160 patients) underwent PVAI and SVCI. Results: AF was paroxysmal in 134 (46%), persistent in 75 (23%), and permanent in 111 (31%) of said patients. SVCI was performed on 134 of the 160 patients (84%) in Group II. SVC isolation was not performed on the remaining 26 patients either because of phrenic nerve capture or the lack of SVC potentials. Comparison of the outcome data between the 2 groups, after a follow-up of 12 months, revealed a significant difference in total procedural success solely with patients manifesting paroxysmal atrial fibrillation (56/73 [77%] Group I vs. 55/61 [90%] Group II; P = 0.04; OR 2.78). Conclusions: In our study, the strategy of the empiric SVCI in addition to PVAI has improved the outcome of AF ablation solely in patients manifesting paroxysmal AF. (J Cardiovasc Electrophysiol, Vol. 21, pp. 1,5, January 2010) [source] An Open Randomized Study of Inactivated Hepatitis A Vaccine Administered Concomitantly with Typhoid Fever and Yellow Fever VaccinesJOURNAL OF TRAVEL MEDICINE, Issue 2 2002Elaine C. Jong Background: Concomitant administration of several vaccines is a common practice when travel clinics prepare persons for international travel. The purpose of the study was to compare the immunogenicity and safety of hepatitis A, typhoid fever, and yellow fever vaccines administered concomitantly with hepatitis A vaccine administered alone and typhoid fever and yellow fever vaccines administered alone. Methods: Healthy adults 18 to 55 years of age were randomized to receive either VAQTA, TyphimVi, and YF-VAX on day 0 and VAQTA at week 24 (Group 1); TyphimVi and YF-VAX on day 0 and an optional dose of VAQTA 1 month later (Group 2); or VAQTA at day 0 and week 24 (Group 3). Results: From March to December 1997, a total of 240 subjects were enrolled, 80 in each treatment group. Most were female and Caucasian, and the mean age was 29.4 years. Four weeks after vaccine dose 1, seroconversion to protective antibody levels against hepatitis A was 95.9% in Group 1 and 100% in Group 3. In Group 1, 93.4% of subjects demonstrated at least a 4-fold rise in neutralizing antibody levels against typhoid, compared with 90% in Group 2. Serum neutralizing antibody against yellow fever developed in 98.6% of subjects in Group 1 compared with 100% in Group 2. Conclusions: These findings were consistent with similarity in the immune responses between treatment groups as defined a priori. The adverse experience (AE) profile did not appear to be substantially affected by concomitant administration of all three vaccines. Providing these three vaccines concomitantly can simplify the process of obtaining pretravel prophylaxis and may help ensure that all needed vaccines are administered. [source] Impact of Fusion Avoidance on Performance of the Automatic Threshold Tracking Feature in Dual Chamber Pacemakers: A Multicenter Prospective Randomized StudyPACING AND CLINICAL ELECTROPHYSIOLOGY, Issue 11 2002RETO CANDINAS CANDINAS, R., et al.: Impact of Fusion Avoidance on Performance of the Automatic Threshold Tracking Feature in Dual Chamber Pacemakers: A Multicenter Prospective Randomized Study. The Autocapture algorithm enables automatic capture verification on a beat-by-beat basis by recognizing the evoked response signal following each pacemaker stimulus. The algorithm intends to increase patient safety while decreasing energy consumption. However, the occurrence of fusion beats, particularly during dual chamber pacing, may limit the energy saving effect of Autocapture. The aim of this multicenter, prospective, randomized study was to evaluate the impact of the Fusion Avoidance (FA) algorithm on the incidence of fusion beats. Thirty-eight patients (mean age 69 ± 13 years) with intrinsic AV conduction who were implanted with an Affinity DR were studied. After programming a PV/AV delay of 120/190 ms, patients were randomized to FA On or Off. Each group was further randomized with respect to activation of the AutoIntrinsic Conduction Search (AICS) algorithm. The total number of beats, ventricular paced beats, fusion beats, backup pulses, and threshold searches were analyzed from 24-hour Holter recordings. The number of total beats was comparable in both FA groups. The number of total ventricular paced beats, fusion beats, backup pulses, and threshold searches were significantly reduced in the FA On group (% reduction: 68% P < 0.001, 75% P < 0.01, 95% P < 0.01, and 94% P < 0.05, respectively). The number of ventricular paced beats with full capture was significantly reduced when AICS was activated (P < 0.05). In conclusion, the FA algorithm substantially reduces the amount of ventricular paced beats, fusion beats, unnecessary backup pulses and threshold searches, and therefore, provides added benefits in energy saving obtained by Autocapture. [source] Low-Flux Versus High-Flux Synthetic Dialysis Membrane in Acute Renal Failure: Prospective Randomized StudyARTIFICIAL ORGANS, Issue 12 2001Jadranka Buturovi, Ponikvar Abstract: The influence of dialyzer membrane on the morbidity and mortality of patients with acute renal failure remains a matter of debate. The aim of the prospective randomized clinical study was to assess the influence of the flux of a synthetic dialyzer membrane on patients' survival rate, restitution of renal function, and duration of hemodialysis treatment of patients with acute renal failure as a part of multiorgan failure. Seventy-two patients treated in intensive care units of the University Medical Center Ljubljana were randomized according to the dialyzer used throughout the duration of hemodialysis treatment. There were 38 patients in the low-flux group (dialyzer F6, low-flux polysuphone, Fresenius, Bad Homburg, Germany) and 34 patients in the high-flux group (dialyzer Filtral 12, sulphonated high-flux polyacrylonitrile, Hospal, Industrie