The response of Crohn 's disease ( CD ) stricture to endoscopic therapy compared with non-CD stricture is unknown .


Our aim was to compare the short - and long-term outcomes of endoscopic management of those strictures .


All eligible patients with benign non-CD strictures who underwent the endoscopic balloon dilation between January @ and September @ were included .


Patients with CD strictures were randomly selected with a ratio ( CD versus non-CD strictures ) of @:@ .


A total of @ patients were included , including @ ( @ % ) with non-CD strictures and @ ( @ % ) with CD strictures .


Patients with CD strictures were younger than those with non-CD strictures at the time of disease diagnosis ( @ @ versus @ @ ; P < @ ) and at the time of the first dilation ( @ @ versus @ @ ; P < @ ) .


There were no significant differences in characteristics of strictures and their endoscopic treatments between the CD and non-CD groups , except for the percentage of patients who were ever treated with intralesional corticosteroid injection ( @ % versus @ % , P = @ ) .


Patients in the @ groups had similar technical success rates ( @ % versus @ % , P = @ ) .


Few patients in CD stricture group required emergency room visits due to obstructive symptoms from recurrence of disease ( @ % versus @ % , P = @ ) .


There were on procedure-related complications in either of the @ groups .


The efficacy and safety of endoscopic balloon dilation in the treatment of CD and non-CD strictures seemed to be comparable .


We compared the effects of intravenous administration of @ % hydroxyethyl starch ( maize-derived ) in @ % saline ( Voluven ; Fresenius Kabi , Runcorn , United Kingdom ) and a `` balanced '' preparation of @ % hydroxyethyl starch ( potato-derived ) -LSB- Plasma Volume Redibag ( PVR ) ; Baxter Healthcare , Thetford , United Kingdom -RSB- on renal blood flow velocity and renal cortical tissue perfusion in humans using magnetic resonance imaging .


Hyperchloremia resulting from @ % saline infusion may adversely affect renal hemodynamics when compared with balanced crystalloids .


This phenomenon has not been studied with colloids .


Twelve healthy adult male subjects received @-L intravenous infusions of Voluven or PVR over @ minutes in a randomized , double-blind manner , with crossover studies @ to @ days later .


Magnetic resonance imaging proceeded for @ minutes after commencement of infusion to measure renal artery blood flow velocity and renal cortical perfusion .


Blood was sampled , and weight was recorded at @ , @ , @ , @ , @ , and @ minutes .


Mean peak serum chloride concentrations were @ and @ mmol/L , respectively , after Voluven and PVR infusion ( P = @ ) .


Changes in blood volume ( P = @ ) , strong ion difference ( P = @ ) , and mean renal artery flow velocity ( P = @ ) were similar .


However , there was a significant increase in mean renal cortical tissue perfusion after PVR when compared with Voluven ( P = @ ) .


There was no difference in urinary neutrophil gelatinase-associated liopcalin to creatinine ratios after the infusion ( P = @ ) .


There was no difference in the blood volume-expanding properties of the @ preparations of @ % hydroxyethyl starch .


The balanced starch produced an increase in renal cortical tissue perfusion , a phenomenon not seen with starch in @ % saline .


The specific attributes of inhaler devices can influence patient use , satisfaction and treatment compliance , and may ultimately impact on clinical outcomes in patients with chronic obstructive pulmonary disease ( COPD ) .


To assess patient preference , satisfaction and critical inhaler technique errors with Genuair ( a multidose inhaler ) and Breezhaler ( a single-dose inhaler ) after @ weeks of daily use .


Patients with COPD and moderate to severe airflow obstruction were randomised in a cross-over , open-label , multicentre study to consecutive once-daily inhalations of placebo via Genuair and Breezhaler , in addition to current COPD medication .


The primary end point was the proportion of patients who preferred Genuair versus Breezhaler after @ weeks ( Patient Satisfaction and Preference Questionnaire ) .


Other end points included overall satisfaction and correct use of the inhalers after @ weeks , and willingness to continue with each device .


Of the @ patients enrolled , @ were included in the safety population ( male n = @ ; mean age @ years ) .


Of the @ of the @ patients in the intent-to-treat population who indicated an inhaler preference , statistically significantly more patients preferred Genuair than Breezhaler ( @ vs. @ % ; P < @ ) .


Mean overall satisfaction scores were also greater for Genuair than for Breezhaler ( @ vs. @ , respectively ; P < @ ) .


After @ weeks , there was no statistically significant difference in the number of patients who made @ critical inhaler technique error with Breezhaler than with Genuair ( @ vs. @ % , respectively ) .


Patient overall preference and satisfaction was significantly higher with Genuair compared with Breezhaler .


The proportion of patients making critical inhaler technique errors was low with Genuair and Breezhaler .


Prior studies of catheter-based renal artery denervation have not systematically performed ambulatory blood pressure monitoring ( ABPM ) to assess the efficacy of the procedure .


SYMPLICITY HTN-@ ( Renal Denervation in Patients With Uncontrolled Hypertension ) was a prospective , blinded , randomized , sham-controlled trial .


The current analysis details the effect of renal denervation or a sham procedure on ABPM measurements @ months post-randomization .


Patients with resistant hypertension were randomized @:@ to renal denervation or sham control .


Patients were on a stable antihypertensive regimen including maximally tolerated doses of at least @ drugs including a diuretic before randomization .


The powered secondary efficacy endpoint was a change in mean @-h ambulatory systolic blood pressure ( SBP ) .


Nondipper to dipper ( nighttime blood pressure -LSB- BP -RSB- @ % to @ % lower than daytime BP ) conversion was calculated at @ months .


The @-h ambulatory SBP changed-@ @ @ mm Hg in the denervation group and-@ @ @ mm Hg in the sham group : difference of-@ @ mm Hg ( @ % confidence interval -LSB- CI -RSB- : -@ to @ ; p = @ with a @ mm Hg superiority margin ) .


The daytime ambulatory SBP change difference between groups was-@ @ ( @ % CI : -@ to @ ; p = @ ) .


The nocturnal ambulatory SBP change difference between groups was-@ @ ( @ CI : -@ to @ ; p = @ ) .


Thepercent of nondippers converted to dippers was @ % in the denervation group and @ % in the sham group ( @ % CI : -@ % to @ % ; p = @ ) .


Change in @-h heart rate was-@ @ @ in the denervation group and-@ @ @ in the sham group ; ( @ % CI : -@ to @ ; p = @ ) .


This trial did not demonstrate a benefit of renal artery denervation on reduction in ambulatory BP ineither the @-h or day and night periods compared with sham ( Renal Denervation in Patients WithUncontrolled Hypertension -LSB- SYMPLICITY HTN-@ -RSB- ; NCT@ ) .


Chemotherapy-induced stomatitis is a major side effect of the treatment .


Numerous approaches are described in the literature for the prevention and treatment of this complication .


the aim was assess the effectiveness of Gelclair in patients undergoing hematopoietic stem-cell transplantation in terms of reducing the incidence of stomatitis , stomatitis-pain and the severity of stomatitis


Fifty-seven patients ( @ control group and @ experimental group ) used a mouthwash @ times a day and were evaluated by means of a specially-tailored form containing the following assessment items : stomatitis evaluation scale ( WHO ) , VAS for pain and Likert-Scale for agreement .


@ % of patients presented with stomatitis .


No difference was observed between the two groups with regard to stomatitis grade throughout the observation period .


Painful symptoms were observed in @ % subjects .


No differences were observed in terms of average pain perception before the use of mouthwashes throughout the period of observation p = @ .


RESULTS showed a pain-relieving effect in the experimental group after using the mouthwash p = @ .


Although Gelclair had no influence on the onset and severity of stomatitis in transplanted patients , a significant benefit was observed in terms of pain control .


Our study suggest the possibility to implementation the use of Gelclair in clinical practice .


However , further multicenter trials are needed to provide stronger evidence on the real usefulness of this product .


To compare laser in situ keratomileusis ( LASIK ) outcomes between @ wavefront-guided excimer laser systems in the treatment of myopia .


University eye clinic , Palo Alto , California , USA .


Prospective comparative case series .


One eye of patients was treated with the Allegretto Wave Eye-Q system ( small-spot scanning laser ) and the fellow eye with the Visx Star Customvue S@ IR system ( variable-spot scanning laser ) .


Evaluations included measurement of uncorrected visual acuity , corrected visual acuity , and wavefront aberrometry .


One hundred eyes ( @ patients ) were treated .


The mean preoperative spherical equivalent ( SE ) refraction was -@ diopters ( D ) @ ( SD ) and -@ @ D in the small-spot scanning laser group and variable-spot scanning laser group , respectively .


There were no significant differences in preoperative higher-order aberrations ( HOAs ) between the groups .


Twelve months postoperatively , all eyes in the small-spot scanning laser group and @ % in the variable-spot scanning laser group were within @ D of the intended correction ( P = @ ) .


At that time , the small-spot scanning laser group had significantly less spherical aberration ( @ versus @ ) ( P = @ ) and significantly less mean total higher-order root mean square ( @ m versus @ m ) ( P = @ ) .


Subjectively , patients reported that the clarity of night and day vision was significantly better in the eye treated with the small-spot scanning laser .


The predictability and self-reported clarity of vision of wavefront-guided LASIK were better with the small-spot scanning laser .


Eyes treated with the small-spot scanning laser had significantly fewer HOAs .


This paper details the research protocol for a study funded by the Australian Research Council .


An integrated approach towards helping young children respond to the significant pressures of ' @ degree marketing ' on their food choices , levels of active play , and sustainability consciousness via the early childhood curriculum is lacking .


The overall goal of this study is to evaluate the efficacy of curriculum interventions that educators design when using a pedagogical communication strategy on children 's knowledge about healthy eating , active play and the sustainability consequences of their toy food and toy selections .


This cluster-randomised trial will be conducted with @ , @ to @ year-old children attending pre-school .


Early childhood educators will develop a curriculum intervention using a pedagogical communication strategy that integrates content knowledge about healthy eating , active play and sustainability consciousness and deliver this to their pre-school class .


Children will be interviewed about their knowledge of healthy eating , active play and the sustainability consequences of their food and toy selections .


Parents will complete an Eating and Physical Activity Questionnaire rating their children 's food preferences , digital media viewing and physical activity habits .


All measures will be administered at baseline , the end of the intervention and @ months post intervention .


Informed consent will be obtained from all parents and the pre-school classes will be allocated randomly to the intervention or wait-list control group .


This study is the first to utilise an integrated pedagogical communication strategy developed specifically for early childhood educators focusing on children 's healthy eating , active play , and sustainability consciousness .


The significance of the early childhood period , for young children 's learning about healthy eating , active play and sustainability , is now unquestioned .


The specific teaching and learning practices used by early childhood educators , as part of the intervention program , will incorporate a sociocultural perspective on learning ; this perspective emphasises building on the play interests of children , that are experienced within the family and home context , as a basis for curriculum provision .


Routine symptom and health-related quality of life ( HRQOL ) assessments can engage patients , give provider feedback , and improve doctor/patient communication .


