Children 's technique was assessed again after watching the video and one month later .


Children were primarily male ( 56 % ) and non-White ( 60 % ) .


When compared with the control group , children in the intervention group demonstrated a significant improvement in MDI technique post-intervention [ mean = 1.12 steps , 95 % CI ( 0.73 , 1.50 ) ] but the improvement was not sustained at 1-month follow-up .


The intervention did not lead to significant improvements in inhaler self-efficacy or asthma control .


A brief video intervention offered during pediatric clinic visits can lead to immediate improvements in children 's inhaler technique .


Future studies should evaluate whether booster training videos can help maintain improvements in children 's inhaler technique over time .


It has been reported that dexmedetomidine ( DEX ) can be used for conscious sedation in awake craniotomy , but few data exist to compare DEX versus propofol ( PRO ) .


To compare the efficacy and safety of DEX versus PRO for conscious sedation in awake craniotomy .


Thirty patients of American Society of Anesthesiologists grade I-II scheduled for awake craniotomy , were randomized into 2 groups each containing 15 subjects .


Group D received DEX and group P received PRO .


Two minutes after tracheal intubation ( T1 ) , PRO ( target plasma concentration ) was titrated down to 1 to 4 g/mL in group P.


In group D , PRO was discontinued and DEX was administered 1.0 g/kg followed by a maintenance dose of 0.2 to 0.7 g/kg/h .


The surgeon preset the anticipated awake point-in-time ( T0 ) preoperatively .


Ten minutes before T0 ( T3 ) , DEX was titrated down to 0.2 g/kg/h in group D , PRO was discontinued and normal saline ( placebo ) 5 mL/h was infused in group P. Arousal time , quality of revival and adverse events during the awake period , degree of satisfaction from surgeons and patients were recorded .


Arousal time was significantly shorter in group D than in group P ( P < .001 ) .


The quality of revival during the awake period in group D was similar to that of group P ( P = .68 ) .


The degree of satisfaction of surgeons was significantly higher in group D than in group P ( P < .001 ) , but no difference was found between the 2 groups with respect to patient satisfaction ( P = .80 ) .


There was no difference between the 2 groups in the incidence of adverse events during the awake period ( P > .05 ) .


Either DEX or PRO can be effectively and safely used for conscious sedation in awake craniotomy .


Comparing the two , DEX produced a shorter arousal time and a higher degree of surgeon satisfaction .


In the last 2 decades , the effectiveness of cricoid pressure ( CP ) in occluding the esophageal entrance has been questioned .


Recent magnetic resonance imaging studies yielded conflicting conclusions .


We used real-time visual and mechanical means to assess the patency of the esophageal entrance with and without CP in anesthetized and paralyzed adult patients .


One hundred seven , nonobese ASA physical status I and II patients were recruited for the study .


A cricoid force of 30 N was used .


This force was standardized by using a weighing scale before application of CP in each patient .


After oxygen administration , anesthetic induction , neuromuscular blockade , and establishment of manual ventilation with FIO2 = 1.0 , the view of the glottis and esophageal entrance was visualized , and video recordings were obtained by using a Glidescope video laryngoscope .


Attempts to insert 2 gastric tubes ( GTs ) , size 12 and 20 F , into the esophagus were made by a `` blinded '' operator without and with CP , the timing of which was randomized .


A successful insertion of a GT in the presence of CP was considered evidence of a patent esophageal entrance ( ineffective CP ) , whereas an unsuccessful insertion of a GT was considered evidence of an occluded esophageal entrance ( effective CP ) .


After the attempts to insert the GTs were completed , tracheal intubation was performed while CP was applied .


The position of the esophageal entrance in relation to the glottis ( midline versus lateral ) was assessed from the video recordings , with and without CP .


We stopped the study when 79 patients ( 41 men and 38 women ) qualified for and completed the study ( 2-sided Clopper-Pearson confidence interval ( CI ) 95 % to 100 % , n = 72 ) .


Advancement of either size GT into the esophagus could not be accomplished during CP in any patient but was easily done in all subjects when CP was not applied .


This occurred whether the esophageal entrance was in a midline position or in a left or right lateral position relative to the glottis .


Esophageal patency was visually observed in the absence of CP , whereas occlusion of the esophageal entrance was observed during CP in all patients .


Without CP , the esophageal entrance was in a left lateral position in relation to the glottis in 57 % ( [ 95 % CI , 45 % -68 % ) ] of patients , at midline in 32 % ( CI , 22 % -43 % ) , and in a right lateral position in 11 % ( CI , 5 % -21 % ) .


The position did not change with CP .


The current study provides additional visual and mechanical evidence supporting a success rate of at least 95 % by using a cricoid force of 30 N to occlude the esophageal entrance in anesthetized and paralyzed normal adult patients .


The efficacy of the maneuver was independent of the position of the esophageal entrance relative to the glottis , whether midline or lateral .


The polymorphic angiotensinogen ( AGT ) gene is one of the most promising candidates for essential hypertension .


The aim of this study was to examine the association between the A-6G variant of the AGT gene and the blood pressure response to angiotensin-converting enzyme ( ACE ) inhibitors in hypertensive subjects .


Five hundred and nine mildly to moderately hypertensive subjects received ACE inhibitors for six weeks after a two-week run-in period .


AGT genotyping was performed by direct polymerase chain reaction amplification and deoxyribonucleic acid ( DNA ) nucleotide sequencing from peripheral blood .


The AA genotype , AG genotype , and GG genotype were present in 301 ( 59.1 % ) , 186 ( 36.6 % ) , and 22 ( 4.3 % ) of patients , respectively .


As compared with patients carrying the AA or AG genotype , those carrying the GG genotype had significantly greater reductions in systolic blood pressure , diastolic blood pressure , pulse pressure and mean arterial pressure ( p = 0.007 , 0.014 , 0.027 and 0.005 , respectively ) .


Moreover , stepwise multiple linear regression analysis showed that the A-6G genotype was a significant predictor of systolic blood pressure and pulse pressure reductions ( p = 0.040 and 0.019 , respectively ) .


Our study indicates that the A-6G variant of the AGT gene may be an important determinant of interindividual variation in the response to ACE inhibitors .


Contradictory results have been reported on the effects of nesiritide on renal function in patients with acute decompensated heart failure .


We studied the effects of nesiritide on renal function during hospitalization for acute decompensated heart failure and associated outcomes .


A total of 7141 patients were randomized to receive either nesiritide or placebo and creatinine was recorded in 5702 patients at baseline , after infusion , discharge , peak/nadir levels until day 30 .


Worsening renal function was defined as an increase of serum creatinine > 0.3 mg/dL and a change of 25 % .


Median ( 25 ( th ) -75 ( th ) percentile ) baseline creatinine was 1.2 ( 1.0-1 .6 ) mg/dL and median baseline blood urea nitrogen was 25 ( 18-39 ) mmol/L .


Changes in both serum creatinine and blood urea nitrogen were similar in nesiritide-treated and placebo-treated patients ( P = 0.20 and P = 0.41 ) from baseline to discharge .


In a multivariable model , independent predictors of change from randomization to hospital discharge in serum creatinine were a lower baseline blood urea nitrogen , higher systolic blood pressure , lower diastolic blood pressure , previous weight gain , and lower baseline potassium ( all P < 0.0001 ) .


The frequency of worsening renal function during hospitalization was similar in the nesiritide and placebo group ( 14.1 % and 12.8 % , respectively ; odds ratio with nesiritide 1.12 ; confidence interval , 0.95-1 .32 ; P = 0.19 ) and was not associated with death alone and death or rehospitalization at 30 days .


However , baseline , discharge , and change in creatinine were associated with death alone and death or rehospitalization for heart failure ( all tests , P < 0.0001 ) .


Nesiritide did not affect renal function in patients with acute decompensated heart failure .


Baseline , discharge , and change in renal function were associated with 30-day mortality or rehospitalization for heart failure .


Activated charcoal is commonly used to manage overdose or accidental ingestion of medicines .


This study evaluated the effect of activated charcoal on apixaban exposure in human subjects .


This was an open-label , three-treatment , three-period , randomized , crossover study of single-dose apixaban ( 20 mg ) administered alone and with activated charcoal given at 2 or 6 h post-dose to healthy subjects .


Blood samples for assay of plasma apixaban concentration were collected up to 72 h post-dose .


Pharmacokinetic parameters , including peak plasma concentration ( Cmax ) , time to Cmax ( Tmax ) , area under the concentration-time curve from time 0 to infinity ( AUCINF ) , and terminal half-life ( T ) , were derived from apixaban plasma concentration-time data .


A general linear mixed-effect model analysis of Cmax and AUCINF was performed to estimate the effect of activated charcoal on apixaban exposure .


A total of 18 subjects were treated and completed the study .


AUCINF for apixaban without activated charcoal decreased by 50 and 28 % , respectively , when charcoal was administered at 2 and 6 h post-dose .


Apixaban Cmax and Tmax were similar across treatments .


The mean T for apixaban alone ( 13.4 h ) decreased to ~ 5 h when activated charcoal was administered at 2 or 6 h post-dose .


Overall , apixaban was well tolerated in this healthy population , and most adverse events were consistent with the known profile of activated charcoal .


Administration of activated charcoal up to 6 h after apixaban reduced apixaban exposure and facilitated the elimination of apixaban .


These results suggest that activated charcoal may be useful in the management of apixaban overdose or accidental ingestion .


The purpose of this study was to assess the efficacy and safety of FOLFOX4 , comprising infusional 5-fluorouracil ( 5-FU ) / leucovorin ( LV ) and oxaliplatin , with cetuximab compared with UFOX , comprising UFT , an oral prodrug of 5-FU , LV , and oxaliplatin , with cetuximab as first-line treatment for mCRC .


Patients , unselected by tumor KRAS status , were randomized 1:1 to FOLFOX4 with cetuximab or UFOX with cetuximab .


Treatment was continued until disease progression or unacceptable toxicity .


The primary end point , assessed in the intention-to-treat population , was progression-free survival ( PFS ) .


Secondary end points included tumor response , overall survival , and safety .


Outcome according to KRAS mutation status was investigated .


Recruitment was curtailed at 302 patients after reporting of the importance of tumor KRAS mutation status for cetuximab activity .


Baseline characteristics were balanced between treatment groups .


PFS was significantly longer in the FOLFOX4 with cetuximab group compared with UFOX with cetuximab group ( median 8.2 vs. 6.6 months ; hazard ratio , 0.68 ; 95 % confidence interval [ CI ] , 0.52-0 .89 ; P = .0048 ) .


The response rate was also significantly greater in the FOLFOX4 with cetuximab group ( 51.3 % vs. 37.5 % , respectively ; odds ratio , 1.76 ; 95 % CI , 1.11-2 .78 ; P = .0160 ) , although overall survival was comparable .


In the KRAS wild type subgroup , efficacy outcomes were similar to those in the intention-to-treat population .


Side effect profiles were manageable and consistent with expectations .


In the first-line treatment of mCRC , UFOX with cetuximab had an acceptable safety profile but inferior activity compared with FOLFOX4 with cetuximab in relation to PFS and response .


The regimens were comparable with regard to overall survival .


