Twenty-seven patients , @ % female ( mean standard deviations age , @ @ years ) , with diabetic neuropathy randomly assigned to receive a multimodal manual treatment approach including analyzing treadmill with feedback focused , isokinetic dynamometric muscle strengthening , and balance retraining on dynamic balance platform or a standard care intervention for activities targeted to improve endurance , manual exercises of muscle strengthening , stretching exercises , gait , and balance exercises ( @ weekly over @ weeks ) .


This study was designed as a double-blind , randomized clinical trial .


Measures were assessed at pretreatment , @ weeks posttreatment , and @-month follow-up .


No important baseline differences were observed between groups .


At the end of the treatment period , the experimental group showed a significant increase in gait endurance in a @-minute walk test , @ m ( F -LSB- @ -RSB- = @ ; P = @ ) .


In addition , the @-minute walk test increased after the intervention , and an even greater difference was found at follow-up ( P = @ ) for the standard care group .


The Functional Independence Measure in both groups increased ( P < @ ) and continued until the follow-up in the standard care group ( P = @ ) .


The results suggest that the experimental rehabilitation program showed positive effects on the gait endurance after @ weeks of treatment , whereas it did not produce significant improvements of the gait speed .


Both the treatments produced significant improvement of functionalities of the patient .


Median sternotomy is the preferred approach for open heart surgeries .


The sternotomy incision is predominantly closed with either steel wire or polyester suture .


The type of material used is primarily based on the surgeon 's choice , and both materials achieve a good result .


No prospective clinical study has been undertaken to evaluate differences in the incidence of wound infection and the degree of pain associated with both techniques .


Our randomized controlled double-blind study included @ adults undergoing single-valve replacement .


The technique of surgery , apart from the material used for sternal closure , was the same in both groups .


Postoperatively , patients were analyzed for wound infection and wound pain based on the ASEPSIS score and Numeric Pain Rating Score , respectively .


The polyester suture group had a significantly higher mean ASEPSIS score , indicating a higher incidence of wound infection , and more late wound complications .


The polyester suture group also had a significantly higher mean pain score .


The steel wire group had significantly higher mediastinal drain output in the first @ h after surgery .


The use of polyester suture for sternal closure in adult patients results in increased wound infection , wound pain , and late wound complications , but lower mediastinal drain output .


To compare surgeons ' intraoperative surgeon acceptability or assessment of the operative field regarding bowel contents and patients ' satisfaction with or without a mechanical bowel preparation before reconstructive vaginal prolapse surgery .


In this single-blind , randomized trial , women scheduled to undergo vaginal prolapse surgery with a planned apical suspension and posterior colporrhaphy were allocated using block randomization to an intervention or control group .


Surgeons were blinded to patient allocation .


One day before surgery , mechanical bowel preparation instructions consisted of a clear liquid diet and two self-administered saline enemas ; the participants in the control group sustained a regular diet and nothing by mouth after midnight .


The primary outcome was surgeons ' intraoperative assessment of the surgical field regarding bowel content as measured on a @-point Likert scale ( @ , excellent ; @ , poor ) .


Secondary outcomes included participant satisfaction and bowel symptoms .


The primary outcome was determined by intention-to-treat analysis and other analyses were per protocol .


Of the @ women randomized ( @ women to intervention and control group ) , @ completed the study .


No differences existed in the demographic , clinical , and intraoperative characteristics between groups ( P > @ ) .


Surgeons ' intraoperative assessment rating was @ % `` excellent or good '' with bowel preparation compared with @ % for participants in the control group ( odds ratio -LSB- OR -RSB- @ , @ % confidence interval -LSB- CI -RSB- @-@ @ ; P = @ ) .


The bowel preparation group was less likely to report `` complete '' satisfaction compared with the participants in the control group ( OR @ , @ % CI @-@ @ ; P < @ ) .


Abdominal fullness and cramping , fatigue , anal irritation , and hunger pains were greater in the bowel preparation group ( all P < @ ) .


Before reconstructive vaginal surgery , mechanical bowel preparation conferred no benefit regarding surgeons ' intraoperative assessment of the operative field , reflected decreased patient satisfaction , and had increased abdominal symptoms .


To observe clinical effect , feasibility and security of preconditioning of thermopaste application at Shenque ( CV @ ) for relieving stretch reflex induced by procedure for prolapse and hemorrhoids ( PPH ) .


A total of @ cases of mixed hemorrhoids ( stage III and IV ) patients were randomized into @ h , @ h , @ h and control ( no application ) groups ( n = @ in each group ) according to a random number table .


Thermopaste was applied to Shenque ( CV @ ) @ h and @ h before PPH or conducted simultaneously with PPH .


The mean arterial pressure , heart rate , blood oxygen saturation of patients before and after anastomose operation , and the incidence of adverse reactions within @ hours after the procedure were monitored and recorded .


The patient 's pain degree was assessed by using visual analogue scale .


After the preconditioning , of the @ patients in the @ h group ( @ h G ) , @ experienced marked improvement ( in the stretch reflex during PPH ) , @ had an improvement , and @ was invalid , respectively .


The markedly effective rate and the total effective rate were @ % and @ % , respectively .


The therapeutic effects for inhibiting stretch reflect being from the better to the poorer were @ h G > @ h G > @ h G > NG .


The heart rate and blood pressure from more stable to lesser stable were @ h G > @ h G > @ h G > NG .


The patients ' pain reaction during operation and their adverse effects of nausea , vomiting , abdominal distention and abdominal pain , etc. occurred during operation also presented the same tendency in the @ groups .


Thermopaste application to Shenque ( CV @ ) can effectively prevent and control visceral reflex in patients undergoing PPH , which effect is significantly better when conducted @ hour before the operation .


This study aims to investigate the safety and efficacy of hepatic arterial infusion chemotherapy ( HAIC ) on liver metastases from pancreatic cancer after pancreatectomy .


We randomly assigned @ patients with pancreatic cancer after pancreatectomy between @ and @ to receive @ cycles of HAIC plus @ cycles of systemic chemotherapy ( Combined Therapy ) or @ cycles of systemic chemotherapy alone ( Monotherapy ) .


Both the HAIC and systemic chemotherapy regimen consisted of a @-hour infusion of @-fluorouracil @ mg/m@ on day @ followed by gemcitabine @ mg/m@ as an over @-min infusion on day @ and day @ .


The treatment was started on an average of @ days after surgery and repeated every @ weeks .


The disease-free survival , overall survival and liver metastases-free survival were compared .


There was no significant difference in adverse effects between two groups .


Significant differences were found in @-year overall survival ( Combined Therapy , @ % ; Monotherapy , @ % ; P = @ ) and liver metastases-free survival ( Combined Therapy , @ % ; Monotherapy , @ % ; P = @ ) .


HAIC effectively and safely prevents liver metastases and improves the prognosis of patients with pancreatic cancer after pancreatectomy .


This study evaluated the performance and acceptability of the Enlite ( ) glucose sensor ( Medtronic MiniMed , Inc. , Northridge , CA ) .


Ninety adults with type @ or type @ diabetes wore two Enlite sensors on the abdomen and/or buttock for @ days and calibrated them at different frequencies .


On Days @ , @ , and @ , accuracy was evaluated by comparison of sensor glucose values with frequently sampled plasma glucose values collected over a @-h period .


Accuracy was assessed at different reference glucose concentrations and during times when absolute glucose concentration rates of change were < @ , @-@ , and > @ mg/dL/min .


The sensor 's ability to detect hypoglycemia or hyperglycemia was evaluated with simulated alerts .


Subject satisfaction was evaluated with a @-point Likert-type questionnaire , with a score of @ indicating strong agreement .


With abdomen sensors under actual-use calibration ( mean , @ @ times/day ) , the overall mean ( median ) absolute relative difference ( ARD ) values between sensor and reference values were @ % ( @ % ) ; the corresponding buttock sensor ARD values were @ % ( @ % ) .


With abdomen sensors under minimal calibration ( mean , @ @ times/day ) , the mean ( median ) ARD values were @ % ( @ % ) .


Mean ARD values of abdomen sensors at rates of change of < @ , @-@ , and > @ mg/dL/min were @ % , @ % , and @ % , respectively .


With abdomen sensors , @ % and @ % of hypoglycemic and hyperglycemic events , respectively , were correctly detected ; @ % and @ % of hypoglycemic and hyperglycemic alerts , respectively , were confirmed .


The failure rates for abdomen and buttock sensors were @ % and @ % , respectively .


Mean responses to survey questions for all subjects related to comfort and ease of use were favorable .


The Enlite sensor provided accurate data at different glucose concentrations and rates of change .


Subjects found the sensor comfortable and easy to use .


Human autoimmune myocarditis is characterized by an increased frequency of serum organ and disease-specific anti-heart autoantibodies ( AHA ) in affected patients .


To assess whether AHA are directly pathogenic , we used the passive transfer technique of AHA from patients to normal Balb/c mice to induce an experimental myocarditis .


In keeping with a classical passive transfer experiment , sera from @ AHA positive myocarditis patients ( @ male , mean age @ @ years , @ with giant cell and @ with lymphocytic myocarditis ) were affinity purified and injected into @ Balb/c mice .


As controls , affinity purified sera from @ healthy donors were passively transferred to @ Balb/c mice .


Further @ control mice were injected with phosphate-buffered saline and @ mice did not receive any injection .


In all patients cardiac-specific AHA of IgG class had been previously detected by an indirect immunofluorescence ( IFL ) technique on cryostat sections of O blood group human heart .


The animals were sacrificed after @ weeks and the hearts were blindly examined for histological evidence of myocarditis by an expert cardiac pathologist .


Myocarditis was present in @/@ ( @ % ) of the mice which received affinity-purified IgG from patients .


The findings of severe , moderate or mild myocarditis were more common in the mice which received affinity-purified IgG from patients ( @ % ; @ % and @ % ) than in control animals ( @ % , p = @ ; @ % , p = @ ; and @ % , p = @ respectively ) .


These findings provide a new evidence for AHA-mediated pathogenicity in human myocarditis , according to Rose-Witebsky criteria .


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


Prophylactic hypothermia is effective in laboratory models , but clinical studies to date have been inconclusive , partly because of methodological limitations .


Our Prophylactic Hypothermia Trial to Lessen Traumatic Brain Injury ( POLAR ) randomised controlled trial is currently underway comparing early , sustained hypothermia versus standard care in patients with severe TBI .


We describe our study protocol and the challenges in conducting prophylactic hypothermia research in TBI .


We aim to randomise @ patients to either prophylactic @C hypothermia initiated within @ hours of injury and continued for at least @ hours , or standard normothermic management .


Patients will be enrolled by paramedic services in the prehospital setting , or by emergency department staff at participating sites in Australia , New Zealand and Europe .


