This study aims to evaluate the efficacy and tolerability of vortioxetine @ - , @ - and @-mg once-daily doses vs. placebo in the treatment of generalised anxiety disorder ( GAD ) .


In this @-week , multicentre , double-blind , placebo-controlled , parallel-group , phase @ study , patients with a primary GAD diagnosis were randomised to receive placebo ( n = @ ) , vortioxetine @ mg , vortioxetine @ mg , vortioxetine @ mg or duloxetine @ mg once daily ( n = @ each ) .


The primary end-point , mean change from baseline in Hamilton Anxiety Scale ( HAM-A ) total score and key secondary end-points for the @ - and @-mg vortioxetine doses were analysed in a prespecified sequential testing procedure ( all at week @ ) .


Sexual dysfunction was evaluated using the Arizona Sexual Experiences Scale .


Differences from placebo in the primary efficacy end-point were not statistically significant for the vortioxetine groups .


The mean difference from placebo was significant in the duloxetine arm .


For all secondary efficacy end-points , results were similar among the vortioxetine groups and did not reach statistical significance .


The vortioxetine @-mg group showed separation from placebo on the Hospital Anxiety and Depression anxiety subscore ( nominal p = @ ) .


Duloxetine @ mg significantly improved the primary end-point ( p < @ vs. placebo ) , validating the study .


Nausea , dry mouth , diarrhoea , nasopharyngitis , headache , dizziness , somnolence , vomiting , dyspepsia , constipation and fatigue were reported in @ % of patients receiving vortioxetine .


Rates of treatment-emergent sexual dysfunction ( TESD ) in the vortioxetine dosing groups were similar to placebo .


In this study , vortioxetine @ - , @ - and @-mg once-daily doses showed no significant improvement in HAM-A total scores vs. placebo .


Vortioxetine was well tolerated at all doses and was not associated with TESD .


The need for surgery for the majority of patients with displaced proximal humeral fractures is unclear , but its use is increasing .


To evaluate the clinical effectiveness of surgical vs nonsurgical treatment for adults with displaced fractures of the proximal humerus involving the surgical neck .


A pragmatic , multicenter , parallel-group , randomized clinical trial , the Proximal Fracture of the Humerus Evaluation by Randomization ( PROFHER ) trial , recruited @ patients aged @ years or older ( mean age , @ years -LSB- range , @-@ years -RSB- ; @ -LSB- @ % -RSB- were female ; and @ -LSB- @ % -RSB- were white ) who presented at the orthopedic departments of @ acute UK National Health Service hospitals between September @ and April @ within @ weeks after sustaining a displaced fracture of the proximal humerus involving the surgical neck .


Patients were followed up for @ years ( up to April @ ) and @ had complete follow-up data .


The data for @ patients ( @ in surgical group and @ in nonsurgical group ) were included in the primary analysis .


Fracture fixation or humeral head replacement were performed by surgeons experienced in these techniques .


Nonsurgical treatment was sling immobilization .


Standardized outpatient and community-based rehabilitation was provided to both groups .


Primary outcome was the Oxford Shoulder Score ( range , @-@ ; higher scores indicate better outcomes ) assessed during a @-year period , with assessment and data collection at @ , @ , and @ months .


Sample size was based on a minimal clinically important difference of @ points for the Oxford Shoulder Score .


Secondary outcomes were the Short-Form @ ( SF-@ ) , complications , subsequent therapy , and mortality .


There was no significant mean treatment group difference in the Oxford Shoulder Score averaged over @ years ( @ points for the surgical group vs @ points for the nonsurgical group ; difference of @ points -LSB- @ % CI , -@ to @ points -RSB- ; P = @ ) or at individual time points .


There were also no significant between-group differences over @ years in the mean SF-@ physical component score ( surgical group : @ points higher -LSB- @ % CI , -@ to @ points -RSB- ; P = @ ) ; the mean SF-@ mental component score ( surgical group : @ points lower -LSB- @ % CI , -@ to @ points -RSB- ; P = @ ) ; complications related to surgery or shoulder fracture ( @ patients in surgical group vs @ patients in nonsurgical group ; P = @ ) , requiring secondary surgery to the shoulder ( @ patients in both groups ) , and increased or new shoulder-related therapy ( @ patients vs @ patients , respectively ; P = @ ) ; and mortality ( @ patients vs @ patients ; P = @ ) .


Ten medical complications ( @ cardiovascular events , @ respiratory events , @ gastrointestinal events , and @ others ) occurred in the surgical group during the postoperative hospital stay .


Among patients with displaced proximal humeral fractures involving the surgical neck , there was no significant difference between surgical treatment compared with nonsurgical treatment in patient-reported clinical outcomes over @ years following fracture occurrence .


These results do not support the trend of increased surgery for patients with displaced fractures of the proximal humerus .


First generation drug-eluting stents ( DES ) were associated with a high incidence of late stent thrombosis ( ST ) , mainly due to delayed healing and re-endothelization by the durable polymer coating .


This study sought to assess the safety and efficacy of the Nano polymer-free sirolimus-eluting stent ( SES ) in the treatment of patients with de novo coronary artery lesions .


The Nano trial is the first randomized trial designed to compare the safety and efficacy of the Nano polymer-free SES and Partner durable-polymer SES ( Lepu Medical Technology , Beijing , China ) in the treatment of patients with de novo native coronary lesions .


The primary endpoint was in-stent late lumen loss ( LLL ) at @-month follow-up .


The secondary endpoint was major adverse cardiac events ( MACE ) , a composite of cardiac death , myocardial infarction or target lesion revascularization .


A total of @ patients ( Nano group : n = @ , Partner group : n = @ ) were enrolled in this trial from @ Chinese centers .


The Nano polymer-free SES was non-inferior to the Partner durable-polymer DES at the primary endpoint of @ months ( P < @ ) .


The @-month in-segment LLL of the polymer-free Nano SES was comparable to the Partner SES ( @ @ ) mm vs. ( @ @ ) mm , P = @ ) .


The incidence of MACE in the Nano group were @ % compared to the Partner group of @ % ( P = @ ) at @ years follow-up .


The frequency of cardiac death and stent thrombosis was low for both Nano and Partner SES ( @ % vs. @ % , @ % vs. @ % , both P = @ ) .


In this multicenter randomized Nano trial , the Nano polymer-free SES showed similar safety and efficacy compared with the Partner SES in the treatment of patients with de novo coronary artery lesions .


Trials in patients with complex lesions and longer term follow-up are necessary to confirm the clinical performance of this novel Nano polymer-free SES .


To investigate the effect of parenteral nutrition support with a lipid emulsion formulation ( containing soybean oil , medium chain triglycerides , olive oil , and fish oil -LSB- SMOF -RSB- ) in intensive care patients following major gastrointestinal surgeries .


According to a randomized , prospective and case-controlled design , @ intensive care patients following major gastrointestinal surgeries between January and December , @ were randomized equally into SMOF group and control group to receive parenteral nutrition support with SMOF and medium or long chain lipid emulsion , respectively .


Before and at @ and @ days after commencement of parenteral nutrition support , the patients were examined for alanine aminotransferase ( ALT ) , total bilirubin ( TBIL ) , albumin ( propagated ) , C-reactive protein ( CRP ) , interleukin @ ( IL-@ ) , and endotoxin levels .


The patients ' average length of stay in intensive care unit ( ICU ) , the days of using antibiotics , and the incidence rate of postoperative complication were recorded .


On day @ postoperatively , the levels of CRP and IL-@ were significantly lower in SMOF group than in the control group ( t = @ and @ , respectively ; P < @ ) , and on day @ , the patients in SMOF group showed significantly lower levels of ALT , TBIL , CRP and IL-@ ( t = @ , @ , @ , @ , respectively ; P < @ ) than the control group , but ALB and endotoxin levels remained comparable between the two groups .


The average length of stay in ICU and the days of using antibiotics were significantly shorter in SMOF group than in the control group ( t = @ and @ , respectively ; P < @ ) ; SMOF group showed a lower incidence of postoperative infections than the control group , but the difference was not statistically significant ( = @ , P > @ ) .


For intensive care patients following major gastrointestinal surgeries , postoperative parenteral nutrition support with SMOF can effectively reduce the release of inflammatory mediators , protect important visceral functions , reduce postoperative complications , shorten the length of ICU stay , and improve the prognosis of the patients .


Physical activity ( PA ) interventions typically include components or doses that are static across participants .


Adaptive interventions are dynamic ; components or doses change in response to short-term variations in participant 's performance .


Emerging theory and technologies make adaptive goal setting and feedback interventions feasible .


To test an adaptive intervention for PA based on Operant and Behavior Economic principles and a percentile-based algorithm .


The adaptive intervention was hypothesized to result in greater increases in steps per day than the static intervention .


Participants ( N = @ ) were randomized to one of two @-month treatments : @ ) static intervention ( SI ) or @ ) adaptive intervention ( AI ) .


Inactive overweight adults ( @ % women , M = @ @ years , @ % non-white ) in both groups received a pedometer , email and text message communication , brief health information , and biweekly motivational prompts .


The AI group received daily step goals that adjusted up and down based on the percentile-rank algorithm and micro-incentives for goal attainment .


This algorithm adjusted goals based on a moving window ; an approach that responded to each individual 's performance and ensured goals were always challenging but within participants ' abilities .


The SI group received a static @,@ steps/day goal with incentives linked to uploading the pedometer 's data .


A random-effects repeated-measures model accounted for @ repeated measures and autocorrelation .


After adjusting for covariates , the treatment phase showed greater steps/day relative to the baseline phase ( p < @ ) and a group by study phase interaction was observed ( p @ ) .


The SI group increased by @,@ steps/day on average between baseline and treatment while the AI group increased by @,@ steps/day on average between baseline and treatment ; a significant between-group difference of @,@ steps/day ( Cohen 's d = @ ) .


The adaptive intervention outperformed the static intervention for increasing PA. .


The adaptive goal and feedback algorithm is a `` behavior change technology '' that could be incorporated into mHealth technologies and scaled to reach large populations .


Prior chemotherapy may affect the efficacy of endocrine therapy .


The tamoxifen exemestane adjuvant multinational ( TEAM ) trial compared @years of adjuvant exemestane with the sequence of tamoxifen followed by exemestane in postmenopausal women with hormone-receptor-positive breast cancer .


A total of @,@ patients were enrolled in Germany ( @ received tamoxifen followed by exemestan and @ exemestan alone ) .


A retrospective analysis of the German cohort of TEAM was conducted to determine whether prior chemotherapy affected clinical outcome of endocrine therapy .


Overall survival , disease-free survival and distant recurrence were similar between patients who received sequential therapy and those who received exemestane monotherapy , irrespective of prior chemotherapy .