To observe the effect of Xingnaojing Injection combined with minimally invasive percutaneous drainage on brain edema and content of serum aquaporin-4 ( AQP4 ) in patients with moderate hypertensive basal ganglia hemorrhage , and discuss the treatment mechanism of Xingnaojing injection combined with minimally invasive percutaneous drainage for cerebral hemorrhage .


Forty-two patients with moderate ( 25-50 mL ) hypertensive basal ganglia hemorrhage ( < 24 h ) were selected and randomly divided into two groups : the observation group ( n = 22 ) and the control group ( n = 20 ) .


The neurological severity score were evaluated by the NIHSS ( national institutes of health stroke scale ) , the volume of brain edemas were measured by head CT , the serum levels of AQP4 were determined by ELISA method on admission and 1 and 2 weeks after treatment .


On admission , there was no significant difference in the scores of NIHSS , the volume of brain edemas and the level of serum AQP4 between the observation group and the control group .


At the end of the first week after the treatment , the score of NIHSS of the observation group were lower than that of the control group , with significant different ( P < 0.05 ) ; the observation group showed reduced volume of brain edemas than that on admission ( P < 0.05 ) , whereas the control group the control group showed increased volume of brain edemas than that on admission ; the control group displayed increased level of serum AQP4 than that on admission , but without significant difference ; the observation group displayed decreased level of serum AQP4 than that on admission ( P < 0.05 ) .


At the end of the second week after the treatment , the control group showed decreased score of NIHSS than that on admission and at the end of the first week after treatment ( P < 0.05 ) .


Compared with the control group , the observation group showed a much lower score of NIHSS ( P < 0.01 ) , the control group displayed reduced volume of brain edemas than that on admission and at the end of the first week after treatment , but the observation group was even lower than the control group .


Both of observation and control groups displayed significantly reduced level of AQP4 ( P < 0.05 ) , but the observation group showed a lower AQP4 level than that of the control group ( P < 0.05 ) .


The therapy of Xingnaojing injection combined with minimally invasive percutaneous drainage could remarkably reduce brain edema , and promote neural functional recovery , thus could be selected as a therapeutic regimen for patients with moderate hypertensive basal ganglia hemorrhage .


To compare the efficacy between acupuncture and ondansetron in the prevention of delayed chemotherapy induced nausea and vomiting ( CINV ) .


70 patients were randomized to receive either 1 ) acupuncture at P6 point before chemotherapy infusion or 2 ) ondansetron 8 mg intravenously 30 min before chemotherapy infusion in their first cycle with cross-over of antiemetic regimen in the consecutive cycle .


All patients received dexamethasone 5mg orally twice a day for 3 days .


Patients were given additional does of ondansetron 4 mg orally every 12h if they experienced emesis .


Emetic episode , severity of nausea score of 0-10 and adverse events were recorded .


Complete response was defined as no nausea , no vomiting and no requirement of additional antiemetic drugs .


FACT-G scale was used to evaluate quality of life ( QOL ) 7 days after each cycle of chemotherapy .


The acupuncture group had a significantly higher rate of complete response in the prevention of delayed CINV ( 52.8 % and 35.7 % , P = 0.02 ) .


Compared to another group , the acupuncture group reported significantly lower delayed nausea ( 45.7 % and 65.7 % , P = 0.004 ) , nausea score ( P < 0.001 ) and fewer dosages of additional oral ondansetron ( P = 0.002 ) .


Adverse effects were also significantly lower in the acupuncture group with less frequent constipation ( P = 0.02 ) and insomnia ( P = 0.01 ) .


Overall FACT-G scores were significantly higher in the acupuncture group .


Acupuncture is effective in preventing delayed CINV and in promoting better QOL .


With fewer adverse effects , it may be used as an alternative treatment option for CINV .


The aim of this study was to assess associations between patient characteristics , intensification of blood glucose-lowering treatment through oral glucose-lowering therapy and/or insulin and effective glycaemic control in type 2 diabetes .


11140 patients from the Action in Diabetes and Vascular disease : preterAx and diamicroN-MR Controlled Evaluation ( ADVANCE ) trial who were randomized to intensive glucose control or standard glucose control and followed up for a median of 5years were categorized into two groups : effective glycaemic control [ haemoglobin A1c ( HbA1c ) 7.0 % or a proportionate reduction in HbA1c over 10 % ] or ineffective glycaemic control ( HbA1c > 7.0 % and a proportionate reduction in HbA1c less than or equal to 10 % ) .


Therapeutic intensification was defined as addition of an oral glucose-lowering agent or commencement of insulin .


Pooled logistic regression models examined the associations between patient factors , intensification and effective glycaemic control .


A total of 7768 patients ( 69.7 % ) , including 3198 in the standard treatment group achieved effective glycaemic control .


Compared to patients with ineffective control , patients with effective glycaemic control had shorter duration of diabetes and lower HbA1c at baseline and at the time of treatment intensification .


Treatment intensification with addition of an oral agent or commencement of insulin was associated with a 107 % [ odds ratio , OR : 2.07 ( 95 % confidence interval , CI : 1.95-2 .20 ) ] and 152 % [ OR : 2.52 ( 95 % CI : 2.30-2 .77 ) ] greater chance of achieving effective glycaemic control , respectively .


These associations were robust after adjustment for several baseline characteristics and not modified by the number of oral medications taken at the time of treatment intensification .


Effective glycaemic control was associated with treatment intensification at lower HbA1c levels at all stages of the disease course and in both arms of the ADVANCE trial .


Panitumumab , a fully human anti-epidermal growth factor receptor monoclonal antibody ( mAb ) , has demonstrated efficacy in patients with wild-type KRAS metastatic colorectal cancer ( mCRC ) .


Rilotumumab and ganitumab are investigational , fully human mAbs against hepatocyte growth factor ( HGF ) / scatter factor and IGF1R , respectively .


Here we evaluate combining rilotumumab or ganitumab with panitumumab in previously treated patients with wild-type KRAS mCRC .


Part 1 was a phase Ib dose-finding study of panitumumab plus rilotumumab .


The primary endpoint was the incidence of dose-limiting toxicities ( DLT ) .


Part 2 was a randomized phase II trial of panitumumab in combination with rilotumumab , ganitumab , or placebo .


The primary endpoint was objective response rate ( ORR ) ; safety , progression-free survival ( PFS ) , and overall survival ( OS ) were secondary endpoints .


Archival tissue specimens were collected for exploratory correlative work .


In part 1 , no DLTs were reported .


A recommended phase II dose of 10 mg/kg rilotumumab was selected .


In part 2 , for the panitumumab plus rilotumumab ( n = 48 ) , panitumumab plus ganitumab ( n = 46 ) , and panitumumab plus placebo arms ( n = 48 ) , the ORRs were 31 % , 22 % , and 21 % , respectively .


The median PFS was 5.2 , 5.3 , and 3.7 months and median OS 13.8 , 10.6 , and 11.6 months , respectively .


Adverse events were tolerable .


Exploratory biomarker analyses , including MET and IGF-related protein expression , failed to indicate conclusive predictive evidence on efficacy endpoints .


Panitumumab plus rilotumumab met the prespecified criterion for improvement in ORR whereas ganitumab did not .


This is the first study to suggest a benefit for combining an HGF inhibitor ( rilotumumab ) with panitumumab in previously treated patients with wild-type KRAS mCRC .


To evaluate femtosecond laser-assisted and manual clear corneal incisions and their effect on surgically induced astigmatism ( SIA ) and corneal higher-order aberrations ( HOAs ) .


In a prospective randomized study , conventional phacoemulsification with a 2.8-mm clear corneal incision using a disposable keratome was performed in 20 eyes of 20 patients ( manual group ) , and femtosecond laser-assisted cataract surgery with a 2.8-mm biplanar clear corneal tunnel created by a femtosecond laser ( LenSx ; Alcon Laboratories , Inc. , Aliso Viejo , CA ) was performed in 20 eyes of 20 patients ( femtosecond laser group ) .


Corneal topography readings and corneal wavefront aberrations ( diameter : 9.0 mm ) were obtained using a Scheimpflug camera ( Pentacam HR ; Oculus Optikgerate , Wetzlar , Germany ) preoperatively and 3 months postoperatively .


There was no significant difference in SIA between the groups ( femtosecond laser group : 0.47 0.13 vs manual group : 0.41 0.14 ; P = .218 ) , but the axis deviation of the SIA axis from the previously planned axis was significantly smaller in the femtosecond laser group compared to the manual group ( 4.47 2.59 vs 7.38 4.72 , respectively ; P = .048 ) .


Corneal HOAs increased significantly in both groups ( femtosecond laser group : 0.13 0.09 to 0.18 0.12 , P = .025 ; manual group : 0.13 0.05 to 0.15 0.05 , P = .002 ) , but preoperative and postoperative values did not differ significantly between them ( P = .472 and .078 , respectively ) .


Lower-order and total corneal aberration values remained stable in both groups ( P > .05 ) .


There was no difference in SIA and induced HOAs between manual and femtosecond laser-created clear corneal incisions .


Opioid-induced hyperalgesia is well known complication of acute high dose and chronic opioid therapy .


In this study , we evaluated development of opioid-induced hyperalgesia following intraoperative short-term use of - opioid agonist fentanyl after coronary artery bypass surgery .


100 patients undergoing elective coronary artery bypass graft surgery is divided into two groups .


In group I ( low dose ) , anesthesia was induced with propofol 1-2 .5 mg/kg and fentanyl 2 mcg/kg , in group II ( high dose ) fentanyl 40-70 mcg/kg was used .


In group I , propofol 5-10 mg/kg/h , fentanyl 1-3 mcg/kg/h , in group II fentanyl 5-10 mcg/kg/h was used for maintenance of anesthesia .


The tactile and thermal thresholds were measured before surgery and in 1st , 3rd and 7th postoperative days by using Von Frey filaments and a thermal source , respectively .


Tactile thresholds were significantly decreased at the first ( 6,080.21 and 3.760.13 g ; p < 0.001 ) and third ( 6.760.24 and 4.960.16 g ; p < 0.001 ) postoperative days compared to baseline preoperative values ( 7.720.26 , and 7.600.21 g ; p = 816 ) in two groups .


Postoperative 1st ( 13.450.33 and 10.050.24 sec ; p < 0.001 ) and 3rd day ( 14.770.28 and 13.170.26 sec ; p < 0.001 ) assessments showed a statistically significant thermal hyperalgesia compared to the preoperative baseline values ( 16.670.51 and 16.450.42 sec ; p = 0.997 ) in two groups .


This decrease in both tactile and thermal thresholds returned to baseline control values at the 7th day of measurement .


Our results showed that patients undergoing coronary artery bypass surgery receiving fentanyl anesthesia developed postoperative tactile allodynia and thermal hyperalgesia and this was more prominent in high dose group .


Rates of preventive asthma care after an asthma emergency department ( ED ) visit are low among inner-city children .


The objective of this study was to test the efficacy of a clinician and caregiver feedback intervention ( INT ) on improving preventive asthma care following an asthma ED visit compared to an attention control group ( CON ) .


Children with persistent asthma and recent asthma ED visits ( N = 300 ) were enrolled and randomized into a feedback intervention or an attention control group and followed for 12 months .


