The primary outcomes are : proportion of age - and screening-eligible patients completing a FIT within @months ; and cost , cost-effectiveness , and return on investment of the intervention .


This large-scale pragmatic trial will leverage electronic health record information and existing clinic staff to enroll a broad range of patients , including many with historically low colorectal-cancer screening rates .


If successful , the program will provide a model for a cost-effective and scalable method to raise colorectal-cancer screening rates .


To compare the effect of monovision correction and multifocal intraocular lens ( IOL ) implantation on patient satisfaction , spectacle dependence , visual acuity , and dysphotopsia in cataract patients .


University Hospital of Alexandroupolis , Democritus University of Thrace , Alexandroupolis , Greece .


Prospective randomized trial .


Patients with a diagnosis of senile cataract with stage @ nuclear opalescence were randomly assigned to @ groups : monovision and multifocal IOL implantation .


Uncorrected ( UDVA ) and corrected ( CDVA ) distance visual acuity , Visual Function Index-@ ( VF-@ ) scores , and spectacle dependence were assessed prior to surgery and @ months postoperatively .


The monovision group comprised @ patients and the multifocal IOL implantation group , @ patients .


Both techniques provided excellent refractive outcomes in UDVA and VF-@ scores ( all P < @ ) .


No significant intergroup differences were detected in VF-@ scores at the final postoperative examination .


The monovision group patients presented significantly more spectacle dependence for near vision but less glare .


Monovision and multifocal IOL implantation provided excellent refractive outcomes for distance vision .


Multifocal IOL insertion was associated with less dependence on glasses overall but significantly more dysphotopsia .


This pilot study was set up to examine the effects of a continuous postoperative wound infusion system with a local anaesthetic on perioperative pain and the consumption of analgesics .


We included @ patients in this prospective observational pilot study .


Patients were divided into two groups .


One group was treated in accordance with the WHO standard pain management protocol and in addition to that received a continuous local wound infusion treatment ( Group @ ) .


Group @ was treated with analgesics in accordance with the WHO standard pain management protocol , exclusively .


The study demonstrated a significantly reduced postoperative VAS score for stump pain in Group @ for the first @ days .


Furthermore , the intake of opiates was significantly reduced in Group @ ( day @ , Group @ : @ vs. Group @ : @ , p = @ ; day @ , Group @ : @ vs. Group @ : @ , p = @ ; day @ , Group @ : @ vs. Group @ : @ , p = @ ; day @ , Group @ : @ vs. Group @ : @ , p = @ ; day @ , Group @ @ vs. Group @ : @ , p = @ ) .


There were no significant differences between the two groups , neither in phantom pain intensity at discharge nor postoperative complications and death .


Continuous postoperative wound infusion with a local anaesthetic in combination with a standard pain management protocol can reduce both stump pain and opiate intake in patients who have undergone transfemoral amputation .


Phantom pain was not significantly affected .


Responses to a number of different plasticity-inducing brain stimulation protocols are highly variable .


However there is little data available on the variability of response to transcranial direct current stimulation ( TDCS ) .


We tested the effects of TDCS over the motor cortex on corticospinal excitability .


We also examined whether an individual 's response could be predicted from measurements of onset latency of motor evoked potential ( MEP ) following stimulation with different orientations of monophasic transcranial magnetic stimulation ( TMS ) .


Fifty-three healthy subjects participated in a crossover-design .


Baseline latency measurements with different coil orientations and MEPs were recorded from the first dorsal interosseous muscle prior to the application of @ min of @ mA TDCS ( @ mA/cm@ ) .


Thirty MEPs were measured every @ min for up to half an hour after the intervention to assess after-effects on corticospinal excitability .


Anodal TDCS at @ mA facilitated MEPs whereas there was no significant effect of @ mA cathodal TDCS .


A two-step cluster analysis suggested that approximately @ % individuals had only a minor , or no response to TDCS whereas the remainder had a facilitatory effect to both forms of stimulation .


There was a significant correlation between the latency difference of MEPs ( anterior-posterior stimulation minus latero-medial stimulation ) and the response to anodal , but not cathodal TDCS .


The large variability in response to these TDCS protocols is in line with similar studies using other forms of non-invasive brain stimulation .


The effects highlight the need to develop more robust protocols , and understand the individual factors that determine responsiveness .


To evaluate the efficacy and safety of solifenacin in the management of irritative symptoms after transurethral resection of bladder tumors ( TURBTs ) with subsequent intravesical chemotherapy .


A total of @ patients undergoing TURBT were randomly allocated into @ groups , @ patients in each group .


Group @ patients received solifenacin @ mg , @ hours before surgery and @ mg per day , after surgery for @ weeks , whereas group @ patients received a placebo .


Patients with low-risk non-muscle-invasive bladder cancer received immediate postoperative instillation of epirubicin .


Patients with medium - or high-risk non-muscle-invasive bladder cancer received postoperative instillation twice within @ weeks , once immediately following the operation and once on the eighth postoperative day .


All patients completed bladder diaries before surgery , on the @st , @th , and @th days after removal of the catheter with overactive bladder symptom scores completed preoperatively , and on the @th and @th days .


Additionally , the incidence and severity of catheter-related bladder discomfort were recorded at @ , @ , @ , @ , and @ hours after the surgery .


The incidence and the severity of catheter-related bladder discomfort in group @ , compared with group @ , were significantly reduced ( P < @ ) .


There was a significant difference in overactive bladder symptom scores between the @ groups ( @ vs @ ; P < @ ) .


Episodes of daytime , frequency , nocturia , urgency , and urge urinary incontinence in group @ were also significantly lower than in group @ ( P < @ ) .


This study demonstrates that solifenacin can be beneficial for the management of irritative symptoms after TURBT with subsequent intravesical chemotherapy .


Oxaliplatin-based adjuvant therapy is the standard of care for stage III colon cancer .


Adjuvant capecitabine with or without oxaliplatin versus leucovorin and fluorouracil with or without oxaliplatin has not been directly compared ; therefore , we aimed to analyse the efficacy and safety of these treatments using individual patient data pooled from four randomised controlled trials .


We also assessed post-relapse survival , which has been postulated to be worse in patients receiving adjuvant oxaliplatin .


Patients with resected stage III colon cancer who were @ years of age or older , with an Eastern Cooperative Oncology Group performance status of @ or @ , from four randomised controlled trials ( NSABP C-@ , XELOXA , X-ACT , and AVANT ; @ patients in total ) were pooled and analysed .


The treatment regimens included in our analyses were : XELOX ( oxaliplatin and capecitabine ) ; leucovorin and fluorouracil ; capecitabine ; FOLFOX-@ ( leucovorin , fluorouracil , and oxaliplatin ) ; and modified FOLFOX-@ ( mFOLFOX-@ ) .


Disease-free survival was the primary endpoint for all trials that supplied patients for this analysis .


Here , we compared disease-free , relapse-free , and overall survival between the patient groups who received capecitabine with or without oxaliplatin and those who received leucovorin and fluorouracil with or without oxaliplatin .


Post-relapse survival was compared between the combined XELOX and FOLFOX groups , and the leucovorin and fluorouracil groups .


Post-relapse survival was also compared between the capecitabine with or without oxaliplatin and leucovorin and fluorouracil with or without oxaliplatin groups .


Disease-free survival did not differ significantly between patients who received leucovorin and fluorouracil versus those who received capecitabine in adjusted analyses ( hazard ratio -LSB- HR -RSB- @ -LSB- @-@ ; p = @ -RSB- ) or in unadjusted analyses ( HR @ -LSB- @ % CI @-@ ; p = @ -RSB- ) .


Relapse-free survival was similar ( adjusted HR @ -LSB- @-@ ; p = @ -RSB- and unadjusted HR @ -LSB- @ % CI @-@ ; p = @ -RSB- ) , as was overall survival ( adjusted HR @ -LSB- @ % CI @-@ ; p = @ -RSB- and unadjusted HR @ -LSB- @-@ -RSB- ; p = @ ) .


For overall survival , a significant interaction between oxaliplatin and fluoropyrimidine was recorded in the multiple Cox regression analysis ( p = @ ) .


Post-relapse survival was similar in adjusted ( p = @ ) and unadjusted analyses ( p = @ ) for the comparison of XELOX or FOLFOX versus leucovorin and fluorouracil , and was also similar for capecitabine-based regimens versus leucovorin and fluorouracil-based regimens ( unadjusted p = @ ) .


Combination therapy with oxaliplatin provided consistently improved outcomes without adversely affecting post-relapse survival in the adjuvant treatment of stage III colon cancer , irrespective of whether the fluoropyrimidine backbone was capecitabine or leucovorin and fluorouracil .


These data add to the existing evidence that oxaliplatin plus capecitabine or leucovorin and fluorouracil is the standard of care for the adjuvant treatment of stage III colon cancer , and offers physicians flexibility to treat patients according to the patients ' overall physical performance and preference .


To determine the effect of vitamin D@ supplementation on @-hydroxyvitamin D -LSB- @ ( OH ) D -RSB- , lipid profile and markers of insulin resistance in obese adolescents .


In this double-blind , randomized , placebo-controlled trial , @ obese adolescents ( n = @ ; @-@ years of age ) received either vitamin D@ ( @,@ IU/day ) or placebo for @ weeks .


Total @ ( OH ) D , fasting plasma glucose , insulin and lipid profile were measured at baseline and following supplementation .


The trial was completed by @/@ enrolled participants .


At the end of the @ weeks , total serum @ ( OH ) D concentrations increased to a modest degree ( median @ ng/ml ) in the vitamin D-supplemented group ( p < @ ) .


Supplementation showed no detectable changes in fasting plasma glucose , insulin , homeostatic model of assessment index ( HOMA-IR ) , lipids and highly sensitive C-reactive protein .


@ weeks of vitamin D@ supplementation in obese adolescents with @,@ IU once daily resulted in a modest increase in @ ( OH ) D concentration in obese adolescents , but did not affect the lipid profile and markers of insulin resistance and inflammation .


Further studies with higher doses of vitamin D@ and/or longer duration of supplementation are needed to understand if vitamin D@ supplementation can impact lipid profiles and markers of insulin resistance and inflammation in obese children .


Device-based pacing-induced diaphragmatic stimulation ( PIDS ) may have therapeutic potential for chronic heart failure ( HF ) patients .


We studied the effects of PIDS on cardiac function and functional outcomes .


In @ chronic HF patients with CRT , an additional electrode was attached to the left diaphragm .


Randomized into two groups , patients received the following PIDS modes for @weeks in a different sequence : ( i ) PIDS off ( control group ) ; ( ii ) PIDS @ms mode ( PIDS simultaneously with ventricular CRT pulse ) ; or ( iii ) PIDS optimized mode ( PIDS with optimized delay to ventricular CRT pulse ) .


For PIDS optimization , acoustic cardiography was used .


Effects of each PIDS mode on dyspnoea , power during exercise testing , and LVEF were assessed .