We compared the impact of a technology-assisted symptom monitoring system versus usual care on HRQOL and doctor/patient communication in early-stage prostate cancer ( PCa ) survivors .


Men ( N = @ ) were on average @-years old , mostly African American ( AA ; @ % ) , and @-@ months post-treatment .


They were randomized to symptom monitoring plus feedback ( SM + F ; n = @ ) or usual care ( UC ; n = @ ) .


SM+F participants completed a @-item telephoneassisted monitoring intervention .


All participants completed a baseline and @ follow-up interviews .


Among the SM+F participants , perceptions of the monitoring system were positive : @ % endorsed it as easy/very easy to use and @ % felt all patients could benefit from it .


At baseline , men reported favorable general and cancer-specific HRQOL and doctor/patient communication , but poorer urinary and sexual function .


Although there was no overall impact of the intervention , post hoc exploratory analyses indicated that among AA men , those who received SM+F improved relative to UC on doctor/patient communication ( P < @ ) , general HRQOL ( P < @ ) , and sexual function ( P < @ ) .


Variability in survivor follow-up care , limited access to eligible participants , and minimal physician training in the use of reports likely decreased physician investment .


Overall , PCa survivors were receptive to this monitoring system .


Exploratory analyses suggest that this technology-assisted monitoring system may be of particular benefit to African American men .


Additional studies with larger samples , more intervention time-points , and increased physician training are needed to strengthen the intervention 's impact .


Recombinant human bone morphogenetic protein-@ ( rhBMP-@ ) applied on an absorbable collagen sponge improves open tibial fracture-healing as an adjunct to unreamed intramedullary nail fixation .


We evaluated rhBMP-@ and a new , injectable calcium phosphate matrix ( CPM ) formulation in acute closed tibial diaphyseal fractures treated with reamed intramedullary nail fixation .


Patients were randomized ( @:@:@:@ ) to receive standard of care , which consisted of definitive fracture fixation within seventy-two hours of injury with a locked intramedullary nail after reaming ; standard of care and injection with @ mg/mL of rhBMP-@ / CPM ; standard of care and injection with @ mg/mL of rhBMP-@ / CPM ; or standard of care and injection with buffer/CPM , to evaluate the activity of the CPM delivery matrix and provide for sponsor and investigator blinding .


The co-primary end points of the study were the effects of rhBMP-@ / CPM on the time to fracture union ( based on blinded assessment of radiographs ) and the time to return to normal function ( based on blinded assessment of the time to full weight-bearing without pain at the fracture site ) compared with standard of care alone .


Three hundred and sixty-nine patients were randomized and included in the intent-to-treat population .


This study was terminated after an interim analysis ( @ patients with six months of follow-up ) revealed no shortening in the time to fracture union in the active treatment arms compared with the standard of care control ( the SOC group ) .


In the final primary analysis , the median time to radiographic fracture union was not significantly different for the SOC ( @ weeks ) , @-mg / mL rhBMP-@ / CPM ( @ weeks ) , @-mg / mL rhBMP-@ / CPM ( @ weeks ) , or buffer/CPM ( @ weeks ) treatment groups .


The median time to pain-free full weight-bearing was also not significantly different among the SOC ( @ weeks ) , @-mg / mL rhBMP-@ / CPM ( @ weeks ) , @-mg / mL rhBMP-@ / CPM ( @ weeks ) , and buffer/CPM ( @ weeks ) treatment groups .


In patients with closed tibial fractures treated with reamed intramedullary nailing , the time to fracture union and pain-free full weight-bearing were not significantly reduced by rhBMP-@ / CPM compared with standard of care alone .


African health services have shortages of clinical staff .


We showed previously , in a cluster-randomized trial , that a home-based strategy using trained lay-workers is as effective as a clinic-based strategy .


It is not known whether home-based care is suitable for patients with advanced HIV disease .


The trial was conducted in Jinja , Uganda .


One thousand , four hundred and fifty-three adults initiating ART between February @ and January @ were randomized to receive either home-based care or routine clinic-based care , and followed up for about @ years .


Trained lay workers , supervised by clinical staff based in a clinic , delivered the home-based care .


In this sub-analysis , we compared survival between the two strategies for those who presented with CD@ cell count less than @ cells/l and those who presented with higher CD@ cell counts .


We used Kaplan-Meier methods and Poisson regression .


Four hundred and forty four of @ ( @ % ) participants had baseline CD@ cell count less than @cells/l .


Overall , @ ( @ % ) deaths occurred among participants with baseline CD@ cell count less than @ cells/l and @ ( @ % ) in those with higher CD@ cell count .


Among participants with CD@ cell count less than @ cells/l , mortality rates were similar for the home and facility-based arms ; adjusted mortality rate ratio @ -LSB- @ % confidence interval ( CI ) @-@ @ -RSB- compared with @ ( @ % CI @-@ @ ) for those who presented with higher CD@ cell count .


HIV home-based care , with lay workers playing a major role in the delivery of care including providing monthly adherence support , leads to similar survival rates as clinic-based care even among patients who present with very low CD@ cell count .


This emphasises the critical role of adherence to antiretroviral therapy .


Approximately @ million South Africans are living with human immunodeficiency virus ( HIV ; UNAIDS , @ ) .


Prevalence among Black adolescents and young adults is particularly alarming .


This pilot study of an HIV preventive intervention targeting South African youth contributes to the growing body of research on culturally competent family-based interventions .


A total of @ parent-child dyads were enrolled in an experimental repeated measures study , using a wait-list control group .


Our @-session intervention targeted general parenting ( relationship quality , parental monitoring , and involvement ) , gender roles , and parent-youth communication about sex ( content and quality ) .


Parents and youth were assessed at baseline , postintervention , and @-month follow-up .


Eligibility included being the primary female caregiver of a @ - to @-year-old child with whom they spent at least @ nights a week and being able to participate in English or Xhosa .


Effect sizes with this small sample met or exceeded those of other family-based HIV interventions for youth in the United States and South Africa ( e.g. , Bell et al. , @ ; Forehand et al. , @ ) .


Parents ' reports at postintervention indicated larger effect sizes for general parenting than youths ' reports indicated .


Parents ' reports showed medium to large effects for all sex communication outcomes at postintervention and the @-month follow-up .


Youth reports demonstrated small to medium effects for most communication variables and these effects lasted through the @-month follow-up period .


Intergenerational social networks ( e.g. , families ) hold promise for HIV prevention among South African youth .


A full efficacy trial with longer-term follow-up and attention to maintenance of effects is warranted .


@-Ethyl-@-methylbutyl-carbamate ( EMC ) and @-isopropylpentyl-carbamate ( IPC ) are among the most potent anticonvulsant carbamate derivatives of valproic acid .


EMC and IPC are chiral compounds .


Consequently , the aim of the current study was to comparatively evaluate the pharmacokinetic ( PK ) and pharmacodynamic ( PD anticonvulsant activity ) profile of EMC and IPC individual enantiomers .


The anticonvulsant activity of EMC and IPC individual enantiomers was evaluated in several anticonvulsant rodent models including maximal electroshock ( MES ) , @ Hz psychomotor , subcutaneous ( pentylenetetrazole ) ( scMet ) , and the pilocarpine-induced and soman-induced status epilepticus ( SE ) .


The PK-PD relationship of EMC and IPC individual enantiomers was evaluated following intraperitoneal administration ( @ mg/kg ) to rats .


Induction of neural tube defects ( NTDs ) was evaluated in a mouse strain that was highly susceptible to teratogen-induced NTDs .


In mice and rats , ( @S ) - EMC exhibited anticonvulsant activity similar to that of racemic EMC in the MES and scMet tests , whereas in the @ Hz test , racemic EMC was more potent than its two individual enantiomers .


Racemic EMC exhibited a potent activity in the soman-induced SE model when administered @ and @ min after seizure onset with median effective dose ( ED@ ) values of @ and @ mg/kg , respectively .


( @R ) - IPC and ( @S ) - IPC exhibited ED@ values similar to those of racemic IPC in the mouse and rat MES and scMet models .


( @R ) - IPC had similar ED@ values on the @ Hz tests .


Racemic IPC had an ED@ value of @ mg/kg in the pilocarpine-induced SE model when given @ min after seizure onset .


Racemic EMC and IPC and their enantiomers had similar clearance ( @-@ @ L/h/kg ) and short half-life ( < @ h ) .


EMC and its enantiomers did not cause NTDs at doses @-@ times higher than their anticonvulsant ED@ values .


EMC and IPC did not exhibit enantioselective PK , a fact that may contribute to their nonenantioselective activity in any of the anticonvulsant models .


The nonsignificant difference between racemic EMC and racemic IPC and their enantiomers , suggests that their wide spectrum of anticonvulsant activity is likely to be caused by multiple mechanisms of action .


Staged clinical treatment of pediatric obesity is recommended , but untested .


Understanding the lowest intensity stage 's effectiveness is necessary for future research .


This was a randomized controlled trial of children ages @ to < @ years .


Participants were recruited after routine evaluations at a primary care pediatric clinic revealed a BMI @th percentile .


The intervention was patterned after the `` Prevention plus , Stage @ '' treatment recommended by an expert committee .


Groups were compared for changes , over a @-month time period , in BMI z-score and parental reports of behavioral issues related to childhood obesity using intent-to-treat ( ITT ) analysis .


Seventy-two ( @ % of eligible ) children were enrolled and @ were remeasured at @-month follow-up .


ITT analysis revealed that both groups improved mean BMI z-score -LSB- adjusted change -@ , control , and -@ , intervention ; @ % confidence interval ( CI ) of difference = -@ -@ -RSB- .


Over half of the children in each group improved their BMI z-score ( adjusted proportion decreasing = @ % in control vs. @ % in intervention ; @ % CI of difference = -@ -@ ) .


The intervention group improved comparatively to the control group on numerous behavioral indicators .


Implementation of the lowest intensity stage of current recommendations is feasible and possibly of benefit toward lifestyle changes .


Results of this study can be used by future clinical researchers designing protocols to test the full multi-staged approach for the treatment of pediatric overweight and obesity in primary care clinical settings .


Tenofovir disoproxil fumarate can cause renal and bone toxic effects related to high plasma tenofovir concentrations .


Tenofovir alafenamide is a novel tenofovir prodrug with a @ % reduction in plasma tenofovir concentrations .


Tenofovir alafenamide-containing regimens can have improved renal and bone safety compared with tenofovir disoproxil fumarate-containing regimens .


In these two controlled , double-blind phase @ studies , we recruited treatment-naive HIV-infected patients with an estimated creatinine clearance of @ mL per min or higher from @ outpatient centres in @ countries .


Patients were randomly assigned ( @:@ ) to receive once-daily oral tablets containing @ mg elvitegravir , @ mg cobicistat , @ mg emtricitabine , and @ mg tenofovir alafenamide ( E/C/F / tenofovir alafenamide ) or @ mg tenofovir disoproxil fumarate ( E/C/F / tenofovir disoproxil fumarate ) with matching placebo .


Randomisation was done by a computer-generated allocation sequence ( block size @ ) and was stratified by HIV-@ RNA , CD@ count , and region ( USA or ex-USA ) .


Investigators , patients , study staff , and those assessing outcomes were masked to treatment group .