All children received nurse visits .


Data were obtained from interviews , child salivary cotinine levels and pharmacy records .


Standard t-test , chi-square and multiple logistic regression tests were used to test for differences between the groups for reporting greater than or equal to two primary care provider ( PCP ) preventive care visits for asthma over 12 months .


Children were primarily male , young ( 3-5 years ) , African American and Medicaid insured .


Mean ED visits over 12 months was high ( 2.29 visits ) .


No difference by group was noted for attending two or more PCP visits/12 months or having an asthma action plan ( AAP ) .


Children having an AAP at baseline were almost twice as likely to attend two or more PCP visits over 12 months while controlling for asthma control , group status , child age and number of asthma ED visits .


A clinician and caregiver feedback intervention was unsuccessful in increasing asthma preventive care compared to an attention control group .


Further research is needed to develop interventions to effectively prevent morbidity in high risk inner-city children with frequent ED utilization .


The New Forest Parenting Programme ( NFPP ) is a home-delivered , evidence-based parenting programme to target symptoms of attention-deficit/hyperactivity disorder ( ADHD ) in preschool children .


It has been adapted for use with ` hard-to-reach ' or ` difficult-to-treat ' children .


This trial will compare the adapted-NFPP with a generic parenting group-based programme , Incredible Years ( IY ) , which has been recommended for children with preschool-type ADHD symptoms .


This multicentre randomized controlled trial comprises three arms : adapted-NFPP , IY and treatment as usual ( TAU ) .


A sample of 329 parents of preschool-aged children with a research diagnosis of ADHD enriched for hard-to-reach and potentially treatment-resistant children will be allocated to the arms in the ratio 3:3:1 .


Participants in the adapted-NFPP and IY arms receive an induction visit followed by 12 weekly parenting sessions of 1hours ( adapted-NFPP ) or 2hours ( IY ) over 2.5 years .


Adapted-NFPP will be delivered as a one-to-one home-based intervention ; IY , as a group-based intervention .


TAU participants are offered a parenting programme at the end of the study .


The primary objective is to test whether the adapted-NFPP produces beneficial effects in terms of core ADHD symptoms .


Secondary objectives include examination of the treatment impact on secondary outcomes , a study of cost-effectiveness and examination of the mediating role of treatment-induced changes in parenting behaviour and neuropsychological function .


The primary outcome is change in ADHD symptoms , as measured by the parent-completed version of the SNAP-IV questionnaire , adjusted for pretreatment SNAP-IV score .


Secondary outcome measures are : a validated index of behaviour during child 's solo play ; teacher-reported SNAP-IV ( ADHD scale ) ; teacher and parent SNAP-IV ( ODD ) Scale ; Eyberg Child Behaviour Inventory - Oppositional Defiant Disorder scale ; Revised Client Service Receipt Inventory - Health Economics Costs measure and EuroQol ( EQ5D ) health-related quality-of-life measure .


Follow-up measures will be collected 6months after treatment for participants allocated to adapted-NFPP and IY .


This trial will provide evidence as to whether the adapted-NFPP is more effective and cost-effective than the recommended treatment and TAU .


It will also provide information about mediating factors ( improved parenting and neuropsychological function ) and moderating factors ( parent and child genetic factors ) in any increased benefit .


Current Controlled Trials , ISRCTN39288126 .


Approximately 30 % of all bone injuries are foot metatarsal fractures .


Metatarsal V basis fractures occur most frequently .


The classification is done into the tuberosity avulsion fractures , Jones fractures and stress fractures of the proximal diaphysis .


The treatments of non-displaced fractures are generally conservative .


The indication for surgical treatment depends on the load and the associated refracture rate .


There are different types of treatment of these fractures .


We present a possible approach to conservative treatments and show how different therapies affect healing of metatarsal V basis fractures and social reintegration of patients .


A retrospective study consisted of 68 patients analysed during a 9-year period , whereas for a prospective analysis 18 patients were included for a period of 3 years .


The treatment was performed using either a splint , closed bandage of theankle or special Gttinger Anklesplint bandage , with immediate pain-oriented full load in all groups .


The subjective and objective treatment results were analysed accoding the Gttinger Phillips score .


In retrospect , the fracture consolidation was observed after 8.1 weeks full load-bearing was achieved after 6.3 weeks on average .


In the prospective analysis , the osseous consolidation occurred after 6.2 weeks , and the full load was applied after 1.7 weeks .


After 10 weeks the treatment with the Anklesplint bandage was assessed with 105 points of a maximum 110 points of the Phillips score .


The Anklesplint bandage was also the cheapest option in the cost comparison .


Using the immobilisation of the metatarsal supination with the Anklesplint bandage the metatarsal V basis fractures can heal in a regular way .


The functional outcome is better in comparison to the that with other treatments and it is a cost-effective treatment .


Epidural administration of dexamethasone might reduce postoperative pain in adults .


We evaluated whether a caudal block of 0.1 mg kg ( -1 ) dexamethasone combined with ropivacaine improves analgesic efficacy in children undergoing day-case orchiopexy .


This randomized , double-blind study included 80 children aged 6 months to 5 yr who underwent day-case , unilateral orchiopexy .


Patients received either 1.5 ml kg ( -1 ) of 0.15 % ropivacaine ( Group C ) or 1.5 ml kg ( -1 ) of 0.15 % ropivacaine in which dexamethasone of 0.1 mg kg ( -1 ) was mixed ( Group D ) for caudal analgesia .


Postoperative pain scores , rescue analgesic consumption , and side-effects were evaluated 48 h after operation .


Postoperative pain scores at 6 and 24 h post-surgery were significantly lower in Group D than in Group C. Furthermore , the number of subjects who remained pain free up to 48 h after operation was significantly greater in Group D [ 19 of 38 ( 50 % ) ] than in Group C [ four of 37 ( 10.8 % ) ; P < 0.001 ] .


The number of subjects who received oral analgesic was significantly lower in Group D [ 11 of 38 ( 28.9 % ) ] than in Group C [ 20 of 37 ( 54.1 % ) ; P = 0.027 ] .


Time to first oral analgesic administration after surgery was also significantly longer in Group D than in Group C ( P = 0.014 ) .


Adverse events after surgery including vomiting , fever , wound infection , and wound dehiscence were comparable between the two groups .


The addition of dexamethasone 0.1 mg kg ( -1 ) to ropivacaine for caudal block can significantly improve analgesic efficacy in children undergoing orchiopexy .


Clinical trial registration NCT01604915 .


Gastrointestinal ( GI ) discomfort , e.g. bloating or rumbling , is a common symptom in otherwise healthy adults .


Approximately 20 % of the population , particularly women suffer from gastrointestinal discomfort and this affects quality of life .


Recent studies discovered a link between the body and mind , called the gut-brain axis .


Psychosocial factors , such as e.g. daily stress may cause altered gut physiology leading to ileum contractions and consequently gastrointestinal symptoms .


In vitro and ex vivo studies clearly showed that a Perilla frutescens extract combines prokinetic , antispasmodic and anti-inflammatory effects .


The aim of the intervention was to investigate the effects of the proprietary Perilla extract on GI discomfort in healthy subjects with gastrointestinal discomfort and reduced bowel movements in comparison to a placebo product .


The pilot study was performed according to a double-blind , randomized , placebo-controlled parallel design .


Fifty healthy subjects with gastrointestinal discomfort and reduced bowel movements , 30-70 years , documented their GI symptoms , stool frequency and consistency daily during a 2-week run-in phase and a 4-week intervention phase with Perilla frutescens extract or placebo .


GI symptoms were assessed on a 5-point scale daily and average scores over 14 days intervals were calculated .


All GI symptoms were significantly improved over time by Perilla frutescens extract during the intervention phase ( bloating : -0.440.56 , p = 0.0003 ; passage of gas : -0.300.66 , p = 0.0264 ; GI rumbling : -0.550.87 , p = 0.0014 ; feeling of fullness : -0.360.72 , p = 0.0152 ; abdominal discomfort : -0.540.75 , p = 0.004 ) , whereas in the placebo group only abdominal discomfort was significantly improved ( -0.310.55 , p = 0.0345 ) .


In the subgroup of women results were strengthened and a subscore out of bloating and abdominal discomfort was significantly improved against placebo ( 95 % CI 0.003 to 0.77 ; p = 0.048 ) .


The demonstrated effects of Perilla frutescens extract to improve GI complaints offer very promising results , taking into consideration the challenging set up of a nutritional human study with healthy subjects and in the area of digestive health , which is known for high placebo effects .


NCT01931930 at ClinicalTrials.gov , Registration date 23rd August 2013 .


Atherosclerosis is a postprandial phenomenon .


The balanced n-6 / n-3 PUFA ratio contributing to the prevention of atherosclerosis has been well shown , but the effect of the ratio on postprandial metabolism has not been fully investigated .


The aim of this study was to investigate the effects of the n-6 / n-3 PUFAs ratio on postprandial metabolism in hypertriacylglycerolemia patients , comparing them to healthy controls .


Test meals with 0.97 ( high n-3 ) and 8.80 ( low n-3 ) n-6 / n-3 PUFAs ratio were administered in a randomized crossover design to 8 healthy and 8 hypertriacylglycerolemia subjects .


Blood samples were collected for 8 hours after meals to measure triglyceride ( TG ) , total cholesterol ( TC ) , HDL , ApoA , ApoB , glucose , insulin , inflammatory makers including tumor necrosis factor alpha ( TNF - ) and interleukin-6 ( IL-6 ) , endothelial function including nitric oxide ( NO ) and endothelin-1 ( ET-1 ) .


According to repeated-measures ANOVA , the postprandial response of lipid , glucose , insulin , inflammation and endothelial function were not significantly different between meals .


The postprandial TG and NO response were significantly different between healthy control ( HC ) and hypertriglyceridemia group ( HTG ) after both meals ( P < 0.01 ) .


After both meals maximal change and iAUC for TG was all higher in HTG group than HC group , the difference was significant after low n-3 meal but not after high n-3 meal .


The concentration of glucose , insulin , IL-6 , TNF and ET-1 at each time point was higher and NO was lower in HTG group , but the maximal change and iAUC had no significant difference except for iAUC of insulin , IL-6 and diAUC of NO after low n-3 meal .


The ratio of n-6 and n-3 maybe do not acutely influence the postprandial metabolism , inflammatory response and endothelial function , but the low n-3 meal can strengthen the difference between HTG and HC group .


Severe asthma is a major public health issue throughout the world .


Increased bronchial smooth muscle ( BSM ) mass , a characteristic feature of airway remodeling in severe asthma , is associated with resistance to high-intensity treatment and poor prognosis .


In vitro , the Ca ( 2 + ) - channel blocker gallopamil decreased the proliferation of BSM cells from patients with severe asthma .


We conducted a double-blind , randomized , placebo-controlled study to evaluate the effect of gallopamil on airway remodeling in patients with severe asthma .


Subjects received either gallopamil ( n = 16 ) or placebo ( n = 15 ) for 1 year and were monitored for an additional 3-month period .


Airway remodeling was analyzed at baseline and after treatment phase using both fiberoptic bronchoscopy and computed tomography scan .


