To evaluate efficacy , safety , and tolerability efinaconazole topical solution , @ % in diabetic patients with onychomycosis .


A post-hoc analysis of @ patients , aged @-@ years , randomized to receive efinaconazole topical solution , @ % or vehicle from two identical multicenter , double-blind , vehicle-controlled @-week studies evaluating safety and efficacy .


The primary end point was complete cure rate ( @ % clinical involvement of target toenail , and both negative potassium hydroxide examination and fungal culture ) at week @ .


Mycologic cure rates ( OC ) were significantly greater with efinaconazole ( @ % and @ % in diabetic and non-diabetic patients respectively ) compared to vehicle ( P = @ and P < @ , respectively ) .


The primary end point , complete cure , was also greater for efinaconazole ( @ % and @ % , respectively vs @ % and @ % ) .


Treatment success ( percent affected target toenail @ % ) for efinaconazole was @ % and @ % , respectively vs @ % and @ % with vehicle .


There was no statistically significant difference between the diabetic and non-diabetic populations for any efficacy endpoint .


Adverse events associated with efinaconazole were local site reactions and clinically similar to vehicle .


Once daily efinaconazole topical solution , @ % may provide a useful topical option in the treatment of diabetic patients with onychomycosis .


Allergic rhinitis is a chronic illness , affecting @ to @ % of the worldwide population .


Chinese herbal medicines , the treatment of allergic rhinitis , adopted thousands of years in ancient China , has recently raised much attention among researchers globally .


This study evaluates the effects of two Chinese herbal formulae -LSB- Cure-allergic-rhinitis Syrup ( CS ) and Yu-ping-feng San ( YS ) -RSB- in treating undergraduate nursing students with allergic rhinitis over a @-month follow-up , when compared to a placebo control group .


A double-blind , randomised controlled trial with repeated-measures , three-parallel-groups design was conducted in a random sample of @ participants recruited from one university in Hong Kong .


After baseline measurements , participants were randomly assigned to CS , YS , or placebo groups ( n = @ per group ) .


The main outcomes , including symptom severity , quality of life , and body constitution , were measured with self-administered questionnaires at baseline and immediately , @ and @ months after the @-week interventions .


@ participants completed the trial , with @ ( @ % ) drop-outs .


The results of Generalised Estimating Equations test followed by pairwise contrasts tests indicated that the participants who received CS showed significantly greater reduction of symptoms ( mean difference of CS vs. placebo = @-@ @ , P < @ ) and improvements in quality of life ( mean difference of CS vs. placebo = @-@ @ , P < @ ) , and body constitution in ` Qi-deficiency ' , ` Yang-deficiency ' , and ` Inherited Special ' ( mean difference of CS vs. placebo = @-@ @ , @-@ @ , and @-@ @ , P = @ - < @ , @-@ @ , and @ - < @ , accordingly , at three post-tests ) .


The participants who received YS also indicated significant greater improvements in symptom severity , quality of life , and a few patterns of body constitution when compared to the placebo group .


However , its effects were lesser in strength ( i.e. , smaller effect sizes ) , varieties of symptoms , and body constitution and sustainability over the @ months .


The herbal formula CS was found effective to reduce symptoms and enhance quality of life in young adults ( nursing students ) with allergic rhinitis in ` Yang - and/or Qi-deficiency ' body constitution .


Further controlled trials of its effects in Chinese and/or Asians with allergic rhinitis in terms of socio-demographic , ethnic and illness characteristics and a longer-term follow-up are recommended .


To determine the impact of educational materials ( EMs ) on the treatment compliance of postmenopausal women with hormone receptor-positive ( HR + ) early-stage breast cancer .


Patients ( n = @ ) were randomized to standard aromatase inhibitors ( AI ) alone ( group A ) or with EMs ( group B ) in a global , real-world setting .


The @-year results ( n = @ ) showed EMs had no impact on compliance ( @ vs. @ % , group A vs. B ) , compliance with initial AI ( @ vs. @ % ) or persistence ( @ vs. @ % ) , confirming the @-year interim analysis ( n = @ ) .


Of the @ patients considered compliant at @ year , @ % remained compliant at @ years .


Discontinuations ( @ % ) were mainly attributed to AI-related side effects ( @ % of discontinuations ) .


Exploratory analyses suggest a relationship between patient characteristics and compliance behaviors .


EMs do not improve compliance in this patient population .


Compliance and persistence are complex end points influenced by multiple variables .


Side effects were the main reasons for discontinuations .


To determine whether the method of specimen preparation after transrectal ultrasound-guided biopsy of the prostate affected core fragmentation , and secondly to determine whether such fragmentation was influenced by the presence of malignancy in the biopsy specimen .


A prospective randomized study comparing @ different mechanisms of specimen preparation , wash vs swipe of biopsy cores , with blinded assessment by a specific uropathologist was undertaken .


For those cores in which prostate cancer was present , the wash method of specimen preparation resulted in fewer and longer core fragments ( P = @ ) .


Those patients in whom cancer was present on biopsy also had a greater degree of biopsy core fragmentation in those cores in which only benign tissue was identified ( P = @ ) .


Gleason score did not appear to influence the extent of fragmentation .


The method of specimen preparation at prostate biopsy influences the degree of fragmentation seen at histologic evaluation .


This has the potential to affect the interpretation of biopsy results , including suitability of patients for inclusion in active surveillance protocols .


Core fragmentation might be minimized by modification of technique .


With aging , the detrimental effects of stress can impair a person 's ability to learn and sustain memory .


Humor and its associated mirthful laughter can reduce stress by decreasing the hormone cortisol .


Chronic release of cortisol can damage hippocampal neurons , leading to impairment of learning and memory .


Objectives The study intended to examine the effect of watching a humor video on short-term memory in older adults .


Design The research team designed a randomized , controlled trial .


The study took place at Loma Linda University in Loma Linda , CA , USA .


The study included @ participants : @ normal , healthy , older adults-@ males and @ females-and @ older adults with type @ diabetes mellitus ( T@DM ) -@ males and @ females .


The study included @ intervention groups of older adults who viewed humorous videos , a healthy group ( humor group ) , aged @ @ y , and the diabetic group , aged @ @ y. Each participant selected @ of @ humorous videos that were @ min in length , either a Red Skeleton comedy or a montage of America 's Funniest Home Videos .


The control group , aged @ @ y , did not watch a humor video and sat in quiescence .


A standardized , neuropsychological , memory-assessment tool , the Rey Auditory Verbal Learning Test ( RAVLT ) , was used to assess the following abilities : ( @ ) learning , ( @ ) recall , and ( @ ) visual recognition .


The testing occurred twice , once before ( RAVLT@ ) and once after ( RAVLT@ ) the humorous video for the humor and diabetic groups , and once before ( RAVLT@ ) and once after ( RAVLT@ ) the period of quiescence for the control group .


At @ time points , measurements of salivary cortisol were also obtained .


The Kruskal-Wallis test was used to measure significance of the data based on the @ groups .


In the humor , diabetic , and control groups , ( @ ) learning ability improved by @ % , @ % , and @ % , respectively ( P = @ ) ; ( @ ) delayed recall improved by @ % , @ % , and @ % , respectively ( P = @ ) ; and ( @ ) visual recognition increased by @ % , @ % , and @ % , respectively ( P = @ ) .


For levels of salivary cortisol , the research team found significant and borderline decreases for the humor group between baseline and ( @ ) post-RAVLT@ ( P = @ ) , ( @ ) postvideo ( P = @ ) , and ( @ ) post-RAVLT@ ( P = @ ) .


The diabetic group showed significant decreases between baseline and ( @ ) post-RAVLT@ ( P = @ ) , ( @ ) postvideo ( P = @ ) , and ( @ ) post-RAVLT@ ( P = @ ) .


The study found no significant changes for the control group .


The research findings supported potential clinical and rehabilitative benefits for humor that can be applied to whole-person wellness programs for older adults .


The cognitive components-learning ability and delayed recall-become more challenging as individuals age and are essential to older adults for providing a high quality of life : mind , body , and spirit .


Because older adults can experience age-related memory deficits , complementary , enjoyable , and beneficial humor therapies should be implemented for them .


Statins have beneficial effects on cardiovascular morbidity and mortality independently of reduction of plasma cholesterol .


In patients with type @ diabetes and nephropathy , chronic kidney disease stage II-III , we tested the hypothesis that atorvastatin increased systemic and renal nitric oxide ( NO ) availability using L-NMMA as an inhibitor of NO production .


We performed a randomized , placebo-controlled , crossover study , using atorvastatin/placebo treatment for five days with a standardized diet and fluid intake .


We measured brachial BP ( bBP ) , central BP ( cBP ) , GFR , urinary output ( OU ) , free water clearance ( CH@O ) , fractional excretion of sodium ( FENa ) , urinary excretion of albumin ( UAER and UACR ) , AQP@ ( u-AQP@ ) and ENaC ( u-ENaC ) and plasma concentrations of vasoactive hormones : renin , angiotensin II , aldosterone , arginine vasopressin , endothelin-@ and brain natriuretic peptide .


During atorvastatin and placebo treatment , L-NMMA infusion , changed the effect variables significantly , but to the same extent , i.e. an increase in bBP and cBP , and a decrease in GFR , OU , CH@O , FENa , u-AQP@ and u-ENaC .


In addition , renin and angiotensin II was reduced , aldosterone increased , and vasopressin , endothelin-@ and brain natriuretic hormone unchanged .


During , atorvastatin and placebo treatment , inhibition of nitric oxide synthesis induced the same response in brachial and central blood pressure , GFR , renal tubular function and vasoactive hormones .


Thus , atorvastatin did not change nitric oxide availability in type @ diabetics with nephropathy .


Despite scientific advances in typing of C. difficile strains very little is known about how hospital staff use typing results during periods of increased incidence ( PIIs ) .


This qualitative study , undertaken alongside a randomised controlled trial ( RCT ) , explored this issue .


The trial compared ribotyping versus more rapid genotyping ( MLVA or multilocus variable repeat analysis ) and found no significant difference in post @ hour cases ( C difficile transmissions ) .


In-depth qualitative interviews with senior staff in @/@ hospital trusts in the trial ( @ MLVA and @ Ribotyping ) .


Semi-structured interviews were conducted at end of the trial period .


Transcripts were content analysed using framework analysis supported by NVivo-@ software .


Common sub-themes were extracted by two researchers independently .


These were compared and organised into over-arching categories or ` super-ordinate themes ' .


The trial recorded that @ % of typing tests had some impact on infection control ( IC ) activities .


Interviews indicated that tests had little impact on initial IC decisions .


These were driven by hospital protocols and automatically triggered when a PII was identified .


To influence decision-making , a laboratory turnaround time < @ days ( ideally @ hours ) was suggested ; MLVA turnaround time was @ days .


