The primary end point was efficacy , which was defined as a rate of increase in total serum bilirubin of less than @ mg per deciliter per hour for infants up to @ hours of age or a decrease in total serum bilirubin for infants older than @ hours of age who received at least @ hours of phototherapy ; we prespecified a noninferiority margin of @ % for the difference in efficacy rates between groups .


The need for an exchange transfusion was a secondary end point .


We also assessed safety , which was defined as the absence of the need to withdraw therapy because of hyperthermia , hypothermia , dehydration , or sunburn .


We enrolled @ infants and randomly assigned @ to filtered sunlight and @ to conventional phototherapy .


Filtered sunlight was efficacious on @ % of treatment days that could be evaluated , as compared with @ % for conventional phototherapy , and had a higher mean level of irradiance ( @ vs. @ W per square centimeter per nanometer , P < @ ) .


Temperatures higher than @ C occurred in @ % of the infants receiving filtered sunlight and in @ % of those receiving conventional phototherapy ( P < @ ) , but no infant met the criteria for withdrawal from the study for reasons of safety or required an exchange transfusion .


Filtered sunlight was noninferior to conventional phototherapy for the treatment of neonatal hyperbilirubinemia and did not result in any study withdrawals for reasons of safety .


( Funded by the Thrasher Research Fund , Salt Lake City , and the National Center for Advancing Translational Sciences of the National Institutes of Health ; Clinical Trials.gov number , NCT@ . )


To assess any changes in the Functional Communicative Profile ( FCP ) and in the Social Cognitive Performance ( SCP ) of children with Autism Spectrum Disorders , based on two short periods of intervention .


The study was conducted with @ children with Autism Spectrum Disorder diagnoses , randomly allocated into two groups , who received the same short-term intervention types ( @ weeks with the mother and @ weeks with the support of an educational software program ) .


The intervention process was conducted by speech-language pathologists who were part of a graduate program in this area .


Samples of @-minute interaction sessions between the child and speech-language pathologist were used to assess the changes in the FCP and the SCP .


The statistic analysis pointed out differences only in Group @ for the variables `` percentage of communicative space used '' and `` use of the mediating object '' .


With the intervention sessions structured over @ weeks , it was possible to observe a few changes in the children 's FCP and in the SCP .


Therefore , we point out the need for new research studies of longer duration .


Urticaria is a distressing condition associated with diverse clinical presentations .


Chronic spontaneous urticaria ( CsU ) is characterized by wheals and angioedema .


Its treatment requires an algorithmic approach to identify the optimum medication .


Cetirizine is commonly used in the treatment of urticaria .


Rupatadine is a selective non-sedating H@ - antihistamine approved for the treatment of CsU .


This trial was conducted to ascertain whether the properties of rupatadine offer advantages over cetirizine .


Seventy patients with CsU were enrolled .


Parameters assessed included : ( i ) mean number of wheals ( MNW ) ; ( ii ) pruritus ; ( iii ) mean total symptom score ( MTSS ) ; ( iv ) size of wheal ; ( v ) interference of wheals with sleep ; and ( vi ) sedation .


Patients with CsU were divided randomly into two groups .


Routine investigations were performed at baseline and at the end of the study .


Evaluations of MTSS , MNW , and pruritus revealed statistically significant differences at week @ compared with baseline in the cetirizine group .


However , greater reductions in these parameters were obtained with rupatadine .


In patients receiving rupatadine , reductions in the MNW , size of wheals , and intensity of erythema were also significant at six weeks ( P < @ ) and were significantly greater than those in the cetirizine group ( P < @ ) .


Improvements in MTSS , MNW , size of wheals , intensity of erythema , and differential eosinophil count imply that rupatadine is a particularly attractive therapeutic modality compared with cetirizine for the treatment of CsU .


This study evaluated the feasibility , acceptability , and initial efficacy of an intervention based on Schachter 's externality theory ; the Regulation of Cues ( ROC ) program .


@ overweight and obese @-@-year-old children and their parents were randomly assigned to a @-month ROC program or the control group .


Outcomes were assessed at baseline , posttreatment , and @ months posttreatment and included acceptability and feasibility , body weight , and eating behaviors .


The ROC program had moderate to high acceptability ratings .


Significant improvements were found for the ROC group compared with the control group on child food responsiveness at posttreatment and eating in the absence of hunger at @ months posttreatment .


Improvements were seen for the ROC group compared with the control group on body weight measures and food responsiveness , although these only approached significance .


The ROC intervention may be useful with overweight and obese children .


Larger , fully powered studies are needed to further evaluate the efficacy of this model .


Although the use of bortezomib alone and in combination with steroids has shown efficacy in AL amyloidosis , its role in combination with high-dose melphalan and autologous stem cell transplantation ( HDM/SCT ) is unknown .


In this study , we evaluated bortezomib in combination with dexamethasone ( BD ) for induction chemotherapy prior to HDM/SCT .


This was a single-center , prospective , randomized controlled trial comparing induction therapy consisting of two BD cycles followed by HDM/SCT ( BD+HDM / SCT ) with HDM/SCT alone in the treatment of patients with newly diagnosed AL amyloidosis .


The hematological and organ responses of the patients were assessed every three months post HDM/SCT .


Fifty-six patients newly diagnosed with renal ( @ % ) , cardiac ( @ % ) , liver ( @ % ) , or nervous system ( @ % ) AL amyloidosis were enrolled in this study ; @ patients were assigned to each arm .


Two patients died within @days of HDM/SCT ( @ % treatment-related mortality ) .


The overall hematologic response rates in the BD+HDM / SCT arm and HDM/SCT arm at three , six and twelve months were @ % versus @ % , @ % versus @ % and @ % versus @ % , respectively .


In the BD+HDM / SCT arm , @ ( @ % ) patients achieved a hematologic response after BD and before HDM/SCT .


An intention-to-treat analysis revealed a higher rate of complete remission in the BD+HDM / SCT arm at both @ and @months ( @ % and @ % , respectively ) than with the HDM/SCT-only therapy ( @ % and @ % , respectively , P = @ ) .


After a median follow-up of @months , the survival rates at @months post-treatment start were @ % in the BD+HDM / SCT group and @ % in the HDM/SCT alone group ( P = @ ) .


Our preliminary data suggest that the outcome of treating AL amyloidosis with BD induction and HDM/SCT was superior to the outcome of the HDM/SCT treatment alone .


The prevalence of fibromyalgia increases worldwide and is characterized by widespread and chronic pain .


Treatment is difficult and includes both drug and non-drug approaches .


Milnacipran , an antidepressant , is used for fibromyalgia , with a possible beneficial effect on central pain modulation .


Our hypothesis is that the efficacy of milnacipran in fibromyalgia depends on the performance of pain inhibitory controls .


A randomized , double blind , clinical trial ( NCT@ ) with two parallel groups , in @ women with fibromyalgia , is planned in the Clinical Pharmacology Center , University Hospital , Clermont-Ferrand , France .


Conditioned pain modulation ( estimated with thermal stimuli using a numeric pain rating scale ) , the primary endpoint measure , is evaluated before and one month after treatment with milnacipran or placebo .


Secondary outcome measures include the predictability of pain descending pathways performance for milnacipran efficacy , tolerance and cognitive function .


Data analysis is performed using mixed models ; the tests are two-sided , with a type I error set at alpha = @ .


Not only will this trial allow estimation of the beneficial effect of milnacipran on pain and on descending pain pathways but it will also evaluate whether the performance of this modulatory system could be predictive of its efficacy in alleviating pain .


This method would allow clinicians to take a pro-active attitude by performing a rapid psychophysical test before starting milnacipran treatment and would avoid unnecessary prescription while preventing therapeutic failure in patients who often face this recurrent problem .


Opioid maintenance treatment is the option of choice to stabilize opioid-dependent patients .


Whilst efficacy of methadone and buprenorphine has been studied extensively , fewer data on slow-release oral morphine are available .


This study analyzes the effects of slow-release oral morphine compared to methadone with regard to self-reported mental symptoms , drug use and satisfaction with treatment .


The study was carried out as an open-label randomized crossover trial in @ treatment sites in Switzerland and Germany .


It comprised @ crossover periods of @ weeks each .


For measuring mental symptoms , the Symptom Checklist-@ ( SCL-@ ) was used .


Drug and alcohol use was assessed by the number of consumption days , and treatment satisfaction by a visual analogue scale .


A total of @ patients were included for the analyses ( per-protocol sample ) .


Statistically significantly better outcomes for morphine as compared to methadone treatment were found for overall severity of mental symptoms ( SCL-@ Global Severity Index ) , as well as @ of the @ syndrome groups of the SCL-@ , and for treatment satisfaction .


There were no statistically significant differences with regard to drug or alcohol use between groups .


This study supports positive effects of slow-release oral morphine compared to methadone on patient-reported outcomes such as mental symptoms and treatment satisfaction with comparable effects on concomitant drug use .


Slow-release oral morphine represents a meaningful alternative to methadone for treatment of opioid dependence .


To document the anatomical effects of clear lens extraction by phacoemulsification versus trabeculectomy on anterior chamber angle in patients with primary angle-closure glaucoma ( PACG ) .


Gonioscopy and ultrasound biomicroscopy ( UBM ) were performed pre-operatively , and at @ year after clear lens extraction or trabeculectomy in PACG eyes .


Fifty PACG eyes of @ patients were included .


Twenty-six eyes had clear lens extraction by phacoemulsification , while @ eyes underwent trabeculectomy .


The mean extent of synechial angle closure was significantly reduced from @ to @ ( p = @ ) by phacoemulsification , but it was only reduced from @ to @ ( p = @ ) by trabeculectomy .


The mean angle-opening distance at @ microns from sclera spur ( AOD@ ) measured by UBM was significantly increased from @ microns to @ microns ( p < @ ) by clear lens extraction , but decreased from @ microns to @ microns ( p = @ ) by trabeculectomy .


The mean anterior chamber depth ( ACD ) measured by UBM was significantly increased from @,@ microns to @ microns ( p < @ ) by clear lens extraction , but decreased from @,@ microns to @ microns ( p = @ ) by trabeculectomy .


Compared to trabeculectomy , clear lens extraction resulted in a significant reduction in synechial angle closure , and an increase in anterior chamber angle width and anterior chamber depth in PACG eyes without cataract .


Human immunodeficiency virus ( HIV ) - infected pregnant women are at increased risk of malaria and its complications .


In vitro and in vivo data suggest that the HIV protease inhibitors lopinavir/ritonavir may have potent antimalarial activity .


We sought to evaluate whether lopinavir/ritonavir-based antiretroviral therapy ( ART ) reduced the risk of placental malaria .


HIV-infected , ART-naive pregnant women were enrolled between gestational weeks @ and @ and randomly assigned to receive lopinavir/ritonavir-based or efavirenz-based ART .


