No worrisome safety signals were encountered .


The aim of this study was to evaluate the effects of umbilical cord milking ( UCM ) on the need for packed red blood cell ( PRBC ) transfusion and hematologic and hemodynamic parameters in very-low-birth-weight infants .


The infants were randomized into @ groups : group @ ( UCM ) and group @ ( control ) .


The primary outcome was the number of PRBC transfusions during the first @ days of life .


The secondary outcome measures were the hemodynamic variables during the first @ hours of life .


A total of @ infants were included with @ infants in each group .


Two of @ infants in group @ and @ of @ infants in group @ received transfusion in the first @ days of life ( P = @ ) .


The number and volume of PRBC transfusions were similar in both groups .


However , the levels of hemoglobin ( Hb ) at the first and @th hour of life were significantly higher in group @ .


Phlebotomy volume was found as a statistically significant risk factor for the need for PRBC transfusion ( P = @ ) .


UCM in delivery room results in a higher Hb level in the first day of life .


In these groups of infants , phlebotomy losses may impact the transfusion need .


Previous studies comparing endoscopic ultrasound-guided fine-needle aspiration ( EUS-FNA ) results with different gauge needles have all been carried out with the stylet in place and show no clear advantage to the larger @-G needle .


Similar data for stylet-free EUS-FNA ( SF-EUS-FNA ) are unavailable .


The aim of the present study was to determine whether diagnostic yield and specimen adequacy is superior with the @-G needle as compared to the @-G needle .


All patients @ years referred for solid-lesion EUS-FNA were eligible .


Patients with suspected diagnosis of lymphoma , gastrointestinal stromal tumor , sarcoidosis , significant coagulopathy ( international normalized ratio > @ or platelets < @/mm ( @ ) ) , use of clopidogrel within @ days of EUS , and pregnancy were excluded .


The two needles were compared regarding diagnostic yield , sample adequacy , bloodiness , ease of puncture , visibility , number of passes , failures , and complications .


One hundred and twenty consecutive patients were included and @ lesions were sampled .


Sensitivity , specificity , positive predictive value and negative predictive value for the @-G SF-EUS-FNA were @ % , @ % , @ % and @ % , respectively , and for the @-G SF-EUS-FNA were @ % , @ % , @ % and @ % , respectively ( P = NS ) .


There were no significant differences between the @-G and the @-G FNA needles in sample adequacy , bloodiness , ease of puncture , FNA failure , visibility , number of passes and complications ; and no significant differences between either needle were found in relation to lesion site .


For SF-EUS-FNA , the larger @-G needle offers no advantage over the smaller @-G needle .


This study was designed with the aim of defining a new surgical procedure for varicose veins and for comparison with classic crossectomy in terms of reducing the recurrence rate of varicose veins .


Double-blind randomized clinical trial .


For easy access , we selected @ patients who came to the Phlebology Consultation Unit meeting inclusion criteria .


With their informed consent , they were included in a study group using random table numbers .


Group @ : ( CS ) Classic saphenectomy , @ patients .


Group @ : ( HCWVS ) High crossectomy without vascular sectioning .


Both groups were monitorised at @ and @ months by Eco-Doppler study .


The incidence of varicose vein recurrence at @ month follow-up was @ % in the group of patients undergoing CS , while in the group receiving HCWVS it was @ % ( p < @ ) .


These differences , though minor , remained statistically significant at @ months of evolution ( @ % vs. @ % , p = @ ) .


The most common recurrence type was type I , with statistically significant differences at @ and @ months .


We believe that saphenectomy with crossectomy without vascular sectioning is the appropriate procedure to treat varicose veins , reducing type @ or reticular relapse rate and maintaining the principles of classic surgery to reduce type @ or truncular recurrence rate .


This technique should be implemented with procedures based on saphenous sclerosis with foam art the saphenous femoral junction , in order to assess the recurrence rate of type @ or truncular varicose veins .


A group-based eating disorder prevention program wherein young women explore the costs of pursuing the thin ideal reduces eating disorder risk factors and symptoms .


However , it can be challenging to identify school clinicians to effectively deliver the intervention .


The present study compares the effects of a new Internet-based version of this prevention program , which could facilitate dissemination , to the group-based program and to educational video and educational brochure control conditions at @ - and @-year follow-up .


Female college students with body dissatisfaction ( n = @ ; M age = @ , SD = @ ) were randomized to these @ conditions .


Internet participants showed reductions in eating disorder risk factors and symptoms relative to the @ control conditions at @ - and @-year follow-up ( M - d = @ and @ , respectively ) , but the effects were smaller than parallel comparisons for the group participants ( M - d = @ and @ , respectively ) .


Yet the Internet intervention produced large weight gain prevention effects relative to the @ control conditions at @ - and @-year follow-up ( M - d = @ and @ , respectively ) , which were larger than the parallel effects for the group intervention ( M - d = @ and @ , respectively ) .


Although the effects for the Internet versus group intervention were similar at posttest , results suggest that the effects faded more quickly for the Internet intervention .


However , the Internet intervention produced large weight gain prevention effects , implying that it might be useful for simultaneously preventing eating disordered behavior and unhealthy weight gain .


Financial incentives and peer networks could be delivered through eHealth technologies to encourage older adults to walk more .


We conducted a @-week randomized trial in which @ older adults with a computer and Internet access received a pedometer , daily walking goals , and weekly feedback on goal achievement .


Participants were randomized to weekly feedback only ( Comparison ) , entry into a lottery with potential to earn up to $ @ each week walking goals were met ( Financial Incentive ) , linkage to four other participants through an online message board ( Peer Network ) , or both interventions ( Combined ) .


Main outcomes were the proportion of days walking goals were met during the @-week intervention and @-week follow-up .


We conducted a content analysis of messages posted by Peer Network and Combined arm participants .


During the @-week intervention , there were no differences in the proportion of days walking goals were met in the Financial Incentive ( @ % ; p = @ ) , Peer Network ( @ % ; p = @ ) , and Combined ( @ % ; p = @ ) arms compared with the Comparison arm ( @ % ) .


During @ weeks of follow-up , the proportion of days walking goals were met was lower in the Peer Network arm ( @ % ; p = @ ) but not in the Financial Incentive ( @ % ; p = @ ) or Combined ( @ % ; p = @ ) arms , relative to the Comparison arm ( @ % ) .


Messages posted by participants focused on barriers to walking and provision of social support .


Financial incentives and peer networks delivered through eHealth technologies did not result in older adults walking more .


Children can find anaesthesia induction especially distressing and postoperative psychological and physical morbidity are common .


Preparation programmes for general anaesthesia ( GA ) are highly effective in reducing this distress .


A Phase II study has already verified the effectiveness of a prototype preoperative GA-coping computer game to help children cope with induction in a dental GA setting .


The biggest patient users of pediatric GA services in the UK are children who need to have teeth removed ( estimated to be @,@ yearly ) .


Tooth decay is the most common disease in children worldwide .


This study is a Phase III randomized controlled trial ( RCT ) and will evaluate the effectiveness of the new internet version of this game .


The Phase III RCT will use a double-blind three-armed design .


The clinical trial will recruit up to @ children and will compare the web-based game against standard care and another non-medical game .


At least @ patients in each group will be required for @ % statistical power .


Distress will be assessed through an evaluation of the child 's behaviour during the visit and later parental reports of physical and psychological morbidity .


The satisfaction of parents and children will be measured ; the mode of usage of the web-based game will be automatically recorded and the impact on the service ( for example , recovery time and throughput ) will be reported.The Phase III study primary outcome will measure : ( @ ) patient experience : acceptance of anaesthetic induction , child cooperation and distress , reduction of peri - and postoperative morbidity , child and family satisfaction , and ( @ ) service improvement : anaesthetic time and improvement in throughput .


Measures will be administered at baseline , at the time of the GA treatment visit , and at @hours and one week postoperatively .


This study aims to determine the effectiveness of an online GA-coping game for children and families undergoing tooth extraction under GA. .


Patients with advanced-stage , low-tumour-burden follicular lymphoma have conventionally undergone watchful waiting until disease progression .


We assessed whether rituximab use could delay the need for chemotherapy or radiotherapy compared with watchful waiting and the effect of this strategy on quality of life ( QoL ) .


Asymptomatic patients ( aged @ years ) with low-tumour-burden follicular lymphoma ( grades @ , @ , and @a ) were randomly assigned centrally ( @:@:@ ) , by the minimisation approach stratified by institution , grade , stage , and age , to watchful waiting , rituximab @ mg/m ( @ ) weekly for @ weeks ( rituximab induction ) , or rituximab induction followed by a maintenance schedule of @ further infusions given at @-monthly intervals for @ years ( maintenance rituximab ) .


On Sept @ , @ , recruitment into the rituximab induction group was closed and the study was amended to a two-arm study .


The primary endpoints were time to start of new treatment and QoL at month @ ( ie , @ months after completion of rituximab induction ) .


All randomly assigned patients were included in the analysis of time to start of new treatment on an intention-to-treat basis .


The main study is now completed and is in long-term follow-up .


The study is registered with ClinicalTrials.gov , NCT@ .


Between Oct @ , @ , and March @ , @ , @ patients from @ centres in the UK , Australia , New Zealand , Turkey , and Poland were randomly assigned to watchful waiting or maintenance rituximab .


@ patients were recruited to the rituximab induction group before it was closed early .


There was a significant difference in the time to start of new treatment , with @ % ( @ % CI @-@ ) of patients in the watchful waiting group not needing treatment at @ years compared with @ % ( @-@ ) in the maintenance rituximab group ( hazard ratio -LSB- HR -RSB- @ , @ % CI @-@ ; p < @ ) .


@ % ( @ % CI @-@ ) of patients in the rituximab induction group did not need treatment at @ years , which was significantly more than in the watchful waiting group ( HR @ , @ % CI @-@ ; p < @ ) , but no different compared with the maintenance rituximab group ( @ , @-@ ; p = @ ) .


Compared with the watchful waiting group , patients in the maintenance rituximab group had significant improvements in the Mental Adjustment to Cancer scale score ( p = @ ) , and Illness Coping Style score ( p = @ ) between baseline and month @ .


Patients in the rituximab induction group did not show improvements in their QoL compared with the watchful waiting group .


There were @ serious adverse events reported in the rituximab groups ( four in the rituximab induction group and @ in the maintenance rituximab group ) , @ of which were grade @ or @ ( five infections , three allergic reactions , and four cases of neutropenia ) , all of which fully resolved .


Rituximab monotherapy should be considered as a treatment option for patients with asymptomatic , advanced-stage , low-tumour-burden follicular lymphoma .


Narrow-band imaging ( NBI ) endoscopy improves the detection of intestinal metaplasia .


However , strategies to improve the visibility and diagnostic performance of NBI should be sought , as endoscopic views are often obscured by the presence of mucus .


To compare the visibility and diagnostic performance of NBI endoscopy according to pronase premedication in patients with precancerous conditions of the stomach .