Dyspnoea improved with the PIDS @ms mode ( P = @ ) and the PIDS optimized mode ( P = @ ) as compared with the control group .


Maximal power increased from median @ W in the control group to @ W in the PIDS @ms mode ( P = @ ) and @ W in the PIDS optimized mode ( P = @ ) .


Median LVEF was @ % in the control group , @ % in the PIDS @ms mode , and @ % in the PIDS optimized mode ( P = @ and P = @ as compared with the control group , respectively ) .


PIDS was asymptomatic in all patients .


PIDS improves dyspnoea , working capacity , and LVEF in chronic HF patients over a @ week period in addition to CRT .


This pilot study demonstrates proof of principle of an innovative technology which should be confirmed in a larger sample .


Outcomes associated with episodes of hypotension while hospitalized with acute decompensated heart failure are not well understood .


Using data from Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure ( ASCEND-HF ) , we assessed factors associated with in-hospital hypotension and subsequent @-day outcomes .


Patients were classified as having symptomatic or asymptomatic hypotension .


Multivariable logistic regression was used to determine factors associated with in-hospital hypotension , and Cox proportional hazards models were used to assess the association between hypotension and @-day outcomes .


We also tested for treatment interaction with nesiritide on @-day outcomes and the association between in-hospital hypotension and renal function at hospital discharge .


Overall , @ of @ ( @ % ) patients had an episode of hypotension , of which @ % were asymptomatic and @ % were symptomatic .


Factors strongly associated with in-hospital hypotension included randomization to nesiritide ( odds ratio , @ ; @ % confidence interval -LSB- CI -RSB- , @-@ @ ; P < @ ) , chronic metolazone therapy ( odds ratio , @ ; @ % CI , @-@ @ ; P < @ ) , and baseline orthopnea ( odds ratio , @ ; @ % CI , @-@ @ ; P = @ ) or S@ gallop ( odds ratio , @ ; @ % CI , @-@ @ ; P = @ ) .


In-hospital hypotension was associated with increased hazard of @-day mortality ( hazard ratio , @ ; @ % CI , @-@ @ ; P < @ ) , @-day heart failure hospitalization or mortality ( hazard ratio , @ ; @ % CI , @-@ @ ; P < @ ) , and @-day all-cause hospitalization or mortality ( hazard ratio , @ ; @ % CI , @-@ @ ; P < @ ) .


Nesiritide had no interaction on the relationship between hypotension and @-day outcomes ( interaction P = @ for death , P = @ for death/heart failure hospitalization , P = @ death/all-cause hospitalization ) .


Hypotension while hospitalized for acute decompensated heart failure is an independent risk factor for adverse @-day outcomes , and its occurrence highlights the need for modified treatment strategies .


There is a lack of treatments providing survival benefit for patients with metastatic triple-negative breast cancer ( mTNBC ) , with no standard of care .


A randomized phase II trial showed significant benefit for gemcitabine , carboplatin , and iniparib ( GCI ) over gemcitabine and carboplatin ( GC ) in clinical benefit rate , response rate , progression-free survival ( PFS ) , and overall survival ( OS ) .


Here , we formally compare the efficacy of these regimens in a phase III trial .


Patients with stage IV/locally recurrent TNBC who had received no more than two previous chemotherapy regimens for mTNBC were randomly allocated to gemcitabine @,@ mg/m ( @ ) and carboplatin area under the curve @ ( days @ and @ ) alone or GC plus iniparib @ mg/kg ( days @ , @ , @ , and @ ) every @ weeks .


Random assignment was stratified by the number of prior chemotherapies .


The coprimary end points were OS and PFS .


Patients receiving GC could cross over to iniparib on progression .


Five hundred nineteen patients were randomly assigned ( @ GCI ; @ GC ) .


In the primary analysis , no statistically significant difference was observed for OS ( hazard ratio -LSB- HR -RSB- = @ ; @ % CI , @ to @ ; P = @ ) nor PFS ( HR = @ ; @ % CI , @ to @ ; P = @ ) .


An exploratory analysis showed that patients in the second - / third-line had improved OS ( HR = @ ; @ % CI , @ to @ ) and PFS ( HR = @ ; @ % CI , @ to @ ) with GCI .


The safety profile for GCI was similar to GC .


The trial did not meet the prespecified criteria for the coprimary end points of PFS and OS in the ITT population .


The potential benefit with iniparib observed in second - / third-line subgroup warrants further evaluation .


Supposing divergent aetiology , we found it interesting to investigate outcomes between primary ( PH ) versus incisional ( IH ) hernias .


In addition , we wanted to analyse the effect of defect closure and mesh fixation techniques .


@ patients with PH and @ with IH were enrolled in a prospective cohort-study , treated with laparoscopic ventral hernia repair ( LVHR ) and randomised to transfascial sutures .


In addition , we analysed results from a retrospective study with @ PH and @ IH patients .


Mean follow-up time was @ months in the prospective study and @ months in the retrospective study .


@ % of PH 's and @ % of IH 's were recurrences after previous suture repair .


No late infections or mesh removals occurred .


Recurrence rates in the prospective study were @ vs. @ % ( p = @ ) and the complication rates were @ vs. @ % ( p = @ ) in favour of the PH cohort .


The IH group had a mesh protrusion rate of @ vs. @ % in the PH group ( p = @ ) , and significantly ( p < @ ) larger hernias and adhesion score , longer operating time ( @ vs. @ min ) and admission time ( @ vs. @ days ) .


Closure of the hernia defect did not influence rate of seroma , pain at @ months , protrusion or recurrence .


An overall increased complication rate was seen after defect closure ( OR @ ; CI @-@ @ ) .


With PH , in comparison to IH treated with LVHR , no differences were observed regarding recurrence , protrusion or complication rates .


Defect closure ( raphe ) , when using absorbable suture , did not benefit long-term outcomes and caused a higher overall complication rate .


( ClinicalTrials.gov number : NCT@ ) .


S-@-based regimens are commonly used for advanced gastric cancer ( AGC ) in Japan .


We performed this trial to evaluate the efficacy and safety of S-@ plus irinotecan ( SIri ) and S-@ plus paclitaxel ( SPac ) as first-line treatments for AGC in order to select the optimal regimen for a subsequent phase III trial .


Patients with previously untreated , locally advanced or metastatic measurable gastric adenocarcinoma were randomly assigned to receive SIri ( irinotecan @ mg/m ( @ ) was administered intravenously ( i.v. ) on day @ and @ , while @ mg/m ( @ ) S-@ was orally administered twice daily for three weeks from days @-@ followed by a two-week pause ) or SPac ( paclitaxel @ mg/m ( @ ) was administered i.v. on day @ and @ , while @ mg/m ( @ ) S-@ was orally administered twice daily for two weeks from day @-@ followed by a one-week pause ) regimen .


The primary end-point was the overall response rate ( ORR ) , and the secondary end-points were progression-free survival ( PFS ) , overall survival ( OS ) , and toxicity .


A total of @ patients were enrolled .


The ORR was @ % for SIri and @ % for SPac , which did not achieved the predicted ORR in either group .


PFS and OS were @ and @ months for SIri , @ and @ months for SPac respectively .


No treatment-related deaths occurred during the study .


Although grade @/@ neutropenia and anemia were more frequent in the Siri group , both regimens were well-tolerated .


Both regimens were well-tolerated in patients with AGC , but we conclude that neither regimen was optimal for a phase III trial .


Population-based studies on aspirin-intolerant asthma ( AIA ) are very few , and no previous population study has investigated risk factors for the condition .


To investigate the prevalence and risk factors of AIA in the general population .


A questionnaire on respiratory health was mailed to @,@ randomly selected subjects aged @-@ years in West Sweden , @,@ could be traced and @,@ ( @ % ) responded .


The questionnaire included questions on asthma , respiratory symptoms , aspirin-induced dyspnoea and possible determinants .


The prevalence of AIA was @ % , @ % in men and @ % in women ( P = @ ) .


Sick leave , emergency visits due to asthma and all investigated lower respiratory symptoms were more common in AIA than in aspirin-tolerant asthma ( ATA ) .


Obesity was a strong risk factor for AIA ( BMI > @ : odds ratio ( OR ) @ ; @ % CI @-@ @ ) , and there was a dose-response relationship between increasing body mass index ( BMI ) and risk of AIA .


Obesity , airborne occupational exposure and visible mould at home were considerably stronger risk factors for AIA than for ATA .


Current smoking was a risk factor for AIA ( OR @ ; @ % CI @-@ @ ) , but not ATA .


Aspirin-intolerant asthma identified in the general population was associated with a high burden of symptoms , uncontrolled disease and a high morbidity .


Increasing BMI increased the risk of AIA in a dose-response manner .


A number of risk factors , including obesity and current smoking , were considerably stronger for AIA than for ATA .


Statistical methods are very important to precisely measure breast cancer patient survival times for healthcare management .


Previous studies considered basic statistics to measure survival times without incorporating statistical modeling strategies .


The objective of this study was to develop a data-based statistical probability model from the female breast cancer patients ' survival times by using the Bayesian approach to predict future inferences of survival times .


A random sample of @ female patients was selected from the Surveillance Epidemiology and End Results cancer registry database .


For goodness of fit , the standard model building criteria were used .


The Bayesian approach is used to obtain the predictive survival times from the data-based Exponentiated Exponential Model .


Markov Chain Monte Carlo method was used to obtain the summary results for predictive inference .


The highest number of female breast cancer patients was found in California and the lowest in New Mexico .


The majority of them were married .


The mean ( SD ) age at diagnosis ( in years ) was @ ( @ ) .


The mean ( SD ) survival time ( in months ) for female patients was @ ( @ ) .


The Exponentiated Exponential Model found better fits for the female survival times compared to the Exponentiated Weibull Model .


The Bayesian method is used to obtain predictive inference for future survival times .


The findings with the proposed modeling strategy will assist healthcare researchers and providers to precisely predict future survival estimates as the recent growing challenges of analyzing healthcare data have created new demand for model-based survival estimates .


The application of Bayesian will produce precise estimates of future survival times .


Improvement has been anecdotally observed in patients with persistent postconcussion symptoms ( PCS ) after mild traumatic brain injury following treatment with hyperbaric oxygen ( HBO ) .


The effectiveness of HBO as an adjunctive treatment for PCS is unknown to date .


To compare the safety of and to estimate the efficacy for symptomatic outcomes from standard PCS care alone , care supplemented with HBO , or a sham procedure .


Multicenter , double-blind , sham-controlled clinical trial of @ military service members with ongoing symptoms at least @ months after mild traumatic brain injury enrolled at military hospitals in Colorado , North Carolina , California , and Georgia between April @ , @ , and August @ , @ .


Assessments occurred before randomization , at the midpoint , and within @ month after completing the interventions .


Routine PCS care was provided in specialized clinics .


In addition , participants were randomized @:@:@ to @ HBO sessions administered at @ atmospheres absolute ( ATA ) , @ sham sessions consisting of room air at @ ATA , or no supplemental chamber procedures .