Overall survival was not significantly different between patients who had received prior chemotherapy and those who had not ( P = @ ) .


Disease-free survival and distant recurrence were significantly better in patients who had not received prior chemotherapy versus those who had ( P = @ and P = @ ) .


In patients receiving sequential therapy , there were no significant differences in overall survival according to prior chemotherapy use ( P = @ ) .


However , disease-free survival and distant recurrence were significantly different dependent on prior chemotherapy ( P = @ and P = @ ) .


In conclusion , there was no difference in overall survival between breast cancer patients who did receive prior chemotherapy before endocrine therapy and those who had not .


Patients who had not received prior chemotherapy had significantly improved disease-free survival and less distant recurrence versus those who had received chemotherapy .


An open-label phase I/II study of single-agent obatoclax determined a maximum tolerated dose ( MTD ) and schedule , safety , and efficacy in older patients ( @ yr ) with untreated acute myeloid leukemia ( AML ) .


Phase I evaluated the safety of obatoclax infused for @ hours on @ consecutive days ( @ h @ d ) in @-week cycles .


Initial obatoclax dose was @ mg/day ( @ h @ d ; n = @ ) .


Obatoclax was increased to @ mg/day ( @ h @ d ) if @ patient had a dose-limiting toxicity ( DLT ) and decreased to @ mg/day ( @ h @ d ) if DLT occurred in @ patients .


In the phase II study , @ patients were randomized to receive obatoclax at the dose identified during phase I ( @ h @ d ) or @ mg/day administered by continuous infusion over @ hours for @ days ( @ h @ d ) to determine the morphologic complete response rate .


In phase I , two of three patients receiving obatoclax @ mg/day ( @ h @ d ) experienced grade @ neurologic DLTs ( confusion , ataxia , and somnolence ) .


Obatoclax was decreased to @ mg/day ( @ h @ d ) .


In phase II , no clinically relevant safety differences were observed between the @ mg/day ( @ h @ d ; n = @ ) and @ mg/day ( @ h @ d ; n = @ ) arms .


Neurologic and psychiatric adverse events were most common and were generally transient and reversible .


Complete response was not achieved in any patient .


Obatoclax @ mg/day was the MTD ( @ h @ d ) in older patients with AML .


In the schedules tested , single-agent obatoclax was not associated with an objective response .


Evaluation in additional subgroups or in combination with other chemotherapy modalities may be considered for future study .


Although inpatient stroke rehabilitation provides clinicians with the opportunity to prepare patients for continuation of prestroke activities , little is known about the patients ' ability to safely resume driving at the point of discharge to the community .


To compare foot pedal response times of @ stroke patients with right hemiplegia ( RH ) or left hemiplegia ( LH ) and @ controls .


A cross-sectional design was used .


Response times were measured using @ foot pedal operation techniques : ( @ ) right-sided accelerator with right leg operating accelerator and brake , ( @ ) right-sided accelerator with left leg operating accelerator and brake , and ( @ ) left-sided accelerator with left leg operating accelerator and brake .


Outcomes included reaction time ( RT ) , movement time ( MT ) , and total response time ( TRT ) .


Controls demonstrated faster RT than patients with RH ( @ vs @ ms ; P < @ ) or LH ( @ ms ; P < @ ) for all conditions , as well as faster MT than patients with RH ( P < @ for all ) but not LH when using the right leg ( @ vs @ ms ; P = @ ) .


Controls demonstrated faster TRT than patients with RH ( P < @ for all ) but not LH when using the right leg ( @ vs @ ms ; P = @ ) .


When using the nonparetic leg , patients with LH had braking response times comparable to controls , but patients with RH demonstrated significant impairment of both the paretic and nonparetic legs .


A recent randomized trial compared a policy of no prophylaxis with a policy of prophylactic platelet ( PLT ) transfusions at counts of fewer than @ ( @ ) / L in patients with hematologic malignancies .


The results suggested the effectiveness of prophylactic PLT transfusions may vary according to patient diagnosis and treatment plan .


This article presents full subgroup analyses and compares treatment effects between autologous hematopoietic stem cell transplantation ( autoHSCT ; n = @ ) and chemotherapy/allogeneic HSCT ( chemo/alloHSCT ; n = @ ) patients .


Prespecified subgroup analysis found that the reduction in proportion of patients experiencing WHO Grade @ to @ bleeds ( main trial outcome ) seen in the prophylaxis arm was of greater magnitude in chemo/alloHSCT than autoHSCT patients ( interaction p = @ ) .


Analysis of secondary outcomes showed a shorter time to first bleeding episode with no prophylaxis in the chemo/alloHSCT group ( hazard ratio , @ ; @ % confidence interval CI , @-@ @ ; p = @ ) compared to the autoHSCT group ( hazard ratio , @ ; @ % CI , @-@ @ ; p = @ ; interaction p = @ ) .


The increased number of days with Grade @ to @ bleeds with a no-prophylaxis policy was similar in chemo/alloHSCT ( rate ratio , @ ; @ % CI , @-@ @ ) and in autoHSCT patients ( rate ratio , @ ; @ % CI , @-@ @ ) .


Both subgroups showed significant reductions in PLT transfusions with a no-prophylaxis strategy .


There is evidence that the effectiveness of prophylactic PLT transfusions may differ between subgroups , with chemo/alloHSCT patients receiving prophylactic PLT transfusions appearing to show a greater reduction in bleeding outcomes compared to patients following a no-prophylaxis policy .


Experimental animal studies provided evidence for a synergistic effect of immunological and psychological stressors on subsequent sickness behaviours .


Up to now , little corroborating evidence for such synergy exists for humans , in whom it may provide a mechanism leading to the expression of functional somatic symptoms .


The aim of the present study was to determine an interaction between stress ( - vulnerability ) and an immunological activation on experimental pain sensitivity , i.e. , pressure pain threshold and tolerance in healthy humans .


In healthy female participants ( n = @ , mean age @ years ) , negative affectivity ( NA ) and experienced stress were assessed by questionnaire before receiving a Salmonella typhi vaccine or saline control in a randomized blinded cross-over design .


Pressure pain threshold was assessed at the lower back and calves and pain tolerance was assessed at the thumbnail , before and six hours after each injection .


Vaccination induced leukocytosis ( +@ % ) and increased serum IL-@ ( +@ % ) .


NA predicted decreased pain tolerance after vaccination ( = -@ , p = @ ) , but not after placebo ( = @ , p = @ ) .


Post-hoc analyses also demonstrated an association with administration order .


NA moderated the effects of inflammation on pain tolerance .


This finding is consistent with a synergistic model whereby inflammation may lower the threshold for pain reporting in individuals with increased vulnerability for somatic symptom reporting .


Devices such as diode laser and intense pulsed light ( IPL ) are in constant development aiming at permanent hair removal , but there are few comparative studies between these technologies .


The objective was to comparatively assess axillary hair removal performed by diode laser and IPL and to obtain parameters of referred pain and evolution response for each method .


A comparative prospective , double-blind , and randomized study of axillary hair removal performed by the diode laser and IPL was conducted in @ females .


Six sessions were held with application of the diode laser in one axilla and the IPL in the other , with intervals of @ days and follow-up of @ months after the last session .


Clinical photographs and digital dermoscopy for hair counts in predefined and fixed fields of the treated areas were performed before , @ weeks after the sixth session , and @ months after the end of treatment .


A questionnaire to assess the pain was applied .


The number of hair shafts was significantly reduced with the diode laser and IPL .


The diode laser was more effective , although more painful than the IPL .


No serious , adverse , or permanent effects were observed with both technologies .


Both diode laser and the IPL are effective , safe , and able to produce lasting results in axillary hair removal .


Stroke treatment is constrained by limited treatment windows and the clinical inefficacy of agents that showed preclinical promise .


Yet animal and clinical data suggest considerable poststroke plasticity , which could allow treatment with recovery-modulating agents .


Memantine is a well-tolerated N-methyl-D-aspartate glutamate receptor antagonist in common use for Alzheimer disease .


Memantine , @ mg/kg per day , or vehicle , was delivered chronically in drinking water beginning > @ hours after photothrombotic stroke .


Although there was no difference in infarct size , behavior , or optical intrinsic signal maps in the first @ days after stroke , mice treated chronically with memantine showed significant improvements in motor control , measured by cylinder test and grid-walking performance , compared with vehicle-treated animals .


Optical intrinsic signal revealed an increased area of forepaw sensory maps at @ days after stroke .


There was decreased reactive astrogliosis and increased vascular density around the infarcted cortex .


Peri-infarct Western blots revealed increased brain-derived neurotrophic factor and phosphorylated-tropomyosin-related kinase-B receptor expression .


Our results suggest that memantine improves stroke outcomes in an apparently non-neuroprotective manner involving increased brain-derived neurotrophic factor signaling , reduced reactive astrogliosis , and improved vascularization , associated with improved recovery of sensory and motor cortical function .


The clinical availability and tolerability of memantine make it an attractive candidate for clinical translation .


To demonstrate benefits for speech perception and everyday listening in quiet and in noise with a speech-enhancement strategy called ClearVoice , which was designed to improve listening in complex acoustic environments without compromising hearing in quiet .


A @-week randomized crossover design was used to evaluate ClearVoice in @ adults unilaterally implanted with a CII/HiRes @K cochlear implant who had at least @ months experience with HiRes Fidelity @ sound processing .


Speech perception was assessed using the AzBio sentences presented in quiet , in speech-spectrum noise and in multitalker babble .


Subjective listening benefit and strategy preference were assessed with a questionnaire .


ClearVoice has @ gain settings ( low , medium , and high ) , each intended as a full-time listening option according to individual preference .


Speech understanding after acute use of ClearVoice-low was compared with HiRes Fidelity @ during an initial test session .


Speech perception abilities were compared with HiRes Fidelity @ after @ weeks of exclusive use of ClearVoice-medium , and after @ weeks of exclusive use of ClearVoice-high .


During a fifth week , participants were fit with @ programs for comparison ( HiRes Fidelity @ , ClearVoice-medium , and ClearVoice-high ) , after which , they reported preference and everyday listening benefits via a questionnaire .


ClearVoice significantly improved speech understanding in speech-spectrum noise and multitalker babble , did not compromise listening in quiet , was preferred for everyday listening , and provided improved hearing in real-life situations .


ClearVoice improves hearing in noise for cochlear implant recipients who use HiRes Fidelity @ sound processing .


Acute pulmonary embolism ( PE ) can worsen quality of life due to persistent dyspnea or exercise intolerance .


Test if tenecteplase increases the probability of a favorable composite patient-oriented outcome after submassive PE .


Normotensive patients with PE and right ventricular ( RV ) strain ( by echocardiography or biomarkers ) were enrolled from eight hospitals .


