The relative bioavailability , partial extent of absorption , overall elimination , food effect , and safety were evaluated .


The estimates of relative bioavailability of new SR with IR formulation based on dose-adjusted AUC@-inf were @ % ( @-@ @ ) for the fasted state and @ % ( @-@ @ ) for the fed state , while these estimates comparing new SR with ER formulation were @ % ( @-@ @ ) in the fasted state and @ % ( @-@ @ ) in the fed state .


The accumulated mean time period at or above the minimal therapeutic plasma paracetamol concentration for the new SR was from @ % to @ % longer than that of the IR formulation , in fasted and fed state , respectively .


Food significantly increased Cmax of SR formulation , with ratios fast vs. fed @ ( p < @ ) and @ ( p < @ ) in study I and II , respectively .


The new SR formulation was well absorbed , with more than @ % relative bioavailability as compared to the currently marketed IR and ER products and better sustained-release PK characteristics , which make it suitable for twice-daily paracetamol treatment .


To use a high-quality multicenter trial dataset to determine dose-volume effects for gastrointestinal ( GI ) toxicity following radiation therapy for prostate carcinoma .


Influential dose-volume histogram regions were to be determined as functions of dose , anatomical location , toxicity , and clinical endpoint .


Planning datasets for @ participants in the TROG @ RADAR trial were available , with Late Effects of Normal Tissues ( LENT ) Subjective , Objective , Management , and Analytic ( SOMA ) toxicity assessment to a median of @ months .


A rank sum method was used to define dose-volume cut-points as near-continuous functions of dose to @ GI anatomical regions , together with a comprehensive assessment of significance .


Univariate and multivariate ordinal regression was used to assess the importance of cut-points at each dose .


Dose ranges providing significant cut-points tended to be consistent with those showing significant univariate regression odds-ratios ( representing the probability of a unitary increase in toxicity grade per percent relative volume ) .


Ranges of significant cut-points for rectal bleeding validated previously published results .


Separation of the lower GI anatomy into complete anorectum , rectum , and anal canal showed the impact of mid-low doses to the anal canal on urgency and tenesmus , completeness of evacuation and stool frequency , and mid-high doses to the anorectum on bleeding and stool frequency .


Derived multivariate models emphasized the importance of the high-dose region of the anorectum and rectum for rectal bleeding and mid - to low-dose regions for diarrhea and urgency and tenesmus , and low-to-mid doses to the anal canal for stool frequency , diarrhea , evacuation , and bleeding .


Results confirm anatomical dependence of specific GI toxicities .


They provide an atlas summarizing dose-histogram effects and derived constraints as functions of anatomical region , dose , toxicity , and endpoint for informing future radiation therapy planning .


In the Interventional Management of Stroke ( IMS ) III trial , we sought to demonstrate evidence of a differential treatment effect of endovascular treatment of acute ischemic stroke compared with intravenous tissue-type plasminogen activator , according to baseline collateral status measured using computed tomographic angiography .


Of @ patients enrolled in Interventional Management of Stroke III trial , @ had baseline computed tomographic angiography .


Of these , @ patients had M@ middle cerebral artery intracranial internal carotid artery occlusion , where baseline collateral status could be measured .


Collateral status was assessed by consensus using @ different ordinal scales and categorized as good , intermediate , and poor .


Multivariable modeling was used to assess the effect of collateral status and treatment type on clinical outcome by modified Rankin Scale ( mRS @-@ , mRS @-@ , and the ordinal mRS ) .


Of @ patients , @ randomized to endovascular therapy ( @ % recanalized , @ % @-day mRS @-@ ) and @ to intravenous tissue-type plasminogen activator only ( @ % recanalized , @ % @-day mRS @-@ ) .


In multivariable modeling , collateral status was a significant predictor of all clinical outcomes ( P < @ ) .


Maximal benefit with endovascular treatment across all clinical outcomes was seen in patients with intermediate collaterals , some benefit in patients with good collaterals , and none in patients with poor collaterals , although small sample size limited the power of the analysis to show a statistically significant interaction between collateral status and treatment type ( P > @ ) .


Using data from a large randomized controlled trial ( IMS III ) , we show that baseline computed tomographic angiography collaterals are a robust determinant of final clinical outcome and could be used to select patients for endovascular therapy .


The combination of an ultrathin bronchoscope , navigational technology , and endobronchial ultrasound ( EBUS ) seems to combine the best of mutual abilities for evaluating peripheral pulmonary lesions , but ultrathin bronchoscopes that allow the use of EBUS have not been developed so far .


To compare the diagnostic yield of transbronchial biopsy under EBUS , fluoroscopy , and virtual bronchoscopic navigation guidance using a novel ultrathin bronchoscope with that using a thin bronchoscope with a guide sheath for peripheral pulmonary lesions .


In four centers , patients with suspected peripheral pulmonary lesions less than or equal to @ mm in the longest diameter were included and randomized to undergo transbronchial biopsy with EBUS , fluoroscopy , and virtual bronchoscopic navigation guidance using a @-mm ultrathin bronchoscope ( UTB group ) or a @-mm thin bronchoscope with a guide sheath ( TB-GS group ) .


A total of @ patients were enrolled and randomized , among whom @ patients ( @ , UTB group ; @ , TB-GS group ) were analyzed .


The ultrathin bronchoscope could reach more distal bronchi than the thin bronchoscope ( median fifth - vs. fourth-generation bronchi ; P < @ ) .


Diagnostic histologic specimens were obtained in @ % ( @ % for benign and @ % for malignant lesions ) of the UTB group and @ % ( @ % for benign and @ % for malignant lesions ) of the TB-GS group ( P = @ , Mantel-Haenszel test ) .


Complications including pneumothorax , bleeding , chest pain , and pneumonia occurred in @ % and @ % in the respective groups .


The diagnostic yield of the UTB method is higher than that of the TB-GS method .


Clinical trial registered with www.umin.ac.jp/ctr/ ( UMIN @ ) .


To compare the function of retinal ganglion cells ( RGCs ) using the photopic negative response ( PhNR ) in patients who had undergone indocyaine green ( ICG ) - assisted , brilliant blue G ( BBG ) - assisted , or triamcinolone acetonide ( TA ) - assisted internal limiting membrane ( ILM ) peeling during macular hole ( MH ) surgery .


Forty-eight eyes of @ patients with a macular hole were randomly divided into those undergoing ICG-assisted , BBG-assisted , or TA-assisted vitrectomy ( n = @ for each group ) .


Full-field cone ERGs were recorded before and @ , @ , @ , @ , and @months postoperatively .


The amplitudes and implicit times of the a-waves and b-waves and the amplitudes of the oscillatory potentials ( OPs ) and PhNRs were measured .


The mean deviations ( MDs ) of standard automated perimetry and the best-corrected visual acuity ( BCVA ) were measured .


The circumferential retinal nerve fiber layer ( RNFL ) thickness was evaluated by SD-OCT .


All macular holes were closed with a significant improvement of the BCVA and MD without differences among the groups .


There was no significant difference between the preoperative and postoperative RNFL thickness .


The implicit times of the a-waves and b-waves were significantly prolonged , and the OPs amplitude was significantly decreased postoperatively in all groups .


These ERG changes were not significantly different among the groups .


The postoperative PhNR amplitudes were significantly lower in the ICG group than in the BBG or TA group .


The results indicate that the PhNR may detect subclinical impairments of RGCs caused by the possible toxic effect of ICG .


This finding adds to the data that BBG and TA may be safer than ICG for use during MH surgery .


Standard therapies for severe dry eye are limited and fail to resolve the problem .


The purpose of this study was to evaluate the safety and efficacy of Thymosin @ eye drops ( RGN-@ ) as a novel therapy for severe dry eye disease ( including that associated with graft vs. host disease ) .


A small , multicenter , randomized , double-masked , placebo-controlled @-day phase @ clinical trial including a @-day follow-up at @ US sites .


Nine patients with severe dry eye were treated with either RGN-@ ( @ % ) or vehicle control @ times daily over a period of @ days .


Dry eye sign and symptom assessments , such as ocular discomfort ( using the OSDI questionnaire ) and corneal fluorescein staining ( using the NEI workshop grading system ) , were evaluated at various time points .


Statistically significant differences in both symptom and sign assessments , were seen at various time points throughout the study .


Of particular note at day @ , the RGN-@-treated group ( @ eyes ) had @ % reduction of ocular discomfort compared with vehicle control ( @ eyes ) ( P = @ ) , and @ % reduction of total corneal fluorescein staining compared with vehicle control ( P = @ ) .


Other improvements seen in the RGN-@-treated patients included tear film breakup time and increased tear volume production .


In this small trial , RGN-@ eye drops were safe and well tolerated and met key efficacy objectives with statistically significant symptom and sign improvements , compared with vehicle control , at various time intervals , including @-days posttreatment .


CLINICAL TRIAL REGISTRATION -- URL : http://www.clinicaltrials.gov .


Unique identifier : NCT@ .


Single-agent gemcitabine ( GEM ) has been considered for many years as the standard first-line treatment for advanced pancreatic cancer .


However , recently , several studies reported encouraging activity and good tolerability for some combination regimens .


Considering the apparently non-overlapping toxicity and the proved individual efficacy of GEM , oxaliplatin ( L-OHP ) , and capecitabine ( CAP ) , this randomized phase II study compared the activity and safety of the combination GEM , L-OHP , and CAP ( GEMOXEL ) versus GEM alone , in patients with metastatic pancreatic cancer .


The treatment in GEMOXEL arm consisted of GEM @,@ mg/m ( @ ) as a @-min intravenous infusion on days @ , @ , @ , @ , L-OHP @ mg/m ( @ ) i.v. on day @ , and CAP @,@ mg/m ( @ ) / day in two divided doses on days @-@ , every @ days ( one cycle ) .


In both treatment groups , GEM was administered weekly for seven consecutive weeks followed by @-week rest for the first @ weeks , and thereafter , GEM was continued on days @ , @ , @ , every @ days .


Chemotherapy was administered until disease progression or unacceptable toxicity .


Sixty-seven patients were enrolled in the study .


Thirty-four were randomly assigned to GEMOXEL and @ to GEM .


At @ months , disease control rate was @ % with GEMOXEL versus @ % with GEM ( p = @ ) .


The median progression-free survival was @ months ( @ % CI @-@ @ months ) in GEMOXEL arm and @ months ( @ % CI @-@ @ months ) in GEM arm ( p < @ ) .


The median OS was @ months ( @ % CI @-@ @ months ) in GEMOXEL arm and @ months ( @ % CI @-@ @ months ) in GEM arm ( p < @ ) .


Hematologic and non-hematologic toxicity was more severe with combination chemotherapy , yet still tolerable .


No grade @ adverse events were observed with either regimen .


GEMOXEL regimen seemed to be safe and more efficient than the standard therapy with GEM alone in the treatment of metastatic pancreatic cancer .


