The proposed perfusion analysis algorithm ( Segment ) was trained in @ patients and validated in the remaining @ patients using visual scoring in MPS by an expert reader as reference standard .


Furthermore , validation was performed with simulated perfusion defects in an anthropomorphic computer model .


Total perfusion deficit ( TPD , range @-@ ) , including both extent and severity of the perfusion defect , was used as the global measurement of the perfusion defects .


Mean bias SD between TPD by Segment and the simulated TPD was @ @ ( R ( @ ) = @ ) .


Mean bias SD between TPD by Segment and the visual scoring in the patients was @ @ ( R ( @ ) = @ ) for stress-induced ischemia and -@ @ ( R ( @ ) = @ ) for infarction .


The proposed algorithm can detect and quantify perfusion defects in MPS with good agreement to expert readers and to simulated values in a computer phantom .


Pentoxifylline , a nonselective phosphodiesterase inhibitor , shows vasodilator effects in certain vascular beds and reduces blood viscosity .


We have previously shown that under states of vasoconstriction an interaction between circulating erythrocytes and leukocytes may play a role in the control of blood flow .


The reason for this observation is not entirely clear but may be related to a mechanical interaction between red and white blood cells .


In the present study we hypothesized that pentoxifylline may alter this interaction during oxygen-induced vasoconstriction .


@ healthy male subjects participated in this double masked , randomized , placebo-controlled @ way cross over trial .


In order to increase white blood cell count ( WBC ) count , @ g of G-CSF was administered intravenously .


Vasoconstriction of retinal vessels was induced by oxygen inhalation .


@mg of pentoxifylline or placebo was infused at two different study days .


White blood cell flux was assessed with the blue-field entoptic technique .


Vessel calibers were measured with a dynamic vessel analyzer ( DVA ) and red blood cell velocity ( RBCV ) was determined with laser Doppler velocimetry ( LDV ) .


Retinal blood flow was calculated based on retinal vessel diameters and RBCV .


Administration of G-CSF induced a significant increase in WBC , both in the placebo and the pentoxifylline group ( p < @ for both groups ) .


Retinal vessel diameter , RBCV , calculated retinal blood flow and white blood cell flow were not altered by administration of pentoxifylline .


Hyperoxia induced a pronounced decrease in retinal blood flow parameters .


No difference was observed between groups during oxygen breathing in vessel diameters ( p = @ ) , RBCV ( p = @ ) , calculated retinal blood flow ( p = @ ) and white blood cell flow ( p = @ ) .


Our data indicate that short time administration of pentoxifylline does not alter the oxygen-induced effect on ocular blood flow parameters during leukocytosis .


Whether long-term treatment could improve retinal blood flow under states of vasoconstriction remains to be investigated .


Randomized clinical trials ( RCTs ) suggest benefits for the transradial approach to percutaneous coronary intervention ( PCI ) for ST-elevation myocardial infarction ( STEMI ) .


However , transradial PCI may delay reperfusion , leading to its avoidance .


We sought to quantify the delay in reperfusion from transradial PCI ( `` transradial delay '' ) that would need to be introduced to offset the potential mortality benefit of transradial PCI , compared with transfemoral , observed in RCTs .


We developed a decision-analytic model to compare transfemoral and transradial PCI in STEMI .


Thirty-day mortality rates were estimated by pooling STEMI patients from @ RCTs comparing transfemoral and transradial PCI .


We projected the impact of transradial delay using estimates of the increase in mortality associated with door-to-balloon time delays .


Sensitivity analyses were performed to understand the impact of uncertainty in assumptions .


In the base case , a transradial delay of @ minutes was needed to offset the mortality benefit of transradial PCI .


When the mortality benefit of transradial PCI was one-quarter that observed in RCTs , the delay associated with equivalent mortality was @ minutes .


In probabilistic sensitivity analyses , transradial PCI was preferred over transfemoral PCI in @ % of simulations when transradial delay was @ minutes and in @ % of simulations when delay was @ minutes .


A substantial transradial delay is required to eliminate even a fraction of the mortality benefit observed with transradial PCI in RCTs .


Results were robust to changing multiple assumptions and have implications for operators reluctant to transition to transradial PCI in STEMI because of concern for delaying reperfusion .


Heart rate ( HR ) plays an important role in the assessment of stress during therapeutic hypothermia ( TH ) for neonatal encephalopathy ; we aimed to quantify the effect on HR of endotracheal ( ET ) intubation and drugs given to facilitate it .


If atropine premedication independently increased HR , the main indicator of effective sedation , we hypothesised that increased sedation would have been given .


Thirty-two , term , neonates recruited into a randomised pilot study comparing TH and TH combined with @ % Xenon inhalation were studied .


Indications for ET intubation included : resuscitation at delivery , clinical need and elective re-intubation with a cuffed ET tube if randomised to Xenon .


Standard intubation drugs comprised one or more of intravenous morphine , atropine , and suxamethonium .


Local cooling guidelines were followed including morphine infusion for sedation .


At postnatal hours five to eight atropine increased HR in a linear regression model ( p < @ ) .


All other independent variables were excluded .


Where more than one dose of atropine was given total morphine sedation given up to @h into the treatment period was significantly higher ( p < @ ) .


We have shown that atropine premedication for ET intubation significantly increased HR , the main indicator of effective sedation and total morphine dose for sedation during early TH was increased where more than one dose of atropine was given .


Bradycardia was not reported in any neonate , even without atropine premedication .


We suggest that the use of atropine as part of standard premedication for ET intubation of term neonates undergoing TH should be reconsidered .


Narrowband UV-B ( NB-UV-B ) phototherapy is used extensively to treat vitiligo .


Afamelanotide , an analogue of - melanocyte-stimulating hormone , is known to induce tanning of the skin .


To evaluate the efficacy and safety of combination therapy for generalized vitiligo consisting of afamelanotide implant and NB-UV-B phototherapy .


This study was performed in @ academic outpatient dermatology centers and @ private dermatology practice .


We enrolled men and women @ years or older with Fitzpatrick skin phototypes ( SPTs ) III to VI and a confirmed diagnosis of nonsegmental vitiligo that involved @ % to @ % of total body surface area .


Vitiligo was stable or slowly progressive for @ months .


Patients were randomized to combination therapy ( n = @ ) vs NB-UV-B monotherapy ( n = @ ) .


After @ month of NB-UV-B phototherapy , @ mg of afamelanotide was administered subcutaneously to the combination therapy group monthly for @ months while NB-UV-B phototherapy continued ; the other group continued to receive NB-UV-B monotherapy .


Narrowband UV-B monotherapy vs combined NB-UV-B phototherapy and afamelanotide .


Response on the Vitiligo Area Scoring Index and Vitiligo European Task Force scoring system .


Response in the combination therapy group was superior to that in the NB-UV-B monotherapy group ( P < @ ) at day @ .


For the face and upper extremities , a significantly higher percentage of patients in the combination therapy group achieved repigmentation , and at earlier times ( face , @ vs @ days -LSB- P = @ -RSB- ; upper extremities , @ vs @ days -LSB- P = @ -RSB- ) .


In the combination therapy group , repigmentation was @ % ( @ % CI , @ % -@ % ) at day @ vs @ % ( @ % CI , @ % -@ % ) in the NB-UV-B monotherapy group .


Notable adverse events included erythema in both groups and minor infections and nausea in the combination therapy group .


Comparison between Fitzpatrick SPTs showed patients with SPTs IV to VI in the combination therapy group had improvement in the Vitiligo Area Scoring Index at days @ and @ ( P < @ ) ; no significant difference was noted in patients with SPT III .


A combination of afamelanotide implant and NB-UV-B phototherapy resulted in clinically apparent , statistically significant superior and faster repigmentation compared with NB-UV-B monotherapy .


The response was more noticeable in patients with SPTs IV to VI .


Cough is an extremely common problem in pediatrics , mostly triggered and perpetuated by inflammatory processes or mechanical irritation leading to viscous mucous production and increased sensitivity of the cough receptors .


Protecting the mucosa might be very useful in limiting the contact with micro-organisms and irritants thus decreasing the inflammation and mucus production .


Natural molecular complexes can act as a mechanical barrier limiting cough stimuli with a non pharmacological approach but with an indirect anti-inflammatory action .


Aim of the study was to assess the efficacy of a medical device containing natural functional components in the treatment of cough persisting more than @ days .


In this randomized , parallel groups , double-blind vs. placebo study , children with cough persisting more than @ days were enrolled .


The clinical efficacy of the study product was assessed evaluating changes in day - and night-time cough scores after @ and @ days ( t@ and t@ ) of product administration .


In the inter-group analysis , in the study product group compared with the placebo group , a significant difference ( t@ study treatment vs. t@ placebo , p = @ ) was observed at t@ in night-time cough score.Considering the intra-group analysis , only the study product group registered a significant improvement from t@ to t@ in both day-time ( t@ vs. t@ , p = @ ) and night-time ( t@ vs. t@ , p = @ ) cough scores.A significant difference , considering the study product , was also found in the following intra-group analyses : day-time scores at t@ vs. t@ ( p = @ ) and at t@ vs. t@ ( p = @ ) ; night-time scores at t@ vs. t@ ( p = @ ) , and at t@ vs. t@ ( p = @ ) .


Considering a subgroup of patients with higher cough ( @ ) scores , @ % of them in the study product group improved at t@ vs. t@ day-time .


Grintuss pediatric syrup showed to possess an interesting profile of efficacy and safety in the treatment of cough persisting more than @ days .


Laparoscopic surgery has been shown to provide important advantages in comparison with open procedures in the treatment of several malignant diseases , such as less perioperative blood loss and faster patient recovery .


It also maintains similar results with regard to tumor resection margins and oncological long-term survival .


In gastric cancer the role of laparoscopic surgery remains unclear .


Current recommended treatment for gastric cancer consists of radical resection of the stomach , with a free margin of @ to @ cm from the tumor , combined with a lymphadenectomy .


The extent of the lymphadenectomy is considered a marker for radicality of surgery and quality of care .


Therefore , it is imperative that a novel surgical technique , such as minimally invasive total gastrectomy , should be non-inferior with regard to radicality of surgery and lymph node yield .


The Surgical Techniques , Open versus Minimally invasive gastrectomy After CHemotherapy ( STOMACH ) study is a randomized , clinical multicenter trial .


All adult patients with primary carcinoma of the stomach , in which the tumor is considered surgically resectable ( T@-@ , N@-@ , M@ ) after neo-adjuvant chemotherapy , are eligible for inclusion and randomization .


The primary endpoint is quality of oncological resection , measured by radicality of surgery and number of retrieved lymph nodes .


The pathologist is blinded towards patient allocation .


