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METHODS MID was identified through effect size ( ES ) and receiver-operating characteristic ( ROC ) curve analyses ( HCV-PRO response vs. SF-36 PCS/MCS and EQ VAS MID thresholds ) . |
RESULTS In 74 patients ( 22 % female ; 81 % White ; 51 % 50years ) , correlations ( 0.64-0 .96 ) between HCV-PRO total scores , SF-36 PCS/MCS scores , and EQ VAS scores at all time points supported convergent validity . |
RESULTS HCV-PRO total scores were reduced to 10-30 points in patients impaired by depression , pain , or fatigue symptoms . |
RESULTS Impact of peg-IFN/RBV regimen on HCV-PRO ES increased over time ( EODT -0.76 ; EOT -0.93 ) . |
RESULTS ES and ROC curve analyses indicated an MID of -10 points . |
CONCLUSIONS The HCV-PRO was valid and responsive in the population studied . |
CONCLUSIONS An MID of -10 points represented a threshold of clinical significance for the HCV-PRO . |
###15622577 |
BACKGROUND Severe fecal incontinence remains a disabling condition for the patient and a major therapeutic challenge for the physician . |
BACKGROUND A series of observational studies have indicated that placement of an artificial bowel sphincter is associated with marked improvement of continence and quality of life . |
BACKGROUND We have performed a prospective , randomized , controlled trial to evaluate the effect of placement of an artificial bowel sphincter ( Acticon Neosphincter ) on continence and quality of life in a group of severely incontinent adults . |
METHODS Fourteen adults ( male : female , 1:13 ; age range , 44-75 years ) were randomized to placement of the artificial bowel sphincter or to a program of supportive care and were followed for six months from operation or entry into the study . |
METHODS The principal outcome measure was the level of continence , measured with the Cleveland Continence Score , which provides a scale from 0 to 20 , representing perfect control through to total incontinence . |
METHODS Secondary outcome measures were perioperative and late complications in the artificial bowel sphincter group , and the changes in quality of life in both groups . |
RESULTS In the control group , the Cleveland Continence Score was not significantly altered , with an initial value of 17.1 + / - 2.3 and a final value of 14.3 + / - 4.6 at six months . |
RESULTS The artificial bowel sphincter group showed a highly significant improvement , changing from 19.0 + / - 1.2 before placement to 4.8 + / - 4.0 at six months after placement . |
RESULTS One patient in the artificial bowel sphincter group had failure of healing of the perineal wound and explantation of the device ( 14 percent explantation rate ) . |
RESULTS There were two other significant perioperative events of recurring fecal impaction initially after placement in one patient and additional suturing of the perineal wound in another . |
RESULTS There were major improvements in the quality of life for all measures in the artificial bowel sphincter group . |
RESULTS There was significant improvement in all eight subscales of the Medical Outcome Study Short Form-36 measures . |
RESULTS The American Medical Systems Quality of Life score was raised from 39 + / - 6 to 83 + / - 14 and the Beck Depression Inventory showed reduction from a level of mild depression ( 10.8 + / - 9.3 ) to a normal value ( 6.8 + / - 8.7 ) . |
RESULTS No significant changes in any of the quality of life measures occurred for the control group . |
CONCLUSIONS Through a prospective , randomized trial format , we have shown that placement of an artificial bowel sphincter is safe and effective when compared with supportive care alone . |
CONCLUSIONS Perioperative and late problems are likely to continue to occur and between 15 percent and 30 percent of patients may require permanent explantation . |
CONCLUSIONS For the remainder , the device is easy and discrete to use , highly effective in achieving continence , and able to generate a major improvement in the quality of life . |
###23218801 |
OBJECTIVE Statins are known to reduce plasma C-reactive protein ( CRP ) concentrations . |
OBJECTIVE Our goal was to define the mechanisms by which CRP was reduced by maximal dose atorvastatin . |
METHODS Eight subjects with combined hyperlipidemia ( 5 men and 3 postmenopausal women ) were enrolled in a randomized , placebo-controlled double-blind , cross over study . |
METHODS Subjects underwent a 15-h primed-constant infusion with deuterated leucine after 8 weeks of placebo and 80mg/day of atorvastatin . |
METHODS CRP was isolated from lipoprotein deficient plasma , ( density > 1.21 g/ml ) by affinity chromatography . |
METHODS Isotopic enrichment was determined by gas chromatography/mass spectrometry . |
METHODS Kinetic parameters were determined using compartmental modeling . |
METHODS Paired t test and Wilcoxon signed ranks test were used to compare differences between placebo and atorvastatin . |
