There were significant improvements with flibanserin versus placebo in the mean ( SE ) changes in the number of SSEs ( @ -LSB- @ -RSB- vs @ -LSB- @ -RSB- ) , FSFI desire domain score ( @ -LSB- @ -RSB- vs @ -LSB- @ -RSB- ) , FSDS-R Item @ score ( -@ -LSB- @ -RSB- vs -@ -LSB- @ -RSB- ) , FSDS-R total score ( -@ -LSB- @ -RSB- vs -@ -LSB- @ -RSB- ) , and FSFI total score ( @ -LSB- @ -RSB- vs @ -LSB- @ -RSB- ; all P < @ ) .


More women on flibanserin ( @ % ) than women on placebo ( @ % ) reported experiencing meaningful benefits from the study medication on treatment discontinuation .


The most frequent adverse events associated with flibanserin were dizziness , somnolence , nausea , and headache .


In naturally postmenopausal women with HSDD , flibanserin , compared with placebo , has been associated with improvement in sexual desire , improvement in the number of SSEs , and reduced distress associated with low sexual desire , and is well tolerated .


Gemigliptin is a selective DPP@ inhibitor used to treat type @ diabetes .


The objective of this study was to evaluate the pharmacokinetics ( PKs ) of gemigliptin , rosuvastatin , and irbesartan monotherapies and combination therapies .


Randomized , open-label , three-treatment , six-sequence , three-period , crossover studies were performed on healthy male volunteers .


The three treatments were : @mg gemigliptin alone ; @mg rosuvastatin ( part A ) or @mg irbesartan alone ( part B ) ; and rosuvastatin or irbesartan with concomitant gemigliptin .


Each drug was administered as part of once daily , @ day , repeated dosing regimens with a @ day washout period .


NCT@ ( part A ) and NCT@ ( part B ) .


The primary PK parameters - Cmax and AUC - were compared to the geometric mean ratios ( GMRs ) and @ % confidence intervals ( @ % CIs ) that were determined for the combination therapies and monotherapies .


A total of @ participants were administered the study drugs , and @ participants ( @ participants in part A ; @ participants in part B ) were analyzed as part of the PK dataset .


In part A , the GMRs ( gemigliptin + rosuvastatin/gemigliptin ) of the Cmax and AUC values of gemigliptin were @ ( @ % CI = @-@ @ ) and @ ( @ % CI = @-@ @ ) , and those of rosuvastatin were @ ( @ % CI = @-@ @ ) and @ ( @ % CI = @-@ @ ) , respectively .


In part B , the GMRs of the Cmax and AUC values of gemigliptin were @ ( @ % CI = @-@ @ ) and @ ( @ % CI = @-@ @ ) , and those of irbesartan were @ ( @ % CI = @-@ @ ) and @ ( @ % CI = @-@ @ ) , respectively .


The limitations of this study include its relatively short treatment period and small sample size , as only healthy participants were included .


Gemigliptin does not affect the PK properties of rosuvastatin or irbesartan ; also , rosuvastatin and irbesartan do not affect the PKs of gemigliptin .


To evaluate the effects of continuous paravertebral nerve block after nephrectomy .


@ cases receiving simple nephrectomy , American Society of Anesthesiologists ( ASA ) grading status I or II , aged from @ to @ years , weighing from @ to @ kg , male or female , were randomly divided into @ groups : control group ( CEA group ) and continuous paravertebral nerve block group ( PVB group ) , @ patients in each one .


Both groups were performed with @ % ropivacaine @ ml in continuous infusion , assisted with intravenous morphine patient-controlled analgesia .


The blood gas was examined in @ , @ , @ and @ h postoperatively , and the VAS scores of quiet state and motion state were assessed.In @ h postoperation , the total amount of morphine was calculated and the complications cases were recorded .


Compared with the CEA group , PaO@ in PVB group increased and PaCO@ declined significantly .


There was no difference of VAS score under quiet state , but under the motion state the VAS scores declined significantly , the total amount of morphine reduced -LSB- ( @ @ ) vs ( @ @ ) mg ) -RSB- , the cases of nausea , vomiting , pruritus , orthostatic hypotension decreased and the postoperative first anal exhaust time interval shortened ( P < @ ) .


Compared with CEA , postoperative administration of PVB for open nephrectomy results in lowering morphine dose as well as side effect related with the use of morphine .


To compare the image quality , evaluability , diagnostic accuracy , and radiation exposure of high-spatial-resolution ( HR , @-mm ) computed tomographic ( CT ) coronary angiography with standard spatial resolution ( SR , @-mm ) @-section imaging in patients at high risk for coronary artery disease ( CAD ) by using invasive coronary angiography ( ICA ) as the reference method .


Written informed consent was obtained from all patients , and the study protocol was approved by the institutional ethical committee .


Patients at high risk for CAD ( n = @ ) who were scheduled for ICA were randomly assigned for study with SR ( n = @ ) or HR ( n = @ ) coronary CT angiography before they underwent ICA .


To compare the two groups , the Student t test or Wilcoxon test were used to evaluate differences in continuous variables .


The ( @ ) test or Fisher exact test were used , as appropriate , for categorical data .


The McNemar test was used to compare the diagnostic performance of coronary CT angiography versus that of ICA in each group .


HR coronary CT angiography showed a higher image quality score ( @ vs @ , P < @ ) and evaluability ( @ % vs @ % , P < @ ) .


In a segment-based analysis , HR coronary CT angiography showed a higher specificity , positive predictive value , and accuracy in comparison with SR coronary CT angiography ( @ % , @ % , and @ % vs @ % , @ % , and @ % , respectively ; P < @ ) .


Moreover , HR coronary CT angiography showed a better agreement with ICA for calcified plaques compared with SR coronary CT angiography and ICA ( @ % vs @ % , P < @ ) .


In a patient-based analysis , HR coronary CT angiography showed higher specificity and accuracy compared with SR coronary CT angiography ( @ % and @ % vs @ % and @ % , respectively ; P < @ ) .


No differences in radiation exposure were found between the two groups .


Improved evaluability and accuracy were seen with HR compared with SR coronary CT angiography of calcified coronary artery lesions , suggesting a potential use for this technology in patients at high risk for CAD .


Live animal studies using an inoculation model of breast cancer indicate that anaesthetic drugs and techniques differentially affect cancer metastasis , inversely related to Natural Killer ( NK ) cell and T lymphocyte levels .


Clinical histological studies demonstrate that the distribution of these immune cells and macrophages in intra-tumoral cancer tissue can predict prognosis and response to therapy .


No study has evaluated whether the anaesthetic technique influences human breast cancer immune cell infiltration .


Excised breast cancer specimens from patients previously enrolled in an ongoing , prospective , randomised trial ( NCT@ ) investigating the effect of anaesthetic technique on long-term breast cancer outcome were immunohistochemically stained to enable a colour deconvolution technique to summate marked immune cell infiltration : CD@ ( NK cells ) , CD@ ( T helper cells ) , CD@ ( T suppressor cells ) and CD@ ( macrophages ) .


Patients were randomised to receive either a propofol-paravertebral anaesthetic with continuing analgesia ( PPA , n = @ ) or a balanced general anaesthesia with opioid analgesia ( GA , n = @ ) for @ h postoperatively .


Investigators were masked to group allocation .


Normalised positive intensity values , ( median ( interquartile range ( IQR ) ) , for CD@ were lower in GA@ ( @-@ ) versus @ ( @-@ ) , p = @ .


CD@ was also lower in GA@ @ ( @-@ @ ) versus PPA @ ( @-@ @ ) , p = @ but CD@ @ ( @-@ @ ) versus @ ( @-@ @ ) respectively , p = @ and CD @ infiltration @ ( @-@ @ ) versus @ ( @-@ @ ) , p = @ were not significantly different .


PPA induces increased levels of NK and T helper cell infiltration into breast cancer tissue compared with GA but not T suppressor cells or macro phages .


This is consistent with the hypothesis that the anaesthetic technique may affect perioperative immune function conducive to resisting breast cancer recurrence and metastasis .


Civilian posttraumatic stress disorder ( PTSD ) and combat PTSD are major public health concerns .


Although a number of psychosocial risk factors have been identified related to PTSD risk , there are no accepted , robust biological predictors that identify who will develop PTSD or who will respond to early intervention following trauma .


We wished to examine whether genetic risk for PTSD can be mitigated with an early intervention .


@ emergency department patients recruited in @-@ at Grady Memorial Hospital in Atlanta , Georgia , who met criterion A of DSM-IV PTSD received either @ sessions of an exposure intervention , beginning in the emergency department shortly after trauma exposure or assessment only .


PTSD symptoms were assessed @ and @ weeks after trauma exposure .


A composite additive risk score was derived from polymorphisms in @ previously identified genes associated with stress-response ( ADCYAP@R@ , COMT , CRHR@ , DBH , DRD@ , FAAH , FKBP@ , NPY , NTRK@ , and PCLO ) , and gene x treatment effects were examined .


The intervention included @ sessions of imaginal exposure to the trauma memory and additional exposure homework .


The primary outcome measure was the PTSD Symptom Scale-Interview Version or DSM-IV-based PTSD diagnosis in patients related to genotype and treatment group .


A gene x intervention x time effect was detected for individual polymorphisms , in particular the PACAP receptor , ADCYAP@R@ , as well as with a combined genotype risk score created from independent SNP markers .


Subjects who did not receive treatment had higher symptoms than those who received intervention .


Furthermore , subjects with the `` risk '' genotypes who did not receive intervention had higher PTSD symptoms compared to those with the `` low-risk '' or `` resilience '' genotypes or those who received intervention .


Additionally , PTSD symptoms correlated with level of genetic risk at week @ ( P < @ ) in the assessment-only group , but with no relationship in the intervention group , even after controlling for age , sex , race , education , income , and childhood trauma .


Using logistic regression , the number of risk alleles was significantly associated with likelihood of PTSD diagnosis at week @ ( P < @ ) .


This pilot prospective study suggests that combined genetic variants may serve to predict those most at risk for developing PTSD following trauma .


A psychotherapeutic intervention initiated in the emergency department within hours of the trauma may mitigate this risk .


The role of genetic predictors of risk and resilience should be further evaluated in larger , prospective intervention and prevention trials .


Despite the general belief that mobility and exercise play an important role in the recovery of functional status , mobility is difficult to implement in patients in intensive care units .


To compare a mobility platform with standard equipment , assessing efficiency ( decreased time and staff required to prepare patient ) , effectiveness ( increased activity time ) , and safety ( no falls , unplanned tube removals , or emergency situations ) for intensive care patients .


This observational study was approved by the institutional review board , and informed consent was obtained from the patient or the medical decision maker .


Intensive care patients were assigned to a room in the usual manner , with platforms in odd-numbered rooms and standard equipment in even-numbered rooms .


Standardized data collection tools were designed to collect data for @ hours for each patient .