The Rivermead Post-Concussion Symptoms Questionnaire ( RPQ ) served as the primary outcome measure .


A change score of at least @ points on the RPQ-@ subscale ( range , @-@ ) was defined as clinically significant .


Change scores from baseline were calculated for the RPQ-@ and for the total RPQ .


Secondary measures included additional patient-reported outcomes and automated neuropsychometric testing .


On average , participants had sustained @ lifetime mild traumatic brain injuries ; the most recent occurred @ months before enrollment .


No differences were observed between groups for improvement of at least @ points on the RPQ-@ subscale ( @ % in the no intervention group , @ % in the HBO group , and @ % in the sham group ; P = @ ) .


Compared with the no intervention group ( mean change score , @ ; @ % CI , -@ to @ ; P = @ ) , both groups undergoing supplemental chamber procedures showed improvement in symptoms on the RPQ ( mean change score , @ ; @ % CI , -@ to @ ; P = @ in the HBO group and @ ; @ % CI , @-@ @ ; P = @ in the sham group ) .


No difference between the HBO group and the sham group was observed ( P = @ ) .


Chamber sessions were well tolerated .


Among service members with persistent PCS , HBO showed no benefits over sham compressions .


Both intervention groups demonstrated improved outcomes compared with PCS care alone .


This finding suggests that the observed improvements were not oxygen mediated but may reflect nonspecific improvements related to placebo effects .


We tested the effect of dietary advice dedicated to increase intake in older patients at risk for malnutrition during chemotherapy , versus usual care , on one-year mortality .


We conducted a multicentre , open-label interventional , stratified ( centre ) , parallel randomised controlled trial , with a @ ratio , with two-year follow-up .


Patients were aged @ years or older treated with chemotherapy for solid tumour and at risk of malnutrition ( MNA , Mini Nutritional Assessment @-@ @ ) .


Intervention consisted of diet counselling with the aim of achieving an energy intake of @ kCal/kg body weight/d and @ g protein/kg/d , by face-to-face discussion targeting the main nutritional symptoms , compared to usual care .


Interviews were performed @ times during the chemotherapy sessions for @ to @ months .


The primary endpoint was @-year mortality and secondary endpoints were @-year mortality , toxicities and chemotherapy outcomes .


Between April @ and March @ we randomised @ patients and @ were analysed : mean ( standard deviation ) age of @ y ( @ ) , @ % male , mean MNA @ ( @ ) .


Distribution of cancer types was similar in the two groups ; the most frequent were colon ( @ % ) , lymphoma ( @ % ) , lung ( @ % ) , and pancreas ( @ % ) .


Both groups increased their dietary intake , but to a larger extent with intervention ( p < @ ) .


At the second visit , the energy target was achieved in @ ( @ % ) patients and the protein target in @ ( @ % ) with the intervention compared respectively to @ ( @ % ) and @ ( @ % ) in the controls .


Death occurred during the first year in @ patients ( @ % ) , without difference according to the intervention ( p = @ ) .


No difference in nutritional status changes was found .


Response to chemotherapy was also similar between the groups .


Early dietary counselling was efficient in increasing intake but had no beneficial effect on mortality or secondary outcomes .


Cancer cachexia antianabolism may explain this lack of effect .


The World Health Organization recommends @ months of isoniazid preventive therapy ( @IPT ) for adults infected with HIV living in TB-endemic countries .


We determined the rates and risk factors for isoniazid-associated hepatitis with the use of @IPT .


One thousand six adults infected with HIV received @IPT during a pragmatic randomized trial set in Botswana public health clinics providing HIV care .


Enrollment exclusion criteria included jaundice or elevations of serum transaminases ( ESTs ) > @-fold the upper limit of normal ( ULN ) .


Participants with any CD@ + lymphocyte count were eligible and received antiretroviral therapy ( ART ) when CD@ + < @ cells/L .


@IPT was stopped for severe hepatitis ( more than fivefold ULN EST ) but not for moderate hepatitis ( @-fold to fivefold ULN EST ) .


Pharmacy refill records showed @,@ person-years of isoniazid receipt ; @ % of participants initiated ART by @ months .


A total of @ % ( @ of @,@ ) of participants were diagnosed with severe hepatitis ; three had jaundice and two of these developed hepatic encephalopathy .


Another @ % ( @ of @,@ ) of participants experienced moderate hepatitis .


Thirty-eight percent ( @ of @ ) of participants with moderate to severe hepatitis concomitantly received ART .


Forty percent ( @ of @ ) of moderate to severe cases occurred within the first @ months of IPT and during this period were not associated with receipt of ART at baseline ( hazard ratio , @ ; @ % CI , @-@ @ ; P = @ ) .


Adults infected with HIV receiving @IPT did not have an increased incidence of moderate to severe hepatitis or hepatic encephalopathy compared with published reports among people infected with HIV , people not infected with HIV in trials or public health programs .


Compared with participants not receiving ART , the risk of moderate to severe hepatitis was not increased by ART .


A disproportionate number of impoverished and minority children have asthma and receive suboptimal preventive care .


To evaluate whether the Prompting Asthma Intervention in Rochester-Uniting Parents and Providers ( PAIR-UP ) intervention , administered in primary care offices , improves the delivery of preventive care and reduces morbidity for urban children with asthma .


Cluster randomized trial in which @ urban primary care practices were matched based on size and type and randomly allocated to the PAIR-UP intervention or usual care ( UC ) .


We enrolled @ children aged @ to @ years with persistent or poorly controlled asthma in the waiting room prior to a visit with a clinician for any reason from October @ to January @ .


Blinded interviewers called caregivers within @ weeks to inquire about preventive measures taken at the visit and called them @ and @ months later to assess symptoms .


Children enrolled at PAIR-UP practices received prompts for the caregiver and clinician at the time of the visit that outlined the child 's asthma severity or control as well as specific guideline-based recommendations to enhance preventive care .


These practices also received educational resources and periodic feedback on their asthma care performance .


The UC practices received copies of the asthma guidelines .


The primary outcome was symptom-free days ( SFDs ) per @ weeks at the @-month follow-up .


We enrolled @ children ( participation rate of @ % ; @ % were black , @ % were Hispanic , and @ % had Medicaid insurance ) .


Groups were similar in demographic characteristics and asthma severity at baseline .


At the index visit , more children in the PAIR-UP group received a preventive medication action ( new medication , increased dose , recommendation to restart preventive medication ) than in the UC group ( @ % vs @ % ; odds ratio -LSB- OR -RSB- = @ ; @ % CI , @ to @ ) .


More children in the PAIR-UP group than in the UC group received an asthma action plan ( @ % vs @ % ; OR = @ ; @ % CI , @ to @ ) , discussions regarding asthma ( @ % vs @ % ; OR = @ ; @ % CI , @ to @ ) , and secondhand smoke counseling ( @ % vs @ % ; OR = @ ; @ % CI , @ to @ ) .


At the @-month follow-up , children in the PAIR-UP group had more SFDs per @ weeks than those in the UC group ( mean difference , @ days ; @ % CI , @ to @ ) .


At @ months , the improvement in SFDs was no longer statistically significant ( mean difference , @ ; @ % CI , -@ to @ ) .


The PAIR-UP intervention improved the delivery of preventive asthma care and reduced asthma morbidity for high-risk urban children with persistent asthma at @ months , but the improvement in SFDs was no longer significant at @ months .


The best treatment option for end-stage renal disease is usually a transplant , preferably a live donor kidney transplant ( LDKT ) .


The most effective ways to educate kidney transplant candidates about the risks , benefits , and process of LDKT remain unknown .


We report the protocol of the Enhancing Living Donor Kidney Transplant Education ( ELITE ) Study , a cluster randomized trial of an educational intervention to be implemented during initial transplant evaluation at a large , suburban U.S. transplant center .


Five hundred potential transplant candidates are cluster randomized ( by date of visit ) to receive either : ( @ ) standard-of-care ( `` usual '' ) transplant education , or ( @ ) intensive education that is based upon the Explore Transplant series of educational materials .


Intensive transplant education includes viewing an educational video about LDKT , receiving print education , and meeting with a transplant educator .


The primary outcome consists of knowledge of the benefits , risks , and process of LDKT , assessed one week after the transplant evaluation .


As a secondary outcome , knowledge and understanding of LDKT are assessed @ months after the evaluation .


Additional secondary outcomes , assessed one week and @ months after the evaluation , include readiness , self-efficacy , and decisional balance regarding transplant and LDKT , with differences assessed by race .


Although the unit of randomization is the date of the transplant evaluation visit , the unit of analysis will be the individual potential transplant candidate .


The ELITE Study will help to determine how education in a transplant center can best be designed to help Black and non-Black patients learn about the option of LDKT .


Controversy exists about whether cutting diathermy for skin incisions leads to a cosmetically inferior scar .


Cosmetic outcomes were compared between skin incisions created with cutting diathermy versus scalpel .


Wound infection rates and postoperative incisional pain were also compared .


This was a randomized double-blind trial comparing cutting diathermy and scalpel in patients undergoing bowel resection .


Scar cosmesis was assessed at @ months after surgery by a plastic surgeon and a research associate using the Vancouver Scar Scale ( VSS ) and the Patient and Observer Scar Assessment Scale ( POSAS ) .


Patients also used POSAS to self-evaluate their scars .


Wound infections within @ days were recorded , and incision pain scores were measured on the first @ days after operation .


A total of @ patients were randomized to cutting diathermy ( @ ) or scalpel ( @ ) .


At @ months , there was no significant difference between the diathermy and scalpel groups in mean ( s.d. ) VSS scores ( @ ( @ ) versus @ ( @ ) ; P = @ ) , mean POSAS total scores ( @ ( @ ) versus @ ( @ ) ; P = @ ) or subjective POSAS total scores ( @ ( @ ) versus @ ( @ ) ; P = @ ) .


Neither were there significant differences in wound infection rates between the groups ( @ of @ versus @ of @ ; P = @ ) .


Pain scores on day @ after operation were significantly lower in the diathermy group ( mean @ versus @ ; P = @ ) , but were not significantly different on days @-@ .


Cutting diathermy is a cosmetically acceptable technique for abdominal skin incisions .


There is no increased risk of wound infection , and diathermy may convey benefit in terms of early postoperative wound pain .


We evaluated the effect of a weight gain prevention intervention ( Shape Program ) on depression among socioeconomically disadvantaged overweight and obese Black women .


Between @ and @ , we conducted a randomized trial comparing a @-month electronic health-based weight gain prevention intervention to usual primary care at @ central North Carolina community health centers .


We assessed depression with the Patient Health Questionnaire ( PHQ-@ ) .


We analyzed change in depression score from baseline to @ - and @-month follow-up across groups with mixed models .


We used generalized estimating equation models to analyze group differences in the proportion above the clinical threshold for depression ( PHQ-@ score @ ) .


At baseline , @ % of participants reported depression .


Twelve-month change in depression scores was larger for intervention participants ( mean difference = -@ ; @ % confidence interval = -@ , -@ ; P = @ ) .


