Topical loteprednol etabonate and eyelid scrubs with warm compresses were tolerated and efficacious for the treatment of moderate and severe MGD .


We suggest that such beneficial effects could manifest after @ month .


Women with primary ovarian insufficiency have significantly lower serum estradiol and T levels compared with regularly menstruating women .


They also have significantly reduced bone mineral density ( BMD ) .


The objective of the study was to evaluate the efficacy of hormone replacement in maintaining BMD in these young women .


This was a randomized , double-blind , single-center , placebo-controlled clinical trial at the National Institutes of Health clinical center ( Bethesda , Maryland ) .


Young women with primary ovarian insufficiency participated in the study .


We compared the effect of estradiol and progestin replacement ( n = @ ) vs estradiol , progestin , and T replacement ( n = @ ) on BMD .


We also compared findings with a contemporaneous control group of normal women ( n = @ ) .


All patients received transdermal estradiol ( @ g/d ) plus oral medroxyprogesterone acetate @ mg/d ( @ d/mo ) for a @-month run-in period before being randomized in a double-blinded fashion to the addition of transdermal T ( @ g/d ) or placebo .


Change in BMD at the femoral neck was measured by dual-energy x-ray absorptiometry .


At screening , patients had significantly lower femoral neck BMD compared with control women ( @ vs @ g/cm ( @ ) , P = @ ) and did not differ in body mass index , age at menarche , or education level .


Normal control women lost femoral neck BMD over the study period , whereas patients on estradiol and progestin therapy gained BMD ; and at the end of the study period , femoral neck BMD of patients on estradiol and progestin therapy did not differ from that of control women ( @ g/cm ( @ ) in both groups , P = @ ) .


The addition of T showed no further benefit ( percentage change in BMD @ vs @ , respectively , P = @ ) .


Nonetheless , using a repeated-measures model , the T group achieved a mean BMD in the femoral neck @ g/cm ( @ ) higher than the placebo group at @ years ( @ % confidence interval -@ to @ , P = @ ) .


Similar findings were observed in the lumbar spine BMD as well .


Long-term physiological transdermal estradiol replacement in combination with oral medroxyprogesterone acetate restores mean femoral neck BMD to normal in young women with spontaneous @ , XX primary ovarian insufficiency .


However , the addition of physiological transdermal T replacement did not provide additional benefit .


Medical education today frequently includes standardized patient ( SP ) encounters to teach history-taking , physical exam , and communication skills .


However , traditional wall-mounted cameras , used to record video for faculty and student feedback and evaluation , provide a limited view of key nonverbal communication behaviors during clinical encounters .


In @ , @ second-year medical students participated in an end-of-life module that included SP encounters in which the SPs used Google Glass to record their first-person perspective .


Students reviewed the Google Glass video and traditional videos and then completed a postencounter , self-evaluation survey and a follow-up survey about the experience .


Google Glass was used successfully to record @ student/SP encounters .


One temporary Google Glass hardware failure was observed .


Of the @ students , @ ( @ % ) reported a `` positive , nondistracting experience '' ; @ ( @ % ) a `` positive , initially distracting experience '' ; @ ( @ % ) a `` neutral experience '' ; and @ ( @ % ) a `` negative experience . ''


Four students ( @ % ) opted to withhold judgment until they reviewed the videos but reported Google Glass as `` distracting . ''


According to follow-up survey responses , @ students ( of @ ; @ % ) found Google Glass `` worth including in the -LSB- clinical skills program -RSB- , '' whereas @ ( @ % ) did not .


Google Glass can be used to video record students during SP encounters and provides a novel perspective for the analysis and evaluation of their interpersonal communication skills and nonverbal behaviors .


Next steps include a larger , more rigorous comparison of Google Glass versus traditional videos and expanded use of this technology in other aspects of the clinical skills training program .


Metabolic syndrome ( MetS ) has become an important public concern due to its increasing prevalence .


An altered fatty acid composition has been associated with MetS , but the Mediterranean diet has been shown to have a protective effect .


The aim of the present study was to analyze the influence of a Mediterranean dietary pattern , as assessed by the biomarkers of food supplied , on the plasma fatty acid composition and its relation with MetS after @ year of intervention .


A total of @ subjects were randomly selected from the PREDIMED randomized dietary trial after completing a @-year intervention program .


Participants aged @ to @ years and at high risk of cardiovascular disease were randomly assigned to three dietary interventions : Mediterranean diet supplemented with virgin olive oil or nuts , or a low-fat diet .


After @ year of intervention participants in the virgin olive oil group showed significantly increased plasma concentrations of palmitic and oleic acids , but reduced proportions of margaric , stearic , and linoleic acids .


In turn , subjects in the nut group showed significantly increased levels of palmitic , linoleic , and - linolenic acids , but reduced proportions of myristic , margaric , palmitoleic , and dihommo -- linoleic acids .


Increases in the biomarkers of foods supplied to the Mediterranean diet groups , i.e. , oleic and - linolenic acids , were beneficially associated with the incidence , reversion and prevalence of MetS .


No weight changes were observed among participants .


The nut and olive oil diets induced a fatty acid composition that has been shown to be beneficial in the face of MetS .


Therefore , a Mediterranean diet rich in fats of vegetable origin may be a useful tool for the management of MetS without the need for concerns over weight gain due to its high fat content .


To assess the expediency of psychotherapy in patients with essential hypertension ( EH ) from clinical and economic standpoints .


Seventy-five ( @ men , @ women ) with grades @-@ EH ( blood pressure ( BP ) was @/@ to @/@ mm Hg ) and the verified psychosomatic background of the disease ) were examined and randomized into @ groups ( the mean age in Groups @ and @ was @ @ and @ @ years , respectively ) .


All the patients received medical therapy using the same regimen ; however , Group @ patients had additionally psychotherapy .


The decrease in BP and the average number of visits required to reach goal BP were estimated as a criterion for therapeutic effectiveness .


A pharmacoeconomic analysis of antihypertensive therapy was made in each group .


The average cost for @ weeks was @ rbl per person in Group @ and @ rbl in Group @ , which was @ % cheaper .


The costs of reductions in systolic-BP ( SBP ) and diastolic BP ( DBP ) were also lower in Group @ ( -@ and -@ rbl , respectively ) .


At the same time , goal BP was achieved more rapidly in Group @ ( in Groups @ and @ , the reduction in SBP was @ and @ mm Hg weekly and that in DBP was @ and @ mm Hg weekly , respectively ) .


This makes it possible to lower a physicians ' load and to save timing budget ( p > @ ) .


The treatment policy in Group @ surpassed that in Group @ in the rate of BP normalization and the number of required visits to a physician and showed significant economic benefits .


The Fas apoptotic pathway has been implicated in type @ diabetes and cardiovascular disease .


Although a polymorphism ( rs@ ; G > A ) near the Fas apoptotic inhibitory molecule @ ( FAIM@ ) locus has been related to obesity , its association with other cardiovascular risk factors and disease remains uncertain .


We analyzed the association between the FAIM@-rs@ polymorphism and obesity , blood pressure and heart rate in @,@ participants ( @ % with type @ diabetes ) in the PREDIMED study at baseline .


We also explored gene-diet interactions with adherence to the Mediterranean diet ( MedDiet ) and examined the effects of the polymorphism on cardiovascular disease incidence per diabetes status after a median @-year dietary intervention ( MedDiet versus control group ) follow-up .


We replicated the association between the FAIM@-rs@ polymorphism and greater obesity risk ( OR : @ ; @ % CI : @-@ @ ; P = @ ; per-A allele ) .


Moreover , we detected novel associations of this polymorphism with higher diastolic blood pressure ( DBP ) and heart rate at baseline ( B = @ ; @ % CI : @-@ @ bmp in AA vs G-carriers for the whole population ) , that remained statistically significant even after adjustment for body mass index ( P = @ ) and correction for multiple comparisons .


This association was greater and statistically significant in type-@ diabetic subjects ( B = @ : @ % CI : @-@ @ bmp ; P = @ for AA versus G-carriers ) .


Likewise , these findings were also observed longitudinally over @-year follow-up .


Nevertheless , we found no statistically significant gene-diet interactions with MedDiet for this trait .


On analyzing myocardial infarction risk , we detected a nominally significant ( P = @ ) association in type-@ diabetic subjects ( HR : @ ; @ % CI :@ -@ for AA versus G-carriers ) , although this association did not remain statistically significant following correction for multiple comparisons .


We confirmed the FAIM@-rs@ relationship with obesity and identified novel and consistent associations with heart rate in particular in type @ diabetic subjects .


Furthermore , our results suggest a possible association of this polymorphism with higher myocardial infarction risk in type-@ diabetic subjects , although this result needs to be replicated as it could represent a false positive .


Public health strategies to lower cardiovascular disease ( CVD ) risk involve reducing dietary saturated fatty acid ( SFA ) intake to @ % of total energy ( % TE ) .


However , the optimal type of replacement fat is unclear .


We investigated the substitution of @-@ @ % TE dietary SFAs with either monounsaturated fatty acids ( MUFAs ) or n-@ ( -@ ) polyunsaturated fatty acids ( PUFAs ) on vascular function and other CVD risk factors .


In a randomized , controlled , single-blind , parallel-group dietary intervention , @ men and women aged @-@ y from the United Kingdom with moderate CVD risk ( @ % above the population mean ) followed one of three @-wk isoenergetic diets ( % TE target compositions , total fat : SFA : MUFA : n-@ PUFA ) that were rich in SFAs ( @:@:@:@ , n = @ ) , MUFAs ( @:@:@:@ , n = @ ) , or n-@ PUFAs ( @:@:@:@ , n = @ ) .


The primary outcome measure was flow-mediated dilatation ; secondary outcome measures included fasting serum lipids , microvascular reactivity , arterial stiffness , ambulatory blood pressure , and markers of insulin resistance , inflammation , and endothelial activation .


Replacing SFAs with MUFAs or n-@ PUFAs did not affect the percentage of flow-mediated dilatation ( primary endpoint ) or other measures of vascular reactivity .


Of the secondary outcome measures , substitution of SFAs with MUFAs attenuated the increase in night systolic blood pressure ( -@ mm Hg , P = @ ) and reduced E-selectin ( -@ % , P = @ ) .


Replacement with MUFAs or n-@ PUFAs lowered fasting serum total cholesterol ( -@ % and -@ % , respectively ) , low-density lipoprotein cholesterol ( -@ % and -@ % ) , and total cholesterol to high-density lipoprotein cholesterol ratio ( -@ % and -@ % ) ( P @ ) .


These changes in low-density lipoprotein cholesterol equate to an estimated @-@ % reduction in CVD mortality .


Substitution of @-@ @ % TE dietary SFAs with either MUFAs or n-@ PUFAs did not significantly affect the percentage of flow-mediated dilatation or other measures of vascular function .


However , the beneficial effects on serum lipid biomarkers , blood pressure , and E-selectin offer a potential public health strategy for CVD risk reduction .