The nurses caring for the patients completed the data collection tools in real time during the activity .


The stages of activity and the physiological states that would preclude mobility were very specifically defined for the research study .


Data were collected for a total of @ patients and @ activities .


Important ( although not significant ) descriptive statistics regarding early mobility in the intensive care unit were discovered .


The unintended result of the research study was a change in the culture and practice regarding early mobility in the intensive care unit .


Early mobility can be implemented in intensive care units .


Standard equipment can be used to mobilize such patients safely ; however , for patients who ambulate , a platform may increase efficiency and effectiveness .


This study aimed to compare sexual function before and @ year after laparoscopic sacrocolpopexy using a porcine dermis or a polypropylene mesh material .


This was a secondary analysis of sexual function measured before and @ year after laparoscopic sacrocolpopexy in a group of @ sexually active women participating in a randomized controlled trial comparing porcine dermis and polypropylene mesh .


Sexual function was assessed using the short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire ( PISQ-@ ) .


Responses to individual questions from the physical domain of the PISQ-@ were also analyzed .


Additional information included the type of mesh material used and whether a concomitant suburethral sling or perineorrhaphy was performed .


There was a significant postoperative improvement in total PISQ-@ scores for the entire cohort ( @ vs @ , P < @ ) .


Similarly , PISQ-@ scores were significantly improved in both groups ( @ preoperative vs @ one year postoperative in the porcine dermis , P < @ and @ vs @ in the polypropylene mesh , P < @ ) .


There were no differences between the @ graft material groups .


Preoperatively , @ % ( @/@ ) of women reported avoiding sexual intercourse because of bulging in vagina ( PISQ@-question # @ ) , at @ year postoperatively only @ % ( @/@ ) had a positive response ( P < @ ) .


We observed a significant decrease in the number of women who reported pain during intercourse at @ months as evidenced by the responses to the PISQ@-question # @ , @ % ( @/@ ) versus @ % ( @/@ ) ( P < @ ) .


The addition of a suburethral sling or a perineorrhaphy did not negatively impact sexual function at @ year .


Laparoscopic sacrocolpopexy had a positive impact on sexual function at @ year regardless of whether a porcine dermis or a polypropylene mesh material was used .


The objective of this study was to investigate the effects of feeding a high-concentrate corn straw diet on the release of endotoxin in the rumen and the changes of pro-inflammatory cytokines in the mammary gland of dairy cows in comparison with a low-concentrate corn straw diet and a low-concentrate mixed forage diet .


Thirty second-parity Chinese Holstein cows in mid-lactation with a body condition score of @ , weighing @kg and producing @ kg milk per day were randomly assigned to @ of the @ diets ( n = @ per treatment ) : @ ) low-concentrate mixed forage diet ( LCF ) with a concentrate to roughage ratio of @ : @ ; @ ) high-concentrate corn straw diet ( HCS ) with a concentrate to roughage ratio of @ : @ ; @ ) low-concentrate corn straw diet ( LCS ) with the same concentrate to roughage ratio ( @ : @ ) as LCF .


The experiment lasted @weeks , and samples were collected in the last week .


Milk samples were analyzed for conventional components , rumen fluid samples were analyzed for pH and endotoxin , and mammary arterial and venous plasma samples were analyzed for concentrations of interleukin ( IL ) -@ , IL-@ , IL-@ and tumor necrosis factor alpha ( TNF - ) .


Concentrations of endotoxin in rumen fluid and feces of cows fed HCS were significantly higher than those of cows fed LCS and LCF .


Feeding HCS increased the release of IL-@ , IL-@ and IL-@ in the mammary gland compared with feeding LCS .


Concentrations of cytokines ( IL-@ and IL-@ ) in mammary venous plasma had a negative correlation with milk production efficiencies .


Results indicated that the high-concentrate corn straw diet increased the concentrations of endotoxin in rumen fluid and feces .


Furthermore , feeding the high-concentrate corn straw diet stimulated the mammary gland to release more pro-inflammatory cytokines .


The results suggest that feeding a high-concentrate corn straw diet induce a higher pro-inflammatory response in the mammary gland and thus may partly decrease the milk production efficiencies in dairy cows .


Periprocedural thromboembolic and hemorrhagic events are worrisome complications of catheter ablation for atrial fibrillation ( AF ) .


The periprocedural anticoagulation management could play a role in the incidence of these complications .


Although ablation procedures performed without warfarin discontinuation seem to be associated with lower thromboembolic risk , no randomized study exists .


This was a prospective , open-label , randomized , parallel-group , multicenter study assessing the role of continuous warfarin therapy in preventing periprocedural thromboembolic and hemorrhagic events after radiofrequency catheter ablation .


Patients with CHADS@ score @ were included .


Patients were randomly assigned in a @:@ ratio to the off-warfarin or on-warfarin arm .


The incidence of thromboembolic events in the @ hours after ablation was the primary end point of the study .


The study enrolled @ patients : @ assigned to discontinue warfarin ( group @ ) and @ assigned to continuous warfarin ( group @ ) .


No statistical difference in baseline characteristics was observed .


There were @ thromboembolic events ( @ % strokes -LSB- n = @ -RSB- and @ % transient ischemic attacks -LSB- n = @ -RSB- ) in group @ : two events ( @ % ) in patients with paroxysmal AF , @ ( @ % ) in patients with persistent AF , and @ ( @ % ) in patients with long-standing persistent AF .


Only @ strokes ( @ % ) in patients with long-standing persistent AF were observed in group @ ( P < @ ) .


Warfarin discontinuation emerged as a strong predictor of periprocedural thromboembolism ( odds ratio , @ ; @ % confidence interval , @-@ @ ; P < @ ) .


This is the first randomized study showing that performing catheter ablation of AF without warfarin discontinuation reduces the occurrence of periprocedural stroke and minor bleeding complications compared with bridging with low-molecular-weight heparin .


Exercise maintenance after completing phase II cardiac rehabilitation ( CR ) is challenging for many patients .


A telephone-based maintenance intervention improved exercise participation compared with a control group at @ months post-CR discharge .


We examined the @-month mediators of intervention effects on exercise .


In a randomized controlled trial , @ patients who had completed CR ( mean age : @ -LSB- SD = @ -RSB- years , @ % female ) were randomized to Maintenance Counseling ( n = @ ) or Contact Control ( n = @ ) .


Putative mediators examined the following : self-efficacy , behavioral processes of change , decisional balance index , social support for exercise , and enjoyment of exercise .


Multiple mediation analyses showed that the intervention significantly increased social support from friends at @ months but not the other constructs .


Decreasing support from friends mediated greater exercise participation in Maintenance Counseling than in Contact Control at @ months .


Social support from friends functioned as a suppressor mediator for exercise maintenance among cardiac patients .


To explore the effect of single-dose dexmedetomidine on recovery period after sevoflurane anesthesia with spontaneous respiration in pediatric patients undergoing cleft lip and palate repair .


A total of @ American Society of Anesthesiologists ( ASA ) I-II pediatric patients undergoing cleft lip and palate repair from October to December @ were randomly divided into groups D and C ( n = @ each ) .


Dexmedetomidine @ g/kg ( group D ) or an equal volume of normal saline ( group C ) was ad ministered intravenously over a period of @ min at @ min before the end of surgery .


Anesthesia was induced and maintained with sevoflurane under spontaneous ventilation .


Heart rate , mean arterial pressure ( MAP ) , hemoglobin oxygen saturation ( SpO@ ) , respiratory rate , tidal volume ( VT ) and pressure of end-tidal carbon dioxide ( PETCO@ ) were recorded at the time before induction ( T@ ) , @ min before the end of surgery ( T@ ) , @ min before the end of surgery ( T@ ) , @ min before the end of surgery ( T@ ) , @ min before the end of surgery ( T@ ) , the end of surgery ( T@ ) , extubation ( T@ ) , @ min after transferal into post-anesthesia care unit ( PACU ) ( T@ ) , @ h after surgery ( T@ ) , extubation time , length of PACU stay , fentanyl consumption and adverse events were all recorded .


The incidence and severity of coughing and emergence agitation were assessed .


Compared to T@ , MAP and heart rate at T@ to T@ all decreased in two groups ( P < @ ) .


MAP and heart rate at T@ both increased in two groups and group C was higher than group D ( P < @ ) .


No inter-group differences existed in SpO@ , respiratory rate , VT or PETCO@ .


The incidence of coughing and emergence agitation ( @ % and @ % ) , fentanyl consumption of group D ( @ @ g ) were all significantly lower than that of group C -LSB- ( @ % vs @ % ) and ( @ @ ) g , P < @ -RSB- .


Length of PACU stay in group D was shorter than that in group C -LSB- ( @ @ ) vs ( @ @ ) min , P < @ -RSB- .


No inter-group difference existed in extubation time or adverse events .


A single intravenous dose of dexmedetomidine is effective in reducing emergence agitation and coughing , shortening length of PACU stay and improving the quality of recovery period after sevoflurane anesthesia in pediatric patients undergoing cleft lip and palate repair .


To test whether subsensory vibratory noise applied to the sole of the foot using a novel piezoelectric vibratory insole can significantly improve sensation , enhance balance , and reduce gait variability in elderly people , as well as to determine the optimal level of vibratory noise and whether the therapeutic effect would endure and the user 's sensory threshold would remain constant during the course of a day .


A randomized , single-blind , crossover study of @ subsensory noise stimulation levels on @ days .


Balance and gait laboratory .


Healthy community-dwelling elderly volunteers ( N = @ ; age , @-@y ) who could feel the maximum insole vibration .


A urethane foam insole with the piezoelectric actuators delivering subsensory vibratory noise stimulation to the soles of the feet .


Balance , gait , and timed Up and Go ( TUG ) test .


The vibratory insoles significantly improved performance on the TUG test , reduced the area of postural sway , and reduced the temporal variability of walking at both @ % and @ % of the sensory threshold and during the course of a day .


Vibratory sensation thresholds remained relatively stable within and across study days .


This study provides proof of concept that the application of the principle of stochastic resonance to the foot sole sensory system using a new low-voltage piezoelectric technology can improve measures of balance and gait that are associated with falls .


Effective vibratory noise amplitudes range from @ % to @ % of the sensory threshold and can be set once daily .


One of the primary goals of endoscopic sinus surgery ( ESS ) is to create widely patent paranasal sinus ostia , but lateralization of the middle turbinate ( MT ) after ESS can obstruct otherwise patent ethmoid and maxillary sinuses .


The aim of this study was to evaluate the effectiveness of turbinate-septal suturing in preventing lateralization of the MT.


A prospective , randomized , blinded controlled study .


The study was performed in @ patients who had undergone ESS .


The patients were randomized to receive nasal ( group A ) or turbinate-septal suture plus nasal packing ( group B ) .


Postoperative lateralization of the MT and synechia formation were assessed as the primary outcome @ months post-ESS .


