Maternal-reduction in pain intensity from baseline ( @-cm visual analogue scale ) at @minutes and over the @-hour period after drug administration .


Neonatal-requirement for resuscitation and Apgar score at @minute .


Diamorphine provided modestly improved pain relief at @minutes , mean difference @cm ( @ % confidence interval -LSB- CI -RSB- @-@ @ ) , and over the @hours , mean difference @ cm ( @ % CI @-@ @ ) .


However , average length of labour in women receiving diamorphine was @minutes longer ( @ % CI @-@ ) and therefore they experienced more pain overall .


There were no statistically significant differences in primary neonatal outcomes .


There is a modest difference between the analgesia provided by diamorphine or pethidine for labour analgesia but diamorphine is associated with significantly longer labours .


Persistent knee pain in people over @ years of age is often attributable to knee osteoarthritis ( OA ) , a common joint condition that causes physical and psychological dysfunction .


Exercise and pain coping skills training ( PCST ) can help reduce the impact of persistent knee pain , however , access to health professionals who deliver these services can be challenging .


With increasing access to the Internet , remotely delivered Internet-based treatment approaches may provide alternatives for healthcare delivery .


This pragmatic randomised controlled trial will investigate whether an Internet-delivered intervention that combines PCST and physiotherapist-guided exercise ( PCST + Ex ) is more effective than online educational material ( educational control ) in people with persistent knee pain .


We will recruit @ people over @ years of age with self-reported persistent knee pain consistent with knee OA from the Australian community .


Following completion of baseline questionnaires , participants will be randomly allocated to access a @-month intervention of either ( i ) online educational material , or ( ii ) the same online material plus an @-module ( once per week ) Internet-based PCST program and seven Internet-delivered physiotherapy sessions with a home exercise programs to be performed @ times per week .


Outcomes will be measured at baseline , @ months and @ months with the primary time point at @ months .


Primary outcomes are average knee pain on walking ( @-point numeric rating scale ) and self-reported physical function ( Western Ontario and McMaster Universities Osteoarthritis Index subscale ) .


Secondary outcomes include additional measures of knee pain , health-related quality-of-life , perceived global change in symptoms , and potential moderators and mediators of outcomes including self-efficacy for pain management and function , pain coping attempts and pain catastrophising .


Other measures of adherence , adverse events , harms , use of health services/co-interventions , and process measures including appropriateness and satisfaction of the intervention , will be collected at @ , @ and @ months .


The findings will help determine the effectiveness and acceptability of Internet access to a combination of interventions that are known to be beneficial to people with persistent knee pain .


This study has the potential to guide clinical practice towards innovative modes of healthcare provision .


To investigate the efficacy and safety of perindopril-lercanidipine combination versus perindopril or lercanidipine monotherapies in patients with mild essential hypertension .


A total of @ patients with mild essential hypertension were randomly assigned to three groups : group A ( perindopril @mg plus lercanidipine @mg ; n = @ ) , group B ( lercanidipine @mg ; n = @ ) and group C ( perindopril @mg ; n = @ ) .


The treatment efficacy and the incidence of adverse events were evaluated at the end of @ , @ and @ weeks after treatment initiation .


The blood pressure in group A was already lower than in group B and group C at week @ after treatment initiation .


Systolic blood pressure was @mmHg in group A , @mmHg in group B , and @ in group C ( p < @ ) ; diastolic blood pressure was @ , @ and @mmHg , respectively ( p < @ ) .


At the end of treatment the normalization rate was significantly higher in group A , compared with group B and group C ( @ % , @ % , and @ % , respectively ; p < @ ) .


Four adverse events were observed in group A , while seven and nineteen adverse events occurred in group B and in group C , respectively .


Statistically significant differences in adverse reaction incidence were reported among three groups .


Although its results were collected in an overall limited number of patients in a single center , this study shows that the combination of perindopril and lercanidipine , compared with lercanidipine alone or perindopril alone , was effective in improving blood pressure in mild essential hypertensive patients , and also decreased the incidence of adverse events .


Longitudinal changes in awareness in dementia have been studied with short follow-up time and mostly in small patient groups ( including patients with moderate dementia ) .


We investigated awareness in patients with mild Alzheimer 's disease ( AD ) over @ months and studied if a decline in awareness was associated with decline in cognition and increase in neuropsychiatric symptoms .


Awareness was measured on a categorical scale in @ AD patients ( age @ years , Mini-Mental State Examination ( MMSE ) score @ ) .


Awareness was rated at three time points ( follow-up at @ and @ months ) where MMSE , Neuropsychiatric Inventory ( NPI-Q ) , and Cornell scale for Depression in Dementia also were applied .


At @ months , @ % had lower awareness rating as compared to baseline and at @ months lower awareness ratings were found in @ % .


At both visits , @ % had higher awareness rating as compared to baseline .


Patients with lower awareness at @ months as compared to baseline had a more rapid increase in NPI-Q score ( p = @ ) over @ months as compared to patients with stable or improved awareness over @ months .


A more rapid decline in MMSE score was observed for patients with lower awareness at @ months ( as compared to baseline ) but only when compared to patients in whom awareness improved over time .


The results show essentially no clear relationship between cognitive decline over three years and awareness .


In some cases , awareness remained stable or even improved despite significant cognitive decline .


In the subgroup where awareness declined over time , overall ratings of neuropsychiatric symptoms declined more rapidly than in the remaining patients .


Hospital readmissions are common and costly , and no single intervention or bundle of interventions has reliably reduced readmissions .


Virtual wards , which use elements of hospital care in the community , have the potential to reduce readmissions , but have not yet been rigorously evaluated .


To determine whether a virtual ward-a model of care that uses some of the systems of a hospital ward to provide interprofessional care for community-dwelling patients-can reduce the risk of readmission in patients at high risk of readmission or death when being discharged from hospital .


High-risk adult hospital discharge patients in Toronto were randomly assigned to either the virtual ward or usual care .


A total of @ patients were randomized during the course of the study : @ to the usual care group and @ to the virtual ward group .


The first patient was enrolled on June @ , @ , and follow-up was completed on June @ , @ .


Patients assigned to the virtual ward received care coordination plus direct care provision ( via a combination of telephone , home visits , or clinic visits ) from an interprofessional team for several weeks after hospital discharge .


The interprofessional team met daily at a central site to design and implement individualized management plans .


Patients assigned to usual care typically received a typed , structured discharge summary , prescription for new medications if indicated , counseling from the resident physician , arrangements for home care as needed , and recommendations , appointments , or both for follow-up care with physicians as indicated .


The primary outcome was a composite of hospital readmission or death within @ days of discharge .


Secondary outcomes included nursing home admission and emergency department visits , each of the components of the primary outcome at @ days , as well as each of the outcomes ( including the composite primary outcome ) at @ days , @ months , and @ year .


There were no statistically significant between-group differences in the primary or secondary outcomes at @ or @ days , @ months , or @ year .


The primary outcome occurred in @ of @ ( @ % ) of the virtual ward patients and @ of @ ( @ % ) of the usual care patients ( absolute difference , @ % ; @ % CI , -@ % to @ % ; P = @ ) .


There were no statistically significant interactions to indicate that the virtual ward model of care was more or less effective in any of the prespecified subgroups .


In a diverse group of high-risk patients being discharged from the hospital , we found no statistically significant effect of a virtual ward model of care on readmissions or death at either @ days or @ days , @ months , or @ year after hospital discharge .


Remoxy ( Pain Therapeutics , Inc. , Austin , TX ) is an abuse-deterrent formulation of extended-release oxycodone .


The effects of renal or hepatic impairment on the pharmacokinetics ( PK ) of single , oral doses of Remoxy @ or @ mg , respectively , were assessed in two phase @ studies in subjects aged @-@ years .


PK parameters included maximum plasma concentration ( C ( max ) ) and area under the concentration-time curve from time @ to the last quantifiable concentration ( AUC ( @-t ) ) , and extrapolated to infinity ( AUCinf ) .


Adverse events ( AEs ) were monitored .


Mean ( SD ) oxycodone Cmax values following Remoxy @-mg administration were @ ( @ ) , @ ( @ ) , @ ( @ ) , and @ ( @ ) ng/mL and AUC@-t values were @ ( @ ) , @ ( @ ) , @ ( @ ) , and @ ( @ ) ngh/mL in subjects with normal or mild ( n = @ each ) , moderate ( n = @ ) , and severely impaired renal function ( n = @ ) , respectively .


Mean ( SD ) oxycodone Cmax following Remoxy @-mg administration was @ ( @ ) , @ ( @ ) , and @ ( @ ) ng/mL and AUC ( @-t ) was @ ( @ ) , @ ( @ ) , and @ ( @ ) ngh/mL in subjects with normal , mild , and moderately impaired hepatic function ( n = @ each ) , respectively .


Differences in exposure values between the different renal and hepatic groups were significant .


Treatment-emergent AEs were reported by @ , @ , @ , and @ percent of subjects with normal , mild , moderate , and severely impaired renal function , respectively , and by @ , @ , and @ percent of subjects with normal , mild , and moderately impaired hepatic function , respectively .


As renal or hepatic function decreased , oxycodone Cmax and AUC ( @-t ) were up to approximately twofold higher following single , oral doses of extended-release Remoxy .


AEs were those typically reported for opioids .


Lower doses of Remoxy may thus be safely prescribed to subjects with renal or hepatic impairment .


Idiopathic bile acid malabsorption ( BAM ) has been suggested as a cause of chronic watery diarrhoea , with a response to colestyramine in @ % of patients .


However , the efficacy of this drug has never been investigated in placebo-controlled trials .


To evaluate the efficacy of colestyramine as compared with hydroxypropyl cellulose in the treatment of functional chronic watery diarrhoea .


Patients with chronic watery diarrhoea were randomly assigned to groups given colestyramine sachets @g twice daily ( n = @ ) or identical hydroxypropyl cellulose sachets ( n = @ ) for @weeks .


The primary end-point was clinical remission defined as a mean of @ or fewer stools per day during the week before the visit , with less than @ watery stool per day .


A secondary end-point was the reduction in daily watery stool number .


SeHCAT test was performed in all patients , but an abnormal test was not a prerequisite to be included .


All included patients had a SeHCAT @-day retention @ % .


There were no statistical differences in the percentage of patients in clinical remission at week @ between colestyramine and hydroxypropyl cellulose with either intention-to-treat ( @ % vs. @ % ; P = @ ) or per-protocol ( @ % vs. @ % ; P = @ ) analyses .


However , the mean per cent decrease in watery stool number was significantly higher with colestyramine than with hydroxypropyl cellulose ( -@ % vs. -@ % ; P = @ ) .


The rate of adverse events related to study drugs did not differ between groups .


Colestyramine ( @g twice daily ) is effective and safe for short-term treatment of patients with chronic watery diarrhoea presumably secondary to BAM .


Clinical Trials Register number EudraCT @-@-@ .