Typing results were predominantly used to modify initiated IC activities such as ward cleaning , audits of practice or staff training ; major decisions ( e.g. ward closure ) were unaffected .


Organisational factors could limit utilisation of MLVA results .


Results were twice as likely to be reported as ` aiding management ' ( indirect benefit ) than impacting on IC activities ( direct effect ) .


Some interviewees considered test results provided reassurance about earlier IC decisions ; others identified secondary benefits on organisational culture .


An underlying benefit of improved discrimination provided by MLVA typing was the ability to explore epidemiology associated with CDI cases in a hospital more thoroughly .


Ribotyping and MLVA are both valued by users .


MLVA had little additional direct impact on initial infection control decisions .


This would require reduced turnaround time .


The major impact is adjustments to earlier IC measures and retrospective reassurance .


For this , turnaround time is less important than discriminatory power .


The potential remains for wider use of genotyping to examine transmission routes .


To test whether red blood cell ( RBC ) levels of marine omega-@ fatty acids measured in the Women 's Health Initiative Memory Study were related to MRI brain volumes measured @ years later .


RBC eicosapentaenoic acid ( EPA ) , docosahexaenoic acid ( DHA ) , and MRI brain volumes were assessed in @,@ postmenopausal women from the Women 's Health Initiative Memory Study .


The endpoints were total brain volume and anatomical regions .


Linear mixed models included multiple imputations of fatty acids and were adjusted for hormone therapy , time since randomization , demographics , intracranial volume , and cardiovascular disease risk factors .


In fully adjusted models , a @ SD greater RBC EPA + DHA ( omega-@ index ) level was correlated with @ cm ( @ ) larger brain volume ( p = @ ) .


DHA was marginally correlated ( p = @ ) with total brain volume while EPA was less so ( p = @ ) .


There were no correlations between ischemic lesion volumes and EPA , DHA , or EPA + DHA .


A @ SD greater omega-@ index was correlated with greater hippocampal volume ( @ mm ( @ ) , p = @ ) in fully adjusted models .


Comparing the fourth quartile vs the first quartile of the omega-@ index confirmed greater hippocampal volume ( @ mm ( @ ) , p = @ ) .


A higher omega-@ index was correlated with larger total normal brain volume and hippocampal volume in postmenopausal women measured @ years later .


While normal aging results in overall brain atrophy , lower omega-@ index may signal increased risk of hippocampal atrophy .


Future studies should examine whether maintaining higher RBC EPA + DHA levels slows the rate of hippocampal or overall brain atrophy .


To evaluate the analgesic and physiological effects of epidural morphine administered at the sixth and seventh lumbar or the fifth and sixth thoracic vertebrae in dogs undergoing thoracotomy .


Prospective , randomized , blinded trial .


Fourteen mixed-breed dogs , weighing @ @ kg .


The animals received acepromazine ( @ mg kg ) IM and anesthesia was induced with propofol ( @ mg kg ) IV .


The lumbosacral space was punctured and an epidural catheter was inserted up to the region between the sixth and seventh lumbar vertebrae ( L , n = @ ) or up to the fifth or sixth intercostal space ( T , n = @ ) .


The dogs were allowed to recover and after radiographic confirmation of correct catheter position , anesthesia was reinduced with propofol IV and maintained with @ % isoflurane .


Following stabilization of monitored parameters , animals received morphine ( @ mg kg ) diluted in @ % NaCl to a final volume of @ mL kg via the epidural catheter , and after @ minutes , thoracotomy was initiated .


Heart rate and rhythm , systolic , mean and diastolic arterial pressures , respiratory rate , arterial hemoglobin oxygen saturation , partial pressure of expired CO and body temperature were measured immediately before the epidural administration of morphine ( @ minute ) and every @ minutes during the anesthetic period .


The Melbourne pain scale and the visual analog scale were used to assess postoperative pain .


The evaluation began @ hours after the epidural administration of morphine and occurred each hour until rescue analgesia .


There were no important variations in the physiological parameters during the anesthetic period .


The post-operative analgesic period differed between the groups , being longer in T ( @ @ hours ) compared with L ( @ @ hours ) .


The use of morphine , at a volume of @ mL kg @ , administered epidurally over the thoracic vertebrae provided longer lasting analgesia than when deposited over the lumbar vertebrae .


There are no randomized studies that compare outcomes after single-incision ( SLC ) and conventional multi-incision ( MLC ) laparoscopic cholecystectomy under an optimized perioperative analgesic regimen .


This patient - and assessor-blinded randomized three-centre clinical trial compared SLC and MLC in women admitted electively with cholecystolithiasis .


Outcomes were registered on the day of operation ( day @ ) , on postoperative days @ , @ , @ and @ , and @months after surgery .


Blinding of the patients was maintained until day @ .


The primary endpoint was pain on movement measured on a visual analogue scale , reported repeatedly by the patient until day @ .


The intention-to-treat population comprised @ patients in the SLC and @ in the MLC group .


There was no significant difference between the groups with regard to any of the pain-related outcomes , on-demand administration of opioids or general discomfort .


Median duration of surgery was @min longer in the SLC group ( P < @ ) .


SLC was associated with a reduced incidence of vomiting on day @ ( @ versus @ per cent ; P = @ ) .


The incidences of wound-related problems were comparable .


One patient in the SLC group experienced a biliary leak requiring endoscopic retrograde cholangiopancreatography .


The rates of incisional hernia at @-month follow-up were @ per cent in both groups .


Cosmetic rating was significantly improved after SLC at @ and @months ( P < @ ) .


SLC did not significantly diminish early pain in a setting with optimized perioperative analgesic patient care .


SLC may reduce postoperative vomiting .


The efficacy of artemisinin-based combination therapy ( ACT ) has been established .


The objective of the present study was to compare the efficacy and safety in the Central African Republic ( CAR ) of three commercially available artemisinin-based combinations , artemether + lumefantrine ( AL ) , artesunate + sulphamethoxypyrazine-pyrimethamine ( AS-SMP ) and artesunate + amodiaquine ( AS-AQ ) , with those of sulphadoxine-pyrimethamine + amodiaquine ( SP-AQ ) , which was the first-line reference treatment in the country from @ , until it was replaced by ACT in @ in accordance with changes in international recommendations based on resistance identified in other regions .


Children aged six to @ months with uncomplicated Plasmodium falciparum malaria were recruited in Bangui , the capital of the CAR .


The @ patients selected were randomly assigned to receive AL ( n = @ ) , AS-SMP ( n = @ ) , AS-AQ ( n = @ ) or SP-AQ ( n = @ ) and were followed up for @ days .


Clinical outcome was classified according to the standard @ World Health Organization protocol .


At day @ , the cure rates in a per-protocol analysis were @ % ( @/@ ) with AL , @ % ( @/@ ) with AS-SMP , @ % ( @/@ ) with AS-AQ and @ % ( @/@ ) with SP-AQ , with no statistically significant difference between the four treatments .


Defervescence was significantly faster with AS-AQ than with AL ( p < @ ) .


Fatigue was reported significantly more frequently by patients receiving AQ than by those treated with AS-SMP or AL ( p = @ ) .


All the other adverse events reported were mild , and no significant difference was noted by treatment .


The three artemisinin-bsed combinations show similar , satisfactory results , comparable to that with SP-AQ .


This evaluation is the first conducted in CAR since the official introduction of ACT .


It should guide the National Malaria Control Programme in choosing the appropriate ACT for treatment of uncomplicated P. falciparum malaria in the future .


The control of body lice in homeless persons remains a challenge .


To determine whether the use of long-lasting insecticide-treated underwear provides effective long-term protection against body lice in homeless persons .


A randomized , double-blind , placebo-controlled trial was conducted in February and December @ in @ homeless shelters ( Madrague Ville and Forbin ) in Marseille , France .


Of the @ homeless persons screened for eligibility , @ body lice-infested homeless persons , @ years or older , were enrolled .


Body lice-infested homeless persons were randomly assigned to receive @ % permethrin-impregnated underwear or an identical-appearing placebo for @ days , in a @:@ ratio , with a permuted block size of @ .


Visits were scheduled at days @ and @ .


Data regarding the presence or absence of live body lice were collected .


The primary and secondary end points were the proportions of homeless persons free of body lice on days @ and @ , respectively .


Mutations associated with permethrin resistance in the body lice were also identified .


Significantly more homeless persons receiving permethrin-impregnated underwear than homeless persons receiving the placebo were free of body lice on day @ in the intent-to-treat population ( @ % vs @ % ; P = @ ) , with a between-group difference of @ percentage points ( @ % CI , @-@ @ ) , and in the per-protocol population ( @ % vs @ % ; P = @ ) , with a between-group difference of @ percentage points ( @ % CI , @-@ @ ) .


This difference was not sustained on day @ .


At baseline , the prevalence of the permethrin-resistant haplotype was @ % in the permethrin group and @ % in the placebo group .


On day @ , the permethrin-resistant haplotype was significantly more frequent in the permethrin group than in the placebo group ( @ % vs @ % , P < @ ) .


Permethrin-impregnated underwear is more efficient than placebo at eliminating body louse infestations by day @ ; however , this difference was not sustained on day @ .


The use of permethrin may have increased the resistance to permethrin in body lice and thus must be avoided .


Animal studies have shown that methylphenidate ( MPH ) and fluoxetine ( FLX ) have different effects on dopaminergic and serotonergic system in the developing brain compared to the developed brain .


The effects of Psychotropic drugs On the Developing brain ( ePOD ) study is a combination of different approaches to determine whether there are related findings in humans .


Animal studies were carried out to investigate age-related effects of psychotropic drugs and to validate new neuroimaging techniques .


In addition , we set up two double-blind placebo controlled clinical trials with MPH in @ boys ( @-@ years ) and @ young men ( @-@ years ) suffering from ADHD ( ePOD-MPH ) and with FLX in @ girls ( @-@ years ) and @ young women ( @-@ years ) suffering from depression and anxiety disorders ( ePOD-SSRI ) .


Trial registration numbers are : Nederlands Trial Register NTR@ and NTR@ .


A cross-sectional cohort study on age-related effects of these psychotropic medications in patients who have been treated previously with MPH or FLX ( ePOD-Pharmo ) is also ongoing .


The effects of psychotropic drugs on the developing brain are studied using neuroimaging techniques together with neuropsychological and psychiatric assessments of cognition , behavior and emotion .


All assessments take place before , during ( only in case of MPH ) and after chronic treatment .


The combined results of these approaches will provide new insight into the modulating effect of MPH and FLX on brain development .


Cigarette demand , or the change in cigarette consumption as a function of price , is a measure of reinforcement that is associated with level of tobacco dependence and other clinically relevant measures , but the effects of experimentally controlled income on real-world cigarette consumption have not been examined .


In this study , income available for cigarette purchases was manipulated to assess the effect on cigarette demand .