Meyzieu, France). Both groups were balanced in terms of sex, age, APACHE II score, oliguria before dialysis, cause of acute renal failure, innotropic support, mechanical ventilation, and the number of failing organs. The patients' survival rate was 18.7% in the low-flux group and 20.6% in the high-flux group. Ten patients (26.3%) recovered their renal function in the low-flux group and 8 (23.5%) in the high-flux group. Hemodialysis treatment lasted 11.2 days in the low-flux and 10.7 days in the high-flux group. An analysis of subgroups with a lower mortality rate (subgroup of patients without oliguria and subgroup of patients with less than 4 failed organ systems) did not show significant differences between the low-flux and high-flux groups in terms of survival rate, recovery of renal function, and duration of hemodialysis treatment. In conclusion, no significant differences were found in the results of low-flux versus high-flux synthetic membrane dialyzer treatment in patients with acute renal failure as a part of multiorgan failure in terms of survival rate, recovery of renal function, incidence of oliguria during hemodialysis, and duration of hemodialysis treatment. The number of failing organs seems to be the most important single factor determining the survival of patients with acute renal failure as a part of multiorgan failure. [source] Procedures Can Be Learned on the Web: A Randomized Study of Ultrasound-guided Vascular Access TrainingACADEMIC EMERGENCY MEDICINE, Issue 10 2008Jordan Chenkin MD Abstract Objectives:, Web-based learning has several potential advantages over lectures, such as anytime,anywhere access, rich multimedia, and nonlinear navigation. While known to be an effective method for learning facts, few studies have examined the effectiveness of Web-based formats for learning procedural skills. The authors sought to determine whether a Web-based tutorial is at least as effective as a didactic lecture for learning ultrasound-guided vascular access (UGVA). Methods:, Participating staff emergency physicians (EPs) and junior emergency medicine (EM) residents with no UGVA experience completed a precourse test and were randomized to either a Web-based or a didactic group. The Web-based group was instructed to use an online tutorial and the didactic group attended a lecture. Participants then practiced on simulators and live models without any further instruction. Following a rest period, participants completed a four-station objective structured clinical examination (OSCE), a written examination, and a postcourse questionnaire. Examination results were compared using a noninferiority data analysis with a 10% margin of difference. Results:, Twenty-one residents and EPs participated in the study. There were no significant differences in mean OSCE scores (absolute difference = ,2.8%; 95% confidence interval [CI] = ,9.3% to 3.8%) or written test scores (absolute difference = ,1.4%; 95% CI = ,7.8% to 5.0%) between the Web group and the didactic group. Both groups demonstrated similar improvements in written test scores (26.1% vs. 25.8%; p = 0.95). Ninety-one percent (10/11) of the Web group and 80% (8/10) of the didactic group participants found the teaching format to be effective (p = 0.59). Conclusions:, Our Web-based tutorial was at least as effective as a traditional didactic lecture for teaching the knowledge and skills essential for UGVA. Participants expressed high satisfaction with this teaching technology. Web-based teaching may be a useful alternative to didactic teaching for learning procedural skills. [source] Natural vegetable fats in the prevention of irritant contact dermatitisCONTACT DERMATITIS, Issue 1 2002S. Schliemann-Willers Chronic irritant contact dermatitis (ICD) is one of the most pressing problems in occupational medicine and is common in the food processing industry. To date, protective creams that fulfil the special requirements in the foodstuffs industry have not been available. Therefore, we studied the efficacy of pre-exposure application of natural vegetable fats in the prevention of experimentally induced ICD. A panel of 20 healthy volunteers was tested with a repetitive irritation test using sodium lauryl sulfate (SLS) as a standard irritant in a randomized study. Application sites were assessed clinically and by the use of bioengineering techniques (evaporimetry, chromametry, and corneometry). Rape seed and palm fats showed significant protective potential. Gas-chromatographic analysis revealed differences in the fatty acid composition of the vegetable. Higher content of linoleic acid and lower content of oleic acid was associated with beneficial effects. Our results are a new approach in the prevention of ICD and towards the development of new protective preparations for workplaces in the foodstuffs industry. [source] Brief communication: A randomized study of iterative hypothesis testing in undergraduate psychiatric educationACTA PSYCHIATRICA SCANDINAVICA, Issue 4 2010K. G. Kahl Kahl KG, Alte C, Sipos V, Kordon A, Hohagen F, Schweiger U. A randomized study of iterative hypothesis testing in undergraduate psychiatric education. Objective:, Iterative hypothesis testing (IHT) or related strategies of diagnostic decision making have been taught in many curricula for medical students but not in psychiatry. We therefore asked whether the addition of training in IHT may add to the quality of the psychiatry course. Method:, Seventy-two medical students were randomized to four weeks problem-based learning or to IHT. Knowledge and skills of the students were tested using a multiple choice exam and simulated patients. Results:, Iterative hypothesis testing-trained students recognized more diagnostic items and more often identified comorbid psychiatric disorders and acute suicidal tendencies. Acquisition of general psychiatric