During puberty , reactivation of the reproductive axis occurs during sleep , with LH pulses specifically tied to deep sleep .


This association suggests that deep sleep may stimulate LH secretion , but there have been no interventional studies to determine the characteristics of deep sleep required for LH pulse initiation .


The objective of this study was to determine the effect of deep sleep fragmentation on LH secretion in pubertal children .


Studies were performed in a clinical research center .


Fourteen healthy pubertal children ( @-@ @ y ) participated in the study .


Subjects were randomized to two overnight studies with polysomnography and frequent blood sampling , with or without deep sleep disruption via auditory stimuli .


An average of @ @ ( SE ) auditory stimuli were delivered to interrupt deep sleep during the disruption night , limiting deep sleep to only brief episodes ( average length disrupted @ @ min vs normal @ @ min , P < @ ) , and increasing the number of transitions between non-rapid eye movement ( NREM ) , REM , and wake ( disrupted @ @ vs normal @ @ , P = @ ) .


There were no differences in mean LH ( normal : @ @ vs disrupted : @ @ IU/L ) , LH pulse frequency ( @ @ vs @ @ pulses/h ) , or LH pulse amplitude ( @ @ vs @ @ IU/L ) between the two nights .


Poisson process modeling demonstrated that the accumulation of deep sleep in the @ minutes before an LH pulse , whether consolidated or fragmented , was a significant predictor of LH pulse onset ( P < @ ) .


In pubertal children , nocturnal LH augmentation and pulse patterning are resistant to deep sleep fragmentation .


These data suggest that , even when fragmented , deep sleep is strongly related to activation of the GnRH pulse generator .


Laparoscopic radical cystectomy ( LRC ) is increasingly being used for muscle-invasive bladder cancer .


However , high levels of clinical evidence comparing laparoscopic vs open radical cystectomy ( ORC ) are lacking .


A prospective randomised controlled clinical trial comparing LRC vs ORC in patients undergoing radical cystectomy for bladder cancer .


Thirty-five patients were eligible for final analysis in each group .


The median follow-up was @ months ( range , @-@ months ) for laparoscopic vs @ months ( range , @-@ months ) for ORC .


Significant differences were noted in operative time , estimated blood loss ( EBL ) , blood transfusion rate , analgesic requirement , and time to resumption of oral intake .


No significant differences were noted in the length of hospital stay , complication rate , lymph node yield ( @ for LRC and @ for ORC ) , positive surgical margin rate , postoperative pathology , or recurrence rate ( @ for LRC and @ for ORC ) .


The @-year recurrence-free survival with laparoscopic vs ORC was @ % vs @ % , respectively ( P = @ ) .


The overall survival with laparoscopic vs ORC was @ % vs @ % , respectively ( P = @ ) .


Our study demonstrated that LRC is superior to ORC in perioperative outcomes , including EBL , blood transfusion rate , and analgesic requirement .


We found no major difference in oncologic outcomes .


The number of patients is too small to allow for a final conclusion .


We present the first study to explore safety and efficacy of the human CD@ monoclonal antibody ofatumumab in relapsing-remitting multiple sclerosis ( RRMS ) .


In this randomized , double-blind , placebo-controlled study , patients received @ ofatumumab infusions ( @ mg , @ mg , or @ mg ) or placebo @ weeks apart .


At week @ , patients received alternate treatment .


Safety and efficacy were assessed .


Thirty-eight patients were randomized ( ofatumumab/placebo , n = @ ; placebo/ofatumumab , n = @ ) and analyzed ; @ completed the study .


Two patients in the @-mg group withdrew from the study because of adverse events .


No unexpected safety signals emerged .


Infusion-related reactions were common on the first infusion day but not observed on the second infusion day .


None of the patients developed human anti-human antibodies .


Ofatumumab was associated with profound selective reduction of B cells as measured by CD@ ( + ) expression .


New brain MRI lesion activity was suppressed ( > @ % ) in the first @ weeks after ofatumumab administration ( all doses ) , with statistically significant reductions ( p < @ ) favoring ofatumumab found in new T@ gadolinium-enhancing lesions , total enhancing T@ lesions , and new and/or enlarging T@ lesions .


Ofatumumab ( up to @ mg ) given @ weeks apart was not associated with any unexpected safety concerns and was well tolerated in patients with RRMS .


MRI data suggest a clinically meaningful effect of ofatumumab for all doses studied .


Results warrant further exploration of ofatumumab in RRMS .


This study provides Class II evidence that in patients with RRMS , ofatumumab compared with placebo does not increase the number of serious adverse events and decreases the number of new MRI lesions .


Home exercise can prevent falls in the general older community but its impact in people recently discharged from hospital is not known .


The study aimed to investigate the effects of a home-based exercise program on falls and mobility among people recently discharged from hospital .


This randomised controlled trial ( ACTRN@ ) was conducted among @ older people .


Intervention group participants ( n = @ ) were asked to exercise at home for @-@ minutes up to @ times weekly for @ months .


The control group ( n = @ ) received usual care .


Primary outcomes were rate of falls ( assessed over @ months using monthly calendars ) , performance-based mobility ( Lower Extremity Summary Performance Score , range @-@ , at baseline and @ months , assessor unaware of group allocation ) and self-reported ease of mobility task performance ( range @-@ , assessed with @ monthly questionaries ) .


Participants had an average age of @ years ( SD @ ) and @ % had fallen in the past year .


Complete primary outcome data were obtained for at least @ % of randomised participants .


Participants in the intervention group reported more falls than the control group ( @ falls versus @ falls ) during the @-month study period and this difference was statistically significant ( incidence rate ratio @ , @ % CI @ to @ , p = @ ) .


At @-months , performance-based mobility had improved significantly more in the intervention group than in the control group ( between-group difference adjusted for baseline performance @ , @ % CI @ to @ , p = @ ) .


Self-reported ease in undertaking mobility tasks over the @-month period was not significantly different between the groups ( @ , @ % CI -@ to @ , p = @ ) .


An individualised home exercise prescription significantly improved performance-based mobility but significantly increased the rate of falls in older people recently discharged from hospital .


Methicillin-resistant Staphylococcus aureus ( MRSA ) accounts for @-@ % of hospital-acquired pneumonia , and even more in intensive care units .


The current guidelines for the treatment of MRSA nosocomial pneumonia include vancomycin and linezolid .


The authors of @ prospective randomized trials comparing vancomycin and linezolid in nosocomial pneumonia had concluded to the non-inferiority of linezolid .


A slight superiority of linezolid was observed in the MRSA pneumonia subgroup , in terms of clinical success and survival , but no definite conclusion could be drawn .


A prospective randomized study was made to compare a fixed linezolid dose to dose-optimized vancomycin for the treatment of bacteriologically proven MRSA nosocomial pneumonia ( ZEPHyR Study ) .


Among the @ patients treated by linezolid ( @ % ) in the PP population , @ were clinically cured at the end of the study , compared to @ of the @ patients treated by vancomycin ( @ % ) ( IC @ % of the difference @ % -@ % , P = @ ) .


Nephrotoxicity in the mITT population reached @ % in the linezolid group compared to @ % in the vancomycin group .


LNZ was superior to vancomycin for the treatment of MRSA nosocomial pneumonia .


Early-phase and preclinical studies suggest that moxifloxacin-containing regimens could allow for effective @-month treatment of uncomplicated , smear-positive pulmonary tuberculosis .


We conducted a randomized , double-blind , placebo-controlled , phase @ trial to test the noninferiority of two moxifloxacin-containing regimens as compared with a control regimen .


One group of patients received isoniazid , rifampin , pyrazinamide , and ethambutol for @ weeks , followed by @ weeks of isoniazid and rifampin ( control group ) .


In the second group , we replaced ethambutol with moxifloxacin for @ weeks , followed by @ weeks of placebo ( isoniazid group ) , and in the third group , we replaced isoniazid with moxifloxacin for @ weeks , followed by @ weeks of placebo ( ethambutol group ) .


The primary end point was treatment failure or relapse within @ months after randomization .


Of the @ patients who underwent randomization , in the per-protocol analysis , a favorable outcome was reported in fewer patients in the isoniazid group ( @ % ) and the ethambutol group ( @ % ) than in the control group ( @ % ) , for a difference favoring the control group of @ percentage points ( @ % confidence interval -LSB- CI -RSB- , @ to @ ) versus the isoniazid group and @ percentage points ( @ % CI , @ to @ ) versus the ethambutol group .


Results were consistent in the modified intention-to-treat analysis and all sensitivity analyses .


The hazard ratios for the time to culture negativity in both solid and liquid mediums for the isoniazid and ethambutol groups , as compared with the control group , ranged from @ to @ , indicating a shorter duration , with the lower bounds of the @ % confidence intervals exceeding @ in all cases .


There was no significant difference in the incidence of grade @ or @ adverse events , with events reported in @ patients ( @ % ) in the isoniazid group , @ ( @ % ) in the ethambutol group , and @ ( @ % ) in the control group .


The two moxifloxacin-containing regimens produced a more rapid initial decline in bacterial load , as compared with the control group .


However , noninferiority for these regimens was not shown , which indicates that shortening treatment to @ months was not effective in this setting .


( Funded by the Global Alliance for TB Drug Development and others ; REMoxTB ClinicalTrials.gov number , NCT@ . )


Polycystic ovary syndrome ( PCOS ) is an insulin resistance ( IR ) state , like obesity and type @ diabetes mellitus ( T@DM ) .


Although previous studies have suggested a correlation between irisin and the metabolic parameters associated with obesity and T@DM , the results have been inconsistent .


Our objective was to ( @ ) determine circulating irisin levels in women with PCOS and control subjects , ( @ ) examine the relationship of irisin and conventional markers of insulin resistance , and ( @ ) examine irisin changes with interventions modulating IR in PCOS women .


This study was comprised of a series of cross-sectional and interventional studies of @ PCOS and @ healthy women from the general population and outpatients of the Internal Medicine Department at the Second Affiliated Hospital , Chongqing Medical University , China .


Forty seven women with PCOS were randomly assigned to @ months of oral metformin ( @ mg bid ) .


The oral glucose tolerance test ( OGTT ) and the euglycemic-hyperinsulinemic clamp ( EHC ) were performed to assess glucose tolerance and insulin sensitivity .


Outcome measures were IR ( AUC ( Insulin ) and M values ) on an OGTT and EHC , irisin levels , and metabolic markers .


Circulating irisin was significantly higher in both overweight/obese ( body mass index -LSB- BMI -RSB- @ kg/m ( @ ) ) and PCOS women ( P < @ ) .


Circulating irisin levels correlated with BMI , WHR , FAT % , total cholesterol ( TC ) , triglyceride ( TG ) , low-density lipoprotein cholesterol ( LDL-C ) , AUC ( Insulin ) , homeostasis model assessment of insulin resistance ( HOMA@-IR ) , M values , and free androgen index ( FAI ) .


During EHC , short-term hyperinsulinemia exhibited an inhibitory effect on irisin levels .