Tobacco-dependent cigarette smokers ( n = @ ) who smoked @-@ cigarettes per day completed a series of cigarette purchasing tasks under a variety of income conditions meant to mimic different weekly cigarette budgets : $ @ , approximately $ @ , $ @ , or approximately $ @ per week .


Prices of $ @ , $ @ , $ @ , and $ @ per cigarette were assessed in each income condition .


Participants were instructed to purchase as many cigarettes as they would like for the next week and to only consume cigarettes purchased in the context of the study .


One price in @ income condition was randomly chosen to be `` real , '' and the cigarettes and the excess money in the budget for that condition were given to the participant .


Results indicate that demand elasticity was negatively correlated with income .


Demand intensity ( consumption at low prices ) was unrelated to income condition and remained high across incomes .


These results indicate that the amount of income that is available for cigarette purchases has a large effect on cigarette consumption , but only at high prices .


Fibrates were found to reduce cytokine release and low-grade inflammation in patients with impaired glucose tolerance .


The aim of this study was to investigate whether these effects of fibrates may be potentiated by metformin treatment .


The study included @ patients with isolated impaired glucose tolerance and normal plasma lipids who had been treated for at least @ months with micronized fenofibrate ( @ mg daily ) .


These subjects were randomly assigned to @ weeks ' treatment with either high dose metformin ( @ g daily in three divided doses ) or placebo .


Plasma lipids , glucose homeostasis markers , monocyte cytokine release and plasma C-reactive protein levels were determined before randomization and at the end of the treatment .


Metformin treatment reduced plasma C-reactive protein levels and monocyte release of tumor necrosis factor - and interleukin-@ , as well as tended to reduce monocyte release of interleukin-@ and monocyte chemoattractant protein-@ , which was accompanied by an improvement in insulin sensitivity .


Our results show that high-dose metformin produces monocyte-suppressing and systemic anti-inflammatory effects in fibrate-treated patients with isolated impaired glucose tolerance .


This suggests that fibrate-metformin combination therapy may bring clinical benefits to impaired glucose tolerance patients at high cardiovascular risk .


New models of health care delivery for dermatological care have the potential to increase access and improve patient-centered outcomes .


To compare effectiveness of a direct-access , online model for follow-up dermatologic care in pediatric and adult patients with atopic dermatitis with that of in-person office visits .


This was a @-year , randomized controlled equivalency clinical trial in medically underserved areas , outpatient clinics , and the general community .


Participants included children and adults with atopic dermatitis with access to the Internet , computers , and digital cameras .


After an initial in-person visit , patients were randomized @:@ to direct-access online or usual in-person care for follow-up management of atopic dermatitis .


In the direct-access online group , patients captured and transmitted clinical images and history asynchronously to dermatologists online ; dermatologists evaluated the clinical information , provided recommendations and education , and prescribed medications online asynchronously .


In the in-person group , patients visited dermatologists in their offices for follow-up care .


Atopic dermatitis disease severity as assessed by patient-oriented eczema measure ( POEM ) and investigator global assessment ( IGA ) .


A total of @ children and adults were randomized .


Between baseline and @ months , the mean ( SD ) within-group difference in POEM score in patients in the direct-access online group was -@ ( @ ) ( @ % CI , -@ to -@ ) ; in the in-person group , the within-group difference was -@ ( @ ) ( @ % CI , -@ to -@ ) .


The difference in the change in POEM scores between the @ groups was @ ( @ ) ( @ % CI , -@ to @ ) , which was contained within the predetermined @ equivalence margin .


The percentage of patients achieving clearance or near-clearance of their disease ( IGA score of @ or @ ) was @ % ( @ % CI , @ % to @ % ) in the direct-access online group and @ % ( @ % CI , @ % -@ % ) in the in-person group .


The difference in the percent of patients achieving clearance or near-clearance between the @ groups was @ % ( @ % CI , @ % -@ % ) , which was contained within the predetermined @ % equivalence margin .


The direct-access online model results in equivalent improvements in atopic dermatitis clinical outcomes as in-person care .


Direct-access online care may represent an innovative model of delivering dermatological services to patients with chronic skin diseases .


We report the results of the investigation of safety and efficacy of venous angioplasty in patients with multiple sclerosis ( MS ) with findings of extracranial venous anomalies , considered hallmarks of chronic cerebrospinal venous insufficiency ( CCSVI ) , in a @-phase study ( ClinicalTrials.gov NCT@ ) .


Phase @ was an open-label safety study ( @ patients ) ; phase @ was sham-controlled , randomized , and double-blind ( @ sham procedure , @ treated ) .


All study patients fulfilled venous hemodynamic screening criteria indicative of CCSVI .


Assessment was at @ , @ , and @ months postprocedure with MRI , clinical , and hemodynamic outcomes .


Primary endpoints were safety at @ hours and @ month , venous outflow restoration > @ % at @ month , and effect of angioplasty on new lesion activity and relapse rate over @ months .


Secondary endpoints included changes in disability , brain volume , cognitive tests , and quality of life .


No perioperative complications were noted ; however , one patient with history of syncope was diagnosed with episodic bradycardia requiring placement of a pacemaker before discharge .


Doppler evidence-based venous hemodynamic insufficiency severity score ( VHISS ) was reduced > @ % compared to baseline in phase @ ( at @ month ) but not phase @ .


In phase @ , higher MRI activity ( cumulative number of new contrast-enhancing lesions -LSB- @ vs @ , p = @ -RSB- and new T@ lesions -LSB- @ vs @ , p = @ -RSB- ) and relapse activity ( @ vs @ , p = @ ) were identified as nonsignificant trends in the treated vs sham arm over @ months .


Using analysis of covariance , significant cumulative new T@ lesions were related to larger VHISS decrease ( p = @ ) and angioplasty ( p = @ ) over the follow-up .


No differences in other endpoints were detected .


Venous angioplasty is not an effective treatment for MS over the short term and may exacerbate underlying disease activity .


This is a Class I study demonstrating that clinical and imaging outcomes are no better or worse in patients with MS identified with venous outflow restriction who receive venous angioplasty compared to sham controls who do not receive angioplasty .


This study also includes a Class IV phase @ study of safety in @ patients receiving the angioplasty procedure .


Previous efforts such as Assessing Care of Vulnerable Elders ( ACOVE ) provide quality indicators for assessing the care of elderly patients , but thus far little has been done to leverage this knowledge to improve care for these patients .


We describe a clinical decision support system to improve general practitioner ( GP ) adherence to ACOVE quality indicators and a protocol for investigating impact on GPs ' adherence to the rules .


We propose two randomized controlled trials among a group of Dutch GP teams on adherence to ACOVE quality indicators .


In both trials a clinical decision support system provides un-intrusive feedback appearing as a color-coded , dynamically updated , list of items needing attention .


The first trial pertains to real-time automatically verifiable rules .


The second trial concerns non-automatically verifiable rules ( adherence can not be established by the clinical decision support system itself , but the GPs report whether they will adhere to the rules ) .


In both trials we will randomize teams of GPs caring for the same patients into two groups , A and B. For the automatically verifiable rules , group A GPs receive support only for a specific inter-related subset of rules , and group B GPs receive support only for the remainder of the rules .


For non-automatically verifiable rules , group A GPs receive feedback framed as actions with positive consequences , and group B GPs receive feedback framed as inaction with negative consequences .


GPs indicate whether they adhere to non-automatically verifiable rules .


In both trials , the main outcome measure is mean adherence , automatically derived or self-reported , to the rules .


We relied on active end-user involvement in selecting the rules to support , and on a model for providing feedback displayed as color-coded real-time messages concerning the patient visiting the GP at that time , without interrupting the GP 's workflow with pop-ups .


While these aspects are believed to increase clinical decision support system acceptance and its impact on adherence to the selected clinical rules , systems with these properties have not yet been evaluated .


To evaluate whether preterm very low birth weight ( VLBW ) infants receiving early iron ( EI ) supplementation ( @ mg/kg/day elemental iron ) at @ weeks postnatal age have improved serum ferritin levels compared with late iron ( LI ) supplementation at @ weeks postnatal age .


Single-blinded parallel-group interventional randomised controlled trial .


Tertiary care centre in southern India .


Randomised at @ weeks postnatal age to EI and LI groups and evaluated at @ , @ and @ weeks postnatal age .


The primary outcome was serum ferritin level at @ weeks , and the secondary outcomes were the incidence of neonatal morbidities , haemoglobin level , anthropometric parameters and blood transfusion requirements .


Of the @ babies randomised , outcomes were analysed in @ and @ babies in EI and LI groups , respectively .


Serum ferritin level was significantly higher ( p < @ ) at @ weeks ( @ vs @ ng/mL ) in the EI group .


Haemoglobin ( @ vs @ g/dL ) and mean corpuscular haemoglobin concentration ( @ vs @ g/dL ) were also significantly ( p < @ ) higher at @ weeks in the EI group .


There was a significant decrease of ferritin in the LI group and significant increase in ferritin in the EI group at @ weeks compared with @ weeks .


There were no significant differences in the incidences of neonatal morbidities ( necrotising enterocolitis , periventricular leukomalacia , retinopathy of prematurity ) , anthropometric parameters and blood transfusion requirements between the two groups .


EI supplementation in preterm VLBW infants improves serum ferritin and haemoglobin levels .


To investigate whether providing sonographic ( US ) / MRI fusion images will enhance the ability of medical students and radiology residents to identify MSK anatomy on sonograms alone .


Medical students ( n = @ ) and radiology residents ( n = @ ) were each randomly divided into two groups : Group A and Group B. Subjects in Group A were shown @ MSK sonograms with arrows pointing to a specific anatomic structure or anatomic region .


Subjects in Group B were shown the exact same @ annotated sonograms as Group A as well as an additional fusion image consisting of an MRI of the same anatomy in the same plane fused with the sonogram without arrows .


Sonograms and MRI were obtained from adult patients who consented to have their images used .


The anatomic regions included the shoulder , hip , and pelvis .


Both groups were given the same @-question multiple choice examination to identify the anatomic structure that the arrow was marking on the sonogram .


The transducer 's location was given for every question .


One minute was allowed to answer each question .


The Wilcoxon rank sum test was used to assess if there was a difference between Group A and Group B in both the medical student and the radiology resident cohorts .


Medical students : subjects in Group A ( n = @ ) gave the correct answers in @ % of the cases ( @/@ ) .


Subjects in Group B ( n = @ ) gave correct answers in @ % of the cases ( @/@ ) ( p value < @ ) .


Radiology residents : subjects in Group A ( n = @ ) gave correct answers in @ % of the cases ( @/@ ) .


The addition of a fusion MRI/US image enhances radiology residents ' ability to identify MSK US anatomy accurately compared with the sonogram alone .


The medical students , however , did not show improvement with the addition of the fusion MRI/sonogram .