Secondary outcomes include patient-reported outcomes measures ( PROMs ) regarding quality of life , postoperative complications and cost-effectiveness .


Based on a non-inferiority model for lymph node yield , with an average lymph node yield of @ , a non-inferiority margin of -@ and a @ % power to detect non-inferiority , a total of @ patients are to be included .


The STOMACH trial is a prospective , multicenter , parallel randomized study to define the optimal surgical strategy in patients with proximal or central gastric cancer after neo-adjuvant therapy : the conventional ` open ' approach or minimally invasive total gastrectomy .


This study aims to investigate the role of fast-track surgery in preventing the development of postoperative delirium and other complications in elderly patients with colorectal carcinoma .


A total of @ elderly patients with colorectal carcinoma ( aged @years ) undergoing open colorectal surgery was randomly assigned into two groups , in which the patients were managed perioperatively either with traditional or fast-track approaches .


The length of hospital stay ( LOS ) and time to pass flatus were compared .


The incidence of postoperative delirium and other complications were evaluated .


Serum interleukin-@ ( IL-@ ) levels were determined before and after surgery .


The LOS was significantly shorter in the fast-track surgery ( FTS ) group than that in the traditional group .


The recovery of bowel movement ( as indicated by the time to pass flatus ) was faster in the FTS group .


The postoperative complications including pulmonary infection , urinary infection and heart failure were significantly less frequent in the FTS group .


Notably , the incidence of postoperative delirium was significantly lower in patients with the fast track therapy ( @/@ , @ % ) than with the traditional therapy ( @/@ , @ % ; p = @ ) .


The serum IL-@ levels on postoperative days @ , @ , and @ in patients with the fast-track therapy were significantly lower than those with the traditional therapy ( p < @ ) .


Compared to traditional perioperative management , fast-track surgery decreases the LOS , facilitates the recovery of bowel movement , and reduces occurrence of postoperative delirium and other complications in elderly patients with colorectal carcinoma .


The lower incidence of delirium is at least partly attributable to the reduced systemic inflammatory response mediated by IL-@ .


We examined whether community translation of an effective evidence-based fall prevention program via standard monetary support can produce a community-wide reduction in fall injuries in older adults and evaluated whether an enhanced version with added technical support and capacity building amplified the fall reduction effect .


We completed a randomized controlled community trial among adults aged @ and older in ( @ ) @ control communities receiving no special resources or guidance on fall prevention , ( @ ) @ standard support communities receiving modest funding to implement Stepping On , and ( @ ) @ enhanced support communities receiving funding and technical support .


The primary outcome was hospital inpatient and emergency department discharges for falls , examined with Poisson regression .


Compared with control communities , standard and enhanced support communities showed significantly higher community-wide reductions ( @ % and @ % , respectively ) in fall injuries from baseline ( @-@ ) to follow-up ( @-@ ) .


No significant difference was found between enhanced and standard support communities .


Population-based fall prevention interventions can be effective when implemented in community settings .


More research is needed to identify the barriers and facilitators that influence the successful adoption and implementation of fall prevention interventions into broad community practice .


There is little evidence on the efficacy of glucocorticoid transnasal nebulization therapy in patients witheosinophilic chronic rhinosinusitis with nasal polyps ( CRSwNP ) .


We sought to evaluate the immunologic and remodeling effects of budesonide transnasal nebulization in patients with eosinophilic CRSwNP .


Sixty patients with eosinophilic CRSwNP were randomized to receive budesonide or placebo treatment for @days by means of transnasal nebulization in a double-blind manner .


Endoscopic polyp size scores ( maximum = @ points , Kennedy score ) and visual analog scale scores for nasal symptoms were assessed before and after treatment .


Similarly , polyp samples were evaluated for inflammatory cytokines , matrix metalloproteinases ( MMPs ) , and tissue inhibitors of metalloproteinases ( TIMPs ) by using an immunoassay ; collagen by using histochemistry ; eosinophils by using hematoxylin and eosin stain ; and T-cell subsets by using flow cytometry .


Budesonide transnasal nebulization significantly reduced polyp size compared with placebo ( mean difference between groups , -@ units ; @ % CI , -@ to -@ units ; P = @ ) and improved symptoms .


Polyp IL-@ and eotaxin expression decreased significantly , whereas TGF - and IL-@ expression increased .


Expression of IFN - and IL-@ was not altered .


Budesonide transnasal nebulization consistently reduced eosinophil infiltration and TH@ cell frequency and increased natural regulatory T-cell and type @ regulatory T-cell frequencies .


Indices of remodeling , including albumin , MMP-@ , MMP-@ , MMP-@ , and MMP-@ , were significantly decreased , whereas collagen deposition and TIMP-@ , TIMP-@ , and TIMP-@ levels were significantly increased .


Budesonide transnasal nebulization did not suppress the hypothalamic-pituitary-adrenal axis or cause any serious side effects .


Short-term budesonide transnasal nebulization is an effective and safe treatment option in patients with eosinophilic CRSwNP , achieving clinical improvement by regulating remodeling , cytokine expression , and T-cell subset distribution .


To report @-year results from a previously reported trial evaluating intravitreal @ mg ranibizumab with prompt versus deferred ( for @ weeks ) focal/grid laser treatment for diabetic macular edema ( DME ) .


Multicenter , randomized clinical trial .


Among participants from the trial with @ years of follow-up who subsequently consented to a @-year extension and survived through @ years , @ ( @ % ) and @ ( @ % ) completed the @-year visit in the prompt and deferred groups , respectively .


Random assignment to ranibizumab every @ weeks until no longer improving ( with resumption if worsening ) and prompt or deferred ( @ weeks ) focal/grid laser treatment .


Best-corrected visual acuity at the @-year visit .


The mean change in visual acuity letter score from baseline to the @-year visit was +@ letters in the prompt laser group compared with +@ letters in the deferred laser group ( mean difference,-@ @ letters ; @ % confidence interval,-@ @ to +@ letters ; P = @ ) .


At the @-year visit in the prompt versus deferred laser groups , there was vision loss of @ letters in @ % versus @ % , an improvement of @ letters in @ % versus @ % , and an improvement of @ letters in @ % versus @ % of participants , respectively .


From baseline to @ years , @ % of participants in the deferred group did not receive laser .


The median number of injections was @ versus @ in the prompt and deferral groups , including @ % and @ % receiving no injections during year @ and @ % and @ % receiving no injections during year @ , respectively .


Five-year results suggest focal/grid laser treatment at the initiation of intravitreal ranibizumab is no better than deferring laser treatment for @ weeks in eyes with DME involving the central macula with vision impairment .


Although more than half of eyes in which laser treatment is deferred may avoid laser for at least @ years , such eyes may require more injections to achieve these results when following this protocol .


Most eyes treated with ranibizumab and either prompt or deferred laser maintain vision gains obtained by the first year through @ years with little additional treatment after @ years .


Postoperative pulmonary complications ( PPCs ) are the most commonly reported complications after esophagectomy .


The aim of this study was to examine the effect and feasibility of preoperative inspiratory muscle training-high intensity ( IMT-HI ) , and IMT-endurance ( IMT-E ) on the incidence of PPCs in patients following esophagectomy for esophageal cancer ( EC ) .


A single-blind , randomized , clinical pilot study was conducted between @ and @ .


Forty-five participants were assigned to either IMT-HI or IMT-E .


Effectiveness was assessed by analyzing PPCs , length of hospital stay ( LOS ) , duration of mechanical ventilation , stay on the intensive care unit , and number of reintubations .


Maximal inspiratory pressure and lung function changes were recorded pre - and post-training .


Feasibility was assessed by IMT-related adverse events , training compliance , and patients ' satisfaction .


Thirty-nine patients could be analyzed , @ patients in the IMT-HI arm and @ patients in the IMT-E arm .


The incidence of PPCs differed significantly between groups and was almost three times lower for the IMT-HI group ( @ vs. @ patients ; p = @ ) .


Other differences in favor of the IMT-HI group were LOS ( @ vs. @ days ; p = @ ) and number of reintubations ( @ vs. @ patients ; p = @ ) .


Both interventions proved to be equally feasible .


Preoperative IMT-HI showed to be a promising , effective , and feasible intervention to reduce PPCs in EC patients undergoing esophagectomy .


Further research with a larger sample size is recommended .


Increased oxidative stress , inflammation , and malnutrition are present in hemodialysis patients and these factors exacerbate cardiovascular comorbidities .


Vitamin E and alpha-lipoic acid ( ALA ) may have a protective role against cardiovascular disease risk factors via anti-oxidative and anti-inflammatory properties .


The aim of this study was to evaluate the effect of ALA and vitamin E administration ( alone or combined ) on hemodialysis-induced stress oxidation , inflammation , and malnutrition .


In a randomized placebo-controlled trial , we examined the effects of @-month supplementation by vitamin E and ALA ( alone or combined ) on biomarkers of lipid peroxidation ( malondialdehyde ) , inflammation ( high-sensitivity C-Reactive protein and interleukin-@ ) , and malnutrition ( Subjective Global Assessment and body mass index ) in @ hemodialysis patients receiving ALA ( @ mg ) , vitamin E ( @ IU ) , ALA and vitamin E , and placebo .


After supplementation , no significant changes were observed in malondialdehyde level ; however , there was a decrease in the ALA and vitamin E group during the period of the study .


Also , a nonsignificant decrease was seen in the high-sensitivity C-Reactive protein concentration of the interventional groups .


Supplementation of vitamin E with and without ALA significantly reduced interleukin-@ concentration .


A significant improvement was observed in malnutrition status of all groups .


Vitamin E and ALA supplementation , especially their combination , might improve inflammation and malnutrition status , which suggest it as a potential preventive strategy against CVD among end-stage renal disease patients .


To investigate the effect of dexmedetomidine on T helper @ ( Th@ ) and T helper @ ( Th@ ) cytokines and their ratio during and after surgery .


Single-blinded , randomized , placebo-controlled clinical comparison study .


Academic medical center .


@ adult , ASA physical status @ and @ patients scheduled for laparoscopic cholecystectomy .


Patients were randomized to two groups : the dexmedetomidine group ( n = @ ) , in which dexmedetomidine was infused with a @ g/kg loading dose followed by infusion of @ g/kg/h ; or the saline group ( n = @ ) .


Interferon-gamma ( IFN-gamma ) and interleukin-@ ( IL-@ ) as Th@ and Th@ cytokines , respectively , were quantified three times : after induction of anesthesia ( T@ ) , at the end of peritoneal closure ( T@ ) , and @ minutes after surgery ( T@ ) .


The IFN-gamma/IL -@ ratio was then calculated .