All patients received low-molecular-weight heparin followed by random assignment to either a single weight-based bolus of tenecteplase or placebo , administered in a double-blinded fashion .


The primary composite outcome included : ( i ) death , circulatory shock , intubation or major bleeding within @days or ( ii ) recurrent PE , poor functional capacity ( RV dysfunction with either dyspnea at rest or exercise intolerance ) or an SF@ ( ) Physical Component Summary ( PCS ) score < @ at @-day follow-up .


Eighty-three patients were randomized ; @ to tenecteplase and @ to placebo .


The trial was terminated prematurely .


Within @days , adverse outcomes occurred in three placebo-treated patients ( death in one and intubation in two ) and one tenecteplase-treated patient ( fatal intracranial hemorrhage ) .


At @days , adverse outcomes occurred in @ unique placebo-treated patients and five unique tenecteplase-treated patients Thus , @ ( @ % ) placebo-treated and six ( @ % ) tenecteplase-treated patients had at least one adverse outcome ( exact two-sided P = @ ) .


Treatment of patients with submassive pulmonary embolism with tenecteplase was associated with increased probability of a favorable composite outcome .


We investigated whether the prokinetic activity of mosapride , a @-hydroxytryptamine @ receptor agonist , in combination with proton pump inhibitor ( PPI ) would ameliorate symptoms of gastroesophageal reflux disease ( GERD ) in Japanese patients .


Patients who experienced reflux symptoms more than twice weekly were eligible for this study .


In all , @ patients were randomized to receive mosapride @mg thrice daily combined with omeprazole @mg once daily ( GO group ) , or omeprazole alone ( O group ) for @ weeks .


The patients completed the frequency scale for the symptoms of GERD ( FSSG ) at the beginning and the end of the study .


The primary outcome compared changes in the FSSG reflux-related symptom ( RS ) score between treatment groups during the study period .


The FSSG RS scores significantly decreased both in the GO group and the O group , with no differences in improvement between the groups ( -@ for the GO group vs -@ for the O group , P = @ ) .


In non-erosive reflux disease ( NERD ) patients the improvement was significantly lower than that in erosive GERD patients ( -@ vs -@ , P = @ ) .


However , the addition of mosapride was effective in subgroup analyses of specific symptoms , such as burping .


Combining mosapride with PPI provided no additional amelioration of reflux symptoms compared to PPI alone .


Both regimens provided less relief from reflux symptoms in NERD than in erosive GERD patients .


The addition of mosapride ameliorated reflux in patients with symptoms like burping .


Web-based personalized feedback interventions , particularly personalized normative feedback ( PNF ) , are efficacious in improving college drinking outcomes ; however , no personalized feedback interventions to date have provided college drinkers with feedback about their own decisional balance .


This study tested the relative efficacy of a novel decisional balance feedback ( DBF ) intervention , PNF , and an assessment-only control condition .


Participants ( N = @ ; @ % female ) were undergraduate students at a @-year university in the U.S. Pacific Northwest and were randomized to receive one-time exposure to web-based DBF , PNF , or assessment only .


Web-based assessment occurred at baseline and at @ - , @ - , and @-month follow-ups and included measures of motivation to change , drinking quantity norms , drinking frequency/quantity , and alcohol-related problems .


At the @-month follow-up , DBF and PNF participants reported reductions in alcohol-related problems ; however , only PNF participants reduced their drinking frequency and quantity .


At the @-month follow-up , only DBF participants showed significant reductions in drinking quantity and alcohol-related problems .


Neither group maintained reductions in alcohol use or alcohol-related problems at the @-month follow-up .


This study provided preliminary evidence that web-based DBF and PNF are efficacious interventions for college drinkers , with DBF having somewhat longer lasting effects .


To evaluate the efficacy and safety of prophylactic ceftazidime on early bacterial infection in APBSCT recipients during neutropenia .


APBSCT recipients were prospectively randomly assigned to intravenous ceftazidime treatment group and control group ( no prophylaxis of antibiotics ) .


The treatment started from the first day until resolution of neutropenia or the appearance of early bacterial infection .


From March @ to January @ , @ APBSCT recipients were enrolled in the study with @ in treatment and @ in control group .


Overall , @ ( @ % ) patients developed early bacterial infection , among which , @ ( @ % ) in the treatment group and @ ( @ % ) in the control group ( P = @ ) .


The median infection free survival ( IFS ) was not reached in the treatment group and was @ days in the control group ( P = @ ) .


Despite whether patients received single high dose melphalan or other conditioning regimes , the early bacterial infection rate was lower in the treatment group than in the control group , and the median IFS was longer in the treatment group than that in the control group .


The mean courses of antibiotic administration were ( @ @ ) days and ( @ @ ) days respectively in the treatment and control groups ( P < @ ) .


However , the duration of empirical carbapenems were ( @ @ ) days and ( @ @ ) days respectively ( P = @ ) .


There was no significant difference of antibiotics cost per patient between the two groups .


Four patients in the treatment group had a transient elevated serum creatinine .


Overall , no infection related mortality was observed in either group .


Prophylaxis of intravenous ceftazidime for APBSCT recipients is effective in preventing early bacterial infection with an acceptable toxicity and cost profile .


However , it does n't have effect on infection related mortality .


Therefore , our results do not support the use of antibiotic prophylaxis for patients undergoing APBSCT .


To observe the curative effect of a recipe for warming the kidney and fortifying the spleen on diarrhea-predominant irritable bowel syndrome ( IBS-D ) .


This multi-center , double-blind , randomized , and controlled trial included @ patients that met the inclusion criterion and were then divided into two groups of @ .


Patients in the treatment group ( group A ) took modified Sishen Wan orally for warming the kidney and fortifying the spleen and patients in the control group ( group B ) took a placebo , Chao Maiya , for @ weeks .


@ days after withdrawal , there was a @-month follow-up to observe patient recurrence condition .


The total effective rate , curative effect , and recurrence rate were evaluated after treatment .


There was statistical difference ( P < @ ) between the two groups in total effective rate ( @ % in the treatment group and @ % in the control group ) , in curative effect of TCM syndrome ( @ % and @ % , respectively ) , and in the recurrence rate ( @ % and @ % , respectively ) within @ months after treatment .


Modified Sishen Wan , for warming the kidney and fortifying the spleen , can effectively treat IBS-D and better control its recurrence .


The purpose of this study was to explore the feasibility of high-intensity focused ultrasound combined with sonographically guided intratumoral ethanol injection in the treatment of uterine fibroids and to compare its therapeutic effects and potential side effects with those of simple high-intensity focused ultrasound treatment .


Forty patients with uterine fibroids from the Department of Ultrasonography in our hospital were randomly divided into @ groups of the same size : group H , which only underwent high-intensity focused ultrasound treatment ; and group H + A , which underwent sonographically guided intratumoral ethanol injection therapy first and then high-intensity focused ultrasound treatment the following day .


The treatment times , treatment doses , pain scores , side effects , and therapeutic effect rates of the groups were then recorded and compared .


Both the treatment time and dose of group H + A were significantly less than those of group H , and the differences were statistically significant ( P < @ ) .


A lower pain score and fewer side effects were achieved in group H + A , also with statistically significant differences ( P < @ ) .


The therapeutic effect rate of group H + A was also higher than that of group H , and the difference was also statistically significant ( P < @ ) .


In the treatment of uterine fibroids , high-intensity focused ultrasound combined with sonographically guided intratumoral ethanol injection requires less treatment time and a lower dose than simple high-intensity focused ultrasound treatment and significantly reduces the pain and side effects commonly experienced by patients .


High-intensity focused ultrasound combined with sonographically guided intratumoral ethanol injection is a feasible , safe , and more effective way to treat patients with uterine fibroids .


The purpose of this study was to compare @-minute delayed transitional phase imaging using a @ flip angle ( hereafter , @ min-FA@ ) and @-minute hepatocyte phase imaging using a @ flip angle ( hereafter , @ min-FA@ ) in gadoxetic acid-enhanced MRI for focal hepatic lesion detection and lesion-to-liver contrast-to-noise ratio ( CNR ) , and to determine whether @ min-FA@ could replace @ min-FA@ with a @-minute time saving .


One hundred sixteen patients with @ focal hepatic lesions ( size range , @-@ @ cm ; malignant , n = @ ; benign , n = @ ) underwent gadoxetic acid-enhanced MRI with @ min-FA@ and @ min-FA@ with a @D T@-weighted gradient-echo sequence .


Three radiologists independently assessed the presence of focal hepatic lesions using a @-point scale , and detection sensitivity of focal hepatic lesions was calculated .


Lesion-to-liver CNRs were calculated and compared in two image groups .


There was no significant difference in detection sensitivity of focal hepatic lesions for all three readers between @ min-FA@ ( mean , @ % ) and @ min-FA@ ( mean , @ % ) , irrespective of lesion size or malignancy .


The mean CNR on @ min-FA@ ( @ @ ) was significantly higher than that on @ min-FA@ ( @ @ ) .


However , the mean CNR difference between the two image groups was relatively small ( @ @ ) .


Compared with @ min-FA@ , @ min-FA@ provided higher CNR and similar sensitivity .


These findings indicate that @ min-FA@ could replace @-min delayed hepatocyte phase imaging using a @ flip angle with similar diagnostic performance and @ minutes of time saving .


Perineal reeducation of stress urinary incontinence is beneficial in @ % of cases .


However , patients have to perform self-retraining exercises of the perineal muscles at home , in order to maintain the benefit of the physiotherapy .


The aim of this study is to assess the benefit of GYNEFFIK ( ) , a perineal electro-stimulator , during this home-care phase .


Women with stress urinary incontinence ( UI ) or with mixed UI ( composed predominantly of stress UI ) that responded to physiotherapy were included in this study in two parallel groups .


The groups followed a self-reeducation program , with or without GYNEFFIK ( ) electro-stimulation sessions .


The comparison of the two groups was based on the rate of women for whom the benefit of the initial perineal reeducation was maintained ( defined as non-worsening ICIQ and Ditrovie scales ' score ) .


According to the protocol , an interim analysis was performed on @ patients ( i.e. almost half of the expected sample size ) who had had at least one evaluation under treatment , among which @ patients had finished the study .


The therapeutic benefit of the initial perineal reeducation was maintained in @ % of the GYNEFFIK ( ) patient group , while it was maintained in @ % ( P = @ ) in the usual care group ( i.e. who did not use electro-stimulation ) .


Likewise , patient had a more favorable subjective impression when using GYNEFFIK ( ) ( @ % versus @ % in the usual care group ) as they felt that they improved during the study .


In the GYNEFFIK ( ) group , no increase in symptoms was reported , whereas almost one out of five patients in the usual care group felt that their condition had worsened .