knowledge and global satisfaction with the course were similar in both groups. Conclusion:, We conclude that teaching IHT to medical students may enhance their clinical ability to recognize complex disease patterns. Further studies are required concerning the enhancement of clinical skills in the psychiatric specialty. [source] A randomized study of massed three-week cognitive behavioural therapy schedule for panic disorderACTA PSYCHIATRICA SCANDINAVICA, Issue 3 2009M. K. Bohni Objective:, To compare the efficacy of massed vs. spaced group cognitive behavioural therapy (CBT) for patients with panic disorder with or without agoraphobia (PD). Method:, Thirty-nine PD patients were randomly assigned to massed group CBT (daily 4-h sessions in week 1, two 2-h sessions in week 2 and one 2-h session in week 3) or traditional spaced weekly group CBT (13 consecutive, weekly 2-h sessions). The content and number of hours in the two treatment schedules were identical. Outcome was assessed after treatment, and at 3, 6 and 18 months of follow-up. Results:, Both treatment groups achieved significant improvement on all measures with large pre- to post-treatment and pre-treatment to follow-up effect sizes. No between-group differences were registered. Adherence and patient satisfaction did not differ between groups. Conclusion:, The massed, 3-week group CBT schedule proved to be effective and feasible for PD patients with outcomes comparable with that of standard, spaced group CBT. [source] Effect of insulin infusion on electrocardiographic findings following acute myocardial infarction: importance of glycaemic controlDIABETIC MEDICINE, Issue 2 2009R. M. Gan Abstract Aims, To determine the effects of insulin infusion and blood glucose levels during acute myocardial infarction (AMI) on electrocardiographic (ECG) features of myocardial electrical activity. Methods, ECGs at admission and 24 h were examined in a randomized study of insulin infusion vs. routine care for AMI patients with diabetes or hyperglycaemia. Results were analysed according to treatment allocation and also according to average blood glucose level. Results, ECG characteristics were similar at admission in both groups. Patients allocated to conventional treatment had prolongation of the QT interval (QTc) after 24 h but those receiving infused insulin did not. In patients with a mean blood glucose in the first 24 h > 8.0 mmol/l, new ECG conduction abnormalities were significantly more common than in patients with mean blood glucose , 8.0 mmol/l (15.0% vs. 6.0%, P < 0.05). Conclusions, Prevention of QTc prolongation by administration of insulin may reflect a protective effect on metabolic and electrical activity in threatened myocardial tissue. Abnormalities of cardiac electrical conduction may also be influenced by blood glucose. [source] An increase in insulin sensitivity and basal beta-cell function in diabetic subjects treated with pioglitazone in a placebo-controlled randomized studyDIABETIC MEDICINE, Issue 6 2004T. M. Wallace Abstract Aims To investigate the effect of treatment with pioglitazone on beta-cell function and insulin sensitivity in Type 2 diabetes. Methods Thirty subjects with diet-controlled Type 2 diabetes were randomized to 3 months treatment with pioglitazone (n = 19) or placebo (n = 11). All subjects underwent basal sampling for homeostatic model assessment (HOMA), followed by an intravenous glucose tolerance test and hyperglycaemic clamp, followed by an euglycaemic hyperinsulinaemic clamp; at baseline and after treatment. Results All results are expressed as mean (sem). Pioglitazone increased basal insulin sensitivity by 24.7% (7.8) HOMA-%S vs. 2.1% (5.9) in the placebo group (P = 0.02). Stimulated insulin sensitivity, M/I, increased in the pioglitazone group compared with placebo: +15.1 (2.8) l kg,1 min,1 vs. +3.2 (2.9) l kg,1 min,1, respectively (P = 0.009). Pioglitazone increased adiponectin by 39.3 (6.3), ng/ml compared with a decrease of 0.8 (1.3) ng/ml with placebo (P = 0.00004). HOMA-%B increased with pioglitazone, +11.5% (4.8) vs. ,2.0% (4.8) with placebo (P = 0.049), but there was no change in stimulated beta-cell function as determined by hyperglycaemic clamps. There was a significant reduction in the proinsulin/insulin ratio in the pioglitazone group, ,0.057 (0.02) compared with placebo, +0.004 (0.02) (P = 0.03). There was a significant reduction in HbA1c of 0.6% (0.1) in the pioglitazone group compared with placebo (P = 0.003). There was no significant weight gain associated with pioglitazone therapy: +0.7 (sem 0.6) kg vs. +1.1 (sem 0.5) kg in placebo group (P = NS). Conclusions Basal beta-cell function and insulin sensitivity improved following pioglitazone therapy. The improvement in proinsulin to insulin ratio suggests that beta-cells are under less stress. [source] Exposure to opioid maintenance treatment reduces long-term mortalityADDICTION, Issue 3 2008Amy Gibson ABSTRACT Aims To (i) examine the predictors of mortality in a randomized study of methadone versus buprenorphine maintenance treatment; (ii) compare the survival experience of the randomized subject groups; and (iii) describe the causes of death. Design Ten-year longitudinal follow-up of mortality among participants in a randomized trial of methadone versus buprenorphine maintenance treatment. Setting Recruitment through three clinics for a randomized trial of buprenorphine versus methadone maintenance. Participants A total of 405 heroin-dependent (DSM-IV) participants aged 18 years and above who consented to participate in original study. Measurements Baseline data from original randomized study; dates and causes of death through data linkage with Births, Deaths and Marriages registries; and longitudinal treatment exposure via State health departments. Predictors of mortality examined through survival