Women received daily trimethoprim-sulfamethoxazole prophylaxis and insecticide-treated bed nets at enrollment and were followed up to @ year after delivery .


The primary outcome was placental malaria , defined by the detection of malaria parasites , using microscopy or polymerase chain reaction ( PCR ) analysis of placental blood specimens .


Secondary outcomes included placental malaria , defined by histopathologic results ; adverse birth outcomes ; incidence of malaria ; and prevalence of asymptomatic parasitemia .


Analyses were done using an intention-to-treat approach .


Of @ subjects randomly assigned to a treatment group , @ were followed through to delivery .


There was no significant difference in the risk of placental malaria , as defined by thick smear or PCR findings , between the lopinavir/ritonavir-based and efavirenz-based ART arms ( @ % vs @ % ; P = @ ) .


Similarly , there were no differences in secondary outcomes between the @ treatment arms .


Lopinavir/ritonavir-based ART did not reduce the risk of placental or maternal malaria or improve birth outcomes , compared with efavirenz-based ART .


TAK-@ is an omega-@ preparation that contains eicosapentaenoic acid ethyl-ester ( EPA-E ) and docosahexaenoic acid-ethyl ester used in the management of hypertriglyceridemia .


The aim of the study was to evaluate the long-term safety ( adverse events -LSB- AEs -RSB- , laboratory parameters , vital signs , weight , and electrocardiograms ) and effects on lipid profiles , especially triglyceride levels , of TAK-@ in Japanese patients with hypertriglyceridemia ( triglyceride levels @ mg/dL and < @ mg/dL ) .


In this multicenter , open-label , randomized study , adults with hypertriglyceridemia undergoing lifestyle modification received TAK-@ @ g ( @ g once daily ; n = @ ) or @ g ( @ g twice daily ; n = @ ) , or EPA-E @ g ( @ g three times daily ; n = @ ) for @ weeks .


Patients were stratified for co-administration of a statin .


TAK-@ was well tolerated throughout the @-week study .


Overall , no substantial differences were found in the tolerability of TAK-@ @ g , TAK-@ @ g , and EPA-E @ g with incidence rates for AEs of @ % , @ % , and @ % , respectively .


Most AEs were mild or moderate in severity .


Triglyceride levels decreased from baseline in all groups by week @ , and the decreases were maintained throughout the study .


At week @ the reduction in triglycerides with TAK-@ @ g ( -@ % ) was similar to that with EPA-E @ g ( -@ % ) , whereas the reduction seen with TAK-@ @ g ( -@ % ) was greater than that with EPA-E @ g , as assessed by point estimates and @ % confidence intervals .


TAK-@ was safe and well tolerated for up to @ weeks of treatment in Japanese patients with hypertriglyceridemia undergoing lifestyle modification .


Reductions in triglyceride levels achieved after @ weeks were maintained at @ weeks .


Various procedures have been used for the management of neglected and resistant clubfoot .


The aim of our study was to assess the clinical and radiological correction by Joshi 's external stabilization system ( JESS fixator ) and Simons subtalar release in resistant and neglected idiopathic congenital talipes equinovarus in children between the ages of @ and @ years .


A total of @ resistant and neglected clubfeet were randomly divided into two equal groups of @ feet each .


Group I was treated with JESS fixator and group II was treated with complete subtalar release as described by Simons .


Assessment of correction achieved was done both clinically and radiologically .


Functional outcome was assessed with Ponseti scale .


The change in clinical deformity and radiological correction of deformity were statistically significant within each group , but not significant when compared to each other .


In group I excellent results were obtained in @ ( @ % ) and good in @ ( @ % ) of the feet .


In group II , excellent results were found in @ ( @ % ) and good in @ ( @ % ) feet out of the @ feet .


Pin-site infections were seen in two cases in group I and serious skin problems occurred in two feet in group II .


We conclude that there were no statistical significant differences between the outcomes of the two techniques in this short-term follow-up of @ years .


Thus , functional distraction using JESS can be utilized as an alternative method in cases of neglected and resistant clubfoot .


Carbon dioxide ( CO@ ) insufflation during colonoscopy can significantly decrease abdominal pain and bloating after the procedure , but its impact on the frequency and duration of toilet use remains unknown .


The aim of this study was to assess the impact of CO@ insufflation on toilet use after screening colonoscopy .


From @ average-risk individuals who underwent screening colonoscopy during March to August @ , @ were enrolled and randomized to receive either CO@ or air insufflation at colonoscopy .


Both the colonoscopist and participant were blinded to the type of gas used .


Abdominal pain and distension were assessed using a visual analog scoring system .


The frequency and duration of toilet visits during a @-hour postcolonoscopy period were recorded using a radiofrequency identification system .


Baseline characteristics were similar in both groups in terms of age , sex , and procedure time .


In the @ hours after colonoscopy , @ participants ( @ % ) in the air group and @ participants ( @ % ) in the CO@ group ( P < @ ) used the toilet at least once .


The mean ( SD ) duration of each toilet visit was @ minutes in the air group and @ minutes in the CO@ group ( P < @ ) .


The abdominal discomfort score was lower in the CO@ group than in the air group both at the end of the colonoscopy ( P < @ ) and @ hours later ( P < @ ) .


Insufflation with CO@ can significantly reduce abdominal discomfort and toilet use after colonoscopy .


Use of this technique may help reduce patient burden and allow more efficient use of space in the endoscopy unit .


Ginsenosides are the proposed bioactive constituent of ginseng , especially for the attenuation of postprandial glycemia ( PPG ) .


The efficacious proportion of total and specific ginsenosides , remains unknown .


Alcohol extraction of whole ginseng root can be used to selectively manipulate the ginsenoside profile with increasing alcohol concentrations producing high yields of total ginsenosides and varying their individual proportions .


We aimed to compare the acute efficacy of different ethanol-extraction preparations of American ginseng ( AG ) and Korean red ginseng ( KRG ) , with their whole-root origins , on PPG and insulin parameters in healthy adults .


Following an overnight fast , @ healthy individuals ( Gender : @M :@ F , with mean SD , age : @ @ years , BMI : @ @ kg/m ( @ ) and fasting plasma glucose : @ @ mmol/L ) randomly received @g of each of the following @ different ginseng treatments on separate visits : whole root KRG and AG ; @ % , @ % or @ % ethanol extracts of KRG and AG and @ cornstarch placebos .


Treatments were consumed @ min prior to a @ g oral glucose challenge test with capillary blood samples collected at baseline , @ , @ , @ , @ , @ and @ min .


Insulin samples were collected at @ , @ , @ and @ min .


There was no difference in attenuation of PPG among the tested ginseng preparations .


Measures of Insulin Sensitivity Index ( ISI ) showed increased insulin sensitivity ( IS ) with KRG-@ % and AG-@ % extracts compared to placebo ( p < @ ) .


The insulin sensitizing effects of KRG-@ % and AG-@ % extracts suggest that other root parts , including other ginsenosides not typically measured , may influence PPG and insulin parameters .


There is potential for AG and KRG extracts to modulate IS , an independent predictor of type @ diabetes .


Bonafide psychotherapy is an effective treatment for generalised anxiety disorder compared to no-treatment .


Rather than creating increasing numbers of new overall treatment-packets within a medical meta-model , an additional approach to investigating clinical research designs may be to increase the understanding of already effective psychotherapies .


Treatment manuals and protocols allow a relatively high degree of freedom for the way therapists implement the overall treatment manuals .


There is a systematic lack of knowledge on how therapists should customise these overall protocols .


The present study experimentally examines three ways of conducting a bonafide psychotherapy based on a @ session time-limited cognitive-behavioural therapy ( CBT ) protocol and their relation to the therapists ' protocol adherence and treatment efficacy .


This trial will investigate three different methods of customising a bonafide CBT-protocol using dyadic peer-tutoring methodology ( primings ) .


The individuals with GAD will be randomly assigned to one of three priming conditions ( resource priming , supportive resource priming , or adherence priming ) .


The participant treatment allocation will be performed randomly .


Therapists will be assigned to a peer-tutoring partner and priming condition based on a mutual agreement .


Treatment outcomes will be assessed at the following times : observer based in-session outcomes , session-by-session post-session outcomes , treatment outcome at post assessment and treatment outcome at @-month follow-up .


The proposed trial addresses the clinically relevant question of how to customise a bonafide psychotherapy protocol using tandem peer-tutoring methodology ( three priming conditions ) .


Through the development and testing of the proposed priming procedures , this study describes levels of adherence and how to conduct an overall treatment protocol in a more systematised way .


De-escalating natalizumab ( NTZ ) to interferon beta @b ( IFN B @B ) is a possible treatment option in multiple sclerosis ( MS ) patients interrupting NTZ because of increased risk of progressive multifocal leukoencephalopathy ( PML ) .


The aim of this study was to evaluate satisfaction and adherence to treatment , behavioral and fatigue changes in patients switched to IFN B @B compared to continued NTZ treatment .


A @ year , prospective , randomized , rater-blinded , parallel-group study .


Nineteen relapsing remitting ( RR ) MS patients , randomly assigned to undergo either NTZ ( n = @ ) or IFN B @B ( n = @ ) treatment , who had previously received NTZ for at least @ months with disease stability and fearing or at risk for PML were included .


Patients underwent behavioral and treatment assessments at baseline , after @-week and @ year follow-up .


Behavioral assessment included measures of cognition , fatigue and quality of life .


Treatment assessment included measures of satisfaction , persistence and adherence to treatment .


Clinical-radiological disease activity and safety were also assessed .


Baseline characteristics of patients were similar between groups except for Euro Quality Visual Analogue Scale , being higher in the NTZ group ( p = @ ) .


Within-group comparisons at the three time points , as well as interaction analysis of treatment effect over time did not show any statistically significant differences in behavioral or treatment assessments , but a coherent trend favoring NTZ over IFN B @B .


De-escalating NTZ to IFN B @B is feasible and associated with overall good patient related outcome and persistently stable behavioral measures .


Three randomised controlled trials have provided strong evidence that Weight Watchers ( ) is an effective weight-loss programme but there is insufficient evidence to determine whether three other weight-loss programmes are also effective .


To examine whether other group-based weight-loss programmes were not inferior to Weight Watchers .


A prospective cohort study using a non-inferiority analysis of @ adults referred through primary care .


METHOD Participants who met the eligibility criteria for primary care obesity management treatment chose a free programme ( Weight Watchers , Rosemary Conley Diet and Fitness Clubs , Slimming World or a NHS group programme ) lasting @ months ; they were weighed at @ months ( programme end ) and self-reported their weight at @ months .


At @ months , weight loss achieved through Rosemary Conley and Slimming World was not inferior to Weight Watchers .


The NHS group programme was inferior .


At @ months Slimming World and Rosemary Conley were not inferior to Weight Watchers , although participants using Slimming World lost significantly more weight than those using Weight Watchers .


