Hypothermia was incident in @patients ( @ % ) in group W and in @ patients ( @ % ) in group R at the end of surgery .


The difference between the initial and the final core body temperature was @ C group W and @ C in group R ( p = @ ) .


The extubation time was @ min in group W and @ min in group R ( p = @ ) .


Shivering was detected in seven patients ( @ % ) in group W and in @patients ( @ % ) in group R ( p = @ ) .


The recovery duration was @ min in group W and @ min in group R ( p = @ ) .


Administration of irrigation solutions at room temperature in PCNL operations causes the body temperature to decrease significantly , which results in postoperative complications such as late emergence from anesthesia , late recovery from anesthesia , and shivering .


The aim of this study was to assess the effect of intraoral aging on the setting status of a resin composite and a glass ionomer adhesive , relative to control specimens stored in water .


Metallic brackets were bonded with resin composite orthodontic adhesive ( Transbond XT ; @M Unitek , Monrovia , Calif ) or a glass ionomer cement ( Fuji I ; GC , Tokyo , Japan ) to recently extracted premolars and kept in water for @ months .


The same materials were also bonded to the premolars of orthodontic patients .


After @ months , the teeth were carefully extracted , with the brackets intact on their buccal surfaces .


All teeth were embedded in epoxy resin and sectioned buccolingually .


Fourier transform infrared microscopy and Raman microscopy were used for the estimation of the degree of cure in the composite and the salt yield in the glass ionomer adhesives .


The control samples of the composite showed significantly lower degrees of cure than did the retrieved specimens ( @ % @ % vs @ % @ % by Fourier transform infrared microscopy , and @ % @ % vs @ % @ % by Raman microscopy ) .


Raman microscopy significantly overestimated the degree of cure and failed to provide reliable information for the salt yield in the glass ionomer cement .


Fourier transform infrared microscopy showed increased , but no statistically significant difference in , aluminum-carboxylate salts in the retrieved specimens .


Enhanced oxidation of residual carbon-carbon bonds in the composite and slightly increased dissolution of the weaker calcium-salt phase in the glass ionomer cement were the main differences in the intraorally aged specimens in comparison with the specimens stored in water .


Conflicting evidence exists on the efficacy and safety of bivalirudin administered as part of percutaneous coronary intervention ( PCI ) in patients with an acute coronary syndrome .


We randomly assigned @ patients with an acute coronary syndrome for whom PCI was anticipated to receive either bivalirudin or unfractionated heparin .


Patients in the bivalirudin group were subsequently randomly assigned to receive or not to receive a post-PCI bivalirudin infusion .


Primary outcomes for the comparison between bivalirudin and heparin were the occurrence of major adverse cardiovascular events ( a composite of death , myocardial infarction , or stroke ) and net adverse clinical events ( a composite of major bleeding or a major adverse cardiovascular event ) .


The primary outcome for the comparison of a post-PCI bivalirudin infusion with no post-PCI infusion was a composite of urgent target-vessel revascularization , definite stent thrombosis , or net adverse clinical events .


The rate of major adverse cardiovascular events was not significantly lower with bivalirudin than with heparin ( @ % and @ % , respectively ; relative risk , @ ; @ % confidence interval -LSB- CI -RSB- , @ to @ ; P = @ ) , nor was the rate of net adverse clinical events ( @ % and @ % , respectively ; relative risk , @ ; @ % CI , @ to @ ; P = @ ) .


Post-PCI bivalirudin infusion , as compared with no infusion , did not significantly decrease the rate of urgent target-vessel revascularization , definite stent thrombosis , or net adverse clinical events ( @ % and @ % , respectively ; relative risk , @ ; @ % CI , @ to @ ; P = @ ) .


In patients with an acute coronary syndrome , the rates of major adverse cardiovascular events and net adverse clinical events were not significantly lower with bivalirudin than with unfractionated heparin .


The rate of the composite of urgent target-vessel revascularization , definite stent thrombosis , or net adverse clinical events was not significantly lower with a post-PCI bivalirudin infusion than with no post-PCI infusion .


( Funded by the Medicines Company and Terumo Medical ; MATRIX ClinicalTrials.gov number , NCT@ . )


Afatinib is an oral , irreversible ErbB family blocker that has shown activity in epidermal growth factor receptor ( EGFR ) - mutated lung cancer .


We hypothesized that the agent would have greater antitumor activity compared with cetuximab in recurrent or metastatic ( R/M ) head and neck squamous cell carcinoma ( HNSCC ) patients , whose disease has progressed after platinum-containing therapy .


An open-label , randomized , phase II trial was conducted in @ centers ; @ patients were randomized ( @ : @ ) to either afatinib ( @ mg/day ) or cetuximab ( @ mg/m ( @ ) / week ) until disease progression or intolerable adverse events ( AEs ) ( stage I ) , with optional crossover ( stage II ) .


The primary end point was tumor shrinkage before crossover assessed by investigator ( IR ) and independent central review ( ICR ) .


A total of @ patients were treated ( @ afatinib , @ cetuximab ) and @ crossed over to stage II ( @ and @ respectively ) .


In stage I , mean tumor shrinkage by IR/ICR was @ % / @ % with afatinib and @ % / @ % with cetuximab ( P = @ / @ ) .


Objective response rate was @ % / @ % with afatinib and @ % / @ % with cetuximab ( IR/ICR ) .


Comparable disease control rates were observed with afatinib ( @ % ) and cetuximab ( @ % ) by IR ; similar results were seen by ICR .


Most common grade @ drug-related AEs ( DRAEs ) were rash/acne ( @ % versus @ % ) , diarrhea ( @ % versus @ % ) , and stomatitis/mucositis ( @ % versus @ % ) with afatinib and cetuximab , respectively .


Patients with DRAEs leading to treatment discontinuation were @ % with afatinib and @ % with cetuximab .


In stage II , disease control rate ( IR/ICR ) was @ % / @ % with afatinib and @ % / @ % with cetuximab .


Afatinib showed antitumor activity comparable to cetuximab in R/M HNSCC in this exploratory phase II trial , although more patients on afatinib discontinued treatment due to AEs .


Sequential EGFR/ErbB treatment with afatinib and cetuximab provided sustained clinical benefit in patients after crossover , suggesting a lack of cross-resistance .


Exercise training may improve components of metabolic syndrome and obstructive sleep apnea syndrome ( OSAS ) .


The objective of our pilot randomized controlled study was to determine the benefits of a short intensive inpatient individualized exercise training ( IET ) program in sedentary untreated OSAS patients .


Twenty-two sedentary patients with moderate to severe OSAS were randomly assigned either to one-month education activity sessions ( n = @ ; control group ) or to inpatient rehabilitation program ( n = @ ) , including IET , education activities sessions , and dietary management .


Full polysomnography ( PSG ) , OSLER ( Oxford Sleep Resistance test ) , body composition , anthropometric measurements , metabolic syndrome components , and questionnaires were performed at baseline and at study end point .


No changes occurred in the control group in all variables .


Compared to controls , participants randomized to the IET group presented a significant decrease in apnea-hypopnea index ( AHI ) ( @ vs. @ ; P < @ ) , oxygen desaturation index ( ODI ) , and arousal index , which occurred in conjunction with significant decrease in body mass index ( BMI ) , neck circumference , fat mass , fasting glucose , and diastolic blood pressure .


Increased sleep latency was found in participants in the IET group with altered values at baseline .


IET reduced OSAS severity with improvement of metabolic syndrome components with concomitant loss in body fat in sedentary adults .


If confirmed on a larger scale , a comprehensive rehabilitation program could constitute an additional or alternative treatment for moderate to severe OSAS patients .


The most appropriate means of capturing data from the Neuropsychiatric Inventory ( NPI ) must be understood to optimize use of this instrument in clinical trials .


The utility of the composite score ( frequency times severity ) was recently demonstrated in mild and moderate dementia .


Determination of frequency compared to composite scores in mild cognitive impairment ( MCI ) warrants investigation .


We used the NPI data from a randomized , placebo-controlled , multi-center , @-week , clinical trial involving @ patients who were diagnosed with amnestic MCI and had clinically significant neuropsychiatric symptoms ( NPS ) .


We calculated standardized changes for both frequency and composite scores .


There were improvements in NPI composite scores in both active drug - and placebo-treated patients , with significant superiority of active drug .


Standardized changes in severity and composite scores tended to be larger than those in the frequency scores , whereas discrimination between treatment groups was similar for all three scores .


Our findings support the hypothesis that in MCI , as in dementia , the NPI frequency score is not more sensitive to treatment-related change than the composite score .


As the severity score adds information , the use of the composite score has better performance characteristics .


Patients with type @ diabetes mellitus ( T@DM ) have clinically relevant disturbances in the effects of the hormone glucose-dependent insulinotropic polypeptide ( GIP ) .


We aimed to evaluate the importance of the prevailing plasma glucose levels for the effect of GIP on responses of glucagon and insulin and glucose disposal in patients with T@DM .


We performed a single center , placebo-controlled , cross-over , experimental study .


We studied twelve patients with T@DM ( age : @ @ years -LSB- mean SEM -RSB- , body mass index : @ @ kg/m ( @ ) ; glycosylated hemoglobin A@c : @ @ % -LSB- @ @ mmol/mol -RSB- ) .


We infused physiological amounts of GIP ( @ pmol kg ( -@ ) min ( -@ ) ) or saline .


We measured plasma concentrations of glucagon , glucose , insulin , C-peptide , intact GIP , and amounts of glucose needed to maintain glucose clamps .


During fasting glycemia ( plasma glucose @ mmol/L ) , GIP elicited significant increments in both insulin and glucagon levels , resulting in neutral effects on plasma glucose .


During insulin-induced hypoglycemia ( plasma glucose @ mmol/L ) , GIP elicited a minor early-phase insulin response and increased glucagon levels during the initial @ minutes , resulting in less glucose needed to be infused to maintain the clamp ( @ @ vs @ @ mg kg ( -@ ) , P < @ ) .


During hyperglycemia ( @ fasting plasma glucose @ mmol/L ) , GIP augmented insulin secretion throughout the clamp , with slightly less glucagon suppression compared with saline , resulting in more glucose needed to maintain the clamp during GIP infusions ( @ @ vs @ @ mg kg ( -@ ) , P < @ ) .


In patients with T@DM , GIP counteracts insulin-induced hypoglycemia , most likely through a predominant glucagonotropic effect .


In contrast , during hyperglycemia , GIP increases glucose disposal through a predominant effect on insulin release .


To determine the effect of fall-related concerns on physical , mental , and social function .


Community-based prospective cohort study ( secondary analysis using control group data from a randomized controlled trial ) .


Two municipalities in the south of the Netherlands .


Community-dwelling older adults ( N = @ ) .


Two groups were created using Modified Falls Efficacy Scale scores ( high and low levels of fall-related concerns ) .


Five outcome measures representing physical , mental , and social function were included : activities of daily living ( ADLs ) , symptoms of depression , feelings of anxiety , social participation , and social support interactions .