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


Tobacco and cannabis use are both highly prevalent worldwide .


Their co-use is also common in adults and adolescents .


Despite this frequent co-occurrence , cessation from both substances is rarely addressed in randomized clinical trials .


Given evidence that tobacco use may increase during cannabis cessation attempts , and additionally that tobacco users have poorer cannabis cessation outcomes , we explored tobacco outcomes , specifically cigarette smoking , from an adolescent cannabis cessation trial that tested the efficacy of N-acetylesteine ( NAC ) .


Cannabis-dependent adolescents ( ages @-@ ; n = @ ) interested in cannabis treatment were randomized to NAC ( @mg bid ) or matched placebo for @ weeks .


Participants did not need to be cigarette smokers or be interested in smoking cessation to qualify for inclusion .


Approximately @ % of enrolled participants were daily and non-daily cigarette smokers , and only differed from non-smoking participants on the compulsion sub-scale of the Marijuana Craving Questionnaire .


Among cigarette smokers who were retained in the study , there was no change in cigarettes per day for either NAC or placebo groups during the eight-week treatment phase .


Being a cigarette smoker did not appear to influence the effects of NAC on cannabis abstinence , though there was a trend in the placebo group of poorer cannabis outcomes for cigarette smokers vs. non-smokers .


No evidence was found of compensatory cigarette smoking during this cannabis cessation trial in adolescents .


Further work assessing interventions to reduce both cannabis and tobacco use in this population is greatly needed .


The aim was to develop a method for the purpose of localizing epilepsy related hemodynamic foci for patients suffering intractable focal epilepsy using task-free fMRI alone .


We studied three groups of subjects : patients with intractable focal epilepsy , healthy volunteers performing motor tasks , and healthy volunteers in resting state .


We performed spatial independent component analysis ( ICA ) on the fMRI alone data and developed a set of IC selection criteria to identify epilepsy related ICs .


The method was then tested in the two healthy groups .


In seven out of the nine surgery patients , identified ICs were concordant with surgical resection .


Our results were also consistent with presurgical evaluation of the remaining one patient without surgery and may explain why she was not suitable for resection treatment .


In the motor task study of ten healthy subjects , our method revealed components with concordant spatial and temporal features as expected from the unilateral motor tasks .


In the resting state study of seven healthy subjects , the method successfully rejected all components in four out of seven subjects as non-epilepsy related components .


These results suggest the lateralization and localization value of fMRI alone in presurgical evaluation for patients with intractable unilateral focal epilepsy .


The proposed method is noninvasive in nature and easy to implement .


It has the potential to be incorporated in current presurgical workup for treating intractable focal epilepsy patients .


In vitro studies rank walnuts ( Juglans regia ) among the plant foods high in antioxidant capacity , but whether the active constituents of walnuts are bioavailable to humans remains to be determined .


The intention of this study was to examine the acute effects of consuming walnuts compared to refined fat on meal induced oxidative stress .


At issue is whether the ellagitannins and tocopherols in walnuts are bioavailable and provide postprandial antioxidant protection .


A randomized , crossover , and controlled-feeding study was conducted to evaluate a walnut test meal compared to one composed of refined ingredients on postprandial serum antioxidants and biomarkers of oxidative status in healthy adults ( n = @ ) with at least @ week between testing sessions .


Following consumption of a low phenolic diet for one day and an overnight fast , blood was sampled prior to the test meals and at intervals up to @ hours post ingestion and analyzed for total phenols , malondiadehyde ( MDA ) , oxidized LDL , ferric reducing antioxidant power ( FRAP ) , hydrophilic and lipophilic oxygen radical absorbance capacity ( ORAC ) , uric acid , catechins and urinary excretion of phenylacetate metabolites and of urolithin A.


Mixed linear models demonstrated a diet effect ( P < @ ) for plasma - tocopherol but not for - tocopherol with the walnut meal .


Following the walnut test meal , the incremental @ hour area under the curve ( AUC ( @-@h ) ) was reduced @ % for MDA , increased @ % for hydrophilic and @ % for lipophilic ORAC and comparable for total phenols , FRAP and uric acid .


Oxidized LDL was reduced at @ hours after the walnut meal .


Plasma concentrations of gallocatechin gallate ( GCG ) , epicatechin gallate ( ECG ) and epicallocatechin gallate ( EGCG ) increased significantly at @ hour after the walnut test meal .


Quantities of urolithin-A excreted in the urine were significantly higher following the walnut meal .


Compared to the refined control meal , the walnut meal acutely increased postprandial - tocopherol and catechins and attenuated some measures of oxidative stress .


Observational studies have indicated that differences in the composition of human milk and infant formula yield benefits in cognitive development and early growth for breastfed infants .


The objective was to test the hypothesis that feeding an infant formula with reduced energy and protein densities and supplemented with bovine milk fat globule membrane ( MFGM ) reduces differences in cognitive development and early growth between formula-fed and breastfed infants .


In a prospective , double-blind , randomized controlled trial , @ infants < @ mo of age were randomly assigned to be fed an MFGM-supplemented , low-energy , low-protein experimental formula ( EF ) or a standard formula ( SF ) until @ mo of age .


The energy and protein contents of the EF and SF were @ and @ kcal/@ mL and @ and @ g/@ mL , respectively .


A breastfed reference ( BFR ) group consisted of @ infants .


At @ mo of age , the cognitive score ( mean SD ) on testing with the Bayley Scales of Infant and Toddler Development , Third Edition , was significantly higher in the EF group than in the SF group ( @ @ compared with @ @ ; P = @ ) but was not significantly different from that in the BFR group ( @ @ ; P = @ ) .


The EF group ingested larger volumes of formula than did the SF group ( @ @ compared with @ @ mL/d ; P = @ ) , fully compensating for the lower energy density .


No significant differences in linear growth , weight gain , body mass index , percentage body fat , or head circumference were found between the EF and SF groups .


MFGM supplementation to infant formula narrows the gap in cognitive development between breastfed and formula-fed infants .


Between @ and @ mo of age , formula-fed term infants have the capacity to upregulate their ingested volumes when the energy density of formula is reduced from @ to @ kcal/@ mL .


We present the final results of the effect of lung cancer screening with low-dose CT on the smoking habits of participants in a @-year screening trial .


The Danish Lung Cancer Screening Trial ( DLCST ) was a @-year screening trial that enrolled @ subjects ; @ were randomised to annual low-dose CT ( CT group ) and @ received no intervention ( control group ) .


Participants were current and ex-smokers ( @weeks abstinence from smoking ) with a tobacco consumption of @ pack years .


Smoking habits were determined annually .


Missing values for smoking status at the final screening round were handled using two different models .


There were no statistically significant differences in annual smoking status between the CT group and control group .


Overall the ex-smoker rates ( CT + control group ) significantly increased from @ % ( baseline ) to @ % at year @ of screening ( p < @ ) .


The annual point prevalence quit rate increased from @ % to @ % during the five screening rounds ; the ex-smokers ' relapse rate remained stable , around @ % , across the same period .


Screening with low-dose CT had no extra effect on smoking status compared with the control group , but overall the screening programme probably promoted smoking cessation .


Data suggest that capnography is a more sensitive measure of ventilation than standard modalities and detects respiratory depression before hypoxemia occurs .


We sought to determine if adding capnography to standard monitoring during sedation of children increased the frequency of interventions for hypoventilation , and whether these interventions would decrease the frequency of oxygen desaturations .


We enrolled @ children receiving procedural sedation in a pediatric emergency department .


All subjects received standard monitoring and capnography , but were randomized to whether staff could view the capnography monitor ( intervention ) or were blinded to it ( controls ) .


Primary outcome were the rate of interventions provided by staff for hypoventilation and the rate of oxygen desaturation less than @ % .


Seventy-seven children were randomized to each group .


Forty-five percent had at least @ episode of hypoventilation .


The rate of hypoventilation per minute was significantly higher among controls ( @ % vs @ % , P = @ ) .


There were significantly fewer interventions in the intervention group than in the control group ( odds ratio , @ ; @ % confidence interval -LSB- CI -RSB- , @-@ @ ) .


Interventions were more likely to occur contemporaneously with hypoventilation in the intervention group ( @ ; @ % CI , @-@ @ ) .


Interventions not in time with hypoventilation were associated with higher odds of oxygen desaturation less than @ % ( odds ratio , @ ; @ % CI , @-@ @ ) .


Hypoventilation is common during sedation of pediatric emergency department patients .


This can be difficult to detect by current monitoring methods other than capnography .


Providers with access to capnography provided fewer but more timely interventions for hypoventilation .


This led to fewer episodes of hypoventilation and of oxygen desaturation .


Prospective , parallel-group , controlled , comparative randomized study .


To compare cement leakage rate and efficacy for vertebral body restoration of balloon kyphoplasty ( BK ) versus Kiva novel implant with polymethylmethacrylate ( PMMA ) for treating osteolytic vertebral body metastasis .


Minimally invasively vertebral augmentation techniques with PMMA are mostly performed for treating osteoporotic compression fractures .


The Kiva implant with PMMA offers better vertebral body restoration and less PMMA leakage than BK in osteoporotic fractures .


No previous study compared leakage rate and efficacy for vertebral body restoration in traditional BK and Kiva with PMMA in osteolytic vertebral body metastases .


This study examined @ patients ( @ @ yr ) with @ osteolytic vertebral bodies , who received Kiva with low viscosity PMMA and @ patients ( @ @ yr ) with @ vertebral body osteolyses , who were reinforced with BK and high viscosity PMMA .


All osteolyses were graded as Tomita @ to @ .


Anterior vertebral body height ratio ( AVBHr ) , posterior vertebral body height ratio ( PVBHr ) , and middle vertebral body height ratio ( MVBHr ) , Gardner kyphotic deformity , PMMA leakage and were measured and compared between the groups .


Visual analogue scale and Oswestry Disability Index were used for functional outcome evaluation .


No patient survived after @ months .


Asymptomatic PMMA leakage occurred in @ ( @ % ) vertebrae in the BK group solely ( @ to the spinal canal , in Tomita grade @ osteolysis ) Anterior , posterior and middle vertebral body height ratio , Gardner angle improved insignificantly in both groups .


Visual anlogue scale and Oswestry Disability Index improved postoperatively similarly in both groups ( P < @ ) .


BK and Kiva provided equally significant spinal pain relief in patients with cancer with osteolytic metastasis .


The absence of cement leakage in the Kiva group and absence of neurological complication in the BK group leakages reflects the safety of both augmentation techniques even in significant osteolysis .


The lack of cement leakage in the Kiva cases , although low viscosity PMMA was used , increases this implant safety in augmenting severely destructed thoracolumbar vertebrae and sacrum from osteolytic metastasis .


Unexplained painful physical symptoms are commonly reported by depressed patients .


The evidence suggests that dual-action antidepressants are potent in relieving pain in depression .