The @R ,@ S stereoisomer of methoxamine hydrochloride , NRL@ , is a highly selective @-adrenoceptor agonist being developed for the local treatment of non-structural faecal incontinence caused by weak internal anal sphincter tone .


This study investigated the steady state pharmacokinetics ( PK ) and safety of @ g rectal suppositories containing NRL@ in different strengths ( @ , @ , @ or @ mg ) .


Healthy volunteers aged @-@ years received @ daily doses of NRL@ @ g suppositories or matching placebo .


In each dose group nine participants received NRL@ and three received placebo .


Blood samples to determine NRL@ concentrations were taken on Days @ , @ and @ .


Cardiovascular parameters were collected via electrocardiograms , Holter monitoring ( three lead Holter monitor ) and vital signs .


Forty-eight volunteers were enrolled ; @ completed the study and were included in the PK analysis population .


AUC and Cmax broadly increased with increasing dose , Tmax generally occurred between @ and @ h. Although the data did not appear strongly dose proportional , dose proportionality analysis did not provide evidence against dose proportionality as the log ( dose ) coefficients were not significantly < @ .


NRL@ did not accumulate over time for any dose .


Increasing NRL@ concentrations were related to changes in vital sign variables , most notably decreased heart rate .


The most commonly reported adverse events ( AEs ) in the active treatment groups were paraesthesia and piloerection .


Treatment with NRL@ was generally well tolerated over @ days once daily dosing and plasma NRL@ did not accumulate over time .


Treatment was associated with changes in vital sign variables , most notably decreased heart rate .


AEs commonly reported with NRL@ treatment were events indicative of a systemic - adrenergic effect .


To show whether a clinically significant difference in success rates exists between expectant and surgical management of early pregnancy loss .


Randomised controlled trial comparing expectant versus surgical management of early pregnancy loss over a @-year period from @st January to @st December @ at Sultanah Aminah Hospital , Johor Bahru .


Pregnant women with missed or incomplete miscarriages at gestations up to @ weeks were recruited in this study .


The success rate in the surgical group was measured as curettage performed without any complications during or after the procedure , while the success rate in the expectant group was defined as complete spontaneous expulsion of products of conception within @ weeks without any complication .


A total of @ women were recruited and randomised to expectant or surgical management , with @ women in each group .


There was no statistically significant difference in the success rate between the groups and between the different types of miscarriage .


With expectant management , @ ( @ % ) patients had a complete spontaneous expulsion of products of conception , of whom @ ( @ % ) women miscarried within @ days .


However , the rates of unplanned admissions ( @ % ) and unplanned surgical evacuations ( @ % ) in the expectant group were significantly higher than the rates ( @ % and @ % respectively ) in the surgical group .


The complications in both groups were similar .


To observe the clinical effect and safety of modified Bushen Zhuanggu Recipe ( BZR ) in treating ankylosing spondylitis ( AS ) .


Recruited were @ AS outpatients of Shen deficiency induced cold-dampness syndrome ( SDCDS ) or Shen deficiency dampness-heat syndrome ( SDDHS ) at clinics of China-Japan Friendship Hospital from May @ to May @ .


They were randomly assigned to the traditional Chinese medicine ( TCM ) treatment group and the Western medicine ( WM ) treatment group in the ratio of @:@ .


Those in the TCM treatment group were syndrome typed as the SDCDS group ( group A , @ cases , treated by Bushen Zhuanggu Quhan Decoction + WM placebos ) and the SDDHS group ( group B , @ cases , treated by Bushen Zhuanggu Qinghua Decoction + WM placebos ) .


Those in the WM treatment group were syndrome typed as SDCDS group ( group C , @ cases , treated by SASP + TCM placebos ) and the SDDHS group ( group D , @ cases , treated by SASP + TCM placebos ) .


Totally @ weeks consisted of one therapeutic course .


BAS-G , BASFI , BASDAI , spine pain , pain at night , TCM symptom score , distance between occipital and wall , distance between finger and ground , thoracic activity , spine activity , Schober test , ESR , CRP were observed as the observing indices ; ASAS@ , ASAS@ , ASAS@ , BASDAI@ , and criteria of TCM were explored for clinical evaluation and safety evaluation .


In comparison with the same group before treatment,BAS-G , BASFI , BASDAI , spine pain , pain at night , TCM syndrome score , distance between finger and ground , Schober test , ESR , and CRP were improved after treatment ( P < @ , P < @ ) .


In group A and C , thoracic activity and spine activity were getting better ( P < @ , P < @ ) .


In group B distance between occipital and wall and spine activity were getting better ( P < @ , P < @ ) .


In comparison with group C , BAS-G , BASFI , BASDAI , spine pain , distance between finger and ground , thoracic activity , spine activity , Schober test , ESR , CRP were getting better in group A after treatment ( P < @ , P < @ ) .


In comparison with group D , BASFI , BASDAI , spine pain , pain at night , distance between finger and ground , distance between occipital and wall , spine activity , Schober test , and ESR were getting better in group B after treatment ( P < @ , P < @ ) .


The total effective rate , ASAS@ , ASAS@ , ASAS@ , and BASDAI@ were higher in the TCM treatment group than in the WM treatment group ( P < @ ) .


Modified BZR was more effective than SASP method in relieving clinical symptoms and signs , TCM syndrome scores , and inflammatory activity indicators of AS patients .


Statins are currently the preferred pharmacological therapy in individuals with familial hypercholesterolemia ( FH ) with the aim to prevent premature atherosclerosis .


In adults , these agents have been proven to be safe and well tolerated ; however , non-adherence is a significant clinical issue .


In this study , we evaluated tolerability and adherence to statin therapy in young adult FH patients @ years after this was initiated in their childhood .


A questionnaire including items on medical history , adherence and reasons for discontinuation was sent to @ young adult FH patients that initiated statin therapy at least @ years ago .


Tolerability was defined as @ % minus the percentage of patients that discontinued statin therapy due to side effects .


Adherence was defined as the extent to which patients took their medication as prescribed by their physician .


We labelled patients adherent if they took @ % or more of their pills in the month preceding our assessment .


Follow-up was successful in @ ( @ % ) subjects ( age @-@ years ) .


A history of side effects was reported by @ ( @ % ) of the patients , and mainly consisted of muscle complaints and gastrointestinal symptoms .


Three patients ( @ % ) discontinued statin therapy because of side effects .


Rhadbomyolysis or other serious adverse events were not reported .


In fact , @ ( @ % ) of @ patients remained on statin treatment and @ % ( @ out of @ ) were adherent .


None of the patient characteristics were significantly associated with adherence .


Individuals with FH who started statin therapy in childhood demonstrated good adherence during ten years of treatment .


Furthermore , statin therapy was well tolerated ; only a small minority discontinued therapy because of side effects and the side effects that were reported were mild in nature .


Delayed graft function ( DGF ) is a consequence of ischemia-reperfusion injuries in kidney allografts , for which no definite treatment is available .


The neutrophil gelatinase-associated lipocalin ( NGAL ) and interleukin-@ ( IL-@ ) are introduced as the most promising urine biomarkers to detect DGF .


N-acetylcysteine ( NAC ) and vitamin C , well-known potent antioxidants that scavenge free radicals , may alleviate kidney injury .


This study investigated the protective effects of NAC alone and in combination with vitamin C on DGF , by measuring IL-@ and NGAL in living donor kidney transplantations .


Patients transplanted between January @ and February @ were randomly divided into @ groups to receive routine anti-rejection medication only ( n = @ ) , NAC plus routine immunosuppressive regimen ( NAC group ; n = @ ) , and NAC and vitamin C plus routine regimen ( NAC and vitamin C group ; n = @ ) .


Urine samples were taken @ hours and @ hours after transplantation .


Enzyme-linked immunosorbent assay kits were utilized for measuring urine NGAL and IL-@ .


There were no significant differences in the DGF prevalence and its duration between the study arms .


Although the levels of NGAL and IL-@ decreased in the NAC and NAC and vitamin C groups , these reductions were not significant .


Glomerular filtration rate at @ and @ days after transplantation were not significantly different between study groups , either .


Our results showed that NAC is a safe drug without significant adverse effects in kidney transplant recipients ; however , its potential useful effects on urinary biomarkers of DGF were not illustrated in the present study .


The purpose of this study was to determine whether obtaining a radiograph of the uninjured contralateral calcaneus ( template ) before surgery allowed for more precise restoration of Bohler 's angle and calcaneal length when performing open reduction internal fixation ( ORIF ) of intra-articular calcaneus fractures .


Patients who sustained an intra-articular calcaneus fracture requiring surgery who met inclusion criteria were prospectively randomized into those who had a preoperative template obtained for review at the time of ORIF ( group @ ) versus those who had the contralateral radiograph obtained after surgery ( group @ ) .


There was no benefit of the preoperative template in allowing for more anatomic restoration of Bohler 's angle or calcaneal length .


Operative time was decreased with the use of a preoperative template when using the extensile lateral or percutaneous approaches .


Preoperative templating of the uninjured contralateral calcaneus did not allow for more anatomic reduction or restoration of pre-injury morphology of the calcaneus undergoing operative fixation as based on Bohler 's angle and calcaneal length .


Templating may be of benefit by reducing operative time .


Level II , prospective comparative series .


To determine the effectiveness of a water flosser in reducing the bleeding on probing ( BOP ) index around dental implants as compared to flossing .


Patients with implants were randomly assigned to one of two groups in this examiner-masked , single-center study .


The study compared the efficacy of a manual toothbrush paired with either traditional string floss or a water flosser .


The primary outcome was the reduction in the incidence of BOP after @ days .


There were no differences in the percent of bleeding sites between the groups at baseline .


At @ days , @ of the @ ( @ % ) implants in the water flosser group showed a reduction in BOP compared to @ of the @ ( @ % ) in the floss group ( P = @ ) .


These results demonstrate that the water flosser group had statistically significantly greater bleeding reduction than the string floss group .


The authors concluded that water flossing may be a useful adjuvant for implant hygiene maintenance .


In Saudi Arabia many studies have addressed cigarette smoking from various perspectives .


Most of these studies , however , were conducted among males and confined to Riyadh , the capital city .


Such limitations have enhanced the need for community-based epidemiological studies that include both genders and various age groups and socio-demographic features , as well as different regions .


This cross-sectional study aims to assess the prevalence of cigarette smoking and to discuss the association between cigarette smoking habits and socio-demographic factors among community members of the Jazan area in southwest Saudi Arabia .


A pre-coded questionnaire was designed and tested for data consistency .


A well-trained health team was assigned to gather the data from the @ primary healthcare centers distributed across eight provinces .


The response rate was @ % ( @,@ respondents @ years old ) .


The associations among the subjects ' socio-demographic characteristics were examined by the chi-square test .


A multiple logistic regression and odds ratios were calculated as well .