The dexmedetomidine group displayed higher levels of IFN-gamma at T@ and T@ ( @ pg/dL vs @ pg/dL at T@ -LSB- P = @ -RSB- ; @ pg/dL vs @ pg/dL at T@ -LSB- P = @ -RSB- ) than the saline group .


The dexmedetomidine group was also associated with higher ratios of IFN-gamma/IL -@ ( @ vs @ , respectively , at T@ -LSB- P = @ -RSB- ; @ vs @ , respectively , at T@ -LSB- P = @ -RSB- ) .


Dexmedetomidine plays an immunomodulatory role , shifting the Th@/Th@ cytokine balance toward Th@ in patients with surgical and anesthetic stress .


Animal studies report photodynamic therapy ( PDT ) to improve healing of excisional wounds ; the mechanism is uncertain and equivalent human studies are lacking .


To explore the impact of methyl aminolaevulinate ( MAL ) - PDT on clinical and microscopic parameters of human cutaneous excisional wound healing , examining potential modulation through production of transforming growth factor ( TGF ) - isoforms .


In @ healthy older men ( @-@ years ) , a @-mm punch biopsy wound was created in skin of the upper inner arm and treated with MAL-PDT three times over @ days .


An identical control wound to the contralateral arm was untreated and both wounds left to heal by secondary intention .


Wounds were re-excised during the inflammatory phase ( @ days , n = @ ) , matrix remodelling ( @ weeks , n = @ ) and cosmetic outcome/dermal structure ( @ months , n = @ ) .


Production of TGF-@ , TGF-@ and matrix metalloproteinases ( MMPs ) was assessed by immunohistochemistry alongside microscopic measurement of wound size/area and clinical assessment of wound appearance .


MAL-PDT delayed re-epithelialization at @ days , associated with increased inflammation .


However , @ weeks postwounding , treated wounds were smaller with higher production of MMP-@ ( P = @ ) , MMP-@ ( P = @ ) and TGF-@ ( P = @ ) .


TGF-@ was lower than control at @ days and higher at @ weeks ( both P = @ ) .


At @ months , MAL-PDT-treated wounds showed greater , more ordered deposition of collagen I , collagen III and elastin ( all P < @ ) .


MAL-PDT increases MMP-@ , MMP-@ and TGF-@ production during matrix remodelling , ultimately producing scars with improved dermal matrix architecture .


Injections of human placental extract , which is known to play a role in skin regulation , have long been used for the treatment of skin wrinkles and non-healing wounds .


Porcine placental extract ( PPE ) , an oral supplement , was recently developed for this purpose .


The aim of this study was to assess whether PPE has a positive effect on the improvement of fine wrinkles below the eye in climacteric women .


We first non-invasively measured wrinkle widths with a skin analyzer in a cross-section of @ healthy adult Japanese women .


Next , @ climacteric women with mild or few climacteric symptoms were enrolled into an open-label , randomized , controlled study of the effect of PPE on wrinkle widths .


A retrospective comparison of wrinkle widths in @ climacteric women with climacteric symptoms with or without PPE treatment was also performed .


Wrinkle widths below the eye in women @ years of age were significantly higher than in women @-@ years of age .


Treatment with three capsules of PPE per day was significantly ( p < @ ) effective in reducing wrinkle widths at @ weeks compared with control subjects .


Retrospective analysis showed that subjects treated with three ( p < @ ) and six ( p < @ ) capsules of PPE per day observed a significant reduction in wrinkle widths compared with untreated subjects .


Oral PPE treatment is a possible option for improving the appearance of fine wrinkles below the eye in climacteric women .


It is recommended to vaccinate pregnant women against influenza .


A possible impact on the immune expression of the fetus has never been studied .


We aim to study the immune signature in the upper airways and the incidence of infections in neonates born to mothers receiving Influenza A ( H@N@ ) pnd@ vaccination during pregnancy .


One hundred and fifty-six women from the unselected Copenhagen Prospective Study on Asthma in Childhood ( COPSAC@ ) received Influenza A ( H@N@ ) pnd@-vaccination during the @ pandemic .


Fifty-one mothers received the vaccine during pregnancy and @ after pregnancy ; @ neonates of nonvaccinated mothers were included as secondary controls .


Nasal mucosal lining fluid was sampled in @ neonates and assessed for interleukin ( IL ) -@ p@ , IP-@ , interferon-gamma ( IFN ) - , tumor necrosis factor-alpha ( TNF ) - , MIP-@ , MCP-@ , MCP-@ , IL-@ , IL-@ , IL-@ , eotaxin-@ , eotaxin-@ , TARC , MDC , IL-@ , IL-@ , IL-@ , transforming growth factor beta ( TGF ) -@ , IL-@ and IL-@ .


Infections were monitored the first year of life by daily diary cards and clinical controls .


Neonates of mothers vaccinated during pregnancy had significant up-regulation of TGF-@ -LSB- ratio = @ ( @-@ @ ) , P = @ -RSB- , and corresponding down-regulation ( P < @ ) of IL-@p@ , IFN - , IL-@ , eotaxin-@ , TARC , MDC , IL-@ in comparison to those vaccinated after pregnancy .


The lag-time from vaccination during pregnancy to assessment of the immune signature showed significant and positive association to up-regulation of TGF-@ levels ( P = @ ) and significant negative association to other mediators .


The study was not powered to study differences in the incidence of infections in early infancy which did not differ between the study groups .


Influenza A ( H@N@ ) pnd@ vaccination during pregnancy up-regulates TGF-@ and down-regulates key mediators of the protective immunity .


Although glucocorticoids are widely used in the treatment of patients with early rheumatoid arthritis , the best dosage of glucocorticoids with regards to efficacy and safety is not known.The aim of the study ` Comparison of the efficacy and safety of two starting dosages of prednisolone in early active rheumatoid arthritis ' ( CORRA ) is to compare two standard glucocorticoid starting dosages and the non-use of glucocorticoids in the treatment of patients with early active rheumatoid arthritis on the background of the established ` anchor ' therapy with methotrexate .


CORRA is an investigator-initiated , randomized , multicenter , double-blind , placebo-controlled trial with two treatment arms , starting with @ mg or @ mg prednisolone per day , tapered down to @ mg prednisolone within eight weeks , and one placebo arm , each arm comprising @ patients .


The duration of the intervention is @ weeks .


In parallel , all patients will be treated with methotrexate ( usual dosage @ mg/week ) .


The primary efficacy endpoint is the progression of radiographic joint damage after one year compared to baseline .


Important secondary endpoints are the percentage of patients in remission , patient global assessment of disease activity , and changes of functional capacity .


Safety monitoring is performed.The statistical analysis is performed in three hierarchical steps .


The first step is an analysis of covariance ( = @ ) to compare the group with the initial prednisolone dosage of @ mg and the placebo group .


In case of a statistically significant result , the comparison of the group starting with @ mg prednisolone with the placebo group will be performed as a second step ( = @ ) .


In case of superiority of the @ mg prednisolone group versus the placebo group , the third step will be a non-inferiority test for the @ mg prednisolone group versus the @ mg prednisolone group ( = @ ) .


The CORRA trial will yield information concerning the optimal glucocorticoid dosage schedule in the treatment of patients with early rheumatoid arthritis .


The aim of the current study was to investigate potential benefits of likelihood alarm systems ( LASs ) over binary alarm systems ( BASs ) in a multitask environment .


Several problems are associated with the use of BASs , because most of them generate high numbers of false alarms .


Operators lose trust in the systems and ignore alarms or cross-check all of them when other information is available .


The first behavior harms safety , whereas the latter one reduces productivity .


LASs represent an alternative , which is supposed to improve operators ' attention allocation .


We investigated LASs and BASs in a dual-task paradigm with and without the possibility to cross-check alerts with raw data information .


Participants ' trust in the system , their behavior , and their performance in the alert and the concurrent task were assessed .


Reported trust , compliance with alarms , and performance in the alert and the concurrent task were higher for the LAS than for the BAS .


The cross-check option led to an increase in alert task performance for both systems and a decrease in concurrent task performance for the BAS , which did not occur in the LAS condition .


LASs improve participants ' attention allocation between two different tasks and therefore lead to an increase in alert task and concurrent task performance .


The performance maximum is achieved when LAS is combined with a cross-check option for validating alerts with additional information .


The use of LASs instead of BASs in safety-related multitask environments has the potential to increase safety and productivity likewise .


Excessive body weight , low physical activity and excessive sedentary time in youth are major public health concerns .


A new generation of video games , the ones that require physical activity to play the games -- i.e. active games -- may be a promising alternative to traditional non-active games to promote physical activity and reduce sedentary behaviors in youth .


The aim of this manuscript is to describe the design of a study evaluating the effects of a family oriented active game intervention , incorporating several motivational elements , on anthropometrics and health behaviors in adolescents .


The study is a randomized controlled trial ( RCT ) , with non-active gaming adolescents aged @-@ years old randomly allocated to a ten month intervention ( receiving active games , as well as an encouragement to play ) or a waiting-list control group ( receiving active games after the intervention period ) .


Primary outcomes are adolescents ' measured BMI-SDS ( SDS = adjusted for mean standard deviation score ) , waist circumference-SDS , hip circumference and sum of skinfolds .


Secondary outcomes are adolescents ' self-reported time spent playing active and non-active games , other sedentary activities and consumption of sugar-sweetened beverages .


In addition , a process evaluation is conducted , assessing the sustainability of the active games , enjoyment , perceived competence , perceived barriers for active game play , game context , injuries from active game play , activity replacement and intention to continue playing the active games .


This is the first adequately powered RCT including normal weight adolescents , evaluating a reasonably long period of provision of and exposure to active games .


Next , strong elements are the incorporating motivational elements for active game play and a comprehensive process evaluation .


This trial will provide evidence regarding the potential contribution of active games in prevention of excessive weight gain in adolescents .


Metabolic syndrome ( MetS ) is diagnosed by the detection of at least three criteria ( hypertriglyceridemia , low HDL-C , hypertension , obesity and altered fasting glucose ) .


Visceral fat excess would be the starting point for its development .


Scientific evidence supports hypocaloric diets - mediterranean or low fat diet and rich in complex carbohydrates diet included - as the best treatment to reduce fat mass ( FM ) , maximizing its impact by combining them with physical exercise ( PE ) .


However , the effects of these treatments on basal metabolic rate ( BMR ) of patients with MetS , are unknown .


To study the effect of the hypocaloric diet - mediterranean or low fat diet - with or without PE on the BMR and body composition ( BC ) of adults with MetS .


@ volunteers , MetS , both sexes , > @ years , meeting the inclusion criteria .


They were randomly assigned to a group of intervention ( @ months ) of hypocaloric diet : mediterranean diet ( MED ) , low fat and rich in complex carbohydrates diet ( CHO ) and both combined with PE ( MEDE and CHOE respectively ) .