All participants who received one dose of study drug were included in the primary intention-to-treat efficacy and safety analyses .


The main outcomes were the proportion of patients with plasma HIV-@ RNA less than @ copies per mL at week @ as defined by the the US Food and Drug Adminstration ( FDA ) snapshot algorithm ( pre-specified non-inferiority margin of @ % ) and pre-specified renal and bone endpoints at @ weeks .


These studies are registered with ClinicalTrials.gov , numbers NCT@ and NCT@ .


We recruited patients from Jan @ , @ , to Nov @ , @ ( @ screened and @ randomly assigned ) , and gave treatment to @ patients ( @ given E/C/F / tenofovir alafenamide and @ given E/C/F / tenofovir disoproxil fumarate ) .


E/C/F / tenofovir alafenamide was non-inferior to E/C/F / tenofovir disoproxil fumarate , with @ ( @ % ) of @ patients in the tenofovir alafenamide group and @ ( @ % ) of @ patients in the tenofovir disoproxil fumarate group having plasma HIV-@ RNA less than @ copies per mL ( adjusted difference @ % , @ % CI -@ to @ ) .


Patients given E/C/F / tenofovir alafenamide had significantly smaller mean serum creatinine increases than those given E/C/F / tenofovir disoproxil fumarate ( @ vs @ mg/dL ; p < @ ) , significantly less proteinuria ( median % change -@ vs @ ; p < @ ) , and a significantly smaller decrease in bone mineral density at spine ( mean % change -@ vs -@ ; p < @ ) and hip ( -@ vs -@ ; p < @ ) at @ weeks .


Through @ weeks , more than @ % of patients given E/C/F / tenofovir alafenamide or E/C/F / tenofovir disoproxil fumarate had virological success .


Renal and bone effects were significantly reduced in patients given E/C/F / tenofovir alafenamide .


Although these studies do not have the power to assess clinical safety events such as renal failure and fractures , our data suggest that E/C/F / tenofovir alafenamide will have a favourable long-term renal and bone safety profile .


Family functioning impairment is widely reported in the eating disorders literature , yet few studies have examined the role of family functioning in treatment for adolescent anorexia nervosa ( AN ) .


This study examined family functioning in two treatments for adolescent AN from multiple family members ' perspectives .


Participants were @ adolescents with AN ages @-@ from a randomized-controlled trial comparing family-based treatment ( FBT ) to individual adolescent-focused therapy ( AFT ) .


Multiple clinical characteristics were assessed at baseline .


Family functioning from the perspective of the adolescent and both parents was assessed at baseline and after @ year of treatment .


Full remission from AN was defined as achieving both weight restoration and normalized eating disorder psychopathology .


In general , families dealing with AN reported some baseline impairment in family functioning , but average ratings were only slightly elevated compared to published impaired functioning cutoffs .


Adolescents ' perspectives on family functioning were the most impaired and were generally associated with poorer psychosocial functioning and greater clinical severity .


Regardless of initial level of family functioning , improvements in several family functioning domains were uniquely related to full remission at the end of treatment in both FBT and AFT .


However , FBT had a more positive impact on several specific aspects of family functioning compared to AFT .


Families seeking treatment for adolescent AN report some difficulties in family functioning , with adolescents reporting the greatest impairment .


Although FBT may be effective in improving some specific aspects of family dynamics , remission from AN was associated with improved family dynamics , regardless of treatment type .


To evaluate the effects of subarachnoid propofol administration ( SPA ) on analgesia , sedation , ataxia , cardiopulmonary , blood gas variables , and its application in ovariectomy in Jennies .


Prospective , randomized , clinical trial .


Adult Jennies ( n = @ ; @-@kg ; @-@ years old ) .


In study @ , @ Jennies had SPA ( n = @ ; group @ ) through Tuohy catheter , and another @ control Jennies had normal saline subarachnoid administration ( n = @ ; group @ ) .


In study @ , @ Jennies had SPA and ovariectomy ( n = @ ; group @ ) .


In groups @ and @ analgesia , sedation and ataxia scores , cardiopulmonary and blood gas variables were recorded at different intervals before and after PSA .


In group @ , only cardiopulmonary and blood gas variables were recorded .


SPA produced pronounced analgesia , mild sedation and minimal ataxia .


Heart rate ( HR ) , respiratory rate ( RR ) , pulse rate ( PR ) , rectal temperature ( RT ) , arterial blood pH , PaO@ , and PaCO@ were not significantly different from base line values after subarachnoid administration of either propofol or normal saline .


SPA was found to be useful , efficient and feasible procedure for ovariectomy through standing flank laparotomy in Jennies .


The aim of this study was to determine the minimum effective volume ( MEV ) of combined lidocaine @ % - bupivacaine @ % with epinephrine @ g/mL in @ % of patients ( MEV@ ) for ultrasound-guided subparaneural popliteal sciatic nerve block .


All subjects received an ultrasound-guided subparaneural popliteal sciatic nerve block ( at the neural bifurcation ) with combined lidocaine @ % - bupivacaine @ % and epinephrine @ g/mL .


Using an out-of-plane technique , a @-gauge , @-cm Tuohy needle was advanced until its tip was positioned between the tibial and peroneal nerves inside the paraneural sheath .


Volume assignment was carried out using a biased coin design , up-and-down sequential method , where the volume of local anesthetic administered to each patient depended on the response of the previous one .


In case of failure , the next subject received a higher volume ( defined as the previous volume with an increment of @ mL ) .


If the previous patient had a successful block , the next subject was randomized to a lower volume ( defined as the previous volume with a decrement of @ mL ) , with a probability of b = @ , or the same volume , with a probability of @ - b = @ .


Using a composite scale encompassing sensory and motor block , success was defined , at @ minutes , as a minimal score of @ points ( out of @ points ) .


The @-point score was intended to mirror successful postoperative analgesia .


Patients undergoing surgery of the leg , ankle , or foot were prospectively enrolled until @ successful blocks were obtained .


Fifty-two patients were recruited for this study .


Using isotonic regression and bootstrap confidence interval , the MEV@ of combined lidocaine @ % - bupivacaine @ % with epinephrine @ g/mL was estimated to be @ mL ( @ % confidence interval , @-@ @ mL ) .


For ultrasound-guided subparaneural ( analgesic ) popliteal sciatic nerve block , the MEV@ of combined lidocaine @ % - bupivacaine @ % with epinephrine @ g/mL is @ mL ( @ % confidence interval , @-@ @ mL ) .


Thrombotic microangiopathy ( TMA ) is a complication that developed in some patients receiving @ Gy total body irradiation ( TBI ) in addition to lymphodepleting preparative chemotherapy prior to infusion of autologous tumor-infiltrating lymphocytes ( TIL ) with high-dose aldesleukin ( IL-@ ) .


This article describes the incidence , presentation , and course of radiation-associated TMA .


The data for patients with metastatic melanoma who received ACT with TIL plus aldesleukin following myeloablative chemotherapy and @-Gy TBI was examined , in order to look at patient characteristics and the natural history of TMA .


The median time to presentation was approximately @ months after completing TBI .


The estimated cumulative incidence of TMA was @ % ( median follow-up of @ months ) .


Noninvasive criteria for diagnosis included newly elevated creatinine levels , new-onset hypertension , new-onset anemia , microscopic hematuria , thrombocytopenia , low haptoglobin , and elevated lactate dehydrogenase values .


Once diagnosed , patients were managed with control of their hypertension with multiple agents and supportive red blood cell transfusions .


TMA typically stabilized or improved and no patient progressed to dialysis .


TMA was associated with a higher probability of an antitumor response .


TMA occurs in approximately a third of patients treated with a lymphodepleting preparative chemotherapy regimen with TBI prior to autologous T cell therapy .


The disease has a variable natural history , however , no patient developed end-stage renal failure .


Successful management with supportive care and aggressive hypertension control is vital to the safe application of a systemic therapy that has shown curative potential for patients with disseminated melanoma .


The present study compared the effect of bupivacaine and bupivacaine + sufentanil on hemodynamic parameters and characteristics of spinal anesthesia in elderly patients undergoing transurethral resection of the prostate ( TURP ) under spinal anesthesia .


The study included @ American Society of Anesthesiologists ( ASA ) I-III patients scheduled to undergo TURP .


Patients were blindly and randomly divided into two groups .


Group B ( n = @ ) received @ mg of intrathecal bupivacaine and group BS ( n = @ ) received @ mg of bupivacaine + @ g of sufentanil .


Sensory and motor block characteristics , hemodynamic changes , side effects , and time to first analgesic requirement were recorded .


No differences in mean arterial pressure or heart rate , time for sensory blockade to reach the T@ level , and maximum sensory level were observed between the two groups .


The time to first analgesic request was longer in group BS ( P < @ ) .


Motor block was significantly higher in group B ( P < @ ) .


In terms of side effects , no statistically significant differences occurred between the groups .


Similar hemodynamic stability and sufficient level of sensory blockade were provided by bupivacaine and bupivacaine + sufentanil used for spinal anesthesia in patients undergoing TUR .


Due to the fact that less motor block was observed and the time to first analgesic request was longer , the combination of bupivacaine + sufentanil might be appropriate for patients undergoing TUR .


This study aimed to assess acute and chronic effects of right ventricular mid-septum ( RVS ) versus right ventricular apex ( RVA ) pacing on left ventricular ( LV ) mechanical dyssynchrony using phase analysis of gated single photon emission computed tomography myocardial perfusion imaging ( MPI ) .


Thirty-nine patients with complete atrioventricular ( AV ) block , who were indicated for permanent pacing , were recruited and randomized to receive RVA ( n = @ ) or RVS ( n = @ ) pacing .


All patients underwent MPI at @ week and @ months after pacemaker implantation .


LV dyssynchrony and cardiac function were assessed by MPI and compared between the two groups .


There were no significant differences in baseline characteristics between the RVS and RVA groups .


The paced QRS duration was significantly longer in the RVA group than in the RVS group .


LV dyssynchrony parameters were not significantly different between the groups at the @-week follow-up , but they were significantly smaller in the RVS group than in the RVA group at the @-month follow-up .


LV dyssynchrony parameters significantly decreased in the RVS group from the @-week follow-up to the @-month follow-up , but were unchanged in the RVA group .


No differences in LV function parameters were observed between the groups at the @-week and @-month follow-ups .


RVS pacing produces better electrical and mechanical synchrony than RVA pacing for patients with complete AV block .


Polyneuropathy , organomegaly , endocrinopathy , M-protein and skin changes ( POEMS ) syndrome is a fatal systemic disorder associated with plasma cell dyscrasia and the overproduction of the vascular endothelial growth factor ( VEGF ) .


Recently , the prognosis of POEMS was substantially improved by introduction of therapeutic intervention for myeloma .


However , no randomised clinical trial has been performed because of the rarity and severity of the disease .


The Japanese POEMS syndrome with Thalidomide ( J-POST ) Trial is a phase II/III multicentre , double-blinded , randomised , controlled trial that aims to evaluate the efficacy and safety of a @-week treatment with thalidomide in POEMS syndrome , with an additional @-week open-label safety study .