Outcomes were measured at baseline and at @ , @ , and @ months .


Data were analyzed using analysis of covariance and mixed-effect regression models for longitudinal data , adjusting for age , sex , living status ( alone or with another person ) , educational level , cognitive status , self-perceived health , and falls history at baseline .


At baseline , significantly more limitations in ADLs and social participation were found for older persons with high levels of fall-related concerns than for those with low levels of concern .


These differences persisted over @ months of follow-up and were consistent over time .


No significant differences were found for symptoms of depression , feelings of anxiety , or social support interactions , except for feelings of anxiety at @ months .


Older persons with higher levels of fall-related concerns reported up to @ months poorer ADL and social participation for up to @ months than those with lower levels of fall-related concerns .


From a clinical point of view , the clear relationship between fall-related concerns and ADL dysfunction and social participation may help to target groups who are at risk of developing adverse consequences of concerns about falls .


To determine whether an intensive lifestyle intervention ( ILI ) designed to sustain weight loss and improve physical fitness in overweight or obese persons with type @ diabetes was associated with bone loss after @ years of follow-up .


This randomized controlled trial of intensive weight loss compared an ILI with a diabetes support and education ( DSE ) group among @,@ overweight or obese subjects .


Bone mineral density was assessed at baseline and after @ year and @ years of intervention .


ILI was effective in producing significant weight loss ( @ % vs. @ % in ILI and DSE , respectively ; P < @ ) and increased fitness ( @ % vs. -@ % ) at year @ .


In men , ILI participants had a greater rate of bone loss during the first year ( -@ % vs. -@ % per year in ILI and DSE , respectively ) .


Differences between groups were diminished by one-half after @ years ( -@ % vs. -@ % per year in ILI and DSE , respectively ) but remained significant ( P < @ ) .


The difference in rate of hip bone loss between groups over @ years was related to increased weight loss in ILI .


Among women , the rate of bone loss did not differ between ILI and DSE after @ years .


A @-year weight loss intervention was significantly associated with a modest increase in bone loss at the hip in men but not in women .


Epidemiological studies have found a U-shaped relationship between serum phosphorus and cardiovascular disease ( CVD ) .


The mechanism ( s ) behind such a relationship are poorly understood .


Phosphorus ( P ) is reported to improve insulin sensitivity , which is involved in lipid metabolism , and thus we were interested in determining the impact of phosphorus ingestion on postprandial lipemia , a recognized CVD risk factor .


A within-subject study design was conducted , whereby @ healthy male subjects received a high fat meal ( @ Kcal ; @ % energy from fat ; @ mg of phosphorus ) with placebo or phosphorus ( @ mg ) in a random order .


Postprandial blood samples ( ~ @ ml ) were collected every hour for @ hours after meal ingestion .


Changes in different parameters were analyzed using a @-factor repeated-measure ANOVA .


In the phosphorus ( P ) supplemented group , postprandial serum P increased ( p = @ ) , while changes in insulin , non-esterified fatty acids ( NEFA ) and triglyceride ( TG ) were not significantly different than that of placebo .


Concurrently , phosphorus supplementation increased postprandial concentrations of apolipoprotein B@ ( ApoB@ ) ( p < @ ) and decreased that of apolipoprotein B@ ( ApoB@ ) ( p < @ ) .


Phosphorus supplementation ( @ mg ) of the meal seems to alter the different components of postprandial lipemia .


These findings highlight the potential role of phosphorus in CVD .


To determine whether extracranial-intracranial ( EC-IC ) bypass can improve cognition over @ years compared to best medical therapy alone in patients with symptomatic internal carotid artery ( ICA ) occlusion and increased oxygen extraction fraction ( OEF ) on PET .


Patients underwent ( @ ) O PET and were randomized if OEF ratio was > @ on the occluded side .


Using blinded baseline and @-year cognitive assessments , age-adjusted composite z scores were generated from subtests sensitive to right/left hemisphere plus global cognitive functioning .


Multiple regression predicted @-year cognitive change .


Eighty-nine patients were enrolled ; @ had increased OEF and were randomized .


Two died , @ were lost to follow-up , and @ refused @-year testing .


Of the @ remaining , @ had ipsilateral stroke or death , leaving @ surgical and @ medical patients .


Controlling for age , education , and depression , there was no difference in @-year cognitive change between the medical and surgical arms ( @ % confidence interval -@ to @ , p = @ ) .


In post hoc analysis of @ patients with no stroke in the follow-up period , cognitive improvement was associated with less impaired PET OEF at baseline ( p = @ ) .


Cognitive improvement following bypass surgery was not superior to medical therapy among patients with recently symptomatic carotid occlusion and increased OEF .


Among those with no recurrent stroke , less hemodynamic impairment at baseline was associated with greater cognitive gain in both groups .


Reversing cognitive impairment in hemodynamic failure remains an open challenge .


This study provides Class II evidence that for patients with symptomatic ICA occlusion and increased OEF on PET , EC-IC bypass compared to no bypass does not improve cognitive function after @ years .


To evaluate the safety , tolerability , and comparative pharmacokinetics ( PK ) of intravenous and oral carbamazepine .


In this phase @ , open-label study , adult patients with epilepsy on a stable oral carbamazepine dosage ( @-@ ,@ mg/day ) were converted to intravenous carbamazepine ( administered at @ % of the oral dosage ) .


A @-day outpatient period preceded an up to @-day inpatient period and a @-day follow-up period .


Intravenous carbamazepine was administered over @ or @ min every @ h on days @-@ ; some patients in the @-min group were eligible to receive four @ - to @-min ( rapid ) infusions on day @ .


Patients underwent blood sampling to determine the area under the concentration-time curve ( AUC ) for carbamazepine and metabolite carbamazepine-@ ,@ - epoxide following oral ( day @ ) and intravenous carbamazepine administration ( days @ , @ , and @ ) .


Bioequivalence was evaluated in patients with normal renal function ( creatinine clearance > @ ml/min ) .


Safety assessments were conducted through day @ .


Ninety-eight patients enrolled and @ completed the PK component .


The mean daily oral and intravenous carbamazepine dosage for @ PK-evaluable patients with normal renal function was @ and @ mg ( @ % of oral dosage ) , respectively .


Steady-state minimum concentration ( C ( min ) ) and overall exposure ( AUC@-@ ) for intravenous carbamazepine infused over @ , @ , or @-@ min were similar to oral carbamazepine .


The @ % confidence intervals ( CIs ) for the ratios of the adjusted means for AUC@-@ , maximum concentration ( Cmax ) , and C ( min ) were within the @ % -@ % bioequivalence range for @-min intravenous infusions versus oral administration , but exceeded the upper limit for Cmax for the @-min and rapid infusions .


All intravenous carbamazepine infusions were well tolerated .


Intravenous carbamazepine infusions ( @ % of oral daily dose ) of @ - , @ - , and @ - to @-min duration , given every @ h , maintained patients ' plasma carbamazepine concentrations .


Intravenous carbamazepine @-min infusions were bioequivalent to oral carbamazepine in patients with normal renal function ; rapid infusions were well-tolerated in this study .


To assess the effectiveness of healthcare team guidance in the implementation of a glycemic control protocol in the non-intensive care unit of a cardiology hospital .


This was a randomized clinical trial comparing @ months of intensive guidance by a healthcare team on a protocol for diabetes care ( Intervention Group , n = @ ) with @ months of standard care ( Control Group , n = @ ) .


Clinicaltrials.gov : NCT@ .


The mean age of the patients was @ years , and the mean glycated hemoglobin level was @ mmol/mol ( @ % ) .


The mean capillary glycemia during hospitalization was similar between the groups ( @ and @ mmol/l for the Intervention Group and Control Group , respectively , p = @ ) .


The number of hypoglycemic episodes ( p = @ ) , hyperglycemic episodes ( @ vs. @ in the Intervention Group and Control Group , p = @ , respectively ) , and the length of stay in the hospital were similar between the groups ( p = @ ) .


The amount of regular insulin administered was @ ( @-@ ) IU in the Intervention Group and @ ( @-@ ) IU in the Control Group ( p < @ ) , and the amount of NPH insulin administered was similar between the groups ( p = @ ) .


While guidance on a glycemic control protocol given by a healthcare team resulted in a modification of the therapeutic strategy , no changes in glycemic control , frequency of episodes of hypoglycemia and hyperglycemia , or hospitalization duration were observed .


Dietary carbohydrates may affect metabolic and physiologic parameters .


The present study evaluated whether a combination of two dietary fibers , oligofructose ( OFS ) and pectin ( P ) , altered satiety and glycemic parameters .


The primary objective of this study was to determine whether dietary supplementation for @weeks with OFS+P would produce a greater reduction in energy intake of an ad libitum test meal compared to control .


This was a single center , randomized , double-blind , placebo-controlled , parallel group study in overweight and obese , otherwise healthy , subjects ( N = @ ) .


There were two OFS+P treatment groups : high-dose ( @g/d ) , low-dose ( @g/d ) , and a control group ( maltodextrin @g/d ) .


Energy intake , appetite measures based on Satiety Labeled Intensity Magnitude ( SLIM ) scale , fasting and post-prandial glucose , and insulin levels and body weight were measured at baseline and at the end of @weeks .


Adverse events and gastrointestinal tolerability of the treatments were also assessed .


An analysis of covariance ( ANCOVA ) performed on the primary endpoint change from baseline in energy intake , showed no statistically significant difference in energy intake among the three treatment groups ( p = @ ) .


The LS mean changes ( SE ) in energy intake from baseline to week @ were -@ ( @ ) kilocalories ( kcal ) for the high dose group , -@ ( @ ) kcal for the low dose group , and -@ ( @ ) kcal for the control group .


For the pairwise comparisons of OFS+P doses and control , confidence intervals were constructed around the difference in LS mean changes .


All study products were generally well tolerated .


There was a directional benefit in ad libitum energy intake for both OFS+P doses compared to control , with a greater reduction in kilocalories in the low dose comparison , but the reductions were not significant .


Further studies are warranted .


To examine protocol fidelity among teachers involved in a six-month cluster-randomized physical activity ( PA ) intervention .


In @ , preschools in Springfield , MA were randomized to short bouts of structured PA ( SBS-PA , n = @ ) or unstructured playtime ( UPA , n = @ ) .


SBS-PA provided structured PA in the classroom during the first @ min of gross-motor playtime followed by @ min of unstructured playtime .


UPA consisted of @ min of unstructured playtime .


All teachers ( SBS-PA and UPA ) received a written study protocol and @ h of training .


SBS-PA also received videos to use to lead structured PA and @ additional hours of training .


Study fidelity and process evaluation were assessed twice weekly via semi-structured questionnaire .


Only @ % of SBS-PA and @ % of UPA free playtimes lasted for @ min ; @ % of SBS-PA teachers implemented structured PA during the first @ min of gross-motor playtime but only @ % delivered the intervention as instructed .


Only @ % of SBS-PA teachers implemented the @-minute unstructured playtime .