The Lund-Kennedy Scores at @ week , @ week , and @ month after ESS were assessed as the secondary outcomes .


A total of @ patients were enrolled ( @ patients in each group ) .


Group B had a significantly lower rate of MT lateralization compared to group A after @ months of surgery ( @ of @ sides vs. @ of @ sides ; P < @ ) .


Synechia formation rates in groups B were also significantly lower than those in group A ( @ of @ sides vs. @ of @ sides ; P = @ ) .


Middle turbinate-septal suturing medialization during ESS is an effective method for preventing lateralization of the MT.


To investigate the effect of `` Xinjingjie compound lysostaphin antibacterial collutorium '' on prevention and treatment of radiation-induced oral mucositis in a prospective , randomized and double-blind clinical trial .


Sixty patients with oral cancer to be treated with radiotherapy were randomized into the experimental and control group .


The experimental group ( @ patients ) was treated with `` Xinjingjie mouthrinse '' during the full course of radiotherapy , @ times daily with @ mL and @ min each time .


The control group ( @ patients ) rinsed the mouth in the same way with normal saline .


Oral mucositis was assessed according to the RTOG criteria .


The severity of mucositis and the degree of pain were recorded and photographed .


Patients should n't be treated with other drugs until the level of oral mucositis reached above grade III .


The results were statistically analyzed using Stata @ software packages .


Age , gender , radiotherapy techniques and dose showed no significant difference between the @ groups ( P > @ ) .


The first onset of oral mucositis in the experimental group was later than that in the control group ( @ times :@ times , P < @ ) , and the incidence of pain at the early time of radiotherapy was lower ( @ % : @ % , P < @ ) .


Also , the onset time of grade III oral mucositis in the emperimental group was later than that in the control group ( @ times :@ times , P < @ ) , and the incidence of grade III oral mucositis in the experimental group was lower ( @ % vs. @ % , P < @ ) .


`` Xinjingjie mouthrinse '' is worthwhile to be used in clinic because it can delay the occurrence time of radiation-induced oral mucositis , alleviate pain and reduce the indication of grade III oral mucositis .


To assess the potential therapeutic effect of intratendinous injection of platelet-rich plasma ( PRP ) under ultrasound ( US ) guidance to treat tendon tears and tendinosis in a pilot study with long-term follow-up .


The study included @ consecutive patients referred for treatment by PRP injection of tendinopathy in the upper ( medial and lateral epicondylar tendons ) and the lower ( patellar , Achilles , hamstring and adductor longus , and peroneal tendons ) limb who received a single intratendinous injection of PRP under US guidance .


Clinical and US data were retrospectively collected for each anatomic compartment for upper and lower limbs before treatment ( baseline ) and @ weeks after treatment .


Late clinical data without US were collected until @ months after the procedure ( mean , @ months ) .


The McNemar test and regression model were used to compare clinical and US data .


QuickDASH score , Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) score , and residual US size of lesions were significantly lower after intratendinous injection of PRP under US guidance at @ weeks and during long-term follow-up compared with baseline ( P < @ in upper and lower limb ) independent of age , gender , and type of tendinopathy ( P > @ ) .


No clinical complication was reported during follow-up .


Intratendinous injection of PRP under US guidance appears to allow rapid tendon healing and is well tolerated .


We compare the rate of return to the emergency department ( ED ) within @ hours between families of children receiving a follow-up telephone call by a non-health care provider asking about the child 's well-being @ hours after their visit to the ED and families not receiving a follow-up call .


This was a prospective , randomized study in which we conducted a follow-up call starting at @ hours after discharge from the ED versus no call for follow-up .


At @ hours after discharge , we contacted all recruited families .


We recorded the rate of return to the ED within @ hours of discharge .


Of @ families in the data analysis , @ % were in the study group , and @ % were male patients .


Mean age was @ years .


The outcome measure was found to be in contrary to our hypothesis .


We found return visits to the ED in @ ( @ % ) of the children in the study group compared with only @ ( @ % ) in the control group ( P < @ ) .


All other parameters were not statistically different between the groups .


Emergency departments practicing follow-up calls by non-health care providers should consider a forecasted increase in return rates .


Inpatients are visited by many health care providers daily ; many can not remember the name of even one member of their clinical care team .


We provided inpatients with photographs of their clinicians and evaluated the impact on patient recall and communication with their health care providers .


A concealed allocation , randomized controlled trial ( ClinicalTrials.gov NCT@ ) was conducted between September @ and April @ in the general internal medicine wards of a large teaching hospital in Toronto , Canada .


Consenting patients were randomized into @ groups : the control group received the current standard of care ; the second group received handouts with the names and roles of their clinical care team ; and the third group received handouts with the names , roles , and photographs of their clinical care team .


Before discharge , patients completed a survey on their ability to recall their clinicians and were asked to rate the quality of communication with their care team .


Of the @ patients ( mean age @ years , female = @ % ) who completed surveys ( control n = @ ; names n = @ ; photos n = @ ) , those receiving photos in the handout correctly identified significantly more clinicians by photograph ( P = @ ) and recalled more names ( P = @ ) than patients assigned to the control group .


Regarding the perceived quality of communication , the results did not show differences between the control and intervention groups .


In this era of patient-centered care , providing patients with more information about who is directly involved with their health care appears to be warranted .


Primary Sjgren 's Syndrome ( PSS ) mainly affects women ( @:@ female : male ratio ) and is one of the commonest autoimmune diseases with a prevalence of @ - @ % of adult women .


For patients with PSS there is currently no effective therapy that can alter the progression of the disease .


The aim of the TRACTISS study is to establish whether in patients with PSS , treatment with rituximab improves clinical outcomes .


TRACTISS is a UK multi-centre , double-blind , randomised , controlled , parallel group trial of @ patients with PSS .


Patients will be randomised on a @:@ basis to receive two courses of either rituximab or placebo infusion in addition to standard therapy , and will be followed up for up to @ weeks .


The primary objective is to assess the extent to which rituximab improves symptoms of fatigue and oral dryness .


Secondary outcomes include ocular dryness , salivary flow rates , lacrimal flow , patient quality of life , measures of disease damage and disease activity , serological and peripheral blood biomarkers , and glandular histology and composition .


The TRACTISS trial will provide direct evidence as to whether rituximab in patients with PSS leads to an improvement in patient symptoms and a reduction in disease damage and activity .


The choice of empirical antibiotic treatment for patients with clinically suspected community-acquired pneumonia ( CAP ) who are admitted to non-intensive care unit ( ICU ) hospital wards is complicated by the limited availability of evidence .


We compared strategies of empirical treatment ( allowing deviations for medical reasons ) with beta-lactam monotherapy , beta-lactam-macrolide combination therapy , or fluoroquinolone monotherapy .


In a cluster-randomized , crossover trial with strategies rotated in @-month periods , we tested the noninferiority of the beta-lactam strategy to the beta-lactam-macrolide and fluoroquinolone strategies with respect to @-day mortality , in an intention-to-treat analysis , using a noninferiority margin of @ percentage points and a two-sided @ % confidence interval .


A total of @ patients were included during the beta-lactam strategy periods , @ during the beta-lactam-macrolide strategy periods , and @ during the fluoroquinolone strategy periods , with rates of adherence to the strategy of @ % , @ % , and @ % , respectively .


The median age of the patients was @ years .


The crude @-day mortality was @ % ( @ patients ) , @ % ( @ patients ) , and @ % ( @ patients ) , respectively , during these strategy periods .


In the intention-to-treat analysis , the risk of death was higher by @ percentage points ( @ % confidence interval -LSB- CI -RSB- , -@ to @ ) with the beta-lactam-macrolide strategy than with the beta-lactam strategy and lower by @ percentage points ( @ % CI , -@ to @ ) with the fluoroquinolone strategy than with the beta-lactam strategy .


These results indicated noninferiority of the beta-lactam strategy .


The median length of hospital stay was @ days for all strategies , and the median time to starting oral treatment was @ days ( interquartile range , @ to @ ) with the fluoroquinolone strategy and @ days ( interquartile range , @ to @ ) with the other strategies .


Among patients with clinically suspected CAP admitted to non-ICU wards , a strategy of preferred empirical treatment with beta-lactam monotherapy was noninferior to strategies with a beta-lactam-macrolide combination or fluoroquinolone monotherapy with regard to @-day mortality .


( Funded by the Netherlands Organization for Health Research and Development ; CAP-START ClinicalTrials.gov number , NCT@ . )


Spinal cord stimulation is a potential therapeutic option for the treatment of Parkinson 's disease ( PD ) - associated symptoms .


Repetitive trans-spinal magnetic stimulation ( rTSMS ) is a non-invasive and safe alternative for stimulation of spinal pathways that has not been studied for therapeutic efficacy in PD .


We assessed the benefits of rTSMS on camptocormia , an often treatment-resistant postural abnormality observed in PD patients .


We compared rTSMS to sham stimulation in PD patients with camptocormia in a single-centre , randomised , single-blind , crossover , placebo-controlled study .


PD patients with camptocormia were administered a single trial of rTSMS ( a train of @ stimuli ) or sham treatment followed @ week later by the alternate treatment .


Primary outcome measure was thoracolumbar spine flexion angle in the standing position immediately after the trial .


Of @ PD patients examined , @ had concomitant camptocormia and were randomly assigned to either the rTSMS first group ( n = @ ) or sham first group ( n = @ ) .


Flexion angle in the standing position decreased by a mean of @ ( @ % CI @ to @ ) after rTSMS but remained unchanged after sham stimulation ( mean , -@ ; @ % CI -@ to @ ) .


The flexion angle while sitting ( secondary outcome ) decreased by @ ( @ % CI @ to @ ) after rTSMS , whereas sham treatment had no significant effect ( mean , -@ ; @ % CI -@ to @ ) .


We found an immediate beneficial effect of rTSMS on camptocormia in PD patients .


Although the effect was transient , this successful trial justifies further studies to test if repeated rTSMS treatments can induce longer term improvements in camptocormia associated with PD .


The SP@ study ( ClinicalTrials.gov , NCT@ ) showed benefits of rotigotine over placebo in improving symptom severity of restless legs syndrome ( RLS ) , also known as Willis-Ekbom disease , on the International Restless Legs Syndrome Study Group rating scale ( IRLS ) , Clinical Global Impression item @ ( CGI-@ ) , RLS @-item questionnaire ( RLS-@ ) , and the RLS-quality of life questionnaire ( RLS-QoL ) in patients with moderate to severe idiopathic RLS .


To provide clinical context for the IRLS and to guide the choice of assessment scales for RLS studies , our post hoc analysis of SP@ data evaluated associations between the IRLS and the CGI-@ , IRLS and RLS-@ , and the IRLS and RLS-QoL .


Scale associations were analyzed at baseline and at the end of maintenance ( EoM ) using data from the safety set ( rotigotine and placebo groups combined -LSB- n = @ -RSB- ) .