However , a direct comparison of the effects of selective serotonergic and selective noradrenergic antidepressants on painful symptoms has not been investigated so far .


Sixty patients who participated in the Genome-based Therapeutic Drugs for Depression study with a diagnosis of moderate or severe episodes of depression according to the International Classification of Diseases , @th Revision , and the Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition , criteria were involved .


All the participants were randomly allocated to receive nortriptyline or escitalopram .


The severity of depression was measured using the Montgomery-sberg Depression Rating Scale , the Hamilton Depression Rating Scale and the Beck Depression Inventory at weeks @ , @ , @ , @ and @ .


The intensity of pain was measured on the Visual Analog Scale at the same points of the study .


At `` week @ , '' @ % of the patients later randomized to treatment with escitalopram and @ % of those treated with nortriptyline reported at least one painful symptom .


A significant decrease of pain intensity was observed after @ weeks of treatment .


The two groups did not differ in degree of pain reduction at weeks @ , @ , @ and @ in comparison to baseline values .


A @ % reduction in pain intensity preceded the @ % reduction of depression severity .


The intensity of pain at `` week @ '' did not differ in remitted or nonremitted patients at week @ .


Both selective serotonergic and selective noradrenergic antidepressants are equally effective in alleviations of painful physical symptoms of depression .


The presence of painful symptoms before the onset of treatment did not determine the final response .


The success of HIV programs relies on widely accessible HIV testing and counseling ( HTC ) services at health facilities as well as in the community .


Home-based HTC ( HB-HTC ) is a popular community-based approach to reach persons who do not test at health facilities .


Data comparing HB-HTC to other community-based HTC approaches are very limited .


This trial compares HB-HTC to mobile clinic HTC ( MC-HTC ) .


The trial was powered to test the hypothesis of higher HTC uptake in HB-HTC campaigns than in MC-HTC campaigns .


Twelve clusters were randomly allocated to HB-HTC or MC-HTC .


The six clusters in the HB-HTC group received @ @-d multi-disease campaigns ( five villages per cluster ) that delivered services by going door-to-door , whereas the six clusters in MC-HTC group received campaigns involving community gatherings in the @ villages with subsequent service provision in mobile clinics .


Time allocation and human resources were standardized and equal in both groups .


All individuals accessing the campaigns with unknown HIV status or whose last HIV test was > @ wk ago and was negative were eligible .


All outcomes were assessed at the individual level .


Statistical analysis used multivariable logistic regression .


Odds ratios and p-values were adjusted for gender , age , and cluster effect .


Out of @,@ participants from the @ clusters , @,@ ( @ % ) were eligible ( HB-HTC : @,@ ; MC-HTC : @,@ ) .


The results for the primary outcomes were as follows .


Overall HTC uptake was higher in the HB-HTC group than in the MC-HTC group ( @ % versus @ % ; adjusted odds ratio -LSB- aOR -RSB- : @ ; @ % CI : @-@ @ ; p = @ ) .


Among adolescents and adults @ y , HTC uptake did not differ significantly between the two groups ; however , in children < @ y , HTC uptake was higher in the HB-HTC arm ( @ % versus @ % ; aOR : @ ; @ % CI : @-@ @ ; p < @ ) .


Out of those who took up HTC , @ ( @ % ) tested HIV-positive , @ ( @ % ) in the HB-HTC arm and @ ( @ % ) in the MC-HTC arm ( aOR : @ ; @ % CI : @-@ @ ; p = @ ) .


Ten ( @ % ) and @ ( @ % ) individuals in the HB-HTC and in the MC-HTC arms , respectively , linked to HIV care within @ mo after testing positive .


Findings for secondary outcomes were as follows : HB-HTC reached more first-time testers , particularly among adolescents and young adults , and had a higher proportion of men among participants .


However , after adjusting for clustering , the difference in male participation was not significant anymore .


Age distribution among participants and immunological and clinical stages among persons newly diagnosed HIV-positive did not differ significantly between the two groups .


Major study limitations included the campaigns ' restriction to weekdays and a relatively low HIV prevalence among participants , the latter indicating that both arms may have reached an underexposed population .


This study demonstrates that both HB-HTC and MC-HTC can achieve high uptake of HTC .


The choice between these two community-based strategies will depend on the objective of the activity : HB-HTC was better in reaching children , individuals who had never tested before , and men , while MC-HTC detected more new HIV infections .


The low rate of linkage to care after a positive HIV test warrants future consideration of combining community-based HTC approaches with strategies to improve linkage to care for persons who test HIV-positive .


Linifanib is a selective inhibitor of the vascular endothelial growth factor and platelet-derived growth factor family of tyrosine kinase inhibitors .


The purpose of this high-precision QT study was to evaluate the effects of linifanib on cardiac repolarization in patients with advanced metastatic tumors .


Enrolled patients ( n = @ ) had measurable disease refractory to standard therapies , ECOG performance status of @-@ , and adequate organ function .


Patients were randomized in a @-sequence , @-period crossover design .


Serial ECG measurements and pharmacokinetic samples were collected for each crossover period .


An intersection-union test was performed for time-matched baseline-adjusted QTcF intervals .


An exposure-response analysis was explored to correlate the plasma concentration and QTcF .


The maximum @ % upper confidence bound for the baseline-adjusted QTcF was @ ms at hour @ at the maximum tolerated linifanib dose of @ mg/kg .


Linifanib did not meet the regulatory threshold ( @ ms ) for QT prolongation .


Exposure-response modeling showed that the QTcF change was not significant at the maximum plasma concentration .


Linifanib does not significantly affect cardiac repolarization in patients with advanced solid tumors .


Colorectal cancer is a major health burden .


Screening is recommended in many countries .


To estimate the effectiveness of flexible sigmoidoscopy screening on colorectal cancer incidence and mortality in a population-based trial .


Randomized clinical trial of @,@ individuals aged @ to @ years , identified from the population of Oslo city and Telemark County , Norway .


Screening was performed in @-@ ( @-@-year age group ) and in @ ( @-@-year age group ) , with follow-up ending December @ , @ .


Of those selected , @ were excluded due to prior colorectal cancer , emigration , or death , and @ could not be traced in the population registry .


Participants randomized to the screening group were invited to undergo screening .


Within the screening group , participants were randomized @:@ to receive once-only flexible sigmoidoscopy or combination of once-only flexible sigmoidoscopy and fecal occult blood testing ( FOBT ) .


Participants with positive screening test results ( cancer , adenoma , polyp @ mm , or positive FOBT ) were offered colonoscopy .


The control group received no intervention .


Colorectal cancer incidence and mortality .


A total of @,@ participants were included in the intention-to-screen analyses , of whom @,@ comprised the control group and @,@ comprised the screening group ( @,@ randomized to receive a flexible sigmoidoscopy and @,@ to receive flexible sigmoidoscopy and FOBT ) .


Adherence with screening was @ % .


After a median of @ years , @ participants died of colorectal cancer in the screening group vs @ in the control group ( @ vs @ deaths per @,@ person-years ; absolute rate difference , @ -LSB- @ % CI , @-@ @ -RSB- ; hazard ratio -LSB- HR -RSB- , @ -LSB- @ % CI , @-@ @ -RSB- ) .


Colorectal cancer was diagnosed in @ participants in the screening group vs @ in the control group ( @ vs @ cases per @,@ person-years ; absolute rate difference , @ -LSB- @ % CI , @-@ @ -RSB- ; HR , @ -LSB- @ % CI , @-@ @ -RSB- ) .


Colorectal cancer incidence was reduced in both the @ - to @-year age group ( HR , @ ; @ % CI , @-@ @ ) and the @ - to @-year age group ( HR , @ ; @ % CI , @-@ @ ) .


There was no difference between the flexible sigmoidoscopy only vs the flexible sigmoidoscopy and FOBT screening groups .


In Norway , once-only flexible sigmoidoscopy screening or flexible sigmoidoscopy and FOBT reduced colorectal cancer incidence and mortality on a population level compared with no screening .


Screening was effective both in the @ - to @-year and the @ - to @-year age groups .


In observational studies , low serum @-hydroxyvitamin D -LSB- @ ( OH ) D -RSB- concentrations have been associated with insulin resistance and other risk factors for cardiovascular disease .


We present @-year data from an ongoing @-year trial in @ individuals with impaired fasting glucose ( IFG ) and/or impaired glucose tolerance ( IGT ) randomly assigned to @,@ IU/week vitamin D@ or placebo .


An oral glucose tolerance test was performed at baseline and after @ year .


Mean baseline serum @ ( OH ) D was @ nmol/L and @ nmol/L in the vitamin D and placebo groups , respectively , and increased by @ nmol/L and @ nmol/L , respectively .


With adjustment for baseline concentrations , no differences in measures of glucose metabolism , insulin secretion or sensitivity , blood pressure , or hs-CRP were found after @ year .


There was a slight , but significant decrease in total and LDL cholesterol in the vitamin D group compared with the placebo group , but as there was also a decrease in HDL cholesterol , the change in the total/HDL cholesterol ratio did not differ significantly .


Only analyzing subjects with @ ( OH ) D < @ nmol/L did not change the results .


This study shows that vitamin D supplementation does not improve glycemic indices , blood pressure , or lipid status in subjects with IFG and/or IGT .


Faecal incontinence affects up to @ % of adults .


Associated social isolation and subsequent depression can have devastating effects on quality of life ( QoL ) .


Faecal incontinence is an underreported health problem as the social isolation and stigma that patients experience makes it difficult for sufferers to discuss their condition with a physician .


There have been few well-designed , placebo-controlled clinical trials of treatment for faecal incontinence and little clinical evidence is available to inform the most appropriate management strategies .


Libertas , a robustly designed study will investigate the efficacy and safety of NRL@ ( @R,@S-methoxamine ) , an @ - adrenoceptor agonist , in the treatment of faecal incontinence .


Libertas is a multicentre , Phase II , double-blind , randomised , placebo-controlled , parallel group study .


Patient recruitment took place across @ study centres in Europe .


Patients suffering with faecal incontinence were randomised into four groups ( approximately @ each ) to receive once daily self-administered doses of NRL@ ( @ , @ or @ mg or placebo in a suppository formulation ) for @ weeks .


The primary objective of Libertas is to assess the impact of once daily administration of NRL@ on the severity and frequency of incontinence episodes as assessed by the Wexner score at @ weeks , compared with placebo .


Secondary outcomes include measures of efficacy of NRL@ compared with placebo following @ weeks treatment ; safety and tolerability ; evaluation of plasma pharmacokinetics ; establishment of any pharmacokinetic/pharmacodynamic relationship to adverse events ; dose-response relationship ; the efficacy of NRL@ therapy at @ and @ weeks assessed by the Vaizey score ; and QoL using the Faecal Incontinence Quality of Life and the EQ-@D-@L Healthcare Questionnaires following @ and @ weeks NRL@ therapy .


Overall patient satisfaction with the treatment will also be evaluated .