Penetrating keratoplasty can commonly restore vision in corneal blindness .


However , immunological graft reactions may induce irreversible graft failure in a substantial percentage .


Repeat keratoplasties in turn are associated with increased risk of graft failure and possibly irreversible blindness .


Topical as well as systemic immunosuppressants are administered for prophylaxis .


However , severe adverse effects limit long-term usage .


By contrast , matching for transplantation antigens might be effective for a long time .


FANCY is a prospective , controlled , randomised , double-blind , multi-centre clinical trial with two parallel arms .


The primary objective is to evaluate superiority of the proposed HLA matching strategy in comparison to random graft assignment with respect to the primary endpoint ` time to first endothelial graft rejection ' .


Relevant inclusion criteria are age over @years and waiting for penetrating or endothelial lamellar keratoplasty .


The most important exclusion criteria are abuse of medication and/or drugs and an anticipated waiting time for an HLA match longer than @months .


After randomisation , patients either receive a HLA-matched graft ( experimental intervention ) or a random graft ( control intervention ) .


The calculated sample size is @ patients .


The trial started in @ with a recruitment period of @months .


A total of @ patients were included during this time .


The primary goal of FANCY is to assess whether histocompatibility matching is feasible and effective in the broad clinical routine .


However , during the course of the trial , the landscape of keratoplasty changed due to the rise of Descemet Membrane Endothelial Keratoplasty ( DMEK ) .


Nowadays , immune reactions are confined mostly to the ` high-risk ' subgroups .


If we would design FANCY in @ , we would narrow down the inclusion criteria to include only the high risk patients and accept longer waiting times for a matching donor here .


We tested the impact of banning tobacco displays and posting graphic health warning signs at the point of sale ( POS ) .


We designed @ variations of the tobacco product display ( open , enclosed -LSB- not visible -RSB- , enclosed with pro-tobacco ads ) and @ variations of the warning sign ( present vs absent ) with virtual store software .


In December @ and January @ , we randomized a national convenience sample of @ adult smokers and recent quitters to @ of @ store conditions and gave them a shopping task .


We tested for the main effects of the enclosed display , the sign , and their interaction on urge to smoke and tobacco purchase attempts .


The enclosed display significantly lowered current smokers ' ( B = -@ ; @ % confidence interval -LSB- CI -RSB- = -@ , -@ ; P < @ ) and recent quitters ' ( = -@ , @ % CI = -@ , -@ ; P < @ ) urge to smoke and current smokers ' purchase attempts ( adjusted odds ratio = @ ; @ % CI = @ , @ ; P < @ ) .


The warning sign had no significant main effect on study outcomes or interaction with enclosed display .


These data show that POS tobacco displays influence purchase behavior .


Banning them may reduce cues to smoke and unplanned tobacco purchases .


Topical corticosteroids are the most common first-line treatment for psoriasis .


Tachyphylaxis , a decreased response to treatment with repetitive application of the drug , is a controversial phenomenon associated with topical corticosteroid treatment .


We sought to prove or disprove tachyphylaxis to occluded halobetasol @ % versus vehicle .


Patients with plaque psoriasis were recruited to this study .


The study involved @ phases ( @ , @A , and @B ) with each phase being separated by a treatment vacation period .


In phases @ and @A , @ plaques were randomized to either halobetasol @ % or vehicle ointment application .


In phase @B , halobetasol @ % was applied to both .


Target Lesion Severity Scale was used for clinical assessment .


Twenty patients were enrolled .


No difference in time to clearance ( P = @ ) or time to recurrence ( P = @ ) of the treated plaques was found between phases @ and @A .


Percentage of improvement was higher in phase @A compared with phase @ ( @ % , P < @ vs @ % , P < @ ) , as a result of reduction of vehicle effect .


In phase @B , a greater improvement was found for previously corticosteroid-treated plaques .


Limitations are small sample size and @ corticosteroid tested .


No evidence of tachyphylaxis to the topical corticosteroid halobetasol @ % ointment treatment in patients with plaque psoriasis was found .


A new , highly filled primer is currently marketed as a fluoride delivery system effective in reducing white spot lesions in orthodontic patients .


However , no studies in the literature support this claim .


The purpose of this in-vivo study was to investigate the retention and the efficacy of this primer in reducing the formation of white spot lesions .


In each patient for whom premolar extractions were planned ( n = @ ) , @ premolar was randomly chosen as the experimental tooth for the application of the fluoride delivery system ( Opal Seal ; Ultradent Products , South Jordan , Utah ) , and the contralateral tooth was assigned as the control to receive the standard treatment ( Transbond XT ; @M Unitek , Monrovia , Calif ) .


After the bonding procedures , separators were placed around the premolar brackets to encourage plaque retention over @ weeks .


After the extractions , the tooth surfaces were evaluated visually and with microhardness techniques for demineralization .


Primer retention was also investigated .


There were no statistically significant differences in the numbers of white spot lesions between the @ groups .


The primer retention was calculated as @ % .


The results indicated no significant difference between the efficacies of the fluoride-releasing primer and the control primer in reducing demineralization over the duration of the study .


We compared the outcomes of patients treated with everolimus-eluting stents ( EES ) versus paclitaxel-eluting stents ( PES ) at @ years from the large-scale randomized SPIRIT IV trial .


SPIRIT IV is the largest randomized trial comparing the outcomes of EES and PES .


The present report represents the final long-term follow-up analysis from this study .


A total of @,@ patients were randomized @:@ to EES or PES , stratified by presence of diabetes mellitus and lesion characteristics .


Prespecified subgroups were compared for interaction with stent allocation .


The primary end point was target lesion failure ( TLF ) ( the composite of cardiac death , target vessel-related myocardial infarction -LSB- MI -RSB- , or ischemia-driven target lesion revascularization ) .


At @ years , TLF occurred in @ % versus @ % of EES - and PES-treated patients ( hazard ratio -LSB- HR -RSB- @ -LSB- @-@ @ -RSB- , P = @ ) .


The incidence of death or MI was @ % versus @ % , respectively ( HR @ -LSB- @-@ @ -RSB- , P = @ ) , and there was a @ % reduction in stent thrombosis ( Academic Research Consortium definite or probable definition ) with EES ( @ % vs @ % , HR @ -LSB- @-@ @ -RSB- , P = @ ) .


The difference in target lesion revascularization at @ years did not reach statistical significance ( @ % vs @ % , respectively , HR @ -LSB- @-@ @ -RSB- , P = @ ) .


There was no significant interaction between treatment allocation and any of the subgroups , including diabetes .


When compared with PES , EES provides durable and significant reduction in TLF , especially due to its enhanced safety profile , with lower rates of death or MI and stent thrombosis up to @ years .


The development of minimally invasive surgical techniques is driven by the quest for better patient outcomes .


There is some evidence for the use of minimally invasive surgery for degenerative lumbar spine stenosis ( LSS ) , but there are currently no studies comparing outcomes with matched controls .


The object of this study was to compare outcomes following minimally invasive unilateral laminectomy for bilateral decompression ( ULBD ) to a standard `` open '' laminectomy for LSS .


The authors conducted a prospective , @:@ randomized trial comparing ULBD to open laminectomy for degenerative LSS .


The study enrolled @ patients between @ and @ , and adequate data for analysis were available in @ patients ( @ in each arm of the study ) .


Patient demographic characteristics and clinical characteristics were recorded and clinical outcomes were obtained using pre - and postoperative Oswestry Disability Index ( ODI ) scores , visual analog scale ( VAS ) scores for leg pain , patient satisfaction index scores , and postoperative @-Item Short Form Health Survey ( SF-@ ) scores .


Significant improvements were observed in ODI and VAS scores for both open and ULBD interventions ( p < @ for both groups using either score ) .


In addition , the ULBD-treated patients had a significantly better mean improvement in the VAS scores ( p = @ ) but not the ODI scores ( p = @ ) compared with patients in the open-surgery group .


ULBD-treated patients had a significantly shorter length of postoperative hospital stay ( @ vs. @ hours , p = @ ) and time to mobilization ( @ vs. @ hours , p < @ ) and were more likely to not use opioids for postoperative pain ( @ % vs. @ % , p = @ ) .


Based on short-term follow-up , microscopic ULBD is as effective as open decompression in improving function ( ODI score ) , with the additional benefits of a significantly greater decrease in pain ( VAS score ) , postoperative recovery time , time to mobilization , and opioid use .


The benefit of adding sciatic nerve block ( SNB ) to femoral nerve block to improve analgesia after total knee arthroplasty ( TKA ) is uncertain .


We hypothesized that the effective duration of single-injection SNB is too short to improve postoperative analgesia and that this contributes to conflicting results on the efficacy of SNB after TKA .


We evaluated this hypothesis in a prospective double-blind randomized controlled trial .


Sixty patients undergoing TKA were randomly allocated to a continuous SNB group or a single-injection SNB group .


All patients received femoral nerve block ( @ % ropivacaine @ mL ) and SNB ( @ % ropivacaine @ mL ) and catheters were inserted into both peripheral nerve block sites before surgery .


Both groups received continuous femoral nerve block and patient-controlled intravenous analgesia with morphine .


Continuous SNB ( @ % ropivacaine @ mL/h ; continuous SNB group ) or sham continuous SNB ( @ % normal saline @ mL/h ; single-injection SNB group ) was provided after surgery .


The primary outcome was total morphine consumption for @ hours after surgery .


Total morphine consumption in the @-hour period after surgery was significantly lower in the continuous SNB group compared with the single-injection SNB group -LSB- @ ( @ ) vs @ ( @ ) mg , P = @ -RSB- .


Visual analog scale pain scores at rest were also significantly lower in the continuous SNB group ( P = @ ) .


The combination of continuous femoral and SNB provides a superior opioid sparing effect and improves analgesia after TKA .


Direct evidence for the effects of vegetable intake on weight loss is qualified .


The study aimed to assess the effect of higher vegetable consumption on weight loss .


A single blind parallel controlled trial was conducted with @ overweight adults ( mean body mass index = @ kg/m ( @ ) ) randomised to two energy deficit healthy diet advice groups differing only by doubling the serving ( portion ) sizes of vegetables in the comparator group .


Data were analysed as intention-to-treat using a linear mixed model .


Spearmans rho bivariate was used to explore relationships between percentage energy from vegetables and weight loss .


After @ months , the study sample lost @ kg ( P < @ time ) with no difference between groups ( P > @ interaction ) .


Both groups increased vegetable intake and lost weight in the first @ months , and the change in weight was significantly correlated with higher proportions of energy consumed as vegetables ( rho = -@ , P = @ ) .


Fasting glucose , insulin and triglyceride levels decreased ( P < @ time ) and high-density lipoprotein cholesterol levels increased ( P < @ time ) , with no difference between groups .