Consecutive outpatients with a previous diagnosis of precancerous condition of the stomach were invited to undergo a surveillance NBI endoscopy between June and December @ .


Enrolled subjects were randomly assigned to pronase or control groups before NBI endoscopy .


The visibility score and diagnostic performance of NBI endoscopy were compared between the two groups .


Patients ' endoscopic and histopathological characteristics were similar between the two groups .


Visibility score in the proximal part of the stomach and satisfaction score of the endoscopist were significantly higher in the pronase group than in the control group ( p = @ and p = @ , respectively ) .


The diagnostic performance of NBI endoscopy to detect intestinal metaplasia was not different in either group ( both p > @ ) .


However , the negative predictive value of NBI endoscopy was much improved over that of white light endoscopy only in the pronase group ( p = @ ) .


Pronase premedication increased the visibility of the proximal part of the stomach and the satisfaction score during NBI endoscopy .


Furthermore , negative predictive value of NBI endoscopy was much improved compared with that of white light endoscopy after pronase premedication .


The incidence , predictors , and prognostic impact of post-discharge bleeding ( PDB ) after percutaneous coronary intervention ( PCI ) with drug-eluting stent ( DES ) implantation are unclear .


This study sought to characterize the determinants and consequences of PDB after PCI .


The prospective ADAPT-DES ( Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents ) study was used to determine the incidence and predictors of clinically relevant bleeding events occurring within @ years after hospital discharge .


The effect of PDB on subsequent @-year all-cause mortality was estimated by time-adjusted Cox proportional hazards regression .


Among @,@ `` all-comers '' who underwent successful PCI with DES in the ADAPT-DES study , PDB occurred in @ of @,@ hospital survivors ( @ % ) at a median time of @ days ( interquartile range : @ to @ days ) post-discharge .


Gastrointestinal bleeding ( @ % ) was the most frequent source of PDB .


Predictors of PDB included older age , lower baseline hemoglobin , lower platelet reactivity on clopidogrel , and use of chronic oral anticoagulation therapy .


PDB was associated with higher crude rates of all-cause mortality ( @ % vs. @ % ; p < @ ) .


Following multivariable adjustment , PDB was strongly associated with @-year mortality ( hazard ratio -LSB- HR -RSB- : @ ; p < @ ) , with an effect size greater than that of post-discharge myocardial infarction ( PDMI ) ( HR : @ ; p = @ ) .


After successful PCI with DES in an unrestricted patient population , PDB is not uncommon and has a strong relationship with subsequent all-cause mortality , greater that that associated with PDMI .


Efforts to reduce PDB may further improve prognosis after successful DES implantation .


( Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents -LSB- ADAPT-DES -RSB- ; NCT@ ) .


Determine the association of children 's susceptibility to large food portion sizes with appetite regulation and obesity .


Normal-weight and obese non-Hispanic black children ( n = @ ) aged @-@ years were observed in four dinner conditions of varying portion size ; portions of all foods ( except milk ) offered were : @ % ( @ kcal ) , @ % ( @ kcal ) , @ % ( @ kcal ) , or @ % ( @ kcal ) of those in the reference condition ( @ % ) .


Condition order was randomly assigned to @-@ children who ate together at each meal .


Child height and weight were measured and caregiver reports of child appetite were obtained .


Hierarchical growth curve models were used to estimate associations of meal energy intake with portion size condition , child weight status , and appetite regulation traits , controlling for demographics .


Total energy intake increased across conditions of increasing food portion size ( P < @ ) .


The effect of portion size condition on total energy intake varied with food responsiveness ( P = @ ) and satiety responsiveness ( P < @ ) , but not weight status ( P = @ ) .


Children with lower satiety responsiveness and greater food responsiveness showed greater increases in meal energy across conditions .


Children with poorer appetite regulation may be more vulnerable to obesogenic dietary environments offering large food portions than other children .


Compression therapy is highly effective in the treatment of post-thrombotic syndrome and venous leg ulcer .


On average , @-@ % of the patients cooperate with compression therapy .


Therefore , it is necessary to improve the user-friendliness .


This prospective study investigated whether the use of donning devices can contribute to improving user-friendliness .


Forty patients aged > @ years with severe chronic venous insufficiency ( CVI ; C@-C@ ) successively donned compression stockings in a randomized order : one @mmHg ( CS@ ) or two superimposed @mmHg ( CS@ +@ ) , each with open toe ( CS-o-t ) and closed toe ( CS-c-t ) , using donning devices ( three foot slips for CS-o-t ; two foot slips and three frames for CS-c-t ) .


The study endpoint was that the stocking was completely donned and correctly positioned on the patient 's leg .


The success rate and its association with age , sex , first time versus second time user , body mass index , abdominal circumference , ability to reach the forefoot with the hand , and hand grip strength were analyzed .


Additionally , subjective evaluation by the patients was performed .


Without donning devices , success with CS@-c-t was @ % ( @/@ patients ) and with CS@ +@ - c-t @ % ( @/@ patients ) ( p = @ ) .


Using donning devices increased success rates significantly .


With CS@-o-t the success rate was @ % ( @/@ patients ; p = @ ) and with CS@-c-t it was @ % ( @/@ patients ; p = @ ) .


With CS@ +@ - o-t and CS@ +@ - c-t , the success rate was @ % ( @/@ patients ; p = @ ) .


The proportion of patients who successfully used either CS@ or CS@ +@ increased from @ % to @ % .


Relevant for the patients ' success was the ability to reach the forefoot with the hand , and hand grip strength .


Subjectively , donning with a device was rated significantly better than without .


Donning devices significantly improve the ability of elderly patients with CVI to don compression stockings successfully .


However , there are differences in user-friendliness among the devices .


In August @ , the U.S. Food and Drug Administration issued draft guidelines for developing antibiotics for treating acute bacterial skin and skin structure infections ( ABSSSI ) , with the outcome measure of such treatment relying primarily on the cessation of spread or on the decrease in size of skin lesions at @-@h after the initiation of such treatment .


In @ , the Foundation for the National Institutes of Health proposed an interim outcome measure defined as a reduction in lesion size by @ % at a @-@h examination .


These recent changes make it necessary to identify reliable methods for measuring the lesions in acute infections of the skin .


In the first study of the Efficacy and Safety of @-day Oral Tedizolid in Acute Bacterial Skin and Skin Structure Infections vs. @-day Oral Linezolid Therapy ( ESTABLISH-@ ) , the sizes of ABSSSI lesions were evaluated with the two methodologies of : ( @ ) Digital planimetry ( DP ) of photographed lesions , and ( @ ) a ruler technique ( RT ) with measurement of the longest head-to-toe length and greatest perpendicular width of lesions , to compare the respective response rates of lesions to the two antimicrobial regimens in the study .


The RT method and DP showed similar percentages of subjects in which treatment stopped the spread of ABSSSI lesions ( @ % vs. @ % , respectively ) but showed less agreement for a reduction in lesion size , of @ % ( @ % vs. @ % , respectively ) across all categories of lesions ( cellulitis/erysipelas , major cutaneous abscess , and acute wound infection ) at @-@h after the initiation of treatment .


The results of the ESTABLISH-@ study show that both the RT method and DP are consistent and reliable techniques for measuring the sizes of ABSSSI lesions .


Ultimately , changes in lesion size , rather than the absolute value of lesion size , will be used to assess the outcomes of treatment for ABSSSI in clinical research .


Goshajinkigan ( GJG ) is used for the treatment of several neurological symptoms .


We investigated the efficacy of GJG and mecobalamin ( B@ ) against neurotoxicity associated with docetaxel ( DOC ) in breast cancer patients .


Sixty breast cancer patients were treated with DOC .


Thirty-three patients ( GJG group ) received oral administration of @ g/day GJG and @ patients ( B@ group ) received oral administration of @ g/day B@ .


Neuropathy was evaluated according to DEB-NTC ( Neurotoxicity Criteria of Debiopharm ) , Common Terminology Criteria for Adverse Events ( NCI-CTC ) ver .


@ , and a visual analogue scale ( VAS ) .


This study employed a randomized open design .


The incidence of neuropathy was @ % in the GJG group , and @ % in the B@ group ( p < @ ) .


In the GJG group , grade @ DEB-NTC was observed in @ cases , grade @ in @ cases and grade @ in @ cases .


Grade @ NCI-CTC was observed in @ cases , grade @ in @ cases , and VAS was @ @ .


In the B@ group , grades @ , @ and @ DEB-NTC were observed in one case , @ cases and @ cases , respectively ; and grades @ , @ and @ NCI-CTC were observed in @ cases , @ cases and one case , and VAS was @ @ .


Concomitant administration of GJG is useful in preventing neuropathy in breast cancer patients treated with a DOC regimen .


Remote ischemic preconditioning ( RIPC ) is reported to reduce biomarkers of ischemic and reperfusion injury in patients undergoing cardiac surgery , but uncertainty about clinical outcomes remains .


We conducted a prospective , double-blind , multicenter , randomized , controlled trial involving adults who were scheduled for elective cardiac surgery requiring cardiopulmonary bypass under total anesthesia with intravenous propofol .


The trial compared upper-limb RIPC with a sham intervention .


The primary end point was a composite of death , myocardial infarction , stroke , or acute renal failure up to the time of hospital discharge .


Secondary end points included the occurrence of any individual component of the primary end point by day @ .


A total of @ patients underwent randomization .


The full analysis set comprised @ patients ( @ in the RIPC group and @ in the sham-RIPC group ) .


There was no significant between-group difference in the rate of the composite primary end point ( @ patients -LSB- @ % -RSB- in the RIPC group and @ -LSB- @ % -RSB- in the sham-RIPC group , P = @ ) or of any of the individual components : death ( @ patients -LSB- @ % -RSB- and @ -LSB- @ % -RSB- , respectively ; P = @ ) , myocardial infarction ( @ -LSB- @ % -RSB- and @ -LSB- @ % -RSB- , P = @ ) , stroke ( @ -LSB- @ % -RSB- and @ -LSB- @ % -RSB- , P = @ ) , and acute renal failure ( @ -LSB- @ % -RSB- and @ -LSB- @ % -RSB- , P = @ ) .


The results were similar in the per-protocol analysis .


No treatment effect was found in any subgroup analysis .


No significant differences between the RIPC group and the sham-RIPC group were seen in the level of troponin release , the duration of mechanical ventilation , the length of stay in the intensive care unit or the hospital , new onset of atrial fibrillation , and the incidence of postoperative delirium .


No RIPC-related adverse events were observed .


Upper-limb RIPC performed while patients were under propofol-induced anesthesia did not show a relevant benefit among patients undergoing elective cardiac surgery .


( Funded by the German Research Foundation ; RIPHeart ClinicalTrials.gov number , NCT@ . )


An estimated @ million people are living with diabetes worldwide and it is predicted that its prevalence will increase to @ million by @ .


Management of this disease and its complications is a challenge for many countries .