There was a significant reduction in the proportion of intervention participants with depression at @ months with no change in the usual-care group ( @ % vs @ % ; P = @ ) .


All effects persisted after we controlled for weight change and medication use .


We saw similar findings at @ months .


The Shape Program , which includes no mention of mood , improved depression among socioeconomically disadvantaged Black women .


To evaluate whether trait and experimentally manipulated state disgust independently and/or interactively predict immediate and anticipated avoidance in decision scenarios related to colorectal cancer ( CRC ) .


Eighty participants , aged @ to @ years , completed questionnaires assessing trait disgust prior to a laboratory session .


Participants were gender block randomized to disgust or control conditions before completing tasks assessing immediate avoidance of a CRC disgust elicitor ( stoma bag ) and anticipated avoidance in hypothetical CRC scenarios .


Manipulation checks confirmed the elicitation of disgust in the experimental condition .


Persons in the experimental condition were more likely to exhibit immediate avoidance behaviors in response to a commonly used bowel disease device ( stoma bag ) , and trait disgust predicted time to touch the device .


Trait disgust also moderated the influence of state disgust on anticipated avoidance , namely delay in help seeking for bowel symptoms and predicted rating disgusting side effects as more deterring to adherence .


The current report suggests the importance of examining disgust in CRC contexts and provides the first empirical demonstration that state and trait aspects of disgust may interactively operate to deter certain types of decisions .


It thus furthers understanding of emotions and avoidance in a health context that has had surprisingly little focus to date .


High rates of sustained virologic response were observed among patients with hepatitis C virus ( HCV ) infection who received @ weeks of treatment with the nucleotide polymerase inhibitor sofosbuvir combined with the NS@A inhibitor ledipasvir .


This study examined @ weeks of treatment with this regimen .


In this phase @ , open-label study , we randomly assigned @ previously untreated patients with HCV genotype @ infection without cirrhosis to receive ledipasvir and sofosbuvir ( ledipasvir-sofosbuvir ) for @ weeks , ledipasvir-sofosbuvir plus ribavirin for @ weeks , or ledipasvir-sofosbuvir for @ weeks .


The primary end point was sustained virologic response at @ weeks after the end of therapy .


The rate of sustained virologic response was @ % ( @ % confidence interval -LSB- CI -RSB- , @ to @ ) with @ weeks of ledipasvir-sofosbuvir , @ % ( @ % CI , @ to @ ) with @ weeks of ledipasvir-sofosbuvir plus ribavirin , and @ % ( @ % CI , @ to @ ) with @ weeks of ledipasvir-sofosbuvir .


As compared with the rate of sustained virologic response in the group that received @ weeks of ledipasvir-sofosbuvir , the rate in the @-week group was @ percentage point higher ( @ % CI , -@ to @ ) and the rate in the group that received @ weeks of ledipasvir-sofosbuvir with ribavirin was @ percentage point lower ( @ % CI , -@ to @ ) ; these results indicated noninferiority of the @-week ledipasvir-sofosbuvir regimen , on the basis of a noninferiority margin of @ percentage points .


Adverse events were more common in the group that received ribavirin than in the other two groups .


No patient who received @ weeks of only ledipasvir-sofosbuvir discontinued treatment owing to adverse events .


Ledipasvir-sofosbuvir for @ weeks was associated with a high rate of sustained virologic response among previously untreated patients with HCV genotype @ infection without cirrhosis .


No additional benefit was associated with the inclusion of ribavirin in the regimen or with extension of the duration of treatment to @ weeks .


( Funded by Gilead Sciences ; ION-@ ClinicalTrials.gov number , NCT@ . )


Investigate the efficacy of nabilone capsules ( NAB ) in reducing the frequency and intensity of nightmares in subjects with PTSD .


Canadian male military personnel with PTSD , who despite standard treatment continued to experience trauma-related nightmares , received double-blind treatment with @ mg NAB or placebo ( PBO ) , and then titrated to the effective dose ( nightmare suppression ) or reaching a maximum of @ mg .


Subjects were followed for @ weeks and then , following a @-week washout period , were titrated with the other study treatment and followed for an additional @ weeks .


The modified intent-to-treat ( mITT ) population , which included all treated subjects that met inclusion/exclusion criteria , was analyzed .


Ten subjects were included in the mITT population .


The mean reduction in nightmares as measured by the CAPS Recurring and Distressing Dream scores were -@ @ and -@ @ in the NAB and PBO groups , respectively ( p = @ ) .


Mean global improvement as measured by the Clinical Global Impression of Change ( CGI-C ) was @ @ ( i.e. much improved ) and @ @ ( i.e. minimally improved ) in the NAB and PBO groups , respectively ( p = @ ) Five out of @ ( @ % ) were much improved on NAB versus @ out of @ ( @ % ) on PBO .


Results for the General Well Being Questionnaire ( WBQ ) were @ @ and -@ @ in the NAB and PBO groups , respectively ( p = @ ) .


The proportion of subjects who experienced a treatment-related occurrence of adverse events was @ % in the NBO group and @ % in the PBO group .


No event was severe nor resulted in a drop-out .


This study is registered with Health Canada .


In this small sample NAB provided significant relief for military personnel with PTSD , indicating that it shows promise as a clinically-relevant treatment for patients with nightmares and a history of non-response to traditional therapies .


These findings need to be replicated in a larger cohort .


There is a need for further exploration of the effect of nabilone on other symptoms of PTSD such as re-experiencing , hyper vigilance and insomnia .


Patients with bone metastases have a widely varying survival .


A reliable estimation of survival is needed for appropriate treatment strategies .


Our goal was to assess the value of simple prognostic factors , namely , patient and tumor characteristics , Karnofsky performance status ( KPS ) , and patient-reported scores of pain and quality of life , to predict survival in patients with painful bone metastases .


In the Dutch Bone Metastasis Study , @ patients were treated with radiation therapy for painful bone metastases .


At randomization , physicians determined the KPS ; patients rated general health on a visual analogue scale ( VAS-gh ) , valuation of life on a verbal rating scale ( VRS-vl ) and pain intensity .


To assess the predictive value of the variables , we used multivariate Cox proportional hazard analyses and C-statistics for discriminative value .


Of the final model , calibration was assessed .


External validation was performed on a dataset of @ patients who were treated with radiation therapy for vertebral metastases .


Patients had mainly breast ( @ % ) , prostate ( @ % ) , or lung cancer ( @ % ) .


After a maximum of @ weeks ' follow-up , @ % of patients had died .


The best predictive model included sex , primary tumor , visceral metastases , KPS , VAS-gh , and VRS-vl ( C-statistic = @ , @ % CI = @-@ @ ) .


A reduced model , with only KPS and primary tumor , showed comparable discriminative capacity ( C-statistic = @ , @ % CI = @-@ @ ) .


External validation showed a C-statistic of @ ( @ % CI = @-@ @ ) .


Calibration of the derivation and the validation dataset showed underestimation of survival .


In predicting survival in patients with painful bone metastases , KPS combined with primary tumor was comparable to a more complex model .


Considering the amount of variables in complex models and the additional burden on patients , the simple model is preferred for daily use .


In addition , a risk table for survival is provided .


Surgical stress may cause immunosuppression especially in patients who have surgery for primary tumor removed .


This study aimed to explore the effects of dexmedetomidine on immune and inflammatory response in patients undergoing radical gastrectomy .


After the institutional review board approval and written informed consent , forty patients undergoing radical gastrectomy were equally randomized to receive dexmedetomidine infusion ( Dex group ; @ g kg ( -@ ) initial dose followed by a maintenance dose of @ g kg ( -@ ) h ( -@ ) ) or normal saline infusion ( NS group ) .


Helper T lymphocytes ( T helper @ -LSB- Th@ -RSB- and T helper @ -LSB- Th@ -RSB- ) , tumor necrosis factor - , and interleukin-@ were measured during and after surgeries .


Plasma catecholamine levels were also measured during surgery .


Postoperative pain was measured by a visual analog scale .


The percentage of Th@ increased significantly at the end of surgery , @ h after surgery ( P = @ and @ , respectively ) , and Th@ decreased notably at the end of surgery in the Dex group ( P = @ ) .


Plasma levels of tumor necrosis factor - ( P = @ and @ , respectively ) and interleukin-@ ( P = @ and @ , respectively ) differed significantly at the end of surgery and @ h after surgery .


Plasma epinephrine and norepinephrine levels decreased significantly at the beginning of surgery in the Dex group ( P = @ and @ , respectively ) .


At the end of surgery , plasma dopamine levels decreased significantly in the Dex group ( P = @ ) , but increased in the NS group .


The visual analog scale pain score was lower in the Dex group than in the NS group @ h after surgery ( P = @ ) .


Dexmedetomidine has been shown to reduce surgical stresses and maintain Th@/Th@ balance .


It has been shown to reduce inflammatory responses and exerts immunoprotective effect .


Although parental support is an important component in overweight prevention programs for children , current programs pay remarkably little attention to the role of parenting .


To close this gap , we developed a web-based parenting program for parents entitled `` Making a healthy deal with your child '' .


This e-learning program can be incorporated into existing prevention programs , thereby improving these interventions by reinforcing the role of parenting and providing parents with practical tools for use in everyday situations in order to stimulate a healthy lifestyle .


Here , we report the research design of a study to determine the effectiveness of our e-learning program .


The effectiveness of an e-learning program was studied in a two-armed cluster randomized controlled trial .


Parents of children @-@ years of age who live in the Nijmegen region , the Netherlands , and who participated in the existing school-based overweight prevention program `` Scoring for Health '' were invited to participate in this study .


Our goal was to recruit @ parent-child dyads .


At the school grade level , parents were randomly assigned to either the intervention group ( which received e-learning and a brochure ) or the control group ( which received only the brochure ) ; the participants were stratified by ethnicity .


Measurements were taken from both the parents and the children at baseline , and then @ and @months after baseline .


Primary outcomes included the child 's dietary and sedentary behavior , and level of physical activity .


Secondary outcomes included general parenting style , specific parenting practices ( e.g. , set of rules , modeling , and monitoring ) , and parental self-efficacy .


We hypothesize that children of parents who follow the e-learning program will have a healthier diet , will be less sedentary , and will have a higher level of physical activity compared to the children in the control group .


If the e-learning program is found to be effective , it can be incorporated into existing overweight prevention programs for children ( e.g. , `` Scoring for Health '' ) , as well as activities regarding Youth Health Care .


Severe neglect in early life is associated with compromises in brain development and associated behavioral functioning .


Although early intervention has been shown to support more normative trajectories of brain development , specific improvements in the white matter pathways that underlie emotional and cognitive development are unknown .


To examine associations among neglect in early life , early intervention , and the microstructural integrity of white matter pathways in middle childhood .


The Bucharest Early Intervention Project is a randomized clinical trial of high-quality foster care as an intervention for institutionally reared children in Bucharest , Romania , from @ through the present .