SBS-PA teachers reported that time limitations was a major barrier in implementing the designed intervention .


Pre-post changes in PA did not differ between groups .


Limited fidelity to intervention protocol likely impacted study findings .


Future studies should focus on strategies to improve adherence among intervention leaders .


Advanced pancreatic cancer ( APC ) , in addition to its high mortality , accounts for the highest rates of venous thromboembolic events ( VTEs ) .


Enoxaparin , a low-molecular weight heparin , is effective in prevention and treatment of VTEs .


Some small studies have indicated that this benefit might extend to patients with cancer .


Patients with histologically proven APC were randomly assigned to ambulant first-line chemotherapy and prophylactic use of enoxaparin or chemotherapy alone to investigate the probable reduction in symptomatic VTEs and the impact on survival .


A total of @ patients were recruited as one of the protocol end points was reached .


Within the first @ months , the numbers of symptomatic VTEs were as follows : @ of @ patients in the observation group and two of @ patients in the enoxaparin group ( hazard ratio -LSB- HR -RSB- , @ ; @ % CI , @ to @ ; ( @ ) P = @ ) .


The numbers of major bleeding events were as follows : five of @ patients in the observation arm and seven of @ patients in the enoxaparin arm ( HR , @ ; @ % CI , @ to @ ; ( @ ) P = @ ) .


Overall cumulative incidence rates of symptomatic VTEs were @ % ( observation ) and @ % ( enoxaparin ; HR , @ ; @ % CI , @ to @ ; P = @ ) .


Progression-free ( HR , @ ; @ % CI , @ to @ ; P = @ ) and overall survival ( HR , @ ; @ % CI , @ to @ ; P = @ ) did not differ between groups .


This study demonstrates the high efficacy and feasibility of primary pharmacologic prevention of symptomatic VTEs in outpatients with APC .


Treatment efficacy was not affected by simultaneous treatment with enoxaparin in this trial setting .


As spaceflight compromises skeletal muscle oxidative and aerobic work capacity , this study assessed the efficacy of resistance exercise ( RE ) to counteract muscle metabolic perturbations induced by @ wk unilateral lower limb unloading ( UL ) .


There were @ men and women ( @-@ yr ) who were randomly assigned to either UL with ( Group , Grp ; UL+RE ; N = @ ) or without ( Grp UL ; N = @ ) concurrent RE .


Iso-inertial RE comprised four sets of seven maximal coupled concentric-eccentric knee extensions executed @-@ times per week .


Percutaneous biopsies were obtained from m. vastus lateralis before and after either intervention .


Levels of mRNA expression of factors regulating skeletal muscle oxidative capacity i.e. , peroxisome proliferator-activated receptor gamma coactivator-@ ( PGC-@alpha ) and vascular endothelial growth factor ( VEGF ) , and glycolytic capacity , i.e. , phosphofructokinase ( PFK ) , glycogen phosphorylase and synthase , hexokinase , and phosphorylase kinase alpha@ , were subsequently analyzed .


Grp UL showed decreased ( @ % ) PGC-@alpha expression , increased ( @-fold ) PFK expression , and a trend toward decreased VEGF post-intervention .


Grp UL+RE showed no changes .


These results suggest that @ wk unloading reduces skeletal muscle oxidative capacity and increases glycolytic enzyme activity .


More importantly , only @ bouts of high-force , low-volume resistance exercise attenuated these responses .


Thus , the current resistance exercise paradigm emphasizing eccentric overload effectively counteracts unwarranted metabolic alterations induced by @ wk unloading and may , therefore , aid in maintaining skeletal muscle integrity and endurance , and hence astronaut health and fitness during spaceflight .


Anti-leishmanial drug regimens that include a single dose AmBisome could be suitable for eastern African patients with symptomatic visceral leishmaniasis ( VL ) but the appropriate single dose is unknown .


A multi-centre , open-label , non-inferiority , randomized controlled trial with an adaptive design , was conducted to compare the efficacy and safety of a single dose and multiple doses of AmBisome for the treatment of VL in eastern Africa .


The primary efficacy endpoint was definitive cure ( DC ) at @ months .


Symptomatic patients with parasitologically-confirmed , non-severe VL , received a single dose of AmBisome @ mg/kg body weight or multiple doses , @ times @ mg/kg on days @-@ , @ , and @ .


If interim analyses , evaluated @ days after the start of treatment following @ or @ patients , showed the single dose gave significantly poorer parasite clearance than multiple doses at the @ % significance level , the single dose was increased by @ mg/kg .


In a sub-set of patients , parasite clearance was measured by quantitative reverse transcriptase ( qRT ) PCR .


The trial was terminated after the third interim analysis because of low efficacy of both regimens .


Based on the intention-to-treat population , DC was @ % ( @ % CI @-@ % ) , @ % ( @ % CI @-@ % ) , and @ % ( @ % CI @-@ % ) in patients treated with multiple doses ( n = @ ) , and single doses of @ ( n = @ ) or @ mg/kg ( n = @ ) , respectively .


qRT-PCR suggested superior parasite clearance with multiple doses as early as day @ .


Safety data accorded with the drug label .


The tested AmBisome regimens would not be suitable for VL treatment across eastern Africa .


An optimal single dose regimen was not identified .


It is not clear whether Modic changes ( MC ) is associated with low back pain ( LBP ) outcome .


To study associations between baseline degenerative manifestations and outcome in sick-listed LBP patients .


Prospective nested cohort study based on a randomized controlled trial .


Out of @ sick-listed LBP patients , @ were consecutively examined by magnetic resonance imaging ( MRI ) and included and @ completed the study .


Degenerative manifestations of the lumbar spine were quantified ; associations were studied in relation to the three primary outcomes : change of back + leg pain , change of function as measured by Roland-Morris questionnaire , and @-year unsuccessful return to work ( U-RTW ) .


By using a previously validated MRI protocol , a specialist in radiology , who had no access to clinical data , described the images .


Associations were studied by linear and logistic regression with adjustment for previously identified prognostic factors for @-year pain and function and for U-RTW .


Clinically , @ % of the patients had radiculopathy .


Degenerative changes were prevalent with altered disc contours in @ % , high-intensity zones in @ % , and nerve root touch or impingement in @ % of the patients .


MC was identified in @ % of the patients , @ % with Type @ changes and @ % with Type @ changes , Type @ including both Type @ and Type @ in combination with Type @ .


Patients with Type @ changes reported more back pain and did not improve in pain or disability .


They increased to include @ % of the patients with U-RTW at @ year .


Patients with Type @ changes did not differ significantly from patients without MC but differed significantly from patients with Type @ changes in all three outcomes .


Other degenerative manifestations were not significantly associated with any of the three outcomes .


The only degenerative manifestation negatively associated with outcome was Type @ MC that affected @ % of the cohort at baseline and implied an increased risk for no improvement in pain and function and for U-RTW , even after adjustment for other prognostic factors .


Knowledge of the excess hospital costs and prolonged length of stay attributable to perioperative respiratory event ( PRE ) in pediatric anesthesia is useful for hospital planning .


In this study , we compared costs ( excess hospital costs and indirect costs ) and length of hospital stay between children who had PRE and did not have PRE for noncardiac surgery at a tertiary care hospital in southern Thailand .


A prospective matched cohort study was conducted in children aged < @ years who underwent general anesthesia between November @ and December @ at Songklanagarind Hospital .


PRE children were matched with no PRE children ( @:@ ) using a random selection procedure on outpatients/inpatients , type of surgery , surgical charge ( baht ) , ASA physical status , age difference < @ years , and difference in time of surgery < @ months .


Primary end points were excess hospital costs and number of days hospitalized after surgery .


Number of days hospitalized after surgery , excess hospital costs and indirect costs regarding transportation , and income loss of parents between groups were compared using Wilcoxon signed rank test .


Any hospital stay after surgery between groups was compared using McNemar test .


A hurdle model was used to predict any hospital stay and number of days hospitalized after surgery .


Multiple mixed-effects linear regression was used to identify predictors of adjusted excess hospital costs and indirect costs .


A total @ children were included ( @ matched pairs ) .


More PRE children required hospital stay after surgery ( @ % vs @ % , P = @ ) , and PRE children had a longer number of days hospitalized after surgery ( median -LSB- interquartile ranges -RSB- : @ -LSB- @-@ @ -RSB- vs @ -LSB- @-@ -RSB- ; P < @ ) and incurred higher excess costs ( P < @ ) but not indirect costs ( P = @ ) .


In multivariate analysis , PRE was a significant predictor for hospital stay after surgery ( odds ratio , @ ; @ % confidence interval , @-@ @ ) , longer hospitalization ( count ratio , @ -LSB- @-@ @ -RSB- ) , higher excess costs ( cost ratio , @ -LSB- @-@ @ -RSB- ) , and indirect cost ( cost ratio , @ -LSB- @-@ @ -RSB- ) after adjusting for patient and anesthesia characteristics .


Universal coverage ( @ % ) was associated with @ % and @ % higher excess cost compared with the Comptroller General 's Department ( @ % ) and self-pay ( @ % ) , respectively ( P = @ ) .


The effects of PRE in pediatric anesthesia were hospital stay after surgery , @ times longer hospitalization , @ % higher excess hospital costs , and @ % higher indirect cost among outpatients .


Hospital policy to efficiently manage hospital beds and compensatory budget should be developed .


The level of evidence regarding the association between red and processed meat intakes and breast cancer risk is still low , due to insufficient prospective studies .


Moreover , mechanistic data suggest that some antioxidants may modulate this relationship but epidemiological evidence is lacking .


Our objectives were to investigate relationships between red and processed meat intakes and breast cancer risk , and to study whether an antioxidant supplementation modulates these associations , which , to our knowledge , has never been investigated before .


The SU.VI.MAX study was a randomized , double-blind , placebo-controlled trial in which participants received a combination of low-dose antioxidants or a placebo from @ to @ .


This observational prospective analysis included @ women among whom @ developed a first incident breast cancer between @ and @ -LSB- mean ( range ) follow-up = @ ( @-@ ) years -RSB- .


Baseline dietary data were assessed by repeated dietary records in @-@ .


Associations between quartiles of red and processed meat intakes and breast cancer risk were characterized by multivariate Cox proportional hazards models .


Breast cancer risk was directly associated with processed meat intake -LSB- hazard ratio ( HR ) Q@vsQ@ = @ ( @-@ @ ) , Ptrend = @ -RSB- and this association was stronger when excluding cooked ham -LSB- HRQ@vsQ@ = @ ( @-@ @ ) , Ptrend = @ -RSB- .


In stratified analyses , processed meat intake was directly associated with breast cancer risk in the placebo group only -LSB- HRQ@vsQ@ = @ ( @-@ @ ) , Ptrend = @ -RSB- , but not in the supplemented group -LSB- HRQ@vsQ@ = @ ( @-@ @ ) , Ptrend = @ -RSB- .


Processed meat intake was prospectively associated with increased breast cancer risk .


