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RESULTS | A smaller size , lower aortic and superior vena cava saturation , and higher ventricular end-diastolic pressure were associated with worse 12-month transplant-free survival . |
RESULTS | The MBTS group had a lower coronary perfusion pressure ( 27 vs 32 mm Hg ; P < .001 ) and greater pulmonary blood flow/systemic blood flow ratio ( 1.1 vs 1.0 , P = .009 ) . |
RESULTS | A greater pulmonary blood flow/systemic blood flow ratio increased the risk of death or transplantation only in the RVPAS group ( P = .01 ) . |
RESULTS | The MBTS group had fewer shunt ( 14 % vs 28 % , P = .004 ) and severe left pulmonary artery ( 0.7 % vs 9.2 % , P = .003 ) stenoses , larger mid-main branch pulmonary artery diameters , and greater Nakata indexes ( 164 vs 134 , P < .001 ) . |
CONCLUSIONS | Compared with the RVPAS subjects , the MBTS subjects had more hemodynamic abnormalities related to shunt physiology , and the RVPAS subjects had more shunt or pulmonary obstruction of a severe degree and inferior pulmonary artery growth at pre-stage II catheterization . |
CONCLUSIONS | A lower body surface area , greater ventricular end-diastolic pressure , and lower superior vena cava saturation were associated with worse 12-month transplant-free survival . |
###24379356 | null |
OBJECTIVE | It has been hypothesized that the development of diabetic polyneuropathy ( DPN ) is due to swelling of the nerve , as well as thickening and stiffening of the surrounding ligaments , causing chronic compression of nerves . |
OBJECTIVE | We aimed to examine the effect of surgical decompression of the tibial nerve on the mean cross-sectional area ( CSA ) . |
METHODS | We performed a randomized controlled trial of 42 subjects with painful DPN diagnosed using the Diabetic Neuropathy Score . |
METHODS | A computer randomized for the surgery arm of the study . |
METHODS | A control group consisting of 38 healthy subjects was included . |
METHODS | An experienced sonographer measured the CSA and thickness-to-width ( T/W ) ratio of the tibial nerve , as well as the thickness of the flexor retinaculum . |
RESULTS | CSA is significantly larger in patients with painful DPN ( 8.4 3.9 mm ( 2 ) ) than in control subjects ( 6.4 1.3 mm ( 2 ) ) , P = 0.007 . |
RESULTS | The T/W ratio in patients with painful DPN is 0.64 and in control subjects 0.59 , P = 0.03 . |
RESULTS | Patients with DPN have a significantly thicker retinaculum ( 1.07 mm ) than control subjects ( 0.84 mm ) , P < 0.001 . |
RESULTS | Mean follow-up was 28.2 weeks ( range 23-45 ) . |
RESULTS | Difference between baseline and follow-up in the operated leg was 1.49 mm ( 2 ) and in the control leg 1.81 mm ( 2 ) , P = 0.674 . |
CONCLUSIONS | Decompression of the tibial nerve does not result in a significant difference between baseline and follow-up in CSA using ultrasound between the operated and control leg . |
CONCLUSIONS | Ultrasound measurements show a significantly increased CSA , a significantly thicker retinaculum , and a significantly increased T/W ratio in patients with painful DPN compared with healthy control subjects . |
CONCLUSIONS | Clinical trial reg . |
CONCLUSIONS | no . |
CONCLUSIONS | NTR2344 , www.trialregister.nl . |
###25018097 | null |
BACKGROUND | A community-based randomized trial was conducted in Costa Rica to evaluate the HPV-16 / 18 AS04-adjuvanted vaccine ( NCT00128661 ) . |
BACKGROUND | The primary objective was to evaluate efficacy of the vaccine to prevent cervical intraepithelial neoplasia 2 or more severe disease ( CIN2 + ) associated with incident HPV-16 / 18 cervical infections . |
BACKGROUND | Secondary objectives were to evaluate efficacy against CIN2 + associated with incident cervical infection by any oncogenic HPVs and to evaluate duration of protection against incident cervical infection with HPV-16 / 18 . |
BACKGROUND | Vaccine safety and immunogenicity over the 4-year follow-up were also evaluated . |
METHODS | We randomized ( 3727 HPV arm ; 3739 control arm ) , vaccinated ( HPV-16 / 18 or Hepatitis A ) and followed ( median 53.8 months ) 7466 healthy women aged 18-25 years . |
METHODS | 5312 women ( 2635 HPV arm ; 2677 control arm ) were included in the according to protocol analysis for efficacy . |
METHODS | The full cohort was evaluated for safety . |
METHODS | Immunogenicity was considered on a subset of 354 ( HPV-16 ) and 379 ( HPV-18 ) women . |
METHODS | HPV type was assessed by PCR on cervical specimens . |
METHODS | Immunogenicity was assessed using ELISA and inhibition enzyme immunoassays . |
METHODS | Disease outcomes were histologically confirmed . |
METHODS | Vaccine efficacy and 95 % confidence intervals ( 95 % CI ) were computed . |
RESULTS | Vaccine efficacy was 89.8 % ( 95 % CI : 39.5-99 .5 ; N = 11 events total ) against HPV-16 / 18 associated CIN2 + , 59.9 % ( 95 % CI : 20.7-80 .8 ; N = 39 events total ) against CIN2 + associated with non-HPV-16 / 18 oncogenic HPVs and 61.4 % ( 95 % CI : 29.5-79 .8 ; N = 51 events total ) against CIN2 + irrespective of HPV type . |