Anthropometric data was taken ( weight , muscle mass ( MM ) and FM ) and BMR was determined by indirect calorimetry , before and after intervention .


The addition of PE to both hypocaloric treatments produced greater FM loss and weight loss than dieting alone , being this loss in CHOE > MEDE ( p < @ ) .


These groups decreased the BMR after treatment being MEDE > CHOE ( p < @ ) .


Mediterranean diet with or without PE lost MM ( p < @ ) being MEDE > MED CONCLUSIONS : CHOE induces less reduction of BMR while supporting a better profile of BC than MEDE .


To determine the relation between thrombus aspiration ( TA ) and/or intra-lesion ( IL ) abciximab with pre-stent Thrombolysis In Myocardial Infarction ( TIMI ) flow grade and infarct size ( IS ) in patients with ST-elevation myocardial infarction ( STEMI ) undergoing primary percutaneous coronary intervention ( PCI ) .


The INFUSE-AMI trial randomised @ patients with anterior STEMI to IL abciximab vs. no abciximab , and to manual TA vs. no TA .


The primary endpoint was cMRI-determined IS at @ days .


Patients were classified according to pre-stent TIMI flow .


Complete data were available in @ patients - @ ( @ % ) with pre-stent TIMI @/@ flow , @ ( @ % ) with TIMI @ flow and @ ( @ % ) with TIMI @ flow .


Patients with pre-stent TIMI @ flow had significantly lower IS ( @ % -LSB- @ , @ -RSB- vs. @ % -LSB- @ , @ -RSB- for TIMI @ vs. @ -LSB- @ , @ -RSB- for TIMI @/@ , p < @ ) and fewer @-day clinical events ( p = @ ) .


Patients receiving TA with or without IL abciximab had the highest rate of pre-stent TIMI @ flow ( p < @ ) and patients receiving both had the smallest IS ( @ % vs. @ % for the other three groups , p = @ ) .


Optimisation of coronary flow prior to stent implantation may reduce infarct size and clinical events in STEMI patients undergoing primary PCI .


Type @ diabetes mellitus ( T@DM ) is a metabolic disease with debilitating effects on multiple organs .


The alveolar-capillary network in the lung is a large microvascular unit which may be affected by T@DM-associated microangiopathy .


This retrospective study investigated whether type @ diabetes mellitus ( T@DM ) affected pulmonary function .


Of the @ patients enrolled in the study , @ had T@DM and @ did not .


Forced expiratory volume in one second ( FEV ) , forced vital capacity ( FVC ) , maximum voluntary ventilation ( MVV ) and total lung capacity ( TLC ) are values as percent of predicted , as well as FEV/FVC ratio which were values measured .


FEV , FVC , FEV/FVC ratio , MVV , and TLC were significantly lower in T@DM than in non-T@DM ( P-values < @ ) .


Multiple linear regression analysis found that for the entire study population fasting plasma glucose levels was negatively associated with FEV , FVC , FEV/FVC ratio and maximum voluntary ventilation ( P-values < @ ) .


Patients with T@DM were negatively associated with total lung capacity ( P-values = @ ) .


Multiple linear regression analysis found for patients with T@DM that fasting plasma glucose was negatively associated with FEV , FVC , FEV/FVC ratio and maximum voluntary ventilation ( P-values < @ ) .


In T@DM patient , height was negatively correlated with FEV and FVC ( all P-values < @ ) , triglycerides were negatively correlated with FEV/FVC ratio ( P-values = @ ) , and creatinine was negatively correlated with total lung capacity ( P-values = @ ) .


In summary , T@DM is associated with impaired pulmonary function consistent with obstructive ventilation pattern and fasting plasma glucose is an independent risk factor of reduced pulmonary function .


The long-term outcome between laparoscopic cholecystectomy ( LC ) and minilaparotomy cholecystectomy ( MC ) with ultrasonic dissection ( UsD ) technique has not been compared in randomized trials .


Therefore , we investigated the outcome after conventional LC and MC with UsD in @ patients ( ClinicalTrials.gov Identifier : NCT@ ) .


Initially @ patients with non-complicated symptomatic gallstone disease were randomized into MC ( n = @ ) or LC ( n = @ ) over a period of @ years ( @-@ ) and @ of them ( @ % ) were reached for a follow-up interview at @ months after the surgery .


Baseline parameters were similar in the two groups , and @/@ MCs and @/@ LCs were converted to open laparotomy .


The prevalence of chronic post-surgical pain ( CPSP ) one year after the procedure was quite similar in the two groups : @/@ ( @ % ) in the MC group and @/@ ( @ % ) in the LC group ( p = @ ) .


Residual abdominal symptoms were common , but the proportion was similar in both groups ( @ % in MC and @ % in LC group , p = @ ) .


Both groups were very satisfied with the cosmetic outcome ( numeric rating scale , p = @ ) .


The Quality of life ( QoL ) improved @/@ ( @ % ) in the MC group and @/@ ( @ % ) in the LC group ( p = @ ) and all patients in both groups were satisfied with the operation overall .


Day-case MC and LC patients have a quite similar one-year outcome with no significant difference regarding residual abdominal symptoms , cosmetic satisfaction , QoL or CPSP .


To describe the variation in household crowding and social mixing patterns in the African meningitis belt and to assess any association with self-reported recent respiratory symptoms .


In @ , the African Meningococcal Carriage Consortium ( MenAfriCar ) conducted cross-sectional surveys in urban and rural areas of seven countries .


The number of household members , rooms per household , attendance at social gatherings and meeting places were recorded .


Associations with self-reported recent respiratory symptoms were analysed by univariate and multivariate regression models .


The geometric mean people per room ranged from @ to @ between Ghana and Ethiopia respectively .


Attendance at different types of social gatherings was variable by country , ranging from @ to @ per week .


Those who attended @ or more different types of social gatherings a week ( frequent mixers ) were more likely to be older , male ( OR @ , p < @ ) and live in urban areas ( OR @ , p < @ ) .


Frequent mixing and young age , but not increased household crowding , were associated with higher odds of self-reported respiratory symptoms ( aOR @ , p < @ and OR @ , p < @ respectively ) .


A limitation is that we did not measure school and workplace attendance .


There are substantial variations in household crowding and social mixing patterns across the African meningitis belt .


This study finds a clear association between age , increased social mixing and respiratory symptoms .


It lays the foundation for designing and implementing more detailed studies of social contact patterns in this region .


It has been reported that even oneyear after total knee arthroplasty ( TKA ) , a relevant percentage of patients does not attain complete recovery and indicate unfavourable long-term pain outcome .


We compared the clinical outcome of @ patients undergoing TKA randomly assigned to the control or the pulsed electromagnetic field group ( I-ONE therapy ) .


I-ONE therapy was administered postoperatively four hours per day for @days .


Patients were assessed before surgery and then at one , two and sixmonths postoperatively using international scores .


One month after TKA , pain , knee swelling and functional score were significantly better in the treated compared with the control group .


Pain was still significantly lower in the treated group at the six month follow-up .


Three years after surgery , severe pain and occasional walking limitations were reported in a significantly lower number of patients in the treated group .


Advantages deriving from early control of joint inflammation may explain the maintenance of results at follow-up .


I-ONE therapy should be considered an effective completion of the TKA procedure .


The objective of this study was to compare the perfusion index ( PI ) variability in premature infants with respiratory distress syndrome ( RDS ) following administration of two different natural surfactant preparations .


This was a prospective study on @ preterm infants with RDS .


Patients were randomized into two groups .


Group @ ( n = @ ) received beractant ; Group @ ( n = @ ) received poractant alfa .


Oxygen saturation , PI , and heart rate were measured by Masimo Rainbow SET Radical-@ pulse oximeter ( Masimo Corp. , Irvine , CA ) before and after surfactant .


The effects of the two treatment regimens on PI and oxygenation were compared .


Repeated doses were more needed in beractant group ( p = @ ) .


Median oxygenation index ( OI ) before surfactant were similar , but improvement in OI was more prominent at @th hour of surfactant in Group @ ( p = @ ) .


Both groups had similar preductal PI values before surfactant .


PI was higher at @th hour of surfactant in Group @ ( p = @ ) .


Pulmonary hemorrhage , intraventricular hemorrhage , patent ductus arteriosus , necrotizing enterocolitis , and mortality were more frequent in infants whose PI values lower than @ within the first @ days of life ( p = @ ) .


Poractant alfa resulted in more prominent improvement in PI and OI .


Low PI values measured at early postnatal period may predict poor clinical outcome in preterm infants with RDS .


Atopic dermatitis ( atopic eczema ) is a chronic inflammatory skin disease that has reached epidemic proportions in children worldwide and is increasing in prevalence .


Because of the significant socioeconomic effect of atopic dermatitis and its effect on the quality of life of children and families , there have been decades of research focused on disease prevention , with limited success .


Recent advances in cutaneous biology suggest skin barrier defects might be key initiators of atopic dermatitis and possibly allergic sensitization .


Our objective was to test whether skin barrier enhancement from birth represents a feasible strategy for reducing the incidence of atopic dermatitis in high-risk neonates .


We performed a randomized controlled trial in the United States and United Kingdom of @ neonates at high risk for atopic dermatitis .


Parents in the intervention arm were instructed to apply full-body emollient therapy at least once per day starting within @ weeks of birth .


Parents in the control arm were asked to use no emollients .


The primary feasibility outcome was the percentage of families willing to be randomized .


The primary clinical outcome was the cumulative incidence of atopic dermatitis at @ months , as assessed by a trained investigator .


Forty-two percent of eligible families agreed to be randomized into the trial .


All participating families in the intervention arm found the intervention acceptable .


A statistically significant protective effect was found with the use of daily emollient on the cumulative incidence of atopic dermatitis with a relative risk reduction of @ % ( relative risk , @ ; @ % CI , @-@ @ ; P = @ ) .


There were no emollient-related adverse events and no differences in adverse events between groups .


The results of this trial demonstrate that emollient therapy from birth represents a feasible , safe , and effective approach for atopic dermatitis prevention .


If confirmed in larger trials , emollient therapy from birth would be a simple and low-cost intervention that could reduce the global burden of allergic diseases .


Fluralaner , a new molecular entity of the isoxazoline class , has potent insecticidal and acaricidal activity and can be safely administered orally to dogs .


A randomized , investigator-blinded , multi-centered field study compared the flea - and tick-control efficacy for dogs over a @-week period with either a single oral dose of Bravecto ( fluralaner ) formulated as a chewable tablet or with three sequential topical Frontline ( fipronil ) treatments .


Individual dogs were the experimental unit for ticks and households were the experimental unit for fleas .