The primary outcome will be the eight-level extended Glasgow outcome scale ( GOSE ) , dichotomised to favourable and unfavourable outcomes at @ months after injury .


Secondary outcomes will include mortality at hospital discharge and at @ months , ordinal analyses of @-month GOSE outcomes , quality of life with health economic evaluations and the differential proportion of adverse events .


We will predefine subgroup and interaction analyses .


After a run-in phase , recruitment for our main study began in December @ .


When the study is completed , we aim to provide evidence on the efficacy of prophylactic hypothermia in TBI to guide clinicians in their management of this devastating condition .


To assess the efficacy and safety of fluvastatin sodium extended-release tablets ( fluvastatin XL ) @ mg once daily compared to fluvastatin sodium immediate-release capsules ( fluvastatin IR ) @ mg twice daily in Chinese hyperlipidemic patients with moderate or high cardiovascular risk .


In this multi-center , randomized , double-blind , double-dummy , active-controlled , parallel-group study , after @-week open-label treatment with fluvastatin IR @ mg once daily , patients who did not reach their lipid goals were randomized to @-week double-blind treatment with fluvastatin XL @ mg once daily or fluvastatin IR @ mg twice daily .


( @ ) There were @ patients enrolled in each group .


At the study endpoint , no statistical difference was found in the mean percent change from baseline for LDL-C with -@ % -LSB- from ( @ @ ) mmol/L to ( @ @ ) mmol/L -RSB- in the fluvastatin XL group and -@ % -LSB- from ( @ @ ) mmol/L to ( @ @ ) mmol/L -RSB- in the fluvastatin IR group ( P > @ ) .


The @ % CI for difference between the two groups in adjusted mean percent change from baseline was ( -@ % -@ % ) , which was within the pre-specified non-inferiority margin .


In the fluvastatin XL group , the proportion of patients with moderate cardiovascular ( CV ) risk and high CV risk achieving their LDL-C treatment goals at endpoint was @ % and @ % respectively , while the proportion was @ % and @ % respectively in the fluvastatin IR group .


No significant difference was found between the two groups in the proportion of patients who reached their lipid goals and the changes from baseline with other lipid parameters .


( @ ) Similar safety profiles were observed in the two treatment groups , with @ % adverse event ( AE ) ( @ % study-drug related AE ) in the fluvastatin XL group and @ % AE ( @ % study-drug related AE ) in the fluvastatin IR group .


The efficacy of fluvastatin XL @ mg once daily is comparable to fluvastatin IR @ mg twice daily in Chinese hyperlipidemic patients with moderate or high cardiovascular risk and both treatments are safe and well-tolerated .


The purpose of this study was to evaluate the short-term effects of classic massage ( CM ) and connective tissue massage ( CTM ) on pressure pain threshold and muscle relaxation response in women with chronic neck pain .


Participants included @ female volunteers ( ages between @ and @ years ) presenting to the Kroglu State Hospital Neurosurgery Polyclinic who had experienced neck pain for @ to @ months .


The volunteers were randomly assigned to @ groups ( CM or CTM to the thoracic spine and the neck ) .


Each treatment was carried out for @ session .


Outcome measures were obtained before and after treatment , which included pressure pain threshold that was measured with an algometer and muscle relaxation response that was evaluated with electromyography biofeedback ( EMG-BF ) .


Pressure pain threshold of the sternocleidomastoid muscle was significantly different for the CM ( P < @ ) group .


The EMG-BF values were significantly different for the CTM group ( P < @ ) .


Comparing the results of CM and CTM , EMG-BF averages favored the CTM group ( P < @ ) .


For the group of women with chronic neck pain that were included in this study , @ treatment of CTM demonstrated relaxation responses and @ treatment of CM demonstrated pain reduction .


It is unclear whether advising a prudent breakfast alone is sufficient to improve blood lipids and cardiometabolic risk factors in overweight hypercholesterolemic subjects .


The aim of this study was to investigate whether a prudent low-fat breakfast ( PB ) rich in dietary fiber lowers low-density lipoprotein cholesterol ( LDL-C ) and other cardiometabolic risk factors in subjects with elevated LDL-cholesterol levels .


In a parallel , controlled , @-week study , @ healthy overweight subjects ( all regular breakfast eaters ) were randomly allocated to a group that received a PB based on Nordic foods provided ad libitum or a control group that consumed their usual breakfast .


The primary outcome was plasma LDL-C .


Secondary outcomes were other blood lipids , body weight , sagittal abdominal diameter ( SAD ) , glucose tolerance , insulin sensitivity and inflammation markers ( C-reactive protein -LSB- CRP -RSB- and tumor necrosis factor receptor-@ -LSB- TNF-R@ -RSB- ) , and blood pressure .


The PB was in accordance with national and Nordic nutrition recommendations and included oat bran porridge with low-fat milk or yogurt , bilberry or lingonberry jam , whole grain bread , low-fat spread , poultry or fatty fish , and fruit .


No differences were found in LDL-C , other blood lipids , body weight , or glucose metabolism , but SAD , plasma CRP , and TNF-R@ decreased more during PB compared with controls ( p < @ ) .


In the overall diet , PB increased dietary fiber and - glucan compared with controls ( p < @ ) .


Advising a prudent breakfast for @ months did not influence blood lipids , body weight , or glucose metabolism but reduced markers of visceral fat and inflammation .


The trial was registered in the Current Controlled Trials database ( http://www.controlled-trials.com ) ; International Standard Randomized Controlled Trial Number ( ISRCTN ) : @ .


Varicose veins are treated under local infiltration anesthesia .


Literature shows that adding sodium bicarbonate reduces the pain associated with local infiltration anesthesia .


Nonetheless , sodium bicarbonate is underused .


We sought to assess if the use of a solution of mepivacaine @ % plus adrenaline with sodium bicarbonate @ % results in less pain associated with local infiltration anesthesia preceding ambulatory phlebectomies , compared with standard preparation diluted with normal saline .


In all , @ adult patients undergoing scheduled ambulatory phlebectomy were randomized to receive either a solution of mepivacaine chlorhydrate @ % plus adrenaline in sodium bicarbonate @ % or a similar solution diluted in normal saline @ % .


Median pain scores associated with local infiltration anesthesia reported in the intervention and control groups were @ ( SD = @ ) and @ ( SD = @ ) ( P < @ ) , respectively .


A general linear model with bootstrapped confidence intervals showed that using the alkalinized solution would lead to a reduction in pain rating of about @ points .


Patients were not asked to distinguish the pain of the needle stick from the pain of the infiltration .


Moreover , a complete clinical study of sensitivity on the infiltrated area was not conducted .


Data obtained from this study may contribute to improve local infiltration anesthesia in ambulatory phlebectomy and other phlebologic procedures .


We hypothesized that the time to successful fibreoptic tracheal intubation through the nasal route would be faster than the oral route for both experts and trainees in children < @ yr of age .


One hundred children , @ months and under in age , were randomized to an operator ( expert or trainee ) , and route ( nasal or oral ) for fibreoptic tracheal intubation .


Three separate times were then measured : ( i ) time to first glottic view , ( ii ) time to carinal view , and ( iii ) total time to successful tracheal intubation .


The number of attempts made , manoeuvres needed to obtain an adequate laryngeal view , and manoeuvres for tracheal tube passage were also recorded .


Time to successful tracheal intubation was significantly faster for experts than trainees .


There was no difference in the time to tracheal intubation between the nasal and oral routes for experts .


In trainees , intubation times were shorter for the nasal route-median ( inter-quartile range ) time ( s ) to carinal view was @ ( @-@ ) for the nasal route vs @ ( @-@ ) for the oral route ( P = @ ) , and the median time to successful tracheal intubation were @ ( @-@ ) vs @ ( @-@ ) , P = @ , for the nasal and oral routes , respectively .


For trainees , the oral route required a greater number of airway manoeuvres for adequate laryngeal views and passage of the tracheal tube compared with the nasal route .


For clinicians with less experience in using paediatric bronchoscopes , fibreoptic tracheal intubation through the nasal route may be a more straightforward process than the oral route in children < @ yr of age .


Adverse events ( AEs ) , defined as unintended patient harm related to healthcare provided rather than an underlying medical condition , represent a significant threat to patient safety and public health .


The emergency department ( ED ) is a high-risk patient safety setting for many reasons including presentation ` outside of regular hours ' , high patient volumes , and a chaotic work environment .


Children have also been identified as particularly vulnerable to AEs .


Despite the identification of the ED as a high-risk setting and the vulnerability of the paediatric population , little research has been conducted regarding paediatric patient safety in the ED .


The study objective is to generate an estimate of the risk and type of AEs , as well as their preventability and severity , for children seen in Canadian paediatric EDs .


This multicentre , prospective cohort study will enrol patients under @ years of age from nine paediatric EDs across Canada .


A stratified cluster random sampling scheme will be used to ensure patients recruited are representative of the overall ED population .


A rigorous , standardised two-stage process will be used for AE identification .


The primary outcome will be the proportion of children with AEs associated with ED care in the @ weeks following the ED visit .


Secondary outcomes will include the proportion of children with preventable AEs and the types and severity of AEs .


We will aim to recruit @ patients over @ year and this will allow us to detect a proportion of patients with an AE of @ % ( to within an absolute margin of error of @ % ) .


To investigate whether Wii Sports Resort training is effective and if any benefits are maintained .


Randomized , single-blind trial .


Sixty-two hemiplegic children with cerebral palsy ( @-@ years ) .


Experimental group undertook six weeks of home-based Wii Sports Resort training plus usual therapy , while the control group received usual therapy .


Outcomes were coordination , strength , hand function , and carers ' perception of hand function , measured at baseline , six , and @ weeks by a blinded assessor .


There was a trend of mean difference ( MD ) for the experimental group to have more grip strength by six ( MD @ N , @ % confidence interval ( CI ) -@ to @ , p = @ ) and @ ( MD @ N , @ % CI -@ to @ , p = @ ) weeks , and to have a higher quantity of hand function according to carers ' perception by six ( MD @ N , @ % CI -@ to @ , p = @ ) and strengthened by @ ( MD @ , @ % CI @ to @ , p = @ ) weeks than the control group .


There was no difference between groups in coordination and hand function by six or @ weeks .


Wii training did not improve coordination , strength , or hand function .


Beyond the intervention , carers perceived that the children used their hands more .


Sickle cell disease ( SCD ) is a genetic disorder common in malaria endemic areas .


In endemic areas , malaria is a major cause of morbidity and mortality among SCD patients .


This suggests the need for prompt initiation of efficacious anti-malarial therapy in SCD patients with acute malaria .


However , there is no information to date , on the efficacy or safety of artemisinin combination therapy when used for malaria treatment in SCD patients .


Children with SCD and acute uncomplicated malaria ( n = @ ) were randomized to treatment with artesunate-amodiaquine ( AA ) , or artemether-lumefantrine ( AL ) .