analysis. Findings There was an overall mortality rate of 8.84 deaths per 1000 person-years of follow-up and causes of death were comparable with the literature. Increased exposure to episodes of opioid treatment longer than 7 days reduced the risk of mortality; there was no differential mortality among methadone versus buprenorphine participants. More dependent, heavier users of heroin at baseline had a lower risk of death, and also higher exposure to opioid treatment. Older participants randomized to buprenorphine treatment had significantly improved survival. Aboriginal or Torres Strait Islander participants had a higher risk of death. Conclusions Increased exposure to opioid maintenance treatment reduces the risk of death in opioid-dependent people. There was no differential reduction between buprenorphine and methadone. Previous studies suggesting differential effects may have been affected by biases in patient selection. [source] Subcutaneous histamine versus botulinum toxin type A in migraine prophylaxis: a randomized, double-blind studyEUROPEAN JOURNAL OF NEUROLOGY, Issue 1 2009R. O. Millán-Guerrero Objectives:, To compare the efficacy and tolerability of the subcutaneous administration of histamine and botulinum toxin type A (BoNTA) in migraine prophylaxis. Background:, Histamine has a selective affinity for H3 receptors and it may specifically inhibit the neurogenic edema response involved in migraine pathophysiology. Methods:, One hundred patients with migraine were selected in a 12-week double-blind controlled clinical trial to evaluate the efficacy of subcutaneous administration of histamine (1,10 ng twice a week) n = 50, compared with administration of 50 U of BoNTA (one injection cycle) n = 50. Results:, The data collected during the 4th week of treatment revealed a significant decrease in all parameters studied, in histamine and BoNTA (P < 0.001). After 4 weeks of treatment, but one injection cycle of 50 U BoNTA had only a 40-day period of efficacy. Conclusions:, This randomized study demonstrated that both histamine and BoNTA are similarly effective and well tolerated in reducing or eliminating headache in migraine prophylaxis. Low doses of histamine applied subcutaneously may represent a novel and effective therapeutic alternative in migraine patients and lay the clinical and pharmacological groundwork for the use of H3 agonist in migraine prophylaxis. [source] Is there a role for physiotherapy during deep brain stimulation surgery in patients with Parkinson's disease?EUROPEAN JOURNAL OF NEUROLOGY, Issue 5 2006E. Chevrier In our center, a physiotherapist is present in the operative room to bring relief to the Parkinsonian patient during subthalamic nucleus stimulation surgery under local anesthesia. This study searched to determine the causes of pain and suffering during bilateral electrode implantation and to assess the role of physiotherapy. Ninety-two consecutive patients operated on between 2001 and 2004 were included in this retrospective study. A questionnaire with eight items was developed and mailed to the patients. Seventy-five responses to questionnaires were available. All patients except one experienced physical pain and psychological suffering, alleviated by physiotherapy. These preliminary results need to be confirmed in a prospective randomized study. [source] Pramipexole and pergolide in the treatment of depression in Parkinson's disease: a national multicentre prospective randomized studyEUROPEAN JOURNAL OF NEUROLOGY, Issue 4 2003I. Rektorová An 8-month multicentre prospective randomized study aimed at comparing the effects of dopamine receptor agonists pramipexole (PPX; Mirapexin®) and pergolide (PRG; Permax®) as add-on to L-dopa therapy on depression [Montgomery and Asberg Depression Rating Scale (MADRS)] in 41 non-demented patients (25 men, 16 women) suffering from both mild or moderate depression and advanced Parkinson's disease (PD). The assessment was performed by a blinded independent observer. Motor symptoms (UPDRS III), motor complications (UPDRS IV), activities of daily living (UPDRS II and VI) and depressive symptoms as measured by Self , Rating Depression Scale by Zung were evaluated in an open-label design. The average value of Zung scores decreased significantly in both groups with no statistical difference between both groups. A significant decrease in the average value of MADRS scores was present only in the PPX group. The average UPDRS scores decreased significantly with no statistical difference between both groups at the comparable average total daily dose of both preparations. In both cases, the total daily dose of L-dopa decreased significantly but the decrease was statistically more pronounced in the PRG group. Our results demonstrate the antidepressant effect of PPX in patients with PD while we can't make any conclusions with regard to antidepressant effect of PRG. [source] Class II restorations in primary teeth: 7-year study on three resin-modified glass ionomer cements and a compomerEUROPEAN JOURNAL OF ORAL SCIENCES, Issue 2 2004V. Qvist The aim of this randomized study was to compare the longevity and cariostatic effects of 1565 class II restorations in primary teeth placed by 15 clinicians in the Danish Public Dental Health Service in 971 children, aged 3.6,14.9 yr. The restorations were performed using three resin-modified glass ionomer cements and one compomer (polyacid-modified composite resin) with and without their respective cavity conditioners. The restorations were in contact with 1023 unrestored proximal surfaces in 853 primary and 170 permanent teeth. The study was terminated after 7 yr with 1% of the restorations in function, 7% patient dropouts, 18% failed restorations, and operative treatment on 24% of the adjacent surfaces. Multivariate survival analyses showed that the restorative