Data on the NHS group programme were inconclusive .


In the short term all commercial weight-loss programmes appear to result in similar weight loss but the NHS alternative appears to produce less weight loss .


At @ months Slimming World led to greater weight loss but the differences between commercial programmes was small and of minor clinical importance .


Our aim is to compare the hemodynamic effects of combined psoas compartment-sciatic nerve block ( PCSNB ) with continuous spinal anaesthesia ( CSA ) in elderly high-risk patients undergoing hip replacement surgery .


Seventy patients over the age of @ with ASA III or IV physical status were randomly allocated to two groups : In the PCSNB group , ultrasound-guided psoas compartment block was performed with modified Winnie technique using @ mL of @ % bupivacaine with @:@ epinephrine ( @ gr/mL ) and iliac crest block was performed using the same local anaesthetic solution ( @ mL ) .


All patients in the PCSNB group needed continuing infusion of propofol ( @ mg/kg/h ) during operation .


In the CSA group , CSA was performed in the L@-L@ interspaced with the patient in lateral decubitus position using @ mg of isobaric bupivacaine @ % .


When sensory block was not reached to the level of T@ within @ minutes in the CSA group , additional @ mg of isobaric bupivacaine @ % was administered through the catheter at @-min intervals by limiting the total dose of @ mg until a T@ level of the sensory block was achieved .


The PCSNB group had significantly higher mean arterial blood pressure values at the beginning of surgery and at @ ( th ) , @ ( th ) and @ ( th ) minutes of surgery compared to the CSA group ( P = @ , P = @ , P = @ , P = @ respectively ) .


There were no significant differences between groups in terms of heart rate and peripheral oxygen saturation values during surgery and the postoperative period ( P > @ ) .


Arterial hypotension required ephedrine was observed in @ patients in the CSA and @ patients in the PCSNB group ( P = @ ) .


CSA and PCSNB produce satisfactory quality of anaesthesia in elderly high-risk patients with fewer hemodynamic changes in PCSNB cases compared with CSA cases .


Mandibular advancement splints ( MAS ) are often preferred to CPAP treatment for OSA but are not always equally efficacious .


High therapeutic CPAP pressure has been associated with MAS treatment failure in a Japanese population .


We sought to assess the relationship between CPAP pressure and MAS treatment response in an Australian population .


Therapeutic CPAP pressure and MAS treatment response were obtained from a one-month crossover trial of both treatments .


Predictive utility of CPAP pressure to identify MAS treatment response was assessed .


Seventy-eight OSA patients were included ( age @ @ years , BMI @ @ kg/m ( @ ) ) with predominantly moderate-severe OSA ( AHI @ @ / h ) .


CPAP pressure was lower in MAS responders ( MAS AHI < @/h ) @ @ vs. @ @ cm H O , p < @ , with area under ROC curve of @ ( @ % CI @-@ @ ) , p < @ .


The best cutoff value of @ cm H O useful for discriminating MAS responders and non-responders in the previous Japanese population , was inadequate for prediction in the current population ( @ negative predictive value -LSB- NPV -RSB- ) .


However a cutoff of @ cm H O identified MAS non-responders ( @ NPV ) .


Multivariate regression identified CPAP pressure ( odds ratio -LSB- @ % confidence interval -RSB- @ -LSB- @-@ @ -RSB- , age ( @ -LSB- @-@ @ -RSB- ) and AHI ( @ -LSB- @-@ @ -RSB- ) as predictors of MAS treatment response ( model r ( @ ) = @ , p < @ ) .


In Australian patients , the majority of whom are Caucasian , a higher therapeutic CPAP pressure requirement in conjunction with age and OSA severity characteristics may be useful to indicate likelihood of success with MAS as an alternative therapy .


Since the results from the randomized TARGIT A trial were published , intraoperative radiotherapy ( IORT ) is used more often .


IORT can be provided as accelerated partial breast irradiation ( APBI ) or as a boost .


The definition of suitable patients for IORT as APBI differs between different national societies ( e.g. ESTRO and ASTRO ) and different inclusion criteria of trials and so does the eligibility of patients .


This analysis identifies eligible patients for IORT according to available consensus statements and inclusion criteria of the ongoing TARGIT trials .


Between @/@ - @/@ , @ breast cancer cases were treated at the breast cancer center at the University Medical Center Mannheim .


Complete data sets for age , stage ( T , N , and M ) , histology and hormone receptor status were available in @ cases .


Parameters to identify eligible patients are as follows : ESTRO : > @ years , invasive ductal carcinoma/other favorable histology ( IDC ) , T@-@ ( @ cm ) , N@ , any hormone receptor status , M@ ; ASTRO : @ years , IDC , T@ , N@ , positive estrogen hormone receptor status , M@ ; TARGIT E `` elderly '' , risk adapted radiotherapy with IORT followed by external beam radiotherapy in case of risk factors in final histopathology , phase II : @ years , IDC , T@ , N@ , any hormone receptor status , M@ ; TARGIT C `` consolidation '' , risk adapted radiotherapy , phase IV : @ years , IDC , T@ , N@ , positive hormone receptor status , M@ ; TARGIT BQR `` boost quality registry '' : every age , every histology , T@-@ ( max .


@ cm ) , any hormone receptor status , N@ / + , M@ / + .


Out of the @ cases , @ cases ( @ % ) were suitable for IORT as APBI regarding the ESTRO and @ ( @ % ) regarding the ASTRO consensus statements .


@ ( @ % ) patients were eligible for the TARGIT E trial , @ ( @ % ) for the TARGIT C trial and @ ( @ % ) for the TARGIT BQR registry .


According to the consensus statements of ASTRO ( @ % ) and ESTRO ( @ % ) about half of the eligible patients were treated with IORT as APBI .


From the eligible patients fulfilling the criteria for IORT boost ( @ % ) about one third was eventually treated .


Patient selection for IORT should be restrictive .


For IORT as APBI the TARGIT trials are even more restrictive including patients than the ESTRO and ASTRO consensus statements .


Cell-culture-derived ( CC ) influenza vaccine production methods could provide benefits over classical embryonated-egg technology , including a higher production capacity and the faster creation of a supply that meets demand .


A CC-inactivated split-virus influenza A/Indonesia/@ / @ ( H@N@ ) vaccine derived from the EB@ cell line ( hereafter , `` CC-H@N@ '' ) was investigated in a phase @ randomized , blinded study .


Healthy adults ( n = @ ) received @ vaccine doses ( days @ and @ ) of either investigational CC-H@N@ vaccine ( @ g or @ g of hemagglutinin antigen -LSB- HA -RSB- with the AS@ adjuvant system or @ g of plain HA ) , embryonated-egg-derived vaccines ( @ g of HA with AS@ or @ g of plain HA ) , or placebo .


Assessment of the adjuvant effect and immunogenicity was performed using Center for Biologics Evaluation and Research acceptability criteria @ days after dose @ .


Safety was assessed until month @ .


AS@-adjuvanted CC-H@N@ elicited a homologous hemagglutination inhibition antibody response that satisfied immunogenicity criteria @ days after dose @ and persisted at month @ .


Adjuvant effect and immune response against a drift-variant strain were demonstrated .


No vaccine-related serious adverse events were reported .


The immunogenicity and safety of the CC-H@N@ formulation containing @ g of HA and AS@ appeared to be similar to those for the licensed egg-derived AS@-adjuvanted control vaccine .


The feasibility of the EB@ cell line to produce an immunogenic influenza vaccine with acceptable safety profile was demonstrated .


Antigen sparing was achieved through combination with AS@ adjuvant .


This CC-H@N@ might contribute to the rapid access of vaccine in the event of an influenza A ( H@N@ ) pandemic .


The aim of this study was to evaluate a tailored physical activity protocol performed in a work environment with a group of female workers employed in manual precision tasks to reduce upper limb pain .


Sixty female subjects were randomly assigned to an intervention group or a control group .


The IG was administered of a @-month , twice-a-week , tailored exercise program , whereas the CG received no intervention .


The IG showed a reduction on shoulder pain accompanied by increases on the range of motion measures .


In addition , reductions in upper limb pain and neck disability were detected with concomitant increases in grip strength .


This study indicated positive effects of a tailored workplace exercise protocol in female workers exposed to moderate risk for work-related musculoskeletal disorders , showing clinically meaningful reductions of pain symptoms and disability on upper limb and neck regions .


Sayana Press ( SP ) , a subcutaneous formulation of depot medroxyprogesterone acetate ( DMPA ) prefilled in a Uniject injection system , could potentially improve and expand contraceptive injection services , but acceptability of SP is unknown .


HIV-positive women need contraception to avoid unintended pregnancy and risk of vertical HIV transmission .


We assessed acceptability of SP versus intramuscular DMPA ( DMPA-IM ) among HIV-positive women and their care providers in Rakai , Uganda .


Women were randomized to DMPA-IM or SP at baseline , received the alternate product at @ months , and chose their preferred method at @ months .


We determined preferences among new and experienced contraceptive injectable users who had tried both types of injection during the trial , and from providers before and after providing both types of injectables to clients .


Among @ women randomized , @ were followed up at @ months ( @ % ) .


Although SP caused more skin irritation than DMPA-IM ( @ % vs. @ % at @ months , p = @ ) , it was associated with marginally fewer side effects ( @ % vs. @ % at @ months , p = @ ) .


Participants reported high levels of willingness to recommend the DMPA contraception to a friend and satisfaction with the injection received , and these did not differ by injection type .


Sixty-four percent of women and @ % of providers preferred SP to DMPA-IM at @ months ; women 's preferences did not differ by previous experience with injectable contraception .


SP is acceptable to HIV-positive women and health care providers in this rural Ugandan population .


SP appears to be acceptable to HIV-positive women and their care providers in Rakai , Uganda , and strategies for appropriate rollout of this innovative technology should be explored .


The aim of this randomised clinical trial was to assess a comprehensive cardiac rehabilitation intervention including exercise training and psycho-education vs ` treatment as usual ' in patients treated with an implantable cardioverter defibrillator ( ICD ) .


In this study @ patients with first time ICD implantation ( mean age @ ( standard deviation ( SD ) = @ ) ; @ % men ) were randomised ( @:@ ) to comprehensive cardiac rehabilitation vs ` treatment as usual ' .


Altogether @ participants completed the @ month follow-up .


The intervention consisted of twelve weeks of exercise training and one year of psycho-educational follow-up focusing on modifiable factors associated with poor outcomes .


Two primary outcomes , general health score ( Short Form-@ ( SF-@ ) ) and peak oxygen uptake ( VO ) , were used .


Post-hoc analyses included SF-@ and ICD therapy history .


Comprehensive cardiac rehabilitation significantly increased VO@ uptake after exercise training to @ ( @ % confidence interval ( CI ) @-@ @ ) vs @ ( @ % CI @-@ @ ) ml/min/kg in the control group ( p = @ ( multiplicity p = @ ) ) .