Long-distance air travel is associated with an increased risk of venous thrombosis .


The most obvious factor that can explain air travel-related thrombosis is prolonged seated immobilization .


In addition , hypobaric hypoxia has been shown to affect coagulation , and the lowered atmospheric pressures present in the cabin during the flight may therefore play an etiologic role .


Because immobilization and hypoxic conditions are usually present simultaneously in airplanes or hypobaric chambers , their separate effects on the coagulation system or on thrombosis risk have not been studied extensively .


To investigate the separate effects of long-term immobilization and profound prolonged hypoxia on blood coagulation .


We performed two studies in collaboration with European Space Agency/European Space Research and Technology Centre .


In the first study , @ healthy , non-smoking , adult women underwent @ days of -@ head-down bed rest .


In the second study , we took blood samples from @ healthy men who participated during their stay in the Concordia station in Antarctica , where , due to the atmospheric conditions , continuous severe hypobaric hypoxia is present .


In both studies , we measured markers of blood coagulation at baseline and at several time points during the exposures .


We observed no increase in coagulation markers during immobilization or in the hypobaric environment , compared with baseline measurements .


Our results indicate that neither immobilization nor hypoxia per se affects blood coagulation .


These results implicate that a combination of risk factors is necessary to induce the coagulation system during air travel .


A proposal has recently been made regarding the potential adjuvant use of platelet-rich plasma ( PRP ) with fractional carbon dioxide laser ( FCL ) for the correction of acne scars .


To compare the efficacy and safety of two administration modes of autologous PRP ( intradermal injection ( ID ) and topical application ) after FCL with that of FCL alone in the treatment of atrophic acne scars .


Thirty patients were randomly divided into two groups .


Both underwent split-face therapy .


Group @ was administered FCL followed by ID PRP on one side and FCL followed by ID saline on the other .


In group @ , one cheek was treated with FCL followed by ID PRP , and the other received FCL followed by topical PRP .


Each patient received @monthly sessions .


The final assessment took place at @months .


Combined PRP - and FCL-treated areas had a significantly better response ( p = @ ) , fewer side effects , and shorter downtime ( p = @ ) than FCL-treated areas , but there were no significant differences in ID - and topical PRP-treated areas in degree of response and downtime ( p = @ ) ; topically treated areas had significantly lower pain scores .


The current study introduces the combination of topical PRP and FCL as an effective , safe modality in the treatment of atrophic acne scars with shorter downtime than FCL alone and better tolerability than FCL combined with ID PRP .


The need for evidence-based practice in nursing is well established ; however , the efficacy of providing online research resources to nurses delivering care at the bedside has yet to undergo empirical testing .


This study evaluated the impact of minimal educational support by a nurse researcher on nurses ' usage of a hospital-based online nursing reference center .


This randomized , comparison group design feasibility study was conducted at a suburban medical center .


Real-time RN usage of an online nursing reference center was collected over @ months ( August to May ) , with the comparative intervention occurring for seven of the @ months ( September to March ) .


Independent samples t tests and analysis of variance demonstrated that nurses receiving weekly or biweekly visits from an educator had significantly higher usage of the reference center .


Nurses who received minimal educational support through weekly and biweekly brief , verbally supportive visits from a nurse researcher were significantly higher users of the online nurse reference center than those receiving in-services only .


The aim of this study was compare the Aldrete score at @ minutes of two groups of patients undergoing carotid endarterectomy with intravenous anesthesia , receiving either anesthetic superficial cervical plexus block or intravenous morphine as transition analgesia .


After Ethics Committee approval , this randomized , controlled , double-blind , single-center study was performed on patients undergoing carotid endarterectomy , who received total intravenous anesthesia with propofol and remifentanil infusion .


After intubation , each patient was randomly assigned to Block ( superficial cervical block with levobupivacaine before the surgical incision ) , or Morphine group ( standardized dose of morphine @ minutes before the end of surgery ) .


In the recovery room , an investigator unaware of the patient randomization recorded time to extubation , Aldrete score , pain , nausea/vomiting , and shiver at T@ ( time of extubation ) , and at @ ( T@ ) , @ ( T@ ) , and @ minutes ( T@ ) after extubation .


Sixty-four patients were studied .


Time to extubation was @ @ min for Block and @ @ min for Morphine group ( P > @ ) .


Median Aldrete score at T@ was @ in the Block and @ in the Morphine group ( P < @ ) , at T@ it was @ and @ ( P < @ ) , respectively .


At T@ , @ ( @ % ) Block and @ ( @ % ) Morphine patients had an Aldrete score @ ( P < @ ) .


Systolic blood pressure was higher in the Block than in Morphine patients at T@ and T@ .


This study demonstrates shorter time to extubation and better emergence from anesthesia when total intravenous anesthesia is associated with superficial cervical block than with morphine as transition analgesia .


The data of MARCH ( Metformin and AcaRbose in Chinese as the initial Hypoglycaemic treatment ) trial demonstrated that acarbose and metformin have similar efficacy as initial therapy for hemoglobin A@c ( HbA@c ) reduction in Chinese patients with newly diagnosed type @ diabetes .


We investigated whether the therapeutic efficacy was diversified under different body mass index ( BMI ) status .


All @ subjects were divided into normal-weight group ( BMI < @ kg/m@ ) , overweight group ( BMI @-@ kg/m@ ) and obese group ( BMI@ kg/m@ ) .


Patients were assigned to @ weeks of therapy with acarbose or metformin , respectively .


The clinical trial registry number was ChiCTR-TRC-@ .


The reduction of HbA@c levels and the proportion of patients with HbA@c of @ % or less were similar in the three groups after acarbose and metformin treatment .


In overweight group , fasting blood glucose ( FBG ) after metformin treatment showed greater decline compared to acarbose group at @ weeks -LSB- -@ ( -@ to -@ ) vs. -@ ( -@ to -@ ) , P < @ ) , however the decrease of @ h post-challenge blood glucose ( PBG ) after acarbose treatment at @ weeks was bigger compared to metformin group -LSB- -@ ( -@ to-@ @ ) vs. -@ ( -@ to -@ ) , P < @ -RSB- .


Both acarbose and metformin treatment resulted in a significant decrease in waist circumference , hip circumference , weight and BMI in the three groups ( all P < @ ) .


Acarbose and metformin decreased HbA@c levels similarly regardless of BMI status of Chinese type @ diabetic patients .


Acarbose and metformin resulted in a significant and modest improvement of anthropometric parametres in different BMI status .


Thus , acarbose treatment may contribute a similar effect on plasma glucose control compared to metformin , even in obesity patients .


According to the latest ART report for Europe , about @ % of pregnancies after frozen embryo transfer are multiple .


Our objective was to analyse the impact on the multiple pregnancy rate of two eSFET ( elective single frozen embryo transfers ) versus a DFET ( double frozen embryo transfer ) in women aged under @ years , who had not achieved pregnancy in their fresh transfer and who had at least two vitrified embryos of A/B quality .


This study was conducted from January @ to June @ at a public hospital .


The couples were divided into three groups .


Group DFET : the first cryotransfer of two embryos ( @ women ) ; cSFET group : the only cryotransfer of a single vitrified embryo ( @ women ) ; eSFET group , individually vitrified embryos : @ patients included in a clinical trial of single-embryo fresh and frozen transfer and @ patients who chose to receive eSFET .


The clinical pregnancy rate was @ % in the DET group and the cumulative clinical pregnancy rate was @ % in the eSFET group .


There were no significant differences between the DFET and eSFET groups ( @ vs @ % ) in cumulative live birth delivery rate .


The rate of multiple pregnancies varied significantly between the DFET and eSFET groups ( @ vs @ % , p < @ ) .


For good-prognosis women aged under @ years , taking embryo quality as a criterion for inclusion , an eSFET policy can be applied , achieving acceptable cumulative clinical pregnancy and live birth rates and reducing multiple pregnancy rates .


Relapses of childhood steroid-sensitive nephrotic syndrome ( SSNS ) are treated with a @ - to @-week course of high-dose oral prednisolone , which may be associated with significant adverse effects .


There is a clear association between upper respiratory tract infection ( URTI ) and relapse development .


Previous studies in developing nations have suggested that introducing a @ - to @-day course of daily prednisolone during an URTI may prevent a relapse developing and the need for a treatment course of high-dose prednisolone .


The aim of PREDNOS @ is to evaluate the effectiveness of a @-day course of daily prednisolone therapy during an URTI in reducing the development of a subsequent relapse in a developed nation .


The subjects will be @ children with relapsing SSNS ( @ relapses in preceding year ) , who will be randomised to receive either a @-day course of daily prednisolone or no change to their current therapy ( with the use of placebo to double blind ) each time they develop an URTI over @months .


A strict definition for URTI will be used .


Subjects will be reviewed at @ , @ , @ and @months to capture data regarding relapse history , ongoing therapy and adverse effect profile , including behavioural problems and quality of life .


A formal health economic analysis will also be performed .


The primary end point of the study will be the incidence of URTI-related relapse ( @days of Albustix + + + ) following the first infection during the @-month follow-up period .


DNA and RNA samples will be collected to identify a potential genetic cause for the disease .


Subjects will be recruited from over @ UK centres with the assistance of the Medicines for Children Research Network.PREDNOS @ is funded by the National Institute for Health Research Health Technology Assessment Programme ( @/@/@ ) .


We propose that PREDNOS @ will be a pivotal study that will inform the future standard of care for children with SSNS .


If it is possible to reduce the disease relapse rate effectively and safely , this will reduce the morbidity and cost associated with drug treatment , notwithstanding hospital admission and parental absence from employment .


To determine the difference in outcome between a @ - day and @ - day antibiotic regimen in the prevention of infective complications following transrectal prostate biopsy .


This prospective comparative study was done in the urology unit of University of Benin Teaching Hospital over a period of @ months .


Eighty seven patients were randomly assigned to @ groups prior to the procedure .


The patients in group I ( N = @ ) received oral ciprofloxacin ( @mg , @ hourly ) and oral metronidazole ( @mg , @ hourly ) for @ day while those in group II ( N = @ ) received same antibiotic combination for @ days .


Urine samples for culture were taken an hour before the procedure and then @ days after in all patients .


Temperature monitoring with an easy-to-use thermometer was done thrice daily by the patients .


Post biopsy fever and positive urine cultures were indicative of infection .


The mean age of the patients was @ @ years .


Infective complications occurred in @ ( @ % ) in group I and @ ( @ % ) in group II .


Fever was noted in @ patients in group I and @ patients in group II ( p = @ ) while positive urine culture was noted in @ patients in each group ( p = @ ) .


Complications were minor and transient except in a case of septicaemia in group II that required hospitalisation .


Escherischia coli was the most common organism isolated from positive urine cultures .