Adults with POEMS syndrome who have no indication for transplantation are assessed for eligibility at @ tertiary neurology centres in Japan .


Patients who satisfy the eligibility criteria are randomised ( @:@ ) to receive thalidomide ( @-@mg daily ) plus dexamethasone ( @mg/m ( @ ) on days @-@ of a @-day cycle ) or placebo plus dexamethasone .


Both treatments were administered for @weeks ( six cycles ; randomised comparative study period ) .


Patients who complete the randomised study period or show subacute deterioration during the randomised period participate in the subsequent @-week open-label safety study ( long-term safety period ) .


The primary end point of the study is the reduction rate of serum VEGF levels at @weeks .


Remote ischemic preconditioning ( RIPC ) may confer the protection in critical organs .


The authors hypothesized that limb RIPC would reduce lung injury in patients undergoing pulmonary resection .


In a randomized , prospective , parallel , controlled trial , @ patients undergoing elective thoracic pulmonary resection under one-lung ventilation with propofol-remifentanil anesthesia were randomized @:@ to receive either limb RIPC or conventional lung resection ( control ) .


Three cycles of @-min ischemia/@-min reperfusion induced by a blood pressure cuff served as RIPC stimulus .


The primary outcome was PaO@/FIO@ .


Secondary outcomes included other pulmonary variables , the incidence of in-hospital complications , markers of oxidative stress , and inflammatory response .


Limb RIPC significantly increased PaO@/FIO@ compared with control at @ and @ min after one-lung ventilation , @ min after re-expansion , and @ h after operation ( @ @ vs. @ @ , P = @ ; @ @ vs. @ @ , P = @ ; @ @ vs. @ @ , P = @ ; @ @ vs. @ @ , P = @ , respectively ) .


In comparison with control , it also significantly reduced serum levels of interleukin-@ and tumor necrosis factor - at @ , @ , @ , and @ h after operation and malondialdehyde levels at @ min after one-lung ventilation and @ min after re-expansion ( all P < @ ) .


The incidence of acute lung injury and the length of postoperative hospital stay were markedly reduced by limb RIPC compared with control ( all P < @ ) .


Limb RIPC attenuates acute lung injury via improving intraoperative pulmonary oxygenation in patients without severe pulmonary disease after lung resection under propofol-remifentanil anesthesia .


To test our hypothesis that initiating therapy with a combination of agents known to improve insulin secretion and insulin sensitivity in subjects with new-onset diabetes would produce greater , more durable reduction in glycated haemoglobin ( HbA@c ) levels , while avoiding hypoglycaemia and weight gain , compared with sequential addition of agents that lower plasma glucose but do not correct established pathophysiological abnormalities .


Drug-nave , recently diagnosed subjects with type @ diabetes mellitus ( T@DM ) were randomized in an open-fashion design in a single-centre study to metformin/pioglitazone/exenatide ( triple therapy ; n = @ ) or an escalating dose of metformin followed by sequential addition of sulfonylurea and glargine insulin ( conventional therapy ; n = @ ) to maintain HbA@c levels at < @ % for @years .


Participants receiving triple therapy experienced a significantly greater reduction in HbA@c level than those receiving conventional therapy ( @ vs. @ % ; p < @ ) .


Despite lower HbA@c values , participants receiving triple therapy experienced a @-fold lower rate of hypoglycaemia compared with participants receiving conventional therapy .


Participants receiving triple therapy experienced a mean weight loss of @ kg versus a mean weight gain of @ kg ( p < @ ) in those receiving conventional therapy .


The results of this exploratory study show that combination therapy with metformin/pioglitazone/exenatide in patients with newly diagnosed T@DM is more effective and results in fewer hypoglycaemic events than sequential add-on therapy with metformin , sulfonylurea and then basal insulin .


A surgical glove will protect surgeons and patients only if the glove 's integrity remains intact .


However , several studies have demonstrated that undetected micro-perforations of surgical gloves are common .


Because of the possibility of surgical glove puncture , an antimicrobial surgical glove was developed .


The aim of this laboratory based experimental study was to assess the antibacterial efficacy of the interior chlorhexidine-gluconate ( CHG ) - coat of an antimicrobial synthetic polyisoprene surgical glove by using a standardized microbiological challenge .


Sixteen healthy adult participants donned one antimicrobial surgical glove and one non-antimicrobial surgical glove randomly allocated to their dominant and non-dominant hand following a crossover design .


During a @-h wear time , participants performed standardized finger and hand movements .


Thereafter , the interior surface of excised fingers of the removed gloves was challenged with @ log@ cfu/mLS .


aureus ( ATCC @ ) or K. pneumoniae ( ATCC @ ) , respectively .


The main outcome measure was the viable mean log@ cfu counts of the two glove groups after @min contact with the interior glove 's surface .


When comparing an antimicrobial glove against an untreated reference glove after @-h simulated use wear-time , a mean reduction factor of @ log@ ( S. aureus ) and @ log@ ( K. pneumoniae ) was achieved after @min contact .


These results demonstrate that wearing antibacterial gloves on hands does not negatively impact their antibacterial activity after @-h of wear .


This may have a potential benefit for patient safety in case of glove puncture during surgical procedures .


To explore the influence of rosa roxburghii tratt preparation on immune function of arseniasis patients caused by burning coal .


According to the diagnosis standard for endemic arseniasis ( WS/T @-@ ) , @ cases of arseniasis patients who resided in endemic arseniasis area in Guizhou province were selected and divided stratified randomly into two groups : rosa roxburghii tratt juice treatment group and superoxide dismutase ( SOD ) - enriched rosa roxburghii tratt juice treatment group , with @ patients in each group.Each patient took @ ml/d rosa roxburghii tratt preparation or SOD-enriched rosa roxburghii tratt orally for one month .


Another @ healthy residents from a neighbour township @ km away where arsenic was not prevalent were selected as controls .


A @ ml blood and @ ml urine samples were collected from individuals and the urine arsenic contents , peripheral blood T-lymphocyte subsets ( CD@ ( + ) , CD@ ( + ) , CD@ ( + ) T cell ) , serum immunoglobulin ( IgG , IgM , IgA ) and complement ( C@ , C@ ) were detected .


The differences between more than two groups on above indicators were compared .


The correlations between urinary arsenic and immune parameters were analyzed .


Among the rosa roxburghii tratt juice group , SOD-enriched rosa roxburghii tratt juice before intervention group and the control group , the levels of urine arsenic were ( @ @ ) , ( @ @ ) and ( @ @ ) g/g Cr respectively and IgG were ( @ @ ) , ( @ @ ) and ( @ @ ) g/L respectively .


The differences were statistically significant ( F values were @ , @ , both P values < @ ) .


After intervention with rosa roxburghii tratt preparation , the levels of urine arsenic were ( @ @ ) and ( @ @ ) g/g Cr , both decreased than before intervention ( t values were @ and @ , both P values < @ ) .


The levels of CD@ ( + ) were ( @ @ ) % , ( @ @ ) % and ( @ @ ) % , CD@ ( + ) were ( @ @ ) % , ( @ @ ) % and ( @ @ ) % , CD@ ( + ) / CD@ ( + ) were ( @ @ ) , ( @ @ ) and ( @ @ ) and C@ were ( @ @ ) , ( @ @ ) and ( @ @ ) g/L respectively among the two treatment group before intervention and the control group .


The differences were significant ( F values were @ , @ , @ and @ , all P values < @ ) .


After intervention , the levels of CD@ ( + ) were ( @ @ ) % and ( @ @ ) % , CD@ ( + ) were ( @ @ ) % and ( @ @ ) % , CD@ ( + ) / CD@ ( + ) were ( @ @ ) and ( @ @ ) , all increased than before intervention ( t values were @ , @ , @ , @ , @ and @ , all P values < @ ) .


The levels of urine arsenic and CD@ ( + ) , CD@ ( + ) , CD@ ( + ) / CD@ ( + ) , C@ were inversely correlated correlation , while positive correlation existed between the level of urine arsenic and IgG ( r values were -@ , -@ , -@ , -@ and @ , all P values < @ ) .


The level of urinary arsenic level is closely related to immune function suppression in arseniasis patients caused by burning coal , rosa roxburghii tratt preparation can effectively improve immune function of arseniasis patients .


Oral mucositis is one of the common complications of cancer chemotherapy and about @ % of the patients who take chemotherapy protocols , experience this irritating problem .


The purpose of this study was to draw comparison between the therapeutic effects of our treatment modalities ( topical steroid , honey , honey plus coffee ) in patients suffering from oral mucositis .


This was a double blinded randomised clinical trial of a total of @ eligible adult participants which they randomly fell into three treatment groups .


For all the participants a syrup-like solution was prepared .


Each @ grams of the product consisted of `` @ eight-mg Betamethasone solution ampoules '' in the Steroid ( S ) group , `` @ grams of honey plus @ grams of instant coffee '' in the Honey plus Coffee ( HC ) group , and `` @ grams of honey '' for the Honey ( H ) group .


The participants were told to sip @ ml of the prescribed product , and then swallow it every three hours for one week .


Severity of lesions was clinically evaluated before the treatment and also one week after the initiation of the intervention .


This study adhered to the principles of the Declaration of Helsinki and guidelines of Good Clinical Practice .


This study showed that all three treatment regimens reduce the severity of lesions .


The best reduction in severity was achieved in HC group .


H group and S group took the second and third places .


In other words , honey plus coffee regimen was the most effective modality for the treatment of oral mucositis .


Oral mucositis can be successfully treated by a combination of honey and coffee as an alternative medicine in a short time .


Further investigations are warranted in this field .


The purpose of this study was to investigate if the levonorgestrel-impregnated intrauterine device ( LNG-IUS , Mirena ( ) ) is safe and effective as therapy for low-risk and medium-risk endometrial hyperplasia compared with oral medroxyprogesterone ( MPA ) .


A multicentre randomised trial .


Norway .


In all , @ women aged @-@years with low - or medium-risk endometrial hyperplasia who met inclusion criteria .


Patients were randomly assigned to one of three treatment arms : LNG-IUS ; oral MPA @mg administered for @days per cycle , or continuous oral MPA @mg daily , for @months .


The primary outcome measure was normalisation or persisting hyperplasia .


After @months all three treatment regimens showed significant effect when the outcome was evaluated as therapy response or not ( P < @ ) .


Responses were obtained for all the women in the LNG-IUS group ( @/@ , @ % CI @-@ @ ) and for @ % of the women in the continuous oral group ( @/@ , @ % CI @-@ @ ) .


Only @ % of the women in the cyclic oral group were responders ( @/@ , @ % CI @-@ @ ) .


Adverse effects were relatively common with minimal differences between therapy groups .


In the first trial of its kind , women treated with the LNG-IUS showed histologically normal endometrium after @months of therapy for endometrial hyperplasia .


Cyclical progestogens are found to be less effective compared with continuous oral therapy and LNG-IUS and should not be used for this purpose .


n-@ polyunsaturated fatty acids reduce insulin resistance , lipogenesis , and inflammation , which are features of nonalcoholic steatohepatitis ( NASH ) .