A total of @ tick-infested dogs were treated with Bravecto ( fluralaner ) and @ tick-infested dogs were treated with Frontline ( fipronil ) .


Dogs in @ flea-infested households received Bravecto ( fluralaner ) and dogs in @ flea-infested households received Frontline ( fipronil ) .


Flea and tick counts were conducted on all dogs at weeks @ , @ , @ , and @ following initial treatment and efficacy was calculated as the mean percent reduction in tick or flea count at each time point compared with the mean pretreatment initiation count for each treatment group .


Additionally , the percentages of tick-free and flea-free households were determined .


At weeks @ , @ , @ , and @ , Bravecto ( fluralaner ) flea-control efficacy in treated households was @ % , @ % , @ % , and @ % respectively , while Frontline ( fipronil ) efficacy was @ % , @ % , @ % , and @ % , respectively .


Bravecto ( fluralaner ) tick-control efficacy on treated dogs at weeks @ , @ , @ , and @ was @ % , @ % , @ % , and @ % , respectively , and Frontline ( fipronil ) tick efficacy was @ % , @ % , @ % , and @ % , respectively .


Of dogs showing clinical flea allergy dermatitis ( FAD ) signs at the study start , @ % in the Bravecto ( fluralaner ) - treated group and @ % in the Frontline ( fipronil ) - treated group were evaluated at each time point as showing no clinical signs of FAD until study completion .


Bravecto ( fluralaner ) administered once orally to dogs in a chewable tablet was highly effective for @ weeks against fleas and ticks on privately-owned dogs and was significantly non-inferior ( ticks ) and superior ( fleas ) in comparison with topical Frontline ( fipronil ) administered @ times sequentially .


Cocaine has become one of the drugs of most concern in Switzerland , being associated with a wide range of medical , psychiatric and social problems .


Available treatment options for cocaine dependence are rare .


The study sought to compare combined prize-based contingency management ( prizeCM ) plus cognitive-behavioral therapy ( CBT ) to CBT alone in cocaine-dependent patients .


Sixty cocaine-dependent patients participated in a randomized , controlled trial with two treatment conditions .


The participants were randomly assigned to the experimental group ( EG ; n = @ ) , who received CBT combined with prizeCM , or to the control group ( CG ; n = @ ) , who received CBT only during @ weeks .


The primary outcome measures were retention , at least @ consecutive weeks of cocaine abstinence , the maximum number of consecutive weeks of abstinence and proportions of cocaine-free urine samples during the entire @-week and at @-month follow-up .


Sixty-three percent of the participants completed the study protocol .


Participants in both groups significantly reduced cocaine use over time .


Overall , no difference in cocaine-free urine screens was found across the two treatment groups , except at weeks @ , @ , @ , @ and @ in favor of the EG .


The addition of prizeCM to CBT seems to enhance treatment effects , especially in the early treatment period , supporting results from previous studies .


Both the combined intervention and CBT alone , led to significant reductions in cocaine use during treatment and these effects were sustained at @-month follow-up .


These findings underline the importance in implementing CM and CBT interventions as treatment options for cocaine dependence in the European context .


Integrated vector management strategies depend on local eco-bio-social conditions , community participation , political will and inter-sectorial partnership .


Previously identified risk factors for persistent Triatoma dimidiata infestation include the presence of rodents and chickens , tiled roofs , dirt floors , partial wall plastering and dog density .


A community-based intervention was developed and implemented based on cyclical stakeholder and situational analyses .


Intervention implementation and evaluation combined participatory action research and cluster randomized pre-test post-test experimental designs .


The intervention included modified insecticide application , education regarding Chagas disease and risk factors , and participatory rodent control .


At final evaluation there was no significant difference in post-test triatomine infestation between intervention and control , keeping pre-test rodent and triatomine infestations constant .


Knowledge levels regarding Chagas disease and prevention practices including rodent control , chicken management and health service access increased significantly only in intervention communities .


The odds of nymph infection and rat infestation were @ and @-fold higher in control compared to intervention communities , respectively .


Vector control measures without reservoir control are insufficient to reduce transmission risk in areas with persistent triatomine infestation .


This integrated vector management program can complement house improvement initiatives by prioritizing households with risk factors such as tiled roofs .


Requirement for active participation and multi-sectorial coordination poses implementation challenges .


To examine whether Modic changes influence pain during a @-year follow-up in patients with lumbar radicular pain .


A total of @ patients with lumbar radicular pain due to disc herniation were recruited from two hospitals in Norway and followed up at @ weeks , @ months , and @ months .


On baseline lumbar magnetic resonance images , two observers independently evaluated Modic changes ( types I-III ; craniocaudal size @-@ ) .


Outcomes were sensory pain ( McGill Pain Questionnaire ) , back and leg pain ( visual analogue scale , VAS ) .


Association between Modic type and outcomes was explored with a mixed model and then by two-way analysis of variance ( ANOVA ) at each time point with Modic and treatment groups ( surgical , n = @ ; nonsurgical , n = @ ) as fixed factors , adjusted for disc degeneration , age , sex , smoking , and duration of radicular pain .


Modic size was also analyzed using ANOVA .


Pain scores had decreased significantly at @-year follow-up .


Modic type was significantly related to McGill sensory scores ( mixed model : p = @-@ @ ; ANOVA : p = @ at @ weeks ) , but not to VAS back pain or VAS leg pain scores .


At @ weeks , the mean McGill sensory score was higher in Modic I than in Modic II-III patients ( p = @ ) and in patients without Modic changes ( p = @ ) .


Modic size L@-S@ was not associated with pain outcomes .


Patients with lumbar radicular pain have a substantial pain reduction during @-year follow-up , but Modic type I changes may imply a slower initial decrease in sensory pain .


This cross-sectional study tested the hypothesis that treatment with the combination of Ezetimibe/Simvastatin ( Vytorin ) leads to broader changes in the expression levels of immunomodulatory genes as compared to Simvastatin monotherapy .


Illumina 's GenomeStudio gene expression module was used to compare gene profiles of Vytorin and Simvastatin in the peripheral blood mononuclear cells of @ hypercholesterolemic subjects .


The characteristics of the immunomodulatory genes , which were altered by Vytorin , differed from those genes which were altered by Simvastatin .


Vytorin mostly altered the expression levels of genes related to inflammation/oxidative stress ; it downregulated the NF-KappaB and upregulated the expression of anti-inflammatory cytokine , IL-@ , and anti-oxidant enzymes , GPX@ and SOD@ , but also upregulated the expression levels of genes involved in cellular activation , adhesion , and coagulation cascade , including VWF , F@ , PF@ , PF@V@ SELP , ITGB@ , ITGB@ .


Simvastatin mostly altered the expression levels of genes related to cellular apoptosis/proliferation .


It upregulated the expression levels of apoptosis-related genes APAF@ , BAX , IER@ , and CSF@R , and downregulated the expression levels of genes related to cellular proliferation , including PTN and CD@ .


Treatment with Vytorin combination therapy modulated lipid profile and serum levels of the C-reactive protein more effectively , than treatment with Simvastatin monotherapy .


The nature of the pleiotropic effects may play a role in Vytorin 's and Simvastatin 's clinical efficacies .


The presence of hyponatremia has been perceived to increase the risk of adverse events on initiation of treatment with angiotensin-converting enzyme inhibition in heart failure patients .


The aim of this study was to investigate if baseline hyponatremia ( plasma Na ( + ) < @mmol/L ) predicts development of hypotension and renal impairment in patients with myocardial infarction ( MI ) and left ventricular dysfunction ( LVD ) treated with angiotensin-converting enzyme inhibitors .


A retrospective analysis was performed with data from the Trandolapril Cardiac Evaluation ( TRACE ) a double-blind randomized study .


Plasma sodium levels were available in @,@ patients , who were considered as the study population .


Patients @-@days after MI with left LVD ( LVEF @ ) , were randomized to trandolapril ( n = @ ) or placebo ( n = @ ) .


Baseline hyponatremia did not predict development of hypotension or worsening renal function after @month in patients treated with trandolapril compared with placebo ( @ mm Hg vs @ mm Hg -LSB- P = @ -RSB- ; and creatinine clearance @ mL/min vs @ mL/min -LSB- P = @ -RSB- ) .


There was no interaction between hyponatremia and the effect of trandolapril ( P = @ ) .


Mild hyponatremia was not a contraindication for the initiation of treatment with angiotensin-converting enzyme inhibitors in patients with post-MI heart failure .


Psoriasis is a chronic inflammatory dermatosis leading to the development of systemic inflammatory reaction .


Previous data indicated the coexistence of psoriasis and the occurrence of metabolic disorders , with the common background of both processes determined by a chronic inflammation .


The coexisting disorders , including type @ diabetes , hypertension , heart ischemic disease , dislipidemia and obesity may have an important impact on intensity of psoriasis activity .


The analysis comprised of @ randomly matched patients with various clinical forms of psoriasis , aged @ to @ years .


In patients PASI and BSA indexes , BMI value and laboratory parameters of metabolic status ( glucose and ureic acid levels , lipid fractions and CRP level in the serum ) were evaluated .


An average age in examined group was @,@ years , an average time of presence of psoriasis symptoms was approximately @ years .


An average PASI value was @,@ ; an average BSA value was @ % .


The coexistence of type @ diabetes was found in @ % of patients , hypertension in @ % and heart ischemic disease in @ % .


Particularly large group of examined patients comprised persons with overweight ( @ % ) and obesity ( @ % ) .


Positive correlation between BSA and body weight , BSA and BMI value , BSA and abdominal circumference as well as positive correlation between PASI and body weight , PASI and BMI value , PASI and abdominal circumference were observed .


Abnormal serum glucose levels were observed in @ % persons , ureic acid level in @ % , total cholesterol in @ % LDL cholesterol in @ % , and HDL cholesterol in @ % .


CRP level was elevated in @ % patients .


Positive correlation between BSA and ureic acid level , as well as PASI and ureic acid level was estimated .


No correlation between PASI and the other laboratory parameters was found .


The occurrence of metabolic syndrome is more common in patients with psoriasis in comparison to the general population .


The extent and severity of psoriatic lesions correlate with high body weight , BMI and the level of ureic acid .


Although exhaled breath condensate ( EBC ) pH has been identified as an `` emerging '' biomarker of interest for asthma clinical trials , the clinical determinants of EBC pH remain poorly understood .


Other studies have associated acid reflux-induced respiratory symptoms , for example , cough , with transient acidification of EBC .


We sought to determine the clinical and physiologic correlates of EBC acidification in a highly characterized sample of children with poorly controlled asthma .