Comprehensive cardiac rehabilitation significantly increased general health ; at three months ( mean @ ( @ % CI @-@ @ ) vs @ ( @ % CI : @-@ @ ) ) points ; at six months ( mean @ ( @ % CI @-@ @ ) vs @ ( @ % CI @-@ @ ) points ) ; and @ months ( mean @ ( @ % CI @-@ @ ) vs @ ( @ % CI @-@ @ ) ) points ( p < @ ) .


Explorative analyses showed a significant difference between groups in favour of the intervention group .


No significant difference was seen in ICD therapy history .


Comprehensive cardiac rehabilitation combining exercise training and a psycho-educational intervention improves VO-uptake and general health .


Furthermore , mental health seems improved .


No significant difference was found in the number of ICD shocks or anti-tachycardia pacing therapy .


The immune system has been implicated as one mechanism underlying the benefits of acupuncture therapy .


Evidence suggests that acupuncture can ameliorate symptoms of chronic prostatitis/chronic pelvic pain syndrome ( CP/CPPS ) , but the association between clinical response and the immune system has not been investigated .


We investigated @ CP/CPPS patients participating in a prospective randomized clinical trial comparing acupuncture versus sham acupuncture for effects on cellular immunity .


Blood samples were taken before the first needling and after the last of @ treatment sessions ( week @ ) .


Patients also completed questionnaires examining their CP/CPPS symptoms and mood status at the baseline and end of study visits .


At the end of study @ of @ participants ( @ % ) were classified as treatment responders , four participants each from the acupuncture and sham groups .


The acupuncture group averaged a @ % increase in natural killer cell levels compared to corresponding sham ( -@ % ; p = @ ) .


Similarly , patients randomized to acupuncture reported a reduction in other white blood cell parameters examined , supporting the possibility that immunity might be important in the pathophysiology of CP/CPPS .


The specific effect of acupuncture on CP/CPPS remains unclear .


Further research is warranted to examine the mechanisms by which acupuncture therapy may improve clinical symptoms in patients with CP/CPPS .


Limited data is available on long-term atrial fibrillation ( AF ) free survival after multi-electrode catheter pulmonary vein isolation ( PVI ) .


The aim of this study was to compare point-by-point PVI to multi-electrode PVI in terms of procedural characteristics and long-term AF free survival .


@ consecutive patients were randomly allocated : @ patients underwent conventional , point-by-point ablation with a radiofrequency ablation catheter ( cPVI group ) and @ patients underwent multi-electrode , phased radiofrequency ablation ( MER group ) .


Median follow-up was @ months .


Mean age was @ years , @ % of patients had paroxysmal AF .


Baseline characteristics did not differ among catheter groups .


Acute electrical PVI was achieved in @ % of pulmonary veins , with no differences among catheter groups .


Procedure time and ablation time were significantly shorter in the MER group .


There were significantly less complications in the MER group ( @ % vs. @ % , P = @ ) .


After a mean of @ procedures , AF free survival without the use of antiarrhythmic drugs was @ % at @ year and @ % at @ years follow-up and did not differ among catheter groups ( cPVI group @ % , MER group @ % , P = @ ) .


In multivariate analysis , BMI , AF duration and CHADSVASc score were predictors of AF free survival .


Multi-electrode ablation was superior in procedure duration and ablation time , with less complications .


However , both conventional point-by-point PVI and multi-electrode PVI achieved a high acute PVI success rate and showed a comparable long-term AF free survival .


To determine whether supplementation with the long-chain omega-@ polyunsaturated fatty acids eicosapentaenoic ( EPA ) and docosahexaenoic acid ( DHA ) affects behavioral symptoms and cognitive impairments in children @-@ years of age diagnosed with attention-deficit/hyperactivity disorder ( ADHD ) .


The randomized , double-blind placebo-controlled @ weeks trial was conducted with @ children diagnosed with ADHD according to DSM-IV criteria .


Behavior was assessed by parents , teachers and investigators using standardized rating scales and questionnaires .


Further outcome variables were working memory , speed of information processing and various measures of attention .


For a subgroup of @ participants , erythrocyte membrane fatty acid composition was analyzed before and after the intervention .


Supplementation with the omega-@ fatty acid mix increased EPA and DHA concentrations in erythrocyte membranes and improved working memory function , but had no effect on other cognitive measures and parent - and teacher-rated behavior in the study population .


Improved working memory correlated significantly with increased EPA , DHA and decreased AA ( arachidonic acid ) .


Transfusion with red blood cells ( RBC ) may be needed during hip revision surgery but the appropriate haemoglobin concentration ( Hb ) threshold for transfusion has not been well established .


We hypothesized that a higher transfusion threshold would improve ambulation after hip revision surgery .


The trial was registered at Clinicaltrials.gov ( NCT@ ) .


Sixty-six patients aged @ years or older undergoing hip revision surgery were randomized to receive RBC at a Hb threshold of either @ g/dL ( restrictive group ) or @ g/dL ( liberal group ) .


Postoperative ambulation was assessed using Timed Up and Go-test ( TUG ) and ability to walk was also assessed daily by a physiotherapist blinded to the allocation .


Fifty-three patients were able to perform the TUG and included in the analysis .


The TUG could be completed in a median of @ sec vs. @ sec in the restrictive group and the liberal group , respectively ( P = @ ) .


The mean difference in TUG was @ sec ( @ % CI @-@ @ sec ) .


No difference was found in the day patients could perform TUG or walk @ meters .


The Hb at the day of testing was @ g/dL in the restrictive group and @ g/dL in the liberal group .


Only @ patients received RBC .


A Hb transfusion threshold of @ g/dL was associated with a statistically significantly faster TUG after hip revision surgery compared to a threshold of @ g/dL but the clinical importance is questionable and the groups did not differ in Hb at the time of testing .


Although acute treatments have been shown to be effective in treating early-onset depression , only one-third or thereabouts reach a remission within @ months .


Unfortunately , delayed time to remission in early-onset depression leads to poorer therapeutic outcomes .


Clearly , there is a need to identify , diagnose , and provide effective treatment of a depressed patient quickly .


A sophisticated understanding of depression subscales and their change over time with treatment could enhance pathways to individualized treatment approaches for childhood depression .


Previous studies have found that the clinician-measured instrument , Children 's Depression Rating Scale-Revised ( CDRS-R ) measures multiple subscales ( or components ) of depression .


The aim of this study was to see how these subscales may change over the course of a @-week study .


This knowledge will help determine if dimensions/subscales of childhood depression ( paralleling the adult literature ) using the subscales derived from factor analysis procedure is useful .


We examined two clinical trials in which youth ( n = @ ) with major depressive disorder ( MDD ) were treated openly with fluoxetine for eight sessions spread over @ weeks .


The CDRS-R was completed based on clinician interviews with parent and child at each session .


Classical test theory and component analysis with associated parallel analysis ( oblique rotation ) were conducted on each week 's scores .


Although more factors were needed for the baseline and first two therapy sessions , a two-factor solution sufficed thereafter .


Depressed facial affect , listless speech , and hypoactivity best defined Factor I , whereas sleep problems , appetite disturbance , physical symptoms , irritability , guilt , and weeping best defined Factor II .


All other symptoms cross-loaded almost equally on the two factors .


The scale 's reliability ( internal consistency ) improved from baseline to exit sessions ( = @-@ @ ) .


As a result , the clinicians ' assessments of the various symptoms became more highly related to one another .


This caused the first eigenvalue to increase from @ to @ and the variance explained to increase ( % ) from @ % to @ % over sessions .


These two factors may reflect @ ) clinician-observed signs and @ ) reported symptoms of depression .


Factor analysis of CDRS-R data in a single session consistently generates a complex and difficult to interpret structure of at least three factors .


This makes it very difficult to understand what these factors measure .


However , when gathered over additional sessions , the CDRS-R structure tends to simplify to two factors .


The reasons for this simplification are as yet unclear and in need of further study .


This study was conducted to determine the effects of folate supplementation on inflammatory factors and biomarkers of oxidative stress among women with polycystic ovary syndrome ( PCOS ) .


This randomized , double-blind , placebo-controlled clinical trial was conducted among @ women diagnosed with PCOS and aged @-@year old .


Participants were randomly assigned to three groups receiving the following : ( @ ) folate-@ : @mg/d folate supplements ( N = @ ) ; ( @ ) folate-@ : @mg/d folate supplements ( N = @ ) and ( @ ) placebo ( N = @ ) for @weeks .


Fasting blood samples were taken at the beginning of the study and after @weeks to measure homocysteine ( Hcy ) , inflammatory factors including high-sensitivity C-reactive protein ( hs-CRP ) , nitric oxide ( NO ) , biomarkers of oxidative stress including total antioxidant capacity ( TAC ) , glutathione ( GSH ) , malondialdehyde ( MDA ) and homoeostatic model assessment-beta cell function ( HOMA-B ) .


Supplementation with @mg/d folate resulted in reduced plasma Hcy ( -@ vs -@ and @m , respectively , P < @ ) , HOMA-B ( -@ vs @ and @ , respectively , P < @ ) , serum hs-CRP ( -@ vs -@ and @g/l , respectively , P < @ ) and plasma MDA concentrations ( -@ vs -@ and @m , respectively , P < @ ) compared with folate-@ and placebo groups .


Furthermore , a significant rise in plasma TAC ( @ vs -@ and -@ mm , respectively , P < @ ) and GSH levels ( @ vs @ and -@ m , respectively , P < @ ) was also observed following the administration of @mg/d folate supplements compared with folate-@ and placebo groups .


In conclusion , folate supplementation ( @mg/d ) in women with PCOS had beneficial effects on inflammatory factors and biomarkers of oxidative stress .


Teenage passengers affect teenage driving performance , possibly by social influence .


To examine the effect of social norms on driving behavior , male teenagers were randomly assigned to drive in a simulator with a peer-aged confederate to whom participants were primed to attribute either risk-accepting or risk-averse social norms .


It was hypothesized that teenage drivers would engage in more risky driving behavior in the presence of peer passengers than no passengers , and with a risk-accepting compared with a risk-averse passenger .


@ male participants aged @ to @ years holding a provisional driver license were randomized to drive with a risk-accepting or risk-averse passenger in a simulator .


Failure to Stop at a red light and percent Time in Red ( light ) were measured as primary risk-relevant outcomes of interest at @ intersections , while driving once alone and once with their assigned passenger .


The effect of passenger presence on risky driving was moderated by passenger type for Failed to Stop in a generalized linear mixed model ( OR = @ , @ % CI -LSB- @ , @ -RSB- , p < @ ) , and percent Time in Red in a mixed model ( B = @ , @ % CI -LSB- @ , @ -RSB- , p < @ ) .


Exposure of teenage males to a risk-accepting confederate peer increased teenage males ' risky simulated driving behavior compared with exposure to a risk-averse confederate peer .