After @ months of metformin treatment , there was a significant decrease in circulating irisin in PCOS women following improved IR .


These data suggest that irisin may be a useful marker of IR in PCOS women .


Novel and promising results in acne treatment with infrared lasers have been reported .


The @,@-nm erbium glass laser is one of the infrared lasers that may be useful in the treatment of acne .


The aim of this study was to evaluate the efficacy of an erbium glass laser in treatment of active acne and to study the effect of this type of laser on sebaceous glands .


Twenty-four patients with active acne lesions were treated using @,@-nm ( @-@ mJ ) fractional erbium glass laser .


Every patient received @ sessions with a @-week interval .


Follow-up was done every @ months for @ year .


The image analyzer computer system was used to measure the sebaceous gland size .


A significant reduction ( p < @ ) in the mean count of lesions was observed after treatment and in the follow-up period .


A significant reduction in the size of sebaceous glands was also evident after laser treatment .


Treatment of active acne with the @,@-nm erbium glass laser is effective .


Papules , pustules , and nodules all respond well to therapy .


The sebaceous gland size decreased significantly , which accounts for the long remission period .


The aim of this study was to determine the level of middle ear pressure and alterations in middle ear pressure levels after septoplasty among the individuals having advanced degree isolated nasal septal deviation .


A prospective randomized study was conducted .


The study included @ adult patients who had severely deviated septum .


The middle ear pressure values at both sides of nasal obstruction and opposite side were determined using tympanometry before the surgery and at postoperative week @ .


The middle ear pressure values were divided into @ groups , side of nasal obstruction ( group @ ) and opposite nonaffected side ( group @ ) .


The middle ear pressure values obtained before and after septoplasty were compared .


Before the septoplasty , the median middle ear pressure value was -@ dPa at the side of nasal obstruction , and -@ dPa at the opposite side .


Three weeks after the septoplasty , it was -@ dPa at the side of nasal obstruction , and -@ dPa at the opposite side .


The middle ear pressure improved by approximately @ % at the side of nasal obstruction and by @ % at the nonaffected side ; a statistically significant decrease was found at the side of nasal obstruction ( P < @ ) .


In adult patients with isolated nasal septum deviation , the middle ear pressure is lower at the side of nasal obstruction , but it remains within reference ranges .


An approximately @ % improvement occurs in the middle ear pressure after septoplasty .


To compare the efficacy and palatability of @ L polyethylene glycol electrolyte ( PEG ) plus sugar-free menthol candy ( PEG + M ) vs reduced-volume @ L ascorbic acid-supplemented PEG ( AscPEG ) .


In a randomized controlled trial setting , ambulatory patients scheduled for elective colonoscopy were prospectively enrolled .


Patients were randomized to receive either PEG + M or AscPEG , both split-dosed with minimal dietary restriction .


Palatability was assessed on a linear scale of @ to @ ( @ = disgusting ; @ = tasty ) .


Quality of preparation was scored by assignment-blinded endoscopists using the modified Aronchick and Ottawa scales .


The main outcomes were the palatability and efficacy of the preparation .


Secondary outcomes included patient willingness to retake the same preparation again in the future and completion of the prescribed preparation .


Overall , @ patients were enrolled ( @ patients per arm ) .


PEG + M was more palatable than AscPEG ( @ % vs @ % , P = @ ) .


Completing the preparation was not different between study groups ( @ % PEG + M vs @ % AscPEG , P = @ ) but more patients were willing to retake PEG + M ( @ % vs @ % respectively , P = @ ) .


There was no significant difference between PEG + M vs AscPEG in adequate cleansing on both the modified Aronchick ( @ % vs @ % , P = @ ) and the Ottawa scale ( @ % vs @ % , P = @ ) .


However , PEG + M was superior in the left colon on the Ottawa subsegmental score ( score @-@ : @ % for PEG + M vs @ % for AscPEG , P = @ ) and received significantly more excellent ratings than AscPEG on the modified Aronchick scale ( @ % vs @ % , P = @ ) .


Both preparations performed less well in afternoon vs morning examinations ( inadequate : @ % vs @ % , P = @ ) .


@ L PEG plus menthol has better palatability and acceptability than @ L ascorbic acid - PEG and is associated with a higher rate of excellent preparations ; Clinicaltrial.gov identifier : NCT@ .


Cough variant asthma ( CVA ) is an important cause of chronic cough , and pathophysiological features of the disease appear to be similar to typical asthma .


Because CVA is recognized as a precursor of asthma , early intervention with long-term anti-inflammatory agents may be recommended .


However , the role of combination therapy with inhaled corticosteroid and @-agonist in the treatment of CVA has not been elucidated .


To evaluate the effectiveness of the combination therapy , we investigated the clinical impact of regular treatment with salmeterol/fliticasone propionate combination ( SFC ) and inhaled salmeterol ( SAL ) alone in patients with CVA .


The study was a randomized , controlled , parallel-group multi-center trial .


Forty-three CVA patients were assigned to SFC ( @/@g once daily ) or SAL ( @g twice daily ) for @ weeks .


Then , these medications were stopped for the next @ weeks .


Main outcome measures were cough symptoms , pulmonary function and airway inflammation .


Treatment with each of SFC and SAL significantly decreased cough scores and increased FEV@ and PEF , where the efficacy was more pronounced with SFC than SAL .


SFC also decreased sputum eosinophil counts and eosinophil cationic protein contents , whereas SAL had no effect .


After discontinuation of the treatment , cough scores increased , pulmonary function and eosinophilic airway inflammation were aggravated and returned to the baseline levels .


Maintenance therapy with SFC provides further improvements in cough symptoms , pulmonary function and airway inflammation , and discontinuation of the therapy causes worsening of the disease , indicating that stopping or interrupting anti-inflammatory therapy may not be advisable in patients with CVA .


Use of acellular dermal matrix in tissue expander breast reconstruction has become a popular adjunct to the total submuscular technique .


The question remains as to which matrix , if any , is ideal for breast reconstruction .


A randomized trial was conducted to analyze outcomes of immediate staged tissue expander breast reconstruction using either AlloDerm or DermaMatrix .


The impact of obesity , radiation , and chemotherapy on complications and biointegration of matrix was investigated .


The trial was divided into three stages , with stage I results reported here .


One hundred twenty-eight patients ( @ breasts ) were randomized equally over @ years .


Most patients were white , healthy nonsmokers .


The overall complication rate was @ percent ; half of the complications were minor .


The AlloDerm and DermaMatrix groups had similar rates of complications ( @ percent versus @ percent ; p = @ ) , consisting mostly of skin necrosis ( @ percent versus @ percent ; p = @ ) and infections ( @ percent versus @ percent ; p = @ ) , both of which led to tissue expander losses ( @ percent versus @ percent ; p = @ ) .


The AlloDerm group required less time for completion of expansion ( @ days versus @ days ; p < @ ) .


Obesity was associated with poor matrix biointegration and a longer drain time , both of which were associated with higher complication rates .


The Breast Reconstruction Evaluation Using Acellular Dermal Matrix as a Sling Trial is the largest randomized trial to date in matrix breast reconstruction and emphasizes the importance of careful patient and allograft selection to minimize complications .


Therapeutic , II .


This study was designed to compare acquisition and maintenance of scripts under two conditions : high cue , which provided numerous multimodality cues designed to minimize errors , and low cue , which provided minimal cues .


In a randomized controlled crossover study , eight individuals with chronic aphasia received intensive computer-based script training under two cuing conditions .


Each condition lasted @ weeks , with a @-week washout period .


Trained and untrained scripts were probed for accuracy and rate at baseline , during treatment , immediately posttreatment , and at @ and @ weeks posttreatment .


Significance testing was conducted on gain scores , and effect sizes were calculated .


Training resulted in significant gains in script acquisition with maintenance of skills at @ and @ weeks posttreatment .


Differences between cuing conditions were not significant .


When severity of aphasia was considered , there also were no significant differences between conditions , although magnitude of change was greater in the high-cue condition versus the low-cue condition for those with more severe aphasia .


Both cuing conditions were effective in acquisition and maintenance of scripts .


The high-cue condition may be advantageous for those with more severe aphasia .


Findings support the clinical use of script training and the importance of considering aphasia severity .


Arterial stiffness is associated with elevated blood pressure ( BP ) , but it is unclear whether it also makes hypertension more resistant to treatment .


Among hypertensive dialysis patients , this study investigated whether aortic stiffness determines ambulatory BP and predicts its improvement with therapy .


Post hoc analysis of the Hypertension in Hemodialysis Patients Treated With Atenolol or Lisinopril ( HDPAL ) trial .


@ hypertensive hemodialysis patients with echocardiographic left ventricular hypertrophy .


Baseline aortic pulse wave velocity ( PWV ) .


Baseline and treatment-induced change in @-hour ambulatory BP at @ , @ , and @ months .


Aortic PWV was assessed with an echocardiographic-Doppler technique ( ACUSON Cypress , Siemens Medical ) , and @-hour interdialytic ambulatory BP monitoring was performed with a Spacelabs @ monitor .


Mean baseline aortic PWV was @ ( SD ) m/s .


Overall treatment-induced changes in ambulatory systolic BP ( SBP ) were -@ , -@ , and -@ mmHg at @ , @ , and @ months .


Changes in SBP were no different among tertiles of baseline PWV .


Aortic PWV was associated directly with baseline ambulatory SBP and pulse pressure ( PP ) and inversely with diastolic BP ( DBP ) .


After adjustment for several cardiovascular risk factors , each @-m/s higher PWV was associated with @-mm Hg higher baseline SBP ( = @ ; P = @ ) and @-mm Hg higher PP ( = @ ; P = @ ) , whereas the association with DBP was no longer significant .


Baseline PWV did not predict treatment-induced changes in SBP ( Wald test , P = @ ) and DBP ( Wald test , P = @ ) , but was a predictor of an overall improvement in PP during follow-up ( Wald test , P = @ ) .


Observational design ; predominantly black patients were studied .


Because aortic PWV is not a predictor of treatment-induced change in ambulatory BP among hypertensive dialysis patients , it indicates that among these patients , hypertension can be controlled successfully regardless of aortic stiffness .


The efficacy of pegloticase , a polyethylene glycol ( PEG ) - conjugated mammalian recombinant uricase , approved for chronic refractory gout , can be limited by the development of antibodies ( Ab ) .


Analyses from @ replicate , @-month , randomized controlled trials were performed to characterize Ab responses to pegloticase .


Anti-pegloticase , anti-PEG , and anti-uricase Ab were determined by validated enzyme-linked immunosorbent assays .


Ab titers were analyzed for possible relationships with serum pegloticase concentrations , serum uric acid ( sUA ) lowering , and risk of infusion reactions ( IRs ) .


Sixty-nine ( @ % ) of @ patients receiving pegloticase developed high titer anti-pegloticase Ab ( > @:@ ) and @ % ( @/@ ) developed anti-PEG Ab ; @ patient receiving placebo developed high titer anti-pegloticase Ab .