Ethyl-eicosapentanoic acid ( EPA-E ) is a synthetic polyunsaturated fatty acid that reduces hypertriglyceridemia .


We report the final results of a phase @b multicenter , prospective , double-blind , randomized , placebo-controlled trial of EPA-E for NASH .


Our study , performed at @ sites in North America , included subjects with NASH and nonalcoholic fatty liver disease ( NAFLD ) activity scores @ , with minimum scores of @ for steatosis and inflammation , along with either ballooning or at least stage @a fibrosis .


A total of @ subjects were randomly assigned to groups given placebo ( n = @ ) , low-dosage EPA-E ( @ mg/d ; n = @ ) , or high-dosage EPA-E ( @ mg/d ; n = @ ) for @ months .


Subjects were examined at @-week intervals for @ months , @-week intervals for the next @ months , and every @ months thereafter , until @ month after the last dose was taken .


Liver biopsies were collected @ weeks after the last dose of EPA-E or placebo .


The primary efficacy end point was NAFLD activity score @ , without worsening of fibrosis ; or a decrease in NAFLD activity score by @ with contribution from > @ parameter , without worsening of fibrosis , @ year after the last dose of EPA-E or placebo was given .


Similar proportions of subjects in each group met the primary end point ( @ % , @ % , and @ % for placebo , low-dosage , and high-dosage EPA-E , respectively ) .


EPA-E had no significant effects on steatosis , inflammation , ballooning , or fibrosis scores .


There were no significant effects on levels of liver enzymes , insulin resistance , adiponectin , keratin @ , high-sensitivity C-reactive protein , or hyaluronic acid .


High-dosage EPA-E reduced levels of triglyceride ( -@ mg/dL vs an increase of @ mg/dL in the placebo group ; P = @ ) .


There were no treatment-related serious adverse events .


In a phase @ trial , EPA-E had no significant effect on the histologic features of NASH .


EPA-E reduced subjects ' levels of triglyceride compared with placebo , without any increase in serious adverse events .


Clinicaltrials.gov Number : @ .


Various preparations of botulinum toxin type A ( BTX-A ) are used to reduces glabellar ( frown ) lines .


However , dose-related safety and efficacy of intramuscular injections of a widely used , locally produced BTX-A in China has not been established .


Assessment of dose-dependent safety and efficacy of Chinese botulinum toxin type A ( Hengli BTX-A -LSB- HBTX-A -RSB- ) intramuscular injections on glabellar lines .


Four hundred eighty-eight BTX-A-naive participants were included in the double-blind trial and randomly divided into placebo ( n = @ ) , low-dose ( n = @ ) , and high-dose ( n = @ ) treatment groups for injection with saline solution , @ units and @ units of HBTX-A , respectively , at @ sites in the corrugator muscle and @ site in the procerus muscle .


Outcomes were recorded before treatment and after @ , @ , @ , and @ days , including glabellar line severity at maximum contraction and relaxation .


Significantly greater improvement was observed in both HBTX-A groups in comparison with the placebo group ( p < @ ) .


Better efficacy was obtained in the high-dose treatment group .


More participants developed adverse events after treatment with HBTX-A doses , than with the placebo ( p < @ ) .


Twenty-unit HBTX-A provided optimal improvement in glabellar lines , and its use might minimize injection frequency while maintaining acceptable safety .


While energy devices are ubiquitous in the operating room , they remain poorly understood and can result in significant complications .


The purpose of this study was to estimate the extent to which adding a novel bench-top component improves learning of SAGES ' Fundamental Use of Surgical Energy ( FUSE ) electrosurgery curriculum among surgical trainees .


Surgical residents participated in a @-h didactic electrosurgery ( ES ) course , based on the FUSE curriculum .


They were then randomized to one of two groups : an unstructured hands-on session where trainees used ES devices ( control group ) or a goal-directed hands-on training session ( Sim group ) .


Pre - and post-curriculum ( immediate and at @ months ) assessments included knowledge of ES ( multiple-choice examination ) , self-perceived competence for each of the @ course objectives ( questionnaire ) , and self-perceived comfort with performance of seven tasks related to safe use of ES .


Data expressed as median -LSB- interquartile range -RSB- , * p < @ .


@ ( @ control ; @ Sim ) surgical trainees completed the curriculum and assessments .


Baseline characteristics , including pre-curriculum exam and questionnaire scores , were similar .


Total score on the exam improved from @ % -LSB- @ ; @ -RSB- to @ % -LSB- @ ; @ -RSB- * for the entire cohort , with higher immediate post-curriculum scores in the Sim group compared to controls ( @ % -LSB- @ ; @ -RSB- vs. @ % -LSB- @ ; @ -RSB- * ) .


At @ months , performance on the exam declined in both groups , but remained higher in the Sim group ( @ % -LSB- @ ; @ -RSB- vs @ % -LSB- @ ; @ -RSB- * ) .


Participants in both groups reported feeling greater comfort and competence post-curriculum ( immediate and at @ months ) compared to baseline .


This improvement was greater in the Sim group with a higher proportion feeling `` Very Comfortable '' or `` Fully Competent '' ( Sim : @/@ tasks and @/@ objectives ; control : @/@ tasks and @/@ objectives ) .


A FUSE-based curriculum improved surgical trainees ' knowledge and comfort in the safe use of electrosurgical devices .


The addition of a structured interactive bench-top simulation component further improved learning and retention at @ months .


To evaluate the efficacy and safety of USL@ , Qudexy ( ) XR ( topiramate ) extended-release capsules , as an adjunctive treatment for refractory partial-onset seizures ( POS ) in adults taking one to three concomitant antiepileptic drugs .


In this global phase III study ( PREVAIL ; NCT@ ) , @ adults with POS were randomized @:@ to once-daily USL@ ( @ mg/day ) or placebo .


The primary and key secondary efficacy endpoints were median percent reduction in weekly POS frequency and responder rate ( proportion of patients with @ % reduction in seizure frequency ) .


Seizure freedom was also assessed .


Safety ( adverse events , clinical and laboratory findings ) , as well as treatment effects on quality of life ( QOLIE-@-P ) and clinical global impression of change ( CGI-C ) , were evaluated .


Across the entire @-week treatment phase , USL@ significantly reduced the median percent seizure frequency and significantly improved responder rate compared with placebo .


Efficacy over placebo was observed early in treatment , in patients with highly refractory POS , and in those with the most debilitating seizure types ( i.e. , complex partial , partial secondarily generalized ) .


USL@ was safe and generally well tolerated with a low incidence of neurocognitive adverse events .


USL@ was associated with significant clinical improvement without adversely affecting quality of life .


The PREVAIL phase III clinical study demonstrated that once-daily USL@ ( @ mg/day ) significantly improved seizure control and was safe and generally well tolerated with few neurocognitive side effects .


Hypertension is one of the most common chronic diseases .


Hypertensive patients who intend to control blood pressure need professional medical assistance .


Auricular acupressure is a patient-dependent task , wherein a person does not have to rely on a healthcare professional to self-perform the task .


To evaluate the effects of auricular acupressure on heart rate variability ( HRV ) and quality of life ( QoL ) in patients with hypertension .


A randomized controlled trial with permuted block randomization was used .


In total , @ participants from a medical teaching hospital were randomly assigned to the experimental group that received auricular acupressure for @ weeks , and the control group that received only routine care of equal duration .


Outcomes were assessed through HRV parameters , heart rate , blood pressure , and QoL before and after the auricular acupressure intervention .


After the adjustment of disease duration and mental health , a significant difference existed between the two groups in body pain ( p = @ ) and mental health ( p = @ ) of QoL , but not in HRV parameters , heart rate , blood pressure , and overall QoL ( p > @ ) .


Acupressure can be applied at the acupoints of shenmen , sympathesis , kidney , liver , heart , and subcortex to improve physical pain and mental health of QoL for hypertensive patients .


Auricular acupressure is acceptable and feasible although it does not support physiological benefits .


Further studies are warranted to assure the effects of using auricular acupressure as an adjunctive care for patients with hypertension .


The treatment of adhesive capsulitis ( AC ) is a well-known , complicated , and long process .


Recent studies have shown that pulsed radiofrequency ( PRF ) lesioning of the suprascapular nerve ( SSN ) using a fluoroscopy - or computed tomography-guided technique can alleviate shoulder pain .


However , there are no studies of PRF lesioning of the SSN in patients with AC using ultrasound-guided ( UG ) techniques , except for @ case reports .


In this study , we compared the effect of physical therapy alone with physical therapy and PRF lesioning of the SSN using a UG technique .


Sixty patients with AC were included in the study .


Patients were randomized into the following @ groups : the intervention group containing patients who received @ weeks of physical therapy after @ treatment of PRF lesioning of the SSN , and the control group containing patients who received @ weeks of physical therapy alone .


All outcome measurements including visual analog scale ( VAS ) , shoulder pain and disability index , and passive range of motion ( PROM ) were performed at @ , @ , @ , and @ weeks after treatment .


Forty-two patients ( @ patients in each group ) completed the study .


The intervention group had a notably shorter time to onset of significant pain relief ( @ @ vs @ @ days ; P < @ ) and noticeable reduction of VAS score at week @ ( @ % vs @ % ) than the control group ( P < @ ) .


All measured variables in the intervention group and most variables in the control group showed significant improvement from the baseline ( P < @ ) .


A comparison of the @ groups indicated significantly greater improvement in the intervention group at all times in VAS and shoulder pain and disability index scores ( all P < @ ) , and for most gain of PROM ( P < @ ) .


There were no serious adverse effects or complications in either group .


This study indicates that the application of PRF lesioning of the SSN using a UG technique combined with physical therapy provided better and faster relief from pain , reduced disability , and improved PROM when compared with physical therapy alone in patients with AC , an effect that persisted for at least @ weeks .


To analyse the influence of serving method on compliance and consumption of nutritional supplement drinks in older adults with cognitive impairment .


Oral nutritional supplement drinks have positive benefits on increasing nutritional status in undernourished older people leading to weight gain .


However , consumption of these drinks is low and therefore limits their effectiveness .


This study was a non-blind randomized control trial where participants either consumed nutritional supplement drinks in a glass/beaker or consumed them through a straw inserted directly into the container .


Participants with long-standing cognitive impairment were recruited from nursing homes ( n = @ ) and hospitals ( n = @ ) .


Participants were randomized to serving method .


Nursing and care staff were instructed to give the supplement drinks three times per day on alternate days over a week by the allocated serving method .


The researcher weighed the amount of supplement drink remaining after consumption .


Data were collected over @ months in @-@ .


Forty-five people participated in this study , mean age @ ( sd @ ) years .


After randomization , there was no significant difference between the baseline characteristics of the two groups .


Participants randomized to consume nutritional drinks from a glass/beaker drank statistically significantly more than those who consumed them via a straw inserted directly into the container .


However , supplements allocated to be given in a glass/beaker were more frequently omitted .


Nutritional supplement drinks should be given to people with dementia who are able to feed themselves in a glass or a beaker if staffing resources allow ( NIHR CSP ref @ ) .


To evaluate the efficacy of a @-week administration of a @ % chlorhexidine mouthwash in the short-term treatment of chronic periodontitis patients and the impact of this product when administered twice by pocket irrigation .