This is the first randomised controlled study to investigate the efficacy and safety of a selective @ - adrenoceptor agonist for the treatment of faecal incontinence .


Furthermore , this is the first time the impact of NRL@ on assessments of QoL , health outcomes and patient satisfaction will be assessed .


Innovative strategies were developed to meet the challenge of recruiting patients for this study , for example , media advertising , posters and mailshots as allowed by each study centre .


Propranolol therapy is changing the treatment paradigm for infantile hemangioma .


This study addresses the effect of propranolol therapy on the treatment of nasal infantile hemangioma ( NIH ) , an area that often does not respond to medical therapy .


To determine if propranolol treatment is associated with fewer invasive treatments for NIH .


Retrospective cohort study conducted within a single pediatric institution 's multidisciplinary vascular anomaly program for patients with NIH treated between January @ , @ , and December @ , @ .


Three NIH cohorts were compared : prepropranolol ( @ in group @ ; @-@ ) , propranolol ( @ in group @ ; @-@ ) , and nonpropranolol ( @ in group @ ; @-@ ) treatment .


Analysis of systemic medical , laser , or surgical therapies for NIH .


The study plan was created to detect a change in invasive therapy for NIH .


Data collected included presenting age , sex , affected nasal subunits , infantile hemangioma morphologic characteristics , treatment type and number , and primary treating service .


An NIH grading system , based on nasal subunit involvement , helped quantify treatment change .


Descriptive statistics summarized data , and a Cox proportional hazards regression model evaluated propranolol use and the likelihood of invasive treatments ( surgical excision or laser ) .


Of the @ patients identified , @ met inclusion criteria : @ in group @ ( mean age ,@ months ) , @ in group @ ( mean age ,@ months ) , and @ in group @ ( mean age ,@ months ) .


Nasal infantile hemangiomas involved the nasal tip subunit in @ of @ patients ( @ % ) .


Eight of @ patients ( @ % ) in group @ frequently had small NIH ( grade @ ) .


Patients in group @ were less likely to undergo any invasive treatments ( relative risk , @ ; @ % CI , @-@ @ ) , have surgical excision only ( @ ; @-@ @ ) , or undergo laser treatment only ( @ ; @-@ @ ) compared with those in group @ .


Patients with higher-grade NIH had more medical or invasive therapy , but invasive procedures were carried out in each subgroup defined by grade .


Patients with isolated propranolol-treated NIH were less likely to undergo invasive treatment , but despite its implementation , the need for invasive treatment was not totally supplanted by its use .


A number of studies have explored the effects of dietary nitrate on human health .


Nitrate in the blood can be recycled to nitric oxide , which is an essential mediator involved in many important biochemical mechanisms .


Nitric oxide is also formed in the body from l-arginine by nitric oxide synthase .


The aim of this study was to investigate whether genetic polymorphisms in endothelial nitric oxide synthase ( eNOS ) and genes involved in folate metabolism affect the concentration of serum nitrate , serum folate , and plasma total homocysteine in healthy individuals after folic acid supplementation .


In a randomized double-blind , crossover study , participants were given either folic acid @ g/d ( n = @ ) or placebo ( n = @ ) for @ wk .


Wash-out period was @ wk .


Fasting blood samples were collected , DNA was extracted by salting-out method and the polymorphisms in eNOS synthase and folate genes were genotyped by polymerase chain reaction methods .


Measurement of serum nitrate and plasma total homocysteine ( p-tHcy ) concentration was done by high-performance liquid chromatography .


The concentration of serum nitrate did not change in individuals after folic acid supplements ( trial @ ) ; however , the concentration of serum nitrate increased in the same individuals after placebo ( P = @ ) ( trial @ ) .


The individuals with three polymorphisms in eNOS gene had increased concentration of serum folate and decreased concentration of p-tHcy after folic acid supplementation .


Among the seven polymorphisms tested in folate metabolizing genes , serum nitrate concentration was significantly decreased only in DHFR del @ gene variant .


A significant difference in the concentration of serum nitrate was detected among individuals with MTHFR C > T@ polymorphisms .


Polymorphisms in eNOS and folate genes affect the concentration of serum folate and p-tHcy but do not have any effect on the concentration of NO@ in healthy individuals after folic acid supplementation .


The aim of this study was to conduct a cost-utility analysis of the Education , Self-management and Upper Limb Exercise Training in People with RA ( EXTRA ) programme compared with usual care .


A within-trial incremental cost-utility analysis was conducted with @ participants randomized to either the EXTRA programme ( n = @ ) or usual care ( n = @ ) .


A health care perspective was assumed for the primary analysis with a @ week follow-up .


Resource use information was collected on interventions , medication , primary and secondary care contacts , private health care and social care costs .


Quality-adjusted life years ( QALYs ) were calculated from the EuroQol five-dimension three-level ( EQ-@D-@L ) questionnaire responses at baseline , @ and @ weeks .


Compared with usual care , total QALYs gained were higher in the EXTRA programme , leading to an increase of @ QALYs .


The mean National Health Service ( NHS ) costs per participant were slightly higher in the EXTRA programme ( by @ ) , resulting in an incremental cost-effectiveness ratio of @ per additional QALY gained .


Thus the EXTRA programme was cost effective from an NHS perspective when assessed against the threshold of @ @-@ @/QALY gained .


Overall , costs were lower in the EXTRA programme compared with usual care , suggesting it was the dominant treatment option from a societal perspective .


At a willingness-to-pay of @ @/QALY gained , there was a @ % probability that the EXTRA programme was the most cost-effective option .


These results were robust to sensitivity analyses accounting for missing data , changing the cost perspective and removing cost outliers .


The physiotherapist-led EXTRA programme represents a cost-effective use of resources compared with usual care and leads to lower health care costs and work absence .


Conclusive data about cardiovascular toxicity of nonsteroidal anti-inflammatory drugs ( NSAIDs ) are sparse .


We hypothesized that regular NSAID use is associated with increased risk for cardiovascular events in postmenopausal women , and that this association is stronger with greater cyclooxygenase ( cox ) -@ when compared with cox-@ inhibition .


Postmenopausal women enrolled in the Women 's Health Initiative were classified as regular users or nonusers of nonaspirin NSAIDs .


Cox regression examined NSAID use as a time-varying covariate and its association with the primary outcome of total cardiovascular disease defined as cardiovascular death , nonfatal myocardial infarction , or nonfatal stroke .


Secondary analyses considered the association of selective cox-@ inhibitors ( eg , celecoxib ) , nonselective agents with cox-@ > cox-@ inhibition ( eg , naproxen ) , and nonselective agents with cox-@ > cox-@ inhibition ( eg , ibuprofen ) with the primary outcome .


Overall , @ @ participants were available for analysis ( mean follow-up , @ years ) .


Regular NSAID use at some point in time was reported by @ @ participants .


Regular NSAID use was associated with an increased hazard for cardiovascular events versus no NSAID use ( hazard ratio -LSB- HR -RSB- , @ ; @ % confidence interval , @-@ @ ; P < @ ) .


Selective cox-@ inhibitors were associated with a modest increased hazard for cardiovascular events ( hazard ratio , @ ; @-@ @ ; P = @ and celecoxib only : HR , @ ; @-@ @ ; P = @ ) .


Among aspirin users , concomitant selective cox-@ inhibitor use was no longer associated with increased hazard for cardiovascular events .


There was an increased risk for agents with cox-@ > cox-@ inhibition ( HR , @ ; @-@ @ ; P < @ and naproxen only : HR , @ ; @-@ @ ; P < @ ) .


This harmful association remained among concomitant aspirin users .


We did not observe a risk elevation for agents with cox-@ > cox-@ inhibition ( HR , @ ; @-@ @ ; P = @ and ibuprofen only : HR , @ ; @-@ @ ; P = @ ) .


Regular use of selective cox-@ inhibitors and nonselective NSAIDs with cox-@ > cox-@ inhibition showed a modestly increased hazard for cardiovascular events .


Nonselective agents with cox-@ > cox-@ inhibition were not associated with increased cardiovascular risk .


To gain insight into who is likely to benefit from activity-based therapy ( ABT ) , as assessed by secondary analysis of data obtained from a clinical trial .


Secondary analysis of results from a randomized controlled trial with delayed treatment design .


Outpatient program in a private , nonprofit rehabilitation hospital .


Volunteer sample of adults ( N = @ ; @ men ; @ women ; age , @-@y ) with chronic ( @mo postinjury ) , motor-incomplete ( American Spinal Injury Association -LSB- ASIA -RSB- Impairment Scale -LSB- AIS -RSB- grade C or D ) spinal cord injury ( SCI ) .


A total of @h/wk of ABT for @ weeks including developmental sequencing ; resistance training ; repetitive , patterned motor activity ; and task-specific locomotor training .


Algorithms were used to guide group allocation , functional electrical stimulation utilization , and locomotor training progression .


Walking speed and endurance ( @-meter walk test and @-minute walk test ) and functional ambulation ( timed Up and Go test ) .


This secondary analysis identified likely responders to ABT on the basis of injury characteristics : AIS classification , time since injury , and initial walking ability .


Training effects were the most clinically significant in AIS grade D participants with injuries < @ years in duration .


This information , along with information about preliminary responsiveness to therapy ( gains after @wk ) , can help predict the degree of recovery likely from participation in an ABT program .


ABT has the potential to promote neurologic recovery and enhance walking ability in individuals with chronic , motor-incomplete SCI .


However , not everyone with goals of walking recovery will benefit .


Individuals with SCI should be advised of the time , effort , and resources required to undertake ABT .


Practitioners are encouraged to use the findings from this trial to assist prospective participants in establishing realistic expectations for recovery .


The Atrial Fibrillation Follow-up Investigation of Rhythm Management trial showed that digoxin was associated with increased mortality in patients with atrial fibrillation .


To assess the association of digoxin with cardiovascular ( CV ) morbidity and mortality in patients with permanent atrial fibrillation enrolled in the Dutch Rate Control Efficacy in Permanent AF : A Comparison Between Lenient Versus Strict Rate Control II trial as well as to assess the role of digoxin to achieve heart rate targets .


The primary outcome was a composite of CV morbidity and mortality .


Secondary outcomes included CV hospitalization and all-cause mortality or heart failure ( HF ) hospitalization .


Of the @ patients , @ ( @ % ) completed the dose-adjustment phase .


Outcome events were analyzed from the end of the dose-adjustment phase until the end of follow-up .


The median follow-up period was @ years ( interquartile range @-@ @ years ) .


In total , @ patients ( @ % ) used digoxin after the dose-adjustment phase ( median dosage @ mg ; interquartile range @-@ @ mg ) .


These patients were more often women , previously admitted for HF , had an increased left ventricular end-systolic diameter , and more often randomized to strict rate control .


By using Cox proportional hazards regression analysis , the use of digoxin was not associated with an increased risk for the primary and secondary outcomes .