During infancy , children were randomly selected to remain in an institution or to be placed in foster care .


Those who remained in institutions experienced neglect , including social , emotional , linguistic , and cognitive impoverishment .


Developmental trajectories of these children were compared with a group of sociodemographically matched children reared in biological families at baseline and several points throughout development .


At approximately @ years of age , @ of the original @ children underwent structural magnetic resonance imaging scans .


Four estimates of white matter integrity ( fractional anisotropy -LSB- FA -RSB- and mean -LSB- MD -RSB- , radial -LSB- RD -RSB- , and axial -LSB- AD -RSB- diffusivity ) for @ white matter tracts throughout the brain were obtained through diffusion tensor imaging .


Significant associations emerged between neglect in early life and microstructural integrity of the body of the corpus callosum ( FA , = @ -LSB- P = @ -RSB- ; RD , = -@ -LSB- P = @ -RSB- ; MD , = -@ -LSB- P = @ -RSB- ) and tracts involved in limbic circuitry ( fornix crus -LSB- AD , = @ ( P = @ ) -RSB- and cingulum -LSB- RD , = -@ ( P = @ ) ; MD , = -@ ( P = @ ) -RSB- ) , frontostriatal circuitry ( anterior -LSB- AD , = -@ ( P = @ ) -RSB- and superior -LSB- AD , = -@ ( P = @ ) ; MD , = -@ ( P = @ ) -RSB- corona radiata and external capsule -LSB- right FA , = @ ( P = @ ) ; left FA , = @ ( P = @ ) ; RD , = -@ ( P = @ ) ; MD , = -@ ( P = @ ) -RSB- ) , and sensory processing ( medial lemniscus -LSB- AD , = -@ ( P = @ ) ; MD , = -@ ( P = @ ) -RSB- and retrolenticular internal capsule -LSB- FA , = -@ ( P = @ ) ; RD , = @ ( P = @ ) ; MD , = @ ( P = @ ) -RSB- ) .


Follow-up analyses revealed that early intervention promoted more normative white matter development among previously neglected children who entered foster care .


Results suggest that removal from conditions of neglect in early life and entry into a high-quality family environment can support more normative trajectories of white matter growth .


Our findings have implications for public health and policy efforts designed to promote normative brain development among vulnerable children .


Famitinib is a novel and potent multitargeting receptor tyrosine kinase inhibitor .


The phase I clinical study showed that famitinib was well tolerated and had a broad anti-tumor spectrum .


The purpose of this study was to examine the efficacy and safety of famitinib for the treatment of metastatic renal cell carcinoma ( mRCC ) .


The data of famitinib in treating patients with mRCC from the single-center phases I and II clinical trials were analyzed .


Famitinib was administered orally at the dose of @-@ mg once daily until tumor progression , occurrence of intolerable adverse reactions or withdrawal of the informed consent .


A total of @ patients with mRCC were treated including @ patients at a dose of @ mg once daily , @ patients at a dose of @ mg and @ patient each at a dose of @ mg , @ mg and @ mg , respectively .


Twelve ( @ % ) patients achieved partial response ( PR ) and @ patients achieved stable disease ( SD ) .


Progressive disease was found in @ ( @ % ) patients .


The disease control rate was @ % .


The median follow-up time was @ months ; the median progression free survival ( PFS ) was @ ( @ % CI @-@ @ ) months ; and the estimated median overall survival ( OS ) time was @ ( @ % CI @-@ @ ) months .


The adverse drug reactions mainly included hypertension ( @ % ) , hand-foot skin reactions ( @ % ) , diarrhea ( @ % ) , mucositis ( @ % ) , neutropenia ( @ % ) , thrombocytopenia ( @ % ) , hyperlipidemia ( @ % ) and proteinuria ( @ % ) .


The incidence rate of grades @ and @ adverse events was low , mainly including hypertension @ % , hand-foot skin reactions @ % , neutropenia @ % , thrombocytopenia @ % , hyperlipidemia @ % and proteinuria @ % .


Famitinib has significant anti-tumor activity in mRCC .


The common adverse reactions are generally manageable .


The aim of this research was to assess the delayed effects of a two-year alcohol prevention program implemented in Polish primary schools .


The program comprised two curricula implemented the school and in family houses : Program Domowych Detektyww and Fantastyczne Mozliwoci .


Both curricula were the Polish versions of two American school-based prevention programs which belonged to Project Northland .


The initial study sample ( N = @ ) comprised @ to @ years old pupils ( fourth and fifth-grade ) from eight primary schools in Warsaw .


Schools were randomly assigned to the intervention ( n = @ ) and the reference group ( n = @ ) .


A self-completion questionnaire was administered to students four times : at the baseline , seven , fifteen and twenty seven months after .


The program had an expected influence on the students ' attitudes , knowledge and resistance skills towards alcohol .


The effects on the participants ' initiation of drunkenness and their first experience in alcohol use with their peers have also been reported .


Most of the positive effects remained significant over time .


The effectiveness of the program , as shown by the outcome evaluation , supports an argument for its wide implementation in Polish schools .


Further progress in the field of alcohol and drug prevention in Poland depends on overcoming the existing barriers in this area of public health .


To investigate the efficacy and tolerability of empagliflozin as an add-on to metformin therapy in patients with type @ diabetes .


Patients with HbA@c levels of @ % to @ % ( @ to @ mmol/mol ) while receiving metformin ( @,@ mg/day ) were randomized and treated with once-daily treatment with empagliflozin @ mg ( n = @ ) , empagliflozin @ mg ( n = @ ) , or placebo ( n = @ ) for @ weeks .


The primary end point was the change in HbA@c level from baseline at week @ .


Key secondary end points were changes from baseline in weight and mean daily glucose ( MDG ) at week @ .


At week @ , adjusted mean ( SE ) changes from baseline in HbA@c were -@ % ( @ ) % ( -@ -LSB- @ -RSB- mmol/mol ) with placebo , -@ % ( @ ) % ( -@ -LSB- @ -RSB- mmol/mol ) with empagliflozin @ mg , and -@ % ( @ ) % ( -@ -LSB- @ -RSB- mmol/mol ) with empagliflozin @ mg ( both P < @ ) .


Empagliflozin significantly reduced MDG level and systolic and diastolic blood pressure ( BP ) versus placebo .


Adjusted mean ( SE ) changes from baseline in weight were -@ kg ( @ kg ) with placebo , -@ kg ( @ kg ) with empagliflozin @ mg , and -@ kg ( @ kg ) with empagliflozin @ mg ( both P < @ ) .


Adverse events ( AEs ) were similar across groups ( placebo @ % ; empagliflozin @-@ @ % ) .


Confirmed hypoglycemic AEs were reported in @ % , @ % , and @ % of patients receiving placebo , empagliflozin @ mg , and empagliflozin @ mg , respectively .


Events consistent with urinary tract infections were reported in @ % , @ % , and @ % of patients , and events consistent with genital infections were reported in @ % , @ % , and @ % of patients , respectively .


Empagliflozin @ and @ mg for @ weeks as add-on to metformin therapy significantly improved glycemic control , weight , and BP , and were well-tolerated .


Centre-based childcare services represent a promising setting to target the prevention of excessive weight gain in preschool-aged children .


Staff training is a key component of multi-strategy interventions to improve implementation of effective physical activity and nutrition promoting practices for obesity prevention in childcare services .


This randomised controlled trial aimed to examine whether an active telephone-based strategy to invite childcare-service staff to attend a training workshop was effective in increasing the proportion of services with staff attending training , compared with a passive strategy .


Services were randomised to an active telephone-based or a passive-recruitment strategy .


Those in the active arm received an email invitation and one to three follow-up phone calls , whereas services in the passive arm were informed of the availability of training only via newsletters .


The proportion of services with staff attending the training workshop was compared between the two arms .


One hundred and twenty-eight services were included in this study .


A significantly larger proportion ( @ % ) of services in the active arm compared with those in the passive-strategy arm ( @ % ) attended training ( d.f. = @ , @ = @ ; P < @ ) .


An active , telephone-based recruitment strategy significantly increased the proportion of childcare services with staff attending training .


Further strategies to improve staff attendance at training need to be identified and implemented .


SO WHAT ?


: Active-recruitment strategies including follow-up telephone calls should be utilised to invite staff to participate in training , in order to maximise the use of training as an implementation strategy for obesity prevention in childcare services .


An aluminum hydroxide-adsorbed depot allergoid preparation of six-grass pollen allergens has been developed for short-term preseasonal immunotherapy in pollinosis .


However , only limited knowledge exists about its immunological and clinical effects .


The aim of this study was to evaluate the basophil response , which can explain early clinical findings of short-term preseasonal allergoid immunotherapy in allergic rhinitis .


In a double-blind , placebo-controlled study , @ patients allergic to grass pollens received one course of short-term preseasonal allergoid immunotherapy or placebo .


Immunogenicity was assessed by the levels of specific IgG@ , IgE antibodies and an allergen-induced CD@c basophil activation test .


The primary clinical end point was the combined symptom and medication score/average combined score ( ACS ) .


There was a @ % difference in ACS between the treatment and placebo groups in favor of immunotherapy ( p = @ ) .


Active treatment induced Phleum pratense-specific IgG@ and IgE antibodies ( p < @ ) .


A decrease in allergen-induced basophil activation at submaximal allergen concentrations was demonstrated at the end of immunotherapy and at the peak of the grass pollen season after immunotherapy .


This study shows that grass pollen-allergic patients treated with one course of short-term preseasonal allergoid immunotherapy exhibit a decrease in allergen-induced basophil activation , an increase in allergen-specific IgG@ antibodies and early clinical improvement .


To examine the effects of a whole-body cryotherapy ( WBC ) protocol ( @ min at -@ C ) on acute recovery and key variables of endurance performance during high-intensity intermittent exercise in a thermoneutral environment .


Eleven endurance athletes were tested twice in a randomized crossover design in which @ min of high-intensity running ( HIR ) were followed by @ h of passive rest at ~ @C , including either @ min of whole-body exposure to -@ C ( WBC ) or a placebo intervention of @ min walking ( PBO ) .


A ramp-test protocol was performed before HIR ( R@ ) and after the @-h recovery period ( R@ ) .


Time to exhaustion ( tlim ) was measured along with alterations in oxygen content of the vastus lateralis ( TSI ) , oxygen consumption ( VO@ ) , capillary blood lactate , heart rate ( HR ) , and rating of perceived exertion ( RPE ) during submaximal and maximal running .


The difference in tlim between R@ and R@ was lower in WBC than in PBO ( P < @ , effect size d = @ ) .


During R@ , TSI was higher in WBC during submaximal and maximal running ( P < @ , d = @-@ @ ) .


In addition , VO@ , HR , and RPE were lower at submaximal level of R@ after WBC than in PBO ( P = @ to < @ , d = @-@ @ ) .


WBC improves acute recovery during high-intensity intermittent exercise in thermoneutral conditions .