Changes from baseline to EoM in IRLS score vs comparator scale scores also were analyzed .


There was a trend towards increasing IRLS severity category with increasing CGI-@ , RLS-@ , and RLS-QoL score .


Pearson product moment correlation coefficients showed correlations between IRLS and comparator scale scores at baseline and EoM as well as correlations for change from baseline to EoM .


Correlations between the IRLS and comparator scales were substantial .


These data indicate that the IRLS is clinically meaningful .


The IRLS and CGI-@ are generally sufficient to evaluate the overall severity and impact of RLS symptoms in clinical trials .


To evaluate sustained improvements @ months after a @-session , in-school computer attention training intervention using neurofeedback or cognitive training ( CT ) administered to @ - to @-year-olds with attention-deficit/hyperactivity disorder ( ADHD ) .


One hundred four children were randomly assigned to receive neurofeedback , CT , or a control condition and were evaluated @ months postintervention .


A @-point growth model assessed change over time across the conditions on the Conners @-Parent Assessment Report ( Conners @-P ) , the Behavior Rating Inventory of Executive Function Parent Form ( BRIEF ) , and a systematic double-blinded classroom observation ( Behavioral Observation of Students in Schools ) .


Analysis of variance assessed community-initiated changes in stimulant medication .


Parent response rates were @ % at the @-month follow-up .


Six months postintervention , neurofeedback participants maintained significant gains on Conners @-P ( Inattention effect size -LSB- ES -RSB- = @ , Executive Functioning ES = @ , Hyperactivity/Impulsivity ES = @ ) and BRIEF subscales including the Global Executive Composite ( ES = @ ) , which remained significantly greater than gains found among children in CT and control conditions .


Children in the CT condition showed delayed improvement over immediate postintervention ratings only on Conners @-P Executive Functioning ( ES = @ ) and @ BRIEF subscales .


At the @-month follow-up , neurofeedback participants maintained the same stimulant medication dosage , whereas participants in both CT and control conditions showed statistically and clinically significant increases ( @ mg -LSB- P = @ -RSB- and @ mg -LSB- P < @ -RSB- , respectively ) .


Neurofeedback participants made more prompt and greater improvements in ADHD symptoms , which were sustained at the @-month follow-up , than did CT participants or those in the control group .


This finding suggests that neurofeedback is a promising attention training treatment for children with ADHD .


Over the years , there has been a strong consensus in dentistry that at least two implants are required to retain a complete mandibular denture .


It has been shown in several clinical trials that one single median implant can retain a mandibular overdenture sufficiently well for up to @years without implant failures , when delayed loading was used .


However , other trials have reported conflicting results with in part considerable failure rates when immediate loading was applied .


Therefore it is the purpose of the current randomized clinical trial to test the hypothesis that immediate loading of a single mandibular midline implant with an overdenture will result in a comparable clinical outcome as using the standard protocol of delayed loading .


This prospective nine-center randomized controlled clinical trial is still ongoing .


The final patient will complete the trial in @ .


In total , @ edentulous patients between @ and @years with sufficient complete dentures will receive one median implant in the edentulous mandible , which will retain the existing complete denture using a ball attachment .


Loading of the median implant is either immediately after implant placement ( experimental group ) or delayed by @months of submerged healing at second-stage surgery ( control group ) .


Follow-up of patients will be performed for @months after implant loading .


The primary outcome measure is non-inferiority of implant success rate of the experimental group compared to the control group .


The secondary outcome measures encompass clinical , technical and subjective variables .


The study was funded by the Deutsche Forschungsgemeinschaft ( German research foundation , KE @/@ -@ ) .


This multi-center clinical trial will give information on the ability of a single median implant to retain a complete mandibular denture when immediately loaded .


If viable , this treatment option will strongly improve everyday dental practice .


This prospective randomized study aimed to evaluate the role of WBRT+SRS compared to SRS alone and to WBRT alone in improvement of overall survival , brain local control and neurologic manifestations .


The trial included @ patients with @ to @ brain metastases treated at the Radiotherapy Department , National Cancer Institute .


@ patients received WBRT+SRS , @ patients received SRS alone and @ patients received WBRT alone .


Median local control was significantly better for WBRT+SRS compared to SRS alone & WBRT alone ( @ vs @ vs @ months , respectively , P = @ ) .


There was non significant survival benefit for WBRT+SRS compared to SRS alone & WBRT alone .


Survival was significantly better for patients with controlled primary tumor who received WBRT+SRS compared to SRS alone & WBRT alone ( median survival was @ vs @ vs @ months , respectively .


P = @ ) .


Regardless of the treatment group , median survival and median local control were highly significantly better for single brain site involvement compared to multiple brain sites involvement ( P = @ & P = @ , respectively ) , and median brain local control was significantly better for single lesion compared to multiple lesions ( P = @ ) .


WBRT+SRS is an effective , safe tool in treatment of patients with @ to @ brain metastses improving the brain local control , but further studies with larger number of patients is recommended .


Depressive symptoms and reduced quality of life ( QOL ) are parts of the chronic stress syndrome and predictive of adverse outcome in patients with ischemic heart disease ( IHD ) .


Chronic stress is associated with increased sensitivity for pain , which can be measured by algometry as Pressure Pain Sensitivity ( PPS ) on the sternum .


To evaluate if stress focus by self-measurement of PPS , followed by stress reducing actions including acupressure , can decrease depressive symptoms and increase psychological well-being in people with stable IHD .


Observer blinded randomized clinical trial over @ months of either intervention or treatment as usual ( TAU ) .


Intention to treat .


Two hundred and thirteen participants with IHD were included : @ to active treatment and @ to TAU .


Drop-out : @ and @ , respectively .


The active intervention included self-measurement of PPS twice daily followed by acupressure as mandatory action , aiming at a reduction in PPS .


Primary endpoint : change in depressive symptoms as measured by Major depression inventory ( MDI ) .


Other endpoints : changes in PPS , Well-being ( WHO-@ ) and mental and physical QOL ( SF-@ ) .


At @ months PPS decreased @ % , to @ , in active and @ % , to @ , in TAU , p < @ .


MDI decreased @ % , to @ , in active group vs. @ % , to @ in TAU , p = @ .


WHO-@ increased to @ and @ , active group and TAU , p = @ .


SF-@ mental score sum increased to @ and @ , active and TAU , p = @ .


PPS measurements followed by acupressure reduce PPS , depressive symptoms and increase QOL in patients with stable IHD .


To investigate the postoperative analgesic effects of preemptive dexketoprofen trometamol in dogs subjected to ovariohysterectomy ( OHE ) .


Seventeen adult bitches of various breeds were used in this study .


The dogs were randomly allocated into of two groups .


Subjects in the dexketoprofen trometamol ( DEX ) group ( n = @ ) , received intravenous ( i.v. ) dexketoprofen trometamol , @ mg/kg , @ minutes before premedication , while those assigned to the control ( C ) group ( n = @ ) were given no analgesics prior to premedication .


Pain level was assessed by two researchers before the administration of anaesthesia ( @ minutes before start ) and @ , @ , @ , @ and @ hours after surgery .


A modified University of Melbourne Pain Scale ( UMPS ) was used to evaluate pain in both groups .


Serum cortisol level changed from @ to @ h and from @ to @ to @ h were compared between the groups ; the increase in the C group was statistically significant .


The modified UMPS was applied to both groups at baseline and postoperative @ , @ , @ and @ h.


According to this test , the values for DEX were significantly lower than controls at @ and @ h ( p < @ ) .


Stable vital signs with unchanged biochemical parameters on dexketoprofen administration are a promising finding .


The clinical advantage shown by the pain scale difference and the low serum cortisol levels should qualify dexketoprofen for preemptive pain management in dogs ( Tab .


@ , Fig. @ , Ref .


This prospective study aims to explore the benefit of cytokine-induced killer cell ( CIK ) treatment in hepatocellular carcinoma patients , which has not yet been thoroughly studied before .


From January @ to May @ , @ patients who were initially diagnosed with hepatocellular carcinoma of Barcelona Clinic Liver Cancer ( BCLC ) stage A , B or C , Child-Pugh scores of A or B and without prior treatment were enrolled in the study .


Patients were randomly assigned to either arm @ ( n = @ ) to receive CIK treatment plus standard treatment , or arm @ ( n = @ ) to receive standard treatment only .


The primary end point was overall survival ( OS ) and the secondary endpoint was progression-free survival as evaluated by Kaplan-Meier analyses and treatment hazard ratios with the Cox proportional hazards model .


The @-year ( OS : @ % vs. @ % , @ % CI : @-@ @ % vs. @-@ @ , p = @ ) , @-year ( OS : @ % vs. @ % , @ % CI : @-@ @ % vs. @-@ @ % , p = @ ) , @-year ( OS : @ % vs. @ % , @ % CI : @-@ @ % vs. @-@ @ % , p = @ ) and median overall and progression-free survivals of arm @ patients were significantly higher than those of arm @ .


Therefore , in patients who are not suitable for surgery , significant benefit is obtained from CIK treatment .


The main adverse effects of CIK included fever , allergy and headache pain .


Hepatocellular carcinoma patients who were not suitable for surgery demonstrate prolonged overall and progression-free survival from CIK treatment .


The risk of brain swelling after dural opening is high in patients with midline shift undergoing supratentorial tumor surgery .


Brain swelling may result in increased intracranial pressure , impeded tumor exposure , and adverse outcomes .


Mannitol is recommended as a first-line dehydration treatment to reduce brain edema and enable brain relaxation during neurosurgery .


Research has indicated that mannitol enhanced brain relaxation in patients undergoing supratentorial tumor surgery ; however , these results need further confirmation , and the optimal mannitol dose has not yet been established .


We propose to examine whether different doses of @ % mannitol improve brain relaxation in a dose-dependent manner when administered at the time of incision .


We will examine patients with preexisting mass effects and midline shift undergoing elective supratentorial brain tumor surgery .


This is a single-center , randomized controlled , parallel group trial that will be carried out at Beijing Tiantan Hospital , Capital Medical University .


Randomization will be achieved using a computer-generated table .


The study will include @ patients undergoing supratentorial tumor surgery whose preoperative computed tomography/magnetic resonance imaging results indicate a brain midline shift .


Patients in group A , group B , and group C will receive dehydration treatment at incision with @ % mannitol solutions of @ , @ , and @ g/kg , respectively , at a rate of @ mL/h .


The patients in the control group will not receive mannitol .


The primary outcome is an improvement in intraoperative brain relaxation and dura tension after dehydration with mannitol .


Secondary outcomes are postoperative outcomes and the incidence of mannitol side effects .


The aim of this study is to determine the optimal dose of @ % mannitol for intraoperative infusion .


We will examine brain relaxation and outcome in patients undergoing supratentorial tumor surgery .