These results indicate that variability in teenage risky driving could be partially explained by social norms .


Transcutaneous electrical tibial nerve stimulation ( TENS ) is of growing interest for the treatment of fecal incontinence ( FI ) , but its mechanism of action remains uninvestigated .


We aimed to further assess the anorectal response to TENS in a dynamic model .


We performed a placebo-controlled , randomized , double-blinded crossover study in @ patients suffering from FI to assess the effects of TENS on anorectal function .


Anorectal physiology and perception were recorded through two sequences of rectal isobaric distension using an electronic barostat device to measure anal and rectal pressures , rectal volumes , and perception scores .


Maximal rectal pressure and volume variation were affected by TENS , with higher mean maximal rectal pressure ( @ and @ mmHg in the active and sham TENS respectively , p < @ ) and lower volume variation ( @ and @ mL in the active and sham stimulation respectively , p < @ ) .


Rectal compliance was not modified by active TENS .


Pressure of the upper anal canal was significantly lower with raised isobaric distension in sequences assigned to active TENS .


Acute TENS modified anorectal physiology by strengthening the myogenic response to distension rather than increasing muscle relaxation and related rectal compliance in patients with FI .


To compare the incidence of wound complications between suture and staple skin closure after cesarean delivery .


This prospective , randomized clinical trial conducted at three hospitals in the United States between @ and @ included women undergoing cesarean delivery at @ weeks of gestation or greater through a low-transverse skin incision .


Women were randomized to closure of the skin incision with suture or staples after stratifying by body mass index and primary compared with repeat cesarean delivery .


The primary outcome was incidence of wound complications , predefined as a composite of infection , hematoma , seroma , separation of @ cm or longer , or readmission for wound complications .


Analysis was according to the intention-to-treat principle ; results were stratified by randomization group and adjusted for hospital by including it as a covariate .


A total of @ women were randomized , @ to suture and @ to staple closure .


The median gestational age was @ weeks .


Fifty-eight women ( @ % ) had wound complications-@ @ % in the suture group and @ % in the staple group ( adjusted odds ratio -LSB- OR -RSB- @ , @ % confidence interval -LSB- CI -RSB- @-@ @ ) ; this was largely the result of the decreased incidence of wound separation in the respective groups ( @ % compared with @ % ; adjusted OR @ , @ % CI @-@ @ ) .


Suture closure of the skin incision at cesarean delivery is associated with a @ % decrease in wound complications compared with staple closure .


The purpose of this study was to compare physical activity ( PA ) outcomes in a sample of high school ( HS ) physical education ( PE ) lessons from schools that adopted traditional versus modified block schedule formats .


We used the System for Observing Fitness Instruction Time ( SOFIT ) to conduct observations of @ HS PE lessons delivered by @ PE teachers in @ schools .


T-tests and multilevel models were used to explore variability in moderate PA and vigorous PA. .


PA outcomes were significantly different between modified block and traditional schools .


Students who attended traditional schools engaged in more vigorous PA in PE lessons .


Modified block lessons lost more scheduled lesson time due to poor transition to and from the locker room .


PA outcomes were positively associated with fitness and teacher promotion of PA and negatively associated with lost time , class size , management , and knowledge .


Although PE proponents widely advocate for more PE minutes , this study showed that greater time scheduled in PE does not necessarily result in more student accrual of moderate to vigorous physical activity ( MVPA ) minutes .


This study evaluated whether a nutrition-education program in child-care centers improved children 's at-home daily consumption of fruits and vegetables , at-home use of low-fat/fat-free milk , and other at-home dietary behaviors .


Twenty-four child-care centers serving low-income families were matched by region , type , and size , and then randomly assigned to either an intervention or control condition .


In the @ intervention centers , registered dietitian nutritionists provided nutrition education to children and parents separately during a @ - to @-week period .


They also held two training sessions for center staff , to educate them on healthy eating and physical activity policies at the centers , and distributed weekly parent newsletters that included activities and recipes .


Parents ( n = @,@ ) completed a mail or telephone survey at baseline and follow-up to report information on their child 's fruit , vegetable , and milk consumption and other dietary behaviors at home .


This study used general and generalized linear mixed models to evaluate program impacts , while accounting for the clustering of children within centers .


This study included child age , child sex , household size , respondent race/ethnicity , respondent age , and respondent sex as covariates .


The program had a substantial impact on children 's at-home daily consumption of vegetables and use of low-fat/fat-free milk .


This study also found a significant increase in the frequency of child-initiated vegetable snacking , which might have contributed to the significant increase in vegetable consumption .


The program did not have a significant impact on fruit consumption or parental offerings of fruits and vegetables , child-initiated fruit snacking , or child fruit consumption .


This intervention in child-care settings that emphasized children , parents , and teachers significantly increased at-home vegetable and low-fat/fat-free milk consumption among low-income preschoolers .


Greater skeletal muscle fat infiltration occurs with age and contributes to numerous negative health outcomes .


The primary purpose was to determine whether intermuscular adipose tissue ( IMAT ) can be influenced by an exercise intervention and if a greater reduction in IMAT occurs with eccentric versus traditional resistance training .


Seventy-seven older adults ( age @ @ ) with multiple comorbidities and a history of falling completed a three-month exercise intervention paired with either eccentric or traditional resistance training .


MRI of the mid-thigh was examined at three time points to determine changes in muscle composition after intervention .


No differences in IMAT were observed over time , and there were no differences in IMAT response between intervention groups .


Participants in the traditional group lost a significant amount of lean tissue ( P = @ ) in the nine months after intervention , while participants in the eccentric group did not ( P = @ ) .


When IMAT levels were partitioned into high and low IMAT groups , there were differential IMAT responses to intervention with the high group lowering thigh IMAT .


There is no decrease in thigh IMAT after a three-month exercise intervention in older adults at risk for falling and no benefit to eccentric training over traditional resistance training for reducing IMAT in these individuals .


Healing is an event that is fundamental to the success of total knee arthroplasty .


The aims of the present study were to compare the rates of complications related to wound healing between two groups of volunteers submitted to total knee arthroplasty and to evaluate the effects of postoperative oxygen supplementation by means of a nasal catheter .


A total of @ patients who underwent total knee arthroplasty were randomized into two groups , namely , groups that did and did not receive postoperative oxygen supplementation via a nasal catheter .


The surgical wound was monitored every day during the hospital stay and on the @th , @th , @st , @th and @nd postoperative days .


Characteristics related to healing were observed , including hyperemia , dehiscence , necrosis , phlyctenules and deep and superficial infection .


There were no cases of deep infection .


Hyperemia was statistically correlated with the total number of complications in the groups , with oxygen demonstrated to be a protective factor against hyperemia .


Approximately @ % of the patients who exhibited hyperemia had other complications , independent of oxygen supplementation .


Oxygen supplementation following total knee arthroplasty was shown to be effective in diminishing hyperemia around the operative wound .


The development of hyperemia was a precursor to other complications , irrespective of whether oxygen supplementation was used .


To explore the clinical effect of Erlong Xizhu acupuncture for retinitis pigmentosa .


Methods Sixty patients with retinitis pigmentosa were randomly divided into an Erlong Xizhu acupuncture group and a conventional acupuncture group , @ cases in each one .


In the conventional acupuncture group , Tongziliao ( GB @ ) , Sizhukong ( TE @ ) , Taiyang ( EX-HN @ ) were acupunctured as the main acupoints by uniform reinforcing-reducing manipulation ; acupoints based on syndrome differentiation were coordinated by acupuncture manipulation of reinforcing deficiency and reducing excess .


The treatment in the Erlong Xizhu acupuncture group was the same as that in the conventional group , except acupuncture manipulation at the main acupoints replaced by Erlong Xizhu acupuncture .


In the two groups , treatment was given once a day , @ days as one session and there were @ days at the interval between sessions .


The change of the vision and visual field and the efficacy were observed after @ sessions in the two groups .


The total effective rate on enhancing the vision of patients in the Erlong Xizhu acupuncture group was @ % ( @/@ ) , which was superior to @ % ( @/@ ) in the conventional acupuncture group ( P < @ ) .


And the effective rate on improving the visual field was @ % ( @/@ ) in the Erlong Xizhu acupuncture group , which was better than @ % ( @/@ ) in the conventional acupuncture group ( P < @ ) .


On the comprehensive effect , the effective rate was @ % ( @/@ ) in the Erlong Xizhu acupuncture group , which was better than @ % ( @/@ ) in the conventional acupuncture group ( P < @ ) .


The clinical effect of Erlong Xizhu acupuncture is superior to that of conventional acupuncture for retinitis pigmentosa and it is worthy of promoting .


A significant number of individuals suffer from plantar heel pain ( PHP ) and many go on to have chronic symptoms and continued disability .


Persistence of symptoms adds to the economic burden of PHP and cost-effective solutions are needed .


Currently , there is a wide variation in treatment , cost , and outcomes of care for PHP with limited information on the cost-effectiveness and comparisons of common treatment approaches .


Two practice guidelines and recent evidence of effective physical therapy intervention are available to direct treatment but the timing and influence of physical therapy intervention in the multidisciplinary management of PHP is unclear .


The purpose of this investigation is to compare the outcomes and costs associated with early physical therapy intervention ( ePT ) following initial presentation to podiatry versus usual podiatric care ( uPOD ) in individuals with PHP .


A parallel-group , block-randomized clinical trial will compare ePT and uPOD .


Both groups will be seen initially by a podiatrist before allocation to a group that will receive physical therapy intervention consisting primarily of manual therapy , exercise , and modalities , or podiatric care consisting primarily of a stretching handout , medication , injections , and orthotics .


Treatment in each group will be directed by practice guidelines and a procedural manual , yet the specific intervention for each participant will be selected by the treating provider .


Between-group differences in the Foot and Ankle Ability Measure @ months following the initial visit will be the primary outcome collected by an independent investigator .


In addition , differences in the European Quality of Life -- Five Dimensions , Numeric Pain Rating Scale , Global Rating of Change ( GROC ) , health-related costs , and cost-effectiveness at @ weeks , @ months , and @ year will be compared between groups .


The association between successful outcomes based on GROC score and participant expectations of recovery generally , and specific to physical therapy and podiatry treatment , will also be analyzed .


This study will be the first pragmatic trial to investigate the clinical outcomes and cost-effectiveness of ePT and uPOD in individuals with PHP .


The results will serve to inform clinical practice decisions and management guidelines of multiple disciplines .


To evaluate the efficacy and safety of canagliflozin , a sodium glucose co-transporter @ inhibitor , in Asian patients with type @ diabetes mellitus ( T@DM ) inadequately controlled by metformin or metformin in combination with sulphonylurea .


In this @-week , randomized , double-blind , placebo-controlled phase III study , patients ( N = @ ) received canagliflozin @ or @mg or placebo once daily .