Only @ % ( @/@ ) of patients developed anti-uricase Ab , usually at low titer .


In responders , patients showing sustained UA lowering , mean anti-pegloticase titers at week @ ( @:@ @ with biweekly and @:@ @ with monthly dosing ) were markedly lower than in nonresponders ( @:@,@ @,@ and @:@,@ @,@ , respectively ) .


Nonresponder status was associated with reduced serum pegloticase concentrations .


Baseline anti-pegloticase Ab , evident in @ % ( @/@ ) of patients , did not predict subsequent loss of urate-lowering response .


Loss of sUA response preceded IRs in @ of @ ( @ % ) pegloticase-treated patients .


Loss of responsiveness to pegloticase is associated with the development of high titer anti-pegloticase Ab that increase clearance of pegloticase and are associated with a loss of the sUA lowering effect and increased IR risk .


Pre-infusion sUA can be used as a surrogate for the presence of deleterious anti-pegloticase Ab .


Sympathetic response associated with laryngoscopy and endotracheal intubation is recognized as a potential cause for a number of complications especially in coronary bypass surgery patients .


Various methods have been used to attenuate these hemodynamic responses , The aim of our study was to compare lidocaine spray in addition to intravenous morphine on attenuating the hemodynamic response to laryngoscopy and endotracheal intubation with intravenous lidocaine and morphine in coronary artery bypass surgery patients .


Sixty patients , scheduled for elective coronary bypass grafting surgery were included in this randomized controlled trial .


The patients randomly divided in group-A ( Intravenous Morphine @ mg/kg and Intravenous lidocaine @ mg/kg ) and group-B ( Intravenous Morphine @ mg/kg and lidocaine spray @ mg/kg ) .


Demographic data was comparable in both groups .


There was no statistically significant difference between two groups in the duration of laryngoscopy and intubation .


There was statistically insignificant attenuation in heart rate in both groups ( p = @ ) , the trends of attenuation of systolic blood pressure , diastolic blood pressure and mean arterial pressure in group-A compared to group-B ( p = @ ) , ( p = @ ) and ( p = @ ) respectively were statistically insignificant .


Under the present study design , lidocaine spray in addition to intravenous morphine had no better effect on attenuating the hemodynamic response to laryngoscopy and endotracheal intubation as compared to intravenous lidocaine and morphine in coronary artery bypass surgery patients .


To help facilitate economic evaluations of oncology treatments , we mapped responses on cancer-specific instrument to generic preference-based measures .


Cancer patients ( n = @ ) completed one cancer-specific instrument , the FACT-G , and two preference-based measures , the EQ-@D and SF-@D .


Responses were randomly divided to form development ( n = @ ) and cross-validation ( n = @ ) samples .


Relationships between the instruments were estimated using ordinary least squares ( OLS ) , generalized linear models ( GLM ) , and censored least absolute deviations ( CLAD ) regression approaches .


The performance of each model was assessed in terms of how well the responses to the cancer-specific instrument predicted EQ-@D and SF-@D utilities using mean absolute error ( MAE ) and root mean squared error ( RMSE ) .


Physical , functional , and emotional well-being domain scores of the FACT-G best explained the EQ-@D and SF-@D .


In terms of accuracy of prediction as measured in RMSE , the CLAD model performed best for the EQ-@D ( RMSE = @ ) whereas the GLM model performed best for the SF-@D ( RMSE = @ ) .


The GLM predicted SF-@D scores matched the observed values more closely than the CLAD and OLS .


Our results demonstrate that the estimation of both EQ-@D and SF-@D utility indices using the FACT-G responses can be achieved .


The CLAD model for the EQ-@D and the GLM model for the SF-@D are recommended .


Thus , it is possible to estimate quality-adjusted life years for economic evaluation from studies where only cancer-specific instrument have been administered .


The Children 's Oncology Group study AHOD@ , a randomized phase III study , was designed to evaluate the role of early chemotherapy response in tailoring subsequent therapy in pediatric intermediate-risk Hodgkin lymphoma .


To avoid treatment-associated risks that compromise long-term health and to maintain high cure rates , dose-intensive chemotherapy with limited cumulative doses was used .


Patients received two cycles of doxorubicin , bleomycin , vincristine , etoposide , cyclophosphamide , and prednisone ( ABVE-PC ) followed by response evaluation .


Rapid early responders ( RERs ) received two additional ABVE-PC cycles , followed by complete response ( CR ) evaluation .


RERs with CR were randomly assigned to involved-field radiotherapy ( IFRT ) or no additional therapy ; RERs with less than CR were nonrandomly assigned to IFRT .


Slow early responders ( SERs ) were randomly assigned to receive two additional ABVE-PC cycles with or without two cycles of dexamethasone , etoposide , cisplatin , and cytarabine ( DECA ) .


All SERs were assigned to receive IFRT .


Among @,@ eligible patients , @-year event-free survival ( EFS ) was @ % : @ % for RERs and @ % for SERs ( P < @ ) .


Four-year overall survival was @ % : @ % for RERs and @ % for SERs ( P < @ ) .


Four-year EFS was @ % versus @ % ( P = @ ) for RERs with CR who were randomly assigned to IFRT versus no IFRT , and @ % versus @ % ( P = @ ) for RERs with positron emission tomography ( PET ) - negative results at response assessment .


Four-year EFS was @ % versus @ % ( P = @ ) for SERs who were randomly assigned to DECA versus no DECA , and @ % versus @ % ( P = @ ) for SERs with PET-positive results at response assessment .


This trial demonstrated that early response assessment supported therapeutic titration ( omitting radiotherapy in RERs with CR ; augmenting chemotherapy in SERs with PET-positive disease ) .


Strategies directed toward improved response assessment and risk stratification may enhance tailoring of treatment to patient characteristics and response .


Some central hypersomnolence syndromes are associated with a positive allosteric modulator of - aminobutyric acid ( GABA ) - A receptors in cerebrospinal fluid .


Negative allosteric modulators of GABA-A receptors , including clarithromycin , have been reported to reduce sleepiness in these patients .


We sought to systematically assess the effects of clarithromycin on objective vigilance and subjective sleepiness .


This was a @-week , randomized , placebo-controlled , double-blind , crossover trial of clarithromycin @mg with breakfast and lunch , in patients with hypersomnolence syndromes ( excluding narcolepsy with cataplexy ) and evidence for abnormal cerebrospinal fluid potentiation of GABA-A receptors .


The study occurred at a university-affiliated medical center .


The primary outcome measure was median reaction time on the psychomotor vigilance task ( PVT ) at week @ in each condition .


Secondary outcomes included the Epworth Sleepiness Scale , Stanford Sleepiness Scale , Functional Outcomes of Sleep Questionnaire , Pittsburgh Sleep Quality Index , SF-@ , and additional PVT measures .


Twenty-three patients began treatment .


Three patients dropped out , and final analyses were performed on @ complete cases .


Median reaction time was not significantly different between clarithromycin and placebo .


Subjective measures of sleepiness were significantly improved on clarithromycin versus placebo .


Altered taste perception occurred , but was the only side effect more common on clarithromycin than placebo .


No serious adverse events occurred .


Subjective sleepiness , but not psychomotor vigilance , improved during a @-week course of clarithromycin .


Although additional studies are needed , this suggests that clarithromycin may be a reasonable treatment option in patients with treatment-refractory hypersomnolence .


This trial was registered at ClinicalTrials.gov ( NCT@ ) and supported by the American Sleep Medicine Foundation .


To report the results of analysis of the economic efficiency of physical rehabilitation of the patients surviving after myocardial infarction with the use of physical exercises .


The study included @ patients ( mean age @,@,@ years ) who were randomized into two groups : the group where the patients were treated with the use of physical training ( n = @ ) and the control group ( n = @ ) .


The physical training included natural walking over the level ground at a speed corresponding to @ % of the maximum heart rate achieved during the initial @ minute of the walking test .


The results of the analysis indicate that the cost of the full course of medicamental therapy for the patients of the control group was @,@ rubles higher than that for the patients treated with the use of physical exercises .


The expenses for the instrumental and laboratory studies in the former group proved to be @,@ rubles higher than in the latter .


The inclusion of controlled physical exercises in the program in the rehabilitative treatment of the patients surviving after myocardial infarction makes it possible to achieve a higher quality of their life with the more favourable cost-benefit ratio compared with use of medicamental therapy alone .


The primary aim of the present study was to evaluate whether usage of self-gripping mesh in open inguinal hernia repair , compared with standard Lichtenstein repair with sutured mesh , could result in a decreased rate of chronic pain at @-mo follow-up .


The secondary outcome was to evaluate foreign body feeling and the quality of life after inguinal hernia repair .


The patients were randomized into two study groups as follows : the OLP group received Optilene LP mesh and the PPG group received self-gripping Parietex ProGrip mesh .


Pain scores were measured on a visual analog scale .


Foreign body feeling was registered as a yes or no question .


Quality of life was evaluated using the Medical Outcome Study Short-Form @ questionnaire .


A total of @ patients in the OLP group and @ patients in the PPG group were included in the analysis .


According to the primary end point , @ % and @ % of the patients in the OLP group and PPG group experienced pain during different activities at @-mo follow-up , respectively ( P = @ ) .


Per secondary end point , @ % in the OLP group and @ % in the PPG group reported foreign body feeling at the operation site at @-mo follow-up ( P = @ , risk ratio @ , @ % confidence interval @-@ @ ) .


There were no significant differences in any domain of quality of life according to the Short-Form @ questionnaire between the two study groups at @-mo follow-up , except for the social functioning domain ( P = @ ) .


In the OLP group , the quality of life scores improved significantly after operation in all domains except for general health and mental health .


In the PPG group , the quality of life scores improved significantly after operation in the domains of bodily pain , physical functioning , and physical role .


Self-gripping mesh compared with standard Lichtenstein operation has no advantages in reducing chronic pain @-mo after surgery .


The rate of foreign body feeling was higher in the self-gripping mesh group .


Scores of bodily pain , physical functioning , and physical role improved significantly in both study groups after hernia surgery .


To perform a subset analysis of patients with very platinum-sensitive recurrent ovarian cancer ( ROC ) enrolled in the phase III CALYPSO trial .


The international non-inferiority trial enrolled women with ROC that relapsed > @ months following first - or second-line platinum - and paclitaxel-based therapies .


Patients were randomised to CD -LSB- carboplatin-pegylated liposomal doxorubicin ( PLD ) -RSB- or CP ( carboplatin-paclitaxel ) and stratified by treatment-free interval ( TFI ) .


In this analysis , patients with a TFI > @ months were analysed separately for progression free survival ( PFS ) , the primary endpoint of CALYPSO , overall survival ( OS ) and safety .


A total of @ very platinum-sensitive patients were included ( n = @ , CD ; n = @ , CP ) .