Sixty patients were enrolled in a single-centre , placebo-controlled , randomized study with the blind allocation of product to two parallel groups .


Clinical assessments were performed , and samples from six selected subgingival sites were collected for microbial analysis by culture at baseline , D@ and D@ .


Three of the six sites were randomly selected and were treated by subgingival irrigation with the same @ % chlorhexidine product at D@ and D@ .


A subsequent statistical analysis was performed using the paired Student 's t-test and Wilcoxon rank sum test for within-group analyses ; analysis of variance and the Kruskall-Wallis test were used for between-group analyses .


Two-week treatment with a @ % chlorhexidine mouthwash slightly reduced the gingival inflammation associated with periodontitis .


We observed a significant decrease in Gram-negative , facultative anaerobes and micro-aerophiles , and a significant increase in Gram-positive cocci .


No increase in the treatment effect was demonstrated by irrigation of the periodontal pockets .


The @ % chlorhexidine mouthwash showed limited beneficial effects in the treatment of periodontitis patients .


The EUROACTION PLUS trial measured the effectiveness of a nurse-led preventive cardiology programme ( EUROACTION ) offering intensive smoking cessation PLUS optional varenicline for persistent high CVD risk smokers to reduce overall cardiovascular risk compared with usual care ( UC ) in general practice ( GP ) .


A parallel group randomized controlled trial in @ GP in Italy , Netherlands , Spain , and UK .


Six hundred and ninety-six current smokers , ( @ vascular disease and @ high total CVD risk ) , were randomized @ to EUROACTION PLUS ( EA + ) and @ to UC .


Specially , trained nurses offered the EUROACTION preventive cardiology programme addressing smoking cessation , diet , physical activity , and risk factor management to reduce overall cardiovascular risk .


The primary endpoint was @ day point prevalence of self-reported abstinence ( validated breath carbon monoxide < @ p.p.m. ) at @ weeks .


Secondary outcomes included dietary habits , physical activity , weight , blood pressure ( BP ) , lipid , and glucose management .


One hundred and seventy-seven ( @ % ) EA + patients ( @ % opted to use varenicline ) were abstinent vs. @ ( @ % ) in UC ; OR @ ( @ % CI : @-@ @ ) .


The Mediterranean diet score of @ in @ ( @ % ) EA + patients vs. @ ( @ % ) in UC ; OR @ ( @ % CI : @-@ @ ) .


Physical activity target achieved in @ ( @ % ) EA + patients vs. @ ( @ % ) in UC ; OR @ ( @ % CI : @-@ @ ) .


Target BP ( < @/@ mm Hg ) achieved in @ ( @ % ) EA + patients vs. @ ( @ % ) in UC , OR @ ( @ % CI : @-@ @ ) with no difference in antihypertensive drugs .


There were no differences in management of cholesterol or glucose .


The EUROACTION preventive cardiology programme in high CVD risk smokers using optional varenicline substantially increased smoking abstinence over @ weeks and also reduced overall cardiovascular risk compared with UC .


REC reference : @/H@/@ ; EudraCT number : @-@-@ ; http://www.controlled-trials.com/ISRCTN@ , @ February @ , date last accessed .


Effectiveness of advanced technologies for diabetes management may differ depending on national healthcare models or population characteristics .


In the setting of a cross-national trial , we aimed to compare efficacy of sensor-augmented pump ( SAP ) therapy in the United States ( US ) and Canada .


In the clinical trial Sensor-Augmented Pump Therapy for A@C Reduction ( STAR @ ) , @ adults with type @ diabetes were randomly allocated to either SAP or glargine-based multiple daily injection ( MDI ) therapy at @ US sites ( n = @ ) and @ Canadian sites ( n = @ ) .


A bootstrap analysis was performed to confirm significant differences in baseline characteristics .


For the primary analysis , we compared the baseline to @-year change in glycated hemoglobin ( A@C ) between Canadian and US subjects .


At baseline , compared with US subjects , Canadian subjects were more likely to be students ( @ % vs. @ % , p < @ ) and to consume alcohol ( @ % vs. @ % , p < @ ) .


Although Canadian subjects had greater A@C reductions from baseline compared with US subjects ( p = @ ) , the incremental benefit of SAP was similar in the US ( SAP compared with MDI,-@ @ % @ % vs.-@ @ % @ % , p < @ ) and Canada ( -@ % @ % vs.-@ @ % @ % , p < @ ) .


Mean sensor use was significantly higher in Canada than in the US ( @ % vs. @ % of the time , p < @ ) .


Despite differences in baseline characteristics and sensor adherence , SAP efficacy was similar between US and Canadian participants .


As long as the intervention is administered with a similar level of expertise as was conducted in the trial , it is likely to be applicable in diverse clinical practice settings .


To evaluate the effect of intravitreal ciliary neurotrophic factor ( CNTF ) implant on mean macular thickness ( MMT ) in eyes with retinitis pigmentosa using high-resolution Fourier domain optical coherence tomography imaging .


A cohort of @ patients ( CNTF-@ : n = @ ; CNTF-@ : n = @ ) enrolled in Neurotech sponsored Phase @ clinical trial underwent Fourier domain optical coherence tomography imaging .


A @ % change in MMT from baseline or fellow eye was considered as a measurable change .


Two patients enrolled in the CNTF-@ study received low-dose implant .


At @ months , a change in MMT from -@ m to @ m from baseline was noted .


Six patients received high-dose implant ( CNTF-@ : n = @ ; CNTF-@ : n = @ ) .


In CNTF-@ group , @ eye showed an increase in MMT by @ m ( +@ % ) from baseline at @ months .


In CNTF-@ group , @ eye had an increase in MMT of @ m ( +@ % ) from baseline at @ months ; second eye had increase in MMT of @ m ( +@ % ) from contralateral eye .


Amongst these @ responsive high-dose implant eyes , overall thickening of the retina could not be attributed to any specific retinal layer .


A heterogeneous dose-dependent response on MMT was noted in eyes treated using intravitreal CNTF implant for retinitis pigmentosa .


We recommend corroboration of our findings with Neurotech sponsored clinical trial results .


To assess the effect of initiating insulin treatment on quality of life of patients with type @ diabetes ( T@DM ) in the @-week All-to-Target trial ( NCT@ ) .


Patient-reported outcomes from a phase IV , multicentre , randomised , open-label , parallel-group study were analysed .


Participants were randomised to : insulin glargine with up to one insulin glulisine injection ( G + @ ) ; insulin glargine with stepwise addition of up to three insulin glulisine injections ( G + @ ) ; or twice-daily premixed @/@ insulin protamine-aspart/aspart ( PM-@ ) .


Patient-reported outcome questionnaires were administered at weeks @ , @ , @ , @ , @ , @ and @ .


There were no between-group differences in the Psychosocial Adjustment to Illness State-Self Report ( PAIS-SR ) or in the EuroQoL Group Five-Dimension Self-Report Index Questionnaire ( EQ-@D ) from baseline to week @ ; however , PAIS-SR scores improved significantly over this period in the G + @ group ( p = @ ) and EQ-@D scores worsened significantly in the PM-@ group ( p = @ ) .


Hypoglycemia Fear Survey Behaviour and Worry subscales worsened significantly for all groups , with greater deterioration being observed in the PM-@ group than in the G + @ group ( Behaviour , p = @ ; Worry , p = @ ) and G + @ groups ( Behaviour , p = @ ; Worry , p = @ ) .


Total scores on the Diabetes Quality of Life ( DQoL ) questionnaire improved more in the G + @ group than in the PM-@ group over the study period ( p = @ ) , with all groups showing a significant improvement in DQoL score over time .


Insulin glargine-based regimens showed advantages over premixed insulin in a number of patient-reported outcome measures .


The potential impact on fear of hypoglycaemia may be of particular relevance when addressing the major barriers to early insulin treatment .


This study examined the effects of atomoxetine ( ATX ) and OROS methylphenidate ( MPH ) on laboratory measures of inhibitory control and attention in youth with attention-deficit/hyperactivity disorder ( ADHD ) .


It was hypothesized that performance would be improved by both treatments , but response profiles would differ because the medications work via different mechanisms .


One hundred and two youth ( @ male ; mean age = @ @ years ) with ADHD received ATX ( @ @ mg/kg ) and MPH ( @ @ mg ) in a randomized , double-blind , crossover design .


Medication was titrated in @-@-week blocks separated by a @-week placebo washout .


Inhibitory control and attention measures were obtained at baseline , following washout , and at the end of each treatment using Conners ' Continuous Performance Test II ( CPT-II ) , which provided age-adjusted T-scores for reaction time ( RT ) , reaction time variability ( RT variability ) , and errors .


Repeated-measures analyses of variance were performed , with Time ( premedication , postmedication ) and Treatment type ( ATX , MPH ) entered as within-subject factors .


Data from the two treatment blocks were checked for order effects and combined if order effects were not present .


Clinicaltrials.gov : NCT@ .


Main effects for Time on RT ( p = @ ) , RTSD ( p = @ ) , and omission errors ( p = @ ) were significant .


A significant Drug Time interaction indicated that MPH improved RT , RTSD , and omission errors more than ATX ( p < @ ) .


Changes in performance with treatment did not correlate with changes in ADHD symptoms .


MPH has greater effects than ATX on CPT measures of sustained attention in youth with ADHD .


However , the dissociation of cognitive and behavioral change with treatment indicates that CPT measures can not be considered proxies for symptomatic improvement .


Further research on the dissociation of cognitive and behavioral endpoints for ADHD is indicated .


Low back pain is a common and costly health care problem .


This pilot study evaluated the sensitivity of the @-stopwatch and Paris plinth methodologies for assessing time-to-onset of pain relief and flexibility , respectively , with continuous , low-level heatwrap therapy .


Subjects aged @ to @ years with at least moderate baseline acute low back pain were randomly assigned to either heatwrap or oral placebo for @ hours .


Unheated wrap ( sham ) and oral ibuprofen were included for blinding purposes only .


Sixty-one subjects were randomly assigned to either heatwrap ( n = @ ) , oral placebo ( n = @ ) , sham wrap ( n = @ ) , or oral ibuprofen ( n = @ ) .


Median time to confirmed first perceptible pain relief and to meaningful pain relief were significantly shorter for the heatwrap group compared with those assigned to oral placebo ( @ vs > @ min and @ vs > @ min , respectively ; P < @ for both ) .


Among subjects receiving the heatwrap , @ % reported first perceptible and meaningful relief , compared with @ % receiving oral placebo .


Subjective measures of pain relief , back stiffness , and global evaluation were more sensitive in detecting treatment differences than the plinth assessments of flexibility , range of motion , and pain .


Three adverse events were reported as mild in severity and considered unrelated to study treatment .


The @-stopwatch methodology is a viable approach for assessing onset of analgesia in low back pain ; however , the plinth may not be a reliable method for assessing flexibility .


Consistent with published studies involving much larger sample sizes , the heatwrap provided significantly faster and sustained pain relief than oral placebo in subjects with acute low back pain .


Clinical Trial Identifier : NCT@ .