If our results are positive , the study will indicate the optimal dose of mannitol to improve brain relaxation and avoid side effects during brain tumor surgery .


Laquinimod is an oral therapeutic agent under investigation for the treatment of Crohn 's disease ( CD ) , Huntington 's disease , lupus nephritis and multiple sclerosis .


This dose escalation study evaluated the safety and efficacy of laquinimod as induction therapy in patients with active moderate-severe CD .


Multicentre , double-blind , sequential-cohort , randomised controlled trial with laquinimod doses of @ , @ , @ or @mg/day or placebo ( n = @ per cohort randomised in a @:@ ratio ) for @weeks with @-week follow-up .


Stable concomittant therapies and prior use of anti-tumour necrosis factor agents were permitted .


Comprehensive safety assessments were performed and efficacy analyses included the proportions of patients in clinical remission ( CD Activity Index ( CDAI ) < @ and no treatment failure ( TF ) ) , and with a clinical response ( @ or @ point CDAI reduction from baseline or remission and no TF ) .


@ patients received laquinimod and @ patients received placebo .


The overall incidence of adverse events ( AEs ) in the laquinimod group was similar to the pooled placebo group ( @ % -@ % vs @ % ) and most AEs were mild to moderate in severity .


Treatment with laquinimod @ mg showed consistent effects on remission ( @ % ( CI @ % to @ % ) vs @ % ( CI @ % to @ % ) ) , response @ ( @ % ( CI @ % to @ % ) vs @ % ( CI @ % to @ % ) ) and response @ ( @ % ( CI @ % to @ % ) vs @ % ( CI @ % to @ % ) ) versus placebo .


Laquinimod @ mg showed less benefit ( @ % remission ( CI @ % to @ % ) and @ % response @ ( CI @ % to @ % ) ) , and no effect was noted on remission/response at higher doses .


Laquinimod was safe and well tolerated , and the effects on remission and response of the @ mg dose suggest a treatment benefit in patients with CD .


Deep general anesthesia has been associated with increased mortality in @ observational studies .


The association may be causal or an epiphenomenon due to increased anesthetic sensitivity in high-risk patients .


We conducted a pilot study to assess the feasibility of performing a definitive randomized controlled trial .


The aims of the study were to determine whether anesthetic depth targeting in a high-risk group was feasible and to document anesthetic doses and arterial blood pressures associated with `` deep '' and `` light '' general anesthesia .


ASA physical status III and IV patients , aged @ years , having surgery lasting @ hours , with expected hospital stay @ days , and receiving general anesthesia were randomly allocated to a Bispectral Index ( BIS ) or spectral entropy ( SE ) target of @ ( `` low '' group ) or @ ( `` high '' group ) .


The primary end point was mean BIS or SE .


Secondary end points were postanesthesia care unit length of stay and pain scores , quality of recovery score , hospital length of stay , postoperative complications , and death .


A composite end point of postoperative complications ( pneumonia , myocardial infarction , stroke , pulmonary embolism , heart failure , and death ) was determined at @ year .


One hundred twenty-five patients were recruited .


The mean of the median BIS/SE values for each patient during the maintenance phase of anesthesia in the low and high groups was significantly different : @ vs @ ( mean difference @ -LSB- @ % confidence interval -LCB- CI@ -RCB- , @ to @ -RSB- , P < @ ) .


There was also a significant difference in mean volatile anesthetic administration ( minimum alveolar concentration ) : @ vs @ ( mean difference -@ -LSB- CI@ , -@ to -@ -RSB- , P < @ ) and target propofol concentrations : @ vs @ g/mL ( mean difference -@ -LSB- CI@ , -@ to -@ -RSB- , P = @ ) .


Intraoperative mean arterial blood pressures were similar ( @ vs @ mm Hg ; mean difference @ -LSB- CI@ , -@ to @ -RSB- , P = @ ) , and there were no differences in short-term recovery characteristics or hospital length of stay .


There was a significant difference in the incidence of wound infection at @ days ( @ % vs @ % ; risk difference -@ % -LSB- CI@ , -@ to -@ -RSB- , P = @ ) .


At @ year , the composite rates of complications in the low and high groups were @ % and @ % ( risk difference -@ -LSB- CI@ , -@ to @ -RSB- , P = @ ) and mortality rates were @ % and @ % , respectively ( risk difference -@ -LSB- CI@ , -@ to @ -RSB- , P = @ ) .


This pilot study demonstrated that depth of anesthesia targeting with BIS or SE was achievable in a high-risk population with adequate separation of processed electroencephalogram monitor targets .


The expected incidence of postoperative complications and mortality occurred .


We conclude that a large , multicenter , randomized controlled trial is feasible .


Daily oral triple therapy is effective at halting HIV disease progression , but can have toxic effects and is costly .


We investigated whether dual therapy with lopinavir and ritonavir plus lamivudine is non-inferior to standard triple therapy .


The GARDEL study ( Global AntiRetroviral Design Encompassing Lopinavir/r and Lamivudine vs LPV/r based standard therapy ) is a @ week , phase @ , randomised , controlled , open-label , non-inferiority trial in antiretroviral-therapy-naive adults ( age @ years ) with documented HIV-@ RNA viral load of at least @ copies per mL .


The study was done at @ centres in six countries .


Patients were randomly assigned ( @:@ ) to dual therapy or triple therapy by sealed envelopes , in blocks of four , stratified by baseline viral load ( < @,@ vs @,@ copies per mL ) .


Dual therapy consisted of lopinavir @ mg and ritonavir @ mg plus lamivudine @ mg , both twice daily .


Triple therapy consisted of lopinavir @ mg and ritonavir @ mg twice daily and lamivudine or emtricitabine plus another nucleoside reverse transcriptase inhibitor ( NRTI ) in fixed-dose combination .


Efficacy was analysed in all participants who received at least one dose of study drug .


The primary endpoint was virological response rate , defined as the proportion of patients with HIV RNA less than @ copies per mL at @ weeks .


Dual therapy was classed as non-inferior to triple therapy if the lower bound of the @ % CI for the difference between groups was no lower than -@ % .


Patients and investigators were unmasked to treatment allocation .


This study is registered with ClinicalTrials.gov , number NCT@ .


Between Dec @ , @ , and May @ , @ , @ patients were randomly assigned to the dual-therapy group and @ to the triple-therapy group .


@ patients in the dual-therapy group and @ in the triple-therapy group completed @ weeks of treatment .


At week @ , @ patients ( @ % ) in the dual-therapy group and @ ( @ % ) in the triple-therapy group had viral response ( difference @ % , @ % CI -@ to @ ; p = @ ) .


Patients with baseline viral load of at least @,@ copies per mL showed similar results ( @ % vs @ % , respectively ; difference @ % , @ % CI -@ to @ ; p = @ ) .


Toxicity-related or tolerability-related discontinuations were more common in the triple-therapy group ( n = @ -LSB- @ % -RSB- ) than in the dual-therapy group ( n = @ -LSB- @ % -RSB- ; difference @ % , @ % CI -@ to -@ ; p = @ ) .


@ adverse events in the dual-therapy group and @ in the triple-therapy group were possibly or probably drug related ( p = @ ) .


Two serious adverse events occurred , both in the dual-therapy arm , one of which ( a case of gastritis ) was reported as possibly or probably related to drug treatment .


Dual therapy with lopinavir and ritonavir plus lamivudine regimen warrants further clinical research and consideration as a potential therapeutic option for antiretroviral-therapy-naive patients .


This phase III randomized trial ( ClinicalTrials.gov identifier : NCT@ ) compared eribulin with capecitabine in patients with locally advanced or metastatic breast cancer ( MBC ) .


Women with MBC who had received prior anthracycline - and taxane-based therapy were randomly assigned to receive eribulin or capecitabine as their first - , second - , or third-line chemotherapy for advanced/metastatic disease .


Stratification factors were human epidermal growth factor receptor-@ ( HER@ ) status and geographic region .


Coprimary end points were overall survival ( OS ) and progression-free survival ( PFS ) .


Median OS times for eribulin ( n = @ ) and capecitabine ( n = @ ) were @ and @ months , respectively ( hazard ratio -LSB- HR -RSB- , @ ; @ % CI , @ to @ ; P = @ ) .


Median PFS times for eribulin and capecitabine were @ and @ months , respectively ( HR , @ ; @ % CI , @ to @ ; P = @ ) .


Objective response rates were @ % for eribulin and @ % for capecitabine .


Global health status and overall quality-of-life scores over time were similar in the treatment arms .


Both treatments had manageable safety profiles consistent with their known adverse effects ; most adverse events were grade @ or @ .


In this phase III study , eribulin was not shown to be superior to capecitabine with regard to OS or PFS .


To examine the association between familial high lipoprotein ( a ) , or Lp ( a ) , concentrations and endothelial function in children participating in the Special Turku Coronary Risk Factor Intervention Project study .


Seven-month-old children ( n = @ ) with their families were randomized to a risk intervention group or to a control group .


The intervention group received individualized dietary counseling to reduce the total cholesterol concentration .


Children 's Lp ( a ) and lipid values were measured repeatedly .


At age @ years , children were recruited to an ultrasound study of the flow-mediated dilation ( FMD ) of the brachial artery .


The association between relative peak FMD and Lp ( a ) concentration was examined in @ control and @ intervention group children by linear regression analyses adjusted for sex , total cholesterol concentration , and basal artery diameter .


The analyses were made in both the control and intervention groups and in the familial risk children who had a parent with Lp ( a ) concentration greater than @ mg/l .


Lp ( a ) concentrations were similar at age @ years in the intervention and control groups .


In all control children , FMD ( % ) associated inversely with Lp ( a ) concentration : ( -LSB- % / @ mg/L -RSB- = -@ , @ % CI -LSB- -@ , -@ -RSB- ; P = @ ) and in @ familial risk children ( = -@ , @ % CI -LSB- -@ , -@ -RSB- ; P = @ ) .


In the intervention group the associations were lacking ( P > @ ) , and FMD in the children with high Lp ( a ) concentrations ( > @ mg/L , n = @ ) had no attenuation ( P = @ ) .


Familial high Lp ( a ) concentration is associated with attenuated endothelial function .


This association may be mitigated by an early lifestyle intervention .


Differences in patient tolerance , acceptance , and satisfaction of esophagogastroduodenoscopy ( EGD ) between transnasal ( TN ) and peroral ( PO ) routes using a @-mm video endoscope .


A total of @ enrolled patients were assigned randomly to two groups undergoing EGD-@ patients each for TN and PO .


The successful rate , procedure time , and adverse events were recorded .


After the procedure , patients answered a validated questionnaire of tolerance , acceptance , and satisfaction .


There were @ failures ( @ % ) of nasal intubation and two nasal bleeding ( @ % ) among @ TN-EGD procedures .


All PO patients ( n = @ ) completed EGD successfully without adverse event .