Median PFS was @ months for the CD arm and @ months for CP -LSB- HR = @ ( @ % CI , @-@ @ ) ; P = @ for superiority -RSB- and median OS was @ months for CD and @ for CP -LSB- HR = @ ( @ % CI @-@ @ ) ; P = @ for superiority -RSB- .


Overall response rates were @ % and @ % , respectively ( P = @ ) .


Toxicities were more common with CP versus CD , including grade @/@ neutropenia ( @ % versus @ % ; P = @ ) , nausea ( @ % versus @ % ; P = @ ) , allergic reaction ( @ % versus @ % ; P = @ ) sensory neuropathy ( @ % versus @ % ; P = @ ) and grade @ alopecia ( @ % versus @ % ; P < @ ) .


Grade @/@ thrombocytopenia ( @ % versus @ % ; P = @ ) and mucositis ( @ % versus @ % ; P = @ ) were more common with CD .


Grade @/@ hand-foot syndrome occurred rarely with CD ( @ patients versus @ in CP arm ; P = @ ) .


CP and CD were equally effective treatment regimens for patients with very platinum-sensitive ROC .


The favourable risk-benefit profile suggests carboplatin-PLD as treatment of choice for these patients .


Allocentric navigation declines with age and neurologic disease whereas egocentric navigation does not ; differences that likely arise from maladaptive changes in brain regions mediating spatial ( parietal cortex ; hippocampus ) but not procedural processing ( caudate nucleus ) .


Transcranial direct current stimulation ( tDCS ) holds promise for treating such decline given its ability to modulate neuronal excitability , but its effects have yet to be examined on spatial navigation .


Using healthy young adults as a model , Study @ intended to validate a novel spatial navigation paradigm using functional magnetic resonance imaging ( fMRI ) .


Using these data to determine targets for tDCS , Study @ aimed to determine if @ ) stimulation modulates activation in a polarity-specific manner ; @ ) stimulation results in global and/or task-specific activation changes ; @ ) activation changes are accompanied by changes in effective connectivity .


All participants underwent fMRI while learning allocentric and egocentric environments .


Twelve participants completed Study @ .


In Study @ , @ participants were randomized to @ min of tDCS ( @ mA ) using a montage with the anode over PZ and cathode over AF@ ( P+F - ) or the reverse montage ( P-F + ) .


Study @ revealed that distinct networks preferentially mediate allocentric and egocentric navigation .


Study @ revealed polarity-dependent changes in activation and connectivity .


The P+F - montage increased these measures in spatial regions , especially during allocentric navigation , and the caudate nucleus .


Conversely , the P-F + montage increased activation and connectivity in lateral prefrontal cortices and posterior hippocampus .


These findings support the neuromodulatory effects of tDCS in non-motor areas and demonstrate proof-of-principle for ameliorating age - and disease-related decline in navigational abilities .


This study aimed to determine whether feeding back patient-reported outcomes ( PROs ) to providers and families of children with advanced cancer improves symptom distress and health-related quality of life ( HRQoL ) .


This study was a parallel , multicentered pilot randomized controlled trial .


At most once per week , children age @ years old with advanced cancer or their parent completed the computer-based Pediatric Quality of Life and Evaluation of Symptoms Technology ( PediQUEST ) survey consisting of age - and respondent-adapted versions of the Memorial Symptom Assessment Scale ( MSAS ) , Pediatric Quality of Life Inventory @ Generic Core Scales ( PedsQL@ @ ) , and an overall Sickness question .


In the intervention group ( n = @ ) , oncologists and families received printed reports summarizing PROs ; e-mails were sent to oncologists and subspecialists when predetermined scores were exceeded .


No feedback was provided in the control group ( n = @ ) .


Primary outcomes included linear trends of MSAS , PedsQL@ @ total and subscale scores , and Sickness scores during @ weeks of follow-up , along with child , parent , and provider satisfaction with PediQUEST feedback .


Feedback did not significantly affect average MSAS , PedsQL@ @ , or Sickness score trends .


Post hoc subgroup analyses among children age @ years who survived @ weeks showed that feedback improved PedsQL@ @ emotional ( +@ ; @ % CI , @ to @ ) and Sickness ( -@ ; @ % CI , -@ to -@ ) scores .


PediQUEST reports were valued by children , parents , and providers and contributed at least sometimes to physician initiation of a psychosocial consult ( @ % ) .


Although routine feedback of PROs did not significantly affect the child 's symptoms or HRQoL , changes were in expected directions and improvements observed in emotional HRQoL through exploratory analyses were encouraging .


Importantly , children , parents , and providers value PRO feedback .


Patients with acute ST-segment elevation myocardial infarction ( STEMI ) and multivessel coronary disease have a worse prognosis compared with individuals with single-vessel disease .


We aimed to study the clinical outcome of patients with STEMI treated with fractional flow reserve ( FFR ) - guided complete revascularisation versus treatment of the infarct-related artery only .


We undertook an open-label , randomised controlled trial at two university hospitals in Denmark .


Patients presenting with STEMI who had one or more clinically significant coronary stenosis in addition to the lesion in the infarct-related artery were included .


After successful percutaneous coronary intervention ( PCI ) of the infarct-related artery , patients were randomly allocated ( in a @:@ ratio ) either no further invasive treatment or complete FFR-guided revascularisation before discharge .


Randomisation was done electronically via a web-based system in permuted blocks of varying size by the clinician who did the primary PCI .


All patients received best medical treatment .


The primary endpoint was a composite of all-cause mortality , non-fatal reinfarction , and ischaemia-driven revascularization of lesions in non-infarct-related arteries and was assessed when the last enrolled patient had been followed up for @ year .


Analysis was on an intention-to-treat basis .


This trial is registered with ClinicalTrials.gov , number NCT@ .


From March , @ , to February , @ , we enrolled @ patients to the trial ; @ were allocated no further invasive treatment after primary PCI of the infarct-related artery only and @ were assigned complete revascularization guided by FFR values .


Median follow-up was @ months ( range @ months ) .


Events comprising the primary endpoint were recorded in @ ( @ % ) patients who had PCI of the infarct-related artery only and in @ ( @ % ) patients who had complete revascularisation ( hazard ratio @ , @ % CI @ ; p = @ ) .


In patients with STEMI and multivessel disease , complete revascularisation guided by FFR measurements significantly reduces the risk of future events compared with no further invasive intervention after primary PCI .


This effect is driven by significantly fewer repeat revascularisations , because all-cause mortality and non-fatal reinfarction did not differ between groups .


Thus , to avoid repeat revascularisation , patients can safely have all their lesions treated during the index admission .


Future studies should clarify whether complete revascularization should be done acutely during the index procedure or at later time and whether it has an effect on hard endpoints .


The treatment of adhesive capsulitis is a dilemma for orthopaedic rehabilitation specialists .


In this study , we assessed whether extracorporeal shockwave therapy ( ESWT ) improves the functional outcome of primary shoulder adhesive capsulitis .


In this prospective , randomized , controlled , single-blind clinical trial , we enrolled @ patients with primary adhesive capsulitis to assess whether ESWT can improve the functional outcome of primary adhesive capsulitis better than oral steroid therapy .


Patients were allocated to the oral steroid group or ESWT group with randomization .


Functional outcome evaluations were performed using the Constant Shoulder Score ( CSS ) and Oxford Shoulder Score .


Both groups showed significant improvement in the Oxford Shoulder Score evaluation throughout the study period .


In the ESWT group , the total CSS and range of motion ( ROM ) parameter of the CSS in the ESWT group showed significant improvement from the fourth week that was better than that in the steroid group ; the activitiesofdaily living ( ADL ) parameter of the CSS achieved significance and was better than that in the steroid group at the sixth week .


For the steroid group , pain was significantly reduced from baseline to the fourth week of the study ; ADL and ROM improved at the fourth to @th week .


For the ESWT group , ADL and ROM improvements were significant from baseline to the sixth week .


Our results showed that ESWT can be an alternative treatment , at least in the short-term , for primary adhesive capsulitis of the shoulder .


In addition , all of the side effects of ESWT were transient and tolerable .


Few treatment options exist for patients with severe emphysema .


We assessed the clinical benefits and safety of lung volume reduction coils ( LVRCs ) for the treatment of patients with severe emphysema with hyperinflation .


In a randomised study , we recruited patients with severe emphysema ( aged @ years ) from three centres in the UK .


Using a computer-generated randomisation sequence , we randomly allocated patients in a one-to-one ratio ( block sizes of four and stratified by centre ) to either LVRC treatment ( treatment group ) or best medical care ( usual care group ) .


The primary endpoint was the difference in response in the St George 's Respiratory Questionnaire ( SGRQ ) between treatment and usual care groups at @ days after final treatment ( by intention-to-treat analysis ) .


The trial is registered with ClinicalTrials.gov , number NCT@ .


Between Jan @ , @ , to Oct @ , @ , we recruited and randomly allocated @ patients : @ to treatment and @ to usual care ( @ patients in each group were included in the intention-to-treat analysis ) .


SGRQ response at @ days after final treatment was greater in the treatment group than it was in the usual care group ( between-group difference in change from baseline -@ points -LSB- @ % CI -@ to -@ -RSB- ; p = @ ) .


We detected no between-group difference in serious adverse events .


Our findings suggest that treatment with endobronchial coils can improve quality of life for patients with severe emphysema and hyperinflation .


To evaluate the change in respiratory function and functional capacity according to the type of preoperative fasting .


Randomized prospective clinical trial , with @ female patients undergoing cholecystectomy by laparotomy with conventional or @ hours shortened fasting .


The variables measured were the peak expiratory flow , forced expiratory volume in the first second , forced vital capacity , dominant handgrip strength , and non-dominant handgrip strength .


Evaluations were performed @ hours before induction of anesthesia and @ hours after the operation .


The two groups were similar in preoperative evaluations regarding demographic and clinical characteristics , as well as for all variables .


However , postoperatively the group with shortened fasting had higher values than the group with conventional fasting for lung function tests peak expiratory flow ( @ versus @ ; p = @ ) , forced expiratory volume in the first second ( @ versus @ ; p = @ ) , forced vital capacity ( @ versus @ ; p = @ ) , and for muscle function tests dominant handgrip strength ( @ versus @ ; p = @ ) and non-dominant handgrip strength ( @ versus @ ; p = @ ) .


In the intragroup evaluation , there was a decrease in preoperative compared with postoperative values , except for dominant handgrip strength ( @ versus @ ; p = @ ) , in the shortened fasting group .


Abbreviation of preoperative fasting time with ingestion of maltodextrin solution is beneficial to pulmonary function and preserves dominant handgrip strength .


Wholegrain rye has been associated with decreased hunger sensations .


This may be partly mediated by colonic fermentation .


Sustained consumption of fermentable components is known to change the gut microflora and may increase numbers of saccharolytic bacteria .


To investigate the effect of wholegrain rye consumption on appetite and colonic fermentation after a subsequent meal .


In a randomized , controlled , three-arm cross-over study , twelve healthy male subjects consumed three iso-caloric evening test meals .