We hypothesized that ( @ ) children with asymptomatic gastroesophageal reflux determined by @-hour esophageal pH monitoring would have a lower EBC pH than children without gastroesophageal reflux , ( @ ) treatment with lansoprazole would alter EBC pH in those children , and ( @ ) EBC acidification would be associated with increased asthma symptoms , poorer asthma control and quality of life , and increased formation of breath nitrogen oxides ( NOx ) .


A total of @ children , age range @ to @ years , with poor asthma control and esophageal pH data enrolled in the Study of Acid Reflux in Children with Asthma ( NCT@ ) were included .


Children submitted EBC samples for pH and NOx measurement at randomization and at study weeks @ , @ , and @ .


Serial EBC pH measurements failed to distinguish asymptomatic gastroesophageal reflux and was not associated with breath NOx formation .


EBC pH also did not discriminate asthma characteristics such as medication and health care utilization , pulmonary function , and asthma control and quality of life both at baseline and across the study period .


Despite the relative ease of EBC collection , EBC pH as a biomarker does not provide useful information of children with asthma who were enrolled in asthma clinical trials .


No therapy directed against diabetes has been shown to unequivocally reduce the excess risk of cardiovascular complications .


Aleglitazar is a dual agonist of peroxisome proliferator-activated receptors with insulin-sensitizing and glucose-lowering actions and favorable effects on lipid profiles .


To determine whether the addition of aleglitazar to standard medical therapy reduces cardiovascular morbidity and mortality among patients with type @ diabetes mellitus and a recent acute coronary syndrome ( ACS ) .


AleCardio was a phase @ , multicenter , randomized , double-blind , placebo-controlled trial conducted in @ hospitals in @ countries throughout North America , Latin America , Europe , and Asia-Pacific regions .


The enrollment of @ patients hospitalized for ACS ( myocardial infarction or unstable angina ) with type @ diabetes occurred between February @ and May @ ; treatment was planned to continue until patients were followed-up for at least @ years and @ primary end point events were positively adjudicated .


Randomized in a @:@ ratio to receive aleglitazar @ g or placebo daily .


The primary efficacy end point was time to cardiovascular death , nonfatal myocardial infarction , or nonfatal stroke .


Principal safety end points were hospitalization due to heart failure and changes in renal function .


The trial was terminated on July @ , @ , after a median follow-up of @ weeks , upon recommendation of the data and safety monitoring board due to futility for efficacy at an unplanned interim analysis and increased rates of safety end points .


A total of @ % of patients were lost to follow-up and @ % of patients withdrew consent .


The primary end point occurred in @ patients ( @ % ) in the aleglitazar group and @ patients ( @ % ) in the placebo group ( hazard ratio , @ -LSB- @ % CI , @-@ @ -RSB- ; P = @ ) .


Rates of serious adverse events , including heart failure ( @ % for aleglitazar vs @ % for placebo , P = @ ) , gastrointestinal hemorrhages ( @ % for aleglitazar vs @ % for placebo , P = @ ) , and renal dysfunction ( @ % for aleglitazar vs @ % for placebo , P < @ ) were increased .


Among patients with type @ diabetes and recent ACS , use of aleglitazar did not reduce the risk of cardiovascular outcomes .


These findings do not support the use of aleglitazar in this setting with a goal of reducing cardiovascular risk .


Pressure ulcers ( PrUs ) are ischemic wounds in the skin and underlying tissues caused by long-standing pressure force over an external bone or cartilaginous surface .


PrUs are an important challenge for the overall health system because can prolong patient hospitalization and reduce quality of life .


Moreover , @ % of PrUs are avoidable , suggesting they are caused by poor quality care assistance .


PrUs are also costly , increasing national costs .


For example , they represent about @ % of overall annual health expenses in Spain .


Stages I and II PrUs have a combined prevalence of @ % .


According main clinical guidelines , stage II PrUs ( PrU-IIs ) are usually treated by applying special dressings ( polyurethane or hydrocolloid ) .


However , little scientific evidence regarding their efficacy has been identified in scientific literature .


Our aim is to assess the comparative efficacy of adhesive polyurethane foam and hydrocolloid dressings in the treatment of PrU-IIs in terms of healed ulcer after @ weeks of follow-up .


This paper describes the development and evaluation protocol of a randomized clinical trial of two parallel treatment arms .


A total of @ patients with at least @ PrU-II will be recruited from primary health care and home care centers .


All patients will receive standardized healing procedures and preventive measures ( e.g. positional changes and pressure-relieving support surfaces ) , following standardized procedures .


The main outcome will be the percentage of wounds healed after @ weeks .


Secondary outcomes will include cost-effectiveness , as evaluated by cost per healed ulcer and cost per treated patient and safety evaluated by adverse events .


This trial will address the hypothesis that hydrocolloid dressings will heal at least @ % more stage II PrUs and be more cost-effective than polyurethane foam dressings after @ weeks .


Despite the widespread use of external ventricular drainage , revision rates , and associated complications are reported between @ and @ % .


Current available image-guided techniques using stereotaxy , endoscopy , or ultrasound for catheter placements remain time-consuming techniques .


Recently , a smartphone-assisted guide with high precision has been described .


The development of an easy-to-use , portable , image-guided system could reduce the need for multiple passes and improve the rate of accurate catheter placement .


This study aims to prospectively compare in a randomized controlled manner the accuracy of the freehand pass technique versus an easy-to-use , portable , adjustable guiding device for ventriculostomy catheter placement .


This is a single center , prospective , randomized trial with a blinded endpoint ( ventricular catheter tip location ) assessment .


Adult patients with the indication for ventriculostomy , as proven by computed tomography ( CT ) , will be randomly assigned to the treatment group or the control group .


For patients in the treatment group , ventriculostomy will be performed using an adjustable guiding device and DICOM ( Digital Imaging and Communications in Medicine ) image-reading software assistance ( for example , using a mini-tablet ) based on preoperative CT imaging.Patients in the control group will receive standard freehand ventriculostomy using anatomical landmarks .


The catheter may be placed for external drainage or internal ( ventriculoperitoneal ) shunting in both groups .


The primary outcome measure is the rate of correct placements of the ventricular catheter , defined as a score of @ to @ on grading system for catheter tip location on a postoperative CT scan .


Participants will be followed for the duration of hospital stay , an expected average of two weeks .


The primary outcome will be determined by one of the authors blinded to the treatment allocation .


We aim to include @ patients in three years .


Secondary outcome measures include : frequency of placements required , frequency of completed placements within the ventricle of the perforated part of the catheter tip , frequency of very early and early shunt failures ( revision of the ventricular drainage within @ hours and within the hospital stay ) , frequency and percentage of complications ( procedure-related and nonsurgical ) at discharge .


This is the study design of a single center , prospective , randomized controlled trial to investigate whether guided ventriculostomy is superior to the standard freehand technique .


One strength of this study is the prospective , randomized , interventional type of study testing a new easy-to-handle guided versus freehand ventricular catheter placement .


A second strength of this study is that the power calculation is based on catheter accuracy using an available grading system for catheter tip location , and is calculated with the use of recent study results of our own population , supported by data from prominent studies .


To compare visual acuity with two visual acuity charts in preschool children .


Visual acuity measurement with Lea symbols and Bailey-Lovie tumbling E chart was performed on children between @ and @ years of age .


Visual acuity data from the two charts were analyzed with Bland-Altman plot to determine the limits of agreement .


The Wilcoxon signed test was performed in children aged @-@ years and in children aged @-@ years separately to evaluate the influence of age .


The inter-eye difference between the two charts were further analyzed with the paired t-test .


A p value > @ was considered statistically significant .


A total of @ children were enrolled for the study .


The average logarithm of the Minimum Angle of Resolution ( LogMAR ) monocular visual acuity with Lea symbols ( @ @ ) was better than the Bailey-Lovie tumbling E chart ( @ @ ) .


The mean difference between Bailey-Lovie tumbling E chart and Lea symbol chart was @ @ in logMAR units .


A second analysis eliminating outliers showed the same result but lower differences ( n = @ , @ @ logMAR units ) .


Visual acuity results between the two charts in children aged @-@ years showed a significant difference ( p = @ ) , but not for children aged @-@ years ( p = @ ) .


Inter-eye differences between the two charts was not statistically significant ( p = @ ) .


Bailey-Lovie tumbling E chart is comparable to the Lea symbols chart in pre-school children .


But preference should be given to Lea symbols for children aged @-@ years as the symbols are more familiar than a directional test for this age group .


Local analgesic injections are commonly used for pain relief after shoulder surgery .


The aim of this study was to compare the efficacy of local injections administered in the glenohumeral joint , the subacromial space , or both locations after arthroscopic rotator cuff repair .


Between March @ and December @ , @ consecutive patients who had undergone arthroscopic rotator cuff repair surgery were enrolled in the study and all patients were randomly allocated to @ groups .


In group @ , @ patients received a postoperative glenohumeral injection of bupivacaine ( @mL ) and lidocaine ( @mL ) .


In group @ , @ patients received the same postoperative injection , but it was administered in the subacromial space .


In group @ , @ patients received the same amount of local anesthesia but with half injected in the glenohumeral joint and half in the subacromial space .


The visual analog scale was used to assess pain intensity before surgery and at postoperative hours @ , @ , @ , @ , and @ .


Demerol was used as a postinjection rescue analgesic , and the total number of administrations was recorded at each time point .


There were no significant differences between groups in patient age , sex , or rotator cuff tear size ( P > @ ) .


The visual analog scale scores for pain between each group were not significantly different at any time point , including before surgery ( P > @ ) .


In addition , the amount of supplementary analgesic administered was not significantly different between the groups ( P > @ ) .


Injection of local analgesics after arthroscopic rotator cuff repair relieves postoperative pain regardless of the injection location .


To assess the efficacy and safety of early , noninvasive inhaled nitric oxide ( iNO ) therapy in premature newborns who do not require mechanical ventilation .


We performed a multicenter randomized trial including @ premature newborns who required noninvasive supplemental oxygen within the first @ hours after birth .


Newborns were stratified into @ different groups by birth weight ( @-@ , @-@ , @-@ g ) prior to randomization to iNO ( @ ppm ) or placebo gas ( controls ) until @ weeks postmenstrual age .


The primary outcome was a composite of death or bronchopulmonary dysplasia ( BPD ) at @ weeks postmenstrual age .


Secondary outcomes included the need for and duration of mechanical ventilation , severity of BPD , and safety outcomes .


There was no difference in the incidence of death or BPD in the iNO and placebo groups ( @ % vs @ % , P = @ , relative risk = @ , @-@ @ ) .


BPD severity was not different between the treatment groups .


There were no differences between the groups in the need for mechanical ventilation ( @ % vs @ % ; P = @ ) , duration of mechanical ventilation ( @ vs @ days ; P = @ ) , or safety outcomes including severe intracranial hemorrhage ( @ % vs @ % , P = @ ) .