This study also suggests that antioxidants may modulate this association by counteracting the potential pro-carcinogenic effects of processed meat on breast cancer .


To evaluate long-term safety and efficacy of tofogliflozin in Japanese patients with type @ diabetes as monotherapy or in combination with other oral antidiabetic agents , we conducted @-week , open-label , randomized controlled trials .


The single-agent trial included patients with inadequate glycemic control on diet and exercise , whereas the add-on trial included those uncontrolled with any of the oral antidiabetic agents .


In both trials , patients were randomly assigned to receive tofogliflozin @ or @ mg once daily orally for @ weeks .


Safety assessments .


A total of @ patients ( @ , @-mg group ; @ , @-mg group ) were enrolled into the single-agent trial , whereas @ ( @ and @ , respectively ) were enrolled into the add-on trial .


Tofogliflozin was well tolerated for @ weeks in both trials with < @ % of treatment discontinuation because of adverse events in each treatment group .


It also reduced hemoglobin A@c .


In the single-agent trial , mean reductions at @ weeks were @ and @ % in the @ - and @-mg groups , respectively .


In the add-on trial , mean reductions ranged from @ to @ % across the subgroups by dose and background therapy .


Tofogliflozin was well tolerated and showed sustained efficacy in both trials .


This @-week , randomized , double-blind , placebo-controlled study , conducted August @-May @ in the United States , evaluated the safety and efficacy of vortioxetine @ mg and @ mg in patients with major depressive disorder ( MDD ) .


The mechanism of action of vortioxetine is thought to be related to direct modulation of serotonin ( @-HT ) receptor activity and inhibition of the serotonin transporter .


Adults aged @-@ years with MDD ( DSM-IV-TR ) and Montgomery-Asberg Depression Rating Scale ( MADRS ) total score @ were randomized ( @:@:@ ) to receive vortioxetine @ mg or @ mg or placebo once daily , with the primary efficacy end point being change from baseline at week @ in MADRS analyzed by mixed model for repeated measures .


Adverse events were recorded during the study , suicidal ideation and behavior were assessed using the Columbia-Suicide Severity Rating Scale ( C-SSRS ) , and sexual dysfunction was assessed using the Arizona Sexual Experience ( ASEX ) scale .


Of the @,@ subjects screened , @ subjects were randomized : @ to placebo , @ to vortioxetine @ mg , and @ to vortioxetine @ mg .


Differences from placebo in the primary efficacy end point were not statistically significant for vortioxetine @ mg or vortioxetine @ mg .


Nausea , headache , dry mouth , constipation , diarrhea , vomiting , dizziness , and flatulence were reported in @ % of subjects receiving vortioxetine .


Discontinuation due to adverse events occurred in @ subjects ( @ % ) in the placebo group , @ ( @ % ) in the vortioxetine @ mg group , and @ ( @ % ) in the vortioxetine @ mg group .


ASEX total scores were similar across groups .


There were no clinically significant trends within or between treatment groups on the C-SSRS , laboratory values , electrocardiogram , or vital sign parameters .


In this study , vortioxetine did not differ significantly from placebo on MADRS total score after @ weeks of treatment in MDD subjects .


To examine the value of self-treatment for Posterior canal benign paroxysmal positional vertigo ( PC-BPPV ) .


The treatment effect was compared between patients treated with modified Epley in outpatient clinic combined with self treatment at home and patients treated by modified Epley alone .


A randomized controlled trial were carried out in the Department of Otolaryngology Head and Neck Surgery , the Affiliated Sixth People 's Hospital of Shanghai Jiao Tong University from December @ to May @ out of @ patients with unilateral idiopathic BPPV-PSC were enrolled in follow-up .


Among which , @ patients were allocated in modified Epley-alone group and @ were allocated in slef-treatment group .


The success rate was @ % in modified Epley-alone group vs @ % in self-treatment group ( P < @ ) after @ week treatment .


In the modified Epley-alone group , the success rate of hand repositioning group and chair-assisted repositioning group was @ % vs @ % ( P > @ ) , the risk rate was @ , @ % CI ( @ - @ ) .


In the self-treatment group , the success rate of hand repositioning group and chair-assisted repositioning group was @ % vs @ % ( P > @ ) , the risk rate was @ , @ % CI ( @-@ @ ) .


Incidence rate of serious complications was @ % in the modified Epley-alone group and @ % in the self-treatment group ( P > @ ) .


Complementary self-treatment with modified Epley maneuver treated PC-BPPV sooner and more effectively , Compared with modified Epley maneuver alone .


And its incidence rate of serious complications did n't increase .


Chair-assisted repositioning showed better result than hand repositioning alone , and self-treatment at home can reduce the effect of the gap .


We found that complementary self-treatment with modified Epley maneuver had more benefits for patients with PC-BPPV .


The use of isotonic electrolytic solutions for the intraoperative fluid management in children is largely recognized , but the exact composition still needs to be defined .


The primary objective of this randomized controlled open trial was to compare the changes in chloride plasma concentration using two intraoperative isotonic fluid regimens ( Sterofundin vs. normal saline , both added with @ % of glucose ) in children undergoing major surgery .


Secondary objectives were to compare changes in other electrolytes , renal function , and the occurrence of hypoglycemia .


Children aged between @ and @ months , scheduled for major surgery , were randomized to receive Sterofundin or saline during the intraoperative time .


Children with preoperative electrolyte abnormalities , hemodynamic instability , and severe renal or hepatic dysfunction were excluded .


The primary outcome was the of Cl ( - ) ( = change in plasma concentration between post - and pre-infusion ) , and secondary outcomes included of other electrolytes and intraoperative hypoglycemia .


A total of @ patients were included in the two study sites and randomized to receive Sterofundin plus @ % glucose or normal saline plus @ % glucose , in a open fashion ( @ were finally analyzed ) .


of Cl - and Mg + + was statistically less relevant in patients who received intraoperative Sterofundin , and of the other electrolytes was comparable between the two study groups .


Relative risk of hyperchloremia was significantly higher when large volumes were infused ( over than @ mlkg ( -@ ) ) , regardless of type of crystalloid infused .


Hypoglycemia occurred in two of @ patients .


Sterofundin is safer than normal saline in protecting young children undergoing major surgery against the risk of increasing plasma chlorides and the subsequent metabolic acidosis .


Treatment with azathioprine within @ months of remission induction with cyclophosphamide is a common treatment strategy for patients with ANCA-associated vasculitis .


This study comprised patients undergoing long-term follow-up who were randomly allocated to azathioprine after @-@ months or after @ months of cyclophosphamide treatment .


Patients from @ European centers between @ and @ with a new diagnosis of ANCA-associated vasculitis that involved the kidneys or another vital organ were eligible .


At the time of diagnosis , participants were randomly allocated to convert to azathioprine after @-@ months ( the azathioprine group ) or after @ months of cyclophosphamide ( the cyclophosphamide group ) .


Patients who did not achieve a remission within @ months were excluded .


This study assessed relapses , ESRD , and death during long-term follow-up .


Patients were allocated to the azathioprine group ( n = @ ) and the cyclophosphamide group ( n = @ ) .


Of these patients , @ ( @ % ) developed a relapse , @ ( @ % ) developed a renal relapse , @ ( @ % ) developed ESRD , and @ ( @ % ) died .


Although there were worse outcomes in the azathioprine group , none were statistically significant .


The subdistribution hazard ratio -LSB- sHR -RSB- for relapse was @ ( @ % confidence interval -LSB- @ % CI -RSB- , @ to @ ) , the composite of relapse or death hazard ratio -LSB- HR -RSB- was @ ( @ % CI , @ to @ ) , the ESRD sHR was @ ( @ % CI , @ to @ ) , and the death HR was @ ( @ % CI , @ to @ ) .


It remains uncertain whether converting to azathioprine after @-@ months of induction cyclophosphamide therapy is as effective as converting after @ months .


Outcomes are still poor for this group of patients and further research is required to determine the optimal timing of maintenance therapy .


To evaluate the efficacy and safety of Chinese medicine ( CM ) intervention in the treatment of nonalcoholic steatohepatitis ( NASH ) from liver enzyme ( ALT ) , imaging ( the liver/spleen CT ratio ) and syndrome scores , and to establish standard methods for diagnosis and therapeutic efficacy evaluation with characteristics of CM .


A multi-center , stratified randomized , parallel controlled , blindness-method evaluated , superiority trial was performed .


Totally @ patients were randomly allocated into two groups , @ patients in the experimental group ( treated with CM ) and @ patients in the control group -LSB- treated with Western medicine ( WM ) -RSB- .


The alanine aminotransferase ( ALT ) , liver/spleen CT ratio , and clinical symptoms were observed in both groups .


Of the randomly allocated @ cases from @ hospitals , @ patients were rejected , and @ were lost .


Totally @ cases con - formed to the plan with complete follow-ups .


After @ months of treatment , syndrome scores and the improvement of partial clinical symptoms ( fatigue and sallow complexion ) were superior in the experimental group to those in the control group ( P < @ ) .


After @ months of follow-up , the syndrome scores and improvement of partial clinical symptoms ( fatigue and sallow complexion ) were superior in the experimental group to those in the control group ( P < @ ) .


There was no statistical difference in improving liver enzymes or the liver/spleen CT ratio between the two groups ( P > @ ) .


There were @ adverse reactions/adverse events in the two groups in the process of treatment , mainly covering drug-induced liver injury , diarrhea , and epigastric distension .


Adverse reactions had nothing to do with CM treatment .


Jianpi Shugan Recipe had obvious efficacy in treatment of NASH .


It could remove the liver fat and play a role in anti-inflammation and liver protection .


It also could improve the indices of liver enzymes and the liver/spleen CT ratio effectively , which was superior to Polyene Phosphatidylcholine Capsule ( PPC ) in improving clinical symptoms , especially for such symptoms as fatigue and sallow complexion .


Chronic obstructive pulmonary disease ( COPD ) is a chronic inflammatory disease mediated by an array of inflammatory cells and mediators , but above all , CD@ + T-lymphocytes , macrophages and neutrophils are important players in disease pathogenesis .


Roflumilast , a first-in-class , potent and selective phosphodiesterase @ ( PDE@ ) inhibitor , reduces the rate of exacerbations in patients with a high risk of future exacerbations and has been shown to reduce inflammatory cells and mediators in induced sputum , a surrogate of airway inflammation .


However , these anti-inflammatory effects are yet to be confirmed in another robust study directly assessing inflammatory markers in bronchial sub-mucosa .


An international , @-week , randomized , double-blind , placebo-controlled , parallel-group study investigating the effects of roflumilast @ g once-daily versus placebo on inflammatory parameters in bronchial biopsy tissue specimens , sputum and blood serum .


One hundred and fifty patients with COPD and chronic bronchitis for at least @ months will be recruited into the study and randomized in a @:@ ratio to receive either roflumilast or placebo .


The primary endpoint will be the number of CD@ + cells ( cell counts per mm@ ) in bronchial biopsy tissue specimens ( sub-mucosa ) and the key secondary endpoint will be the number of CD@ + cells ( cell counts per mm@ ) , assessed by indirect immunohistochemistry .