The test meals were based on white wheat bread ( WBB ) , wholegrain rye kernel bread ( RKB ) , or boiled rye kernels ( RK ) .


Breath hydrogen excretion and subjective appetite sensation were measured before and at @min intervals for @h after a standardized breakfast in the subsequent morning .


After the @h , an ad libitum lunch meal was served to assess energy intake .


In an in vitro study , RKB and RK were subjected to digestion and @h-fermentation in order to study SCFA production and growth of selected saccharolytic bacteria .


The test meals did not differ in their effect on parameters of subjective appetite sensation the following day .


Ad libitum energy intake at lunch was , however , reduced by @ % ( P < @ ) after RKB and @ % ( P < @ ) after RK compared with after WWB evening meal .


Breath hydrogen excretion was significantly increased following RKB and RK evening meals compared with WWB ( P < @ and P < @ , respectively ) .


Overall , RKB and RK were readily fermented in vitro and exhibited similar fermentation profiles , although total SCFA production was higher for RK compared with RKB ( P < @ ) .


In vitro fermentation of RKB and RK both increased the relative quantities of Bifidobacterium and decreased Bacteroides compared with inoculum ( P < @ ) .


The C. coccoides group was reduced after RKB ( P < @ ) .


Consumption of wholegrain rye products reduced subsequent ad libitum energy intake in young healthy men , possibly mediated by mechanisms related to colonic fermentation .


We investigated the safety of a telemetric IOP sensor and the accuracy of its IOP measurements in six patients with open-angle glaucoma and cataract .


The study design was a prospective , single-center clinical trial .


Here we present @-year follow-up data .


A ring-shaped telemetric IOP sensor was implanted in the ciliary sulcus after implantation of the intracapsular lens , during planned cataract surgery .


The sensor is encapsulated in silicone rubber and consists of a miniature device with eight pressure-sensitive capacitors and a circular microcoil antenna .


IOP measurements are performed with a reader unit held in front of the eye .


IOP is calculated as the differences between the absolute pressure inside the eye ( pressure sensor ) and that outside the eye ( reader unit ) .


The sensor was successfully implanted in all patients .


Four patients developed sterile anterior chamber inflammation that resolved completely within @ days after surgery with anti-inflammatory treatment .


All patients showed mild to moderate pupillary distortion and pigment dispersion after surgery .


Telemetric IOP measurement was performed in all patients at all visits , and the patients successfully performed self-tonometry at home after receiving instructions .


Telemetric IOP values showed similar profiles compared to those of Goldmann applanation tonometry ( GAT ) .


Three patients showed a relevant IOP step during follow-up , and in one patient , negative values were obtained throughout the study .


Despite early postoperative anterior chamber inflammation , the IOP sensor was well tolerated by all patients .


We describe the first prospective clinical study of a noncontact IOP sensor that potentially enables continuous IOP monitoring in patients with glaucoma .


The sensor shape and size needs to be adapted to avoid pupillary distortion and to confirm that IOP measurements are accurately recorded in comparison to those of GAT .


( www.germanctr.de ; number DRKS@ . )


Sleep-disturbed breathing ( SDB ) is common in patients with precapillary pulmonary hypertension ( PH ) .


Nocturnal oxygen therapy ( NOT ) and acetazolamide improve SDB in patients with PH , and NOT improves exercise capacity .


We investigated the effect of NOT and acetazolamide on nocturnal cardiac conduction , repolarization , and arrhythmias in patients with PH and SDB .


In a randomized , placebo-controlled , double-blind , crossover trial , @ patients with arterial ( n = @ ) or chronic thromboembolic PH ( n = @ ) and SDB defined as a mean nocturnal oxygen saturation < @ % or dips ( > @ % ) > @/h with daytime Pao@ @ kPa were studied .


Participants received NOT ( @ L/min ) , acetazolamide tablets ( @ @ mg ) , and sham-NOT/placebo each during @ week separated by a @-week washout period .


Three-lead ECG was recorded during overnight polysomnography at the end of each treatment period .


Repolarization indices were averaged over three cardiac cycles at late evening and at early morning , and nocturnal arrhythmias were counted .


NOT was associated with a lower overnight ( @ @ beats/min vs @ @ beats/min , P = @ ) and early morning heart rate compared with placebo .


At late evening , the heart rate-adjusted PQ time was increased under acetazolamide compared with placebo ( mean difference , @ milliseconds ; @ % CI , @-@ milliseconds ; P = @ ) .


In the morning under NOT , the heart rate-adjusted QT ( QTc ) interval was decreased compared with placebo ( mean difference , -@ milliseconds ; @ % CI , -@ to -@ milliseconds ; P = @ ) , and the interval between the peak and the end of the T wave on the ECG was shorter compared with acetazolamide ( mean difference , -@ milliseconds ; @ % CI , -@ to -@ milliseconds ; P = @ ) .


Arrhythmias were rare and similar with all treatments .


In patients with PH with SDB , NOT reduces nocturnal heart rate and QTc in the morning , thus , favorably modifying prognostic markers .


The objective of the present work was to study effects of low-level laser irradiation on the endothelial function and selected parameters of microcirculation in the patients presenting with rheumatoid arthritis .


This study included @ patients at the age varying from @ to @ years presenting with rheumatoid arthritis .


They were divided into @ groups .


The patients of the main group ( n = @ ) underwent daily intravenous laser blood irradiation during @ days .


The control group was comprised of @ patients .


Laser therapy was performed with the help of a laser therapeutic device Matrix - VLOK ( `` Matrix '' , Russia ) using alternation of two radiating heads : KI-VLOK-@ ( wavelength @ pm , for @ minutes ) and KI-VLOK-@ ( wavelength @ microm , for @ minutes ) in the continuous emission regime .


The parameters of interest were measured before and after the treatment .


The overall duration of intravenous laser irradiation of blood was @ days without a break for the weekend .


The data obtained suggest the improvement of the endothelial function and the microcirculation indices .


Few clinical trials in chronic idiopathic constipation ( CIC ) patients have evaluated abdominal symptom severity and whether CIC patients with abdominal symptoms respond similarly to patients with limited abdominal symptoms .


To examine abdominal symptom severity and relationships between symptoms and global measures at baseline ; compare linaclotide 's effect on symptoms in subpopulations with more or less abdominal pain ; and assess relationships between symptom improvement and global measures in these two subpopulations .


In two phase @ trials , patients meeting modified Rome II CIC criteria were assigned to linaclotide @g , @g , or placebo once daily .


Patients rated abdominal and bowel symptoms daily during @-week pre-treatment and @-week treatment periods .


Linaclotide 's effect on symptoms and global measures -LSB- constipation severity , health-related quality of life ( HRQOL ) , treatment satisfaction -RSB- and their inter-relationships were assessed in post hoc analyses of abdominal pain subpopulations .


Of @ CIC patients , @ % , @ % , and @ % reported moderate-to-severe abdominal pain , discomfort , and bloating , respectively , during baseline .


In more-severe abdominal pain patients , abdominal symptoms were more strongly correlated than bowel symptoms with global measures , but in less-severeabdominal pain patients , abdominal and bowel symptoms were similarly correlated with global measures , at baseline and post-treatment .


Linaclotide significantly improved all symptoms and global measures in both subpopulations .


When abdominal pain is present in CIC , abdominal and not bowel symptoms may drive patient assessments of constipation severity , HRQOL , and treatment satisfaction .


Linaclotide ( @g and @g ) is an effective treatment for both abdominal and bowel symptoms , even in CIC patients with more severe abdominal pain at baseline .


( Clinicaltrials.gov : NCT@ , NCT@ ) .


To investigate the safety and efficacy of QMF@ , a once-daily , fixed-dose combination of the long-acting @-agonist ( LABA ) indacaterol maleate and inhaled corticosteroid ( ICS ) mometasone furoate ( MF ) for the treatment of persistent asthma .


The hypothesis was that QMF@ would not increase the risk of serious asthma exacerbations .


@ research centres in nine countries .


@ adolescents and adults with persistent asthma who were treated or qualified for treatment with combination LABA/ICS were randomised , and @ were included in the intention-to-treat analysis .


Patients were randomised to QMF@ ( indacaterol maleate @g/MF @g ) or MF ( @g ) once daily via Twisthaler inhalation device in a double-blind , parallel-group study for @-@months .


The primary end point was time to first serious asthma exacerbation ( resulting in hospitalisation , intubation or death ) .


The key secondary end point was annual rate of exacerbations requiring systemic corticosteroids .


Treatment with QMF@ resulted in no significant difference in time to first serious exacerbation compared to MF ( @ ( @ % ) vs @ events ( @ % ) ; difference -@ percentage point ; @ % CI -@ to @ , p = @ , HR = @ ; @ % CI @ to @ , p = @ ) .


QMF@ significantly reduced the annual rate of exacerbations requiring systemic corticosteroids ( rate ratio = @ ; @ % CI @ to @ , p = @ ) .


Proportions of patients experiencing adverse events were similar across groups ( @ % in the QMF@ group and @ % in the MF group ) .


Serious adverse events occurred in @ % and @ % of patients in the QMF@ and MF groups , respectively .


No significant difference was observed in the primary outcome of time to first serious asthma exacerbation in patients treated with QMF@ compared with patients treated with MF .


Long-term treatment with QMF@ once daily had a favourable safety/efficacy profile in adolescent and adult patients with persistent asthma .


To study the clinical effect of Dengzhanhua injection and Xiongqin injection combined with Xuesaitong to treat the elderly patients with acute cerebral infarction .


From March @ to March @,@ patients with acute cerebral infarction elderly patients were treated , as research subjects were randomly divided into two groups , the observation group and the control group ,@ cases in each group .


The control group were treated using Xuesaitong ; The observation group using Dengzhanhua injection and Xiongqin injection combined with Xuesaitong .


The changes of cerebral blood flow , plasma viscosity and platelet adhesion rate were com - pared before and after the treatment ; Nerve function and living abilities of the two groups were recorded and compared ; Cure rate of the two groups were compared .


The cerebral blood flow , plasma viscosity and platelet adhesion rate had improved to some extent af - ter treatment both of the two groups , the degree of improvement in the observation group was significantly better than the control group ( P < @ ) ; Nerve function and living abilities of the observation group was significantly better than the control group ( P < @ ) ; Cure rate in the observation group was significantly higher than the control group ( P < @ ) .


Using Dengzhanhua injection and Xiongqin injection combined with Xuesaitong to treat elderly patients with acute cerebral infarction has significantly high curative rate , which can significantly improve patients ' cerebral blood flow , plasma viscosity , platelet adhesion rate , nerve function and life skills .


Implant migration , bone mineral density ( BMD ) , length of glenohumeral offset ( LGHO ) , and clinical results were compared for the Copeland ( Biomet Inc , Warsaw , IN , USA ) and the Global C.A.P. ( DePuy Int , Warsaw , IN , USA ) humeral head resurfacing implants ( HHRIs ) .