RESULTS | The vaccine had an acceptable safety profile and induced robust and long-lasting antibody responses . |
CONCLUSIONS | Our findings confirm the high efficacy and immunogenicity of the HPV-16 / 18 vaccine against incident HPV infections and cervical disease associated with HPV-16 / 18 and other oncogenic HPV types . |
CONCLUSIONS | These results will serve as a benchmark to which we can compare future findings from the ongoing extended follow-up of participants in the Costa Rica trial . |
BACKGROUND | Registered with clinicaltrials.gov : NCT00128661 . |
###24736930 | null |
BACKGROUND | There is a long-held concept among spine surgeons that endoscopic lumbar discectomy procedures are reserved for small-contained disc herniation ; 8-year follow-up has not been reported . |
BACKGROUND | The purpose of this study is to assess microendoscopic discectomy ( MED ) in patients with large uncontained lumbar disc herniation ( the antero-posterior diameter of the extruded fragment is 6-12 mm or more on axial cuts of MRI ) and report long-term outcome . |
METHODS | One hundred eighty-five patients with MED or standard open discectomy underwent follow-up for 8 years . |
METHODS | Primary ( clinical ) outcomes data included Numerical Rating Scale ( NRS ) for back and leg symptoms and Oswestry Disability Index ( ODI ) to quantify pain and disability , respectively . |
METHODS | Secondary ( objective ) outcomes data included operative time , blood loss , postoperative analgesics , length of hospital stay , time to return to work , reoperation and complication rate , patient satisfaction index ( PSI ) , and modified ( MacNab ) criteria . |
RESULTS | At the end of the follow-up , the leg pain relief was statistically significant for both groups . |
RESULTS | NRS back pain , ODI , PSI and MacNab criteria showed significant deterioration for control group . |
RESULTS | Secondary outcomes data of MED group were significantly better than the control group . |
CONCLUSIONS | Large , uncontained , lumbar disc herniations can be sufficiently removed using MED which is an effective alternative to open discectomy procedures with remarkable long-term outcome . |
CONCLUSIONS | Although the neurological outcome of the two procedures is the same , the morbidity of MED is significantly less than open discectomy . |
CONCLUSIONS | Maximum benefit can be gained if we adhere to strict selection criteria . |
CONCLUSIONS | The optimum indication is single - or multi-level radiculopathy secondary to a single-level , large , uncontained , lumbar disc herniation . |
###25498992 | null |
BACKGROUND | Heart failure ( HF ) patients suffer from frequent and repeated hospitalizations , causing a substantial economic burden on society . |
BACKGROUND | Hospitalizations can be reduced considerably by better compliance with self-care . |
BACKGROUND | Home telemonitoring has the potential to boost patients ' compliance with self-care , although the results are still contradictory . |
OBJECTIVE | A randomized controlled trial was conducted in order to study whether the multidisciplinary care of heart failure patients promoted with telemonitoring leads to decreased HF-related hospitalization . |
METHODS | HF patients were eligible whose left ventricular ejection fraction was lower than 35 % , NYHA functional class 2 , and who needed regular follow-up . |
METHODS | Patients in the telemonitoring group ( n = 47 ) measured their body weight , blood pressure , and pulse and answered symptom-related questions on a weekly basis , reporting their values to the heart failure nurse using a mobile phone app . |
METHODS | The heart failure nurse followed the status of patients weekly and if necessary contacted the patient . |
METHODS | The primary outcome was the number of HF-related hospital days . |
METHODS | Control patients ( n = 47 ) received multidisciplinary treatment according to standard practices . |
METHODS | Patients ' clinical status , use of health care resources , adherence , and user experience from the patients ' and the health care professionals ' perspective were studied . |
RESULTS | Adherence , calculated as a proportion of weekly submitted self-measurements , was close to 90 % . |
RESULTS | No difference was found in the number of HF-related hospital days ( incidence rate ratio [ IRR ] = 0.812 , P = .351 ) , which was the primary outcome . |
RESULTS | The intervention group used more health care resources : they paid an increased number of visits to the nurse ( IRR = 1.73 , P < .001 ) , spent more time at the nurse reception ( mean difference of 48.7 minutes , P < .001 ) , and there was a greater number of telephone contacts between the nurse and intervention patients ( IRR = 3.82 , P < .001 for nurse-induced contacts and IRR = 1.63 , P = .049 for patient-induced contacts ) . |
RESULTS | There were no statistically significant differences in patients ' clinical health status or in their self-care behavior . |