It is hypothesized that treatment with roflumilast reduces the characteristic inflammation found in the airways of patients with moderate-to-severe COPD , compared with placebo .


The design of the present study has built on the work of previous bronchial biopsy studies available in the literature .


It is hoped that it will reveal the cellular mechanisms underlying the anti-inflammatory effects of roflumilast and identify potentially important biomarkers and other surrogate endpoints in patients with COPD .


The design and rationale for this trial are described herein .


Obesity during pregnancy is associated with adverse outcomes for the offspring and mother .


Lifestyle interventions in pregnancy such as antenatal exercise , are proposed to improve both short - and long-term health of mother and child .


We hypothesise that regular moderate-intensity exercise during the second half of pregnancy will result in improved maternal and offspring outcomes , including a reduction in birth weight and adiposity in the offspring , which may be protective against obesity in later life .


The IMPROVE ( Improving Maternal and Progeny Risks of Obesity Via Exercise ) study is a two-arm parallel randomised controlled clinical trial being conducted in Auckland , New Zealand .


Overweight and obese women ( BMI @kg/m@ ) aged @-@ years , with a singleton pregnancy of < @weeks of gestation , from the Auckland region , are eligible for the trial .


Exclusion criteria are ongoing smoking or medical contra-indications to antenatal exercise.Participants are randomised with @:@ allocation ratio to either intervention or control group , using computer-generated randomisation sequences in variable block sizes , stratified on ethnicity and parity , after completion of baseline assessments .


The intervention consists of a @-week structured home-based moderate-intensity exercise programme utilising stationary cycles and heart rate monitors , commencing at @ weeks of gestation .


The control group do not receive any exercise intervention .


Both groups undergo regular fetal ultrasonography and receive standard antenatal care .


Due to the nature of the intervention , participants are un-blinded to group assignment during the trial.The primary outcome is offspring birth weight .


Secondary offspring outcomes include fetal and neonatal body composition and anthropometry , neonatal complications and cord blood metabolic markers .


Maternal outcomes include weight gain , pregnancy and delivery complications , aerobic fitness , quality of life , metabolic markers and post-partum body composition .


The results of this trial will provide valuable insights on the effects of antenatal exercise on health outcomes in overweight and obese mothers and their offspring .


This randomized clinical trial assessed the effect of three different prosthetic abutments ( titanium , gold-hue titanium and zirconia ) on peri-implant soft tissue @ years after treatment in partially edentulous subjects .


Baseline data concerning ( @ ) thickness of the buccal peri-implant soft tissue , ( @ ) soft tissue thickness above the bone crest , ( @ ) depth/length of transmucosal pathway , and ( @ ) periodontal biotype at adjacent teeth were collected .


The final sample consisted of @ subjects ( @ males , @ females ) with a total of @ implants .


A two-level ( patient , implant ) statistical model was applied .


At the @-year clinical observation , recession of the gingival margin was observed only at @ % of implants irrespective of the type of abutment .


No significant correlation between periodontal biotype at adjacent teeth and peri-implant biotype was observed .


Furthermore , none of the investigated variables at patient level ( age , gender , implant type , periodontal biotype ) or at implant level ( keratinized tissue thickness , probing depth , soft tissue thickness ) was identified as a significant predictor of recession .


In conclusion , this study pointed out that ( @ ) abutment type was not able to influence peri-implant variables after @ years , and ( @ ) caution should be used in considering periodontal biotype at patient level as a possible indicator of the future peri-implant biotype .


Transient post-ischemic LV dysfunction due to myocardial stunning in patients with coronary artery disease can be missed by conventional gated SPECT ( GSPECT ) acquisitions .


The aim of this IAEA-sponsored multi-center study was to determine whether early post-exercise imaging is more likely to detect stunning than conventional without adversely affecting image quality or perfusion information .


Patients undergoing exercise/rest GSPECT were enrolled in this international multicenter study .


Post-exercise studies were acquired at @ @ minutes after radiotracer injection ( Stress-@ ) and repeated at @ @ minutes ( Stress-@ ) .


Rest studies ( R ) were acquired at @ minutes post injection .


A core laboratory quantitatively assessed perfusion pattern and LV blinded to the acquisition time .


Ischemia was defined as summed stress score ( SDS ) @ , and stunning was defined as the difference between rest and post-stress LVEF ( - LVEF ) .


In the @ patients enrolled into the study , both image quality and perfusion information were similar between Stress-@ and Stress-@ .


Post-stress LVEF was associated with both ischemia and time of acquisition , with a significant correlation between SDS and - LVEF , which was stronger at Stress-@ than Stress-@ in the ischemic compared to the non-ischemic population ( r = @ vs @ , P = @ ) .


Early post-exercise imaging is feasible , and can potentially improve the detection of post-ischemic stunning without compromising image quality and perfusion data .


The aim of this study was to evaluate and compare the long-term clinical outcomes of the spot drug-eluting stent ( DES ) implantation strategy , which is used to minimize implanted stent length and the number of stents , versus full lesion coverage for treatment of coronary artery stenoses .


We evaluated @-year clinical outcomes of @ patients with stent implantation for a single coronary lesion .


They were divided into two groups : those treated by full lesion coverage ( n = @ ) and those treated with the spot stenting strategy ( n = @ ) .


The combined occurrence of @-year target vessel failure ( TVF ) , including cardiac death , target-vessel related myocardial infarction , or ischemia-driven target-vessel revascularization was evaluated .


The spot DES implantation group had a shorter stent length ( @ mm vs. @ mm , respectively ; p < @ ) and a fewer number of stents ( @ vs. @ , respectively ; p < @ ) , even though the average lesion length was similar to the full lesion coverage group ( @ mm vs. @ mm , respectively ; p = @ ) .


Spot DES implantation was superior to full DES coverage with respect to @-year TVF ( @ % vs. @ % , p = @ ) .


Cox proportional hazard model analysis showed that the risk for @-year TVF was almost @ % lower among patients who received spot DESs compared to those who received full DES coverage after adjustment for other risk factors ( HR = @ , @ % confidence interval = @-@ @ ; p = @ ) .


Minimizing stent length and the number of stents with overlapping by spot DES implantation may result in reduced rates of @-year TVF , compared with full DES coverage .


To compare pro re nata ( PRN ) and monthly injections of @ mg ranibizumab in retinal vein occlusion ( RVO ) patients stabilized by monthly injections .


Randomized , open-label , vision-examiner masked , @-month study .


Subjects with macular edema secondary to branch or central RVO .


Subjects received monthly injections of @ mg ranibizumab for @ months and those meeting stability criteria between months @ and @ were randomized ( @:@ ) to PRN injections versus continued monthly injections .


Non-randomized ( NR ) subjects ( never met stability criteria ) received monthly injections .


The primary endpoint was the slope of change in best-corrected visual acuity ( BCVA ) between months @ and @ .


There was no significant difference in the slope of change in BCVA between months @ and @ in patients treated PRN versus those treated with monthly injections ( P = @ ) .


Mean ( standard deviation ) change from baseline BCVA in Early Treatment Diabetic Retinopathy Study letter score at month @ was @ @ in the PRN group ( n = @ ) versus @ @ in the monthly group ( n = @ ) and @ @ in NR subjects ( n = @ ) .


The percentage of subjects who achieved BCVA @/@ at month @ was @ % in the PRN group , @ % in the monthly group , and @ % in NR subjects .


The mean ( standard deviation ) change from baseline central subfield thickness was -@ @ m in the PRN group , -@ @ m in the monthly group , and -@ @ m in NR subjects .


There were no significant differences in mean BCVA gains or central subfield thickness reductions at month @ between the PRN and monthly injection groups ( all > @ ) .


After edema resolution from @ or more monthly ranibizumab injections in RVO subjects , visual outcomes at month @ were excellent and not significantly different in subjects treated PRN versus those who continued monthly injections .


To determine whether a @-month contraceptive vaginal ring ( CVR ) delivering ulipristal acetate ( UPA ) can inhibit ovulation in @ % of cycles .


This was a randomized dose-finding parallel group clinical trial .


Fifty-five healthy women with normal ovulation at baseline were randomized to receive a low-dose ( @ g/day ) or a high-dose ( @ g/day ) UPA-CVR for two consecutive @-week treatment periods , followed by a recovery cycle .


A subgroup of women received levonorgestrel ( LNG ) @ mg orally twice ( at the end of both @-week ring periods ) or once ( at the end of the @-week treatment ) .


The primary outcome was ovulation suppression assessed by transvaginal ultrasound and hormone levels .


Secondary outcomes included endometrial safety and bleeding patterns .


All subjects showed normal ovulation at baseline and recovery .


Ovulation suppression was seen in @ % ( @ % CI : @ % , @ % ) and @ % ( @ % CI : @ % , @ % ) of treatment cycles with low and high-dose , respectively .


Benign progesterone receptor modulator associated endometrial changes ( PAEC ) were seen during treatment ; @ % at week @ , but resolved at recovery cycle .


A few cases of heavy bleeding occurred near the end of the @-week treatment , but a single dose of LNG every @ weeks reduced the increase in endometrial thickness during the second treatment period and prevented excessive bleeding .


The @-month UPA-CVR may become an effective long-acting , user-controlled estrogen-free contraceptive .


The greatest suppression of ovulation was seen with the @-g/day ring .


The @-month CVR delivering UPA @ g/day can become an effective user-controlled estrogen-free contraceptive method .


Benign PAEC during treatment returns to normal after discontinuation .


The prevention of occasional excessive withdrawal bleeding , either by a progestin or by using higher UPA levels to increase follicle suppression may permit prolonged treatment .


Docetaxel/cisplatin/infusional @-fluorouracil ( @-FU ; DCF ) is a standard chemotherapy regimen for patients with advanced gastric cancer ( GC ) .


This phase II study evaluated docetaxel/oxaliplatin ( TE ) , docetaxel/oxaliplatin/@-FU ( TEF ) , and docetaxel/oxaliplatin/capecitabine ( TEX ) in patients with advanced GC .


Patients with metastatic or locally recurrent gastric adenocarcinoma ( including carcinoma of the gastro-oesophageal junction ) were randomly assigned ( @ : @ : @ ) to TE , TEF , or TEX. .


Each regimen was tested at two doses before full evaluation at optimized dose levels .


The primary end point was progression-free survival ( PFS ) .


Overall survival ( OS ) , tumour response , and safety were also assessed .


A therapeutic index ( median PFS relative to the incidence of febrile neutropenia ) was calculated for each regimen and compared with DCF ( historical data ) .


Overall , @ patients were randomly assigned to receive optimized dose treatment .


Median PFS was longer with TEF ( @ -LSB- @ % confidence interval ( CI ) : @-@ @ -RSB- months ) versus TE ( @ -LSB- @-@ @ -RSB- months ) and TEX ( @ -LSB- @-@ @ -RSB- months ) .