For the primary outcome , the @-year estimated cumulative incidence was @ % vs @ % in the digoxin group vs the no-digoxin group ( unadjusted hazard ratio -LSB- HR -RSB- @ ; @ % confidence interval -LSB- CI -RSB- @-@ @ ) .


Incidence was @ % vs. @ % for CV hospitalization ( unadjusted HR @ ; @ % CI @-@ @ ) and @ % vs. @ % for all-cause mortality or HF hospitalization ( unadjusted HR @ ; @ % CI @-@ @ ) in the digoxin group vs the no-digoxin group .


The use of digoxin was not associated with increased morbidity and mortality .


Single-port access ( SPA ) laparoscopic ovarian cystectomy has been reported as a comparable procedure to conventional laparoscopy in terms of operative outcomes .


However , whether ovarian function after SPA laparoscopic surgery is similar to conventional laparoscopy is questioned due to the limitations in moving instruments .


The aim of this study was to evaluate whether the reduced port number affects the ovarian reserve after laparoscopic ovarian cystectomy .


This was a randomized controlled trial of @ women with benign ovarian cyst , who attended a university hospital and were scheduled for laparoscopic ovarian cystectomy .


Women were randomized to SPA , two-port access ( TPA ) , or four-port access ( FPA ) laparoscopic groups .


The primary outcome was the serum anti-Mllerian hormone ( AMH ) levels : preoperative , @ week , @ month and @ months after the operation .


Secondary outcomes were operative outcomes .


The mean serum AMH levels of preoperative , @ week , @ month and @ months after laparoscopy were @ , @ , @ , and @ ng/mL ( in the SPA group ) , @ , @ , @ , and @ ng/mL ( in the TPA group ) , and @ , @ , @ , and @ ng/mL ( in the FPA group ) , respectively .


There was no statistically significant difference in the serial change of AMH levels among the SPA , TPA and FPA groups .


The laparoscopic ovarian cystectomy with reduced port number does not affect the serial change of ovarian reserve .


The SPA or TPA laparoscopy may be the alternative method to conventional laparoscopy in terms of ovarian reserve .


Studies reporting that budesonide is effective for the treatment of collagenous colitis have been small and differed in efficacy measures .


Mesalamine has been proposed as a treatment option for collagenous colitis , although its efficacy has never been investigated in placebo-controlled trials .


We performed a phase @ , placebo-controlled , multicenter study to evaluate budesonide and mesalamine as short-term treatments for collagenous colitis .


Patients with active collagenous colitis were randomly assigned to groups given pH-modified release oral budesonide capsules ( @ mg budesonide once daily , Budenofalk , n = @ ) , mesalamine granules ( @ g mesalamine once daily , Salofalk , n = @ ) , or placebo for @ weeks ( n = @ ) in a double-blind , double-dummy fashion .


The study was conducted in @ centers ( hospital clinics and private practices ) in Germany , Denmark , Lithuania , Spain , and the United Kingdom .


The primary end point was clinical remission at @ weeks defined as @ stools per day .


Secondary end points included clinical remission at @ weeks , according to the Hjortswang-Criteria of disease activity , taking stool consistency into account .


A greater percentage of patients in the budesonide group were in clinical remission at week @ than the placebo group ( intention-to-treat analysis , @ % vs @ % ; P = @ ; per-protocol analysis , @ % vs @ % ; P = @ ) .


Based on the Hjortswang-Criteria , @ % of patients given budesonide achieved clinical remission compared with @ % of patients given placebo ( P = @ ) ; @ % of patients given mesalamine achieved clinical remission , but budesonide was superior to mesalamine ( P = @ ) .


Budesonide significantly improved stool consistency and mucosal histology , and alleviated abdominal pain .


The rate of adverse events did not differ among groups .


Oral budesonide ( @ mg once daily ) is effective and safe for short-term treatment of collagenous colitis .


Short-term treatment with oral mesalamine ( @ g once daily ) appears to be ineffective .


ClinicalTrials.gov number , NCT@ .


In a double-blind , placebo-controlled trial ( EudraCT identifier : @-@-@ ) , the standardised quality ( SQ ) house dust mite ( HDM ) sublingual immunotherapy ( SLIT ) - tablet ( ALK , Denmark ) was investigated .


The trial included @ subjects , @ years , with mild-moderate HDM allergic asthma .


Subjects were randomised @:@:@:@ to @ , @ or @ SQ-HDM or placebo once daily .


The primary endpoint was reduction in inhaled corticosteroid ( ICS ) after one year .


ICS reduction , asthma quality of life questionnaire ( AQLQ ) and asthma control questionnaire ( ACQ ) score was analysed post hoc in a subgroup with daily ICS use of @-@g and ACQ score of @-@ @ , corresponding to partly controlled asthma ( N = @ ) .


The trial met its primary endpoint .


In the subgroup , the difference between placebo and @ SQ-HDM in change from baseline in daily ICS use was @g ( p < @ ) , while it was @ ( p = @ ) for AQLQ .


The treatment effect on ICS reduction and AQLQ was increased for the subgroup versus the residual population ( ICS reduction : p < @ ) ; AQLQ : p = @ ) .


In this subgroup , including only patients with partly controlled asthma , the benefit of @ year of treatment with SQ HDM SLIT-tablet was significantly higher than for the less severe full population , both in terms of increased asthma control and improved quality of life .


Continuous infusion of epoprostenol is the treatment of choice in patients with pulmonary arterial hypertension in functional classes III to IV .


However , this treatment 's limitations include instability at room temperature .


A new epoprostenol formulation offers improved storage conditions and patient convenience .


The EPITOME-@ trial was an open-label , prospective , multicenter , single-arm , phase IIIb study .


Patients with pulmonary arterial hypertension on long-term , stable epoprostenol therapy were transitioned from epoprostenol with glycine and mannitol excipients ( Flolan ; GlaxoSmithKline , Durham , NC ) to epoprostenol with arginine and sucrose excipients ( Veletri ; Actelion Pharmaceuticals Ltd , Allschwil , Switzerland ) .


Patients were followed up for @ months , and dose adjustments were recorded .


Efficacy measures included the @-minute walk distance , hemodynamics assessed by right heart catheterization , and New York Heart Association functional class .


Safety and tolerability of the transition were also evaluated .


Quality of life was assessed using the Treatment Satisfaction Questionnaire for Medication .


Forty-two patients enrolled in the study , and @ patient withdrew consent before treatment ; thus , @ patients received treatment and completed the study .


Six patients required dose adjustments .


There were no clinically relevant changes from baseline to month @ in any of the efficacy end points .


Adverse events were those previously described with intravenous prostacyclin therapy .


Treatment Satisfaction Questionnaire for Medication scores showed an improvement from baseline to month @ in the domain of treatment convenience .


Transition from epoprostenol with glycine and mannitol excipients to epoprostenol with arginine and sucrose excipients did not affect treatment efficacy , raised no new safety or tolerability concerns , and provided patients with an increased sense of treatment convenience .


Bronchopulmonary dysplasia ( BPD ) is one ofthe most significant complications among very-low-birth-weight ( VLBW ) premature infants .


Vitamin A deficiency increases the risk of BPD in VLBWinfants .


To assess the effect of vitamin A supplementation for prevention of bronchopulmonary dysplasia in VLBW premature Thai infants .


Randomized control trial .


Eighty premature infants weighing < @,@ g who received mechanical ventilation or oxygen supplementation at @ hours ofage-admitted to Neonatal units ofSrinagarind Hospital , Khon Kaen University , Khon Kaen , Thailand-were assigned to receive either intramuscular vitaminA @ , @ IU@ times/week ( treatment group ) or sham procedure ( control group ) for four weeks .


Serum vitamin A levels were measured before and after administration of the vitamin A.


The baseline of mean serum vitamin A levels were similar in both groups .


The mean serum level of vitamin A was significantly higher in the vitamin A supplemented infants than in the control infants on day @ ( @ + / - @ vs. @ +@ pmol / L , p < @ ) , day @ ( @ + / - @ vs. @ + / - @ micromol/L , p = @ ) and day @ ( @ + / - @ vs. @ + / - @ micromol/L , p < @ ) after vitamin A supplementation .


None of the infants in the vitamin A supplemented group , compared to @ % of the infants in the control group , had vitamin A level < @ micromol/L , ( indicating severe vitamin A deficiency ) at @ days .


Fewer of the premature infants in the vitamin A supplemented group required oxygen supplementation at @ weeks postmenstrual age than in the control group albeit not statistically significant ( @ vs. @ % relative risk @ ; @ % CI @ + / - @ ; p = @ ) .


Supplementation with vitamin A was also associated with a significant reduction in the duration ofintubation ( @ + / - @ days vitamin A supplemented group vs. @ + / - @ days control group , p = @ ) , days on oxygen therapy ( @ + / - @ days vitamin A supplemented group vs. @ + / - @ days control group , p = @ ) and length of hospital stay ( @ + / - @ days vitamin A supplemented group vs. @ + / - @ days control group , p = @ ) .


The dose of vitamin A used in this study reduced biochemical evidence of vitamin A deficiency and , without complications , resulted in reducing duration of intubation , days of oxygen therapy , and length of hospital stay in premature infants suffering VLBW


Iodine contrast medium ( ICM ) is considered gold standard in endovascular revascularization procedures .


However , nephrotoxicity and hypersensitivity to ICM are causes that limit its indiscriminate use .


Carbon dioxide ( CO@ ) contrast angiography has been used as an alternative in patients with formal contraindication to ICM .


However , no studies to the present date have compared in a randomized and prospective way , outcomes of revascularization procedures performed with either ICM or CO@ in patients eligible for use of both contrasts .


Between April @ and April @ , @ patients with peripheral arterial disease with arterial lesions classified as Trans-Atlantic Inter-Society Consensus A or B ( identified on preoperative angio computed tomography scan ) and adequate runoff underwent femoropopliteal revascularization by endovascular technique in a prospective , randomized , and controlled study .


Patients were randomized into @ groups : CO@ group and ICM group , according to the contrast media selected of the procedure .


We evaluated the following outcomes in both groups : feasibility of the procedures , complications , surgical outcomes ( ankle-brachial index -LSB- ABI -RSB- ) , glomerular filtration rate using the Cockcroft-Gault formula , relationship between the volume of injected iodine and postoperative creatinine clearance , quality of the angiographic images obtained with CO@ , costs of the endovascular materials , and finally , cost of contrast agents .


We were able to perform the proposed procedures in all patients treated in this series ( ICM group and CO@ ) .


There were no CO@-related complications .


No procedures required conversion to open surgery .


Clinical results were satisfactory , with regression of ischemia and increased levels of ABI in both groups .


Variations in creatinine clearance levels showed a numerical increase in the CO@ group and a decrease in ICM group , however , with no statistically significant difference between the delta clearance in each group .


All CO@ arteriograms of the supragenicular arteries were graded as good or fair by both observers with high interobserver image quality concordance .