Optimal glycaemic control is necessary to minimize complications , but less than @ % of diabetic patients achieve target levels of blood glucose , partly due to poor access to qualified health care providers .


Telemedicine has the potential to improve access to health care , especially for rural and remote residents .


Video teleconsultation , a real-time ( or synchronous ) mode of telemedicine , is gaining more popularity around the world through recent improvements in digital telecommunications .


If video consultation is to be offered as an alternative to face-to-face consultation in diabetes assessment and management , then it is important to demonstrate that this can be achieved without loss of clinical fidelity .


This paper describes the protocol of a randomised controlled trail for assessing the reliability of remote video consultation for people with diabetes .


A total of @ people with diabetes will be randomised into either a Telemedicine or a Reference group .


Participants in the Reference group will receive two sequential face-to-face consultations whereas in the Telemedicine group one consultation will be conducted face-to-face and the other via videoconference .


The primary outcome measure will be a change in the patient 's medication .


Secondary outcome measures will be findings in physical examination , detecting complications , and patient satisfaction .


A difference of less than @ % in the aggregated level of agreement between the two study groups will be used to identify if videoconference is non-inferior to traditional mode of clinical care ( face-to-face ) .


Despite rapid growth in application of telemedicine in a variety of medical specialties , little is known about the reliability of videoconferencing for remote consultation of people with diabetes .


Results of this proposed study will provide evidence of the reliability of specialist consultation offered by videoconference for people with diabetes .


The relationship of hormones adiponectin , leptin and tumor necrosis factor-alpha in adipose tissue on the atherogenic process is one of the most promising models in preventive medicine .


The numerous tests performed to identify the effect of exercise on these hormones have not been clear on the type of exercise routine and physical effort calculated to contribute to changing plasma concentrations in obese women .


Analyze controlledcardiovascular exercise effect on serum level of adiponectin , leptin , and tumournecrosis factor-alpha in obese young women .


A simple blind clinical essay .


The intervention covered a @-week controlled , cardiovascular exercise program by @ women ( cases n = @ , controls n = @ ) with a body mass index > @kg/m ( @ ) .


Molecular analysis was performed by immune-fluorescence .


Following the intervention , cases and controls means were as follows : adiponectin @ vs. @ / ml ( P = @ ) ; leptin @ vs. @ / L ( P = @ ) ; and tumour necrosis factor-alpha @ vs. @ pg/ml ( P = @ ) .


The established exercise ( @ sessions a week of exercise of @min each for @ weeks with a heart rate reserve of @ to @ % ) improved plasma concentrations of these hormones in the expected direction .


This finding highlights an unpublished amount of exercise , controlled by the reserve cardiac frequency that might contribute the cardiovascular and metabolic protection to obese women .


To determine the feasibility and pilot a sleep education program in New Zealand high school students .


A parallel , two-arm randomized controlled pilot trial was conducted .


High school students ( @ to @ years ) were randomly allocated to either a classroom-based sleep education program intervention ( n = @ ) or to a usual curriculum control group ( n = @ ) .


The sleep education program involved four @-minute classroom-based education sessions with interactive groups .


Students completed a @-day sleep diary , a sleep questionnaire ( including sleep hygiene , knowledge and problems ) at baseline , post-intervention ( @ weeks ) and @ weeks follow-up .


An overall treatment effect was observed for weekend sleep duration ( F @,@ = @ , p = @ ) .


Participants in the intervention group slept longer during weekend nights at @ weeks ( @:@ h : min , p = @ ) and @ weeks : ( @:@ h : min , p = @ ) compared to those in the control group .


No differences were found between groups for sleep duration on weekday nights .


No significant differences were observed between groups for any of the secondary outcomes ( sleep hygiene , sleep problems , or sleep knowledge ) .


A sleep education program appears to increase weekend sleep duration in the short term .


Although this program was feasible , most schools are under time and resource pressure , thus alternative methods of delivery should be assessed for feasibility and efficacy .


Larger trials of longer duration are needed to confirm these findings and determine the sustained effect of sleep education on sleep behavior and its impact on health and psychosocial outcomes .


A commentary on this article appears in this issue on page @ .


X-linked hypophosphatemia ( XLH ) is the most common heritable form of rickets and osteomalacia .


XLH-associated mutations in phosphate-regulating endopeptidase ( PHEX ) result in elevated serum FGF@ , decreased renal phosphate reabsorption , and low serum concentrations of phosphate ( inorganic phosphorus , Pi ) and @,@-dihydroxyvitamin D -LSB- @,@ ( OH ) @D -RSB- .


KRN@ is a human anti-FGF@ antibody developed as a potential treatment for XLH .


Here , we have assessed the safety , tolerability , pharmacokinetics ( PK ) , pharmacodynamics ( PD ) , and immunogenicity of KRN@ following a single i.v. or s.c. dose of KRN@ in adults with XLH .


Thirty-eight XLH patients were randomized to receive a single dose of KRN@ ( @-@ @ mg/kg i.v. or @-@ mg/kg s.c. ) or placebo .


PK , PD , immunogenicity , safety , and tolerability were assessed for up to @ days .


KRN@ significantly increased the maximum renal tubular threshold for phosphate reabsorption ( TmP/GFR ) , serum Pi , and @,@ ( OH ) @D compared with that of placebo ( P < @ ) .


The maximum serum Pi concentration occurred later following s.c. dosing ( @-@ days ) compared with that seen with i.v. dosing ( @-@ days ) .


The effect duration was dose related and persisted longer in patients who received s.c. administration .


Changes from baseline in TmP/GFR , serum Pi , and serum @,@ ( OH ) @D correlated with serum KRN@ concentrations .


The mean t@/@ of KRN@ was @-@ days after i.v. administration and @-@ days after s.c. administration .


Patients did not exhibit increased nephrocalcinosis or develop hypercalciuria , hypercalcemia , anti-KRN@ antibodies , or elevated serum parathyroid hormone ( PTH ) or creatinine .


KRN@ increased TmP/GFR , serum Pi , and serum @,@ ( OH ) @D .


The positive effect of KR@ on serum Pi and its favorable safety profile suggest utility for KRN@ in XLH patients .


Trial registration .


Clinicaltrials.gov NCT@ .


Funding .


Kyowa Hakko Kirin Pharma , Inc. .


The PREDIMED ( Prevencin con Dieta Mediterrnea ) randomized primary prevention trial showed that a Mediterranean diet enriched with either extravirgin olive oil or mixed nuts reduces the incidence of stroke , myocardial infarction , and cardiovascular mortality .


We assessed the effect of these diets on the incidence of atrial fibrillation in the PREDIMED trial .


Participants were randomly assigned to @ of @ diets : Mediterranean diet supplemented with extravirgin olive oil , Mediterranean diet supplemented with mixed nuts , or advice to follow a low-fat diet ( control group ) .


Incident atrial fibrillation was adjudicated during follow-up by an events committee blinded to dietary group allocation .


Among @ participants without prevalent atrial fibrillation at randomization , we observed @ new cases of atrial fibrillation in the Mediterranean diet with extravirgin olive oil group , @ in the Mediterranean diet with mixed nuts group , and @ in the control group after median follow-up of @ years .


The Mediterranean diet with extravirgin olive oil significantly reduced the risk of atrial fibrillation ( hazard ratio , @ ; @ % confidence interval , @-@ @ compared with the control group ) .


No effect was found for the Mediterranean diet with nuts ( hazard ratio , @ ; @ % confidence interval , @-@ @ ) .


In the absence of proven interventions for the primary prevention of atrial fibrillation , this post hoc analysis of the PREDIMED trial suggests that extravirgin olive oil in the context of a Mediterranean dietary pattern may reduce the risk of atrial fibrillation .


To evaluate the analgesic effect of music and audiobooks in children undergoing major surgical procedures when compared to a control ( silence ) group .


The study was a prospective and randomized trial .


Children undergoing major surgeries were randomized to one of the three groups : music , audiobook or control ( silence ) .


The primary outcome was the pain burden reduction by two treatments within @h postoperatively .


Pain burden was measured using the area under the pain scale versus the @min interval for each treatment .


@ patients were recruited and @ completed the study .


Pain burden was reduced in the music and audiobook groups compared to control , median ( IQR ) of -@ ( -@ to @ ) , -@ ( -@ to @ ) and @ ( -@ to @ ) ( minpain score ) , respectively , P = @ .


A linear regression analysis demonstrated an independent group effect on pain reduction even after adjusting for the mean pain scores recorded at the beginning of the treatment , slope of regression line -@ goodness of fit r ( @ ) = @ and slope significantly different from @ ( P = @ ) .


Audio therapy is an efficacious adjunct method to decrease post-surgical pain in children undergoing major surgeries .


Audio therapy should be considered as an important strategy to minimize pain in children undergoing major surgery .


Low birth weight ( LBW ) is an important public health problem in undernourished populations .


We tested whether improving women 's dietary micronutrient quality before conception and throughout pregnancy increases birth weight in a high-risk Indian population .


The study was a nonblinded , individually randomized controlled trial .


The intervention was a daily snack made from green leafy vegetables , fruit , and milk ( treatment group ) or low-micronutrient vegetables ( potato and onion ) ( control group ) from @ d before pregnancy until delivery in addition to the usual diet .


Treatment snacks contained @ MJ of energy ( controls : @ MJ ) and @-@ % of WHO Reference Nutrient Intakes of - carotene , riboflavin , folate , vitamin B-@ , calcium , and iron ( controls : @-@ % ) .


The primary outcome was birth weight .


Of @ women randomly assigned , @ women became pregnant , @ women delivered live singleton newborns , and @ newborns were measured .


In an intention-to-treat analysis , there was no overall increase in birth weight in the treatment group ( +@ g ; @ % CI : -@ , @ g ; P = @ ) .


There was an interaction ( P < @ ) between the allocation group and maternal prepregnant body mass index ( BMI ; in kg/m ( @ ) ) -LSB- birth-weight effect : -@ , +@ , and +@ g in lowest ( < @ ) , middle ( @-@ @ ) , and highest ( > @ ) thirds of BMI , respectively -RSB- .


In @ newborns whose mothers started supplementation @ d before pregnancy ( per-protocol analysis ) , birth weight was higher in the treatment group ( +@ g ; @ % CI : @ , @ g ; P = @ ) .


Again , the effect increased with maternal BMI ( -@ , +@ , and +@ g ; P-interaction = @ ) .


There were similar results for LBW ( intention-to-treat OR : @ ; @ % CI : @ , @ ; P = @ ; per-protocol OR = @ ; @ % CI : @ , @ ; P = @ ) but no effect on gestational age in either analysis .


A daily snack providing additional green leafy vegetables , fruit , and milk before conception and throughout pregnancy had no overall effect on birth weight .


Per-protocol and subgroup analyses indicated a possible increase in birth weight if the mother was supplemented @ mo before conception and was not underweight .


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


It is unclear whether thiazide diuretics ( TZs ) or calcium channel blockers ( CCBs ) are more effective as add-on therapy to angiotensin receptor blockers ( ARBs ) in controlling hypertension .