Median OS was @ ( @ % CI : @-@ @ ) months for TEF versus @ ( @-@ @ ) months for TE and @ ( @-@ @ ) months for TEX. .


The rate of tumour response ( complete or partial ) was @ % ( @ % CI @-@ @ ) for TEF versus @ % ( @-@ @ ) for TE and @ % ( @-@ @ ) for TEX. .


The frequency and type of adverse events ( AEs ) were similar across the three arms .


Common grade @/@ AEs were fatigue ( @ % ) , sensory neuropathy ( @ % ) , and diarrhoea ( @ % ) .


Febrile neutropenia was reported in @ % ( TEF ) , @ % ( TE ) , and @ % ( TEX ) of patients .


The therapeutic index was improved with TEF versus TEX , TE , or DCF .


These results suggest that TEF is worthy of evaluation as an arm in a phase III trial or as a backbone regimen for new targeted agents in advanced GC .


CLINICALTRIALS.GOV : Identifier Trial registration number : NCT@ .


Procollagen @ amino-terminal propeptide ( P@NP ) is a bone formation marker and has been shown to have a strong association with the extent of bone metastases ( BM ) in patients with advanced prostate cancer .


More recently , its levels were found to be affected by androgen deprivation therapies and bisphosphonates .


We investigated the role of P@NP as a surrogate marker of sub-radiological skeletal metastases in prostate cancer patients with biochemical failure ( BF ) .


BePrepared is a prospective longitudinal substudy of RADAR trial in which serial P@NPs were collected at regular intervals for @ patients who had completed RADAR protocol treatment .


There was no trend identified in P@NP levels prior to diagnosis of BM .


We found that there was no difference in P@NP concentrations at the time of diagnosis of BM in the group that developed BM compared with P@NP levels in groups with only nodal metastases or BF .


In the group of patients who did not experience BF , P@NP was affected by previous luteinizing hormone-releasing hormone-agonist and bisphosphonate therapy .


Hence , patients who received an @-month course of androgen deprivation without bisphosphonates had significantly higher P@NP values than patients with shorter androgen deprivation therapy ( ADT ) course combined with a course of bisphosphonates .


P@NP is not a sensitive serum marker of early BM in high-risk prostate cancer patients with BF and low prostate-specific antigen levels as its levels are affected by prior history of bone remodelling therapies such as ADT and bisphosphonates .


Postmenopausal bone loss can be exacerbated by environmental contaminants , including the heavy metal cadmium ( Cd ) .


We hypothesized that incorporating phosphorus ( P ) into the diet would lead to the chelation of Cd into P , preventing its absorption and subsequent bone loss .


To test this hypothesis , we used ovariectomized rats as a model of postmenopausal osteoporosis to examine the deleterious effects of Cd on bone with and without added P. Fifty @-month-old ovariectomized Sprague-Dawley rats were assigned to five treatment groups ( n = @ per group ) for @ months as follows : ( @ ) control ; ( @ ) @ ppm Cd ; ( @ ) @ ppm Cd plus @ % P ; ( @ ) @ ppm Cd ; and ( @ ) @ ppm Cd plus @ % P.


Cd plus P caused a significant loss of whole body ( P = @ and P < @ ) and femoral ( P = @ and P < @ ) bone mineral density ( BMD ) and bone mineral content , respectively , and a loss of fourth lumbar vertebra BMD and bone mineral content ( P < @ and P < @ , respectively ) .


Nonetheless , @ ppm Cd plus @ % P had the most deleterious effects on whole body and femoral BMD .


For femoral neck microstructural properties , @ ppm Cd plus @ % P caused an increase in trabecular separation , whereas @ ppm Cd plus @ % P caused a decrease in bone volume-to-total volume ratio , a decrease in trabecular number , and an increase in trabecular separation and structural model index .


Our findings indicate that Cd exposure , along with high intake of P , may be a public health hazard with respect to bone health .


To evaluate the clinical efficacy and safety of integrative medical program based on blood cooling and detoxification recipe ( BCDR ) in treating patients with hepatitis B virus related acute-on-chronic liver failure ( HBV-ACLF ) of heat-toxicity accumulation syndrome ( HTAS ) .


Adopting randomized controlled clinical design , a total of @ HBV-ACLF patients of HTAS were randomly assigned to the trial group ( @ cases ) and the control group ( @ cases ) .


Patients in the control group were treated with comprehensive Western therapy , while those in the trial group were treated with comprehensive Western therapy plus BCDR .


All were treated for @ weeks and followed up for @ weeks .


Effect and safety of the treatment were assessed , including fatality , liver functions -LSB- total bilirubin ( TBIL ) , albumin ( ALB ) , alanine aminotransferase ( ALT ) , and aspartate transaminase ( AST ) -RSB- , and prothrombin activity ( PTA ) after treatment and at week @ of follow-ups .


After @-week treatment , there was statistical difference in the overall fatality rate ( @ % vs @ % ) , the fatality rate in the mid-term ( @ % vs @ % ) , TBIL at week @ ( @ + / - @ ) , AST -LSB- at week @ : ( @ + / - @ ) U/L vs ( @ + / - @ ) U/L ; at week @ : ( @ + / - @ ) U/L vs ( @ + / - @ ) U/L -RSB- and PTA -LSB- at week @ : ( @ + / - @ ) vs ( @ + / - @ ) ; at week @ : ( @ + / - @ ) vs ( @ + / - @ ) -RSB- ( all P < @ ) .


At week @ of the followup , the fatality rate of the trial group ( @ % ) decreased by @ % when compared with that of the control group ( @ % ; P < @ ) .


No obvious adverse event occurred in the two groups during the @-week treatment period .


BCDR could significantly reduce the mortality of HBV-ACLF patients .


This study was conducted for the nutritional assessment of cancer patients undergoing radiotherapy ( RT ) and to investigate the changes in nutrition status , oral intake , morbidity and quality of life ( QOL ) in cancer patients after intensive nutrition counseling .


Eighty-seven cancer patients were randomized to either a nutrition counseling group ( n = @ , age @ years ) or a control group ( n = @ , @ years ) .


Nutrition counseling accompanied RT , and the subjects received at least three sessions of individualized dietary counseling over the duration of RT. .


Assessment parameters were nutritional intake ( @-h recall method ) , nutritional status Patient-Generated Subjective Global Assessment ( PG-SGA ) , QOL and blood parameters including albumin .


All parameters were measured at baseline , at the end of RT , and @ month after the termination of RT. .


Body weight , body mass index ( BMI ) , and energy and protein intake for the intervention and control groups did not differ significantly between baseline and the end of RT. .


However , at @ month follow-up , protein intake was significantly decreased in the control group ( p < @ ) .


Blood albumin , total protein ( TP ) , total lymphocyte count ( TLC ) were not different between the two groups .


According to PG-SGA stage , at @ month follow-up , patients in the intervention group showed increased number of patients with stage A status ( well nourished ) .


In addition , insomnia and nausea was significantly improved in the intervention group assessed by QOL .


We suggest that repetitive and intensive nutritional counseling is necessary to improve QOL and to prevent deterioration of nutritional status in cancer patients receiving RT. .


Gentamicin is an aminoglycoside antibiotic that is highly effective in treating Gram-negative infections , but inappropriate use leads to toxicity .


In @ , the Australian Therapeutic Guidelines ( Antibiotic ) were revised to recommend the use of computerised methods to individualise dosing of gentamicin and optimise therapy , rather than traditional nomogram approaches .


To determine whether gentamicin prescribing was compliant with the Australian Therapeutic Guidelines , version @ ( @ ) in a setting where computerised dose recommendation resources and computerised decision support were available , and to determine why the resources were effective or ineffective in achieving compliance to guidelines .


During phase @ , a retrospective audit of gentamicin prescribing from @ January @ to @ December @ ( n = @ ) at a @-bed teaching hospital in Sydney was undertaken .


In phase @ , @ doctors from specialties with high-volume prescribing of gentamicin were interviewed .


Intravenous gentamicin was used in @ cases , @ % of which were for short-term therapy ( @h ) .


Doctors feared inducing toxicity in patients , but limited the dose rather than altering the dosing interval according to renal function .


Of the ` continued ' dosing cases , @ % went unmonitored and the computerised dose recommendation service was rarely used .


Doctors were unaware of its availability despite electronic alerts accompanying prescriptions of gentamicin .


In comparison with the national guidelines , there was significant under-dosing and monitoring practices were haphazard .


Computerised electronic alerts were ineffective in informing users .


To improve prescribing practices , we recommend exploring alternative computerised decision support approaches ( e.g. pre-written orders ) and more pervasive and persuasive implementation strategies .


The construction of a colostomy is a common procedure , but the evidence for the different parts of the construction of the colostomy is lacking .


Parastomal hernia is a common complication of colostomy formation .


The aim of this study is to standardise the colostomy formation and to compare three types of colostomy formation ( one including a mesh ) regarding the development of parastomal hernia .


Stoma-Const is a Scandinavian randomised trial comparing three types of colostomy formation .


The primary endpoint is parastomal herniation as shown by clinical examination or CT scan within one year .


Secondary endpoints are re-admission rate , postoperative complications ( classified according to Clavien-Dindo ) , stoma-related complications ( registered in the case record form at stoma care nurse follow-up ) , total length of hospital stay during @months , health-related quality of life and health economic analysis as well as re-operation rate and mortality within @days and @months of primary surgery .


Follow-up is scheduled at @-@ weeks , and @ and @months .


Inclusion is set at @ patients .


Parastomal hernia is a common complication after colostomy formation .


Several studies have been performed with the aim to reduce the rate of this complication .


However , none are fully conclusive and data on quality of life and health economy are lacking .


The aim of this study is to develop new standardised techniques for colostomy formation and evaluate this with patient reported outcomes as well as clinical and radiological assessment .


Zonisamide has been associated with weight loss in children and adults .


To assess the effects of adjunctive zonisamide on weight and body mass index ( BMI ) in children with partial epilepsy .


A subanalysis was conducted of a Phase III trial and extension study , in which children with partial epilepsy received adjunctive zonisamide ( target dose @ mg/kg/day ; maximum @ mg/day ) .


Changes in weight were correlated with skeletal development and sexual maturation .


Overall , @ children ( @ male , @ female ; age @-@ years ) received zonisamide ( mean duration @ days ) .


Weight loss @ % was reported for @ of @ ( @ % ) zonisamide-treated children .


Of these , @ % were overweight/obese at study entry , compared with @ % at study end ( P = @ ) ; @ % had normal weight at study entry , compared with @ % at study end ( P = @ ) .


Three patients were underweight at study entry , and four more became underweight by study end .


No consistent correlations between weight loss and skeletal development or sexual maturation were observed .


Approximately one-third of children treated with zonisamide experienced @ % weight loss .


Weight loss was most apparent in children with high baseline BMI values and did not appear to be associated with any consistent effects on growth and development .


A multi-center large scale study is needed to confirm the efficacy and safety of domestic peritoneal dialysis ( PD ) solutions .