A total of @,@ ( @ % ) , @,@ ( @ % ) , and @,@ ( @ % ) respondents were , respectively , current smokers ( TCS ) , ever-smokers ( TES ) , and non-smokers ( TNS ) .


Though current smokers seem to be more prevalent in urban populations ( @ % ) than in rural populations ( @ % ) , the association of urbanization with a current smoking habit is insignificant .


Having fun , relieving stress , and the influence of parents , particularly of mothers , were the main motives that encouraged participants ' cigarette-smoking habits .


This situation was worsened by the fact that accessing cigarettes was either very easy or easy for over @ % of the respondents .


To evaluate the efficacy and safety of holmium laser enucleation of the prostate ( HoLEP ) and transurethral resection of the prostate ( TURP ) , for treatment of benign prostatic hyperplasia ( BPH ) .


A total of @ cases of BPH were selected from patients who were hospitalized between January @ and December @ .


Patients had received either HoLEP or TURP treatment .


Clinical data were collected from the perioperative period , @ month after surgery , and @ months after surgery .


There was no significant difference between the two groups in the maximum urinary flow rate ( Q max ) , postvoid residual volume ( PVR ) , international prostate symptom score ( IPSS ) , or quality-of-life score ( QOL score ) at @ month after surgery ( p = @ , p = @ , p = @ and p = @ , respectively ) .


However , after @ months , patients from the HoLEP group demonstrated better scores in Qmax , PVR , IPSS , and QOL than those from the TURP group ( p = @ , p = @ , p < @ and p = @ , respectively ) .


The two groups had comparable operation time ( p = @ ) , catheterization time ( p = @ ) , and length of hospital stay ( p = @ ) , but were statistically different in the weight of resected prostate tissue ( p < @ ) , bladder irrigation time ( p < @ ) , hemoglobin levels ( p = @ ) , and blood sodium levels ( p = @ ) after surgery .


Compared to TURP , HoLEP was safer and had better long-term efficacy as assessed by multiple quantitative measures .


Therefore , HoLEP may present a better option in the treatment of BPH .


Young people in South Africa are at high risk of HIV infection and yet may have more limited access to prevention and treatment services than others in the population .


Testing facilitates the sharing of prevention messages but also enables the linkage to care and treatment of those who test positive and therefore has wider public health implications .


This baseline survey conducted in @ for a community randomized trial in rural KwaZulu-Natal explored factors associated with a history of ever , repeat and recent testing amongst sexually debuted men and women aged @ to @ years .


Over @ % of this rural population ever tested for HIV , with men less likely to ever ( unadjusted OR @ , @ % CI : @-@ @ ) and repeatedly test than women ( adjusted OR ( aOR ) @ , @ % CI : @-@ @ ) .


Men aged @-@ years ( aOR @ , @ % CI : @-@ @ ) and @-@ years ( aOR @ , @ % CI : @-@ @ ) were more likely to ever test than those < @ years .


Those who reported having discussed HIV with others had significantly greater odds of reporting ever ( men 's aOR @ , @ % CI : @-@ @ ; women 's aOR @ , @ % CI : @-@ @ ) , recent ( irrespective of sex , aOR @ , @ % CI : @-@ @ ) and repeat testing ( aOR @ , @ % CI : @-@ @ ) .


These findings highlight the need for novel youth - and men-friendly testing services and emphasises the importance of discussions about HIV in the home and community to encourage testing .


The purpose of the present study was to evaluate the effects of six-week aerobic training program including running and rope skipping on cardiovascular fitness , body mass index ( BMI ) , and mental health among female students at the University of Isfahan , Iran .


In this interventional study we included @ female students in academic year @-@ .


The participants were randomly assigned in experimental group ( n = @ , meanSD for age = @ , weight ( kg ) = @ , height ( cm ) = @ ) and control group ( n = @ , meanSD for age = @ , weight = @ , height = @ ) .


Pre-test and post-test measurements include VO@ max with Queen Step test ; BMI and General Health Questionnaire-@ as a measure of mental health were done .


Analysis of covariance ( ANCOVA ) was used to test the effects of aerobic training as intervention ( P < @ ) .


There was statistically significance difference between experimental and control groups after adjustment for their own baseline values concerning cardiovascular fitness ( P = @ ) , BMI ( P < @ ) and mental health indices ( P < @ ) .


A six-week aerobic practice improves cardiovascular strength , mental health and BMI considerably and could be more encouraged at universities .


To explore the necessity of periodontal-pulp combined therapy for severe periodontitis .


From May @ to September @ , @ patients who were diagnosed of severe periodontitis were involved in this study .


They were randomly divided into @ groups .


Patients in group A were given periodontal-pulp combined therapy , while patients in group B were given periodontal therapy .


SBI , PD , AL were recorded in baseline , @ months , @ months , @ year and @ years after treatment .


Statistical analysis was performed with SPSS@ @ software package .


All the indexes were different between @ groups in baseline .


Three months after treatment , all the indexes were not significantly different between two groups .


Six months after treatment , SBI was significantly different between @ groups , but PD and AL were not significantly different between @ groups .


One year after treatment , all the indexes were significantly different between @ groups .


Two years after treatment , SBI was not significantly different between @ groups , but PD and AL were significantly different between two groups .


The results of periodontal-pulp combined therapy were better than periodontal therapy .


Periodontal-pulp combined therapy is necessary for patients with severe periodontitis .


In the PLATO trial , ticagrelor was superior to clopidogrel in reducing cardiovascular events among patients with acute coronary syndrome ( ACS ) at the expense of increased nonfatal bleeding .


Because Asian patients , when compared with non-Asian patients , are believed to be more susceptible to bleeding , we evaluated the effects of ticagrelor compared with clopidogrel in Asian ( n = @,@ ) and non-Asian ( n = @,@ ) patients with acute coronary syndrome enrolled in the PLATO study .


Interaction between Asian/non-Asian and primary efficacy end point ( a composite of vascular death , myocardial infarction , and stroke ) and net clinical benefit ( composite of primary efficacy end point and coronary artery bypass graft -LSB- CABG -RSB- surgery or non-CABG-related major bleeding ) were evaluated with a Cox proportional hazards model .


Baseline demographics and comorbidities were different between Asians and non-Asians .


The overall cardiovascular event rates were higher in Asians , but bleeding rates were similar .


Despite these observed differences , the effects of ticagrelor versus clopidogrel were not significantly different between Asians and non-Asians with respect to the primary efficacy outcome ( hazard ratio for Asians vs non-Asians , @ -LSB- @ % CI @-@ @ -RSB- vs @ -LSB- @ % CI @-@ @ -RSB- , P = @ ) , net clinical benefit ( @ -LSB- @ % CI @-@ @ -RSB- vs @ -LSB- @ % CI @-@ @ -RSB- , P = @ ) , or individual efficacy end points .


There was no significant interaction for bleeding ( PLATO major bleeding , @ -LSB- @ % CI @-@ @ -RSB- vs @ -LSB- @ % CI @-@ @ -RSB- , P = @ ) and other related adverse events with ticagrelor compared with clopidogrel between Asians and non-Asians .


We observed consistency of effects in Asian patients receiving ticagrelor and clopidogrel in the PLATO study .


The relatively modest number of Asian patients in this analysis supports further investigation of larger cohorts to confirm our observations .


Increased elevation of the head of the bed is linked to a higher risk for sacral pressure ulcers .


A semirecumbent position of at least @ is recommended for the prevention of ventilator-associated pneumonia in patients treated with mechanical ventilation .


Therefore , prevention of pressure ulcers and prevention of pneumonia seem to demand contradictory , possibly incompatible , positioning .


To measure pressure at the interface between sacral skin and the supporting surface in healthy volunteers at different degrees of upright position with different types of mattresses .


An open , prospective , randomized crossover trial was conducted with @ healthy volunteers .


Interface pressure was measured by using a pressure mapping device with the participant in a supine position at @ , @ , @ , and @ elevation and in the reverse Trendelenburg position at @ and @ .


Four types of mattresses were examined : @ different foam mattresses and @ air suspension beds , @ of the latter with low-air-loss technology .


Peak sacral interface pressures increased significantly only at @ of backrest elevation ( P < @ ) .


A mattress system with low-air-loss technology significantly reduced peak interface pressures at all angles ( P < @ ) .


The reverse Trendelenburg position led to lower peak pressures for all positions ( P = @ ) .


Backrest elevation up to @ might be a compromise between the seemingly incompatible demands of skin integrity and the prevention of ventilator-associated pneumonia .


The reverse Trendelenburg position and a mattress system with low-air-loss technology could be additional useful tools to help prevent skin breakdown at the sacrum .


Moderate-intensity exercise training improves skeletal muscle aerobic capacity and increased oxidative enzyme activity , as well as exercise tolerance in COPD patients .


To investigate whether the home-based exercise training program can reduce inflammatory biomarkers in patients with COPD , twelve patients using mobile phone assistance and @ with free walk were assessed by incremental shuttle walk test ( ISWT ) , spirometry , strength of limb muscles , and serum C-reactive protein ( CRP ) and inflammatory cytokines .


Patients in the mobile phone group improved their ISWT walking distance , with decrease in serum CRP after @ months , and sustained at @ months .


Patients in the control group had no improvement .


Serum IL-@ in the mobile phone group was significantly reduced at @ , @ and @ months after doing home exercise training compared to baseline .


IL-@ and TNF - were significantly elevated at @ and @ months in control group , while there were no changes in mobile phone group .


The strength of limb muscles was significantly greater compared to baseline at @ and @ months in the mobile phone group .


A mobile-phone-based system can provide an efficient home endurance exercise training program with improved exercise capacity , strength of limb muscles and a decrease in serum CRP and IL-@ in COPD patients .


Decreased systemic inflammation may contribute to these clinical benefits .


( Clinical trial registration No. : NCT@ ) .


Recent studies have indicated that serum testosterone in aging men is associated with insulin sensitivity and expression of genes involved in oxidative phosphorylation ( OxPhos ) , and that testosterone treatment increases lipid oxidation .


Herein , we investigated the effect of testosterone therapy on regulators of mitochondrial biogenesis and markers of OxPhos and lipid metabolism in the skeletal muscle of aging men with subnormal bioavailable testosterone levels .


Skeletal muscle biopsies were obtained before and after treatment with either testosterone gel ( n = @ ) or placebo ( n = @ ) for @ months .


Insulin sensitivity and substrate oxidation were assessed by euglycemic-hyperinsulinemic clamp and indirect calorimetry .


Muscle mRNA levels and protein abundance and phosphorylation of enzymes involved in mitochondrial biogenesis , OxPhos , and lipid metabolism were examined by quantitative real-time PCR and western blotting .