Because TZs are a rational choice in salt-sensitive hypertension , patients with high salt intake might preferentially benefit from ARB/TZ over ARB/CCB combination therapy .


Hypertensive patients who failed to reach blood pressure goals despite treatment with ARBs alone were randomly assigned to receive either ARB/TZ or ARB/CCB combination therapy .


Estimated daily sodium intake was calculated from spot urine values of sodium and creatinine .


Blood pressure was measured at baseline , and at @ , @ and @ weeks after starting combination therapy .


For all study patients ( n = @ ) , diastolic blood pressure reduction was greater in patients receiving ARB/CCB treatment .


However , in the @ patients with a baseline estimated daily salt intake greater than @ g and baseline systolic blood pressure ( SBP ) ranging from @ to @ mm Hg , SBP was lower ( P < @ ) and SBP reduction was greater ( P < @ ) @ weeks after starting combination therapy in those receiving ARB/TZ treatment .


In the @ patients whose estimated daily salt intake increased at @ weeks compared with baseline , SBP at @ weeks was lower in those receiving ARB/TZ treatment ( P < @ ) .


Estimated daily salt intake is a useful tool for guiding antihypertensive therapy and should be measured repeatedly during the therapeutic course .


To evaluate the effects of preservative-free @ % ketorolac tromethamine and artificial tears ( carboxymethylcellulose ) compared with those of preservative-free artificial tears alone on the symptoms and signs of acute viral conjunctivitis .


This was a randomized , double-masked clinical trial that included @ patients who were diagnosed with acute viral conjunctivitis and distributed into two groups ( Group @ : artificial tears and Group @ : @ % ketorolac tromethamine + carboxymethylcellulose ) .


The patients were instructed to use the medication @ times daily .


Signs ( conjunctival hyperemia , chemosis , follicles , and secretion ) and symptoms ( general ocular discomfort , itching , foreign body sensation , tearing , redness , and swelling of the eyelids ) were scored at baseline and on the third and seventh days of treatment using a standardized questionnaire and slitlamp anterior segment examination .


Both groups showed an improvement in the signs and symptoms of conjunctivitis in their follow-up visits .


There was no significant difference in symptom and sign scores between Group @ and Group @ in the study visits ( p > @ ) .


The frequency of side effects during treatment was similar between groups ( p > @ ) .


Our findings indicate that @ % ketorolac tromethamine was not superior to the use of artificial tears in relieving the signs and symptoms of viral conjunctivitis .


To apply role - play simulation in pre-clinical practice of the fourth grade students in department of endodontics .


Thirty-two students were randomly divided into @ groups , there were @ students in each group .


Students in one group were taught with role-play simulation while the other group with lecture-based learning method .


The teaching effect was measured with examination and questionnaire survey .


The data was analyzed by using SPSS @ software package .


There were no significant differences in basic knowledge , case analysis and oral examination between @ groups ( P > @ ) , but there was significant difference in history taking and medical records writing , practical examination and total scores between @ groups ( P < @ ) .


The role-play simulation was generally approved by both teachers and students in experimental group .


The abilities of the fourth grade students can be developed by role-play simulation in different aspects .


Role-play simulation can be applied in pre-clinical practice of the fourth grade students in department of endodontics .


The purpose of this @-phase project was to conduct a formative evaluation and to test the preliminary efficacy of a newly developed Web-based Tailored Intervention for Preparation of parents and children undergoing Surgery ( WebTIPS ) .


Phase @ enrolled @ children @ to @ years of age undergoing outpatient elective surgery and their parents for formative evaluation of WebTIPS .


Parent participation focus groups are common in qualitative research and are a method of asking research participants about their perceptions and attitudes regarding a product or concept .


In phase @ , children @ to @ years of age in @ medical centers were assigned randomly to receive the WebTIPS program ( n = @ ) compared with children receiving the standard of care ( n = @ ) .


The primary outcome of phase II was child and parent preoperative anxiety .


In phase @ , parents reported WebTIPS to be both helpful ( P < @ ) and easy to use ( P < @ ) .


In phase @ , children in the WebTIPS group ( @ @ ) were less anxious than children in the standard of care group ( @ @ ) at entrance to the operating room ( P = @ ; Cohen d = @ ) and introduction of the anesthesia mask ( @ @ vs @ @ , respectively , P = @ ; Cohen d = @ ) .


Parents in the WebTIPS group ( @ @ ) also experienced less anxiety compared with parents in the control group ( @ @ ) in the preoperative holding area ( P = @ ; Cohen d = @ ) .


WebTIPS was well received by parents and children and led to reductions in preoperative anxiety .


To investigate the efficacy of a standard triple therapy ( comprising rabeprazole , clarithromycin , and amoxicillin ) for Helicobacter pylori ( H. pylori ) eradication , noting factors that influence the outcome and documenting any adverse events .


Following institutional ethical approval , fifty consecutive and consenting symptomatic patients with evidence of H. pylori infection by either a positive urea breath test ( UBT ) and/or a campylobacter-like organism test who presented to the Gastroenterology clinic of Lagos State University Teaching Hospital between @ and @ were recruited into the study .


Patients were openly randomized to either a @-d or a @-d regimen of amoxicillin @ g , clarithromycin @ mg and rabeprazole @ mg twice daily .


The extent of symptom resolution was noted following the treatment , and at the end of one month after the completion of treatment , a repeat UBT was performed in each patient to document the eradication of the infection .


All data ( demographics , symptoms , and eradication rates ) were collated and analyzed with SPSS version @ .


Forty-seven patients completed the study ( three were excluded from the analysis for breaching the study protocol ) .


The patients included @ males and @ females within the age range of @-@ years ( mean @ , SD @ ) .


The clinical features of the study subjects were dyspepsia , reflux symptoms and features of gastrointestinal bleeding .


The average eradication rate was @ % .


Eighteen subjects were enrolled in the @-d arm , while @ were in the @-d arm .


There was no statistically significant difference in the age or sex distributions of the two arms .


There was no significant advantage of the @-d treatment duration over the @-d duration ( P = @ ) , and the eradication outcomes were not influenced by the gender or age of the subjects .


No adverse effects were reported in either arm .


The triple therapy regime , employing a combination of amoxicillin , clarithromycin and rabeprazole , showed great efficacy and safety in the eradication of H. pylori , and this outcome was not influenced by gender or age .


No difference was observed between the @-d and @-d regimens .


Traditional Chinese medicine ( TCM ) has accumulated some experience in curing stable angina pectoris ( SAP ) and efficacy has been demonstrated .


Chinese patent medicines , known as modern dosage forms of TCM , can attain the desired effect in clinical application only with the guidance of TCM syndrome theory .


However , due to their use by a large number of persons with little knowledge of TCM theories and practices , their efficacy and reputation have been seriously affected .


Two common syndrome types of SAP in TCM , ` qi deficiency and blood stasis ' and ` qi stagnation and blood stasis ' , will be studied in @ subjects from four TCM hospitals in Tianjin in China using a partial crossover design .


The two syndromes will be broken down into six symptom combinations ; patients will select a combination of the most distressing to them , and then will be randomised into two groups .


Each group , on the basis of routine medication , will be administered one kind of Chinese patent drug : Qishenyiqi Dripping Pills or Compound Danshen Dripping Pills .


The treatment characteristics of the two medicines will be evaluated with the COME-PIO method developed by our research team .


Oral appliances that move the mandible forward during sleep are suggested as treatment for mild to moderate obstructive sleep apnea .


To test whether an adjustable , custom-made oral appliance improves daytime sleepiness and quality of life in patients with daytime sleepiness and snoring or mild to moderate obstructive sleep apnea .


Ninety-six patients with daytime sleepiness and an apnea-hypopnea index ( AHI ) lower than @ were included in a randomized , placebo-controlled , parallel trial in Ume , Sweden , from May @ through August @ .


Four months ' intervention with an oral appliance or a placebo device .


Daytime sleepiness was measured with the Epworth Sleepiness Scale , the Karolinska Sleepiness Scale , and the Oxford Sleep Resistance ( OSLER ) test .


Quality of life was assessed with the Short-Form @-Item Health Survey ( SF-@ ) and the Functional Outcomes of Sleep Questionnaire ( FOSQ ) .


Secondary outcomes included the apnea-hypopnea index , headaches , symptoms of restless legs , and insomnia .


Oral appliance therapy was not associated with improvements in daytime sleepiness from baseline to @-month follow-up when compared with the placebo device ; Epworth score > @ : @ % at baseline to @ % at follow-up for the oral appliance group vs @ % at baseline to @ % at follow-up for the placebo device group , P = @ ; median ( IQR ) for Karolinska score @/wk : @ ( @ to @ ) at baseline to @ ( @ to @ ) at follow-up for the oral appliance group vs @ ( @ to @ ) at baseline to @ ( @ to @ ) at follow-up for the placebo device group , P = @ ; mean between-group difference in OSLER test , -@ min ( @ % CI , -@ to @ ) .


The mean between-group difference for the total FOSQ score was insignificant ( -@ -LSB- @ % CI , -@ to @ -RSB- ) .


No domain of the SF-@ differed significantly between the groups .


The AHI was below @ in @ % of patients using the active appliance and in @ % using placebo , with an odds ratio of @ ( @ % CI , @-@ @ ) and a number needed to treat of @ .


Snoring ( P < @ ) and symptoms of restless legs ( P = @ ) were less frequent when using the oral appliance vs placebo , but this did not apply to headache or insomnia .


A custom-made , adjustable oral appliance reduces obstructive sleep apnea , snoring , and possibly restless legs without effects on daytime sleepiness and quality of life among patients with daytime sleepiness and snoring or mild to moderate sleep apnea .


Non-invasive brain stimulation with transcranial direct current stimulation ( tDCS ) modulates cortical excitability and improves upper limb motor performance when applied to chronic stroke patients .


The objective was to evaluate whether tDCS can influence gait function in sub-acute stroke patients .


We assessed the effect of single session , bi-cephalic tDCS on gait performance in @ subacute patients with stroke involving the cerebral hemisphere ( @-@ weeks post-stroke ) in a double-blinded , sham-controlled study .


Patients were randomly allocated to receive either active ( n = @ ) or sham ( n = @ ) tDCS .


The anodal electrode was placed on the scalp over the ipsilesional lower limb primary motor cortex and the cathode was placed over the contralesional leg motor cortex .


Gait performance was measured using the Timed Up and Go test and the Performance Oriented Mobility Assessment before and after active or sham tDCS .


The tDCS group was significantly quicker in the Timed Up and Go test in the tDCS group , compared to the sham group ( p = @ ) .


The Performance Oriented Mobility Assessment was not different between groups ( p = @ ) .


This is the first study to examine the effects of tDCS on gait in stroke patients in the sub-acute stage .


Active tDCS improved gait performance ( Timed Up and Go ) in stroke patients , despite no changes to limb biomechanics of the hemiparetic side ( Performance Oriented Mobility Assessment ) , as compared to sham stimulation .