Trikatu is composed of dried fruits of Piper nigrum L and Piper retrofractum Vahl , and dried rhizomes of Zingiber officinale R. Although this preparation has been used to relieve pruritis , pain , and inflammation for a long time , there is no clinical evidence to confirm its efficacy and safety .


Therefore , we performed a double-blind , within person-randomized controlled study of @ healthy volunteers to determine efficacy and safety of topical Trikatu on mosquito bite reactions .


All subjects were bitten by Aedes aegypti laboratory mosquitoes on their forearms and they were randomly assigned arms to apply either Trikatu or reference product on the mosquito bite papule .


The main outcome was the difference of papule size reduction at @ min , measured by a caliper , between the Trikatu and reference arms .


Pruritis , redness , pain , and patient satisfaction were assessed at @ , @ , @ , @ , and @ min as secondary outcomes .


There were no significant differences between treatment and reference arms on any outcome at any time of measurement .


Trikatu did not show additional effects for relieving mosquito bite reaction as compared with the reference product containing camphor , menthol , and eucalyptus .


For further study , it is very important to consider a proper selection of subjects , comparator product , and concentration of extract when Trikatu preparation is investigated .


We assessed the efficacy and safety of brodalumab , a human monoclonal antibody against interleukin-@ receptor A ( IL@RA ) , in a phase @ , randomized , double-blind , placebo-controlled study involving patients with psoriatic arthritis .


We randomly assigned patients with active psoriatic arthritis to receive brodalumab ( @ or @ mg subcutaneously ) or placebo on day @ and at weeks @ , @ , @ , @ , @ , and @ .


At week @ , patients who had not discontinued their participation in the study were offered open-label brodalumab ( @ mg ) every @ weeks .


The primary end point was @ % improvement in American College of Rheumatology response criteria ( ACR @ ) at week @ .


Of the @ patients who underwent randomization ( @ in the brodalumab @-mg group , @ in the brodalumab @-mg group , and @ in the placebo group ) , @ completed the double-blind phase and @ completed @ weeks of the open-label extension .


At week @ , the brodalumab @-mg and @-mg groups had higher rates of ACR @ than the placebo group ( @ % -LSB- P = @ -RSB- and @ % -LSB- P = @ -RSB- , respectively , vs. @ % ) ; they also had higher rates of @ % improvement ( ACR @ ) ( @ % -LSB- P = @ -RSB- and @ % -LSB- P = @ -RSB- vs. @ % ) .


Rates of @ % improvement were not significantly higher in the brodalumab groups .


Similar degrees of improvement were noted among patients who had received previous biologic therapy and those who had not received such therapy .


At week @ , ACR @ response rates in the brodalumab @-mg and @-mg groups were @ % and @ % , respectively , as compared with @ % among patients who switched from placebo to open-label brodalumab ; responses were sustained through week @ .


At week @ , serious adverse events had occurred in @ % of patients in the brodalumab groups and in @ % of those in the placebo group .


Brodalumab significantly improved response rates among patients with psoriatic arthritis .


Larger studies of longer duration are necessary to assess adverse events .


( Funded by Amgen ; ClinicalTrials.gov number , NCT@ . )


Prolonged grief disorder ( PGD ) is a potentially disabling condition that affects approximately @ % of bereaved people .


Grief-focused cognitive behavior therapy ( CBT ) has been shown to be effective in treating PGD .


Although treatments for PGD have focused on exposure therapy , much debate remains about whether exposure therapy is optimal for PGD .


To determine the relative efficacies of CBT with exposure therapy ( CBT/exposure ) or CBT alone for PGD .


A randomized clinical trial of @ patients with PGD attending the outpatient University of New South Wales Traumatic Stress Clinic from September @ , @ , through June @ , @ .


All patients received @ weekly @-hour group therapy sessions that consisted of CBT techniques .


Patients also received @ individual sessions , in which they were randomized to receive exposure therapy for memories of the death or supportive counseling .


Measures of PGD by clinical interview and self-reported measures of depression , cognitive appraisals , and functioning at the @-month follow-up .


Intention-to-treat analyses at follow-up indicated a significant quadratic timetreatment condition interaction effect ( B -LSB- SE -RSB- , @ -LSB- @ -RSB- ; t@ @ = @ -LSB- @ % CI , @-@ @ -RSB- ; P = @ ) , indicating that CBT/exposure led to greater PGD reductions than CBT alone .


At follow-up , CBT/exposure led to greater reductions in depression ( B -LSB- SE -RSB- , @ -LSB- @ -RSB- ; t@ @ = @ -LSB- @ % CI , @-@ @ -RSB- ; P = @ ) , negative appraisals ( B -LSB- SE -RSB- , @ -LSB- @ -RSB- ; t@ @ = @ -LSB- @ % CI , @-@ @ -RSB- ; P = @ ) , and functional impairment ( B -LSB- SE -RSB- , @ -LSB- @ -RSB- ; t@ @ = @ -LSB- @ % CI , @-@ @ -RSB- ; P = @ ) than CBT alone .


In terms of treatment completers , fewer patients in the CBT/exposure condition at follow-up ( @ % ) met criteria for PGD than those in the CBT condition ( @ % ) ( odds ratio , @ ; @ % CI , @-@ @ ; @ = @ ; P = @ ) .


Including exposure therapy that promotes emotional processing of memories of the death is an important component to achieve optimal reductions in PGD severity .


Facilitating emotional responses to the death may promote greater changes in appraisals about the loss , which are associated with symptom reduction .


Promotion of emotional processing techniques in therapies to treat patients with PGD is needed .


Colonoscopy is the recommended screening procedure for first-degree relatives of patients with colorectal cancer ( CRC ) , but few studies have compared its efficacy for CRC detection with that of other screening strategies .


We conducted a controlled randomized trial to compare the efficacy of repeated fecal immunochemical tests ( FITs ) and colonoscopy in detecting advanced neoplasia ( advanced adenoma or CRC ) in family members of patients with CRC .


In a prospective study , @ first-degree relatives of patients with CRC were randomly assigned ( @:@ ratio ) to receive a single colonoscopy examination or @ FITs ( @/year for @ years ; OC-Sensor ; cutoff @ g hemoglobin/g feces , corresponding to @ ng hemoglobin/mL buffer ) .


The strategies were considered to be equivalent if the @ % confidence interval of the difference for the detection of advanced neoplasia was @ % .


Follow-up analyses were performed to identify false-negative FIT results and interval CRCs .


Of all eligible asymptomatic first-degree relatives , @ were included in the colonoscopy group and @ in the FIT group .


In the intention-to-screen analysis , advanced neoplasia was detected in @ ( @ % ) and @ ( @ % ) first-degree relatives in the FIT and colonoscopy groups , respectively ( odds ratio = @ ; @ % confidence interval : @-@ @ ; P = @ ) .


In the per-protocol analysis , @ first-degree relatives ( @ % ) in the FIT group and @ ( @ % ) in the colonoscopy group had advanced neoplasia ( odds ratio = @ ; @ % confidence interval : @-@ @ ; P = @ ) .


FIT missed @ of @ advanced adenomas but no CRCs .


The FIT strategy required endoscopic evaluation of @-fold fewer individuals to detect @ advanced neoplasia than the colonoscopy strategy .


Repeated FIT screening ( @/year for @ years ) detected all CRCs and proved equivalent to colonoscopy in detecting advanced neoplasia in first-degree relatives of patients with CRC .


This strategy should be considered for populations where compliance with FITs is higher than with colonoscopy .


ClinicalTrials.gov number : NCT@ ( COLONFAM Study ) .


We had for aim to compare the effects of intra-operative opioid analgesia according to the drug kinetics .


We conducted a prospective , controlled , randomized , double-blinded trial including @ patients scheduled for ambulatory multiple third molar avulsion .


The general anesthesia , performed with propofol and analgesia was a target-controlled infusion of either remifentanil or sufentanil .


The anesthesia was set to reach an optimal bispectral index and adjusted to a clinical target throughout the procedure .


The main endpoints were : postoperative request for morphine and other opioids ; postoperative pain ; postoperative adverse effects of opioids .


In the post-operative care unit ( French acronym PACU ) , patients who received remifentanil were extubated earlier ( @ vs. @ min . )


, but had more pain and required twice more morphine for analgesia ( @ vs. @ mg ) , than those who had received sufentanil .


However , the need for post-surgery oral opioid intake was greater in the sufentanil group , so the overall postoperative opioid consumption and patient satisfaction were identical in both groups .


The time spent in the PACU was also identical for both groups .


Using an ultra-short kinetic opioid such as remifentanil does not seem useful , since the shorter delay before extubation is compensated by a greater need for morphine in the PACU .


The first oxycodone once daily ( OOD ) has been developed and after successful pharmacokinetic characterization , therapeutic efficacy and safety were compared to an established oxycodone twice daily ( OTD : Oxygesic/OxyContin , Mundipharma ) .


A randomized , double-blind , multicenter , cross-over , non-inferiority study was conducted in patients ( n = @ ) with chronic malignant or non-malignant pain .


The new OOD was compared to OTD at identical total daily doses ( TDD : @-@mg / day ) employing intensive , five times daily current pain ( @-@mm visual analog scale , VAS ) and twice daily @h recalled pain assessments as well as safety parameters such as nausea and sedation ( VAS ) over @ days for each treatment ( after a @day run-in phase ) .


There was no significant difference in analgesic potency detected between the two treatments based on @ % CI for difference in the daily mean current pain ( -@ mm VAS ) over @ days , determined as -@ to @ mm VAS .


A difference @mm VAS indicated non-inferiority of OOD , i.e. lack of clinically relevant difference in analgesia .


Intake of rescue medication had no effect on study results as evaluated by ANCOVA .


The difference in adverse events ( AEs ) between the two treatments did not reach significance , as @ % and @ % of patients experienced treatment-related AEs while on OOD and OTD , respectively .


Advantages for OOD regarding consistency of analgesia ( i.e. use of rescue medication , current and recalled pain ) and sedation did not reach statistical significance in this limited study population .


Despite the small number of patients and short study duration , the results support the conclusion that new OOD is ( at least ) equivalent to established OTD regarding safety and efficacy .


To investigate factors mediating the effects of a European school-based intervention ( Unplugged ) based on a social influence approach to youths ' substance use .


Schools in seven European countries ( n = @ , including @,@ pupils ) were randomly assigned to an experimental condition ( Unplugged curriculum ) or a control condition ( usual health education ) .


Data were collected before ( pretest ) and @ months after the end of the program ( posttest ) .


Multilevel multiple mediation models were applied to the study of effect mediation separately for tobacco , alcohol , and cannabis use .


Analyses were conducted on the whole sample , and separately on baseline users and nonusers of each substance .


Compared with the control group , participants in the program endorsed less positive attitudes toward drugs ; positive beliefs about cigarettes , alcohol , and cannabis ; and the normative perception of peers using tobacco and cannabis .


They also increased in knowledge about all substances and refusal skills toward tobacco .


Decreased positive attitudes toward drugs , increase in refusal skills , and reappraisal of norms about peer using tobacco and cannabis appeared to mediate the effects of the program on the use of substances .