Weight loss was sustained for @ months by both groups , but the comparator group reported greater hunger satisfaction ( P = @ ) .


Advice to consume a healthy low-energy diet leads to sustained weight loss , with reductions in cardiovascular disease risk factors regardless of an emphasis on more vegetables .


In the short term , consuming a higher proportion of the dietary energy as vegetables may support a greater weight loss and the dietary pattern appears sustainable .


To study the effectiveness of yoga intervention on oxidative stress , glycemic status , blood pressure and anthropometry in prediabetes .


Randomized-controlled trial .


Twenty nine prediabetes subjects aged @-@ years .


Yoga was conducted at @ different community diabetes clinics in Mangalore , India .


Participants were randomized to either @-month yoga or wait-list control groups .


Malondialdehyde , glutathione , vitamin C , vitamin E , superoxide dismutase , plasma glucose , glycated haemoglobin , BMI , waist circumference , waist-to-hip ratio and blood pressure .


Yoga intervention resulted in a significant decline in malondialdehyde ( p < @ ) , relative to the control group .


In comparison with the control , there was a significant improvement in BMI , waist circumference , systolic blood pressure and fasting glucose levels at follow-up .


No significant improvement in glycated haemoglobin , waist-to-hip ratio or any of the antioxidants was observed .


Yoga intervention may be helpful in control of oxidative stress in prediabetes subjects .


Yoga can also be beneficial in reduction in BMI , waist circumference , systolic blood pressure and fasting glucose .


Effect of yoga on antioxidant parameters was not evident in this study .


The findings of this study need to be confirmed in larger trials involving active control groups .


Preliminary evidence suggests intravenous ketamine has rapid effects on suicidal cognition , making it an attractive candidate for depressed patients at imminent risk of suicide .


In the first randomized controlled trial of ketamine using an anesthetic control condition , we tested ketamine 's acute effects on explicit suicidal cognition and a performance-based index of implicit suicidal cognition ( Implicit Association Test ; IAT ) previously linked to suicidal behavior .


Symptomatic patients with treatment-resistant unipolar major depression ( inadequate response to @ antidepressants ) were assessed using a composite index of explicit suicidal ideation ( Beck Scale for Suicidal Ideation , Montgomery-Asberg Rating Scale suicide item , Quick Inventory of Depressive Symptoms suicide item ) and the IAT to assess suicidality implicitly .


Measures were taken at baseline and @ hr following a single subanesthetic dose of ketamine ( n = @ ) or midazolam ( n = @ ) , a psychoactive placebo agent selected for its similar , rapid anesthetic effects .


Twenty four hours postinfusion , explicit suicidal cognition was significantly reduced in the ketamine but not the midazolam group .


Fifty three percent of ketamine-treated patients scored zero on all three explicit suicide measures at @ hr , compared with @ % of the midazolam group ( ( @ ) = @ ; P = @ ) .


Implicit associations between self - and escape-related words were reduced following ketamine ( P = @ ; d = @ ) but not midazolam ( P = @ ; d = @ ) .


Ketamine-specific decreases in explicit suicidal cognition were largest in patients with elevated suicidal cognition at baseline , and were mediated by decreases in nonsuicide-related depressive symptoms .


Intravenous ketamine produces rapid reductions in suicidal cognition over and above active placebo .


Further study is warranted to test ketamine 's antisuicidal effects in higher-risk samples .


To evaluate the efficacy and safety of twice-daily dosing of dapagliflozin and metformin , exploring the feasibility of a fixed-dose combination .


In this @-week , phase III , randomized , double-blind placebo-controlled study , adults who were receiving metformin administered twice daily ( @mg/day ) and had inadequate glycaemic control were randomized @:@:@:@ to receive dapagliflozin twice daily ( @ or @mg ) , placebo or dapagliflozin @mg once daily ( which was included as a benchmark ) .


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


Secondary endpoints included changes in fasting plasma glucose ( FPG ) level and body weight .


Four hundred adults were randomized to dapagliflozin ( @ mg twice daily , @mg twice daily , @mg once daily ) or placebo co-administered with metformin twice daily .


At @ weeks , the adjusted mean change in HbA@c from baseline was significantly reduced in the dapagliflozin @ mg twice daily and @mg twice daily groups versus placebo ( -@ vs. -@ % , p = @ and -@ % vs. -@ % , p < @ ) .


There were also significantly greater improvements for dapagliflozin twice daily groups versus placebo in FPG body weight and achievement of HbA@c level of < @ % .


Efficacy outcomes for dapagliflozin twice daily were numerically similar to those for dapagliflozin once daily .


Dapagliflozin twice daily was well tolerated .


Dapagliflozin @ or @mg twice daily added to metformin was effective in reducing glycaemic levels in patients with type @ diabetes inadequately controlled with metformin alone .


This study supports the development of a fixed-dose combination regimen .


The commonly used therapeutic approach , the contemporary Bobath approach ( CBA ) , is not sufficient to restore independent locomotion for individuals with severe motor deficit ( SMD ) after stroke .


Therefore , we propose that the early sitting , standing , and walking in conjunction with the CBA ( ECBA ) be used to treat individuals with SMD after stroke .


To investigate whether ECBA may enhance mobility and balance in subjects with SMD after stroke .


Thirty-three men and @ women , aged @ to @ years , with SMD after stroke were recruited for the study .


CBA or ECBA was performed with the subjects @ times per week in @-minute sessions for @ weeks .


The Stroke Rehabilitation Assessment of Movement ( STREAM ) and the Berg Balance Scale were implemented before treatment and at @ and @ weeks after treatment , respectively .


The STREAM scores indicated that ECBA was more efficient than the CBA intervention for lower extremity mobility , F ( @ , @ ) = @ , P < @ , and basic mobility , F ( @ , @ ) = @ , P < @ .


Overall STREAM scores were higher in the ECBA group , F ( @ , @ ) = @ , P < @ , after @ weeks of therapy .


Balance scores of the ECBA subjects were higher than those of the CBA subjects after @ weeks of therapy , F ( @ , @ ) = @ , P < @ .


However , there was no difference in upper extremity mobility between the @ groups .


ECBA is a valuable intervention to improve lower extremity mobility , basic mobility , and balance ability for individuals with SMD after stroke .


Clomiphene is the current first-line infertility treatment in women with the polycystic ovary syndrome , but aromatase inhibitors , including letrozole , might result in better pregnancy outcomes .


In this double-blind , multicenter trial , we randomly assigned @ women , in a @:@ ratio , to receive letrozole or clomiphene for up to five treatment cycles , with visits to determine ovulation and pregnancy , followed by tracking of pregnancies .


The polycystic ovary syndrome was defined according to modified Rotterdam criteria ( anovulation with either hyperandrogenism or polycystic ovaries ) .


Participants were @ to @ years of age , had at least one patent fallopian tube and a normal uterine cavity , and had a male partner with a sperm concentration of at least @ million per milliliter ; the women and their partners agreed to have regular intercourse with the intent of conception during the study .


The primary outcome was live birth during the treatment period .


Women who received letrozole had more cumulative live births than those who received clomiphene ( @ of @ -LSB- @ % -RSB- vs. @ of @ -LSB- @ % -RSB- , P = @ ; rate ratio for live birth , @ ; @ % confidence interval , @ to @ ) without significant differences in overall congenital anomalies , though there were four major congenital anomalies in the letrozole group versus one in the clomiphene group ( P = @ ) .


The cumulative ovulation rate was higher with letrozole than with clomiphene ( @ of @ treatment cycles -LSB- @ % -RSB- vs. @ of @ treatment cycles -LSB- @ % -RSB- , P < @ ) .


There were no significant between-group differences in pregnancy loss ( @ of @ pregnancies in the letrozole group -LSB- @ % -RSB- and @ of @ pregnancies in the clomiphene group -LSB- @ % -RSB- ) or twin pregnancy ( @ % and @ % , respectively ) .


Clomiphene was associated with a higher incidence of hot flushes , and letrozole was associated with higher incidences of fatigue and dizziness .


Rates of other adverse events were similar in the two treatment groups .


As compared with clomiphene , letrozole was associated with higher live-birth and ovulation rates among infertile women with the polycystic ovary syndrome .


( Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and others ; ClinicalTrials.gov number , NCT@ . )


Retrospective subgroup analysis in JMDB study indicates that the between-arm differences in overall survival ( OS ) in the East Asian subgroup were consistent with those observed in the entire JMDB study population .


This bridging study ( JMIL ) further evaluated the efficacy and safety of first-line pemetrexed/cisplatin ( PC ) versus gemcitabine/cisplatin ( GC ) in Chinese patients with nonsquamous non-small cell lung cancer ( NSCLC ) .


The primary endpoint of this local registration trial was designed to compare OS in the combined dataset , consisting of Chinese patients in JMIL and @ nonsquamous patients in JMDB .


Chinese patients with stage IIIB/IV nonsquamous NSCLC were randomly assigned ( @:@ ) to @ cycles maximum ( @ days/cycle ) of pemetrexed @mg/m ( @ ) + cisplatin @mg/m ( @ ) ( day @ ) , or gemcitabine @mg/m ( @ ) ( days @ and @ ) + cisplatin @mg/m ( @ ) ( day @ ) .


In JMIL , @ Chinese patients were randomized ( PC , n = @ ; GC , n = @ ) .


Patient baseline characteristics were balanced between treatment arms .


In the combined dataset , PC was superior to GC in prolonging OS , with adjusted hazard ratio ( HR ) of @ ( @ % CI : @-@ @ , p = @ ) and median OS of @ versus @ months .


In the JMIL-only population , no significant OS difference observed between treatment arms ( adjusted HR = @ -LSB- @ % CI : @-@ @ , p = @ -RSB- ; unadjusted HR = @ -LSB- @ % CI : @-@ @ , p = @ -RSB- ) , nor for other secondary efficacy endpoints .


Significantly fewer patients in the PC arm experienced drug-related grade @/@ toxicities , @ ( @ % ) versus @ ( @ % ) for GC ( p = @ ) , with significantly lower rates of leukocytopenia , thrombocytopenia , and fatigue .


This study showed that in the combined population , OS of PC was superior to GC , while in the Chinese-only population , no significant difference was observed ; a better safety and risk/benefit profile was found in the PC arm .


A PC regimen should be considered as a standard of care in Chinese nonsquamous NSCLC patients in a first-line setting .


Physical inactivity is a major , potentially modifiable , risk factor for cardiovascular disease , cancer , and other chronic diseases .


Effective , simple , and generalisable interventions that will increase physical activity in populations are needed .


To evaluate the effectiveness of a smartphone application ( app ) to increase physical activity in primary care .


An @-week , open-label , randomised controlled trial in rural , primary care in the west of Ireland .


Android smartphone users > @ years of age were recruited .


All participants were provided with similar physical activity goals and information on the benefits of exercise .