The primary efficacy endpoint was change in glycated haemoglobin ( HbA@c ) level from baseline at week @ .


Additional endpoints included change in fasting plasma glucose ( FPG ) and percent change in body weight .


Adverse events ( AEs ) were recorded throughout the study .


Efficacy and safety were assessed in the overall population and in two strata based on background therapy .


At week @ , canagliflozin @ and @mg provided significant reductions from baseline in HbA@c compared with placebo ( -@ , -@ and -@ % , respectively ; p < @ ) .


Relative to placebo , canagliflozin @ and @mg also significantly reduced FPG ( -@ and -@ mmol/l ) and body weight -LSB- -@ % ( -@ kg ) and -@ % ( -@ kg ) -RSB- .


Both canagliflozin doses lowered systolic blood pressure ( BP ) compared with placebo .


The overall incidence of AEs was @ , @ and @ % with canagliflozin @ and @mg and placebo , respectively .


The incidence of genital mycotic infections and urinary tract infections was low and similar across groups .


Efficacy and safety findings in the two strata were generally consistent with the overall population .


Canagliflozin provided glycaemic improvements and reductions in body weight and systolic BP , and was generally well tolerated in Asian patients with T@DM on metformin or metformin in combination with sulphonylurea .


Fish oil intake reduces serum triglycerides ; however , little is known about the effects of dietary fish intake on lipoprotein subclasses .


We aimed at assessing the effect of fatty and lean fish intake on the lipoprotein subclasses in an intervention study .


The intervention study included @ patients with coronary heart disease , who were aged @ @ ( mean SD ) years .


The subjects were randomly assigned to a fatty fish ( n = @ ) , lean fish ( n = @ ) , or control ( n = @ ) diet for @ weeks .


Fish diets included at least @ fish meals per week .


Subjects in the control group consumed lean beef , pork , and chicken .


Lipoprotein subclasses and their lipid components were determined by nuclear magnetic resonance spectroscopy .


Concentrations of n-@ fatty acids and docosahexaenoic acid increased in the fatty fish group .


The concentrations of cholesterol , cholesterol esters , and total lipids in very large high-density lipoproteins ( HDLs ) increased in the fatty fish group ( overall difference P = @ , P = @ , and P = @ , respectively ; false discovery rate P = @ , P = @ , and P = @ , respectively ) .


The mean size of HDL particles increased in the fatty fish group ( @ @ nm at baseline and @ @ nm at end of study ; overall difference P = @ , false discovery rate P = @ ) .


The fish diets did not affect very-low-density lipoprotein or low-density lipoprotein size .


Fatty fish intake at least @ times per week increases HDL particle size which might have beneficial effect in patients with coronary heart disease .


The purpose of our study is to present a surgical technique of primary porous orbital ball implantation with overlying mucus membrane graft ( MMG ) for reconstruction of severely contracted socket and to evaluate prosthesis retention and motility in comparison to dermis fat graft ( DFG ) .


Prospective comparative study .


A total of @ patients of severe socket contracture ( Grade @-@ Krishna 's classification ) were subdivided into two groups , @ patients in each group .


In Group I , DFG have been used for reconstruction .


In Group II , porous polyethylene implant with MMG has been used as a primary procedure for socket reconstruction .


In Group I DFG was carried out in usual procedure .


In case of Group II , vascularized scar tissues were separated @ and were fashioned into four strips .


A scleral capped porous polyethylene implant was placed in the intraconal space and four strips of scar tissue were secured to the scleral cap and extended part overlapped the implant to make a twofold barrier between the implant and MMG .


Patients were followed-up as per prefixed proforma .


Prosthesis motility and retention between the two groups were measured .


In Group I , four patients had recurrence of contracture with fall out of prosthesis .


In Group II stable reconstruction was achieved in all the patients .


In terms of prosthesis motility , maximum in Group I was @ % and Group II , was @ % .


The difference in prosthesis retention ( P = @ ) and motility ( P = @ ) between the two groups was significant .


Primary socket reconstruction with porous orbital implant and MMG for severe socket contracture is an effective method in terms of prosthesis motility and prosthesis retention .


Female adolescents at high pregnancy risk frequently visit the emergency department ( ED ) and lack primary providers .


It is unclear if current methods of ED referral are successful .


The objective of this pilot study was to assess the potential effect and feasibility of a standardized , enhanced method of referral of sexually active females from an ED for family planning ( FP ) .


We conducted an ED-based intervention study using an enhanced referral process , which included a wallet card advertising a walk-in , adolescent-friendly FP clinic and a standardized ED physician monologue .


ED physicians were instructed to disseminate the enhanced process to sexually active females ages @-@ years ( intervention group ) .


Patients receiving the intervention were prospectively enrolled .


The control group consisted of patients who , on retrospective review , came to the ED during the enrollment period and were eligible but were not enrolled .


We used the electronic medical record ( EMR ) to identify and randomly select missed eligible patients ( control group ) and accumulated one control for each case .


The primary outcome was FP follow-up within @ months , measured by EMR review .


The intervention ( n = @ ) and control groups ( n = @ ) were similar in age , prior ED visits ( @ % versus @ % ) , and previous FP visits ( @ % versus @ % ) .


The absolute difference in follow-up to a FP clinic between the enhanced referral group ( @ % ; @/@ ) compared with the nonenhanced referral group ( @ % ; @/@ ) was only @ % ( @ % confidence interval -@ % to @ % ) .


Feasibility of the intervention was modest , with a best-case scenario of @/@ ( @ % ) of eligible patients captured .


An enhanced referral initiative relying on physician participation did not substantially increase follow-up rates to a FP clinic and showed modest feasibility .


More research is required to identify effective means of ED-based referral for preventive reproductive care .


Commonly used trivalent vaccines contain one influenza B virus lineage and may be ineffective against viruses of the other B lineage .


We evaluated the efficacy of a candidate inactivated quadrivalent influenza vaccine ( QIV ) containing both B lineages .


In this multinational , phase @ , observer-blinded study , we randomly assigned children @ to @ years of age , in a @:@ ratio , to receive the QIV or a hepatitis A vaccine ( control ) .


The primary end point was influenza A or B confirmed by real-time polymerase chain reaction ( rt-PCR ) .


Secondary end points were rt-PCR-confirmed , moderate-to-severe influenza and rt-PCR-positive , culture-confirmed influenza .


The vaccine efficacy and the effect of vaccination on daily activities and utilization of health care resources were assessed in the total vaccinated cohort ( @ children in each group ) and the per-protocol cohort ( @ children in the QIV group and @ in the control group ) .


In the total vaccinated cohort , @ children in the QIV group ( @ % ) and @ in the control group ( @ % ) had rt-PCR-confirmed influenza , representing a QIV efficacy of @ % ( @ % confidence interval -LSB- CI -RSB- , @ to @ ) , with efficacy against culture-confirmed influenza of @ % ( @ % CI , @ to @ ) .


For moderate-to-severe rt-PCR-confirmed influenza , the attack rate was @ % ( @ cases ) in the QIV group and @ % ( @ cases ) in the control group , representing a QIV efficacy of @ % ( @ % CI , @ to @ ) .


In the per-protocol cohort , the QIV efficacy was @ % ( @ % CI , @ to @ ) , and the efficacy against culture-confirmed influenza @ % ( @ % CI , @ to @ ) ; the efficacy among children with moderate-to-severe influenza was @ % ( @ % CI , @ to @ ) .


The QIV was associated with reduced risks of a body temperature above @C and lower respiratory tract illness , as compared with the control vaccine , in the per-protocol cohort ( relative risk , @ -LSB- @ % CI , @ to @ -RSB- and @ -LSB- @ % CI , @ to @ -RSB- , respectively ) .


The QIV was immunogenic against all four strains .


Serious adverse events occurred in @ children in the QIV group ( @ % ) and in @ children in the control group ( @ % ) .


The QIV was efficacious in preventing influenza in children .


( Funded by GlaxoSmithKline Biologicals ; ClinicalTrials.gov number , NCT@ . )


To compare the analgesic effects of buprenorphine and butorphanol in domestic cats .


@-phase positive-controlled randomized masked clinical trial .


@ healthy female cats ( @ in phase @ and @ in phase @ ) .


Cats admitted for ovariohysterectomy received buprenorphine ( @ in phase @ ; @ in phase @ ) or butorphanol ( @ in phase @ ; @ in phase @ ) .


In phase @ , cats were premedicated with buprenorphine ( @ mg/kg -LSB- @ mg/lb -RSB- , IM ) or butorphanol ( @ mg/kg -LSB- @ mg/lb -RSB- , IM ) , in combination with medetomidine .


Anesthesia was induced with propofol ( IV ) and maintained with isoflurane in oxygen .


After extubation , medetomidine was antagonized with atipamezole .


A validated multidimensional composite scale was used to assess signs of pain after surgery starting @ minutes after extubation and continuing for up to @ minutes , and pain score comparisons were made between the @ groups .


Phase @ proceeded similar to phase @ with the following addition : during wound closure , cats from the butorphanol and buprenorphine groups received butorphanol ( @ mg/kg , IM ) or buprenorphine ( @ mg/kg , IM ) , respectively .


Phase @ of the study was stopped after @ cats were ovariohysterectomized because @ of @ cats required rescue analgesia at the first evaluation .


In phase @ , at the first pain evaluation , pain scores from the buprenorphine group were lower , and all cats from the butorphanol group required rescue analgesia .


None of the cats from the buprenorphine group required rescue analgesia at any time .


Buprenorphine ( @ mg/kg , IM ) given before surgery and during wound closure provided adequate analgesia for @ hours following ovariohysterectomy in cats , whereas butorphanol did not .


Family-centered rounds ( FCR ) are becoming the status quo for inpatient pediatric medical care ; however , barriers still exist .


The use of facilitators in FCR is gaining popularity .


Although facilitators can increase comfort with FCR , the choice of preferred facilitator has not been studied by using rigorous methodology .


In this study , we performed a randomized trial of facilitated FCR with bunnies and clowns , @ commonly mentioned facilitators , and compared their results with the usual care condition .


The @ floor teams were randomized to have rounds facilitated with bunnies and clowns or the usual care model facilitated by distracted residents and overbearing attending physicians .


Infection control procedures were instituted .


Outcome measures were parent satisfaction scores , use of anxiolytic agents during examinations as part of FCR , resident satisfaction , and the number of times presenters were interrupted by their attending .


Differences between the experimental and control groups were analyzed by using ttests , chi@ statistics , and multiple regression analysis .


Qualitative analyses were also performed by using participant-observers .


Bunnies had the best overall improvement in parent satisfaction , anxiety , and resident satisfaction .


Both intervention groups were successful at reducing attending interruptions .


The clown arm was suspended by the Data Safety Monitoring Board before study completion due to adverse events .


Facilitated FCR has the potential to improve satisfaction among parents , patients , and residents , and to decrease attending interruptions .