The study randomly allocated @ patients ( @ women ) , mean age @ years ( range , @-@ years ) , with shoulder osteoarthritis to a Copeland ( n = @ ) or Global C.A.P. ( n = @ ) HHRI .


Patients were monitored for @ years with radiostereometry , dual-energy X-ray absorptiometry , Constant Shoulder Score ( CSS ) , and the Western Ontario Osteoarthritis of the Shoulder Index ( WOOS ) .


LGHO was measured preoperatively and @ months postoperatively .


At @ years , total translation ( TT ) was @ mm ( standard deviation -LSB- SD -RSB- , @ mm ) for the Copeland and @ mm ( SD , @ mm ) for the Global C.A.P. ( P = @ ) .


Five HHRI were revised , and in the interval before the last follow-up ( revision or @ years ) , TT of @ mm ( SD , @ mm ) for revised HHRI was higher ( P = @ ) than TT of @ mm ( SD , @ mm ) in nonrevised HHRI .


A comparison of TT at the last follow-up ( revision or @ years ) found no difference between the HHRIs ( P = @ ) .


Periprosthetic BMD decreased initially but increased continuously after @ months for both HHRIs .


At @ years , BMD was @ % higher around the Copeland HHRI ( P = @ ) .


The mean difference in LGHO was significantly higher for the Copeland than for the Global C.A.P. HHRI ( P = @ ) .


Clinical results evaluated with CSS and WOOS improved over time for both implant groups ( P < @ ) , with no differences between the groups .


Both implants had only little migration and good clinical results .


Periprosthetic BMD and LGHO both increased for the Copeland HHRI more than for the Global C.A.P HHRI .


The role of glucagon-like peptide-@ receptor ( GLP-@R ) variants on body weight response after dietary intervention has not been evaluated so far .


Our aim was to evaluate weight loss and adipocytokine levels after two hypocaloric diets with different macronutrient distribution in obese subjects with rs@ .


A sample of @ obese subjects was randomized to two hypocaloric diets .


@ patients ( @ % ) had the genotype GG ( wild-type ) and @ ( @ % ) had another genotype ( mutant ) , i.e. GA ( n = @ , @ % ) or AA ( n = @ , @ % ) .


With the type I diet ( low in carbohydrates ) in the wild-type and mutant groups , BMI , weight , fat mass , waist circumference , insulin levels , insulin resistance and triglycerides decreased .


Anthropometric parameters were higher in non-A-allele carriers than A-allele carriers .


With the type II diet ( low in fats ) in all genotypes , BMI , weight , fat mass , waist circumference , insulin levels , total cholesterol and LDL cholesterol decreased .


Our data showed better anthropometric parameters in obese subjects with the mutant allele ( A ) of the rs@ GLP-@R polymorphism .


A lack of association of this polymorphism with weight loss or biochemical parameters after two different hypocaloric diets was observed .


Missing data are a significant problem in clinical trials , particularly for quality of life ( QOL ) , which can not be obtained retrospectively .


The purpose of this study was to evaluate the feasibility of an electronic web-based strategy for QOL data collection in a cooperative group radiation oncology trial setting .


Radiation Therapy Oncology Group ( RTOG ) @ was a prospective National Cancer Institute cooperative group companion study of RTOG-@ , a randomized study of conventional versus hypofractionated radiation .


Forty-nine English-speaking patients with favorable risk prostate cancer who enrolled on RTOG-@ consented to using web-based technology for completing QOL .


In RTOG-@ , using paper forms , the @-month QOL compliance rate was @ % .


The purpose of RTOG-@ was to test the feasibility of a web-based strategy with the goal of increasing the @-month QOL completion rate by @ % ( from @ % to @ % ) for a relative improvement of ~ @ % .


The web-based tool used in this study was VisionTree Optimal Care ( VTOC ; VisionTree Software , Inc , San Diego , CA ) , a Health-Insurance-Portability-Accountability-Act secure , online technology that allows real-time tracking and e-mail reminders .


The primary endpoint was the @-month compliance rate for the validated QOL instrument , Expanded Prostate Index Composite .


The QOL completion rate at baseline was @ % .


Compared with the prior @ % QOL completion rate at @ months using paper forms , the QOL web-based completion rate at @ months was @ % ( @-sided P value < @ ) .


At @ months , the EPIC completion rate was @ % ( compared with @ % using paper forms ) .


This RTOG study suggests that a web-based strategy to collect QOL appears to be feasible in the cooperative group radiation oncology trial setting and is associated with an increase in the @-month QOL compliance rate compared with the prior method of using paper forms .


The RTOG plans to further test this strategy in a head-and-neck cancer trial across all participating RTOG sites .


The increase in numbers of patients requiring oral anti-coagulation testing in outpatient clinics has focused attention on alternative flexible systems of anti-coagulation management .


One option is pharmacist led patient self-testing ( PST ) of international normalised ratio ( INR ) levels .


PST has demonstrated improvements in anti-coagulation control , but its cost-effectiveness is inconclusive .


This study reports the first cost-effectiveness evaluation of a randomized controlled trial of an automated direct-to-patient expert system , enabling remote and effective management of patients on oral anti-coagulation therapy .


We conducted an economic evaluation alongside a randomised controlled trial investigating a pharmacist led PST method .


The primary outcome was to determine the cost effectiveness of PST in comparison with usual care ( management in a hospital based anti-coagulation clinic ) .


Long term anti-coagulation patients were recruited to a @ month cross over study between PST and routine care in an anti-coagulation clinic .


Economic evaluation was from the healthcare payer perspective .


On a per patient basis over a @ month period , PST resulted in an incremental cost of @ in comparison with routine care .


Patients achieved a significantly higher time in therapeutic range ( TTR ) during the PST arm in comparison with routine care , ( @ @ % vs. @ @ % ) .


Overall cost of managing a patient through pharmacist supervised PST for a @ month period is @ .


Additional analysis of strategies from a societal perspective indicated that PST was the dominant strategy .


Pharmacist led patient self-testing is a viable method of management .


It provides significant increases in anti-coagulation control for a minimal increase in cost .


Psoriasis causes worldwide concern because of its high-prevalence , as well as its harmful , and incurable characteristics .


Topical therapy is a conventional treatment for psoriasis vulgaris .


Chinese medicine ( CM ) has been commonly used in an integrative way for psoriasis patients for many years .


Some CM therapies have shown therapeutic effects for psoriasis vulgaris ( PV ) , including relieving symptoms and improving quality of life , and may reduce the relapse rate .


However , explicit evidence has not yet been obtained .


The purpose of the present trial is to examine the efficacy and safety of the YXBCM@ granule , a compound Chinese herbal medicine , with a combination of topical therapy for PV patients .


Using an add-on design , the trial is to evaluate whether the YXBCM@ granule combined topical therapy is more effective than topical therapy alone for the treatment of PV .


The study design is a double-blind , parallel , randomized controlled trial comparing the YXBCM@ granule ( @ g twice daily ) to a placebo .


The duration of treatment is @weeks .


A total of @ participants will be randomly allocated into two groups , YXBCM@ granule group and placebo group , from @ general or dermatological hospitals in China .


Topical use of calcipotriol betamethasone for the first @weeks and calcipotriol ointment for the remaining @weeks will be the same standard therapy for the two groups .


Patients will be enrolled if they have a clinical diagnosis of PV , a psoriasis area severe index ( PASI ) of more than @ or body surface area ( BSA ) of more than @ % , but PASI of less than @ and BSA of less than @ % , are aged between @ and @-years-old , and provide signed informed consent .


The primary outcome , relapse rate , is based on PASI assessed blindly during the treatment .


Secondary outcomes include : ( i ) relapse time interval , ( ii ) time to onset , ( iii ) rebound rate , ( iv ) PASI score , ( v ) cumulative consumption of medicine , ( vi ) the dermatology quality life index ( DLQI ) , and ( vii ) the medical outcomes study ( MOS ) item short form health survey ( SF-@ ) .


Analysis will be on intention-to-treat and per-protocol subject analysis principles .


To address the effectual remission of the YXBCM@ granule for PV , this trial may provide a novel regimen for PV patients if the granule can decrease relapse rate without more adverse effects .


This study sought to report the results of a prospective randomized controlled trial comparing paclitaxel-coated balloons ( PCB ) versus drug-eluting stents ( DES ) in long infrapopliteal lesions .


DES have an established role in the treatment of short infrapopliteal lesions , whereas there is increasing evidence for the use of PCB in longer below-the-knee lesions .


Inclusion criteria were patients with Rutherford classes @ to @ and angiographically documented infrapopliteal disease with a minimum lesion length of @ mm .


The primary endpoint was target lesion restenosis > @ % assessed by digital angiography at @ months .


Secondary endpoints included immediate post-procedure stenosis and target lesion revascularization .


Fifty patients were randomized to undergo infrapopliteal PCB angioplasty ( @ arteries in @ limbs ; PCB group ) or primary DES placement ( @ arteries in @ limbs ; DES group ) .


Immediate residual post-procedure stenosis was significantly lower in DES ( @ @ % vs. @ @ % in PCB ; p < @ ) .


At @ months , @ patients died ( @ in PCB vs. @ in DES ; p = @ ) and @ suffered a major amputation ( @ in PCB vs. @ in DES ; p = @ ) .


In total , @ angiograms were evaluable with quantitative vessel analysis .


Binary ( > @ % ) angiographic restenosis rate was significantly lower in DES ( @of @ -LSB- @ % -RSB- vs. @ of @ -LSB- @ % -RSB- in PCB ; p = @ ) .


There were no significant differences with regard to target lesion revascularization ( @ of @ -LSB- @ % -RSB- in DES vs. @ of @ -LSB- @ % -RSB- in PCB ; p = @ ) .


Positive vessel wall remodeling was observed in @ cases in the PCB arm ( @ of @ -LSB- ( @ % ) -RSB- vs. @ of @ -LSB- @ % -RSB- in DES ; p = @ ) .


Compared with PCB in long infrapopliteal lesions , DES are related with significantly lower residual immediate post-procedure stenosis and have shown significantly reduced vessel restenosis at @ months .


PCB may produce positive vessel remodeling .


( Infrapopliteal Drug-Eluting Angioplasty Versus Stenting -LSB- IDEAS-I -RSB- ; NCT@ ) .


Recent studies have suggested that epidermal barrier dysfunction contributes to the development of atopic dermatitis ( AD ) and other allergic diseases .


We performed a prospective , randomized controlled trial to investigate whether protecting the skin barrier with a moisturizer during the neonatal period prevents development of AD and allergic sensitization .


An emulsion-type moisturizer was applied daily during the first @ weeks of life to @ of @ neonates at high risk for AD ( based on having a parent or sibling with AD ) who were enrolled in this study .


The onset of AD ( eczematous symptoms lasting > @ weeks ) and eczema ( lasting > @ weeks ) was assessed by a dermatology specialist on the basis of the modified Hanifin and Rajka criteria .


The primary outcome was the cumulative incidence of AD plus eczema ( AD/eczema ) at week @ of life .