A @-day antibiotic regimen of oral ciprofloxacin and metronidazole is as effective as a @-day regimenin the prevention of infective complications following transrectalprostate biopsy .


The use of perioperative pharmacologic - blockade in patients at low risk of myocardial ischemic events undergoing noncardiac surgery ( NCS ) is controversial because of the risk of stroke and hypotension .


Published studies have not found a consistent benefit in this cohort .


To determine the effect of perioperative - blockade on patients undergoing NCS , particularly those with no risk factors .


This is a retrospective observational analysis of patients undergoing surgery in Veterans Affairs hospitals from October @ , @ , through September @ , @ .


- Blocker use was determined if a dose was ordered at any time between @ hours before surgery and @ hours postoperatively .


Data from the Veterans Affairs electronic database included demographics , diagnosis and procedural codes , medications , perioperative laboratory values , and date of death .


A @-point cardiac risk score was calculated by assigning @ point each for renal failure , coronary artery disease , diabetes mellitus , and surgery in a major body cavity .


Previously validated linear regression models for all hospitalized acute care medical or surgical patients were used to calculate predicted mortality and then to calculate odds ratios ( ORs ) .


The end point was @-day surgical mortality .


There were @,@ patients in this cohort : @,@ underwent NCS and @,@ underwent cardiac surgery .


- Blockade lowered the OR for mortality significantly in patients with @ to @ cardiac risk factors undergoing NCS ( OR , @ ; @ % CI , @-@ @ ) .


It had no effect on patients with @ to @ risk factors .


However , - blockade resulted in a significantly higher chance of death in patients ( OR , @ ; @ % CI , @-@ @ ) with no risk factors undergoing NCS .


In this large series , - blockade appears to be beneficial perioperatively in patients with high cardiac risk undergoing NCS .


However , the use of - blockers in patients with no cardiac risk factors undergoing NCS increased risk of death in this patient cohort .


The role of positive end-expiratory pressure in mechanical ventilation during general anaesthesia for surgery remains uncertain .


Levels of pressure higher than @ cm H@O might protect against postoperative pulmonary complications but could also cause intraoperative circulatory depression and lung injury from overdistension .


We tested the hypothesis that a high level of positive end-expiratory pressure with recruitment manoeuvres protects against postoperative pulmonary complications in patients at risk of complications who are receiving mechanical ventilation with low tidal volumes during general anaesthesia for open abdominal surgery .


In this randomised controlled trial at @ centres in Europe and North and South America , we recruited @ patients at risk for postoperative pulmonary complications who were planned for open abdominal surgery under general anaesthesia and ventilation at tidal volumes of @ mL/kg .


We randomly allocated patients to either a high level of positive end-expiratory pressure ( @ cm H@O ) with recruitment manoeuvres ( higher PEEP group ) or a low level of pressure ( @ cm H@O ) without recruitment manoeuvres ( lower PEEP group ) .


We used a centralised computer-generated randomisation system .


Patients and outcome assessors were masked to the intervention .


Primary endpoint was a composite of postoperative pulmonary complications by postoperative day @ .


Analysis was by intention-to-treat .


The study is registered at Controlled-Trials .


com , number ISRCTN@ .


From February , @ , to January , @ , @ patients were randomly allocated to the higher PEEP group and @ to the lower PEEP group .


Six patients were excluded from the analysis , four because they withdrew consent and two for violation of inclusion criteria .


Median levels of positive end-expiratory pressure were @ cm H@O ( IQR @-@ ) in the higher PEEP group and @ cm H@O ( @-@ ) in the lower PEEP group .


Postoperative pulmonary complications were reported in @ ( @ % ) of @ patients in the higher PEEP group versus @ ( @ % ) of @ patients in the lower PEEP group ( relative risk @ ; @ % CI @-@ ; p = @ ) .


Compared with patients in the lower PEEP group , those in the higher PEEP group developed intraoperative hypotension and needed more vasoactive drugs .


A strategy with a high level of positive end-expiratory pressure and recruitment manoeuvres during open abdominal surgery does not protect against postoperative pulmonary complications .


An intraoperative protective ventilation strategy should include a low tidal volume and low positive end-expiratory pressure , without recruitment manoeuvres .


An objective measure of added sugar ( AS ) and sugar-sweetened beverage ( SSB ) intake is needed .


The ( @ ) C value of finger-stick blood is a novel validated biomarker of AS/SSB intake ; however , nonsweetener corn products and animal protein also carry a ( @ ) C value similar to AS sources , which may affect blood ( @ ) C values .


The ( @ ) N value of blood has been proposed as a `` correction factor '' for animal protein intake .


The objectives were to @ ) identify foods associated with ( @ ) C and ( @ ) N blood values , @ ) determine the contribution of nonsweetener corn to the diet relative to AS intake , and @ ) determine if the dual-isotope model ( ( @ ) C and ( @ ) N ) is a better predictor of AS/SSB intake than ( @ ) C alone .


A cross-sectional sample of southwest Virginian adults ( n = @ ; aged @ @ y ; @ % overweight/obese ) underwent dietary intake assessments and provided finger-stick blood samples , which were analyzed for ( @ ) C and ( @ ) N values by using natural abundance stable isotope mass spectrometry .


Statistical analyses included ANOVAs , paired-samples t tests , and multiple linear regressions .


The mean SD daily AS intake was @ @ g and nonsweetener corn intake was @ @ g.


The mean ( @ ) C value was -@ @ , which was significantly correlated with AS and SSB intakes ( r = @ and @ , respectively ; P @ ) .


The ( @ ) C value and nonsweetener corn intake and the ( @ ) N value and animal protein intake were not correlated .


AS intake was significantly greater than nonsweetener corn intake ( mean difference = @ @ g ; P @ ) .


The ( @ ) C value was predictive of AS/SSB intake ( range : @-@ @ ; P @ ) ; however , ( @ ) N was not predictive and minimal increases in R ( @ ) values were observed when the ( @ ) N value was added to the model .


The data do not provide evidence that the dual-isotope method is superior for predicting AS/SSB intakes within a southwest Virginian population .


Our results support the potential of the ( @ ) C value of finger-stick blood to serve as an objective measure of AS/SSB intake .


This trial was registered at clinicaltrials.gov as NCT@ .


To comprehensively compare the effects of a very low-carbohydrate , high-unsaturated/low-saturated fat diet ( LC ) with those of a high-unrefined carbohydrate , low-fat diet ( HC ) on glycemic control and cardiovascular disease ( CVD ) risk factors in type @ diabetes ( T@DM ) .


Obese adults ( n = @ , BMI @ @ kg/m ( @ ) , age @ @ years ) with T@DM were randomized to a hypocaloric LC diet ( @ % carbohydrate -LSB- < @ g/day -RSB- , @ % protein , and @ % fat -LSB- < @ % saturated fat -RSB- ) or an energy-matched HC diet ( @ % carbohydrate , @ % protein , and @ % fat -LSB- < @ % saturated fat -RSB- ) combined with structured exercise for @ weeks .


The outcomes measured were as follows : glycosylated hemoglobin ( HbA@c ) , glycemic variability ( GV ; assessed by @-h continuous glucose monitoring ) , antiglycemic medication changes ( antiglycemic medication effects score -LSB- MES -RSB- ) , and blood lipids and pressure .


A total of @ participants completed @ weeks .


Both groups achieved similar completion rates ( LC @ % , HC @ % ) and weight loss ( LC -@ @ kg , HC -@ @ kg ) ; P @ .


Blood pressure ( -@ / -@ @ / @ mmHg ) , fasting blood glucose ( -@ @ mmol/L ) , and LDL cholesterol ( -@ @ mmol/L ) decreased , with no diet effect ( P @ ) .


LC achieved greater reductions in triglycerides ( -@ @ vs. -@ @ mmol/L ) , MES ( -@ @ vs. -@ @ ) , and GV indices ; P @ .


LC induced greater HbA@c reductions ( -@ @ % -LSB- -@ @ mmol/mol -RSB- vs. -@ @ % -LSB- -@ @ mmol/mol -RSB- ; P = @ ) and HDL cholesterol ( HDL-C ) increases ( @ @ vs. @ @ mmol/L ; P = @ ) in participants with the respective baseline values HbA@c > @ % ( @ mmol/mol ) and HDL-C < @ mmol/L .


Both diets achieved substantial improvements for several clinical glycemic control and CVD risk markers .


These improvements and reductions in GV and antiglycemic medication requirements were greatest with the LC compared with HC .


This suggests an LC diet with low saturated fat may be an effective dietary approach for T@DM management if effects are sustained beyond @ weeks .


To evaluate the safety of electrocautery for coagulation during Caesarean sections .


A randomized , controlled , clinical pilot study was performed at a university maternity hospital .


After admission for delivery and decision to perform a C-section , volunteers were randomized to either the intervention group ( use of electrocautery for coagulation ) or nonintervention group .


The women were examined at the time of postpartum discharge ( day @ ) , at days @ to @ , and again at days @ to @ for signs of infection , hematoma , seroma , or dehiscence .


Data were analyzed using an intention-to-treat analysis , and risk ratios were calculated .


No significant differences were found between the two groups .


Only @ % of patients in the intervention group developed surgical wound complications during hospitalization .


However , @ to @ days following discharge , these rates reached @ % and @ % in the intervention and nonintervention groups , respectively ( RR = @ , @ % CI = @-@ @ ) .


Further studies should confirm whether the use of electrocautery for coagulation does not increase the risk of surgical wound complications in patients undergoing Caesarean sections .


The ToyBox-study developed an evidence - and theory-based intervention to improve preschoolers ' energy balance-related behaviours - including physical activity ( PA ) - by targeting the kindergarten environment and involving their parents/caregivers .


The present study aimed to examine the effect of the ToyBox-intervention on increasing Belgian preschoolers ' objectively measured PA levels .


A sample of @ preschoolers ( @ @ years ; @ % boys ) from @ kindergartens ( @ intervention , @ control kindergartens ) in Flanders , Belgium were included in the data analyses .


Preschoolers wore an ActiGraph accelerometer for six consecutive days and were included in the data analyses if they had a minimum of two weekdays and one weekend day , both at baseline and follow-up ( one year later ) .


Preschoolers ' PA outcomes were estimated for an average day , weekday , weekend day , during school hours , and during after school hours .


To assess intervention effects , multilevel repeated measures analyses were conducted for the total sample , and for sub-groups ( according to sex , kindergarten levels of socio-economic status ( SES ) and risk groups ( low levels of PA at baseline ) ) of preschoolers .


Small intervention effects were found in the total sample .


Most intervention effects were found in boys and in preschoolers from high SES kindergartens .


Boys from the intervention group had an increase in vigorous PA ( = @ , p = @ ) and moderate-to-vigorous PA ( = @ , p = @ ) from baseline to follow-up , whereas PA levels in boys from the control group stagnated or decreased .


In preschoolers from high SES kindergartens , the largest effects were found for PA outcomes during school hours and during after school hours .