A comparison group of non-SCD children ( HbAA genotype ; n = @ ) with uncomplicated malaria were also randomized to treatment with AA or AL. .


Recruited children were followed up and selected investigations were done on days @ , @ , @ , @ , @ , @ , @ , and @ .


Selected clinical and laboratory parameters of the SCD patients were also compared with a group of malaria-negative SCD children ( n = @ ) in steady state .


The parasite densities on admission were significantly lower in the SCD group , compared with the non-SCD group ( p = @ ) .


The parasite reduction ratio ( PRR ) was lower , clearance was slower ( p < @ ) , and time for initial parasitaemia to decline by @ and @ % were longer for the SCD group .


Adequate clinical and parasitological response ( ACPR ) on day @ was @ % ( @/@ ) in the SCD group and @ % ( @/@ ) in the non-SCD group .


Corresponding ACPR rates on day @ were @ % ( @/@ ) in the SCD group and @ % ( @/@ ) in the non-SCD group .


The fractional changes in haemoglobin , platelets and white blood cell counts between baseline ( day @ ) and endpoint ( day @ ) were @ , @ and @ % , respectively , for the SCD group , and , @ , @ and @ % , respectively , for the non-SCD group .


There were no differences in these indices between AA - and AL-treated subjects .


The parasite clearance of SCD children with uncomplicated malaria was slower compared with non-SCD children .


AA and AL showed similar clinical and parasitological effects in the SCD and non-SCD groups .


The alterations in WBC and platelet counts may have implications for SCD severity .


To investigate the pharmacokinetics of enteric-coated mycophenolate sodium ( EC-MPS ) and the clinical outcome in kidney transplant recipients in the early post-transplantation phase .


Then explain which regimen is more suitable for Chinese renal transplant recipients .


In total , @ de novo kidney transplant recipients treated with tacrolimus and steroids were randomised to receive EC-MPS at standard dose ( SD ; @mg/day ; n = @ ) or low dose ( LD ; @mg/day ; n = @ ) .


Efficacy parameters , safety and tolerability were assessed over a @-month study period .


Full mycophenolic acid ( MPA ) areas under the curve ( AUCs ) were completed on days @ and @ , whereas a three-point limited sampling strategy ( LSS ) was utilised for MPA AUC assessments at @weeks and months @ , @ and @ ( the LSS for three-time-point MPA AUC @-@h ( mgh/l ) = @ +@ C@h +@ C@h +@ C@h ; r ( @ ) = @ .


The mean AUC levels at day @ and day @ in the SD group were significantly higher than in the LD group ( @ mgh/l vs. @ mgh/l and @ mgh/l vs. @ mgh/l , respectively , p < @ ) .


There was a trend for fewer clinically diagnosed acute rejections in the SD group vs. the LD group at @months ( @ % vs. @ % ) .


This trend was also present when acute rejection was analysed as biopsy-proven cases .


There were significantly more acute rejections ( all definitions ) in patients with MPA AUC levels < @mgh/l compared with those with MPA AUC levels @mgh/l within @months ( p < @ ) .


Renal function , incidence of infection and haematological disorders were not significantly different in either study group .


Early adequate MPA exposure in renal transplant recipients can be achieved with a higher starting dose .


In addition , a SD regimen was as well-tolerated as a LD regimen .


Furthermore , early adequate MPA exposure significantly lowered the rate of acute rejection without compromising safety and tolerability .


Blunt head trauma is a common cause of death and disability in children worldwide .


Cranial computed tomography ( CT ) , the reference standard for the diagnosis of traumatic brain injury ( TBI ) , exposes children to ionizing radiation which has been linked to the development of brain tumors , leukemia , and other cancers .


We describe the methods used to develop and test the effectiveness of a decision aid to facilitate shared decision-making with parents regarding whether to obtain a head CT scan or to further observe their child at home .


This is a protocol for a multicenter clinician-level parallel randomized trial to compare an intervention group receiving a decision aid , ` Head CT Choice ' , to a control group receiving usual care .


The trial will be conducted at five diverse emergency departments ( EDs ) in Minnesota and California .


Clinicians will be randomized to decision aid or usual care .


Parents visiting the ED with children who are less than @-years-old , have experienced blunt head trauma within @ hours , and have one or two risk factors for clinically-important TBI ( ciTBI ) from the Pediatric Emergency Care Applied Research Network head injury clinical prediction rules will be eligible for enrollment .


We will measure the effect of Head CT Choice on : ( @ ) parent knowledge regarding their child 's risk of ciTBI , the available diagnostic options , and the risks of radiation exposure associated with a cranial CT scan ( primary outcome ) ; ( @ ) parent engagement in the decision-making process ; ( @ ) the degree of conflict parents experience related to feeling uninformed ; ( @ ) patient and clinician satisfaction with the decision made ; ( @ ) the rate of ciTBI at seven days ; ( @ ) the proportion of patients in whom a cranial CT scan is obtained ; and ( @ ) seven-day healthcare utilization .


To capture these outcomes , we will administer parent and clinician surveys immediately after each clinical encounter , obtain video recordings of parent-clinician discussions , administer parent healthcare utilization diaries , analyze hospital billing records , review the electronic medical record , and conduct telephone follow-up .


This multicenter trial will robustly assess the effectiveness of a decision aid on patient-centered outcomes , safety , and healthcare utilization in parents of children with minor head trauma in five diverse EDs .


The aim of the study was to evaluate whether dietary intervention could reduce maternal and perinatal morbidity in pregnancies with one elevated @ g oral glucose tolerance test ( OGTT ) value .


The study was conducted among patients with positive @ g glucose challenge test ( GCT ) and one elevated @ g OGTT value .


Plasma glucose value of @ mg/dL was used as the threshold to define an abnormal GCT result .


Carpenter and Coustan criteria were used to evaluate the OGTT results .


Seventy-four women with normal GCT values comprised group I. Ninety-nine women with one elevated @ g OGTT value who were given a caloric diet and @ women with one elevated OGTT value in group III who received antenatal care with no special diet were randomly assigned to groups II and III , respectively .


All women were followed up until the end of pregnancy .


Poor maternal outcome was defined as : cesarean delivery performed due to cephalopelvic disproportion , failure to progress or fetal distress , preeclampsia , and/or preterm labor .


Poor perinatal outcome was defined as : small for gestational age , large for gestational age or admission to a neonatal intensive care unit .


The groups were compared in terms of maternal and perinatal outcomes .


The rates of macrosomia and large for gestational age incidence were significantly higher in group III as compared to groups I and II .


When we examined the multivariate effects of the risk factors considered to be predictive of poor maternal outcomes , group III was the only statistically significant risk factor ( OR = @ , @ % CI :@ - @ ; p = < @ ) .


In terms of poor perinatal outcome , one elevated OGTT value ( group III ) was the only significant risk factor ( OR = @ , @ % CI :@ -@ ; p = < @ ) .


Women with one elevated OGTT value benefit from a structured program of diet therapy aimed to reduce adverse maternal and perinatal outcomes .


Solar ultraviolet ( UV ) radiation has deleterious effects on the skin , including sunburn , photoaging and cancer .


Chocolate flavanols are naturally-occurring antioxidant and anti-inflammatory molecules that could play a role in preventing cutaneous UV damage .


We investigated the influence of @-week high-flavanol chocolate ( HFC ) consumption on skin sensitivity to UV radiation , measured by minimal erythema dose ( MED ) .


We also evaluated skin elasticity and hydration .


In this @-group , parallel , double-blind , randomized controlled trial , @ women aged @-@ years and Fitzpatrick skin phototypes I or II were recruited from the general community in Quebec City , for randomization to either HFC ( n = @ ) or low-flavanol chocolate ( LFC ) ( n = @ ) .


A blocked randomisation ( @ ) , considering date of entry , skin type and age as factors , generated a sequentially-numbered allocation list .


Study participants and research assistants were blinded .


Totally , @g of chocolate were consumed daily for @weeks , followed by a @-week washout period .


MED was assessed at baseline and at @ , @ , @ and @weeks .


Main outcome was changes in MED at week @ .


@ participants in the HFC group and @ in the LFC group were analyzed with @weeks of follow-up .


Both groups showed similarly-increased MED at @weeks ( HFC : @ J/cm@ -LSB- meanstandard deviation ( SD ) -RSB- ; LFC : @ ; mean difference ( MD ) : @ J/cm@ ; @ % confidence interval ( CI ) : -@ to @ ) .


However , after @-week washout , the HFC group presented decreased MED ( -@ ) whereas no effect was seen in the LFC group ( @ ) ( MD : -@ ; @ % CI : -@ to @ ) .


Net temple elasticity increased slightly but significantly by @ mm in the HFC group at @weeks compared to @ mm in the LFC group ( MD : @ ; @ % CI : @ to @ ) .


No significant adverse events were reported .


Our study failed to demonstrate a statistically-significant protective effect of HFC vs. LFC consumption on skin sensitivity to UV radiation as measured by MED .


Timely and efficient upper esophageal sphincter ( UES ) opening may be critical to safe transport of food or liquid to the stomach and to prevent aspiration during the swallow .


The purpose of this study was to examine the temporal and biomechanical characteristics of the UES opening in stroke survivors .


Maximum duration and width of the UES opening were obtained from @ stroke survivors with aspiration and @ stroke survivors with no aspiration .


The control group was composed of @ normal subjects undergoing videofluoroscopic swallowing examinations .


The videofluoroscopic swallowing examination protocol was as follows : two swallows of @ ml thin liquid and two swallows of @ ml thin liquid .


Statistical comparisons were made by repeated measurements of analysis of variance , and the significance level was set at P < @ .


The stroke survivors with aspiration , the stroke survivors without aspiration , and the control group differed significantly for duration of UES opening ( P < @ ) but not maximum width of UES opening .


Prolonged UES opening may be related to prolonged pharyngeal transition of the bolus and slower UES muscle contraction and hyolaryngeal excursion after stroke .


Ceftobiprole , the active moiety of ceftobiprole medocaril , is a novel broad-spectrum cephalosporin , with bactericidal activity against a wide range of gram-positive bacteria , including Staphylococcus aureus ( including methicillin-resistant strains ) and penicillin - and ceftriaxone-resistant pneumococci , and gram-negative bacteria , including Enterobacteriaceae and Pseudomonas aeruginosa .


This was a double-blind , randomized , multicenter study of @ patients with hospital-acquired pneumonia ( HAP ) , including @ with ventilator-associated pneumonia ( VAP ) .


Treatment was intravenous ceftobiprole @ mg every @ hours , or ceftazidime @ g every @ hours plus linezolid @ mg every @ hours ; primary outcome was clinical cure at the test-of-cure visit .