RESULTS Compared with placebo , atorvastatin decreased median CRP pool size by 28.4 % ( 13.313.78 vs 10.263.93 mg ; p = 0.16 ) , associated with a median CRP fractional catabolic rate increase of 39.9 % ( 0.340.06 vs 0.500.11 pools/day ; p = 0.09 ) , with no significant effect on median CRP production rate ( 0.0500.01 vs 0.0490.01 mg/kg/day ; p = 0.78 ) . |
CONCLUSIONS Our data indicate that maximal doses of atorvastatin lower plasma CRP levels by substantially decreasing the median CRP plasma residence time from 2.94 days to 2.0 days , with no significant effect on the median CRP production rate . |
###8117360 |
OBJECTIVE To compare the influence on blood pressure , glucose , and lipid levels of a diet rich in monounsaturated fatty acids with an isocaloric , high-carbohydrate diet in 15 NIDDM subjects . |
METHODS A crossover design with diet interventions and wash-out periods of 3 wk was applied . |
METHODS The patients were randomly assigned to a 3-wk treatment with a high-carbohydrate diet containing 50 % of energy as carbohydrate and 30 % of energy as fat ( 10 % of energy as monounsaturated fatty acids ) or an isocaloric diet with 30 % of energy as carbohydrate and 50 % of energy as fat ( 30 % of energy as monounsaturated fatty acids ) . |
METHODS On the last day of the two diets , 24-h ambulatory blood pressure was measured and day profiles of glucose , hormones , and lipids were performed to a test menu rich in carbohydrates . |
RESULTS The diet rich in monounsaturated fat reduced daytime systolic ( 131 + / - 3 vs. 137 + / - 3 mmHg , P < 0.04 ) and 24-h systolic blood pressure ( 126 + / - 8 vs. 130 + / - 10 mmHg , P < 0.03 ) as well as daytime diastolic ( 78 + / - 2 vs. 84 + / - 2 mmHg , P < 0.02 ) and diurnal diastolic blood pressure ( 75 + / - 6 vs. 78 + / - 5 mmHg , P < 0.03 ) as compared with the high-carbohydrate diet . |
RESULTS Evidence of lowered blood glucose levels on the high-monounsaturated diet compared with the high-carbohydrate diet were found with lower fasting blood glucose ( 6.1 + / - 0.3 vs. 6.8 + / - 0.5 mM , P < 0.05 ) , lower average blood glucose levels ( 7.4 + / - 0.5 vs. 8.2 + / - 0.6 mM , P < 0.04 ) , and peak blood glucose responses ( 9.9 + / - 0.6 vs. 11.3 + / - 0.7 mM , P < 0.02 ) . |
RESULTS The two diets had the same impact on lipid levels . |
CONCLUSIONS A diet rich in monounsaturated fat has beneficial effects on blood pressure and glucose metabolism , whereas no adverse effects on lipid composition in NIDDM subjects is detected . |
###22193396 |
BACKGROUND The injection of stem cells in the context of acute myocardial infarction ( AMI ) has been tested almost exclusively by anterograde intra-arterial coronary ( IAC ) delivery . |
BACKGROUND The retrograde intravenous coronary ( IVC ) delivery may be an additional route . |
OBJECTIVE To compare the cell distribution and retention pattern in the anterograde and retrograde routes . |
OBJECTIVE To investigate the role of microvascular obstruction by magnetic resonance imaging in cell retention by cardiac tissue after the injection of bone marrow mononuclear cells ( BMMC ) in AMI . |
METHODS This was a prospective , open label , randomized study . |
METHODS Patients with AMI who presented : ( 1 ) successful chemical or mechanical reperfusion within 24 hours of symptom onset and ( 2 ) infarction involving more than 10 % of the left ventricle ( LV ) at the myocardial scintigraphy were included in the study . |
METHODS One hundred million BMMC were injected into the infarction-related artery through IAC route , or vein through the IVC route . |
METHODS One percent of the injected cells were labeled with 99mTc-hexamethyl-propylene-amine-oxime ( 99mTc-HMPAO ) . |
METHODS Cell distribution was evaluated at 4 and 24 hours after the myocardial scintigraphy injection . |
METHODS Cardiac magnetic resonance imaging was performed before cell injection . |
RESULTS Thirty patients were randomized into three groups . |
RESULTS There were no serious adverse events related to the procedure . |
RESULTS The early and late retention of labeled cells was higher in the IAC group than in IVC group , regardless of the presence of microcirculation obstruction . |
CONCLUSIONS The injection using the retrograde approach was feasible and safe . |
CONCLUSIONS Cell retention by cardiac tissue was higher using the anterograde approach . |
CONCLUSIONS More studies are needed to confirm these findings . |
###22249909 |
BACKGROUND Maximal consumption of oxygen ( VO ( 2 ) max ) during exercise is used in patients with chronic obstructive pulmonary disease ( COPD ) to stratify perioperative risk . |
BACKGROUND However , the impact of therapeutic hyperoxia ( i.e. , use of supplemental oxygen to prevent hypoxemia during exercise ) on ( VO ( 2 ) max and other ventilatory parameters during maximal exercise in the resting normoxic COPD population is poorly defined . |
METHODS A randomized , double-blind crossover study was performed in which resting normoxic subjects ( n = 16 ) with COPD underwent two standard symptom-limited , ramped-protocol bicycle ergometry cardiopulmonary exercise tests > 5 days apart with FiO ( 2 ) of 0.21 ( control ) and ~ 0.28 ( therapeutic hyperoxia ) . |