Despite an increase in lipid oxidation ( P < @ ) , testosterone therapy had no effect on insulin sensitivity or mRNA levels of genes involved in mitochondrial biogenesis ( PPARGC@A , PRKAA@ , and PRKAG@ ) , OxPhos ( NDUFS@ , ETFA , SDHA , UQCRC@ , and COX@B ) , or lipid metabolism ( ACADVL , CD@ , CPT@B , HADH , and PDK@ ) .


Consistently , protein abundance of OxPhos subunits encoded by both nuclear ( SDHA and UQCRC@ ) and mitochondrial DNA ( ND@ ) and protein abundance and phosphorylation of AMP-activated protein kinase and p@ MAPK were unaffected by testosterone therapy .


The beneficial effect of testosterone treatment on lipid oxidation is not explained by increased abundance or phosphorylation-dependent activity of enzymes known to regulate mitochondrial biogenesis or markers of OxPhos and lipid metabolism in the skeletal muscle of aging men with subnormal bioavailable testosterone levels .


To explore synergistic effect between angiotensin II receptor blockers ( ARBs ) and statins on Th@/Treg functional imbalance in hypertensive patients with carotid atherosclerosis .


This study was a @ @ factorial randomized , prospective , double-blind , placebo-controlled trial .


One hundred and fifty nine hypertensive patients with carotid atherosclerosis were randomized to the administration of control group , telmisartan group , rosuvastatin group , and combination group ( telmisartan plus rosuvastatin ) base on hydrochlorothiazide treatment .


Carotid ultrasonography , parameters of Th@/Treg functional axis , interleukin ( IL ) -@ , IL-@ , interferon ( IFN ) - , hypersensitive C-reactive protein ( hsCRP ) , monocyte chemotactic protein ( MCP ) -@ were evaluated .


Blood pressure level markedly reduced in four groups .


There was significantly synergistic effect of combination of telmisartan with rosuvastatin on reducing carotid imtima-media thickness ( IMT ) , Th@ cells frequency , IL-@ , IL-@ , IL-@ , tumor necrosis factor ( TNF ) - , expression of retinoic acid receptor-related orphan receptor ( ROR ) t mRNA , Th@/Treg ratio , IL-@ , IL-@ , IFN - , hsCRP , and MCP-@ , and increasing Treg cells frequency , IL-@ , transforming growth factor ( TGF ) -@ , and expression of forkhead/winged helix transcription factor ( Foxp@ ) mRNA ( all P < @ ) .


Change rate of IMT statistical positively related to descent rates of Th@ cells frequency , IL-@ , IL-@ , IL-@ , TNF - , expression of RORt mRNA , Th@/Treg ratio , IL-@ , IL-@ , IFN - , hsCRP , and MCP-@ , and negatively related to increased rates of Treg frequency , IL-@ , TGF-@ , and expression of Foxp@ mRNA , respectively ( all P < @ ) .


There is a synergistic effect of combination of telmisartan with rosuvastatin on ameliorating Th@/Treg functional imbalance in hypertensive patients with carotid atherosclerosis .


The RELAX ( Phosphodiesterase-@ Inhibition to Improve Clinical Status and Exercise Capacity in Heart Failure with Preserved Ejection Fraction ) study was a multicenter , randomized trial of sildenafil versus placebo in heart failure with preserved ejection fraction ( HFpEF ) with rigorous entry criteria and extensive phenotypic characterization of participants .


The aim of this study was to characterize clinical features , exercise capacity , and outcomes in patients with HFpEF with or without diabetes and gain insight into contributing pathophysiological mechanisms .


The RELAX study enrolled @ stable outpatients with heart failure , an ejection fraction @ % , increased natriuretic peptide or intracardiac pressures , and reduced exercise capacity .


Prospectively collected data included echocardiography , cardiac magnetic resonance , a comprehensive biomarker panel , exercise testing , and clinical events over @ months .


Compared with nondiabetic patients ( n = @ ) , diabetic HFpEF patients ( n = @ ) were younger , more obese , and more often male and had a higher prevalence of hypertension , renal dysfunction , pulmonary disease , and vascular disease ( p < @ for all ) .


Uric acid , C-reactive protein , galectin-@ , carboxy-terminal telopeptide of collagen type I , and endothelin-@ levels were higher in diabetic patients ( p < @ for all ) .


Diabetic patients had more ventricular hypertrophy , but systolic and diastolic ventricular function parameters were similar in diabetic and nondiabetic patients except for a trend toward higher filling pressures ( E/e ' ) in diabetic patients .


Diabetic patients had worse maximal ( peak oxygen uptake ) and submaximal ( @-min walk distance ) exercise capacity ( p < @ for both ) .


Diabetic patients were more likely to have been hospitalized for heart failure in the year before study entry ( @ % vs. @ % , p = @ ) and had a higher incidence of cardiac or renal hospitalization at @ months after enrollment ( @ % vs. @ % , p < @ ) .


HFpEF patients with diabetes are at increased risk of hospitalization and have reduced exercise capacity .


Multimorbidity , impaired chronotropic reserve , left ventricular hypertrophy , and activation of inflammatory , pro-oxidative , vasoconstrictor , and profibrotic pathways may contribute to adverse outcomes in HFpEF patients with diabetes .


( Evaluating the Effectiveness of Sildenafil at Improving Health Outcomes and Exercise Ability in People With Diastolic Heart Failure -LSB- The RELAX Study -RSB- ; NCT@ ) .


To evaluate the contribution of auriculotherapy in smoking cessation .


Double-blind randomized controlled trial , conducted with @ smokers allocated into two groups : Experimental Group ( @ participants received @ sessions of auriculotherapy at specific points for smoking ) and Control Group ( nine participants received auriculotherapy in points that have no effect on the focus of research ) .


Auriculotherapy contributed in reducing the number of cigarettes smoked in @ % of participants ( p = @ ) , in reducing the difficult to abstain from smoking in places where it is forbidden by @ % ( p = @ ) and in not smoking when ill @ % ( p = @ ) .


Given the efficacy only in terms of reducing the number of cigarettes smoked and other parameters , we suggest that future studies consider the use of auriculotherapy combined with other treatment methods , in order to achieve better results in cessation/abstinence .


The Bleeding Academic Research Consortium ( BARC ) classification has been proposed by consensus to standardize bleeding endpoint definition and reporting in cardiovascular clinical trials .


There are no prospective studies on its prognostic impact .


We explored the association of BARC-defined bleeding with mortality and compared its prognostic value against two validated bleeding scales : the Thrombolysis in Myocardial Infarction ( TIMI ) and the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries ( GUSTO ) scales .


Non-coronary artery bypass graft ( CABG ) - related bleedings within the PRODIGY trial were prospectively adjudicated by a blinded Clinical Event Committee and analysed according to multiple statistical modelling .


At @ years , bleeding occurred in @ patients ( @ % ) according to BARC Type @ , @ , or @ ; in @ patients ( @ % ) according to TIMI minor or major ; and in @ patients ( @ % ) according to GUSTO moderate or severe .


One hundred sixty-three patients died ( @ % ) .


After multivariable modelling , BARC Type @ , @ , or @ bleeding was associated with increased @-year mortality -LSB- hazard ratio ( HR ) : @ ; @ % confidence interval ( CI ) : @-@ @ -RSB- .


Bleeding Academic Research Consortium Type @ or @ was associated with an increased mortality rate at @ years ( adjusted HR : @ ; @ % CI : @-@ @ ) similar to that provided by TIMI ( HR : @ , @ % CI : @-@ @ ) or GUSTO ( HR : @ , @ % CI : @-@ @ ) criteria .


In a contemporary , all-comer percutaneous coronary intervention trial actionable BARC bleedings were associated with increased risk of mortality with BARC Type @ or @ bleedings providing a similar mortality risk to that posed by TIMI or GUSTO scales .


Given the complexity of the health insurance market in the United States and the confusion that often stems from these complexities , patient perception about the value of health insurance in managing chronic disease is important to understand .


To examine differences between public and private health insurance in perceptions of financial burden with managing asthma , outcomes , and factors that explain these perceptions .


Secondary analysis was performed using baseline data from a randomized clinical trial that were collected through telephone interviews with @ African American women seeking services for asthma and reporting perceptions of financial burden with asthma management .


Path analysis with multigroup models and multiple variable regression analyses were used to examine associations .


For public ( P < @ ) and private ( P < @ ) coverage , being married and more educated were indirectly associated with greater perceptions of financial burden through different explanatory pathways .


When adjusted for multiple morbidities , asthma control , income , and out-of-pocket expenses , those with private insurance used fewer inpatient ( P < @ ) and emergency department ( P < @ ) services compared with those with public insurance .


When also adjusted for health insurance , greater financial burden was associated with more urgent office visits ( P < @ ) and lower quality of life ( P < @ ) .


African American women who perceive asthma as a financial burden regardless of health insurance report more urgent health care visits and lower quality of life .


Burden may be present despite having and being able to generate economic resources and health insurance .


Further policy efforts are indicated and special attention should focus on type of coverage .


The development and spread of Plasmodium falciparum resistance to most commonly used antimalarials remain a major challenge in the control of malaria .


Constant monitoring of drug efficacy is an important tool in establishing rational antimalarial drug policies .


A randomized comparative study was conducted at the Wesley Guild Hospital , Ilesa , Nigeria between February @ and September @ comparing the efficacy and safety of artemether-lumefantrine ( Coartem ) and fixed dose of artesunate plus amodiaquine ( Larimal ) in the treatment of uncomplicated P. falciparum malaria in children betweem @ and @ months of age .


P. falciparum malaria parasitemia was assessed by microscopy and rapid diagnostic test .


Drugs were administered according to age for three days under supervision .


The primary efficacy endpoint was a day @ PCR-corrected parasitological cure .


A total of @ patients were enrolled in the two treatment groups , Coartem ( n = @ ) and Larimal ( n = @ ) , and tested after @ days .


In the intention-to-treat population , Coartem ( n = @ ) and Larimal ( n = @ ) had a PCR-corrected cure rate of @ % and @ % respectively , while in the per-protocol population , Coartem ( n = @ ) and Larimal ( n = @ ) both had a PCR-corrected cure rate of @ % at day @ .


Although parasite and fever clearance time was faster in the Larimal group , no significant difference was observed between the two drugs .


No serious adverse effects were reported .


Five years after being introduced in Nigeria , both Coartem and Larimal have been shown to be safe and highly effective in the treatment of uncomplicated P. falciparum malaria in children .


This double-blind , sham-controlled trial investigated the effects of two daily tDCS sessions over a @-day period in treatment-resistant depression .


Twenty-four treatment-resistant depressed patients received two daily sessions of active or sham anodal tDCS to the left prefrontal cortex ( @ mA , @ sessions over @ week ) .


Depression severity , psychomotor retardation and cognitive function were assessed .