Care needs to be taken , however , to avoid unanticipated adverse effects from potentially emotionally damaging interventions .


Tularemia was not identified in any of our treatment conditions .


This study assessed oral health status for preschool-aged children in the Navajo Nation to obtain data on baseline decayed , missing , and filled tooth surfaces ( dmfs ) and dental caries patterns , describe sociodemographic correlates of children 's baseline dmfs measures , and compare the children 's dmfs measures with previous dental survey data for the Navajo Nation from the Indian Health Service and the National Health and Nutrition Examination Survey ( NHANES ) .


The analyzed study sample included @ child/caregiver dyads residing in the Navajo Nation who completed baseline dmfs assessments for an ongoing randomized clinical trial involving Navajo Nation Head Start Centers .


Calibrated dental hygienists collected baseline dmfs data from child participants ages @-@ years ( @ males and @ females ) , and caregivers completed a basic research factors questionnaire .


Mean dmfs for the study population was @ ( SD = @ ) and not appreciably different from the @ Indian Health Service survey of Navajo Nation preschool-aged children ( mean = @ , SD = @ , P = @ ) .


However , only @ percent of children in the current study had untreated decay compared with @ percent in the @ Indian Health Service survey ( P < @ ) .


Study results were considerably higher than the @ percent reported for @-@-year-old children in the whites-only group from the @-@ NHANES data .


Age had the strongest association with dmfs , followed by child gender , then caregiver income and education .


Dental caries in preschool-aged Navajo children is extremely high compared with other US population segments , and dmfs has not appreciably changed for more than a decade .


To compare the post cataract surgery anti-inflammatory effect of bromfenac monotherapy and of bromfenac and betamethasone combination therapy in diabetes mellitus patients .


A prospective study approved by the Institutional Review Board .


Fifty-one eyes of @ patients were randomly allocated to either bromfenac @ % monotherapy ( n = @ ) or combined therapy with bromfenac @ % and betamethasone @ % ( n = @ ) .


After surgery , monotherapy group was administered bromfenac alone for @ weeks , while the combined therapy group was administered both bromfenac and betamethasone for @ weeks , bromfenac alone for the next @ weeks .


The amount of change from preoperative values in anterior chamber flare and foveal thickness were compared between the @ groups .


There was no significant difference in change in anterior chamber flare between the @ groups .


The increase in foveal thickness @ weeks postoperatively was significantly larger in the bromfenac group ( p = @ ) .


Four patients of the bromfenac group , all with a history of diabetic macular edema , developed macular edema after surgery .


Bromfenac and betamethasone combination exhibited a stronger anti-inflammatory effect after cataract surgery patients with diabetes mellitus .


In particular , patients with a history of diabetic macular edema were susceptible to foveal thickening and macular edema , and a combined treatment is desirable .


The role of implantable loop recorders ( ILRs ) in the evaluation strategy for recurrent syncope in France is limited by lack of knowledge of the cost .


To compare a conventional evaluation strategy for syncope with the early use of an ILR in low-risk patients , in terms of diagnostic yield , cost and impact on quality of life ( QoL ) .


National prospective randomized open-label multicenter study of patients with a single syncope ( if severe and recent ) or at least two syncopes in the past year .


Seventy-eight patients ( @ men ) were randomized to the ILR strategy ( ILR group , n = @ ) or the conventional evaluation strategy ( CONV group , n = @ ) : mean age @ years ; @ previous syncopes .


After @ months of follow-up , a certain cause of syncope was established in @ ( @ % ) patients in the ILR group and two ( @ % ) patients in the CONV group ( P < @ ) .


Advanced cardiological tests were performed less frequently in the ILR group than in the CONV group ( @ vs. @ tests per patient ; P = @ ) .


Patients in the ILR group were hospitalized for a non-significantly shorter period than patients in the CONV group ( @ vs. @ days ) .


There was no difference between the two groups in terms of QoL main composite score .


In patients with unexplained syncope , the early use of an ILR has a superior diagnostic yield compared with the conventional evaluation strategy , with lower healthcare-related costs .


More severe influenza disease and poor vaccine immunogenicity is reported in HIV-infected patients .


We measured antibody avidity after influenza vaccination in HIV patients to assess vaccine efficacy .


Two dosing strategies ( Group@ : single dose , n = @ .


Group@ : single dose plus booster , n = @ ) with an AS@A-adjuvanted H@N@ pandemic influenza vaccine ( Arepanrix , GSK ) were assessed in HIV patients .


Serum hemagglutination inhibition ( HAI ) titers and antibody avidity reported as an avidity index ( AI ) were measured at days @ and @ and at @months .


Baseline HIV parameters were similar among all participants .


Eighteen participants had measurable baseline HAI titers .


In these subjects , AI was at ~ @ at baseline and was not significantly increased by one or two vaccine doses .


In those without detectable baseline antibodies , immunization induced modest antibody titers -LSB- Group@ HAI , @ ( @-@ ) ; Group@ HAI , @ ( @-@ ) -RSB- with high AI after one dose at day @ -LSB- Group@ AI , @ ( @-@ @ ) ; Group@ AI , @ ( @-@ @ ) -RSB- .


A second dose of vaccine generated significantly higher HAI titers at day @ -LSB- Group@ HAI , @ ( @-@ ) ; Group@ HAI , @ ( @-@ ) -RSB- and persisted to @months -LSB- Group@ HAI , @ ( @-@ ) ; Group@ HAI , @ ( @-@ ) -RSB- .


All subjects who produced detectable HAI titers after vaccination generated high antibody avidity ( AI , @-@ ) , which persisted up to @months .


In participants initially seronegative , two doses of vaccine enabled a greater percentage of subjects to respond to the vaccine and elicited higher HAI titers .


All subjects who produced detectable HAI titers also rapidly generated high AI in the short and long term .


We demonstrate that high avidity antibodies can be achieved after vaccination and support a two-dose immunization strategy for HIV-positive subjects .


The present paper aims to investigate the effect of psoriatic arthritis ( PsA ) disease duration on the outcome of treatment with etanercept ( ETN ) in patients with PsA who also have moderate-to-severe psoriasis .


Patients from the PRESTA trial who received @ ETN @ mg once weekly ( QW ) dose and had @ post-baseline value were evaluated .


Baseline and after-treatment changes were compared between patients with PsA @ years versus PsA > @ years in efficacy measures ( physician global assessment -LSB- PGA -RSB- arthritis , swollen joint count and Psoriasis Area and Severity Index -LSB- PASI -RSB- ) and patient reported outcomes ( PROs ; joint pain , arthritis activity , Euro-Qol -LSB- EQ-@D -RSB- utility and visual analogue score -LSB- VAS -RSB- ) using linear regression analysis .


Baseline efficacy measures were similar between the PsA @ years ( n = @ ) and PsA > @ years ( n = @ ) groups , with the exception of PGA arthritis ( p = @ ) .


At week @ , improvements in efficacy measures were observed in both groups but were significantly greater for PGA arthritis in the PsA @ years group ( p = @ ) .


Quality of life ( QoL ) , measured using PROs , was generally lower at baseline in patients with PsA > @ years .


Clinically meaningful improvements were seen in QoL with ETN treatment in both groups , but the change from baseline scores at week @ were significantly higher in PsA @ years group for joint pain ( p = @ ) , arthritis activity ( p = @ ) , EQ-@D utility ( p = @ ) and EQ-@D VAS ( p = @ ) responses .


PsA patients responded to ETN @ mg QW treatment irrespective of disease duration ; however , patients with shorter PsA duration had greater improvements in arthritis scores and several PRO measures .


To compare anaesthetic induction in healthy dogs using propofol or ketofol ( a propofol-ketamine mixture ) .


Prospective , randomized , controlled , ` blinded ' study .


Seventy healthy dogs ( @ males and @ females ) , aged @-@ months and weighing @-@ kg .


Following premedication , either propofol ( @ mg mL ( -@ ) ) or ketofol ( @ mg propofol and @ mg ketamine mL ( -@ ) ) was titrated intravenously until laryngoscopy and tracheal intubation were possible .


Pulse rate ( PR ) , respiratory rate ( f ( R ) ) and arterial blood pressure ( ABP ) were compared to post-premedication values and time to first breath ( TTFB ) recorded .


Sedation quality , tracheal intubation and anaesthetic induction were scored by an observer who was unaware of treatment group .


Mann-Whitney or t-tests were performed and significance set at p @ .


Induction mixture volume ( mean SD ) was lower for ketofol ( @ @ mL kg ( -@ ) ) than propofol ( @ @ mL kg ( -@ ) ) ( p < @ ) .


PR increased following ketofol ( by @ @ beats minute ( -@ ) ) but not consistently following propofol ( @ @ beats minute ( -@ ) ) ( p < @ ) .


Ketofol administration was associated with a higher mean arterial blood pressure ( MAP ) ( @ @ mmHg ) than propofol ( @ @ ) ( p = @ ) .


TTFB was similar , but ketofol use resulted in a greater decrease in f ( R ) ( median ( range ) : ketofol -@ ( -@ to @ ) propofol -@ ( -@ to @ ) breaths minute ( -@ ) ) ( p < @ ) .


Sedation was similar between groups .


Tracheal intubation and induction qualities were better with ketofol than propofol ( p = @ and @ respectively ) .


Induction of anaesthesia with ketofol resulted in higher PR and MAP than when propofol was used , but lower f ( R ) .


Quality of induction and tracheal intubation were consistently good with ketofol , but more variable when using propofol .


Unfractionated ( UF ) heparin is the most common anticoagulant used during hemodialysis .


Failure of the kidneys to excrete potassium as well as heparin-induced reduction of aldosterone synthesis put hemodialysis patients at risk of hyperkalemia .


It has not yet been clearly known whether hyperkalemia is also induced by low-molecular-weight ( LMW ) heparins .


This study aimed to evaluate the effect of switching UF heparin to LMW heparin enoxaparin , as an anticoagulant during hemodialysis , on serum potassium level in patients on hemodialysis .


In two hemodialysis units , @ patients were randomly assigned into two groups , to receive two different anticoagulation protocols for @ weeks ; one group continued to receive their routine dose of UF heparin , @ units , and the other received enoxaparin , @ mg/kg , at the beginning of each hemodialysis session .


While there was no significant difference between baseline blood measurements of the two groups in terms of kidney function tests and electrolytes , following @ weeks of the study , the mean serum potassium level decreased from @ @ mEq/L to @ @ mEq/L in the LMW heparin group ( P = @ ) ; however , there was no change in the mean serum potassium level in those who continued to receive their usual dose of UF heparin .


In a subgroup analysis , diabetic patients in the enoxaparin group did not experience significant reduction in serum potassium levels .


Our study revealed the role of LMW heparins as a potential alternative to UF heparins in the hemodialysis patients with hyperkalemia .


Antidepressants are often the first-line treatment for depression in primary care .