METHODS VO ( 2 ) max and other ventilatory parameters were compared using a paired two-sample t-test . |
RESULTS Therapeutic hyperoxia significantly increased VO ( 2 ) max ( 12.2 2.9 vs. 13.6 3.8 ml/kg/min , P = 0.03 ) , partial pressure of end-tidal carbon dioxide , and oxygen saturation and significantly decreased VE-VCO ( 2 ) slope , but it did not affect exercise time , maximum watts achieved , maximum minute ventilation , or change in end-expiratory lung volume . |
RESULTS Three of four subjects with VO ( 2 ) max < 10 ml/kg/min without supplemental oxygen increased VO ( 2 ) max to 10 ml/kg/min on therapeutic hyperoxia and potentially changed perioperative risk category . |
CONCLUSIONS Therapeutic hyperoxia in a resting normoxic COPD population significantly improves VO ( 2 ) max and may change perioperative risk stratification by conventional criteria . |
CONCLUSIONS Further studies are needed to determine if this change in stratification is appropriate . |
###1384949 |
BACKGROUND Survivors of advanced Hodgkin disease , who were assigned randomly to treatment by mechlorethamine , vincristine , procarbazine , and prednisone ( MOPP ) ; doxorubicin , bleomycin , vinblastine , and dacarbazine ( ABVD ) ; or MOPP alternating with ABVD in a clinical trial of the Cancer and Leukemia Group B ( protocol 8251 ) , were compared in terms of their psychosocial adaptation and psychosexual function an average of 2.2 years after completion of treatment ( range , 1-5 years ) . |
BACKGROUND The study was undertaken to determine if there were differences among treatments in these functional areas as a consequence of differential long-term gonadal damage in the three regimens . |
METHODS Ninety-three disease-free survivors of advanced Hodgkin disease ( 56 men and 37 women ) were studied ( a minimum of 1 year after completion of treatment ) by an interview conducted over the telephone . |
METHODS Standardized measures were used to assess their psychologic , sexual , family , and vocational functioning , including the following tests : the Psychosocial Adjustment to Illness Scale -- Self Report , the Brief Symptom Inventory , the Profile of Mood States , and the Impact of Event Scale . |
RESULTS Contrary to expectation , no statistically significant differences in survivors ' psychosocial adaptation or psychosexual function were found by treatment arm . |
RESULTS Infertility ( based on survivors ' reports of medical test results and perceptions ) and lower income 1 year before the diagnosis of cancer were significant predictors of poorer adjustment . |
RESULTS Most survivors reported a range of problems that they attributed to having had cancer : 35 % , proven or perceived infertility ; 24 % , sexual problems ; 31 % , health and life insurance problems ; 26 % , a negative socioeconomic effect ; and 51 % , conditioned nausea , associated with visual or olfactory reminders of chemotherapy . |
CONCLUSIONS No significant long-term advantage in psychosocial adaptation or psychosexual function was found for survivors of Hodgkin disease treated by the less gonadally toxic ABVD regimen 1 to 5 years after completion of treatment . |
###7868872 |
BACKGROUND Calcitonin gene-related peptide is a pleiotropic neuropeptide with potent vasodilatory properties , which interferes with renin release and might participate in cardiovascular homeostasis . |
METHODS We studied the influence of salt intake on the plasma concentration of calcitonin gene-related peptide , parathyroid hormone and on the renin-aldosterone system in 15 patients with mild hypertension . |
METHODS Each participant was studied after 1 week of high salt intake ( 200 mmol/day ) and after 1 week of low salt intake ( 50 mmol/day ) . |
METHODS The order of the two diet periods was randomized and crossover . |
METHODS Plasma calcitonin gene-related peptide concentration was measured by radioimmunoassay after pre-extraction by reverse chromatography . |
METHODS Seven patients were classified as salt-sensitive and eight as salt-resistant . |
RESULTS In the whole group the low salt intake caused a significant decrease in arterial pressure and the expected increase in plasma renin activity and in plasma aldosterone concentration . |
RESULTS Such changes were accompanied by a significant increase in plasma calcitonin gene-related peptide . |
RESULTS In salt-resistant patients in the sodium-replete state calcitonin gene-related peptide levels tended to be reduced in comparison with salt-sensitive patients . |
RESULTS Sodium depletion , however , caused a more pronounced rise in plasma calcitonin gene-related peptide in salt-resistant hypertensives , who attained levels close to those in salt-sensitive hypertensives . |
RESULTS Interestingly , in salt-resistant hypertensives changes in plasma calcitonin gene-related peptide were closely related to plasma renin activity ( r = 0.71 , P = 0.003 ) , whereas no such correlation was found in salt-sensitive patients . |
RESULTS Parathyroid hormone was not influenced by changes in salt intake . |