The intervention group was provided with a smartphone app and detailed instructions on how to use it to achieve these goals .


The primary outcome was change in physical activity , as measured by a daily step count between baseline and follow-up .


A total of @ patients were referred by their primary care health professional or self-referred .


In total , @ ( @ % ) were screened out and @ ( @ % ) declined to participate , leaving @ ( @ % ) patients who were randomised .


Of these , @ provided baseline data ( intervention = @ ; control = @ ) and @ provided outcome data ( intervention = @ ; control = @ ) .


The mean daily step count at baseline for intervention and control groups was @ and @ steps per day respectively .


After adjusting , there was evidence of a significant treatment effect ( P = @ ) ; the difference in mean improvement in daily step count from week @ to week @ inclusive was @ ( @ % confidence interval @ to @ ) steps per day , favouring the intervention .


Improvements in physical activity in the intervention group were sustained until the end of the trial .


A simple smartphone app significantly increased physical activity over @ weeks in a primary care population .


To observe the therapeutic effect of cervical paravertebral block plus acupuncture treatment for cervicogenic headache .


Sixty cases of cervicogenic headache were randomly and equally divided into cervical paravertebral block ( control ) group and acupuncture plus cervical paravertebral block ( acupuncture ) group .


Paravertebral block was performed by injection of @ mL of @ % lidocaine solution containing triamcinolone ( @ mg ) into the @nd cervical paravertebral tissue from the cross point between the posterior border of the sternomastoid muscle and the angle of jaw , once every week for three weeks .


Manual acupuncture stimulation was applied to Baihui ( GV @ ) , unilateral Fengchi ( GB @ ) and Jiaosun ( SJ @ ) , once daily for @ weeks .


The patients ' headache severity was assessed by visual analogue scale ( VAS ) and their cervical vertebral activity assessed by range of motion ( ROM ) before and after the treatment .


Compared with pre-treatment in the same one group , the scores of both VAS and ROM at time points of one , two and three weeks after the treatment were significantly decreased in the control and acupuncture groups ( P < @ ) , suggesting a marked improvement of both headache and cervical motion after the treatment .


Comparison between the two groups showed that the VAS and ROM scores of the acupuncture group were evidently lower than those of the control group at each time point after the treatment ( P < @ ) , displaying a better therapeutic effect of acupuncture plus paravertebral block for cervicogenic headache .


Acupuncture combined with cervical paravertebral block is effective in relieving cervicogenic headache and improving cervical vertebral activity in cervicogenic headache patients , and can strengthen the therapeutic effect of simple paravertebral block .


Anatomy education on embalmed specimens is presumed to have added educational value .


However , although embalmed specimens have been used for anatomy education for years , there is little evidence on the added educational value of dissection-based teaching .


The objective of this randomized study is to examine the added value of dissection-based teaching , using models of the inguinal region in embalmed specimens .


In @ , medical students at Erasmus Medical Center , The Netherlands , were randomly assigned to three groups .


Group I attended lectures , group II attended dissection-based training using laparoscopic dissection models , and group III attended lectures as well as dissection-based laparoscopic training .


To assess the improvement of anatomical knowledge , all students had to complete a practical test before , immediately after , and two weeks after training .


Data were analyzed with mixed modeling .


Forty-six students participated in this study .


No significant difference in results was observed among the three groups before the start of training .


Immediately after the course , groups II and III scored significantly higher than group I ( P < @ ; P < @ ) , and group II scored higher than group III ( P = @ ) .


The difference between group I and groups II and III persisted during follow-up ( P = @ ; P = @ ) .


The difference between groups II and III disappeared .


Three-dimensional anatomy education with dissection models enhances anatomy learning by medical students .


Students who received dissection-based training scored higher in the short - and long term compared with students who did not receive this type of education .


Active immunotherapy is a promising antitumoral strategy ; however its use in combination with chemotherapy in dogs with large B-cell lymphoma ( DLBCL ) remains largely untested .


Heat shock proteins ( HSP ) bind the small peptides they chaperone ( HSPPC ) , allowing for immunization of the host against a large repertoire of tumor-associated antigens .


Hydroxylapatite vehicles HSPPCs and acts as an immunologic adjuvant .


The aim of this study was to show that an autologous vaccine with hydroxylapatite and tumor-derived HSPPCs is safe and therapeutically effective in dogs with DLBCL .


Nineteen dogs with naturally occurring DLBCL were entered into a prospective randomized placebo-controlled double-blinded trial of HSPPCs-hydroxylapatite plus chemotherapy versus chemotherapy alone .


Endpoints included time to progression ( TTP ) , lymphoma-specific survival ( LSS ) , and incidence of toxicoses .


Median first TTP after randomization to the vaccine arm was @ days versus @ days for the control arm ( P = @ ) .


There was also a statistically significant difference in duration of second remission between the two groups ( P = @ ) .


Median LSS was @ days for the vaccinated dogs versus @ days for the unvaccinated dogs ( P = @ ) .


Six vaccinated dogs achieved molecular remission , as shown by clonal immunoglobulin H ( IgH ) rearrangement .


Toxicoses were comparable between the two treatment arms .


The results of this trial demonstrate that the autologous vaccine tested here is safe and efficacious in prolonging TTP and LSS in dogs with DLBCL when used in combination with dose-intense chemotherapy .


On the basis of these results , additional evaluation of this novel therapeutic strategy is warranted in human DLBCL .


Longitudinal studies have begun to clarify the phenotypic characteristics of adolescents and young adults at clinical high risk for psychosis .


This @-site randomized trial examined whether a @-month program of family psychoeducation was effective in reducing the severity of attenuated positive and negative psychotic symptoms and enhancing functioning among individuals at high risk .


Adolescents and young adults ( mean age @ @ years ) with attenuated positive psychotic symptoms , brief and intermittent psychosis , or genetic risk with functional deterioration were randomly assigned to @ sessions of family-focused therapy for individuals at clinical high risk ( FFT-CHR ) in @ months or @ sessions of family psychoeducation ( enhanced care -LSB- EC -RSB- ) .


FFT-CHR included psychoeducation about early signs of psychosis , stress management , communication training , and problem-solving skills training , whereas EC focused on symptom prevention .


Independent evaluators assessed participants at baseline and @ months on positive and negative symptoms andsocial-role functioning .


Of @ participants , @ ( @ % ) were followed up at @months .


Participants in FFT-CHR showed greater improvements in attenuated positive symptoms over @ months than participants in EC ( F@ ,@ = @ , p = @ ) .


Negative symptoms improved independently of psychosocial treatments .


Changes in psychosocial functioning depended on age : participants more than @ years of age showed more role improvement inFFT-CHR , whereas participants between @ and @ years of age showed more role improvement in EC .


The results were independent of concurrent pharmacotherapy .


Interventions that focus on improving family relationships may have prophylactic efficacy in individuals at high risk for psychosis .


Future studies should examine the specificity of effects of family intervention compared to individual therapy of the sameduration and frequency .


Clinical trial registration information-Prevention Trial of Family Focused Treatment in Youth at Risk for Psychosis ; http://clinicaltrials.gov/; NCT@ .


Cancer anorexia-cachexia syndrome ( CACS ) is common in advanced cancer patients and associated with weight loss , fatigue , impaired quality of life ( QoL ) , and poor prognosis .


The goal of this project was to identify the most responsive items from two QoL measures in the ROMANA @ ( NCT@ ) phase III global study evaluating anamorelin HCl in the treatment of non-small cell lung cancer ( NSCLC ) cachexia : the Functional Assessment of Chronic Illness Therapy-Fatigue ( FACIT-F ) and the Functional Assessment of Anorexia/Cachexia Therapy ( FAACT ) .


In the ROMANA @ trial , @ patients with unresectable stage III or IV NSCLC and cachexia were to be enrolled and randomized ( @:@ ) to receive anamorelin HCl or placebo once daily for @weeks .


All @ patients who reached the week @ visit at the time of data analysis were included .


Co-primary endpoints were change from baseline in lean body mass and handgrip strength .


QoL was a secondary outcome with FACIT-F and FAACT questionnaires administered at baseline and at weeks @ , @ , @ , and @ .


Two @-item scales ( fatigue/activity and appetite/eating ) from the FACIT-F and FAACT questionnaires , respectively , demonstrated good internal consistency reliability , validity , and responsiveness ( also referred to as the Simplified Evaluation of Fatigue ( SEF ) and Simplified Evaluation of Appetite ( SEA ) , respectively ) .


The estimated important difference for each scale was @-@ points .


These brief scales provide the psychometric properties necessary to promote future research in NSCLC patients with CACS .


Additional work should examine the clinical utility of these scales and their impact on treatment decision-making .


To evaluate the occurrence of reflux from the great saphenous vein by color Doppler ultrasonography in subjects undergoing treatment of insufficiency of the saphenofemoral junction by simple ligation or ligation with section of the saphenous arch .


We performed @ operations ( in @ subjects ) of varicose insufficiency of the saphenofemoral junction ( SFJ ) , belonging to the CEAP clinical classification of @-@ , who were randomly divided into two groups .


A group called C , with ligature and section of the saphenous arch , and a group called L , with simple ligation of the saphenous vein and no sectioning of its arch .


We then investigated the occurrence of reflux from the great saphenous vein in groups C and L through postoperative color Doppler ultrasonography at intervals of six months to one year .


Of the @ members submitted to the approach of the saphenous arch , @ were evaluated by postoperative doppler ultrasound , since two subjects ( three limbs ) did not return and were excluded from the study .


The mean age was @ years , with @ % females and predominance of CEAP classification @ in @ % .


Of the @ operations for the treatment of reflux of the saphenous arch , @ % had reflux postoperatively ,@ % in group C and @ % in group L ( p < @,@ ) .


The relative risk of reflux of the saphenous arch in group L was @ times higher compared with group C.


the section of the arch of the great saphenous vein causes less postoperative reflux than simple ligation in treatment of insufficiency of the great saphenous vein .


To examine the measurement differences in sleep and EEG arousal statistics between the American Academy of Sleep Medicine ( AASM ) recommended EEG montage ( F@-M@ , C@-M@ , O@-M@ ) and acceptable EEG montage ( Fz-Cz , C@-M@ , Oz-Cz ) .


Prospective , blinded , randomized comparison .


Australian clinical sleep laboratory in a tertiary hospital .


@ consecutive patients undertaking polysomnography ( PSG ) for the clinical suspicion of sleep disordered breathing .


N/A .


Patient EEGs were recorded using both the AASM recommended and acceptable EEG montages during the PSG .


Two scorers were used to examine the difference in PSG statistics using the two EEG montages .


The scorers analyzed the @ studies using the two EEG montages .


Ten of the studies were scored twice for each montage by each scorer to calculate intra-scorer and inter-scorer agreement .


No statistically significant differences were observed between the PSG statistics of the recommended and acceptable EEG montages .