Compared to PO , the procedure of TN achieved lower successful rate ( @ % vs. @ % , p = @ ) , was complicated with epistaxis ( @ % vs. @ % ) and took longer ( mean SD @ @ min vs. @ @ min , p = @ ) .


The patients undergoing TN-EGD indicated less discomfort during passing pharynx ( scores of @ @ vs. @ @ , p = @ ) but more pain during inserting scope ( scores of @ @ vs. @ @ , p = @ ) .


Eventually , there were no significant differences between TN and PO regarding the overall procedure discomfort ( scores of @ @ vs. @ @ scores , p = @ ) , satisfaction ( scores of @ @ vs. @ @ , p = @ ) , and acceptability ( @ % vs. @ % , p = @ ) .


PO intubation seems an excellent alternative method when using a @-mm ultrathin endoscopy because it achieves comparable patient tolerance , acceptance , and satisfaction as TN intubation , takes less time and causes lower intubation failure and epistaxis .


The purpose was to evaluate the acceptability and feasibility of hand massage therapy in the intensive care unit ( ICU ) .


Clinical guidelines suggest the use of non-pharmacological interventions for pain management in ICU adults .


The results presented are secondary to a pilot RCT evaluating the preliminary effectiveness of hand massage on pain after cardiac surgery .


A qualitative descriptive design was used .


Acceptability was evaluated using individual interviews with participants in both groups i.e. , experimental and control ( n = @ ) .


Feasibility was examined using field notes and video recordings .


While participants receiving the massage perceived it as appropriate , the control group suggested different dosages of the treatment and body areas targeted .


Results also suggest that barriers ( e.g. noise , numerous clinical activities ) need to be overcome .


Increasing staff acceptance , reducing the rest period , involving families , and repeating the treatment are avenues to consider .


Building evidence for non-pharmacological pain management in the critical care setting is necessary .


The purpose of this study was to investigate whether a shorter language sample elicited with fewer pictures ( i.e. , @ ) would yield a percent grammatical utterances ( PGU ) score similar to that computed from a longer language sample elicited with @ pictures for @-year-old children .


Language samples were elicited by asking forty @-year-old children with varying language skills to talk about pictures in response to prompts .


PGU scores were computed for each of two @-picture sets and for the full set of @ pictures .


PGU scores for the two @-picture sets did not differ significantly from , and were highly correlated with , PGU scores for the full set and with each other .


Agreement for making pass-fail decisions between each @-picture set and the full set and between the two @-picture sets ranged from @ % to @ % .


The current study suggests that the PGU measure is robust enough that it can be computed on the basis of @ , at least in @-year-old children whose language samples were elicited using similar procedures .


This was a prospective randomized single-blinded clinical trial comparing the glottic views obtained during direct laryngoscopy between the ` sniffing the morning air ' position and simple head extension .


A sample of @ patients , aged @ to @ years old with ASA physical status I or II , scheduled for elective surgery under general anesthesia with endotracheal intubation , were randomized into @ groups .


Group A used the sniffing position during the first laryngoscopy while Group B was put in simple head extension position .


Positions were then interchanged for the second laryngoscopy .


Sniffing position was obtained by placing a @ cm height non-compressible cushion under the patient 's head .


In simple head extension , patient 's head was placed flat .


Glottic visualization was assessed based on the Cormack & Lehane scale .


Intubation was performed after second laryngoscopy and success rate of first attempt intubation was compared .


The distribution of patients with different Cormack & Lehane scores between the two intubation positions were significantly different ( p < @ ) .


Changing over to the ` Sniffing position ' resulted in improvement of the Cormack & Lehane scores in @ ( @ % ) patients , no change in @ ( @ % ) or worsening in @ ( @ % ) patients .


Successful intubation at first attempt was better ( p < @ ) with Group A : @ ( @ % ) while Group B : @ ( @ % ) .


Sniffing position provided better glottic visualization score and increased the successful rate of intubation as compared to simple head extension .


Many risks of death in childhood bacterial meningitis are well-identified , but factors influencing survival time have received less attention .


Better understanding of this issue could help explain why adjuvant medications have performed unevenly in different trials .


In a post hoc analysis of prospectively collected data from a large bacterial meningitis treatment trial in Luanda , Angola , we compared time to death after initiation of antimicrobial treatment among @ children with etiology and other patient characteristics .


The risks of dying very quickly ( @-@ hours ) , quickly ( @-@ hours ) or after longer periods were analyzed by logistic regression .


Median time to death was @ hours , half the time in Streptococcus pneumoniae ( @ hours ) compared with Haemophilus influenzae ( @ hours ) meningitis .


Of all deaths caused by pneumococcal or H.influenzae meningitis , @ % versus @ % , respectively , occurred within the first @ hours .


In addition , patients who succumbed within @ hours , unlike those dying later , had a short disease history , shock , hypoglycemia and poor cerebrospinal fluid white cell response .


Time to death in Angola is so short that hardly anything , except perhaps modern intensive care , is likely to improve outcome in a patient with meningitis , especially the pneumococcal disease .


Quadrivalent human papillomavirus ( HPV ) vaccine , for protection against sexually transmitted HPV infection , is licensed for females and males @-@ years on a @-dose schedule ( @ , @ , and @ months ; Standard schedule ) .


Vaccine uptake has been low and catch-up vaccination of older adolescents using an alternate dosing schedule may increase coverage .


This study tested the non-inferiority of the immunogenicity of an alternate dosing schedule ( @ , @ , @ months ) among college age males .


@ @-@ year old males were randomly assigned to Standard or Alternate schedules .


Blood samples were drawn immediately before Dose @ and @-@ weeks after Dose @ and analyzed for antibody titers using a Luminex immunoassay .


A value < @ for the upper @ % confidence interval ( CI ) bound of the Standard to Alternate schedule geometric mean titer ( GMT ) ratio was deemed non-inferior .


Participants averaged @ years old ; @ % were non-white ; completion rate was @ % .


The anti-HPV titers for the Alternate schedule group were non-inferior to those of Standard schedule group for all four HPV vaccine virus types .


Our results also demonstrated superiority of the Alternate schedule group for all four HPV vaccine virus types .


A delayed third dose at @ months is immunologically non-inferior and superior for four HPV virus types .


Using an alternate dosing schedule offers more flexibility to receive the @-dose HPV vaccine and may result in higher vaccination rates among college-age males .


Various hospital accreditation and quality assurance entities in the United States have approved and endorsed performance measures promoting alcohol brief intervention ( BI ) for hospitalized individuals who screen positive for unhealthy alcohol use , the spectrum of use ranging from hazardous use to alcohol use disorders .


These performance measures have been controversial due to the limited and equivocal evidence for the efficacy of BI among hospitalized individuals .


The few BI trials conducted with hospital inpatients vary widely in methodological quality .


While the majority of these studies indicate limited to no effects of BI in this population , none have been designed to account for the most pervasive methodological issue in BI studies presumed to drive study findings towards the null : assessment reactivity ( AR ) .


This is a three-arm , single-site , randomized controlled trial of BI for hospitalized patients at a large academic medical center affiliated with the U.S. Department of Veterans Affairs who use alcohol at hazardous levels but do not have an alcohol use disorder .


Participants are randomized to one of three study conditions .


Study Arm @ receives a three-part alcohol BI .


Study Arm @ receives attention control .


To account for potential AR , Study Arm @ receives AC with limited assessment .


Primary outcomes will include the number of standard drinks/week and binge drinking episodes reported in the @-day period prior to a final measurement visit obtained @ months after hospital discharge .


Additional outcomes will include readiness to change drinking behavior and number of adverse consequences of alcohol use .


To assess differences in primary outcomes across the three arms , we will use mixed-effects regression models that account for a patient 's repeated measures over the timepoints and clustering within medical units .


Intervention implementation will be assessed by : a ) review of intervention audio recordings to characterize barriers to intervention fidelity ; and b ) feasibility of participant recruitment , enrollment , and follow-up .


The results of this methodologically rigorous trial will provide greater justification for or against the use of BI performance measures in the inpatient setting and inform organizational responses to BI-related hospital accreditation and performance measures .


Although brief intervention is effective for reducing problem alcohol use , few data exist on its effectiveness for reducing problem drug use , a common issue in disadvantaged populations seeking care in safety-net medical settings ( hospitals and community health clinics serving low-income patients with limited or no insurance ) .


To determine whether brief intervention improves drug use outcomes compared with enhanced care as usual .


A randomized clinical trial with blinded assessments at baseline and at @ , @ , @ , and @ months conducted in @ safety-net primary care clinics in Washington State .


Of @ eligible patients reporting any problem drug use in the past @ days , @ consented and were randomized between April @ and September @ .


Follow-up participation was more than @ % at all points .


Participants received a single brief intervention using motivational interviewing , a handout and list of substance abuse resources , and an attempted @-minute telephone booster within @ weeks ( n = @ ) or enhanced care as usual , which included a handout and list of substance abuse resources ( n = @ ) .


The primary outcomes were self-reported days of problem drug use in the past @ days and Addiction Severity Index-Lite ( ASI ) Drug Use composite score .


Secondary outcomes were admission to substance abuse treatment ; ASI composite scores for medical , psychiatric , social , and legal domains ; emergency department and inpatient hospital admissions , arrests , mortality , and human immunodeficiency virus risk behavior .


Mean days used of the most common problem drug at baseline were @ ( SD , @ ) ( brief intervention ) and @ ( SD , @ ) ( enhanced care as usual ) ; at @ months postintervention , means were @ ( SD , @ ) ( brief intervention ) and @ ( SD , @ ) ( enhanced care as usual ) and not significantly different ( difference in differences , = @ -LSB- @ % CI , -@ to @ -RSB- ) .


Mean ASI Drug Use composite score at baseline was @ ( SD , @ ) ( brief intervention ) and @ ( SD , @ ) ( enhanced care as usual ) and at @ months was @ ( SD , @ ) ( brief intervention ) and @ ( SD , @ ) ( enhanced care as usual ) and not significantly different ( difference in differences , = @ -LSB- @ % CI , -@ to @ -RSB- ) .


During the @ months following intervention , no significant treatment differences were found for either variable .


No significant differences were found for secondary outcomes .


A one-time brief intervention with attempted telephone booster had no effect on drug use in patients seen in safety-net primary care settings .


This finding suggests a need for caution in promoting widespread adoption of this intervention for drug use in primary care .


An equivalence randomized controlled trial within the subject was organized to evaluate the clinical long-term success of a new @-step etch & rinse adhesive and a new nano-filled ormocer .


@ subjects , @ males and @ females aged between @ and @ , were randomized to receive @ restorations , @ with the new restorative material , @ with the composite as control , placed in non-carious cervical lesions with the same bonding system .


The main outcome measure was the cause of failure at @ years .


Randomization was number table-generated , with allocation concealment by opaque sequentially numbered sealed and stapled envelopes .