These results suggest that tDCS could be used as a therapeutic adjunct for gait rehabilitation following stroke .


The Paliperidone Palmitate Research in Demonstrating Effectiveness ( PRIDE ) study compared the effects of once-monthly paliperidone palmitate with daily oral antipsychotics on treatment failure in adults with schizophrenia .


The PRIDE study is a @-month , randomized , multicenter study ( May @ , @ , to December @ , @ ) of adult subjects with a DSM-IV diagnosis of schizophrenia and a history of incarceration .


Subjects were randomly assigned to once-monthly paliperidone palmitate injections or daily oral antipsychotics ( randomly assigned from @ acceptable , prespecified oral antipsychotics ) for @ months .


The primary end point was time to first treatment failure , defined as arrest/incarceration ; psychiatric hospitalization ; suicide ; treatment discontinuation or supplementation due to inadequate efficacy , safety , or tolerability ; or increased psychiatric services to prevent hospitalization .


Time to first treatment failure was determined by a blinded event-monitoring board and analyzed with the Kaplan-Meier method .


In this study , @ patients were randomly assigned , and @ were included in the intent-to-treat population .


Paliperidone palmitate was associated with significant delay in time to first treatment failure versus oral antipsychotics ( hazard ratio , @ ; @ % CI , @-@ @ ; log rank P = @ ) .


Observed treatment failure rates over @ months were @ % and @ % , respectively .


Arrest/incarceration and psychiatric hospitalization were the most common reasons for treatment failure in the paliperidone palmitate and oral antipsychotic groups ( @ % vs @ % and @ % vs @ % , respectively ) .


The @ most common treatment-emergent adverse events for the paliperidone palmitate treatment group were injection site pain ( @ % of subjects ) , insomnia ( @ % ) , weight increased ( @ % ) , akathisia ( @ % ) , and anxiety ( @ % ) .


In a trial designed to reflect real-world management of schizophrenia , once-monthly paliperidone palmitate demonstrated superiority compared to oral antipsychotics in delaying time to treatment failure .


Booster sessions as a means of maintaining the benefits of psycho-educational programs have received little attention in caregiving research .


Caregivers were offered a booster session following participation in a program entitled Learning to Become a Family Caregiver ( LBFC ) intended to facilitate transition to the caregiver role after diagnostic disclosure of dementia in a relative .


The @-minute booster session served to review program content and afforded the opportunity to discuss and practice learned skills .


This study sought to test the efficacy of the booster session in maintaining or recovering program effects at six months post-program .


Participants in the program were randomly assigned to a group that received the booster session ( n = @ ) or a group that did not ( n = @ ) .


A third control group was also formed , which continued to receive only the usual care provided in memory clinics .


Eligible participants - French-speaking primary caregivers of a relative diagnosed with Alzheimer 's in the past nine months - were recruited in memory clinics in Quebec ( Canada ) .


Participants were blindly assessed before randomization and six months after the booster session on outcomes associated with a healthy role transition .


Prediction analyses revealed one significant positive effect of the booster session : emergence of preparedness to provide care .


Moreover , with or without the booster session , the program continued to have a positive effect on psychological distress and contributed to the emergence of self-efficacy in dealing with caregiving situations .


The booster session had no significant effect on knowledge of services , planning for future care needs , use of reframing as a coping strategy , perceived informal support , and family conflicts .


The limited effect observed is discussed in terms of the booster session 's content and intensity .


Recommendations are made for designing future research on the effect of booster sessions , including the importance of including a placebo booster group .


The aim of this study was to compare the effect of a @-wk exercise therapy program and arthroscopic partial meniscectomy on knee strength and functional performance in middle-aged patients with degenerative meniscus tears .


A total of @ patients ( mean age , @ yrs ; @ % women ) with a symptomatic , unilateral , magnetic resonance imaging-verified degenerative meniscus tear and no or mild radiographic osteoarthritis were randomly assigned to a supervised neuromuscular and strength exercise program or arthroscopic partial meniscectomy .


Outcomes assessed @ mos after intervention initiation were isokinetic knee muscle strength , lower extremity performance , and self-reported global rating of change .


Mean difference in isokinetic knee extension peak torque between the two groups was @ % ( @ % confidence interval , @-@ @ ) ( P < @ ) , favoring the exercise group .


Patients in the exercise group improved isokinetic knee extension peak by a mean of @ Nm ( range , @-@ Nm ) from baseline to follow-up .


Furthermore , patients assigned to exercise therapy showed statistically significant improvements ( P @ ) in all other measured variables , with moderate to large effect sizes ( @-@ @ ) .


Patients reported a similar and positive effect of both interventions .


A @-wk supervised exercise therapy program yielded clinically relevant and statistically significant improvement in isokinetic quadriceps strength immediately after completion of the program , as compared with treatment with arthroscopic partial meniscectomy .


Cervical dystonia is managed mainly by repeated botulinum toxin injections .


We aimed to establish whether pallidal neurostimulation could improve symptoms in patients not adequately responding to chemodenervation or oral drug treatment .


In this randomised , sham-controlled trial , we recruited patients with cervical dystonia from centres in Germany , Norway , and Austria .


Eligible patients ( ie , those aged @-@ years , disease duration @ years , Toronto Western Spasmodic Torticollis Rating Scale -LSB- TWSTRS -RSB- severity score @ points ) were randomly assigned ( @:@ ) to receive active neurostimulation ( frequency @ Hz ; pulse width @ s ; amplitude @ V below adverse event threshold ) or sham stimulation ( amplitude @ V ) by computer-generated randomisation lists with randomly permuted block lengths stratified by centre .


All patients , masked to treatment assignment , were implanted with a deep brain stimulation device and received their assigned treatment for @ months .


Neurostimulation was activated in the sham group at @ months and outcomes were reassessed in all patients after @ months of active treatment .


Treating physicians were not masked .


The primary endpoint was the change in the TWSTRS severity score from baseline to @ months , assessed by two masked dystonia experts using standardised videos , analysed by intention to treat .


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


Between Jan @ , @ , and May @ , @ , we recruited @ patients , of whom @ were randomly assigned to neurostimulation and @ to sham stimulation .


Outcome data were recorded in @ ( @ % ) patients at @ months and @ ( @ % ) patients at @ months .


At @ months , the reduction in dystonia severity was significantly greater with neurostimulation ( -@ points -LSB- SD @ -RSB- , @ % CI -@ to -@ ) than with sham stimulation ( -@ -LSB- @ -RSB- , -@ to -@ , p = @ ; mean between-group difference @ points , @ to @ ) in the intention-to-treat population .


Over the course of the study , @ adverse events ( five serious ) were reported in @ ( @ % ) of @ patients in the neurostimulation group compared with @ ( @ serious ) in nine ( @ % ) of @ patients in the sham-stimulation group .


Serious adverse events were typically related to the implant procedure or the implanted device , and @ of @ resolved without sequelae .


Dysarthria ( in four patients assigned to neurostimulation vs three patients assigned to sham stimulation ) , involuntary movements ( ie , dyskinesia or worsening of dystonia ; five vs one ) , and depression ( one vs two ) were the most common non-serious adverse events reported during the course of the study .


Pallidal neurostimulation for @ months is more effective than sham stimulation at reducing symptoms of cervical dystonia .


Extended follow-up is needed to ascertain the magnitude and stability of chronic neurostimulation effects before this treatment can be recommended as routine for patients who are not responding to conventional medical therapy .


The @ nicotinic acetylcholine receptor partial agonist varenicline has been reported to reduce drinking among both heavy-drinking smokers and primary alcoholics , and this effect may be related to varenicline-mediated reduction of alcohol craving .


Among smokers , varenicline has been reported to modulate cigarette cue-elicited brain activation in several reward-related areas .


This pilot study tested varenicline 's effects on drinking , alcohol craving , and alcohol cue-elicited activation of reward-related brain areas among non-treatment-seeking alcohol-dependent individuals .


Thirty-five such individuals ( mean age = @ , @ % male , @ % heavy drinking days in the past month , @ smokers ) were randomized to either varenicline ( titrated to @ mg ) or placebo for @ days , and were administered an alcohol cue reactivity fMRI task on day @ .


A priori regions of interest ( ROIs ) were bilateral and medial orbitofrontal cortex ( OFC ) , right ventral striatum ( VS ) , and medial prefrontal cortex ( mPFC ) .


Despite good medication adherence , varenicline did not reduce heavy drinking days or other drinking parameters .


It did , however , increase self-reported control over alcohol-related thoughts and reduced cue-elicited activation bilaterally in the OFC , but not in other brain areas .


These data indicate that varenicline reduces alcohol craving and some of the neural substrates of alcohol cue reactivity .


However , varenicline effects on drinking mediated by cue-elicited brain activation and craving might be best observed among treatment-seekers motivated to reduce their alcohol consumption .


Methotrexate ( MTX ) remains the gold standard disease-modifying antirheumatic drug for the treatment of rheumatoid arthritis ( RA ) .


Few studies have compared different starting doses of MTX in RA .


We hypothesized that starting with a higher MTX dose may be more effective but associated with more adverse effects .


We compared a starting dose of @ versus @ mg per week of MTX followed by similar fast escalation .


This was an open-label ( blinded assessor ) , parallel-group , randomized controlled trial that included RA patients aged @ to @ years , not on MTX , and having active disease ( Disease Activity Score for @ joints using @ variables -LSB- DAS@ ( @ ) -RSB- @ ) .


Patients were randomized to receive MTX at a starting dose of @ mg ( group @ ) or @ mg ( group @ ) per week .


The dose of MTX was escalated by @ mg every @ weeks to a maximum of @ mg .


Patients were seen every @ weeks , and dose escalation was continued if DAS@ ( @ ) was > @ and there were no laboratory abnormalities ( transaminitis -LSB- > @ upper limit of normal -RSB- or cytopenia ) .


The primary endpoint was change in disease activity at @ weeks ( assessed by using the DAS@ -LSB- @ -RSB- ) .


Secondary endpoints were patient withdrawals and episodes ofcytopenia or transaminitis .


Adverse effects were ascertained by using a questionnaire .


Both intention-to-treat and per-protocol analyses were performed .


We enrolled @ patients ( female : male ratio , @:@ ) with a mean ( SD ) age of @ ( @ ) years and a disease duration of @ ( @ ) years .


At baseline , patients had a mean DAS@ ( @ ) of @ ( @ ) and a Health Assessment Questionnaire score of @ ( @ ) .


Group @ ( @ mg ) and group @ ( @ mg ) included @ and @ patients , respectively , with no significant differences in baseline characteristics .


At @ weeks , the mean dose of MTX reached was @ ( @ ) mg in group @ and @ ( @ ) mg in group @ ( P < @ ) .


The @ groups had a similar number of patient withdrawals .


The mean change in DAS@ ( @ ) at @ weeks in group @ ( -@ -LSB- @ -RSB- ) and group @ ( -@ -LSB- @ -RSB- ) was not significantly different ( P = @ ) .