Some researchers believe that @ L/d is enough for adequate dialysis , but there is no multi-center prospective study on Chinese population to confirm this .


In this study , we evaluated the efficacy and safety of domestic PD solution ( Changfu ) and its difference between @ L and @ L dosage .


Adult PD patients who had taken PD therapy for at least one month were selected and divided into four groups according to two dialysis solution brands and two dialysis dosages , i.e. , @ L dose with Changfu dialysis solution , @ L dose with Baxter dialysis solution , @ L dose with Changfu dialysis solution , and @ L dose with Baxter dialysis solution .


After @ weeks , the changes of primary and secondary efficacy indices were compared between different types and different dosages .


We also analyzed the changes of safety indices .


Changes of Kt/V from baseline to @ weeks between Changfu and Baxter showed no statistical differences ; so did those of creatinine clearance rate ( Ccr ) .


Normalized protein catabolic rate ( nPCR ) from baseline to @ weeks between Changfu and Baxter showed no statistical differences ; so did those of net ultrafiltration volume ( nUF ) and estimated glomerular filtration rate ( eGFR ) .


Changes of nPCR from baseline to @ weeks between @ L and @ L showed no statistical differences ; so did those of nUF and eGFR .


The decline of Kt/V from baseline to @ weeks in @ L group was more than that in @ L group .


Change of Ccr was similar .


During the @-week period , the mean Kt/V was above @ / w , and mean Ccr was above @ L@ @ m ( -@ ) w ( -@ ) .


More adverse events were found in Changfu group before Changfu Corporation commenced technology optimization , and the statistical differences disappeared after that .


The domestic PD solution ( Changfu ) was proven to be as effective as Baxter dialysis solution .


During @-week period , a dosage of @ L/d was enough for these patients to reach adequate PD .


Clinical study promotes technological optimization , further helps to improve the safety indices of the medical products .


To assess and compare efficacy , pain , and the learning curve associated with diagnostic therapeutic hysteroscopy using mechanical tissue removal versus bipolar electrical resection in the management of endometrial polyps in an ambulatory care setting .


A randomized controlled clinical trial ( Canadian Task Force classification I ) .


Hospital de Igulada , Barcelona , Spain .


A total of @ patients diagnosed with endometrial polyp ( s ) were included and randomly assigned to @ of the @ hysteroscopic methods .


Criteria assessed were total hysteroscopy time , full polypectomy procedure time , pain experienced by patients , and learning curve of staff in training .


The average time to perform total hysteroscopy using the mechanical tissue removal system ( TRUCLEAR @ System ; Smith & Nephew Inc. , Andover , MD ) was @ minutes @ seconds versus @ minutes @ seconds required for the bipolar electrosurgery system ( GYNECARE VERSAPOINT ; Ethicon Inc , Somerville , NJ ) ( p < @ ) .


Results for complete polypectomy time favored the TRUCLEAR System at @ minutes @ seconds over the VERSAPOINT System at @ minutes @ seconds ( p < @ ) .


If a successful procedure is predicated on access to cavity , visualization , and complete resection and excision of endometrial polyp , the mechanical TRUCLEAR Tissue Removal System shows a higher success rate than the VERSAPOINT Bipolar Electrosurgery System at @ % and @ % , respectively .


Analysis of pain using the visual analog scale revealed no significant differences between the @ techniques ( p > @ ) .


A study of the residents ' learning curve showed a higher level of autonomy with hysteroscopy using the TRUCLEAR Tissue Removal System with which residents showed a higher level of confidence compared with hysteroscopy with the VERSAPOINT Bipolar Electrosurgery System .


In hysteroscopic polypectomy , the mechanical tissue removal system was significantly faster , achieved a greater success rate for complete polypectomy , and required a shorter learning curve from staff being trained in the management of endometrial polyps when compared with bipolar electrical resection .


Complicated skin and skin structure infections ( cSSSIs ) are characterized by infections with gram-positive or gram-negative aerobic or anaerobic bacteria , as well as by a polymicrobial etiology .


These invading microorganisms are recognized by pattern-recognition receptors ( PRRs ) of the innate immune system .


This study assessed whether genetic variation in genes encoding PRRs influences the susceptibility to cSSSIs .


A total of @ patients with cSSSI and @ healthy controls were genotyped for @ nonsynonymous single-nucleotide polymorphisms ( SNPs ) in PRR genes coding for Toll-like receptors ( TLRs ) @ , @ , @ , and @ ; NOD-like receptor @ ; and the signaling adaptor molecule TIRAP .


Associations between susceptibility to cSSSIs and a SNP were investigated by means of logistic regression models .


In an additional cohort of @ healthy individuals in whom the same SNPs were genotyped , peripheral blood mononuclear cells ( PBMCs ) were obtained and stimulated with Staphylococcus aureus .


Interleukin @ concentrations were determined in supernatants by enzyme-linked immunosorbent assay to determine the correlation between genotypes and levels of IL-@ secretion .


In the genetic association analysis , polymorphisms in TLR@ ( S@N and R@T ) , TLR@ ( P@H ) , and TLR@ ( P@S ) were associated with an increased susceptibility to cSSSIs .


No association with susceptibility to cSSSIs was observed for polymorphisms TLR@ ( R@Q ) , TLR@ ( D@G and T@I ) , NOD@ ( P@S ) , and TIRAP ( S@L ) .


In the functional analysis , individuals bearing the TLR@ @N or @T allele showed lower IL-@ secretion upon stimulation with S. aureus .


Polymorphisms in TLR@ , TLR@ , and TLR@ are associated with increased susceptibility to cSSSIs .


For TLR@ , impaired proinflammatory cytokine production due to the polymorphism is most likely the mechanism mediating this effect .


Cognitive benefits of multivitamins have been observed in the elderly , but fewer trials have investigated younger , healthy cohorts .


This randomised , double-blind , placebo-controlled study investigated the cognitive effects of @-week multivitamin supplementation in adults aged @-@years .


A total of @ participants aged @-@years were randomised and @ completed the trial .


The participants completed a computerised battery of cognitive tasks before and after @-week supplementation with a multivitamin containing minerals and herbs or placebo .


Blood measures of homocysteine , vitamin B@ , B@ and folate were collected at both time points .


In men , there was a strong trend ( p = @ ; which did not reach significance when adjusted for multiple comparisons ) for the multivitamin to improve performance on the incongruent stroop task , a measure of selective attention and response inhibition .


There were no cognitive benefits of multivitamin supplements in women .


Multivitamin supplementation substantially increased blood levels of vitamin B@ , B@ and folate in both genders and decreased homocysteine in men .


In men who received the multivitamin , improved stroop congruent performance was associated with increased vitamin B@ levels .


Multivitamin supplementation may be useful for maintaining levels of B vitamins .


The effects of multivitamins on speeded attention such as the stroop task in young adults warrant further investigation .


Current cognitive behavioral models of hoarding view hoarding as a multifaceted problem stemming from various information processing deficits .


However , there is also reason to suspect that the consequences of hoarding may in turn impact or modulate deficits in information processing .


The current study sought to expand upon the existing literature by manipulating clutter to examine whether the presence of a cluttered environment affects information processing .


Participants included @ individuals with hoarding disorder .


Participants were randomized into a clutter or non-clutter condition and asked to complete various neuropsychological tasks of memory and attention .


Results revealed that hoarding severity was associated with difficulties in sustained attention .


However , individuals in the clutter condition relative to the non-clutter condition did not experience greater deficits in information processing .


Limitations include the cross-sectional design and small sample size .


The current findings add considerably to a growing body of literature on the relationships between information processing deficits and hoarding behaviors .


Research of this type is integral to understanding the etiology and maintenance of hoarding .


To evaluate the safety and efficacy of methazolamide as a potential therapy for type @ diabetes .


This double-blind , placebo-controlled study randomized @ patients to oral methazolamide ( @ mg b.i.d. ) or placebo for @ weeks .


The primary efficacy end point for methazolamide treatment was a placebo-corrected reduction in HbA@c from baseline after @ weeks ( HbA@c ) .


Mean SD baseline HbA@c was @ @ % ( @ @ mmol/mol ; n = @ ) and @ @ % ( @ @ mmol/mol ; n = @ ) in the methazolamide and placebo groups , respectively .


Methazolamide treatment was associated with a HbA@c of -@ % ( @ % CI -@ , @ ; P < @ ) ( -@ mmol/mol -LSB- -@ , @ -RSB- ) , an increase in the proportion of patients achieving HbA@c @ % ( @ mmol/mol ) from @ to @ % , a rapid reduction in alanine aminotransferase ( @ units/L ) , and weight loss ( @ % ) in metformin-cotreated patients .


Methazolamide is the archetype for a new intervention in type @ diabetes with clinical benefits beyond glucose control .


Although procedural sedation using intravenous agents is highly effective for forearm fracture reduction , the process is both resource and time intensive .


Our objective was to determine whether the use of a hematoma block as an adjunct to procedural sedation with ketamine and midazolam reduces ( @ ) pain during the procedure ( scored using the Observational Score for Behavioral Distress-Revised score ) or ( @ ) the excess sedation time , defined by the time between procedure completion and discharge from sedation .


Our secondary outcome measure was total ketamine dose administered during the procedure .


A randomized , double-blind , placebo-controlled clinical trial was conducted .


Before fracture reduction , children @ to @ years of age randomly received @ % lidocaine ( L ) or normal saline ( NS ) into the hematoma of their fracture site during sedation with intravenous ketamine and midazolam .


Ninety patients were randomized : @ to L and @ to NS .


The groups were similar with regard to age , sex , type of fracture , and prior administration of pain medication .


Median Observational Score for Behavioral Distress-Revised scores were @ and @ for the L and NS groups , respectively ( P = @ ) .


Excess sedation time was not significantly different between the groups ( P = @ ) , with a median excess sedation time of @ and @ minutes for the L and NS groups , respectively .


Mean ketamine dose administered was not different between the groups ( P = @ ) .


The mean total dose administered was @ mg/kg and @ mg/kg in the L and NS groups , respectively .


Mean midazolam dose was @ mg/kg for both groups .


The use of a hematoma block as an adjunct to procedural sedation with ketamine and midazolam for forearm fracture reduction conferred no additional benefit and did not decrease observed pain scores , excess sedation time , or total ketamine dose administered .


This study assessed the safety , tolerability , and pharmacodynamics of emixustat hydrochloride ( ACU-@ ) , a novel visual cycle modulator , in subjects with geographic atrophy associated with dry age-related macular degeneration .


Subjects were randomly assigned to oral emixustat ( @ , @ , @ , or @ mg once daily ) or placebo ( @:@ ratio ) for @ days .


Recovery of rod photoreceptor sensitivity after a photobleach was measured by electroretinography .


Safety evaluations included analysis of adverse events and ophthalmic examinations .


Seventy-two subjects ( @ emixustat and @ placebo ) were evaluated .


Emixustat suppressed rod photoreceptor sensitivity in a dose-dependent manner .


Suppression plateaued by Day @ and was reversible within @ days to @ days after drug cessation .