The recommended EEG montage had greater inter-scorer agreement but no difference in intra-scorer agreement .


This study demonstrates that the two EEG montages endorsed by the AASM Manual produce similar sleep and EEG arousal statistics .


It is recommended that treatments that include clarithromycin should be avoided in eradication of Helicobacter pylori ( HP ) in cases where clarithromycin resistance is higher than @ % .


We aimed to compare levofloxacin - and moxifloxacin-based triple therapies with standard treatment and with each other in eradication of helicobacter pylori as first-line therapy .


Patients were randomized prospectively as three groups .


There were @ patients in the levofloxacin group , @ patients in the moxifloxacin group , and @ patients in the standard treatment group .


The patients received levofloxacin @ mg daily , amoxicillin @ g b.i.d. and lansoprazole @ mg b.i.d. for ten days ( LAL ) in the levofloxacin group ; moxifloxacin @ mg daily , amoxicillin @ g b.i.d. and lansoprazole @ mg b.i.d. ( MAL ) in the moxifloxacin group ; and clarithromycin @ mg b.i.d. , amoxicillin @ g b.i.d. and lansoprazole @ mg b.i.d. ( CAL ) in the standard treatment group .


At post-treatment week @ , HP was checked by using stool antigen test .


In the eradication of Helicobacter pylori , the success rate as determined by per protocol ( PP ) analysis was @ % in the LAL group , @ % in the MAL group , and @ % in the CAL group .


A statistically significant difference was found in the LAL and MAL groups compared to the CAL group ( p < @ ) .


There was no difference between the LAL and MAL groups .


It was determined that levofloxacin - and moxifloxacin-based triple therapies were more effective than the standard treatment in first-line setting in the eradication of Helicobacter pylori .


In addition , no difference was found between levofloxacin - and moxifloxacin-based triple therapies .


Currently observed high efficacy may be evaluated in treatment .


Although quinolon resistance is not considered a major problem , it appears to be a factor that may reduce treatment success over a period of time .


Bone tunnel enlargement after anterior cruciate ligament ( ACL ) reconstruction is well documented in the literature .


The cause of this tunnel enlargement is unclear , but is thought to be multifactorial , with mechanical and biological factors playing a role .


The aim of this prospective study was to evaluate how the different techniques may affect the bone tunnel enlargement and clinical outcome .


Forty-five consecutive patients undergoing ACL reconstruction with autologous doubled semitendinosus and gracilis tendons entered this study .


They were randomly assigned to enter group A ( In-Out technique , with cortical fixation and Interference screw ) and group B ( Out-In technique , metal cortical fixation on the femour and tibia ) .


At a mean follow-up of @ months , all the patients underwent CT scan exam to evaluate the post-operative diameters of both femoral and they underwent tibial tunnels clinical examination after @ months .


The mean femoral tunnel diameter increased significantly from @ mm to @ mm in group A and from @ mm to @ mm in group B.


The mean increase in femoral tunnel diameters observed in group A was significantly higher than that observed in group B ( p < @ ) The mean tibial tunnel diameter increased significantly from @ mm to @ mm in group A and from @ mm to @ mm in group B.


The mean increase in tibial tunnel diameters observed in group A was significantly higher than that observed in group B ( p < @ ) .


No clinical differences were found between two groups and no correlations between clinical and radiological results were found in any patients of both groups .


Results of the study suggest that different mechanical fixation devices could influence tunnel widening .


The lower stiffness of the fixation devices is probably responsible of the tunnel widening through the fixation devices 's micromotions in the femoral and tibial tunnels .


Laboratory skills training is now required for general surgery residents .


The optimal method of teaching vascular anastomosis ( VA ) is not well defined .


Teaching VA skills one-on-one with a faculty instructor will result in a more rapid accumulation of skills than teaching in a large group setting .


Residents were shown an instructional video on how to perform a VA using a standardized model ( cadaver saphenous vein and porcine aorta ) .


Each resident then performed a baseline VA. .


Sixteen first - and second-year surgical residents were then randomized to @ VA teaching sessions that consisted of either @ ) group teaching ( GT , @ residents in a room with @ faculty instructor circulating ) or @ ) one-on-one teaching ( @-on-@ , faculty member focused on individual resident ) .


After each of these sessions , residents performed a standardized VA. .


The anastomoses were video recorded .


Performance was evaluated using a standardized scoring system by a separate expert who viewed the video recordings in a blinded fashion .


Outcome measures included total errors , total time , global rating scale , and an anastomosis-specific end-product evaluation ( leak and passage of coronary dilator ) .


Overall , significant decreases in total errors ( @ to @ , P = @ ) and time to complete anastomoses ( @ to @ min , P = @ ) and an increase in global rating scales ( @ to @ , P = @ ) were noted in both groups from baseline after @ VA teaching session .


The @-on-@ group demonstrated significantly greater improvement in terms of reduced anastomotic time ( @ vs. @ min , P = @ ) and in reduction of errors ( @ vs. @ errors , P = @ ) than the GT group .


The high-fidelity VA model is a useful tool for junior general surgery residents .


Both GT and @-on-@ groups demonstrated significant improvement in total errors and time after only @ sessions .


Greater improvement was noted using the @-on-@ model .


Preincisional analgesia is an antinociceptive treatment that prevents altered central excitability from high-intensity noxious stimuli .


To determine the analgesic efficacy of preoperative infiltration with bupivacaine for reduction mammaplasty , a randomized , double-blind , placebo-controlled trial was designed .


Women with mammary hypertrophy were allocated randomly to one of two study groups .


Patients in group I received preincision infiltration with bupivacaine into each breast after general anesthesia .


Group II patients received similar injections of saline injection alone after general anesthesia .


Visual analogue pain score , verbal pain score , and short-form McGill Pain Questionnaire scores were higher in group II patients until @ hours after surgery ( p < @ ) .


Patients in the saline group had higher intravenous meperidine consumption for @ hours postoperatively and solicited opioids before the patients in the bupivacaine group ( p < @ ) .


The difference between groups was statistically significant .


Preincisional infiltration with bupivacaine results in reduced pain and lower postoperative opioid requirements in the early postoperative phase of pain following breast reduction .


Therapeutic , I.


This study aims to investigate the efficacy and safety of oral fixed-dose combination of strontium ranelate @ g/vitamin D @ IU daily vs strontium ranelate @ g daily for correcting vitamin D insufficiency in osteoporosis .


A @-month international , randomized , double-blind , parallel-group , phase @ study .


A total of @ men and postmenopausal women aged @ years with primary osteoporosis ( T-score -@ s.d. ) and serum @-hydroxyvitamin D ( @ ( OH ) D ) > @ nmol/l were included .


Patients were allocated to strontium ranelate @ g/vitamin D @ IU daily ( n = @ ) or strontium ranelate @ g daily ( n = @ ) .


The participants received calcium @ g daily .


The primary endpoint was serum @ ( OH ) D at last post-baseline evaluation during @ months .


Both groups were comparable at baseline .


Mean baseline of @ ( OH ) D was @ @ nmol/l .


After @ months , the percentage of patients with @ ( OH ) D @ nmol/l was higher with strontium ranelate/vitamin D vs strontium ranelate ( @ vs @ % , P < @ ; adjusted between-group odds ratio = @ ; @ % CI , @-@ @ ) .


The efficacy of the fixed-dose combination on @ ( OH ) D was maintained at @ months ( @ vs @ % , P < @ ) .


Mean @ ( OH ) D was @ and @ nmol/l , respectively , after @ months and @ and @ nmol/l after @ months .


Physical performance improved in both groups .


Falls were @ and @ % in the strontium ranelate/vitamin D and strontium ranelate groups respectively .


Parathyroid hormone levels were inversely correlated with @ ( OH ) D. No clinically relevant differences in safety were observed .


This study confirms the efficacy and safety of fixed-dose combination of strontium ranelate @ g/vitamin D @ IU for correction of vitamin D insufficiency in osteoporotic patients .


CBP@ , a synthetic duodecapeptide , increases cisplatin influx into tumor cells through an interaction with calmodulin enhancing cisplatin cytotoxicity , and effects cell cycle progression by abrogating DNA repair at the G@ checkpoint .


In phase I clinical trials of CBP@ alone or in combination with cisplatin , the most common toxicity was infusion-related urticaria .


Activity of CBP@ plus cisplatin was observed in patients with ovarian cancer and mesothelioma , including some patients previously treated with cisplatin .


Chemotherapy nave patients with unresectable MPM were stratified by histology and performance status , and randomized @:@ to pemetrexed/cisplatin plus CBP@ @mg/m ( @ ) IV ( Arm A ) or pemetrexed/cisplatin alone ( Arm B ) .


The primary endpoint was progression free survival ( PFS ) at @ months .


@ patients were randomized , and @ were treated .


Patient characteristics in the two arms were balanced .


Based on independent radiology review of the treated population , @/@ patients ( @ % ) in Arm A and @/@ ( @ % ) in Arm B had PFS@mo ; the median PFS was @ mo ( @ % CI , @ , @ ) vs @ mo ( @ , @ ) .


Median OS was @ mo ( @ , @ ) in Arm A and @ ( @ , @ ) in Arm B. Adverse events were not different than expected from standard chemotherapy , and comparable in the two arms , aside from infusion reactions which occurred in @ % of patients treated with CBP@ .


While this randomized phase II trial met its primary endpoint of PFS at @ months , other parameters such as response rate and overall survival suggest that the addition of CBP@ does not improve the efficacy of standard chemotherapy for MPM .


The home food environment is an important setting for the development of dietary patterns in childhood .


Interventions that support parents to modify the home food environment for their children , however , may also improve parent diet .


The purpose of this study was to assess the impact of a telephone-based intervention targeting the home food environment of preschool children on the fruit and vegetable consumption of parents .


In @ , @ parents of @-@ year-old children from @ preschools in the Hunter region of Australia were recruited to this cluster randomised controlled trial and were randomly assigned to an intervention or control group .


Intervention group parents received four weekly @-minute telephone calls and written resources .


The scripted calls focused on ; fruit and vegetable availability and accessibility , parental role-modelling , and supportive home food routines .


Two items from the Australian National Nutrition Survey were used to assess the average number of serves of fruit and vegetables consumed each day by parents at baseline , and @ - , @ - , @ - , and @-months later , using generalised estimating equations ( adjusted for baseline values and clustering by preschool ) and an intention-to-treat-approach .


At each follow-up , vegetable consumption among intervention parents significantly exceeded that of controls .


At @-months the difference was @ serves ( @ % CI : @-@ @ , p < @ ) , and at @-months the difference was @ serves ( @ % CI : @-@ @ , p = @ ) .


Fruit consumption among intervention parents was found to significantly exceed consumption of control parents at the @ -,@ - and @-month follow-up , with the difference at @-months being @ serves ( @ % CI : @-@ @ , p = @ ) , and @ serves maintained at @-months , ( @ % CI : @-@ @ , p = @ ) .