The change in the Health Assessment Questionnaire score was also similar in the groups .


The frequency of episodes of transaminitis ( @ and @ ; P = @ ) and cytopenia ( @ and @ ; P = @ ) did not differ significantly between groups @ and @ , respectively .


Results remained the same according to the per-protocol analysis .


Among adverse effects , nausea was more common in group @ compared with group @ ( relative risk , @ -LSB- @ % CI , @-@ @ -RSB- ) .


There were no significant differences in efficacy between the @ starting doses of MTX .


The fast escalation of dose in both groups may have blunted any advantage of starting at a higher dose .


Nausea occurred more commonly in patients started on @ mg of MTX .


We suggest longer trials to confirm our findings .


ClinicalTrials.gov identifier : NCT@ .


To determine the effects of Anshendingzhi decoction ( ASDZD ) on depression , to compare ASDZD with Danzhixiaoyao pill ( DZXYP ) , and to provide evidence for the clinical treatment of depression with Traditional Chinese Medicine .


Seventy-eight patients with depression were enrolled from @ to @ in this double-blinded study .


Patients were randomly divided into two groups : ASDZD ( treatment group , n = @ ) and DZXYP ( control group , n = @ ) .


Hamilton Depressive Scale and TCM Syndrome Differentiation Scale were used to assess depression and efficacy before treatment and @ , @ , and @ weeks after treatment .


The Treatment Emergent Symptoms Scale ( TESS ) was used to evaluate adverse reactions , observe , and record treatment outcomes .


ASDZD was significantly more effective than DZXYP .


There were significant differences between the two groups in terms of recovered patients , overall response rate , and TESS score ( all P < @ ) .


ASDZD is an effective treatment for depression .


ASDZD could improve clinical symptoms and warrants further clinical research and application .


We studied the relationship between heart rate and renal function and the effects of heart rate reduction with ivabradine in heart failure patients with and without renal dysfunction .


From the @ patients who were randomized in SHIFT , baseline creatinine and at least one follow-up measurement were available in @ patients .


Median follow-up was @ months .


Worsening renal function ( WRF ) was defined as a creatinine increase of @ mg/dL and @ % from the baseline value .


WRF developed in @ ( @ % ) patients and was directly related to baseline heart rate , with an incremental risk of @ % for every @ b.p.m. heart rate increment ( P = @ ) .


WRF was associated with an increased risk of the primary composite endpoint of hospitalization for worsening heart failure or cardiovascular death -LSB- hazard ratio ( HR ) @ , P < @ -RSB- and of all-cause mortality ( HR @ , P < @ ) .


Ivabradine use was associated with a reduction of the primary composite endpoint in patients both with ( HR @ , P = @ ) and without renal dysfunction ( HR @ , P < @ ) at baseline ( P for interaction = @ ) , and tolerability of ivabradine was comparable in the two groups .


No differences were found in changes in renal function over time between ivabradine - and placebo-treated patients .


In chronic stable systolic heart failure patients , heart rate is directly and independently associated with the risk of WRF , but reduction in heart rate by ivabradine had a neutral effect on renal function during @ years of follow-up .


The beneficial cardiovascular effects and safety of ivabradine were similar in patients with and without renal dysfunction .


To compare the effect of bimatoprost and the fixed combination latanoprost-timolol ( LTFC ) on @-hour systolic ( SBP ) and diastolic ( DBP ) blood pressure and on @-hour ocular perfusion pressure ( OPP ) .


@ patients with glaucoma or ocular hypertension , controlled on the unfixed combination of latanoprost and timolol or eligible for dual therapy being not being fully controlled on monotherapy were enrolled in a randomized , double-masked , placebo-controlled , multicentre clinical trial .


They were randomized to LTFC ( @ a.m. ) or bimatoprost ( @ p.m. ) and received @-hour IOP curve at baseline , @ and @ weeks ( supine and sitting position IOPs were recorded at @ p.m. , midnight , @ a.m. , @a .


m. , noon and @ p.m. ) .


Holter @-hour blood pressure curve was obtained between weeks @ and @ .


SBP , DBP , OPP were calculated and compared with ANOVA .


Rates of diastolic OPP ( DPP ) @ , @ , @ mmHg in the @ groups were calculated and compared using Fisher 's test .


Mean baseline SBP and DBP were @ vs @ mmHg ( p = @ ) and @ vs @ mmHg ( p = @ ) in the bimatoprost and LTFC groups respectively .


Holter SBP was significantly higher for bimatoprost ( @ mmHg vs @ mmHg , p = @ ) , while no statistically significant difference in DBP was found .


DPP was similar in the @ groups , and proportions of patients with at least one value of the @-hour curve@ , @ , @ mmHg were @ % , @ % , @ % respectively .


Bimatoprost and LTFC had similar DBPs and OPPs ; SBP was significantly lower with LTFC .


In this study , the percentage of `` dippers '' was considerably higher than the one described in previous studies on the role of perfusion pressure in glaucoma .


Primary percutaneous coronary intervention ( PCI ) is the most common method of reperfusion in patients with ST-segment elevation myocardial infarction ( STEMI ) in the United States .


The intersection between processes of care and performance measures such as door-to-balloon ( D@B ) times and clinical trials evaluating novel therapies for STEMI has not been fully investigated .


Processes of STEMI care , incorporating clinical trial enrollment and randomization , in patients undergoing reperfusion with primary PCI in the Counterpulsation Reduces Infarct Size Pre-Percutaneous Coronary Intervention Acute Myocardial Infarction trial ( CRISP-AMI ) will conform to current standards of care .


Patients enrolled in CRISP-AMI were included in the current analysis .


Processes of care during reperfusion were recorded prospectively and compared between groups .


A total of @ patients with anterior STEMI without cardiogenic shock were randomized in CRISP-AMI .


Complete processes-of-care data were available for @ patients ( @ % ) .


In this cohort , @ % of patients underwent reperfusion within @ minutes of hospital contact , and the median D@B time was @ minutes .


Time from hospital contact to informed consent was significantly different across different regions ( North America , @ minutes ; India , @ minutes ; Europe , @ minutes ) .


In CRISP-AMI , reperfusion was accomplished in a timely fashion while incorporating informed consent and randomization among patients with anterior myocardial infarction .


Further study of patients ' comprehension and preferences during the informed-consent process in STEMI patients is warranted so that innovative drugs and devices can be safely and ethically tested .


To compare the epithelial wound healing response of two preservative-free fluoroquinolones , moxifloxacin and levofloxacin , in patients who underwent cataract surgery .


In this prospective , evaluator-masked , randomized clinical trial , @ eyes of @ patients who underwent cataract surgery were enrolled .


Patients were randomized to receive moxifloxacin @ % ( n = @ eyes ) or levofloxacin @ % ( n = @ eyes ) .


All patients instilled moxifloxacin or levofloxain four times daily for @ week prior to surgery and @ weeks after surgery .


The epithelial wound healing status in the corneal incision site was scanned with a raster scan mode of fourier-domain optical coherence tomography ( FD-OCT ) .


The number of eyes showing epithelial defect images and average number of corneal epithelial defect cuts per eye were compared between groups .


All patients were evaluated on postoperative days @ , @ , @ , and @ .


On postoperative days @ , @ , and @ , the number of eyes showing epithelial defects in FD-OCT was not statistically different ( all p > @ ) .


The average number of corneal epithelial defect cuts was also not statistically different between the two groups ( all p > @ ) .


No eyes showed epithelial defects on postoperative day @ in either group .


There were no differences on epithelial wound healing comparing these two different fluoroquinolones at the incision site of cataract surgery .


This Phase @ , international , randomized , single-blind , controlled trial ( FINISH-@ ) compared the efficacy and safety of Fibrocaps , a ready-to-use , dry-powder fibrin sealant containing human plasma-derived thrombin and fibrinogen , vs gelatin sponge alone for use as a hemostat for surgical bleeding in @ indications ( ie , spinal , hepatic , vascular , soft tissue dissection ) .


Adults with mild to moderate surgical bleeding ( randomized @:@ ; Fibrocaps vs gelatin sponge ) were treated at a single bleeding site ( day @ ) .


Time to hemostasis ( TTH ) during @ minutes was compared ( log-rank statistic ) within each indication .


Safety follow-up continued to day@ .


Patients were treated ( Fibrocaps , n = @ ; gelatin sponge , n = @ ) when undergoing spinal ( n = @ ) , vascular ( n = @ ) , hepatic ( n = @ ) , or soft-tissue ( n = @ ) procedures .


Fibrocaps was applied by spray device in @ % of all procedures ( @ % of hepatic and soft-tissue procedures ) .


Fibrocaps significantly reduced TTH compared with gelatin sponge ; estimated hazard ratios were @ , @ , @ , and @ for the @ surgical indications , respectively ( each p < @ ; primary end point ) .


Fibrocaps significantly reduced median TTH for each indication ( p < @ ) and was superior for secondary efficacy end points of restricted mean TTH ( p < @ ) and probability of hemostasis at @ ( p < @ ) and @ ( p @ ) minutes .


Adverse event incidences were generally similar between treatment arms .


Non-neutralizing , anti-thrombin antibodies developed in @ % of Fibrocaps-treated and @ % of gelatin sponge-treated patients .


Fibrocaps was well tolerated and significantly reduced TTH relative to gelatin sponge alone in all @ surgical indications .


These findings demonstrate the broad utility of Fibrocaps as a hemostatic agent for mild to moderate surgical bleeding .


High-dose therapy followed by autologous stem-cell transplantation is standard of care for patients with relapsed or primary refractory Hodgkin 's lymphoma .


Roughly @ % of patients might be cured after autologous stem-cell transplantation ; however , most patients with unfavourable risk factors progress after transplantation .


We aimed to assess whether brentuximab vedotin improves progression-free survival when given as early consolidation after autologous stem-cell transplantation .


We did this randomised , double-blind , placebo-controlled , phase @ trial at @ sites in North America and Europe .


Patients with unfavourable-risk relapsed or primary refractory classic Hodgkin 's lymphoma who had undergone autologous stem-cell transplantation were randomly assigned , by fixed-block randomisation with a computer-generated random number sequence , to receive @ cycles of @ mg/kg brentuximab vedotin or placebo intravenously every @ weeks , starting @-@ days after transplantation .


Randomisation was stratified by best clinical response after completion of salvage chemotherapy ( complete response vs partial response vs stable disease ) and primary refractory Hodgkin 's lymphoma versus relapsed disease less than @ months after completion of frontline therapy versus relapse @ months or more after treatment completion .


Patients and study investigators were masked to treatment assignment .


The primary endpoint was progression-free survival by independent review , defined as the time from randomisation to the first documentation of tumour progression or death .


Analysis was by intention to treat .


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


Between April @ , @ , and Sept @ , @ , we randomly assigned @ patients to the brentuximab vedotin group ( n = @ ) or the placebo group ( n = @ ) .