Overall cure rates for ceftobiprole vs ceftazidime/linezolid were @ % vs @ % ( intent-to-treat -LSB- ITT -RSB- , @ % confidence interval -LSB- CI -RSB- for the difference , -@ to @ ) and @ % vs @ % ( clinically evaluable -LSB- CE -RSB- , @ % CI , -@ to @ ) .


Cure rates in HAP ( excluding VAP ) patients were @ % vs @ % ( ITT , @ % CI , -@ to @ ) , and @ % vs @ % ( CE , @ % CI , -@ to @ ) .


Cure rates in VAP patients were @ % vs @ % ( ITT , @ % CI , -@ to -@ ) and @ % vs @ % ( CE , @ % CI , -@ to @ ) .


Microbiological eradication rates in HAP ( excluding VAP ) patients were , respectively , @ % vs @ % ( microbiologically evaluable -LSB- ME -RSB- , @ % CI , -@ to @ ) , and in VAP patients @ % vs @ % ( ME , @ % CI , -@ to -@ ) .


Treatment-related adverse events were comparable for ceftobiprole ( @ % ) and ceftazidime/linezolid ( @ % ) .


Ceftobiprole is a safe and effective bactericidal antibiotic for the empiric treatment of HAP ( excluding VAP ) .


Further investigations are needed before recommending the use of ceftobiprole in VAP patients .


Clinical Trials Registration .


NCT@ , NCT@ .


The efficacy of nebulized sodium nitrite ( AIR@ ) has been demonstrated in animal models of pulmonary arterial hypertension ( PAH ) , but it was not known if inhaled nitrite would be well tolerated in human subjects at exposure levels associated with efficacy in these models .


Inhaled nebulized sodium nitrite was assessed in three independent studies in a total of @ healthy male and female subjects .


Study objectives included determination of the maximum tolerated dose ( MTD ) and dose-limiting toxicity ( DLT ) under normal and mildly hypoxic conditions , and following co-administration with steady-state sildenafil , assessment of nitrite pharmacokinetics , and evaluation of the fraction exhaled nitric oxide ( FENO ) and concentrations of iron-nitrosyl hemoglobin ( Hb ( Fe ) - NO ) and S-nitrosothiols ( R-SNO ) as biomarkers of local and systemic NO exposure , respectively .


Nebulized sodium nitrite was well tolerated following @days of every @ h administration up to @mg , producing significant increases in circulating Hb ( Fe ) - NO , R-SNO , and FENO .


Pulmonary absorption of nitrite was rapid and complete , and plasma exposure dose was proportional through the MTD dosage level of @mg , without accumulation following repeated inhalation .


At higher dosage levels , DLTs were orthostasis ( observed at @mg ) and hypotension with tachycardia ( at @mg ) , but venous methemoglobin did not exceed @ % at any time in any subject .


Neither the tolerability nor pharmacokinetics of nitrite was impacted by conditions of mild hypoxia , or co-administration with sildenafil , supporting the safe use of inhaled nitrite in the clinical setting of PAH .


On the basis of these results , nebulized sodium nitrite ( AIR@ ) has been advanced into randomized trials in PAH patients .


To determine if temperature regulation is improved during neonatal transport using a servo-regulated cooling device when compared with standard practice .


We performed a multicenter , randomized , nonmasked clinical trial in newborns with neonatal encephalopathy cooled during transport to @ neonatal intensive care units in California .


Newborns who met institutional criteria for therapeutic hypothermia were randomly assigned to receive cooling according to usual center practices vs device servo-regulated cooling .


The primary outcome was the percentage of temperatures in target range ( @-@C ) during transport .


Secondary outcomes included percentage of newborns reaching target temperature any time during transport , time to target temperature , and percentage of newborns in target range @ hour after cooling initiation .


One hundred newborns were enrolled : @ to control arm and @ to device arm .


Baseline demographics did not differ with the exception of cord pH. For each subject , the percentage of temperatures in the target range was calculated .


Infants cooled using the device had a higher percentage of temperatures in target range compared with control infants ( median @ % -LSB- IQR @-@ -RSB- vs @ % -LSB- IQR @-@ -RSB- , P < @ ) .


More subjects reached target temperature during transport using the servo-regulated device ( @ % vs @ % , P < @ ) , and in a shorter time period ( @ @ minutes vs @ @ minutes , P = @ ) .


Device-cooled infants reached target temperature by @ hour with greater frequency than control infants ( @ % vs @ % , P < @ ) .


Cooling using a servo-regulated device provides more predictable temperature management during neonatal transport than does usual care for outborn newborns with neonatal encephalopathy .


Analysis of the patient-therapist relationship ( relationship work ) is considered a core active ingredient in dynamic psychotherapy .


However , there are contradictory findings as for whom and under what circumstances these interventions are beneficial .


This study investigates long-term effects of relationship work in the context of patients ' level of personality pathology and therapists ' self-reported parental feelings .


One hundred outpatients seeking psychotherapy for depression , anxiety , and personality disorders were randomly assigned to weekly dynamic psychotherapy , either with or without relationship work , for @ year .


Personality pathology was evaluated before treatment as the sum of fulfilled personality disorder criteria items on the Structured Clinical Interview for DSM-III-R Personality Disorders .


Therapist feelings were assessed using the Feeling Word Checklist-@ .


The outcome variables were the Psychodynamic Functioning Scales and Inventory of Interpersonal Problems , measured at pretreatment , midtreatment , posttreatment , @ year , and @ years after treatment termination .


A significant interaction of treatment group ( relationship work vs. no relationship work ) by personality pathology by parental therapist feelings was present , indicating that parental feelings were differentially associated with long-term effects of relationship work , depending on the level of personality pathology .


In the context of low parental feelings , relationship work was positive for all patients .


However , when parental feelings were stronger , the specific effects of such interventions were even more positive for patients with high levels of personality pathology , but negative for patients with low levels of personality pathology .


The interaction of parental therapist feelings and patients ' personality pathology was strongly associated with the long-term specific effects of analysis of the patient-therapist relationship .


A number of effective strategies have been developed to improve the quality of life in patients with COPD .


However , few have been implemented in patients with COPD at all stages in a community setting .


This study evaluated the efficacy of a complex COPD health management intervention in rural communities in China .


A randomized controlled trial including @,@ subjects with COPD was implemented from May @ to May @ in @ community health-care centers .


The control group of subjects received usual care , whereas the management group of subjects participated in a health management program that included assessing the subjects ' health status , giving regular health lectures , smoking cessation counseling , encouraging regular exercise , providing rehabilitative training and psychological counseling , and regular follow-up .


As a primary outcome , we examined the changes in the BODE index .


Secondary outcomes included depression and anxiety rates , current smoking rate , awareness of COPD , mortality , risk factors , respiratory medication use , hospital admissions , and emergency department visits .


After @ y , the mean cumulative value of the BODE index increased by @ per subject in the control group and decreased by @ per subject in the health management group ( difference of @ , @ % CI @-@ @ , P < @ ) .


Health management reduced anxiety symptoms by @ % , depression symptoms by @ % , current smoking by @ % , mortality due to all causes by @ % , hospitalizations due to all causes by @ % , and emergency department visits due to all causes by @ % ( P < @ for all ) .


However , it increased immunomodulator use by @ % , respiratory medication use by @-@ @ % , and awareness scores for COPD by @ % ( P < @ for all ) .


The health management program is an effective community-based strategy for the prevention and management of COPD in China , increasing awareness and knowledge among patients and practitioners and improving management within the limitations of access to pharmacotherapy .


Telomeres are repetitive nucleoproteins that help maintain chromosomal stability by inhibiting exonucleolytic degradation , prohibiting inappropriate homologous recombination , and preventing chromosomal fusions by suppressing double-strand break signals .


We recently observed that men treated for clinically localized prostate cancer with shorter telomeres in their cancer-associated stromal cells , in combination with greater variation in cancer cell telomere lengths , were significantly more likely to progress to distant metastases , and die from their disease .


Here , we hypothesized that shorter stromal cell telomere length would be associated with prostate cancer risk at time of biopsy .


Telomere-specific fluorescence in situ hybridization ( FISH ) analysis was performed in normal-appearing stromal , basal epithelial , and luminal epithelial cells in biopsies from men randomized to the placebo arm of the Prostate Cancer Prevention Trial .


Prostate cancer cases ( N = @ ) were either detected on a biopsy performed for cause or at the end of the study per trial protocol , and controls ( N = @ ) , defined as negative for cancer on an end-of-study biopsy performed per trial protocol ( e.g. , irrespective of indication ) , were sampled .


Logistic regression was used to estimate the association between mean telomere length of the particular cell populations , cell-to-cell telomere length variability , and risk of prostate cancer .


Men with short stromal cell telomere lengths ( below median ) had @ ( @ % CI @-@ @ ; P = @ ) times the odds of prostate cancer compared with men who had longer lengths ( at or above median ) .


Conversely , we did not observe statistically significant associations for short telomere lengths in normal-appearing basal ( OR = @ , @ % CI @-@ @ ; P = @ ) or luminal ( OR = @ , @ % CI @-@ @ ; P = @ ) cells .


These findings suggest that telomere shortening in normal stromal cells is associated with prostate cancer risk .


It is essential to extend and validate these findings , while also identifying the cellular milieu that comprises the subset of cells with short telomeres within the prostate tumor microenvironment .


Exposure to particulate air pollution increases respiratory and cardiovascular morbidity and mortality , especially in elderly , possibly through inflammation and vascular dysfunction .


We examined potential beneficial effects of indoor air filtration in the homes of elderly , including people taking vasoactive drugs.Forty-eight nonsmoking subjects ( @ to @ years ) in @ homes were included in this randomized , double-blind , crossover intervention study with consecutive two-week periods with or without the inclusion of a high-efficiency particle air filter in re-circulating custom built units in their living room and bedroom .


We measured blood pressure , microvascular and lung function and collected blood samples for hematological , inflammation , monocyte surface and lung cell damage markers before and at day @ , @ and @ during each exposure scenario .


The particle filters reduced the median concentration of PM@ @ from approximately @ to @ g/m@ and the particle number concentration from @ to @ particles/cm@ .


No statistically significant effects of filtration as category were observed on microvascular and lung function or the biomarkers of systemic inflammation among all subjects , or in the subgroups taking ( n = @ ) or not taking vasoactive drugs ( n = @ ) .


However , the filtration efficacy was variable and microvascular function was within @ days significantly increased with the actual PM@ @ decrease in the bedroom , especially among @ subjects not taking any drugs .


Substantial exposure contrasts in the bedroom and no confounding by drugs appear required for improved microvascular function by air filtration , whereas no other beneficial effect was found in this elderly population .


Postmenopausal women have a high prevalence of hypertension and often develop arterial stiffness thereby increasing cardiovascular disease risk .


Although antihypertensive drug therapies exist , increasing numbers of people prefer natural therapies .