Subjects , examiner , and analyst were blinded to group assignment .


Two interim analyses were performed .


Data were analyzed by ANOVA and Cox test ( P < @ ) .


After @ years , @ subjects and @ teeth were included in the analysis of the primary outcome .


There were eight failures in the experimental group and four failures in the control group .


The cumulative loss rate was @ % for both restorative materials , with the annual failure lower than @ % , without any statistically significant difference .


There were two key elements of failure : the presence of sclerotic dentin and the relationship between lesion and gingival margin .


The therapeutic and economic benefits of continuous positive airway pressure ( CPAP ) for moderate to severe obstructive sleep apnoea ( OSA ) syndrome have been established in middle-aged people ; however , the benefits in older people are unknown .


This trial was designed to address this evidence gap .


This @-month , multicentre , randomised trial enrolled patients across @ National Health Service sleep centres in the UK .


Consecutive patients aged @ years or older with newly diagnosed OSA syndrome were eligible to join the trial .


Patients were randomly assigned ( @:@ ) into parallel groups to receive either CPAP with best supportive care ( BSC ) or BSC alone for @ months .


Randomisation was done by the Medical Research Council Clinical Trials Unit with computer-generated randomisation .


The main investigator at each centre was masked to the trial randomisation .


Coprimary endpoints were Epworth sleepiness score ( ESS ) at @ months and cost-effectiveness over the @-month trial period .


Secondary outcomes were subjective sleepiness at @ months , plus objective sleepiness , quality of life , mood , functionality , nocturia , mobility , accidents , cognitive function , and cardiovascular risk factors and events at @ months and @ months .


The analysis was by intention to treat .


This study is registered as an International Standard Randomised Controlled Trial , number ISRCTN@ .


Between Feb @ , @ , and May @ , @ , @ patients were randomly assigned to the trial , of whom @ ( @ % ) completed the trial .


@ patients were allocated to and received CPAP plus BSC and @ were allocated to and received BSC only .


CPAP reduced ESS by @ points ( @ % CI -@ to -@ ; p < @ ) at @ months for @ ( @ % ) of @ patients compared with @ ( @ % ) of @ patients given BSC , and by @ points ( -@ to -@ ; p < @ ) at @ months for @ patients compared with @ patients given BSC .


The effect was greater in patients with higher CPAP usage or higher baseline ESS .


Quality-adjusted life-years were similar between the groups ( treatment effect @ ( @ % CI -@ to @ ; p = @ ) and health-care costs were marginally reduced with CPAP ( -@ , -@ to @ ; p = @ ) .


CPAP improved objective sleepiness ( p = @ ) , mobility ( p = @ ) , total cholesterol ( p = @ ) , and LDL cholesterol ( p = @ ) at @ months , but these were not sustained at @ months .


Measures of mood , functionality , nocturia , accidents , cognitive function , and cardiovascular events remained unchanged .


Systolic blood pressure fell in the BSC group .


@ serious adverse events occurred in the CPAP group , and @ in BSC group ; all were independently classified as being unrelated to the trial and no significant harm was attributed to CPAP use .


In older people with OSA syndrome , CPAP reduces sleepiness and is marginally more cost effective over @ months than is BSC alone .


On the basis of these results , we recommend that CPAP treatment should be offered routinely to older patients with OSA syndrome .


During lower limb lengthening , poor bone regeneration is a devastating complication .


Several local or systemic applications have been used to promote osteogenesis , and biologic stimulations are gaining attention , but their utility has not been proven in this setting .


In patients undergoing bilateral tibial lengthening , we compared those receiving an osteotomy site injection of autologous bone marrow aspirate concentrate ( BMAC ) plus platelet-rich plasma ( PRP ) with those not receiving such an injection in terms of external fixator index ( time in external fixation divided by amount of lengthening ) , full weightbearing index ( time until a patient was permitted to do full weightbearing divided by amount of lengthening ) , four cortical healing indexes ( time until each cortical union divided by amount of lengthening ) , and callus shape and type .


Twenty-two patients ( @ tibias ) undergoing bilateral tibial lengthening enrolled in this randomized trial .


Two patients were excluded , one due to insufficient radiographic evaluation and one who was lost to followup , leaving @ patients ( @ segments ) for inclusion .


Ten patients ( @ segments ) received BMAC combined with PRP injection ( treatment group ) and @ patients ( @ segments ) received no injection ( control group ) .


All patients underwent stature lengthening for familial short stature with the lengthening over nail technique .


Autologous BMAC combined with PRP was injected at the tibial osteotomy site at the end of the index surgery .


Mean distraction rates were similar between groups ( @ mm/day in the treatment group versus @ mm/day in the control group ; p = @ ) .


Full weightbearing was permitted when we observed radiographic evidence of healing at two cortices ; this assessment was made by the surgeon who was blinded to the treatment each patient received .


Minimum followup was @ months ( mean , @ months ; range , @-@ months ) .


There was no difference in mean external fixator index between groups .


However , mean cortical healing indexes ( anterior/posterior/medial / lateral ) were @ / @ / @ / @ months/cm in the treatment group and @ / @ / @ / @ months/cm in the control group ( all p < @ ) , showing faster healing in the treatment group at each cortex .


Full weightbearing was permitted earlier in the treatment group than in the control group ( index : @ months/cm and @ months/cm , respectively , p < @ ) .


Callus shape and type were not different between groups .


Autologous BMAC combined with PRP injection at the osteotomy site helped improve bone healing in distraction osteogenesis of the tibia , although the effect size was small .


Level I , therapeutic study .


See Instructions for Authors for a complete description of levels of evidence .


We determined the effectiveness of primary care-based , and pre - and postnatal interventions to increase breastfeeding .


We conducted @ trials at obstetrics and gynecology practices in the Bronx , New York , from @ to @ .


The Provider Approaches to Improved Rates of Infant Nutrition & Growth Study ( PAIRINGS ) had @ arms : usual care versus pre - and postnatal visits with a lactation consultant ( LC ) and electronically prompted guidance from prenatal care providers ( EP ) .


The Best Infant Nutrition for Good Outcomes ( BINGO ) study had @ arms : usual care , LC alone , EP alone , or LC+EP .


In BINGO at @ months , high intensity was greater for the LC+EP ( odds ratio -LSB- OR -RSB- = @ ; @ % confidence interval -LSB- CI -RSB- = @ , @ ) and LC ( OR = @ ; @ % CI = @ , @ ) groups versus usual care , but not for the EP group alone .


In PAIRINGS at @ months , intervention rates exceeded usual care ( OR = @ ; @ % CI = @ , @ ) ; the number needed to treat to prevent @ dyad from nonexclusive breastfeeding at @ months was @ ( @ % CI = @ , @ ) .


LCs integrated into routine care alone and combined with EP guidance from prenatal care providers increased breastfeeding intensity at @ months postpartum .


Recurrent aphthous stomatitis ( RAS ) is the most common oral mucosal disease .


However , the available therapies for RAS only relieve symptoms and do not provide a cure .


This study assessed the response to treatment with levamisole and low-dose prednisolone drug combination in patients with RAS .


Fifty RAS subjects were enrolled in the single-blind randomized placebo-controlled trial .


Study medications were administered thrice daily for @ consecutive days/week for @ consecutive weeks .


Patients in Group @ received placebo , Group @ received levamisole ( @ mg ) and Group @ received levamisole ( @ mg ) and low-dose prednisolone ( @ mg ) .


Patients were followed up for @ days after treatment .


Response to treatment was assessed using the following clinical parameters : pain due to ulcers , number of ulcers/episode , size of ulcers , duration of ulcers , and frequency of ulcers ( episodes/month ) .


MannWhitney U-test .


A statistically significant improvement was noted in all parameters except for the size of ulcers in patients treated with levamisole alone and with combination of levamisole and low-dose prednisolone .


There was no statistically significant improvement in the placebo group .


Both active groups had significantly better improvement when compared to placebo group , while there was no significant difference between the two active groups .


Levamisole alone and combination of levamisole and low-dose prednisolone are effective modes of therapy for RAS .


Substance use disorder ( SUD ) is a major health issue , especially among military veterans .


We previously reported the effects of auricular acupuncture and the relaxation response ( RR ) on reducing craving and anxiety following @-week interventions among veterans who were in recovery from SUDs .


Our current analysis examines effects following each intervention session and RR daily practice .


We conducted a three-arm randomized controlled trial on residents of a homeless veteran rehabilitation program .


Sixty-Seven enroled participants were randomly assigned to acupuncture ( n = @ ) , RR ( n = @ ) , or usual care ( n = @ ) .


Participants in the two intervention groups rated their degree of craving for substance on a scale of @-@ and anxiety levels on a scale of @-@ ( total score @-@ ) before and after each intervention session .


Mixed effects regression models were used for analysis .


Craving and anxiety levels decreased significantly following one session of acupuncture ( -@ , p = @ ; -@ , p < @ ) or RR intervention ( -@ , p = @ ; -@ , p = @ ) .


The level of craving continued to drop with additional intervention sessions ( regression coefficient b = -@ , p = @ , and b = -@ , p = @ for acupuncture and RR groups , respectively ) .


Number of daily practice days of RR-eliciting techniques is also associated with reduction in craving ratings ( b = -@ , p = @ ) .


Findings demonstrate the value of attending regular acupuncture and RR-eliciting intervention sessions , as well as the daily practice of RR-eliciting techniques .


Substance addiction is a complex disease and effective treatment remains a challenge .


Our study findings add to the scientific evidence of these two non-pharmaceutical approaches for SUD .


An estimated @ million people have symptomatic dengue infection every year .


This is the first report of a phase @ vaccine efficacy trial of a candidate dengue vaccine .


We aimed to assess the efficacy of the CYD dengue vaccine against symptomatic , virologically confirmed dengue in children .


We did an observer-masked , randomised controlled , multicentre , phase @ trial in five countries in the Asia-Pacific region .


Between June @ , and Dec @ , @ , healthy children aged @-@ years were randomly assigned ( @:@ ) , by computer-generated permuted blocks of six with an interactive voice or web response system , to receive three injections of a recombinant , live , attenuated , tetravalent dengue vaccine ( CYD-TDV ) , or placebo , at months @ , @ , and @ .


Randomisation was stratified by age and site .


Participants were followed up until month @ .


Trial staff responsible for the preparation and administration of injections were unmasked to group allocation , but were not included in the follow-up of the participants ; allocation was concealed from the study sponsor , investigators , and parents and guardians .


Our primary objective was to assess protective efficacy against symptomatic , virologically confirmed dengue , irrespective of disease severity or serotype , that took place more than @ days after the third injection .


The primary endpoint was for the lower bound of the @ % CI of vaccine efficacy to be greater than @ % .


Analysis was by intention to treat and per procotol .


This trial is registered with ClinicalTrials.gov , number NCT@ .