The primary end point was the BSM area .


Secondary end points included normalized BSM thickness and frequency of asthma exacerbations .


BSM area was reduced in the gallopamil group ( baseline vs. end of treatment ) but was unchanged in the placebo group .


Between-group differences in BSM area were not significantly different in gallopamil versus placebo groups .


By contrast , between-group differences in normalized BSM thickness were significantly different between the two groups .


The mean number of exacerbations per month was not different during the treatment phase in gallopamil versus placebo group but was significantly lower in patients previously treated with gallopamil during the follow-up period .


There were no differences between the groups with respect to overall side effects .


Gallopamil treatment for 12 months reduces BSM remodeling and prevents the occurrence of asthma exacerbations .


Clinical trial registered with www.clinicaltrials.gov ( NCT 00896428 ) .


Previous studies have demonstrated variable patterns of longitudinal septal deformation in patients with left ventricular ( LV ) dysfunction and left bundle branch block .


This prospective single center study was designed to assess the relationship between septal deformation patterns obtained by two-dimensional speckle-tracking echocardiography and response to cardiac resynchronization therapy ( CRT ) .


One hundred one patients with New York Heart Association class II to IV heart failure , LV ejection fractions 35 % , and left bundle branch block underwent echocardiography before CRT .


Longitudinal two-dimensional speckle-tracking strain analysis in the apical four-chamber view identified three patterns : double-peaked systolic shortening ( pattern 1 ) , early pre-ejection shortening peak followed by prominent systolic stretch ( pattern 2 ) , and pseudonormal shortening with a late systolic shortening peak and less pronounced end-systolic stretch ( pattern 3 ) .


CRT response was defined as a relative reduction in LV end-systolic volume of 15 % at 9-month follow-up .


CRT super-response was defined as an absolute LV ejection fraction of 50 % associated with a relative reduction in LV end-systolic volume of 15 % and an improvement in New York Heart Association functional class .


Cardiac death or hospitalization for heart failure during follow-up was systematically investigated .


Ninety-two percent of patients with pattern 1 or 2 were responders to CRT compared with 59 % with pattern 3 ( P < .0001 ) .


Thirty-six percent of patients with pattern 1 were super-responders compared with 15 % of those with pattern 2 and 12 % of those with pattern 3 ( P = .037 ) .


The improvement in LV volumes , LV ejection fraction , and global longitudinal strain after CRT was better in patients with pattern 1 or 2 compared with those with pattern 3 ( P < .0001 for all ) .


Eighteen-month outcomes were excellent in patients with pattern 1 or 2 , with event-free survival of 95 3 % compared with 75 7 % in patients with pattern 3 ( P = .010 ) .


Septal deformation strain pattern 1 or 2 is highly predictive of CRT response .


Further studies are needed to identify predictors of `` nonresponse '' in patients with a pattern 3 .


The purpose of this study was to determine the plaque-reducing effectiveness of two new powered toothbrushes and compare them to a manual toothbrush control .


This examiner-blind , randomized study used a crossover design .


Sixty-five qualifying male and female subjects were randomly assigned one of the two test powered brushes ( Spinbrush Truly Radiant Deep Clean [ TRDC ] or Spinbrush Truly Radiant Extra Whitening [ TREW ] , Church & Dwight Co. , Inc. , Princeton , NJ , USA ) or an ADA standard manual toothbrush ( MT ; American Dental Association , Chicago , IL , USA ) according to one of three computer-generated sequences .


Following instruction in the use of their assigned toothbrush , subjects brushed at home with a standard fluoride toothpaste twice daily for two minutes during a one-week familiarization period .


At the end of this period , the subjects returned to the study site after refraining from oral hygiene for 12-16 hours , and from eating , drinking , and smoking for four hours .


Plaque was scored using the Rustogi Modification of the Navy Plaque Index .


Subjects brushed under supervision with their assigned toothbrush for two minutes , and plaque was rescored .


They were then given one of the alternate toothbrushes according to their assigned sequence , and the familiarization routine and evaluation processes were repeated until each of the subjects used each of the three brushes .


Within-group analyses showed that all three toothbrushes produced statistically significant reductions from the pre-brushing baseline in whole mouth and regional plaque scores ( p < 0.001 ) , with respective whole mouth reductions of 17.9 % , 42.3 % , and 38.1 % for MT , TRDC , and TREW .


Between-group analyses showed that TRDC and TREW were each significantly more effective ( p < 0.001 ) than MT , as each showed at least twice as much of a reduction in whole mouth scores .


Both of the powered brushes also produced statistically significantly greater reductions than the manual brush at each of the twelve subsets of sites examined , with the greatest differences at interpoximal sites and sites presenting access difficulty , such as those in the lingual posterior region .


Additionally , TRDC produced a statistically significant 11.5 % greater reduction than TREW ( p = 0.001 ) in whole mouth plaque scores , and statistically significantly greater reductions in two of the subsets evaluated .


Both of the powered brushes tested proved to be safe and significantly more effective than the standard manual control brush in reducing plaque .


While the finding that the TRDC was significantly more effective than the TREW in reducing whole mouth plaque and plaque in two subsets demonstrates that small differences in toothbrush design may impact performance , longer-term studies would be needed to assess the extent to which this translates to meaningful clinical outcomes .


This study 's aims were to detect and quantify bacterial DNA in the urine of randomized trial participants about to undergo treatment for urinary urgency incontinence ( UUI ) without clinical evidence of urinary tract infection ( UTI ) and to determine if the presence of bacterial DNA in baseline urine relates to either baseline urinary symptoms or UTI risk after urinary tract instrumentation .


Women without clinical evidence of baseline UTI were randomized to cystoscopic onabotulinum toxin A injection and oral placebo medication versus cystoscopic placebo injection and active oral medication .


Bacterial DNA in participants ' catheterized urine was measured by quantitative polymerase chain reaction ( qPCR ) .


Bacterial DNA was detected in the urine of 38.7 % of participants ( 60 out of 155 ) .


In these 60 qPCR-positive participants , baseline daily UUI episodes were greater than in the 95 qPCR-negative participants ( 5.71 [ 2.60 ] vs 4.72 [ 2.86 ] , p = 0.004 ) .


Neither symptom severity by questionnaire nor treatment outcome was associated with qPCR status or with qPCR level in qPCR-positive subjects .


In contrast , the presence of urinary bacterial DNA was associated with UTI risk : only 10 % of the qPCR-positive women developed a UTI post-treatment , while 24 % of the qPCR-negative women did so .


The median qPCR level for qPCR-positive samples did not differ significantly by UTI status ( UTI 2.5810 ( 5 ) vs no UTI 1.3510 ( 5 ) copies/mL , p = 0.6 ) .


These results may indicate a urinary bacterial contribution to both baseline UUI and the risk of post-treatment UTI .


The increased intraocular pressure ( IOP ) - which decreases perfusion pressure on the optic nerve - increases by prone positioning ( 1 ) .


The aim of our study was to compare the effect of head rotation 45 laterally in prone position on the increase in IOP of upper placed and lower placed eyes in patients undergoing percutaneous nephrolithotomy ( PCNL ) .


Forty-five patients were randomly divided into 2 Groups .


IOP of the patients were recorded bilaterally in supine position before the operation had started .


Patients were turned to prone position .


The head was placed on a prone headrest without external direct compression to both eyes .


Patients in Group I were kept in strictly neutral prone position where as patients in Group II were placed prone with their heads rotated 45 laterally to the right side .


At the end of the operation , patients were turned to supine position and their IOP was measured immediately .


There was no difference related to demographics , duration of surgery , blood loss and fluid input data .


IOP values after surgery in prone position increased significantly compared to preoperative values in both groups ( p < 0.05 ) .


After surgery in prone position IOP values of the upper positioned eyes in Group II were significantly lower than Group I and lower positioned eyes in Group II ( p < 0.05 ) .


prone positioning increases IOP .


In patients with prone position with a head rotation of 45 laterally , IOP in the upper positioned eye was significantly lower .


It is estimated that about 275,000 inhabitants experience an out-of-hospital cardiac arrest ( OHCA ) every year in Europe .


Survival in out-of-hospital cardiac arrest is relatively low , generally between five per cent and 10 % .


Being able to explore new methods to improve the relatively low survival rate is vital for people with these conditions .


Passive leg raise ( PLR ) during cardiopulmonary resuscitation ( CPR ) has been found to improve cardiac preload and blood flow during chest compressions .


The aim of our study is to evaluate whether early PLR during CPR also has an impact on one-month survival in sudden and unexpected out-of-hospital cardiac arrest ( OHCA ) .


A prospective , randomized , controlled trial in which all patients ( 18years ) receiving out-of hospital CPR are randomized by envelope to be treated with either PLR or in the flat position .


The ambulance crew use a special folding stool which allows the legs to be elevated about 20 degrees .


Primary end-point : survival to one month .


Secondary end-point : survival to hospital admission to one month and to one year with acceptable cerebral performance classification ( CPC ) 1-2 .


PLR is a simple and fast maneuver .


We believe that the greatest benefit with PLR is when performed early in the process , during the first minutes of CPR and before the first defibrillation .


To reach power this study need 3000 patients , we hope that this method article will encourage other sites to contact us and take part in our study .


ClinicalTrials.gov NCT01952197 .


To investigate the possibility of influencing adolescents ' caries incidence , knowledge and attitudes to oral health and tobacco through a school-based oral health intervention programme .


Four schools in a county in Sweden were randomised to one intervention and one control group .


At the intervention schools , two dental hygienists worked 4 h every week for two years .


Health education and preventive measures , such as fluoride varnish treatments every 6 months , were performed .


The control group had no intervention .


The study included a total of 534 participants aged 12-16 years .


Outcome variables of the study were 1 ) caries incidence assessed on bite-wing radiographs and 2 ) knowledge and attitudes measured through questionnaires .


The intervention programme impacted on the incidence of enamel caries , while no effect on dentin caries could be seen .


Data from the questionnaires showed that the adolescents considered their teeth as important .


Adolescents in the intervention group had better knowledge about oral health and oral hygiene compared to the control group after the two years , but no impact on attitudes toward tobacco could be seen .


A majority of the adolescents were positive to the education about oral health and tobacco and they believed that the dental hygienists would help them improve their oral health .


Although the effects of the intervention as regards to caries incidence , knowledge and attitudes were limited , the presence of dental hygienists in school was appreciated by the adolescents and seemed to increase their interest in their oral health .


Traumatic brain injury ( TBI ) is a major cause of death and disability worldwide .


Progesterone has been shown to improve neurologic outcome in multiple experimental models and two early-phase trials involving patients with TBI .


We conducted a double-blind , multicenter clinical trial in which patients with severe , moderate-to-severe , or moderate acute TBI ( Glasgow Coma Scale score of 4 to 12 , on a scale from 3 to 15 , with lower scores indicating a lower level of consciousness ) were randomly assigned to intravenous progesterone or placebo , with the study treatment initiated within 4 hours after injury and administered for a total of 96 hours .


Efficacy was defined as an increase of 10 percentage points in the proportion of patients with a favorable outcome , as determined with the use of the stratified dichotomy of the Extended Glasgow Outcome Scale score at 6 months after injury .