The improvements might be induced by enhanced oxygenation of the working muscles , as well as a reduction in cardiovascular strain and increased work economy at submaximal intensities .


Previously , a healthy Nordic diet ( ND ) has been shown to have beneficial health effects close to those of Mediterranean diets .


The objective was to explore whether the ND has an impact on gene expression in abdominal subcutaneous adipose tissue ( SAT ) and whether changes in gene expression are associated with clinical and biochemical effects .


Obese adults with features of the metabolic syndrome underwent an @ - to @-wk randomized intervention study comparing the ND with the control diet ( CD ) ( the SYSDIET study , carried out within Nordic Centre of Excellence of the Systems Biology in Controlled Dietary Interventions and Cohort Studies ) .


The present study included participants from @ Nordic SYSDIET centers -LSB- Kuopio ( n = @ ) , Lund ( n = @ ) , and Oulu ( n = @ ) -RSB- with a maximum weight change of @ kg , highly sensitive C-reactive protein concentration < @ mg/L at the beginning and the end of the intervention , and baseline body mass index ( in kg/m ) < @ .


SAT biopsy specimens were obtained before and after the intervention and subjected to global transcriptome analysis with Gene @ ST Arrays ( Affymetrix ) .


Altogether , @ genes were differentially expressed in SAT between the ND and CD ( nominal P < @ ; false discovery rate , @ % ) .


These genes were overrepresented in pathways related to immune response ( adjusted P = @ ) , resulting mainly from slightly decreased expression in the ND and increased expression in the CD .


Immune-related pathways included leukocyte trafficking and macrophage recruitment ( e.g. , interferon regulatory factor @ , CD@ ) , adaptive immune response ( interleukin@ , interleukin @ receptor ) , and reactive oxygen species ( neutrophil cytosolic factor @ ) .


Interestingly , the regulatory region of the @ genes was overrepresented for binding sites for the nuclear transcription factor B.


A healthy Nordic diet reduces inflammatory gene expression in SAT compared with a control diet independently of body weight change in individuals with features of the metabolic syndrome .


To investigate the effects of anodal transcranial direct current stimulation ( a-tDCS ) intensity on corticospinal excitability and affected muscle activation in individuals with chronic spinal cord injury ( SCI ) .


Single-blind , randomized , sham-controlled , crossover study .


Medical research institute and rehabilitation hospital .


Volunteers ( N = @ ) with chronic SCI and motor dysfunction in wrist extensor muscles .


Three single session exposures to @ minutes of a-tDCS ( anode over the extensor carpi radialis -LSB- ECR -RSB- muscle representation on the left primary motor cortex , cathode over the right supraorbital area ) using @ mA , @ mA , or sham stimulation , delivered at rest , with at least @ week between sessions .


Corticospinal excitability was assessed with motor-evoked potentials ( MEPs ) from the ECR muscle using surface electromyography after transcranial magnetic stimulation .


Changes in spinal excitability , sensory threshold , and muscle strength were also investigated .


Mean MEP amplitude significantly increased by approximately @ % immediately after @mA a-tDCS ( pre : @ @ mV ; post : @ @ mV ; P = @ ) , but not with @ mA or sham .


Maximal voluntary contraction measures remained unaltered across all conditions .


Sensory threshold significantly decreased over time after @mA ( P = @ ) and @mA ( P = @ ) a-tDCS and did not change with sham .


F-wave persistence showed a nonsignificant trend for increase ( pre : @ % @ % ; post : @ % @ % ; follow-up : @ % @ % ) after @ mA stimulation .


No adverse effects were reported with any of the experimental conditions .


The a-tDCS can transiently raise corticospinal excitability to affected muscles in patients with chronic SCI after @ mA stimulation .


Sensory perception can improve with both @ and @ mA stimulation .


This study gives support to the safe and effective use of a-tDCS using small electrodes in patients with SCI and highlights the importance of stimulation intensity .


The feasibility and safety of D@ surgery following neoadjuvant chemotherapy ( NAC ) has not been fully evaluated in patients with gastric cancer .


Moreover , risk factor for surgical complications after D@ gastrectomy following NAC is also unknown .


The purpose of the present study was to identify risk factors of postoperative complications after D@ surgery following NAC .


This study was conducted as an exploratory analysis of a prospective , randomized Phase II trial of NAC .


The surgical complications were assessed and classified according to the Clavien-Dindo classification .


A uni - and multivariate logistic regression analyses were performed to identify risk factors for morbidity .


Among @ patients who were registered to the Phase II trial , @ patients received the NAC and D@ gastrectomy .


Postoperative complications were identified in @ patients and the overall morbidity rate was @ % .


The results of univariate and multivariate analyses of various factors for overall operative morbidity , creatinine clearance ( CCr ) @ ml/min ( P = @ ) was identified as sole significant independent risk factor for overall morbidity .


Occurrence of pancreatic fistula was significantly higher in the patients with a low CCr than in those with a high CCr .


Low CCr was a significant risk factor for surgical complications in D@ gastrectomy after NAC .


Careful attention is required for these patients .


In recent years , armed conflicts in the Middle East have resulted in high rates of exposure to traumatic events .


Despite the increasing demand of mental health care provision , ongoing violence limits conventional approaches of mental health care provision .


Internet-based interventions for posttraumatic stress disorder ( PTSD ) have proved feasible and effective in Western countries , but their applicability and efficacy in war and conflict regions remains unknown .


This study investigated the efficacy of a cognitive behavioral Internet-based intervention for war-traumatized Arab patients , with focus on Iraq .


A total of @ individuals with PTSD participated in a parallel group randomized trial .


Participants were randomly allocated by a computer-generated sequence to a treatment group ( n = @ ) or a waiting list control group ( n = @ ) .


The treatment group received @ weekly @-minute cognitive behavioral interventions via Internet over a @-week period ( @ sessions in total ) .


The primary outcome was recovery from posttraumatic stress symptoms .


Posttraumatic stress symptoms were significantly reduced from baseline to posttreatment ( intention-to-treat analysis ) in the treatment group relative to the control group ( F@ ,@ = @ , P < @ , d = @ ) .


Treatment effects were sustained at @-month follow-up .


Completer analysis indicated that @ of @ patients ( @ % ) in the treatment group had recovered from posttraumatic stress symptoms at posttreatment ( reliable change and Posttraumatic Stress Diagnostic Scale score < @ ) versus @ patient ( @ % ) in the control group ( OR @ , @ % CI @-@ @ , P < @ ) indicating that the chance of recovering was @ times higher in the treatment than in the control group .


The results indicate , even in unstable and insecure settings with ongoing exposure to human rights violations through war and dictatorships , people with posttraumatic stress symptoms benefit from a cognitive behavioral treatment provided entirely through the Internet .


This method of delivery could improve patients ' access to humanitarian aid in the form of e-mental health services .


To our knowledge , no randomized study has shown whether zinc replacement therapy is effective for hyperammonemia in liver cirrhosis ; therefore , we performed a double-blind , placebo-controlled trial to examine efficacy and safety of the zinc replacement therapy .


Patients with liver cirrhosis and hyperammonemia ( at or above the institutional reference value ) and hypozincemia ( @ g/dL ) were enrolled in the outpatient units of the participating institutions and were randomly divided to receive placebo ( P group ) or zinc acetate preparation at a dose of @ capsules/d for a total zinc content of @ mg/d ( Z group ) by the envelope method .


Of the @ enrolled patients , @ dropped out ; thus , the analyses included @ patients ( @ in the P group and @ in the Z group ) .


Variations in blood concentrations of zinc and ammonia as well as liver function test results were compared .


Blood zinc levels significantly increased in the Z group ( P = @ ; Friedman test ) but not the P group .


Blood ammonia levels significantly decreased in the Z group ( P = @ ; Friedman test ) but not the P group .


The percent change in blood ammonia level also revealed significant reduction at the eighth week in the Z group ( P = @ : Mann-Whitney test ) .


No serious adverse events attributable to the zinc preparation were noted .


Although this study is preliminary and includes a small sample , it is , to our knowledge , the first randomized controlled trial to show that zinc supplementation for @ mo seems effective and safe for treating hyperammonemia in liver cirrhosis .


Studies with a larger sample size are needed to confirm our findings .


The relative efficiency of different eye exercise regimes is unclear , and in particular the influences of practice , placebo and the amount of effort required are rarely considered .


This study measured conventional clinical measures following different regimes in typical young adults .


A total of @ asymptomatic young adults were directed to carry out eye exercises three times daily for @ weeks .


Exercises were directed at improving blur responses ( accommodation ) , disparity responses ( convergence ) , both in a naturalistic relationship , convergence in excess of accommodation , accommodation in excess of convergence , and a placebo regime .


They were compared to two control groups , neither of which were given exercises , but the second of which were asked to make maximum effort during the second testing .


Instruction set and participant effort were more effective than many exercises .


Convergence exercises independent of accommodation were the most effective treatment , followed by accommodation exercises , and both regimes resulted in changes in both vergence and accommodation test responses .


Exercises targeting convergence and accommodation working together were less effective than those where they were separated .


Accommodation measures were prone to large instruction/effort effects and monocular accommodation facility was subject to large practice effects .


Separating convergence and accommodation exercises seemed more effective than exercising both systems concurrently and suggests that stimulation of accommodation and convergence may act in an additive fashion to aid responses .


Instruction/effort effects are large and should be carefully controlled if claims for the efficacy of any exercise regime are to be made .


Pulmonary coagulopathy may play a pathogenetic role in acute respiratory distress syndrome ( ARDS ) , by contributing to alveolocapillary inflammation and increased permeability .


Recombinant human activated protein C ( rh-APC ) may inhibit this process and thereby improve patient outcome .


A prospective randomized , saline-controlled , single-blinded clinical trial was performed in the intensive care units of two university hospitals , and patients with ARDS were included within @ h after meeting inclusion criteria .


A @-day course of intravenous rh-APC ( @ mcg/kg/h ) ( n = @ ) versus saline ( n = @ ) .


The primary outcome parameter was the pulmonary leak index ( PLI ) of @Gallium-transferrin as a measure of alveolocapillary permeability and secondary outcomes were disease severity scores and ventilator-free days , among others .


Baseline characteristics were similar ; in @ % of patients the PLI was above normal and in @ % mechanical or non-invasive ventilation was instituted at a median lung injury score of @ .


There was no evidence that Rh-APC treatment affected the PLI or attenuated lung injury and sequential organ failure assessment scores .


Mean ventilator-free days amounted to @ ( rh-APC ) and @ days ( saline , P = @ ) .


@-day mortality was @ % in rh-APC - and @ % in saline-treated patients ( P = @ ) .


There was no difference in bleeding events .


The study was prematurely discontinued because rh-APC was withdrawn from the market .


There is no evidence that treatment with intravenous rh-APC during @ days for infectious or inflammatory ARDS ameliorates increased alveolocapillary permeability or the clinical course of ARDS patients .


We can not exclude underpowering .