We found that iNO delivered noninvasively to premature infants who have not progressed to early respiratory failure is a safe treatment , but does not decrease the incidence or severity of BPD , reduce the need for mechanical ventilation , or alter the clinical course .


Foods that are high in dietary fiber can promote satiety , but previous studies report conflicting results .


The objective was to determine differences in satiety response to three conditions ( @g oat bran , @g barley bran and a low fiber condition ) consumed at dinner and breakfast .


In addition , we compared energy intake at an ad libitum lunch after consumption of the breakfast bars .


Randomized , double-blind crossover study .


@ normal weight women .


Women consumed a dinner food bar from one of the three conditions the evening before testing .


On test mornings , fasted women consumed the corresponding breakfast food bar with their choice of coffee , tea or water .


An ad libitum pizza lunch was served @ hours after breakfast .


Visual analogue scales ( VAS ) were used to assess satiety at baseline , @ , @ , @ , @ , @ , @ , @ and @ minutes .


Energy intake was assessed by an ad libitum pizza lunch ( @ hours after breakfast ) and @-hour energy intake was measured by a food diary .


Treatments were compared using the mixed-effects linear models .


Outcomes are reported as mean SEM .


There were no significant differences among conditions on any of the satiety scales and no significant differences among conditions in energy consumed at lunch or over @ hours .


The fiber bars were well tolerated and no significant differences were found for gastrointestinal tolerance .


Our results do not support an effect of bran fibers on satiety above a low fiber control .


We acknowledge results of this study may be intricately tied to the choice of a single pizza lunch , as other ad libitum meal options could have resulted in different outcomes .


The -@ receptor ( Sig-@R ) agonist cutamesine ( SA@ ) enhanced functional recovery after experimental stroke with a treatment initiation window of @ hours and chronic treatment for @ days .


We conducted a phase @ clinical trial exploring the safety , tolerability , dose range , and functional effects of cutamesine in patients with ischemic stroke .


Subjects were randomized between @ and @ hours after stroke to receive cutamesine @ mg/d , @ mg/d , or placebo for @ days .


Effects on safety and function were assessed at baseline , at end of treatment ( day @ ) , and at end of follow-up ( day @ ) .


In @ patients , treatment with both cutamesine dosages was safe and well tolerated without significant differences in numbers of treatment emergent or serious adverse events .


No significant effect was observed on the primary efficacy measure ( change in National Institutes of Health Stroke Scale from baseline to day @ ) or modified Rankin Scale and Barthel Index scores .


Post hoc analysis of moderately and severely affected patients ( baseline National Institutes of Health Stroke Scale , @ and @ ) showed greater National Institutes of Health Stroke Scale improvements in the @ mg/d cutamesine group when compared with placebo ( P = @ and P = @ , respectively ) .


A trend toward a higher proportion being able to complete a @m timed walk was observed for cutamesine-treated subjects .


Cutamesine was safe and well tolerated at both dosage levels .


Although no significant effects on functional end points were seen in the population as a whole , greater improvement in National Institutes of Health Stroke Scale scores among patients with greater pretreatment deficits seen in post hoc analysis warrants further investigation .


Additional studies should focus on the patient population with moderate-to-severe stroke .


Frailty is a major concern due to its costly and widespread consequences , yet evidence of effective interventions to delay or reduce frailty is lacking .


Our previous study found that a multifactorial intervention was feasible and effective in reducing frailty in older people who were already frail .


Identifying and treating people in the pre-frail state may be an effective means to prevent or delay frailty .


This study describes a randomised controlled trial that aims to evaluate the effectiveness of a multifactorial intervention on development of frailty in older people who are pre-frail .


A single centre randomised controlled trial with concealed allocation , assessor blinding and intention-to-treat analysis .


Two hundred and thirty people aged above @ who meet the Cardiovascular Health Study frailty criteria for pre-frailty , reside in the community and are without severe cognitive impairment will be recruited .


Participants will be randomised to receive a multifactorial intervention or usual care .


The intervention group will receive a @-month interdisciplinary intervention targeting identified characteristics of frailty and problems identified during geriatric assessment .


Participants will be followed for a @-month period .


Primary outcome measures will be degree of frailty measured by the number of Cardiovascular Health Study frailty criteria present , and mobility measured with the Short Physical Performance Battery .


Secondary outcomes will include measures of mobility , mood and use of health and community services .


To assess the effect of aerobic exercise training on maternal and neonatal outcome


The case-control study was conducted between January and July , @ .


It was approved by the Research Ethics Committee of Toyserkan Azad University , and data was collected at prenatal clinics and delivery centres located in Hamedan , Iran .


It comprised @ pregnant women between @-@ weeks of gestation randomly assigned to two equal and matching groups of cases and controls .


The intervention group did exercise continuously on a bicycle ergometre for @ minutes , three times a week ; the intensity being @-@ % of maximal heart rate .


The control group did not do any exercise training .


All information was obtained from the clinics , delivery centres , and from the reports of delivery room midwives .


No statistically significant difference was found between the two groups in gestational weight gain , pregnancy length , mode of delivery , first and second stage of labour , perineal tear , and @st and @th min Apgar score .


Mean neonatal weight was significantly less in the intervention group than the control group ( p < @ ) .


Exercising on a bicycle ergometer during pregnancy seems to be safe for the mother and the neonate .


To determine patient independency , health-related and disease-specific quality of life ( QOL ) , gait pattern , and muscle strength in patients after salvage arthroplasty for failed internal fixation of a femoral neck fracture .


Secondary cohort study to a randomized controlled trial .


Multicenter trial in the Netherlands , including @ academic and nonacademic hospitals .


Patients after salvage arthroplasty for failed internal fixation of a femoral neck fracture were studied .


A comparison was made with patients who healed uneventfully after internal fixation .


None ( observatory study ) .


Patient characteristics , SF-@ , and Western Ontario McMaster osteoarthritis index scores were collected .


Gait parameters were measured using plantar pressure measurement .


Maximum isometric forces of the hip muscles were measured using a handheld dynamometer .


Differences between the fractured and contralateral leg were calculated .


Groups were compared using univariate analysis .


Of @ internal fixation patients ( median age , @ years ) , salvage arthroplasty was performed in @ patients ( @ % ) .


Salvage arthroplasty patients had a significantly lower Western Ontario McMaster osteoarthritis index score ( median , @ vs. @ ; P = @ ) than patients who healed uneventfully after internal fixation .


Health-related QOL ( SF-@ ) and patient independency did not differ significantly between the groups .


Gait analysis showed a significantly impaired progression of the center of pressure in the salvage surgery patients ( median ratio , -@ vs. @ , P = @ ) and a significant greater loss of abduction strength ( median , -@ vs. -@ N , P = @ ) .


Despite a similar level of dependency and QOL , salvage arthroplasty patients have inferior functional outcome than patients who heal after internal fixation of a femoral neck fracture .


Therapeutic level III .


Among patients with acute ischemic stroke due to occlusions in the proximal anterior intracranial circulation , less than @ % regain functional independence when treated with intravenous tissue plasminogen activator ( t-PA ) alone .


Thrombectomy with the use of a stent retriever , in addition to intravenous t-PA , increases reperfusion rates and may improve long-term functional outcome .


We randomly assigned eligible patients with stroke who were receiving or had received intravenous t-PA to continue with t-PA alone ( control group ) or to undergo endovascular thrombectomy with the use of a stent retriever within @ hours after symptom onset ( intervention group ) .


Patients had confirmed occlusions in the proximal anterior intracranial circulation and an absence of large ischemic-core lesions .


The primary outcome was the severity of global disability at @ days , as assessed by means of the modified Rankin scale ( with scores ranging from @ -LSB- no symptoms -RSB- to @ -LSB- death -RSB- ) .


The study was stopped early because of efficacy .


At @ centers , @ patients underwent randomization ( @ patients in each group ) .


In the intervention group , the median time from qualifying imaging to groin puncture was @ minutes , and the rate of substantial reperfusion at the end of the procedure was @ % .


Thrombectomy with the stent retriever plus intravenous t-PA reduced disability at @ days over the entire range of scores on the modified Rankin scale ( P < @ ) .


The rate of functional independence ( modified Rankin scale score , @ to @ ) was higher in the intervention group than in the control group ( @ % vs. @ % , P < @ ) .


There were no significant between-group differences in @-day mortality ( @ % vs. @ % , P = @ ) or symptomatic intracranial hemorrhage ( @ % vs. @ % , P = @ ) .


In patients receiving intravenous t-PA for acute ischemic stroke due to occlusions in the proximal anterior intracranial circulation , thrombectomy with a stent retriever within @ hours after onset improved functional outcomes at @ days .


( Funded by Covidien ; SWIFT PRIME ClinicalTrials.gov number , NCT@ . )


Medication nonadherence is a common problem , resulting in significant human and economic cost , which can be a challenge to identify and resolve in practice .


Adherence tools have been developed to assist health care providers with managing medication nonadherence ; however , there is a need to develop a literature base for using adherence tools effectively .


To ( a ) describe the experiences and perspectives of pharmacists and student pharmacists using the Adherence Estimator ( AE ) and Drug Adherence Work-up ( DRAW ) tools and ( b ) describe medication nonadherence issues identified via use of the AE and DRAW tools in community pharmacies and outpatient clinics .


A practice-based study involving @ primary care clinics and @ community pharmacies in Iowa and Michigan was conducted .


Each adherence tool was administered approximately @ times by pharmacists or student pharmacists to patients at each site , using a crossover design with randomization to the initial tool .


Sites determined how to incorporate tools into workflow and how to select patients .


Data from completed tools were analyzed descriptively .


Data from an online survey completed by tool administrators about their experiences and suggestions were analyzed thematically .


Sites submitted @ AE and @ DRAW tools .


Half of patients with a completed AE had at least @ medication of medium or high risk of nonadherence , and @ % had at least @ medication of high risk .


For DRAW , @ % of patients reported at least @ yes answer for reasons for nonadherence , and @ % reported @ .


On average , the AE tool took @ minutes , and the DRAW tool took @ minutes .


Forty-four surveys were submitted ( @ community and @ clinic ) .


Two themes emerged from the open-ended responses : tool benefits and translating tools into practice .


While the tools were useful for identifying specific reasons for nonadherence and promoting dialogue , they required additional time and effort from both patients and pharmacists .


Health literacy , patient reluctance to discuss nonadherence , AE scaling , and DRAW length were voiced as concerns .


Both tools were useful for uncovering specific reasons for medication nonadherence in @-@ minute encounters , but barriers exist to incorporating such tools into busy workflows .


Prior telemonitoring trials of blood pressure and blood glucose have shown improvements in blood pressure and glycemic targets .