In vivo studies and a limited number of clinical studies have demonstrated the antihypertensive and vascular-protective effects of blueberries .


To examine the effects of daily blueberry consumption for @ weeks on blood pressure and arterial stiffness in postmenopausal women with pre - and stage @-hypertension .


This was an @-week , randomized , double-blind , placebo-controlled clinical trial .


Forty-eight postmenopausal women with pre - and stage @-hypertension recruited from the greater Tallahassee , FL , area participated .


Participants were randomly assigned to receive either @ g freeze-dried blueberry powder or @ g control powder .


Resting brachial systolic and diastolic blood pressures were evaluated and arterial stiffness was assessed using carotid-femoral pulse wave velocity and brachial-ankle pulse wave velocity .


C-reactive protein , nitric oxide , and superoxide dismutase were measured at baseline , @ weeks , and @ weeks .


Statistical analysis was performed using a split plot model of repeated measures analysis of variance .


After @ weeks , systolic blood pressure and diastolic blood pressure ( @ mm Hg -LSB- P < @ -RSB- and @ mm Hg -LSB- P < @ -RSB- , respectively ) and brachial-ankle pulse wave velocity ( @,@ cm/second ; P < @ ) were significantly lower than baseline levels ( @ mm Hg , @ mm Hg , and @,@ cm/second , respectively ) , with significant ( P < @ ) grouptime interactions in the blueberry powder group , whereas there were no changes in the group receiving the control powder .


Nitric oxide levels were greater ( @ mol/L ; P < @ ) in the blueberry powder group at @ weeks compared with baseline values ( @ mol/L ) , whereas there were no changes in the control group .


Daily blueberry consumption may reduce blood pressure and arterial stiffness , which may be due , in part , to increased nitric oxide production .


To evaluate and compare the @-year postoperative levels of posterior capsule opacification ( PCO ) as well as the level of anterior capsule retraction and opacification ( ACO ) after implantation of two single-piece hydrophobic acrylic intraocular lens ( IOL ) models .


Randomised , controlled , prospective and double-blind study including @ eyes of @ patients ( age range , @-@ years ) with bilateral senile cataract .


Each patient underwent surgery with implantation of an AcrySof SA@AT ( Group A ) in one eye and Tecnis ZCB@ ( Group B ) in the fellow eye by the same experienced surgeon .


Lens allocation to the first or second operated eye followed a randomisation process .


At @ months postoperatively , the PCO level was evaluated with the Evaluation of Posterior Capsule Opacification software , whereas the level of ACO and capsule retraction was evaluated and graded subjectively .


All surgeries were uneventful .


The mean PCO scores were @ @ and @ @ in Groups A and B , respectively , with no statistically significant differences between the groups ( p = @ ) .


No significant correlation was found between the PCO scores in Groups A and B ( r = @ , p = @ ) .


Regarding ACO , it was present in @ eyes ( @ % ) and two eyes ( @ % ) in Groups A and B , respectively ( p = @ ) .


Capsular phimosis ( @ eyes , @ % ) was only observed in Group A.


Both IOLs had a similar low rate of PCO @ year after surgery .


However , there seems to be a difference in the anterior capsule behaviour between both IOL models .


Subjective symptoms represent significant criteria of a patient 's health condition ; therefore , we focused on the long-term prevalence of heart failure symptoms and angina pectoris after myocardial infarction between two groups of patients in which two different therapeutic strategies were used during the acute phase of ST-elevation myocardial infarction ( STEMI ) .


The PRAGUE-@ study enrolled @ patients with STEMI .


The patients were randomized into two groups - transport to a primary percutaneous coronary intervention ( PCI ) centre ( n = @ ) vs. fibrinolysis in community hospitals ( n = @ ) .


The data were collected from either primary hospitals or PCI centres , as well as via questionnaires .


The mean follow-up was @ months .


At @ years , @ % of patients were in New York Heart Association class I following primary PCI vs. @ % of those treated with fibrinolysis ( OR @ , @ % CI @-@ @ , p < @ ) .


At @ years , @ % of patients had no symptoms of angina pectoris following invasive therapy vs. @ % of patients treated with fibrinolysis ( OR @ , @ % CI @-@ @ , p < @ ) .


The symptoms of angina pectoris and heart failure were significantly lower in patients assigned to primary PCI in the acute stage of myocardial infarction compared with patients treated with fibrinolysis at the @-year follow up .


Allergic rhinitis ( AR ) presents as the main and most invasive symptom in the blocking of the nose .


This condition is almost always related to hypertrophy of the inferior turbinates .


When the medical treatments are found to be insufficient to solve the obstructive symptom of the patient , the quality of life is considerably impaired and it is often necessary to submit the patient to a surgical approach .


In the present study we aimed to establish the efficacy and safety of a new technique recently introduced for the shrinkage of hypertrophic turbinates using a specific device , based on a new radiofrequency energy that does not produce thermal mucosal damage , viz. , quantic molecular resonance ( QMR ) in a group of patients with persistent moderate-severe allergic rhinitis , in addition to standard medical treatment ( nasal steroid and oral antihistamine ) .


All patients were randomly assigned to two homogeneous groups ( group A , control subjects ; group B , treated patients ) ; each group included @ individuals .


During the study , both groups received standard medications ( ebastine , @-mg tablet , and budesonide nasal spray at @ micrograms/nostril per day ) for @ days .


Before the medical treatment , patients in group B underwent inferior endoscopic turbinoplasty using QMR .


All of the patients enrolled in this study were submitted to a complete otorhinolaryngologic evaluation with objective clinical examination ( basal rhinomanometry , nasal provocation test rhinomanometry , and mucociliary transport time ) , endoscopy , and questionnaires ( @-item Sino-Nasal Outcome Test and visual analog scale for nasal symptoms ) .


Greater efficacy has been achieved using a combined approach with the association of medical and QMR treatment , compared with medical treatment alone , in the control of AR associated with hypertrophy of the inferior turbinates , in particular in the reduction of turbinate volume at rhinoendoscopy .


QMR inferior turbinoplasty , in conjunction with medical therapy , improves the nasal flow , without any thermal mucosal damage , more effectively when compared with medical treatment alone in persistent moderate-to-severe AR .


In particular , local reactivity , as measured with nasal provocation test , was noticeably reduced .


To assess whether immunization attenuates nicotinic stimulation of the brain and elucidate brain and behavioural responses during exposure to smoking cues and a working memory task .


Randomized , placebo-controlled parallel-group , repeated-measures design .


Maastricht University , the Netherlands .


Forty-eight male smokers were randomized to receive five injections with either @g/ml of the @ ' - aminomethylnicotine Pseudomonasaeruginosa r-Exoprotein-conjugated vaccine or placebo .


Subjects were tested on two occasions , once after a nicotine challenge and once after a placebo challenge , and were asked to refrain from smoking @ hours before testing .


Reaction-times and accuracies were recorded during an n-back task .


Moreover , regional blood oxygenated level-dependent ( BOLD ) response was measured during this task and during smoking cue exposure .


Greater activation was found in response to smoking cues compared to neutral cues in bilateral trans-occipital sulcus ( P < @ ) ; however , this effect did not survive correction for multiple comparisons .


There was no difference in brain activity to smoking cues between the treatment groups and no effects of acute nicotine challenge were established .


For the n-back task we found working memory load-sensitive increases in brain activity in several frontal and parietal areas ( P < @ ) .


However , no effects of immunization or nicotine challenge were observed .


No significant effects of immunization on brain activity in response to a nicotine challenge were established .


Therefore this vaccine is not likely to be an effective aid in smoking cessation .


The aim of the present study was to evaluate three mouth rinse solutions ' ( Plax , Listerine and Periogard ) influence on the microhardness and color stability of a composite resin ( Esthet.X , Dentsply ) .


For this purpose , forty specimens were prepared , being @ specimens for each solution and @ for artificial saliva ( control group ) .


Initially , specimens were polished and immersed in artificial saliva and following the initial color , an evaluation was made .


For @ days , specimens were immersed in the solutions three times a day for @ min .


After this cycling period , color change was analyzed and Knoop microhardness measures were carried out .


A new color measurement was performed after repolishing the specimens .


The microhardness and color stability results showed no statistically significant difference among the studied solutions .


However , samples immersed in Periogard showed a significant alteration in the composite resin brightness test .


It can be concluded that mouth rinse can influence the luminosity of composite resin .


To evaluate short-term perineal pain among primiparous women after mediolateral episiotomy ( MLE ) and lateral episiotomy ( LE ) .


The prospective randomized study was conducted in the Czech Republic during @-@ .


Consecutive primiparous women who gave birth at or after @ weeks of pregnancy and had indications for an episiotomy were enrolled and randomly assigned to undergo MLE or LE .


Patients were unaware of the episiotomy type performed .


The primary outcomes were pain at @ hours , @ hours , and @ days post partum , measured by a visual analog scale , verbal rating scale , interference with activities of daily living , and amount of analgesic use .


The analysis included @ women who underwent MLE and @ women who underwent LE .


Complete relief of pain was observed in @ ( @ % ) of @ women after @ hours , @ ( @ % ) of @ after @ hours , and @ ( @ % ) of @ after @ days in the MLE group , and in @ ( @ % ) of @ , @ ( @ % ) of @ , and @ ( @ % ) of @ in the LE group , respectively ( P = @ ) .


There were no significant differences in overall pain scores from any rating system or in the amount of analgesics used .


Incidence and extent of pain in the first @ days after LE correspond to those after adequately performed MLE .


Preterm birth is the most important single determinant of adverse outcome in the United Kingdom ; one in every @ babies ( @ % ) is born before @weeks ( very preterm ) , yet these births account for over half of infant deaths.Deferring cord clamping allows blood flow between baby and placenta to continue for a short time .


This often leads to increased neonatal blood volume at birth and may allow longer for transition to the neonatal circulation .


Optimal timing for clamping the cord remains uncertain , however .


The Cochrane Review suggests that deferring umbilical cord clamping for preterm births may improve outcome , but larger studies reporting substantive outcomes and with long-term follow-up are needed .


Studies of the physiology of placental transfusion suggest that flow in the umbilical cord at very preterm birth may continue for several minutes .


This pilot trial aims to assess the feasibility of conducting a large randomised trial comparing immediate and deferred cord clamping in the UK .


Women are eligible for the trial if they are expected to have a live birth before @weeks gestation .


Exclusion criteria are known monochorionic twins or clinical evidence of twin-twin transfusion syndrome , triplet or higher order multiple pregnancy , and known major congenital malformation .


The interventions will be cord clamping within @seconds compared with cord clamping after at least two minutes .


For births with cord clamping after at least two minutes , initial neonatal care is at the bedside .


For the pilot trial , outcomes include measures of recruitment , compliance with the intervention , retention of participants and data quality for the clinical outcomes.Information about the trial is available to women during their antenatal care .