RESULTS | The technology received excellent feedback from the patient and professional side with a high adherence rate throughout the study . |
CONCLUSIONS | Home telemonitoring did not reduce the number of patients ' HF-related hospital days and did not improve the patients ' clinical condition . |
CONCLUSIONS | Patients in the telemonitoring group contacted the Cardiology Outpatient Clinic more frequently , and on this way increased the use of health care resources . |
BACKGROUND | Clinicaltrials.gov NCT01759368 ; http://clinicaltrials.gov/show/NCT01759368 ( Archived by WebCite at http://www.webcitation.org/6UFxiCk8Z ) . |
###24411490 | null |
OBJECTIVE | Probiotics help maintain balance in composition of the gut microbiota , and have been considered as a potential treatment for obesity . |
OBJECTIVE | This study was conducted in order to assess the effects of probiotics when combined with herbal medicine in treatment of obesity . |
OBJECTIVE | Probiotics were tested for the ability to modulate gut microbiota , gut permeability , and endotoxin level , which may have correlation with factors involved in obesity . |
METHODS | A randomized , double-blind , placebo controlled study was conducted , in which patients with higher BMI ( > 25kg/m ( 2 ) ) and waist circumference ( > 85cm ) were enrolled and randomly assigned to receive Bofutsushosan with either probiotics or placebo capsules for a period of eight weeks . |
METHODS | Assessment of body composition parameters , metabolic biomarkers , endotoxin level , gut permeability , and fecal bacteria in stool was performed at baseline and at week 8 . |
METHODS | The study was registered at the Clinical Research Information Service , approved by the Korea National Institute of Health ( KCT0000386 ) . |
RESULTS | Although both groups showed a significant reduction in weight and waist circumference ( p = 0.000 ) , no significant differences in body composition and metabolic markers were observed . |
RESULTS | In correlation analysis , change in body composition showed positive correlation with endotoxin level ( r = 0.441 , p < 0.05 for BW ; and r = 0.350 , p < 0.05 for fat mass ) and the population of gut Lactobacillus plantarum ( r = 0.425 , p < 0.05 for BW ; and r = 0.407 , p < 0.05 for BMI ) . |
RESULTS | The Gram negative bacterial population in gut also exhibited positive correlation with changes in body composition ( WC ) and total cholesterol level ( r = 0.359 , and 0.393 , for the former and later parameters , respectively , p < 0.05 for both ) . |
RESULTS | While , the profile of gut Bifidobacterium breve population showed negative correlation with endotoxin level ( r = -0.350 , p < 0.05 ) . |
CONCLUSIONS | Correlations between gut microbiota and change in body composition indicate that probiotics may influence energy metabolism in obesity . |
CONCLUSIONS | Correlation between endotoxin level and weight reduction indicates that probiotics may play an important role in prevention of endotoxin production , which can lead to gut microbiota dysbiosis associated with obesity . |
###24471516 | null |
OBJECTIVE | The objective of this study is to analyze the effects of a 12-week indoor intermittent training program on lung function , physical capacity , body composition and quality of life in children with asthma . |
METHODS | Participants were randomized in an experimental group ( EG , 58 children , age = 11.551.01 years ) and in a control group ( CG , 47 children , age = 11.511.42 years ) . |
METHODS | The training program was conducted indoors and consisted of alternating high - and low-intensity stimuli , for three sessions of 60min/week , for 12 weeks . |
METHODS | Physical exercise and sports activities were organized to follow the criteria of the American College of Sports Medicine ( 1999 ) and previous interventions ' studies . |
RESULTS | In EG , there was a significant improvement ( p < 0.05 ) in FEV1 , FEV6 , 6MWT , handgrip strength , CMJ and flexibility . |
RESULTS | Reductions in BMI and fat mass as well as an increase in quality of life were all shown . |
RESULTS | The dyspnea index decreased significantly and there were no episodes of EIA . |
RESULTS | There is a significant positive correlation ( p < 0.01 ) between the FEV1 with handgrip strength and 6MWT and a negative correlation with fat mass . |
CONCLUSIONS | An indoor intermittent training program with these characteristics has improved lung function , physical capacity , body composition and quality of life in children with asthma . |
CONCLUSIONS | These training adaptations are particularly relevant for those patients suffering from asthma as a regular physical exercise routine will greatly improve their quality of life . |
###26255514 | null |
OBJECTIVE | To observe the efficacy of catgut implantation at back-shu points in treatment of mild perimenopausal depression of kidney , deficiency and liver stagnation syndrome and analyze its essential function on target symptoms . |
METHODS | Forty-five cases were randomized into a catgut implantation group ( 23 cases ) and atid acupuncture group ( 22 cases ) . |