There was no statistical difference between endovascular material costs between the groups , but the contrast cost was significantly lower in CO@ group ( P < @ ) .


The use of CO@ in patients with no restriction for ICM is an alternative that does not limit the feasibility of the procedures .


Similar outcomes were observed with CO@ when compared with the gold standard contrast ( ICM ) regarding quality of images produced , with no associated changes in creatinine clearance or hypersensitivity reactions and also allows a reduction in contrast-related costs in angioplasty procedures .


Negative emotional states and abnormal stress reactivity are central components in drug addiction .


The brain stress system in the amygdala is thought to play a key role in the maintenance of drug dependence through negative reinforcement .


Although acute heroin administration was found to reduce anxiety , craving , and stress hormone release , whether these effects are reflected in amygdala activity has not yet been investigated .


With a randomized , crossover , double-blind design , saline and heroin were administered to @ heroin-dependent patients , whereas @ healthy control subjects were included for the placebo administration only .


We used functional magnetic resonance imaging to investigate blood oxygen level-dependent responses during fearful faces processing .


Stress reactivity was measured by adrenocorticotropic hormone levels and by cortisol concentrations in serum and saliva @ min after substance administration .


Anxiety and craving levels were assessed with self-report ratings .


Heroin administration acutely reduced the left amygdala response to fearful faces relative to the saline injection .


Patients receiving saline showed a significantly higher left amygdala response to fearful faces than healthy control subjects , whose activity did not differ from patients receiving heroin .


The left amygdala activity correlated significantly with scores on state-anxiety and levels of adrenocorticotropic hormone , serum cortisol , and saliva cortisol among all patients and control subjects .


Our results show a direct relation between the acute heroin effects on stress-related emotions , stress reactivity , and left amygdala response to negative facial expressions .


These findings provide new insights into the mechanisms underlying negative reinforcement in heroin addiction and the effects of regular heroin substitution .


Impairments of muscle function and strength in patients with primary hyperparathyroidism ( PHPT ) are rarely addressed , although decreased muscle function may contribute to increased fracture risk .


We aimed to assess the changes in muscle strength , muscle function , postural stability , quality of life ( QoL ) , and well-being during treatment with vitamin D or placebo before and after parathyroidectomy ( PTX ) in PHPT patients .


A randomized placebo-controlled trial .


We included @ PHPT patients , mean age @ ( range @-@ ) years and @ ( @ % ) were women .


Daily treatment with @g ( @IU ) cholecalciferol or placebo for @ weeks .


Treatment was administered @ weeks before PTX and continued for @ weeks after PTX .


Changes in QoL and measures of muscle strength and function .


Preoperatively , @-hydroxyvitamin D ( @OHD ) increased significantly ( @-@nmol / l ) compared with placebo ( @-@nmol / l ) .


We did not measure any beneficial effects of supplementation with vitamin D compared with placebo regarding well-being , QoL , postural stability , muscle strength , or function .


In all patients , we measured marked improvements in QoL , well-being ( P < @ ) , muscle strength in the knee flexion and extension ( P < @ ) , and muscle function tests ( P < @ ) after surgical cure .


Postural stability improved during standing with eyes closed ( P < @ ) , but decreased with eyes open ( P < @ ) .


Patients with PHPT and @OHD levels around @nmol/l did not benefit from vitamin D supplementation concerning muscle strength , muscle function , postural stability , well-being , or QoL .


Independent of preoperative @OHD levels , PTX improved these parameters .


It has been assumed that the increase in urine calcium ( Ca ) that accompanies an increase in dietary protein was due to increased bone resorption .


However , studies using stable Ca isotopes have found that dietary protein increases Ca absorption without increasing bone resorption .


The objective of the study was to investigate the impact of a moderately high protein diet on bone mineral density ( BMD ) .


This was a randomized , double-blind , placebo-controlled trial of protein supplementation daily for @ months .


The study was conducted at two institutional research centers .


Two hundred eight older women and men with a body mass index between @ and @ kg/m ( @ ) and a self-reported protein intake between @ and @ g/kg participated in the study .


Subjects were asked to incorporate either a @-g whey protein or isocaloric maltodextrin supplement into their usual diet for @ months .


BMD by dual-energy x-ray absorptiometry , body composition , and markers of skeletal and mineral metabolism were measured at baseline and at @ and @ months .


There were no significant differences between groups for changes in L-spine BMD ( primary outcome ) or the other skeletal sites of interest .


Truncal lean mass was significantly higher in the protein group at @ months ( P = @ ) .


C-terminal telopeptide ( P = @ ) , IGF-@ ( P = @ ) , and urinary urea ( P < @ ) were also higher in the protein group at the end of the study period .


There was no difference in estimated glomerular filtration rate at @ months .


Our data suggest that protein supplementation above the recommended dietary allowance ( @ g/kg ) may preserve fat-free mass without adversely affecting skeletal health or renal function in healthy older adults .


To assess whether add-back therapy with norethindrone acetate or norethindrone acetate plus conjugated equine estrogens is superior to maintain bone health in adolescents and young women using gonadotropin-releasing hormone agonists for endometriosis .


Gonadotropin-releasing hormone agonists are associated with deleterious effects on bone .


Hormonal add-back may mitigate these effects .


Adolescents and young women ( n = @ ) received a random , double-blind assignment to add-back with norethindrone acetate ( @ mg/day ) plus conjugated equine estrogens ( @ mg/day ) or norethindrone acetate plus placebo for @ months .


Body composition , bone mineral content , and bone mineral density ( BMD ) were obtained by dual-energy X-ray absorptiometry every @ months .


Quality-of-life measures were collected every @ months .


Intention-to-treat comparison of outcomes was conducted by repeated-measures analysis of variance .


Thirty-four adolescents and young women completed the trial ; dropouts did not differ from those who completed the trial .


Bone mineral density was normal at baseline .


At @ months , total body bone mineral content and BMD had increased in the norethindrone acetate plus conjugated equine estrogens group ( bone mineral content +@ g , P < @ and BMD +@ g/cm , P = @ ) , but not in those receiving norethindrone acetate plus placebo ( bone mineral content P = @ and BMD P = @ ) .


Lean mass increased only in those receiving conjugated equine estrogens ( +@ kg , P = @ ) .


Improvements in physical functioning domains of quality-of-life assessments were greater with norethindrone acetate plus conjugated equine estrogens ( P = @ ) .


No differences were seen at the hip or lumbar spine by dual-energy X-ray absorptiometry .


No significant adverse events occurred .


Hormonal add-back successfully preserved bone health and improved quality of life for adolescents and young women with endometriosis during @ months of gonadotropin-releasing hormone agonist therapy .


Combination norethindrone acetate plus conjugated equine estrogens add-back appears to be more effective for increasing total body bone mineral content , areal BMD , and lean mass than norethindrone acetate monotherapy .


Summarizes the frequency , type , and context of sexual assault in a large sample of first-year university women at three Canadian universities .


As part of a randomized controlled trial assessing the efficacy of a sexual assault resistance education program , baseline data were collected from women between ages of @ and @ using computerized surveys .


Participants ' experience with sexual victimization since the age of @ years was assessed using the Sexual Experiences Survey -- Short Form Victimization ( SES-SFV ) .


Among @ first-year university women ( mean age = @ years ) , @ % ( @ % CI : @ % , @ % ) had experienced one or more forms of victimization since the age of @ years , @ % ( @ % CI : @ % , @ % ) had experienced at least one completed or attempted rape , and @ % ( @ % CI : @ % , @ % ) had been raped .


Among the @ rape victims , @ % ( @ % CI : @ % , @ % ) had experienced more than one type of assault ( oral , vaginal , anal ) in a single incident or across multiple incidents .


More than three-quarters ( @ % ; @ % CI : @ % , @ % ) of the rapes occurred while women were incapacitated by alcohol or drugs .


One-third ( @ % ) of women had previous self-defence training , but few ( @ % ) had previous sexual assault education .


Findings from the first large Canadian study of university women since the @s indicate that a large proportion of women arrive on campuses with histories of sexual victimization , and they are generally unprepared for the perpetrators they may face during their academic years .


There is an urgent need for effective rape prevention programs on university campuses .


Non-response bias is a major problem for the validity of survey answers .


Analyses of reasons for non-response in surveys with nursing home residents ( NHR ) are scarce .


The aim of this study was to develop reliable and valid categories which represent reasons for non-response in nursing homes using the `` Prozessmodell induktiver Kategorienbildung '' following Mayring ( @ ) .


Furthermore , characteristics of unit non-responder and responder were compared .


Forming of categories of reasons for non-response was conducted with @ NHR , longitudinally .


Four major categories were identified ( general refusal , health reasons , accessibility , excessive demand ) and further @ subcategories .


Unit-non-responder and responder did not differ in age and sex ; however follow-up non-responder showed differences in marital status , training qualification , and cognitive status .


The presented scheme of categories can be used to assess reasons for non-response in nursing homes .


Standardised assessment of reasons for non-response may contribute to higher response rates in this setting .


Many patients with quiescent Crohn 's disease are maintained on long-term treatment with azathioprine ( AZA ) , but controlled data are limited .


We aimed to evaluate the efficacy of AZA therapy for more than @ years to maintain clinical remission .


We performed a randomized double-blind placebo-controlled AZA withdrawal trial with a follow-up period of @ months .


Patients had to have continuous AZA therapy @ years without exacerbation of disease during the @ months before enrollment , and a Crohn 's disease activity index < @ at baseline .


Patients were randomized to continue on AZA or switch to placebo .


The primary endpoint was time to clinical relapse during follow-up .


After inclusion of @ patients , the trial was stopped prematurely due to slow recruitment .


During the @-year follow-up , clinical relapse occurred in @ of @ ( @ % ) patients on continued AZA and in @ of @ ( @ % ) patients on placebo .


Time to clinical relapse averaged @ months ( @ % CI @-@ @ ) on AZA and @ months ( @ % CI @-@ @ ) on placebo ( p = @ ) .


According to life-table analysis , the proportion of patients in remission after @ and @ months was @ @ and @ @ % in patients receiving AZA versus @ @ and @ @ % in patients receiving placebo ( month @ , p = @ ; month @ , p = @ ) .


A higher AZA dose at enrollment was an independent predictor for relapse ( p < @ ) .


AZA withdrawal resulted in a significantly increased relapse risk after @ year and a nonstatistically significant trend for relapse after @ years .


Our results are in line with previous observations .


Suboptimal availability of circulating thyroid hormones may contribute to the high rate of treatment failures in bipolar disorder .


This study tested the efficacy of adjunctive treatment with supraphysiologic doses of levothyroxine in patients with bipolar depression and the hypothesis that women would display a better outcome compared to men .


The aims of this multicenter , @-week , double-blind , randomized , placebo-controlled fixed-dose ( @ g/d ) trial conducted from @ to @ were to assess efficacy and tolerability of levothyroxine adjunctive to continuing treatment with mood stabilizer and/or antidepressant medication for patients with bipolar I or II disorder , currently depressed ( DSM-IV ) , and to investigate gender differences in treatment response .