However , implementation of telemonitoring in primary care practices may not yield the same results as research trials with extra resources and rigid protocols .


In this study we examined the process of implementing home telemonitoring of blood glucose and blood pressure for patients with diabetes in six primary care practices .


Grounded theory qualitative analysis was conducted in parallel with a randomized controlled effectiveness trial of home telemonitoring .


Data included semistructured interviews with @ nurse care coordinators and @ physicians in six participating practices and field notes from exit interviews with @ of @ randomized patients .


The three stakeholder groups ( patients , nurse care coordinators , and physicians ) exhibited some shared themes and some unique to the particular stakeholder group .


Major themes were that practices should ( @ ) understand the capabilities and limitations of the technology and the willingness of patient and physician stakeholders to use it , ( @ ) understand the workflow , flow of information , and human factors needed to optimize use of the technology , ( @ ) engage and prepare the physicians , and ( @ ) involve the patient in the process .


Although there was enthusiasm for a patient-centered medical home model that included between-visit telemonitoring , there was concern about the support and resources needed to provide this service to patients .


As with many technology interventions , careful consideration of workflow and information flow will help enable effective implementations .


Because smoking has a profound impact on socioeconomic disparities in illness and death , it is crucial that vulnerable populations of smokers be targeted with treatment .


The U.S. Public Health Service recommends that all patients be asked about their smoking at every visit and that smokers be given brief advice to quit and referred to treatment .


Initiatives to facilitate these practices include the @A 's ( ask , advise , assess , assist , arrange ) and Ask-Advise-Refer ( AAR ) .


Unfortunately , primary care referrals are low , and most smokers referred fail to enroll .


This study evaluated the efficacy of the Ask-Advise-Connect ( AAC ) approach to linking smokers with treatment in a large , safety net public healthcare system .


The study design was a pair-matched group-randomized trial with two treatment arms .


Ten safety net clinics in Houston TX .


Clinics were randomized to AAC ( n = @ ; intervention ) or AAR ( n = @ ; control ) .


Licensed vocational nurses ( LVNs ) were trained to assess and record the smoking status of all patients at all visits in the electronic health record .


Smokers were given brief advice to quit .


In AAC , the names and phone numbers of smokers who agreed to be connected were sent electronically to the Texas quitline daily , and patients were proactively called by the quitline within @ hours .


In AAR , smokers were offered a quitline referral card and encouraged to call on their own .


Data were collected between June @ and March @ and analyzed in @ .


The primary outcome was impact , defined here as the proportion of identified smokers that enrolled in treatment .


The impact ( proportion of identified smokers who enrolled in treatment ) of AAC ( @ % ) was significantly greater than the impact of AAR ( @ % ) , t ( @ ) = @ , p = @ , OR = @ ( @ % CI = @ , @ ) .


The AAC approach to aiding smoking cessation has tremendous potential to reduce tobacco-related health disparities .


Nanosomal docetaxel lipid suspension formulation was developed to eliminate ethanol and polysorbate @ from the currently used docetaxel ( Taxotere ) drug for treatment of cancer patients .


NDLS clinical safety and efficacy was evaluated and compared with Taxotere at @ mg/m ( @ ) in metastatic breast cancer patients .


A total of @ patients were randomized in a ratio of @:@ ( NDLS : Taxotere ) .


Patients treated with NDLS were not premedicated with corticosteroids as required with solvent-based Taxotere .


Disease status and tumor response was assessed after every @ cycles of treatment using Response Evaluation Criteria in Solid Tumors @ guidelines through cycle@ .


Overall therapeutic response ( complete + partial ) rate in metastatic breast cancer patients treated with NDLS and Taxotere were @ % and @ % , respectively , indicating better response in patients treated with NDLS .


Patients in the NDLS group were not premedicated but the safety results of NDLS were found to be comparable with Taxotere .


NDLS formulation with no premedication provides an alternative treatment option for breast cancer patients .


Social anxiety disorder ( SAD ) impacts social , occupational and academic functioning .


Although many interventions report change in social distress , improvement in social behavior remains under-addressed .


This investigation examined the additive impact of social skills training ( SST ) for the treatment of SAD .


Using a sample of @ adults who endorsed SAD across numerous social settings , participants were randomized to exposure therapy ( imaginal and in vivo ) alone , a combination of SST and exposure therapy known as Social Effectiveness Therapy ( SET ) , or a wait list control .


The assessment strategy included self-report measures , blinded clinical ratings and blinded assessment of social behavior .


Both interventions significantly reduced distress in comparison to the wait list control and at post-treatment , @ % of patients treated with SET and @ % of patients treated with exposure therapy alone no longer met diagnostic criteria for SAD , a difference that was not statistically significant .


When compared to exposure therapy alone , SET produced superior outcomes ( p < @ ) on measures of social skill and general clinical status .


In addition to statistical significance , participants treated with SET or exposure reported clinically significant decreases on two measures of self-reported social anxiety and several measures of observed social behavior ( all ps < @ ) .


Both interventions produced efficacious treatment outcome , although SET may provide additional benefit on measures of social distress and social behavior .


To determine the impact of losing health insurance coverage on perceived need for and access to mental health care in women screened for postpartum depression ( PPD ) in primary care settings .


The study sample included @ women enrolled in a @-month , multisite , randomized trial that compared clinical outcomes of a comprehensive PPD screening and management program with usual care ( March @ , @ , through August @ , @ ) .


Screening for PPD occurred at the first postpartum visit ( @-@ weeks ) using the Edinburgh Postnatal Depression Scale followed by the @-item Patient Health Questionnaire .


Insurance status during the prenatal period , at delivery , and during the first postpartum year and perceived need for and access to mental health care during the first postpartum year were assessed via questionnaires completed by individual patients and participating practices .


Rates of uninsured increased from @ % during pregnancy and delivery ( n = @ of @ ) to @ % at the first postpartum visit ( n = @ of @ ) and @ % at any subsequent visit to the practice after @ months post partum ( n = @ of @ ) ( P < @ , both comparisons vs baseline ) .


For patients with data on insurance type during follow-up , insurance loss occurred primarily in Medicaid beneficiaries .


Nine-item Patient Health Questionnaire scores and self-reported need for mental health care did not differ significantly between patients who remained insured and those who lost insurance during the first postpartum year .


However , of patients who reported the need for mental health care , @ % of the uninsured ( n = @ of @ ) vs @ % of the insured ( n = @ of @ ) reported an inability to obtain mental health care ( P < @ ) .


Loss of insurance during the first postpartum year did not significantly affect depressive symptoms or perceived need for mental health care but did adversely affect self-reported ability to obtain mental health care .


In most treated patients with hypertension , a two or more drug combination is required to achieve adequate blood pressure ( BP ) control .


In our study we assessed whether the combination of zofenopril + hydrochlorothiazide ( HCTZ ) was at least as effective as irbesartan + HCTZ in essential hypertensives with at least one additional cardiovascular risk factor , uncontrolled by a previous monotherapy .


After a @-week placebo washout , @ treated hypertensive patients -LSB- office sitting diastolic BP ( DBP ) , @mmHg -RSB- , aged @-@years , were randomized double blind to @-week treatment with zofenopril @mg plus HCTZ @ mg or irbesartan @mg plus HCTZ @ mg once daily , in an international , multicenter study .


After the first @ and @weeks , zofenopril and irbesartan doses could be doubled in non-normalized subjects .


The primary study end point was the office sitting DBP reduction after @weeks of treatment .


Secondary end points included office systolic BP ( SBP ) , ambulatory BP and high sensitivity C-reactive protein ( hs-CRP ) .


The between-treatment difference for office DBP averaged to +@ ( @ % CI -@ , +@ ) mmHg ( P = @ ) , the upper limit of the @ % confidence interval being inferior to the protocol-defined non-inferiority limit ( @mmHg ) .


In the subset of patients with valid ambulatory BP , no difference in @-h average DBP -LSB- n = @ ; @ ( @ , @ ) zofenopril + HCTZ vs. @ ( @ , @ ) mmHg irbesartan + HCTZ , P = @ -RSB- and SBP reductions -LSB- @ ( @ , @ ) vs. @ ( @ , @ ) mmHg , P = @ -RSB- were observed between the two treatment groups .


hs-CRP was reduced by zofenopril + HCTZ -LSB- -@ ( -@ , @ ) mg/L -RSB- , while it was increased by irbesartan plus HCTZ -LSB- @ ( @ , @ ) mg/L , P = @ between treatments -RSB- .


In previously monotherapy-treated , uncontrolled patients with hypertension , zofenopril @-@mg + HCTZ @ mg is as effective as irbesartan @-@mg plus HCTZ @ mg , with the added value of a potential protective effect against vascular inflammation .


Antithrombotic drugs , such as low-dose aspirin ( LDA ) and clopidogrel , can cause upper gastrointestinal complications .


The goal of the present study was to investigate whether a mucosal-protective agent , rebamipide , could prevent gastric mucosal injuries induced by LDA with or without clopidogrel in healthy subjects .


A randomized , double-blind , placebo-controlled trial was performed with @ healthy male volunteers .


Subjects were randomly assigned to a @-day course of one of the following regimens : group A , placebo ( tid ) + LDA ; group B , rebamipide ( @ mg tid ) + LDA ( @ mg once-daily ) ; group C , placebo + LDA + clopidogrel ( @ mg once-daily ) ; or group D , rebamipide + LDA + clopidogrel .


The grade of gastric mucosal injuries was evaluated by esophagogastroduodenoscopy before and after dosing ( on day @ and day @ ) , and the grade of gastric mucosal injury was assessed according to the modified Lanza score .


Subjective symptoms were assessed using the Gastrointestinal Symptom Rating Scale ( GSRS ) .


A rapid urease test was performed on day @ , and blood tests were performed on day @ and day @ .


Rebamipide significantly inhibited gastric mucosal injury induced by LDA alone or by LDA plus clopidogrel when compared with placebo in healthy subjects .


GSRS score and hemoglobin level were not significantly different among the four groups .


Rebamipide is useful for the primary prevention of gastric mucosal injury induced by LDA alone or by LDA plus clopidogrel in healthy subjects .


A new twice daily sustained-release ( SR ) paracetamol formulation was developed to improve convenience and enhance patient compliance for treatment of pain from chronic diseases .


This research aimed to evaluate bioavailability and compare pharmacokinetic ( PK ) properties of the new SR paracetamol formulation ( @x@ ,@ mg ) with those of immediate-release ( IR ) paracetamol ( @x@ mg ) and existing extended-release ( ER ) paracetamol ( @x@ mg ) .


Two randomized , single-dose , @-way crossover studies were conducted .


A total of @ healthy male and female volunteers participated in each study .