The results from the Belgian sample demonstrate that effects of the PA-component of the ToyBox-intervention on objectively measured PA were found in preschool boys and in preschoolers from high SES kindergartens , which means that the ToyBox-intervention was mainly effective in those sub-groups .


Future interventions should search for alternative strategies to increase preschoolers ' PA levels in preschool girls and preschoolers from low SES kindergartens , as these are the most important at-risk groups regarding PA. .


The World Health Organisation suggests that simplification of the medical abortion regime will contribute to an increased acceptability of medical abortion , among women as well as providers .


It is expected that a home-based follow-up after a medical abortion will increase the willingness to opt for medical abortion as well as decrease the workload and service costs in the clinic .


This study protocol describes a study that is a randomised , controlled , non-superiority trial .


Women screened to participate in the study are those with unwanted pregnancies and gestational ages equal to or less than nine weeks .


The randomisation list will be generated using a computerized random number generator and opaque sealed envelopes with group allocation will be prepared .


Randomization of the study participants will occur after the first clinical encounter with the doctor .


Eligible women randomised to the home-based assessment group will use a low-sensitivity pregnancy test and a pictorial instruction sheet at home , while the women in the clinic follow-up group will return to the clinic for routine follow-up carried out by a doctor .


The primary objective of the study this study protocol describes is to evaluate the efficacy of home-based assessment using a low-sensitivity pregnancy test and a pictorial instruction sheet @-@ days after an early medical abortion .


Providers or research assistants will not be blinded during outcome assessment .


To ensure feasibility of the self-assessment intervention an adaption phase took place at the selected study sites before study initiation .


This resulted in an optimized , tailor-made intervention and in the development of the pictorial instruction sheet with a guide on how to use the low-sensitivity pregnancy test and the danger signs after a medical abortion .


In this paper , we will describe the study protocol for a randomised control trial investigating the efficacy of simplified follow-up in terms of home-based assessment , @-@ days after a medical abortion .


Moreover , a description of the adaptation phase is included for a better understanding of the implementation of the intervention in a setting where literacy is low and the road-connections are poor .


The AeroChamber Plus ( AC ) valved holding chamber has been enhanced to include the Flow-Vu ( FV ) inspiratory flow indicator that provides visual inhalation feedback during use .


We have investigated if FV alters asthma control and whether parents accept it .


At visit @ , children with asthma , age @-@ years , used an AC with their pressurised metered dose inhaler and @ weeks later ( visit @ ) they were randomised to use either AC or FV .


Subjects returned @ ( visit @ ) and @ ( visit @ ) weeks later .


The Asthma Control ( ACQ ) and Paediatric Asthma Caregiver 's Quality of Life ( PACQLQ ) questionnaires were scored at each visit , and their peak inhalation flow ( PIF ) when they used their spacer was measured .


Forty participants in each group completed the study .


There was no difference in the ACQ scores from visits @ to @ between the two groups .


The improvements in the PACQLQ scores were greater in the FV group ( p = @ ) .


The mean difference ( @ % confidence interval ) for the change from visits @ to @ between FV and AC groups was @ ( -@ , @ ) and @ ( @ , @ ) for the ACQ and PACQLQ , respectively .


Most parents preferred the FV ( p < @ ) .


There was no difference in the PIF rates at each visit and between the two spacers .


There was no change in asthma control of the young children but that of their parents improved .


Parents preferred the FV and this could be related to their improved perception of their children 's asthma control by better PACQLQ scores .


The adverse effects of inadvertent perioperative hypothermia in the surgical population are well established .


The aim of this study was to investigate whether a resistive warming mattress would reduce the incidence of inadvertent perioperative hypothermia in patients undergoing elective caesarean section .


A total of @ pregnant women booked for elective caesarean section were randomised to either intraoperative warming with a mattress or control .


The primary outcome was the incidence of inadvertent perioperative hypothermia , defined as a temperature < @ C on admission to the recovery room .


Shivering in the perioperative period , severity of shivering and the need for treatment , total blood loss , fall in haemoglobin , incidence of blood transfusion , immediate health of baby , and length of hospital stay were also recorded .


The incidence of inadvertent perioperative hypothermia in the mattress-warmed group was significantly lower than in the control group ( @ % vs. @ % , P = @ ) ; mean temperatures differed between the two groups , @ C and @ C , respectively ( P = @ ) .


There was also a significantly lower mean ( SD ) haemoglobin change in the mattress-warmed group at -@ g/dL versus -@ g/dL in the control group ( P = @ ) .


There was no difference in shivering ( P = @ ) .


A resistive warming mattress reduced the incidence of inadvertent perioperative hypothermia and attenuated the fall in haemoglobin .


The use of resistive mattress warming should be considered during caesarean section .


Exercise-based cardiac rehabilitation increases peak oxygen uptake ( peak VO ) , which is an important predictor of mortality in cardiac patients .


However , it remains unclear which exercise characteristics are most effective for improving peak VO in coronary artery disease ( CAD ) patients .


Proof of concept papers comparing Aerobic Interval Training ( AIT ) and Moderate Continuous Training ( MCT ) were conducted in small sample sizes and findings were inconsistent and heterogeneous .


Therefore , we aimed to compare the effects of AIT and Aerobic Continuous Training ( ACT ) on peak VO , peripheral endothelial function , cardiovascular risk factors , quality of life and safety , in a large multicentre study .


Two-hundred CAD patients ( LVEF > @ % , @ % men , mean age @ @ years ) were randomized to a supervised @-week cardiac rehabilitation programme of three weekly sessions of either AIT ( @-@ % of peak heart rate ( HR ) ) or ACT ( @-@ % of peak HR ) on a bicycle .


Primary outcome was peak VO ; secondary outcomes were peripheral endothelial function , cardiovascular risk factors , quality of life and safety .


Peak VO ( ml/kg/min ) increased significantly in both groups ( AIT @ @ % versus ACT @ @ % ; p-time < @ ) .


In addition , flow-mediated dilation ( AIT +@ % ( range -@ to @ % ) versus ACT +@ % ( range -@ to @ % ) ; p-time < @ ) quality of life and some other cardiovascular risk factors including resting diastolic blood pressure and HDL-C improved significantly after training .


Improvements were equal for both training interventions .


Contrary to earlier smaller trials , we observed similar improvements in exercise capacity and peripheral endothelial function following AIT and ACT in a large population of CAD patients .


Flexible nasolaryngoscopy is an essential skill for otolaryngology trainees to develop , but there is a lack of standardized training for this procedure .


The aim of this study was to assess whether using training on a realistic human mannequin together with structured video feedback improved trainees ' performance at flexible nasolaryngoscopy .


Three-armed , single-blinded , randomized controlled study .


Thirty-six junior doctors and final-year medical students were randomly allocated to one of three groups .


All received a lecture and video presentation on flexible nasolaryngoscopy .


One group received additional tuition using a training mannequin .


The last group received mannequin training and feedback on their performance using a video recording .


The trainees then undertook flexible nasolaryngoscopy on volunteers with these endoscopies recorded .


Blinded observers scored the trainees on a range of objective and subjective measures .


The volunteers who were also blinded to the candidates ' training scored the comfort of the procedure .


Adding mannequin training showed a trend toward improvement of performance but did not reach statistical significance .


Mannequin training together with video feedback produced significant performance improvement in patient comfort ( P = @ ) , time to reach the vocal folds ( P = @ ) , and global ability ( P = @ ) .


Inter-rater reliability was excellent with P < @ in all assessments .


Simulation-based training using an anatomically correct model of the upper airway together with formalized video-assisted feedback on that training is a simple and effective way to improve endoscopy skills prior to starting flexible nasolaryngoscopy on patients .


This study characterized a medically managed population in a non-ST-segment elevation acute coronary syndrome ( NSTEACS ) cohort and evaluated prognosis and outcomes of vorapaxar vs. placebo .


In the TRACER study , @,@ NSTEACS patients were treated with standard care and vorapaxar ( a novel platelet protease-activated receptor-@ antagonist ) or placebo .


Of those , @ patients ( @ % ) did not undergo revascularization during index hospitalization , and @ ( @ % ) underwent percutaneous coronary intervention or coronary artery bypass grafting .


Patients managed medically were heterogeneous with different risk profiles , including @ ( @ % ) who did not undergo coronary angiography .


Patients who underwent angiography but were selected for medical management included those without evidence of significant coronary artery disease ( CAD ) , with prior CAD but no new significant lesions , and with significant lesions who were not treated with revascularization .


Cardiovascular event rates were highest among those without angiography and lowest in the group with angiography but without CAD .


In the medically managed cohort , @-year primary outcome ( cardiovascular death , myocardial infarction , stroke , recurrent ischaemia with rehospitalization , urgent coronary revascularization ) event rates were @ % with vorapaxar and @ % with placebo ( HR @ , @ % CI @-@ @ ) , with no interaction between drug and management strategy ( p = @ ) .


Key secondary endpoint ( cardiovascular death , myocardial infarction , stroke ) rates were @ % with vorapaxar and @ % with placebo ( HR @ , @ % CI @-@ @ ) , with no interaction ( p = @ ) .


Vorapaxar increased GUSTO moderate/severe bleeding numerically in medically managed patients ( adjusted HR @ , @ % CI @-@ @ ) .


NSTEACS patients who were initially medically managed had a higher risk-factor burden , and one-third had normal coronary arteries .


Outcome in the medically managed cohort was significantly related to degree of CAD , highlighting the importance of coronary angiography .


Efficacy and safety of vorapaxar appeared consistent with the overall trial results .


The Totaled Health Risks in Vascular Events ( THRIVE ) score strongly predicts clinical outcome , mortality , and risk of thrombolytic haemorrhage in ischemic stroke patients , and performs similarly well in patients receiving intravenous tissue plasminogen activator , endovascular stroke treatment , or no acute treatment .


It is not known if the THRIVE score predicts outcomes with the Solitaire endovascular stroke treatment device .


To validate the relationship between the THRIVE score and outcomes after treatment with the Solitaire endovascular stroke treatment device .


The study conducted a retrospective analysis of the prospective SWIFT and STAR trials to examine the relationship between THRIVE and outcomes after treatment with the Solitaire device .


We examined the relationship between THRIVE and clinical outcomes ( good outcome or death at @days ) among patients in SWIFT and STAR .


Receiver-operator characteristics curve analysis was used to compare THRIVE score performance with other stroke prediction scores .


Multivariable modeling was used to confirm the independence of the THRIVE score from procedure-specific predictors ( successful recanalization or device used ) and other predictors of functional outcome .


The THRIVE score strongly predicts good outcome and death among patients treated with the Solitaire device in SWIFT and STAR ( Mantel-Haenszel chi-square test for trend P < @ for good outcome , P = @ for death ) .