The primary efficacy variable was mean change in Hamilton Depression Rating Scale ( HDRS ) score .


Of @ patients enrolled in the study , @ ( @ with bipolar I ; mean age = @ years ) were randomized .


Mean change in HDRS score from randomization to week @ was larger in the levothyroxine group compared to the placebo group , with a @-point difference ( decline of -@ -LSB- @ % -RSB- vs -@ -LSB- @ % -RSB- ; last-observation-carried-forward analysis ) .


The course of HDRS scores over time from randomization to week @ was significantly different between groups at week @ ( P = @ ) but not at the end of the placebo-controlled phase ( P = @ ) .


The secondary analysis of women ( n = @ ) revealed a significant difference between groups in mean change in HDRS score ( -@ % placebo vs -@ % levothyroxine , P = @ ) .


A mixed-effects model for repeated-measures analysis showed a significant between-group difference in HDRS score ( @ , P = @ ) for women .


High thyroid-stimulating hormone levels , indicating suboptimal levels of circulating thyroid hormones , were predictive for positive treatment outcome in women treated with levothyroxine in a linear regression model ( F@ = @ ; P = @ ) .


This trial demonstrated that patients treated with levothyroxine did numerically better than those treated with placebo ; however , the study failed to detect a statistically significant difference between the @ groups in the primary outcome measure due to a high placebo response rate .


Previous findings that women show better improvement in depression scores with levothyroxine compared to men were confirmed .


Exercise training has been demonstrated to enhance physical function and to have a protective effect against functional limitations and disability in older adults .


The objective of this study was to determine whether the effects of a home-based , DVD-delivered exercise intervention on functional performance and limitations were maintained @-month postintervention termination .


Follow-up assessments of functional performance and limitations were conducted in a sample of community-dwelling older adults ( N = @ ) who participated in a @-month randomized controlled exercise trial .


Participants were initially randomized to a DVD-delivered exercise intervention or an attentional control condition .


The Short Physical Performance Battery , measures of flexibility and strength , and functional limitations were assessed immediately before and after the intervention and then again @ months later .


Analyses of covariance were conducted to examine changes in physical function between the two conditions at the end of the intervention to @-month follow-up .


There were statistically significant adjusted group differences in the Short Physical Performance Battery ( ( @ ) = @ , p = @ ) , upper-body strength ( ( @ ) = @ , p = @ ) , and lower-body flexibility ( ( @ ) = @ , p = @ ) , indicating that gains brought about by the intervention were maintained @ months later .


A DVD-delivered exercise program specifically designed to target elements of functional fitness in older adults can produce clinically meaningful gains in physical function that are maintained beyond intervention cessation .


NEPA is a novel oral fixed-dose combination of netupitant ( NETU ) , a new highly selective neurokinin-@ ( NK@ ) receptor antagonist ( RA ) and palonosetron ( PALO ) , a pharmacologically and clinically distinct @-hydroxytryptamine type @ ( @-HT@ ) RA .


This study was designed to determine the appropriate clinical dose of NETU to combine with PALO for evaluation in the phase @ NEPA program .


This randomized , double-blind , parallel group study in @ chemotherapy nave patients undergoing cisplatin-based chemotherapy for solid tumors compared three different oral doses of NETU ( @ , @ , and @ mg ) + PALO @ mg with oral PALO @ mg , all given on day @ .


A standard @-day aprepitant ( APR ) + IV ondansetron ( OND ) @ mg regimen was included as an exploratory arm .


All patients received oral dexamethasone on days @-@ .


The primary efficacy endpoint was complete response ( CR : no emesis , no rescue medication ) during the overall ( @-@ h ) phase .


All NEPA doses showed superior overall CR rates compared with PALO ( @ % , @ % , and @ % for NEPA@ , NEPA@ , and NEPA@ , respectively versus @ % PALO ; P < @ ) with the highest NEPA@ dose studied showing an incremental benefit over lower NEPA doses for all efficacy endpoints .


NEPA@ was significantly more effective than PALO and numerically better than APR + OND for all secondary efficacy endpoints of no emesis , no significant nausea , and complete protection ( CR plus no significant nausea ) rates during the acute ( @-@ h ) , delayed ( @-@ h ) , and overall phases .


Adverse events were comparable across groups with no dose response .


The percent of patients developing electrocardiogram changes was also comparable .


Each NEPA dose provided superior prevention of chemotherapy-induced nausea and vomiting ( CINV ) compared with PALO following highly emetogenic chemotherapy ; however , NEPA@ was the best dose studied , with an advantage over lower doses for all efficacy endpoints .


The combination of NETU and PALO was well tolerated with a similar safety profile to PALO and APR + OND .


GSK@ ( @ ) is an HIV-@ integrase inhibitor in clinical development as a long-acting ( LA ) injectable formulation .


This study evaluated plasma and tissue pharmacokinetics after single-dose administration of @ LA administered by intramuscular ( IM ) or subcutaneous injections .


This was a phase I , open-label , @-cohort , parallel study of @ in healthy subjects .


@ was administered as a @ mg/mL nanosuspension at doses of @-@ mg IM and @-@ mg subcutaneous .


Eight ( @ active and @ placebo ) male and female subjects participated in each of the first @ cohorts .


All @ subjects , @ males and @ females , received active @ LA in cohorts @ and @ and underwent rectal and cervicovaginal tissue sampling , respectively .


Plasma pharmacokinetic sampling was performed for a minimum of @ weeks or until @ concentrations were @ g/mL .


Rectal and cervicovaginal tissue biopsies were performed at weeks @ and @ ( cohort @ ) and weeks @ and @ ( cohort @ ) .


@ LA was generally safe and well tolerated after single injections .


A majority of subjects reported injection site reactions , all graded as mild in intensity .


Plasma concentration-time profiles were prolonged with measureable concentrations up to @ weeks after dosing .


@ LA @ mg IM achieved mean concentrations above protein adjusted-IC@ for approximately @ weeks .


Rectal and cervicovaginal tissue concentrations ranged from < @ % to @ % of corresponding plasma concentrations .


These data suggest @ LA injection has potential application as a monthly or less frequent HIV treatment or prevention agent .


The aim of this study was to investigate patient reported outcomes ( PROs ) of functional ability and health related quality of life ( HRQoL ) in patients with early ( rheumatoid ) arthritis during one year of remission steered treatment .


In this study , @ patients with early rheumatoid arthritis ( RA ) or undifferentiated arthritis ( UA ) were treated with methotrexate ( MTX ) and tapered high dose of prednisone .


Patients in early remission ( Disease Activity Score ( DAS ) < @ after @ months ) tapered prednisone to zero and when in persistent remission , also tapered MTX .


Patients not in early remission were randomized to either MTX + hydroxychloroquine + sulphasalazine + prednisone ( arm @ ) or to MTX + adalimumab ( arm @ ) .


Every @ months , patients filled out the Health Assessment Questionnaire ( HAQ ) and the McMaster Toronto Arthritis Patient Preference Questionnaire ( MACTAR ) , the Short Form @ ( SF-@ ) and visual analogue scales ( VAS ) .


Change scores were compared between treatment groups .


The association with achieving remission was analyzed using linear mixed models .


During year @ , patients who achieved early remission had the most improvement in PROs with scores comparable to the general population .


Patients in the randomization arms showed less improvement .


Scores were comparable between the arms .


There was a significant association between achieving remission and scores of HAQ , MACTAR and physical HRQoL .


In early arthritis , PROs of functional ability and HRQoL after one year of remission steered treatment reach normal values in patients who achieved early remission .


In patients not in early remission , who were randomized to two strategy arms , PROs improved less , with similar scores in both treatment arms .


Addition of a second bronchodilator from a different pharmacological class may benefit patients with moderate-to-severe chronic obstructive pulmonary disease ( COPD ) whose symptoms are insufficiently controlled by bronchodilator monotherapy .


GLOW@ evaluated the efficacy and safety of once-daily coadministration of the long-acting @-agonist indacaterol ( IND ) and the long-acting muscarinic antagonist glycopyrronium ( GLY ) versus IND alone in patients with moderate-to-severe COPD .


In this randomized , double-blind , parallel group , placebo-controlled , @-week study , patients were randomized @:@ to IND @ g and GLY @ g daily ( IND + GLY ) or IND @ g daily and placebo ( IND + PBO ) ( all delivered via separate Breezhaler devices ) .


The primary objective was to demonstrate the superiority of IND + GLY versus IND + PBO for trough forced expiratory volume in @ second ( FEV@ ) at week @ .


Other end points included trough FEV@ at day @ , FEV@ area under the curve from @ minutes to @ hours ( AUC@min-@h ) , peak FEV@ , inspiratory capacity and trough forced vital capacity ( FVC ) at day @ and week @ , and transition dyspnea index ( TDI ) focal score , COPD symptoms , and rescue medication use over @ weeks .


A total of @ patients were randomized ( IND + GLY , @ ; IND + PBO , @ ) ; @ % completed the study .


On day @ and at week @ , IND + GLY significantly improved trough FEV@ versus IND + PBO , with treatment differences of @ mL ( @ % CI @-@ mL ) and @ mL ( @ % CI @-@ mL ) , respectively ( both P < @ ) .


IND + GLY significantly improved postdose peak FEV@ , FEV@ AUC@min-@h , and trough FVC at day @ and week @ versus IND + PBO ( all P < @ ) .


TDI focal score and COPD symptoms ( percentage of days able to perform usual daily activities and change from baseline in mean daytime respiratory score ) were significantly improved with IND + GLY versus IND + PBO ( P < @ ) .


The incidence of adverse events was similar for the two treatment groups .


In patients with moderate-to-severe COPD , once-daily coadministration of IND and GLY provides significant and sustained improvement in bronchodilation versus IND alone from day @ , with significant improvements in patient-centered outcomes .


The DBCG @C trial compared one year of tamoxifen in postmenopausal , steroid-receptor unknown , high-risk breast cancer patients to no adjuvant systemic therapy .


After a potential follow-up of @years we report overall efficacy of the study and results according to subtypes subsequently assessed by immunohistochemistry and fluorescent in situ hybridisation ( FISH ) .


Between @ and @ , @ postmenopausal patients with tumours larger than @cm or positive axillary nodes were randomly assigned to no systemic therapy or tamoxifen @mg daily for one year .


Archival tumour tissue from @ patients was analysed and the hormone receptor positive ( estrogen receptor ( ER ) and/or progesterone receptor ( PR ) ) cancers were defined as luminal A if Ki@ low and HER@-negative ; as luminal B if Ki@ high or HER@-positive ; and otherwise as non-luminal-HER@ positive or triple negative .