material and cavity conditioning influenced the survival of restorations but not the progression of caries on adjacent surfaces. The 50% survival times were estimated to exceed 5 yr for the restorations and 4.5 yr for the adjacent unfilled surfaces in all treatment groups. It was concluded that resin-modified glass ionomer cement and compomer are both appropriate materials for class II restorations in primary teeth. The differences in longevity and cariostatic effects among the four materials used with and without conditioner were less than the intra-individual differences between clinicians. [source] Antiplatelet drug use preceding the onset of intracerebral hemorrhage is associated with increased mortalityFUNDAMENTAL & CLINICAL PHARMACOLOGY, Issue 3 2007Karine Lacut Abstract Recent studies highlight the contribution of antiplatelet therapy to clinical severity and increased mortality of intracerebral hemorrhage (ICH) but results are discrepant. The aim of this report was to evaluate the association between antiplatelet drug use preceding the onset of ICH and the mortality, assessed at regular intervals, among patients with acute ICH. We analyzed data from a randomized study which enrolled consecutive patients with a documented acute ICH to evaluate the efficacy of intermittent pneumatic compression of the legs in venous thrombosis prevention. Clinical characteristics and treatment used before the onset of ICH were checked at the time of inclusion. Mortality was assessed at regular intervals until 3 months after ICH diagnosis. Among 138 patients included in this report, 30 were current users of antiplatelet therapy at the time of ICH; they were significantly older and less frequently heavy drinkers than non-users of antiplatelet drugs. Mortality rates were 20% at 8 days, 40% at 1 month, and 47% at 3 months among antiplatelet drug users compared with 6.5%, 13% and 19% among non-users. The corresponding estimated risks for mortality related to antiplatelet drug use were 3.6 (95% CI 1.1,12), 4.5 (95% CI 1.8,11), and 3.6 (95% CI 1.5,8.6). Adjusted for age, hypertension and alcohol over use, antiplatelet therapy remained significantly associated with an increased mortality rate of acute ICH. Current antiplatelet drug use preceding the onset of ICH is associated with increased short-term ICH mortality, independently of age. [source] Comparison of pharyngoesophageal segment pressure in total laryngectomy patients with and without pharyngeal neurectomyHEAD & NECK: JOURNAL FOR THE SCIENCES & SPECIALTIES OF THE HEAD AND NECK, Issue 8 2003Ahmet Köyba, lu MD Abstract Background. To compare pharyngoesophageal segment (PES) pressure values in total laryngectomy patients with and without pharyngeal neurectomy (PN) in the early postoperative period. Methods. Forty-five previously untreated laryngeal carcinoma patients were enrolled into this prospective randomized study. Twenty of them underwent total laryngectomy with PN, and 25 underwent total laryngectomy without PN. PES pressures were measured on the tenth postoperative day with a four-channel catheter. Results. Average PES pressures in patients with and without pharyngeal neurectomy were 12.82 ± 6.11 mmHg and 17.40 ± .72 mmHg respectively (p < .05). When compared with the critical point of 20 mmHg that is closely related to voice attainment in the group without pharyngeal neurectomy, 10 (40%) patients had pressure levels greater than 20 mmHg and in the other group only 1 (5%) patient had a pressure level greater than 20 mmHg. The difference between the groups with pressure levels greater than 20 mmHg was found to be statistically significant (p < .05). Conclusions. Pharyngeal neurectomy results in a statistically significant decrease of PES pressures in total laryngectomy patients. © 2003 Wiley Periodicals, Inc. Head Neck 25: 617,623, 2003 [source] A randomized study of adefovir dipivoxil in place of HBIG in combination with lamivudine as post,liver transplantation hepatitis B prophylaxis,HEPATOLOGY, Issue 5 2008Peter W. Angus Prior to effective prophylaxis, liver transplantation for hepatitis B virus (HBV)-related disease was frequently complicated by recurrence, which could be severe and rapidly progressive. Combination hepatitis B immunoglobulin (HBIG) and lamivudine prophylaxis reduces this rate of recurrence to <5% at 5 years; however, HBIG administration is costly and inconvenient. We conducted a multicenter randomized study of adefovir dipivoxil substitution for low-dose intramuscular (IM) HBIG in patients without HBV recurrence at least 12 months posttransplantation for HBV-related disease. Thirty-four patients were randomized, 16 to adefovir (1 patient withdrew consent at 3 months and is not considered in the results) and 18 to continue HBIG. All continued lamivudine. Groups were well matched by age, sex, and time since transplantation (median, 4.5 years), and background virological risk for HBV recurrence (30% of patients in the adefovir group, 24% in the HBIG group having detectable HBV DNA at transplantation). All patients were alive at study completion without recurrence. One patient in the adefovir group became hepatitis B surface antigen,positive at 5 months but was persistently HBV DNA undetectable via polymerase chain reaction (sensitivity 14 IU/mL) over the following 20 months. Median creatinine was not significantly changed over the course of the study in either group. One patient in the adefovir group with a background of diabetic and hypertensive nephropathy (baseline creatinine 150 ,mol/L) developed increased creatinine leading to dose reduction and ultimately cessation of adefovir at 15 months. Yearly cost of combination adefovir/lamivudine prophylaxis was $8,290 versus $13,718 IM HBIG/lamivudine. Conclusion: Compared with combination HBIG plus lamivudine prophylaxis, combination adefovir