A four-contact telephone-based intervention that focuses on changing characteristics of preschoolers ' home food environment can increase parents ' fruit and vegetable consumption .


( ANZCTR@ ) .


We previously demonstrated that @ % of patients with pain at sites of previously irradiated bone metastases benefit from reirradiation .


It is unknown whether alleviating pain also improves patient perception of quality of life ( QOL ) .


We used the database of a randomized trial comparing radiation treatment dose fractionation schedules to evaluate whether response , determined using the International Consensus Endpoint ( ICE ) and Brief Pain Inventory pain score ( BPI-PS ) , is associated with patient perception of benefit , as measured using the European Organisation for Resesarch and Treatment of Cancer ( EORTC ) Quality of Life Questionnaire Core @ ( QLQ-C@ ) and functional interference scale of the BPI ( BPI-FI ) .


Evaluable patients completed baseline and @-month follow-up assessments .


Among @ randomly assigned patients , @ were evaluable for response using the ICE and @ using the BPI-PS .


Using the ICE , @ patients experienced a response and @ did not .


Responding patients had superior scores on all items of the BPI-FI ( ie , general activity , mood , walking ability , normal work , relations with other people , sleep , and enjoyment of life ) and improved QOL , as determined by scores on the EORTC QLQ-C@ scales of physical , role , emotional and social functioning , global QOL , fatigue , pain , and appetite .


Similar results were obtained using the BPI-PS ; observed improvements were typically of lesser magnitude .


Patients responding to reirradiation of painful bone metastases experience superior QOL scores and less functional interference associated with pain .


Patients should be offered re-treatment for painful bone metastases in the hope of reducing pain severity as well as improving QOL and pain interference .


To evaluate wrinkle improvement and safety of a novel cosmetic dissolving microneedle patches loaded with two active compounds with different hydrophilicities , namely ascorbic acid and retinyl retinoate .


Clinical studies were performed on @ Korean women for @ weeks .


Patients in group A were treated with retinyl retinoate-loaded dissolving microneedle patches on the left eye crow 's feet area , and patients in group B were treated with ascorbic acidloaded patches on the right eye crow 's feet area twice daily .


Wrinkle improvement was evaluated by skin Visiometer SV @ .


Both the retinyl retinoate - and ascorbic acid-loaded dissolving microneedle patches demonstrated statistically significant differences in all Visiometer R-values ( P < @ ) .


In particular , highly significant differences were shown at R@ ( skin roughness ) and R@ ( arithmetic average roughness ) ( P < @ ) .


Also , there were no side effects such as allergies or irritant contact dermatitis .


Retinyl retinoate and ascorbic acid were successfully loaded into dissolving microneedles and used to produce novel cosmetic patches .


These novel patches can be used efficiently in cosmetics given their patient usability , safety and effectiveness in wrinkle improvement .


To determine whether fitness-center attendance established with the provision of weekly monetary incentives persisted after the discontinuation , or decreased frequency , of incentives .


One hundred seventeen first-year college students participated during the @-@ academic year .


A randomized controlled trial with control , discontinued-incentive , and continued-incentive conditions was conducted .


During fall semester , students in incentive conditions received weekly monetary payments for meeting fitness-center attendance goals .


During spring semester , discontinued-incentive condition participants no longer received incentives , whereas continued-incentive condition participants received payments on a variable-interval schedule .


ID-card attendance records tracked fitness-center attendance .


Goal completion decreased from @ % in the incentive groups during the fall semester to @ % in the discontinued-incentive condition , and @ % in the continued-incentive condition during the spring semester .


There was not a significant interaction between condition and body mass index change , F ( @ , @ ) = @ , p = @ .


Incentive discontinuation resulted in students no longer meeting fitness-center attendance goals .


A variable-interval reward schedule better maintained attendance .


Statins have a beneficial effect on bone mineral density ( BMD ) and lean mass in some studies of HIV-uninfected adults ; however , this has never been investigated in the setting of HIV infection .


HIV-infected individuals on stable antiretroviral therapy with a low-density lipoprotein cholesterol level of @ mg/dl or less and evidence of heightened immune activation or inflammation were randomized to rosuvastatin @ mg daily or placebo for @ weeks .


This was a prespecified interim analysis at @ weeks .


Between-group and within-group differences were compared ; multivariable regression models were constructed .


Seventy-two individuals were randomized to statin therapy and @ to placebo .


Modest @-week relative increases in trochanter BMD -LSB- @ % ; @ % confidence interval ( @ % CI ) -@ to @ -RSB- and total hip BMD ( @ % ; @ % CI @-@ @ ) in the statin arm were significantly greater than placebo ( P < @ ) .


The relationship between statin use and total hip BMD change was robust to adjustment of age , sex , race and smoking status ( P = @ ) and strengthened by inclusion of baseline ( P = @ ) and week @ change in soluble tumour necrosis factor - receptor ( sTNFR ) -@ ( P = @ ) .


Relative increases in total body , trunk and limb fat were similar between statin and placebo arms ( P@ @ ) .


Although a significant gain in leg lean mass was seen in the statin arm , this was not significantly different compared with placebo ( P = @ ) .


The improvements seen in total hip BMD after @ weeks of rosuvastatin therapy support further potential benefits of statin therapy in HIV , beyond a reduction of cardiovascular risk .


Mobilization-Observation-Behavior-Intensity-Dementia-@ ( MOBID-@ ) pain scale is a staff-administered pain tool for patients with dementia .


This study explores MOBID-@ 's test-retest reliability , measurement error and responsiveness to change .


Analyses are based upon data from a cluster randomized trial including @ patients with advanced dementia from @ Norwegian nursing homes .


Test-retest reliability between baseline and week @ ( n = @ ) , and weeks @ and @ ( n = @ ) was examined in patients not expected to change ( controls ) , using intraclass correlation coefficient ( ICC@ @ ) , standard error of measurement ( SEM ) and smallest detectable change ( SDC ) .


Responsiveness was examined by testing six priori-formulated hypotheses about the association between change scores on MOBID-@ and other outcome measures .


ICCs of the total MOBID-@ scores were @ ( @-@ weeks ) and @ ( @-@ weeks ) .


SEM and SDC were @ and @ ( @-@ weeks ) and @ and @ ( @-@ weeks ) , respectively .


Five out of six hypotheses were confirmed : MOBID-@ discriminated ( p < @ ) between change in patients with and without a stepwise protocol for treatment of pain ( SPTP ) .


Moderate association ( r = @ ) was demonstrated with Cohen-Mansfield Agitation Inventory , and no association with Mini-Mental State Examination , Functional Assessment Staging and Activity of Daily Living .


Expected associations between change scores of MOBID-@ and Neuropsychiatric Inventory - Nursing Home version were not confirmed .


The SEM and SDC in connection with the MOBID-@ pain scale indicate that the instrument is responsive to a decrease in pain after a SPTP .


Satisfactory test-retest reliability across test periods was demonstrated .


Change scores @ on total and subscales are clinically relevant and are beyond measurement error .


To test whether a brief mindfulness meditation training intervention buffers self-reported psychological and neuroendocrine responses to the Trier Social Stress Test ( TSST ) in young adult volunteers .


A second objective evaluates whether pre-existing levels of dispositional mindfulness moderate the effects of brief mindfulness meditation training on stress reactivity .


Sixty-six ( N = @ ) participants were randomly assigned to either a brief @-day ( @-min per day ) mindfulness meditation training or an analytic cognitive training control program .


All participants completed a standardized laboratory social-evaluative stress challenge task ( the TSST ) following the third mindfulness meditation or cognitive training session .


Measures of psychological ( stress perceptions ) and biological ( salivary cortisol , blood pressure ) stress reactivity were collected during the social evaluative stress-challenge session .


Brief mindfulness meditation training reduced self-reported psychological stress reactivity but increased salivary cortisol reactivity to the TSST , relative to the cognitive training comparison program .


Participants who were low in pre-existing levels of dispositional mindfulness and then received mindfulness meditation training had the greatest cortisol reactivity to the TSST .


No significant main or interactive effects were observed for systolic or diastolic blood pressure reactivity to the TSST .


The present study provides an initial indication that brief mindfulness meditation training buffers self-reported psychological stress reactivity , but also increases cortisol reactivity to social evaluative stress .


This pattern may indicate that initially brief mindfulness meditation training fosters greater active coping efforts , resulting in reduced psychological stress appraisals and greater cortisol reactivity during social evaluative stressors .


Palmar-plantar erythrodysesthesia ( PPE ) is a common chemotherapy and anti-VEGF multi-kinase inhibitor class-related toxicity that often results in debilitating skin changes and often limits the use of active anti-cancer regimens .


Mechanistic and anecdotal clinical evidence suggested that topical application of sildenafil cream may help reduce the severity of PPE .


Therefore , we conducted a randomized , double-blind , placebo-controlled pilot study to evaluate the feasibility , safety and efficacy of topical sildenafil cream for the treatment of PPE .


Eligible subjects were required to have grade @-@ PPE associated with either capecitabine or sunitinib .


Subjects were randomized to receive @ % topical sildenafil cream to the left extremities or right extremities and placebo cream on the opposite extremity .


Two times per day , @ mL of cream was applied to each affected hand/foot .


The primary endpoint was improvement in PPE grading at any point on study .


Clinical assessments were evaluated by NCI-CTC @ grading and patient self-reported pain .


Ten subjects were enrolled , nine were evaluable for safety and efficacy .


Five of nine subjects reported some improvement in foot pain and three of eight subjects for hand pain improvement .


One of these subjects noted specific improvement in tactile function .


No treatment-related toxicities were observed .


In this limited , single-center study , topical cream containing @ % sildenafil is feasible to administer , is well-tolerated , and may mitigate PPE-related symptoms due to anti-cancer therapeutic agents .


Further validation is necessary .


We set out to compare emergency medicine residents ' intubating times and success rates for direct laryngoscopy ( DL ) , GlideScope-assisted intubation ( GS ) , and the Supraglottic Airway Laryngopharyngeal Tube ( SALT ) airway with and without biohazard gear .


Each resident passed through @ sets of @ testing stations ( DL , GS , SALT ) in succession , intubating Laerdal mannequin heads with the @ modalities after randomization to start with or without biohazard gear .


Thirty-seven residents participated , and @ were male ( @ % ) ; @ ( @ % ) had prior experience intubating in biohazard suits .


There was a statistically significant difference in those who had prior intubation experience between DL ( @ , @ % ) , GS ( @ , @ % ) , and SALT ( @ , @ % ) ( P < @ ) and in median time to intubation ( @ seconds , no suit ; @ seconds , with suits ) ( P = @ ) .


There was no statistically significant difference between the overall times to intubate for the @ devices .