Progression-free survival by independent review was significantly improved in patients in the brentuximab vedotin group compared with those in the placebo group ( hazard ratio -LSB- HR -RSB- @ , @ % CI @-@ ; p = @ ) .


Median progression-free survival by independent review was @ months ( @ % CI @-@ ) for patients in the brentuximab vedotin group compared with @ months ( @-not estimable ) for those in the placebo group .


We recorded consistent benefit ( HR < @ ) of brentuximab vedotin consolidation across subgroups .


The most frequent adverse events in the brentuximab vedotin group were peripheral sensory neuropathy ( @ -LSB- @ % -RSB- of @ patients vs @ -LSB- @ % -RSB- of @ patients in the placebo group ) and neutropenia ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- patients ) .


At time of analysis , @ ( @ % ) of @ patients had died in the brentuximab vedotin group compared with @ ( @ % ) of @ patients in the placebo group .


Early consolidation with brentuximab vedotin after autologous stem-cell transplantation improved progression-free survival in patients with Hodgkin 's lymphoma with risk factors for relapse or progression after transplantation .


This treatment provides an important therapeutic option for patients undergoing autologous stem-cell transplantation .


The aim of this study was to evaluate the effects of losartan on left ventricular ( LV ) hypertrophy and fibrosis in patients with nonobstructive hypertrophic cardiomyopathy ( HCM ) .


Despite evidence that myocardial hypertrophy and fibrosis are mediated by angiotensin II and are important determinants of morbidity and mortality in patients with HCM , no prior studies have evaluated the effects of angiotensin receptor blockers on LV hypertrophy and fibrosis with cardiac magnetic resonance imaging .


In double-blind fashion , @ patients ( @ women , @ men ; age : @ @ years ) with HCM were randomly assigned to receive placebo ( n = @ ) or losartan @ mg twice a day ( n = @ ) for @ year .


Cardiac magnetic resonance imaging was performed at baseline and @ year to measure LV mass and extent of fibrosis as assessed by late gadolinium enhancement .


There was a trend toward a significant difference in the percent change in LV mass ( median -LSB- interquartile range -RSB- : +@ % -LSB- -@ % to +@ % -RSB- with placebo vs.-@ % -LSB- -@ % to-@ @ % -RSB- with losartan ; p = @ ) .


There was a significant difference in the percent change in extent of late gadolinium enhancement , with the placebo group experiencing a larger increase ( +@ % @ % with placebo vs.-@ % @ % with losartan ; p = @ ) .


This pilot study suggests attenuation of progression of myocardial hypertrophy and fibrosis with losartan in patients with nonobstructive HCM .


Confirmation of these results in a larger trial is required to confirm a place for angiotensin receptor blockers in the management of patients with HCM .


( Effect of Losartan in Patients With Nonobstructive Hypertrophic Cardiomyopathy ; NCT@ ) .


This study sought to test whether the newly developed platinum chromium ( PtCr ) - based everolimus-eluting stent ( EES ) is noninferior to the cobalt chromium ( CoCr ) - based zotarolimus-eluting stent ( ZES ) in all-comers receiving percutaneous coronary intervention ( PCI ) .


PtCr provides improved radial strength , conformability , and visibility compared with the CoCr alloy , but PtCr-based stents have not been tested in a wide range of patients receiving PCI .


Also , recent case series have raised the issue of longitudinal stent deformation ( LSD ) with newer drug-eluting stents .


We randomly assigned @,@ all-comers receiving PCI to PtCr-EES or CoCr-ZES .


The primary outcome was target lesion failure ( TLF ) at @-year post-PCI , defined as the composite of cardiac death , nonfatal target vessel-related myocardial infarction , and ischemia-driven target lesion revascularization .


Post-hoc angiographic analysis was performed to qualitatively and quantitatively analyze LSD .


At @ year , TLF occurred in @ % and @ % of the population in the PtCr-EES and CoCr-ZES groups , respectively ( superiority p = @ , noninferiority p = @ ) .


There were no significant differences in the individual components of TLF as well as the patient-oriented clinical outcome .


Of @,@ stents analyzed , LSD occurred in @ % and @ % in the PtCr-EES and CoCr-ZES groups , respectively ( p = @ ) .


There was no significant difference in post-deployment stent length ratio between the @ stents ( p = @ ) .


At @ year , PtCr-EES was noninferior to CoCr-ZES in all-comers receiving PCI .


Although LSD was observed only in PtCr-EES , both the stent length ratio and the frequency of LSD were not significantly different between the @ stent types , and PtCr-EES was not associated with adverse clinical outcomes .


( Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis-SAfety & EffectiveneSS of Drug-ElUting Stents & Anti-platelet REgimen -LSB- HOST-ASSURE -RSB- ; NCT@ ) .


Prospective long-term analyses of the role of drug-induced mydriasis and laser peripheral iridotomy ( LPI ) are needed to identify and manage the eyes of patients with pigment dispersion syndrome ( PDS ) at risk for progressing to ocular hypertension .


To assess the @-year incidence of increased intraocular pressure ( IOP ) in the @ eyes of patients with PDS , with @ eye that underwent LPI and the other that did not .


In a randomized clinical trial in the glaucoma research unit at the University Hospital of Parma , Italy , @ patients with PDS underwent phenylephrine testing .


Of these @ patients , @ ( @ eyes ) tested positive for succeeding IOP elevation , and @ ( @ eyes ) tested negative .


For the @ high-risk patients ( all in both eyes ) , one eye was randomly assigned to LPI , and the fellow eye was left untreated .


For the @ low-risk patients , the affected eyes were left untreated .


An IOP elevation of @ mm Hg or higher vs baseline ( daily phasing ) was considered to be a significant increase ( ie , an event ) .


In the high-risk group , @ of @ eyes that underwent LPI ( @ % ) and @ of @ untreated eyes ( @ % ) showed an increase in IOP of @ mm Hg or higher during the follow-up period ; @ of @ low-risk eyes ( @ % ) showed a similar increase .


Event-free mean ( SD ) time was @ ( @ ) years for high-risk treated eyes , @ ( @ ) years for high-risk untreated eyes , and @ ( @ ) years for low-risk eyes .


The log-rank test showed the following : P < @ for treated high-risk eyes vs untreated high-risk eyes , P = @ for treated high-risk eyes vs low-risk eyes , and P < @ for untreated high-risk eyes vs low-risk eyes .


At the end of the @-year follow-up , ( @ ) approximately one-third of the whole PDS patient population showed an IOP increase of @ mm Hg or higher in at least @ eye ; ( @ ) phenylephrine testing identified eyes at high risk for developing IOP elevation ; and ( @ ) LPI , when performed on high-risk eyes , reduced the rate of IOP elevation to the same level as the low-risk eyes .


Compared with a dry environment with talcum powder , a wet , alkaline environment with NaHCO@ solution is better for hair removal , as it can soften and expand the hair , decrease the friction and shear forces on the skin , and make hair removal easier and more efficient .


The purpose of this study was to compare the effects of a preoperative skin preparation of @ % NaHCO@ with that of talcum powder for softening hair in patients undergoing coronary artery bypass graft ( CABG ) surgery with the saphenous vein .


A prospective randomized , single-blinded , controlled study was established .


Between March @ and June @ , @ patients who met the inclusion and exclusion criteria underwent elective CABG surgery with the saphenous vein in our hospital .


The same doctor obtained the saphenous vein of each patient by a uniform method .


CABG surgery was performed through an open or endoscopic technique , according to each patient 's condition .


Patients were divided into two groups of @ patients each , according to whether the preoperative skin preparation procedure was performed with a @ % solution of NaHCO@ at @-@C ( experimental group ) or with talcum powder ( control group ) .


Main outcome measures were the incision inflammation rate , skin preparation time , presence of shaving-induced macroscopic haemorrhagic spots , verbal rating scale ( VRS ) pain score and satisfaction .


Neither group had any evidence of incision inflammation .


The average ( mean standard deviation ) skin preparation time of the experimental group was shorter than that of the control group ( @ @ vs @ @ min , P < @ ) .


Three patients in the experimental group and @ in the control group had shaving-induced macroscopic haemorrhagic spots after skin preparation ( P = @ ) .


The VRS pain scores were different between the two groups ( P < @ ) .


In the control group , @ % of patients and @ % of nurses were satisfied with the skin preparation procedure , compared with @ and @ % , respectively , in the experimental group ( both P < @ ) .


Hair softening with a @ % NaHCO@ solution protected the skin integrity , alleviated pain and improved patient satisfaction to a greater extent than talcum powder .


Nurses found the @ % NaHCO@ solution to be more convenient and less time-consuming to use .


The Coronary Psychosocial Evaluation Studies trial demonstrated promising results for enhanced depression treatment to reduce cardiovascular risk of patients with acute coronary syndrome and comorbid depression , but the long-term effectiveness of this intervention is unclear .


A total of @ participants with persistent depression after hospitalization for acute coronary syndromes were enrolled in the Coronary Psychosocial Evaluation Studies trial .


A total of @ participants were allocated to @ months of enhanced depression treatment , and @ participants were allocated to usual care .


We report on an additional @ months of observational follow-up for the composite outcome of death or first hospitalization for myocardial infarction or unstable angina .


Although the intervention was previously shown to have favorable cardiovascular effects during the treatment period , we observed a significant time-by-treatment group interaction during extended follow-up ( P = @ ) .


Specifically , during the @-month treatment period , death or hospitalization for myocardial infarction/unstable angina occurred in @ participants ( @ % ) in the treatment group compared with @ participants ( @ % ) in the usual care group ( hazard ratio , @ ; @ % confidence interval , @-@ @ ; P = @ ) .


In contrast , during @ months of additional observational follow-up , @ participants ( @ % ) in the treatment group experienced the composite outcome of deathorhospitalization for myocardial infarction/unstable angina compared with @ participants ( @ % ) in the usual caregroup ( hazard ratio , @ ; @ % confidence interval , @-@ @ ; P = @ ) .


Enhanced depression treatment was associated with a reduced risk of death or hospitalization for myocardial infarction/unstable angina during active treatment , but this effect did not persist after treatment ceased .


Future research is needed to confirm our findings and to determine the optimal duration of depression treatment in patients with depression after acute coronary syndromes .


A complication of long-term use of tunneled cuffed catheters for hemodialysis is the high rate of infection and thrombus-related dysfunction .


Specific mechanical features of tunneled cuffed catheters may improve hemodynamic performance and decrease thrombosis and infection rates .


However , there currently is no proven advantage of one design over another .


Single-center randomized clinical trial .


@ hemodialysis patients who required a tunneled cuffed catheter as temporary or definite vascular access .


Palindrome Symmetric Tip Dialysis Catheter or HemoStar Long-Term Hemodialysis Catheter .


The primary end point was primary assisted patency .


Secondary end points were incidence of catheter-related bloodstream infections ( CRBSIs ) , thrombosis , and @ indicators of rheologic function : mean effective blood flow rate and urokinase use .