In receiver-operator characteristics ( ROC ) curve comparisons , totaled health risks in vascular events score is superior to Stroke Prognostication using Age and NIH Stroke Scale score-@ ( P < @ ) and performed similarly to Houston Intra-Arterial Therapy score ( HIAT ) ( P = @ ) and HIAT-@ ( P = @ ) .


In multivariable models , THRIVE 's prediction of good outcome is not altered after controlling for recanalization or after controlling for device used .


The THRIVE score remains a strong independent predictor after controlling for the above predictors together with time to procedure , rate of symptomatic haemorrhage , and use of general anesthesia .


Of note , use of general anesthesia was not an independent predictor of outcome in SWIFT+STAR after controlling for totaled health risks in vascular events and other factors .


The THRIVE score strongly predicts clinical outcome and mortality in patients treated with the Solitaire device in the SWIFT and STAR trials .


The lack of interaction between THRIVE and procedure-specific elements such as vessel recanalization or device choice makes the THRIVE score a reasonable candidate for use as a patient selection criterion in stroke clinical trials .


Individual placement and support ( IPS ) is effective in helping patients return to work but is poorly implemented because of clinical ambivalence and fears of relapse .


To assess whether a motivational intervention ( motivational interviewing ) directed at clinical staff to address ambivalence about employment improved patients ' occupational outcomes .


Two of four early intervention teams that already provided IPS were randomised to receive motivational interviewing training for clinicians , focused on attitudinal barriers to employment .


The trial was registered with the International Standard Randomised Controlled Trial Register ( ISRCTN@ ) .


Of @ eligible participants , @ consented to the research .


Occupational outcomes were obtained for @ patients ( @ % ) at @-month follow-up .


More patients in the intervention teams than in the IPS-only teams achieved employment by @ months ( @/@ v. @/@ ) .


A random effects logistic regression accounting for clustering by care coordinator , and adjusted for participants ' gender , ethnicity , educational and employment history and clinical status scores , confirmed superiority of the intervention ( odds ratio = @ , @ % CI @-@ @ ) .


Employment outcomes were enhanced by addressing clinicians ' ambivalence about their patients returning to work .


Lower body negative pressure ( LBNP ) decreases middle cerebral artery blood velocity ( MCAv ) and can induce hypotension .


Mental stress increases MCAv , but the MCAv response to combined LBNP and mental stress ( COMBO ) is unknown .


We hypothesized that performing a stressful cognitive challenge ( i.e. , mental stress ) concurrently with LBNP would prevent LBNP-induced reductions of MCAv .


There were @ subjects ( @ men , @ women ; ages @ yr ) who completed @ randomized @-min trials : @ ) LBNP ( -@ mmHg ) ; @ ) mental stress ( serial subtraction ) ; and @ ) COMBO ( LBNP + mental stress ) .


All reported values are meanSE .


Mean arterial pressure ( MAP ) , heart rate ( HR ) , forearm blood flow ( FBF ) , and MCAv were measured continuously .


Subjects also reported perceived stress following the mental stress and COMBO trials .


LBNP decreased MAP ( -@ mmHg ) , MCAv ( -@ cm s ( -@ ) ) and FBF ( -@ units ) , and increased HR ( @ bpm ) .


Mental stress increased MAP ( @ mmHg ) , HR ( @ bpm ) , and FBF ( @ units ) , while MCAv ( @ cm s ( -@ ) ) tended to increase .


COMBO increased MAP ( @ mmHg ) and HR ( @ bpm ) , and tended to increase FBF ( @ units ) .


However , MCAv ( -@ cm s ( -@ ) ) decreased during COMBO .


Decreases in MCAv during COMBO were not statistically different from LBNP-induced decreases ( -@ vs. -@ cm s ( -@ ) ) .


Subjective ratings of perceived stress ( standard @ to @ scale ) tended to be higher during COMBO than mental stress ( @ vs. @ units ) .


Our results suggest that mental stress does not effectively preserve MCAv when combined with central hypovolemia ( i.e. , LBNP ) .


A number of clinical trials have shown that patients with overt atherovascular disease may benefit from more aggressive dosage of statins .


We aimed to determined the usual dosage of statin in clinical practice and the adherence to recommended target concentration of LDL-cholesterol .


We analyzed @ patients with mean age @ years ( SD @ ) after acute coronary syndrome and/or coronary revascularization ( Czech samples of EUROASPIRE III and IV ) .


In spite that more than @ % of patients were in @/@ treated with statin , only @ % with the highest dose ( atorvastatin @ mg or equivalent ) .


On the other hand , medium-dosed statin ( atorvastatin @ mg ) was more often prescribed , in comparison to @/@ .


We observed mild improvement in adherence to former LDL-cholesterol target < @ mmol/l ( from @ % to @ % ) , but the recent target < @ mmol/l was reached only in less than one quarter of patients in @/@ .


It can be approximate ( using individual LDL-cholesterol values ) , that after maximal possible up-titration of statin , the adherence to recent LDL-cholesterol target may improve up to @ % .


Although the majority of CHD patients are currently being treated with statin , the usual dosage regimen and adherence to the recommended target values were not consistent with current therapeutic standards for secondary prevention of CHD .


Among the multiple nonsurgical modalities , epidural injections are one of the most commonly utilized treatment modalities in managing chronic low back and lower extremity pain due to disc herniation and radiculitis .


There is a paucity of randomized trials from contemporary interventional pain management settings utilizing fluoroscopy with long-term follow-up .


Randomized , double-blind , active-controlled trial with @-year follow-up .


An interventional pain management practice in the United States .


The objective was to assess the effectiveness of lumbar interlaminar epidural injections of local anesthetic with or without steroids for managing chronic low back pain of disc herniation or radiculitis .


Two groups of patients were studied , with @ patients in each group receiving either local anesthetic only or local anesthetic mixed with betamethasone .


The primary outcome measure was defined as pain relief and functional status improvement of @ % .


The outcomes were assessed by numeric rating scale ( NRS ) of pain and functional status with Oswestry Disability Index ( ODI ) .


Secondary outcome measures included employment status and opioid intake .


Results showed significant improvement in @ % of patients in Group I and @ % of patients in Group II at the end of @ years .


In addition , in the successful groups , those with at least @ weeks of relief ( with the first @ procedures ) , the improvement was @ % in Group I and @ % in Group II .


Results were somewhat superior for pain relief at @ months and functional status at @ months in the steroid group .


Thus , the results indicate that a patient 's failure to respond to local anesthetic alone , may be treated with addition of steroids .


The results of the study are limited by the lack of a placebo group .


Lumbar interlaminar epidural injections of local anesthetic with or without steroids is an effective modality , in patients with chronic function limiting low back and lower extremity pain secondary to disc herniation after failure of conservative modalities .


Distal radius fractures are among the most common fractures and account for approximately one-sixth of all fractures diagnosed .


Therapy results after distal radius fracture , especially of elderly patients , are often suboptimal .


The inevitable immobilization for several weeks leads to reduction in range of motion , deterioration of muscle strength , malfunction of fine motor skills as well as changes of motor and sensory representations in the brain .


Currently , there are no strategies to counteract these immobilization problems .


The overall aim of the study is to investigate the therapeutic potential of motor-cognitive approaches ( mental practice or mirror therapy ) on hand function after wrist fracture .


This study is a controlled , randomized , longitudinal intervention study with three intervention groups .


One experimental group imagines movements of the fractured upper extremity without executing them ( mental practice ) .


The second experimental group receives a mirror therapy program consisting of the performance of functional movement synergies using the unaffected forearm , wrist , and hand .


The control group completes a relaxation training regime .


Additionally , all patients receive usual care by the general practitioner .


We include women aged @ years and older having a distal radius fracture and sufficient cognitive function .


All groups are visited at home for therapy sessions @ times per week for the first @ weeks and @ times per week for weeks @ to @ .


Measurements are taken at therapy onset , and after @ , @ and @ weeks .


The primary outcome measure will assess upper extremity functioning ( Patient-Rated Wrist Evaluation -LSB- PRWE -RSB- ) , while secondary outcome measures cover subjective wrist function ( Disabilities of the Arm and Shoulder ; -LSB- DASH -RSB- , objective impairment ( range of motion , grip force ) and quality of life ( EuroQol-@D , -LSB- EQ@D -RSB- ) .


Results from this trial will contribute to the evidence on motor-cognitive approaches in the early therapy of distal radius fractures .


We evaluated eating behaviors and quality of life ( QOL ) in preadolescent children at risk for obesity , with and without abdominal pain ( AP ) .


Participants were parent-child dyads enrolled in a randomized , controlled obesity prevention trial .


The children were between @ and @ years of age and at risk for obesity ( @th-@th percentile of body mass index , n = @ ) .


Parents completed measures of their child 's eating behaviors , QOL , AP , and bowel function and their own depression status , concern about child weight , and feeding practices .


Children 's height and weight were also measured .


Children with frequent AP ( @/month , n = @ ) were compared with children reporting infrequent AP ( < @/month , n = @ ) .


Age and body mass index did not differ between groups , but AP was more prevalent in girls .


Child emotional overeating and parental depression scores were higher in the frequent AP group ( P < @ ) , and child QOL was lower ( P < @ ) .


In multivariable analysis , female gender ( odds ratio -LSB- OR -RSB- @ , @ % confidence interval -LSB- CI -RSB- @-@ @ ) , emotional overeating ( OR @ , @ % CI @-@ @ ) , and parental depression ( OR @ , @ % CI @-@ @ ) were associated with more frequent AP .


Secondary analyses were completed for children who met Rome III criteria for irritable bowel syndrome .


Clinicians working with children with AP at risk for obesity should consider assessing for and , when appropriate , addressing parent and child factors that could exacerbate AP .


The efficacy of macrolides in chronic rhinosinusitis ( CRS ) is still under controversy .


To date , only two double-blind , placebo-controlled studies have been published with differing results .


None of these studies investigated the possible benefit of macrolides in the postoperative period .


We conducted an investigator-initiated clinical trial using @-mg erythromycin once a day over a period of @ months , beginning the administration of either erythromycin or placebo @ weeks after a surgical intervention for CRS .


Randomized double-blind , placebo-controlled trial .


The concentrations of eosinophilic cationic protein ( ECP ) and myeloperoxidase in nasal secretion were chosen as primary outcome measures .


Additionally , as a secondary outcome measure , changes in the Sino-Nasal Outcome Test-@ score , olfaction , saccharin transit time , nasal endoscopy score , and self-rating of nasal health using a visual analogue scale were evaluated .


Sixty-seven patients after surgery for CRS with or without nasal polyps were screened , and @ patients were randomized to the study groups .


For the primary outcomes , the concentrations of ECP changed from @ l/l@ @ to @ l/l@ @ in the erythromycin group and from @ l/l@ @ to @ l/l@ @ in the placebo group ; no statistical differences were found .