Active tDCS was not significantly superior to sham tDCS on the HDRS at week @ , as well as on the MADRS and SRRS scales , and on neuropsychological tests .


Response rates were not significantly higher with active tDCS .


tDCS was well tolerated , with mild adverse events limited to transient scalp discomfort .


tDCS did not induce clinically relevant antidepressant effect in active and sham stimulation groups .


There was no impact on psychomotor and neuropsychological functioning .


tDCS efficacy on specific symptom profiles in pharmacotherapy-resistant depression is limited .


The use of optimized stimulation protocol and longer period of follow up may valuably contribute to specify the place of tDCS in treatment-resistant depression .


The aim of this study was to evaluate the role of suture closure of the subcutaneous tissue in preventing wound complications after cesarean section with a Pfannenstiel incision , and to investigate factors associated with wound complications .


Patients undergoing cesarean delivery were randomly assigned to either suture closure or non-closure of the subcutaneous tissue .


The participants were invited to two follow-up examinations at the @st and @th postoperative weeks for the detection of wound complications .


The two main outcomes were composite wound complication and superficial wound separation .


Factors associated with wound complications were analyzed using multiple logistic regression .


During the study period , a total of @ patients ( @ in the closure group , @ in non-closure group ) were analyzed .


Composite wound complication occurred in @ % ( @/@ ) of the closure group , and in @ % ( @/@ ) of the non-closure group with no significant difference ( P = @ ) .


Wound separation occurred in @ % ( @/@ ) of the closure group and @ % ( @/@ ) of the non-closure group without any significant differences ( P = @ ) .


None of the factors were found to be associated with the rate of composite complication .


The significant factors found to be associated with wound separation were subcutaneous tissue thickness of @cm or more ( P = @ ) and maternal diabetes mellitus ( P = @ ) , however they lost their significance in multivariate analyses .


The rate of wound complications , including superficial wound separation , did not differ according to the subcutaneous closure in cesarean delivery with Pfannenstiel incision .


It is not possible to predict wound complications using previously defined clinical and operative risk factors , including subcutaneous tissue thickness .


To determine the effectiveness of a novel sonic toothbrush in reducing plaque and in maintenance of gingival health when compared to a standard manual brush .


This study was a block-randomized , examiner-blind , two-treatment , parallel group , single centre clinical investigation .


A total of @ subjects were enrolled and randomly assigned to receive either the Panasonic EW-DL@ or an American Dental Association-endorsed manual toothbrush .


Subjects were instructed to follow a twice-daily brushing regimen without flossing .


Plaque levels and gingival health were assessed at baseline and after @ and @ weeks of treatment using the Turesky Modification of the Quigley-Hein Plaque Index and the Papillary Bleeding Score .


Subjects assigned to the EW-DL@ group had significantly lower plaque levels after @ and @ weeks of treatment than those in the manual group ( P = @ and @ , respectively ) .


Both groups showed a reduction in plaque levels at Week @ relative to baseline .


The EW-DL@ group had significantly lower gingival inflammation scores after @ week of treatment ( P = @ ) , but there was no difference between groups after @ weeks of treatment .


The EW-DL@ toothbrush safely and effectively removes more plaque than a standard manual toothbrush .


Improvement in gingival inflammation was observed after @ week of treatment .


There was no difference in Papillary Bleeding Score between the two groups after @ weeks of treatment .


The newly developed sonic brush ( Panasonic EW-DL@ ) tested in this study was found to be more effective than a manual toothbrush at plaque removal .


The papillary bleeding scores were significantly lower in the sonic brush group after @ week of product use .


After @ weeks of product use , both treatment groups had similar papillary bleeding scores almost returning to baseline values .


This study aimed to assess the effectiveness of Benson 's relaxation technique in improving the hemodialysis patients ' dietary and fluid adherence and biomedical markers .


This randomized controlled trial with a pre-post test design was conducted on @ hemodialysis patients randomly divided into an intervention ( receiving Benson 's relaxation technique ) and a control group ( usual care ) .


The setting of the study was two hemodialysis units affiliated to Shiraz University of Medical Sciences , Shiraz , Iran .


The patients listened to the audiotape of Benson 's relaxation technique twice a day each time for @min for @ weeks .


Dietary and fluid adherence and some biomedical markers were measured in both the intervention and the control group at baseline and at the @th week after the intervention .


The results showed significant differences between the two groups regarding blood urea nitrogen and phosphate as dietary adherence and interdialytic weight gain as fluid adherence in the @th week of the intervention ( P < @ ) .


Also , a significant difference was found between the two groups concerning blood glucose level after the intervention ( P < @ ) .


This study highlighted the importance of Benson 's relaxation technique in improvement of adherence and some biomedical markers in hemodialysis patients .


Thus , Benson 's relaxation therapy could be used as a part of the nursing care practice for hemodialysis patients and those suffering from chronic diseases .


Early postnatal head growth failure is well recognized in very preterm infants ( VPIs ) .


This coincides with the characteristic nutritional deficits that occur in these parenteral nutrition ( PN ) dependent infants in the first month of life .


Head circumference ( HC ) is correlated with brain volume and later neurodevelopmental outcome .


We hypothesized that a Standardized , Concentrated With Added Macronutrients Parenteral ( SCAMP ) nutrition regimen would improve early head growth .


The aim was to compare the change in HC ( HC ) and HC SD score ( SDS ) achieved at day @ in VPIs randomly assigned to receive SCAMP nutrition or a control standardized , concentrated PN regimen .


Control PN ( @ % glucose , @ g/kg per day protein/lipid ) was started within @ hours of birth .


VPIs ( birth weight < @ g ; gestation < @ weeks ) were randomly assigned to either start SCAMP ( @ % glucose , @ g/kg per day protein/lipid ) or remain on the control regimen .


HC was measured weekly .


Actual daily nutritional intake data were collected for days @ to @ .


There were no differences in demographic data between SCAMP ( n = @ ) and control ( n = @ ) groups .


Comparing cumulative @-day intakes , the SCAMP group received @ % more protein and @ % more energy .


The SCAMP group had a greater HC at @ days ( P < @ ) .


The difference between the means ( @ % confidence interval ) for HC was @ mm ( @ to @ ) , and SDS was @ ( @ to @ ) .


HC differences are still apparent at @ weeks ' corrected gestational age .


Early postnatal head growth failure in VPIs can be ameliorated by optimizing PN .


Chronic shoulder pain ( CSP ) is the third most common type of musculoskeletal pain .


It has a major impact on health-related quality of life .


In Chinese medicine , CSP is considered one of the conditions most amenable to treatment with acupuncture .


The purpose of this study is to evaluate the efficacy of local acupoints in combination with distal acupoints in pain relief and shoulder function improvement in CSP patients .


This is a multicenter , single blind , factorial randomized controlled clinical trial .


A total of @ participants will be randomly allocated to four different groups : Group A will receive acupuncture at local acupoints in combination with distal acupoint .


Group B will receive acupuncture at local acupoints in combination with distal non-acupoint .


Group C will receive acupuncture at local non-acupoints in combination with distal acupoint .


Group D will receive acupuncture at local non-acupoints in combination with distal non-acupoint .


Each group will receive @ treatments of acupuncture one to three times per week for six weeks in total .


The primary outcome is shoulder pain intensity , which is graded using a @ - mm Visual Analogue Scale .


The assessment is at baseline ( before treatment initiation ) , @weeks after the first acupuncture , @weeks after the first acupuncture and @weeks after the first acupuncture .


This trial will be helpful in identifying whether acupuncture at local acupoints in combination with distal acupoints may be more effective than needling points separately .


Rivaroxaban is an oral , direct Factor Xa inhibitor , approved for the treatment of pulmonary embolism ( PE ) and deep vein thrombosis ( DVT ) and the secondary prevention of recurrent PE and DVT as a fixed-dose , monotherapy regimen that does not require initial heparinisation , routine coagulation monitoring or dose adjustment .


Approval in this indication was supported by results from EINSTEIN PE , a large , randomised , open-label study that compared rivaroxaban with enoxaparin/vitamin K antagonist ( VKA ) therapy in patients with acute symptomatic PE with or without DVT .


Patient-reported treatment satisfaction was evaluated in a predefined subanalysis of EINSTEIN PE to enable monitoring and optimisation of patient-reported outcomes and , therefore , patient compliance .


As part of EINSTEIN PE , @,@ patients in seven countries were asked to complete a validated measure of treatment satisfaction , the Anti-Clot Treatment Scale ( ACTS ) throughout the duration of treatment ( up to @ months ) .


Patients reported greater satisfaction in the rivaroxaban treatment arm as compared with the enoxaparin/VKA treatment arm .


Treatment with rivaroxaban was reported as being significantly less burdensome than enoxaparin/VKA therapy , and the benefits of treatment were significantly greater .


Rivaroxaban treatment resulted in improved treatment satisfaction compared with enoxaparin/VKA in PE patients , particularly in reducing patient-reported anticoagulation burden .


A sub-study to evaluate safety , tolerability , ease-of-use and patient satisfaction with a single-use autoinjector administering subcutaneous peginterferon-@a ( a pegylated interferon-@a in clinical development ) in a subset of relapsing-remitting multiple sclerosis ( MS ) patients participating in ATTAIN , a long-term dose-frequency blinded extension of the Phase III randomized ADVANCE study .


Over @ weeks , patients self-administered peginterferon-@a @ g or placebo every @ weeks ( two injections via manual pre-filled syringe -LSB- PFS -RSB- ; two injections via single-use autoinjector ) .


Primary end points were incidence of adverse events ( AEs ) , patient assessment of injection pain score ( @-point Visual Analog Scale ) , and clinician assessment of injection site reactions ( ISRs ) .


Secondary objectives included patient assessment of ease-of-use and satisfaction with the autoinjector and evaluation of autoinjector training materials .


In @ patients , the safety profile of peginterferon-@a was similar when delivered via autoinjector or PFS ; AEs were mostly mild or moderate in severity .


Clinicians and patients reported a similar tolerability profile using both PFS and autoinjector , and pain scores were low ( < @ ) , with no reports of clinician-assessed ISRs after administration with the autoinjector .


Patients perceived the single-use autoinjector to be easy to use and convenient ; overall patient satisfaction with the autoinjector and accompanying training materials was high .


The safety and tolerability profile of peginterferon-@a delivered via autoinjector was similar to delivery via PFS .


Patients found the autoinjector easy to use and convenient ; this device may simplify the injection process for MS patients who require long-term therapy , thereby potentially improving patient 's quality of life and adherence .


To demonstrate the safety and efficacy of up to @ years of degarelix treatment and the effects of crossing over from leuprolide to degarelix in the extension phase of a phase III pivotal @-year trial .


Patients receiving degarelix who completed the @-year trial continued on @ mg ( n = @ ) or @ mg ( n = @ ) maintenance doses .