A secondary outcome , allergic sensitization , was evaluated based on serum levels of allergen-specific IgE determined by using a high-sensitivity allergen microarray of diamond-like carbon-coated chips .


Approximately @ % fewer neonates who received the moisturizer had AD/eczema by week @ than control subjects ( P = @ , log-rank test ) .


We did not show a statistically significant effect of emollient on allergic sensitization based on the level of IgE antibody against egg white at @ kUA/L CAP-FEIA equivalents .


However , the sensitization rate was significantly higher in infants who had AD/eczema than in those who did not ( odds ratio , @ ; @ % CI , @-@ @ ) .


Daily application of moisturizer during the first @ weeks of life reduces the risk of AD/eczema in infants .


Allergic sensitization during this time period is associated with the presence of eczematous skin but not with moisturizer use .


The aim of this study was to compare efficacy outcomes of initial treatment with adalimumab + MTX vs adalimumab addition following @ weeks of MTX monotherapy in Japanese early RA patients naive to MTX with high disease activity .


Patients completing the @-week , randomized , placebo-controlled trial of adalimumab + MTX were eligible to receive @ weeks of open-label adalimumab + MTX .


Patients were assessed for mean change from baseline in the @-joint DAS with ESR ( DAS@-ESR ) and modified total Sharp score ( mTSS ) , and for the proportions of patients achieving clinical , functional or radiographic remission .


Of @ patients assessed , @ ( @ from the initial adalimumab + MTX and @ from the initial placebo + MTX groups ) completed the @-week study .


Significant differences in clinical and functional parameters observed during the @-week blinded period were not apparent following the addition of open-label adalimumab to MTX .


Open-label adalimumab + MTX slowed radiographic progression through week @ in both groups , but patients who received adalimumab + MTX throughout the study exhibited less radiographic progression than those who received placebo + MTX during the first @ weeks ( mean mTSS at week @ = @ vs @ , P < @ ) .


Delayed addition of adalimumab in Japanese MTX-naive early RA patients did not impact clinical and functional outcomes at week @ compared with the earlier addition of adalimumab .


However , the accrual of significant structural damage during blinded placebo + MTX therapy contributed to the persistence of differences between the treatment strategies , suggesting that Japanese patients at risk for aggressive disease should benefit from the early inclusion of adalimumab + MTX combination therapy .


Trial registration .


ClinicalTrials.gov ( http://clinicaltrials.gov/ ) , NCT@ .


Patient-reported outcomes may help inform treatment choice in advanced/metastatic renal cell carcinoma ( RCC ) , particularly between approved targeted therapies with similar efficacy .


This double-blind cross-over study evaluated patient preference for pazopanib or sunitinib and the influence of health-related quality of life ( HRQoL ) and safety factors on their stated preference .


Patients with metastatic RCC were randomly assigned to pazopanib @ mg per day for @ weeks , a @-week washout , and then sunitinib @ mg per day ( @ weeks on , @ weeks off , @ weeks on ) for @ weeks , or the reverse sequence .


The primary end point , patient preference for a specific treatment , was assessed by questionnaire at the end of the two treatment periods .


Other end points and analyses included reasons for preference , physician preference , safety , and HRQoL .


Of @ randomly assigned patients , @ met the following prespecified modified intent-to-treat criteria for the primary analysis : exposure to both treatments , no disease progression before cross over , and completion of the preference questionnaire .


Significantly more patients preferred pazopanib ( @ % ) over sunitinib ( @ % ) ; @ % expressed no preference ( P < @ ) .


All preplanned sensitivity analyses , including the intent-to-treat population , statistically favored pazopanib .


Less fatigue and better overall quality of life were the main reasons for preferring pazopanib , with less diarrhea being the most cited reason for preferring sunitinib .


Physicians also preferred pazopanib ( @ % ) over sunitinib ( @ % ) ; @ % expressed no preference .


Adverse events were consistent with each drug 's known profile .


Pazopanib was superior to sunitinib in HRQoL measures evaluating fatigue , hand/foot soreness , and mouth/throat soreness .


This innovative cross-over trial demonstrated a significant patient preference for pazopanib over sunitinib , with HRQoL and safety as key influencing factors .


Only a few , small , monocentric randomized controlled trials ( RCTs ) have compared routine vs. no placement of a nasogastric or nasojejunal tube decompression ( NG/NJT ) in patients undergoing partial distal gastrectomy ( PDG ) for gastric cancer .


However , to our knowledge , no multicenter prospective RCT has analyzed the role of decompression after both the Billroth II ( BII ) procedure and Roux-en-Y ( RY ) gastrojejunostomy .


The aim of this study was to determine whether NG/NJT prevents the consequences of postoperative ileus after PDG for gastric cancer after both BII reconstruction and RY .


Two hundred seventy patients undergoing PDG for gastric cancer were randomly assigned NG/NJT placement ( NG/NJT group ) or not ( no-NG/NJT group ) with either Billroth II gastrojejunostomy or Roux-en-Y gastrojejunostomy .


The patients were monitored for postoperative complications , mortality , and postoperative course .


By January @ to June @ , among @ patients undergoing PDG for gastric cancer , @ were randomly assigned to NG/NJT placement ( NG/NJT group ) and @ to no decompression ( no-NG/NJT group ) .


Time to passage of flatus was significantly shorter in the NG/NJT group than in the no-NG/NJT group , but only after RY reconstruction ( @ @ vs. @ @ days , P < @ , respectively ) .


Postoperative abdominal distention was significantly lower in the NG/NJT group than in the no-NG/NJT group after both BII and the RY procedure ( P < @ ) .


No significant differences in postoperative mortality or morbidity , especially anastomotic leakage or intra-abdominal sepsis , were observed between the groups .


Routine placement of an NG/NJT after BII and RY PDG is not necessary in elective surgery for gastric cancer .


Once daily doses of @-@ mg lumiracoxib have been proposed to inhibit local prostaglandin synthesis longer than systemic prostaglandin synthesis due to local accumulation in inflamed , acidic tissue .


Lower , less toxic doses , however , might still achieve the clinical goal and merit further contemplation .


In a randomized , double-blind , placebo-controlled , three-way cross-over study , @ healthy men received , with an interval of @ h , two oral doses of @ mg lumiracoxib or for comparison , @ mg etoricoxib , for which local tissue accumulation has not been claimed as therapeutic component .


Systemic and local drug concentrations , assessed by means of subcutaneous in-vivo microdialysis , were related to COX-@ inhibiting effects , quantified as inhibition of prostaglandin ex-vivo production in whole blood as well as local tissue prostaglandin ( PG ) concentrations .


Twenty-four hours after the first dose , only etoricoxib was detectable in plasma and inhibited PGE@ production .


In contrast , after the second dose , systemic PGE@ concentrations were significantly reduced by both coxibs , indicating similar maximum systemic effects of the selected doses .


The local COX-@ inhibition by etoricoxib was most pronounced for PGD@ .


To the contrary , no indication was given of local inhibition of PG production by lumiracoxib at the dose tested .


Doses of @ mg lumiracoxib and @ mg etoricoxib produced similar maximum inhibition of systemic COX-@ function whereas @ mg lumiracoxib was ineffective in producing local COX-@ inhibition .


At a @ mg dosage , lumiracoxib does not provide peripheral effects that outlast its systemic actions in therapies of rheumatic diseases such as osteoarthritis .


To observe the acupuncture effect on urinary retention after spinal anesthesia .


One hundred and fifty-four patients with spinal anesthesia were randomized into an observation group ( @ cases ) and a control group ( @ cases ) .


In the observation group , the electroacupuncture was applied to bilateral Fushe ( SP @ ) and Shuidao ( ST @ ) ; @ Hz/@ Hz , retaining for @ min .


One treatment was required .


In the control group , no any intervention was applied after operation .


The incidence of the postoperative urinary retention , the time of the first automatic micturition since @ min after spinal anesthesia , the volume of the first micturition , the postoperative urine condition , the lower abdominal distention , incomplete urination and the others were observed .


The incidence of urinary retention in the observation group was lower than that in the control group ; the first automatic micturition in @ min after spinal anesthesia was earlier than that in the control group ; the comfortable urination rate was higher than that in the control group ; the incidence of incomplete urination and lower abdominal distention were lower than those in the control group .


The differences were significant in comparison of the two groups ( all P < @ ) .


Acupuncture apparently shortens the time of first automatic micturition after spinal anesthesia and promotes the recovery of bladder urinary reflection .


This therapy acts on promoting urination and reducing postoperative urinary retention .


Chronic Obstructive Pulmonary Disease ( COPD ) is a growing worldwide problem that imposes a great burden on the daily life of patients .


Since there is no cure , the goal of treating COPD is to maintain or improve quality of life .


We have developed a new tool , the Assessment of Burden of COPD ( ABC ) tool , to assess and visualize the integrated health status of patients with COPD , and to provide patients and healthcare providers with a treatment algorithm .


This tool may be used during consultations to monitor the burden of COPD and to adjust treatment if necessary .


The aim of the current study is to analyse the effectiveness of the ABC tool compared with usual care on health related quality of life among COPD patients over a period of @ months .


A cluster randomised controlled trial will be conducted in COPD patients in both primary and secondary care throughout the Netherlands .


An intervention group , receiving care based on the ABC tool , will be compared with a control group receiving usual care .


The primary outcome will be the change in score on a disease-specific-quality-of-life questionnaire , the Saint George Respiratory Questionnaire .


Secondary outcomes will be a different questionnaire ( the COPD Assessment Test ) , lung function and number of exacerbations .


During the @ months follow-up , seven measurements will be conducted , including a baseline and final measurement .


Patients will receive questionnaires to be completed at home .


Additional data , such as number of exacerbations , will be recorded by the patients ' healthcare providers .


A total of @ patients will be recruited by @ general practitioners and @ pulmonologists .


Additionally , a process evaluation will be performed among patients and healthcare providers .


The new ABC tool complies with the @ Global Initiative for Chronic Obstructive Lung Disease guidelines , which describe the necessity to classify patients on both their airway obstruction and a comprehensive symptom assessment .


It has been developed to classify patients , but also to provide visual insight into the burden of COPD and to provide treatment advice .


The aim of this study was to assess the effects of darapladib , a selective oral investigational lipoprotein-associated phospholipase A@ inhibitor , on both plasma and plaque lipoprotein-associated phospholipase A@ activity .


Patients undergoing elective carotid endarterectomy were randomized to darapladib @ mg ( n = @ ) , @ mg ( n = @ ) , or placebo ( n = @ ) for @ days , followed by carotid endarterectomy @ hours after the last dose of study medication .


Darapladib @ mg and @ mg reduced plasma lipoprotein-associated phospholipase A@ activity by @ % and @ % , respectively , versus placebo ( both P < @ ) .


Significant reductions in plaque lipoprotein-associated phospholipase A@ activity were also observed compared with placebo ( P < @ ) , which equated to a @ % and @ % decrease compared with placebo .