Of the secondary outcomes , only the nasal endoscopy score showed a statistically significant improvement in the erythromycin group ( from @ to @ points ) compared to the placebo group ( from @ to @ points ) .


The subgroup of patients without nasal polyps in the erythromycin group showed a tendency to improvement in some secondary outcome criteria .


A general recommendation for long-term , low-dose erythromycin treatment after surgery for CRS can not be given .


In patients with CRS without nasal polyps , a tendency to improved parameters was detected .


The purpose of this study is to evaluate the effects of an @-week exercise-based cardiac rehabilitation program on traditional and nonlinear heart rate variability ( HRV ) indexes , assessing the potential confounding influences of habitual physical activity ( PA ) and dietary intake .


In this parallel-group trial , @ patients ( @ @ years old ) were randomized to the exercise group ( EG ) or to the control group ( CG ) @ weeks after an acute myocardial infarction .


Exercise-based cardiac rehabilitation program consisted of aerobic exercise at @ % to @ % of maximal heart rate for @ sessions per week plus usual care .


The CG received only usual care .


The baseline and final assessments comprised resting short-term HRV ( primary outcome ) by a Polar R-R recorder under controlled breathing ( @ breaths per minute ) , habitual PA by accelerometers , and dietary intake by a @-day food diary .


Two patients in each group dropped out and were not included in the intention-to-treat analysis .


In the remaining @ patients ( EG = @ and CG = @ ) , at baseline , only a difference in the proportion of nitrate medication use was significant between groups .


After @ weeks , no significant changes were found between groups on traditional and nonlinear HRV indexes ( eg , ln HF , EG from @ @ to @ @ and CG from @ @ to @ @ ) , habitual PA , and dietary intake .


Eight weeks of exercise-based cardiac rehabilitation program is an insufficient stimulus to improve cardiac autonomic function in post-myocardial infarction patients under optimal medication and with high levels of traditional and nonlinear HRV indexes at baseline .


The modulation of gut microbiota is considered to be the first target to establish probiotic efficacy in a healthy population .


This study was conducted to determine the impact of a probiotic on the intestinal microbial ecology of healthy volunteers .


High-throughput @S ribosomal RNA gene sequencing was used to characterize the fecal microbiota in healthy adults ( @-@ y old ) of both sexes , before and after @ wk of daily consumption of a capsule containing at least @ billion viable Lactobacillus paracasei DG cells , according to a randomized , double-blind , crossover placebo-controlled design .


Probiotic intake induced an increase in Proteobacteria ( P = @ ) and in the Clostridiales genus Coprococcus ( P = @ ) , whereas the Clostridiales genus Blautia ( P = @ ) was decreased ; a trend of reduction was also observed for Anaerostipes ( P = @ ) and Clostridium ( P = @ ) .


We also found that the probiotic effect depended on the initial butyrate concentration .


In fact , participants with butyrate > @ mmol/kg of wet feces had a mean butyrate reduction of @ @ % and a concomitant decrease in the sum of @ Clostridiales genera , namely Faecalibacterium , Blautia , Anaerostipes , Pseudobutyrivibrio , Clostridium , and Butyrivibrio ( P = @ ) , after the probiotic intervention .


In contrast , in participants with initial butyrate concentrations < @ mmol/kg of wet feces , the probiotic contributed to a @ @ % ( mean SD ) increment in butyrate concomitantly with an @ % decrease in Ruminococcus ( P = @ ) and a @ % increase in an abundantly represented unclassified Bacteroidales genus ( P = @ ) .


The intake of L. paracasei DG increased the Blautia : Coprococcus ratio , which , according to the literature , can potentially confer a health benefit on the host .


The probiotic impact on the microbiota and on short-chain fatty acids , however , seems to strictly depend on the initial characteristics of the intestinal microbial ecosystem .


In particular , fecal butyrate concentrations could represent an important biomarker for identifying subjects who may benefit from probiotic treatment .


This trial was registered at www.controlled-trials.com/isrctn as ISRCTN@ .


Vitiligo is an acquired skin disorder with great social impact .


It can be successfully treated using cultured autologous melanocytes transplantation .


To evaluate the effect of different modalities of narrow-band ultraviolet B ( NB-UVB ) therapy on the outcome of cultured autologous melanocyte transplantation in treating vitiligo .


Patients undergoing cultured autologous melanocyte transplantation were randomly assigned to four different study groups .


Group @ underwent @ sessions of NB-UVB treatment before transplantation ; Group @ underwent @ sessions of NB-UVB treatment after transplantation ; Group @ underwent @ sessions of NB-UVB treatment before transplantation and @ sessions after transplantation ; Group @ underwent only transplantation .


Four hundred thirty-seven patients were enrolled .


Group @ responded best , more than @ % repigmentation was achieved in @ % of patients , and @ % patients experienced @ % or greater repigmentation .


Statistical analysis showed that there was a highly significant difference between the four groups ( ( @ ) = @ , p < @ ) .


Homogeneous skin color was obtained on the repigmentation areas , and no scarring or other serious side effects were observed .


Cultured autologous melanocyte transplantation is an effective treatment for stable vitiligo .


Combination of NB-UVB therapy with melanocyte transplantation can accelerate repigmentation of transplanted vitiliginous areas , especially if NB-UVB is given before and after transplantation .


To assess whether interspinous process device implantation is more effective in the short term than conventional surgical decompression for patients with intermittent neurogenic claudication due to lumbar spinal stenosis .


Randomized controlled trial .


Five neurosurgical centers ( including one academic and four secondary level care centers ) in the Netherlands .


@ participants were referred to the Leiden-The Hague Spine Prognostic Study Group between October @ and September @ ; @ participants with intermittent neurogenic claudication due to lumbar spinal stenosis at one or two levels with an indication for surgery were randomized .


@ participants received an interspinous process device and @ participants underwent spinal bony decompression .


The primary outcome at short term ( eight weeks ) and long term ( one year ) follow-up was the Zurich Claudication Questionnaire score .


Repeated measurements were made to compare outcomes over time .


At eight weeks , the success rate according to the Zurich Claudication Questionnaire for the interspinous process device group ( @ % , @ % confidence interval @ % to @ % ) was not superior to that for standard bony decompression ( @ % , @ % to @ % ) .


No differences in disability ( Zurich Claudication Questionnaire ; P = @ ) or other outcomes were observed between groups during the first year .


The repeat surgery rate in the interspinous implant group was substantially higher ( n = @ ; @ % ) than that in the conventional group ( n = @ ; @ % ) in the early post-surgical period ( P < @ ) .


This double blinded study could not confirm the hypothesized short term advantage of interspinous process device over conventional `` simple '' decompression and even showed a fairly high reoperation rate after interspinous process device implantation .


Despite the increasing need to identify and implement effective interventions to reduce drinking with mandated college students , peer-led brief alcohol interventions have received minimal research attention .


The current pilot study tested whether enhanced supervision ( evidence-based application approach -LSB- EAA ; group plus individual -RSB- ) would improve peer counseling skills beyond those acquired by a common practice approach ( CPA ; group only ) .


Following initial peer counselor skill evaluation , drinking outcomes after intervention were compared between supervision groups with a mandated college student sample ( N = @ ; @ men ) .


The relationship between acquired motivational interviewing skills and subsequent drinking behaviors was also assessed .


EAA peer counselors showed higher motivational interviewing skill acquisition than CPA peer counselors .


Despite differences in counselor skill demonstration , mandated clients in both intervention groups significantly reduced drinking behaviors .


Further , higher reflection-to-question ratio and motivational interviewing spirit demonstrated by peer counselors were significantly related to poorer follow-up drinking outcomes .


Findings identify supervision practices that may result in optimal peer counselor learning and brief intervention implementation while also offering initial data about the way in which peer counseling session implementation may relate to drinking outcomes .


Future research is needed to identify the within-session processes of peer-led interventions that predict drinking outcomes , which may offer additional direction for training approaches .


It is estimated that up to two thirds of patients presenting with ST-segment-elevation myocardial infarction have multivessel disease .


The optimal strategy for treating nonculprit disease is currently under debate .


This study provides a real-world analysis comparing a strategy of culprit-vessel intervention ( CVI ) versus multivessel intervention at the time of primary percutaneous coronary intervention in patients with ST-segment-elevation myocardial infarction .


We compared CVI versus multivessel intervention in @ patients with multivessel disease undergoing primary percutaneous coronary intervention between @ and @ at all @ tertiary cardiac centers in London .


Multivariable-adjusted models were built to determine independent predictors for in-hospital major adverse cardiovascular events ( MACEs ) and all-cause mortality at @ year .


To reduce confounding and bias , propensity score methods were used .


CVI was associated with reduced in-hospital MACE ( @ % versus @ % ; P = @ ) and mortality at @ year ( @ % versus @ % ; P = @ ) .


CVI was an independent predictor for reduced in-hospital MACE ( odds ratio , @ ; @ % confidence interval -LSB- CI -RSB- , @-@ @ ; P < @ ) and survival at @ year ( hazard ratio , @ ; @ % CI , @-@ @ ; P = @ ) in the complete cohort ; and in @ patients in propensity-matched cohort ( in-hospital MACE : odds ratio , @ ; @ % CI , @-@ @ ; P = @ ; and @-year survival : hazard ratio , @ ; @ % CI , @-@ @ ; P = @ ) .


Inverse probability treatment weighted analyses also confirmed CVI as an independent predictor for reduced in-hospital MACE ( odds ratio , @ ; @ % CI , @-@ @ ; P = @ ) and survival at @ year ( hazard ratio , @ ; @ % CI , @-@ @ ; P = @ ) .


In this observational analysis of patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention , CVI was associated with increased survival at @ year .


Acknowledging the limitations with observational analyses , our findings support current recommended practice guidelines .


In @ there were @,@ people in Australia who had acquired brain injury ( ABI ) with some limitation of activities ; @ % of these were traumatic brain injuries ( TBIs ) and nearly a third sustained injury below age @years .


One to four years post injury , @ % to @ % of children with traumatic brain injury ( TBI ) have clinically significant disorders of attention .


There is controversy as to whether central nervous system ( CNS ) stimulants can be an effective method of treating these.Objectives were to determine the efficacy of CNS stimulants for children with TBI , and to calculate the sample size for a larger trial using the Conners ' @ Parent Rating Scales Score as the primary endpoint .


Pilot series of aggregated prospective randomised , double-blind , n-of-@ trials of stimulant versus placebo within individual patients .


tertiary children 's public hospital .


ten children aged @ to @years more than @months post TBI with attention , concentration and behavioral difficulties on stimulants .


Three cycles of methylphenidate or dexamphetamine orally at doses titrated by physician compared to placebo .


Conners @ Parent ( Conners @-P ) and Teacher ( Conners @-T ) Rating Scales ( Global Index ) , Behaviour Rating Inventory of Executive Function ( BRIEF ) and Eyberg Child Behaviour Inventory ( ECBI ) .