We randomly assigned @,@ children to receive either vaccine ( n = @ ) or placebo ( n = @ ) , of whom @ ( @ % ) and @ ( @ % ) , respectively , were included in the primary analysis .


@ cases of virologically confirmed dengue took place more than @ days after the third injection ( @ -LSB- @ % -RSB- in the vaccine group and @ -LSB- @ % -RSB- in the control group ) .


The primary endpoint was achieved with @ % ( @ % CI @-@ ) efficacy .


We recorded @ serious adverse events ( @ -LSB- @ % -RSB- in the vaccine group and @ -LSB- @ % -RSB- in the control group ) .


@ ( @ % ) children in the vaccine group and @ ( @ % ) of those in the control group had serious adverse events that happened within @ days of vaccination .


Serious adverse events were consistent with medical disorders in this age group and were mainly infections and injuries .


Our findings show that dengue vaccine is efficacious when given as three injections at months @ , @ , and @ to children aged @-@ years in endemic areas in Asia , and has a good safety profile .


Vaccination could reduce the incidence of symptomatic infection and hospital admission and has the potential to provide an important public health benefit .


This study aimed @ ) to quantify the strength of patient preferences for different aspects of early assisted discharge in The Netherlands for patients who were admitted with a chronic obstructive pulmonary disease exacerbation and @ ) to illustrate the benefits of latent class modeling of discrete choice data .


This technique is rarely used in health economics .


Respondents made multiple choices between hospital treatment as usual ( @ days ) and two combinations of hospital admission ( @ days ) followed by treatment at home .


The latter was described by a set of attributes .


Hospital treatment was constant across choice sets .


Respondents were patients with chronic obstructive pulmonary disease in a randomized controlled trial investigating the cost-effectiveness of early assisted discharge and their informal caregivers .


The data were analyzed using mixed logit , generalized multinomial logit , and latent-class conditional logit regression .


These methods allow for heterogeneous preferences across groups , but in different ways .


Twenty-five percent of the respondents opted for hospital treatment regardless of the description of the early assisted discharge program , and @ % never opted for the hospital .


The best model contained four latent classes of respondents , defined by different preferences for the hospital and caregiver burden .


Preferences for other attributes were constant across classes .


Attributes with the strongest effect on choices were the burden on informal caregivers and co-payments .


Except for the number of visits , all attributes had a significant effect on choices in the expected direction .


Considerable segments of respondents had fixed preferences for either treatment option .


Applying latent class analysis was essential in quantifying preferences for attributes of early assisted discharge .


Polio eradication remains a challenge in Pakistan and the causes for the failure to eradicate poliomyelitis are complex .


Undernutrition and micronutrient deficiencies , especially zinc deficiency , are major public health problems in Pakistan and could potentially affect the response to enteric vaccines , including oral poliovirus vaccine ( OPV ) .


To assess the impact of zinc supplementation among infants on immune response to oral poliovirus vaccine ( OPV ) .


A double-blind , randomized placebo-controlled trial was conducted in newborns ( aged @-@ days ) .


Subjects were assigned to either receive @mg of zinc or placebo supplementation daily for @ weeks .


Both groups received OPV doses at birth , at @ weeks , @ weeks and @ weeks .


Data was collected on prior immunization status , diarrheal episodes , breastfeeding practices and anthropometric measurements at recruitment and at @ and @ weeks .


Blood samples were similarly collected to determine the antibody response to OPV and for micronutrient analysis .


Logistic regression was used to determine the relationship between seroconversion and zinc status .


Overall , @ subjects were recruited .


At recruitment , seropositivity was already high for poliovirus ( PV ) serotype @ ( zinc : @ % ; control : @ % ) and PV@ ( @ % ; @ % ) , with lower estimates for PV@ ( @ % ; @ % ) .


By week @ , the proportion of subjects with measured zinc levels in the normal range ( i.e. @ g/dL ) was significantly greater in the intervention group compared to the control group ( @ % ; @ % ; p < @ ) .


No significant difference in seroconversion was demonstrated between the groups for PV@ , PV@ , or PV@ .


There was no effect of zinc supplementation on OPV immunogenicity .


These conclusions were confirmed when restricting the analysis to those with measured higher zinc levels .


To evaluate the efficacy and safety of tacrolimus mouth rinse on the treatment of erosive and ulcerative oral lichen planus ( OLP ) .


A randomized single-blind open trial of tacrolimus mouth rinse with dexamethasone as control was designed .


The VAS and REU scoring system was utilized to compare the signs and symptoms .


The scores and therapeutic effects were analyzed with SPSS @ software package .


There was no significant difference in effective rate between the treatment group and control group ( X ( @ ) = @,@ , P > @ ) at @-week and @-week after treatment .


There was significant difference in REU scores between the @ groups ( P < @ ) @ weeks after treatment .


Tacrolimus mouth rinse effects quickly and is worthy of application in the treatment of erosive and ulcerative OLP .


This double-blind sham-controlled crossover study investigated the interactions between primary sensory and motor cortex after stroke and their response to Theta Burst Stimulation ( TBS ) .


Thirteen chronic subcortical stroke patients with upper limb impairment performed standardised dexterity training primed with ipsilesional M@ intermittent TBS ( iTBSiM@ ) , contralesional M@ continuous TBS ( cTBScM@ ) or sham TBS .


The effects on sensorimotor integration , corticomotor excitability , sensation and grip-lift kinetics were examined .


After iTBSiM@ , improvements in paretic grip-lift performance were accompanied by an immediate facilitation of ipsilesional M@ excitability and a subsequent increase in ipsilesional short latency afferent inhibition ( SAI ) during training .


Precision grip-lift performance improved after cTBScM@ and training , alongside increased ipsilesional M@ excitability with no effect on ipsilesional SAI .


There were no effects on sensory performance .


Primary motor cortex iTBS not only modulates M@ corticospinal excitability but also increases M@ receptiveness to sensory input .


Priming with iTBSiM@ may enhance ipsilesional sensorimotor integration and facilitate better quality sensorimotor training after subcortical stroke .


To evaluate the analgesic effect of pregabalin combined with intrathecal sufentanil infusion for the treatment of breakthrough pain in patients with bone metastases .


A total of @ breakthrough pain patients with bone metastases were randomly divided to @ groups : group A ( pregabalin combined with intrathecal sufentanil infusion group , n = @ ) , group B ( placebo combined with intrathecal sufentanil infusion group , n = @ ) and group C ( oral morphine sulfate controlled-release tablet group , n = @ ) .


The differences in visual analogue scale ( VAS ) between background pain and breakthrough pain , the seizure frequency of breakthrough pain , general satisfaction and side effects of the @ groups were observed .


The seizure frequency and VAS of breakthrough pain in group A decreased significantly after the treatment ( P < @ ) and the general satisfaction was the best among the the @ groups ( P < @ ) , with less nausea and vomiting , constipation , drowsiness and fewer other side effects .


Pregabalin combined with intrathecal sufentanil infusion can effectively relieve breakthrough pain in patients with bone metastases .


Durability of good glycaemic control ( HbA@c ) is of importance as it can be the foundation for delaying diabetic complications .


It has been hypothesized that early initiation of treatment with the combination of oral anti-diabetes agents with complementary mechanisms of action can increase the durability of glycaemic control compared with metformin monotherapy followed by a stepwise addition of oral agents .


Dipeptidyl peptidase-@ inhibitors are good candidates for early use as they are efficacious in combination with metformin , show weight neutrality and a low risk of hypoglycaemia .


We aimed to test the hypothesis that early combined treatment of metformin and vildagliptin slows - cell deterioration as measured by HbA@c .


Approximately @ people with Type @ diabetes mellitus who were drug-naive or who were treated with metformin for less than @ month , and who have HbA@c of @-@ mmol/mol ( @-@ @ % ) , will be randomized in a @:@ ratio in VERIFY , a @-year multinational , double-blind , parallel-group study designed to compare early initiation of a vildagliptin-metformin combination with standard-of-care initiation of metformin monotherapy , followed by the stepwise addition of vildagliptin when glycaemia deteriorates .


Further deterioration will be treated with insulin .


The primary analysis for treatment failure will be from a Cox proportional hazard regression model and the durability of glycaemic control will be evaluated by assessing treatment failure rate and the rate of loss in glycaemic control over time as co-primary endpoints .


VERIFY is the first study to investigate the long-term clinical benefits of early combination treatment vs. the standard-of-care metformin monotherapy with a second agent added by threshold criteria .


To determine the effects of participation in a @-year community-based dance class on disease severity and functional mobility in people with Parkinson disease ( PD ) .


Randomized controlled trial .


Dance classes took place in a community-based location .


Outcome measures were collected in a university laboratory .


Ten individuals with PD were randomly assigned to the Argentine tango ( AT ) group ( n = @ -LSB- @ men -RSB- ; mean agestandard deviation , @ years ) or the control group ( n = @ -LSB- @ men -RSB- ; mean agestandard deviation , @ years ) .


The AT group participated in a community-based AT class for @ hour twice weekly for @ years .


Control group participants were given no prescribed exercise .


Blinded assessments occurred at baseline and @ and @ months .


Movement Disorder Society-Unified Parkinson Disease Rating Scale ( MDS-UPDRS ) III , Mini-Balance Evaluation Systems Test ( Mini-BESTest ) , gait velocity ( forward and backward ) , Timed Up and Go and dual-task Timed Up and Go , Six-Minute Walk Test ( @MWT ) , MDS-UPDRS II , MDS-UPDRS I , and Freezing of Gait Questionnaire .


There were no differences between groups at baseline .


A significant group-by-time interaction ( F -LSB- @,@ -RSB- = @ ; p < @ ) was noted for the MDS-UPDRS III , with the AT group having lower scores at @ and @ months than the controls .


Significant interactions were also noted for the Mini-BESTest , MDS-UPDRS II and I , and @MWT .


This is believed to be one of the longest-duration studies to examine the effects of exercise on PD .


Participation in community-based dance classes over @ years was associated with improvements in motor and nonmotor symptom severity , performance on activities of daily living , and balance in a small group of people with PD .


This is noteworthy given the progressive nature of PD and the fact that the control group declined on some outcome measures over @ years .


Falls are the most frequent adverse events that are reported in hospitals .


We examined the effectiveness of individualised falls-prevention education for patients , supported by training and feedback for staff , delivered as a ward-level programme .


Eight rehabilitation units in general hospitals in Australia participated in this stepped-wedge , cluster-randomised study , undertaken during a @ week period .


Units were randomly assigned to intervention or control groups by use of computer-generated , random allocation sequences .


We included patients admitted to the unit during the study with a Mini-Mental State Examination ( MMSE ) score of more than @/@ to receive individualised education that was based on principles of changes in health behaviour from a trained health professional , in addition to usual care .


We provided information about patients ' goals , feedback about the ward environment , and perceived barriers to engagement in falls-prevention strategies to staff who were trained to support the uptake of strategies by patients .