plus lamivudine provides equivalent protection against recurrent HBV infection but with better tolerability and less cost. (HEPATOLOGY 2008.) [source] A randomized, two-year study of the efficacy of cognitive intervention on elderly people: the Donostia Longitudinal StudyINTERNATIONAL JOURNAL OF GERIATRIC PSYCHIATRY, Issue 1 2008Cristina Buiza Abstract Background Research on non-pharmacological therapies (cognitive rehabilitation) in old age has been very limited, and most has not considered the effect of interventions of this type over extended periods of time. Objective To investigate a new cognitive therapy in a randomized study with elderly people who did not suffer cognitive impairment. Methods The efficacy of this therapy was evaluated by means of post-hoc analysis of 238 people using biomedical, cognitive, behavioural, quality of life (QoL), subjective memory, and affective assessments. Results Scores for learning potential and different types of memory (working memory, immediate memory, logic memory) for the treatment group improved significantly relative to the untreated controls. Conclusions The most significant finding in this study was that learning potential continued at enhanced levels in trained subjects over an intervention period lasting two years, thereby increasing rehabilitation potential and contributing to successful ageing. Copyright © 2007 John Wiley & Sons, Ltd. [source] Procedural pain of an ultrasound-guided brachial plexus block: a comparison of axillary and infraclavicular approachesACTA ANAESTHESIOLOGICA SCANDINAVICA, Issue 4 2010B. S. FREDERIKSEN Background: Ultrasound (US)-guided infraclavicular (IC) and axillary (AX) blocks have similar effectiveness. Therefore, limiting procedural pain may help to choose a standard approach. The primary aims of this randomized study were to assess patient's pain during the block and to recognize its cause. Methods: Eighty patients were randomly allocated to the IC or the AX group. A blinded investigator asked the patients to quantify block pain on a Visual Analogue Scale (VAS 0,100) and to indicate the most unpleasant component (needle passes, paraesthesie or local anaesthetics injection). Sensory block was assessed every 10 min. After 30 min, the unblocked nerves were supplemented. Patients were ready for surgery when they had analgesia or anaesthesia of the five nerves distal to the elbow. Preliminary scan time, block performance and latency times, readiness for surgery, adverse events and patient's acceptance were recorded. Results: The axillary approach resulted in lower maximum VAS scores (median 12) than the infraclavicular approach (median 21). This difference was not statistically significant (P=0.07). Numbers of patients indicating the most painful component were similar in both groups. Patients in either group were ready for surgery after 25 min. Two patients in the IC group and seven in the AX group needed block supplementation (n.s.). Block performance times and number of needle passes were significantly lower in the IC group. Patients' acceptance was 98% in both groups. Conclusions: We did not find significant differences between the two approaches in procedural pain and patient's acceptance. The choice of approach may depend on the anaesthesiologist's experience and the patient's preferences. [source] Adjuvant methotrexate, vinblastine, adriamycin, and cisplatin chemotherapy has potential to prevent recurrence of bladder tumors after surgical removal of upper urinary tract transitional cell carcinomaINTERNATIONAL JOURNAL OF UROLOGY, Issue 9 2008Norihito Soga Objectives: To evaluate the efficacy of adjuvant platinum based chemotherapy in upper urinary tract urothelial cancer following surgical resection in terms of survival benefit and inhibition of bladder cancer recurrence. Methods: Between April 1986 and August 2005, a total of 132 patients with a diagnosis of upper urinary tract urothelial cancer underwent radical nephroureterectomy with cuff of bladder at our department. A total of 46 patients (13 with pT2pN0M0 and 33 with pT3 pN0M0 transitional cell carcinoma without prior bladder cancer) were enrolled. Patients with locally advanced disease were divided into two groups: the adjuvant chemotherapy group (24 patients) who received adjuvant methotrexate, vinblastine, adriamycin, and cisplatin (M-VAC) and the non-adjuvant chemotherapy group who did not receive adjuvant M-VAC (22 patients). Results: There were no statistically significant differences in patient characteristics or 10-year survival between the two groups. The recurrence rate in the non-adjuvant chemotherapy group was significantly higher than in the adjuvant chemotherapy group (log-rank test, P < 0.0001). Only non-adjuvant chemotherapy was a significant and independent risk factor (hazard ratio 6.97) for the development of intravesical recurrence (P < 0.01). Conclusion: Adjuvant M-VAC is an important optional adjuvant therapy and can prevent recurrent bladder tumors following surgery for upper urinary tract transitional cell carcinoma. To determine whether adjuvant chemotherapy has further benefit, a randomized study would be needed. [source] Prophylactic intravesical instillation of mitomycin C and cytosine arabinoside for prevention of recurrent bladder tumors following surgery for upper urinary tract tumors: A prospective randomized studyINTERNATIONAL JOURNAL OF UROLOGY, Issue 5 2001Naotaka Sakamoto Abstract Background: A recurrence of bladder tumors following surgery for transitional cell carcinoma of the upper urinary tract is not rarely observed. A prospective randomized study was conducted to examine the significance of prophylactic intravesical instillation of mitomycin C (MMC) and cytosine arabinoside (Ara-C) to prevent recurrent bladder tumors after surgery for superficial transitional cell carcinoma