Five of ten patients completed the study .


Data from @ completed cycles from seven patients were analysed .


The posterior mean difference between stimulant and placebo scores for the Conners @-PS ( Global Index ) was @ ( SD @ ; @ % credible region -@ to @ ; posterior probability that this mean difference was greater than zero was @ ) , and for the Conners @-T ( Global Index ) the posterior mean difference was @ ( SD @ ; @ % credible region -@ to @ ; posterior probability @ ) .


Posterior mean differences suggest improvement in behaviour and executive function and a decrease in number and intensity of child behaviour problems when taking stimulants compared to placebo .


Taken together these data are suggestive of a small benefit at group level .


In this pilot study , there was sufficient evidence that stimulants may be useful in management of behavioral and cognitive sequelae following TBI , to warrant a larger trial .


To investigate the effects of maxillary protraction combined with repetitive rapid palatal expansions and constrictions ( RPE/C ) vs. rapid palatal expansion ( RPE ) alone using cone-beam computed tomography ( CBCT ) .


Twenty four subjects with maxillary retrusion were recruited and block randomized into either the control group ( n = @ ) or the RPE/C ( n = @ ) group .


facemask protraction after RPE .


RPE/C group : facemask protraction after RPE/C .


@D reconstruction , landmarks identifying , superimposition and cephalometric analysis were performed to compare the pre-treatment and post - treatment CBCT images .


One subject in the RPE/C group was lost to follow up during the treatment .


Maxilla moved forward -LSB- ( @ ) mm -RSB- after maxillary protraction with RPE/C , which was significantly greater than that in the control group -LSB- ( @ ) mm -RSB- ( P < @ ) .


The distance of basion to subspinale ( Ba-A ) increased -LSB- ( @ ) mm -RSB- in the RPE/C group , which was significantly greater than that in the control group -LSB- ( @ @ ) mm -RSB- ( P < @ ) .


The amount of forward movement of upper first molars was significantly greater in the RPE/C group ( P < @ ) .


Maxillary protraction with RPE/C might positively affect the forward movement of maxilla compared with the RPE alone protocol with the early treatment of maxillary retrusion patients .


Subcutaneous pegylated interferon ( peginterferon ) beta-@a is being developed for treatment of relapsing multiple sclerosis , with less frequent dosing than currently available first-line injectable treatments .


We assessed the safety and efficacy of peginterferon beta-@a after @ weeks of treatment in the placebo-controlled phase of the ADVANCE trial , a study of patients with relapsing-remitting multiple sclerosis .


We did this @-year , double-blind , parallel group , phase @ study , with a placebo-controlled design for the first @ weeks , at @ sites in @ countries .


Patients with relapsing-remitting multiple sclerosis ( age @-@ years , with Expanded Disability Status Scale score @ ) were randomly assigned ( @:@:@ ) via an interactive voice response or web system , and stratified by site , to placebo or subcutaneous peginterferon beta-@a @ g once every @ weeks or every @ weeks .


The primary endpoint was annualised relapse rate at @ weeks .


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


We screened @ patients and enrolled @ , of whom @ were randomly assigned ( @ to placebo , @ to peginterferon every @ weeks , @ to peginterferon every @ weeks ) ; @ ( @ % ) patients completed @ weeks of treatment .


Adjusted annualised relapse rates were @ ( @ % CI @-@ ) in the placebo group versus @ ( @-@ ) in the every @ weeks group and @ ( @-@ ) in the every @ weeks group ( rate ratio for every @ weeks group @ , @ % CI @-@ , p = @ ; rate ratio for the every @ weeks group @ , @ % CI @-@ , p = @ ) .


@ ( @ % ) patients taking placebo , @ ( @ % ) patients taking peginterferon every @ weeks , and @ ( @ % ) patients taking peginterferon every @ weeks reported adverse events including relapses .


The most common adverse events associated with peginterferon beta-@a were injection site reactions , influenza-like symptoms , pyrexia , and headache .


@ ( @ % ) patients taking placebo , @ ( @ % ) patients taking study drug every @ weeks , and @ ( @ % ) patients taking study drug every @ weeks reported serious adverse events ; relapse , pneumonia , and urinary tract infection were the most common .


After @ weeks , peginterferon beta-@a significantly reduced relapse rate compared with placebo .


The drug might be an effective treatment for relapsing-remitting multiple sclerosis with less frequent administration than available treatments .


This randomized , double-blind , and placebo-controlled trial evaluated the effect of isolated daidzein and genistein on glycemic control and insulin sensitivity in @ Chinese women aged @-@ with impaired glucose regulation ( IGR ) .


Participants were randomly assigned to one of three groups with a daily dose of @ g of soy protein plus ( i ) no addition , ( ii ) @ mg of daidzein , or ( iii ) @ mg of genistein for @ wk .


Fasting glucose ( FG ) , insulin , and glycosylated hemoglobin ( HbA@c ) , and glucose concentrations at @ , @ , @ , and @ min and insulin concentrations at @ , @ , and @ min after an oral @-g glucose tolerance test were assessed at baseline and at @ and @ wk postintervention .


a total of @ and @ subjects completed the measures at wk @ and @ , respectively .


There were no significant differences in the changes ( % ) of FG and the @-h glucose , HbA@c , fasting , and @-h insulin or the area under the curve of glucose and insulin between the three treatment groups at wk @ or @ ( all p > @ ) .


Neither isolated daidzein nor genistein has a significant effect on glycemic control and insulin sensitivity in Chinese women with IGR over a @-month supplementation period .


Although there have been several reports that statins cause insulin resistance that leads to the occurrence of type @ diabetes in Caucasians , there has been no Japanese prospective studies investigating the effects of statins on the glucose metabolism system .


Our subjects were @ Japanese patients with type @ diabetes with hypercholesterolemia .


Pitavastatin @mg/day was administered for @ months and the lipid-related values , glucose metabolism values , and the presence/absence of side effects were investigated .


None of these factors was found to differ between before and after administration of pitavastatin in overall analysis of all subjects .


In subgroup analysis , fasting blood glucose showed a decrease in the BMI @ group and there was a significant difference between the BMI < @ and BMI @ @ groups ( P-values : @ and @ ) .


Although HbA@c showed an increase both in the group switched to pitavastatin and the BMI < @ group ( P-values : @ and @ ) and HOMA - showed a decrease in the BMI < @ group ( P-values : @ ) , there were no significant differences in changes between each divided group and their counterparts .


In the Japanese obese group with BMI @ , pitavastatin elicited a significant decrease in fasting blood glucose .


It is not clear whether or not this is due to improved insulin resistance as a direct effect of pitavastatin , but in contrast to findings in Caucasians pitavastatin does not worsen insulin resistance in Japanese patients with type @ diabetes complicated by hypercholesterolemia .


The aim of this in vitro study is to evaluate the effects of three different caries removal techniques on the microtensile bond strength of adhesive materials to caries-affected dentin .


Thirty primary molar teeth were used .


The teeth were randomly divided into three groups according to the caries removal technique employed : conventional steel bur ( group @ ) ; Er : YAG laser ( group @ ) ; chemomechanical method ( group @ ) .


Each group was divided into two subgroups according to bonding agents : one-step self-etch adhesive and etch-and-rinse adhesive .


The teeth were restored with composite resin .


Vertical sticks were obtained and subjected to tensile stress .


Data were analyzed by two-way analysis of variance ( ANOVA ) , Tukey 's test and an independent samples t-test .


The values for the laser groups were significantly lower than those of the bur groups for both bonding agents ( p < @ ) .


There were no significant differences between the bur and chemomechanical groups ( p > @ ) .


Bur and chemomechanical techniques in primary teeth were found more successful .


Similar results were found according to the adhesives used for each caries removal techniques .


The administration of single dose intrathecal ( IT ) morphine with local anesthetics during spinal anesthesia produces an effective postoperative analgesia .


In this study , we evaluated the efficacy and safety of two different doses of IT morphine with bupivacaine for postoperative analgesia after transurethral resection of prostate ( TURP ) .


Prospective , randomized study .


Urology Department .


Sixty patients who were scheduled to undergo TURP with spinal anesthesia .


Patients were allocated to receive IT morphine ( @ g ) with bupivacaine heavy ( group I ) and IT morphine ( @ g ) with bupivacaine heavy ( group II ) .


Postoperative pain was evaluated by Visual Analogous Scale during @ hours .


The need for rescue analgesia , adverse effects and patient satisfaction were recorded .


Groups were comparable with respect to demographic data .


VAS scores were similarly low in both groups .


However , the request for analgesia was significantly higher in group I ( @ percent ) than group II ( @ percent ; p = @ ) .


The incidence of postoperative nausea was similarly low in both groups .


No patients reported pruritis in group I where as six patients ( @ percent ) reported mild pruritis not necessitating treatment in group II ( p = @ ) Patients satisfaction was similarly high in both the groups .


IT morphine @ g reduced the need for rescue analgesia compared to IT morphine @ g in patients undergoing TURP under spinal anesthesia .


As the incidence of pruritis was low with no treatment , IT morphine @ g may be a suitable dose for postoperative analgesia for patients undergoing TURP under spinal anesthesia .


Specialized Early Intervention services ( SEI ) for first episode psychosis are shown to be effective for the treatment of positive and negative symptoms , medication adherence , rates of relapse , substance abuse disorders , functional outcome and quality of life at two-year treatment follow up .


However , it is also reported that these benefits are not maintained when SEI is not sustained .


The objective of this trial is to test the efficacy of a @-year extension of a SEI service ( following @ years of SEI prior to randomization ) for the maintenance and consolidation of therapeutic gains as compared to regular care in the community .


Following an initial @ years of SEI , patients are randomized to receive either @-years of continued SEI or regular care .


SEI provided at three sites within the McGill network of SEI services , using a model of treatment comprised of : modified assertive case management ; psycho education for families ; multiple family intervention ; cognitive behavioural therapy ; and substance abuse treatment and monitoring .


Blinded research assistants conduct ongoing evaluation of the outcome variables every three months .


The primary outcome measure is remission status measured both as the proportion of patients in complete remission and the mean length of remission achieved following randomization during the additional three years of follow up .


Based on preliminary data , it is determined that a total of @ patients are needed to achieve adequate statistical power .


Intent to treat with the last observation carried forward will be the primary method of statistical analysis .


The `` critical period '' hypothesis posits that there is a five year window during which the effects of the nascent psychotic illness can be countered and the impact of the disorder on symptomatic and functional outcomes can be offset through active and sustained treatment .


Providing SEI throughout this critical period may solidify the benefits of treatment such that gains may be more sustainable over time as compared to intervention delivered for a shorter period .


Findings from this study will have implications for service provision in first episode psychosis .


To assess the effectiveness of a child care center-based parent and teacher healthy lifestyle role-modeling program on child nutrition and physical activity outcomes .