Secondary outcomes included mortality and the Disability Rating Scale score .


A total of 882 of the planned sample of 1140 patients underwent randomization before the trial was stopped for futility with respect to the primary outcome .


The study groups were similar with regard to baseline characteristics ; the median age of the patients was 35 years , 73.7 % were men , 15.2 % were black , and the mean Injury Severity Score was 24.4 ( on a scale from 0 to 75 , with higher scores indicating greater severity ) .


The most frequent mechanism of injury was a motor vehicle accident .


There was no significant difference between the progesterone group and the placebo group in the proportion of patients with a favorable outcome ( relative benefit of progesterone , 0.95 ; 95 % confidence interval [ CI ] , 0.85 to 1.06 ; P = 0.35 ) .


Phlebitis or thrombophlebitis was more frequent in the progesterone group than in the placebo group ( relative risk , 3.03 ; CI , 1.96 to 4.66 ) .


There were no significant differences in the other prespecified safety outcomes .


This clinical trial did not show a benefit of progesterone over placebo in the improvement of outcomes in patients with acute TBI .


( Funded by the National Institute of Neurological Disorders and Stroke and others ; PROTECT III ClinicalTrials.gov number , NCT00822900 . )


Family members and caregivers play a significant supporting role in the rehabilitation process after stroke , a role that may increase with the growing trend of providing stroke rehabilitation in the individual 's own home after discharge from the hospital .


To explore the impact of family involvement in exercise delivery after stroke from the perspective of the individual with stroke and his or her family member .


A qualitative research design was used in which in-depth semi-structured interviews were carried out with participants who had taken part in an 8-week family-mediated exercise program ( FAME ) .


A phenomenological theoretical framework and a grounded theory methodology were used to inform the data analysis .


Fifteen individuals with acute stroke and 15 designated `` family '' members participated in the study after completion of an 8-week , individually tailored , family-mediated exercise intervention .


An overarching concept of patient-centeredness emerged after data analysis , which detailed the extent to which individuals with stroke and their families felt that their rehabilitation was enhanced by the active role of their families .


Four key themes that expanded the concept of patient-centeredness were identified : personalized nature of the reported benefits , therapeutic value of the program , family involvement , and caregiver commitment to program .


This research serves to increase our understanding of the role of family members in the rehabilitation process after stroke , particularly in relation to exercise delivery , from the perspective of the individuals with stroke and their family members .


Scaling and root planing ( SRP ) is the primary non-surgical treatment for periodontitis , but its effectiveness is limited .


Consequently , various adjunctive therapies have been investigated to improve clinical outcome .


This study evaluated the clinical effects of one SRP procedure alone or combined with local administration of hydrogen peroxide gel using customized trays for the treatment of subjects with chronic periodontitis over a period of six months .


An examiner-blind clinical trial was conducted among 30 subjects with moderate to advanced periodontitis who were randomized to SRP alone or SRP combined with prescription custom-tray application ( Perio Tray ) of 1.7 % hydrogen peroxide gel ( Perio Gel ) for a period of three months , then extended to six months .


Following impressions for the test group , all subjects brushed twice daily with a regular dentifrice and toothbrush for a four-week acclimation phase to standardize oral conditions ( while trays were fabricated ) prior to initiating the treatment phase .


SRP was performed three weeks after baseline , and clinical assessments , i.e. , pocket probing depth ( PPD ) and bleeding index ( BI ) , were conducted at baseline and after two , five , 13 , and 26 weeks of peroxide gel applications .


Clinical variables were compared by ANCOVA and paired t-tests after each treatment interval .


A total of 13 test and 15 control subjects completed the original three-month trial , of whom 10 test and 13 control subjects finished the three-month extension .


After two weeks of peroxide gel use prior to SRP , mean PPD for the test group significantly decreased from baseline by 0.21 mm and mean BI significantly dropped by 0.14 ; clinical parameters for the control group were unchanged .


Two weeks following SRP , mean PPD significantly decreased from baseline by 0.65 mm for the test group and 0.17 mm for the control ; mean BI significantly dropped by 0.17 for the test group and 0.05 for the control .


Ten weeks following SRP , mean PPD decreases were 0.77 mm for the test group and 0.13 mm for the control , and mean BI reductions were 0.14 for the test group and 0.00 for the control .


For subjects who completed the three-month extension ( i.e. , 23 weeks post-SRP ) , mean PPD decreases were 0.72 mm for the test group and 0.13 mm for the control , and mean BI reductions were 0.05 for the test group and 0.01 for the control .


Analysis of deeper pockets ( i.e. , > 5 mm at baseline ) showed the same relationship for PPD , but with larger differences between groups .


For example , after two weeks of peroxide gel use prior to SRP , mean PPD decreased by 0.48 mm for the test group compared to 0.04 mm for the control .


Two weeks after SRP , mean PPD decreased from baseline by 1.40 mm for the test group and 0.60 mm for the control , and 10 weeks after SRP by 1.57 mm for the test group and 0.58 mm for the control .


After the extension ( i.e. , 23 weeks post-SRP ) , mean PPD changed from baseline by 1.50 mm for the test group and 0.55 mm for the control .


With the exception of BI at 23 weeks post-SRP , all reductions cited above for the test group were statistically significantly different from the control group for both PPD and BI for all comparisons .


When compared with SRP alone , clinical improvements in PPD ( e.g. , -1.0 mm for pockets > 5 mm at baseline ) were maintained for up to six months after SRP with adjunctive use of 1.7 % hydrogen peroxide gel , locally administered using prescription customized trays in the treatment of subjects with moderate to advanced periodontitis .


To evaluate the association between low-dose aspirin initiated before conception and the risk of preterm birth .


This was a secondary analysis of the Effects of Aspirin in Gestation and Reproduction trial .


Women with a history of pregnancy loss ( original stratum : one loss less than 20 weeks of gestation during the previous year ; expanded stratum : one or two losses with no restrictions on timing or gestational age of the losses ) were randomized to either daily low-dose aspirin ( 81 mg , n = 615 ) and folic acid or folic acid alone ( placebo ; n = 613 ) .


Preterm birth was compared between groups using intent-to-treat analysis .


Preterm birth rates were 4.1 % ( 22/535 low-dose aspirin ) and 5.7 % ( 31/543 placebo ) ( relative risk [ RR ] 0.72 , 95 % confidence interval [ CI ] 0.42-1 .23 ) ; spontaneous preterm birth rates were 1.1 % ( 6/535 low-dose aspirin ) and 2.2 % ( 12/543 placebo ) ( RR 0.51 , 95 % CI 0.19-1 .34 ) ; medically indicated preterm birth rates were 2.6 % ( 14/535 low-dose aspirin ) and 2.9 % ( 16/543 placebo ) ( RR 0.89 , 95 % CI 0.44-1 .80 ) .


After restriction to confirmed pregnancies using inverse probability weighting , preterm birth rates were 5.7 % and 9.0 % ( RR 0.63 , 95 % CI 0.37-1 .09 ) and spontaneous preterm birth rates were 1.4 % and 3.2 % ( RR 0.44 , 95 % CI 0.17-1 .18 ) .


In confirmed pregnancies in the original stratum , preterm birth occurred in 3.8 % and 9.7 % of the low-dose aspirin and placebo groups , respectively ( RR 0.39 , 95 % CI 0.16-0 .94 ) .


Preconception low-dose aspirin was not significantly associated with the overall rate of preterm birth .


Although the study was underpowered for this secondary analysis , numeric trends in favor of benefit , particularly in the women with a recent , single early pregnancy loss , warrant further investigation .


ClinicalTrials.gov , www.clinicaltrials.gov , NCT00467363 .


Cardiovascular disease is the leading cause of death worldwide .


Higher oxidative stress may contribute to the pathogenesis of coronary artery disease ( CAD ) .


The purpose of this study was to investigate the effect of L-carnitine ( LC , 1000mg/d ) on the markers of oxidative stress and antioxidant enzymes activities in CAD patients .


We enrolled 47 CAD patients in the study .


The CAD patients were identified by cardiac catheterization as having at least 50 % stenosis of one major coronary artery .


The subjects were randomly assigned to the placebo ( n = 24 ) and LC ( n = 23 ) groups .


The intervention was administered for 12weeks .


The levels of serum LC , plasma malondialdehyde ( MDA ) , and erythrocyte antioxidant enzymes activities [ catalase ( CAT ) , superoxide dismutase ( SOD ) , glutathione peroxidase ( GPx ) ] were measured before and after intervention .


Thirty-nine subjects completed the study ( placebo , n = 19 ; LC , n = 20 ) .


After 12weeks of LC supplementation , the level of MDA was significantly reduced ( 2.00.3 to 1.80.3 mol/L , P = 0.02 ) and the level of LC ( 33.613.6 to 40.012.0 mol/L , P = 0.04 ) and antioxidant enzymes activities [ CAT ( 12.75.5 to 13.15.8 U/mg of protein , P = 0.02 ) , SOD ( 14.82.9 to 20.75.8 U/mg of protein , P < 0.01 ) , and GPx ( 20.33.4 to 23.03.1 U/mg of protein , P = 0.01 ) ] were significantly increased .


The level of LC was significantly positively correlated with the antioxidant enzymes activities ( CAT , = 0.87 , P = 0.02 ; SOD , = 0.72 , P < 0.01 ) .


LC supplementation at a dose of 1000mg/d was associated with a significant reduction in oxidative stress and an increase in antioxidant enzymes activities in CAD patients .


CAD patients might benefit from using LC supplements to increase their anti-oxidation capacity .


Clinical Trials.gov Identifier : NCT01819701 .


Patients with recurrent or metastatic squamous-cell carcinoma of the head and neck ( HNSCC ) progressing after first-line platinum regimens have a poor prognosis and few treatment options .


Afatinib , an irreversible ERBB family blocker , has shown efficacy in a phase 2 study in this setting .


We aimed to assess the efficacy and safety of afatinib compared with methotrexate as second-line treatment in patients with recurrent or metastatic HNSCC progressing on or after platinum-based therapy .


In this open-label , phase 3 , randomised controlled trial conducted in 101 centres in 19 countries , we enrolled patients aged 18 years or older with histologically or cytologically confirmed HNSCC that was recurrent , metastatic , or both who had progressed on or after first-line platinum-based therapy , were not amenable for salvage surgery or radiotherapy , and who had an Eastern Cooperative Oncology Group ( ECOG ) performance status of 0 or 1 .


Previous treatment with more than one systemic regimen in this setting was not allowed ; previous treatment with EGFR-targeted antibody therapy ( but not EGFR-targeted tyrosine-kinase inhibitors ) was allowed .


We randomly assigned eligible patients in a 2:1 ratio to receive oral afatinib ( 40 mg/day ) or intravenous methotrexate ( 40 mg/m ( 2 ) per week ) , stratified by ECOG performance status and previous EGFR-targeted antibody therapy for recurrent or metastatic disease .


Randomisation was done centrally with an interactive voice or web-based response system .


Clinicians and patients were not masked to treatment allocation ; independent review of tumour response was done in a blinded manner .


The primary endpoint was progression-free survival as assessed by an independent , central imaging review committee .