Women considered likely to have a very preterm birth are approached for informed consent .


Randomisation is close to the time of birth .


Follow-up for the women is for one year , and for the children to two years of age ( corrected for gestation at birth ) .


The target sample size is @ to @ mother-infant pairs recruited over @months at eight sites .


Exercises aiming to strengthen the upper extremities are recommended to increase activities of daily living ( ADLs ) in patients with spinal cord injury ( SCI ) .


The aim of this study was to compare the effects of upper extremity progressive resistance exercises ( PRE ) and endurance exercises ( EE ) performed with an arm ergometer in patients with paraplegia due to SCI .


A total of @ SCI patients were included in the study , and randomly divided into two groups .


The first group performed PRE while the second group performed arm EE .


The functional independence measurement ( FIM ) was used on each patient at the beginning and at the end of the study .


The elbow flexion and extension muscle strengths of each patient were determined with the computerized isokinetic dynamometer at the beginning and end of the study .


Post-training increased the FIM scores in both PRE ( p = @ ) and EE groups ( p = @ ) .


There were increases in the extension peak torque ( PT ) and total work ( TW ) at @/sec and @/sec angular velocity in the PRE group compared to the EE group ( all p < @ ) .


There were improvement in post-training muscle strength values in both the PRE ( found to be more effective ) and EE groups .


Randomized trial ( Level I ) .


In the TRial to assess Improvement in Therapeutic Outcomes by optimizing platelet inhibitioN with prasugrel Thrombolysis In Myocardial Infarction @ ( TRITON-TIMI @ ) , prasugrel reduced the primary ischaemic endpoint as compared with clopidogrel in acute coronary syndrome ( ACS ) patients planned to undergo percutaneous coronary interventions , but increased the risk of bleeding .


The present analysis shows the efficacy and safety data for the @,@ non-ST segment elevation ( NSTE ) - ACS patients included in that trial .


The primary endpoint was significantly reduced by prasugrel in the overall NSTE-ACS population ( hazard ratio ( HR ) @ , @ % confidence interval ( CI ) @-@ @ , p = @ ) as well as in unstable angina ( UA ) and in non-ST elevation myocardial infarction ( NSTEMI ) patient subgroups ( interaction p value = @ ) .


Although non-coronary artery bypass graft ( CABG ) TIMI major bleeding was increased with prasugrel as compared with clopidogrel ( HR @ , @ % CI @-@ @ , p = @ ) , there was a net clinical benefit in patients assigned to prasugrel ( HR @ , @ % CI @-@ @ , p = @ ) , which was consistent for UA and NSTEMI subgroups ( interaction p value = @ and @ ) .


In patients who met the criteria for prasugrel use recommended by the European Medicines Agency , thus excluding from the analysis patients with prior transient ischemic attack ( TIA ) / stroke , with weight < @ kg or age @ years , and censoring follow-up at @ days , ( European Union ( EU ) - label cohort ) prasugrel showed superiority over clopidogrel with regard to the primary endpoint ( HR @ , @ % CI @-@ @ , p < @ ) for the entire NSTE-ACS population , as well as for UA patients and NSTEMI patients without significant differences in non-CABG TIMI major bleeding .


Prasugrel , as compared with clopidogrel , significantly reduced the primary endpoint of the TRITON-TIMI @ trial in NSTE-ACS patients , as well as in the UA and NSTEMI groups .


A significant reduction in the primary endpoint without increased bleeding was observed in the EU-label cohort .


ANTHEM-HF evaluated a novel autonomic regulation therapy ( ART ) via either left or right vagus nerve stimulation ( VNS ) in patients with heart failure ( HF ) and reduced ejection fraction ( HFrEF ) .


Sixty subjects ( New York Heart Association -LSB- NYHA -RSB- functional class II-III , left ventricular ejection fraction ( LVEF ) @ % , left ventricular end-diastolic diameter @ mm to < @ mm ) receiving optimal pharmacologic therapy were randomized at @ sites .


VNS systems were randomly implanted on the left ( n = @ ) or right ( n = @ ) side .


All patients were successfully implanted and @ were titrated over @ weeks to a well tolerated stimulation intensity .


One patient died @ days after an embolic stroke that occurred during implantation .


Common device-related adverse events after VNS titration were transient mild dysphonia , cough , and oropharyngeal pain , which were similar for left - and right-side VNS .


After @ months of ART , the adjusted left-right differences in LVEF , left ventricular end-systolic volume ( LVESV ) , and left ventricular end-systolic diameter ( LVESD ) were @ % ( @ % CI -@ to @ ) , @ mL ( @ % CI -@ to @ ) , and @ mm ( @ % CI -@ to @ ) , respectively .


In the combined population , absolute LVEF improved by @ % ( @ % CI @-@ @ ) , LVESV improved by -@ mL ( @ % CI -@ to @ ) , and LVESD improved by -@ mm ( @ % CI -@ to -@ ) .


Heart rate variability improved by @ ms ( @ % CI @-@ ) with minimal left-right difference .


Six-minute walk distance improved an average of @ m ( @ % CI @-@ ) ; however , improvement was greater for right-side ART ( @ m -LSB- @ % CI @-@ -RSB- ) .


NYHA functional class improved in @ % of patients ( baseline to @ months ) .


Chronic open-loop ART via left - or right-side VNS is feasible and well tolerated in HFrEF patients .


Safety and efficacy measures are encouraging and warrant further study .


Moderate alcohol consumption exerts a cardioprotective effect , but no studies have evaluated the alcohol-independent cardiovascular effects of the non-alcoholic components of beer .


We aimed to evaluate the effects of ethanol and the phenolic compounds of beer on classical and novel cardiovascular risk factors .


Thirty-three high risk male volunteers were included in a randomized , crossover feeding trial .


After a washout period , all subjects received beer ( @ g alcohol/d , @ mL ) , the equivalent amount of polyphenols as non-alcoholic beer ( @ mL ) , and gin ( @ g alcohol/d , @ mL ) for @ weeks .


All outcomes were evaluated before and after each intervention period .


Moderate alcohol consumption increased serum HDL-cholesterol ( @ % ) , ApoA-I ( @ % ) , ApoA-II ( @ % ) and adiponectin ( @ % ) , and decreased serum fibrinogen ( @ % ) , and interleukin ( IL ) -@ ( @ % ) concentrations , whereas the non-alcoholic fraction of beer ( mainly polyphenols ) increased the receptor antagonist of IL-@ ( @ % ) , and decreased lymphocyte expression of lymphocyte function-associated antigen-@ ( @ % ) , lymphocyte and monocyte expression of Sialil-Lewis X ( @ % ) and monocyte expression of CCR@ ( @ % ) , and tumor necrosis factor ( TNF ) - ( @ % ) and IL-@ ( @ % ) plasma concentrations .


No changes were observed in glucose metabolism parameters or in body weight and adiposity parameters .


The phenolic content of beer reduces leukocyte adhesion molecules and inflammatory biomarkers , whereas alcohol mainly improves the lipid profile and reduces some plasma inflammatory biomarkers related to atherosclerosis .


Defaecatory function is often poor after anterior resection .


Denervation of the neorectum following high ligation of the inferior mesenteric artery ( IMA ) is a possible cause of impaired defaecatory function .


The purpose of this randomized clinical trial was to clarify whether the level of ligation of the IMA in patients with rectal cancer affects defaecatory function .


Between @ and @ , patients who underwent anterior resection for rectal cancer were randomized to receive either high or low ligation of the IMA .


The primary endpoint was to demonstrate the superiority of low ligation in terms of defaecatory function .


One hundred patients were enrolled in the study ; @ were randomized to high ligation of the IMA and @ to low ligation .


There were no differences between the groups in terms of clinical data , except tumour stage , which was more advanced in the high-ligation group ( P = @ ) .


Nor were there any differences in defaecatory function , self-assessment of defaecation , Faecal Incontinence Quality of Life scale or continence score between groups at @months and @year .


The number of harvested lymph nodes was similar .


The rate of symptomatic anastomotic leakage was @ per cent in the high-ligation group and @ per cent in the low-ligation group ( P = @ ) .


The level of ligation of the IMA in patients with rectal cancer did not affect defaecatory function or the incidence of postoperative complications .


A high percentage of biventricular pacing is required for optimal outcome in patients treated with cardiac resynchronization therapy ( CRT ) , but the influence of ectopic beats on the success of biventricular pacing has not been well established .


This study sought to determine if increased ectopic beats reduce the chance of high biventricular pacing percentage and are associated with subsequent adverse outcomes .


From the MADIT-CRT ( Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy ) , @ patients with an implanted CRT-defibrillator device with data available on biventricular pacing percentage and pre-implantation @-h Holter recordings were included .


Using logistic regression , we estimated the influence of ectopic beats on the percentage of biventricular pacing .


Reverse remodeling was measured as reductions in atrial and left ventricular end-systolic volumes ( LVESV ) at @ year .


Cox models were used to assess the influence of ectopic beats on the outcomes of heart failure ( HF ) or death , ventricular tachyarrhythmias ( VTAs ) , and death .


In the pre-implantation Holter recording , ectopic beats accounted for a mean @ @ % of all beats .


The probability of subsequent low biventricular pacing percentage ( < @ % ) was increased @-fold ( odds ratio : @ ; @ % confidence interval : @ to @ ; p < @ ) in patients with @ % to @ % ectopic beats and @-fold ( odds ratio : @ ; @ % confidence interval : @ to @ ; p < @ ) in patients with > @ % ectopic beats compared with those with < @ % ectopic beats .


Patients with @ % ectopic beats had significantly less reverse remodeling ( percent reduction in LVESV @ @ % ) than patients with < @ % ectopic beats ( percent reduction in LVESV @ @ % ; p < @ ) .


The risk of HF/death and VTA was increased significantly in those with @ % to @ % ectopic beats ( hazard ratio : @ and @ , respectively ) and for > @ % ectopic beats ( hazard ratio : @ and @ , respectively ) .


Relatively low frequencies of ectopic beats ( @ % ) dramatically increase the probability of low biventricular pacing ( < @ % ) , with reduced CRT efficacy by less reverse remodeling and higher risk of HF/death and VTA .


This supports pre-implantation Holter monitoring of patients selected for CRT for optimal outcome .


( MADIT-CRT : Multicenter Automatic Defibrillator Implantation With Cardiac Resynchronization Therapy ; NCT@ ) .


Indacaterol @ g once daily is a long-acting @ agonist approved for maintenance bronchodilator treatment in patients with chronic obstructive pulmonary disease ( COPD ) .


The purpose of this study was to evaluate patients ' perception of onset of effect with a single dose .


In this double-blind , crossover , Phase IV study , @ patients were randomized to receive a single dose of indacaterol @ g or placebo via a dry powder inhaler device .