However , not all patients respond to medication after an adequate dose and duration of treatment .


Currently , there are no estimates of the prevalence of treatment-resistant depression ( TRD ) from UK primary care .


To estimate the prevalence of TRD in UK primary care .


Design and setting Data were collected as part of a multicentre randomised controlled trial , from @ general practices in UK primary care .


Potential participants ( aged @-@ years who had received repeated prescriptions for antidepressants ) were identified from general practice records .


Those who agreed to be contacted were mailed a questionnaire that included questions on depressive symptoms ( Beck Depression Inventory -LSB- BDI-II -RSB- ) , and adherence to antidepressants .


Those who scored @ on the BDI-II and had taken antidepressants for at least @ weeks at an adequate dose were defined as treatment resistant .


A total of @ patients completed the questionnaire ( @ % of those who agreed to be contacted ) , of whom @ had been prescribed an adequate dose of antidepressants for at least @ weeks .


Seventy-seven per cent ( @ % CI = @ % to @ % ) had a BDI score of @ .


Fifty-five per cent ( @ % CI = @ % to @ % ) ( n = @ ) met the study 's definition of TRD , of whom @ % had taken their antidepressants for more than @ months .


The high prevalence of TRD is an important challenge facing clinicians in UK primary care .


A more proactive approach to managing this patient population is required to improve outcome .


Cognitive enhancement resulting from nicotinic acetylcholine receptor stimulation may be evidenced by increased efficiency of the auditory-frontal cortex network of auditory discrimination , which is impaired in schizophrenia , a cognitive disorder associated with excessive tobacco use .


Investigating automatic ( preattentive ) detection of acoustic change with the mismatch negativity ( MMN ) brain event-related potential in response to nicotine in individuals with varying baseline levels of auditory discrimination may provide useful insight into the cholinergic regulation of this neural network and its potential amelioration with novel nicotinic agents .


Sixty healthy , non-smoking male volunteers were presented with an ` optimal ' multi-feature MMN paradigm in a randomized , placebo controlled double-blind design with @mg of nicotine gum .


Participants with low , medium , and high baseline amplitudes responded differently to nicotine ( vs. placebo ) , and nicotine response was feature specific .


Whereas MMN in individuals with high amplitudes was diminished by nicotine , MMN increased in those with low amplitudes .


Nicotine effects were not shown in medium amplitude participants .


These findings provide preliminary support for the role of nicotinic neurotransmission in sensory memory processing of auditory change and suggest that nicotinic receptor modulation can both enhance and diminish change detection , depending on baseline MMN and its eliciting stimulus feature .


Community-acquired pneumonia ( CAP ) is considered the leading cause of death from infectious disease in developed countries , while complications of CAP - sepsis being the most common and challenging - increase the risk of mortality .


During the progression of sepsis , a state of neutrophil ` paralysis ' develops resulting in the impairment of neutrophil anti-microbial functions including : chemotaxis , production of reactive oxygen species , and formation of neutrophil extracellular traps ( NETs ) .


Mechanisms underlying defective neutrophil function remain elusive although NET formation has been implicated in the immunosuppression and increased rates of sepsis observed in neonates .


There is , however , increasing evidence that statins are able to modulate neutrophil function in sepsis as several systematic reviews have concluded that statins have a role in improving infection-related outcomes and mortality while , in vitro , statins have also been shown to boost NET formation in healthy individuals .


The ` SNOOPI ' trial is a phase @ , randomised placebo-controlled trial .


The aim of this study is to determine whether oral treatment with simvastatin compared to placebo optimises neutrophil anti-microbial functions in elderly patients with septic pneumonia improving patient outcomes in the elderly .


The primary outcome will be NET production within @ to @ hours of treatment with simvastatin or placebo measured in response to a number of inflammatory mediators , including IL@ , f-Met-Leu-Phe and lipopolysaccharide .


Secondary outcomes include neutrophil migratory capacity ; reactive oxygen species production ; neutrophil phagocytic capacity ; safety and tolerability of simvastatin administration within this patient group ; biological markers of neutrophil activation , the inflammatory response , alveolar epithelial and endothelial injury ; systemic endothelial function biomarkers and pulmonary extracellular matrix degradation .


This study aims to recruit @ patients admitted into Queen Elizabeth Hospital Birmingham NHS-Foundation Trust .


This study will investigate the ability of in vivo simvastatin therapy to modulate neutrophil anti-microbial functions in CAP-associated sepsis .


The identification of patients at risk for developing left ventricular ( LV ) remodeling after acute myocardial infarction ( AMI ) has crucial prognostic implications .


The aims of this study were ( @ ) to investigate the relationship between peak subepicardial and subendocardial twist and infarct transmurality , as assessed using contrast-enhanced magnetic resonance imaging , and ( @ ) to evaluate the association between peak subepicardial and subendocardial twist and LV remodeling @ months after AMI .


A total of @ patients with ST-segment elevation AMIs who underwent three-dimensional echocardiography for LV volumes and functional assessment and two-dimensional speckle-tracking analysis for the evaluation of LV twist ( subendocardial vs subepicardial ) were retrospectively included .


A subgroup of @ patients underwent magnetic resonance imaging within @ months for infarct size quantification .


Peak subepicardial twist was strongly related to infarct size ( number of segments with transmural scar : r ( @ ) = @ , P < @ ; total scar score : r ( @ ) = @ , P < @ ) compared with peak subendocardial twist ( number of segments with transmural scar : r ( @ ) = @ , P < @ ; total scar score : r ( @ ) = @ , P < @ ) .


In the overall population , @ patients ( @ % ) developed significant LV remodeling at @-month follow-up ( LV end-systolic volume increase @ % ) .


These patients showed significantly more impaired peak subepicardial and subendocardial twist at baseline compared with patients without LV remodeling ( @ @ vs @ @ , P < @ ; @ @ vs @ @ , P < @ , respectively ) .


Importantly , peak subepicardial twist ( odds ratio , @ ; @ % confidence interval , @-@ @ ; P < @ ) and peak troponin T ( odds ratio , @ ; @ % confidence interval , @-@ @ ; P = @ ) were independently associated with the development of LV remodeling .


Peak subepicardial twist strongly reflects infarct transmurality as assessed with magnetic resonance imaging and is independently associated with LV remodeling after AMI .


To compare the clinical outcome of single implants which underwent immediate nonocclusal loading with implants subjected to early non-occlusal loading at @ weeks , and implants conventionally loaded at @ months .


One hundred and five patients in five private practices requiring a single implant-supported crown were randomised to immediate loading ( @ patients ) , early loading ( @ patients ) and conventional loading ( @ patients ) groups .


To be immediately or early loaded , implants had to be inserted with a torque superior to @ Ncm .


Immediately and early loaded implants received non-occluding temporary crows , whereas conventionally loaded implants were directly restored with definitive crowns .


Temporary crowns were replaced by definitive ones after @ months .


Outcome measures were crown and implant failures , complications and peri-implant marginal bone level changes recorded by a blinded assessor .


Two patients dropped out from the immediate loading group up to @-year post-loading .


Two implants failed , one in the immediately loaded and one in the early loaded group ( P = @ ) .


One immediately loaded implant and two early loaded implants were affected by one complication each ( P = @ ) .


Mean peri-implant marginal bone loss after @ year was -@ mm ( @ % CI -@ , @ ) for immediate , -@ mm ( @ % CI -@ , @ ) for early and -@ mm ( @ % CI -@ ; @ ) for conventionally loaded implants .


There were no statistically significant differences for any of the outcome measures between the three loading strategies up to @-year post-loading .


No major clinical differences were observed with regard to implant survival , complications and marginal bone level changes when loading single implants immediately , early or conventionally .


Assess the effects of a home exercise programme , based on aerobic training and muscle strength training , in patients with cystic fibrosis ( CF ) , for a period of @ months .


Randomised controlled clinical experiment , with an analysis of intention to treat including clinically stable patients with CF and of age @ .


Assessments include : a @ min walk test ( @ MWT ) , one-repetition maximum strength test ( @ RM ) , spirometry and quality of life questionnaires .


The patients randomised for the exercise group exercise group followed a home exercise protocol , supervised by telephone , while the control group maintained their usual activities .


@ Patients were included , @ in the control group and @ in the exercise group .


The exercise group presented a significant increase in muscle strength in upper limbs ( UULL ) on the @ RM test .


There was no significant difference between groups on the scores for general quality of life and specifically for CF and in the distance walked on the @ MWT .


The study demonstrated that a home exercise programme had positive effects in adult patients with CF , including gain in muscle strength in UULL .


No increase in tolerance to exercise was shown and improvement in the quality of life of the patients who received intervention .


Posttraumatic stress disorder ( PTSD ) is a chronic disabling illness , resulting from exposure to extreme traumatic event .


Although different pharmacologic agents are suggested for treatment of PTSD , none have been completely effective in eliminating symptoms .


The purpose of this study was to assess the use of baclofen as an add-on to citalopram in treatment of PTSD .


In this double-blind clinical trial , @ Iranian combat veterans with PTSD were randomly assigned to @ groups .


The first group received a combination treatment of @ to @ mg/d citalopram and @ mg/d baclofen , and the second group received @ to @ mg/d citalopram plus placebo .


Symptom severity was assessed by Clinician-Administered PTSD Scale at the beginning of the study and after @ , @ , @ , and @ weeks .


Global Assessment of Functioning and Hamilton Rating Scale for Anxiety and Depression were also used at the same periods .


Data were analyzed with independent t test and paired t test using SPSS software version @ ( IBM , Armonk , NY ) .


Twenty-three male patients ( baclofen group , @ patients ; placebo group , @ patients ) completed the study .


Dropout from the treatment was not caused by adverse effects of the new medications in any of the subjects .


Baclofen group showed significantly larger improvement in Clinician-Administered PTSD Scale total ( P = @ ) , hyperarousal ( P = @ ) , and avoidance ( @ ) scores , Global Assessment of Functioning score ( @ ) , depression ( P = @ ) , and anxiety ( P = @ ) after @ weeks of treatment .


No intergroup difference was found in improvement of reexperience symptoms ( P = @ ) .


Baclofen showed to be an effective add-on to selective serotonin reuptake inhibitors in treatment of PTSD for better symptom recovery and functional improvement .


We previously described the prognostic impact of tumor regression grading ( TRG ) on the outcome of patients with rectal carcinoma treated with preoperative chemoradiotherapy ( CRT ) in the CAO/ARO/AIO -@ trial .


Here we report long-term results after a median follow-up of @ months .


TRG after preoperative CRT was determined in @ surgical specimens by the amount of viable tumor cells versus fibrosis , ranging from TRG @ ( no viable tumor cells ) to TRG @ ( no signs of regression ) .


Clinicopathologic parameters and TRG were correlated to the cumulative incidence of local recurrence , distant metastasis , and disease-free survival ( DFS ) .