Mean primary assisted patency was @ days for Palindrome and @ days for HemoStar ( P = @ ) .


Definite CRBSI occurred in @ and @ / @,@ catheter-days for Palindrome and HemoStar , respectively ( P = @ ) .


Removal rates for thrombosis that could not be resolved with thrombolysis were @ and @ / @,@ catheter-days for Palindrome and HemoStar , respectively ( P = @ ) .


Urokinase use was lower for Palindrome than for HemoStar , as evidenced by a lower number of urokinase infusions/@ ,@ catheter-days ( @ and @ ; P < @ ) and higher number of catheters that never required thrombolysis ( @ % and @ % ; P = @ ) .


Mean effective blood flow rate was higher for Palindrome than for HemoStar ( @ and @mL/min ; P < @ ) .


Single-center nonblinded trial .


Primary assisted patency and incidence of infection and thrombosis were similar for both catheter types .


The Palindrome catheter required less thrombolysis and achieved higher blood flow rates than the HemoStar catheter .


These findings suggest that mechanical catheter design may improve catheter rheology , but does not affect risks for thrombosis and infection and hence catheter survival .


To assess whether the addition of a peer testimonial to an informational mailing increases conversion rates from brand name prescription medications to lower-cost therapeutic equivalents , and whether the testimonial 's efficacy increases when information is added about an affiliation the quoted individual shares with the recipient .


A total of @ union members were randomly assigned to receive @ of @ different informational letters : @ without a testimonial ( No Testimonial Group ) , @ with a testimonial from a person whose shared union affiliation with the recipient was not disclosed ( Unaffiliated Testimonial Group ) , and @ with a testimonial from a person whose shared union affiliation with the recipient was disclosed ( Affiliated Testimonial Group ) .


The conversion rate for the No Testimonial Group was @ % , which is higher than the Unaffiliated Testimonial Group rate of @ % and the Affiliated Testimonial Group rate of @ % .


The differences between the groups are not statistically significant .


Short peer testimonials do not increase the impact of a mailed communication on conversion rates to lower-cost , therapeutically equivalent medications , even when the testimonial is presented as coming from a more socially proximate peer


Chronic systemic inflammation is common in patients with chronic kidney disease on dialysis ( CKD@D ) and has been considered a key mediator of the increased cardiovascular risk in this patient population .


In this study , we tested the hypothesis that supplementation of omega-@ polyunsaturated fatty acids ( -@ PUFAs ) will attenuate the systemic inflammatory process in CKD@D patients .


The design was a randomized , double-blinded , placebo controlled pilot trial ( NCT@ ) .


Thirty-eight patients were randomly assigned in a @ : @ fashion to receive @ g of eicosapentaenoic acid ( C@ :@ , n-@ ) plus docosahexaenoic acid ( C@ :@ , n-@ ) versus placebo for @ weeks .


The primary outcome was change in pro-inflammatory chemokines measured by lipopolysaccharide ( LPS ) - stimulated peripheral blood mononuclear cells ( PBMCs ) .


Secondary outcomes were changes in systemic inflammatory markers .


Analysis of covariance was used to compare percent change from baseline to @ weeks .


Thirty-one patients completed @ weeks and three patients completed @ weeks of the study .


Median age was @ ( interquartile range @ , @ ) years , @ % were African-American and @ % were male .


Supplementation of -@ PUFAs effectively decreased the LPS-induced PBMC expression of RANTES ( Regulated upon Activation , Normal T cell Expressed and Secreted ) and MCP-@ ( Monocyte Chemotactic Protein-@ ; unadjusted P = @ and @ ; adjusted for demographics P = @ and @ , respectively ) .


There was no significant effect of the intervention on serum inflammatory markers ( C-reactive protein , interleukin-@ and procalcitonin ) .


The results of this pilot study suggest that supplementation of -@ PUFAs is beneficial in decreasing the levels of endothelial chemokines , RANTES and MCP-@ .


Studies of larger sample size and longer duration are required to further evaluate effects of -@ PUFAs on systemic markers of inflammation , other metabolic parameters and clinical outcomes , particularly cardiovascular outcomes in CKD@D patients .


This large-scale randomized study aimed to show the noninferiority in terms of diagnostic performance of gadoterate meglumine-enhanced versus gadobutrol-enhanced @-T MR angiography ( MRA ) using digital subtraction angiography ( DSA ) as the reference standard in patients with peripheral arterial occlusive disease ( PAOD ) .


In this prospective international randomized double-blind phase IV trial , @ patients were enrolled .


Of them , @ could be included in the per-protocol population for on-site assessments and @ for off-site readings .


Subjects underwent peripheral MRA , after injection of @ mmol/kg of either gadoterate meglumine or gadobutrol , and DSA within @ days .


The diagnostic accuracy was evaluated and compared using a noninferiority analysis .


Secondary endpoints included sensitivity , specificity , diagnostic confidence , contrast-to-noise ratio , and signal-to-noise ratio evaluations .


The percentage agreement between MRA and DSA for stenosis detection was similar for on-site readings for both groups ( mean SD , @ % @ % with gadoterate meglumine vs @ % @ % with gadobutrol ; @ % difference ) , and the same was true for off-site readings ( @ % @ % with gadoterate meglumine vs @ % @ % with gadobutrol ; @ % difference ) .


The noninferiority of gadoterate meglumine to gadobutrol was shown for both on - and off-site readings .


Sensitivity in detecting significant stenosis ( > @ % ) was @ % for gadoterate meglumine versus @ % for gadobutrol , whereas specificity ( @ % vs @ % ) , diagnostic confidence ( @ % vs @ % ) , signal-to-noise ratio ( @ vs @ ) , and contrast-to-noise ratio ( @ vs @ ) did not differ statistically significantly between the two groups .


Gadoterate meglumine was found to be not inferior to gadobutrol in terms of diagnostic performance in patients with PAOD undergoing @-T contrast-enhanced MRA .


No statistically significant differences were detected between the two MRA groups .


The Scandinavian Candesartan Acute Stroke Trial ( SCAST ) found no benefits of blood pressure-lowering treatment with candesartan in acute stroke .


We have investigated whether the effect of treatment is different in different subtypes of ischemic stroke .


SCAST was a randomized - and placebo-controlled trial of candesartan in @ patients presenting within @ hours of ischemic or hemorrhagic stroke and systolic blood pressure @ mm Hg .


Ischemic stroke subtype was categorized by the Oxfordshire Community Stroke Project classification .


There were @ primary effect variables : the composite vascular end point of vascular death , myocardial infarction , or stroke during the first @ months and functional outcome at @ months .


A total of @ patients with ischemic stroke were included : total anterior circulation infarcts in @ , partial anterior in @ , posterior in @ , and lacunar in @ patients .


For functional outcome there was a significant trend toward a better effect of candesartan in patients with larger infarcts ( total anterior circulation or partial anterior circulation ) than in patients with smaller infarcts ( lacunar infarction ; P = @ ) .


For the composite vascular end point , there were no differences in treatment effect .


The results suggest that the effect of blood pressure-lowering treatment with candesartan may differ according to different types of acute ischemic stroke , but this needs to be confirmed in future trials .


To evaluate the efficacy and safety of oral lubiprostone for relieving symptoms of opioid-induced constipation ( OIC ) in patients with chronic noncancer pain .


Prospective , randomized , double-blind , placebo-controlled trial .


Seventy-nine US and Canadian centers .


Patients aged @ years with OIC , defined as < @ spontaneous bowel movements ( SBMs ) per week .


Patients received lubiprostone @ mcg or placebo twice daily for @ weeks .


The primary endpoint was change from baseline in SBM frequency at week @ .


Among randomized patients ( N = @ ; lubiprostone , N = @ ; placebo , N = @ ) , most completed the study ( lubiprostone , @ % ; placebo , @ % ) .


The safety and efficacy ( intent-to-treat ) populations included @ ( lubiprostone , N = @ ; placebo , N = @ ) and @ ( lubiprostone , N = @ ; placebo , N = @ ) patients , respectively .


The mean ( standard deviation ) age was @ ( @ ) years ; most patients were female ( @ % ) and white ( @ % ) .


Changes from baseline in SBM frequency rates were significantly higher at week @ ( P = @ ) and overall ( P = @ ) in patients treated with lubiprostone compared with placebo .


Pairwise comparisons showed significantly greater overall improvement for abdominal discomfort ( P = @ ) , straining ( P < @ ) , constipation severity ( P = @ ) , and stool consistency ( P < @ ) with lubiprostone compared with placebo .


Moreover , patients rated the effectiveness of lubiprostone as significantly ( P < @ ) better than placebo for @ of @ weeks .


The most common treatment-related adverse events ( AEs ) with lubiprostone and placebo were nausea ( @ % vs @ % , respectively ) , diarrhea ( @ % vs @ % ) , and abdominal distention ( @ % vs @ % ) .


No lubiprostone-related serious AEs occurred .


Lubiprostone effectively relieved OIC and associated signs and symptoms and was well tolerated in patients with chronic noncancer pain ( http://clinicaltrials.gov/ct@/show/NCT@ ) .


Despite the efforts of the healthcare community to improve the quality of diabetes care , about @ % of people with type @ diabetes do not reach their treatment targets , increasing the risk of future micro-and macro-vascular complications .


Diabetes self-management education has been shown to contribute to better disease control .


However , it is not known which strategies involving educational programs are cost-effective .


Telehealth applications might support chronic disease management .


Transferability of successful distant patient self-management support programs to the Belgian setting needs to be confirmed by studies of a high methodological quality .


`` The COACH Program '' was developed in Australia as target driven educational telephone delivered intervention to support people with different chronic conditions .


It proved to be effective in patients with coronary heart disease after hospitalization .


Clinical and cost-effectiveness of The COACH Program in people with type @ diabetes in Belgium needs to be assessed .


Randomized controlled trial in patients with type @ diabetes .


Patients were selected based on their medication consumption data and were recruited by their sickness fund .


They were randomized to receive either usual care plus `` The COACH Program '' or usual care alone .


The study will assess the difference in outcomes between groups .


The primary outcome measure is the level of HbA@c .


The secondary outcomes are : Total Cholesterol , LDL-Cholesterol , HDL-Cholesterol , Triglycerides , Blood Pressure , body mass index , smoking status ; proportion of people at target for HbA@c , LDL-Cholesterol and Blood Pressure ; self-perceived health status , diabetes-specific emotional distress and satisfaction with diabetes care .


The follow-up period is @ months .


Within-trial and modeled cost-utility analyses , to project effects over life-time horizon beyond the trial duration , will be undertaken from the perspective of the health care system if the intervention is effective .


The study will enhance our understanding of the potential of telehealth in diabetes management in Belgium .


Research on the clinical effectiveness and the cost-effectiveness is essential to support policy makers in future reimbursement and implementation decisions .


Diet and exercise interventions for cancer survivors result in health benefits ; however , few studies have examined health outcomes in relation to adherence .


We examined associations between adherence to components of a diet-exercise intervention and survivors ' physical and mental health .