The primary variable was time until patient 's perception of onset of effect , using a simple self-administered ( nonvalidated ) questionnaire that patients answered at nine protocol-specified time points .


Exploratory variables included change in forced expiratory volume in @ second ( FEV@ ) and change in percent predicted FEV@ from predose to postdose ( determined @-@ minutes postdose ) .


The least-squares mean time to patient 's perception of onset of effect was @ minutes and @ minutes for indacaterol and placebo , respectively .


There was no significant effect for treatment , period , or sequence on the time to patient 's perception .


In addition , no statistically significant differences between treatments were observed for patient 's global satisfaction with onset of effect and global expectation of treatment adherence .


For the exploratory variable change in FEV@ from predose to postdose , indacaterol showed superiority over placebo with a clinically relevant least-squares mean treatment difference of @ L ( P < @ ) .


There was little or no association between patient 's perception of time to onset of effect and change in FEV@ , or change in percent predicted FEV@ .


Both treatments were well tolerated .


A single dose of indacaterol @ g did not separate from placebo in terms of patient perception of onset , although there was an improvement in FEV@ for indacaterol compared with placebo .


Development and use of a validated questionnaire may be needed to address the inconsistency in evaluating this patient-related outcome .


Injectable bulking treatment for fecal incontinence ( FI ) is intended to expand tissue in the anal canal and prevent fecal leakage .


Use of injectable bulking agents is increasing because it can be performed in an outpatient setting and with low risk for morbidity .


This study evaluated the long-term ( @-month ) clinical effectiveness and safety of injection of non-animal stabilized hyaluronic acid/dextranomer ( NASHA Dx ) on FI symptoms .


In a prospective multicenter trial , @ patients with FI received the NASHA Dx bulking agent .


Treatment success defined as a reduction in number of FI episodes by @ % or more compared with baseline ( Responder@ ) .


Change from baseline in Cleveland Clinic Florida Fecal Incontinence Score ( CCFIS ) and Fecal Incontinence Quality of Life Scale ( FIQL ) , and adverse events were also evaluated .


Successful decrease in symptoms was achieved in @ % of patients at @months and this was sustained at @months ( @ % ) and @months ( @ % ) .


Mean CCFIS decreased from @ at baseline to @ at @months ( p < @ ) .


Quality-of-life scores for all four domains improved significantly between baseline and @months of follow-up .


Severe adverse events were rare and most adverse events were transient and pertained to minor bleeding and pain or discomfort .


Submucosal injection of NASHA Dx provided a significant improvement of FI symptoms in a majority of patients and this effect was stable during the course of the follow-up and maintained for @years .


We sought to examine the prevalence of EEG abnormalities in Smith-Lemli-Opitz syndrome ( SLOS ) as well as the relationship between interictal epileptiform discharges ( IEDs ) and within-subject variations in attentional symptom severity .


In the context of a clinical trial for SLOS , we performed cross-sectional and repeated-measure observational studies of the relationship between EEG findings and cognitive/behavioral factors on @ children ( aged @-@ years ) .


EEGs were reviewed for clinical abnormalities , including IEDs , by readers blinded to participants ' behavioral symptoms .


Between-group differences in baseline characteristics of participants with and without IEDs were analyzed .


Within-subject analyses examined the association between the presence of IEDs and changes in attention-deficit/hyperactivity disorder ( ADHD ) symptoms .


Of @ EEGs , @ ( @ % ) were abnormal , predominantly because of IEDs .


Only one subject had documented clinical seizures .


IEDs clustered in @ subjects ( @ % ) , whereas @ subjects ( @ % ) had EEGs consistently free of IEDs .


While there were no significant group differences in sex , age , intellectual disability , language level , or baseline ADHD symptoms , autistic symptoms tended to be more prevalent in the `` IED '' group ( according to Autism Diagnostic Observation Schedule-@ criteria ) .


Within individuals , the presence of IEDs on a particular EEG predicted , on average , a @ % increase in ADHD symptom severity .


Epileptiform discharges are common in SLOS , despite a relatively low prevalence of epilepsy .


Fluctuations in the presence of epileptiform discharges within individual children with a developmental disability syndrome may be associated with fluctuations in ADHD symptomatology , even in the absence of clinical seizures .


To describe the effectiveness , reach and implementation of a weight gain prevention intervention among public school employees .


A multi-level intervention was tested in a cluster randomized trial among @ employees in @ central Massachusetts public high schools from @ to @ .


The intervention targeted the nutrition and physical activity environment and policies , the social environment and individual knowledge , attitudes and skills .


The intervention was compared to a materials only condition .


The primary outcome measures were change in weight and body mass index ( BMI ) at @-month follow-up .


Implementation of physical environment , policy and social environment strategies at the school and interpersonal levels , and intervention participation at the individual level were assessed .


At @-month follow-up , there was a net change ( difference of the difference ) of -@ pounds ( p = @ ) and of -@ BMI units ( p = @ ) between intervention and comparison conditions .


The majority of intervention strategies were successfully implemented by all intervention schools , although establishing formal policies was challenging .


Employee participation in programs targeting the physical and social environment was maintained over time .


This study supports that a multi-level intervention integrated within the organizational culture can be successfully implemented and prevent weight gain in public high school employees .


It is important to engage patients and surrogates in conversations about goals and preferences for medical treatment before high-risk surgery .


However , few interventions have been tested to facilitate these discussions .


To assess the acceptability and feasibility of a facilitated , structured conversation with patients and surrogates about patient goals and preferences for medical treatment during their visit to a preoperative testing center before high-risk surgery .


A randomized controlled pilot study in the preoperative testing center at a tertiary academic hospital over a @-month period .


We used baseline and preoperative surveys to assess feasibility , and to compare differences in worry , surrogate burden , and patient-surrogate concordance about treatment preferences in conversation and control groups .


We assessed acceptability of the conversation qualitatively and through surveys .


Of @ eligible patients , @ were approached , and @ declined to participate .


Thirteen completed the study and @ were randomized to the structured conversation .


Major recruitment barriers included lack of time , or surrogate unavailability .


Most postconversation patients were less worried , and more hopeful for a good recovery before surgery ; @ of @ would recommend the conversation .


Six of @ surrogates reported postoperatively that the conversation helped prepare them to be a surrogate .


Concordance improved in the intervention group only .


Current processes of care present major barriers to conducting facilitated conversations in the preoperative testing center .


Among a small group of patients and surrogates , most found a structured conversation about the patient 's goals and preferences for medical treatment helpful before high-risk surgery .


Transradial approach catheterization is now widely used in coronary angiography and angioplasty .


The ulnar artery , which is one of the two terminal branches of the brachial artery , may be a potential approach for cardiac catheterization .


The aim of this study was to evaluate the safety and feasibility of a transulnar approach for coronary catheterization in non-selective patients .


A total of @ consecutive patients were randomly assigned to transulnar approach ( TUA ) group ( n = @ ) or transradial approach ( TRA ) group ( n = @ ) upon arrival at the catheterization laboratory .


Allen 's test and inverse Allen 's test were not routinely performed .


Ultrasound-Doppler assessment of the forearm artery was performed before the procedure , two days after the procedure , and @ days after the procedure .


The primary endpoints of study were the rate of successful artery cannulation and the access-site related complications .


The secondary endpoints included the number of needle punctures , total time for the procedure , and major adverse cardiac events ( MACE ) .


Successful puncture of the objective artery was obtained in @ % of the patients in the TUA group , and @ % of the patients in the TRA group ( P > @ ) .


There was no significant difference in hematoma complications between the two groups ( @ % vs. @ % , P = @ ) .


A motor abnormality of the hand was observed in one patient in the TUA group .


There were no arteriovenous fistula or pseudoaneurysm observed in our study .


Three ( @ % ) patients in the TUA group and @ ( @ % ) patients in the TRA group had occlusion of the access artery ( P = @ ) , but none of the patients had symptoms or signs of hand ischemia .


There were no significant differences in MACE between the two groups during follow-up .


The transulnar approach is an effective and safe technique for coronary catheterization in non-selective patients .


To evaluate the feasibility of a @ kVp tube voltage combined with an iterative reconstruction algorithm in retrospective electrocardiogram ( ECG ) - gated thoracoabdominal aortic CT angiography ( CTA ) .


Ninety-eight patients who underwent clinically indicated thoracoabdominal aortic CTA were randomly assigned to two groups : group A ( n = @ ) were scanned to @ kVp and group B ( n = @ ) to @ kVp .


The body mass index of all included patients was < @ kg/m ( @ ) .


Group A scans were reconstructed with a standard filtered back projection ( FBP ) algorithm , and group B scans with FBP , iDose , and non-tagged algorithms .


Data comparison between groups was performed using t-test and analysis of variance .


Compared with group A , the iDose algorithm in group B yielded a higher contrast-to-noise ratio ( CNR ; @ @ , p < @ ) , a higher signal-to-noise ratio ( SNR ; @ @ , p < @ ) , and a lower standard deviation ( SD ; @ @ , p < @ ) .


The subjective score of iDose reconstructions from group B was significantly lower than that of FBP reconstruction from group A ( p < @ ) .


In group B , the non-tagged algorithm resulted in a higher CNR and a higher SNR , but a higher SD and a higher subjective score than did the iDose algorithm .


The average effective dose for group B was @ % lower than that for group A.


A combination of a @ kVp tube voltage and the iDose algorithm can help to improve image quality and reduce radiation dose in retrospective ECG-gated thoracoabdominal aortic CTA .


The use of different limbs for the administration of sequential doses of an intradermal rabies vaccine was shown to result in reduced vaccine immunogenicity .


We aimed to assess whether this phenomenon also occurs with routine infant vaccines .


In this open-label , randomised , controlled study , eligible healthy infants @-@ weeks of age recruited through five clinical trials units ( four in the UK and one in Malta ) were randomly assigned in a @:@ ratio to two vaccination groups : consistent limb or alternating limb .


Infants in the consistent limb group received the diphtheria-tetanus-acellular pertussis-inactived polio-Haemophilus influenzae type b combined vaccine ( DTaP-IPV-Hib ) at @ , @ , and @ months of age , and the pneumococcal conjugate vaccine ( PCV@ ) at @ , @ , and @ months , all administered to the right leg .


Infants in the alternating limb group received DTaP-IPV-Hib in the left leg at @ months and in the right leg at @ and @ months ; and PCV@ in the left leg at @ months , in the right leg at @ months , and in the left arm at @ months .


All infants in both groups received the combined H influenzae type b and capsular group C Neisseria meningitidis tetanus toxoid conjugate vaccine ( Hib-MenC-TT ) , administered in the left leg at @ months .


Randomisation was achieved by randomly generated codes , with permuted block size of @ , and was stratified by study site .