Efficacy analyses were done in the intention-to-treat population and safety analyses were done in patients who received at least one dose of study drug .


This ongoing study is registered with ClinicalTrials.gov , number NCT01345682 .


Between Jan 10 , 2012 , and Dec 12 , 2013 , we enrolled 483 patients and randomly assigned 322 to afatinib and 161 to methotrexate .


After a median follow-up of 67 months ( IQR 31-90 ) , progression-free survival was longer in the afatinib group than in the methotrexate group ( median 26 months [ 95 % CI 20-27 ] for the afatinib group vs 17 months [ 15-24 ] for the methotrexate group ; hazard ratio [ HR ] 080 [ 95 % CI 065-098 ] , p = 0030 ) .


The most frequent grade 3 or 4 drug-related adverse events were rash or acne ( 31 [ 10 % ] of 320 patients in the afatinib group vs none of 160 patients in the methotrexate group ) , diarrhoea ( 30 [ 9 % ] vs three [ 2 % ] ) , stomatitis ( 20 [ 6 % ] vs 13 [ 8 % ] ) , fatigue ( 18 [ 6 % ] vs five [ 3 % ] ) , and neutropenia ( 1 [ < 1 % ] vs 11 [ 7 % ] ) ; serious adverse events occurred in 44 ( 14 % ) of afatinib-treated patients and 18 ( 11 % ) of methotrexate-treated patients .


Afatinib was associated with significant improvements in progression-free survival and had a manageable safety profile .


These findings provide important new insights into the treatment of this patient population and support further investigations with irreversible ERBB family blockers in HNSCC .


Boehringer Ingelheim .


Infants are at the highest risk for meningococcal disease and a broadly protective and safe vaccine is an unmet need in this youngest population .


We evaluated the immunogenicity and safety of a 4-dose infant/toddler regimen of MenACWY-CRM given at 2 , 4 , 6 , and 12 months of age concomitantly with pentavalent diphtheria-tetanus-acellular pertussis-Hemophilus influenzae type b-inactivated poliovirus-combination vaccine ( DTaP-IPV/Hib ) , hepatitis B vaccine ( HBV ) , 7 - or 13-valent conjugate pneumococcal vaccine ( PCV ) , and measles , mumps , and rubella vaccine ( MMR ) .


Four doses of MenACWY-CRM induced hSBA titers 8 in 89 % , 95 % , 97 % , and 96 % of participants against serogroups A , C , W-135 , and Y , respectively .


hSBA titers 8 were present in 76-98 % of participants after the first 3 doses .


A categorical linear analysis incorporating vaccine group and study center showed responses to routine vaccines administered with MenACWY-CRM were non-inferior to routine vaccines alone , except for seroresponse to the pertussis antigen fimbriae .


The reactogenicity profile was not affected when MenACWY-CRM was administered concomitantly with routine vaccines .


MenACWY-CRM administered with routine concomitant vaccinations in young infants was well tolerated and induced highly immunogenic responses against each of the serogroups without significant interference with the immune responses to routine infant vaccinations .


Healthy 2 month old infants were randomized to receive MenACWY-CRM with routine vaccines ( n = 258 ) or routine vaccines alone ( n = 271 ) .


Immunogenicity was assessed by serum bactericidal assay using human complement ( hSBA ) .


Medically attended adverse events ( AEs ) , serious AEs ( SAEs ) and AEs leading to study withdrawal were collected throughout the study period .


To compare the efficacy on acute pain treated under the different time of needle retention so as to provide the scientific evidence for the optimization of needle retention time for acupuncture analgesia .


Eighty cases of acute pain ( acute lumbar sprain , stiffness of neck ) were randomized into 4 groups .


Acupuncture was applied to all the patients .


After the arrival of needling sensation , the needles were retained for 20 min , 30 min , 45 min and 60 min in different groups separately .


For acute lumbar sprain , Ashi ( Extra ) , Houxi ( SI 3 ) and Weizhong ( BL 40 ) were the main points .


For stiffness of neck , Ashi ( Extra ) , Fengchi ( GB 20 ) and Lieque ( LU 7 ) were the main points .


McGill pain scale , the internationally recognized pain description and measurement was adopted to observe the indexes and record the score changes of each item of pain symptoms before and 3 months after treatment .


The immediate analgesic efficacy under different time of needle retention and the longterm efficacy in follow-up visit 3 months after treatment were compared and assessed among the groups .


The scores of visual analogue scale ( VAS ) and present pain intensity ( PPI ) after treatment were all improved significantly as compared with those before treatment in the 4 groups ( all P < 0.01 ) , and the result in the 45 min group was superior to the other 3 groups ( VAS : 2.90 + / -0.87 vs 5.52 + / -1.01 , 4.45 + / -0.81 , 5.95 + / -1.07 ; PPI : 1.40 + / -0.21 vs 2.26 + / -0.54 , 2.21 + / -0.43 , 2.28 + / -0.74 , all P < 0.01 ) .


The total effective rate of the immediate analgesia was 95.0 % ( 19/20 ) in the 45 min group , which was better than that in each of the other 3 groups .


The 45 min of needle retention achieves the best efficacy of acupuncture analgesia in treatment of acute pain .


The aim of the study was to determine whether experimental manipulation of sense of control would change moderate drinkers ' ( N = 106 ) task-specific motivational structure and explicit and implicit determinants of their urge to drink alcohol .


The effects of various levels of information-enhancement and goal-setting on participants ' performance on experimental tasks were assessed .


Participants were randomly assigned to a high-sense-of-control , low-sense-of-control , or no-intervention group .


Dependent measures were indices derived from a task-specific version of the Personal Concerns Inventory and the Shapiro Control Inventory , Alcohol Urge Questionnaire , and alcohol Stroop test .


At baseline , there were no differences among the groups on any of the measures ; however , post-experimentally , induced sense of control had led to increases in adaptive motivation and decreases in explicit and implicit measures of the urge to drink .


The results show that sense of control can be experimentally induced .


This finding has important clinical implications .


To estimate contraceptive efficacy , safety , acceptability , and fit of a single-size diaphragm used with contraceptive gel .


We conducted a multicenter trial in which 450 couples used the single-size diaphragm , 300 randomized to acid-buffering gel and 150 to nonoxynol-9 , for at least 190 days and six menstrual cycles .


Visits were at enrollment and after menstrual cycles 1 , 3 , and 6 .


Study outcomes included pregnancy probability , safety , acceptability , and fit .


Pregnancy and safety were compared with an historical control group who used a standard diaphragm with these gels .


Most ( 439/450 [ 98 % ] ) women could be fitted with the single-size diaphragm .


A total of 421 of 450 ( 94 % ) provided follow-up .


The 35 study pregnancies yielded 6-month Kaplan-Meier cumulative typical use pregnancy probabilities per 100 women with 95 % confidence intervals ( CIs ) of 10.4 ( 6.9-14 .0 ) for all users and 9.6 ( 5.5-13 .6 ) and 12.5 ( 5.4-19 .5 ) with acid-buffering gel and nonoxynol-9 , respectively .


Historical control analysis yielded a propensity score-adjusted estimate of this pregnancy probability for the single-size diaphragm of 11.3 compared with 10.7 per 100 women for the standard diaphragm ( [ rounded ] difference 0.7 , 95 % CI -3.6 to 4.9 ) .


Approximately half ( 51 % ) reported at least one urogenital event but compared favorably to the standard diaphragm in historical control analysis .


Most ( 282/342 [ 82 % ] ) liked the diaphragm .


Results suggest that if provided by a clinician , 94 % ( 95 % CI 92-96 % ) could insert , correctly position , and remove the diaphragm .


The single-size diaphragm was safe , as effective as a standard diaphragm , and acceptable when used with contraceptive gel .


ClinicalTrials.gov , www.clinicaltrials.gov , NCT00578877 .


The present study investigated the effectiveness of a newly developed 3-week self-compassion group intervention for enhancing resilience and well-being among female college students .


Fifty-two students were randomly assigned to either an intervention designed to teach skills of self-compassion ( n = 27 ) or an active control group intervention in which general time management skills were taught ( n = 25 ) .


Both interventions comprised 3 group meetings held over 3 weeks .


To measure resilience and well-being gains , participants filled out a number of questionnaires before and after the intervention .


Results showed that the self-compassion intervention led to significantly greater increases in self-compassion , mindfulness , optimism , and self-efficacy , as well as significantly greater decreases in rumination in comparison to the active control intervention .


Whereas both interventions increased life satisfaction and connectedness , no differences were found for worry and mood .


These findings suggest that a brief self-compassion intervention has potential for improving student resilience and well-being .


Gram-negative organisms are a major health care concern with increasing prevalence of infection and community spread .


Our primary aim was to characterize the transmission dynamics of frequently encountered gram-negative bacteria in the anesthesia work area environment ( AWE ) .


Our secondary aim was to examine links between these transmission events and 30-day postoperative health care-associated infections ( HCAIs ) .


Gram-negative isolates obtained from the AWE ( patient nasopharynx and axilla , anesthesia provider hands , and the adjustable pressure-limiting valve and agent dial of the anesthesia machine ) at 3 major academic medical centers were identified as possible intraoperative bacterial transmission events by class of pathogen , temporal association , and phenotypic analysis ( analytical profile indexing ) .


The top 5 frequently encountered genera were subjected to antibiotic disk diffusion sensitivity to identify epidemiologically related transmission events .


Complete multivariable logistic regression analysis and binomial tests of proportion were then used to examine the relative contributions of reservoirs of origin and within - and between-case modes of transmission , respectively , to epidemiologically related transmission events .


Analyses were conducted with and without the inclusion of duplicate transmission events of the same genera occurring in a given study unit ( first and second case of the day in each operating room observed ) to examine the potential effect of statistical dependency .


Transmitted isolates were compared by pulsed-field gel electrophoresis to disease-causing bacteria for 30-day postoperative HCAIs .


The top 5 frequently encountered gram-negative genera included Acinetobacter , Pseudomonas , Brevundimonas , Enterobacter , and Moraxella that together accounted for 81 % ( 767/945 ) of possible transmission events .


For all isolates , 22 % ( 167/767 ) of possible transmission events were identified by antibiotic susceptibility patterns as epidemiologically related and underwent further study of transmission dynamics .


There were 20 duplicates involving within - and between-case transmission events .


Thus , approximately 19 % ( 147/767 ) of isolates excluding duplicates were considered epidemiologically related .


Contaminated provider hand reservoirs were less likely ( all isolates , odds ratio 0.12 , 95 % confidence interval 0.03-0 .50 , P = 0.004 ; without duplicate events , odds ratio 0.05 , 95 % confidence interval 0.01-0 .49 , P = 0.010 ) than contaminated patient or environmental sites to serve as the reservoir of origin for epidemiologically related transmission events .


Within - and between-case modes of gram-negative bacilli transmission occurred at similar rates ( all isolates , 7 % between-case , 5.2 % within-case , binomial P value 0.176 ; without duplicates , 6.3 % between-case , 3.7 % within-case , binomial P value 0.036 ) .


Overall , 4.0 % ( 23/548 ) of patients suffered from HCAIs and had an intraoperative exposure to gram-negative isolates .