However , mediating effects were generally weak and some of them were only marginally significant .


This study lends some support to the notion that school-based programs based on a social influence model may prevent juvenile substance use through the modification of attitudes , refusal skills , and normative perceptions .


Patients with heart failure ( HF ) have left ventricular dysfunction and reduced mean arterial pressure ( MAP ) .


Increased adrenergic drive causes vasoconstriction and vessel resistance maintaining MAP , while increasing peripheral vascular resistance and conduit vessel stiffness .


Increased pulse pressure ( PP ) reflects a complex interaction of the heart with the arterial and venous systems .


Increased PP is an important risk marker in patients with chronic HF ( CHF ) .


Non-invasive ventilation ( NIV ) has been used for acute decompensated HF , to improve congestion and ventilation through both respiratory and hemodynamic effects .


However , none of these studies have reported the effect of NIV on PP .


The objective of this study was to determine the acute effects of NIV with CPAP on PP in outpatients with CHF .


Following a double-blind , randomized , cross-over , and placebo-controlled protocol , twenty three patients with CHF ( @ males ; @ years ; BMI @ kg/cm@ , NYHA class II , III ) underwent CPAP via nasal mask for @ min in a recumbent position .


Mask pressure was @ cmH@O , whereas placebo was fixed at @-@ cmH@O .


PP and other non invasive hemodynamics variables were assessed before , during and after placebo and CPAP mode .


CPAP decreased resting heart rate ( Pre : @ ; vs. Post @ min : @ bpm ; p < @ ) and MAP ( CPAP : @ ; vs. control @ mmHg ; p < @ post @ min ) .


CPAP decreased PP ( CPAP : @ pre to @ mmHg post ; vs. control : @ mmHg , pre to @ post p < @ post @ min ) .


NIV with CPAP decreased pulse pressure in patients with stable CHF .


Future clinical trials should investigate whether this effect is associated with improved clinical outcome .


This study aims to evaluate the role of a decision aid intervention in knowledge of menopausal symptom management .


Five hundred fifteen U.S. women who had menopausal symptoms and had discussed symptom management with providers within the past @ months were assigned to either receive a decision aid or not .


Participants completed a telephone survey @ weeks after enrollment to assess knowledge .


Overall knowledge scores and knowledge scores for general symptoms , benefits of hormone therapy , and risks of HT were compared between the decision aid arm and the control arm .


Four hundred one women completed the survey .


Participants in the decision aid arm had a significantly higher mean ( SD ) knowledge score ( @ % -LSB- @ % -RSB- ) compared with the control arm ( @ % -LSB- @ % -RSB- ; P = @ ) .


Specifically , participants in the decision aid arm had significantly higher scores for general symptoms ( mean difference , @ ; @ % CI , @ to @ ; P < @ ) and knowledge about benefits of HT ( mean difference , @ ; @ % CI , @ to @ ; P = @ ) compared with the control arm .


However , scores on knowledge about HT risks were not different between the arms ( mean difference , @ ; @ % CI , -@ to @ ; P = @ ) .


The decision aid arm has greater knowledge of menopausal symptom management compared with the control arm , although the difference is small .


In general , there is a considerable lack of knowledge about menopausal symptoms and HT risks .


To examine the association between odor identification deficits and future mortality in a multiethnic community cohort of older adults .


Participants were evaluated with the @-item University of Pennsylvania Smell Identification Test ( UPSIT ) .


Follow-up occurred at @-year intervals with information on death obtained from informant interviews and the National Death Index .


During follow-up ( mean = @ years , standard deviation = @ ) , @ of @,@ ( @ % ) participants died .


Participants who died were more likely to be older ( p < @ ) , be male ( p < @ ) , have lower UPSIT scores ( p < @ ) , and have a diagnosis of dementia ( p < @ ) .


In a Cox model , the association between lower UPSIT score and mortality ( hazard ratio -LSB- HR -RSB- = @ per point interval , @ % confidence interval -LSB- CI -RSB- = @-@ @ , p < @ ) persisted after controlling for age , gender , education , ethnicity , language , modified Charlson medical comorbidity index , dementia , depression , alcohol abuse , head injury , smoking , body mass index , and vision and hearing impairment ( HR = @ , @ % CI = @-@ @ , p < @ ) .


Compared to the fourth quartile with the highest UPSIT scores , HRs for mortality for the first , second , and third quartiles of UPSIT scores were @ ( @ % CI = @-@ @ ) , @ ( @ % CI = @-@ @ ) , and @ ( @ % CI = @-@ @ ) , respectively .


Participant mortality rate was @ % in the lowest quartile of UPSIT scores ( anosmia ) and @ % in the highest quartile of UPSIT scores .


Impaired odor identification , particularly in the anosmic range , is associated with increased mortality in older adults even after controlling for dementia and medical comorbidity .


To compare the efficacy of air and octafluoropropane ( C@F@ ) in treating rhegmatogenous retinal detachments with inferior breaks after @-gauge pars plana vitrectomy .


A prospective , randomized comparative interventional study .


Sixty-four patients with rhegmatogenous retinal detachment with inferior breaks underwent pars plana vitrectomy with air ( @ eyes ) or gas ( @ eyes ) tamponade .


Anatomical and visual outcomes of the two groups were compared .


The mean follow-up period was @ @ months .


Significant differences were identified regarding prone positioning period ( P < @ ) , intraocular pressure ( P < @ ) , and gas volume ( P = @ ) on the first postoperative day .


The single-operation success rates for the air and gas groups were @ % and @ % ( P = @ ) , and the final surgery success rates increased to @ % and @ % ( P = @ ) , respectively .


The single-operation success rate between the groups was not statistically significant , even after adjustment for confounding factors .


Multivariate logistic regression also indicated that the number of involved retinal quadrants ( odds ratio = @ , P = @ ) was an independent predictor of surgery failure .


The only postoperative complication observed was new or missed breaks , which occurred in @ patients ( @ % ) .


Air had equivalent tamponade effects to C@F@ , with a shorter prone positioning period , fewer complications , and less expense , in the surgical management of rhegmatogenous retinal detachment with inferior breaks .


The purpose of this study was to determine whether sonographic measurement of the inferior vena cava ( IVC ) in college football players during preseason camp is a reliable way to detect and monitor dehydration .


Our primary hypothesis was that IVC diameter measurements , the postpractice caval index , and expiratory diameter were significantly related to percent weight loss after a preseason football practice .


A prospective cohort sample of Division I intercollegiate football players in preseason training camp was recruited before practice .


All football players on the active roster who were at least @ years of age were eligible to participate in the study .


Sonographic IVC measurements were obtained in the long axis using either the subcostal or subxiphoid approach during inspiration and expiration both before and after an approximately @-hour practice with moderate to high levels of exertion at high ambient temperatures .


Player weights were recorded in the locker room before and after practice .


A total of @ prepractice and postpractice sonographic measurements were obtained .


The postpractice expiratory IVC diameter was significantly related to percent weight loss after practice ( R ( @ ) = @ ; P = @ ) , with the IVC diameter being significantly inversely correlated with percent weight loss ; the regression coefficient was -@ ( @ % confidence interval , -@ to -@ ) .


There was no statistically significant relationship between percent weight loss and the postpractice caval index ; the regression coefficient was @ ( @ % confidence interval , -@ to @ ; R ( @ ) = @ ; P = @ ) .


The postpractice expiratory IVC diameter was significantly related to percent weight loss after practice , whereas the caval index was not found to correlate with weight loss .


We compared three methods of ultrasound-guided axillary brachial plexus block , which were single , and double perivascular ( PV ) infiltration techniques , and a perineural ( PN ) injection technique .


@ patients of American Society of Anesthesiologists physical status I-II undergoing surgery of the forearm , wrist , or hand were randomly allocated to three groups .


@ % lidocaine with epinephrine @ g/mL was used .


The PN group ( n = @ ) received injections at the median , ulnar , and radial nerve with @ mL for each nerve .


The PV@ group ( n = @ ) received a single injection of @ mL at @-o'clock position of the axillary artery .


The PV@ group ( n = @ ) received two injections of @ mL each at @-o'clock and @-o'clock position .


For all groups , musculocutaneous nerve was blocked separately .


The PN group ( @ sec ) had the longest anesthetic procedure duration than PV@ ( @ sec ) and PV@ ( @ sec ) .


There were no differences in onset time .


The average induction time was longer in PN group ( @ sec ) than PV@ ( @ sec ) and PV@ ( @ sec ) .


There were no differences in the success rate ( @ % vs. @ % vs. @ % ) .


The PV injection technique consisting of a single injection in @-o'clock position above the axillary artery in addition to a musculocutaneous nerve block is equally effective and less time consuming than the PN technique .


Therefore , the PV technique is an alternative method that may be used in busy clinics or for difficult cases .


Pasireotide , a multireceptor-targeted somatostatin analogue with efficacy in Cushing 's disease and acromegaly , can affect glucose metabolism due to inhibition of insulin secretion and incretin hormone responses .


A study was therefore conducted to evaluate different antihyperglycemic drugs in the management of pasireotide-associated hyperglycemia .


This was a @-week , Phase I , open-label study .


Healthy male volunteers were randomized to pasireotide @ g sc bid alone or co-administered with metformin @ mg po bid , nateglinide @ mg po tid , vildagliptin @mg po bid , or liraglutide @ mg sc qd .


An oral glucose tolerance test ( OGTT ) was performed on days @ and @ to evaluate effects on serum insulin , plasma glucose and glucagon levels .


Safety/tolerability and pharmacokinetic effects were also evaluated .


Ninety healthy male volunteers were enrolled ( n = @ per arm ) .


After @ days of treatment , plasma glucose AUC post-OGTT increased by @ % with pasireotide alone .


The effect was reduced by @ % , @ % , @ % and @ % with co-administration of metformin , nateglinide , vildagliptin and liraglutide , respectively .


On day @ , compared with pasireotide alone , the decrease in serum insulin was attenuated with nateglinide , metformin , liraglutide and vildagliptin co-administration ( levels were @ % , @ % , @ % and @ % higher , respectively ) .


Minimal changes in plasma glucagon were observed .


Adverse events were consistent with the safety profiles of the drugs used .


Vildagliptin and liraglutide were most effective in minimizing pasireotide-associated hyperglycemia in healthy volunteers .


Approximately @ % higher grade premalignant oral intraepithelial neoplasia ( OIN ) lesions will progress to oral cancer .


Although surgery is the OIN treatment mainstay , many OIN lesions recur , which is highly problematic for both surgeons and patients .


This clinical trial assessed the chemopreventive efficacy of a natural product-based bioadhesive gel on OIN lesions .


This placebo-controlled multicenter study investigated the effects of topical application of bioadhesive gels that contained either @ % w/w freeze-dried black raspberries ( BRB ) or an identical formulation devoid of BRB placebo to biopsy-confirmed OIN lesions ( @ g q.i.d. , @ weeks ) .


Baseline evaluative parameters ( size , histologic grade , LOH events ) were comparable in the randomly assigned BRB ( n = @ ) and placebo ( n = @ ) gel cohorts .


Evaluative parameters were : histologic grade , clinical size , and LOH .