Group allocation was not masked from study staff and parents of participants after enrolment , but group allocation was masked from laboratory staff assessing blood samples .


The current study was a prespecified secondary objective of a parent phase @ trial that assessed the induction of immunity following varying schedules of vaccination with glyco-conjugate capsular group C Neisseria meningitidis ( Men C ) vaccines in infancy .


The objective of the current study was to compare the immunogenicity and reactogenicity of vaccines delivered in either consistent or alternating limbs .


Immunogenicity was assessed by comparing serum IgG geometric mean concentrations at @ , @ , @ , and @ months , analysed per protocol .


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


Between July @ , @ , and Aug @ , @ , we enrolled @ infants and randomly allocated them to the consistent limb group ( n = @ ) or the alternating limb group ( n = @ ) .


Anti-H influenzae type b anti-polyribosylribitol phosphate IgG geometric mean concentrations were lower in the consistent limb group than in the alternating limb group at @ months ( consistent limb @ g/mL -LSB- @ % CI @-@ -RSB- vs alternating limb @ g/mL -LSB- @-@ -RSB- ; p = @ ) and at @ months ( @ g/mL -LSB- @-@ -RSB- vs @ g/mL -LSB- @-@ -RSB- ; p = @ ) .


Anti-tetanus toxoid antibody IgG geometric mean concentrations were lower in the consistent limb group ( @ IU/mL -LSB- @ % CI @-@ -RSB- ) than in the alternating limb group ( @ IU/mL -LSB- @-@ -RSB- ) at @ months ( p = @ ) and at @ months ( @ IU/mL -LSB- @-@ -RSB- vs @ IU/mL -LSB- @-@ -RSB- ; p = @ ) .


Anti-pneumococcal IgG geometric mean concentrations were similar between both groups at all timepoints .


The proportions of participants who had adverse events did not differ between the two groups .


Use of different ( alternating ) limbs for sequential doses of routine infant vaccines does not reduce , and might enhance , immunogenicity .


The underlying mechanism for this finding warrants further research .


Most minor hand operations can be performed with local anesthesia and tourniquet .


Some literature supports this concept based on the believe that the `` patient can tolerate it '' .


Nowadays , the wide-awake technique with epinephrine - contained lidocaine is safe .


This technique does not need a tourniquet because epinephrine provides local vasoconstriction .


The present study was designed to compare patients ' comfort and effectiveness of local anesthesia as well as bleeding at the surgical site between wide-awake anesthesia and local lidocaine with tourniquet application .


Prospective Clinical Trial was performed in @ patients who received outpatient surgery for common hand problems at Maharaj Nakorn Chiang Mai Hospital .


With randomization , @ patients were in wide-awake group , who received adrenaline-contained lidocaine as a local anesthetic agent , with tourniquet wrapping but with no pressure applied ( group @ ) .


The other @ patients were in the conventional group that received lidocaine ( no adrenaline ) and a @-mmHg tourniquet application ( group @ ) .


Operations were performed with standard methods .


Visual analog scores , surgical field bleeding , amount of bleeding , any complications within @ weeks were recorded .


There are no significant differences between the two groups in terms of patient profiles ( sex , age and diseases ) , injected site pain and surgeon 's opinion of surgical site bleeding .


Tourniquet 's pain and the amount of blood loss in the conventional group were significantly higher than the wide-awake group .


Wide-awake technique ( no tourniquet applied ) offers better comfort for patients and less total blood loss while providing effective anesthesia and patient safety as with the conventional technique .


To evaluate if the intake of a fluoridated food supplement in breastfeeding mothers increases the fluoride concentration in breast milk .


A double-blind randomized placebo-controlled study was designed .


Two groups of women were formed : a fluoride group ( n = @ ) , using a non-sucrose food supplement containing fluoride ( @,@ g/l for each dose ) and a control group ( n = @ ) , using a non-sucrose food supplement without fluoride content .


The women were followed for @ weeks .


Samples of breast milk were collected and analyzed using an ion-specific electrode .


@ women in the fluoride group and @ in the control group concluded the trial .


Fluoride concentrations in the two groups were statistically significantly different ( @ g/l in the fluoride and @ g/l in the control group P = @ ) at the end of the experimental period .


In the fluoride group , a statistically significant increment in fluoride concentration during the experimental period was also observed ( from @ @ g/l to @ @ g/l ) .


The use of a non-sucrose food supplement containing fluoride resulted in a significant increment in fluoride concentration in breast milk .


Research investigating the effectiveness of universal interventions to reduce the risk of mental health problems remains limited .


Schools are a promising setting within which adolescents can receive interventions aimed at promoting their mental health .


The aim of this study is to assess the effectiveness of a resilience-based prevention-focused intervention in reducing the risk of mental health problems among adolescents attending secondary school in socio-economically disadvantaged areas .


A cluster randomised control trial will be conducted , with schools as the unit of randomisation .


Initially , @ secondary schools will be randomly allocated to a control or intervention group ( @ control and @ intervention ) .


An intervention focused on improving student internal and external resilience factors will be implemented in intervention schools .


A survey of students in Grade @ in both intervention and control schools will be conducted ( baseline ) and repeated three years later when the students are in Grade @ .


The Strengths and Difficulties Questionnaire will be used to measure the risk of mental health problems .


At follow-up , the risk of mental health problems will be compared between Grade @ students in intervention and control schools to determine intervention effectiveness .


The study presents an opportunity to determine the effectiveness of a comprehensive resilience-based intervention in reducing the risk of mental health problems in adolescents attending secondary schools .


The outcomes of the trial are of importance to youth , schools , mental health clinicians and policymakers .


Seroma formation , the most prevalent postoperative complication after mastectomy , is an inflammatory process that is potentially preventable via local steroid administration .


This study investigated the effect of local steroid administration on seroma formation .


This was a double-blind randomized placebo-controlled intervention study of a single dose of @ mg methylprednisolone versus saline on seroma formation after mastectomy .


Patients were further classified according to the surgical axillary procedure : mastectomy with sentinel lymph node biopsy ( M + SLNB ) or mastectomy with level I-II axillary lymph node dissection ( M + ALND ) .


Treatments were administered into the wound cavity via the drain orifice following removal of the drain on the first day after surgery .


The primary endpoint was seroma formation ; secondary endpoints included the frequency of side-effects and complications .


A total of @ women scheduled for mastectomy for primary breast cancer were included .


After M + SLNB , @ ( @ per cent ) of @ women developed a seroma in the methylprednisolone group , compared with @ ( @ per cent ) of @ in the saline group ( P < @ ) .


The mean cumulative seroma volume in the intention-to-treat population for the first @ and @ days was significantly lower in the methylprednisolone group ( @ ml versus @ ml in the saline group , and @ versus @ ml respectively ) ( P < @ ) .


After M + ALND , similar proportions of patients developed a seroma in the methylprednisolone ( @ of @ , @ per cent ) and saline ( @ of @ , @ per cent ) groups , and methylprednisolone administration had no significant effect on seroma formation .


No differences in infection rate were observed .


Methylprednisolone administered into the wound cavity on the first day after M + SLNB exerted a highly significant preventive effect against seroma formation during the next @ days .


This effect was not seen in the M + ALND group .


Future studies may clarify whether higher or repeated methylprednisolone doses increase the efficacy .


To test the effects of pressure-controlled ( PCV ) and volume-controlled ( VCV ) ventilation during one-lung ventilation ( OLV ) for thoracic surgery on right ventricular ( RV ) function .


A prospective , randomized , double-blind , controlled , crossover study .


A single university hospital .


Fourteen pairs of consecutive patients scheduled for elective thoracotomy .


Patients were assigned randomly to ventilate the dependent lung with PCV or VCV mode , each in a randomized crossover order using tidal volume of @ mL/kg , I : E ratio @ : @ , positive end-expiratory pressure ( PEEP ) of @ cm H@O and respiratory rate adjusted to maintain normocapnia .


Intraoperative changes in RV function ( systolic and early diastolic tricuspid annular velocity ( TAV ) , end-systolic volume ( ESV ) , end-diastolic volume ( EDV ) and fractional area changes ( FAC ) ) , airway pressures , compliance and oxygenation index were recorded .


The use of PCV during OLV resulted in faster systolic ( @ vs. @ cm/s , respectively ) , diastolic TAV ( @ vs. @ cm/s , respectively ) ( p < @ ) and compliance and lower ESV , EDV and airway pressures ( p < @ ) than during the use of VCV .


Oxygenation indices were similar during the use of VCV and PCV .


The use of PCV offers more improved RV function than the use of VCV during OLV for open thoracotomy .


These results apply specifically to younger patients with good ventricular and pulmonary functions .


Middle molecular weight uraemic toxins are considered to play an important role in vascular dysfunction and cardiovascular outcomes in end-stage renal disease ( ESRD ) patients .


Recent dialysis techniques based on convection , specifically high-efficiency on-line haemodiafiltration ( HDF ) , enhance the removal of middle molecular weight toxins and reduce all-cause mortality in haemodialysis ( HD ) patients .


However , the mechanisms of these improved outcomes remain to be established .


This prospective study randomly assigned @ ESRD patients to switch from high-flux HD to high-efficiency on-line HDF ( n = @ ) or to continue HD ( n = @ ) .


Brachial artery endothelium-dependent flow-mediated dilatation , central pulse pressure , carotid artery intima-media thickness ( IMT ) , internal diastolic diameter and distensibility and circulating markers of uraemia , inflammation and oxidative stress were blindly assessed before and after a @-month follow-up .


Brachial flow-mediated dilatation and carotid artery distensibility increased significantly in the HDF group compared with HD , while carotid IMT and diameter remained similar .


HDF decreased predialysis levels of the uraemic toxins @-microglobulin , phosphate and blood TNF mRNA expression .


Oxidative stress markers were not different between the HD and HDF groups .


Blood mRNA expression of protein kinase C @ , an endothelial NO-synthase ( eNOS ) inhibitor , decreased significantly with HDF .


High-efficiency on-line HDF prevents the endothelial dysfunction and stiffening of the conduit arteries in ESRD patients compared with high-flux HD .


HDF decreases uraemic toxins , vascular inflammation , and is associated with subsequent improvement in eNOS functionality .


These results suggest that reduced endothelial dysfunction may be an intermediate mechanism explaining the beneficial outcomes associated with HDF .


Anatomic double-bundle anterior cruciate ligament ( ACL ) reconstruction provides excellent results for restoring normal kinematics to the knee .


Nevertheless , strong evidence supporting an ideal method for fixation of the ACL graft is lacking .


Intratunnel femoral fixation of the ACL graft via a cross-pin fixation technique would provide better clinical and objective results than the extratunnel femoral fixation with cortical buttons .


Randomized clinical trial ; Level of evidence , @ .


Seventy patients with a unilateral ACL-deficient knee were randomly assigned to @ of @ femoral fixation groups .