In the intent-to-treat ( ITT ) population one year of tamoxifen improved the disease-free-survival ( DFS ) ( hazard ratio ( HR ) = @ ; @ % confidence interval ( CI ) @-@ @ ) , the Breast Cancer Recurrence Rate ( BCRR ) ( HR = @ ; @-@ @ ) and reduced the breast-cancer-specific-mortality ( BCM ) ( HR = @ ; @-@ @ ) .


BCRR were improved significantly by tamoxifen in luminal A ( HR = @ ; @-@ @ ) and luminal B/HER@ - ( HR = @ ; @-@ @ ) but not in the other subsets , and with similar results for BCM with @years follow-up .


One year of treatment with tamoxifen significantly improves BCRR and BCM in postmenopausal patients with ER positive breast cancers .


The relative benefit from tamoxifen was not significantly different in luminal A and B subtypes .


For patients with advanced cancer , visits to the emergency department ( ED ) are common .


Such patients present to the ED with a specific profile of palliative care needs , including burdensome symptoms such as pain , dyspnea , or vomiting that can not be controlled in other settings and a lack of well-defined goals of care .


The goals of this study are : i ) to test the feasibility of recruiting , enrolling , and randomizing patients with serious illness in the ED ; and ii ) to evaluate the impact of ED-initiated palliative care on health care utilization , quality of life , and survival .


This is a protocol for a single center parallel , two-arm randomized controlled trial in ED patients with metastatic solid tumors comparing ED-initiated palliative care referral to a control group receiving usual care .


We plan to enroll @ to @ ED-advanced cancer patients at Mount Sinai Hospital in New York , USA , who meet the following criteria : i ) pass a brief cognitive screen ; ii ) speak fluent English or Spanish ; and iii ) have never been seen by palliative care .


We will use balanced block randomization in groups of @ to assign patients to the intervention or control group after completion of a baseline questionnaire .


All research staff performing assessment or analysis will be blinded to patient assignment .


We will measure the impact of the palliative care intervention on the following outcomes : i ) timing and rate of palliative care consultation ; ii ) quality of life and depression at @ weeks , measured using the FACT-G and PHQ-@ ; iii ) health care utilization ; and iv ) length of survival .


The primary analysis will be based on intention-to-treat .


This pilot randomized controlled trial will test the feasibility of recruiting , enrolling , and randomizing patients with advanced cancer in the ED , and provide a preliminary estimate of the impact of palliative care referral on health care utilization , quality of life , and survival .


The objective of this randomised trial was to compare surgical rotator cuff repair to simple decompression by acromioplasty and biceps tenotomy in patients older than @ years of age with a mean follow-up of @ years .


Tendon repair produces better functional outcomes than simple decompression and prevents progression towards cuff tear arthropathy in the longer term .


Of @ initially included patients older than @ years of age and having rotator cuff tears deemed amenable to surgical repair , @ ( @ % ) were evaluated after a mean of @ years .


These patients had been randomly allocated to acromioplasty and tenotomy ( AT group , n = @ ) or to acromioplasty , tenotomy , and tendon suture ( CR group , n = @ ) .


The tear was distal in @ patients , intermediate in @ , and retracted in @ .


At last follow-up , the evaluation included the clinical Constant 's Score , radiographs and , in the CR group , ultrasonography .


The complication rate was @ % .


The mean Constant Score was @ preoperatively ; values after @ years were @ overall ( P = @ ) , @ in the CR group , and @ in the AT group ( P = @ ) .


The tendon-healing rate as assessed using ultrasonography was @ % .


The Constant Score was significantly better when tendon healing was achieved ( @/@ , P < @ ) .


In the AT group , the acromio-humeral distance was significantly shorter ( @ mm/@ @ mm , P = @ ) and eccentric humeral head position was more common ( @ % / @ % , P = @ ) .


Arthroscopic rotator cuff repair provides better functional outcomes than does simple decompression in patients older than @ years and prevents cuff tear arthropathy with eccentric humeral head position in the medium term .


Tendon healing is the main determinant of outcomes after rotator cuff repair .


II , randomised trial .


Medication regimens for asthma are particularly vulnerable to adherence problems because of the requirement for long-term use and periods of symptom remission experienced by patients .


Pharmacists are suited to impact medication adherence given their training , skills , and frequent contact with patients .


The Empowering pharmacists in asthma management through interactive SMS ( EmPhAsIS ) trial involves an intervention leveraging mobile health ( mHealth ) technology to support community pharmacy practice with the hypothesis of improved medication adherence in asthma .


This study is a pragmatic pharmacy-based , cluster , randomized controlled trial with @months of intervention delivery and follow-up .


Pharmacies ( the clusters ) will be randomized at a @:@ ratio to provide intervention or usual care .


The EmPhAsIS intervention consists of patient asthma education , short message service ( SMS ) - based monthly assessment of adherence , and follow-up of non-adherent individuals by community pharmacists .


There are no inclusion or exclusion criteria for pharmacies .


Patients are eligible if they : are @years of age or older , fill a prescription for inhaled corticosteroid ( either monotherapy or in a combination inhaler with long-acting beta-agonists ) , have been diagnosed with asthma , possess a mobile phone with SMS capabilities , and have no communication difficulties such as inability to communicate in English , or significant impairment in vision , hearing , or speech .


The primary outcome is adherence to inhaled corticosteroids ascertained by the medication possession ratio , the ratio of the days of medication supplied to days in a given time interval .


This study will also evaluate secondary outcomes including : asthma control , asthma-related quality of life , asthma-related hospital admissions , and use of reliever medications during the follow-up period .


A nested economic evaluation using a probabilistic decision-analytic model will be used to perform a cost-effectiveness analysis from the societal perspective of the intervention compared with usual care over a @-year time horizon .


Considering the prevalence of asthma , the extent of the non-adherence problem in this disease , and the availability of effective treatments , there is a tremendous potential to reduce the burden of asthma through improving adherence .


This is the first study of an intervention based on mobile communication technology involving community pharmacists in asthma management .


To determine if aspheric intraocular lens ( IOL ) implantation produces the same degree of postoperative ocular aberration and contrast sensitivity as spherical IOL implantation .


In this randomized prospective comparative study , @ eyes of @ cataract surgery patients were randomly assigned to receive a spherical IOL ( Rayner @H ) in one eye and an aspheric IOL ( Rayner @H ) in the contralateral eye .


All patients were examined at @ month postoperatively .


Primary outcomes of contrast sensitivity and ocular wavefront higher order aberrations ( HOAs ) were assessed .


Aspheric IOLs ( median total HOAs @ root mean square -LSB- RMS -RSB- ; range @-@ @ RMS ) produced significantly lower total HOAs than spherical IOLs ( median total HOAs @ RMS ; range @-@ @ RMS ; p < @ ) .


Contrast sensitivity was significantly better with aspheric IOLs ( median contrast sensitivity @ log units ; range @-@ @ log units ) than with spherical IOLs ( median contrast sensitivity @ log units ; range @-@ @ log units ; p < @ ) .


When compared with a structurally ( platform and material ) similar spherical IOL ( Rayner @H ) , aspheric IOLs ( Rayner @H ) appear to significantly reduce HOAs and yield better levels of contrast sensitivity under photopic conditions .


The aim of this study was to evaluate , under farm conditions , the use of a teat sealant in addition to whole herd dry cow antibiotic therapy on the risk of clinical mastitis in dairy cattle at pasture , and to evaluate the impact of dry period length on that risk and the impact of the teat sealant on that risk .


Dairy cows in three herds which used routine whole herd antibiotic therapy were randomly assigned to receive either treatment with an internal teat sealant ( n = @ ) or no additional treatment ( n = @ ) at drying-off between March and May @ .


All clinical mastitis cases during the dry period and to the end of the subsequent lactation were recorded by farm staff ; factors affecting risk of clinical mastitis were then analysed using a Cox proportional hazards model .


Median duration of the dry period was @ days with > @ % of cows having a dry period > @ days .


The incidence risk of mastitis during lactation for cows treated with teat sealant was @ ( @ % CI = @-@ @ ) cases per @ cows compared with @ ( @ % CI = @-@ @ ) cases per @ cows for cows treated with antibiotic alone .


The addition of a teat sealant to dry cow antibiotic therapy decreased the risk of clinical mastitis only in the first @ days after calving ( Hazard risk @ ( @ % CI = @-@ @ ) ) .


Length of dry period did not significantly affect the risk of clinical mastitis , or the effect of adding teat sealant to dry cow antibiotic therapy on the risk of clinical mastitis .


In these herds where , based on the mastitis history , whole herd antibiotic therapy had been recommended , the use of a teat sealant significantly reduced the risk of clinical mastitis .


This effect was limited to the first @ days after calving ; subsequently there was no significant effect of treatment .


There was no effect of dry period length on risk of clinical mastitis , nor any significant interaction with treatment .


Combination therapy with teat sealant and antibiotic was effective under New Zealand conditions in herds using whole herd antibiotic treatment at drying off .


Teat sealant reduced risk of clinical mastitis in cattle with dry periods substantially longer than @ days , and there was no evidence that this effect changed as dry period length increased .


To determine the dose of triptorelin that is sufficient to maintain complete ovarian suppression in female patients with childhood-onset systemic lupus erythematosus ( SLE ) who require cyclophosphamide therapy , to determine the length of time needed to achieve ovarian suppression after initiation of triptorelin treatment , and to investigate the safety of triptorelin .


In this randomized , double-blind , placebo-controlled , dose-escalation study , female patients ages < @ years were randomized @:@ to receive triptorelin ( n = @ ) or placebo ( n = @ ) .


The starting doses of triptorelin were @ , @ , @ , and @ g/kg , and the dose was escalated until complete ovarian suppression was maintained .


The primary outcome was the weight-adjusted dose of triptorelin that provided complete ovarian suppression in at least @ % of the patients , as determined by gonadotropin-releasing hormone agonist stimulation testing .


The secondary outcome was the period of time required to achieve ovarian suppression , as measured by unstimulated follicle-stimulating hormone and luteinizing hormone levels after the initiation of triptorelin treatment .


Treatment with triptorelin at a weight-adjusted dose of @ g/kg body weight provided sustained complete ovarian suppression in @ % of the patients .


After administration of the initial dose of triptorelin , @ days were required to achieve complete ovarian suppression .


The rates of adverse events ( AEs ) and serious adverse events ( SAEs ) per @ patient-months of followup were not higher in the triptorelin group compared with the placebo group ( for AEs , @ versus @ ; for SAEs , @ versus @ ) .


High doses of triptorelin are needed to achieve and maintain complete ovarian suppression , but such doses appear to be well tolerated in adolescent female patients with childhood-onset SLE .


Our data suggest that a lag time of @ days after initiation of triptorelin treatment is required before cyclophosphamide therapy is started or continued .


To examine the association between baseline body mass index ( BMI ) , and disease-free survival ( DFS ) and overall survival ( OS ) in a large French early-stage breast cancer population included in the UNICANCER Programme d'Action Concert Sein-@ ( PACS@ ) and PACS@ phase III randomised trials .