In 8.0 % ( 2/23 ) of those patients , gram-negative bacteria were linked by pulsed-field gel electrophoresis to the causative organism of infection .


Patient and provider hands were identified as the reservoirs of origin and the environment confirmed as a vehicle for between-case transmission events linked to HCAIs .


Between - and within-case AWE gram-negative bacterial transmission occurs frequently and is linked by pulsed-field gel electrophoresis to 30-day postoperative infections .


Provider hands are less likely than contaminated environmental or patient skin surfaces to serve as the reservoir of origin for transmission events .


Health-related quality of life ( HRQOL ) is an important indicator of well-being in patients with epilepsy .


When assessing changes in HRQOL over time , some of the changes observed may be due to the patients ' change in the internal standards , value , or meaning that they attribute to the HRQOL domain being measured , rather than actual change , a phenomenon known as response shift .


Response shifts are increasingly recognized as an important explanation for the seemingly paradoxical or counterintuitive HRQOL results often observed in chronic conditions .


We investigated the presence of changing values ( reprioritization response shift ) in data from a surgical randomized controlled trial of patients with temporal lobe epilepsy ( TLE ) .


Eighty patients with TLE , who were randomized to surgical and medical treatment , provided data on the epilepsy-specific 31-item Quality of life in Epilepsy ( QOLIE-31 ) questionnaire at baseline and 1 year after randomization .


Reprioritization response shift among the seven QOLIE-31 domains was assessed using changes in the relative importance weights derived from logistic regression and discriminant analysis .


The relative importance analysis showed a statistically significant increase over time in the importance of social function , but a significant decrease in the relative importance of seizure worry .


There were no significant changes in the relative importance of the remaining five domains in distinguishing between surgical and medical group over time .


Patients that receive surgical treatment are more likely to experience a decrease in the valuation of seizure worry and an increase in the value of social function as compared to patients who are medically treated .


Changes in expectation about seizure freedom and social function may confound the assessment of longitudinal change on these outcomes , and highlight the importance of assessing response shift and the limitations of assessing HRQOL at a single point in time or without a control group .


A PowerPoint slide summarizing this article is available for download in the Supporting Information section here .


Longevity results in changes to patterns of health , with an increased prevalence of chronic diseases .


Parkinson 's disease ( PD ) is described as a progressive neurodegenerative disease related to age that influences quality of life ( QoL ) and leads to depression .


The study intended to assess changes in QoL and depression in older adults with PD through use of Feldenkrais method-based exercise .


The study was a controlled , blinded , and randomized clinical trial .


The study occurred at the University Hospital of the Federal University of Sergipe in Aracaju , Sergipe , Brazil .


Participants were 30 patients , aged between 50 and 70 y , with idiopathic PD , who signed an informed consent form and were randomly assigned to 2 groups : treatment and control .


The treatment group underwent 50 sessions of an exercise program based on the Feldenkrais method .


The control group received educational lectures during this period .


The treatment group 's 50 sessions , given 2 / wk on alternate days and lasting 60 min , were conducted in an appropriate room at the hospital .


Two surveys , the Parkinson 's Disease Quality of Life ( PDQL ) questionnaire and the Beck Depression Inventory ( BDI ) , were administered before and after the sessions for both groups .


After the exercises based on the Feldenkrais method , the treated group showed improvement in QoL scores ( P = .004 ) as well as a reduction in the level of depression ( P = .05 ) compared with the control group .


The findings in the current study indicate that it is likely that the practice of a program based on the Feldenkrais method can contribute greatly to the QoL of patients with PD , suggesting the importance of interventions that promote wellness for this population .


Fibrocaps , a ready-to-use , dry-powder fibrin sealant containing human plasma-derived thrombin and fibrinogen , is being developed as an adjunct for surgical hemostasis .


Safety and efficacy of Fibrocaps applied directly or by spray device , in combination with gelatin sponge , was compared with that of gelatin sponge-alone in two randomized , single-blind controlled trials : FC-002 US ( United States ) and FC-002 NL ( the Netherlands ) .


A total of 126 adult patients were randomized ( Fibrocaps : n = 47 [ FC-002 US ] , n = 39 [ FC-002 NL ] ; gelatin sponge alone : n = 23 [ FC-002 US ] , n = 17 [ FC-002 NL ) .


One bleeding site was treated during a surgical procedure ( n = 125 ) .


Time to hemostasis ( primary end point ) was measured , with a 28-d safety follow-up .


Four surgical indications included hepatic resection ( n = 58 ) , spinal procedures ( n = 37 ) , peripheral vascular procedures ( n = 30 ) , and soft tissue dissection ( n = 1 ) .


Mean ( standard deviation ) time to hemostasis was significantly shorter after Fibrocaps treatment than after gelatin sponge alone ( FC-002 US : 1.9 [ 1.3 ] versus 4.8 min [ 3.1 ] , P < 0.001 ; FC-002 NL : 2.2 [ 1.3 ] versus 4.4 min [ 3.1 ] , P = 0.004 ) .


The incidence of hemostasis was greater after Fibrocaps compared with that of gelatin sponge alone within 3min ( FC-002 US : 83 % versus 35 % , P < 0.001 ; FC-002 NL : 77 % versus 53 % , P = 0.11 ) , 5min ( 94 % versus 61 % , P = 0.001 ; 95 % versus 71 % , P = 0.022 ) , and 10min ( 100 % versus 78 % , P = 0.003 ; 100 % versus 82 % , P = 0.025 ) .


Adverse events were consistent with surgical procedures performed and patients ' underlying diseases and generally similar between treatment arms ; most were mild or moderate in severity .


Non-neutralizing antithrombin antibodies were detected in 5 % of Fibrocaps-treated patients on day29 .


Fibrocaps had good safety and efficacy profiles , supporting continuing clinical development as a novel fibrin sealant .


Refraining from breastfeeding to prevent HIV transmission has been associated with increased morbidity and mortality in HIV-exposed African infants .


The objective was to assess risks of common and serious infectious morbidity by feeding mode in HIV-exposed , uninfected infants 6 mo of age with special attention to the issue of reverse causality .


HIV-infected pregnant women from 5 sites in Burkina Faso , Kenya , and South Africa were enrolled in the prevention of mother-to-child transmission Kesho Bora trial and counseled to either breastfeed exclusively and cease by 6 mo postpartum or formula feed exclusively .


Maternal-reported morbidity ( fever , diarrhea , and vomiting ) and serious infectious events ( SIEs ) ( gastroenteritis and lower respiratory tract infections ) were investigated for 751 infants for 2 age periods ( 0-2 .9 and 3-6 mo ) by using generalized linear mixed models with breastfeeding as a time-dependent variable and adjustment for study site , maternal education , economic level , and cotrimoxazole prophylaxis .


Reported morbidity was not significantly higher in nonbreastfed compared with breastfed infants [ OR : 1.31 ( 95 % CI : 0.97 , 1.75 ) and 1.21 ( 0.90 , 1.62 ) at 0-2 .9 and 3-6 mo of age , respectively ] .


Between 0 and 2.9 mo of age , never-breastfed infants had increased risks of morbidity compared with those of infants who were exclusively breastfed ( OR : 1.49 ; 95 % CI : 1.01 , 2.2 ; P = 0.042 ) .


The adjusted excess risk of SIEs in nonbreastfed infants was large between 0 and 2.9 mo ( OR : 6.0 ; 95 % CI : 2.2 , 16.4 ; P = 0.001 ) .


Between 3 and 6 mo , the OR for SIEs was sensitive to the timing of breastfeeding status , i.e. , 4.3 ( 95 % CI : 1.2 , 15.3 ; P = 0.02 ) when defined at end of monthly intervals and 2.0 ( 95 % CI : 0.8 , 5.0 ; P = 0.13 ) when defined at the beginning of intervals .


Of 52 SIEs , 3 mothers reported changes in feeding mode during the SIE although none of the mothers ceased breastfeeding completely .


Not breastfeeding was associated with increased risk of serious infections especially between 0 and 2.9 mo of age .


The randomized controlled trial component of the Kesho Bora study was registered at Current Controlled Trials ( www.controlled-trials.com ) as ISRCTN71468401 .


To study the synergistic effects of electroacupuncture on the treatment of knee osteoarthritis after arthroscopic debridement .


From May 2008 to July 2010 , 78 patients with knee osteoarthritis were randomly divided into two groups .


There were 42 patients in the experimental group , including 16 males and 26 females , ranging in age from 41 to 63 years , with an average of ( 53.62 + / - 6.53 ) years ; the disease course ranged from 8 to 24 months , with an average of ( 10.35 + / - 6.42 ) months .


The patients were treated with arthroscopic debridement combined with electroacupuncture after operation .


There were 36 patients in the control group , including 14 males and 22 females , ranging in age from 40 to 62 years , with an average of ( 54.34 + / - 7.67 ) years ; the disease course ranged from 6 to 25 months , with an average of ( 11.94 + / - 5.13 ) months .


Those patients were treated only with arthroscopic debridment .


All the patients performed isometric quadriceps femoris contraction exercise and knee flexion and extension activities after operation .


The visual analog scale ( VAS ) score and Lysholm knee score were used to evaluate the therapeutic effects .


All the patients were followed up , and the duration ranged from 12 to 30 months , with an average of 15.6 months .


At the final follow-up , VAS score was significantly decreased , and the Lysholm score , except for the item demanding for support , significantly increased , compared with those before surgery respectively in both groups .


There was significant difference in VAS score between two groups after treatment .


As to Lysholm score , there were significant differences in limp , pain , swelling , stair activity and squat , but there were no significant differences in items of interlocking and instability between two groups after treatment .


Electroacupuncture can effectively improve the clinical symptoms and knee joint 's motor function of knee joints in patients with knee osteoarthritis , as well as the synergistic effects on the treatment of knee osteoarthritis after arthroscopic debridement , leading to a much better long-term therapeutic effect with respect of improving the function of knee joint .


This therapy , combined with traditional Chinese medicine and Western Medicine , is worth of clinical application in the treatment of knee osteoarthritis .


Preclinical studies suggest that P2X3 receptors are expressed by airway vagal afferent nerves and contribute to the hypersensitisation of sensory neurons .


P2X3 receptors could mediate sensitisation of the cough reflex , leading to chronic cough .


We aimed to investigate the efficacy of a first-in-class oral P2X3 antagonist , AF-219 , to reduce cough frequency in patients with refractory chronic cough .


We did a double-blind , placebo-controlled , two-period , crossover study at one UK centre .


With a computer-generated sequence , we randomly assigned patients with refractory chronic cough to AF-219 , 600 mg twice a day , or to placebo ( 1:1 ) , and then , after a 2 week washout , assigned patients to receive the other treatment .


Patients , health-care providers , and investigators were masked to sequence assignment .


We assessed daytime cough frequency ( primary endpoint ) at baseline and after 2 weeks of treatment using 24 h ambulatory cough recordings .


The primary analysis used a mixed effects model with the intention-to-treat population .


This study was registered at ClinicalTrials.gov , number NCT01432730 .


Of 34 individuals assessed between Sept 22 , 2011 , and Nov 29 , 2012 , we randomly assigned 24 patients ( mean age 545 years ; SD 111 ) .