Patients who received leuprolide were rerandomized to degarelix @/@ mg ( n = @ ) or @/@ mg ( n = @ ) .


Safety and tolerability were assessed ( primary end point ) , as well as testosterone and prostate-specific antigen levels and prostate-specific antigen progression-free survival ( secondary end points ) .


Adverse event frequency was similar between both the groups .


Adverse events included initial injection site reactions , hot flushes , and increased weight .


Testosterone and prostate-specific antigen values during the extension study were similar to those seen during the @-year trial in patients who continued on degarelix or crossed over from leuprolide .


The prostate-specific antigen progression-free survival hazard rate was decreased significantly after the crossover in the leuprolide to degarelix group ( from @ to @ ; P = @ ) , whereas in patients who continued on degarelix , the rate did not change significantly .


In patients with baseline prostate-specific antigen > @ ng/mL , the same hazard rate change pattern was observed on crossover ( from @ to @ ; P = @ ) .


Degarelix was well tolerated ; no safety concerns were identified .


The significant prostate-specific antigen progression-free survival benefit established for degarelix over leuprolide during year @ remained consistent at @ years .


Oral biofilm formation and progression on the surface of the tooth can lead to advanced oral disease such as gingivitis .


The purpose of this randomized , controlled , double-blinded study was to evaluate the effects of a novel dental gel on oral plaque biofilm using multimodal imaging techniques .


Twenty-five subjects with moderate gingival inflammation ( Le and Silness Gingival Index @ ) and pocket depths < @ were randomly assigned to brush twice daily for @ days with the test or the control dental gel .


In vivo multimodality in situ imaging was performed over a @-week period using in vivo Optical Coherence Tomography ( OCT ) and Non-Linear Optical microscopy ( NLOM ) .


Plaque levels , gingival inflammation and gingival bleeding were also charted on days @ , @ , @ , and @ using standard clinical indices .


After @ weeks , OCT and NLOM images showed a macroscopic break-up of the plaque layer and smaller , fragmented residual deposits in the test group with no apparent changes in the pellicle .


Biofilm was also reduced in the control group , but to a lesser degree with regard to thickness , continuity and surface area .


Paralleling these imaging results , clinical indices were significantly improved in both groups ( P < @ ) and significantly lower in the test group ( P < @ ) .


Both dental gels reduced oral biofilm with the test gel showing greater efficacy ( P < @ ) as determined by clinical and imaging parameters .


This study examined the impact of pictorial cigarette-warning labels , warning-label message framing and plain cigarette packaging , on young adult smokers ' motivation to quit .


Smokers aged @-@ years ( n = @ ) from a consumer research panel were randomised to one of four experimental conditions where they viewed online images of four cigarette packs with warnings about lung disease , cancer , stroke/heart disease and death , respectively .


Packs differed across conditions by warning-message framing ( gain vs loss ) and packaging ( branded vs plain ) .


Measures captured demographics , smoking behaviour , covariates and motivation to quit in response to cigarette packs .


Pictorial warnings about lung disease and cancer generated the strongest motivation to quit across conditions .


Adjusting for pretest motivation and covariates , a message framing by packaging interaction revealed gain-framed warnings on plain packs generated greater motivation to quit for lung disease , cancer and mortality warnings ( p < @ ) , compared with loss-framed warnings on plain packs .


Warnings combining pictorial depictions of smoking-related health risks with text-based messages about how quitting reduces risks , may achieve better outcomes among young adults , especially in countries considering or implementing plain packaging regulations .


The aim of this study was to investigate the effects of CO@ insufflation on the pressure of the middle ear cavity ( PMEC ) during laparoscopic surgery under total intravenous anesthesia ( TIVA ) with propofol or sevoflurane as an inhalational anesthetic maintenance .


Sixty patients who underwent laparoscopic/or non-laparoscopic surgery under general anesthesia were included in the study .


For anesthetic maintenance with inhalation agents , @ non-laparoscopic surgery patients in Group @ were applied sevoflurane ( @-@ @ % ) .


Forty patients who underwent laparoscopic surgery were randomized into two groups .


Anesthesia was maintained with sevoflurane ( @-@ @ % ) in twenty patients in Group @ and the TIVA technique in @ patients in Group @ .


In Group @ , PMEC was measured before anesthesia , @ and @ min after endotracheal intubation , @ min before extubation , and @ , @ , @ min and @ hours in the postoperative period .


In Group @ and @ , PMEC was measured before the anesthesia , @ min after intubation , @ and @ min after CO@ insufflation , just before the CO@ elimination , @ min before the extubation , and @ , @ , @ min and @ hours after extubation in the postoperative period .


PMEC was significantly increased in Group @ at @ min after intubation , at @ min of the operation , before extubation , and at postoperative @ and @ min ( p < @ ) .


In Group @ , differences between PMECs were detected at the @th min of insufflation ( p = @ ) , and during elimination ( p = @ ) compared to the initial measurement .


Generally , the values remained positive in Group @ and negative in Group @ .


There was a significant difference between Group @ and Group @ at @ min after the induction ( p = @ ) .


There was no statistically significant difference in PMECs between Group @ and @ patients undergoing laparoscopic surgery .


Our results indicate that , in laparoscopic surgery , TIVA used for the maintenance of anesthesia did not increase the PMEC and the changes caused by sevoflurane were also in the normal range of middle ear pressures .


In patients with previous ear surgery , if there is a need of classical surgical procedures in the future , sevoflurane anesthesia should not be the first choice due to its effects on PMEC , which cause it to be increased over @ daPa , especially at @ min after intubation .


Patient characteristics including previous ear surgery should be considered in selecting the optimum anesthetic agents and technique .


It has been suggested that statins have an effect on the modulation of the cytokine cascade and on the outcome of patients with community-acquired pneumonia ( CAP ) .


The aim of this prospective , randomised , double-blind , placebo-controlled trial was to determine whether statin therapy given to hospitalised patients with CAP improves clinical outcomes and reduces the concentration of inflammatory cytokines .


A tertiary teaching hospital in Barcelona , Spain .


Thirty-four patients were randomly assigned and included in an intention-to-treat analysis ( @ to the simvastatin group and @ to the placebo group ) .


Patients were randomly assigned to receive @mg of simvastatin or placebo administered in the first @h of hospital admission and once daily thereafter for @days .


Primary end point was the time from hospital admission to clinical stability .


The secondary end points were serum concentrations of inflammatory cytokines and partial pressure of arterial oxygen/fractional inspired oxygen ( PaO@/FiO@ ) at @h after treatment administration .


The trial was stopped because enrolment was much slower than originally anticipated .


The baseline characteristics of the patients and cytokine concentrations at the time of enrolment were similar in the two groups .


No significant differences in the time from hospital admission to clinical stability were found between study groups ( median @days , IQR @-@ vs @days , IQR @-@ ; p = @ ) .


No significant differences in PaO@/FiO@ ( p = @ ) , C reactive protein ( p = @ ) , tumour necrosis factor - ( p = @ ) , interleukin @ ( IL-@ ; p = @ ) , and IL-@ ( p = @ ) levels at @h of hospitalisation were found between simvastatin and placebo groups .


Similarly , transaminase and total creatine kinase levels were similar between study groups at @h of hospitalisation ( p = @ , @ and @ , respectively ) .


Our results suggest that the use of simvastatin , @mg once daily for @days , since hospital admission did not reduce the time to clinical stability and the levels of inflammatory cytokines in hospitalised patients with CAP .


The emergence of HIV as a chronic condition means that people living with HIV are required to take more responsibility for the self-management of their condition , including making physical , emotional and social adjustments .


This paper describes the design and evaluation of Positive Outlook , an online program aiming to enhance the self-management skills of gay men living with HIV .


This study is designed as a randomised controlled trial in which men living with HIV in Australia will be assigned to either an intervention group or usual care control group .


The intervention group will participate in the online group program ` Positive Outlook ' .


The program is based on self-efficacy theory and uses a self-management approach to enhance skills , confidence and abilities to manage the psychosocial issues associated with HIV in daily life .


Participants will access the program for a minimum of @ minutes per week over seven weeks .


Primary outcomes are domain specific self-efficacy , HIV related quality of life , and outcomes of health education .


Secondary outcomes include : depression , anxiety and stress ; general health and quality of life ; adjustment to HIV ; and social support .


Data collection will take place at baseline , completion of the intervention ( or eight weeks post randomisation ) and at @ week follow-up .


Results of the Positive Outlook study will provide information regarding the effectiveness of online group programs improving health related outcomes for men living with HIV .


Despite significant increases in global health investment and the availability of low-cost , efficacious interventions to prevent mother-to-child HIV transmission ( pMTCT ) in low - and middle-income countries with high HIV burden , the translation of scientific advances into effective delivery strategies has been slow , uneven and incomplete .


As a result , pediatric HIV infection remains largely uncontrolled .


A five-step , facility-level systems analysis and improvement intervention ( SAIA ) was designed to maximize effectiveness of pMTCT service provision by improving understanding of inefficiencies ( step one : cascade analysis ) , guiding identification and prioritization of low-cost workflow modifications ( step two : value stream mapping ) , and iteratively testing and redesigning these modifications ( steps three through five ) .


This protocol describes the SAIA intervention and methods to evaluate the intervention 's impact on reducing drop-offs along the pMTCT cascade .


This study employs a two-arm , longitudinal cluster randomized trial design .


The unit of randomization is the health facility .


A total of @ facilities were identified in Cte d'Ivoire , Kenya and Mozambique ( @ per country ) .


A subset was randomly selected and assigned to intervention and comparison arms , stratified by country and service volume , resulting in @ intervention and @ comparison facilities across all three countries , with six intervention and six comparison facilities per country .


The SAIA intervention will be implemented for six months in the @ intervention facilities .


Primary trial outcomes are designed to assess improvements in the pMTCT service cascade , and include the percentage of pregnant women being tested for HIV at the first antenatal care visit , the percentage of HIV-infected pregnant women receiving adequate prophylaxis or combination antiretroviral therapy in pregnancy , and the percentage of newborns exposed to HIV in pregnancy receiving an HIV diagnosis eight weeks postpartum .


The Consolidated Framework for Implementation Research ( CFIR ) will guide collection and analysis of qualitative data on implementation process .


This study is a pragmatic trial that has the potential benefit of improving maternal and infant outcomes by reducing drop-offs along the pMTCT cascade .


The SAIA intervention is designed to provide simple tools to guide decision-making for pMTCT program staff at the facility level , and to identify low cost , contextually appropriate pMTCT improvement strategies .


To assess the impact of a web-based intervention supplemented with text messages to reduce cancer risk linked with smoking , unhealthy diet , alcohol consumption , obesity , sedentary lifestyle and sun exposure .