of the upper urinary tract. Methods: The patients were randomized into an instillation group, who received postoperative intravesical instillation of MMC (20 mg) and Ara-C (200 mg) 28 times over a period of 2 years, and a non-instillation group. The non-recurrence rate was then compared between the groups. Results: Of the 27 patients registered, 25 patients (13 with instillation and 12 without instillation) were able to be evaluated, with a median follow-up period of 45 months. The non-recurrence rate of bladder tumors in the instillation group was higher than that in the non-instillation group. Although the difference was not statistically significant, the P -value (P = 0.079) demonstrated a strong trend. When any possible bias was allowed for a multivariate analysis, the difference was almost significant (P = 0.0567). No patients withdrew from this study due to any side-effects. Conclusion: The postoperative instillation of MMC and Ara-C may be a useful approach for reducing the recurrence of bladder tumors after surgery for upper urinary tract tumors. [source] Analgesia before a spinal block for femoral neck fracture: fascia iliaca compartment blockACTA ANAESTHESIOLOGICA SCANDINAVICA, Issue 10 2009M. J. YUN Background: In this prospective randomized study, the authors compared the analgesic effect of a fascia iliaca compartment (FIC) block with that of intravenous (i.v.) alfentanil when administered to facilitate positioning for spinal anaesthesia in elderly patients undergoing surgery for a femoral neck fracture. Methods: The 40 patients were randomly assigned to one of two groups, namely, the FIC group (fascia iliaca compartment block, n=20) and the IVA group (intravenous analgesia with alfentanil, n=20). Group IVA patients received a bolus dose of i.v. alfentanil 10 ,g/kg, followed by a continuous infusion of alfentanil 0.25 ,g/kg/min starting 2 min before the spinal block, and group FIC patients received a FIC block with 30 ml of ropivacaine 3.75 mg/ml (112.5 mg) 20 min before the spinal block. Visual analogue pain scale (VAS) scores, time to achieve spinal anaesthesia, quality of patient positioning, and patient acceptance were compared. Results: VAS scores during positioning (mean and range) were lower in the FIC group than in the IVA group [2.0 (1,4) vs. 3.5 (2,6), P=0.001], and the mean (± SD) time to achieve spinal anaesthesia was shorter in the FIC group (6.9 ± 2.7 min vs. 10.8 ± 5.6 min; P=0.009). Patient acceptance (yes/no) was also better in the FIC group (19/1) than in the IVA group (12/8)(P=0.008). Conclusions: An FIC block is more efficacious than i.v. alfentanil in terms of facilitating the lateral position for spinal anaesthesia in elderly patients undergoing surgery for femoral neck fractures. [source] Ineffectiveness of Local Wound Anesthesia to Reduce Postoperative Pain After Median SternotomyJOURNAL OF CARDIAC SURGERY, Issue 4 2005Diego Magnano M.D. Bupivacaine wound infiltration is frequently used to reduce the pain related to the surgical incision itself. In this randomized study, we investigated the efficacy of bupivacaine local anesthesia after median sternotomy to reduce postoperative pain. Forty-seven patients undergoing major cardiac surgery procedures were allocated randomly to group A (bupivacaine wound infiltration 0.5%; 10 mL, followed by continuous infusion: 10 mg/24 H) or to group C (controls). Extubation time, postoperative arterial blood gases, postoperative pain (assessed by means of a visual analog scale), and morphine consumption were the endpoints of the study. Patients of group C were extubated earlier; blood gases and VAS values were similar in both group. Bupivacaine local analgesia did not improve postoperative pain control after median sternotomy. [source] Is Defibrillation Testing Still Necessary?JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, Issue 4 2008A Decision Analysis, Markov Model Objective: To assess the impact of defibrillation threshold (DFT) testing of implanted cardioverter-defibrillators (ICDs) on survival. Background: DFT testing is generally performed during implantation of ICDs to assess sensing and termination of ventricular fibrillation. It is common clinical practice to defibrillate ventricular fibrillation twice at an output at least 10 J below the maximum output of the device, providing a 10 J safety margin. However, there are few data regarding impact of DFT testing on outcomes. Methods: Decision analysis and Monte Carlo simulation were used to assess expected outcomes of DFT testing. Survival of a hypothetical cohort of patients was assessed according to two strategies,routine DFT testing at time of ICD implant versus no DFT testing. Assumptions in the model were varied over a range of reasonable values to assess outcomes under a variety of scenarios. Results: Five-year survival with DFT and no-DFT strategies were similar at 59.72% and 59.36%, respectively. The results were not sensitive to changing risk estimates for arrhythmia incidence and safety margin. Results of the Monte Carlo simulation were qualitatively similar to the base case scenario and consistent with a small and nonsignificant survival advantage with routine DFT testing. Conclusions: The impact of DFT testing on 5-year survival in ICD patients, if it exists, is small. Survival appears higher with DFT testing as long as annual risk of lethal arrhythmia or the risk of a narrow safety margin is at least 5%, although the incremental benefit is marginal and 95% confidence intervals cross zero. A prospective randomized study of DFT testing in modern devices is warranted. [source] Electroanatomic Versus Fluoroscopic Mapping for Catheter Ablation Procedures:JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, Issue 3 2004A Prospective Randomized Study Introduction: The aim of this prospective randomized study was