Child care centers ( N = @ ) serving low-income families were randomized to intervention or control arms .


Intervention centers ( N = @ ) implemented ( @ ) menu modifications , ( @ ) a child 's healthy lifestyle curriculum , and ( @ ) an adult ( teacher - and parent-focused ) healthy lifestyle role-modeling curriculum .


Control centers ( N = @ ) received an attention control safety curriculum .


Nutrition and physical activity data were collected at the beginning ( T@ ) and at the end ( T@ ) of the school year .


Exploratory factor analysis identified positive and negative nutrition and physical activity practices by children , parents , and teachers .


Intervention parents ' baseline ( = @ , p < @ ) and school year consumption ( = @ , p < @ ) of fruits/vegetables significantly increased their children 's consumption of fruits/vegetables from T@ to T@ .


Intervention parents significantly influenced a decrease in children 's junk food consumption ( = -@ , p < @ ) , whereas control parents significantly influenced an increase in their children 's junk food consumption ( = @ , p < @ ) from T@ to T@ .


Control children showed a significant increase in junk food consumption ( = @ , p = @ ) and sedentary behavior ( = @ , p < @ ) from T@ to T@ .


Teachers did not significantly influence preschool-age children 's nutrition or physical activity patterns from T@ to T@ .


Parent nutrition and physical activity patterns significantly influence their preschool-age children 's consumption of fruits/vegetables , junk food , and level of sedentary behavior .


Future obesity prevention intervention efforts targeting this age group should include parents as healthy lifestyle role models for their children .


Our objective was to compare the pain/stress levels of newborns among the @ most common circumcision techniques after resident-wide education .


The study period of this randomized control trial was October @ through March @ .


Following informed consent , full-term males from uncomplicated singleton pregnancies were randomized to Gomco ( n = @ ) or Mogen ( n = @ ) devices .


Resident-wide education for an obstetrics and gynecology residency program at a single institution was performed to ensure standardized training .


All infants received a subcutaneous ring block before the procedure and oral sucrose intraoperatively .


The primary outcome was neonatal pain assessed physiologically by salivary cortisol levels ( enzyme-linked immunosorbent assay ) and clinically by a validated neonatal pain score ( crying , requires increased oxygen administration , increased vital signs , expression , sleeplessness -LSB- CRIES -RSB- ) .


Secondary outcomes were immediate complications , duration of procedure , and short-term outcomes as reported by mothers and pediatricians .


A sample size of @ ( accounting for @ % loss of follow-up ) was determined sufficient to detect a mean difference of @ g/dL in cortisol levels ( Gomco , SD@ @ ; Mogen , SD@ @ ) with @ % power , P = @ level of significance .


A total of @ infants completed the protocol .


There were no significant differences in maternal or neonatal demographics including preoperative heart rate and mean arterial pressure .


In the Mogen circumcision , the percentage change of cortisol was significantly lower than Gomco ( @ vs @ ; P = @ ) .


There were no differences in postoperative CRIES scores .


Postoperative heart rate was higher in infants undergoing Gomco circumcision than Mogen circumcision ( @ vs @ ; P = @ ) as was mean arterial blood pressure ( @ vs @ ; P = @ ) .


Mogen circumcisions were shorter ( @ vs @ minutes ; P < @ ) .


There were no significant differences in bleeding complications .


A total of @ maternal surveys were completed , with @ % maternal satisfaction in Gomco vs @ % in Mogen .


There were no reports of bleeding after discharge or circumcision revisions in either group to date .


Mogen clamp is associated with less neonatal pain physiologically by significantly lower percentage change in salivary cortisol , lower heart rate , and mean arterial blood pressure .


There was no difference in CRIES scores .


Mogen clamp circumcision duration is significantly shorter than Gomco clamp .


Both methods demonstrate satisfactory maternal and pediatrician short-term follow-up .


Remote ischaemic preconditioning ( RIPC ) , using brief cycles of limb ischaemia/reperfusion , is a non-invasive , low-cost intervention that may reduce perioperative myocardial injury ( PMI ) in patients undergoing cardiac surgery .


We investigated whether RIPC can also improve short-term clinical outcomes .


One hundred and eighty patients undergoing elective coronary artery bypass graft ( CABG ) surgery and/or valve surgery were randomised to receive either RIPC ( @-@min cycles of simultaneous upper arm and thigh cuff inflation/deflation ; N = @ ) or control ( uninflated cuffs placed on the upper arm and thigh ; N = @ ) .


The study primary end point was PMI , measured by @h area under the curve ( AUC ) serum high-sensitive troponin-T ( hsTnT ) ; secondary end point included short-term clinical outcomes .


RIPC reduced PMI magnitude by @ % ( -@ difference ( CI -@ to -@ ) @h hsTnT-AUC ; p = @ ) compared with control .


There was also evidence that RIPC reduced the incidence of postoperative atrial fibrillation by @ % ( @ % RIPC vs @ % control ; p = @ ) and decreased the incidence of acute kidney injury by @ % ( @ % RIPC vs @ % control ; p = @ ) , and intensive care unit stay by @day ( @ days RIPC ( CI @ to @ ) vs @ days control ( CI @ to @ ) ; p = @ ) .


In a post hoc analysis , we found that control patients administered intravenous glyceryl trinitrate ( GTN ) intraoperatively sustained @ % less PMI compared with those not receiving GTN , and RIPC did not appear to reduce PMI in patients given GTN .


RIPC reduced the extent of PMI in patients undergoing CABG and/or valve surgery .


RIPC may also have beneficial effects on short-term clinical outcomes , although this will need to be confirmed in future studies .


Quality of life ( QoL ) is considered an important outcome in health research .


It can be rated by the patient , or by an external assessor .


We wished to identify the predictors of any discrepancies between these two approaches in people with schizophrenia .


Patients with DSM schizophrenia and related disorders ( N = @ ) completed both patient-rated ( Lancashire Quality of Life Profile ; LQOLP ) and assessor-rated ( Heinrich 's Quality of Life Scale ; QLS ) measures of QoL .


Patient-rated ( LQOLP ) and assessor-rated ( QLS ) measures showed a modest correlation ( r = @ ) .


In a regression analysis , independent predictors of subjectively-rated QoL being higher than objectively-assessed QoL in the same patient , were low insight score ( BIS ) , negative symptoms ( PANSS ) , absence of depression ( CDSS ) , and less positive attitude toward prescribed treatment ( DAI ) .


In people with schizophrenia , scores on objectively - and subjectively-rated measures of quality of life can differ markedly .


When comparing subjective to objective assessments , patients with depressive symptoms will value their QoL lower , and those with low insight will value their QoL higher .


This has important implications for the utility and interpretation of QoL measures in schizophrenia .


Low serum levels of high density lipoprotein cholesterol ( HDL-C ) is an established risk factor for coronary heart disease ( CHD ) .


Among a variety of lipid modifying drugs , the best single drug therapy to increase HDL-C levels , especially among high risk , isolated low HDL-C ( ILHDL-C ) cases is yet to be identified .


The objectives of the present study were to evaluate the best pharmacological measure among atorvastatin , fenofibrate and niacin aimed to raise HDL-C and its effect in decreasing the estimated Framingham-@-year CHD risk percentage ( CHD-RP ) among high risk ILHDL-C cases in north India .


Two hundred CHD equivalent ( CHD-RP@ ) , ILHDL-C cases were randomly assigned for treatment either with atorvastatin @ mg/day ( n = @ ) , micronized fenofibrate @ mg/day ( n = @ ) or niacin-extended release ( ER ) @ mg/day ( n = @ ) .


After @ wk of treatment , the dosages of drugs were doubled and the patients were finally assessed after @ wk for their lipid values .


Baseline characteristics were similar in the three groups .


Niacin therapy @ mg and @ g/day resulted in a significant rise in HDL-C by @ @ and @ @ per cent ( P < @ ) , respectively .


Fenofibrate @ and @ mg/day also resulted in a significant rise in HDL-C by @ @ and @ @ per cent ( P < @ ) , respectively , while atorvastatin @ and @ mg/day resulted in a non-significant increase in HDL-C by @ @ per cent and @ @ per cent , respectively .


By increasing HDL-C values , niacin was found to be most effective in reduction of @-year CHD-RP ( P < @ ) , followed by fenofibrate ( P = @ ) , while atorvastatin had no effect .


Our findings indicate that niacin rather than fibrates or statins seems to provide a safe and effective therapy for increasing HDL-C , thus reducing the cumulative CHD risk among ILHDL-C cases .


Calcineurin inhibitors ( CNIs ) are essential immunosuppressive drugs after renal transplantation .


Because of nephrotoxicity , withdrawal has been a challenge since their introduction .


A randomized multicenter trial included @ kidney patients transplanted between @ and @ .


All patients were initially treated with mycophenolate mofetil ( MMF ) , cyclosporine A ( CsA ) , and prednisone ( pred ) .


At @ months after transplantation , @ patients were randomized for MMF/pred , @ for MMF/CsA , and @ for MMF/CsA/pred .


Within @ months after randomization @ patients experienced a rejection episode : MMF/pred ( @ % ) , MMF/CsA ( @ % ) and MMF/CsA/pred ( @ % ) ( P < @ ) .


During @ years of follow-up , @ patients died with a functioning graft , and @ patients lost their graft .


Ninety-six were alive with a functioning graft .


Intention-to-treat analysis did not show a significant difference in patient and graft survival .


In multivariate analysis , death-censored graft survival was significantly associated with serum creatinine at @ months after transplantation and maximum PRA but not with the randomization group .


CNI withdrawal did not result in a reduced incidence of or death by malignancy or cardiovascular disease .


Death-censored graft survival was significantly worse in those patients randomized for CNI withdrawal that had to be reverted to CNI .


Independent of randomization group , compared with no rejection , death-censored graft survival was significantly worse in @ patients with acute rejection after randomization .


Fifteen years after conversion to a CNI free regimen , there was no benefit regarding graft and patient survival or regarding prevalence of or death by comorbidities .


However , rejection shortly after CNI withdrawal was associated with decreased graft survival .


To report the safety of intravitreal ocriplasmin injection based on @ Phase @ clinical trials in patients with symptomatic vitreomacular adhesion/vitreomacular traction , including when associated with full-thickness macular holes .


Safety analyses were based on @ completed Phase @ studies assessing intravitreal ocriplasmin injection .


Adverse events ( AEs ) , serious AEs , and suspected adverse drug reactions are reported .


The authors also report AEs of special interest from @ other completed Phase @ studies and @ ongoing studies .


A total of @ eyes were injected with ocriplasmin ( @ g ) , and @ eyes were treated with placebo injection in Phase @ studies .


Overall AE rate was @ % in the placebo group and @ % for ocriplasmin-treated patients .


Most AEs were in the study eye , mild or moderate in severity , and transient .


All suspected adverse drug reactions were ocular ; the majority was nonserious , of mild intensity , and transient .