Most systemic adverse events were not considered treatment related .


Dose-related ocular adverse events ( chromatopsia , @ % emixustat vs. @ % placebo and delayed dark adaptation , @ % emixustat vs. @ % placebo ) were mild to moderate in severity , and the majority resolved on study or within @ days to @ days after study drug cessation .


Reversibility of these adverse events with long-term administration , however , is undetermined .


In this Phase II study , emixustat produced a dose-dependent reversible effect on rod function that is consistent with the proposed mechanism of action .


These results support further testing of emixustat for the treatment of geographic atrophy associated with dry age-related macular degeneration .


Various surgical meshes are used in the repair of inguinal hernia and are associated with numerous complications .


Our main objective in this study was to determine whether a biologic hernia matrix is equivalent to polypropylene mesh in an open inguinal hernia repair using the Lichtenstein technique .


A prospective , randomized , double-blinded , single-center trial was conducted to evaluate the efficacy of a biologic Inguinal Hernia Matrix ( IHM ; Cook Medical ) compared with polypropylene ( PP ) mesh using Lichtenstein 's inguinal hernia repair in a @-year outcomes study .


Patients were evaluated for recurrence and complications by a blinded surgeon at @ weeks , @ months , @ months , and @ year post procedure .


Patient demographics , including comorbidities and nutrition status , were recorded .


Intraoperative information including hernia type and location , procedure time , level of difficulty , degree of surgeon frustration , and surgical experience were collected .


One hundred male patients provided informed consent and were randomized into the study in a @:@ fashion .


There were no significant differences in degree of difficulty and level of frustration between the @ groups .


At @-year follow-up , @ recurrences were diagnosed in the IHM group as compared with none in the PP group ( p = @ ) .


Persistent pain trended higher in the PP group ( @ % vs @ % ) .


All @ recurrences occurred in the direct inguinal hernia group and were performed by attendings in the first year post training ( @ different attendings ) .


No recurrences occurred in patients operated on by more senior surgeons .


The IHM hernioplasty compares favorably with PP mesh at @-year follow-up with similar recurrence rates and complications .


Surgeon experience appears to be a major factor affecting successful outcomes .


The authors compared the effectiveness of @ sessions of schema therapy with clarification-oriented psychotherapy and with treatment as usual among patients with cluster C , paranoid , histrionic , or narcissistic personality disorder .


A multicenter randomized controlled trial , with a single-blind parallel design , was conducted between @ and @ in @ Dutch mental health institutes .


A total of @ patients with personality disorders were randomly assigned ( schema therapy , N = @ ; treatment as usual , N = @ ; clarification-oriented psychotherapy , N = @ ) .


There were two cohorts of schema therapy therapists , with the first trained primarily with lectures and the second primarily with exercises .


The primary outcome was recovery from personality disorder @ years after treatment started ( assessed by blinded interviewers ) .


Secondary outcomes were dropout rates and measures of personality disorder traits , depressive and anxiety disorders , general psychological complaints , general and social functioning , self-ideal discrepancy , and quality of life .


A significantly greater proportion of patients recovered in schema therapy compared with treatment as usual and clarification-oriented psychotherapy .


Second-cohort schema therapists had better results than first-cohort therapists .


Clarification-oriented psychotherapy and treatment as usual did not differ .


Findings did not vary with specific personality disorder diagnosis .


Dropout was lower in the schema therapy and clarification-oriented psychotherapy conditions .


All treatments showed improvements on secondary outcomes .


Schema therapy patients had less depressive disorder and higher general and social functioning at follow-up .


While interview-based measures demonstrated significant differences between treatments , differences were not found with self-report measures .


Schema therapy was superior to treatment as usual on recovery , other interview-based outcomes , and dropout .


Exercise-based schema therapy training was superior to lecture-based training .


To reduce the incidence of incisional hernia ( IH ) in colorectal surgery by implanting a mesh on the overlay position .


The incidence of IH in colorectal surgery may be as high as @ % .


IH causes severe health and cosmetic problems , and its repair increases health care costs .


Randomized , controlled , prospective trial .


Patients undergoing any colorectal procedure ( both elective and emergency ) through a midline laparotomy were divided into @ groups .


The abdomen was closed with an identical technique in both groups , except for the implantation of an overlay large-pore polypropylene mesh in the study group .


Patients were followed up clinically and radiologically for @ months .


A total of @ patients were included : @ in the study group and @ in the control group .


Both groups were homogeneous , except for a higher incidence of diabetes in the mesh group .


There were @ emergency procedures in the study group and @ in the control group .


There were no statistical differences in surgical site infections , seromas , or mortality between the groups ( @ % , @ % , and @ % in the control group and @ % , @ % , and @ % in the study group ) .


No mesh rejection was reported .


The incidence of IH was @ of @ ( @ % ) in the control group and @ of @ ( @ % ) in the study group ( P = @ ) .


The incidence of IH is high in patients undergoing elective or emergency surgery for colorectal diseases .


The addition of a prophylactic large-pore polypropylene mesh on the overlay position decreases the incidence of IH without adding morbidity .


The purpose of this trial was to evaluate the effect of a Web-based , self-report assessment and educational intervention on symptom distress during cancer therapy .


A total of @ ambulatory adult participants were randomly assigned to symptom/quality-of-life ( SxQOL ) screening at four time points ( control ) versus screening , targeted education , communication coaching , and the opportunity to track/graph SxQOL over time ( intervention ) .


A summary of the participant-reported data was delivered to clinicians at each time point in both groups .


All participants used the assessment before a new therapeutic regimen , at @ to @ weeks and @ to @ weeks later , completing the final assessment at the end of therapy .


Change in Symptom Distress Scale-@ ( SDS-@ ) score from pretreatment to end of study was compared using analysis of covariance and regression analysis adjusting for selected variables .


We detected a significant difference between study groups in mean SDS-@ score change from baseline to end of study : @ ( standard deviation -LSB- SD -RSB- , @ ) in the control group ( higher distress ) versus -@ ( SD , @ ) in the intervention group ( lower distress ) .


SDS-@ score was reduced by an estimated @ ( @ % CI , @ to @ ; P = @ ) in the intervention group .


Baseline SDS-@ score ( P < @ ) and clinical service ( P = @ ) were predictive .


Multivariable analyses suggested an interaction between age and study group ( P = @ ) ; in subset analysis , the benefit of intervention was strongest in those age > @ years ( P = @ ) .


Web-based self-care support and communication coaching added to SxQOL screening reduced symptom distress in a multicenter sample of participants with various diagnoses during and after active cancer treatment .


Participants age > @ years , in particular , may have benefited from the intervention .


Findings from inflammatory bowel disease ( IBD ) genome-wide association studies are being translated clinically into prognostic and diagnostic indicators of disease .


Yet , patient perception and understanding of these tests and their applicability to providing risk information is unclear .


The goal of this study was to determine , using hypothetical scenarios , whether patients with IBD perceive genetic testing to be useful for risk assessment , whether genetic test results impact perceived control , and whether low genetic literacy may be a barrier to patient understanding of these tests .


Two hundred fifty seven patients with IBD from the Johns Hopkins gastroenterology clinics were randomized to receive a vignette depicting either a genetic testing scenario or a standard blood testing scenario .


Participants were asked questions about the vignette and responses were compared between groups .


Perceptions of test utility for risk assessment were higher among participants responding to the genetic vignette ( P < @ ) .


There were no significant differences in perceptions of control over IBD after hypothetical testing between vignettes ( P = @ ) .


Participant responses were modified by genetic literacy , measured using a scale developed for this study .


Participants randomized to the genetic vignette who scored higher on the genetic literacy scale perceived greater utility of testing for risk assessment ( P = @ ) and more control after testing ( P = @ ) .


Patients with IBD perceive utility in genetic testing for providing information relevant to family members , and this appreciation is promoted by genetic literacy .


Low genetic literacy among patients poses a potential threat to effective translation of genetic and genomic tests .


Recent epidemiological studies revealed a striking inverse relationship between vitamin D levels , glucose intolerance/insulin resistance ( IR ) , and cardiovascular disease .


However , few interventional studies have evaluated the effect of vitamin D supplementation on cardiovascular risk , such as IR and arterial stiffness , in diabetes .


We investigated the role of vitamin D supplementation on cardiovascular risk in type @ diabetes patients , including metabolic parameters , IR , and arterial stiffness .


We enrolled patients who were taking antidiabetic medications or managed their diabetes using lifestyle changes .


We excluded patients who were taking vitamin D or calcium supplements .


We randomized participants into the vitamin D group ( cholecalciferol @,@ IU/day + calcium @ mg/day , n = @ ) or the placebo group ( calcium @ mg/day , n = @ ) .


We compared their IR ( homeostasis model of assessment -LSB- HOMA -RSB- - IR ) and arterial stiffness ( brachial-ankle pulse wave velocity and radial augmentation index ) before and after @ weeks of intervention .


The baseline characteristics of the two groups were similar .


A total of @ participants ( placebo , @ ; vitamin D , @ ) completed the study protocol .


At the end of the study period , the @-hydroxyvitamin D -LSB- @ ( OH ) D -RSB- levels were significantly higher in the vitamin D group than in the placebo group ( @ @ ng/mL vs. @ @ ng/mL , p < @ ) .


There was no difference in HOMA-IR or changes in arterial stiffness ( placebo , @ , vitamin D , @ ) between the groups .


Our data suggest that high-dose vitamin D supplementation might be effective in terms of elevating @ ( OH ) D levels .


However , we identified no beneficial effects on cardiovascular risk in type @ diabetes , including IR and arterial stiffness .


To determine the efficacy and safety of Curcuma domestica extracts in pain reduction and functional improvement .


@ primary knee osteoarthritis patients with a pain score of @ or higher were randomized to receive ibuprofen @,@ mg/day or C. domestica extracts @,@ mg/day for @ weeks .


The main outcomes were Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) total , WOMAC pain , WOMAC stiffness , and WOMAC function scores .


Adverse events ( AEs ) were also recorded .


@ and @ patients were randomly assigned into C. domestica extracts and ibuprofen groups , respectively .


The baseline characteristics were no different between groups .


The mean of all WOMAC scores at weeks @ , @ , and @ showed significant improvement when compared with the baseline in both groups .


After using the noninferiority test , the mean difference ( @ % confidence interval ) of WOMAC total , WOMAC pain , and WOMAC function scores at week @ adjusted by values at week @ of C. domestica extracts were noninferior to those for the ibuprofen group ( P = @ , P = @ , and P = @ , respectively ) , except for the WOMAC stiffness subscale , which showed a trend toward significance ( P = @ ) .


The number of patients who developed AEs was no different between groups .


However , the number of events of abdominal pain/discomfort was significantly higher in the ibuprofen group than that in the C. domestica extracts group ( P = @ ) .


Most subjects ( @ % -@ % ) were satisfied with the treatment , and two-thirds rated themselves as improved in a global assessment .


C. domestica extracts are as effective as ibuprofen for the treatment of knee osteoarthritis .