To assess the efficacy and safety of once daily olmesartan medoxomil ( OM ) / amlodipine besylate ( AM ) / hydrochlorothiazide ( HCTZ ) @/@/@ mg in patients with hypertension not at goal with mono , dual or triple drug therapy .


This was a single-center , prospective , open-label , blinded-endpoint study .


After a @-week screening visit , @ patients were enrolled into the study and given once daily treatment with OM/AM/HCTZ after the patients underwent baseline ambulatory blood pressure monitoring ( ABPM ) on their original therapy .


The primary endpoint was changes from baseline in mean @ h ABPM -LSB- systolic blood pressure ( SBP ) -RSB- after the first day of therapy with OM/AM/HCTZ @/@/@ mg .


Secondary endpoints were changes from baseline in mean @ h ABPM -LSB- diastolic blood pressure ( DBP ) -RSB- after the first day of therapy with OM/AM/HCTZ @/@/@ mg ; mean changes from baseline in trough seated SBP ( SeSBP ) at day @ and SeSBP at weeks @ , @ , @ and @ ; mean changes from baseline in trough seated DBP ( SeDBP ) at day @ and SeDBP at weeks @ , @ , @ and @ ; and the percentage of subjects achieving mean @ h , daytime and night-time ABPM BP goals .


The baseline paired t-test systolic ABPM was @ @ mmHg and day @ was @ @ mmHg with a treatment difference of -@ @ mmHg ( p < @ ) .


At week @ , paired t-test ABPM SBP reduction was @ @ mmHg with a treatment difference of -@ @ mmHg ( p < @ ) .


The baseline paired t-test SeSBP was @ @ mmHg and day @ was @ @ mmHg with a treatment difference of -@ @ mmHg ( p < @ ) .


At week @ , paired t-test SeSBP reduction was @ @ mmHg with a treatment difference of -@ @ mmHg ( p < @ ) .


Treatment with OM/AM/HCTZ achieved superior ( SBP ) ABPM reductions compared with mono , dual or triple drug therapy , resulting in all patients achieving systolic ABPM goal without ABPM documented hypotension .


To examine whether sleep disturbance is associated with poor physical function in older veterans in an adult day healthcare ( ADHC ) program .


Cross-sectional .


One ADHC program in a Veterans Affairs Ambulatory Care Center .


Older veterans ( N = @ ) enrolled in a randomized controlled trial of a sleep intervention program who had complete baseline data .


Information on participant characteristics ( e.g. , age , depression , relationship to caregiver , pain , comorbidity ) was collected using appropriate questionnaires .


Physical function was measured using activity of daily living ( ADL ) and instrumental ADL ( IADL ) total scores from the Older Americans Resources and Services Multidimensional Functional Assessment Questionnaire .


Sleep was assessed subjectively ( Pittsburgh Sleep Quality Index , Insomnia Severity Index ) and objectively ( wrist actigraphy ) .


Participants required substantial assistance with ADLs and IADLs .


A regression model showed that participant characteristics ( marital status , use of sleep medication , comorbidity , posttraumatic stress disorder ) and living arrangement ( living with a spouse or others ) were significantly associated with poor physical function .


Poorer objective sleep ( total sleep time , total numbers of awakenings , total wake time ) was significantly associated with poor physical function , accounting for a significant proportion of the variance other than participant characteristics .


Objective measures of nighttime sleep disturbance were associated with poor physical function in older veterans in an ADHC program .


Further research is needed to determine whether interventions to improve sleep will delay functional decline in this vulnerable population .


Shoulder instability is a common problem affecting young adults .


Stabilization surgery followed by physiotherapy rehabilitation has been shown to reduce the chance of further episodes of shoulder dislocation and to improve quality of life in patients who sustain a shoulder dislocation as a result of a high collision trauma , but it is unclear if surgical intervention is beneficial for patients with atraumatic shoulder instability who have structural damage at the shoulder .


The aim of this randomized controlled clinical trial is to determine if the addition of surgical intervention to physiotherapy rehabilitation improves outcomes for patients with atraumatic shoulder instability who have sustained soft tissue damage at their joint .


@ participants will be recruited .


Patients with feelings of insecurity ( apprehension ) at their shoulder joint , which is not the result of a collision injury , with physical signs of shoulder joint instability will be invited to participate .


Consenting participants will undergo arthroscopic investigation of the shoulder joint .


Patients with capsulolabral damage will be randomly allocated using a concealed allocation procedure to either stabilization surgery immediately following the arthroscopic examination or no additional surgical procedure .


All participants will then receive the same postoperative physiotherapy protocol for up to @ months .


Outcomes ( pain , functional impairment and number of shoulder dislocations sustained ) will be evaluated prior to surgery and , together with participant-reported improvement , again at @ , @ and @ months after randomization .


The primary endpoint will be pain and functional impairment at @ years .


Participants , clinical staff ( but not surgeons ) and assessors will be blind to whether stabilization surgery was performed .


Data analysis will be conducted on an intention-to-treat basis with the focus on estimation of the effect .


This trial will have a direct and immediate impact on clinical decision making by establishing if patients presenting with soft tissue shoulder damage associated with atraumatic shoulder instability should be referred for stabilization surgery before commencing physiotherapy rehabilitation in order to ensure optimal outcome .


This in turn will ensure effective , efficient use of scarce health resources to manage this common often disabling musculoskeletal condition .


This study assessed the effects of two doses of glucose and a caffeine-glucose combination on mood and performance of an ecologically valid , computerised multi-tasking platform .


Following a double-blind , placebo-controlled , randomised , parallel-groups design , @ healthy adults ( mean age @ years ) consumed drinks containing placebo , @g glucose , @g glucose or @g glucose with @mg caffeine .


They completed a multi-tasking framework at baseline and then @min following drink consumption with mood assessments immediately before and after the multi-tasking framework .


Blood glucose and salivary caffeine were co-monitored .


The caffeine-glucose group had significantly better total multi-tasking scores than the placebo or @g glucose groups and were significantly faster at mental arithmetic tasks than either glucose drink group .


There were no significant treatment effects on mood .


Caffeine and glucose levels confirmed compliance with overnight abstinence/fasting , respectively , and followed the predicted post-drink patterns .


These data suggest that co-administration of glucose and caffeine allows greater allocation of attentional resources than placebo or glucose alone .


At present , we can not rule out the possibility that the effects are due to caffeine alone Future studies should aim at disentangling caffeine and glucose effects .


Breakfast is associated with lower body weight in observational studies .


Public health authorities commonly recommend breakfast consumption to reduce obesity , but the effectiveness of adopting these recommendations for reducing body weight is unknown .


We tested the relative effectiveness of a recommendation to eat or skip breakfast on weight loss in adults trying to lose weight in a free-living setting .


We conducted a multisite , @-wk , @-parallel-arm randomized controlled trial in otherwise healthy overweight and obese adults -LSB- body mass index ( in kg/m ) between @ and @ -RSB- aged @-@ y.


Our primary outcome was weight change .


We compared weight change in a control group with weight loss in experimental groups told to eat breakfast or to skip breakfast -LSB- no breakfast ( NB ) -RSB- .


Randomization was stratified by prerandomization breakfast eating habits .


A total of @ participants were randomly assigned .


A total of @ of the @ participants who were randomly assigned completed the intervention .


Treatment assignment did not have a significant effect on weight loss , and there was no interaction between initial breakfast eating status and treatment .


Among skippers , mean ( SD ) baseline weight - , age - , sex - , site - , and race-adjusted weight changes were -@ @ , -@ @ , and -@ @ kg for the control , breakfast , and NB groups , respectively .


Among breakfast consumers , mean ( SD ) baseline weight - , age - , sex - , site - , and race-adjusted weight changes were -@ @ , -@ @ , and -@ @ kg for the control , breakfast , and NB groups , respectively .


Self-reported compliance with the recommendation was @ % for the breakfast group and @ % for the NB group .


A recommendation to eat or skip breakfast for weight loss was effective at changing self-reported breakfast eating habits , but contrary to widely espoused views this had no discernable effect on weight loss in free-living adults who were attempting to lose weight .


Although blood flow-restricted low-intensity resistance training ( BFR-RT ) increases muscle size and strength in older adults , the effect of detraining on muscle adaptation is unclear .


We investigated the effects of @weeks of detraining on thigh muscle cross-sectional area ( CSA ) and one-repetition maximum strength ( @-RM ) in older adults who had previously participated in @weeks of training ( BFR-RT , @-@ % @-RM , knee extension and leg press ) or non-BFR training .


Both @-RM and relative dynamic strengths ( @-RM divided by quadriceps femoris ( QF ) muscle CSA ) were higher at both post-training and detraining than at pre-training for the BFR-RT group ( p < @ ) .


QF muscle CSA was higher at only post-training than at pre-training for the BFR-RT group ( p < @ ) .


Increased muscle strength following @weeks of training with BFR-RT was well preserved at @weeks of detraining , which is due mainly to neural adaptation in older adults .


Acute radicular back pain is a frequent complaint of patients presenting to the Emergency Department .


Determine the efficacy of intravenous lidocaine when compared to ketorolac for the treatment of acute radicular low back pain .


Randomized double-blind study of @ patients aged @-@ years presenting with acute radicular low back pain .


Patients were randomized to receive either @ mg lidocaine or @ mg ketorolac intravenously over @ min .


A @-mm visual analog scale ( VAS ) was used to assess pain at Time @ ( baseline ) , and @ , @ , and @ minutes .


Changes in -LSB- median -RSB- VAS scores were compared over time ( within groups ) by the signed-rank test and between groups by the rank-sum test .


A @-point Pain Relief Scale ( PRS ) was administered at the conclusion of the study ( @ min ) and again at @ week by telephone follow-up ; -LSB- median -RSB- scores were compared between groups by rank-sum .


Forty-four patients were recruited ; @ completed the study ( @ lidocaine , @ ketorolac ) .


Initial VAS scores were not significantly different between the lidocaine and ketorolac groups ( @ ; @ % confidence interval -LSB- CI -RSB- @-@ vs. @ ; @ % CI @-@ ; p = @ ) .


Median VAS scores from baseline to @ min significantly declined in both groups ( lidocaine -LSB- @ ; @ % CI @-@ ; p = @ -RSB- ; ketorolac -LSB- @ ; @ % CI @-@ ; p = @ -RSB- ) , with no significant difference in the degree of reduction between groups ( p = @ ) .


Rescue medication was required by @ % receiving lidocaine , compared to @ % receiving ketorolac .


No significant change in PRS between groups was found at the conclusion or at the follow-up .


Intravenous lidocaine failed to clinically alleviate the pain associated with acute radicular low back pain .


Hospitalized patients with heart failure who are malnourished present a worse prognosis than those with an adequate nutritional status .


It is unknown whether a nutritional intervention can modify the prognosis of these patients .


The aim of this study is to assess the efficacy of a nutritional intervention on morbidity and mortality in hospitalized patients with heart failure who are malnourished .