to compare the routine use of electroanatomic imaging (CARTO) with that of conventional fluoroscopically guided activation mapping (conventional) in an unselected population referred for catheter ablation. We sought to compare the two approaches with respect to procedure outcome and duration, radiation exposure, and cost. Methods and Results: All patients undergoing catheter ablation (with the exception of complete AV nodal ablation) were prospectively randomized to either a CARTO or conventional procedure for mapping and ablation. One hundred two patients were randomized. Acute procedural success was similar with either strategy (CARTO vs conventional 43/47 vs 51/55, P > 0.5), as was procedure duration (144 [58] vs 125 [48] min, P = 0.07 (mean [SD]). CARTO was associated with a substantial reduction in fluoroscopy time (9.3 [7.6] vs 28.8 [19.5] min, P < 0.001) and radiation dose (6.2 [6.1] vs 20.8 [32.7] Gray, P = 0.003). CARTO cases used fewer catheters (2.5 [0.7] vs 4.4 [1.1], P < 0.001), but catheter costs were higher (13.8 vs 9.3 units, P < 0.001, where one unit is equivalent to the cost of a nonsteerable quadripolar catheter). Conclusion: For all catheter ablation procedures, even when a center's "learning curve" for CARTO is included, procedure duration and outcome are similar for CARTO and conventional procedures. CARTO is associated with drastically reduced fluoroscopy time and radiation dose. Although fewer catheters are used with CARTO, catheter costs remain higher. (J Cardiovasc Electrophysiol, Vol. 15, pp. 310-315, March 2004) [source] Randomized Comparison of Bipolar versus Unipolar Plus Bipolar Recordings During Segmental Ostial Ablation of Pulmonary VeinsJOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, Issue 9 2002HIROSHI TADA M.D. Unipolar vs Bipolar Electrograms.Introduction: Segmental ostial ablation to isolate pulmonary veins is guided by pulmonary vein potentials. The aim of this prospective randomized study was to compare the utility of unipolar plus bipolar electrograms versus only bipolar electrograms as a guide for segmental ablation to isolate the pulmonary veins in patients with atrial fibrillation. Methods and Results: Isolation of the left superior, right superior, and left inferior pulmonary veins was attempted in 44 patients (35 men and 9 women; mean age 54 ± 10 years) with paroxysmal atrial fibrillation. A decapolar Lasso catheter was positioned in the pulmonary veins, near the ostium, and a conventional ablation catheter was used for segmental ablation aimed at elimination of all pulmonary vein potentials. One hundred fourteen pulmonary veins were randomly assigned for ostial ablation guided by either bipolar or unipolar plus bipolar recordings. Electrical isolation was achieved in 51 (96%) of 53 pulmonary veins randomized to the bipolar approach, and 57 (93%) of 61 pulmonary veins randomized to the unipolar plus bipolar approach (P = 0.7). In the unipolar plus bipolar group, the total duration of radiofrequency energy needed to achieve isolation, 5.5 ± 2.8 minutes/vein, was significant shorter than in the bipolar group, 7.6 ± 4.1 minutes/vein (P < 0.01). Mean procedure and fluoroscopy durations per vein were 19% to 28% shorter in the unipolar plus bipolar group. Conclusion: Segmental ostial ablation to isolate the pulmonary veins can be achieved more efficiently and with less radiofrequency energy when guided by both unipolar and bipolar recordings than by bipolar recordings alone. [source] Mandibular overdentures supported by two Brånemark, IMZ or ITI implants: a ten-year prospective randomized studyJOURNAL OF CLINICAL PERIODONTOLOGY, Issue 9 2009Henny J. A. Meijer Abstract Objectives: The aim of this prospective comparative study was to evaluate the survival rate, condition of peri-implant tissues, patient satisfaction and surgical and prosthetic aftercare of the IMZ-implant system (two-stage cylinder type), the Brånemark-implant system (two-stage screw type) and the ITI-implant system (one-stage screw type) supporting a mandibular overdenture during a 10-year follow-up period. Materials and Methods: Three groups of 30 edentulous patients were treated with two endosseous implants in the interforaminal region of the mandible. Clinical and radiographic parameters were evaluated immediately after completion of the prosthetic treatment and after 1, 5 and 10 years of functional loading. Prosthetic and surgical aftercare was scored during the evaluation period, as well as patient satisfaction. Results: The 10-year survival rate was 93% for the IMZ group, 98% for the Brånemark group and 100% for the ITI group (IMZ Prosper study of evidence-based intervention implementation quality by community,university partnershipsJOURNAL OF COMMUNITY PSYCHOLOGY, Issue 8 2007Richard Spoth This study examined a community,university partnership model for sustained, high-quality implementation of evidence-based interventions. In the context of a randomized study, it assessed whether implementation quality for both family-focused and school-based universal interventions could be achieved and maintained through community,university partnerships. It also conducted exploratory analyses of factors influencing implementation quality. Results revealed uniformly high rates of both implementation adherence,averaging over 90%,and of other indicators of implementation quality for both family-focused and school-based interventions. Moreover, implementation quality was sustained across two cohorts. Exploratory analyses failed to reveal any significant correlates for family-intervention implementation quality, but did show that some team and instructor characteristics were associated with school-based implementation quality. © 2007 Wiley Periodicals, Inc. J Comm Psychol 35: 981,999, 2007. [source]
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