In the observed case analysis , cough frequency was reduced by 75 % when patients were allocated to AF-219 compared when allocated to placebo ( p = 00003 ) .


Daytime cough frequency fell from a mean 37 coughs per h ( SD 32 ) to 11 ( 8 ) coughs per h after AF-219 treatment versus 65 ( 163 ) coughs per h to 44 ( 51 ) coughs per h after placebo .


Six patients withdrew before the end of the study because of taste disturbances , which were reported by all patients taking AF-219 .


P2X3 receptors seem to have a key role in mediation of cough neuronal hypersensitivity .


Antagonists of P2X3 receptors such as AF-219 are a promising new group of antitussives .


Afferent Pharmaceuticals .


Children with borderline to mild intellectual disability ( BMID ) have been shown to be at increased risk for psychosocial problems .


The presence of these psychosocial problems leads to parenting stress .


Stepping Stones Triple P ( SSTP ) is a parenting support program to support parents with children with BMID and psychosocial problems .


The aim of this study was to evaluate the effectiveness of SSTP compared to Care as Usual ( CAU ) in reducing psychosocial problems in children with BMID .


We conducted a randomized controlled trial in the Northern provinces of the Netherlands .


Parents of children aged 5 to 12 with borderline ( IQ 70 to 85 ) or mild ( IQ 70 to 50 ) ID and psychosocial problems were invited .


Psychosocial problems were identified using the Strengths and Difficulties Questionnaire ( SDQ ) parent report ( 14 ) .


Measurements were assessed before the intervention ( T0 ) , immediately after the intervention ( T1 ) and after a follow-up of six months ( T2 ) .


SSTP takes 8 to 10 individual sessions of 40-90 minutes , provided over 10 to 12weeks .


CAU concerned any service , except SSTP .


Primary outcomes were the child 's psychosocial problems ( SDQ parent and teacher forms and the Eyberg Child Behavior Inventory , ECBI ) .


Secondary outcomes were parenting stress ( Parenting Stress Index , PSI ) and parenting skills ( Alabama Parenting Questionnaire , APQ ) .


In total 209 parents of children aged 5 to 12 with BMID were allocated blindly to either SSTP ( n = 111 ) or CAU ( n = 98 ) .


In the intention to treat analyses , SSTP achieved no significantly better effect than CAU for the SDQ parent report , the ECBI and the APQ on the short - and long - term .


In the short term , SSTP was significantly more effective than CAU for the SDQ teacher report ( B = -2.25 , 95 % CI -3.79 to -0.71 ) and the PSI ( B = -7.06 , 95 % CI -12.11 to -2.01 ) .


For both SDQ teacher report and PSI , there was no statistically significant effect in the long term .


Dropout from SSTP was considerable ( 49 % ) , with the effects being solely found in the adherent SSTP subgroup .


SSTP had some short-term advantages over CAU , but not in the longer term .


Dutch Trial Register NTR2624 .


Registered 26 November 2010 .


We aimed to assess the safety and tolerability of different doses of canakinumab versus placebo in patients with type 2 diabetes mellitus ( T2DM ) .


Data were pooled from three studies in 1026 T2DM patients with different routes of administration , treatment regimens and follow-up duration .


Canakinumab groups were categorised as low ( 0.03 mg/kg i.v. once ; N = 20 ) , intermediate ( 0.1 and 0.3 mg/kg i.v. once , 5 and 15 mg s.c. monthly ; N = 247 ) , medium ( 1.5 mg/kg i.v. once , 50 mg s.c. monthly and 150 mg s.c. once ; N = 268 ) , and high doses ( 10 mg/kg i.v. once and 150 mg s.c. monthly ; N = 137 ) and compared with placebo ( N = 354 ) .


Incidences of adverse events ( AEs ) , serious AEs ( SAEs ) , discontinuations due to AEs , deaths , AEs of special interest related to interleukin-1 inhibition and T2DM disease , and laboratory abnormalities related to haematology and biochemistry parameters were reported .


Safety was also analysed by age ( < 65 , 65 ) and gender .


Average exposure across all groups was6 months ( maximum ~ 17 months ) .


No dose response in AEs was observed but a trend towards more patients having at least one AE across canakinumab groups relative to placebo ( P = 0.0152 ) was observed .


SAEs were few and the incidence rate for most canakinumab groups was lower than that of placebo group except for the high-dose group ( 0.94 % versus 0.58 % per month in placebo ) .


A total of five patients discontinued treatment due to AEs across treatment groups .


No death was reported in any of the three studies .


A small , non-significant increase in the incidence rate of infection AEs was observed on canakinumab groups relative to placebo .


Canakinumab was associated with mostly mild decreases in WBC , neutrophils and platelet counts .


Additionally , mild increases in SGPT , SGOT and bilirubin were reported .


Overall , despite small differences , no clinically relevant findings were observed with respect to laboratory values and vital signs .


This pooled analysis demonstrated that canakinumab was safe and well tolerated over a treatment period up to 1.4 years at the four pooled doses evaluated , in agreement with safety findings reported in the individual studies .


This study was undertaken to compare the immunogenicity of a three dose and five dose schedule of an oral live-attenuated human rotavirus vaccine , Rotarix in south Indian infants .


Healthy infants ( N = 90 ) , six to seven weeks of age were enrolled to receive three doses ( n = 45 ) or five doses of Rotarix vaccine ( n = 45 ) along with other scheduled vaccines , each dose separated by a four week interval .


Blood samples were taken before vaccination and one month post-dose three in the Rotarix three dose group and one month post-dose five in the Rotarix five dose group ; all were tested for anti-rotavirus IgA by an antibody sandwich enzyme immunoassay .


At baseline , > 50 % of infants had > 20 units of anti-rotavirus IgA .


The seroconversion rates after three and five doses were low and not significantly different in the two groups .


However , among vaccine responders , children seropositive at baseline showed a much greater absolute increase in IgA antibody levels than children seronegative at baseline .


Rotarix vaccine showed low immunogenicity in south Indian children and increasing the number of doses did not increase the proportion of infants seroconverting after vaccination .


To determine whether outcomes for patients with cellulitis treated with oral antimicrobials are as good as for those who are treated with parenteral antimicrobials .


A prospective randomized non-inferiority trial was conducted at a tertiary teaching hospital in Melbourne , Australia .


Participants were patients referred by the emergency department for treatment of uncomplicated cellulitis with parenteral antimicrobials .


Patients were randomized to receive either oral cefalexin or parenteral cefazolin .


Parenteral antimicrobials were changed to oral after the area of cellulitis ceased progressing .


The primary outcome was days until no advancement of the area of cellulitis .


A non-inferiority margin of 15 % was set for the oral arm compared with the parenteral arm .


Secondary outcomes were failure of treatment , pain , complications and satisfaction with care .


This trial is registered with the Australian New Zealand Clinical Trials Registry ( ACTRN12611000685910 ) .


Twenty-four patients were randomized to oral antimicrobials and 23 to parenteral antimicrobials .


Mean days to no advancement of cellulitis was 1.29 ( SD 0.62 ) for the oral arm and 1.78 ( SD 1.13 ) for the parenteral arm , with a mean difference of -0.49 ( 95 % CI : -1.02 to +0.04 ) .


The upper limit of the 95 % CI of the difference in means of +0.04 was below the 15 % non-inferiority margin of +0.27 days , indicating non-inferiority .


More patients failed treatment in the parenteral arm ( 5 of 23 , 22 % ) compared with the oral arm ( 1 of 24 , 4 % ) , although this difference was not statistically significant ( P = 0.10 ) .


Pain , complications and satisfaction with care were similar for both groups .


Oral antimicrobials are as effective as parenteral antimicrobials for the treatment of uncomplicated cellulitis .


This study aimed to examine the effects of a multidisciplinary treatment program on health-related quality of life of Iranian patients living with chronic low back , at 12months follow-up .


This study is an extended follow-up of an original randomized , controlled trial with registration number NCT00600197 .


In the present study 87 patients in an intervention group and 91 patients in a control group were assessed at 12months follow-up .


The intervention was a group-based multidisciplinary rehabilitation program which continued by monthly motivational consultation by telephone from 6 to 12months after intervention .


Data from three standard measures , Short Form 36 ( SF-36 ) , QDS and RDQ were collected at 3 , 6 and 12months follow-up and analyzed through repeated measures analysis of variance .


Despite the similarity between the two groups who completed the 6month follow-up in terms of all baseline variables , there were significant differences between the two groups in all domains of the SF-36 scale , as well as QDS and RDQ scales ( P < 0.05 ) .


Also , there were differences within each group over time in the SF-36 domains and disability measurements ( P < 0.05 ) .


The physical function mean score differed significantly when the interaction between groups and time points was examined ( P = 0.02 ) .


This study indicates that the multidisciplinary program could improve the domains of health related quality of life and disability in chronic low back pain patients up to 12months .


The optimal duration of dual antiplatelet therapy ( DAPT ) following second-generation drug-eluting stent ( DES ) implantation is still debated .


The aim of this study was to test the noninferiority of 6 versus 12 months of DAPT in patients undergoing percutaneous coronary intervention with second-generation DES .


The SECURITY ( Second Generation Drug-Eluting Stent Implantation Followed by Six - Versus Twelve-Month Dual Antiplatelet Therapy ) trial was a 1:1 randomized , multicenter , international , investigator-driven , noninferiority study conducted from July 2009 to June 2014 .


Patients with a stable or unstable angina diagnosis or documented silent ischemia undergoing revascularization with at least 1 second-generation DES were eligible .


The primary endpoint was a composite of cardiac death , myocardial infarction ( MI ) , stroke , definite or probable stent thrombosis , or Bleeding Academic Research Consortium ( BARC ) type 3 or 5 bleeding at 12 months .


The main secondary endpoint was a composite of cardiac death , MI , stroke , definite or probable stent thrombosis , or BARC type 2 , 3 , or 5 bleeding at 12 and 24 months .


Overall , 1,399 patients were enrolled in the study and randomized to receive 6 months ( n = 682 ) versus 12months ( n = 717 ) DAPT .


The primary composite endpoint occurred , respectively , in 4.5 % versus 3.7 % ( risk difference 0.8 % ; 95 % confidence interval [ CI ] : -2.4 % to 1.7 % ; p = 0.469 ) at 12 months .


The upper 95 % CI limit was lower than the pre-set margin of 2 % , confirming the noninferiority hypothesis ( p < 0.05 ) .


Moreover , no differences were observed in the occurrence of the secondary endpoint at 12 months ( 5.3 % vs. 4.0 % , difference : 1.2 % ; 95 % CI : -1.0 to 3.4 ; p = 0.273 ) and between 12 and 24 months ( 1.5 % vs. 2.2 % , difference : -0.7 % ; 95 % CI : -2.1 to 0.6 ; p = 0.289 ) .


Finally , no differences were observed in definite or probable stent thrombosis at 12 months ( 0.3 % vs. 0.4 % ; difference : -0.1 % ; 95 % CI : -0.7 to 0.4 ; p = 0.694 ) and between 12 and 24 months of follow-up ( 0.1 % vs. 0 % ; difference : 0.1 % ; 95 % CI : -0.1 to 0.4 ; p = 0.305 ) .