PICNIC is a multicentre , randomized , controlled trial in which hospitalized patients with heart failure and malnutrition , as defined by the Mini Nutritional Assessment , are randomly assigned to conventional management of heart failure or conventional management of heart failure and an individualized nutritional intervention consisting of @ points : optimization of diet , specific recommendations , and prescription , if deemed necessary , of nutritional supplements .


A sample size of @ patients for a maximum follow-up of @ months has been estimated .


The primary endpoint is time to death from any cause or rehospitalization because of heart failure .


Analysis is by intention to treat .


PICNIC study will determine the prognostic impact of a nutritional intervention in hospitalized patients with heart failure who are malnourished .


Angioedema induced by treatment with angiotensin-converting-enzyme ( ACE ) inhibitors accounts for one third of angioedema cases in the emergency room ; it is usually manifested in the upper airway and the head and neck region .


There is no approved treatment for this potentially life-threatening condition .


In this multicenter , double-blind , double-dummy , randomized phase @ study , we assigned patients who had ACE-inhibitor-induced angioedema of the upper aerodigestive tract to treatment with @ mg of subcutaneous icatibant , a selective bradykinin B@ receptor antagonist , or to the current off-label standard therapy consisting of intravenous prednisolone ( @ mg ) plus clemastine ( @ mg ) .


The primary efficacy end point was the median time to complete resolution of edema .


All @ patients in the per-protocol population had complete resolution of edema .


The median time to complete resolution was @ hours ( interquartile range , @ to @ ) with icatibant as compared with @ hours ( interquartile range , @ to @ ) with standard therapy ( P = @ ) .


Three patients receiving standard therapy required rescue intervention with icatibant and prednisolone ; @ patient required tracheotomy .


Significantly more patients in the icatibant group than in the standard-therapy group had complete resolution of edema within @ hours after treatment ( @ of @ vs. @ of @ , P = @ ) .


The median time to the onset of symptom relief ( according to a composite investigator-assessed symptom score ) was significantly shorter with icatibant than with standard therapy ( @ hours vs. @ hours , P = @ ) .


The results were similar when patient-assessed symptom scores were used .


Among patients with ACE-inhibitor-induced angioedema , the time to complete resolution of edema was significantly shorter with icatibant than with combination therapy with a glucocorticoid and an antihistamine .


( Funded by Shire and the Federal Ministry of Education and Research of Germany ; ClinicalTrials.gov number , NCT@ . )


Deep brain stimulation ( DBS ) of the globus pallidus internus is an effective treatment for cervical dystonia ( CD ) .


Interestingly , the onset of initial DBS effects is significantly prolonged compared with that in other diseases , such as Parkinson 's disease .


The return of symptoms after cessation of DBS could be delayed as well , but this has not been studied systematically .


In patients who were treated for CD using DBS and had a good treatment effect , we compared interruption of DBS with sham-OFF in a randomized , double-blind crossover trial .


We observed that dystonic features appeared within a few minutes at almost full intensity in all patients after the cessation of DBS .


The almost immediate onset of dystonic features in our sample seems to exclude mechanisms with long time constants from the pathophysiology of dystonia .


Thus , it is likely that , in these patients , an aberrant pattern of neural activity representing an inappropriate set point value for the position of the head is responsible for dystonia .


Adequate biomarkers for the dietary supply of fatty acids ( FA ) are FA of adipose tissue and blood fractions .


In human studies , invasive sample collection is unpleasant for subjects .


In contrast , cheek cell sampling can be considered as a non-invasive alternative to investigate FA status.The aim of this study was to analyze whether cheek cell FA composition reflect the supplementation of alpha-linolenic acid ( ALA ) using a linseed oil mixture compared to olive oil supplementation .


Additionally , it was investigated if cheek cell FA composition correlates with the FA composition of plasma , red blood cells ( RBC ) and peripheral blood mononuclear cells ( PBMC ) before and during both interventions .


During a @-week randomized , controlled , double-blind human intervention study , @ subjects provided cheek cell and blood samples .


After a two-week run-in period , the test group ( n = @ ) received @ g/d of an ALA-rich linseed oil mixture , while the control group ( n = @ ) received @ g/d of an omega-@ ( n-@ ) polyunsaturated FA ( PUFA ) - free olive oil .


Cheek cells and blood were collected on days @ , @ and @ of the @-week intervention period .


Compared to olive oil , the linseed oil intervention increased ALA and also the endogenously converted long-chain n-@ metabolites eicosatetraenoic - , eicosapentaenoic - and docosapentaenoic acid in cheek cells ( P@ @ ) .


Docosahexaenoic acid remained unchanged .


Reflecting the treatment , the n-@ / n-@ ratio decreased in the test group .


In general , cheek cell FA reflected the changes of FA in blood fractions .


Independent of treatment , significant correlations ( P@ @ ) of n-@ PUFA and n-@ PUFA between cheek cells and plasma , RBC and PBMC were found , except for linoleic acid and ALA. .


The changes in FA composition of cheek cells confirmed that ALA from linseed oil increased endogenously derived n-@ PUFA in cheek cell lipids .


These changes in cheek cells and their correlation to the respective FA in blood fractions indicate the cheek cell FA profile as an adequate non-invasive biomarker for short-term n-@ PUFA intake and metabolism .


Therefore , cheek cell FA can be used in human intervention studies or large-scale epidemiological studies , especially for assessment of the n-@ PUFA status .


Iron supplementation for hypoferremic anemia could potentiate bacterial growth in the cystic fibrosis ( CF ) lung , but clinical trials testing this hypothesis are lacking .


Twenty-two adults with CF and hypoferremic anemia participated in a randomized , double-blind , placebo-controlled , crossover trial of ferrous sulfate @mg daily for @weeks .


Iron-related hematologic parameters , anthropometric data , sputum iron , Akron Pulmonary Exacerbation Score ( PES ) , and the sputum microbiome were serially assessed .


Fixed-effect models were used to describe how ferrous sulfate affected these variables .


Ferrous sulfate increased serum iron by @ % and transferrin saturation ( TSAT ) by @ % from baseline ( p < @ ) but did not affect hemoglobin , sputum iron , Akron PES , and the sputum microbiome .


Low-dose ferrous sulfate improved hypoferremia without correcting anemia after @weeks .


We did not observe significant effects on sputum iron , Akron PES , and the sputum microbiome .


Although we did not identify untoward health effects of iron supplementation , a larger blinded randomized controlled trial would be needed to fully demonstrate safety .


Although totally implantable venous access devices ( TIVAD ) are increasingly being used in oncology patients , more robust evidence about the best technique is lacking , especially regarding to ultrasound ( US ) guided puncture .


One hundred ten patients with indication of intravenous chemotherapy were randomly assigned to TIVAD implant through US-guided internal jugular vein ( USG ) puncture ( @ ) or internal jugular vein blindly ( IJB ) ( @ ) or subclavian vein blindly ( SCB ) ( @ ) .


Procedure data and complications were prospectively recorded within @ days of the procedure .


All patients completed the follow up .


Immediate complication rate was @ % , @ % , and @ % in the USG , IJB , and SCB groups , respectively ( P = @ ) .


First attempt success rate was @ % in the USG , @ % in the IJB and @ % in the SCB group ( P = @ ) .


Technique failure was observed in @ % , @ % , and @ % of the population in the USG , IJB , and SCB , respectively ( P = @ ) .


Early complication rate was @ % in USG group , @ % in the IJB , and @ % in the SCB ( P = @ ) .


The findings of our study suggest superiority of the USG approach in terms of first puncture success rate and technique failure , without increasing the procedure duration .


Long-term follow-up results should help to further clarify the current debates .


Many studies have examined laser treatment of scars , but cosmetic results have been variable .


Although no studies have examined the effect of purpura on scar improvement using the pulsed dye laser ( PDL ) , many clinicians believe inducing purpura results in better and quicker improvement .


To determine whether PDL treatment of fresh surgical scars with purpura-inducing settings improves clinical appearance more than non-purpura-inducing settings or no treatment .


Twenty-six subjects with surgical scars enrolled in this prospective study .


Scars were divided into three equal segments ; treatment was randomized : @-nm PDL with purpuric ( @ ms ) or nonpurpuric ( @ms ) settings or no treatment .


Fluences were adjusted to Fitzpatrick skin type .


Scars were treated three times , @month apart , beginning at suture removal .


Outcome measures included Vancouver Scar Scale ( VSS ) and blind clinical ratings .


The nonpurpuric condition showed significant improvement on the VSS total score , vascularity , and pliability ratings .


The purpuric condition demonstrated a trend for improvement on the VSS total .


According to blind observer ratings , all conditions improved , without differences between groups .


Nonpurpuric settings on the PDL resulted in significant improvements in the appearance of fresh surgical scars for vascularity , pliability , and VSS total scores , although all scar segments improved over time .


Persistent weakness is a common problem after anterior cruciate ligament - ( ACL - ) reconstruction .


This study investigated the effects of high-intensity ( HRT ) versus low-intensity ( LRT ) resistance training on leg extensor power and recovery of knee function after ACL-reconstruction .


@ males and @ females were randomized to HRT ( n = @ ) or LRT ( n = @ ) from week @-@ after ACL-reconstruction .


Leg extensor power , joint laxity , and self-reported knee function were measured before and @ , @ , and @ weeks after surgery .


Hop tests were assessed before and after @ weeks .


Power in the injured leg was @ % ( @ % CI @-@ % ) of the noninjured leg , decreasing to @ % ( @ % CI @-@ % ) @ weeks after surgery .


During the resistance training phase there was a significant group by time interaction for power ( P = @ ) .


Power was regained more with HRT compared to LRT at week @ ( @ % versus @ % of noninjured leg , resp. ; P = @ ) and at week @ ( @ % versus @ % of noninjured leg , resp. ; P = @ ) without adverse effects on joint laxity .


No other between-group differences were found .


High-intensity resistance training during rehabilitation after ACL-reconstruction can improve muscle power without adverse effects on joint laxity .


Functional electrical stimulation ( FES ) to patients early after stroke has been proved to improve walking ability .


The effects on abilities in activities of daily living ( ADL ) are not clear .


To investigate the effectiveness of FES in improving lower limb function and ability in ADL of early stroke patients .


Thirty-seven stroke patients were randomly allocated to standard rehabilitation ( SR ) group ( n = @ ) , and FES group with FES and SR ( n = @ ) .


SR included @ minutes each for physiotherapy and occupational therapy .


FES was delivered for @ min to induce ankle dorsiflexion and eversion .


Treatments were @ days per week for @ weeks .


Evaluations including the composite spasticity scale ( CSS ) , lower-extremity subscale of Fugl-Myer Assessment ( FMA ) , postural assessment scale for stroke patients ( PASS ) , Berg Balance Scale ( BBS ) , and modified Barthel Index ( MBI ) assessed before treatment , after @ and @ week treatment respectively .


After @ week treatment , FES group showed a significant reduction of CSS and improvements of FMA , MBI and PASS .


After @ week treatment , FES group showed a further reduction of CSS and also improvement of FMA , MBI and BBS as well .